“One-Stop Shop”: safety of combining transcatheter aortic valve replacement and left atrial appendage occlusion

: OBJECTIVES: The aim of this study was to investigate the safety and efficacy of combining transcatheter valve replacement (TAVR) and left atrial appendage occlusion (LAAO) versus TAVR alone. BACKGROUND: Patients with severe aortic stenosis and atrial fibrillation undergoing TAVR are at increased risk for stroke and bleeding complications. METHODS: A cohort of 52 patients undergoing concomitant TAVR and LAAO were compared with 52 patients undergoing isolated TAVR. A primary safety endpoint at 30 days, a clinical efficacy endpoint from day 30 to last follow-up, and an LAAO efficacy endpoint from the first post-interventional day to the last follow-up were chosen. RESULTS: The mean age of the study population was 85 ± 5 years. The mean CHA2DS2-VASc score and HAS-BLED score were 3.9 ± 1.1 and 2.6 ± 0.9, respectively. The mean Society of Thoracic Surgeons score was 7.8 ± 5.5. The median follow-up duration of the study population was 9.4 months (range 0 to 48 months). The primary safety endpoint occurred in 10 patients in the concomitant group and in 7 patients in the isolated TAVR group (19% vs. 14%; 95% confidence interval: 0.59 to 4.06). The clinical and LAAO efficacy endpoints were achieved in 81 (79%) (75% vs. 82%; 95% confidence interval: 0.49 to 2.92) and 75 (73%) patients (69% vs. 76%; 95% confidence interval: 0.54 to 2.51), respectively. CONCLUSIONS: This pilot study shows that concomitant TAVR and LAAO is feasible and seems to be safe among patients with severe aortic stenosis and atrial fibrillation. Larger trials and longer follow-up are needed to confirm the safety and efficacy of such an approach. ABSTRACT OBJECTIVES The aim of this study was to investigate the safety and ef ﬁ cacy of combining transcatheter valve replacement (TAVR) and left atrial appendage occlusion (LAAO) versus TAVR alone. BACKGROUND Patients with severe aortic stenosis and atrial ﬁ brillation undergoing TAVR are at increased risk for stroke and bleeding complications. METHODS A cohort of 52 patients undergoing concomitant TAVR and LAAO were compared with 52 patients undergoing isolated TAVR. A primary safety endpoint at 30 days, a clinical ef ﬁ cacy endpoint from day 30 to last follow-up, and an LAAO ef ﬁ cacy endpoint from the ﬁ rst post-interventional day to the last follow-up were chosen. RESULTS The mean age of the study population was 85 (cid:1) 5 years. The mean CHA 2 DS 2 -VASc score and HAS-BLED score were 3.9 (cid:1) 1.1 and 2.6 (cid:1) 0.9, respectively. The mean Society of Thoracic Surgeons score was 7.8 (cid:1) 5.5. The median follow-up duration of the study population was 9.4 months (range 0 to 48 months). The primary safety endpoint occurred in 10 patientsintheconcomitantgroupandin7patientsintheisolatedTAVRgroup(19%vs.14%;95%con ﬁ denceinterval:0.59 to4.06). TheclinicalandLAAOef ﬁ cacyendpointswereachievedin81(79%)(75%vs.82%;95%con ﬁ denceinterval:0.49 to 2.92) and 75 (73%) patients (69% vs. 76%; 95% con ﬁ dence interval: 0.54 to 2.51), respectively. CONCLUSIONS This pilot study shows that concomitant TAVR and LAAO is feasible and seems to be safe among patients with severe aortic stenosis and atrial ﬁ brillation. Larger trials and longer follow-up are needed to con ﬁ rm the safety and ef ﬁ cacy of such an approach. (J Am Coll Cardiol Intv 2016;9:1487 – 95) © 2016 by the American College of Cardiology Foundation.