Real world long-term outcomes among adults undergoing transcatheter patent foramen closure with amplatzer PFO occluder

Abrahamyan L 1 , Barker M 2 , Dharma C 3 , Lee DS 4 , Austin PC 5 , Asghar A 6 Show all authors , Muthuppalaniappan A 7 , Benson L 8 , Osten M 9 , Horlick EM 10

Affiliations 

  • 1 Toronto General Hospital Research Institute, University Health Network (UHN), Toronto, ON, Canada; Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada
  • 2 Center for Cardiovascular Innovation - Centre d'Innovation Cardiovasculaire (CCI-CIC), University of British Columbia, Vancouver, BC, Canada
  • 3 ICES, Toronto, ON, Canada
  • 4 ICES, Toronto, ON, Canada; Division of Cardiology, Peter Munk Cardiac Centre, UHN, Toronto, ON, Canada
  • 5 Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada; ICES, Toronto, ON, Canada
  • 6 Toronto General Hospital Research Institute, University Health Network (UHN), Toronto, ON, Canada; McMaster University, Hamilton, ON, Canada
  • 7 Gleneagles Hospital Penang, Pulau Pinang, Malaysia
  • 8 The Labatt Family Heart Centre, The Hospital for Sick Children, University of Toronto, Toronto, ON, Canada
  • 9 Toronto Congenital Cardiac Centre for Adults, Peter Munk Cardiac Centre, UHN, Toronto, ON, Canada
  • 10 Toronto Congenital Cardiac Centre for Adults, Peter Munk Cardiac Centre, UHN, Toronto, ON, Canada. Electronic address: Eric.horlick@uhn.ca
Int J Cardiol, 2023 Jan 15;371:109-115.
PMID: 36165815 DOI: 10.1016/j.ijcard.2022.09.033

Abstract

BACKGROUND: Patent foramen ovale (PFO) is a congenital heart defect associated with an increased risk of cryptogenic stroke. We aimed to evaluate real-world outcomes of adult patients undergoing transcatheter PFO closure with the Amplatzer PFO Occluder.

METHODS: In this single centre, retrospective cohort study, we linked a detailed clinical registry with provincial administrative databases to obtain short and long-term outcomes. Validated algorithms were used to established baseline comorbidities and adverse outcomes.

RESULTS: Between 1999 and 2017, 479 patients had PFO closure with an Amplatzer PFO Occluder. The average age of the patients was 47.3 years (standard deviation (SD) = 12.4), and 54.7% were males. The procedural success was 100%, and 96% of patients were discharged on the same day. Any in-hospital complication was observed in 2.5% (n = 12) of patients. At 30 days post-discharge, 18% of patients had an ED visit and 5% a hospitalization. Over a mean follow-up of 9.1 (SD = 3.8) years, 4% experienced TIA, 1.5% stroke, and 7.6% atrial fibrillation. The composite outcome of stroke/TIA/death was observed in 10.9% of patients (1.22 events per 100 person-years). Patients >60 years old experienced higher rates of adverse events than younger patients.

CONCLUSIONS: In this large real-world cohort of patients with cryptogenic stroke, we observed excellent safety and effectiveness outcomes for PFO closure conducted with Amplatzer PFO Occluder, similar to randomized controlled trials or other long-term cohort studies. New onset atrial fibrillation was one of the most commonly adverse events. Future studies should investigate early post-discharge management of patients to prevent readmissions.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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