Patent foramen ovale closure vs. medical therapy for cryptogenic stroke: a meta-analysis of randomized controlled trials

Abstract

AimsThe efficacy of patent foramen ovale (PFO) closure for cryptogenic stroke has been controversial. We undertook a meta-analysis of randomized controlled trials (RCTs) comparing device closure with medical therapy to prevent recurrent stroke for patients with PFO.Methods and resultsWe systematically identified all RCTs comparing device closure to medical therapy for cryptogenic stroke in patients with PFO. The primary efficacy endpoint was recurrent stroke, analysed on an intention-to-treat basis. The primary safety endpoint was new onset atrial fibrillation (AF). Five studies (3440 patients) were included. In all, 1829 patients were randomized to device closure and 1611 to medical therapy. Across all patients, PFO closure was superior to medical therapy for prevention of stroke [hazard ratio (HR) 0.32, 95% confidence interval (95% CI) 0.13–0.82; P = 0.018, I2 = 73.4%]. The risk of AF was significantly increased with device closure [risk ratio (RR) 4.68, 95% CI 2.19–10.00, P<0.001, heterogeneity I2 = 27.5%)]. In patients with large shunts, PFO closure was associated with a significant reduction in stroke (HR 0.33, 95% CI 0.16–0.72; P = 0.005), whilst there was no significant reduction in stroke in patients with a small shunt (HR 0.90, 95% CI 0.50–1.60; P = 0.712). There was no effect from the presence or absence of an atrial septal aneurysm on outcomes (P = 0.994).ConclusionIn selected patients with cryptogenic stroke, PFO closure is superior to medical therapy for the prevention of further stroke: this is particularly true for patients with moderate-to-large shunts. Guidelines should be updated to reflect this.

Role of Transesophageal Echocardiography in Patients with Ischemic Stroke

“…44 A recent meta-analysis of all 5 randomized controlled trials to date showed PFO closure was superior to medical therapy for the prevention of stroke (HR 0.32, 95% CI 0.13-0.82, p=0.018). 45 With these most recent results, in selected populations it is clear that PFO closure provides benefit. With many of the trials however the rate of procedural complication was near 4%.…”

“…41 Also at issue is the low event rate such that many devices are needed to prevent one stroke, especially when compared against anticoagulation. 45 There has yet been no formal modification of the American Stroke Association/AHA or European Society of Cardiology (ESC) guidelines, but the British Medical Journal published recommendations in favor of PFO closure over antiplatelet therapy, with weak recommendations over anticoagulation. 46 Two more metaanalyses suggested that a change in the guidelines for the management of cryptogenic stroke might be warranted giving percutaneous PFO closure the predominant role.…”

Cryptogenic stroke and patent foramen ovale (abridged and translated version)

“…Until the end of April 2018, the results of 6 meta-analyses were available on the closure of patent foramen ovale in patients with cryptogenic stroke [11][12][13][14][15]. Results are shown in Table 3.…”

LMA Gastro Airway Seen Through the Eyes of a Cardiac Anesthesiologist

“…6 We report the successful insertion of a TEE probe in the channel for esophageal intubation of the LMA Gastro in 9 patients undergoing percutaneous patent foramen ovale (PFO) closures, a short procedure done with increasing relevance and frequency. [7][8][9][10][11][12] Written informed consent was obtained from patients.…”