Revival of transcatheter PFO closure: A meta-analysis of randomized controlled trials - impact of shunt size and age.

Abstract:

BACKGROUND:Transcatheter foramen ovale closure (TPC) has emerged as a potential treatment option for patients with cryptogenic strokes and persistent foramen ovale (PFO). However, previous randomized controlled trials could hardly demonstrate any benefit compared to medical treatment (Med-Tx). Recently new data have become available which may change current practice of transcatheter PFO closure. METHODS:A systematic review and meta-analysis comparing TPC and Med-Tx based on all available multicentric randomized controlled trials was performed. The primary outcome of interest was the recurrence of stroke in both groups. RESULTS:Five studies met the inclusion criteria with 1829 patients in the TPC and 1622 in the Med-Tx group. The median follow-up was 4 years. In the intention-to-treat analysis we found a statistically significant relative risk reduction in recurrence of strokes in the TPC group compared to the Med-Tx group (pooled hazard ratio (HR): 0.32; 95% CI: 0.13-0.8; P = .018). Excluding one study due to potential publication bias resulted in a pooled HR of 0.48 (95% CI: 0.25-0.91, P = .024). Patients younger than 45 years of age (pooled HR: 0.35; 95% CI: 0.16-0.75; P = .007) and those with moderate to severe shunt (pooled HR: 0.28; 95% CI: 0.14-0.55; P < .001) were more likely to benefit from closure. CONCLUSION:According to our meta-analysis TPC plus antiplatelets was superior in terms of stroke prevention when compared to Med-Tx. Furthermore, patients with moderate to severe shunts and those younger than 45 years of age were found to benefit most from TPC.

journal_name

Am Heart J

journal_title

American heart journal

authors

Reinthaler M,Ozga AK,Sinning D,Curio J,Al-Hindwan HS,Bäckemo Johansson J,Jung F,Lendlein A,Rauch G,Landmesser U

doi

10.1016/j.ahj.2018.03.025

subject

Has Abstract

pub_date

2018-07-01 00:00:00

pages

95-102

eissn

0002-8703

issn

1097-6744

pii

S0002-8703(18)30115-7

journal_volume

201

pub_type

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