PERCUTANEOUS STRUCTURAL UPDATES TAVR WATCHMAN(LEFT ATRIAL APPENDAGE OCCLUDERS) MITRACLIP PARAVALVULAR LEAK REPAIRS ASD/PFO CLOSURES VALVULOPLASTIES

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1 PERCUTANEOUS STRUCTURAL UPDATES TAVR WATCHMAN(LEFT ATRIAL APPENDAGE OCCLUDERS) MITRACLIP PARAVALVULAR LEAK REPAIRS ASD/PFO CLOSURES VALVULOPLASTIES Dr.Vinny K.Ram No disclosures TAVR 1

2 Lesson number 1: TAVR should be the standard of care in the inoperable patients because it saves lives and improves quality of life All Cause Mortality (%) 100% 80% 60% 40% 20% Numbers at Risk All Cause Mortality (ITT) Crossover Patients Censored at Crossover 0% Standard Rx TAVR 50.8% 30.7% HR [95% CI] = 0.53 [0.41, 0.68] p (log rank) < % NNT = 5.0 pts 68.0% 43.0% 25.0% NNT = 4.0 pts 80.9% 54.1% Standard Rx TAVR % NNT = 3.7 pts 2

3 Repeat Hospitalization (ITT) Rehospitalization (%) Rehospitalization 100% Standard Rx HR [95% CI] = 0.39 [0.28, 0.54] TAVR p (log rank) < % 72.5% 75.7% 60% 53.9% 33.4% 37.6% 40% 26.9% 42.3% 34.9% NNT = 3.0 pts 20% 27.0% NNT = 2.7 pts NNT = 3.7 pts 0% Mortality or Rehospitalization (%) Mortality or Rehospitalization 100% 80% 71.6% 88.0% 93.1% 60% 27.5% 66.3% NNT = 3.7 pts 56.5% NNT = 3.2 pts 40% 44.1% NNT = 3.6 pts 20% HR [95% CI] = 0.46 [0.36, 0.58] p (log rank) < % % 26.8% Days Alive Out of Hospital Median [IQR] TAVR 944 [ ] Standard Rx 368 [ ] p <.0001 Numbers at Risk Standard Rx TAVR Lesson number 2: In patients with high surgical risk, TAVR is an acceptable alternative 3

4 All-Cause Mortality (ITT) HR [95% CI] = 0.93 [0.74, 1.15] p (log rank) = % 44.8% 44.2% 26.8% 33.7% 24.3% No. at Risk TAVR AVR Lesson number 3 TAVR is associated with early stroke hazard 4

5 All Stroke (ITT) 50% 40% TAVR Standard Rx HR [95% CI] = 2.77 [1.24, 6.19] p (log rank) = Stroke (%) 30% 20% NNT = 17.5 pts 11.2% NNT = 12.2 pts 13.7% NNT = 9.8 pts 15.7% 10% = 5.7% = 8.2% = 10.2% 5.5% 5.5% 5.5% 0% Numbers at Risk TAVR Standard Rx Lesson number 4: Vascular complications matter, they can affect survival and newer systems are better 5

6 Mortality vs. Major Vasc Complics TAVI patients Major Vascular Complication (n=31) No Major Vascular Complication (n=148) P (log rank) = % Mortality (%) 27.7% Lesson number 5: There are some patients where TAVR may not be of benefit due to overwhelming co-morbidities 6

7 Mortality Stratified by STS Score (ITT) Standard Rx TAVR STS <5 100% STS % 100% STS 15 80% 80% 80% Death Incidence (%) 60% 60% 40% 40% 20% 20% 0% 0% Numbers at Risk 60% 40% 20% 0% Lesson number 6: Cost-effectiveness of TAVR is comparable to SAVR. 7

8 Index admission resource use and costs, Transfemoral cohort 647 TAVR/SAVR patients in the PARTNER A Trial Overall index admission costs were not different between TF-TAVR and SAVR $73,219 vs. $74,067, mean difference, $849; 95% CI: $8,977 to $7,014 Cumulative 1 year resource use and costs, Transfemoral cohort 647 TAVR/SAVR patients in the PARTNER A Trial Cumulative 12 month costs were not different between TF- TAVR and SAVR $96,743 vs. $97,992 mean diff, $1,250; 95% CI: $18,132 to $13,867 8

9 Lessons from the PARTNER Trial 1. Outcomes in Inoperable patients 2. Outcomes in high risk patients 3. Complications Stroke Vascular complications Aortic regurgitation 4. Hemodynamics 5. Futility 6. Learning curve 7. Risk scores 8. Sapien XT/Novaflex 9. Cost effectiveness LEFT ATRIAL APPENDAGE OCCLUDERS 1)People with AF have 5 times the risk of stroke compared to people without AF⁸ 2)Stroke is more severe for patients with AF, as they have a 70% chance of death or permanent disability⁹ AF-associated ischemic strokes generally occlude large intracranial arteries depriving a more extensive region of the brain of blood flow⁸ 3)Compared with non-af patients, AF patients have poorer survival and more recurrences of stroke during the first year of follow-up⁷ 4)Relative or absolute contraindications to long-term anticoagulation are present in up to 40% of AF patients, usually due to a history of bleeding or an elevated risk of falls and trauma. In fact, anticoagulation is not currently utilized in up to 50% of eligible AF patients 5)The economic burden of stroke will continue to rise globally as the incidence of stroke increases⁴ 6)91% of stroke in AF is caused by thrombus formed in the LAA⁵ 8-Holmes DR. Seminars in Neurology. 2010;30: Tu HT et al, Cerebrovascular Disease. 2010;30(4): Patel et al, Cardiol Res Pract. 2012; 2012: Klein A et al, Datamonitor. July Blackshear JL, Odell JA, Ann of Thor Surgery, 1996;61: Caution: In the United States, WATCHMAN is an investigational device limited by Federal law and investigational use only. Not for sale in the US. Prior to use please review device indications, contraindications, warnings, precautions, adverse events, and operational instructions. Only available according to applicable local law. CE Mark received in

10 The WATCHMAN product is a device for percutaneous closure of the left atrial appendage WATCHMAN is a self-expanding nitinol frame with fixation anchors and a permeable fabric cover It is designed to be permanently implanted at or slightly distal to the opening of the LAA to trap potential emboli before they exit the LAA It is implanted via a trans-septal approach by use of a catheter based delivery system The delivery catheter is capable of recapturing the device if necessary Received CE mark in

11 PROTECT AF Primary Efficacy Results Reddy, VY et al. Circulation. 2013;127: CONCLUSIONS Despite implantation in higher risk patients the Watchman device can be safely implanted by new operators The Watchman device is an alternative to oral anticoagulation therapy for thromboembolic prevention in patients with non valvular atrial fibrillation 11

12 MITRACLIP Percutaneous repair or Surgery for mitral regurgitation; Feldman et.al.,nejm,apr 2011,Vol.364,Pg

13 Percutaneous Mitral repair, Feldman et.al, JACC 2005 Dec:Vol.46,Pg EVEREST II Percutaneous repair or Surgery for mitral regurgitation; Feldman et.al.,nejm,apr 2011,Vol.364,Pg

14 REDUCTION OF MR Percutaneous Mitral Interventions in the ACCESS-EU study; Maisano et.al., JACC 2013 Vol-62;No.12,Pg QUESTIONS??? Vinny K.Ram, MD Interventional Cardiovascular Medicine Carondelet Heart and Vascular Institute 445 N.Silverbell Rd, Suite 201 Tucson,AZ 85745(St.Mary s Hospital) Office(520) Fax(520)