mhif research highlights dashboard march 2018 · pdf filecontact info: andrew nauertz ......

Percutaneous Coronary Intervention for a CTO with Bifurcation at Distal CapThe Double Stingray TechniqueDr. Tajti and Dr. BrilakisSun., March 11 – 12pm

MHIF Research Highlights Dashboard: March 2018

ACC 2018

AVERAGEPATIENTS

PERACTIVATED

SITE

DISSEMINATING MHIF RESEARCHJournal of the Minneapolis Heart Institute FoundationHelp raise visibility to MHIF research via the Journal

Share with your peers at ACC

Take postcards from the back table as you leave today

Tanscatheter TricuspidDr. GoesslSat., March 10 2:50pm

What in the Tricuspid is That?

Panelists representing MHIF:Challenging Cases: Dr. GoesslPFO Closure: Lisa Tindell

4 LIVE CASES

Live Case OperatorsInterventional Live Case SessionDr. Sorajja and Dr. Brilakis

Strategy Planning:Angiographic Review, Selection & Basic Concepts of Antegrade/ Retrograde and Hybrid TechniquesDr. BrilakisSun., March 11 12:50pm

Representing MHIF Research

2 PANELS

3 PRESENTATIONS

34 POSTERS

Percutaneous Mitral Valve Therapies and PV LeaksDr. SorajjaSun., March 11 -10:45am

1 of 23

PACES

• CONDITION: ACS

• PI: Michael Miedema, MD

• CONTACT INFO: Andrew Nauertz | [email protected] | 612.863.1661

• DESCRIPTION: This is smoking cessation/behavioral modification study in patients hospitalized for ACS

• CRITERIA LIST/ QUALIFICATIONS:Hospitalized with an ACS eventSmoked 1 or more cigarettes per day prior to hospitalizationAge 18-75Willing to consider quitting smoking

• FUNDING: MHIF is a sub recipient of a NIH Grant through HCMC

2 of 23

C A R D I O L O G Y G R A N D R O U N D S Title: ACC Scientific Sessions - 2018 PREVIEW

Speaker: Long-Term Outcomes of a Ranolazine Refractory Angina Registry: 3 Years Results Ross Garberich, MS, MBA, Manager, Scientific Services, Minneapolis Heart Institute Foundation® (ill day of presentation) Risk Evaluation For Vascular Complication Severity With Transfemoral Transcatheter Aortic Valve Replacement Cody Hou, 2017 Research Intern, Minneapolis Heart Institute Foundation®, Student University of MN Sleep Deprivation in Cardiology: A Multidisciplinary Survey Angie S. Lobo, MD, Internal Medicine Resident Physician, Abbott Northwestern Hospital PCSK9 Inhibitors in Patients With Familial Hypercholesterolemia and/or CVD: The Impact of a Systematic, Team-Based Approach to Prescription on Rates of Insurance Approval and Lipid Lowering Thomas Knickelbine, MD, Director, Preventive Cardiology Minneapolis Heart Institute® at Abbott Northwestern Hospital

Date: Monday, March 5, 2018 Time: 7:00 - 8:00 AM

Location: ANW Education Building, Watson Room

OBJECTIVES At the completion of this activity, the participants should be able to: 1. Summarize emerging research that colleagues will present at upcoming national scientific meeting. 2. Synthesize ideas and input from across disciplines relevant to each presentation. 3. Recommend content revisions or areas of focus to the presenters.

ACCREDITATION Physician This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of Allina Health and Minneapolis Heart Institute Foundation. Allina Health is accredited by the ACCME to provide continuing medical education for physicians.

Allina Health designates this live activity for a maximum of 1.0 AMA PRA Category 1 Credit(s)TM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Nurse This activity has been designed to meet the Minnesota Board of Nursing continuing education requirements for 1.0 hours of credit. However, the nurse is responsible for determining whether this activity meets the requirements for acceptable continuing education.

3 of 23

DISCLOSURE STATEMENTS Moderator(s)/Speaker(s) Mr. Garberich and Mr. Hou have disclosed that they do not have any conflicts of interest in making this presentation. Dr. Knickelbine declares the following relationship – Sanofi/Regeneron: Grant/Research Support. Dr. Lobo has not disclosed any relationships.

Planning Committee Dr. Alex Campbell, Jake Cohen, Jane Fox, Dr. Mario Goessl, Dr. Kevin Harris, Dr. Kasia Hryniewicz, Rebecca Lindberg, Amy McMeans, Dr. Michael Miedema, Dr. JoEllyn Moore, Pamela Morley, Laura Onstot, Dr. Scott Sharkey, and Jolene Bell Makowesky have declared that they do not have any conflicts of interest associated with the planning of this activity. Dr. David Hurrell declares the following relationship -Boston Scientific: Chair, Clinical Events Committee.

We gratefully acknowledge the following organizations for their commercial support for this activity. Bristol-Myers Squibb Janssen Pharmaceutical Companies of

Johnson & Johnson

PLEASE SAVE A COPY OF THIS FLIER AS YOUR CERTIFICATE OF ATTENDANCE

Signature: __________________________________________________________________________ My signature verifies that I have attended the above stated number of hours of the CME activity.

Allina Health - Learning & Development - 2925 Chicago Ave - MR 10701 - Minneapolis MN 55407

4 of 23

MHIF CV Grand Rounds – March 5, 2018

Sleep Deprivation in Cardiology: A Multidisciplinary Survey

Angie S. Lobo, M.D.

Internal Medicine Resident, PGY-2.

Abbott Northwestern Hospital, Minneapolis, MN.

March 5th, 2018

American College of Cardiology.18 Scientific Sessions, Orlando, FL

Spotlight on Special Topics: Education and Training

Authors

Angie S. Lobo, MD, Yader Sandoval, MD, M. Nicholas Burke, MD, Ivan Chavez,

MD, Mario Gossl, MD, Timothy Henry, MD, Daniel Lips, MD, Steven Bradley,

MD, Michael Mooney, MD, Anil Poulose, MD, Paul Sorajja, MD, Jay Traverse,

MD, Yale Wang, MD, Emmanouil Brilakis, MD PhD.

Sleep Deprivation in Cardiology: A Multidisciplinary Survey

5 of 23


Disclosures

Dr. Brilakis: consulting/speaker honoraria from Abbott Vascular, ACIST, Amgen, Asahi, CSI, Elsevier, GE Healthcare, Medicure, Medtronic, and Nitiloop; research support from Boston Scientific and Osprey. Board of Directors: Cardiovascular Innovations Foundation. Board of Trustees: Society of Cardiovascular Angiography and Interventions

Background

The burden and impact of sleep deprivation in cardiology

has received limited study.

6 of 23


So, what is sleep?

• Reversible state of reduced responsiveness, motor activity and metabolism that is necessary for life and essential for optimal health.

MetabolismMetabolism

Safety-related performance

Safety-related performance

Cognitive performance

Cognitive performance

• Adults should sleep a minimum of 7 hours on a regular night.

• Consistently sleeping <7 hours per night has been associated with numerous adverse health outcomes:

Consensus Conference Panel, Watson NF et al. Recommended amount of sleep for a healthy adult: A joint consensus statement of the American Academy of Sleep Medicine and Sleep Research Society. J Clin Sleep Med 2015;11:591–592.

7 of 23


https://www.google.com/search=diabetes

https://www.google.com/search=cardiovasculardisease

8 of 23


https://www.google.com/search=hypertension

https://www.google.com/search=obesity

9 of 23


https://www.google.com/search=depression

Aronow HD, Gurm HS, Blankenship JC, et al. Middle-of-the-night percutaneous coronary intervention and its association with percutaneous coronary intervention outcomes performed the following day: An analysis from the National. Cardiovascular Data Registry. JACC Cardiovasc Interv 2015;8:49–56.

10 of 23


Aronow HD, Gurm HS, Blankenship JC, et al. Middle-of-the-night percutaneous coronary intervention and its association with percutaneous coronary intervention outcomes performed the following day: An analysis from the National. Cardiovascular Data Registry. JACC Cardiovasc Interv 2015;8:49–56.

Study Objective

To improve our understanding of the burden and

impact of sleep deprivation in cardiology.

11 of 23


Methods

• Design: Multidisciplinary, online-based survey on sleep health pattern and potential impact of sleep deprivation involving 44 closed-ended questions distributed via email.

• Population: cardiovascular providers, involving physicians, nurses, and technicians.

Total email surveys

n=6,683

Respondents

n=481 (7.2%)

Interventional cardiologist

n=337 (70%)

Non-respondents

n=6,202 (92.8%)

12 of 23


Results

• 80% of the respondents were men.

• 91% had call responsibilities with 43% doing ≥7-call

nights per month.

• Sleep disorders were reported in 25%, with 25% using

sleep-inducing medications (8.4% at least once per

week).

Results

Main factors affecting quality and/or quantity of sleep:

Related to work 66%

Family and/or personal activities 56%

Staying up late at night writing or studying 48%

Sleep deprivation was associated with:

Irritability 68%

Difficulty concentrating 58%

Lack of motivation 56%

13 of 23


Results

Work performance was felt to be hindered by 46% of participants and 8.6% reported an adverse event.

ResultsAdverse events directly affecting the respondent

Procedure-related Decision-making Patient-related

Motor vehicle related (e.g.: accidents, reckless driving)Irritability

Procedural complications (e.g.: Pacer-perforation, vessel dissection/perforation, stroke)

Altered management and/or therapeutic plan (e.g.: staging procedures, cancelling cases, rushing procedures)

Procedural complications and major adverse events, including death.

Reduced procedure efficiency (e.g: longer procedural time, difficult access, delayed reaction time)

Impaired decision-making (e.g.: missed diagnosis, incorrect EKG interpretation)

Reduced procedural success (e.g.: failed interventions)

Impaired concentration (e.g: difficult documentation)

Team interactions (e.g.: lack of patience with other staff, such as fellows)

14 of 23


Results

Many (56.5%) felt burnout and 85% opined that policies should exist that allows sleep-deprived individuals to go home early post-call.

• Our survey provides insights into sleep health patterns

among cardiovascular workers and potential factors

contributing to sleep deprivation.

• Sleep deprivation may impact performance, with >8%

of respondents describing sleep deprivation-related

adverse events.

• More study is required to both identify measures to

attenuate the burden and better understand the impact

of sleep deprivation on both healthcare personnel and

patient outcomes.

Conclusions

15 of 23


Thank you!

@esbrilakis@ALoboMD

16 of 23

BackgroundTranscatheter aor t ic valve replacem ent (TAVR) of fers t reatm ent for severe aor t ic stenosis in h igh and in term ediate r isk pat ients. M ost TAVRs are per form edpercutaneously at t he com m on fem oral ar tery ( t ransfem oral access).

Percutaneous TAVR accesses are of ten closed w i th percutaneous closure devices. Inadequate closure m ay cause vascular com pl icat ions (VCs) and lead to worse cl in ical outcom es. Exist ing l i t erature fai ls t o address when surgical cut - down m ay be a bet ter opt ion.

We hypothesized that a com binat ion of dem ographic- and com puted tom ography angiography (CTA)- der ived data would be h ighly predict ive of VC sever i t y.

Risk evaluat ion for vascularcomplicat ion severit y wit h TF TAVRCody Hou, Sara Olson, John Lesser, Larissa Stanberry, Ross Garberich, David Caye, Paul Sorajja, Mario GösslMinneapolis Heart Inst it ut e Foundat ion at Abbot t Northwestern Hospit al

ConclusionsWe found no st rong associat ion between dem ographic- or CTA- der ived r isk factors and VC sever i t y. High 45° skin-to- CFA depth m ay raise chances of closure device fai lure.

The authors would l ike to thank in tern program funders, including the Abbot t Nor thwestern Hospi tal Foundat ion, Ruth St r icker Dayton, Richard D. Kant rud, t he Culp Fam i ly Foundat ion, Piper Jaf f ray, and m any individual cont r ibutors for t hei r ongoing suppor t .

Result sTable 1. Dem ogr ap h ic da t a of com p lica t ion p a t ien t s (n=9 9 ).

Figur e 1. CTA da t a t r en ds bet w een com p lica t ion gr ou p s .

Met h ods

DisclosuresTh e lead au t h or an d in ves t iga t or h ave n ot h in g t o d isclose.

Vessels can be n a r r ow (t op ),

t or t u ou s (m idd le) , an d / or ca lcified

(bot t om ).We a lso im p lem en t eda n ovel m easu r e, sk in - t o- vessel dep t h a t 9 0 ° an d 4 5°, in ou r an a lyses .

Var iable Device Fai lur e (n=56)

M inor Vascular (n=37)

M ajor Vascular (n=6)

Age (yr s ) 8 1.5±6 .9 (8 3) 8 1.6 ±8 .4 (8 2) 8 6 .7±7.0 (8 9 )

Fem ale 19 (33.9 % ) 12 (32.4 % ) 4 (6 6 .7% )

BMI 30 .7±7.4 (29 .8 ) 28 .8 ±6 .2 (26 .6 ) 27.4 ±7.8 (27.1)

STS Mor t a lit y 5.6 ±3.1% (5.0 % ) 5.2±3.0 % (4 .1% ) 5.0 ±1.9 % (4 .7% )

Diabet es 19 (33.9 % ) 11 (29 .7% ) 1 (16 .7% )

P2Y12 In h ibit or 17 (30 .4 % ) 18 (4 8 .7% ) 0 (0 % )

Sh ea t h Size (Fr ) 16 .7±2.1 (17) 16 .5±2.1 (16 ) 17.3±2.7 (18 )

St a t ist icsTable 2. St a t is t ica l an a lys is of r isk fact or s .

Var iable Test p- value

CFA Min im u m Diam et er ANOVA 0 .70 59

CFA Maxim u m Diam et er ANOVA 0 .6 137

CFA Calciu m Scor e χ² 0 .2571

CFA Tor t u os it y ANOVA 0 .19 6 2

Skin - t o- CFA 9 0 ° Dep t h ANOVA 0 .0 9 8 4 9

Skin - t o- CFA 4 5° Dep t h ANOVA 0 .0 59 34

EIA Min im u m Diam et er ANOVA 0 .4 113

EIA Maxim u m Diam et er ANOVA 0 .0 8 8 0 5

log(SFAR) ANOVA 0 .4 6 58

log(SEIAR) ANOVA 0 .30 0 3

P2Y12 In h ibit or χ² 0.03414CFA = com m on fem or a l a r t er y; EIA = ext er n a l iliac a r t er y; SFAR = sh ea t h t o fem or a l a r t er y r a t io; SEIAR = sh ea t h t o ext er n a l iliac r a t io.

1

2

3

4

Scr een in g (n=4 8 1)

CTA da t a collect ion

St a t is t ica l an a lys is

Dem ogr ap h ic da t a collect ion

17 of 23


The Impact of a Systematic Team‐Based Approach to Prescription of PCSK9

Inhibitors on Rates of Insurance Approval and Subsequent Lipid Lowering

American College of Cardiology Meetings 2018: Orlando, FL

Thomas Knickelbine, Ross Garberich, Susan White, Sandra Oberembt, Samantha Wills, Michael Miedema, Minneapolis Heart Institute Foundation, Minneapolis, MN, USA,

Allina Health, Minneapolis, MN, USA

18 of 23


Disclosures

• none

BACKGROUND

• PCSK9 Inhibitors are newer lipid lowering agents approved for patients with Familial Hypercholesterolemia (FH) and CVD with suboptimal LDL reduction

• Large scale use in clinical practice has been limited by high costs/copay, insurance denials related to incomplete documentation and poor point of care communication

• Overall national approval rates low 20-40 range%

19 of 23


METHODS

• From Sept 2015 to May 2017, we instituted a comprehensive team‐based approach to the PCSK9 approval process at Allina Health/Minneapolis Heart Institute

• Specific FH diagnosis protocols: Dutch lipid, Simone Brome, MED PED criteria

• Point of care in house use of pharmacy (EPIC Willow and Cover My Meds) to allow complete prior authorization process and appeal processes

20 of 23


Methods Con’t

• Patients were divided into 3 clinical groups:

• FH • CAD with suboptimal LDL levels• Both FH/CAD

• Insurance type (commercial vs. Medicare), indication, approval/denial rates, % LDL reduction and patient adherence were followed

• We also documented ability to obviate LDL apheresis therapy

RESULTSAll Patients

(n=196)

Alirocumab (n=64) Evolocumab

(n=132)

P‐Value

Age (years), mean ± SD 62.9 ± 10.2 66.5 ± 8.9 61.2 ± 10.4 <0.001

Male, (%) 130 (66.3) 41 (64.1) 89 (67.4) 0.64

Baseline Lipids, median (25th, 75th

%ile)

Total Cholesterol

Triglycerides

HDL

LDL

223 (199, 285)

155.5 (107, 211)

44 (36, 54)

148 (120, 197)

215 (188, 275)

154 (102, 201)

45 (36, 55)

140 (116, 190)

225 (202, 291)

156 (113, 215)

44 (37, 53)

150 (123, 205)

0.14

0.28

0.98

0.17

Disease Type

FH Only, (%)

CAD Only, (%)

FH + CAD, (%)

49 (25.1)

103 (52.8)

43 (22.1)

14 (22.2)

31 (49.2)

18 (28.6)

35 (26.5)

72 (54.6)

25 (18.9)

0.31

Insurance Type†

Commercial, (%)

Medicare, (%)

105 (53.9)

90 (46.2)

29 (45.3)

35 (54.7)

76 (58.0)

55 (42.0)0.095

Statin Intolerant, (%) 132 (86.3) 45 (70.3) 87 (97.8) <0.001

Approval Rate, (%) 186 (96.9) 63 (98.4) 123 (96.1) 0.38

Discontinued Use Reason

Side Effects, (%)

Cost, (%)

Other, (%)

9 (4.6)

8 (4.1)

9 (4.6)

1 (1.6)

4 (6.3)

2 (3.1)

8 (6.1)

4 (3.0)

7 (5.3)

0.32

Change in Lipids, median (25th, 75th

%ile)

Total Cholesterol

Triglycerides

HDL

LDL

‐95, ‐42% (‐31%, ‐50%)

‐25, ‐18% (+4.3%, ‐34)

+1.5, +3.4% (‐6.1%, 14%)

‐92, ‐61% (‐47%, ‐71%)

‐73,‐35% (‐29%, ‐45%)

‐26, ‐19% (4.0%, ‐35%)

+2.5,+5.6 (‐2.7%, 12%)

‐71,‐53% (‐41%, ‐63%)

‐101,‐44% (‐35%, ‐52%)

‐25, ‐18% (4.4%, ‐32%))

+1, +2.2% (‐7.1%, 17%)

‐100, ‐65% (‐52%, ‐75%)

<0.001

0.82

0.52

<0.001

Follow‐up Interval (Weeks) 12 (8, 16) 10 (8, 16) 12 (8, 16) 0.40

21 of 23


Table 2. Approval vs Denial by Insurance, Disease or Drug Type

Approved

(n=186)

Denied

(n=6)P‐Value

Insurance

Commercial, (%)

Medicare, (%)

98 (96.1)

88 (97.8)

4 (3.9)

2 (2.2)0.50

Disease Type

FH Only, (%)

CAD Only, (%)

Both, (%)

47 (97.9)

95 (95.0)

43 (100)

1 (2.1)

5 (5.0)

0 (0)

0.26

Type

Praluent, (%)

Repatha, (%)

63 (98.4)

123 (96.1)

1 (1.6)

5 (3.9)0.38

Figure 1. Oral Lipid Lowering Agent Use Within Cohort

39

21

7 10

0

10

20

30

40

50

Any Oral LipidLowering Agent

Statin Zetia Statin + Zetia

Patien

ts (%)

22 of 23


• The overall approval rate was 97%, highest for FH/CAD (100%)• Evolocumab users were younger, more statin intolerant and

had more prominent LDL lowering• Median LDL reduction was 62% observed at 12 weeks

– 51% Alirocumab vs 67% Evolocumab, p<0. 001– Similar across the three clinical groups (p=NS)

• Therapy was discontinued in low percentage (13%) due to sideeffects

• Denial rates for insurance type, clinical indication, or drug typewere similar (p=NS)

• Amgen Safety Net patient assistance program was utilized in20/132 (15%) of Repatha users

• Four patients previously enrolled in apheresis were able to stopdue to drug therapy

SUMMARY FINDINGS

CONCLUSIONS• PCSK9 Inhibitors were extremely well tolerated in clinical practice, resulted

in dramatic LDL reductions and provided apheresis users with a viablealternative

• Insurance type, clinical indication and drug type did not affect approval

• Most important features for approval:

• Team based approach with on site pharmacy support

• Proper provider documentation of FH diagnosis and statinintolerance

• Electronic prior authorization and appeal procedures

• Use of pt assistance programs

• Amgen Safety Net program: Medicare pts

• Insurance co‐pay assistance: commercial

• Process resulted in extremely high approval rates of 97%

23 of 23

mhif research highlights dashboard march 2018 · pdf filecontact info: andrew nauertz ......

Documents