Transcatheter or Surgical Aortic Valve Replacement in IntermediateRisk

Transcatheter or Surgical Aortic Valve Replacement in Intermediate-Risk Patients with Previous Coronary Artery Bypass Graft Surgery A Sub-Analysis from the SURTAVI Trial Michael J. Reardon, MD 1, Nicolas M. Van Mieghem, MD, Ph. D 2, Jeffrey J. Popma, MD 3, for the SURTAVI Investigators 1 Houston Methodist De. Bakey Heart and Vascular Center, Houston, TX; 2 Erasmus University Medical Center, Rotterdam, The Netherlands; 3 Beth Israel Deaconess Medical Center, Boston, MA Background • • SURTAVI Randomized Controlled Trial 1, 746 Patients This analysis compares the clinical outcomes in prior CABG patients treated with SAVR or TAVR in the SURTAVI trial Methods • SURTAVI was a prospective, international study randomizing intermediate risk patients to TAVR with a self-expanding valve or SAVR between June 2012 and June 2016 • TAVR m. ITT* N=864 The 1, 660 patients having an attempted implant make up the primary analysis cohort • Within each treatment arm, patients were stratified by history of CABG operation, and clinical outcomes were compared SAVR m. ITT* N=796 TAVR + Prior CABG N=136 TAVR N=728 SAVR N=659 76. 9 ± 6. 5 76. 6 ± 6. 5 0. 70 30 DAYS STS PROM, % 5. 0 ± 1. 6 5. 2 ± 1. 7 0. 60 All-cause mortality 0. 0 0. 7 81. 6 85. 4 0. 40 Stroke 3. 7 5. 1 0. 55 Transfusion of PRBCs* 9. 6 38. 7 <0. 01 Major vascular complications 5. 1 2. 2 0. 20 Acute kidney injury stage 2 or 3 0. 0 2. 9 0. 04 Myocardial infarction 0. 7 >0. 99 Permanent pacemaker implant 24. 3 5. 2 <0. 01 Atrial fibrillation 9. 6 37. 5 <0. 01 39. 0 41. 6 0. 66 Prior stroke 10. 3 9. 5 0. 82 Cerebrovascular disease 21. 3 19. 7 0. 74 Peripheral vascular disease 44. 9 43. 8 0. 86 Coronary artery disease 100 -- Prior myocardial infarction 31. 6 34. 3 0. 64 12 MONTHS 35. 3 37. 2 0. 74 All-cause mortality 5. 9 4. 5 0. 60 13. 0 ± 6. 3 13. 0 ± 6. 4 0. 93 Stroke 6. 7 7. 5 0. 79 Reintervention 2. 2 0. 7 0. 32 Aortic valve hospitalization 6. 7 6. 0 0. 82 Post-CABG, years *The modified intention-to-treat (m. ITT) population includes all subjects with an attempted procedure *Percentage rate Change in Meters Walked in 6 Minutes (Relative to Baseline) NYHA Functional Class Quality of Life p=0. 39 48. 3 42. 4 16. 8 20 -8. 0 0 -20 TAVR (N=112) SAVR (N=103) 30 Days TAVR (N=103) TAVR SAVR 90 SAVR (N=90) 12 Months KCCQ Summary Score Meters 40 p<0. 01 100 % of Prior CABG Patients p=0. 04 60 0. 32 Diabetes mellitus Prior PCI SAVR + Prior CABG N=137 % (Kaplan-Meier Estimates) Patients with Prior CABG TAVR SAVR N=136 N=137 P-value Age, years Male sex 71 not attempted: - 4 died - 43 withdrew consent - 23 physician withdrew - 1 lost to follow-up 15 not attempted: - 4 died - 6 withdrew consent - 5 physician withdrew Clinical Outcomes Patients with Prior CABG TAVR SAVR N=136 N=137 P-value Characteristic % or mean ± SD SAVR Intention to Treat (ITT) N=867 TAVR Intention to Treat (ITT) N=879 Transcatheter aortic valve replacement (TAVR) may be a preferred treatment approach for prior CABG patients • Baseline Characteristics Patient Flow The risk associated with surgical aortic valve replacement (SAVR) is often higher for aortic stenosis patients with a history of coronary artery bypass graft (CABG) surgery, mainly due to the technical complexity of a redo operation and because these patients present with more comorbidity 80 70 p<0. 01 60 50 Baseline 30 Days 6 Months 12 Months 100% 80% 60% p<0. 01 1. 5% 2. 9% 57. 0% 60. 3% p=0. 78 8. 1% 2. 6% 19. 0% 2. 9% 20. 2% 78. 4% 76. 9% 35. 5% 74. 8% 41. 5% 36. 0% 0. 7% TAVR (N=135) SAVR (N=136) 0% Baseline 56. 5% SAVR (N=124) 30 Days TAVR (N=116) SAVR (N=104) 12 Months This randomized comparison of surgical and transcatheter aortic valve replacement in intermediate-risk patients with a history of CABG demonstrates that both treatments are safe. The rates of all-cause mortality and stroke were similar between treatments through 1 year. • Treatment modality influences post-operative course, with TAVR facilitating a more rapid and robust improvement in physical condition and quality of life. • The risk for certain serious complications depends on treatment approach. The incidences of atrial fibrillation, AKI, and transfusions were higher for SAVR patients, while permanent pacemaker implantation was more frequent for TAVR patients. II I TAVR (N=131) • IV III 40% 20% 6. 1% 19. 1% Conclusions