Berkompas, Duane

Objective: Patent foramen ovale (PFO) closure is recommended for patients younger than 60 years with embolic stroke of undetermined source (ESUS) or cryptogenic stroke, but it’s role in patients older than 60 years remains unclear. We aim to investigate the benefit of closure in patients older than 60 with ESUS or cryptogenic stroke. Methods: Patients older than 60 years with ESUS or cryptogenic stroke from several large tertiary hospitals were recruited, who received a PFO closure after multidisciplinary brain-heart case conference, compared to age-matched cohort patients with ESUS or cryptogenic stroke. The primary outcome included recurrent ischemic stroke that occurred up to a median follow up of 5 years following PFO closure between two groups. The safety outcome was the occurrence of any complications after PFO closure, including new onset atrial fibrillation (AF). Results: A total of 102 patients (Table 1) were included (mean age 66±4), 56 male (55%), who received a PFO closure. Procedure-related complications, including new onset transient AF were low (1%). After following patients up to 5 years, patients with PFO closure demonstrated a relatively low incidence of recurrent ischemic stroke (3.9%, 4/102), compared to age-matched control cohort with a total of 97 patients (mean age 67±4), which had higher incidence of stroke recurrency (8.2%, 8/97) (Table 2). Kaplan-Meier event curve (Figure 1) reveals a trend of reducing recurrent stroke in patients with PFO closure but not achieved statistical significance. Conclusions: In patients with cryptogenic stroke or ESUS who are older than 60 years, PFO closure demonstrated safety profiles with a noticeable trend of reducing recurrent ischemic stroke compared to their age-matched counterparts. Prospective randomized trials are warranted in this young-older population.

Importance In patients with severe aortic valve stenosis at intermediate surgical risk, transcatheter aortic valve replacement (TAVR) with a self-expanding supra-annular valve was noninferior to surgery for all-cause mortality or disabling stroke at 2 years. Comparisons of longer-term clinical and hemodynamic outcomes in these patients are limited. Objective To report prespecified secondary 5-year outcomes from the Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI) randomized clinical trial. Design, Setting, and Participants SURTAVI is a prospective randomized, unblinded clinical trial. Randomization was stratified by investigational site and need for revascularization determined by the local heart teams. Patients with severe aortic valve stenosis deemed to be at intermediate risk of 30-day surgical mortality were enrolled at 87 centers from June 19, 2012, to June 30, 2016, in Europe and North America. Analysis took place between August and October 2021. Intervention Patients were randomized to TAVR with a self-expanding, supra-annular transcatheter or a surgical bioprosthesis. Main Outcomes and Measures The prespecified secondary end points of death or disabling stroke and other adverse events and hemodynamic findings at 5 years. An independent clinical event committee adjudicated all serious adverse events and an independent echocardiographic core laboratory evaluated all echocardiograms at 5 years. Results A total of 1660 individuals underwent an attempted TAVR (n = 864) or surgical (n = 796) procedure. The mean (SD) age was 79.8 (6.2) years, 724 (43.6%) were female, and the mean (SD) Society of Thoracic Surgery Predicted Risk of Mortality score was 4.5% (1.6%). At 5 years, the rates of death or disabling stroke were similar (TAVR, 31.3% vs surgery, 30.8%; hazard ratio, 1.02 [95% CI, 0.85-1.22]; P = .85). Transprosthetic gradients remained lower (mean [SD], 8.6 [5.5] mm Hg vs 11.2 [6.0] mm Hg; P < .001) and aortic valve areas were higher (mean [SD], 2.2 [0.7] cm 2 vs 1.8 [0.6] cm 2 ; P < .001) with TAVR vs surgery. More patients had moderate/severe paravalvular leak with TAVR than surgery (11 [3.0%] vs 2 [0.7%]; risk difference, 2.37% [95% CI, 0.17%- 4.85%]; P = .05). New pacemaker implantation rates were higher for TAVR than surgery at 5 years (289 [39.1%] vs 94 [15.1%]; hazard ratio, 3.30 [95% CI, 2.61-4.17]; log-rank P < .001), as were valve reintervention rates (27 [3.5%] vs 11 [1.9%]; hazard ratio, 2.21 [95% CI, 1.10-4.45]; log-rank P = .02), although between 2 and 5 years only 6 patients who underwent TAVR and 7 who underwent surgery required a reintervention. Conclusions and Relevance Among intermediate-risk patients with symptomatic severe aortic stenosis, major clinical outcomes at 5 years were similar for TAVR and surgery. TAVR was associated with superior hemodynamic valve performance but also with more paravalvular leak and valve reinterventions.