Mahin R Khan1, Waleed T Kayani2, Malalai Manan3, Ahmad Munir1, Ihab Hamzeh2, Salim S Virani2,4, Yochai Birnbaum2, Hani Jneid2,4, Mahboob Alam2. 1. Division of Cardiology, McLaren-Flint/Michigan State University, Flint, MI, USA. 2. Section of Cardiology, Department of Internal Medicine, Baylor College of Medicine, Houston, TX, USA. 3. King Edward Medical University, Lahore, Pakistan. 4. Section of Cardiology, Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX, USA.
Abstract
BACKGROUND: To compare safety and efficacy of transcatheter aortic valve replacement (TAVR) with surgical aortic valve replacement (SAVR) in patients at low-intermediate risk, given the paucity of robust data. METHODS: We performed an aggregate data meta-analysis of 7 randomized controlled trials (RCTs) and 6,778 patients comparing TAVR with SAVR for aortic stenosis (AS) in low-intermediate risk patients (Society of Thoracic Surgeons risk-score ≤8%) using the random-effects model. Primary outcome was all-cause mortality at 30-day, 1-year and 2-year of follow-up. Secondary outcomes included cardiac-mortality, stroke, acute kidney injury (AKI), atrial fibrillation (AF), permanent pacemaker (PPM) implantation, major-bleeding, moderate-severe paravalvular regurgitation (PVR) and rehospitalization. RESULTS: All-cause mortality, cardiac-mortality and stroke were comparable between the two groups. AF was higher with SAVR at 30-day [odds ratio (OR) 0.17, 95% confidence intervals (CI): 0.12-0.24] thorough to 2-year (OR 0.34, 95% CI: 0.21-0.55), while PPM implantation was higher with TAVR (30-day: OR 3.31, 95% CI: 1.64-6.66, 2-year: OR 3.17, 95% CI: 1.02-9.86). Moderate-severe PVR was more prevalent with TAVR at all follow-ups. On inter-group comparison, patients in the low-risk group had an even lower risk of AF, but a higher risk of PPM implantation as compared to the patients in the intermediate-risk group undergoing TAVR. CONCLUSIONS: Compared to SAVR, TAVR had comparable all-cause mortality and stroke, lower-risk of AF, but was associated with a higher risk of PPM implantation and moderate-severe PVR in low-intermediate-risk patients. Thus, highlighting the need for longer-term follow-up before robust inferences are drawn. 2020 Cardiovascular Diagnosis and Therapy. All rights reserved.
BACKGROUND: To compare safety and efficacy of transcatheter aortic valve replacement (TAVR) with surgical aortic valve replacement (SAVR) in patients at low-intermediate risk, given the paucity of robust data. METHODS: We performed an aggregate data meta-analysis of 7 randomized controlled trials (RCTs) and 6,778 patients comparing TAVR with SAVR for aortic stenosis (AS) in low-intermediate risk patients (Society of Thoracic Surgeons risk-score ≤8%) using the random-effects model. Primary outcome was all-cause mortality at 30-day, 1-year and 2-year of follow-up. Secondary outcomes included cardiac-mortality, stroke, acute kidney injury (AKI), atrial fibrillation (AF), permanent pacemaker (PPM) implantation, major-bleeding, moderate-severe paravalvular regurgitation (PVR) and rehospitalization. RESULTS: All-cause mortality, cardiac-mortality and stroke were comparable between the two groups. AF was higher with SAVR at 30-day [odds ratio (OR) 0.17, 95% confidence intervals (CI): 0.12-0.24] thorough to 2-year (OR 0.34, 95% CI: 0.21-0.55), while PPM implantation was higher with TAVR (30-day: OR 3.31, 95% CI: 1.64-6.66, 2-year: OR 3.17, 95% CI: 1.02-9.86). Moderate-severe PVR was more prevalent with TAVR at all follow-ups. On inter-group comparison, patients in the low-risk group had an even lower risk of AF, but a higher risk of PPM implantation as compared to the patients in the intermediate-risk group undergoing TAVR. CONCLUSIONS: Compared to SAVR, TAVR had comparable all-cause mortality and stroke, lower-risk of AF, but was associated with a higher risk of PPM implantation and moderate-severe PVR in low-intermediate-risk patients. Thus, highlighting the need for longer-term follow-up before robust inferences are drawn. 2020 Cardiovascular Diagnosis and Therapy. All rights reserved.
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