Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic Severe Bicuspid Aortic Valve Stenosis

Waksman, Ron; Craig, Paige; Torguson, Rebecca; Asch, Federico M.; Weissman, Gaby; Ruiz, Daniel; Gordon, Paul; Ehsan, Afshin; Parikh, Puja B.; Bilfinger, Thomas V.; Levitt, Robert G.; Hahn, C; Roberts, David H.; Ingram, Michael T.; Hanna, Nicholas; Comas, George M.; Zhang, Cheng; Ben‐Dor, Itsik; Satler, Lowell F.; García‐García, Héctor M.; Shults, Christian; Rogers, Toby

doi:10.1016/j.jcin.2020.02.008

Cited by 86 publications

(50 citation statements)

References 15 publications

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“…In recent trials it has shown superior outcomes, even in patients with low surgical risk. 43 However, despite the increase in procedural expertise, conduction disturbances, and pacemaker insertion remain major complications following TAVR, with incidence reported to be approximately 7.8%-20.3% in prior studies. 44,45 There have been several studies of post-TAVR PPMI looking for various risk predictors including anatomic, procedural, electrophysiological and demographic factors.…”

Section: Discussionmentioning

confidence: 99%

Predictors of permanent pacemaker insertion after TAVR: A systematic review and updated meta‐analysis

Mahajan

Gupta

Malik

et al. 2021

Cardiovasc electrophysiol

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The aim of this analysis was to evaluate the predictors associated with increased risk of permanent pacemaker implantation (PPMI) following transcatheter aortic valve replacement (TAVR).Background: While TAVR has evolved as the standard of care for patients with severe aortic stenosis, conduction abnormalities leading to the need for PPMI is one of the most common postprocedural complications.Methods: A systematic literature search was performed to identify relevant trials from inception to May 2020. Summary effects were calculated using a DerSimonian and Laird random-effects model as odds ratio with 95% confidence intervals for all the clinical endpoints.Results: Thirty-seven observational studies with 71 455 patients were identified.The incidence of PPMI following TAVR was 22%. Risk was greater in men and increased with age. Patients with diabetes mellitus, presence of right bundle branch block, baseline atrioventricular conduction block, and left anterior fascicular block were noted to be at higher risk. Other significant predictors include the presence of high calcium volume in the area below the left coronary cusp and noncoronary cusp, use of self-expandable valve over balloon-expandable valve, depth of implant, valve size/annulus size, predilatation balloon valvuloplasty, and postimplant balloon dilation. Conclusion:Fourteen factors were found to be associated with increased risk of PPMI after TAVR, suggesting early identification of high-risk populations and targeting modifiable risk factors may aid in reducing the need for this post TAVR PPMI.

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Section: Discussionmentioning

confidence: 99%

Predictors of permanent pacemaker insertion after TAVR: A systematic review and updated meta‐analysis

Mahajan

Gupta

Malik

et al. 2021

Cardiovasc electrophysiol

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“…TAVI has evolved to be the standard of care for elderly patients with symptomatic severe AS, with recent research showing benefits across the entire surgical‐risk spectrum 13‐23 . Inspired by the early and ongoing success of TAVI, newer valves and technologies were rapidly introduced incorporating features that could potentially overcome the limitations of earlier devices 24,25 .…”

Section: Discussionmentioning

confidence: 99%

Clinical evaluation of the Hydra self‐expanding transcatheter aortic valve: 6 month results from the GENESIS trial

Chandra¹,

Jose

Mattummal³

et al. 2021

Cathet Cardio Intervent

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Objectives To evaluate the safety and performance of the Hydra transcatheter aortic valve (THV) in the treatment of symptomatic severe aortic stenosis in patients at high or extreme surgical risk. Background The Hydra THV (Vascular Innovations Co. Ltd., Nonthaburi, Thailand) is a novel flexible repositionable self‐expanding system with supra‐annular bovine pericardial leaflets, available in three sizes, covering aortic annuli between 17 and 27 mm. Methods The GENESIS trial was a prospective, multi‐center, single‐arm, 6 month follow‐up study conducted in India. The primary performance endpoint was device success defined as per VARC‐II criteria at 30 days. The primary safety endpoint was all‐cause mortality at 30 days. All endpoints were adjudicated by an independent clinical events committee. Results Forty high‐risk patients (74.5 ± 6.7 years, 60% men; STS Score:5.6 ± 4.2%) were enrolled in 11 centres. Device success was achieved in 92.5%. The effective orifice area improved from 0.7 ± 0.2 to 2.3 ± 0.6 cm2 at 30 days and to 2.2 ± 0.7 cm2 at 6 months (p < .0001). Mean aortic valve gradient decreased from 53.5 ± 18.1 to 8.9 ± 4.9 mmHg at 30 days and to 7.6 ± 2.7 mmHg at 6 months (p < .0001). The rate of new permanent pacemaker implantation was 7.5% at 30 days, and no patient had more than mild paravalvular leak at 6 months. The 30 days and 6 month all‐cause mortality was 10.0 and 17.5%, cardiovascular mortality 7.5 and 7.5%, device‐related mortality 5.0 and 5.0%, respectively. No patients had stroke up to 6 months. Conclusions The GENESIS trial demonstrated high efficacy of the self‐expanding Hydra THV. The cardiovascular mortality rate of 7.5% may partly be explained by the inclusion of some centres with no or limited previous experience in transcatheter aortic valve implantation.

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“…Though only 16% under expanded compared to TAV, device placement in this BAV configuration loses axisymmetry with three-fold greater device centroid displacement, between annulus and leaflet free edge, compared to both TAV and Sievers 0 and maximum strut deviation that is three-fold greater than devices deployed in TAV ( Fig 3 ). Such deviations in expansion and alignment are thought to be associated with clinical complications [ 17 – 20 ]. Indeed, the loss of axisymmetry observed in devices deployed in Sievers 1 BAV, are unlikely to reconstitute normal flow and instead may impose eccentric jets that effect perfusion, which may manifest clinically as higher rates of stroke at 30 days compared to TAV [ 15 ].…”

Section: Discussionmentioning

confidence: 99%

Understanding TAVR device expansion as it relates to morphology of the bicuspid aortic valve: A simulation study

et al. 2021

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The bicuspid aortic valve (BAV) is a common and heterogeneous congenital heart abnormality that is often complicated by aortic stenosis. Although initially developed for tricuspid aortic valves (TAV), transcatheter aortic valve replacement (TAVR) devices are increasingly applied to the treatment of BAV stenosis. It is known that patient-device relationship between TAVR and BAV are not equivalent to those observed in TAV but the nature of these differences are not well understood. We sought to better understand the patient-device relationships between TAVR devices and the two most common morphologies of BAV. We performed finite element simulation of TAVR deployment into three cases of idealized aortic anatomies (TAV, Sievers 0 BAV, Sievers 1 BAV), derived from patient-specific measurements. Valve leaflet von Mises stress at the aortic commissures differed by valve configuration over a ten-fold range (TAV: 0.55 MPa, Sievers 0: 6.64 MPa, and Sievers 1: 4.19 MPa). First principle stress on the aortic wall was greater in Sievers 1 (0.316 MPa) and Sievers 0 BAV (0.137 MPa) compared to TAV (0.056 MPa). TAVR placement in Sievers 1 BAV demonstrated significant device asymmetric alignment, with 1.09 mm of displacement between the center of the device measured at the annulus and at the leaflet free edge. This orifice displacement was marginal in TAV (0.33 mm) and even lower in Sievers 0 BAV (0.23 mm). BAV TAVR, depending on the subtype involved, may encounter disparate combinations of device under expansion and asymmetry compared to TAV deployment. Understanding the impacts of BAV morphology on patient-device relationships can help improve device selection, patient eligibility, and the overall safety of TAVR in BAV.

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Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic Severe Bicuspid Aortic Valve Stenosis

Cited by 86 publications

References 15 publications

Predictors of permanent pacemaker insertion after TAVR: A systematic review and updated meta‐analysis

Predictors of permanent pacemaker insertion after TAVR: A systematic review and updated meta‐analysis

Clinical evaluation of the Hydra self‐expanding transcatheter aortic valve: 6 month results from the GENESIS trial

Understanding TAVR device expansion as it relates to morphology of the bicuspid aortic valve: A simulation study

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