Device therapy for atrial septal defects in a multicenter cohort: acute outcomes and adverse events.

BACKGROUND: Secundum atrial septal defect (ASD) closure devices were granted approval based on industry-sponsored, prospective, nonrandomized, single device studies, demonstrating acceptable efficacy and safety in selected patients. We sought to report community practice and outcomes. METHODS AND RESULTS: Procedure specific data was collected on cases considered for ASD closure in the congenital cardiac catheterization project on outcomes (C3PO) between February 1, 2007 and June 31, 2010. Eight centers contributed data during this time period. All adverse events (AE) were independently reviewed and classified by a five level severity scale. In 40 months (2/07-6/10), 653 of 688 ASDs were occluded with a single device using an AMPLATZER(®) Septal Occluder (ASO) in 566 (87%), GORE(®) HELEX(®) Septal Occluder (HSO) in 33 (5%), and a CardioSEAL(®) or STARFlex™ device (CSD) in 54 (8%). Most patients had an isolated ASD (93%). 85% were >2 years of age. The ASD median diameter was 12 mm [8,16] for ASO, with smaller diameters in HSO 8 mm [7,10] and CSD 8 mm [5,10] (P < 0.001). AE (n = 82) were recorded in 76 cases, 11.5% (95% CI 9.2%, 14.1%) and classified as high severity in 4.7% (95% CI 3.2%, 6.5%), with no mortality. A new conduction abnormality was detected during 15 cases and did not resolve in one. Transcatheter device retrieval was possible in 7 of 10 device embolizations. Device erosion occurred in 3 of 566, 0.5% (95% CI 0.1%, 1.5%), ASO implants. CONCLUSION: Although device closure of ASDs is associated with low morbidity and rare mortality, ongoing assessment of device safety profiles are warranted, and registries offer opportunities to facilitate the required surveillance.

Atresia del orificio del seno coronario / Coronary sinus orifice atresia

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Optimized temporary biventricular pacing acutely improves intraoperative cardiac output after weaning from cardiopulmonary bypass: a substudy of a randomized clinical trial.

OBJECTIVE: Permanent biventricular pacing benefits patients with heart failure and interventricular conduction delay, but the importance of pacing with and without optimization in patients at risk of low cardiac output after cardiac surgery is unknown. We hypothesized that pacing parameters independently affect cardiac output. Accordingly, we analyzed aortic flow measured with an electromagnetic flowmeter in patients at risk of low cardiac output during an ongoing randomized clinical trial of biventricular pacing (n = 11) versus standard of care (n = 9). METHODS: A substudy was conducted in all 20 patients in both groups with stable pacing after coronary artery bypass grafting, valve surgery, or both. Ejection fraction averaged 33% ± 15%, and QRS duration was 116 ± 19 ms. Effects were measured within 1 hour of the conclusion of cardiopulmonary bypass. Atrioventricular delay (7 settings) and interventricular delay (9 settings) were optimized in random sequence. RESULTS: Optimization of atrioventricular delay (171 ± 8 ms) at an interventricular delay of 0 ms increased flow by 14% versus the worst setting (111 ± 11 ms, P < .001) and 7% versus nominal atrioventricular delay (120 ms, P < .001). Interventricular delay optimization increased flow 10% versus the worst setting (P < .001) and 5% versus nominal interventricular delay (0 ms, P < .001). Optimized pacing increased cardiac output 13% versus atrial pacing at matched heart rate (5.5 ± 0.5 vs 4.9 ± 0.6 L/min, P = .003) and 10% versus sinus rhythm (5.0 ± 0.6 L/min, P = .019). CONCLUSIONS: Temporary biventricular pacing increases intraoperative cardiac output in patients with left ventricular dysfunction undergoing cardiac surgery. Atrioventricular and interventricular delay optimization maximizes this benefit.