Left Atrial Appendage Occlusion in Nonagenarians

Abstract

Background. Nonagenarians constitute a fast-growing and high-risk segment of the population, with scarce data on specific outcomes for percutaneous left atrial appendage occlusion (LAAO). The aim of the present paper was to assess the outcomes of nonagenarian patients undergoing LAAO from the prospective global Amplatzer Amulet observational study. Overall, 1088 subjects were prospectively included in the study. Among them, 9 (1%) were nonagenarians. Amulet device implant success was achieved in all patients and the only major procedural adverse event was a pseudoaneurysm. During the 2-year follow-up after LAAO, no ischemic strokes or transient ischemic attacks were reported. Further studies will be necessary to confirm the favorable LAAO outcomes in this growing segment of the atrial fibrillation population.

Key words: atrial fibrillation, elderly, left atrial appendage occlusion, oral anticoagulation

The current cornerstone for stroke prevention in atrial fibrillation (AF) is the use of oral anticoagulation (OAC). However, its use might be complex in very old patients as the incidence of both ischemic and bleeding events is age dependent.¹ Percutaneous left atrial appendage occlusion (LAAO) might represent a promising non-pharmacological alternative for these high-risk patients. In this sense, nonagenarians constitute a fast-growing and high-risk segment of population with scarce outcome data. The aim of this report was to assess outcomes of nonagenarian patients undergoing LAAO.

The present report analyzed procedural and 2-year follow-up data of patients ≥90 years old undergoing LAAO in the prospective global Amplatzer Amulet observational study (NCT02447081).² The study was approved by each institution’s ethics committee and complied with the Declaration of Helsinki.

Overall, 1088 subjects were prospectively included in the study. Among them, 9 (1%) were nonagenarians (Table 1). The mean age was 92 ± 1.1 years, with slightly more women (55.5%). The mean CHA₂DS₂-VASc and HAS-BLED scores were 5.0 ± 1.7 and 3.8 ± 1.0, respectively. The LAAO indication was contraindication to OAC in 88.8%, mainly because of known bleeding risk (55.5%). Amplatzer Amulet device (Abbott Structural Heart) implant success was achieved in all patients and the only major procedural adverse event was a pseudoaneurysm the day of the procedure (Table 1). Most patients (66.7%) were discharged on dual-antiplatelet therapy, followed by most (83.3%) receiving single-antiplatelet therapy by 6 months post procedure. During the 2-year follow-up after LAAO, no ischemic strokes or transient ischemic attacks were reported. A single subject suffered major bleeding events on days 3 and 543 post procedure (anemias and hematoma, respectively). Four patients died during the follow-up period, 2 for non-cardiovascular cause (trauma and cancer, respectively) and 2 for unknown cause (Table 1). One device-related thrombus was detected, without a related neurological event.

Population aging is a growing and global phenomenon. It is expected that female life expectancy will break the 90-year barrier by 2030, a level that was deemed unattainable by some at the turn of the 21st century.³ Hence, the nonagenarian population will soon become clinically and numerically relevant in daily practice. Atrial fibrillation guidelines underline nonagenarians as a high-risk population that has been under-represented in randomized controlled trials. Data from different registries highlighted that the use of OAC in nonagenarians, while having a clear benefit in terms of cardioembolic protection, was associated with a high rate of major bleeding, leading to higher mortality.⁴ In this context, LAAO seems to represent a valid alternative to provide ischemic protection without OAC-associated risks. The present report describes the outcomes of all 9 nonagenarian patients undergoing LAAO in a large, prospective study. As shown, procedural outcomes were very favorable, with a 100% success rate and very low incidence of complications. In addition, follow-up data in terms of ischemic and bleeding protection were also very promising, with no neurological events and only a single patient suffering bleeding events. Cruz-Gonzalez et al reported similar results in patients ≥85 years old undergoing LAAO with the Watchman device (Boston Scientific) in the EWOLUTION registry, showing a low rate of procedural complications (2.6%) and good cardioembolic protection at follow-up (0.8/100 patient years).⁵ Interestingly, the most relevant problem in this population was the occurrence of bleeding events within the first year after the intervention, which was probably linked to postprocedural antithrombotic therapy. In our series, only 1 patient experienced major bleeding events. As expected in this very old segment of population, the mortality rate over 2 years was high (44%), but it did not seem to be related to the intervention, with all deaths ≥37 days post procedure. In agreement with our observations, the EWOLUTION registry showed that patients ≥85 years old presented a mortality rate of almost 30% at 2 years. The high-risk profile of this population is the most plausible explanation for such high mortality rates. Further studies are necessary to confirm the favorable LAAO outcomes in this growing segment of the atrial fibrillation population.

Affiliations and Disclosures

From the ¹Cardiology Department, Cardiovascular Institute (ICCV), Hospital Clinic, IDIBAPS, University of Barcelona, Barcelona, Spain; ²Cardioangiologisches Centrum Bethanien, Agaplesion Markus Krankenhaus, Medizinische Klinik 3 – Kardiologie, Frankfurt, Germany; ³Department of Interventional and Diagnostic Cardiology, Fondazione Toscana Gabriele Monasterio, Pisa, Italy; ⁴Department of Cardiology, Harzklinikum Dorothea Christiane Erxleben GmbH, Quedlinburg, Germany; ⁵Department of Cardiology, Zentrum fur Herzgesundheit, Darmstadt, Germany; ⁶Department of Cardiology, Universitatsmedizin Berlin – Campus Benjamin Franklin, Berlin, Germany; and ⁷Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Düsseldorf, Düsseldorf, Germany.

Funding: Abbott provided funding for the Amplatzer Amulet Observational Study, but no funding for this specific analysis.

Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Magnusson reports grant support from Abbott, Pfizer, and Astra Zeneca; payment or honoraria from Astra Zeneca, Pfzer, Bayer, and Boehringer. Dr Schmidt reports research grant support, speaker’s fees, and data safety monitoring/advisory board for Abbott and Boston Scientific. The remaining authors report no conflicts of interest regarding the content herein.

Manuscript accepted April 14, 2021.

Address for correspondence: Xavier Freixa, MD, PhD, Hospital Clinic; C/Villarroel, 170, Cardiology Department; 08036 Barcelona, Spain. Email: freixa@clinic.cat

References

1. Yiin GSC, Howard DPJ, Paul NLM, et al. Age-specific incidence, outcome, cost, and projected future burden of atrial fibrillation-related embolic vascular events: a population-based study. Circulation. 2014;130(15):1236-1244.

2. Hildick-Smith D, Landmesser U, Camm AJ, et al. Left atrial appendage occlusion with the Amplatzer™ Amulet™ device: full results of the prospective global observational study. Eur Heart J. 2020;41(30):2894-2901.

3. Kontis V, Bennett JE, Mathers CD, Li G, Foreman K, Ezzati M. Future life expectancy in 35 industrialised countries: projections with a Bayesian model ensemble. Lancet. 2017;389(10076):1323-1335.

4. Raposeiras-Roubín S, Alonso Rodríguez D, Camacho Freire SJ, et al. Vitamin K antagonists and direct oral anticoagulants in nonagenarian patients with atrial fibrillation. J Am Med Dir Assoc. 2020;21(3):367-373.e1.

5. Cruz-González I, Ince H, Kische S, et al. Left atrial appendage occlusion in patients older than 85 years. Safety and efficacy in the EWOLUTION registry. Rev Esp Cardiol. 2020;73(1):21-27.