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Outcomes of the Initial Experience with Commercial Transcatheter Mitral Valve Repair in the U.S. A report from the STS/ACC TVT Registry ACC 2015 LBCT Paul.

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Presentation on theme: "Outcomes of the Initial Experience with Commercial Transcatheter Mitral Valve Repair in the U.S. A report from the STS/ACC TVT Registry ACC 2015 LBCT Paul."— Presentation transcript:

1 Outcomes of the Initial Experience with Commercial Transcatheter Mitral Valve Repair in the U.S. A report from the STS/ACC TVT Registry ACC 2015 LBCT 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, Wesley A. Pedersen, MD, and Gorav Ailawadi, MD

2 Disclosures Paul Sorajja, MD Abbott Vascular, Medtronic David R. Holmes, Jr, MD Boston Scientific Wesley A. Pedersen, MD Abbott Vascular, Intervalve, Lake Regions Medical, Medtronic D. Scott Lim, MD Abbott Vascular, Edwards Lifesciences, Mitralign Saibal Kar, MD Abbott Vascular, AGA Medical, Boston Scientific, Coherex Medical, Medtronic, St. Jude Medical Michael Mack, MD Abbott Vascular, Edwards Lifesciences Gorav Ailawadi, MD Abbott Vascular, Atricure, Edwards Lifesciences, Mitraaling, St. Jude Vinod Thourani, MD Abbott Vascular, Apica Cardiovascular, Boston Scientific, Edwards Lifesciences, Medtronic, Sorin, St. Jude Medical Sreekanth Vemulapalli, MD Abbott Vascular, Boston Scientific, Medtronic Amanda Stebbins, MS None

3 Background Degenerative MR is common, affectingDegenerative 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 patients with symptoms or LV dysfunctionSurgery is the standard of care, and is indicated for patients with symptoms or LV dysfunction However, there are patients in whom the risk of surgery is prohibitiveHowever, there are patients in whom the risk of surgery is prohibitive

4 Transcatheter 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 System

5 Outcomes of commercial experience unknown TMVR with MitraClip in the U.S. Over 100 sites activated

6 Study Objective To analyze and report the initial commercial experience of TMVR with the MitraClip System in the U.S.

7 STS/ACC TVT Registry Collaboration of STS, ACC, CMS, hospitals, medical industryCollaboration 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 Repair

8 Methods All commercial TMVR cases with MitraClip enrolled in TVT registry through August 31, 2014 were identified (n=564)All commercial TMVR cases with MitraClip enrolled in TVT registry through August 31, 2014 were identified (n=564) Examined in-hospital and 30-day outcomes for procedure success, complications, and device-related events.Examined in-hospital and 30-day outcomes for procedure success, complications, and device-related events.

9 Outcome Definitions Procedure successProcedure success Post-implant MR grade ≤2, without CV surgery and without in-hospital mortality Procedure complicationsProcedure complications cardiac perforation, major bleeding, stroke, MI, mitral injury, or death Device-related adverse eventsDevice-related adverse events Single leaflet device attachment, complete clip detachment, device thrombosis, device or delivery component embolization

10 Surgical Risk and Cases Surgical Risk and Cases 564 patients at 61 hospitals No. Cases

11 Study Population 564 Patients Study Population 564 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%) 83.9%51.8%62.6%8.7%25.0%32.4%24.6%16.7%14.7% 7.9% (4.7, 12.2) 10.0% (6.3, 14.5)

12 Other Procedure Indications Other 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%6.0%3.4%2.3%1.2%0.5%1.4%25.3%

13 Echocardiographic data Echocardiographic 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 cm 2 …………………………..MVA <4 cm 2 ………………………….. Severe TR…………………………….Severe TR……………………………. 56% (45, 63%) 94.0% 5.2 cm (4.6, 5.8 cm) 3.6 cm (3.0, 4.5 cm) 85.5%28.9%28.0%14.4%38.4%17.2%8.0%19.7%14.7%

14 Grade 4 Grade 3 Grade 2 Grade 1 Mitral Regurgitation Change in Mitral Regurgitation Clip implantation occurred in 94% 93% MR ≤2 63.7% MR≤1 p<0.001

15 Clinical Outcomes Procedure success….Procedure success…. Complications............Complications............ Length-of-stay............Length-of-stay............ Home discharge.........Home discharge......... 91.8%7.8% 3 d (1,6 d) 81.9%

16 Adverse 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%5.8%0.5%1.8%0%3.9%0.7%2.7%1.1%0.4%1.2%

17 EDDEDD Case vol. (per 2)Case vol. (per 2) A2-P2 clip siteA2-P2 clip site Univariate Odds Ratios for MR grade ≤2 0 1 2 3 Baseline MRBaseline MR Clinical Variables and Residual MR   p=0.01  p=0.03 p=0.01 p=0.03  Odds Ratios

18 Commercial TMVR with MitraClip Data 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%

19 U.S. vs. Other Registries U.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%95%91%95%85%88%100%93%94% MR ≤2 DMR In-hospitaldeath 2.3%2.9%2.9%4.0%3.3%4.2% Age (yrs) 837474757773727371 86%28%23%29%38%23%24%18%46% EVEREST I………………..EVEREST I……………….. EVEREST II RCT…...….…EVEREST II RCT…...….… EVEREST II HRS……......EVEREST II HRS……......716776 74%77%85% 0.9%1.1%2.6% 79%51%30%

20 Conclusions Conclusions 1)In this first report of the U.S. commercial experience with TMVR, procedure success, clinical outcomes, and adverse events were favorable in comparison to pre-approval studies and other national registries 2) These data demonstrate effectiveness and safety of TMVR with MitraClip for the treatment of prohibitive risk patients with symptomatic MR

21

22 0 1 3 2 EDD (↑) Case volume (↑) A2-P2 implant Baseline MR (↑) Age (↑) Male gender ESD (↑) MAC Mitral gradient (↑) MVA <4 cm 2 > 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 MR

23 Surgical Risk and Cases Surgical Risk and Cases 564 patients at 61 hospitals No. Cases

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