percutaneous technologies to correct tr : myth or … a...pasp, lvef, ivc size, rv size/ function,...

42
Percutaneous technologies to correct TR : Myth or Reality ? Steven F. Bolling , M.D. Professor of Cardiac Surgery University of Michigan

Upload: others

Post on 19-Apr-2020

1 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: Percutaneous technologies to correct TR : Myth or … A...PASP, LVEF, IVC size, RV size/ function, 5223 pts Severe and MODERATE TR decreases survival Having TR is BAD ! Topilsky. JACC

Percutaneous technologies to correct TR

Myth or Reality

Steven F Bolling MD

Professor of Cardiac Surgery

University of Michigan

Disclosures

bull Ownership Interest Millipede and Pipeline

TR is BADDecreased CO

Fatigue decreased exercise tolerance

ldquoRight-sidedrdquo Heart Failure

Ascites edema decreased appetite fullness

FTR - feel terrible

Valve repair for functional tricuspid valve regurgitation

anatomical and surgical considerations

Rogers JH Bolling SF Semin Thorac Cardiovasc Surg 2010 22(1)84-9

FTR increases Mortality

Nath JACC 200443405

Severe and MODERATE TR increase mortality

independent of PASP LVEF IVC size RV size function 5223 pts

Severe and MODERATE TR decreases survival

Having TR is BAD

Topilsky JACC 2014

TR after MitraClip for FMR

More TR at baseline - worse outcome

Moderate or Severe TR is BAD

hellipeven percutaneously

Ohno et al EHJ 2014151246

TR SeverityDeathRehosp

FTR Reality

Mod severe TR - BAD

Pathophysiology of Functional Secondary TR

What size

NORMAL TRICUSPID ANNULAR DIMENSION

28 + 05 cm Sugimoto T J Thorac Cardiovasc Surg 1999117463-71

Late TR after Functional MR Surgery

More TR with TV annulus size

Matsunaga Duran Circulation 2005

FTR Reality

Mod severe TR - Bad

Dilated annulus - Bad

Dreyfus Annals of Thoracic Surgery 2005

Tricuspid Valve Repair- Does it matter

matter

311 Patients MV Repair

Preop TR 07 ndash 09

93 notracemild

7 moderate

NONE Severe

TR Does Not Just ldquoGo Awayrdquo After MVr

311 undergoing MVr mostly degenerative all with dilated TV annulus

Dreyfus Ann Thorac Surg 200579127

0

10

20

30

40

50

60

TR Worsening by gt 2 Grades

MVR only

48

MVR+TVR

2

Plt0001

ldquoUndersizedrdquo TV repair for FTR

Actually Re-NORMAL size

TR Grade

Preoperative

Predischarge

Follow-up (mean = 1 yr)

None Mild Moderate Mod-to-Severe

Severe

None Mild Moderate Mod-to-Severe

Severe

None Mild Moderate Mod-to-Severe

Severe

ldquoUndersizedrdquo TV repair for FTR

Far less TR better RV

NO mortality or PPM

Outcomes of Guideline directed repair

of FTR performed during MV surgery

Ward Romano Bolling JTCVS 2018

262 pts TVr mod or lt mod TR 262830 ring

No mortality No TS RV improved

1 progression to severe TR

26 de novo PPM rate

FTR Reality

Modsevere TR - BAD

TR ring - GOOD

Gammie JS Annals of Thoracic Surgery 2009

Yilmaz J Thorac Cardiovasc Surg 2011142608

Matsuyama Ann Thorac Surg 2003751826

Do many patients have TR

STS Database 58000 Patients Isolated MR

Moderate TR 124

Severe TR 71

Moderate or Severe 195

Mayo 115699 16 ModSev TR

Matsuyama 46174 26 Mod + TR

Fukuda Circulation 2006114I-492

Normal Tricuspid Annulus Tricuspid Annulus with Functional TR

Annular Dilation Shape Change of FTR

75- all cases of MR

-40

-20

0

20

40

-40 -20 0 20 40

-40

-20

0

20

40

-40 -20 0 20 40

TR is ignored STS Database

MR + TR

Annual New MR

Annual MR Surgeries

Annual TR Surgeries

MR - 4000000

TR - 1600000250000

60000

7000 TVr

Why Not Fix TR at Surgery

bull 136 pts mostly TV repair

bull 8 yr follow up PPM in 21

I HATE PACEMAKERS

Tricuspid Repair Rate when fixing MR

Based on Preop TR Grade

139

39

79

0

20

40

60

80

100

Percent of Patients Having Tricuspid Repair

Preoperative TR Grade

None Mild Moderate Severe

Source STS Database N = 46500

V 273 2011-2013

FTR Reality

Modsevere TR - Bad

TR ring - Good

TVR - Sad

Percutaneous Implications for TR

FTR Percutaneous ldquoNotrdquo Rings

Tricuspid Regurgitation

4-TECH

Tricuspid Regurgitation

Mitralignhellip Trialign

FTR Perc McKay

FAILED

bull 4 pledgets

bull 2 Locks

bull Target Full Posterior Annulus

2 Pair

29

Pre Procedure Post 2nd PairPost 1st Pair

Perc DeVega

31

1214 patients received one pair of implants

Average annular reduction ndash 35

Average EROA reduction ndash 58

Adverse event ndash 1 access complication

0

5

10

15

20

25

Pre Procedure Post Procedure

Annular Area cm2

0

05

1

15

2

25

3

35

4

45

5

Pre Procedure Post Procedure

EROA cm2

10 cm2 15 cm2

Tricuspid Percutaneous - Myth

TR goal is different

TR grades 1- 4 andhellip

5+ ldquomassiverdquo

6+ ldquotorrentialrdquo

FTR Percutaneous ldquoother thingsrdquo

Remain calm

Carry on

FTR Surgery Percutaneous Implications

TV Perc

Rings

Tricuspid Regurgitation

Cardioband

36

Pre-op Echo 4+ MR 3-4+ TR

Millipede

Post MVR TVR Millipede FLUORO

37

24 month Post MVR TVR Millipede TTE

38

24 month Post MVR TVR Millipede TTE

39

Tricuspid Regurgitation - Reality

TR is BADldquoThe biology of TR will not change

with the method of therapyrdquo

A new grading method

will not ldquofoolrdquo nature

TR severity - reality

Sustained meaningful

reduction of TR

TR Percutaneous Myth and reality

Less impacthellipEarlier intervention

Best TR is zero

Good enough 1-2+TR

Reality Huge market - $$

Patients want ithellipit will happen

Page 2: Percutaneous technologies to correct TR : Myth or … A...PASP, LVEF, IVC size, RV size/ function, 5223 pts Severe and MODERATE TR decreases survival Having TR is BAD ! Topilsky. JACC

Disclosures

bull Ownership Interest Millipede and Pipeline

TR is BADDecreased CO

Fatigue decreased exercise tolerance

ldquoRight-sidedrdquo Heart Failure

Ascites edema decreased appetite fullness

FTR - feel terrible

Valve repair for functional tricuspid valve regurgitation

anatomical and surgical considerations

Rogers JH Bolling SF Semin Thorac Cardiovasc Surg 2010 22(1)84-9

FTR increases Mortality

Nath JACC 200443405

Severe and MODERATE TR increase mortality

independent of PASP LVEF IVC size RV size function 5223 pts

Severe and MODERATE TR decreases survival

Having TR is BAD

Topilsky JACC 2014

TR after MitraClip for FMR

More TR at baseline - worse outcome

Moderate or Severe TR is BAD

hellipeven percutaneously

Ohno et al EHJ 2014151246

TR SeverityDeathRehosp

FTR Reality

Mod severe TR - BAD

Pathophysiology of Functional Secondary TR

What size

NORMAL TRICUSPID ANNULAR DIMENSION

28 + 05 cm Sugimoto T J Thorac Cardiovasc Surg 1999117463-71

Late TR after Functional MR Surgery

More TR with TV annulus size

Matsunaga Duran Circulation 2005

FTR Reality

Mod severe TR - Bad

Dilated annulus - Bad

Dreyfus Annals of Thoracic Surgery 2005

Tricuspid Valve Repair- Does it matter

matter

311 Patients MV Repair

Preop TR 07 ndash 09

93 notracemild

7 moderate

NONE Severe

TR Does Not Just ldquoGo Awayrdquo After MVr

311 undergoing MVr mostly degenerative all with dilated TV annulus

Dreyfus Ann Thorac Surg 200579127

0

10

20

30

40

50

60

TR Worsening by gt 2 Grades

MVR only

48

MVR+TVR

2

Plt0001

ldquoUndersizedrdquo TV repair for FTR

Actually Re-NORMAL size

TR Grade

Preoperative

Predischarge

Follow-up (mean = 1 yr)

None Mild Moderate Mod-to-Severe

Severe

None Mild Moderate Mod-to-Severe

Severe

None Mild Moderate Mod-to-Severe

Severe

ldquoUndersizedrdquo TV repair for FTR

Far less TR better RV

NO mortality or PPM

Outcomes of Guideline directed repair

of FTR performed during MV surgery

Ward Romano Bolling JTCVS 2018

262 pts TVr mod or lt mod TR 262830 ring

No mortality No TS RV improved

1 progression to severe TR

26 de novo PPM rate

FTR Reality

Modsevere TR - BAD

TR ring - GOOD

Gammie JS Annals of Thoracic Surgery 2009

Yilmaz J Thorac Cardiovasc Surg 2011142608

Matsuyama Ann Thorac Surg 2003751826

Do many patients have TR

STS Database 58000 Patients Isolated MR

Moderate TR 124

Severe TR 71

Moderate or Severe 195

Mayo 115699 16 ModSev TR

Matsuyama 46174 26 Mod + TR

Fukuda Circulation 2006114I-492

Normal Tricuspid Annulus Tricuspid Annulus with Functional TR

Annular Dilation Shape Change of FTR

75- all cases of MR

-40

-20

0

20

40

-40 -20 0 20 40

-40

-20

0

20

40

-40 -20 0 20 40

TR is ignored STS Database

MR + TR

Annual New MR

Annual MR Surgeries

Annual TR Surgeries

MR - 4000000

TR - 1600000250000

60000

7000 TVr

Why Not Fix TR at Surgery

bull 136 pts mostly TV repair

bull 8 yr follow up PPM in 21

I HATE PACEMAKERS

Tricuspid Repair Rate when fixing MR

Based on Preop TR Grade

139

39

79

0

20

40

60

80

100

Percent of Patients Having Tricuspid Repair

Preoperative TR Grade

None Mild Moderate Severe

Source STS Database N = 46500

V 273 2011-2013

FTR Reality

Modsevere TR - Bad

TR ring - Good

TVR - Sad

Percutaneous Implications for TR

FTR Percutaneous ldquoNotrdquo Rings

Tricuspid Regurgitation

4-TECH

Tricuspid Regurgitation

Mitralignhellip Trialign

FTR Perc McKay

FAILED

bull 4 pledgets

bull 2 Locks

bull Target Full Posterior Annulus

2 Pair

29

Pre Procedure Post 2nd PairPost 1st Pair

Perc DeVega

31

1214 patients received one pair of implants

Average annular reduction ndash 35

Average EROA reduction ndash 58

Adverse event ndash 1 access complication

0

5

10

15

20

25

Pre Procedure Post Procedure

Annular Area cm2

0

05

1

15

2

25

3

35

4

45

5

Pre Procedure Post Procedure

EROA cm2

10 cm2 15 cm2

Tricuspid Percutaneous - Myth

TR goal is different

TR grades 1- 4 andhellip

5+ ldquomassiverdquo

6+ ldquotorrentialrdquo

FTR Percutaneous ldquoother thingsrdquo

Remain calm

Carry on

FTR Surgery Percutaneous Implications

TV Perc

Rings

Tricuspid Regurgitation

Cardioband

36

Pre-op Echo 4+ MR 3-4+ TR

Millipede

Post MVR TVR Millipede FLUORO

37

24 month Post MVR TVR Millipede TTE

38

24 month Post MVR TVR Millipede TTE

39

Tricuspid Regurgitation - Reality

TR is BADldquoThe biology of TR will not change

with the method of therapyrdquo

A new grading method

will not ldquofoolrdquo nature

TR severity - reality

Sustained meaningful

reduction of TR

TR Percutaneous Myth and reality

Less impacthellipEarlier intervention

Best TR is zero

Good enough 1-2+TR

Reality Huge market - $$

Patients want ithellipit will happen

Page 3: Percutaneous technologies to correct TR : Myth or … A...PASP, LVEF, IVC size, RV size/ function, 5223 pts Severe and MODERATE TR decreases survival Having TR is BAD ! Topilsky. JACC

TR is BADDecreased CO

Fatigue decreased exercise tolerance

ldquoRight-sidedrdquo Heart Failure

Ascites edema decreased appetite fullness

FTR - feel terrible

Valve repair for functional tricuspid valve regurgitation

anatomical and surgical considerations

Rogers JH Bolling SF Semin Thorac Cardiovasc Surg 2010 22(1)84-9

FTR increases Mortality

Nath JACC 200443405

Severe and MODERATE TR increase mortality

independent of PASP LVEF IVC size RV size function 5223 pts

Severe and MODERATE TR decreases survival

Having TR is BAD

Topilsky JACC 2014

TR after MitraClip for FMR

More TR at baseline - worse outcome

Moderate or Severe TR is BAD

hellipeven percutaneously

Ohno et al EHJ 2014151246

TR SeverityDeathRehosp

FTR Reality

Mod severe TR - BAD

Pathophysiology of Functional Secondary TR

What size

NORMAL TRICUSPID ANNULAR DIMENSION

28 + 05 cm Sugimoto T J Thorac Cardiovasc Surg 1999117463-71

Late TR after Functional MR Surgery

More TR with TV annulus size

Matsunaga Duran Circulation 2005

FTR Reality

Mod severe TR - Bad

Dilated annulus - Bad

Dreyfus Annals of Thoracic Surgery 2005

Tricuspid Valve Repair- Does it matter

matter

311 Patients MV Repair

Preop TR 07 ndash 09

93 notracemild

7 moderate

NONE Severe

TR Does Not Just ldquoGo Awayrdquo After MVr

311 undergoing MVr mostly degenerative all with dilated TV annulus

Dreyfus Ann Thorac Surg 200579127

0

10

20

30

40

50

60

TR Worsening by gt 2 Grades

MVR only

48

MVR+TVR

2

Plt0001

ldquoUndersizedrdquo TV repair for FTR

Actually Re-NORMAL size

TR Grade

Preoperative

Predischarge

Follow-up (mean = 1 yr)

None Mild Moderate Mod-to-Severe

Severe

None Mild Moderate Mod-to-Severe

Severe

None Mild Moderate Mod-to-Severe

Severe

ldquoUndersizedrdquo TV repair for FTR

Far less TR better RV

NO mortality or PPM

Outcomes of Guideline directed repair

of FTR performed during MV surgery

Ward Romano Bolling JTCVS 2018

262 pts TVr mod or lt mod TR 262830 ring

No mortality No TS RV improved

1 progression to severe TR

26 de novo PPM rate

FTR Reality

Modsevere TR - BAD

TR ring - GOOD

Gammie JS Annals of Thoracic Surgery 2009

Yilmaz J Thorac Cardiovasc Surg 2011142608

Matsuyama Ann Thorac Surg 2003751826

Do many patients have TR

STS Database 58000 Patients Isolated MR

Moderate TR 124

Severe TR 71

Moderate or Severe 195

Mayo 115699 16 ModSev TR

Matsuyama 46174 26 Mod + TR

Fukuda Circulation 2006114I-492

Normal Tricuspid Annulus Tricuspid Annulus with Functional TR

Annular Dilation Shape Change of FTR

75- all cases of MR

-40

-20

0

20

40

-40 -20 0 20 40

-40

-20

0

20

40

-40 -20 0 20 40

TR is ignored STS Database

MR + TR

Annual New MR

Annual MR Surgeries

Annual TR Surgeries

MR - 4000000

TR - 1600000250000

60000

7000 TVr

Why Not Fix TR at Surgery

bull 136 pts mostly TV repair

bull 8 yr follow up PPM in 21

I HATE PACEMAKERS

Tricuspid Repair Rate when fixing MR

Based on Preop TR Grade

139

39

79

0

20

40

60

80

100

Percent of Patients Having Tricuspid Repair

Preoperative TR Grade

None Mild Moderate Severe

Source STS Database N = 46500

V 273 2011-2013

FTR Reality

Modsevere TR - Bad

TR ring - Good

TVR - Sad

Percutaneous Implications for TR

FTR Percutaneous ldquoNotrdquo Rings

Tricuspid Regurgitation

4-TECH

Tricuspid Regurgitation

Mitralignhellip Trialign

FTR Perc McKay

FAILED

bull 4 pledgets

bull 2 Locks

bull Target Full Posterior Annulus

2 Pair

29

Pre Procedure Post 2nd PairPost 1st Pair

Perc DeVega

31

1214 patients received one pair of implants

Average annular reduction ndash 35

Average EROA reduction ndash 58

Adverse event ndash 1 access complication

0

5

10

15

20

25

Pre Procedure Post Procedure

Annular Area cm2

0

05

1

15

2

25

3

35

4

45

5

Pre Procedure Post Procedure

EROA cm2

10 cm2 15 cm2

Tricuspid Percutaneous - Myth

TR goal is different

TR grades 1- 4 andhellip

5+ ldquomassiverdquo

6+ ldquotorrentialrdquo

FTR Percutaneous ldquoother thingsrdquo

Remain calm

Carry on

FTR Surgery Percutaneous Implications

TV Perc

Rings

Tricuspid Regurgitation

Cardioband

36

Pre-op Echo 4+ MR 3-4+ TR

Millipede

Post MVR TVR Millipede FLUORO

37

24 month Post MVR TVR Millipede TTE

38

24 month Post MVR TVR Millipede TTE

39

Tricuspid Regurgitation - Reality

TR is BADldquoThe biology of TR will not change

with the method of therapyrdquo

A new grading method

will not ldquofoolrdquo nature

TR severity - reality

Sustained meaningful

reduction of TR

TR Percutaneous Myth and reality

Less impacthellipEarlier intervention

Best TR is zero

Good enough 1-2+TR

Reality Huge market - $$

Patients want ithellipit will happen

Page 4: Percutaneous technologies to correct TR : Myth or … A...PASP, LVEF, IVC size, RV size/ function, 5223 pts Severe and MODERATE TR decreases survival Having TR is BAD ! Topilsky. JACC

FTR increases Mortality

Nath JACC 200443405

Severe and MODERATE TR increase mortality

independent of PASP LVEF IVC size RV size function 5223 pts

Severe and MODERATE TR decreases survival

Having TR is BAD

Topilsky JACC 2014

TR after MitraClip for FMR

More TR at baseline - worse outcome

Moderate or Severe TR is BAD

hellipeven percutaneously

Ohno et al EHJ 2014151246

TR SeverityDeathRehosp

FTR Reality

Mod severe TR - BAD

Pathophysiology of Functional Secondary TR

What size

NORMAL TRICUSPID ANNULAR DIMENSION

28 + 05 cm Sugimoto T J Thorac Cardiovasc Surg 1999117463-71

Late TR after Functional MR Surgery

More TR with TV annulus size

Matsunaga Duran Circulation 2005

FTR Reality

Mod severe TR - Bad

Dilated annulus - Bad

Dreyfus Annals of Thoracic Surgery 2005

Tricuspid Valve Repair- Does it matter

matter

311 Patients MV Repair

Preop TR 07 ndash 09

93 notracemild

7 moderate

NONE Severe

TR Does Not Just ldquoGo Awayrdquo After MVr

311 undergoing MVr mostly degenerative all with dilated TV annulus

Dreyfus Ann Thorac Surg 200579127

0

10

20

30

40

50

60

TR Worsening by gt 2 Grades

MVR only

48

MVR+TVR

2

Plt0001

ldquoUndersizedrdquo TV repair for FTR

Actually Re-NORMAL size

TR Grade

Preoperative

Predischarge

Follow-up (mean = 1 yr)

None Mild Moderate Mod-to-Severe

Severe

None Mild Moderate Mod-to-Severe

Severe

None Mild Moderate Mod-to-Severe

Severe

ldquoUndersizedrdquo TV repair for FTR

Far less TR better RV

NO mortality or PPM

Outcomes of Guideline directed repair

of FTR performed during MV surgery

Ward Romano Bolling JTCVS 2018

262 pts TVr mod or lt mod TR 262830 ring

No mortality No TS RV improved

1 progression to severe TR

26 de novo PPM rate

FTR Reality

Modsevere TR - BAD

TR ring - GOOD

Gammie JS Annals of Thoracic Surgery 2009

Yilmaz J Thorac Cardiovasc Surg 2011142608

Matsuyama Ann Thorac Surg 2003751826

Do many patients have TR

STS Database 58000 Patients Isolated MR

Moderate TR 124

Severe TR 71

Moderate or Severe 195

Mayo 115699 16 ModSev TR

Matsuyama 46174 26 Mod + TR

Fukuda Circulation 2006114I-492

Normal Tricuspid Annulus Tricuspid Annulus with Functional TR

Annular Dilation Shape Change of FTR

75- all cases of MR

-40

-20

0

20

40

-40 -20 0 20 40

-40

-20

0

20

40

-40 -20 0 20 40

TR is ignored STS Database

MR + TR

Annual New MR

Annual MR Surgeries

Annual TR Surgeries

MR - 4000000

TR - 1600000250000

60000

7000 TVr

Why Not Fix TR at Surgery

bull 136 pts mostly TV repair

bull 8 yr follow up PPM in 21

I HATE PACEMAKERS

Tricuspid Repair Rate when fixing MR

Based on Preop TR Grade

139

39

79

0

20

40

60

80

100

Percent of Patients Having Tricuspid Repair

Preoperative TR Grade

None Mild Moderate Severe

Source STS Database N = 46500

V 273 2011-2013

FTR Reality

Modsevere TR - Bad

TR ring - Good

TVR - Sad

Percutaneous Implications for TR

FTR Percutaneous ldquoNotrdquo Rings

Tricuspid Regurgitation

4-TECH

Tricuspid Regurgitation

Mitralignhellip Trialign

FTR Perc McKay

FAILED

bull 4 pledgets

bull 2 Locks

bull Target Full Posterior Annulus

2 Pair

29

Pre Procedure Post 2nd PairPost 1st Pair

Perc DeVega

31

1214 patients received one pair of implants

Average annular reduction ndash 35

Average EROA reduction ndash 58

Adverse event ndash 1 access complication

0

5

10

15

20

25

Pre Procedure Post Procedure

Annular Area cm2

0

05

1

15

2

25

3

35

4

45

5

Pre Procedure Post Procedure

EROA cm2

10 cm2 15 cm2

Tricuspid Percutaneous - Myth

TR goal is different

TR grades 1- 4 andhellip

5+ ldquomassiverdquo

6+ ldquotorrentialrdquo

FTR Percutaneous ldquoother thingsrdquo

Remain calm

Carry on

FTR Surgery Percutaneous Implications

TV Perc

Rings

Tricuspid Regurgitation

Cardioband

36

Pre-op Echo 4+ MR 3-4+ TR

Millipede

Post MVR TVR Millipede FLUORO

37

24 month Post MVR TVR Millipede TTE

38

24 month Post MVR TVR Millipede TTE

39

Tricuspid Regurgitation - Reality

TR is BADldquoThe biology of TR will not change

with the method of therapyrdquo

A new grading method

will not ldquofoolrdquo nature

TR severity - reality

Sustained meaningful

reduction of TR

TR Percutaneous Myth and reality

Less impacthellipEarlier intervention

Best TR is zero

Good enough 1-2+TR

Reality Huge market - $$

Patients want ithellipit will happen

Page 5: Percutaneous technologies to correct TR : Myth or … A...PASP, LVEF, IVC size, RV size/ function, 5223 pts Severe and MODERATE TR decreases survival Having TR is BAD ! Topilsky. JACC

Severe and MODERATE TR decreases survival

Having TR is BAD

Topilsky JACC 2014

TR after MitraClip for FMR

More TR at baseline - worse outcome

Moderate or Severe TR is BAD

hellipeven percutaneously

Ohno et al EHJ 2014151246

TR SeverityDeathRehosp

FTR Reality

Mod severe TR - BAD

Pathophysiology of Functional Secondary TR

What size

NORMAL TRICUSPID ANNULAR DIMENSION

28 + 05 cm Sugimoto T J Thorac Cardiovasc Surg 1999117463-71

Late TR after Functional MR Surgery

More TR with TV annulus size

Matsunaga Duran Circulation 2005

FTR Reality

Mod severe TR - Bad

Dilated annulus - Bad

Dreyfus Annals of Thoracic Surgery 2005

Tricuspid Valve Repair- Does it matter

matter

311 Patients MV Repair

Preop TR 07 ndash 09

93 notracemild

7 moderate

NONE Severe

TR Does Not Just ldquoGo Awayrdquo After MVr

311 undergoing MVr mostly degenerative all with dilated TV annulus

Dreyfus Ann Thorac Surg 200579127

0

10

20

30

40

50

60

TR Worsening by gt 2 Grades

MVR only

48

MVR+TVR

2

Plt0001

ldquoUndersizedrdquo TV repair for FTR

Actually Re-NORMAL size

TR Grade

Preoperative

Predischarge

Follow-up (mean = 1 yr)

None Mild Moderate Mod-to-Severe

Severe

None Mild Moderate Mod-to-Severe

Severe

None Mild Moderate Mod-to-Severe

Severe

ldquoUndersizedrdquo TV repair for FTR

Far less TR better RV

NO mortality or PPM

Outcomes of Guideline directed repair

of FTR performed during MV surgery

Ward Romano Bolling JTCVS 2018

262 pts TVr mod or lt mod TR 262830 ring

No mortality No TS RV improved

1 progression to severe TR

26 de novo PPM rate

FTR Reality

Modsevere TR - BAD

TR ring - GOOD

Gammie JS Annals of Thoracic Surgery 2009

Yilmaz J Thorac Cardiovasc Surg 2011142608

Matsuyama Ann Thorac Surg 2003751826

Do many patients have TR

STS Database 58000 Patients Isolated MR

Moderate TR 124

Severe TR 71

Moderate or Severe 195

Mayo 115699 16 ModSev TR

Matsuyama 46174 26 Mod + TR

Fukuda Circulation 2006114I-492

Normal Tricuspid Annulus Tricuspid Annulus with Functional TR

Annular Dilation Shape Change of FTR

75- all cases of MR

-40

-20

0

20

40

-40 -20 0 20 40

-40

-20

0

20

40

-40 -20 0 20 40

TR is ignored STS Database

MR + TR

Annual New MR

Annual MR Surgeries

Annual TR Surgeries

MR - 4000000

TR - 1600000250000

60000

7000 TVr

Why Not Fix TR at Surgery

bull 136 pts mostly TV repair

bull 8 yr follow up PPM in 21

I HATE PACEMAKERS

Tricuspid Repair Rate when fixing MR

Based on Preop TR Grade

139

39

79

0

20

40

60

80

100

Percent of Patients Having Tricuspid Repair

Preoperative TR Grade

None Mild Moderate Severe

Source STS Database N = 46500

V 273 2011-2013

FTR Reality

Modsevere TR - Bad

TR ring - Good

TVR - Sad

Percutaneous Implications for TR

FTR Percutaneous ldquoNotrdquo Rings

Tricuspid Regurgitation

4-TECH

Tricuspid Regurgitation

Mitralignhellip Trialign

FTR Perc McKay

FAILED

bull 4 pledgets

bull 2 Locks

bull Target Full Posterior Annulus

2 Pair

29

Pre Procedure Post 2nd PairPost 1st Pair

Perc DeVega

31

1214 patients received one pair of implants

Average annular reduction ndash 35

Average EROA reduction ndash 58

Adverse event ndash 1 access complication

0

5

10

15

20

25

Pre Procedure Post Procedure

Annular Area cm2

0

05

1

15

2

25

3

35

4

45

5

Pre Procedure Post Procedure

EROA cm2

10 cm2 15 cm2

Tricuspid Percutaneous - Myth

TR goal is different

TR grades 1- 4 andhellip

5+ ldquomassiverdquo

6+ ldquotorrentialrdquo

FTR Percutaneous ldquoother thingsrdquo

Remain calm

Carry on

FTR Surgery Percutaneous Implications

TV Perc

Rings

Tricuspid Regurgitation

Cardioband

36

Pre-op Echo 4+ MR 3-4+ TR

Millipede

Post MVR TVR Millipede FLUORO

37

24 month Post MVR TVR Millipede TTE

38

24 month Post MVR TVR Millipede TTE

39

Tricuspid Regurgitation - Reality

TR is BADldquoThe biology of TR will not change

with the method of therapyrdquo

A new grading method

will not ldquofoolrdquo nature

TR severity - reality

Sustained meaningful

reduction of TR

TR Percutaneous Myth and reality

Less impacthellipEarlier intervention

Best TR is zero

Good enough 1-2+TR

Reality Huge market - $$

Patients want ithellipit will happen

Page 6: Percutaneous technologies to correct TR : Myth or … A...PASP, LVEF, IVC size, RV size/ function, 5223 pts Severe and MODERATE TR decreases survival Having TR is BAD ! Topilsky. JACC

TR after MitraClip for FMR

More TR at baseline - worse outcome

Moderate or Severe TR is BAD

hellipeven percutaneously

Ohno et al EHJ 2014151246

TR SeverityDeathRehosp

FTR Reality

Mod severe TR - BAD

Pathophysiology of Functional Secondary TR

What size

NORMAL TRICUSPID ANNULAR DIMENSION

28 + 05 cm Sugimoto T J Thorac Cardiovasc Surg 1999117463-71

Late TR after Functional MR Surgery

More TR with TV annulus size

Matsunaga Duran Circulation 2005

FTR Reality

Mod severe TR - Bad

Dilated annulus - Bad

Dreyfus Annals of Thoracic Surgery 2005

Tricuspid Valve Repair- Does it matter

matter

311 Patients MV Repair

Preop TR 07 ndash 09

93 notracemild

7 moderate

NONE Severe

TR Does Not Just ldquoGo Awayrdquo After MVr

311 undergoing MVr mostly degenerative all with dilated TV annulus

Dreyfus Ann Thorac Surg 200579127

0

10

20

30

40

50

60

TR Worsening by gt 2 Grades

MVR only

48

MVR+TVR

2

Plt0001

ldquoUndersizedrdquo TV repair for FTR

Actually Re-NORMAL size

TR Grade

Preoperative

Predischarge

Follow-up (mean = 1 yr)

None Mild Moderate Mod-to-Severe

Severe

None Mild Moderate Mod-to-Severe

Severe

None Mild Moderate Mod-to-Severe

Severe

ldquoUndersizedrdquo TV repair for FTR

Far less TR better RV

NO mortality or PPM

Outcomes of Guideline directed repair

of FTR performed during MV surgery

Ward Romano Bolling JTCVS 2018

262 pts TVr mod or lt mod TR 262830 ring

No mortality No TS RV improved

1 progression to severe TR

26 de novo PPM rate

FTR Reality

Modsevere TR - BAD

TR ring - GOOD

Gammie JS Annals of Thoracic Surgery 2009

Yilmaz J Thorac Cardiovasc Surg 2011142608

Matsuyama Ann Thorac Surg 2003751826

Do many patients have TR

STS Database 58000 Patients Isolated MR

Moderate TR 124

Severe TR 71

Moderate or Severe 195

Mayo 115699 16 ModSev TR

Matsuyama 46174 26 Mod + TR

Fukuda Circulation 2006114I-492

Normal Tricuspid Annulus Tricuspid Annulus with Functional TR

Annular Dilation Shape Change of FTR

75- all cases of MR

-40

-20

0

20

40

-40 -20 0 20 40

-40

-20

0

20

40

-40 -20 0 20 40

TR is ignored STS Database

MR + TR

Annual New MR

Annual MR Surgeries

Annual TR Surgeries

MR - 4000000

TR - 1600000250000

60000

7000 TVr

Why Not Fix TR at Surgery

bull 136 pts mostly TV repair

bull 8 yr follow up PPM in 21

I HATE PACEMAKERS

Tricuspid Repair Rate when fixing MR

Based on Preop TR Grade

139

39

79

0

20

40

60

80

100

Percent of Patients Having Tricuspid Repair

Preoperative TR Grade

None Mild Moderate Severe

Source STS Database N = 46500

V 273 2011-2013

FTR Reality

Modsevere TR - Bad

TR ring - Good

TVR - Sad

Percutaneous Implications for TR

FTR Percutaneous ldquoNotrdquo Rings

Tricuspid Regurgitation

4-TECH

Tricuspid Regurgitation

Mitralignhellip Trialign

FTR Perc McKay

FAILED

bull 4 pledgets

bull 2 Locks

bull Target Full Posterior Annulus

2 Pair

29

Pre Procedure Post 2nd PairPost 1st Pair

Perc DeVega

31

1214 patients received one pair of implants

Average annular reduction ndash 35

Average EROA reduction ndash 58

Adverse event ndash 1 access complication

0

5

10

15

20

25

Pre Procedure Post Procedure

Annular Area cm2

0

05

1

15

2

25

3

35

4

45

5

Pre Procedure Post Procedure

EROA cm2

10 cm2 15 cm2

Tricuspid Percutaneous - Myth

TR goal is different

TR grades 1- 4 andhellip

5+ ldquomassiverdquo

6+ ldquotorrentialrdquo

FTR Percutaneous ldquoother thingsrdquo

Remain calm

Carry on

FTR Surgery Percutaneous Implications

TV Perc

Rings

Tricuspid Regurgitation

Cardioband

36

Pre-op Echo 4+ MR 3-4+ TR

Millipede

Post MVR TVR Millipede FLUORO

37

24 month Post MVR TVR Millipede TTE

38

24 month Post MVR TVR Millipede TTE

39

Tricuspid Regurgitation - Reality

TR is BADldquoThe biology of TR will not change

with the method of therapyrdquo

A new grading method

will not ldquofoolrdquo nature

TR severity - reality

Sustained meaningful

reduction of TR

TR Percutaneous Myth and reality

Less impacthellipEarlier intervention

Best TR is zero

Good enough 1-2+TR

Reality Huge market - $$

Patients want ithellipit will happen

Page 7: Percutaneous technologies to correct TR : Myth or … A...PASP, LVEF, IVC size, RV size/ function, 5223 pts Severe and MODERATE TR decreases survival Having TR is BAD ! Topilsky. JACC

FTR Reality

Mod severe TR - BAD

Pathophysiology of Functional Secondary TR

What size

NORMAL TRICUSPID ANNULAR DIMENSION

28 + 05 cm Sugimoto T J Thorac Cardiovasc Surg 1999117463-71

Late TR after Functional MR Surgery

More TR with TV annulus size

Matsunaga Duran Circulation 2005

FTR Reality

Mod severe TR - Bad

Dilated annulus - Bad

Dreyfus Annals of Thoracic Surgery 2005

Tricuspid Valve Repair- Does it matter

matter

311 Patients MV Repair

Preop TR 07 ndash 09

93 notracemild

7 moderate

NONE Severe

TR Does Not Just ldquoGo Awayrdquo After MVr

311 undergoing MVr mostly degenerative all with dilated TV annulus

Dreyfus Ann Thorac Surg 200579127

0

10

20

30

40

50

60

TR Worsening by gt 2 Grades

MVR only

48

MVR+TVR

2

Plt0001

ldquoUndersizedrdquo TV repair for FTR

Actually Re-NORMAL size

TR Grade

Preoperative

Predischarge

Follow-up (mean = 1 yr)

None Mild Moderate Mod-to-Severe

Severe

None Mild Moderate Mod-to-Severe

Severe

None Mild Moderate Mod-to-Severe

Severe

ldquoUndersizedrdquo TV repair for FTR

Far less TR better RV

NO mortality or PPM

Outcomes of Guideline directed repair

of FTR performed during MV surgery

Ward Romano Bolling JTCVS 2018

262 pts TVr mod or lt mod TR 262830 ring

No mortality No TS RV improved

1 progression to severe TR

26 de novo PPM rate

FTR Reality

Modsevere TR - BAD

TR ring - GOOD

Gammie JS Annals of Thoracic Surgery 2009

Yilmaz J Thorac Cardiovasc Surg 2011142608

Matsuyama Ann Thorac Surg 2003751826

Do many patients have TR

STS Database 58000 Patients Isolated MR

Moderate TR 124

Severe TR 71

Moderate or Severe 195

Mayo 115699 16 ModSev TR

Matsuyama 46174 26 Mod + TR

Fukuda Circulation 2006114I-492

Normal Tricuspid Annulus Tricuspid Annulus with Functional TR

Annular Dilation Shape Change of FTR

75- all cases of MR

-40

-20

0

20

40

-40 -20 0 20 40

-40

-20

0

20

40

-40 -20 0 20 40

TR is ignored STS Database

MR + TR

Annual New MR

Annual MR Surgeries

Annual TR Surgeries

MR - 4000000

TR - 1600000250000

60000

7000 TVr

Why Not Fix TR at Surgery

bull 136 pts mostly TV repair

bull 8 yr follow up PPM in 21

I HATE PACEMAKERS

Tricuspid Repair Rate when fixing MR

Based on Preop TR Grade

139

39

79

0

20

40

60

80

100

Percent of Patients Having Tricuspid Repair

Preoperative TR Grade

None Mild Moderate Severe

Source STS Database N = 46500

V 273 2011-2013

FTR Reality

Modsevere TR - Bad

TR ring - Good

TVR - Sad

Percutaneous Implications for TR

FTR Percutaneous ldquoNotrdquo Rings

Tricuspid Regurgitation

4-TECH

Tricuspid Regurgitation

Mitralignhellip Trialign

FTR Perc McKay

FAILED

bull 4 pledgets

bull 2 Locks

bull Target Full Posterior Annulus

2 Pair

29

Pre Procedure Post 2nd PairPost 1st Pair

Perc DeVega

31

1214 patients received one pair of implants

Average annular reduction ndash 35

Average EROA reduction ndash 58

Adverse event ndash 1 access complication

0

5

10

15

20

25

Pre Procedure Post Procedure

Annular Area cm2

0

05

1

15

2

25

3

35

4

45

5

Pre Procedure Post Procedure

EROA cm2

10 cm2 15 cm2

Tricuspid Percutaneous - Myth

TR goal is different

TR grades 1- 4 andhellip

5+ ldquomassiverdquo

6+ ldquotorrentialrdquo

FTR Percutaneous ldquoother thingsrdquo

Remain calm

Carry on

FTR Surgery Percutaneous Implications

TV Perc

Rings

Tricuspid Regurgitation

Cardioband

36

Pre-op Echo 4+ MR 3-4+ TR

Millipede

Post MVR TVR Millipede FLUORO

37

24 month Post MVR TVR Millipede TTE

38

24 month Post MVR TVR Millipede TTE

39

Tricuspid Regurgitation - Reality

TR is BADldquoThe biology of TR will not change

with the method of therapyrdquo

A new grading method

will not ldquofoolrdquo nature

TR severity - reality

Sustained meaningful

reduction of TR

TR Percutaneous Myth and reality

Less impacthellipEarlier intervention

Best TR is zero

Good enough 1-2+TR

Reality Huge market - $$

Patients want ithellipit will happen

Page 8: Percutaneous technologies to correct TR : Myth or … A...PASP, LVEF, IVC size, RV size/ function, 5223 pts Severe and MODERATE TR decreases survival Having TR is BAD ! Topilsky. JACC

Pathophysiology of Functional Secondary TR

What size

NORMAL TRICUSPID ANNULAR DIMENSION

28 + 05 cm Sugimoto T J Thorac Cardiovasc Surg 1999117463-71

Late TR after Functional MR Surgery

More TR with TV annulus size

Matsunaga Duran Circulation 2005

FTR Reality

Mod severe TR - Bad

Dilated annulus - Bad

Dreyfus Annals of Thoracic Surgery 2005

Tricuspid Valve Repair- Does it matter

matter

311 Patients MV Repair

Preop TR 07 ndash 09

93 notracemild

7 moderate

NONE Severe

TR Does Not Just ldquoGo Awayrdquo After MVr

311 undergoing MVr mostly degenerative all with dilated TV annulus

Dreyfus Ann Thorac Surg 200579127

0

10

20

30

40

50

60

TR Worsening by gt 2 Grades

MVR only

48

MVR+TVR

2

Plt0001

ldquoUndersizedrdquo TV repair for FTR

Actually Re-NORMAL size

TR Grade

Preoperative

Predischarge

Follow-up (mean = 1 yr)

None Mild Moderate Mod-to-Severe

Severe

None Mild Moderate Mod-to-Severe

Severe

None Mild Moderate Mod-to-Severe

Severe

ldquoUndersizedrdquo TV repair for FTR

Far less TR better RV

NO mortality or PPM

Outcomes of Guideline directed repair

of FTR performed during MV surgery

Ward Romano Bolling JTCVS 2018

262 pts TVr mod or lt mod TR 262830 ring

No mortality No TS RV improved

1 progression to severe TR

26 de novo PPM rate

FTR Reality

Modsevere TR - BAD

TR ring - GOOD

Gammie JS Annals of Thoracic Surgery 2009

Yilmaz J Thorac Cardiovasc Surg 2011142608

Matsuyama Ann Thorac Surg 2003751826

Do many patients have TR

STS Database 58000 Patients Isolated MR

Moderate TR 124

Severe TR 71

Moderate or Severe 195

Mayo 115699 16 ModSev TR

Matsuyama 46174 26 Mod + TR

Fukuda Circulation 2006114I-492

Normal Tricuspid Annulus Tricuspid Annulus with Functional TR

Annular Dilation Shape Change of FTR

75- all cases of MR

-40

-20

0

20

40

-40 -20 0 20 40

-40

-20

0

20

40

-40 -20 0 20 40

TR is ignored STS Database

MR + TR

Annual New MR

Annual MR Surgeries

Annual TR Surgeries

MR - 4000000

TR - 1600000250000

60000

7000 TVr

Why Not Fix TR at Surgery

bull 136 pts mostly TV repair

bull 8 yr follow up PPM in 21

I HATE PACEMAKERS

Tricuspid Repair Rate when fixing MR

Based on Preop TR Grade

139

39

79

0

20

40

60

80

100

Percent of Patients Having Tricuspid Repair

Preoperative TR Grade

None Mild Moderate Severe

Source STS Database N = 46500

V 273 2011-2013

FTR Reality

Modsevere TR - Bad

TR ring - Good

TVR - Sad

Percutaneous Implications for TR

FTR Percutaneous ldquoNotrdquo Rings

Tricuspid Regurgitation

4-TECH

Tricuspid Regurgitation

Mitralignhellip Trialign

FTR Perc McKay

FAILED

bull 4 pledgets

bull 2 Locks

bull Target Full Posterior Annulus

2 Pair

29

Pre Procedure Post 2nd PairPost 1st Pair

Perc DeVega

31

1214 patients received one pair of implants

Average annular reduction ndash 35

Average EROA reduction ndash 58

Adverse event ndash 1 access complication

0

5

10

15

20

25

Pre Procedure Post Procedure

Annular Area cm2

0

05

1

15

2

25

3

35

4

45

5

Pre Procedure Post Procedure

EROA cm2

10 cm2 15 cm2

Tricuspid Percutaneous - Myth

TR goal is different

TR grades 1- 4 andhellip

5+ ldquomassiverdquo

6+ ldquotorrentialrdquo

FTR Percutaneous ldquoother thingsrdquo

Remain calm

Carry on

FTR Surgery Percutaneous Implications

TV Perc

Rings

Tricuspid Regurgitation

Cardioband

36

Pre-op Echo 4+ MR 3-4+ TR

Millipede

Post MVR TVR Millipede FLUORO

37

24 month Post MVR TVR Millipede TTE

38

24 month Post MVR TVR Millipede TTE

39

Tricuspid Regurgitation - Reality

TR is BADldquoThe biology of TR will not change

with the method of therapyrdquo

A new grading method

will not ldquofoolrdquo nature

TR severity - reality

Sustained meaningful

reduction of TR

TR Percutaneous Myth and reality

Less impacthellipEarlier intervention

Best TR is zero

Good enough 1-2+TR

Reality Huge market - $$

Patients want ithellipit will happen

Page 9: Percutaneous technologies to correct TR : Myth or … A...PASP, LVEF, IVC size, RV size/ function, 5223 pts Severe and MODERATE TR decreases survival Having TR is BAD ! Topilsky. JACC

Late TR after Functional MR Surgery

More TR with TV annulus size

Matsunaga Duran Circulation 2005

FTR Reality

Mod severe TR - Bad

Dilated annulus - Bad

Dreyfus Annals of Thoracic Surgery 2005

Tricuspid Valve Repair- Does it matter

matter

311 Patients MV Repair

Preop TR 07 ndash 09

93 notracemild

7 moderate

NONE Severe

TR Does Not Just ldquoGo Awayrdquo After MVr

311 undergoing MVr mostly degenerative all with dilated TV annulus

Dreyfus Ann Thorac Surg 200579127

0

10

20

30

40

50

60

TR Worsening by gt 2 Grades

MVR only

48

MVR+TVR

2

Plt0001

ldquoUndersizedrdquo TV repair for FTR

Actually Re-NORMAL size

TR Grade

Preoperative

Predischarge

Follow-up (mean = 1 yr)

None Mild Moderate Mod-to-Severe

Severe

None Mild Moderate Mod-to-Severe

Severe

None Mild Moderate Mod-to-Severe

Severe

ldquoUndersizedrdquo TV repair for FTR

Far less TR better RV

NO mortality or PPM

Outcomes of Guideline directed repair

of FTR performed during MV surgery

Ward Romano Bolling JTCVS 2018

262 pts TVr mod or lt mod TR 262830 ring

No mortality No TS RV improved

1 progression to severe TR

26 de novo PPM rate

FTR Reality

Modsevere TR - BAD

TR ring - GOOD

Gammie JS Annals of Thoracic Surgery 2009

Yilmaz J Thorac Cardiovasc Surg 2011142608

Matsuyama Ann Thorac Surg 2003751826

Do many patients have TR

STS Database 58000 Patients Isolated MR

Moderate TR 124

Severe TR 71

Moderate or Severe 195

Mayo 115699 16 ModSev TR

Matsuyama 46174 26 Mod + TR

Fukuda Circulation 2006114I-492

Normal Tricuspid Annulus Tricuspid Annulus with Functional TR

Annular Dilation Shape Change of FTR

75- all cases of MR

-40

-20

0

20

40

-40 -20 0 20 40

-40

-20

0

20

40

-40 -20 0 20 40

TR is ignored STS Database

MR + TR

Annual New MR

Annual MR Surgeries

Annual TR Surgeries

MR - 4000000

TR - 1600000250000

60000

7000 TVr

Why Not Fix TR at Surgery

bull 136 pts mostly TV repair

bull 8 yr follow up PPM in 21

I HATE PACEMAKERS

Tricuspid Repair Rate when fixing MR

Based on Preop TR Grade

139

39

79

0

20

40

60

80

100

Percent of Patients Having Tricuspid Repair

Preoperative TR Grade

None Mild Moderate Severe

Source STS Database N = 46500

V 273 2011-2013

FTR Reality

Modsevere TR - Bad

TR ring - Good

TVR - Sad

Percutaneous Implications for TR

FTR Percutaneous ldquoNotrdquo Rings

Tricuspid Regurgitation

4-TECH

Tricuspid Regurgitation

Mitralignhellip Trialign

FTR Perc McKay

FAILED

bull 4 pledgets

bull 2 Locks

bull Target Full Posterior Annulus

2 Pair

29

Pre Procedure Post 2nd PairPost 1st Pair

Perc DeVega

31

1214 patients received one pair of implants

Average annular reduction ndash 35

Average EROA reduction ndash 58

Adverse event ndash 1 access complication

0

5

10

15

20

25

Pre Procedure Post Procedure

Annular Area cm2

0

05

1

15

2

25

3

35

4

45

5

Pre Procedure Post Procedure

EROA cm2

10 cm2 15 cm2

Tricuspid Percutaneous - Myth

TR goal is different

TR grades 1- 4 andhellip

5+ ldquomassiverdquo

6+ ldquotorrentialrdquo

FTR Percutaneous ldquoother thingsrdquo

Remain calm

Carry on

FTR Surgery Percutaneous Implications

TV Perc

Rings

Tricuspid Regurgitation

Cardioband

36

Pre-op Echo 4+ MR 3-4+ TR

Millipede

Post MVR TVR Millipede FLUORO

37

24 month Post MVR TVR Millipede TTE

38

24 month Post MVR TVR Millipede TTE

39

Tricuspid Regurgitation - Reality

TR is BADldquoThe biology of TR will not change

with the method of therapyrdquo

A new grading method

will not ldquofoolrdquo nature

TR severity - reality

Sustained meaningful

reduction of TR

TR Percutaneous Myth and reality

Less impacthellipEarlier intervention

Best TR is zero

Good enough 1-2+TR

Reality Huge market - $$

Patients want ithellipit will happen

Page 10: Percutaneous technologies to correct TR : Myth or … A...PASP, LVEF, IVC size, RV size/ function, 5223 pts Severe and MODERATE TR decreases survival Having TR is BAD ! Topilsky. JACC

FTR Reality

Mod severe TR - Bad

Dilated annulus - Bad

Dreyfus Annals of Thoracic Surgery 2005

Tricuspid Valve Repair- Does it matter

matter

311 Patients MV Repair

Preop TR 07 ndash 09

93 notracemild

7 moderate

NONE Severe

TR Does Not Just ldquoGo Awayrdquo After MVr

311 undergoing MVr mostly degenerative all with dilated TV annulus

Dreyfus Ann Thorac Surg 200579127

0

10

20

30

40

50

60

TR Worsening by gt 2 Grades

MVR only

48

MVR+TVR

2

Plt0001

ldquoUndersizedrdquo TV repair for FTR

Actually Re-NORMAL size

TR Grade

Preoperative

Predischarge

Follow-up (mean = 1 yr)

None Mild Moderate Mod-to-Severe

Severe

None Mild Moderate Mod-to-Severe

Severe

None Mild Moderate Mod-to-Severe

Severe

ldquoUndersizedrdquo TV repair for FTR

Far less TR better RV

NO mortality or PPM

Outcomes of Guideline directed repair

of FTR performed during MV surgery

Ward Romano Bolling JTCVS 2018

262 pts TVr mod or lt mod TR 262830 ring

No mortality No TS RV improved

1 progression to severe TR

26 de novo PPM rate

FTR Reality

Modsevere TR - BAD

TR ring - GOOD

Gammie JS Annals of Thoracic Surgery 2009

Yilmaz J Thorac Cardiovasc Surg 2011142608

Matsuyama Ann Thorac Surg 2003751826

Do many patients have TR

STS Database 58000 Patients Isolated MR

Moderate TR 124

Severe TR 71

Moderate or Severe 195

Mayo 115699 16 ModSev TR

Matsuyama 46174 26 Mod + TR

Fukuda Circulation 2006114I-492

Normal Tricuspid Annulus Tricuspid Annulus with Functional TR

Annular Dilation Shape Change of FTR

75- all cases of MR

-40

-20

0

20

40

-40 -20 0 20 40

-40

-20

0

20

40

-40 -20 0 20 40

TR is ignored STS Database

MR + TR

Annual New MR

Annual MR Surgeries

Annual TR Surgeries

MR - 4000000

TR - 1600000250000

60000

7000 TVr

Why Not Fix TR at Surgery

bull 136 pts mostly TV repair

bull 8 yr follow up PPM in 21

I HATE PACEMAKERS

Tricuspid Repair Rate when fixing MR

Based on Preop TR Grade

139

39

79

0

20

40

60

80

100

Percent of Patients Having Tricuspid Repair

Preoperative TR Grade

None Mild Moderate Severe

Source STS Database N = 46500

V 273 2011-2013

FTR Reality

Modsevere TR - Bad

TR ring - Good

TVR - Sad

Percutaneous Implications for TR

FTR Percutaneous ldquoNotrdquo Rings

Tricuspid Regurgitation

4-TECH

Tricuspid Regurgitation

Mitralignhellip Trialign

FTR Perc McKay

FAILED

bull 4 pledgets

bull 2 Locks

bull Target Full Posterior Annulus

2 Pair

29

Pre Procedure Post 2nd PairPost 1st Pair

Perc DeVega

31

1214 patients received one pair of implants

Average annular reduction ndash 35

Average EROA reduction ndash 58

Adverse event ndash 1 access complication

0

5

10

15

20

25

Pre Procedure Post Procedure

Annular Area cm2

0

05

1

15

2

25

3

35

4

45

5

Pre Procedure Post Procedure

EROA cm2

10 cm2 15 cm2

Tricuspid Percutaneous - Myth

TR goal is different

TR grades 1- 4 andhellip

5+ ldquomassiverdquo

6+ ldquotorrentialrdquo

FTR Percutaneous ldquoother thingsrdquo

Remain calm

Carry on

FTR Surgery Percutaneous Implications

TV Perc

Rings

Tricuspid Regurgitation

Cardioband

36

Pre-op Echo 4+ MR 3-4+ TR

Millipede

Post MVR TVR Millipede FLUORO

37

24 month Post MVR TVR Millipede TTE

38

24 month Post MVR TVR Millipede TTE

39

Tricuspid Regurgitation - Reality

TR is BADldquoThe biology of TR will not change

with the method of therapyrdquo

A new grading method

will not ldquofoolrdquo nature

TR severity - reality

Sustained meaningful

reduction of TR

TR Percutaneous Myth and reality

Less impacthellipEarlier intervention

Best TR is zero

Good enough 1-2+TR

Reality Huge market - $$

Patients want ithellipit will happen

Page 11: Percutaneous technologies to correct TR : Myth or … A...PASP, LVEF, IVC size, RV size/ function, 5223 pts Severe and MODERATE TR decreases survival Having TR is BAD ! Topilsky. JACC

Dreyfus Annals of Thoracic Surgery 2005

Tricuspid Valve Repair- Does it matter

matter

311 Patients MV Repair

Preop TR 07 ndash 09

93 notracemild

7 moderate

NONE Severe

TR Does Not Just ldquoGo Awayrdquo After MVr

311 undergoing MVr mostly degenerative all with dilated TV annulus

Dreyfus Ann Thorac Surg 200579127

0

10

20

30

40

50

60

TR Worsening by gt 2 Grades

MVR only

48

MVR+TVR

2

Plt0001

ldquoUndersizedrdquo TV repair for FTR

Actually Re-NORMAL size

TR Grade

Preoperative

Predischarge

Follow-up (mean = 1 yr)

None Mild Moderate Mod-to-Severe

Severe

None Mild Moderate Mod-to-Severe

Severe

None Mild Moderate Mod-to-Severe

Severe

ldquoUndersizedrdquo TV repair for FTR

Far less TR better RV

NO mortality or PPM

Outcomes of Guideline directed repair

of FTR performed during MV surgery

Ward Romano Bolling JTCVS 2018

262 pts TVr mod or lt mod TR 262830 ring

No mortality No TS RV improved

1 progression to severe TR

26 de novo PPM rate

FTR Reality

Modsevere TR - BAD

TR ring - GOOD

Gammie JS Annals of Thoracic Surgery 2009

Yilmaz J Thorac Cardiovasc Surg 2011142608

Matsuyama Ann Thorac Surg 2003751826

Do many patients have TR

STS Database 58000 Patients Isolated MR

Moderate TR 124

Severe TR 71

Moderate or Severe 195

Mayo 115699 16 ModSev TR

Matsuyama 46174 26 Mod + TR

Fukuda Circulation 2006114I-492

Normal Tricuspid Annulus Tricuspid Annulus with Functional TR

Annular Dilation Shape Change of FTR

75- all cases of MR

-40

-20

0

20

40

-40 -20 0 20 40

-40

-20

0

20

40

-40 -20 0 20 40

TR is ignored STS Database

MR + TR

Annual New MR

Annual MR Surgeries

Annual TR Surgeries

MR - 4000000

TR - 1600000250000

60000

7000 TVr

Why Not Fix TR at Surgery

bull 136 pts mostly TV repair

bull 8 yr follow up PPM in 21

I HATE PACEMAKERS

Tricuspid Repair Rate when fixing MR

Based on Preop TR Grade

139

39

79

0

20

40

60

80

100

Percent of Patients Having Tricuspid Repair

Preoperative TR Grade

None Mild Moderate Severe

Source STS Database N = 46500

V 273 2011-2013

FTR Reality

Modsevere TR - Bad

TR ring - Good

TVR - Sad

Percutaneous Implications for TR

FTR Percutaneous ldquoNotrdquo Rings

Tricuspid Regurgitation

4-TECH

Tricuspid Regurgitation

Mitralignhellip Trialign

FTR Perc McKay

FAILED

bull 4 pledgets

bull 2 Locks

bull Target Full Posterior Annulus

2 Pair

29

Pre Procedure Post 2nd PairPost 1st Pair

Perc DeVega

31

1214 patients received one pair of implants

Average annular reduction ndash 35

Average EROA reduction ndash 58

Adverse event ndash 1 access complication

0

5

10

15

20

25

Pre Procedure Post Procedure

Annular Area cm2

0

05

1

15

2

25

3

35

4

45

5

Pre Procedure Post Procedure

EROA cm2

10 cm2 15 cm2

Tricuspid Percutaneous - Myth

TR goal is different

TR grades 1- 4 andhellip

5+ ldquomassiverdquo

6+ ldquotorrentialrdquo

FTR Percutaneous ldquoother thingsrdquo

Remain calm

Carry on

FTR Surgery Percutaneous Implications

TV Perc

Rings

Tricuspid Regurgitation

Cardioband

36

Pre-op Echo 4+ MR 3-4+ TR

Millipede

Post MVR TVR Millipede FLUORO

37

24 month Post MVR TVR Millipede TTE

38

24 month Post MVR TVR Millipede TTE

39

Tricuspid Regurgitation - Reality

TR is BADldquoThe biology of TR will not change

with the method of therapyrdquo

A new grading method

will not ldquofoolrdquo nature

TR severity - reality

Sustained meaningful

reduction of TR

TR Percutaneous Myth and reality

Less impacthellipEarlier intervention

Best TR is zero

Good enough 1-2+TR

Reality Huge market - $$

Patients want ithellipit will happen

Page 12: Percutaneous technologies to correct TR : Myth or … A...PASP, LVEF, IVC size, RV size/ function, 5223 pts Severe and MODERATE TR decreases survival Having TR is BAD ! Topilsky. JACC

TR Does Not Just ldquoGo Awayrdquo After MVr

311 undergoing MVr mostly degenerative all with dilated TV annulus

Dreyfus Ann Thorac Surg 200579127

0

10

20

30

40

50

60

TR Worsening by gt 2 Grades

MVR only

48

MVR+TVR

2

Plt0001

ldquoUndersizedrdquo TV repair for FTR

Actually Re-NORMAL size

TR Grade

Preoperative

Predischarge

Follow-up (mean = 1 yr)

None Mild Moderate Mod-to-Severe

Severe

None Mild Moderate Mod-to-Severe

Severe

None Mild Moderate Mod-to-Severe

Severe

ldquoUndersizedrdquo TV repair for FTR

Far less TR better RV

NO mortality or PPM

Outcomes of Guideline directed repair

of FTR performed during MV surgery

Ward Romano Bolling JTCVS 2018

262 pts TVr mod or lt mod TR 262830 ring

No mortality No TS RV improved

1 progression to severe TR

26 de novo PPM rate

FTR Reality

Modsevere TR - BAD

TR ring - GOOD

Gammie JS Annals of Thoracic Surgery 2009

Yilmaz J Thorac Cardiovasc Surg 2011142608

Matsuyama Ann Thorac Surg 2003751826

Do many patients have TR

STS Database 58000 Patients Isolated MR

Moderate TR 124

Severe TR 71

Moderate or Severe 195

Mayo 115699 16 ModSev TR

Matsuyama 46174 26 Mod + TR

Fukuda Circulation 2006114I-492

Normal Tricuspid Annulus Tricuspid Annulus with Functional TR

Annular Dilation Shape Change of FTR

75- all cases of MR

-40

-20

0

20

40

-40 -20 0 20 40

-40

-20

0

20

40

-40 -20 0 20 40

TR is ignored STS Database

MR + TR

Annual New MR

Annual MR Surgeries

Annual TR Surgeries

MR - 4000000

TR - 1600000250000

60000

7000 TVr

Why Not Fix TR at Surgery

bull 136 pts mostly TV repair

bull 8 yr follow up PPM in 21

I HATE PACEMAKERS

Tricuspid Repair Rate when fixing MR

Based on Preop TR Grade

139

39

79

0

20

40

60

80

100

Percent of Patients Having Tricuspid Repair

Preoperative TR Grade

None Mild Moderate Severe

Source STS Database N = 46500

V 273 2011-2013

FTR Reality

Modsevere TR - Bad

TR ring - Good

TVR - Sad

Percutaneous Implications for TR

FTR Percutaneous ldquoNotrdquo Rings

Tricuspid Regurgitation

4-TECH

Tricuspid Regurgitation

Mitralignhellip Trialign

FTR Perc McKay

FAILED

bull 4 pledgets

bull 2 Locks

bull Target Full Posterior Annulus

2 Pair

29

Pre Procedure Post 2nd PairPost 1st Pair

Perc DeVega

31

1214 patients received one pair of implants

Average annular reduction ndash 35

Average EROA reduction ndash 58

Adverse event ndash 1 access complication

0

5

10

15

20

25

Pre Procedure Post Procedure

Annular Area cm2

0

05

1

15

2

25

3

35

4

45

5

Pre Procedure Post Procedure

EROA cm2

10 cm2 15 cm2

Tricuspid Percutaneous - Myth

TR goal is different

TR grades 1- 4 andhellip

5+ ldquomassiverdquo

6+ ldquotorrentialrdquo

FTR Percutaneous ldquoother thingsrdquo

Remain calm

Carry on

FTR Surgery Percutaneous Implications

TV Perc

Rings

Tricuspid Regurgitation

Cardioband

36

Pre-op Echo 4+ MR 3-4+ TR

Millipede

Post MVR TVR Millipede FLUORO

37

24 month Post MVR TVR Millipede TTE

38

24 month Post MVR TVR Millipede TTE

39

Tricuspid Regurgitation - Reality

TR is BADldquoThe biology of TR will not change

with the method of therapyrdquo

A new grading method

will not ldquofoolrdquo nature

TR severity - reality

Sustained meaningful

reduction of TR

TR Percutaneous Myth and reality

Less impacthellipEarlier intervention

Best TR is zero

Good enough 1-2+TR

Reality Huge market - $$

Patients want ithellipit will happen

Page 13: Percutaneous technologies to correct TR : Myth or … A...PASP, LVEF, IVC size, RV size/ function, 5223 pts Severe and MODERATE TR decreases survival Having TR is BAD ! Topilsky. JACC

ldquoUndersizedrdquo TV repair for FTR

Actually Re-NORMAL size

TR Grade

Preoperative

Predischarge

Follow-up (mean = 1 yr)

None Mild Moderate Mod-to-Severe

Severe

None Mild Moderate Mod-to-Severe

Severe

None Mild Moderate Mod-to-Severe

Severe

ldquoUndersizedrdquo TV repair for FTR

Far less TR better RV

NO mortality or PPM

Outcomes of Guideline directed repair

of FTR performed during MV surgery

Ward Romano Bolling JTCVS 2018

262 pts TVr mod or lt mod TR 262830 ring

No mortality No TS RV improved

1 progression to severe TR

26 de novo PPM rate

FTR Reality

Modsevere TR - BAD

TR ring - GOOD

Gammie JS Annals of Thoracic Surgery 2009

Yilmaz J Thorac Cardiovasc Surg 2011142608

Matsuyama Ann Thorac Surg 2003751826

Do many patients have TR

STS Database 58000 Patients Isolated MR

Moderate TR 124

Severe TR 71

Moderate or Severe 195

Mayo 115699 16 ModSev TR

Matsuyama 46174 26 Mod + TR

Fukuda Circulation 2006114I-492

Normal Tricuspid Annulus Tricuspid Annulus with Functional TR

Annular Dilation Shape Change of FTR

75- all cases of MR

-40

-20

0

20

40

-40 -20 0 20 40

-40

-20

0

20

40

-40 -20 0 20 40

TR is ignored STS Database

MR + TR

Annual New MR

Annual MR Surgeries

Annual TR Surgeries

MR - 4000000

TR - 1600000250000

60000

7000 TVr

Why Not Fix TR at Surgery

bull 136 pts mostly TV repair

bull 8 yr follow up PPM in 21

I HATE PACEMAKERS

Tricuspid Repair Rate when fixing MR

Based on Preop TR Grade

139

39

79

0

20

40

60

80

100

Percent of Patients Having Tricuspid Repair

Preoperative TR Grade

None Mild Moderate Severe

Source STS Database N = 46500

V 273 2011-2013

FTR Reality

Modsevere TR - Bad

TR ring - Good

TVR - Sad

Percutaneous Implications for TR

FTR Percutaneous ldquoNotrdquo Rings

Tricuspid Regurgitation

4-TECH

Tricuspid Regurgitation

Mitralignhellip Trialign

FTR Perc McKay

FAILED

bull 4 pledgets

bull 2 Locks

bull Target Full Posterior Annulus

2 Pair

29

Pre Procedure Post 2nd PairPost 1st Pair

Perc DeVega

31

1214 patients received one pair of implants

Average annular reduction ndash 35

Average EROA reduction ndash 58

Adverse event ndash 1 access complication

0

5

10

15

20

25

Pre Procedure Post Procedure

Annular Area cm2

0

05

1

15

2

25

3

35

4

45

5

Pre Procedure Post Procedure

EROA cm2

10 cm2 15 cm2

Tricuspid Percutaneous - Myth

TR goal is different

TR grades 1- 4 andhellip

5+ ldquomassiverdquo

6+ ldquotorrentialrdquo

FTR Percutaneous ldquoother thingsrdquo

Remain calm

Carry on

FTR Surgery Percutaneous Implications

TV Perc

Rings

Tricuspid Regurgitation

Cardioband

36

Pre-op Echo 4+ MR 3-4+ TR

Millipede

Post MVR TVR Millipede FLUORO

37

24 month Post MVR TVR Millipede TTE

38

24 month Post MVR TVR Millipede TTE

39

Tricuspid Regurgitation - Reality

TR is BADldquoThe biology of TR will not change

with the method of therapyrdquo

A new grading method

will not ldquofoolrdquo nature

TR severity - reality

Sustained meaningful

reduction of TR

TR Percutaneous Myth and reality

Less impacthellipEarlier intervention

Best TR is zero

Good enough 1-2+TR

Reality Huge market - $$

Patients want ithellipit will happen

Page 14: Percutaneous technologies to correct TR : Myth or … A...PASP, LVEF, IVC size, RV size/ function, 5223 pts Severe and MODERATE TR decreases survival Having TR is BAD ! Topilsky. JACC

TR Grade

Preoperative

Predischarge

Follow-up (mean = 1 yr)

None Mild Moderate Mod-to-Severe

Severe

None Mild Moderate Mod-to-Severe

Severe

None Mild Moderate Mod-to-Severe

Severe

ldquoUndersizedrdquo TV repair for FTR

Far less TR better RV

NO mortality or PPM

Outcomes of Guideline directed repair

of FTR performed during MV surgery

Ward Romano Bolling JTCVS 2018

262 pts TVr mod or lt mod TR 262830 ring

No mortality No TS RV improved

1 progression to severe TR

26 de novo PPM rate

FTR Reality

Modsevere TR - BAD

TR ring - GOOD

Gammie JS Annals of Thoracic Surgery 2009

Yilmaz J Thorac Cardiovasc Surg 2011142608

Matsuyama Ann Thorac Surg 2003751826

Do many patients have TR

STS Database 58000 Patients Isolated MR

Moderate TR 124

Severe TR 71

Moderate or Severe 195

Mayo 115699 16 ModSev TR

Matsuyama 46174 26 Mod + TR

Fukuda Circulation 2006114I-492

Normal Tricuspid Annulus Tricuspid Annulus with Functional TR

Annular Dilation Shape Change of FTR

75- all cases of MR

-40

-20

0

20

40

-40 -20 0 20 40

-40

-20

0

20

40

-40 -20 0 20 40

TR is ignored STS Database

MR + TR

Annual New MR

Annual MR Surgeries

Annual TR Surgeries

MR - 4000000

TR - 1600000250000

60000

7000 TVr

Why Not Fix TR at Surgery

bull 136 pts mostly TV repair

bull 8 yr follow up PPM in 21

I HATE PACEMAKERS

Tricuspid Repair Rate when fixing MR

Based on Preop TR Grade

139

39

79

0

20

40

60

80

100

Percent of Patients Having Tricuspid Repair

Preoperative TR Grade

None Mild Moderate Severe

Source STS Database N = 46500

V 273 2011-2013

FTR Reality

Modsevere TR - Bad

TR ring - Good

TVR - Sad

Percutaneous Implications for TR

FTR Percutaneous ldquoNotrdquo Rings

Tricuspid Regurgitation

4-TECH

Tricuspid Regurgitation

Mitralignhellip Trialign

FTR Perc McKay

FAILED

bull 4 pledgets

bull 2 Locks

bull Target Full Posterior Annulus

2 Pair

29

Pre Procedure Post 2nd PairPost 1st Pair

Perc DeVega

31

1214 patients received one pair of implants

Average annular reduction ndash 35

Average EROA reduction ndash 58

Adverse event ndash 1 access complication

0

5

10

15

20

25

Pre Procedure Post Procedure

Annular Area cm2

0

05

1

15

2

25

3

35

4

45

5

Pre Procedure Post Procedure

EROA cm2

10 cm2 15 cm2

Tricuspid Percutaneous - Myth

TR goal is different

TR grades 1- 4 andhellip

5+ ldquomassiverdquo

6+ ldquotorrentialrdquo

FTR Percutaneous ldquoother thingsrdquo

Remain calm

Carry on

FTR Surgery Percutaneous Implications

TV Perc

Rings

Tricuspid Regurgitation

Cardioband

36

Pre-op Echo 4+ MR 3-4+ TR

Millipede

Post MVR TVR Millipede FLUORO

37

24 month Post MVR TVR Millipede TTE

38

24 month Post MVR TVR Millipede TTE

39

Tricuspid Regurgitation - Reality

TR is BADldquoThe biology of TR will not change

with the method of therapyrdquo

A new grading method

will not ldquofoolrdquo nature

TR severity - reality

Sustained meaningful

reduction of TR

TR Percutaneous Myth and reality

Less impacthellipEarlier intervention

Best TR is zero

Good enough 1-2+TR

Reality Huge market - $$

Patients want ithellipit will happen

Page 15: Percutaneous technologies to correct TR : Myth or … A...PASP, LVEF, IVC size, RV size/ function, 5223 pts Severe and MODERATE TR decreases survival Having TR is BAD ! Topilsky. JACC

Far less TR better RV

NO mortality or PPM

Outcomes of Guideline directed repair

of FTR performed during MV surgery

Ward Romano Bolling JTCVS 2018

262 pts TVr mod or lt mod TR 262830 ring

No mortality No TS RV improved

1 progression to severe TR

26 de novo PPM rate

FTR Reality

Modsevere TR - BAD

TR ring - GOOD

Gammie JS Annals of Thoracic Surgery 2009

Yilmaz J Thorac Cardiovasc Surg 2011142608

Matsuyama Ann Thorac Surg 2003751826

Do many patients have TR

STS Database 58000 Patients Isolated MR

Moderate TR 124

Severe TR 71

Moderate or Severe 195

Mayo 115699 16 ModSev TR

Matsuyama 46174 26 Mod + TR

Fukuda Circulation 2006114I-492

Normal Tricuspid Annulus Tricuspid Annulus with Functional TR

Annular Dilation Shape Change of FTR

75- all cases of MR

-40

-20

0

20

40

-40 -20 0 20 40

-40

-20

0

20

40

-40 -20 0 20 40

TR is ignored STS Database

MR + TR

Annual New MR

Annual MR Surgeries

Annual TR Surgeries

MR - 4000000

TR - 1600000250000

60000

7000 TVr

Why Not Fix TR at Surgery

bull 136 pts mostly TV repair

bull 8 yr follow up PPM in 21

I HATE PACEMAKERS

Tricuspid Repair Rate when fixing MR

Based on Preop TR Grade

139

39

79

0

20

40

60

80

100

Percent of Patients Having Tricuspid Repair

Preoperative TR Grade

None Mild Moderate Severe

Source STS Database N = 46500

V 273 2011-2013

FTR Reality

Modsevere TR - Bad

TR ring - Good

TVR - Sad

Percutaneous Implications for TR

FTR Percutaneous ldquoNotrdquo Rings

Tricuspid Regurgitation

4-TECH

Tricuspid Regurgitation

Mitralignhellip Trialign

FTR Perc McKay

FAILED

bull 4 pledgets

bull 2 Locks

bull Target Full Posterior Annulus

2 Pair

29

Pre Procedure Post 2nd PairPost 1st Pair

Perc DeVega

31

1214 patients received one pair of implants

Average annular reduction ndash 35

Average EROA reduction ndash 58

Adverse event ndash 1 access complication

0

5

10

15

20

25

Pre Procedure Post Procedure

Annular Area cm2

0

05

1

15

2

25

3

35

4

45

5

Pre Procedure Post Procedure

EROA cm2

10 cm2 15 cm2

Tricuspid Percutaneous - Myth

TR goal is different

TR grades 1- 4 andhellip

5+ ldquomassiverdquo

6+ ldquotorrentialrdquo

FTR Percutaneous ldquoother thingsrdquo

Remain calm

Carry on

FTR Surgery Percutaneous Implications

TV Perc

Rings

Tricuspid Regurgitation

Cardioband

36

Pre-op Echo 4+ MR 3-4+ TR

Millipede

Post MVR TVR Millipede FLUORO

37

24 month Post MVR TVR Millipede TTE

38

24 month Post MVR TVR Millipede TTE

39

Tricuspid Regurgitation - Reality

TR is BADldquoThe biology of TR will not change

with the method of therapyrdquo

A new grading method

will not ldquofoolrdquo nature

TR severity - reality

Sustained meaningful

reduction of TR

TR Percutaneous Myth and reality

Less impacthellipEarlier intervention

Best TR is zero

Good enough 1-2+TR

Reality Huge market - $$

Patients want ithellipit will happen

Page 16: Percutaneous technologies to correct TR : Myth or … A...PASP, LVEF, IVC size, RV size/ function, 5223 pts Severe and MODERATE TR decreases survival Having TR is BAD ! Topilsky. JACC

Outcomes of Guideline directed repair

of FTR performed during MV surgery

Ward Romano Bolling JTCVS 2018

262 pts TVr mod or lt mod TR 262830 ring

No mortality No TS RV improved

1 progression to severe TR

26 de novo PPM rate

FTR Reality

Modsevere TR - BAD

TR ring - GOOD

Gammie JS Annals of Thoracic Surgery 2009

Yilmaz J Thorac Cardiovasc Surg 2011142608

Matsuyama Ann Thorac Surg 2003751826

Do many patients have TR

STS Database 58000 Patients Isolated MR

Moderate TR 124

Severe TR 71

Moderate or Severe 195

Mayo 115699 16 ModSev TR

Matsuyama 46174 26 Mod + TR

Fukuda Circulation 2006114I-492

Normal Tricuspid Annulus Tricuspid Annulus with Functional TR

Annular Dilation Shape Change of FTR

75- all cases of MR

-40

-20

0

20

40

-40 -20 0 20 40

-40

-20

0

20

40

-40 -20 0 20 40

TR is ignored STS Database

MR + TR

Annual New MR

Annual MR Surgeries

Annual TR Surgeries

MR - 4000000

TR - 1600000250000

60000

7000 TVr

Why Not Fix TR at Surgery

bull 136 pts mostly TV repair

bull 8 yr follow up PPM in 21

I HATE PACEMAKERS

Tricuspid Repair Rate when fixing MR

Based on Preop TR Grade

139

39

79

0

20

40

60

80

100

Percent of Patients Having Tricuspid Repair

Preoperative TR Grade

None Mild Moderate Severe

Source STS Database N = 46500

V 273 2011-2013

FTR Reality

Modsevere TR - Bad

TR ring - Good

TVR - Sad

Percutaneous Implications for TR

FTR Percutaneous ldquoNotrdquo Rings

Tricuspid Regurgitation

4-TECH

Tricuspid Regurgitation

Mitralignhellip Trialign

FTR Perc McKay

FAILED

bull 4 pledgets

bull 2 Locks

bull Target Full Posterior Annulus

2 Pair

29

Pre Procedure Post 2nd PairPost 1st Pair

Perc DeVega

31

1214 patients received one pair of implants

Average annular reduction ndash 35

Average EROA reduction ndash 58

Adverse event ndash 1 access complication

0

5

10

15

20

25

Pre Procedure Post Procedure

Annular Area cm2

0

05

1

15

2

25

3

35

4

45

5

Pre Procedure Post Procedure

EROA cm2

10 cm2 15 cm2

Tricuspid Percutaneous - Myth

TR goal is different

TR grades 1- 4 andhellip

5+ ldquomassiverdquo

6+ ldquotorrentialrdquo

FTR Percutaneous ldquoother thingsrdquo

Remain calm

Carry on

FTR Surgery Percutaneous Implications

TV Perc

Rings

Tricuspid Regurgitation

Cardioband

36

Pre-op Echo 4+ MR 3-4+ TR

Millipede

Post MVR TVR Millipede FLUORO

37

24 month Post MVR TVR Millipede TTE

38

24 month Post MVR TVR Millipede TTE

39

Tricuspid Regurgitation - Reality

TR is BADldquoThe biology of TR will not change

with the method of therapyrdquo

A new grading method

will not ldquofoolrdquo nature

TR severity - reality

Sustained meaningful

reduction of TR

TR Percutaneous Myth and reality

Less impacthellipEarlier intervention

Best TR is zero

Good enough 1-2+TR

Reality Huge market - $$

Patients want ithellipit will happen

Page 17: Percutaneous technologies to correct TR : Myth or … A...PASP, LVEF, IVC size, RV size/ function, 5223 pts Severe and MODERATE TR decreases survival Having TR is BAD ! Topilsky. JACC

FTR Reality

Modsevere TR - BAD

TR ring - GOOD

Gammie JS Annals of Thoracic Surgery 2009

Yilmaz J Thorac Cardiovasc Surg 2011142608

Matsuyama Ann Thorac Surg 2003751826

Do many patients have TR

STS Database 58000 Patients Isolated MR

Moderate TR 124

Severe TR 71

Moderate or Severe 195

Mayo 115699 16 ModSev TR

Matsuyama 46174 26 Mod + TR

Fukuda Circulation 2006114I-492

Normal Tricuspid Annulus Tricuspid Annulus with Functional TR

Annular Dilation Shape Change of FTR

75- all cases of MR

-40

-20

0

20

40

-40 -20 0 20 40

-40

-20

0

20

40

-40 -20 0 20 40

TR is ignored STS Database

MR + TR

Annual New MR

Annual MR Surgeries

Annual TR Surgeries

MR - 4000000

TR - 1600000250000

60000

7000 TVr

Why Not Fix TR at Surgery

bull 136 pts mostly TV repair

bull 8 yr follow up PPM in 21

I HATE PACEMAKERS

Tricuspid Repair Rate when fixing MR

Based on Preop TR Grade

139

39

79

0

20

40

60

80

100

Percent of Patients Having Tricuspid Repair

Preoperative TR Grade

None Mild Moderate Severe

Source STS Database N = 46500

V 273 2011-2013

FTR Reality

Modsevere TR - Bad

TR ring - Good

TVR - Sad

Percutaneous Implications for TR

FTR Percutaneous ldquoNotrdquo Rings

Tricuspid Regurgitation

4-TECH

Tricuspid Regurgitation

Mitralignhellip Trialign

FTR Perc McKay

FAILED

bull 4 pledgets

bull 2 Locks

bull Target Full Posterior Annulus

2 Pair

29

Pre Procedure Post 2nd PairPost 1st Pair

Perc DeVega

31

1214 patients received one pair of implants

Average annular reduction ndash 35

Average EROA reduction ndash 58

Adverse event ndash 1 access complication

0

5

10

15

20

25

Pre Procedure Post Procedure

Annular Area cm2

0

05

1

15

2

25

3

35

4

45

5

Pre Procedure Post Procedure

EROA cm2

10 cm2 15 cm2

Tricuspid Percutaneous - Myth

TR goal is different

TR grades 1- 4 andhellip

5+ ldquomassiverdquo

6+ ldquotorrentialrdquo

FTR Percutaneous ldquoother thingsrdquo

Remain calm

Carry on

FTR Surgery Percutaneous Implications

TV Perc

Rings

Tricuspid Regurgitation

Cardioband

36

Pre-op Echo 4+ MR 3-4+ TR

Millipede

Post MVR TVR Millipede FLUORO

37

24 month Post MVR TVR Millipede TTE

38

24 month Post MVR TVR Millipede TTE

39

Tricuspid Regurgitation - Reality

TR is BADldquoThe biology of TR will not change

with the method of therapyrdquo

A new grading method

will not ldquofoolrdquo nature

TR severity - reality

Sustained meaningful

reduction of TR

TR Percutaneous Myth and reality

Less impacthellipEarlier intervention

Best TR is zero

Good enough 1-2+TR

Reality Huge market - $$

Patients want ithellipit will happen

Page 18: Percutaneous technologies to correct TR : Myth or … A...PASP, LVEF, IVC size, RV size/ function, 5223 pts Severe and MODERATE TR decreases survival Having TR is BAD ! Topilsky. JACC

Gammie JS Annals of Thoracic Surgery 2009

Yilmaz J Thorac Cardiovasc Surg 2011142608

Matsuyama Ann Thorac Surg 2003751826

Do many patients have TR

STS Database 58000 Patients Isolated MR

Moderate TR 124

Severe TR 71

Moderate or Severe 195

Mayo 115699 16 ModSev TR

Matsuyama 46174 26 Mod + TR

Fukuda Circulation 2006114I-492

Normal Tricuspid Annulus Tricuspid Annulus with Functional TR

Annular Dilation Shape Change of FTR

75- all cases of MR

-40

-20

0

20

40

-40 -20 0 20 40

-40

-20

0

20

40

-40 -20 0 20 40

TR is ignored STS Database

MR + TR

Annual New MR

Annual MR Surgeries

Annual TR Surgeries

MR - 4000000

TR - 1600000250000

60000

7000 TVr

Why Not Fix TR at Surgery

bull 136 pts mostly TV repair

bull 8 yr follow up PPM in 21

I HATE PACEMAKERS

Tricuspid Repair Rate when fixing MR

Based on Preop TR Grade

139

39

79

0

20

40

60

80

100

Percent of Patients Having Tricuspid Repair

Preoperative TR Grade

None Mild Moderate Severe

Source STS Database N = 46500

V 273 2011-2013

FTR Reality

Modsevere TR - Bad

TR ring - Good

TVR - Sad

Percutaneous Implications for TR

FTR Percutaneous ldquoNotrdquo Rings

Tricuspid Regurgitation

4-TECH

Tricuspid Regurgitation

Mitralignhellip Trialign

FTR Perc McKay

FAILED

bull 4 pledgets

bull 2 Locks

bull Target Full Posterior Annulus

2 Pair

29

Pre Procedure Post 2nd PairPost 1st Pair

Perc DeVega

31

1214 patients received one pair of implants

Average annular reduction ndash 35

Average EROA reduction ndash 58

Adverse event ndash 1 access complication

0

5

10

15

20

25

Pre Procedure Post Procedure

Annular Area cm2

0

05

1

15

2

25

3

35

4

45

5

Pre Procedure Post Procedure

EROA cm2

10 cm2 15 cm2

Tricuspid Percutaneous - Myth

TR goal is different

TR grades 1- 4 andhellip

5+ ldquomassiverdquo

6+ ldquotorrentialrdquo

FTR Percutaneous ldquoother thingsrdquo

Remain calm

Carry on

FTR Surgery Percutaneous Implications

TV Perc

Rings

Tricuspid Regurgitation

Cardioband

36

Pre-op Echo 4+ MR 3-4+ TR

Millipede

Post MVR TVR Millipede FLUORO

37

24 month Post MVR TVR Millipede TTE

38

24 month Post MVR TVR Millipede TTE

39

Tricuspid Regurgitation - Reality

TR is BADldquoThe biology of TR will not change

with the method of therapyrdquo

A new grading method

will not ldquofoolrdquo nature

TR severity - reality

Sustained meaningful

reduction of TR

TR Percutaneous Myth and reality

Less impacthellipEarlier intervention

Best TR is zero

Good enough 1-2+TR

Reality Huge market - $$

Patients want ithellipit will happen

Page 19: Percutaneous technologies to correct TR : Myth or … A...PASP, LVEF, IVC size, RV size/ function, 5223 pts Severe and MODERATE TR decreases survival Having TR is BAD ! Topilsky. JACC

Fukuda Circulation 2006114I-492

Normal Tricuspid Annulus Tricuspid Annulus with Functional TR

Annular Dilation Shape Change of FTR

75- all cases of MR

-40

-20

0

20

40

-40 -20 0 20 40

-40

-20

0

20

40

-40 -20 0 20 40

TR is ignored STS Database

MR + TR

Annual New MR

Annual MR Surgeries

Annual TR Surgeries

MR - 4000000

TR - 1600000250000

60000

7000 TVr

Why Not Fix TR at Surgery

bull 136 pts mostly TV repair

bull 8 yr follow up PPM in 21

I HATE PACEMAKERS

Tricuspid Repair Rate when fixing MR

Based on Preop TR Grade

139

39

79

0

20

40

60

80

100

Percent of Patients Having Tricuspid Repair

Preoperative TR Grade

None Mild Moderate Severe

Source STS Database N = 46500

V 273 2011-2013

FTR Reality

Modsevere TR - Bad

TR ring - Good

TVR - Sad

Percutaneous Implications for TR

FTR Percutaneous ldquoNotrdquo Rings

Tricuspid Regurgitation

4-TECH

Tricuspid Regurgitation

Mitralignhellip Trialign

FTR Perc McKay

FAILED

bull 4 pledgets

bull 2 Locks

bull Target Full Posterior Annulus

2 Pair

29

Pre Procedure Post 2nd PairPost 1st Pair

Perc DeVega

31

1214 patients received one pair of implants

Average annular reduction ndash 35

Average EROA reduction ndash 58

Adverse event ndash 1 access complication

0

5

10

15

20

25

Pre Procedure Post Procedure

Annular Area cm2

0

05

1

15

2

25

3

35

4

45

5

Pre Procedure Post Procedure

EROA cm2

10 cm2 15 cm2

Tricuspid Percutaneous - Myth

TR goal is different

TR grades 1- 4 andhellip

5+ ldquomassiverdquo

6+ ldquotorrentialrdquo

FTR Percutaneous ldquoother thingsrdquo

Remain calm

Carry on

FTR Surgery Percutaneous Implications

TV Perc

Rings

Tricuspid Regurgitation

Cardioband

36

Pre-op Echo 4+ MR 3-4+ TR

Millipede

Post MVR TVR Millipede FLUORO

37

24 month Post MVR TVR Millipede TTE

38

24 month Post MVR TVR Millipede TTE

39

Tricuspid Regurgitation - Reality

TR is BADldquoThe biology of TR will not change

with the method of therapyrdquo

A new grading method

will not ldquofoolrdquo nature

TR severity - reality

Sustained meaningful

reduction of TR

TR Percutaneous Myth and reality

Less impacthellipEarlier intervention

Best TR is zero

Good enough 1-2+TR

Reality Huge market - $$

Patients want ithellipit will happen

Page 20: Percutaneous technologies to correct TR : Myth or … A...PASP, LVEF, IVC size, RV size/ function, 5223 pts Severe and MODERATE TR decreases survival Having TR is BAD ! Topilsky. JACC

TR is ignored STS Database

MR + TR

Annual New MR

Annual MR Surgeries

Annual TR Surgeries

MR - 4000000

TR - 1600000250000

60000

7000 TVr

Why Not Fix TR at Surgery

bull 136 pts mostly TV repair

bull 8 yr follow up PPM in 21

I HATE PACEMAKERS

Tricuspid Repair Rate when fixing MR

Based on Preop TR Grade

139

39

79

0

20

40

60

80

100

Percent of Patients Having Tricuspid Repair

Preoperative TR Grade

None Mild Moderate Severe

Source STS Database N = 46500

V 273 2011-2013

FTR Reality

Modsevere TR - Bad

TR ring - Good

TVR - Sad

Percutaneous Implications for TR

FTR Percutaneous ldquoNotrdquo Rings

Tricuspid Regurgitation

4-TECH

Tricuspid Regurgitation

Mitralignhellip Trialign

FTR Perc McKay

FAILED

bull 4 pledgets

bull 2 Locks

bull Target Full Posterior Annulus

2 Pair

29

Pre Procedure Post 2nd PairPost 1st Pair

Perc DeVega

31

1214 patients received one pair of implants

Average annular reduction ndash 35

Average EROA reduction ndash 58

Adverse event ndash 1 access complication

0

5

10

15

20

25

Pre Procedure Post Procedure

Annular Area cm2

0

05

1

15

2

25

3

35

4

45

5

Pre Procedure Post Procedure

EROA cm2

10 cm2 15 cm2

Tricuspid Percutaneous - Myth

TR goal is different

TR grades 1- 4 andhellip

5+ ldquomassiverdquo

6+ ldquotorrentialrdquo

FTR Percutaneous ldquoother thingsrdquo

Remain calm

Carry on

FTR Surgery Percutaneous Implications

TV Perc

Rings

Tricuspid Regurgitation

Cardioband

36

Pre-op Echo 4+ MR 3-4+ TR

Millipede

Post MVR TVR Millipede FLUORO

37

24 month Post MVR TVR Millipede TTE

38

24 month Post MVR TVR Millipede TTE

39

Tricuspid Regurgitation - Reality

TR is BADldquoThe biology of TR will not change

with the method of therapyrdquo

A new grading method

will not ldquofoolrdquo nature

TR severity - reality

Sustained meaningful

reduction of TR

TR Percutaneous Myth and reality

Less impacthellipEarlier intervention

Best TR is zero

Good enough 1-2+TR

Reality Huge market - $$

Patients want ithellipit will happen

Page 21: Percutaneous technologies to correct TR : Myth or … A...PASP, LVEF, IVC size, RV size/ function, 5223 pts Severe and MODERATE TR decreases survival Having TR is BAD ! Topilsky. JACC

Why Not Fix TR at Surgery

bull 136 pts mostly TV repair

bull 8 yr follow up PPM in 21

I HATE PACEMAKERS

Tricuspid Repair Rate when fixing MR

Based on Preop TR Grade

139

39

79

0

20

40

60

80

100

Percent of Patients Having Tricuspid Repair

Preoperative TR Grade

None Mild Moderate Severe

Source STS Database N = 46500

V 273 2011-2013

FTR Reality

Modsevere TR - Bad

TR ring - Good

TVR - Sad

Percutaneous Implications for TR

FTR Percutaneous ldquoNotrdquo Rings

Tricuspid Regurgitation

4-TECH

Tricuspid Regurgitation

Mitralignhellip Trialign

FTR Perc McKay

FAILED

bull 4 pledgets

bull 2 Locks

bull Target Full Posterior Annulus

2 Pair

29

Pre Procedure Post 2nd PairPost 1st Pair

Perc DeVega

31

1214 patients received one pair of implants

Average annular reduction ndash 35

Average EROA reduction ndash 58

Adverse event ndash 1 access complication

0

5

10

15

20

25

Pre Procedure Post Procedure

Annular Area cm2

0

05

1

15

2

25

3

35

4

45

5

Pre Procedure Post Procedure

EROA cm2

10 cm2 15 cm2

Tricuspid Percutaneous - Myth

TR goal is different

TR grades 1- 4 andhellip

5+ ldquomassiverdquo

6+ ldquotorrentialrdquo

FTR Percutaneous ldquoother thingsrdquo

Remain calm

Carry on

FTR Surgery Percutaneous Implications

TV Perc

Rings

Tricuspid Regurgitation

Cardioband

36

Pre-op Echo 4+ MR 3-4+ TR

Millipede

Post MVR TVR Millipede FLUORO

37

24 month Post MVR TVR Millipede TTE

38

24 month Post MVR TVR Millipede TTE

39

Tricuspid Regurgitation - Reality

TR is BADldquoThe biology of TR will not change

with the method of therapyrdquo

A new grading method

will not ldquofoolrdquo nature

TR severity - reality

Sustained meaningful

reduction of TR

TR Percutaneous Myth and reality

Less impacthellipEarlier intervention

Best TR is zero

Good enough 1-2+TR

Reality Huge market - $$

Patients want ithellipit will happen

Page 22: Percutaneous technologies to correct TR : Myth or … A...PASP, LVEF, IVC size, RV size/ function, 5223 pts Severe and MODERATE TR decreases survival Having TR is BAD ! Topilsky. JACC

Tricuspid Repair Rate when fixing MR

Based on Preop TR Grade

139

39

79

0

20

40

60

80

100

Percent of Patients Having Tricuspid Repair

Preoperative TR Grade

None Mild Moderate Severe

Source STS Database N = 46500

V 273 2011-2013

FTR Reality

Modsevere TR - Bad

TR ring - Good

TVR - Sad

Percutaneous Implications for TR

FTR Percutaneous ldquoNotrdquo Rings

Tricuspid Regurgitation

4-TECH

Tricuspid Regurgitation

Mitralignhellip Trialign

FTR Perc McKay

FAILED

bull 4 pledgets

bull 2 Locks

bull Target Full Posterior Annulus

2 Pair

29

Pre Procedure Post 2nd PairPost 1st Pair

Perc DeVega

31

1214 patients received one pair of implants

Average annular reduction ndash 35

Average EROA reduction ndash 58

Adverse event ndash 1 access complication

0

5

10

15

20

25

Pre Procedure Post Procedure

Annular Area cm2

0

05

1

15

2

25

3

35

4

45

5

Pre Procedure Post Procedure

EROA cm2

10 cm2 15 cm2

Tricuspid Percutaneous - Myth

TR goal is different

TR grades 1- 4 andhellip

5+ ldquomassiverdquo

6+ ldquotorrentialrdquo

FTR Percutaneous ldquoother thingsrdquo

Remain calm

Carry on

FTR Surgery Percutaneous Implications

TV Perc

Rings

Tricuspid Regurgitation

Cardioband

36

Pre-op Echo 4+ MR 3-4+ TR

Millipede

Post MVR TVR Millipede FLUORO

37

24 month Post MVR TVR Millipede TTE

38

24 month Post MVR TVR Millipede TTE

39

Tricuspid Regurgitation - Reality

TR is BADldquoThe biology of TR will not change

with the method of therapyrdquo

A new grading method

will not ldquofoolrdquo nature

TR severity - reality

Sustained meaningful

reduction of TR

TR Percutaneous Myth and reality

Less impacthellipEarlier intervention

Best TR is zero

Good enough 1-2+TR

Reality Huge market - $$

Patients want ithellipit will happen

Page 23: Percutaneous technologies to correct TR : Myth or … A...PASP, LVEF, IVC size, RV size/ function, 5223 pts Severe and MODERATE TR decreases survival Having TR is BAD ! Topilsky. JACC

FTR Reality

Modsevere TR - Bad

TR ring - Good

TVR - Sad

Percutaneous Implications for TR

FTR Percutaneous ldquoNotrdquo Rings

Tricuspid Regurgitation

4-TECH

Tricuspid Regurgitation

Mitralignhellip Trialign

FTR Perc McKay

FAILED

bull 4 pledgets

bull 2 Locks

bull Target Full Posterior Annulus

2 Pair

29

Pre Procedure Post 2nd PairPost 1st Pair

Perc DeVega

31

1214 patients received one pair of implants

Average annular reduction ndash 35

Average EROA reduction ndash 58

Adverse event ndash 1 access complication

0

5

10

15

20

25

Pre Procedure Post Procedure

Annular Area cm2

0

05

1

15

2

25

3

35

4

45

5

Pre Procedure Post Procedure

EROA cm2

10 cm2 15 cm2

Tricuspid Percutaneous - Myth

TR goal is different

TR grades 1- 4 andhellip

5+ ldquomassiverdquo

6+ ldquotorrentialrdquo

FTR Percutaneous ldquoother thingsrdquo

Remain calm

Carry on

FTR Surgery Percutaneous Implications

TV Perc

Rings

Tricuspid Regurgitation

Cardioband

36

Pre-op Echo 4+ MR 3-4+ TR

Millipede

Post MVR TVR Millipede FLUORO

37

24 month Post MVR TVR Millipede TTE

38

24 month Post MVR TVR Millipede TTE

39

Tricuspid Regurgitation - Reality

TR is BADldquoThe biology of TR will not change

with the method of therapyrdquo

A new grading method

will not ldquofoolrdquo nature

TR severity - reality

Sustained meaningful

reduction of TR

TR Percutaneous Myth and reality

Less impacthellipEarlier intervention

Best TR is zero

Good enough 1-2+TR

Reality Huge market - $$

Patients want ithellipit will happen

Page 24: Percutaneous technologies to correct TR : Myth or … A...PASP, LVEF, IVC size, RV size/ function, 5223 pts Severe and MODERATE TR decreases survival Having TR is BAD ! Topilsky. JACC

Percutaneous Implications for TR

FTR Percutaneous ldquoNotrdquo Rings

Tricuspid Regurgitation

4-TECH

Tricuspid Regurgitation

Mitralignhellip Trialign

FTR Perc McKay

FAILED

bull 4 pledgets

bull 2 Locks

bull Target Full Posterior Annulus

2 Pair

29

Pre Procedure Post 2nd PairPost 1st Pair

Perc DeVega

31

1214 patients received one pair of implants

Average annular reduction ndash 35

Average EROA reduction ndash 58

Adverse event ndash 1 access complication

0

5

10

15

20

25

Pre Procedure Post Procedure

Annular Area cm2

0

05

1

15

2

25

3

35

4

45

5

Pre Procedure Post Procedure

EROA cm2

10 cm2 15 cm2

Tricuspid Percutaneous - Myth

TR goal is different

TR grades 1- 4 andhellip

5+ ldquomassiverdquo

6+ ldquotorrentialrdquo

FTR Percutaneous ldquoother thingsrdquo

Remain calm

Carry on

FTR Surgery Percutaneous Implications

TV Perc

Rings

Tricuspid Regurgitation

Cardioband

36

Pre-op Echo 4+ MR 3-4+ TR

Millipede

Post MVR TVR Millipede FLUORO

37

24 month Post MVR TVR Millipede TTE

38

24 month Post MVR TVR Millipede TTE

39

Tricuspid Regurgitation - Reality

TR is BADldquoThe biology of TR will not change

with the method of therapyrdquo

A new grading method

will not ldquofoolrdquo nature

TR severity - reality

Sustained meaningful

reduction of TR

TR Percutaneous Myth and reality

Less impacthellipEarlier intervention

Best TR is zero

Good enough 1-2+TR

Reality Huge market - $$

Patients want ithellipit will happen

Page 25: Percutaneous technologies to correct TR : Myth or … A...PASP, LVEF, IVC size, RV size/ function, 5223 pts Severe and MODERATE TR decreases survival Having TR is BAD ! Topilsky. JACC

FTR Percutaneous ldquoNotrdquo Rings

Tricuspid Regurgitation

4-TECH

Tricuspid Regurgitation

Mitralignhellip Trialign

FTR Perc McKay

FAILED

bull 4 pledgets

bull 2 Locks

bull Target Full Posterior Annulus

2 Pair

29

Pre Procedure Post 2nd PairPost 1st Pair

Perc DeVega

31

1214 patients received one pair of implants

Average annular reduction ndash 35

Average EROA reduction ndash 58

Adverse event ndash 1 access complication

0

5

10

15

20

25

Pre Procedure Post Procedure

Annular Area cm2

0

05

1

15

2

25

3

35

4

45

5

Pre Procedure Post Procedure

EROA cm2

10 cm2 15 cm2

Tricuspid Percutaneous - Myth

TR goal is different

TR grades 1- 4 andhellip

5+ ldquomassiverdquo

6+ ldquotorrentialrdquo

FTR Percutaneous ldquoother thingsrdquo

Remain calm

Carry on

FTR Surgery Percutaneous Implications

TV Perc

Rings

Tricuspid Regurgitation

Cardioband

36

Pre-op Echo 4+ MR 3-4+ TR

Millipede

Post MVR TVR Millipede FLUORO

37

24 month Post MVR TVR Millipede TTE

38

24 month Post MVR TVR Millipede TTE

39

Tricuspid Regurgitation - Reality

TR is BADldquoThe biology of TR will not change

with the method of therapyrdquo

A new grading method

will not ldquofoolrdquo nature

TR severity - reality

Sustained meaningful

reduction of TR

TR Percutaneous Myth and reality

Less impacthellipEarlier intervention

Best TR is zero

Good enough 1-2+TR

Reality Huge market - $$

Patients want ithellipit will happen

Page 26: Percutaneous technologies to correct TR : Myth or … A...PASP, LVEF, IVC size, RV size/ function, 5223 pts Severe and MODERATE TR decreases survival Having TR is BAD ! Topilsky. JACC

Tricuspid Regurgitation

4-TECH

Tricuspid Regurgitation

Mitralignhellip Trialign

FTR Perc McKay

FAILED

bull 4 pledgets

bull 2 Locks

bull Target Full Posterior Annulus

2 Pair

29

Pre Procedure Post 2nd PairPost 1st Pair

Perc DeVega

31

1214 patients received one pair of implants

Average annular reduction ndash 35

Average EROA reduction ndash 58

Adverse event ndash 1 access complication

0

5

10

15

20

25

Pre Procedure Post Procedure

Annular Area cm2

0

05

1

15

2

25

3

35

4

45

5

Pre Procedure Post Procedure

EROA cm2

10 cm2 15 cm2

Tricuspid Percutaneous - Myth

TR goal is different

TR grades 1- 4 andhellip

5+ ldquomassiverdquo

6+ ldquotorrentialrdquo

FTR Percutaneous ldquoother thingsrdquo

Remain calm

Carry on

FTR Surgery Percutaneous Implications

TV Perc

Rings

Tricuspid Regurgitation

Cardioband

36

Pre-op Echo 4+ MR 3-4+ TR

Millipede

Post MVR TVR Millipede FLUORO

37

24 month Post MVR TVR Millipede TTE

38

24 month Post MVR TVR Millipede TTE

39

Tricuspid Regurgitation - Reality

TR is BADldquoThe biology of TR will not change

with the method of therapyrdquo

A new grading method

will not ldquofoolrdquo nature

TR severity - reality

Sustained meaningful

reduction of TR

TR Percutaneous Myth and reality

Less impacthellipEarlier intervention

Best TR is zero

Good enough 1-2+TR

Reality Huge market - $$

Patients want ithellipit will happen

Page 27: Percutaneous technologies to correct TR : Myth or … A...PASP, LVEF, IVC size, RV size/ function, 5223 pts Severe and MODERATE TR decreases survival Having TR is BAD ! Topilsky. JACC

Tricuspid Regurgitation

Mitralignhellip Trialign

FTR Perc McKay

FAILED

bull 4 pledgets

bull 2 Locks

bull Target Full Posterior Annulus

2 Pair

29

Pre Procedure Post 2nd PairPost 1st Pair

Perc DeVega

31

1214 patients received one pair of implants

Average annular reduction ndash 35

Average EROA reduction ndash 58

Adverse event ndash 1 access complication

0

5

10

15

20

25

Pre Procedure Post Procedure

Annular Area cm2

0

05

1

15

2

25

3

35

4

45

5

Pre Procedure Post Procedure

EROA cm2

10 cm2 15 cm2

Tricuspid Percutaneous - Myth

TR goal is different

TR grades 1- 4 andhellip

5+ ldquomassiverdquo

6+ ldquotorrentialrdquo

FTR Percutaneous ldquoother thingsrdquo

Remain calm

Carry on

FTR Surgery Percutaneous Implications

TV Perc

Rings

Tricuspid Regurgitation

Cardioband

36

Pre-op Echo 4+ MR 3-4+ TR

Millipede

Post MVR TVR Millipede FLUORO

37

24 month Post MVR TVR Millipede TTE

38

24 month Post MVR TVR Millipede TTE

39

Tricuspid Regurgitation - Reality

TR is BADldquoThe biology of TR will not change

with the method of therapyrdquo

A new grading method

will not ldquofoolrdquo nature

TR severity - reality

Sustained meaningful

reduction of TR

TR Percutaneous Myth and reality

Less impacthellipEarlier intervention

Best TR is zero

Good enough 1-2+TR

Reality Huge market - $$

Patients want ithellipit will happen

Page 28: Percutaneous technologies to correct TR : Myth or … A...PASP, LVEF, IVC size, RV size/ function, 5223 pts Severe and MODERATE TR decreases survival Having TR is BAD ! Topilsky. JACC

FTR Perc McKay

FAILED

bull 4 pledgets

bull 2 Locks

bull Target Full Posterior Annulus

2 Pair

29

Pre Procedure Post 2nd PairPost 1st Pair

Perc DeVega

31

1214 patients received one pair of implants

Average annular reduction ndash 35

Average EROA reduction ndash 58

Adverse event ndash 1 access complication

0

5

10

15

20

25

Pre Procedure Post Procedure

Annular Area cm2

0

05

1

15

2

25

3

35

4

45

5

Pre Procedure Post Procedure

EROA cm2

10 cm2 15 cm2

Tricuspid Percutaneous - Myth

TR goal is different

TR grades 1- 4 andhellip

5+ ldquomassiverdquo

6+ ldquotorrentialrdquo

FTR Percutaneous ldquoother thingsrdquo

Remain calm

Carry on

FTR Surgery Percutaneous Implications

TV Perc

Rings

Tricuspid Regurgitation

Cardioband

36

Pre-op Echo 4+ MR 3-4+ TR

Millipede

Post MVR TVR Millipede FLUORO

37

24 month Post MVR TVR Millipede TTE

38

24 month Post MVR TVR Millipede TTE

39

Tricuspid Regurgitation - Reality

TR is BADldquoThe biology of TR will not change

with the method of therapyrdquo

A new grading method

will not ldquofoolrdquo nature

TR severity - reality

Sustained meaningful

reduction of TR

TR Percutaneous Myth and reality

Less impacthellipEarlier intervention

Best TR is zero

Good enough 1-2+TR

Reality Huge market - $$

Patients want ithellipit will happen

Page 29: Percutaneous technologies to correct TR : Myth or … A...PASP, LVEF, IVC size, RV size/ function, 5223 pts Severe and MODERATE TR decreases survival Having TR is BAD ! Topilsky. JACC

bull 4 pledgets

bull 2 Locks

bull Target Full Posterior Annulus

2 Pair

29

Pre Procedure Post 2nd PairPost 1st Pair

Perc DeVega

31

1214 patients received one pair of implants

Average annular reduction ndash 35

Average EROA reduction ndash 58

Adverse event ndash 1 access complication

0

5

10

15

20

25

Pre Procedure Post Procedure

Annular Area cm2

0

05

1

15

2

25

3

35

4

45

5

Pre Procedure Post Procedure

EROA cm2

10 cm2 15 cm2

Tricuspid Percutaneous - Myth

TR goal is different

TR grades 1- 4 andhellip

5+ ldquomassiverdquo

6+ ldquotorrentialrdquo

FTR Percutaneous ldquoother thingsrdquo

Remain calm

Carry on

FTR Surgery Percutaneous Implications

TV Perc

Rings

Tricuspid Regurgitation

Cardioband

36

Pre-op Echo 4+ MR 3-4+ TR

Millipede

Post MVR TVR Millipede FLUORO

37

24 month Post MVR TVR Millipede TTE

38

24 month Post MVR TVR Millipede TTE

39

Tricuspid Regurgitation - Reality

TR is BADldquoThe biology of TR will not change

with the method of therapyrdquo

A new grading method

will not ldquofoolrdquo nature

TR severity - reality

Sustained meaningful

reduction of TR

TR Percutaneous Myth and reality

Less impacthellipEarlier intervention

Best TR is zero

Good enough 1-2+TR

Reality Huge market - $$

Patients want ithellipit will happen

Page 30: Percutaneous technologies to correct TR : Myth or … A...PASP, LVEF, IVC size, RV size/ function, 5223 pts Severe and MODERATE TR decreases survival Having TR is BAD ! Topilsky. JACC

Pre Procedure Post 2nd PairPost 1st Pair

Perc DeVega

31

1214 patients received one pair of implants

Average annular reduction ndash 35

Average EROA reduction ndash 58

Adverse event ndash 1 access complication

0

5

10

15

20

25

Pre Procedure Post Procedure

Annular Area cm2

0

05

1

15

2

25

3

35

4

45

5

Pre Procedure Post Procedure

EROA cm2

10 cm2 15 cm2

Tricuspid Percutaneous - Myth

TR goal is different

TR grades 1- 4 andhellip

5+ ldquomassiverdquo

6+ ldquotorrentialrdquo

FTR Percutaneous ldquoother thingsrdquo

Remain calm

Carry on

FTR Surgery Percutaneous Implications

TV Perc

Rings

Tricuspid Regurgitation

Cardioband

36

Pre-op Echo 4+ MR 3-4+ TR

Millipede

Post MVR TVR Millipede FLUORO

37

24 month Post MVR TVR Millipede TTE

38

24 month Post MVR TVR Millipede TTE

39

Tricuspid Regurgitation - Reality

TR is BADldquoThe biology of TR will not change

with the method of therapyrdquo

A new grading method

will not ldquofoolrdquo nature

TR severity - reality

Sustained meaningful

reduction of TR

TR Percutaneous Myth and reality

Less impacthellipEarlier intervention

Best TR is zero

Good enough 1-2+TR

Reality Huge market - $$

Patients want ithellipit will happen

Page 31: Percutaneous technologies to correct TR : Myth or … A...PASP, LVEF, IVC size, RV size/ function, 5223 pts Severe and MODERATE TR decreases survival Having TR is BAD ! Topilsky. JACC

31

1214 patients received one pair of implants

Average annular reduction ndash 35

Average EROA reduction ndash 58

Adverse event ndash 1 access complication

0

5

10

15

20

25

Pre Procedure Post Procedure

Annular Area cm2

0

05

1

15

2

25

3

35

4

45

5

Pre Procedure Post Procedure

EROA cm2

10 cm2 15 cm2

Tricuspid Percutaneous - Myth

TR goal is different

TR grades 1- 4 andhellip

5+ ldquomassiverdquo

6+ ldquotorrentialrdquo

FTR Percutaneous ldquoother thingsrdquo

Remain calm

Carry on

FTR Surgery Percutaneous Implications

TV Perc

Rings

Tricuspid Regurgitation

Cardioband

36

Pre-op Echo 4+ MR 3-4+ TR

Millipede

Post MVR TVR Millipede FLUORO

37

24 month Post MVR TVR Millipede TTE

38

24 month Post MVR TVR Millipede TTE

39

Tricuspid Regurgitation - Reality

TR is BADldquoThe biology of TR will not change

with the method of therapyrdquo

A new grading method

will not ldquofoolrdquo nature

TR severity - reality

Sustained meaningful

reduction of TR

TR Percutaneous Myth and reality

Less impacthellipEarlier intervention

Best TR is zero

Good enough 1-2+TR

Reality Huge market - $$

Patients want ithellipit will happen

Page 32: Percutaneous technologies to correct TR : Myth or … A...PASP, LVEF, IVC size, RV size/ function, 5223 pts Severe and MODERATE TR decreases survival Having TR is BAD ! Topilsky. JACC

Tricuspid Percutaneous - Myth

TR goal is different

TR grades 1- 4 andhellip

5+ ldquomassiverdquo

6+ ldquotorrentialrdquo

FTR Percutaneous ldquoother thingsrdquo

Remain calm

Carry on

FTR Surgery Percutaneous Implications

TV Perc

Rings

Tricuspid Regurgitation

Cardioband

36

Pre-op Echo 4+ MR 3-4+ TR

Millipede

Post MVR TVR Millipede FLUORO

37

24 month Post MVR TVR Millipede TTE

38

24 month Post MVR TVR Millipede TTE

39

Tricuspid Regurgitation - Reality

TR is BADldquoThe biology of TR will not change

with the method of therapyrdquo

A new grading method

will not ldquofoolrdquo nature

TR severity - reality

Sustained meaningful

reduction of TR

TR Percutaneous Myth and reality

Less impacthellipEarlier intervention

Best TR is zero

Good enough 1-2+TR

Reality Huge market - $$

Patients want ithellipit will happen

Page 33: Percutaneous technologies to correct TR : Myth or … A...PASP, LVEF, IVC size, RV size/ function, 5223 pts Severe and MODERATE TR decreases survival Having TR is BAD ! Topilsky. JACC

FTR Percutaneous ldquoother thingsrdquo

Remain calm

Carry on

FTR Surgery Percutaneous Implications

TV Perc

Rings

Tricuspid Regurgitation

Cardioband

36

Pre-op Echo 4+ MR 3-4+ TR

Millipede

Post MVR TVR Millipede FLUORO

37

24 month Post MVR TVR Millipede TTE

38

24 month Post MVR TVR Millipede TTE

39

Tricuspid Regurgitation - Reality

TR is BADldquoThe biology of TR will not change

with the method of therapyrdquo

A new grading method

will not ldquofoolrdquo nature

TR severity - reality

Sustained meaningful

reduction of TR

TR Percutaneous Myth and reality

Less impacthellipEarlier intervention

Best TR is zero

Good enough 1-2+TR

Reality Huge market - $$

Patients want ithellipit will happen

Page 34: Percutaneous technologies to correct TR : Myth or … A...PASP, LVEF, IVC size, RV size/ function, 5223 pts Severe and MODERATE TR decreases survival Having TR is BAD ! Topilsky. JACC

FTR Surgery Percutaneous Implications

TV Perc

Rings

Tricuspid Regurgitation

Cardioband

36

Pre-op Echo 4+ MR 3-4+ TR

Millipede

Post MVR TVR Millipede FLUORO

37

24 month Post MVR TVR Millipede TTE

38

24 month Post MVR TVR Millipede TTE

39

Tricuspid Regurgitation - Reality

TR is BADldquoThe biology of TR will not change

with the method of therapyrdquo

A new grading method

will not ldquofoolrdquo nature

TR severity - reality

Sustained meaningful

reduction of TR

TR Percutaneous Myth and reality

Less impacthellipEarlier intervention

Best TR is zero

Good enough 1-2+TR

Reality Huge market - $$

Patients want ithellipit will happen

Page 35: Percutaneous technologies to correct TR : Myth or … A...PASP, LVEF, IVC size, RV size/ function, 5223 pts Severe and MODERATE TR decreases survival Having TR is BAD ! Topilsky. JACC

Tricuspid Regurgitation

Cardioband

36

Pre-op Echo 4+ MR 3-4+ TR

Millipede

Post MVR TVR Millipede FLUORO

37

24 month Post MVR TVR Millipede TTE

38

24 month Post MVR TVR Millipede TTE

39

Tricuspid Regurgitation - Reality

TR is BADldquoThe biology of TR will not change

with the method of therapyrdquo

A new grading method

will not ldquofoolrdquo nature

TR severity - reality

Sustained meaningful

reduction of TR

TR Percutaneous Myth and reality

Less impacthellipEarlier intervention

Best TR is zero

Good enough 1-2+TR

Reality Huge market - $$

Patients want ithellipit will happen

Page 36: Percutaneous technologies to correct TR : Myth or … A...PASP, LVEF, IVC size, RV size/ function, 5223 pts Severe and MODERATE TR decreases survival Having TR is BAD ! Topilsky. JACC

36

Pre-op Echo 4+ MR 3-4+ TR

Millipede

Post MVR TVR Millipede FLUORO

37

24 month Post MVR TVR Millipede TTE

38

24 month Post MVR TVR Millipede TTE

39

Tricuspid Regurgitation - Reality

TR is BADldquoThe biology of TR will not change

with the method of therapyrdquo

A new grading method

will not ldquofoolrdquo nature

TR severity - reality

Sustained meaningful

reduction of TR

TR Percutaneous Myth and reality

Less impacthellipEarlier intervention

Best TR is zero

Good enough 1-2+TR

Reality Huge market - $$

Patients want ithellipit will happen

Page 37: Percutaneous technologies to correct TR : Myth or … A...PASP, LVEF, IVC size, RV size/ function, 5223 pts Severe and MODERATE TR decreases survival Having TR is BAD ! Topilsky. JACC

Post MVR TVR Millipede FLUORO

37

24 month Post MVR TVR Millipede TTE

38

24 month Post MVR TVR Millipede TTE

39

Tricuspid Regurgitation - Reality

TR is BADldquoThe biology of TR will not change

with the method of therapyrdquo

A new grading method

will not ldquofoolrdquo nature

TR severity - reality

Sustained meaningful

reduction of TR

TR Percutaneous Myth and reality

Less impacthellipEarlier intervention

Best TR is zero

Good enough 1-2+TR

Reality Huge market - $$

Patients want ithellipit will happen

Page 38: Percutaneous technologies to correct TR : Myth or … A...PASP, LVEF, IVC size, RV size/ function, 5223 pts Severe and MODERATE TR decreases survival Having TR is BAD ! Topilsky. JACC

24 month Post MVR TVR Millipede TTE

38

24 month Post MVR TVR Millipede TTE

39

Tricuspid Regurgitation - Reality

TR is BADldquoThe biology of TR will not change

with the method of therapyrdquo

A new grading method

will not ldquofoolrdquo nature

TR severity - reality

Sustained meaningful

reduction of TR

TR Percutaneous Myth and reality

Less impacthellipEarlier intervention

Best TR is zero

Good enough 1-2+TR

Reality Huge market - $$

Patients want ithellipit will happen

Page 39: Percutaneous technologies to correct TR : Myth or … A...PASP, LVEF, IVC size, RV size/ function, 5223 pts Severe and MODERATE TR decreases survival Having TR is BAD ! Topilsky. JACC

24 month Post MVR TVR Millipede TTE

39

Tricuspid Regurgitation - Reality

TR is BADldquoThe biology of TR will not change

with the method of therapyrdquo

A new grading method

will not ldquofoolrdquo nature

TR severity - reality

Sustained meaningful

reduction of TR

TR Percutaneous Myth and reality

Less impacthellipEarlier intervention

Best TR is zero

Good enough 1-2+TR

Reality Huge market - $$

Patients want ithellipit will happen

Page 40: Percutaneous technologies to correct TR : Myth or … A...PASP, LVEF, IVC size, RV size/ function, 5223 pts Severe and MODERATE TR decreases survival Having TR is BAD ! Topilsky. JACC

Tricuspid Regurgitation - Reality

TR is BADldquoThe biology of TR will not change

with the method of therapyrdquo

A new grading method

will not ldquofoolrdquo nature

TR severity - reality

Sustained meaningful

reduction of TR

TR Percutaneous Myth and reality

Less impacthellipEarlier intervention

Best TR is zero

Good enough 1-2+TR

Reality Huge market - $$

Patients want ithellipit will happen

Page 41: Percutaneous technologies to correct TR : Myth or … A...PASP, LVEF, IVC size, RV size/ function, 5223 pts Severe and MODERATE TR decreases survival Having TR is BAD ! Topilsky. JACC

TR severity - reality

Sustained meaningful

reduction of TR

TR Percutaneous Myth and reality

Less impacthellipEarlier intervention

Best TR is zero

Good enough 1-2+TR

Reality Huge market - $$

Patients want ithellipit will happen

Page 42: Percutaneous technologies to correct TR : Myth or … A...PASP, LVEF, IVC size, RV size/ function, 5223 pts Severe and MODERATE TR decreases survival Having TR is BAD ! Topilsky. JACC

TR Percutaneous Myth and reality

Less impacthellipEarlier intervention

Best TR is zero

Good enough 1-2+TR

Reality Huge market - $$

Patients want ithellipit will happen