An assessment of annual procedure volumes and therapy adoption of transcatheter closure of patent foramen ovale in four European countries

Jan B. Pietzsch, Benjamin P. Geisler, Matthew J. Daniels, Rachele M. Busca, Giuseppe Tarantini, Lars Søndergaard, Scott E. Kasner

Research output: Contribution to journalArticle

Abstract

Introduction: Patent foramen ovale closure reduces recurrence of cryptogenic ischaemic stroke compared to anti-platelet therapy. Our goal was to determine procedure volumes and closure utilisation as a proportion of candidates in four large European countries. Patients and methods: National statistics were obtained for Germany, England, France, and Italy for the last available five years (2014–2018). Eligibility was aligned to the enrolment criteria of pivotal trials and current consensus documents. Stroke and transient ischaemic attack incidences were obtained from epidemiological registries and claims data. The eligible candidate pool for analysis included current year candidates plus untreated patients from the prior two years. Absolute strokes avoided assumed the hazard ratio for ischaemic stroke recurrence from a recent meta-analysis. Results: In 2018, closure incidence rates were 5.64, 0.53, 2.94 and 5.26 per 100,000 in Germany, England, France and Italy, respectively. This reflects five-year increases of 128% in Germany, 462% in France and 36% in Italy (p < 0.05 for all), and a decline of 37% in England. The proportions of treated patients versus candidates for the combined stroke and transient ischaemic attack pool were 55%, 30%, 80%, and 6%, respectively. Discussion: Patent foramen ovale closure volumes increased after the 2017 announcement of positive trial results but still differ substantially across large European countries. If all closure candidates in 2018 with prior ischaemic stroke were treated, the resulting absolute reduction of recurrent ischaemic strokes, compared to anti-platelet therapy alone, would be between 782 and 2295 across the four countries over five years. Conclusion: Many eligible patients at risk for a recurrent cryptogenic event might remain untreated due to regional practice variations.

Original languageEnglish
Number of pages9
JournalEuropean Stroke Journal
Early online date24 Sep 2020
DOIs
Publication statusE-pub ahead of print - 24 Sep 2020
Externally publishedYes

Keywords

  • cryptogenic stroke
  • Equipment and Supplies Utilization
  • foramen ovale
  • Health Services Misuse
  • Ischaemic stroke
  • Patent
  • patent foramen ovale closure
  • Procedures and Techniques Utilization
  • underutilization

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