Left Atrial Appendage Occlusion: The Current Device Landscape and Future Perspectives.

Since the first percutaneous left atrial appendage occlusion (LAAO), many studies have shown the safety and efficacy of this technique to prevent embolic strokes in nonvavular atrial fibrillation. The design, characteristics, and clinical data of the most frequently used devices for LAAO are reviewed, including the Amplatzer cardiac plug and Amulet (Abbott Vascular), the Watchman (Boston Scientific), and the LARIAT device (SentreHEART). Similarly, newer closer devices, such as Ultraseal (Cardia), LAmbre (Lifetech), and Coherex WaveCrest (Johnson & Johnson), are also discussed. Finally, new technologies still in the stage of preclinical study or in the initial clinical experience are also reviewed.

Paravalvular Regurgitation: Clinical Outcomes in Surgical and Percutaneous Treatments / Regurgitação Paravalvar: Análise de Desfechos Clínicos no Tratamento Cirúrgico e Percutâneo

Abstract Background: Paravalvular regurgitation (paravalvular leak) is a serious and rare complication associated with valve replacement surgery. Studies have shown a 3% to 6% incidence of paravalvular regurgitation with hemodynamic repercussion. Few studies have compared surgical and percutaneous approaches for repair. Objectives: To compare the surgical and percutaneous approaches for paravalvular regurgitation repair regarding clinical outcomes during hospitalization and one year after the procedure. Methods: This is a retrospective, descriptive and observational study that included 35 patients with paravalvular leak, requiring repair, and followed up at the Dante Pazzanese Institute of Cardiology between January 2011 and December 2013. Patients were divided into groups according to the established treatment and followed up for 1 year after the procedure. Results: The group submitted to percutaneous treatment was considered to be at higher risk for complications because of the older age of patients, higher prevalence of diabetes, greater number of previous valve surgeries and lower mean creatinine clearance value. During hospitalization, both groups had a large number of complications (74.3% of cases), with no statistical difference in the analyzed outcomes. After 1 year, the percutaneous group had a greater number of re-interventions (8.7% vs 20%, p = 0.57) and a higher mortality rate (0% vs. 20%, p = 0.08). A high incidence of residual mitral leak was observed after the percutaneous procedure (8.7% vs. 50%, p = 0.08). Conclusion: Surgery is the treatment of choice for paravalvular regurgitation. The percutaneous approach can be an alternative for patients at high surgical risk.

Resumo Fundamento: Regurgitação ou escape paravalvar é uma complicação grave e incomum associada ao implante de prótese valvar. Estudos mostram incidência de 3% a 6% com repercussão hemodinâmica. Existem poucos estudos na literatura que comparam as abordagens cirúrgica e percutânea para sua correção. Objetivos: Comparar as abordagens cirúrgica e percutânea de correção da regurgitação paravalvar quanto a desfechos clínicos durante a internação e após 1 ano do procedimento. Métodos: Este é um estudo retrospectivo, descritivo e observacional, que incluiu 35 pacientes com escape paravalvar acompanhados no Instituto Dante Pazzanese de Cardiologia entre janeiro de 2011 e dezembro de 2013 e que necessitaram de correção. Os pacientes foram divididos de acordo com o tratamento estabelecido e acompanhados por um período 1 ano após o procedimento. Resultados: O grupo submetido ao tratamento percutâneo foi considerado como de maior risco para complicações por apresentar pacientes mais idosos, com maior prevalência de diabetes, maior quantidade de cirurgias valvares prévias e menor valor médio de clearance de creatinina. Durante a evolução intra-hospitalar, observou-se grande número de complicações nos dois grupos (74,3% dos casos), sem diferença estatística nos desfechos analisados. Após 1 ano, o grupo percutâneo teve maior número de reintervenções (8,7% vs. 20%, p = 0,57) e mortalidade maior (0% vs. 20%, p = 0,08). Uma alta incidência de escape residual mitral foi verificada após procedimento percutâneo (8,7% vs. 50%, p = 0,08). Conclusão: A cirurgia é o tratamento de escolha da regurgitação paravalvar. A abordagem percutânea pode ser uma alternativa para os pacientes com risco cirúrgico elevado.

Paravalvular Regurgitation: Clinical Outcomes in Surgical and Percutaneous Treatments.

BACKGROUND: Paravalvular regurgitation (paravalvular leak) is a serious and rare complication associated with valve replacement surgery. Studies have shown a 3% to 6% incidence of paravalvular regurgitation with hemodynamic repercussion. Few studies have compared surgical and percutaneous approaches for repair. OBJECTIVES: To compare the surgical and percutaneous approaches for paravalvular regurgitation repair regarding clinical outcomes during hospitalization and one year after the procedure. METHODS: This is a retrospective, descriptive and observational study that included 35 patients with paravalvular leak, requiring repair, and followed up at the Dante Pazzanese Institute of Cardiology between January 2011 and December 2013. Patients were divided into groups according to the established treatment and followed up for 1 year after the procedure. RESULTS: The group submitted to percutaneous treatment was considered to be at higher risk for complications because of the older age of patients, higher prevalence of diabetes, greater number of previous valve surgeries and lower mean creatinine clearance value. During hospitalization, both groups had a large number of complications (74.3% of cases), with no statistical difference in the analyzed outcomes. After 1 year, the percutaneous group had a greater number of re-interventions (8.7% vs 20%, p = 0.57) and a higher mortality rate (0% vs. 20%, p = 0.08). A high incidence of residual mitral leak was observed after the percutaneous procedure (8.7% vs. 50%, p = 0.08). CONCLUSION: Surgery is the treatment of choice for paravalvular regurgitation. The percutaneous approach can be an alternative for patients at high surgical risk.

Left atrial appendage occlusion for prevention of stroke in nonvalvular atrial fibrillation: a meta-analysis.

PURPOSE: When anticoagulation for stroke prevention is contraindicated, left atrial appendage occlusion (LAAO) may be performed. Studies of LAAO have been limited by their small size, disparate patient populations, and lack of control group. Our purpose was to perform a meta-analysis of the safety and efficacy of LAAO in comparison with standard therapy for stroke prevention in nonvalvular AF. METHODS: Due to the lack of a control group in studies of LAAO, data on stroke prevention from multiple large outcomes studies were used to produce a hypothetical control group based on clinical variables in the individual studies. Results were stratified according to LAAO device type. RESULTS: We identified 16 studies with a total of 1759 patients receiving LAAO. Summary estimates demonstrate LAAO reduced risk of stroke in comparison with no therapy or aspirin therapy [relative risk (RR), 0.34; 95 % CI, 0.25-0.46] and in comparison with warfarin therapy (RR, 0.65; 95 % CI, 0.46-0.91). Summary estimates differed based on the study used to derive the hypothetical control group. Device deployment was unsuccessful in 6.1 % of patients, and overall complication rate was 7.1 %. Efficacy and safety were similar across LAAO device type although a majority of patients in the meta-analysis received a Watchman device. CONCLUSION: Our data suggest that LAAO is a reasonable option for stroke prophylaxis in AF when anticoagulation is not an option, and the risk for stroke outweighs the risk of procedural complications. Data were limited with the use of most available devices. To better establish the risk and benefit of LAAO in comparison with standard therapy, more randomized controlled trials are necessary.

Reduced mortality and severe disability rates in the SENTIS trial.

BACKGROUND AND PURPOSE: The Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke trial showed a trend for reduced all-cause mortality and positive secondary safety end point outcomes. We present further analyses of the mortality and severe disability data from the Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke trial. MATERIALS AND METHODS: The Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke trial was a multicenter, randomized, controlled trial that evaluated the safety and effectiveness of the NeuroFlo catheter in patients with stroke. The current analysis was performed on the as-treated population. All-cause and stroke-related mortality rates at 90 days were compared between groups, and logistic regression models were fit to obtain ORs and 95% CIs for the treated versus not-treated groups. We categorized death-associated serious adverse events as neurologic versus non-neurologic events and performed multiple logistic regression analyses. We analyzed severe disability and mortality by outcomes of the mRS. Patient allocation was gathered by use of a poststudy survey. RESULTS: All-cause mortality trended in favor of treated patients (11.5% versus 16.1%; P = .079) and stroke-related mortality was significantly reduced in treated patients (7.5% versus 14.2%; P = .009). Logistic regression analysis for freedom from stroke-related mortality favored treatment (OR, 2.41; 95% CI, 1.22, 4.77; P = .012). Treated patients had numerically fewer neurologic causes of stroke-related deaths (52.9% versus 73.0%; P = .214). Among the 90-day survivors, nominally fewer treated patients were severely disabled (mRS 5) (5.6% versus 7.5%; OR, 1.72; 95% CI, 0.72, 4.14; P = .223). Differences in allocation of care did not account for the reduced mortality rates. CONCLUSIONS: There were consistent reductions in all-cause and stroke-related mortality in the NeuroFlo-treated patients. This reduction in mortality did not result in an increase in severe disability.

Safety and occlusion rates of surgical treatment of unruptured intracranial aneurysms: a systematic review and meta-analysis of the literature from 1990 to 2011.

BACKGROUND AND PURPOSE: Surgical clipping of unruptured intracranial aneurysms (UIAs) has recently been challenged by the emergence of endovascular treatment. We performed an updated systematic review and meta-analysis on the surgical treatment of UIAs, in an attempt to determine the aneurysm occlusion rates and safety of surgery in the modern era. METHODS: A detailed protocol was developed prior to conducting the review according to the Cochrane Collaboration guidelines. Electronic databases spanning January 1990-April 2011 were searched, complemented by hand searching. Heterogeneity was assessed using I(2), and publication bias with funnel plots. Surgical mortality and morbidity were analysed with weighted random effect models. RESULTS: 60 studies with 9845 patients harbouring 10 845 aneurysms were included. Mortality occurred in 157 patients (1.7%; 99% CI 0.9% to 3.0%; I(2)=82%). Unfavourable outcomes, including death, occurred in 692 patients (6.7%; 99% CI 4.9% to 9.0%; I(2)=85%). Morbidity rates were significantly greater in higher quality studies, and with large or posterior circulation aneurysms. Reported morbidity rates decreased over time. Studies were generally of poor quality; funnel plots showed heterogeneous results and publication bias, and data on aneurysm occlusion rates were scant. CONCLUSIONS: In studies published between 1990 and 2011, clipping of UIAs was associated with 1.7% mortality and 6.7% overall morbidity. The reputed durability of clipping has not been rigorously documented. Due to the quality of the included studies, the available literature cannot properly guide clinical decisions.

Percutaneous left atrial appendage closure for stroke prevention in patients with atrial fibrillation: an assessment of net clinical benefit.

AIMS: The PROTECT-AF (WATCHMAN Left Atrial Appendage System for Embolic Protection in Patients with Atrial Fibrillation) trial found left atrial appendage (LAA) closure an alternative to anticoagulation in selected patients with non-valvular atrial fibrillation (AF). We aim to estimate the net clinical benefit (NCB) of percutaneous LAA closure. METHODS AND RESULTS: Post hoc analysis of outcomes among 707 adults with AF in the PROTECT-AF trial and 566 in the Continued Access (CAP) registry undergoing LAA closure with the Watchman device compared with sustained anticoagulation. Outcomes were ischaemic stroke, intracranial haemorrhage, major bleeding, pericardial effusion, and death, weighted to reflect the relative impact in terms of death and disability. Net clinical benefit was calculated as the sum of annualized rates of these outcomes after intervention minus rates on warfarin. The NCB of LAA closure during 1623 person-years follow-up in the trial was 1.73%/year (95% CI: -0.54 to 4.39%/year) and during 741 patient-years in the registry was 4.97%/year (95% CI: 3.07-7.15%/year). Among patients with a history of ischaemic stroke, the NCB was greater in the registry (8.68%/year, CI: 2.82-14.92%/year) than the trial (4.30%/year, CI -2.07 to 11.25%/year). In the registry, the NCB of LAA closure increased from 2.22%/year (CI: 0.27-6.01%/year) in patients with CHADS(2) scores = 1 to 6.12%/year (CI: 3.19-8.92%/year) in those with scores ≥2. CONCLUSION: Combining rates of thrombo-embolism, intracranial haemorrhage, major adverse events, and death allows objective comparison of the benefit and risk of device therapy vs. anticoagulation in patients with AF. The NCB of LAA closure is greatest for patients at a higher risk of stroke.