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
General Trends in the Nation
The Journal of Thoracic and Cardiovascular Surgery January 2009
Lots more BioValves
National Use Snapshot Use of Bioprosthetic Valves has increased by >70% in 14 years particularly for patients 55-64 National Inpatient sample: Issacs, et al; JTCVS 2015 64% 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)
Early Data Regarding the Concept
Mechanical Valves have higher Acute mortality
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;28:417 80.
Recent Data on a 60 year old??
Short Term Outcomes: The Same
No Difference in Outcomes NY State Database 1997-2004 Analyzed to 2014 Propensity matched Median follow up = 11 years 50-69 years old
Complications: Stroke the same; Reoperation higher in Bioprosthetic; Bleeding higher in Mechanical
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):501-507.
Bioprosthetic AVR, age <60 (416, 1977-2013), Freedom from SVD Reasonable outcomes with Tissue Valves in age 50-60 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. 2017.
Bioprosthetic AVR, age <60 (416, 1977-2013), 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. 2017. Interesting data: Survival for 50-60 BETTER than 40-50!! Not sure this should go below 50??
Age 50-65 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 50-65 years. Eur J Cardiothorac Surg. 2016;49(5):1462-1468.
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 50-65 years. Eur J Cardiothorac Surg. 2016;49(5):1462-1468.
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 50-65 years. Eur J Cardiothorac Surg. 2016;49(5):1462-1468.
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):1730-1736.
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):1730-1736.
The Myth of Superior Hemodynamics in Mechanical Valves Results from Recent FDA Trials
NO PPM at ALL
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
(or TAVR) in this 60 year old?
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
ACC 2015 Clinical Performance Evolute CE Mark Event, % N=60 Absence of procedural mortality 100.0 (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 [2101-295]. Presented at the Annual Meeting of the American College of Cardiology. March 14, 2015. 29
Secondary Endpoints Events* 1 Month 1 Year Any Stroke, % 4.0 7.0 Major, % 2.3 4.3 Myocardial Infarction, % 1.2 2.0 Reintervention, % 1.1 1.8 VARC Bleeding, % 36.7 42.8 Life Threatening or Disabling, % 12.7 17.6 Major, % 24.9 28.5 Major Vascular Complications, % 8.2 8.4 Permanent Pacemaker Implant, % 21.6 26.2 Per ACC Guidelines, % 17.1 19.2 * Percentages obtained from Kaplan Meier estimates TCT 2013 LBCT (JACC 2014) Extreme Risk Study Iliofemoral Pivotal 30
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. 5.0 5.3 3.3 5.6 5.9 3.2 Bleeding - Life Threatening 6.3 5.5 10.9 5.4 4.4 12.9 Annular Rupture 0.3 0.2 1.1 0.2 0.2 0 Myocardial Infarctions 0.5 0.4 1.1 0.3 0.3 0 Coronary Obstruction 0.2 0 1.1 0.4 0.4 0 Acute Kidney Injury 1.0 0.8 2.2 0.5 0.3 1.6 New Permanent Pacemaker Aortic Valve Reintervention 13.0 13.2 12.0 10.1 10.4 7.2 1.0 0.8 2.2 0.7 0.8 0 Endocarditis 0.2 0.2 0 0.1 0.1 0
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% 2012 2013 2014 2015 2016q1-3 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
Guidelines
Guideline Cutoffs Figure: Head SJ, Celik M, Kappetein AP. Mechanical versus bioprosthetic aortic valve replacement. Eur Heart J. 2017;38(28):2183-2191.
Factors that could influence changes in cutoff @ 60 Figure: Head SJ, Celik M, Kappetein AP. Mechanical versus bioprosthetic aortic valve replacement. Eur Heart J. 2017;38(28):2183-2191.
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!!!