Impact of Device Implant Depth After Left Atrial Appendage Occlusion.

BACKGROUND: Device-related thrombus (DRT) remains one of the main concerns after left atrial appendage occlusion (LAAO). Several risk factors have been proposed, but most cannot be modulated. A modifiable factor such as device implantation depth is a potential target to adjust the risk for DRT. OBJECTIVES: The aim of this study was to assess the impact of LAAO device implantation depth as a predisposing factor for DRT. METHODS: The study included patients who underwent successful LAAO at 9 centers in Europe and Canada. Patients were classified into 2 groups: proximal device implantation (covered pulmonary ridge [PR] in the lobe and disc cohort or <5 mm from the PR in the single-lobe cohort) and distal device implantation (uncovered PR in the disc and lobe cohort and ≥5 mm in the single-lobe cohort). RESULTS: A total of 1,317 patients were included. Among these, proximal and distal device implantation was achieved in 732 (55%) and 585 (45%) patients, respectively. No differences in procedural outcomes were observed between the groups. At follow-up, patients with proximal implantation had a lower incidence of DRT (2.3%) than those with distal implantation (12.2%) (P < 0.001). Deeper device implantation and a larger uncovered left atrial appendage area were associated with a higher incidence of DRT (P < 0.001), regardless of device type. In multivariable analysis, distal implant (HR: 5.92; 95% CI: 3.39-10.36) and no or single antiplatelet therapy (HR: 1.62; 95% CI: 0.99-2.62) emerged as independent predictors of DRT. CONCLUSIONS: LAAO device implantation depth is an independent risk factor for DRT. Deeper device implantation and larger uncovered left atrial appendage areas were associated with a higher incidence of DRT.

Cost consequence analysis of use of a balloon expandable vascular access system and standard vascular sheath for transcatheter aortic valve implantation.

BACKGROUND: Vascular complications are an important complication of transcatheter aortic valve implantation and are associated with increased morbidity and mortality as well as cost. The Solopath device is an expandable vascular access system that has previously been shown to be associated with lower rates of vascular complications. This study sought to evaluate the impact of the use of this system on vascular complications and costs in a decision model analysis. METHODS: A cost-consequence analysis was undertaken utilizing event rate data from the PARTNER trials and a published retrospective analysis of the Solopath device. The decision model estimated costs and benefits in a hypothetical cohort of patients with aortic stenosis undergoing TAVI using either a standard sheath or Solopath. The modeled analysis compared the occurrence of vascular complications and mortality at 30 days and 1 year using TreeAge Pro. RESULTS: The decision model demonstrated that use of the Solopath sheath resulted in 36 fewer major vascular complications, three fewer deaths at 30 days, and five fewer deaths at 1 year, resulting in a discounted cost savings of $846 CDN. Results were sensitive to decreasing rates of vascular complications with newer generation devices, however maintained modest cost-savings. CONCLUSIONS: Reduction in vascular complications is an important part of improving care for TAVI patients. The Solopath vascular access device offers an alternative to standard sheaths with a potential reduction in complications and cost-savings.

Long-term results after surgical treatment of paravalvular leak in the aortic and mitral position.

OBJECTIVES: The aim of this study was to determine immediate results and long-term outcomes after surgical management of paravalvular leak (PVL). METHODS: Between 1995 and 2012, a total of 190 patients underwent primary surgical repair (n = 142) or valve replacement (n = 48) for a PVL at our institution. The PVL was mild in 6 (3%) patients, moderate in 85 (45%), moderate to severe in 84 (44%), and severe in 15 (8%). Among these, 120 (63%) had PVL in the mitral position, 63 (33%) had PVL in the aortic position, and 7 (4%) had PVL in both valves. Mean follow-up was 5.3 ± 4.6 years. RESULTS: Mean age at surgery was 63 ± 12 years (64% men). Operative mortality occurred in 13 (7%) patients (10 [8%] in mitral; 2 [3%] in aortic; and 1 [14%] in double valve procedures). Survival at 1, 5, and 10 years was 85% ± 3%, 73% ± 4%, and 56% ± 5%, respectively. The cumulative incidence of PVL recurrence was 3% ± 1%, 14% ± 3%, and 32% ± 6%, at 1, 5, and 10 years, respectively. The number of previous surgeries was a predictor of survival and PVL recurrence. Freedom from New York Heart Association class ≥III was 96% ± 2%, 82% ± 4%, and 58% ± 6%, at 1, 5, and 10 years, respectively. The freedom from rehospitalization for heart failure was 92% ± 2%, 83% ± 4%, and 67% ± 6%, at 1, 5, and 10 years. CONCLUSIONS: Surgical treatment of PVL resulted in acceptable outcomes. Nevertheless, the continued risk of PVL recurrence is higher in patients who have had multiple previous surgeries. More studies are needed to compare these results with the transcatheter PVL reduction technique.