Twelve-month follow-up of left atrial appendage occlusion with Amplatzer Amulet

  Background: The Amplatzer Amulet (St. Jude Medical, Minneapolis, MN, USA) is a second gen­eration Amplatzer device for left atrial appendage (LAA) occlusion (LAAO) for stroke prophylaxis in patients with atrial fibrillation. This research sought to assess the clinical performance of the Amplatzer Amulet device and in follow up for 12 months. Methods: In this single-center registry patients with atrial fibrillation and contraindication to oral anticoagulation underwent LAAO with the Amplatzer Amulet device. Follow-up was performed before discharge, by transesophageal echocardiography (TEE) after 6 weeks and telephone interview after 3, 6 and 12 months. Results: Between October 2014 and August 2015 50 patients (76.1 ± 8.3 years; 30 male) were en­rolled. Procedural success was achieved in 49 (98%) patients. Major periprocedural adverse events were observed in 4 (8%) of patients: 1 device embolization, 2 pericardial effusions requiring pericardiocente­sis and 1 prolonged hospital stay due to retropharyngeal hematoma from the TEE probe. Follow-up TEE was available in 38 of 50 patients showing complete LAA sealing in all. 2 device-related thrombi were also documented. At 12-month follow-up 7 patients had died unrelated to the device. Ischemic stroke occurred in 3 patients. According to neurological examination two were classified as microangiopathic and not cardio-embolic. The other one could not be classified. Bleeding complications (5 minor, 3 major) were documented in 8 patients. Conclusions: Although minimizing procedure-related complications remains challenging, LAAO with the Amplatzer Amulet device showed high procedural success and excellent LAA sealing. (Cardiol J 2017; 24, 2: 131–138

Cost-effectiveness analysis of left atrial appendage occlusion compared with pharmacological strategies for stroke prevention in atrial fibrillation

Background Transcatheter left atrial appendage occlusion (LAAO) is a promising therapy for stroke prophylaxis in non-valvular atrial fibrillation (NVAF) but its cost-effectiveness remains understudied. This study evaluated the cost- effectiveness of LAAO for stroke prophylaxis in NVAF. Methods A Markov decision analytic model was used to compare the cost-effectiveness of LAAO with 7 pharmacological strategies: aspirin alone, clopidogrel plus aspirin, warfarin, dabigatran 110 mg, dabigatran 150 mg, apixaban, and rivaroxaban. Outcome measures included quality-adjusted life years (QALYs), lifetime costs and incremental cost-effectiveness ratios (ICERs). Base-case data were derived from ACTIVE, RE-LY, ARISTOTLE, ROCKET-AF, PROTECT-AF and PREVAIL trials. One- way sensitivity analysis varied by CHADS2 score, HAS-BLED score, time horizons, and LAAO costs; and probabilistic sensitivity analysis using 10,000 Monte Carlo simulations was conducted to assess parameter uncertainty. Results LAAO was considered cost-effective compared with aspirin, clopidogrel plus aspirin, and warfarin, with ICER of US$5,115,$2,447, and $6,298 per QALY gained, respectively. LAAO was dominant (i.e. less costly but more effective) compared to other strategies. Sensitivity analysis demonstrated favorable ICERs of LAAO against other strategies in varied CHADS2 score, HAS-BLED score, time horizons (5 to 15 years) and LAAO costs. LAAO was cost-effective in 86.24$50,000/QALY. Conclusions Transcatheter LAAO is cost-effective for prevention of stroke in NVAF compared with 7 pharmacological strategies. Condensed abstract The transcatheter left atrial appendage occlusion (LAAO) is considered cost-effective against the standard 7 oral pharmacological strategies including acetylsalicylic acid (ASA) alone, clopidogrel plus ASA, warfarin, dabigatran 110 mg, dabigatran 150 mg, apixaban, and rivaroxaban for stroke prophylaxis in non-valvular atrial fibrillation management

Przezskórne zamknięcie uszka lewego przedsionka przy użyciu okludera Amplatzer® Cardiac Plug u pacjentów z migotaniem przedsionków i wysokim ryzykiem udaru mózgu - wczesne doświadczenia

Background: Atrial fibrillation is the most common arrythmia in patients beyond 65 years of age. Several of those patients have contraindications to coumadin treatment. Ninety percent of atrial thrombi related to atrial fibrillation are found in the left atrial appendage. Aim: We present our early experience with the left atrial appendage transcatheter closure using the Amplatzer® Cardiac Plug. Methods: Transcatheter closure was performed in general anaesthesia and under transoesophageal echocardiography control in three patients aged 69, 73 and 61 years (two female). All had atrial fibrillation with high risk of thromboembolic events (CHADS2 score ≥ 2 points). In all of them coumadin treatment was contraindicated. Results: The procedure time was 112, 109 and 60 min (fluoroscopy time: 25, 29 and 12,5 min). The Amplatzer® Cardiac Plugs of 24, 26 and 22 mm were implanted successfully and without complications. The day after, transthoracic echocardiogram revealed proper position of the implant and complete occlusion of the appendage in all patients. The patients were discharged on antiplatelet treatment. Conclusion: Transcatheter left atrial appendage closure with the Amplatzer® Cardiac Plug may be a promissing therapeutic option for patients with atrial fibrillation-related high risk of thromboembolic events and with contraindications to anti-vitamin K treatment

Cardioembolic Stroke in Atrial Fibrillation-Rationale for Preventive Closure of the Left Atrial Appendage

Atrial fibrillation is the most common cardiac arrhythmias, and a major cause of morbidity and mortality due to cardioembolic stroke. The left atrial appendage is the major site of thrombus formation in non-valvular atrial fibrillation. Loss of atrial systole in atrial fibrillation and increased relative risk of associated stroke point strongly toward a role for stasis of blood in left atrial thrombosis, although thrombus formation is multifactorial, and much more than blood flow irregularities are implicated. Oral anticoagulation with vitamin-K-antagonists is currently the most effective prophylaxis for stroke in atrial fibrillation. Unfortunately, this treatment is often contraindicated, particularly in the elderly, in whom risk of stroke is high. Moreover, given the risk of major bleeding, there is reason to be skeptical of the net benefit when warfarin is used in those patients. This work reviews the pathophysiology of cardioembolic stroke and critically spotlights the current status of preventive anticoagulation therapy. Various techniques to exclude the left atrial appendage from circulation were discussed as a considerable alternative for stroke prophylaxis

Eliminacja uszka lewego przedsionka za pomocą okludera Amplatza u chorych z migotaniem przedsionków - opis 2 przypadków

Percutaneous left atrial appendage device closure is currently under evaluation as a method for reducing stroke risk in patients with atrial fibrillation and contraindications for long-term oral anticoagulation therapy. We present two cases of successful implantation of new left atrial appendage occluder - Amplatzer Cardiac Plug. Kardiol Pol 2011; 69, 1: 85-8

Preclinical evaluation of a new left atrial appendage occluder (Lifetech LAmbre (TM) Device) in a canine model

Objectives: The study evaluated the feasibility and safety of a novel left atrial appendage (LAA) occluder (LAmbre (TM), Lifetech Scientific Corp., China) in canines. Objectives: &nbsp; The study evaluated the feasibility and safety of a novel left atrial appendage (LAA) occluder (LAmbre&trade;, Lifetech Scienti &nbsp; fic Corp., China) in canines. Background: &nbsp; Transcatheter LAA occlusion is comparable towarfarin in preventing atrial fibrillation-related strokes. Methods: &nbsp; Twenty-two healthy dogs (28 &plusmn; 3 kg) received LAmbre implants. The device is delivered by an 8 &nbsp; &ndash;10 French sheath and has full recapture and repositioning capabilities. All dogs received 1-week antibiotics and 4-week aspirin (80 mg daily) after implants and they were sacri &nbsp; ficed in groups at Days 1&ndash;3 (n = 5), 1- (n = 7), 3- (n = 4) and 6-months (n = 6) for pathological examinations. Transthoracic echocardiography (TTE) was performed immediately after implant, at Day 3 and before sacri &nbsp; fice. Results: &nbsp; The LAmbre was successfully implanted, retrieved, repositioned and re-implanted in all dogs. The mean implant size was 24 &plusmn; 3 mm and the device chosen was 36 &plusmn; 7% larger than the measured landing zone diameter. Improper device selection (only 21% oversizing) resulted in dislodgement and death of 1 dog on Day 3. Post-implant angiography and TTE showed well-positioned device without pericardial effusion or impingement on surrounding structures. Late complications included device-related thrombus at 1 month (n = 1) and clinically insigni &nbsp; ficant pericardial effusion at Day 3 (n = 1). Complete healing on the atrial facing surface with optimal LAA obliteration was con &nbsp; firmed by gross andmicroscopic examinations in dogs that have been followed up &nbsp; &ge;3 months (n=10). No infarctwas detected inmajor organs. Conclusions: &nbsp; Our preliminary data suggested the LAmbre&trade; device is feasible with high success rate in canines. Further studies are needed to evaluate its safety and ef &nbsp; ficacy.</p