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In Favor of Hybrid Stage 1 In Favor of Hybrid Stage 1

The Heart Center At Nationwide Children’s HospitalThe Heart Center At Nationwide Children’s Hospital

Mark Galantowicz, MDMark Galantowicz, MDChief, Chief, DeptartmentDeptartment of Cardiothoracic Surgeryof Cardiothoracic Surgery

Murray D. Lincoln Endowed Chair in Cardiothoracic SurgeryMurray D. Lincoln Endowed Chair in Cardiothoracic SurgeryCoCo--Director, The Heart CenterDirector, The Heart CenterNationwide Children’s HospitalNationwide Children’s Hospital

Professor of SurgeryProfessor of SurgeryThe Ohio State UniversityThe Ohio State University

DisclosuresDisclosures

•• NoneNone

•• OffOff--label use of stents will be discussedlabel use of stents will be discussed


# 1# 1

•• There has been no significant improvement in There has been no significant improvement in over a decade, despite multiple centers, with over a decade, despite multiple centers, with many bright people trying. Perhaps the many bright people trying. Perhaps the anatomy, physiology, and impact of the anatomy, physiology, and impact of the


anatomy, physiology, and impact of the anatomy, physiology, and impact of the traditional procedures for HLHS have reached traditional procedures for HLHS have reached their limit.their limit.

•• It is time to evolve.It is time to evolve.

CHSS DataCHSS Data

•• Prospective, 29 institutions, 1994Prospective, 29 institutions, 1994--20002000

•• 710 neonates, classic HLHS710 neonates, classic HLHS

•• Survival: Survival: –– 1 month 72%1 month 72%

–– 1 year 60%1 year 60%


–– 1 year 60%1 year 60%

–– 5 years 54%5 years 54%

•• Fontan completion in 46%Fontan completion in 46%

•• Mortality and morbidity concentrated around the Stage 1 Mortality and morbidity concentrated around the Stage 1 procedureprocedure

Ashburn, et al, JTCVS, 5/2003

MorbidityMorbidity

• Neurologic & Developmental Morbidity

– After Norwood repair: Full Scale IQ

•Kern, et al: 91

•Mahle, et al: 86

•Goldberg, et al: 94


•Goldberg, et al: 94

– After Cardiac Transplantation: Full Scale IQ

• Ikle, et al: 89

– Abnormalities of speech & language, oral aversion & poor feeding, poor adaptive behavior, & growth failure

– Later, there is significant emotional & behavior dysfunction, low self esteem, & psychosocial and physical health issues

–Wernovsky & Newburger, JPeds, Vol 142: Jan, 2003

The Heart Center At Nationwide ChildrenThe Heart Center At Nationwide Children’’s Hospital s Hospital smsmThe Heart Center At Nationwide ChildrenThe Heart Center At Nationwide Children’’s Hospital s Hospital smsm

• As reported by Dr. Ohye at the AHA 2009

• Death/txp at 1 year post-op

– 36% Norwood

– 26% Sano

• Serious (non-fatal) complications

– ~30% both groups

# 2# 2

•• Hybrid procedure can be a platform for Hybrid procedure can be a platform for learning and innovating towards learning and innovating towards improvements in managing HLHS. improvements in managing HLHS.

•• TThis is the beginning of a new evolution for his is the beginning of a new evolution for


•• TThis is the beginning of a new evolution for his is the beginning of a new evolution for these patients, not the end.these patients, not the end.

And Many Others are helpingAnd Many Others are helpingthe Evolution the Evolution

•• PubMed PubMed –– Hybrid HLHSHybrid HLHS

•• > > 70 manuscripts in past 5 years from 70 manuscripts in past 5 years from around the world sharing results and insightsaround the world sharing results and insights

•• MModifications odifications of technique of technique from many e.g. from many e.g.


•• MModifications odifications of technique of technique from many e.g. from many e.g. GermanyGermany, Canada, Japan, , Canada, Japan, Russia Russia

Pediatr Cardiol. 2008 May;29(3):498-506. Epub 2007 Dec 13.

Hybrid management for hypoplastic left heart syndrome : an experience from Brazil.Pilla CB, Pedra CA, Nogueira AJ, Jatene M, et al

-Over 40 programs Worldwide

-At least 20 programs in USA

Congenital Cardiovascular Interventional

Study Consortium (CCISC)

Courtesy of Daniel Gruenstein, MD

University of Minnesota


# 3# 3

•• Reduced resource utilization using a Hybrid Reduced resource utilization using a Hybrid procedure.procedure.


Resource UtilizationResource Utilization

MMWR Morb Mortal Wkly Rep. 2007 Jan 19;56(2):25-9. Centers for Disease

Control and Prevention (CDC)

Hospital stays, hospital charges, and in-hospital deaths among

infants with selected birth defects--United States, 2003.


Analysis of resource utilization for the 35 most common birth

defects showed that the Norwood procedure is associated with the

highest cost and the third longest length of stay.

The most expensive average neonatal hospital charges were for

two congenital heart defects: hypoplastic left heart at $199,597

and common truncus arteriosus at $192,781

infants with selected birth defects--United States, 2003.


• Combined LOS = 32days

• ECMO use = ~10%

• Delayed sternal closure = ~75%

NCH Results: Combined Hybrid 1&2 NCH Results: Combined Hybrid 1&2 (including (including interstageinterstage))

Intra-operative Blood Utilization


•• Combined LOS = 21daysCombined LOS = 21days

•• ECMO = 0ECMO = 0

•• DelayedDelayed sternalsternal closureclosure = = 00

Patient Charges

Combined Stage I & II Data


Clinical Outcomes, Program Evolution, and Pulmonary Artery Growth in Single Ventricle

Palliation Using Hybrid and Norwood Palliative Strategies

Osami Honjo, MD, et al

Ann Thorac Surg 2009;87:1885–93

# 4# 4

•• Hybrid Stage 1 procedure can effectively be Hybrid Stage 1 procedure can effectively be used as a bridge to recovery.used as a bridge to recovery.-- can salvage a late diagnosis can salvage a late diagnosis ptpt

-- allow coallow co--morbid states to improve; intramorbid states to improve; intra--cranial bleed, renal cranial bleed, renal


-- allow coallow co--morbid states to improve; intramorbid states to improve; intra--cranial bleed, renal cranial bleed, renal insufficiencyinsufficiency

-- stabilize for other procedures; CDHstabilize for other procedures; CDH

-- allow cardiac recovery; RV allow cardiac recovery; RV fxnfxn, TR , TR

-- allow education and time to for family to decide what they allow education and time to for family to decide what they wantwant

Ann Thorac Surg. 2003 Jan;75(1):277-9.

Bilateral pulmonary artery banding for resuscitation in hypoplastic left

Pediatr Cardiol. 2009 Jan;30(1):77-9. Epub 2008 Jul 15.

"Rapid two-stage" Norwood operation in a child with multiorgan failure.

Schmitz C, Schirrmeister J, Herberg U, Kozlik-Feldmann R, Stüber F, Welz

Department of Cardiac Surgery, University of Munich, Marchioninistr. 15, 81377 Munich, Germany.

[email protected]


Bilateral pulmonary artery banding for resuscitation in hypoplastic left

heart syndrome.

Ishizaka T, Ohye RG, Suzuki T, Devaney EJ, Bove EL.

AbstractWe report a case of a hypoplastic left heart syndrome with a nearly intact atrial

septum and an obstructed anomalous pulmonary to systemic venous connection.

Surgical atrial septectomy followed by bilateral pulmonary artery banding provided

an optimal condition for the Norwood operation.

# 5# 5

•• Hybrid Stage 1 can be an effective bridge to Hybrid Stage 1 can be an effective bridge to heart transplantation.heart transplantation.


““““Off-pump palliation followed by heart transplant or further staged

palliation should be considered for these hypoplastic left heart

syndrome patients.””””Artrip, et al; Ann Thorac Surg 2006;82:1259-9

REVIEWA Review of Ductal Stenting in Hypoplastic Left Heart Syndrome: Bridge to

Transplantation and Hybrid Stage I Palliation

D. J. DiBardino, D. B. McElhinney, A. C. Marshall and E. A. Bacha


# 6# 6

•• Hybrid Stage 1 procedure can be used as a Hybrid Stage 1 procedure can be used as a bridge to a two ventricle repair.bridge to a two ventricle repair.


PEDIATRIC CARDIOLOGYVolume 28, Number 2, 79-87, DOI: 10.1007/s00246-006-1444-7

ORIGINAL ARTICLE

Hybrid Transcatheter–Surgical Palliation

Basis for Univentricular or Biventricular Repair: The Giessen Experience

Hakan Akintürk, Ina Michel-Behnke, Klaus Valeske, Matthias Mueller, Josef Thul, Juergen Bauer,

Karl-Juergen Hagel a Dietmar Schranz

““““Using hybrid palliation C.. and observation for left ventricular

growth suitable for biventricular repair as well. The actuarial


growth suitable for biventricular repair as well. The actuarial

survival rate for patients with BVR is 93%. “

# 7# 7

•• Hybrid Stage 1 procedure is an effective Hybrid Stage 1 procedure is an effective palliation for highpalliation for high--risk HLHS patients, with at risk HLHS patients, with at least equivalent results to traditional least equivalent results to traditional procedures.procedures.


procedures.procedures.

Single-ventricle palliation for high-risk neonates: The emergence of an

alternative Hybrid stage I strategy Emile A. Bacha, Suanne Daves, Joel Hardin, Ra-id Abdulla, Jennifer Anderson,

Madelyn Kahana, Peter Koenig, Bassem N. Mora, Mehmet Gulecyuz, Joanne P. Starr, Ernerio

Alboliras, Satinder Sandhu and Ziyad M. Hijazi

J Thorac Cardiovasc Surg 2006;131:163-171

Conclusion“The hybrid stage I palliation is a

valid option in high-risk neonates.


valid option in high-risk neonates.

As experience is accrued, it may

become the preferred alternative.”

J Thorac Cardiovasc Surg 2010;139:1211-1215

Hybrid procedure as an alternative to surgical palliation of high-

risk infants with hypoplastic left heart syndrome and its variants

Prem S. Venugopal, MCh, FRCS, Karyn P. Luna, MD, David R. Anderson, FRCS, Conal

B. Austin, FRCS, Eric Rosenthal, FRCP, MRCPCH, Thomas Krasemann, MD, Shakeel

A. Qureshi, FRCP*

Conclusion: A hybrid approach may be a


Conclusion: A hybrid approach may be a

valuable alternative to the management of

high-risk neonates with hypoplastic left heart

syndrome and its variants.

Improving the outcome of high-risk neonates with hypoplastic left heart

syndrome: hybrid procedure or conventional surgical palliation?Christian Pizarro, Christopher D. Derby, Jeanne M. Baffa, Kenneth A. Murdison and

Wolfgang A. Radtke

Eur J Cardiothorac Surg 2008;33:613-618

# 8# 8

•• Can even use the Hybrid Stage 1 procedure to Can even use the Hybrid Stage 1 procedure to delay an eventual Norwood or Sano palliation. delay an eventual Norwood or Sano palliation.

•• Theoretically, bridging a baby out of a Theoretically, bridging a baby out of a neurologically vulnerable period to a neurologically vulnerable period to a


neurologically vulnerable period to a neurologically vulnerable period to a potentially safer age to undergo open heart potentially safer age to undergo open heart surgery.surgery.

Eur J Cardiothorac Surg. 2009 Dec;36(6):973-9. Epub 2009 Jul 8.

Early results of bilateral pulmonary artery banding for hypoplastic left heart syndrome.

Sakurai T Kado H, Nakano T, Hinokiyama K, Shiose A, Kajimoto M, Joo K,

Ueda Y.Source

Department of Cardiovascular Surgery, Fukuoka Children's Hospital, 2-5-1 Toujinmachi, Chuuo-ku, Fukuoka,

810-0063, Japan.

““““In conclusion, our study supports the use of PAB with PGE1 for

the management of HLHS. Bilateral PAB with continuous PGE1

administration may improve early and intermediate mortality...””””


administration may improve early and intermediate mortality...””””

# 9# 9

•• Hybrid Stage 1 procedure has at least Hybrid Stage 1 procedure has at least equivalent results to traditional approaches for equivalent results to traditional approaches for standard risk HLHS patients.standard risk HLHS patients.


HybridHybrid Treatment of HLHTreatment of HLH--(S): the Giessen experience(S): the Giessen experience

DietmarDietmar SchranzSchranz

Ina MichelIna Michel--BehnkeBehnke Jürgen Bauer Jürgen Bauer HakanHakan AkintürkAkintürk

0,6

0,8

1,0

Pro

bability

Hybrid Approach Surgical BPA and Hybrid Approach Surgical BPA and PercutaneousPercutaneous DADA--stentingstenting

Giessen experience in Pts born from 06 /1998 to 31.12.2011Giessen experience in Pts born from 06 /1998 to 31.12.2011

n = 139

Including 6 pts not further treated after S I

Actuarial survival is 76% Actuarial survival is 76% > > 12 12 yearsyears

Current Status of all Cases with HYBRID stage I

0 730 1460 2190 2920 3650 4380

0,0

0,2

0,4Pro

bability

Survival Time (days)

Actuarial survival is 76% Actuarial survival is 76% > > 12 12 yearsyears

Norwood BT vs Sano (NEJM)

Norwood BT vs Sano (NEJM)

Median = 32 days

Hybrid

Combined Stage I & II Hybrid

Daniel Gruenstein, M.D.Director, Pediatric Interventional Cardiology

University of Minnesota

(NEJM)

Median = 9 days

Hybrid

Mean = 4 days

Mean = 24 days

Korean Circ J. 2010 Mar;40(3):103-11. Epub 2010 Mar 24.

Hybrid palliation for neonates with hypoplastic left heart syndrome: current strategies

and outcomes.

Honjo O, Caldarone CA.Division of Cardiovascular Surgery, Hospital for Sick Children, Toronto, Ontario, Canada.

“In the last decade the hybrid procedure has emerged as an alternative stage I palliation in


emerged as an alternative stage I palliation in neonates with hypoplastic left heart syndrome.”

# 10# 10

•• Hybrid Stage 1 procedure does lead to Hybrid Stage 1 procedure does lead to successful palliation for ultimate successful palliation for ultimate FontanFontancompletion.completion.


Comprehensive Stage II RepairComprehensive Stage II RepairExit Angiogram: Looks Good!Exit Angiogram: Looks Good!



Clinical Outcomes, Program Evolution, and Pulmonary Artery Growth in Single

Ventricle




Hybrid Norwood


Clinical Outcomes, Program Evolution, and Pulmonary Artery Growth in Single Ventricle




Transplants due to RV dysfunction:

Hybrid = 0

Norwood = 2

AV valve replacement due to TR:

Hybrid = 1

Norwood = 1

Is a Hybrid Is a Hybrid ptpt a good a good FontanFontan Candidate? Candidate?

•• PrePre--Fontan echo dataFontan echo data–– 0% moderate or greater ventricular dysfunction0% moderate or greater ventricular dysfunction–– 5% moderate or greater AV valve regurgitation5% moderate or greater AV valve regurgitation

•• PrePre--Fontan cath data (n=25)Fontan cath data (n=25)–– average end diastolic pressure=5mmHgaverage end diastolic pressure=5mmHg


–– average end diastolic pressure=5mmHgaverage end diastolic pressure=5mmHg–– average atrial pressure=5mmHgaverage atrial pressure=5mmHg–– average SVC pressure=11mmHgaverage SVC pressure=11mmHg–– mean McGoon Index=1.57mean McGoon Index=1.57–– mean Nakata Index=217mean Nakata Index=217

•• YES!!!YES!!!

Results: FontanResults: Fontan

•• 43 43 ptspts s/p Hybrid 1s/p Hybrid 1–– Only 2 Only 2 ptspts fenestrated & 2 fenestrated & 2 ptspts required Xrequired X--clamp for TV repairclamp for TV repair

•• No deathsNo deaths

•• No end organ damageNo end organ damage

•• All with normal ventricular functionAll with normal ventricular function


•• All with normal ventricular functionAll with normal ventricular function–– 85 minutes X85 minutes X--clamp thru all 3 stages & no circulatory arrestclamp thru all 3 stages & no circulatory arrest

•• 100% 100% extubatedextubated in the ORin the OR

•• 75% bloodless75% bloodless

•• no inotropesno inotropes

•• 2 day CTICU 2 day CTICU LOSLOS

•• 10 10 day hospital LOS (range 4day hospital LOS (range 4--29) (median 7)29) (median 7)

HLH-(S, C)Surgical „Outcome“ (Giessen Procedure)

0,8

1,0

Pro

bability

of surv

ival

Surgical Mortality n = 6Surgical Mortality n = 6 / 298 (2%)/ 298 (2%)

0 730 1460 2190 2920 3650

0,0

0,2

0,4

0,6

Pro

bability

of surv

ival

Survival time (days)

Surgical Mortality n = 6Surgical Mortality n = 6 / 298 (2%)/ 298 (2%)

bPABbPAB n = 1 / n = 1 / 138 (0.8%)138 (0.8%)

AAR + BCPC AAR + BCPC n = 3 / n = 3 / 79 (3,79 (3,77%%) (Stage II as rescue therapy)) (Stage II as rescue therapy)

TCPCTCPC n = 0 / n = 0 / 49 49 (1 take down)(1 take down)

BVRBVR nn = 2 / = 2 / 31 (6.4%)31 (6.4%)

HTXHTX nn = 0 / = 0 / 1212

# 11# 11

•• We need to change our emphasis from which We need to change our emphasis from which procedure is better (procedure is better (txptxp vsvs norwoodnorwood, , norwoodnorwood vsvssanosano, hybrid , hybrid vsvs norwoodnorwood) to which procedure is ) to which procedure is better for which patient, better for which patient, afterallafterall hypoplastichypoplastic left left heart syndrome includes a spectrum of subtypesheart syndrome includes a spectrum of subtypes..


heart syndrome includes a spectrum of subtypesheart syndrome includes a spectrum of subtypes..

•• Individualized Care !!Individualized Care !!

Management Management Algorithm Algorithm in in Pulmonary Atresia Pulmonary Atresia with with Intact Intact Ventricular SeptumVentricular Septum


Catheterization and Cardiovascular InterventionsVolume 67, Issue 5 pages 679-686

HLHS

End organ dysfunction

Well balanced

ImagineImagine


Persistent unbalanced circulation

Bilateral PA bands &

PGE1

Recovers

3.5kg

Sano

AS/MA

Norwood

1.3kg

Hybrid

AA/MS

Sinusoids

Transplant

ConclusionConclusion

•• The Hybrid Stage 1 procedure should be used The Hybrid Stage 1 procedure should be used as an initial palliation for HLHS. It allows all as an initial palliation for HLHS. It allows all options for treatment, including a delayed options for treatment, including a delayed traditional approach.traditional approach.


•• But more importantly, the more the collected But more importantly, the more the collected we use it, the more we learn and improve this we use it, the more we learn and improve this early version of the Hybrid Stage 1, thereby early version of the Hybrid Stage 1, thereby evolving and progressing in the care of babies evolving and progressing in the care of babies with HLHS.with HLHS.

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