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 language | English |
|---|---|
| Pages (from-to) | 373-381 |
| Number of pages | 9 |
| Journal | Journal of cardiovascular medicine (Hagerstown, Md.) |
| Volume | 19 |
| Issue number | 7 |
| DOIs | |
| Publication status | Published - Jul 1 2018 |
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ASJC Scopus subject areas
- Cardiology and Cardiovascular Medicine
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Closure of patent foramen ovale or medical therapy alone for secondary prevention of cryptogenic cerebrovascular events. / Fortuni, Federico; Crimi, Gabriele; Leonardi, Sergio; Angelini, Filippo; Raisaro, Arturo; Lanzarini, Luca Franco; Oltrona Visconti, Luigi; Ferrario, Maurizio; De Ferrari, Gaetano Maria.
In: Journal of cardiovascular medicine (Hagerstown, Md.), Vol. 19, No. 7, 01.07.2018, p. 373-381.Research output: Contribution to journal › Article
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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.
UR - http://www.scopus.com/inward/record.url?scp=85057555175&partnerID=8YFLogxK
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U2 - 10.2459/JCM.0000000000000648
DO - 10.2459/JCM.0000000000000648
M3 - Article
C2 - 29708911
AN - SCOPUS:85057555175
VL - 19
SP - 373
EP - 381
JO - Journal of Cardiovascular Medicine
JF - Journal of Cardiovascular Medicine
SN - 1558-2027
IS - 7
ER -