Early Canadian Multicenter Experience With WATCHMAN for Percutaneous Left Atrial Appendage Closure

Saw, Jacqueline; Fahmy, Peter; Azzalini, Lorenzo; Marquis, Jean-François; Hibbert, Benjamin; Morillo, Carlos A.; Carrizo, Aldo; Ibrahim, Réda

doi:10.1111/jce.13168

Cited by 26 publications

(33 citation statements)

References 17 publications

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“…Many authors indicated that patient eligibility was dependent upon the clinical indication ( Amat-Santos et al 2015 ; Basmadjian et al 2016 ; Campelo-Parada et al 2016 ; Chu et al 2016 ; de Varennes et al 2016 ; Gonzalez-Barlatay et al 2017 ; Peters 2002 ; Rodés-Cabau et al 2010; Sapp et al 2013 ; Saw et al 2015 , 2017 ; Webb et al 2006 ). Peters (2002) explained that MDSAP “provides approval for the use of silicone gel implants for the following patients: mastectomy, augmentation after failed saline implants (usually with ripples and folds) and primary augmentation if a saline failure is strongly predicted.…”

Section: Resultsmentioning

confidence: 99%

“…The MDSAP approves the use of unlicensed alternatives to licensed medical devices when they are perceived to be clinically superior ( Almashham et al 2008 ; Abraham et al 2012 ; Bagur et al 2016 ; Campelo-Parada et al 2016 ; Humpl et al 2010 ; Nietlispach et al 2010 ; Raymond et al 2001 ; Regueiro et al 2017 ; Ricci et al 2017 ; Saw et al 2017 ). Peters' (2002) review of breast implants noted the availability of two types of implants: saline-filled (comprising 95% of implants), which were licensed, and gel-filled (5%), which, at the time, were unlicensed.…”

Section: Resultsmentioning

confidence: 99%

“…Several papers discussed technical feasibility, safety, procedural success rate, efficacy or short-term patient outcomes, all key information elements for technology uptake and diffusion (e.g., Chu et al 2017 ; Helton et al [2011] and Purdham et al [2012] on cardiac valves; de Hemptinne et al 2017 ; Saw et al 2017 ). Health Canada has acknowledged the importance of publishing studies that report on such elements to communicate findings to the relevant clinical community ( Health Canada 2016 ).…”

Section: Resultsmentioning

confidence: 99%

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The Medical Devices Special Access Program in Canada: A Scoping Study

Maier

Menon

Stafinski

2018

hcpol

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New health technologies enter Canadian healthcare organizations in various ways, and understanding them is essential to the development of a pan-Canadian Health Technology Management (HTM) Strategy, now a priority of governments across Canada. One way is through Health Canada's Medical Devices Special Access Program (MDSAP), which permits unlicensed devices to be obtained by healthcare professionals. However, the circumstances around and implications of the current use of this program are not clear. A scoping literature review was conducted to clarify these and identify important roles and issues related to the MDSAP. Limited information was found on the MDSAP. Nevertheless, three themes demonstrating the roles of the MDSAP in HTM emerged: arbiter in technology selection, a route to technology procurement and facilitator of health technology innovation. No information suggesting that MDSAP is used to circumvent licensing was found. Rather, it enables desired patient outcomes and product commercialization.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

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The Medical Devices Special Access Program in Canada: A Scoping Study

Maier

Menon

Stafinski

2018

hcpol

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“…It is well known that the implant success rate improves significantly as operator experience increases and techniques improve. This rate increased from 88% in the Watchman Left Atrial Appendage System for Embolic Protection in Patients with Atrial Fibrillation PROTECT AF) trial (11) to 95% in the Prospective Randomized Evaluation of the Watchman Left Atrial Appendage Closure Device in Patients with Atrial Fibrillation in Patients With Atrial Fibrillation Versus Long-Tern Warfarin Therapy (PREVAIL) trial (10), 97.2% in the Canadian experience (14), and then improved to 98.5% in the Registry to Evaluate Real-Word Clinical Outcomes in Patients With Atrial Fibrillation and High Stroke Risk-Treated With the Watchman Left Atrial Appendage Closure Technology (EWOLUTION) (15). Overall, successful implant placement is achieved in 88%–98.5% of cases.…”

Section: Discussionmentioning

confidence: 99%

Experience of left atrial appendage occlusion with the WATCHMAN device in Chinese patients

Zhai

Tang

et al. 2019

Anatol J Cardiol

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Experience of left atrial appendage occlusion with the WATCHMAN device in Chinese patients Objective: Little is known about left atrial appendage occlusion (LAAO) with WATCHMAN device in patients with atrial fibrillation (AF) in China. The aim of the present study was to evaluate the acute procedural performance and complication rate of LAAO procedures and patient selection in China. Methods: A total of 658 consecutive Chinese patients who were referred to receive LAAO procedures with the WATCHMAN device between 2014 and 2017 were retrospectively included in the study. Patients were divided into four groups according to the year of procedures: Group 2014, Group 2015, Group 2016, and Group 2017. The procedural success, complication rates, and characteristics of Chinese patients, as well as the trends of patients' selection and management, were analyzed. Results: The average age of the patients was 67.7±9.2 years, the CHA 2 DS 2-VASc score was 3.7±1.6, and the HAS-BLED score was 2.5±1.1. Both scores of patients in different years show obvious increasing trends (r=0.126, p=0.001 and r=0.145, p<0.001, respectively). Indications for LAAO included increased bleeding risk (45.6%), recent bleeding under oral anticoagulation (OAC) (9.0%), and non-compliance with OAC (51.4%). The implantation was successful in 643 (97.7%) patients, with a procedural complication rate of 0.6%. Approximately 80.1% of the patients received OAC after LAAO. Conclusion: In China, LAAO with WATCHMAN devices in patients with AF can be performed successfully with a low complication rate. Most of the target population had increased bleeding risk or non-compliance for OAC as indications and received OAC for antithrombotic therapy after the procedure.

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“…The Canadian multicenter experience with Watchman for percutaneous LAAC conducted by Saw et al reported pooled consecutive series of patients who underwent Watchman LAAC at four major Canadian centers. In this study, 20) they included 106 patients who had the Watchman implant starting from May 2013 up to October 2015. The primary objective of the study was to evaluate the safety and efficacy of the Watchman device.…”

Section: Trials and Studies Looking At Efficacy And Safety Of Watchmamentioning

confidence: 99%

The Efficacy and Safety of the WATCHMAN Device in LAA Occlusion in Patients with Non-Valvular Atrial Fibrillation Contraindicated to Oral Anticoagulation: A Focused Review

Majule

Chang

Rutahoile

et al. 2018

ATCS

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The standard treatment for stroke risk patients with non-valvular atrial fibrillation (NVAF) is the use of oral anticoagulants (OACs). However, a substantial number of patients have relative or absolute contraindications to OACs due to concerns of major bleeding risk and other adverse effects while using oral anticoagulation therapy. Recently, occurrences of exclusion of the left atrial appendage (LAA) in patients with contraindication to anticoagulation therapy are widely expanding worldwide, causing major contentious discussions. The LAA is the commonest place of thrombus formation; therefore, the concept of LAA occlusion in reducing stroke and other embolic events in NVAF patients is very important. The current understanding of the available evidence on efficacy and safety of LAA closure (LAAC) with the Watchman device in patients contraindicated to OACs is the major aim of this focused review. After reviewing a significant body of literature, a world experience with no randomized trials, it is suggested that Watchman device implantation is effective and safe in high-risk patients with NVAF contraindicated to OACs therapy.

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Early Canadian Multicenter Experience With WATCHMAN for Percutaneous Left Atrial Appendage Closure

Abstract: In our early Canadian experience, WATCHMAN for LAA closure in patients contraindicated to anticoagulation appeared safe and effective.

Cited by 26 publications

References 17 publications

The Medical Devices Special Access Program in Canada: A Scoping Study

The Medical Devices Special Access Program in Canada: A Scoping Study

Experience of left atrial appendage occlusion with the WATCHMAN device in Chinese patients

The Efficacy and Safety of the WATCHMAN Device in LAA Occlusion in Patients with Non-Valvular Atrial Fibrillation Contraindicated to Oral Anticoagulation: A Focused Review

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