P1440Left atrial appendage closure for stroke prevention in nonvalvular atrial fibrillation with Watchman device versus Amplatzer Cardiac Plug. Results of the multicenter Russian trial

EP Europace ◽  
2020 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
K V Davtyan ◽  
G Simonyan ◽  
A A Kalemberg ◽  
A H Topchyan ◽  
D S Lebedev ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Survival Rate ◽  
Stroke Prevention ◽  
Atrial Appendage ◽  
Efficacy And Safety ◽  
Nonvalvular Atrial Fibrillation ◽  
Significant Difference ◽  
Watchman Device ◽  
Complications Rate

Abstract Background The data are limited on comparative efficacy and safety of the left atrial appendage occlusion (LAAO) using the Watchman device (WD) and Amplatzer Cardiac Plug (ACP) for stroke prevention in nonvalvular atrial fibrillation (AF) patients. Objective To assess the safety and efficacy of the WD compared with ACP for stroke prevention and adverse events in patients with AF. Methods 200 consecutive patients (median age 67.5yrs, 94 female, median CHA2DS2VASc score - 4, median HASBLED score 3) with nonvalvular AF and contraindications to oral anticoagulation therapy from 5 medical centers in Russia, who undergone LAAO implantation using WD (n = 108; WD group) and ACP (n = 92; ACP group) were enrolled into this study. The coprimary end point was the composite of TIA/stroke and procedure-related complications during follow up.  Secondary end points included successful LAA occluder implantation rate and incidence rates of significant leakage. Patients were followed at 45 days, 3, 6 and 12 months after enrollment. At each follow-up visit the data regarding clinical events and healthcare utilization were collected. Results During the follow-up TIA/stroke has occurred in 6.2% of patients in the WD group with no such events in ACP group (6.2% vs 0%, p = 0.012). The composite safety-efficacy survival rate in WD group was 91.7% versus 92.4% in ACP group (p = 0.85). The periprocedural major complications rate (pulmonary trunk perforation with fatal haemotamponade, nonfatal haemotamponade with pericardiocentesis, device embolisation) was significantly higher in ACP group compared with WD group (5.4% vs 0%, p = 0.005). There was no significant difference in overall events rate between groups (3.7% vs 7.6%, p = 0.2). Successful LAA occluder implantation was performed in all 92 (100%) patients with ACP and in 105 (97,2%) with WD (p = 0.053). The significant leakage (≥5mm) was 3.03% in WD group with no such events in ACP group (3.03% vs 0%, p = 0.059). Conclusion LAAO using ACP was associated with higher major procedure-related complications rate. Despite a higher TIA/stroke rate in WD group, the composite efficacy and safety survival rate of LAAO using the WD and ACP was comparable during 12 month follow up.

scholarly journals A meta-analysis indicating extra-short implants (≤ 6 mm) as an alternative to longer implants (≥ 8 mm) with bone augmentation

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Xiaoran Yu ◽  
Ruogu Xu ◽  
Zhengchuan Zhang ◽  
Yang Yang ◽  
Feilong Deng
Keyword(s):  
Survival Rate ◽  
Clinical Outcomes ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Bone Augmentation ◽  
Moderate Quality ◽  
Short Implants ◽  
Significant Difference ◽  
Complications Rate

AbstractExtra-short implants, of which clinical outcomes remain controversial, are becoming a potential option rather than long implants with bone augmentation in atrophic partially or totally edentulous jaws. The aim of this study was to compare the clinical outcomes and complications between extra-short implants (≤ 6 mm) and longer implants (≥ 8 mm), with and without bone augmentation procedures. Electronic (via PubMed, Web of Science, EMBASE, Cochrane Library) and manual searches were performed for articles published prior to November 2020. Only randomized controlled trials (RCTs) comparing extra-short implants and longer implants in the same study reporting survival rate with an observation period at least 1 year were selected. Data extraction and methodological quality (AMSTAR-2) was assessed by 2 authors independently. A quantitative meta-analysis was performed to compare the survival rate, marginal bone loss (MBL), biological and prosthesis complication rate. Risk of bias was assessed with the Cochrane risk of bias tool 2 and the quality of evidence was determined with the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. 21 RCTs were included, among which two were prior registered and 14 adhered to the CONSORT statement. No significant difference was found in the survival rate between extra-short and longer implant at 1- and 3-years follow-up (RR: 1.002, CI 0.981 to 1.024, P = 0.856 at 1 year; RR: 0.996, CI 0.968 to 1.025, P  = 0.772 at 3 years, moderate quality), while longer implants had significantly higher survival rate than extra-short implants (RR: 0.970, CI 0.944 to 0.997, P < 0.05) at 5 years. Interestingly, no significant difference was observed when bone augmentations were performed at 5 years (RR: 0.977, CI 0.945 to 1.010, P = 0.171 for reconstructed bone; RR: 0.955, CI 0.912 to 0.999, P < 0.05 for native bone). Both the MBL (from implant placement) (WMD: − 0.22, CI − 0.277 to − 0.164, P < 0.01, low quality) and biological complications rate (RR: 0.321, CI 0.243 to 0.422, P < 0.01, moderate quality) preferred extra-short implants. However, there was no significant difference in terms of MBL (from prosthesis restoration) (WMD: 0.016, CI − 0.036 to 0.068, P = 0.555, moderate quality) or prosthesis complications rate (RR: 1.308, CI 0.893 to 1.915, P = 0.168, moderate quality). The placement of extra-short implants could be an acceptable alternative to longer implants in atrophic posterior arch. Further high-quality RCTs with a long follow-up period are required to corroborate the present outcomes.Registration number The review protocol was registered with PROSPERO (CRD42020155342).

Outcome of left atrial appendage occlusion in high-risk patients

Heart ◽  
2017 ◽  
Vol 104 (7) ◽  
pp. 594-599 ◽  
Author(s):  
Ahmed Masoud ◽  
Stefano Bartoletti ◽  
Timothy Fairbairn ◽  
Ayush Khurana ◽  
Periaswamy Velavan ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Adverse Events ◽  
Stroke Prevention ◽  
Left Atrial ◽  
Left Atrial Appendage ◽  
Atrial Appendage ◽  
Complication Rates ◽  
Serious Adverse Events ◽  
Risk Patients

ObjectivePercutaneous left atrial appendage (LAA) occlusion can be an interventional alternative to oral anticoagulation for stroke prevention in patients with atrial fibrillation.MethodsWe delivered LAA occlusion therapy using a standardised approach to patient referral, multidisciplinary team assessment, implant criteria, imaging and follow-up. We analysed patient characteristics, efficacy and safety of the implant procedure, and 12-month outcomes.ResultsOf 143 referrals from October 2014 to December 2016, 83 patients (age 76±8years, 32.5% female, mean CHAD2S2-VASc score 4 ±1) were offered LAA occlusion. Eighty (95.3%) had previous major bleeding (intracranial in 59%). LAA occluder implantation with an Amulet device was successful in 82 (98.8%), with periprocedural major adverse events occurring in 5 (6.0%) patients (2 device embolisations including 1 death, 2 major bleeds). Cardiac imaging in 75 (94%) patients 2months following implant showed device-related thrombus in 1 case (1.3%) and minor (<5mm) device leaks in 13 (17.1%). Over a median 12-month follow-up, 3 (3.8%) ischaemic strokes, 2 (2.5%) haemorrhagic strokes and 5 (6.3%) major extracranial bleeds occurred. All-cause mortality was 10%, with most deaths (7, 87.5%) due to non-cardiovascular causes.ConclusionsLAA occlusion may be a reasonable option for stroke prevention inhigh-risk patients with atrial fibrillation ineligible for anticoagulation. However, procedural complication rates are not insignificant, and patients remain at risk of serious adverse events and death even after successful implant.

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