Outcomes of the Initial Experience Outcomes of the Initial Experience

with Commercial Transcatheter Mitral with Commercial Transcatheter Mitral

Valve Repair in the U.S.Valve Repair in the U.S.

A report from the STS/ACC TVT Registry A report from the STS/ACC TVT Registry

ACC 2015 LBCTACC 2015 LBCT

Paul Sorajja, MD, Saibal Kar, MD, Amanda Stebbins, Sreekanth Vemulapalli, MD, D. Scott Lim, MD, Vinod Thourani, Paul Sorajja, MD, Saibal Kar, MD, Amanda Stebbins, Sreekanth Vemulapalli, MD, D. Scott Lim, MD, Vinod Thourani,

MD, Michael Mack, MD, David R. Holmes, Jr., MD, MD, Michael Mack, MD, David R. Holmes, Jr., MD,

Wesley A. Pedersen, MD, and Gorav Ailawadi, MDWesley A. Pedersen, MD, and Gorav Ailawadi, MD

DisclosuresDisclosuresPaul Sorajja, MDPaul Sorajja, MDAbbott Vascular, MedtronicAbbott Vascular, Medtronic

David R. Holmes, Jr, MDDavid R. Holmes, Jr, MDBoston ScientificBoston Scientific

Wesley A. Pedersen, MDWesley A. Pedersen, MDAbbott Vascular, Intervalve, Lake Abbott Vascular, Intervalve, Lake Regions Medical, MedtronicRegions Medical, Medtronic

D. Scott Lim, MDD. Scott Lim, MDAbbott Vascular, Edwards Abbott Vascular, Edwards Lifesciences, MitralignLifesciences, Mitralign

Saibal Kar, MDSaibal Kar, MDAbbott Vascular, AGA Medical, Boston Abbott Vascular, AGA Medical, Boston Scientific, Coherex Medical, Medtronic, St. Scientific, Coherex Medical, Medtronic, St. Jude MedicalJude Medical

Michael Mack, MDMichael Mack, MDAbbott Vascular, Edwards LifesciencesAbbott Vascular, Edwards Lifesciences

Gorav Ailawadi, MDGorav Ailawadi, MDAbbott Vascular, Atricure, Edwards Abbott Vascular, Atricure, Edwards Lifesciences, Mitraaling, St. JudeLifesciences, Mitraaling, St. Jude

Vinod Thourani, MDVinod Thourani, MDAbbott Vascular, Apica Cardiovascular , Abbott Vascular, Apica Cardiovascular , Boston Scientific, Edwards Lifesciences, Boston Scientific, Edwards Lifesciences, Medtronic, Sorin, St. Jude MedicalMedtronic, Sorin, St. Jude Medical

Sreekanth Vemulapalli, MDSreekanth Vemulapalli, MDAbbott Vascular, Boston Abbott Vascular, Boston Scientific, MedtronicScientific, Medtronic

Amanda Stebbins, MSAmanda Stebbins, MSNoneNone

BackgroundBackground

• Degenerative MR is common, affecting Degenerative MR is common, affecting

~600,000 persons in the U.S.600,000 persons in the U.S.

• Surgery is the standard of care, and is indicated for Surgery is the standard of care, and is indicated for

patients with symptoms or LV dysfunction patients with symptoms or LV dysfunction

• However, there are patients in whom the risk of However, there are patients in whom the risk of

surgery is prohibitivesurgery is prohibitive

Transcatheter Mitral Valve RepairTranscatheter Mitral Valve Repair

• Commercial approval October 24, 2013Commercial approval October 24, 2013

• Indicated for symptomatic patients with primary MR ≥3 and prohibitive surgical riskIndicated for symptomatic patients with primary MR ≥3 and prohibitive surgical risk

The MitraClip SystemThe MitraClip System

Outcomes of commercial experience unknownOutcomes of commercial experience unknown

TMVR with MitraClip in the U.S.TMVR with MitraClip in the U.S.

Over 100 sites activatedOver 100 sites activated

Study ObjectiveStudy Objective

To analyze and report the initial commercial experience To analyze and report the initial commercial experience

of TMVR with the MitraClip System in the U.S. of TMVR with the MitraClip System in the U.S.

STS/ACC TVT RegistrySTS/ACC TVT Registry

• Collaboration of STS, ACC, CMS, hospitals, medical industry Collaboration of STS, ACC, CMS, hospitals, medical industry

• Patient-level data housed at DCRIPatient-level data housed at DCRI

• Participation satisfies NCDParticipation satisfies NCD

Transcatheter Mitral Valve RepairTranscatheter Mitral Valve Repair

MethodsMethods

• All commercial TMVR cases with MitraClip enrolled in TVT All commercial TMVR cases with MitraClip enrolled in TVT

registry through August 31, 2014 were identified (n=564)registry through August 31, 2014 were identified (n=564)

• Examined in-hospital and 30-day outcomes for procedure Examined in-hospital and 30-day outcomes for procedure

success, complications, and device-related events.success, complications, and device-related events.

Outcome DefinitionsOutcome Definitions• Procedure successProcedure success

Post-implant MR grade ≤2, without CV surgery and without in-hospital mortalityPost-implant MR grade ≤2, without CV surgery and without in-hospital mortality

• Procedure complicationsProcedure complications

cardiac perforation, major bleeding, stroke, MI, mitral cardiac perforation, major bleeding, stroke, MI, mitral injury, or deathinjury, or death

• Device-related adverse eventsDevice-related adverse events

Single leaflet device attachment, complete clip Single leaflet device attachment, complete clip detachment, device thrombosis, detachment, device thrombosis,

device or delivery device or delivery component embolizationcomponent embolization

Surgical Risk and CasesSurgical Risk and Cases564 patients at 61 hospitals564 patients at 61 hospitals

No. No. CasesCases

Study PopulationStudy Population564 Patients564 Patients

• Median age (% men)…………………..…..Median age (% men)…………………..…..• NYHA III/IV……………………………….……….NYHA III/IV……………………………….……….• HF hospitalization prior yr…………….……....HF hospitalization prior yr…………….……....• Atrial fibrillation………………………….……...Atrial fibrillation………………………….……...• Prior CVA………………………………….………Prior CVA………………………………….………• Diabetes………………………………….……….Diabetes………………………………….……….• Prior CABG……………………………….………Prior CABG……………………………….………• Prior MI…………………………………………...Prior MI…………………………………………...• Creatinine ≥2 g/dl……………………………….Creatinine ≥2 g/dl……………………………….• O2-dependency………………………….………O2-dependency………………………….………• Median STS-PROM MV repair..............…Median STS-PROM MV repair..............…• Median STS-PROM MV replacement.….Median STS-PROM MV replacement.….

83 yrs (56%)83 yrs (56%)

83.9%83.9%

51.8%51.8%

62.6%62.6%

8.7%8.7%

25.0%25.0%

32.4%32.4%

24.6%24.6%

16.7%16.7%

14.7%14.7%

7.9% (4.7, 12.2)7.9% (4.7, 12.2)

10.0% (6.3, 14.5)10.0% (6.3, 14.5)

Other Procedure IndicationsOther Procedure Indications

•Frailty……………...........................................Frailty……………...........................................

•Hostile chest…………………….....................Hostile chest…………………….....................

•Porcelain aorta………………….……………..Porcelain aorta………………….……………..

•RV dysfunction with severe TR….…....……RV dysfunction with severe TR….…....……

•Immobility………………………………....……Immobility………………………………....……

•Severe liver disease (MELD >12)……..........Severe liver disease (MELD >12)……..........

•IMA at high risk of injury…………………….IMA at high risk of injury…………………….

•Unusual extenuating circumstance…….…Unusual extenuating circumstance…….…

57.2%57.2%

6.0%6.0%

3.4%3.4%

2.3%2.3%

1.2%1.2%

0.5%0.5%

1.4%1.4%

25.3%25.3%

Echocardiographic dataEchocardiographic data• LV ejection fraction..………..…..….LV ejection fraction..………..…..….

• MR severity grade 3 or 4……….….MR severity grade 3 or 4……….….

• LV EDD………………………………..LV EDD………………………………..

• LV ESD………………………………..LV ESD………………………………..

• Degenerative MR…………...............Degenerative MR…………...............

• Posterior prolapse.………………Posterior prolapse.………………

• Posterior flail………………...……Posterior flail………………...……

• Functional MR………………............Functional MR………………............

• Mitral annular calcification…….….Mitral annular calcification…….….

• Leaflet calcification…….…………...Leaflet calcification…….…………...

• Mitral gradient ≥5 mmHg…………...Mitral gradient ≥5 mmHg…………...

• MVA <4 cmMVA <4 cm22…………………………..…………………………..

• Severe TR…………………………….Severe TR…………………………….

56% (45, 63%)56% (45, 63%)

94.0%94.0%

5.2 cm (4.6, 5.8 cm)5.2 cm (4.6, 5.8 cm)

3.6 cm (3.0, 4.5 cm)3.6 cm (3.0, 4.5 cm)

85.5%85.5%

28.9%28.9%

28.0%28.0%

14.4%14.4%

38.4%38.4%

17.2%17.2%

8.0%8.0%

19.7%19.7%

14.7%14.7%

Grade 4

Grade 3

Grade 2

Grade 1

Mitral Regurgitation

Change in Mitral RegurgitationChange in Mitral RegurgitationClip implantation occurred in 94%Clip implantation occurred in 94%

93% MR ≤293% MR ≤2

63.7% MR≤163.7% MR≤1

p<0.001p<0.001

Clinical OutcomesClinical Outcomes

• Procedure success….Procedure success….

• Complications............Complications............

• Length-of-stay............Length-of-stay............

• Home discharge.........Home discharge.........

91.8%91.8%

7.8%7.8%

3 d (1,6 d)3 d (1,6 d)

81.9% 81.9%

Adverse EventsAdverse Events• In-hospital mortality……………..…….In-hospital mortality……………..…….

• 30-day mortality…………………………30-day mortality…………………………

• Cardiac surgery…….....………….…….Cardiac surgery…….....………….…….

• Stroke……………………………..………Stroke……………………………..………

• Myocardial infarction……………...……Myocardial infarction……………...……

• Major bleeding………………….….……Major bleeding………………….….……

• Cardiac perforation……………….……Cardiac perforation……………….……

• Device-related events……………..…...Device-related events……………..…...

• Single leaflet device attachment....Single leaflet device attachment....

• Device embolization…………..……Device embolization…………..……

• Other…………………………….….…Other…………………………….….…

2.3%2.3%

5.8%5.8%

0.5%0.5%

1.8%1.8%

0%0%

3.9%3.9%

0.7%0.7%

2.7%2.7%

1.1%1.1%

0.4%0.4%

1.2%1.2%

• EDDEDD

• Case vol. (per 2)Case vol. (per 2)

• A2-P2 clip siteA2-P2 clip site

Univariate Odds Ratios for MR grade ≤2Univariate Odds Ratios for MR grade ≤2

00 11 22 33

• Baseline MRBaseline MR

Clinical Variables and Residual Clinical Variables and Residual MR MR

pp=0.01=0.01

pp=0.03=0.03

pp=0.01=0.01

pp=0.03=0.03

Odds RatiosOdds Ratios

Commercial TMVR with MitraClip Commercial TMVR with MitraClip Data SummaryData Summary

• Prohibitive risk population with 86% DMRProhibitive risk population with 86% DMR

• Mortality: 2.3% in-hospital, 5.8% at 30-daysMortality: 2.3% in-hospital, 5.8% at 30-days

• 91.8% procedure success91.8% procedure success

• EDD, MR, volume, clip site related to successEDD, MR, volume, clip site related to success

• Procedure complications: 7.8%Procedure complications: 7.8%

• Device-related adverse events: 2.7%Device-related adverse events: 2.7%

U.S. vs. Other RegistriesU.S. vs. Other Registries

• STS/ACC TVT (US)...…….STS/ACC TVT (US)...…….• SENTINEL (EU)….………..SENTINEL (EU)….………..• ACCESS (EU)….……...….ACCESS (EU)….……...….• TRAMI (DE)………..………TRAMI (DE)………..………• MitraSwiss (CH)................MitraSwiss (CH)................• France (FR)……................France (FR)……................• GRASP (IT)……..….…….…GRASP (IT)……..….…….…• Netherlands (NL)…………Netherlands (NL)…………• MARS (Asia)………………MARS (Asia)………………

93%93%

95%95%

91%91%

95%95%

85%85%

88%88%

100%100%

93%93%

94%94%

MR ≤2MR ≤2DMR DMR

In-hospitalIn-hospitaldeathdeath

2.3%2.3%

2.9%2.9%

2.9%2.9%

4.0%4.0%

3.3%3.3%

4.2%4.2%

Age (yrs)Age (yrs)

8383

7474

7474

7575

7777

7373

7272

7373

7171

86%86%

28%28%

23%23%

29%29%

38%38%

23%23%

24%24%

18%18%

46%46%• EVEREST I………………..EVEREST I………………..• EVEREST II RCT…...….…EVEREST II RCT…...….…• EVEREST II HRS……......EVEREST II HRS……......

7171

6767

7676

74%74%

77%77%

85%85%

0.9%0.9%

1.1%1.1%

2.6%2.6%

79%79%

51%51%

30%30%

ConclusionsConclusions

1)1) In this first report of the U.S. commercial experience with In this first report of the U.S. commercial experience with

TMVR, procedure success, clinical outcomes, and adverse TMVR, procedure success, clinical outcomes, and adverse

events were favorable in comparison to pre-approval events were favorable in comparison to pre-approval

studies and other national registriesstudies and other national registries

2) These data demonstrate effectiveness and safety of 2) These data demonstrate effectiveness and safety of

TMVR with MitraClip for the treatment of prohibitive TMVR with MitraClip for the treatment of prohibitive

risk patients with symptomatic MRrisk patients with symptomatic MR

0 1 32

• EDD (↑)

• Case volume (↑)

• A2-P2 implant

• Baseline MR (↑)

• Age (↑)

• Male gender

• ESD (↑)

• MAC

• Mitral gradient (↑)

• MVA <4 cm2

• > 1 clip placed

• FMR

p

0.12

0.17

0.07

0.03

• Severe TR

Odds Ratio for MR grade ≤2

0.29

0.03

0.01

0.12

0.90

0.33

0.23

0.43

0.01

Clinical Variables and Residual Clinical Variables and Residual MRMR

Surgical Risk and CasesSurgical Risk and Cases564 patients at 61 hospitals564 patients at 61 hospitals

No. No. CasesCases