2,246 runners congratulations radiance-trio€¦ · 2,246 runners celebrated heart health at. the...

2,246 runners celebrated heart health at

the Valentine’s 5K Presented by MHIF

MHIF Research Highlights Dashboard: February 2018

Radiance-TrioMHIF successfully completed enrollment in first study arm

Focus is on second arm for patients who’ve failed three or more hypertension medications, including a diuretic

AVERAGEPATIENTS

PERACTIVATED

SITE

ON NEWSTANDS NOW:Journal of the Minneapolis Heart Institute Foundation

Percutaneous Treatment of Mitral Regurgitation: Present and FutureGanesh Athappan, Paul Sorajja and Mario Gössl

…to Dr. Romero and Kelly Wilson for the first enrollment in the Vent-Avoid study

CONGRATULATIONS

MHIF research publishedAMERICAN HEART JOURNAL

“Resource Utilization and outcome among patients with selective vs. nonselective troponin testing”Alex Campbell, MD; Alexander Rodriguez, BS; David Larson, MD; Craig Strauss, MD; Ross Garberich, MS; Matthew Partridge, BA; Timothy Henry, MD; Scott Sharkey, MD

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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 – MHIF SCHOLARS PREVIEW

Speaker: Application of the Hybrid Approach for Percutaneous Coronary Interventions for Chronic Total Occlusions: Update from an International Multicenter Registry Peter Tajti, MD, Postgraduate Research Fellow Minneapolis Heart Institute Foundation® Percutaneous Coronary Intervention In Patients With Previous Coronary Artery Bypass Graft Surgery: Insights from a Multicenter Registry Peter Tajti, MD, Postgraduate Research Fellow Minneapolis Heart Institute Foundation® Impact of the Commercial Introduction of Transcatheter Mitral Valve Repair on Mitral Surgical Practice Hiroki Niikura, MD, Research Scholar, Valve Science Center Minneapolis Heart Institute Foundation® Contemporary Reasons and Clinical Outcomes for Patients with Severe, Symptomatic Aortic Stenosis Not Undergoing Aortic Valve Replacement Liang Tang, MD, Research Scholar, Valve Science Center Minneapolis Heart Institute Foundation®

Date: Monday, February 26, 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.

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DISCLOSURE STATEMENTS Moderator(s)/Speaker(s) Dr. Tajti, Dr. Niikura and Dr. Tang have disclosed that he does not have a conflict of interest in making this presentation.

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. Actelion Pharmaceutical Companies of

Johnson & Johnson Portola Pharmaceuticals

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

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MHIF CV Grand Rounds – Feb. 26, 2018

Percutaneous coronary intervention for chronic total occlusions:Insights from a Multicenter International Registry.

Peter Tajti MD

Minneapolis Heart Institute, Abbott Northwestern Hospital, MN, USA

University of Szeged, Division of Invasive Cardiology, Second Department of Internal Medicine and Cardiology Center, Hungary

ACC 2018

1. Application of the Hybrid Approach for Percutaneous Coronary Interventions for Chronic Total

Occlusions: Update from an International Multicenter Registry.

2. Percutaneous Coronary Intervention In Patients With Previous Coronary Artery Bypass Graft Surgery:

Insights from a Multicenter Registry.

3. Procedural Outcomes of Multiple CTO Intervention Carried Out In the Same Procedure: Insight from a

Multicenter CTO Registry

4. Percutaneous Coronary Interventions for AortoOstial Chronic Total Occlusions: Insights from a

Multicenter Registry.

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Triple injection; retrograde via septal

Epicardial collateral crossing

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Final result

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35 Sites – Study PI: E. S. Brilakis – National coordinator: B.V. Rangan – Database manager: P. Tajti

International sites:•Meshalkin Novosibirsk Research Institute, Russia, O. Krestyaninov, D. Khelimskii•Korgialeneio-Benakeio Hellenic Red Cross Hospital, Greece,M. Koutouzis, Y. Tsiafoutis•Henry Dunant Heart Hospital, Greece, V.Tzifos, A. Kolyviras, D. Damaskos Funding: Abbott Northwestern Hospital Foundation

Appleton Cardiology, WIK. Alaswad

Mid America Heart Institute, MO J.A. Grantham

Dallas VAMC, TXS. Abdullah, H. Khalili

Minneapolis VAMC, MNS. Garcia

Providence Health Center, TXC. Shoultz

PeaceHealth St. Joseph Medical Center, WA W. Lombardi Henry Ford, MI

K. Alaswad

CAVHS, ARB. Uretsky

Baylor Dallas, TXJ. Choi

Medical Center of the Rockies, COA. Doing, P. Dattilo

Tulane, LAN. Abi-Rafeh, O. Mogabgab

Piedmont Heart Institute, GAD. Kandzari

UT Southwestern, TXS. Banerjee

Northwestern Cardiovascular Institute, ILM. Ricciardi

Minneapolis Heart Institute, MN N. Burke, E.S. Brilakis

Baylor Plano, TXL. Holper

Banner Samaritan Medical Center, AZ A. Pershad

Memorial Hospital, FLL. Van-Thomas Crisco

Tristar Centennial, TNB. Jefferson, T. Patel

Emory Hospital, GAW. Jaber, H. Samady

UPMC, PAC. Toma, A.J. Conrad Smith

Trinity Medical, NYH. Meltser

Carolina East HC, NC D. Jessup, M. Groove, Alex R. Kirby

Maimonides MC, NYB.A. Malik

CWRU, OHM. Costa, H. Bezerra, P. Poommipanit, F. Forouzandeh

Columbia University, NYD. Karmpaliotis, J. Moses, N. Lembo, A.J. Kirtane, R. Hatem, M. Parikh, Z. Ali

San Diego VAMC and UCSD, CAE. Mahmud, M. Patel

Torrance Medical Center, CAM.R. Wyman

Massachusetts General Hospital, MAF. Jaffer

Beth Israel Deaconess MC, MAR.W. Yeh

PROspective Global REgiStry for the Study of CTO interventionswww.progresscto.org

NCT02061436

Hybrid algorithm

Brilakis et al. JACC Cardiovasc Interv. 2012 Apr;5(4):367-79.

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ACC 2018



2. Percutaneous Coronary Intervention In Patients With Previous Coronary Artery Bypass Graft Surgery:

Insights from a Multicenter Registry.





Application of the Hybrid Approach for CTO PCI

1. Appleton Cardiology, WI

2. Baylor Heart and Vascular Hospital, TX

3. Beth Israel Deaconess Medical Center, MA

4. Columbia University, NY

5. Central Arkansas VAMC, AR

6. Dallas VAMC/UTSW, TX

7. Henry Ford Hospital, MI

8. Korgialeneio-Benakeio Hellenic Red Cross General Hospital of Athens, Athens, Greece

9. Massachusetts General Hospital, MA

10. Medical Center of the Rockies, CO

11. Minneapolis VAMC, MN

12. Minneapolis Heart Institute, MN

13. Meshalkin Novosibirsk Research Institute, Novosibirsk, Russia

14. PeaceHealth St. Joseph MC, WA

15. Piedmont Heart Institute, GA

16. San Diego VAMC and UCSD, CA

17. St Luke’s Mid America Heart Institute, MO

18. The Heart Hospital Baylor Plano, TX

19. Torrance Medical Center, CA

20. UPMC Medical Center, PA

5/2012 to 12/201720 centers, 3,122 lesions in 3055 patients

87%

13%

Technical success Technical failure

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Baseline patient demographics

Clinical characteristicsTechnical success

(n=2657)Technical failure

(n=398)p value

Age (years) * 64.6 ± 10.2 66.0 ± 9.6 0.014

Male gender 85% 89% 0.038

Diabetes 44% 40% 0.176

Dyslipidemia 92% 93% 0.678

Hypertension 90% 95% 0.004

Family history of CAD 33% 33% 0.842

CCS Angina Classification 0.477

• Class ≤1 12% 10%

• Class 2≤ 88% 90%

* mean ± SD; † median (IQR)


Clinical characteristicsTechnical success


(n=398)p value

Prior MI 45% 54% 0.002

Heart failure 29.71% 36% 0.016

Prior PCI 65% 71% 0.018

Prior CABG 31% 41% <0.001

Baseline creatinine (mg/dL) † 1.0 (0.9, 1.2) 1.1 (0.9, 1.3) 0.130

Prior CVD 12% 13% 0.457

Prior PAD 15% 18.29% 0.071

Left ventricular EF (%) † 55 (44, 60) 50 (40, 60) 0.036


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Angiographic characteristicsTechnical success


(n=411)p value

Target vessel 0.064

• RCA 55% 57%

• LAD 25% 19%

• LCX 19% 23%

• Other 1% 1%

CTO length (mm)* 33.4 ± 24.1 37.8 ± 24.0 0.003

Proximal cap ambiguity 32% 54% <0.001

Blunt stump/no stump 51% 73% <0.001

Baseline angiographic characteristics


Angiographic characteristicsTechnical success


(n=411)p value

Side branch at proximal cap 48% 64% <0.001

Interventional collaterals 59% 44% <0.001

Moderate/severe calcification 52% 67% <0.001

Moderate/severe tortuosity 33% 45% <0.001

Previously failed CTO PCI 19% 27% <0.001

J-CTO score * 2.3 ± 1.3 3.1 ± 1.1 <0.001

PROGRESS-CTO score * 1.3 ± 1.0 1.8 ± 1.0 <0.001

PROGRESS complication score * 3.0 ± 1.9 3.5 ± 2.0 <0.001



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Technical characteristics


ADR: antegrade dissection and re-entry; AWE: antegrade wire escalation

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Procedural outcomes Technical success Technical failure p value

Radial access 38% 33% 0.058

Femoral access 81% 85% 0.048

Procedure time (min) * 121 (80, 184) 140 (85, 224) <0.001

Contrast volume (mL) * 260 (200, 350) 300 (220, 400) <0.001

Fluoroscopy time (min) * 45.0 (27.3, 73.7) 66.0 (39.0, 93.6) <0.001

Patient AK dose (Gray) * 2.8 (1.6, 4.5) 3.9 (2.4, 6.0) <0.001

Number of stents †§ 2.4 ± 1.1 2.7 ± 1.6 0.556

Stent length (mm) †§ 71.7 ± 36.3 78.6 ± 47.6 0.660

Technical and procedural characteristics


§ Stents implanted: successful 97.10% vs. failed 4.89% PCIs, p<0.0001.

Procedural complications

ADR: antegrade dissection and re-entry; AWE: antegrade wire escalation; CABG: coronary artery bypass graft; MI: myocardial infraction; PCI: percutaneous coronary intervention

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Annual CTO PCI volume


ACC 2018



2. Percutaneous Coronary Intervention In Patients With Previous Coronary Artery Bypass Graft

Surgery: Insights from a Multicenter Registry.





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Percutaneous Coronary Intervention In Patients With Previous Coronary Artery

Bypass Graft Surgery: Insights from a Multicenter Registry.

5/2012 to 10/201720 centers, 2,860 lesions in 2,803 patients

32.8%

67.2%

Prior CABG No Prior CABG

Clinical characteristicsPrior CABG

(n=920)No Prior CABG

(n=1886)p value

Age (years) * 67.4 ± 9.2 63.5 ± 10.2 <0.001

Male gender 86.4% 84.3% 0.163

CAD presentation

<0.001• ACS 30.6% 22.2%

• Stabile angina 62.2% 65.1%

• Other 7.2% 12.7%

CCS angina score

<0.001• CCS 2 or more 92.4% 86.1%

• CCS <2 7.6% 13.9%

Diabetes 50.0% 39.6% <0.001

Dyslipidemia 96.8% 90.2% <0.001

Hypertension 94.2% 88.1% <0.001



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Clinical characteristicsPrior CABG

(n=920)No Prior CABG

(n=1886)p value

Prior MI 55.7% 40.4% <0.001

Heart failure 37.7% 26.6% <0.001

Prior valve surgery or procedure 6.1% 1.6% <0.001

Prior PCI 74.5% 60.6% <0.001

eGFR (mL/min/1.73m^2) * 69.3 ± 21.3 74.5 ± 22.2 <0.001

Left ventricular EF (%) * 49.0 ± 12.9 50.7 ± 13.2 0.009




* mean ± SD

Angiographic characteristics Prior CABG (n=938)No Prior CABG

(n=1924)p value

Target vessel

<0.001

RCA 55.7% 55.0%

LAD 16.1% 27.2%

LCX 26.6% 17.4%

Other 1.6% 0.5%

Bypassed target vessel 67.5% 0.0% <0.001

CTO length (mm) * 42.3 ± 29.0 30.1 ± 20.5 <0.001

Proximal cap ambiguity 40.7% 31.2% <0.001

Blunt stump/no stump 60.5% 50.0% <0.001

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* mean ± SD

Angiographic characteristics Prior CABG (n=938)No Prior CABG

(n=1924)p value

Interventional collaterals 57.9% 56.3% 0.495

Moderate/severe calcification 73.4% 46.8% <0.001

Moderate/severe tortuosity 46.7% 30.3% <0.001

Previously failed CTO PCI 19.7% 19.5% 0.890

J-CTO score * 2.9 ± 1.1 2.3 ± 1.3 <0.001

PROGRESS score * 1.5 ± 1.1 1.2 ± 1.0 <0.001

PROGRESS complication score * 3.8 ± 1.8 2.7 ± 1.9 <0.001


Technical characteristics Prior CABG (n=938) No Prior CABG (n=1924) p value

Dual injection 77.0% 65.8% <0.001

Balloon uncrossable 18.9% 7.8% <0.001

Balloon undilatable 15.4% 9.0% 0.013

IVUS used 43.3% 40.4% 0.248

Access site

• Radial access 33.7% 38.4% 0.015

• Bi-radial access 12.4% 14.9% 0.071

• Femoral access 90.5% 77.6% <0.001

• Bi-femoral access 61.2% 46.9% <0.001

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Crossing strategy used

73%

36%

55%

84%

30% 31%

0%

20%

40%

60%

80%

100%

AWE ADR Retrograde

38%

23%

38%

58%

21% 21%

0%

10%

20%

30%

40%

50%

60%

AWE ADR Retrograde

p<0.001 p<0.001

Prior CABG No prior CABG

Final crossing strategy

ADR: antegrade dissection and re-entry; AWE: antegrade wire escalation

82% 83%87% 89%

0%

20%

40%

60%

80%

100%

Procedural success Technical success


Procedural outcomes

0.0

1.0

2.0

3.0

4.0

5.0

6.0

Prior CABG No prior CABG150

200

250

300

350

400


Co

ntr

ast

volu

me

(ml)

Rad

iati

on

do

se (

Gra

y)

Radiation dose Contrast volume

p<0.001

p<0.001p<0.001

p<0.001

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In-hospital major complications

In-hospitalMACE

Death Acute MI Stroke Re-PCI Re-CABGPericardiocen

tesisTamponade Perforation

Prior CABG 3.3% 1.1% 1.5% 0.1% 0.5% 0.2% 0.0% 0.1% 6.9%No prior CABG 2.8% 0.4% 1.0% 0.3% 0.3% 0.2% 1.3% 1.1% 3.2%

0%

2%

4%

6%

8%

p=0.039p<0.001

p<0.001

p=0.005

MACE: major adverse cardiac event; MI: myocardial infarction; PCI: percutaneous coronary intervention; CABG: coronary artery bypass graft

Conclusions

1. CTO PCI with using the hybrid approach : high procedural success, reasonably low

complication rate

2. Higher annual CTO PCI volume is associated with higher procedural success

3. Prior CABG patients are associated with lower procedural success and higher in-

hospital mortality

4. Immediate treatment of coronary perforation in prior CABG patients may result in

lower in-hospital mortality

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Thank you for your attention!

Email: [email protected]

Phone: 612-295-5371

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MHIF CV Grand Rounds – February 26, 2018

Impact of the Commercial Introduction of Transcatheter Mitral Valve Repair on Mitral Surgical Practice

Hiroki Niikura, MDResearch scholar in the Valve Science Center

Mitral Regurgitation (MR)

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Background

Surgical treatment, with either mitral repair or valve replacement, is the standard of care for patients with severe MR who are symptomatic.

With the commercial introduction of transcatheter mitral valve repair with Mitraclip into the U.S. in 2013, there has been uncertainty regarding the effect of this therapy on mitral surgical practice.

The object of this study was to examine the impact (e.g. patient volume, outcomes) of the commercial introduction of Mitraclip on mitral surgical practice in a tertiary referral center.

Methods

• From January 2012 to December 2016, all patients who underwent surgical or transcatheter therapy for MR at our hospital were evaluated.

• This time period was chosen to examine surgical practice prior to and following the commercial introduction of MitraClip, which was approved for commercial use on October, 2013.

• The trend of patients volume, characteristics and outcomes were compared MitraClip with surgical repair/replacement.

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From January 2012 to December 2016at our hospital.

Methods

All(n=604)

Mitraclip(n=161)

Surgical repair/replacement

(n=443)p-value

Age (yrs) 69±14 83±7 64±12 <0.0001Male gender - (%) 367 (60.8) 85 (52.8) 282 (63.7) 0.02NYHA class Ⅲ or Ⅳ - (%) 289 (47.8) 148 (91.9) 141 (31.8) <0.0001

Medical history - (%)CAD 217 (35.9) 81 (50.3) 136 (30.7) <0.0001Hypertension 370 (61.3) 127 (78.9) 243 (54.9) <0.0001Diabetes mellitus 105 (17.4) 43 (26.7) 62 (14) <0.0001Atrial fibrillation 213 (35.3) 110 (68.3) 103 (23.3) <0.0001COPD 94 (15.6) 50 (31.1) 44 (9.9) <0.0001Prior MI 68 (11.3) 28 (17.4) 40 (9) 0.004Prior stroke 65 (10.8) 31 (19.3) 34 (7.7) 0.0001

Creatine, mg/dl 1.1±1.0 1.3±0.5 1.08±1.1 0.005Prior sternotomy 113 (18.7) 53 (32.9) 60 (13.5) <0.0001STS-PROM – (%) 3.8±5.0 7.2±2.5 2.5±4.5 <0.0001

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Patients demographicsAll

(n=604)Mitraclip(n=161)


(n=443)p-value

Prior procedure - no. (%)

Prior sternotomy 113 (18.7) 53 (32.9) 60 (13.5) <0.0001

History of PCI 89 (14.7) 43 (26.7) 46 (10.4) <0.0001

History of CABG 61 (10.1) 39 (24.2) 22 (5) <0.0001

PM or ICD 64 (10.5) 35 (21.7) 29 (6.5) <0.0001

Medications - no. (%)

Aspirin 362 (59.9) 105 (65.2) 257 (58) 0.11

Anticoagulation 146 (24.2) 81 (50.3) 65 (14.7) <0.0001

Beta-receptor antagonist 299 (49.5) 113 (70.2) 186 (42) <0.0001

ACE-inhibitor or ARB 239 (39.6) 70 (43.5) 169 (38.1) 0.24

Diuretic 232 (38.4) 114 (70.8) 118 (26.6) <0.0001

STS-PROM – (%) 3.8±5.0 7.2±2.5 2.5±4.5 <0.0001

Echo demographicsAll

(n=604)Mitraclip(n=161)


(n=443)p-value

Grade 3 or 4 Mitral regurgitation - (%) 558 (92.4) 160 (99.4) 398 (89.8) <0.0001

Effective regurgitant orifice (cm2) 0.48±0.29 0.46±0.3 0.49±0.29 0.42

Regurgltant volume (ml) 73.6±42.3 68.9±40.9 75.7±42.9 0.21

Mitral stenosis - (%) 50 (8.3) 2 (1.2) 48 (10.8) <0.0001

LVEF (%) 59.0±9.6 57.8±9.8 59.5±9.5 0.064

LVDd (cm) 5.1±1.5 5.1±2.5 5.2±0.8 0.48

LVDs (cm) 3.5±2.0 3.7±3.4 3.4±0.8 0.23

RVSP (mmHg) 35.7±13.8 41.3±13.9 33.3±13.0 <0.0001

Etiology of MR - (%)

Degenerative 467 (77.3) 128 (79.5) 339 (76.5) 0.44

Functional 42 (7) 7 (4.3) 35 (7.9) 0.13

Both degenerative and functional 7 (1.2) 3 (1.9) 4 (0.9) 0.33

Other 88 (14.6) 23 (14.3) 65 (14.7) 0.91

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(Year)

Annual volumes per year for procedures

Annual volumes per year for procedures

0

20

40

60

80

100

120

140

2012 2013 2014 2015 2016

All surgical mitral procedures Isolated mitral therapy MitraClip

The commercial introduction of MitraClip

(Year)

Nu

mb

er o

f P

atie

nts

14±2% / Year (P＜0.001)

10±4% / year (P＜0.001)

r=0.99, P＜0.001

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Procedure and in-hospital outcome

Alln = 604

Mitraclipn = 161


n = 443p value

Procedure success - (%) 98.1 98.1 99.3 0.19

Residual regurgitation grade ≦2 - (%) 561 (92.9) 134 (83.2) 427 (96.4) <0.0001

Mean gradient after procedure (mmHg) 4.6±2.2 4.1±2.1 4.8±2.1 <0.0001

In-hospital mortality - (%) 2.2 2.5 2 0.74

Length of stay after procedure (days) 6.5±4.2 3.4±4.1 7.5±3.7 <0.0001

Myocardial infarction - (%) 10 (1.7) 1 (0.6) 9 (2) 0.23

Stroke - (%) 13 (2.2) 4 (2.5) 9 (2) 0.74

New PPM and ICD implantation - (%) 32 (5.3) 0 32 (7.2) <0.0001

Major vascular complication - (%) 10 (1.7) 3 (1.9) 7 (1.6) 0.81

Survival at 30 days

MitraClip


Log-rank test: p=0.24

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Survival at 30days

Mitraclip 96.3%

Surgical repair/replacement 98%


Mitraclip 98.1%

Surgical repair/replacement 98.4%


Freedom form Heart failure rehospitalization at 30days

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Mitraclip 94.4%

Surgical repair/replacement 96.4%


Freedom from death and heart failure rehospitalization at 30days

Survival at 30 days

MitraClip



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Heart failure rehospitalization at 30 days

MitraClip



Death or heart failure rehospitalization at 30 days

MitraClip



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Conclusions

Transcatheter mitral valve repair could be introduced into a comprehensive valve center without detraction from surgery, and with growth in mitral surgical procedures and favorable clinical outcomes for treated patients.

Although the transcatheter patients were older, had more severe heart failure and comorbidities, the short-term outcomes were similar for transcatheter and surgical therapies.

Our findings demonstrate the potential benefits of complementary therapies in the treatment of patients with MR.

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Contemporary Reasons and Clinical Outcomes for Patients with Severe, Symptomatic Aortic Stenosis Not Undergoing Aortic Valve Replacement

Liang Tang, MD, Mario Gössl, MD, PhD, Aisha Ahmed, BS, Ross Garberich, MS, Steven M. Bradley, MD, MPH, Hiroki Niikura, MD, Dawn Witt, PhD, Wesley A. Pedersen, MD, Richard Bae, MD, John Lesser, MD, Kevin M. Harris, MD, Benjamin Sun, MD, Karol Mudy, MD, Paul Sorajja, MD

Valve Science Center, Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital

Disclosures

• I have no conflict of interest in relation to this presentation.

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Backgrounds

• Aortic stenosis (AS) affects 3 to 4% of people over 65 years of age, and therefore is expected to increase in prevalence with continued population aging. The mortality from untreated, symptomatic AS is comparable to or worse than that of many advanced malignancies.

• TAVR or SAVR is the only effective therapy and can be life-saving in appropriate patients. Nonetheless, a significant subset of these patients do not undergo appropriate therapy.

1. Nkomo VT, et al. Lancet. 2006; 368(9540):1005-1011.2. Iung B, et al. Eur Heart J. 2003; 24(13):1231-1243.3. Osnabrugge RL, et al. J Am Coll Cardiol. 2013; 62(11):1002-1012.

4. Varadarajan P, et al. Ann Thorac Surg. 2006; 82(6):2111-2115.5. Clark MA, et al. Circ Cardiovasc Qual Outcomes. 2012; 5(5):697-704.6. Thaden JJ, et al. Prog Cardiovasc Dis. 2014; 56(6):565-571. 7. Nishimura RA, et al. J Am Coll Cardiol.2014; 63(22):e57-185.

Objectives

• The present study was undertaken to determine the characteristics, clinical outcomes, and contemporary reasons for patients with severe, symptomatic AS not pursuing AVR.

• Our study aim was to gain insight into the barriers to appropriate care for patients with severe, symptomatic AS, in order to help guide efforts to improve the health of these patient populations.

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Methods

Inclusion criteria

1) Severe AS:

• calculated aortic valve area (AVA) < 1.0 cm2 or indexed AVA ≤0.6 cm2/m2, and

• MG ≥40 mm Hg or Vmax of ≥4 m/s, or

• Dimensionless index of <0.25.

2) Cardiac symptoms: dyspnea or other symptoms of heart failure, angina pectoris, syncope or pre-syncope

3) No AVR or balloon aortic valvuloplasty planned

Exclusion criteria

• Asymptomatic

• Patients with prior surgical or catheter-based aortic valve intervention

Study Population

All patients who were diagnosed with severe AS at the Allina Health system between January 2014 and March 2017 were considered for enrollment.

Nishimura RA, et al. J Am Coll Cardiol.2014; 63(22):e57-185.Martínez-Sellés M, et al. J Intern Med. 2014; 275(6):608-620.

Methods

Data Collection

• Medical record was manually reviewed for the clinical presentation, demographics, co-morbidities, rationale for no AVR therapy, and subsequent clinical outcomes.

• The rationale for the absence of AVR was determined by a thorough examination of all available clinical documentation, including records from primary care providers, cardiologists, surgeons, palliative care specialists, and any hospital records.

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MethodsDefinitions

1. Patients were classified into two groups:

• Appropriate (i.e., reasonable candidates for AVR)

• Medically futile (i.e., those likely to have no benefit from AVR).

2. Medical futility was defined as the presence of any of the following criteria:

• severe lung disease, severe liver disease (MELD >12), ESRD or dialysis treatment, excessive frailty, severe dementia, life-threatening malignancy(life expectancy ≤12 months), critical illness not related to AS, or any condition besides AS associated with a life expectancy of ≤12 months, as determined by the evaluating physicians and care providers.

All patients with severe AS confirmed by echo in the Allina Health System,January 2014 to March 2017

(n= 2,370 )

• 1,198 patients received SAVR• 386 patients received TAVR • 29 patients received PBAV• 10 patients planned to receive AVR ( 3 died

before TAVR)• 171 patients were asymptomatic• 22 Young patients with congenital severe AS• 6 patients with echocardiogram image

quality not well

Study population: Severe, symptomatic AS patients not received TAVR, SAVR or BAV

(n= 548)

Medical futile (n= 189)

Appropriate candidates for AVR (n= 359)

Exclude

Figure 1. Study flow chart

Results

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All

n=548

Appropriate

n=359

Futile

n=189

P-Value

Age, yrs 84.6 ± 9.4 84.2 ± 10.0 85.4 ± 7.9 0.15

Men — no. (%) 284 (51.8) 181 (50.4) 103 (54.5) 0.38

NYHA functional class — no. (%)

I 40 (7.3) 28 (7.8) 12 (6.3)

<0.001II 135 (24.6) 108 (30.1) 27 (14.3)

III 331 (60.4) 206 (57.4) 125 (66.1)

IV 42 (7.7) 17 (4.7) 25 (13.2)

Angina pectoris — no. (%) 42 (7.7) 28 (7.8) 14 (7.4) 0.96

Syncope or presyncope — no. (%) 73 (13.3) 53 (14.8) 20 (10.6) 0.17

Current smoker — no. (%) 21 (3.8) 12 (3.3) 9 (4.8) 0.41

Diabetes mellitus — no. (%) 166 (30.3) 101 (28.1) 65 (34.4) 0.13

Hypertension — no. (%) 446 (81.4) 292 (81.3) 154 (81.5) 0.97

Hyperlipidemia — no. (%) 347 (63.3) 229 (63.8) 118 (62.4) 0.75

Coronary artery disease — no. (%) 221 (40.3) 131 (36.5) 90 (47.6) 0.012

History of PCI — no. (%) 111 (20.3) 65 (18.1) 46 (24.3) 0.084

History of CABG — no. (%) 72 (13.1) 45 (12.5) 27 (14.3) 0.56

Previous MI — no. (%) 73 (13.3) 51 (14.2) 22 (11.6) 0.40

Atrial fibrillation — no. (%) 245 (44.7) 157 (43.7) 88 (46.6) 0.53

Cerebrovascular disease — no. (%) 103 (18.8) 67 (18.7) 36 (19.0) 0.91

Peripheral vascular disease — no. (%) 95 (17.3) 51 (14.2) 44 (23.3) 0.008

Table 1. Baseline clinical characteristics (n=548).Results

All

n=548

Appropriate

n=359

Futile

n=189

P-Value

Permanent pacemaker — no. (%) 61 (11.1) 39 (10.9) 22 (11.6) 0.78

Implanted defibrillator — no. (%) 16 (2.9) 10 (2.8) 6 (3.2) 0.80

Number of sternotomies ≥1 — no. (%) 74 (13.5) 46 (12.8) 28 (14.8) 0.52

COPD — no. (%) 84 (15.3) 43 (12.0) 41 (21.7) 0.003

Body mass index, kg/m2 27.9 ± 6.5 28.4 ± 6.7 26.9 ± 6.0 0.006

Anemia — no. (%) 361 (65.9) 218 (60.7) 143 (75.7) <0.001

Creatinine, mg/dL 1.5 ± 2.9 1.1 ± 0.3 2.3 ± 4.8 <0.001

eGFR, ml/min/1.73m2 47.4 ± 15.3 53.4 ± 9.3 36.9 ± 17.9 <0.001

Medication — no. (%)

Aspirin 334 (60.9) 223 (62.1) 111 (58.7) 0.44

P2Y12 receptor inhibitor 79 (14.4) 52 (14.5) 27 (14.3) 0.95

Anticoagulant therapy 164 (29.9) 109 (30.4) 55 (29.1) 0.76

ACEI/ARB 187 (34.1) 140 (39.0) 47 (24.9) 0.001

Beta-blockers 308 (56.2) 195 (54.3) 113 (59.8) 0.22

Diuretic 348 (63.5) 223 (62.1) 125 (66.1) 0.35

Aldosterone antagonist 18 (3.3) 12 (3.3) 6 (3.2) 0.92

STS-PROM, % 6.63 ± 4.99 5.46 ± 3.63 8.86 ± 6.31 <0.001

> 8% — no. (%) 162 (29.6) 74 (20.6) 88 (46.6)

<0.0014% ~ 8% — no. (%) 208 (38.0) 141 (39.3) 67 (35.4)

< 4% — no. (%) 178 (32.5) 144 (40.1) 34 (18.0)

Table 1. Baseline clinical characteristics (n=548).Results

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All

n=548

Appropriate

n=359

Futile

n=189

P-value

Peak aortic velocity, m/s 4.0 ± 2.7 4.1 ± 3.3 3.8 ± 0.7 0.20

Aortic valve area, cm2 0.74 ± 0.16 0.74 ± 0.15 0.73 ± 0.16 0.43

Aortic valve area index, cm2/m2 0.41 ± 0.15 0.41 ± 0.17 0.40 ± 0.09 0.46

Mean aortic gradient, mmHg 35.6 ± 13.4 35.9 ± 13.2 35.0 ± 13.7 0.62

Dimensionless index 0.21 ± 0.04 0.21 ± 0.05 0.21 ± 0.04 0.22

Bicuspid aortic valve — no. (%) 28 (5.1) 25 (7.0) 3 (1.6) 0.007

LVEF, % 53 ± 14 54 ± 13 50 ± 15 0.009

LVEF ≤ 40% — no. (%) 113 (20.6) 66 (18.4) 47 (24.9) 0.077

Stroke volume index, ml/m² 33.9 ± 10.5 34.6 ± 10.5 32.6 ± 10.5 0.083

LV end-diastolic diameter, mm 45.1 ± 8.2 44.9 ± 7.9 45.6 ± 8.8 0.34

LV end-systolic diameter, mm 32.1 ± 9.7 31.5 ± 9.5 33.3 ± 9.9 0.039

LA volume index, ml/m2 49.5 ± 22.7 48.9 ± 24.3 50.7 ± 19.1 0.51

LA diameter, mm 45.7 ± 9.5 45.6 ± 9.5 45.9 ± 9.7 0.67

Zva, mm Hg/ml/m2 5.2 ± 1.7 5.1 ± 1.6 5.3 ± 1.9 0.20

Moderate or severe AR — no. (%) 75 (13.7) 48 (13.4) 27 (14.3) 0.77

Moderate or severe MR — no. (%) 163 (29.7) 99 (27.6) 64 (33.9) 0.13

Moderate or severe TR — no. (%) 178 (32.5) 110 (30.6) 68 (36.0) 0.21

Estimated RVSP, mmHg 38.0 ± 13.9 37.0 ± 13.9 39.9 ± 13.8 0.071

Table 2. Echocardiographic data (n=548).Results

Figure 2. Decision pathways for no aortic valve replacement.

Results

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87.8

23.4

16.6 16.6

85.2

20.315.9 15.9

92.6

29.1

18.0 18.0

0

10

20

30

40

50

60

70

80

90

100

Cardiologyconsultation

Structuralinterventionalcardiologistconsultation

Surgicalconsultation

Heartteamevaluation

%ofpatients

AllAppropriateFutile

Figure 3. Proportion of patients seen by cardiovascular practitioner

p=0.012

p=0.528

p=0.021

p=0.528

Results

All

n=548

Appropriate

n=359

Futile

n=189

Patient or family refusal — no. (%) 221 (40.3) 196 (54.6) 25 (13.2)

AS incorrectly deemed not severe — no. (%) 56 (10.2) 47 (13.1) 9 (4.8)

Symptoms not attributable to AS — no. (%) 33 (6.0) 29 (8.1) 4 (2.1)

Mild symptoms — no. (%) 26 (4.7) 26 (7.2) 0 (0)

Malignancy — no. (%) 37 (6.8) 0 (0) 37 (19.6)

Excessive frailty — no. (%) 59 (10.8) 0 (0) 59 (31.2)

Critically ill not due to AS — no. (%) 85 (15.5) 0 (0) 85 (45.0)

No benefit due to short life expectancy — no. (%) 71 (13.0) 0 (0) 71 (37.6)

Dementia — no. (%) 36 (6.6) 0 (0) 36 (19.0)

Mental retardation — no. (%) 2 (0.4) 0 (0) 2 (1.1)

Severe pulmonary disease — no. (%) 29 (5.3) 0 (0) 29 (15.3)

Severe liver disease (MELD >12) — no. (%) 5 (0.9) 0 (0) 5 (2.6)

Porcelain aorta — no. (%) 1 (0.2) 1 (0.3) 0 (0)

Aortic annulus too large — no. (%) 3 (0.6) 3 (0.8) 0 (0)

LV apical thrombus — no. (%) 1 (0.2) 1 (0.3) 0 (0)

LAA and RAA massive thrombus — no. (%) 1 (0.2) 1 (0.3) 0 (0)

No medical insurance — no. (%) 3 (0.5) 3 (0.8) 0 (0)

Excessive obesity — no. (%) 1 (0.2) 1 (0.3) 0 (0)

Psychiatric disease — no. (%) 1 (0.2) 1 (0.3) 0 (0)

Table 3. Cited reasons for no aortic valve replacementResults

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40.3

10.2

64.7

54.6

13.1

8.1 7.2

13.2

4.82.1

00

10

20

30

40

50

60

Patientrefusal ASdeemednotsevere

SymptomsuncertainforAS

Mildorstablesymptoms

%ofpatients

Reasonsfornosurgicaltherapy

AllAppropriateFutile

Figure 4. The primary reasons for no surgical therapy. p<0.001

p=0.002p=0.004

p<0.001

Results

Results

Major adverse events All

n=548

Appropriate

n=359

Futile

n=189

P-Value

Death — no. (%) 300 (54.7) 162 (45.1) 138 (73.0) 0.000

Non-fatal MI — no. (%) 28 (5.1) 16 (4.5) 12 (6.4) 0.339

Non-fatal stroke — no. (%) 15 (2.7) 9 (2.5) 6 (3.2) 0.649

Rehospitalization for CHF — no. (%) 106 (19.3) 64 (17.8) 42 (22.2) 0.216

Table 5. Clinical outcomes.

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Figure 5A. Kaplan-Meier curve for survival free of all-cause mortality

Figure 5B. Kaplan-Meier curve for survival free of all-cause mortality and heart failure re-hospitalization

Results

Results

Figure 6A. Kaplan-Meier curve for survival free of all-cause mortality for appropriate patients stratified by STS-PROM group

Figure 6B. Kaplan-Meier curve for survival free of all-cause mortality and heart failure re-hospitalization for appropriate patients stratified by STS-PROM group

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Conclusion

• In this contemporary study, two-thirds of patients with severe symptomatic AS treated medically were appropriate AVR candidates and had poor outcomes.

• Most patients had incomplete heart team evaluations, and commonly had symptoms or lesion severity misinterpreted.

• Given the potential for beneficial outcomes among those untreated, further educational efforts to address these shortcomings are warranted.

Acknowledgments

I would like to express my sincere appreciation to:

• Dr. Paul Sorajja, Mario Gössl, Steven M. Bradley, John Lesser, Kevin M. Harris

• Ross Garberich

• Dawn Witt

• Aisha Ahmed

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Thank you！

Your advice will be highly appreciated！

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