Tissue vs Mechanical What s the Data??

Transcription

1 Biological (Tissue) Valve in a 60 year old patient: Debate Tissue vs Mechanical What s the Data?? Joseph E. Bavaria, MD Immediate-Past President - Society of Thoracic Surgeons (STS) Brooke Roberts-William M. Measey Professor of Surgery Vice-Chief, Division of Cardiovascular Surgery, Hospital of the University of Pennsylvania Surgical Director, Heart and Vascular Center Director, Thoracic Aortic Surgery Program

2 General Trends in the Nation

3 The Journal of Thoracic and Cardiovascular Surgery January 2009

4 Lots more BioValves

5 National Use Snapshot Use of Bioprosthetic Valves has increased by >70% in 14 years particularly for patients National Inpatient sample: Issacs, et al; JTCVS % of Valves in 2011 were Bioprosthetic Important: Despite Bioprosthetic Valves having: Higher CHF rates, Higher diabetes, higher COPD, and higher CRI There was LOWER mortality = 4.4% vs 4.9% and propensity adjusted was 4.4% vs 5.2% (P<.001) Bioprosthetic Valves were preferentially used in Mid-High Volume centers Thomboembolism and Bleeding account 75% of all complications after mechanical Valves (Kulik, et al Ann Thor Surg 2006)

6 Early Data Regarding the Concept

7 Mechanical Valves have higher Acute mortality

8 From STS Guidelines Not Much difference. Svensson LG, Blackstone EH, Cosgrove DM. Surgical options in young adults with aortic valve disease. Curr Probl Cardiol 2003;28:

9 Recent Data on a 60 year old??

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11 Short Term Outcomes: The Same

12 No Difference in Outcomes NY State Database Analyzed to 2014 Propensity matched Median follow up = 11 years years old

13 Complications: Stroke the same; Reoperation higher in Bioprosthetic; Bleeding higher in Mechanical

14 Bioprostheses in Patients <65 N=84, no SVD above age 56 Niclauss L, von Segesser LK, Ferrari E. Aortic biological valve prosthesis in patients younger than 65 years of age: Transition to a flexible age limit? Interact Cardiovasc Thorac Surg. 2013;16(4):

15 Bioprosthetic AVR, age <60 (416, ), Freedom from SVD Reasonable outcomes with Tissue Valves in age Anselmi A, Flecher E, Chabanne C, et al. Long-term follow-up of bioprosthetic aortic valve replacement in patients aged 60 years. The Journal of Thoracic and Cardiovascular Surgery

16 Bioprosthetic AVR, age <60 (416, ), Freedom from SVD, survival, reoperation for SVD Anselmi A, Flecher E, Chabanne C, et al. Long-term follow-up of bioprosthetic aortic valve replacement in patients aged 60 years. The Journal of Thoracic and Cardiovascular Surgery Interesting data: Survival for BETTER than 40-50!! Not sure this should go below 50??

17 Age Kaplan Meier estimates of freedom from SVD by age group. Age was not a significant risk factor among this age subgroup. Bourguignon T, Lhommet P, El Khoury R, et al. Very long-term outcomes of the carpentier-edwards perimount aortic valve in patients aged years. Eur J Cardiothorac Surg. 2016;49(5):

18 Kaplan Meier estimates of freedom from reoperation due to structural valve deterioration (SVD) by age group. Age was not a significant risk factor among this age subgroup. Bourguignon T, Lhommet P, El Khoury R, et al. Very long-term outcomes of the carpentier-edwards perimount aortic valve in patients aged years. Eur J Cardiothorac Surg. 2016;49(5):

19 Comparison of expected valve durability, life expectancy after AVR and relative life expectancy of the general population in France. The cohort was sub-divided by decile of age (10 groups mean age on the X - axis). AVR reduces life expectancy compared with the general population, although the difference declines with age at surgery. In most of the age groups, the expected valve durability estimate is similar to or slightly higher than the life expectancy after AVR. After age 54, The Durability of the Valve is longer than Life Expectancy Bourguignon T, Lhommet P, El Khoury R, et al. Very longterm outcomes of the carpentier-edwards perimount aortic valve in patients aged years. Eur J Cardiothorac Surg. 2016;49(5):

20 Life expectancy edge by age of implant Stoica S, Goldsmith K, Demiris N, et al. Microsimulation and clinical outcomes analysis support a lower age threshold for use of biological valves. Heart. 2010;96(21):

21 Event Free Life Expectancy difference Stoica S, Goldsmith K, Demiris N, et al. Microsimulation and clinical outcomes analysis support a lower age threshold for use of biological valves. Heart. 2010;96(21):

22 The Myth of Superior Hemodynamics in Mechanical Valves Results from Recent FDA Trials

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24 NO PPM at ALL

25 Mean Gradients at 2 years: 16 mmhg for 19 mm; 11 mmhg for 21 mm, 10 mmhg for 23 mm 9 mmhg for 25 mm; 8 mmhg for 27mm, and 5 mmhg for 29mm Simply Excellent! EJTCVS 2017

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27 (or TAVR) in this 60 year old?

28 Paravalvular Leak: S3HR & S3i (Valve Implant Patients) 0.1% 4.2% in S3I Lots of Residual AI: Even with 3 rd generation S3 No. of Echos 1504

29 ACC 2015 Clinical Performance Evolute CE Mark Event, % N=60 Absence of procedural mortality (60/60) Correct positioning of 1 valve in proper location 98.3 (59/60) Mean gradient < 20 mm Hg or peak velocity < 3m/sec 98.3 (59/60) Absence of moderate or severe regurgitation 93.3 (56/60) Absence of patient prosthesis mismatch* 83.6 (46/55) VARC-2 device success 78.6 (44/56) 6.7% *Effective orifice area could not be determined in 5 patients to calculate patient prosthesis mismatch. First time reporting of device success according to VARC-2 criteria Source: Meredith IT, et al. Early Results from the CoreValve Evolut R CE Study [ ]. Presented at the Annual Meeting of the American College of Cardiology. March 14,

30 Secondary Endpoints Events* 1 Month 1 Year Any Stroke, % Major, % Myocardial Infarction, % Reintervention, % VARC Bleeding, % Life Threatening or Disabling, % Major, % Major Vascular Complications, % Permanent Pacemaker Implant, % Per ACC Guidelines, % * Percentages obtained from Kaplan Meier estimates TCT 2013 LBCT (JACC 2014) Extreme Risk Study Iliofemoral Pivotal 30

31 Other Clinical Events Intermediate Risk At 30 Days (As Treated Patients) Events (%) S3HR Overal l (n=583) S3HR TF (n=491) S3HR TA/TA o (n=92) S3i Overall (n=1076) S3i TF (n=951) S3i TA/TA o (n=125) Major Vascular Comps Bleeding - Life Threatening Annular Rupture Myocardial Infarctions Coronary Obstruction Acute Kidney Injury New Permanent Pacemaker Aortic Valve Reintervention Endocarditis

32 TAVR: Catastrophic Procedure Details 5.0% 4.0% 3.0% 2.0% 1.0% 0.0% 3.4% 3.5% 1.1% 4.4% 2.7% 1.5% 2.7% 1.3% 1.4% 0.9% 0.9% 0.5% 0.7% q1-3 CPB req Convert to OHS Procedure Aborted 2016: 2.1% Catastrophe Source: STS/ACC TVT Registry Database. 80,130 records as of Jan 18, 2017

33 Guidelines

34 Guideline Cutoffs Figure: Head SJ, Celik M, Kappetein AP. Mechanical versus bioprosthetic aortic valve replacement. Eur Heart J. 2017;38(28):

35 Factors that could influence changes in 60 Figure: Head SJ, Celik M, Kappetein AP. Mechanical versus bioprosthetic aortic valve replacement. Eur Heart J. 2017;38(28):

36 60 year old who needs an Aortic Valve?? (What would I want for Myself 59) Surgically Placed NEW Tissue Aortic Valves Great hemodynamics, Longer Durability, Incredibly low mortality, and basically zero AI and close to zero pacemakers!!!