Closure of patent foramen ovale or medical therapy alone for secondary prevention of cryptogenic cerebrovascular events

Research output: Contribution to journalArticle

Abstract

AIMS: About one-third of ischemic stroke are cryptogenic. Paradoxical embolism through patent foramen ovale (PFO) has been identified as a possible cause of cryptogenic stroke. Therefore, PFO closure has been considered for secondary prevention of cryptogenic stroke. However, randomized clinical trials (RCTs) comparing PFO closure versus medical therapy led to conflicting results. Our objectives were to examine if PFO closure is superior to medical therapy alone for secondary prevention of cryptogenic stroke and to investigate whether PFO closure is associated with an increased incidence of atrial fibrillation/atrial flutter (AFL). METHODS: The authors systematically searched MEDLINE for RCTs that compared PFO closure with medical therapy. Efficacy outcome was cerebrovascular event (CVE) recurrence and safety outcome was new-onset atrial fibrillation/AFL. The outcomes of interest were investigated according to device type with subgroup analyses and meta-regression. RESULTS: The authors included eight RCTs constituting 4114 patients. Patients who underwent PFO closure had a lower risk of CVE recurrence compared with medically treated patients [relative risk (RR): 0.56; 95% confidence interval (CI) 0.40-0.80; P = 0.001; I = 30%]. This protective effect was consistent across the different device types. Patients who underwent PFO closure developed more frequently atrial fibrillation/AFL (RR 4.96; 95% CI 2.74-8.99; P < 0.00001; I = 0%), which was mainly transient and within 1 month. Atrial fibrillation/AFL risk was consistent according to device types, although marginally significant in the Amplatzer subgroup. CONCLUSION: PFO closure might have a role in secondary CVE prevention of patients with PFO and cryptogenic stroke. However, it is associated with an increased incidence of new-onset atrial fibrillation/AFL especially within 1 month.

Original languageEnglish
Pages (from-to)373-381
Number of pages9
JournalJournal of cardiovascular medicine (Hagerstown, Md.)
Volume19
Issue number7
DOIs
Publication statusPublished - Jul 1 2018

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Patent Foramen Ovale
Secondary Prevention
Atrial Flutter
Atrial Fibrillation
Stroke
Therapeutics
Randomized Controlled Trials
Equipment and Supplies
Paradoxical Embolism
Confidence Intervals
Recurrence
Incidence
MEDLINE
Regression Analysis
Safety

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

@article{36867cce094e4416958669eba773c2d8,
title = "Closure of patent foramen ovale or medical therapy alone for secondary prevention of cryptogenic cerebrovascular events",
abstract = "AIMS: About one-third of ischemic stroke are cryptogenic. Paradoxical embolism through patent foramen ovale (PFO) has been identified as a possible cause of cryptogenic stroke. Therefore, PFO closure has been considered for secondary prevention of cryptogenic stroke. However, randomized clinical trials (RCTs) comparing PFO closure versus medical therapy led to conflicting results. Our objectives were to examine if PFO closure is superior to medical therapy alone for secondary prevention of cryptogenic stroke and to investigate whether PFO closure is associated with an increased incidence of atrial fibrillation/atrial flutter (AFL). METHODS: The authors systematically searched MEDLINE for RCTs that compared PFO closure with medical therapy. Efficacy outcome was cerebrovascular event (CVE) recurrence and safety outcome was new-onset atrial fibrillation/AFL. The outcomes of interest were investigated according to device type with subgroup analyses and meta-regression. RESULTS: The authors included eight RCTs constituting 4114 patients. Patients who underwent PFO closure had a lower risk of CVE recurrence compared with medically treated patients [relative risk (RR): 0.56; 95{\%} confidence interval (CI) 0.40-0.80; P = 0.001; I = 30{\%}]. This protective effect was consistent across the different device types. Patients who underwent PFO closure developed more frequently atrial fibrillation/AFL (RR 4.96; 95{\%} CI 2.74-8.99; P < 0.00001; I = 0{\%}), which was mainly transient and within 1 month. Atrial fibrillation/AFL risk was consistent according to device types, although marginally significant in the Amplatzer subgroup. CONCLUSION: PFO closure might have a role in secondary CVE prevention of patients with PFO and cryptogenic stroke. However, it is associated with an increased incidence of new-onset atrial fibrillation/AFL especially within 1 month.",
author = "Federico Fortuni and Gabriele Crimi and Sergio Leonardi and Filippo Angelini and Arturo Raisaro and Lanzarini, {Luca Franco} and {Oltrona Visconti}, Luigi and Maurizio Ferrario and {De Ferrari}, {Gaetano Maria}",
year = "2018",
month = "7",
day = "1",
doi = "10.2459/JCM.0000000000000648",
language = "English",
volume = "19",
pages = "373--381",
journal = "Journal of Cardiovascular Medicine",
issn = "1558-2027",
publisher = "Lippincott Williams and Wilkins",
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TY - JOUR

T1 - Closure of patent foramen ovale or medical therapy alone for secondary prevention of cryptogenic cerebrovascular events

AU - Fortuni, Federico

AU - Crimi, Gabriele

AU - Leonardi, Sergio

AU - Angelini, Filippo

AU - Raisaro, Arturo

AU - Lanzarini, Luca Franco

AU - Oltrona Visconti, Luigi

AU - Ferrario, Maurizio

AU - De Ferrari, Gaetano Maria

PY - 2018/7/1

Y1 - 2018/7/1

N2 - AIMS: About one-third of ischemic stroke are cryptogenic. Paradoxical embolism through patent foramen ovale (PFO) has been identified as a possible cause of cryptogenic stroke. Therefore, PFO closure has been considered for secondary prevention of cryptogenic stroke. However, randomized clinical trials (RCTs) comparing PFO closure versus medical therapy led to conflicting results. Our objectives were to examine if PFO closure is superior to medical therapy alone for secondary prevention of cryptogenic stroke and to investigate whether PFO closure is associated with an increased incidence of atrial fibrillation/atrial flutter (AFL). METHODS: The authors systematically searched MEDLINE for RCTs that compared PFO closure with medical therapy. Efficacy outcome was cerebrovascular event (CVE) recurrence and safety outcome was new-onset atrial fibrillation/AFL. The outcomes of interest were investigated according to device type with subgroup analyses and meta-regression. RESULTS: The authors included eight RCTs constituting 4114 patients. Patients who underwent PFO closure had a lower risk of CVE recurrence compared with medically treated patients [relative risk (RR): 0.56; 95% confidence interval (CI) 0.40-0.80; P = 0.001; I = 30%]. This protective effect was consistent across the different device types. Patients who underwent PFO closure developed more frequently atrial fibrillation/AFL (RR 4.96; 95% CI 2.74-8.99; P < 0.00001; I = 0%), which was mainly transient and within 1 month. Atrial fibrillation/AFL risk was consistent according to device types, although marginally significant in the Amplatzer subgroup. CONCLUSION: PFO closure might have a role in secondary CVE prevention of patients with PFO and cryptogenic stroke. However, it is associated with an increased incidence of new-onset atrial fibrillation/AFL especially within 1 month.

AB - AIMS: About one-third of ischemic stroke are cryptogenic. Paradoxical embolism through patent foramen ovale (PFO) has been identified as a possible cause of cryptogenic stroke. Therefore, PFO closure has been considered for secondary prevention of cryptogenic stroke. However, randomized clinical trials (RCTs) comparing PFO closure versus medical therapy led to conflicting results. Our objectives were to examine if PFO closure is superior to medical therapy alone for secondary prevention of cryptogenic stroke and to investigate whether PFO closure is associated with an increased incidence of atrial fibrillation/atrial flutter (AFL). METHODS: The authors systematically searched MEDLINE for RCTs that compared PFO closure with medical therapy. Efficacy outcome was cerebrovascular event (CVE) recurrence and safety outcome was new-onset atrial fibrillation/AFL. The outcomes of interest were investigated according to device type with subgroup analyses and meta-regression. RESULTS: The authors included eight RCTs constituting 4114 patients. Patients who underwent PFO closure had a lower risk of CVE recurrence compared with medically treated patients [relative risk (RR): 0.56; 95% confidence interval (CI) 0.40-0.80; P = 0.001; I = 30%]. This protective effect was consistent across the different device types. Patients who underwent PFO closure developed more frequently atrial fibrillation/AFL (RR 4.96; 95% CI 2.74-8.99; P < 0.00001; I = 0%), which was mainly transient and within 1 month. Atrial fibrillation/AFL risk was consistent according to device types, although marginally significant in the Amplatzer subgroup. CONCLUSION: PFO closure might have a role in secondary CVE prevention of patients with PFO and cryptogenic stroke. However, it is associated with an increased incidence of new-onset atrial fibrillation/AFL especially within 1 month.

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U2 - 10.2459/JCM.0000000000000648

DO - 10.2459/JCM.0000000000000648

M3 - Article

VL - 19

SP - 373

EP - 381

JO - Journal of Cardiovascular Medicine

JF - Journal of Cardiovascular Medicine

SN - 1558-2027

IS - 7

ER -