Outcomes of Surgical Aortic Valve Replacement in Moderate Risk Patients: Implications for Determination of Equipoise in the Transcatheter Era
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1 Outcomes of Surgical Aortic Valve Replacement in Moderate Risk Patients: Implications for Determination of Equipoise in the Transcatheter Era Sebastian A. Iturra, Rakesh M. Suri, Kevin L. Greason, John M. Stulak, Lyle D. Joyce, Richard C. Daly, Soon J. Park, Harold M. Burkhart, Joseph A. Dearani, Hartzell V. Schaff
2 Outcomes of Surgical Aortic Valve Replacement in Moderate Risk Patients: Implications for Determination of Equipoise in the Transcatheter Era Sebastian A. Iturra, Rakesh M. Suri, Kevin L. Greason, John M. Stulak, Lyle D. Joyce, Richard C. Daly, Soon J. Park, Harold M. Burkhart, Joseph A. Dearani, Hartzell V. Schaff AATS Annual Meeting MFMER
3 Disclosure Mayo Clinic Divisions of Cardiovascular Surgery and Cardiovascular Diseases Research Funding Edwards Lifesciences St. Jude Medical Sorin Group Patent Application Sorin Group Consultant/Advisory Board Thoratec Principal Investigator FDA Perceval Trial Sorin Group
4 Background SAVR is effective to improve symptoms and increase survival in AS In high surgical risk, TAVR Similar rates of survival and improvement of symptoms at a 3-yr follow-up 2013 MFMER
5 Background Genuine uncertainty of best option of treatment in moderate risk patients Current clinical trials are ongoing to compare TAVR to SAVR in this population The STS score may overestimate the mortality in this specific group 2013 MFMER
6 Objective Determine early-midterm mortality and morbidity in primary SAVR Severe AS Moderate surgical risk Determine predictors of mortality in this specific population 2013 MFMER
7 Methods January 2002 to June AVR at Mayo Clinic SAVR Severe AS (mean gradient 40 mm Hg) STS PROM between 4-8% Included associated CABG Excluded Multiple valve procedures or other major non valve-related operations 2013 MFMER
8 Patients aortic valve replacement 79 yr (49-96 yr) Mean STS PROM 5.6% MFMER
9 Patient Characteristics Characteristics Patients (n=502) Mean aortic valve gradient (mm Hg) 51 Previous CABG, no. (%) 101 (20) NYHA class, no. (%) III or IV 323 Mean LVEF (%) 63 Mean body mass index 28 Aortic regurgitation, no. (%) Trivial/Mild Mod Severe 325 (65) 72 (14) 5 (1) Mitral regurgitation moderate no. (%) 85 (17) 2013 MFMER
10 Patient Comorbidities Characteristics Patients, no. (%) Peripheral vascular disease 77 (15) Chronic lung disease Mild Mod Severe 70 (14) 14 (3) 35 (7) Atrial fib 45 (9) Creatinine 2.0 mg/dl 20 (4) Cerebral vascular disease 125 (25) Permanent pacemaker 26 (5) Prior myocardial infarction 43 (9) Prior PCI 79 (16) Prior aortic balloon valvuloplasty 2 (0.4) 2013 MFMER
11 Surgical Characteristics Characteristics Urgent surgery, no. (%) 64 (13) Use of bioprosthesis, no. (%) 477 (95) Associated procedure, no. (%) CABG Aortic annular enlargement Surgical time Median cross-clamp time (minutes) Isolated AVR Median perfusion time (minutes) Isolated AVR 270 (54) 25 (5) MFMER
12 Results Early mortality 14 patients (2.8%) Median length of stay 9 (3-70) days 30-day readmission 41 (8.2%) Median follow-up 3.2 yr 2013 MFMER
13 Early Postoperative Complications Characteristics Patients, no. (%) Transfusion of RBC 296 (59) Atrial fib/flutter 207 (41) Reoperation for bleeding 29 (5.8) Pneumonia 20 (4) Dialysis 11 (2) Permanent pacemaker 10 (2) Permanent stroke 9 (1.8) Perioperative myocardial infarct 2 (0.4) Vascular complications 2 (0.4) Deep sternal infection 1 (0.2) Endocarditis MFMER
14 Potential Predictors Perioperative Mortality Gender Age EF STS PROM BMI Diabetes HTN Chronic lung disease PVD CVD Renal failure Atrial fib Mitral Regurgitation Prior Pacemaker Prior PCI Prior CABG Prior MI Aortic gradient CHF Annular enlargement Associated CABG Urgent surgery 2013 MFMER
15 Survival (%) Kaplan-Meier Late-Survival Curve Age/Gender Match General Population yr survival 75% ( ) 6 yr survival 59% ( ) 20 Observed Expected P= Follow-up (years) MFMER
16 Predictors Mid-term Mortality Gender Age EF STS PROM BMI Diabetes HTN Chronic lung disease PVD CVD Renal failure Atrial fib Mitral Regurgitation Prior Pacemaker Prior PCI Prior CABG Prior MI Aortic gradient CHF Annular enlargement Associated CABG Urgent surgery 2013 MFMER
17 Cox Regression Model Predicting Mid-term Mortality Univariate Multivariate Variable HR (95% CL) P HR (95% CL) Pr >Chi 2 Chronic lung dis 1.74 ( ) < ( ) <0.001 PVD 1.62 ( ) ( ) Atrial fib 1.67 ( ) ( ) MFMER
18 Conclusions SAVR for severe AS in moderate surgical risk Currently utilized risk models overestimate early mortality 5.6% vs 2.8% Low risk of complications Stroke 1.8% Vascular complications <1% 2013 MFMER
19 Clinical Implications Pt counselled for TAVR should be informed of the excellent early to mid-term outcomes of SAVR, particularly in those without chronic lung disease, peripheral vascular disease or atrial fibrillation 2013 MFMER
20 Questions & Discussion 2013 MFMER
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