Cost Implications of Left Atrial Appendage Occlusion During Cardiac Surgery: A Cost Analysis of the LAAOS III Trial.

Background The LAAOS III (Left Atrial Appendage Occlusion Study) clinical trial demonstrated that concomitant left atrial appendage (LAA) occlusion leads to a lower risk of ischemic stroke or systemic embolism compared with no occlusion in participants with atrial fibrillation and a CHA2DS2-VASc score of ≥2 undergoing cardiac surgery for another indication. We report the cost implications of concomitant LAA occlusion during cardiac surgery. Methods and Results Using LAAOS III data, we compared the costs (in US dollars) associated with LAA occlusion to no occlusion from the perspective of the Centers for Medicare and Medicaid Services. We calculated the average cost per participant during the trial by applying Medicare reimbursement costs to cardiovascular events for all trial participants. We conducted sensitivity analyses, varying the cost of stroke ±25% and occlusion technique use. Cost neutrality was defined as a mean cost difference within ±5% of the cost per participant in the no-occlusion group. Total study cost per participant was $3878 in the LAA occlusion group and $4490 in the no-occlusion group, a mean difference of -$612 (95% CI, -$1276 to $45). The main drivers of cost savings were fewer stroke events during the trial (mean difference of -$1021). In sensitivity analyses, LAA occlusion was cost saving for suture and stapler techniques but more expensive with closure device. Conclusions Concomitant LAA occlusion was cost saving for participants in LAAOS III. Our findings support concomitant LAA occlusion as an economically dominant strategy for patients with atrial fibrillation and a CHA2DS2-VASc score of ≥2 undergoing cardiac surgery.

Randomized Trials in Cardiac Surgery: JACC Review Topic of the Week.

Compared with randomized controlled trials (RCTs) in medical specialties, RCTs in cardiac surgery face specific issues. Individual and collective equipoise, rapid evolution of the surgical techniques, as well as difficulties in obtaining funding, and limited education in clinical epidemiology in the surgical community are among the most important challenges in the design phase of the trial. Use of complex interventions and learning curve effect, differences in individual operators' expertise, difficulties in blinding, and slow recruitment make the successful completion of cardiac surgery RCTs particularly challenging. In fact, over the course of the last 20 years, the number of cardiac surgery RCTs has declined significantly. In this review, a team of surgeons, trialists, and epidemiologists discusses the most important challenges faced by RCTs in cardiac surgery and provides a list of suggestions for the successful design and completion of cardiac surgery RCTs.

Emergency cardiac surgery during transfemoral and transapical transcatheter aortic valve implantation: incidence, reasons, management, and outcome of 411 patients from a single center.

OBJECTIVES AND BACKGROUND: Transcatheter aortic valve implantation (TAVI) is increasingly performed in high-risk patients with severe aortic valve stenosis. Incidence and impact of emergency cardiac surgery (ECS) during TAVI is unclear. METHODS AND RESULTS: Two-hundred twenty one transapical (TA) and 190 transfemoral (TF) TAVIs were performed at our hospital between 01/2009 and 12/2012. Twenty patients (4.9%) required ECS, more frequently in the TF- (n = 11; 5.8%) than in the TA-group (n = 9; 4.1%; P = 0.017). ECS-cases were evenly distributed throughout the 4 years. Baseline characteristics of the ECS-patients were not different from the non-ECS-patients. Reasons were acute cardiac failure, coronary obstruction, annular rupture, valve migration, right- and left-ventricular perforation, severe paravalvular leakage, aortic dissection, and mitral valve damage. Surgical intervention consisted of peripheral CPB, switch to TA, thoracotomy and suture of perforated cardiac chambers and conventional aortic valve replacement with concomitant repair of associated cardiovascular injury. Thirty-day mortality was 35.0%, and 55.0% could be salvaged to hospital discharge. Kaplan-Meier 1-year survival curves were significantly impaired for patients requiring ECS (TF: P < 0.0001, HR 8.716; TA: P = 0.013, HR 2.813). CONCLUSIONS: Life-threatening complications requiring bail-out ECS occur in a substantial proportion during TAVI. ECS dramatically affects early and late outcome after TAVI. Under optimal conditions more than half of the ECS-patients can be salvaged. With the current technology of THV-systems ECS should be an integral part of the logistic conditions surrounding TAVI and is far from being futile in this patient population.