Predictors of Permanent Pacemaker Implantations and New-Onset Conduction Abnormalities With the SAPIEN 3 Balloon-Expandable Transcatheter Heart Valve

Hüsser, Oliver; Pellegrini, Costanza; Kessler, Thorsten; Burgdorf, Christof; Thaller, Hannah; Mayr, N. Patrick; Kasel, Albert M.; Kastrati, Adnan; Schunkert, Heribert; Hengstenberg, Christian

doi:10.1016/j.jcin.2015.09.036

Cited by 155 publications

(116 citation statements)

References 31 publications

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“…A recent report identified implantation depth and oversizing as independent predictors of new permanent pacemaker implantation with SAPIEN 3, suggesting a potential procedural opportunity to reduce the rate. 14 The small increase in stroke between 30 days and 1 year is not surprising in this elderly population with multiple risk factors for stroke, including atrial fibrillation in >40% of patients. Studies, including GALILEO (Global Study Comparing a Rivaroxaban-Based Antithrombotic Strategy to an Anti-Platelet-Based Strategy After Transcatheter Aortic Valve Replacement; Clinicaltrials.gov NCT02556203), comparing antiplatelet and anticoagulation strategies aimed at reducing post-TAVR thromboembolic events are underway.…”

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confidence: 96%

One-Year Clinical Outcomes With SAPIEN 3 Transcatheter Aortic Valve Replacement in High-Risk and Inoperable Patients With Severe Aortic Stenosis

et al. 2016

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Background:In the initial PARTNER trial (Placement of Aortic Transcatheter Valves) of transcatheter aortic valve replacement for high-risk (HR) and inoperable patients, mortality at 1 year was 24% in HR and 31% in inoperable patients. A recent report of the 30-day outcomes with the lowprofile SAPIEN 3 transcatheter aortic valve replacement system demonstrated very low rates of adverse events, but little is known about the longer-term outcomes with this device. Methods:Between October 2013 and September 2014, 583 HR (65%) or inoperable (35%) patients were treated via the transfemoral (84%) or transapical/transaortic (16%) access route at 29 US sites. Major clinical events at 1 year were adjudicated by an independent clinical events committee, and echocardiographic results were analyzed by a core laboratory. results: Baseline characteristics included age of 83 years, 42% female, and median Society of Thoracic Surgeons score of 8.4%. At the 1-year follow-up, survival (all-cause) was 85.6% for all patients, 87.3% in the HR subgroup, and 82.3% in the inoperable subgroup. Survival free of all-cause and cardiovascular mortality in the transfemoral patients from the HR cohort was 87.7% and 93.3%, respectively. There was no severe paravalvular leak. Moderate paravalvular leak (2.7%) was associated with an increase in mortality at 1 year, whereas mild paravalvular leak had no significant association with mortality. Symptomatic improvement as assessed by the percentage of patients in New York Heart Association class III and IV (90.1% to 7.7% at 1 year; P<0.0001) and by Kansas City Cardiomyopathy Questionnaire overall summary score (improved from 46.9 to 72.4; P<0.0001) was marked. Multivariable predictors of 1-year mortality included alternative access, Society of Thoracic Surgeons score, and disabling stroke. conclusions:In this large, adjudicated registry of SAPIEN 3 HR and inoperable patients, the very low rates of important complications resulted in a strikingly low mortality rate at 1 year. Between 30 and 365 days, the incidence of moderate paravalvular aortic regurgitation did not increase, and no association between mild paravalvular leak and 1-year mortality was observed, although a small increase in disabling stroke occurred. These results, which likely reflect device iteration and procedural evolution, support the use of transcatheter aortic valve replacement as the preferred therapy in HR and inoperable patients with aortic stenosis. clinical trial registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01314313.

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confidence: 96%

One-Year Clinical Outcomes With SAPIEN 3 Transcatheter Aortic Valve Replacement in High-Risk and Inoperable Patients With Severe Aortic Stenosis

et al. 2016

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“…The overall rates of permanent pacemaker implantation after TAVR were around 17%, versus 5% with SAVR. 66,67 The need for a new permanent pacemaker in the Partner A cohort was not significantly different at 30 days (3.8% vs 3.6%), 1 year (5.7% vs 5%) and 5 years (9.7% vs 9.1%) for patients undergoing TAVR versus SAVR, respectively. Siontis and colleagues 66 suggested that male sex, baseline conduction disturbances, and intraprocedural atrioventricular block had roles as predictors of permanent pacemaker implantation after TAVR.…”

Section: Technical Sequelae Of Tavrmentioning

confidence: 93%

“…However, the rates of permanent pacemaker implantation and conduction abnormalities were also found to be higher with the new Edwards Sapien 3 system because of prosthesis oversizing and the depth of the implantation. 67 Other Sequelae. Paravalvular leak after TAVR is a frequent occurrence that is associated with increased mortality rates.…”

Section: Technical Sequelae Of Tavrmentioning

confidence: 99%

Transcatheter Aortic Valve Replacement: Comprehensive Review and Present Status

Arora¹,

Misenheimer²,

Ramaraj³

2017

Texas Heart Institute Journal

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“…The continuous development of TAVI procedures has decreased the incidence of various complications regarding TAVI. This includes vascular complication, annulus rupture, paravalvular regurgitation, stroke, and conduction disturbance . Coronary artery obstruction still remains a critical concern of this procedure .…”

Section: Discussionmentioning

confidence: 99%

Clinical utility of intraprocedural three‐dimensional integrated image guided transcatheter aortic valve implantation using novel automated computed tomography software: A single‐center preliminary experience

Butter

Kaneko

Tambor

et al. 2018

Cathet Cardio Intervent

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Objectives Novel automated computed tomography (CT) software (Valve ASSIST 2) has been developed for transcatheter aortic valve implantation (TAVI), which not only provides three‐dimensional (3D) reconstruction of multidetector (MD) CT images, but also enables intraprocedural real‐time fusion of fluoroscopic and MDCT images. We aimed to clarify the reproducibility and accuracy of this software in the aortic annulus assessment and verify the potential of intraprocedural integrated MDCT imaging for TAVI. Methods and results We examined 50 patients with severe aortic stenosis undergoing transfemoral TAVI. Aortic annulus measurements were performed using 3mensio and the novel planning software. For intraprocedural imaging, preoperative CT dataset was overlaid onto fluoroscopy with the fusion software. The two images were aligned using the aortic root anatomy visible on both modalities. Novel planning software provided excellent reproducibility for the measurement of aortic annulus area (intraobserver intraclass correlation coefficients [ICC] 0.959, interobserver ICC 0.941), and perimeter (intraobserver ICC 0.915, interobserver ICC 0.912). Excellent correlation was found between novel planning software and 3mensio (ICC 0.952 for aortic annulus area, and 0.923 for perimeter). Intraprocedural fusion image of CT aortography and fluoroscopic aortic root aortography generated by this novel software identified coronary orifices and the distribution of aortic valve calcification during the device positioning. Fusion image displayed coronary orifices after device implantation. Conclusions Novel planning software showed excellent reproducibility and accuracy in the assessment of aortic root anatomy. Furthermore, the integrated 3D fusion image might have a potential as an intraprocedural imaging modality to contribute to the development of a safer TAVI procedure.

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Predictors of Permanent Pacemaker Implantations and New-Onset Conduction Abnormalities With the SAPIEN 3 Balloon-Expandable Transcatheter Heart Valve

Abstract: Implantation depth and prosthesis oversizing were associated with a higher rate of new CA or PPI using the SAPIEN 3. Thus, avoidance of deep implantation and extreme oversizing may reduce these complications.

Cited by 155 publications

References 31 publications

One-Year Clinical Outcomes With SAPIEN 3 Transcatheter Aortic Valve Replacement in High-Risk and Inoperable Patients With Severe Aortic Stenosis

One-Year Clinical Outcomes With SAPIEN 3 Transcatheter Aortic Valve Replacement in High-Risk and Inoperable Patients With Severe Aortic Stenosis

Transcatheter Aortic Valve Replacement: Comprehensive Review and Present Status

Clinical utility of intraprocedural three‐dimensional integrated image guided transcatheter aortic valve implantation using novel automated computed tomography software: A single‐center preliminary experience

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