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Strategies for Recovering an Embolized Percutaneous Device

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Thomas Nestelberger
Thomas Nestelberger
Thomas Nestelberger
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Mesfer Alfadhel
Mesfer Alfadhel
Mesfer Alfadhel
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Cameron McAlister at Canterbury District Health Board
Cameron McAlister
Rohit Samuel at Vancouver General Hospital
Rohit Samuel
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Abstract and Figures

Purpose of Review Device embolization is a rare but potentially life-threatening complication of transcatheter structural heart interventions and may require prompt intervention. The present work aims to provide an overview of strategies for device retrievals in order to better guide the evaluation and management of device embolization. Recent Findings Although the evolution of transcatheter device therapies has had a tremendous impact on the management in structural heart disease, availability of various retrieval devices, knowledge in how to use them, and multidisciplinary collaboration are key for successful device retrieval. Summary Understanding the reasons for embolization, strategies to avoid embolization, and the techniques for retrieval of devices used in structural heart disease should be appreciated by the treating physician.
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STRUCTURAL HEART DISEASE (RJ SIEGEL AND NC WUNDERLICH, SECTION EDITORS)
Strategies for Recovering an Embolized Percutaneous Device
Thomas Nestelberger
1,2
&Mesfer Alfadhel
1
&Cameron McAlister
1
&Rohit Samuel
1
&Jacqueline Saw
1
Accepted: 17 March 2021
#The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature 2021
Abstract
Purpose of Review Device embolization is a rare but potentially life-threatening complication of transcatheter structural heart
interventions and may require prompt intervention. The present work aims to provide an overview of strategies for device
retrievals in order to better guide the evaluation and management of device embolization.
Recent Findings Although the evolution of transcatheter device therapies has had a tremendous impact on the management in
structural heart disease, availability of various retrieval devices, knowledge in how to use them, and multidisciplinary collabo-
ration are key for successful device retrieval.
Summary Understanding the reasons for embolization, strategies to avoid embolization, and the techniques for retrieval of
devices used in structural heart disease should be appreciated by the treating physician.
Keywords Structural heart disease .Transcatheter interventions .Device retrieval
Introduction
Device embolization (DE) is an uncommon, but a potential
life-threatening complication of transcatheter structural heart
disease (SHD) interventions. Clinical manifestations of DE
range from massive hemodynamic impairment immediately
after embolization to an incidental finding on cardiac or body
imaging [1,2]. In many cases, an embolization iscaused by an
under sizing or suboptimal deployment of the device, but they
may also occur despite accurate preparation/planning and ex-
ecution of the procedure [1,3]. Management strategies of DE
depend on the type, the size, and the location of the embolized
device, the timing of diagnosis, and the clinical status of the
patient [4••,5•]. Knowledge and some kind of experience with
the available tools and understanding of the role and limita-
tions of percutaneous retrieval techniques are paramount for
successful management of DE [4••]. This review focus on the
mechanisms and strategies to manage DE in patients under-
going three common SHD interventions: transcatheter aortic
valve replacement, (TAVR), left atrial appendage closure;
(LAAC) and atrial septal defect/patent foramen ovale (ASD/
PFO) closure.
Incidence of Device Embolization
TAVR
The true incidence of DE is difficult to assess due to
underreporting [4••]. Nevertheless, important insights are pro-
vided in randomized trials and large registries. Most DEs of
transcatheter heart valves are reported with TAVR proce-
dures. Early large randomized trials such as the PARTNER
trial using a balloon expandable valve (Sapien valve, Edwards
Lifesciences, Irvine, California, USA) reported DEs in 26 of
This article is part of the Topical Collection on Structural Heart Disease
*Jacqueline Saw
jsaw@mail.ubc.ca
Thomas Nestelberger
thomas.nestelberger@usb.ch
Mesfer Alfadhel
mesfer_nz@hotmail.com
Cameron McAlister
cameron.mcalister@gmail.com
Rohit Samuel
rsamuel23@gmail.com
1
Division of Cardiology, Vancouver General Hospital, University of
British Columbia, 2775 Laurel Street, 9th Floor, Vancouver, British
Columbia V5Z 1M9, Canada
2
Cardiovascular Research Institute Basel (CRIB) and Department of
Cardiology, University Hospital Basel, University of Basel,
Basel, Switzerland
https://doi.org/10.1007/s11886-021-01554-8
/ Published online: 16 July 2021
Current Cardiology Reports (2021) 23: 123
Content courtesy of Springer Nature, terms of use apply. Rights reserved.
ResearchGate has not been able to resolve any citations for this publication.
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  • Jan 2021
Transcatheter aortic valve replacement is currently used off-label for noncalcified aortic valve regurgitation and therefore is restricted to selected cases. In this setting we describe a rare complication of Sapien 3 (Edwards Lifesciences, Irvine, California) embolization from the left ventricle to the descending aorta. Given their technical challenges, such procedures require specific considerations and management. (Level of Difficulty: Advanced.)
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Incidence and outcome of peri-procedural transcatheter heart valve embolization and migration: the TRAVEL registry (TranscatheteR HeArt Valve EmboLization and Migration)
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  • Jun 2019
  • EUR HEART J
Aims: Peri-procedural transcatheter valve embolization and migration (TVEM) is a rare but potentially devastating complication of transcatheter aortic valve implantation (TAVI). We sought to assess the incidence, causes, and outcome of TVEM in a large multicentre cohort. Methods and results: We recorded cases of peri-procedural TVEM in patients undergoing TAVI between January 2010 and December 2017 from 26 international sites. Peri-procedural TVEM occurred in 273/29 636 (0.92%) TAVI cases (age 80.8 ± 7.3 years; 53.8% female), of which 217 were to the ascending aorta and 56 to the left ventricle. The use of self-expanding or first-generation prostheses and presence of a bicuspid aortic valve were independent predictors of TVEM. Bail-out measures included repositioning attempts using snares or miscellaneous tools (41.0%), multiple valve implantations (83.2%), and conversion to surgery (19.0%). Using 1:4-propensity matching, we identified a cohort of 235 patients with TVEM (TVEMPS) and 932 patients without TVEM (non-TVEMPS). In the matched cohort, all-cause mortality was higher in TVEMPS than in non-TVEMPS at 30 days (18.6% vs. 4.9%; P < 0.001) and after 1 year (30.5% vs. 16.6%; P < 0.001). Major stroke was more frequent in TVEMPS at 30 days (10.6% vs. 2.8%; P < 0.001), but not at 1 year (4.6% vs. 1.9%; P = 0.17). The need for emergent cardiopulmonary support, major stroke at 30 days, and acute kidney injury Stages 2 and 3 increased the risk of 1-year mortality, whereas a better renal function at baseline was protective. Conclusion: Transcatheter valve embolization and migration occurred in approximately 1% and was associated with increased morbidity and mortality.
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Procedural and Short-Term Results With the New Watchman FLX Left Atrial Appendage Occlusion Device
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  • Dec 2020
Objectives This study sought to report early experience with the new-generation Watchman FLX device (Boston Scientific, Marlborough, Massachusetts). Background The new-generation Watchman FLX features a reduced height, improved anchoring and fabric coverage, and a closed distal end. These design modifications aim to simplify implantation, allow full recapture and repositioning, and reduce peridevice leak and device-related thrombosis. Methods A total of 165 patients undergoing left atrial appendage (LAA) occlusion (LAAO) with Watchman FLX were enrolled in a prospective, multicenter registry at 12 centers participating in the European limited market release program. Results Mean age was 75.4 ± 8.9 years, and CHA2DS2-VASc score 4.4 ± 1.4. A total of 128 patients (77.6%) had a history of major bleeding, including previous intracranial hemorrhage in 55 cases (33.3%). LAA landing zone minimal and maximal mean diameters were 19.1 ± 3.6 mm and 22.3 ± 3.7 mm, and 24.2% of LAA were considered complex by dimensions. Technical success was achieved in all patients. Successful implantation at first attempt was achieved in 129 cases (78.2%), and a second device was required in 6 cases (3.6%). Procedure-related complications occurred in 3 patients (1.8%): 2 access-related (1.2%) and 1 pericardial effusion (0.6%). No peri-procedural strokes, deaths, or device embolizations occurred. Forty-nine patients (29.7%) were discharged with single antiplatelet therapy, 105 (63.6%) on dual antiplatelet, and 11 (6.7%) on anticoagulation. Imaging follow-up displayed just 1 peridevice leak ≥5 mm and 7 cases of device-related thrombosis (4.7%). During a median follow-up of 55 days (interquartile range: 45 to 148 days), there were 6 hemorrhagic complications (4.8%), 1 patient (0.8%) had an ischemic stroke, and 1 (0.8%) died. No late device embolizations occurred. Conclusions LAAO with the Watchman FLX is safe and effective in a wide range of LAA morphologies, with a low procedural complication rate, high degree of LAA sealing, and favorable short-term efficacy.
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The Watchman FLX Device
Article
  • Aug 2020
Objectives The aim of this study was to investigate the procedural efficacy and safety of the novel Watchman FLX (Boston Scientific, Marlborough, Massachusetts) device for left atrial appendage occlusion (LAAO) and to assess the feasibility of intracardiac echocardiography (ICE) to guide implantation. Background The Watchman FLX device for transcatheter LAAO was introduced for a simplified implantation in a wider range of LAA anatomies. Methods This single-center study included consecutive patients undergoing LAAO with the Watchman FLX between March 2019 and January 2020 (N = 91). Patients underwent cardiac computed tomography (CT) imaging for pre-procedural planning. Initial procedures were guided by transesophageal echocardiography (TEE; n = 8) and thereafter by ICE (n = 83) from the left atrium. TEE and cardiac CT imaging were performed at 8 weeks’ follow-up. Results Technical success was achieved in 90 (99%) patients, with the first device implanted in 86 (96%) procedures. Procedural success was 93.4%. Peri-procedural complications occurred in 5 (5.5%), with pericardial effusion being the most common (2.2%). Only 3.3% had a peri-device leak on TEE follow-up. No device-related thrombosis occurred. The mean device compression rate at end of procedure was 18.3 ± 7.7%, compared with 12.2 ± 7.8% by TEE at 8 weeks’ follow-up (p < 0.001) and 5.8 ± 8.8% by cardiac CT imaging at follow-up (p < 0.001). Conclusions The Watchman FLX device was suitable for closure of a wide range of LAA anatomies, including shallow appendages. The follow-up closure rate was higher than previously reported with other devices. ICE from the left atrium was used, with high procedural success and a low complication rate, comparable to previous studies on LAAO.
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The NCDR Left Atrial Appendage Occlusion Registry
Article
  • Mar 2020
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Background Left atrial appendage occlusion (LAAO) to prevent stroke in patients with atrial fibrillation has been evaluated in 2 randomized trials; post-approval clinical data are limited. Objectives The purpose of this study was to describe the National Cardiovascular Data Registry (NCDR) LAAO Registry and present patient, hospital, and physician characteristics and in-hospital adverse event rates for Watchman procedures in the United States during its first 3 years. Methods The authors describe the LAAO Registry structure and governance, the outcome adjudication processes, and the data quality and collection processes. They characterize the patient population, performing hospitals, and in-hospital adverse event rates. Results A total of 38,158 procedures from 495 hospitals performed by 1,318 physicians in the United States were included between January 2016 and December 2018. The mean patient age was 76.1 ± 8.1 years, the mean CHA2DS2-VASc (congestive heart failure, hypertension, 65 years of age and older, diabetes mellitus, previous stroke or transient ischemic attack, vascular disease, female) score was 4.6 ± 1.5, and the mean HAS-BLED (hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly, drugs/alcohol concomitantly) score was 3.0 ± 1.1. The median annual number of LAAO procedures performed for hospitals was 30 (interquartile range: 4 to 56) and for physicians was 12 (interquartile range: 0 to 14). Procedures were canceled or aborted in 7% of cases; among cases in which a device was deployed, 98.1% were implanted with <5-mm leak. Major in-hospital adverse events occurred in 2.16% of patients; the most common complications were pericardial effusion requiring intervention (1.39%) and major bleeding (1.25%), whereas stroke (0.17%) and death (0.19%) were rare. Conclusions The LAAO Registry has enrolled >38,000 patients implanted with the device. Patients were generally older with more comorbidities than those enrolled in the pivotal trials; however, major in-hospital adverse event rates were lower than reported in those trials.
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Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients
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Device Embolization in Structural Heart Interventions
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Device embolization is a rare complication of transcatheter structural heart interventions. Although the majority of device embolizations can be treated in a semielective manner, some are life threatening and require prompt intervention. Awareness of this potential complication, and knowledge of retrieval tools and techniques are essential to the structural interventionalist. This paper offers a succinct review of the incidence, and outcomes of device embolization during common structural heart interventions. It also provides an overview of the essential component of the “percutaneous retrieval toolbox” and suggests a systematic algorithmic approach for the management of device embolization.
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Endovascular Retrieval of an Embolized Atrial Septal Occluder Device From the Abdominal Aorta
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  • Jul 2018
Patent foramen ovale (PFO) is a common heart condition in adults. Closure with a septal occluder device is a safe, well-established treatment option with excellent clinical outcomes. One rare complication of percutaneous PFO closure is embolization of the device to the heart chambers or distal vasculature. Most device migrations are recognized during or shortly after implantation. While many endovascular retrievals of migrated devices are successful, there are still a high percentage of surgical interventions performed. We report a case of a septal occluder device that embolized to the abdominal aorta and was discovered 7 days after implantation. Endovascular techniques with a snare and endobronchial forceps were used to retrieve the device safely.
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