scholarly journals Primary Outcome Evaluation of a Next Generation Left Atrial Appendage Closure Device: Results from the PINNACLE FLX Trial

Circulation ◽  
2021 ◽  
Author(s):  
Saibal Kar ◽  
Shephal K. Doshi ◽  
Ashish Sadhu ◽  
Rodney Horton ◽  
Jose Osorio ◽  
...  
Keyword(s):  
Cardiac Surgery ◽  
Left Atrial ◽  
Left Atrial Appendage ◽  
Closure Device ◽  
Next Generation ◽  
Safety Endpoint ◽  
The Mean ◽  
Effectiveness Endpoint ◽  
Primary Safety Endpoint ◽  
Laa Closure

Background: Left atrial appendage (LAA) occlusion provides an alternative to oral anticoagulation (OAC) for thromboembolic risk reduction in patients with non-valvular atrial fibrillation (NVAF). Since regulatory approval in 2015, the WATCHMAN device has been the only LAA closure device available for clinical use in the United States. The PINNACLE FLX study evaluated the safety and effectiveness of the next-generation WATCHMAN FLX LAA closure device in patients with NVAF in whom OAC is indicated, but who have an appropriate rationale to seek a non-pharmaceutical alternative. Methods: This was a prospective, non-randomized, multi-center FDA study. The primary safety endpoint was the occurrence of one of the following events within 7 days post-procedure or by hospital discharge, whichever was later: death, ischemic stroke, systemic embolism, or device- or procedure-related events requiring cardiac surgery. The primary effectiveness endpoint was the incidence of effective LAA closure (peri-device flow ≤5mm), as assessed by the echocardiography core laboratory at 12-month follow-up. Results: A total of 400 patients were enrolled. The mean age was 73.8{plus minus}8.6 years and the mean CHA2DS2-VASc score was 4.2{plus minus}1.5. The incidence of the primary safety endpoint was 0.5% with a one-sided 95% upper confidence interval (CI) of 1.6%, meeting the performance goal (PG) of 4.2% (P<0.0001). The incidence of the primary effectiveness endpoint was 100%, with a onesided 95% lower CI of 99.1%, again meeting the PG of 97.0% (P<0.0001). Device-related thrombus was reported in 7 patients, no patients experienced pericardial effusion requiring open cardiac surgery, and there were no device embolizations. Conclusions: LAA closure with this next generation LAA closure device was associated with a low incidence of adverse events and a high incidence of anatomic closure. Clinical Trial Registration: URL https://clinicaltrials.gov Unique Identifier NCT02702271

Image fusion of integrating fluoroscopy into 3D computed tomography in guidance of left atrial appendage closure

2019 ◽  
Vol 22 (1) ◽  
pp. 92-101 ◽  
Author(s):  
Bin-Feng Mo ◽  
Yi Wan ◽  
Abudushalamu Alimu ◽  
Jian Sun ◽  
Peng-Pai Zhang ◽  
...  
Keyword(s):  
Computed Tomography ◽  
Image Fusion ◽  
Left Atrial ◽  
Left Atrial Appendage ◽  
Atrial Appendage ◽  
Control Group ◽  
Closure Device ◽  
Transseptal Puncture ◽  
3D Computed Tomography ◽  
Laa Closure

Abstract Aims  We evaluated the feasibility of left atrial appendage (LAA) closure guided by the image fusion of integrating fluoroscopy into 3D computed tomography (CT). Methods and results  A total of 117 consecutive patients who underwent LAA closure with or without the image fusion were matched (1:2). Each LAA closure step of the Image fusion group was guided by the preprocedure CT and image fusion, especially in the plan of LAA measurement and transseptal puncture. All patients were successfully implanted with a WATCHMAN closure device. Comparing the two groups, the mean number of recapture times and the number of devices per patient of the Image fusion group were significantly lower (0.4 ± 0.5 vs. 0.7 ± 0.8, P = 0.031 and 1.0 ± 0.2 vs. 1.1 ± 0.3, P = 0.027, respectively). The one-time successful deployment rate by the support of the image fusion was higher than in the control group (66.7% vs. 44.9%, P = 0.026). Each case of the Image fusion group was completely occluded with one transseptal puncture, while five of the Non-image fusion group required redo transseptal punctures. During the 45-day follow-up, both group cases presented occlusion efficiency and no major adverse cardiac events were observed. Conclusion  Image fusion technique integrating fluoroscopy into the 3D CT is safe and feasible which can be easily incorporated into the procedural work-flow of percutaneous LAA closure. The fusion image can play an important alternative role in the plan of LAA measurement and transseptal puncture site for improving the LAA closure procedure.

scholarly journals Comparative Safety and Efficacy of Left Atrial Appendage Occlusion with the Watchman Device and Amplatzer Cardiac Plug: Results of the Russian National Registry

2020 ◽  
Vol 2020 ◽  
pp. 1-7
Author(s):  
Karapet Davtyan ◽  
Georgiy Simonyan ◽  
Arpi Topchyan ◽  
Andrey Kalemberg ◽  
Alexander Romanov ◽  
...  
Keyword(s):  
Left Atrial ◽  
Left Atrial Appendage ◽  
Primary Efficacy ◽  
Left Atrial Appendage Occlusion ◽  
Safety Endpoint ◽  
Watchman Device ◽  
Comparative Safety ◽  
Major Adverse Events ◽  
Primary Safety Endpoint

Purpose. This multicenter, prospective registry evaluated the comparative safety and efficacy of left atrial appendage occlusion (LAAO) using the Watchman device (WD) and the Amplatzer Cardiac Plug (ACP) in patients with nonvalvular atrial fibrillation (NVAF) in real-world clinical practice in Russia. Methods. The study included data from 200 consecutive NVAF patients ( 66.8 ± 7.8 years, 44.5% female, median CHA2DS2VASc 4, median HAS-BLED 3) who had undergone LAAO implantation using WD ( n = 108 ) or ACP ( n = 92 ) from September 2015 to December 2017 in 5 medical centers in Russia. The primary safety endpoint was the procedure-related major adverse events, and the primary efficacy endpoint was the composite of thromboembolic events, device thrombosis, hemorrhagic events, and unexplained death during the 12-month follow-up. Results. Successful LAAO was performed in all 92 (100%) patients with ACP and 105 (97.2%) with WD ( p = 0.053 ). At 12 months, primary safety endpoint occurred in 6.5% of patients in the ACP group with no events in the WD group (6.5% vs. 0%, p = 0.008 ). During the 12-month follow-up, the primary efficacy endpoint has occurred in 8.3% of patients in the WD group ( n = 9 ) and 1.1% of patients in the ACP group ( n = 1 ) ( p = 0.016 ). Conclusions. In this multicenter prospective registry, LAA closure with the WD was associated with significantly higher thromboembolic events rate in NVAF patients. Patients, receiving the ACP, had more procedure-related major adverse events. However, further multicenter studies are necessary to evaluate these findings.

scholarly journals “One-stop shop”: Safety and efficacy of combining atrial septal defect occlusion and left atrial appendage closure for patients with atrial septal defect and atrial fibrillation.

2020 ◽  
Author(s):  
zhang zhihui ◽  
yao qing ◽  
Huang haiyun ◽  
zhu ping ◽  
xu xiang ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Atrial Septal Defect ◽  
Left Atrial ◽  
Septal Defect ◽  
Left Atrial Appendage ◽  
Oral Anticoagulants ◽  
Safety And Efficacy ◽  
One Stop ◽  
The Mean ◽  
Laa Closure

Abstract Background: One-stop occlusion, which is defined as the combination of atrial septal defect [ASD] or patent foramen ovale [PFO] occlusion and left atrial appendage [LAA] closure, in patients with ASD/PFO and atrial fibrillation (AF) has not yet been investigated systematically. This study aimed to evaluate the safety and efficacy of one-stop occlusion in the treatment of adult patients with ASD/PFO and AF.Methods: Inpatients with AF and ASD/PFO were recruited between August 2014 and April 2019. Preoperatively, transthoracic echocardiography (TTE) and transesophageal echocardiography (TEE) were conducted to identify the ASD/PFO size and margin, presence of thrombus in the LAA, and LAA orifice width and depth at 0°, 45°, 90°, and 135°. After confirmation of the indications of LAA closure (LAAC) and ASD/PFO occlusion, the procedures were performed simultaneously under general anesthesia. Oral anticoagulants were administered for 45-60 days, followed with regular evaluation of TTE and TEE.Results: Forty-nine patients (age, 65.6±9.6 years) were recruited in this study, including 24 patients with ASD and 25 patients with PFO. They were treated with LAAC and ASD/PFO occlusion successfully. The mean ASD size and mean diameter of the ASD occluders were 14.2±7.7 and 25.4±8.5 mm, respectively. The mean PFO size was 3.5±0.4 mm. The mean maximal LAA orifice width and depth were 20.5±3.4 and 28.3±3.6 mm, respectively. All patients were implanted with a Watchman device (diameter, 27.1±2.9 mm). Postoperatively, all patients took anticoagulants orally for 45-60 days, and their mean postoperative follow-up duration was 29.0±12.1 months. Postoperative TEE showed that all had normal positioning of the LAA and ASD/PFO occluders. At 45-60 days after operation, TEE showed that the LAA and ASD/PFO occluder were in the normal position; however, two patients who took warfarin and novel oral anticoagulants, respectively, have developed occluder thrombosis. After adjusted anticoagulant therapy, TEE showed that the thrombus disappeared at 6 months after operation.Conclusion: One-stop occlusion is safe and effective for the treatment of adult patients with ASD/PFO and AF. It is also feasible to administer warfarin or novel oral anticoagulants after operation.

scholarly journals Left atrial appendage perforation during appendage angiography treated by percutaneous left atrial appendage closure: a case report

2021 ◽  
Vol 5 (5) ◽  
Author(s):  
Catherine Champagne ◽  
Nicolas Dognin ◽  
Josep Rodés-Cabau ◽  
Jean Champagne
Keyword(s):  
Case Report ◽  
Pericardial Effusion ◽  
Left Atrial ◽  
Left Atrial Appendage ◽  
Atrial Appendage ◽  
Closure Device ◽  
Left Atrial Appendage Closure ◽  
Case Summary ◽  
Device Deployment ◽  
Laa Closure

Abstract Background Pericardial effusion is a common complication of percutaneous left atrial appendage (LAA) closure. Acute management is the cornerstone of pericardial effusion treatment and interrupting the intervention is often required. Case summary A 65-year-old man presented an acute 10 mm pericardial effusion following pigtail contrast appendage injection. A rapid Watchman Flex 24 mm (Boston Scientific) deployment permitted bleeding interruption. A needle pericardiocentesis was achieved in order to prevent any haemodynamical instability. Discussion This case report describes an atypical cause of pericardial effusion and a technique for bleeding control with LAA closure device deployment.

scholarly journals “One-stop shop”: Safety and efficacy of combining atrial septal defect occlusion and left atrial appendage closure for patients with atrial septal defect and atrial fibrillation.

2020 ◽  
Author(s):  
zhang zhihui ◽  
yao qing ◽  
Huang haiyun ◽  
zhu ping ◽  
xu xiang ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Atrial Septal Defect ◽  
Left Atrial ◽  
Septal Defect ◽  
Left Atrial Appendage ◽  
Oral Anticoagulants ◽  
Safety And Efficacy ◽  
One Stop ◽  
The Mean ◽  
Laa Closure

Abstract Background: One-stop occlusion (combination of atrial septal defect [ASD] or patent foramen ovale [PFO] occlusion and left atrial appendage [LAA] closure) in patients with ASD/PFO and atrial fibrillation (AF) has not yet been investigated systematically. This study aimed to evaluate the safety and efficacy of one-stop occlusion in the treatment of adult patients with ASD/PFO and AF.Methods: We recruited inpatients with AF and ASD/PFO between August 2014 and April 2019. Preoperatively, they underwent transthoracic echocardiography (TTE) and transesophageal echocardiography (TEE) to determine the ASD/PFO size and margin, presence of thrombus in the LAA, and LAA orifice width and depth at 0°, 45°, 90°, and 135°. After confirmation of the indications of LAA closure (LAAC) and ASD/PFO occlusion, the procedures were performed simultaneously under general anesthesia. Oral anticoagulants were administered for 6 months, and the TTE and TEE were evaluated regularly.Results: Forty-nine patients (age, 65.6±9.6 years) were recruited in this study, including 24 patients with ASD and 25 patients with PFO. They underwent simultaneous LAAC and ASD/PFO occlusion successfully. The mean ASD size and mean diameter of the plug devices for ASD occlusion were 14.2±7.7 and 25.4±8.5 mm, respectively. The mean PFO size was 3.5±0.4 mm. The mean maximal LAA orifice width and depth were 20.5±3.4 and 28.3±3.6 mm, respectively. All patients were implanted with a Watchman device (diameter, 27.1±2.9 mm). Postoperatively, all patients took oral anticoagulants for 6 months, and their mean postoperative follow-up duration was 29.0±12.1 months. Postoperative TEE showed that all had normal positioning of the LAA and ASD/PFO plug devices. At 45-60 days after operation, TEE showed that the LAA and ASD/PFO occluder were in the normal position; however, two patients developed occluder thrombosis (warfarin and novel oral anticoagulants were used, respectively). The anticoagulant therapy was adjusted, and TEE showed that the thrombus disappeared at 6 months after operation.Conclusion: One-stop occlusion is safe and effective for the treatment of adult patients with ASD/PFO and AF. It is also feasible to administer warfarin or novel oral anticoagulants after operation.

scholarly journals Late left atrial appendage closure device displacement and massive thrombus formation: a case report

2020 ◽  
Vol 4 (2) ◽  
pp. 1-5 ◽  
Author(s):  
Benjamin Sasko ◽  
Oliver Ritter ◽  
Peter Bramlage ◽  
Fabian Riediger
Keyword(s):  
Left Atrial ◽  
Left Atrial Appendage ◽  
Thrombus Formation ◽  
Anticoagulation Therapy ◽  
Bleeding Risk ◽  
Atrial Appendage ◽  
Closure Device ◽  
Watchman Device ◽  
High Bleeding Risk ◽  
Laa Closure

Abstract Background  Left atrial appendage (LAA) closure with the WATCHMAN device is an alternative to anticoagulation therapy for the prevention of stroke in selected patients with atrial fibrillation (AF). Infrequently, left atrial (LA) device-related thrombus formation occurs and it is poorly understood. Thrombus formation due to incomplete covering of the LAA is even rarer and may occur within the first few months after device implantation. Case summary  Here, we present a case of a 68-year-old male patient with permanent AF, drug- and hepatitis induced liver cirrhosis (CILD Score B), and prior aortic valve replacement. The patient had a history of percutaneous LAA closure using a WATCHMAN device. He developed massive peri-device leak and thrombus arising from the space between the device and appendage cleft 2 years after implantation. Because of the high bleeding risk with a HAS-BLED score of 5 points, surgery was chosen as the therapy of choice instead of long-term anticoagulation. The patient was discharged in good clinical condition and has been scheduled for a yearly follow-up. Discussion  This case emphasizes the importance of choosing appropriately sized LAA occluder devices and planning for regular post-interventional follow-ups to minimize the risk of per-device leaks and thrombi.

scholarly journals “One-stop shop”: Safety and efficacy of combining atrial septal defect occlusion and left atrial appendage closure for patients with atrial septal defect and atrial fibrillation.

2020 ◽  
Author(s):  
zhang zhihui ◽  
yao qing ◽  
Huang haiyun ◽  
zhu ping ◽  
xu xiang ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Atrial Septal Defect ◽  
Left Atrial ◽  
Septal Defect ◽  
Left Atrial Appendage ◽  
Oral Anticoagulants ◽  
Safety And Efficacy ◽  
One Stop ◽  
The Mean ◽  
Laa Closure

Abstract Background: One-stop occlusion, which is defined as the combination of atrial septal defect [ASD] or patent foramen ovale [PFO] occlusion and left atrial appendage [LAA] closure, in patients with ASD/PFO and atrial fibrillation (AF) has not yet been investigated systematically. This study aimed to evaluate the safety and efficacy of one-stop occlusion in the treatment of adult patients with ASD/PFO and AF.Methods: Inpatients with AF and ASD/PFO were recruited between August 2014 and April 2019. Preoperatively, transthoracic echocardiography (TTE) and transesophageal echocardiography (TEE) were conducted to identify the ASD/PFO size and margin, presence of thrombus in the LAA, and LAA orifice width and depth at 0°, 45°, 90°, and 135°. After confirmation of the indications of LAA closure (LAAC) and ASD/PFO occlusion, the procedures were performed simultaneously under general anesthesia. Oral anticoagulants were administered for 45-60 days, followed with regular evaluation of TTE and TEE.Results: Forty-nine patients (age, 65.6±9.6 years) were recruited in this study, including 24 patients with ASD and 25 patients with PFO. They were treated with LAAC and ASD/PFO occlusion successfully. The mean ASD size and mean diameter of the ASD occluders were 14.2±7.7 and 25.4±8.5 mm, respectively. The mean PFO size was 3.5±0.4 mm. The mean maximal LAA orifice width and depth were 20.5±3.4 and 28.3±3.6 mm, respectively. All patients were implanted with a Watchman device (diameter, 27.1±2.9 mm). Postoperatively, all patients took anticoagulants orally for 45-60 days, and their mean postoperative follow-up duration was 29.0±12.1 months. Postoperative TEE showed that all had normal positioning of the LAA and ASD/PFO occluders. At 45-60 days after operation, TEE showed that the LAA and ASD/PFO occluder were in the normal position; however, two patients who took warfarin and novel oral anticoagulants, respectively, have developed occluder thrombosis. After adjusted anticoagulant therapy, TEE showed that the thrombus disappeared at 6 months after operation.Conclusion: One-stop occlusion is safe and effective for the treatment of adult patients with ASD/PFO and AF. It is also feasible to administer warfarin or novel oral anticoagulants after operation.

scholarly journals “One-stop shop”: safety and efficacy of combining atrial septal defect occlusion and left atrial appendage closure for patients with atrial septal defect and atrial fibrillation

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Zhi-hui Zhang ◽  
Qing Yao ◽  
Hai-yun Huang ◽  
Ping Zhu ◽  
Xiang Xu ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Atrial Septal Defect ◽  
Left Atrial ◽  
Septal Defect ◽  
Left Atrial Appendage ◽  
Oral Anticoagulants ◽  
Safety And Efficacy ◽  
One Stop ◽  
The Mean ◽  
Laa Closure

Abstract Background One-stop occlusion, which is defined as the combination of atrial septal defect [ASD] or patent foramen ovale [PFO] occlusion and left atrial appendage [LAA] closure, in patients with ASD/PFO and atrial fibrillation (AF) has not yet been investigated systematically. This study aimed to evaluate the safety and efficacy of one-stop occlusion in the treatment of adult patients with ASD/PFO and AF. Methods Inpatients with AF and ASD/PFO were recruited between August 2014 and April 2019. Preoperatively, transthoracic echocardiography (TTE) and transesophageal echocardiography (TEE) were conducted to identify the ASD/PFO size and margin, presence of thrombus in the LAA, and LAA orifice width and depth at 0°, 45°, 90°, and 135°. After confirmation of the indications of LAA closure (LAAC) and ASD/PFO occlusion, the procedures were performed simultaneously under general anesthesia. Oral anticoagulants were administered for 45–60 days, followed with regular evaluation of TTE and TEE. Results Forty-nine patients (age, 65.6 ± 9.6 years) were recruited in this study, including 24 patients with ASD and 25 patients with PFO. They were treated with LAAC and ASD/PFO occlusion successfully. The mean ASD size and mean diameter of the ASD occluders were 14.2 ± 7.7 and 25.4 ± 8.5 mm, respectively. The mean PFO size was 3.5 ± 0.4 mm. The mean maximal LAA orifice width and depth were 20.5 ± 3.4 and 28.3 ± 3.6 mm, respectively. All patients were implanted with a Watchman device (diameter, 27.1 ± 2.9 mm). Postoperatively, all patients took anticoagulants orally for 45–60 days, and their mean postoperative follow-up duration was 29.0 ± 12.1 months. Postoperative TEE showed that all had normal positioning of the LAA and ASD/PFO occluders. At 45–60 days after operation, TEE showed that the LAA and ASD/PFO occluder were in the normal position; however, two patients who took warfarin and novel oral anticoagulants, respectively, have developed occluder thrombosis. After adjusted anticoagulant therapy, TEE showed that the thrombus disappeared at 6 months after operation. Conclusion One-stop occlusion is safe and effective for the treatment of adult patients with ASD/PFO and AF. It is also feasible to administer warfarin or novel oral anticoagulants after operation.

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