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
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% 0 6 12 18 24 30 36 Standard Rx TAVR 50.8% 30.7% HR [95% CI] = 0.53 [0.41, 0.68] p (log rank) < 0.0001 20.1% NNT = 5.0 pts 68.0% 43.0% 25.0% NNT = 4.0 pts 80.9% 54.1% Standard Rx 179 121 85 62 46 27 17 TAVR 179 138 124 110 101 88 70 26.8% NNT = 3.7 pts 2
Repeat Hospitalization (ITT) Rehospitalization (%) Rehospitalization 100% Standard Rx HR [95% CI] = 0.39 [0.28, 0.54] TAVR p (log rank) < 0.0001 80% 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% 0 6 12 18 24 30 36 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) < 0.0001 0% 0 6 12 18 24 30 36 31.5% 26.8% Days Alive Out of Hospital Median [IQR] TAVR 944 [233-1096] Standard Rx 368 [147-1096] p <.0001 Numbers at Risk Standard Rx 179 86 49 30 19 11 7 179 86 49 30 19 11 7 TAVR 179 115 100 89 77 64 49 179 115 100 89 77 64 49 Lesson number 2: In patients with high surgical risk, TAVR is an acceptable alternative 3
All-Cause Mortality (ITT) HR [95% CI] = 0.93 [0.74, 1.15] p (log rank) = 0.483 34.6% 44.8% 44.2% 26.8% 33.7% 24.3% No. at Risk TAVR 348 298 261 239 222 187 149 AVR 351 252 236 223 202 174 142 Lesson number 3 TAVR is associated with early stroke hazard 4
All Stroke (ITT) 50% 40% TAVR Standard Rx HR [95% CI] = 2.77 [1.24, 6.19] p (log rank) = 0.0094 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% 0 6 12 18 24 30 36 Numbers at Risk TAVR 179 128 116 105 96 82 65 Standard Rx 179 118 84 62 46 27 17 Lesson number 4: Vascular complications matter, they can affect survival and newer systems are better 5
Mortality vs. Major Vasc Complics TAVI patients Major Vascular Complication (n=31) No Major Vascular Complication (n=148) P (log rank) = 0.069 47.2% Mortality (%) 27.7% Lesson number 5: There are some patients where TAVR may not be of benefit due to overwhelming co-morbidities 6
Mortality Stratified by STS Score (ITT) Standard Rx TAVR STS <5 100% STS 5-14.9 100% 100% STS 15 80% 80% 80% Death Incidence (%) 60% 60% 40% 40% 20% 20% 0% 0% 0 6 12 18 24 Numbers at Risk 60% 40% 20% 0% 0 6 12 18 24 0 6 12 18 24 28 26 25 24 16 12 19 8 7 6 5 108 80 76 67 52 119 84 59 42 29 43 32 23 19 15 47 29 19 14 8 Lesson number 6: Cost-effectiveness of TAVR is comparable to SAVR. 7
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
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;30:528 536 9-Tu HT et al, Cerebrovascular Disease. 2010;30(4):389-95 7-Patel et al, Cardiol Res Pract. 2012; 2012: 610827 4Klein A et al, Datamonitor. July 2011 5Blackshear JL, Odell JA, Ann of Thor Surgery, 1996;61:755-759 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 2005 9
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 2005 10
PROTECT AF Primary Efficacy Results Reddy, VY et al. Circulation. 2013;127:720-729 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
MITRACLIP Percutaneous repair or Surgery for mitral regurgitation; Feldman et.al.,nejm,apr 2011,Vol.364,Pg1395-1406 12
Percutaneous Mitral repair, Feldman et.al, JACC 2005 Dec:Vol.46,Pg2135-40 EVEREST II Percutaneous repair or Surgery for mitral regurgitation; Feldman et.al.,nejm,apr 2011,Vol.364,Pg1395-1406 13
REDUCTION OF MR Percutaneous Mitral Interventions in the ACCESS-EU study; Maisano et.al., JACC 2013 Vol-62;No.12,Pg 1052-1061 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)-396-1370 Fax(520)-396-1375 14