Case Presentations TAVR: The Good Bad and The Ugly Vincent J. Pompili, MD, FACC, FSCAI Professor of Internal Medicine Director of Interventional Cardiovascular Medicine and Cardiac Catheterization Laboratories PARTNER 5-Yr Follow-Up PARTNER Inoperable 1
All-Cause Mortality (ITT) Crossover Patients Censored at Crossover Standard Rx (n = 179) TAVR (n = 179) 80.9% 87.5% 93.6%** All-Cause Mortality (%) 50.8% 30.7% 68.0% 43.0% 53.9% 64.1% HR [95% CI] = 0.50 [0.39, 0.65] p (log rank) < 0.0001 71.8% Months * In an age and gender matched US population without comorbidities, the mortality at 5 years is 40.5%. ** Only 1 standard Rx patient was alive at 5 years who didn t crossover to TAVR or had SAVR (out of protocol) All-Cause Mortality (ITT) Median Survival 11.1 Months p (log rank) < 0.0001 29.7 Months Months 2
All Strokes (ITT) Incidence (%) * High mortality in both groups, makes competing risk analysis difficult; no constant hazard of increased post-procedural strokes 14.6% 5.7% Months PARTNER 5-Yr Follow-Up PARTNER High-Risk 3
All-Cause Mortality (ITT) All Patients HR [95% CI] = 1.04 [0.86, 1.24] p (log rank) = 0.76 67.8% 62.4% Error Bars Represent 95% Confidence Limits No. at Risk TAVR 348 262 228 191 154 61 SAVR 351 236 210 174 131 64 All-Cause Mortality (ITT) Transfemoral Patients All-Cause Mortality 100% 90% 80% 70% 60% 50% 40% 30% TAVR AVR HR [95% CI] = 0.91 [0.72, 1.14] p (log rank) = 0.41 63.3% 63.3% 20% Error Bars Represent 10% 95% Confidence Limits 0% 0 12 24 36 48 60 No. at Risk Months post Randomization TAVR 244 189 167 141 115 50 AVR 248 168 150 125 93 46 4
All Strokes (ITT) All Patients HR [95% CI] = 1.14 [0.68, 1.93] p (log rank) = 0.61 Error Bars Represent 95% Confidence Limits 11.3% 10.4% No. at Risk TAVR 348 251 217 181 144 57 SAVR 351 230 205 169 128 64 All-Cause Mortality or Stroke (ITT) All Patients HR [95% CI] = 1.09 [0.90, 1.31] p (log rank) = 0.39 69.8% 62.9% Error Bars Represent 95% Confidence Limits No. at Risk TAVR 348 251 217 181 144 57 SAVR 351 230 205 169 128 64 5
ACC 2015 CoreValve US Pivotal Trial High Risk 2 Year Results All Cause Mortality ACC 2015 Δ = 6.5 Δ = 4.8 18.9% 28.6% 22.2% 14.1% Log rank P=0.04 No. at Risk Months Post Procedure Transcatheter 391 378 354 334 219 Surgical 359 343 304 282 191 12 6
All Stroke ACC 2015 13 Major Stroke ACC 2015 14 7
Other Clinical Endpoints ACC 2015 Events* 1 Month 1 Year 2 Years TAVR SAVR P TAVR SAVR P TAVR SAVR P Vascular complications (major) 6.2 1.7 0.002 6.4 2.0 0.003 7.1 2.0 0.001 Pacemaker implant 20.0 7.1 <0.001 22.5 11.6 <0.001 25.8 12.8 <0.001 Bleeding (life threatening or disabling) 13.6 35.1 <0.001 16.5 38.4 <0.001 18.1 39.6 <0.001 New onset or worsening atrial fibrillation 11.7 31.0 <0.001 16.4 33.2 <0.001 19.5 34.9 <0.001 Acute kidney injury 6.2 15.1 <0.001 6.2 15.1 <0.001 6.2 15.1 <0.001 * Percentages reported are Kaplan Meier estimates and log rank P values 15 Additional Adverse Events ACC 2015 Events* 1 Month 1 Year 2 Years TAVR SAVR P TAVR SAVR P TAVR SAVR P Reintervention 0.8 0.0 0.10 2.2 0.0 0.008 2.5 0.4 0.02 Surgical 0.5 0.0 0.18 0.8 0.0 0.10 0.8 0.4 0.38 Percutaneous 0.3 0.0 0.34 1.4 0.0 0.04 1.7 0.0 0.02 Valve endocarditis 0.0 0.0 0.6 1.3 0.31 0.9 1.7 0.35 Valve thrombosis 0.0 0.0 0.0 0.0 0.0 0.0 Embolization 0.0 0.0 0.0 0.0 0.0 0.0 * Percentages reported are Kaplan Meier estimates and log rank P values 16 8
Implications Nishimura RA, Otta CM, Bonow RO, et al. 2014 AHA/ACC guideline for the management of patients with valvular heart disease. J Am Coll Cardiol. 2014;63:e57 185. 17 Still the Ugly from time to time 18 9
87 year old male with Severe Aortic Stenosis PMH: 1. Severe Aortic stenosis, peak velocity 4.6 m/s, 0.7cm2, mean gradient 42mmHg, main symptom exertional chest pain 2. CAD, stents x2 proximal and mid LAD 2012 now LAD ischemia 3. Mild chronic anemia 4. HTN 5. Gout 6. Hyperlipidemia 7. DM Type II 8. Lung nodule - 9 mm - stable, evaluated multiple times 9. Interstitial pulmonary fibrosis 10. Colon adenoma with dysplasia; last colonoscopy 2013 -remainder truncated-. 19 20 10
9/17/2016 Cor angio FFR proximal LAD 0.80 Severe stenosis proximal LAD, high grade mid D1 lesion and significant restenosis mid LAD in previously stented segment. 21 Movie 22 11
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Movie 29 Movie VFib Shock x 1 30 15
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JB1 Conclusions: 1) Embolic occlusion of LM trunk leading to cardiac arrest requiring LM revascularization under Lucas CPR. 2) Uneventful TAVR with balloon expandable valve under rapid pacing despite preceding cardiac arrest/stunning. 3) Try to keep things simple, LAD ischemia was probably not relevant to be addressed prior to TAVR. 35 CASE 2.Ugly 78 year old gentleman with background of Type 2 DM, asbestosis Increasing SOB on exertion, NYHA 3 CABGx3 (SVG to LAD, OM and RCA) DDD PPM Severe AS, PG 86 mmhg, mean 45 mmhg, EF 40%, PASP 60mmHg. Patent SVG to Cx, patent but atheromatous SVG to LAD STS 9.9% 18
Slide 35 JB1 Johannes Brechtken, 6/14/2016
29mm Edwards Sapien S3 valve suitably positioned and deployed Valve deployed under rapid pacing via PPM at 210bpm Good position on echo/fluoroscopy with mild paravalvular AR 19
Post op patient developed pulmonary edema and hypertension BP 180/90 Bedside TTE reported satisfactory valve position, no AR and good LV Responded to IV diuretics Next day patient patient had further decompensation requiring intubation Decompensated with pulmonary edema and hypotension requiring intubation and inotropic support BP now 90/30 TTE suggestive of significant AR 20
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Post-Procedure Haemodynamically stable Extubated within 1 hour Neurological symptoms suggestive of stroke - CT head left sided subacute infarct - neurology improved and now mobilizing with normal speech and swallow - Repatriated for ongoing rehabilitation Conclusions Late valve migration can occur Mechanism unclear Inadequate fixation (large annulus) Inadequate deployment Native valve leaflet rupture Low DBP marker of severe AR Can usually be managed by ViV procedure 22