Background Data reporting a head-to-head comparison between Amulet and Watchman devices are scarce. The aim of this study was to compare the Watchman™ versus Amulet™ left atrial appendage closure (LAAC) devices in a consecutive, industry-independent registry. Methods Patients who underwent LAAC using Watchman or Amulet devices from January 2014 to December 2019 at the University Heart Center Lübeck, Lübeck, Germany were included in the present analysis. Primary endpoints included periprocedural complications (in-hospital death, pericardial tamponade, device embolization, stroke, major bleeding and vascular access complications), and complications during long-term follow-up (ischemic stroke, hemorrhagic stroke, thromboembolism, device thrombus, bleeding and death). Results After matching the patients for age (±5 years), gender, CHA2DS2Vasc score (±1) and HASBLED score (±1), each of the Watchman and the Amulet groups included 113 patients. Patients in the Amulet group had significantly more periprocedural complications (2.7% vs 10.6%, p = 0.029; respectively) and more major bleeding complications (0% vs 5.3%, p = 0.029; respectively). During long-term follow-up, the rate of events was comparable between the Watchman and Amulet groups (18.3% versus 20.8%, p = 0.729; respectively). Conclusion Amulet LAAC device was associated with increased periprocedural complications as compared to Watchman LAAC device. On long-term follow-up, both devices showed comparable efficacy and safety.
Objectives To compare the Watchman™ versus Amulet™ left atrial appendage closure (LAAC) devices in a consecutive, industry-independent registry. Background Data reporting a head-to-head comparison between Amulet and Watchman devices are scarce. Methods Patients who underwent LAAC using Watchman or Amulet devices from January 2014 to December 2019 at the University Heart Center Lübeck, Lübeck, Germany were included in the present analysis. Primary endpoints included periprocedural complications (in-hospital death, pericardial tamponade, device embolization, stroke, major bleeding and vascular access complications), and complications during 2-year-follow-up (ischemic stroke, hemorrhagic stroke, thromboembolism, device thrombus, bleeding and death). Results After matching the patients for age (± 5 years), gender, CHA2DS2Vasc score (± 1) and HASBLED score (± 1), each of the Watchman and the Amulet groups included 113 patients. Patients in the Amulet group had significantly more periprocedural complications (2.7% vs 10.6%, p = 0.029; respectively) and more major bleeding complications (0% vs 5.3%, p = 0.029; respectively). During 2-year follow-up, the rate of events was comparable between the Watchman and Amulet groups (18.3% versus 20.8%, p = 0.729; respectively). Conclusion Amulet LAAC device was associated with increased periprocedural complications as compared to Watchman LAAC device. On 2-year follow-up, both devices showed comparable efficacy and safety.
AimsTo evaluate outcomes of percutaneous left atrial appendage closure (LAAC) in patients with congestive heart failure (CHF) and non-valvular atrial fibrillation (AF) in a consecutive, industry-independent registry associated with periprocedural success and complications during long-term follow-up. Methods and resultsFor this analysis, we included patients who underwent transcatheter LAAC from January 2014 to December 2019 at the University Heart Center in Lübeck, Germany, and compared patients with presence of CHF defined as patients with a reduced left ventricular ejection fraction (LVEF ≤ 40%), patients with a mid-range LVEF (LVEF 41-49%), patients with diastolic dysfunction and preserved LVEF (LVEF ≥ 50%), and patients with right-sided heart failure and impaired right ventricular function (tricuspid annular plane systolic excursion < 17) to patients undergoing LAAC with no CHF. Primary endpoints were defined as periprocedural complications, and complications during long-term follow-up presented as major adverse cardiac and cerebrovascular events (MACCE). A total of 300 consecutive patients underwent LAAC. Of these, 96 patients in the CHF group were compared with 204 patients in the non-CHF group. Implantation success was lower in CHF group in comparison with non-CHF group (99.5% vs. 96%, P = 0.038); otherwise, there were no differences in periprocedural complications between groups. Patients with CHF showed a significantly higher incidence of MACCE rate (31.9% vs. 15.1%, P = 0.002) and more deaths (24.2% vs. 7%, P ≤ 0.001) during long-term follow-up. In Cox multivariable regression analysis, CHF was an independent predictor of mortality after LAAC implantation at long-term follow-up (hazard ratio 3.23, 95% confidence intervals 1.52-6.86, P = 0.002). Conclusions Implantation of LAAC devices in patients with non-valvular AF and CHF is safe. The increased mortality in patients with CHF compared with patients without CHF during the long-term follow-up is mainly attributed to comorbidities associated with CHF.
Funding Acknowledgements Type of funding sources: None. Background Transcatheter edge-to-edge tricuspid valve repair (TTVR) for tricuspid regurgitation (TR) is an emerging treatment option in inoperable patients. TTVR is always guided by transesophageal echocardiography (TOE) and performed under general anesthesia. In patients with excellent acoustic window, transthoracic echocardiography (TTE) can also provide a comprehensive morphological understanding. Moreover, in TTVR there is no need for transseptal puncture. Purpose We investigated if TTVR can be successfully conducted by a novel TTE guiding approach, in conjunction with fluoroscopy, based on the concept of the 4 right-sided chamber views. Methods Thirty TTVR patients were assigned to a TTE (n=10) and a TOE group (n=20), depending on acoustic window and corresponding guidance. Multimodality imaging was paramount for procedural planning and included TTE, TOE and cardiac CT, from which the corresponding fluoroscopic angulations of the 4 right-sided chamber views were derived. Thus, interventionalists and cardiac imaging specialists were assessing the same chamber views from their respective imaging modality. TR severity and quality of life parameters were assessed at baseline and up to 12 months. Results Except for lower BMI (TTE 22.3±0.8 vs TOE 29.8±4.3, p<0.001), baseline characteristics were similar between groups e.g., age (81.7±3.9 vs 82.8±4.1, p = 0.483) or EuroSCORE II (11.9±10.3 vs 10.4±8, p = 0.692). Device success was achieved in all patients, with a total of 15 implanted clips in the TTE (clips / patient 1.5±0.7) vs 31 clips in the TOE group (1.5±0.6), and device times of 75±37.1 vs 65.7±31.3 minutes (p = 0.506). TR reduction was successful in all but one patient, in each group (90% vs 95%, p = 1.000). TR improvement was equal between-groups, with 2- or more grade reduction in 60% of cases, at 30 days. No device associated complications occurred. Nine patients in the TTE group and 17 in the TOE group completed one-year follow-up. Quality of life and functional capacity similarly improved in both groups, with NYHA class reduction in all survivals [100% (9/9) vs 95% (17/17), p = 1.000], and significant improvement in KCCQ score and 6-minute walk distance in each respective group (∆24.8±21.4 vs 20.1±13.6 points, p = 0.227; ∆93.5±100.4 vs 80.8±64 meters, p = 0.121). TR reduction impacted major organs e.g., liver and kidney. Thus, glomerular filtration rate (GFR) increased [TTE group 56.8±18.7 vs 64.6±14.9 ml/m2/1,73m2, p = 0.050; TOE group 50.7±19.9 vs 53.8±20.9, p = 0.347], while liver congestion parameters decreased e.g, aspartate aminotransferase (AST) [TTE group 28.6±7.5 vs 26.2±8.6 U/L, p = 0.274; TOE group 33.1±5.8 vs 23.6±9, p = 0.388]. Conclusions TTE guidance of TTVR is feasible in selected patients with excellent acoustic window and represents an alternative to TOE or, in combination, may facilitate transition to conscious sedation. Successful TTVR leads to improvement in quality of life, symptom control, and multiorgan function.
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