Short‐term safety and efficacy of left atrial appendage closure with the WATCHMAN device in patients with small left atrial appendage ostia

Venkataraman, Ganesh; Strickberger, S. Adam; Doshi, Shephal K.; Ellis, Christopher R.; Lakkireddy, Dhanunjaya; Whalen, S. Patrick; Cuoco, Frank

doi:10.1111/jce.13333

Cited by 9 publications

(10 citation statements)

References 9 publications

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“…29 The only published study concerning LAAC in patients with a small LAA only had shortterm follow-up results. 9 In our study, the annual stroke risk in the small LAA group was slightly higher than that in the indicated LAA group (1.1/100 person-years vs. 0.3/100 person-years) but comparable to prior investigations. Therefore, LAAC with the Watchman device for stroke prevention in patients with a small LAA orifice may be efficient.…”

Section: Safety and Efficacy Of Laac In Patients With Small Laasupporting

confidence: 90%

“…No pericardial effusion, device embolization, or stroke/TIA occurred periprocedurally in the study of Venkataraman et al 9 and the present investigation. In the EWOLUTION study, the device oversizing percentage was over 30% in nearly 1/3 patients, indicating that overcompression rate of over 20% was not uncommon in clinical practice.…”

Section: Safety and Efficacy Of Laac In Patients With Small Laasupporting

confidence: 49%

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Long‐term safety and efficacy of left atrial appendage closure in patients with small appendage orifices measured with transesophageal echocardiography

Wang

et al. 2022

Clinical Cardiology

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Background The Watchman device is the most widely used occluder but is indicated in atrial fibrillation (AF) patients with a maximal left atrial appendage (LAA) orifice diameter between 17 and 31 mm. We aimed to compare the long‐term safety and efficacy of left atrial appendage closure (LAAC) between patients with a small LAA (<17 mm) and those with an indicated LAA (17–31 mm) measured by transesophageal echocardiography (TEE). Methods A total of 369 AF patients treated with LAAC between March 2015 and February 2019 were included and divided into two groups based on the maximal LAA orifice diameter measured by TEE: small LAA group (n = 22) and indicated LAA group (n = 347). Periprocedural complications and long‐term clinical outcomes were compared. Results The Watchman device was successfully implanted in all patients. Mean device compression was higher in the small LAA group. Four patients (1.2%) in the indicated LAA group experienced pericardial effusion, and none experienced pericardial effusion in the small LAA group. Device‐related thrombus was detected in one (4.5%) patient in the small LAA group and five (1.4%) in the indicated LAA group (p = .310). After a mean follow‐up period of 4.1 ± 1.6 years, one patient in the small LAA group (4.5%; 1.1/100 person‐years) and four in the indicated LAA group (1.2%; 0.3/100 person‐years) suffered an ischemic stroke (p = .266). Conclusions The safety and efficacy of LAAC with the Watchman device were comparable between patients with small and indicated LAA orifice diameters measured by TEE.

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Section: Safety and Efficacy Of Laac In Patients With Small Laasupporting

confidence: 90%

Section: Safety and Efficacy Of Laac In Patients With Small Laasupporting

confidence: 49%

Long‐term safety and efficacy of left atrial appendage closure in patients with small appendage orifices measured with transesophageal echocardiography

Wang

et al. 2022

Clinical Cardiology

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“…9 Small case series and cohort studies support the feasibility of using Watchman 2.5 for very small ostia ,17 mm or in failed surgical LAA ligation with narrow necks, whereas cases with ostia .31 mm would be at high risk for device embolization. 10,11 Anterior chicken wing anatomy often poses an anatomic challenge to LAAC regardless of width with an increased risk of pericardial effusion and cardiac perforation. 12 The Watchman FLX device is a self-expanding nitinol frame with a permeable polyester fabric covering the atrial facing surface and 18 peripheral fixation anchors in 2 layers designed to improve stability and reduce embolization risk in comparison to the Watchman 2.5 device.…”

Section: Introductionmentioning

confidence: 99%

Left atrial appendage closure in patients with prohibitive anatomy: Insights from PINNACLE FLX

et al. 2021

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BACKGROUND Watchman 2.5 (Boston Scientific Inc, Marlborough, MA) implant success approaches 95% in registries, yet many patients are not attempted because of complex left atrial appendage (LAA) anatomy. Watchman FLX can expand the range of ostium width (14-31.5 mm) and depth available for LAA closure.OBJECTIVE The purpose of this study was to evaluate the safety and efficacy of Watchman FLX in patients with a failed Watchman 2.5 attempt or prohibitive LAA anatomy.METHODS The roll-in (n 5 58) and primary effectiveness (n 5 400) cohorts of the PINNACLE FLX trial comprised the study population. Subjects were identified who previously failed implantation of Watchman 2.5 (n 5 11) or were not attempted because of prohibitive LAA anatomy (n 5 88). Demographic characteristics, implant procedure details, and TEE follow-up data were compared to controls composed of enrollees not meeting these criteria (n 5 359).RESULTS Watchman FLX LAA closure was successfully implanted in all subjects with a prior failed Watchman 2.5 attempt (n 5 11 of 11). Subjects with previously failed Watchman 2.5 were more likely to receive a 35 mm FLX device than controls (27.3% vs 7.3%; P 5 .047). Patients with prohibitive anatomy had smaller LAA dimensions than did controls (diameter 18.0 6 4 mm vs 20.4 6 3 mm; P , .001 and length 23.7 6 5 mm vs 28.9 6 5 mm; P , .001). There was no difference in age, sex, CHA 2 DS 2 -VASc score, HAS-BLED score, or primary efficacy between cohorts. Transesophageal echocardiography (TEE) at 12 months showed zero leak in 90.9% in the failed Watchman 2.5 cohort, 91.3% in the prohibitive anatomy cohort, and 89.5% in the control cohort (P 5 .84). Overall and cardiovascular mortality was lower in the prohibitive anatomy cohort (1.2% vs 8.8% in controls; P 5 .02).CONCLUSION Watchman FLX implantation in patients with a prior failed Watchman 2.5 attempt or prohibitive LAA anatomy remained safe and highly effective. The association of reduced overall mortality with smaller LAA dimension warrants future study.

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“…A recent study showed that LAA ostia smaller than those specified in the directions for use (o17 mm) for WATCHMANt (Boston Scientific, Inc., Natick, MA, USA) can be closed effectively, though caution is advised in these cases to ensure good compression, and abstaining from undersizing a smaller device to avoid embolization is suggested. 9 In our experience with LAA ostia measuring closer to 31 mm, closure can still be accomplished if at least two implant angles on TEE are o28 mm, and 8% to 10% compression is clearly seen with a stable tug test on a 33-mm WATCHMANt (Boston Scientific, Inc., Natick, MA, USA) device. We make an extra effort to avoid any TEE or contrast leak at implant, with the ultimate goal of obliteration of any trabeculated portion of the LAA.…”

Section: Eyeing the Futurementioning

confidence: 99%

Left Atrial Appendage Closure to Prevent Strokes and Ligation to Prevent Atrial Fibrillation

Ellis

2017

J Innov Cardiac Rhythm Manage

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Short‐term safety and efficacy of left atrial appendage closure with the WATCHMAN device in patients with small left atrial appendage ostia

Abstract: LAA closure with the WATCHMAN device can be successfully and safely achieved in patients with a maximal LAA ostial width < 17 mm.

Cited by 9 publications

References 9 publications

Long‐term safety and efficacy of left atrial appendage closure in patients with small appendage orifices measured with transesophageal echocardiography

Long‐term safety and efficacy of left atrial appendage closure in patients with small appendage orifices measured with transesophageal echocardiography

Left atrial appendage closure in patients with prohibitive anatomy: Insights from PINNACLE FLX

Left Atrial Appendage Closure to Prevent Strokes and Ligation to Prevent Atrial Fibrillation

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