Author + information
- Received January 21, 2016
- Revision received April 25, 2016
- Accepted April 26, 2016
- Published online July 25, 2016.
- Adrian Attinger-Toller, MDa,
- Francesco Maisano, MDa,
- Oliver Senn, MDb,
- Maurizio Taramasso, MDa,
- Samera Shakir, MDc,
- Mathias Possner, MDa,
- Steffen Gloekler, MDc,
- Stephan Windecker, MDc,
- Stefan Stortecky, MDc,
- Thomas F. Lüscher, MDa,
- Bernhard Meier, MDc and
- Fabian Nietlispach, MD, PhDa,∗ ()
- aUniversity Heart Center, University Hospital Zurich, Zurich, Switzerland
- bInstitute of Primary Care, University of Zurich, University Hospital Zurich, Zurich, Switzerland
- cDepartment of Cardiology, University Hospital of Bern, Bern, Switzerland
- ↵∗Reprint requests and correspondence:
Dr. Fabian Nietlispach, University Heart Center Zurich, Department of Cardiology, Raemistrasse 100, 8091 Zurich, Switzerland.
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.
Dr. Nietlispach is a consultant for Edwards Lifesciences, Medtronic, St. Jude Medical, and Direct Flow Medical. Dr. Maisano is a consultant for Medtronic and St. Jude Medical and receives royalties from Edwards Lifesciences. Dr. Meier is a consultant to and has received grants to the institution from St. Jude Medical. Drs. Windecker and Gloekler have received grants to the institution from St. Jude Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received January 21, 2016.
- Revision received April 25, 2016.
- Accepted April 26, 2016.
- American College of Cardiology Foundation