Routine use of optical coherence tomography in bioresorbable vascular scaffold implantation: insights on technique optimization and long-term outcomes.

BACKGROUND: Data from prior studies have shown increased risk of adverse outcomes with bioresorbable vascular scaffolds (BVS) compared with drug-eluting stents. OBJECTIVE: The objective of this study was to study the long-term outcomes with routine use of optical coherence tomography (OCT) for optimization of BVS implantation. PATIENTS AND METHODS: Clinical, procedural, and outcome data were collected for all patients who received ABSORB BVS between February 2014 and March 2016 in our tertiary center (n=86). Preimplantation and postimplantation OCT was performed in all cases. Outcomes of interest included acute device success and long-term clinical outcomes including cardiac mortality, target vessel myocardial infarction, ischemia-driven target lesion revascularization, and scaffold thrombosis. RESULTS: A total of 86 patients were included (106 lesions, 115 BVS implanted). Mean age was 59.5±10.9 years, with 66% men. Mean lesion length was 25.2±15.6 mm and mean reference vessel diameter was 3.42±0.45 mm. Type B2/C accounted for 40% of the lesions. All scaffold implantations followed the predilation, proper sizing, and postdilation strategy. Of the 115 scaffolds analyzed, 11 (9.5%) required further intervention based on prespecified OCT endpoints. On multivariate regression analysis, complex coronary lesion (type B2/C) was the single independent predictor of OCT use in scaffold optimization (odds ratio=6.3, 95% confidence interval: 1.3-7.8, P=0.02). At a mean follow-up duration of 31±7.1 months, no cases of cardiac mortality, target vessel myocardial infarction, ischemia-driven target lesion revascularization, or scaffold thrombosis were reported. CONCLUSION: Operators may consider OCT use for optimization of BVS implantation particularly in patients with complex coronary lesions.

Long-term outcomes of patent foramen ovale closure or medical therapy after cryptogenic stroke: A meta-analysis of randomized trials.

OBJECTIVES: To examine long-term clinical outcomes with transcatheter patent foramen ovale (PFO) closure versus medical therapy alone in patients with cryptogenic stroke. BACKGROUND: A long-standing debate regarding the optimal approach for the management of patients with PFO after a cryptogenic stroke exists. METHODS: An electronic search was performed for randomized clinical trials (RCTs) reporting clinical outcomes with PFO closure vs. medical therapy alone after stroke. Random effects DerSimonian-Laird risk ratios (RR) were calculated. The main outcome was recurrence of stroke. Other outcomes included transient ischemic attack (TIA), new-onset atrial fibrillation/flutter (AF/AFL), major bleeding, serious adverse events, and device-related complications. All-cause mortality was also examined. RESULTS: Five RCTs with a total of 3,440 patients were included. At a mean follow-up of 4.02 ± 1.57 years, PFO closure was associated with less recurrence of stroke (RR = 0.43; 95% CI 0.19-0.91; P = .027) compared with medical therapy alone. No difference was observed between both strategies for TIA (P = .21), major bleeding (P = .69), serious adverse events (P = .35), and all-cause death (P = .48). However, PFO closure, was associated with increased new-onset AF/AFL (P < .001), risk of pulmonary embolism (P = .04), and device-related complications (P < .001). On a subgroup analysis, stroke recurrence rate remained lower in PFO closure arm regardless of the type of closure device used (Pinteraction = .50), or the presence of substantial shunt in the majority of study population (Pinteraction = .13). CONCLUSIONS: Transcatheter PFO closure reduces the recurrence of stroke compared with medical therapy alone, with no significant safety concerns. Close follow-up of patients after PFO closure is recommended to detect new-onset atrial arrhythmias.