Clinical Impact of Standardized TAVR Technique and Care Pathway

Grubb, Kendra J.; Gada, Hemal; Mittal, Suneet; Nazif, Tamim; Rodés‐Cabau, Josep; Fraser, Douglas G.; Lin, Lang; Rovin, Joshua D.; Khalil, Ramzi; Sultan, Ibrahim; Gardner, Blake; Lorenz, David H.; Chetcuti, Stanley; Patel, Nainesh C; Harvey, James E.; Mahoney, Paul; Schwartz, Brian S.; Jafar, Zubair; Wang, John; Potluri, Srinivasa; Vora, Amit N.; Sanchez, Carlos E.; Corrigan, Amy; Li, Shuzhen; Yakubov, Steven J.

doi:10.1016/j.jcin.2023.01.016

Cited by 39 publications

(15 citation statements)

References 18 publications

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“…Recently, an interim analysis of the first 400 main cohort patients and 104 roll‐in patients in the OPTIMIZE PRO study 29 (http://ClinicalTrials.gov Identifier: NCT04091048) was presented at the EuroPCR 2022 in Paris. The primary objective of this study was to collect evidence on valve performance and procedural outcomes associated with an optimized care pathway before and after TAVI using COV to deploy SEVs (Medtronic Evolut PRO and PRO + valves).…”

Section: Discussionmentioning

confidence: 99%

Cusp‐overlap versus coplanar view in transcatheter aortic valve implantation with self‐expandable valves: A meta‐analysis of comparative studies

Sá

Eynde

Jacquemyn

et al. 2023

Cathet Cardio Intervent

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Background Permanent pacemaker implantation (PPI) is a common complication after transcatheter aortic valve implantation (TAVI). The cusp‐overlap view (COV) was adopted to reduce PPI risk after TAVI with self‐expandable valves (SEVs); however, the evidence remains scarce. We performed a systematic review with meta‐analysis comparing COV and the standard coplanar view (CPV) technique to evaluate their effectiveness and safety. Methods Following the PRISMA statement, data were extracted from studies published by August 2022 and found in PubMed/MEDLINE, EMBASE, CENTRAL/CCTR, http://ClinicalTrials.gov, SciELO, LILACS, and Google Scholar. The primary outcome of interest was post‐procedural PPI and the secondary outcomes were new left bundle branch block (LBBB), moderate/severe paravalvular leak (PVL), valve dislocation (pop‐out); need of second transcatheter heart valve, 30‐day mortality, stroke, conversion to surgery, coronary obstruction, implantation depth (mm), and post‐TAVI mean gradients (mmHg). Results Eleven studies met our eligibility criteria and included 1464 patients in the COV group and 1743 patients in the CPV group. Patients who underwent TAVI with COV had lower risk of PPI (odds ratio 0.48; 95% confidence interval [CI] 0.33–0.70; p = 0.001) and higher implantation depths with COV (mean difference −0.83; 95% CI −1.2 to −0.45; p < 0.001). We did not observe any statistically significant differences in the rates of new LBBB, moderate/severe PVL, valve dislocation, need of second transcatheter heart valve, 30‐day mortality, stroke, conversion to surgery, coronary obstruction, and post‐TAVI mean gradients (mmHg). Conclusion In TAVI with SEVs, the application of COV is associated with lower risk of PPI compared with the standard CPV without increasing risk for adverse outcomes.

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Section: Discussionmentioning

confidence: 99%

Cusp‐overlap versus coplanar view in transcatheter aortic valve implantation with self‐expandable valves: A meta‐analysis of comparative studies

Sá

Eynde

Jacquemyn

et al. 2023

Cathet Cardio Intervent

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“…In a large meta-analysis with 3,647 patients from 11 studies undergoing self-expanding TAVR COP was associated with a significantly reduced PPI rate and higher ID compared to the standard TCC view (23). In the recently published Optimize PRO study with 400 patients receiving Evolut PRO/PRO + (Medtronic) self-expanding valves Grubb et al displayed that the use of TAVR care pathway and COP resulted in favorable clinical outcomes with low PPI rates of only 9.8% at 30 days (37). The present study corroborates and further extends these findings.…”

Section: Discussionmentioning

confidence: 99%

Cusp-overlap view reduces conduction disturbances and permanent pacemaker implantation after transcatheter aortic valve replacement even with balloon-expandable and mechanically-expandable heart valves

Stephan,

Krohn-Grimberghe,

von Lindeiner genannt von Wildau

et al. 2023

Front. Cardiovasc. Med.

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BackgroundConduction disturbances demanding permanent pacemaker implantation (PPI) remain a common complication after transcatheter aortic valve replacement (TAVR). Optimization of the implantation depth (ID) by introducing the cusp-overlap projection (COP) technique led to a reduced rate of PPI when self-expanding valves were used.ObjectivesThe aim of the present study was to determine if using the novel COP view is applicable for all types of TAVR prosthesis and results in a higher ID and reduced incidence of new conduction disturbances and PPI.MethodsIn this prospective case-control study 586 consecutive patients undergoing TAVR with either balloon-expandable Edwards SAPIEN S3 (n = 280; 47.8%), or mechanically expandable Boston LOTUS Edge heart valve prostheses (n = 306; 52.2%) were included. ID as well as rates of periprocedural PPI and left bundle branch block (LBBB) were compared between the conventional three-cusp coplanar (TCC) projection and the COP view for implantation.ResultsOf 586 patients, 282 (48.1%) underwent TAVR using COP, whereas in 304 patients (51.9%) the TCC view was applied. Using COP a significantly higher ID was achieved in Edwards SAPIEN S3 TAVR procedures (ID mean difference −1.0 mm, 95%−CI −1.9 to −0.1 mm; P = 0.029), whereas the final platform position did not differ significantly between both techniques when a Boston LOTUS Edge valve was used (ID mean difference −0.1 mm, 95%-CI −1.1 to +0.9 mm; P = 0.890). In Edwards SAPIEN S3 valves, higher ID was associated with a numerically lower post-procedural PPI incidence (4.9% vs. 7.3%; P = 0.464). Moreover, ID was significantly deeper in patients requiring PPI post TAVR compared to those without PPI [8.7 mm (6.8–10.6 mm) vs. 6.5 mm (6.1–7.0 mm); P = 0.005]. In Boston LOTUS Edge devices, COP view significantly decreased the incidence of LBBB post procedure (28.1% vs. 47.9%; P < 0.001), while PPI rates were similar in both groups (21.6% vs. 25.7%; P = 0.396).ConclusionThe present study demonstrates the safety, efficacy and reproducibility of the cusp-overlap view even in balloon-expandable and mechanically-expandable TAVR procedures. Application of COP leads to significantly less LBBB in repositionable Boston LOTUS Edge valves and a numerically lower PPI rate in Edwards SAPIEN S3 valves post TAVR compared to the standard TCC projection. The results should encourage to apply the COP view more widely in clinical practice.

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“…Two Evolut implant depths were evaluated in this study: 3 and 5 mm below the annular plane. A 3-mm implant depth is considered optimal with the cusp-overlap method, 9 , 10 and a 5-mm implant depth was used to evaluate the optimal depth to facilitate coronary access. Commissural alignment of the index Evolut valve was assumed.…”

Section: Methodsmentioning

confidence: 99%

Feasibility of Coronary Access Following Redo-TAVR for Evolut Failure: A Computed Tomography Simulation Study

Tang,

Spencer,

Rogers

et al. 2023

Circ: Cardiovascular Interventions

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BACKGROUND: Coronary accessibility following redo–transcatheter aortic valve replacement (redo-TAVR) is increasingly important, particularly in younger low-risk patients. This study aimed to predict coronary accessibility after simulated Sapien-3 balloon-expandable valve implantation within an Evolut supra-annular, self-expanding valve using pre-TAVR computed tomography (CT) imaging. METHODS: A total of 219 pre-TAVR CT scans from the Evolut Low-Risk CT substudy were analyzed. Virtual Evolut and Sapien-3 valves were sized using CT-based diameters. Two initial Evolut implant depths were analyzed, 3 and 5 mm. Coronary accessibility was evaluated for 2 Sapien-3 in Evolut implant positions: Sapien-3 outflow at Evolut node 4 and Evolut node 5. RESULTS: With a 3-mm initial Evolut implant depth, suitable coronary access was predicted in 84% of patients with the Sapien-3 outflow at Evolut node 4, and in 31% of cases with the Sapien-3 outflow at Evolut node 5 ( P <0.001). Coronary accessibility improved with a 5-mm Evolut implant depth: 97% at node 4 and 65% at node 5 ( P <0.001). When comparing 3- to 5-mm Evolut implant depth, sinus sequestration was the lowest with Sapien-3 outflow at Evolut node 4 (13% versus 2%; P <0.001), and the highest at Evolut node 5 (61% versus 32%; P <0.001). CONCLUSIONS: Coronary accessibility after Sapien-3 in Evolut redo-TAVR relates to the initial Evolut implant depth, the Sapien-3 outflow position within the Evolut, and the native annular anatomy. This CT-based quantitative analysis may provide useful information to inform and refine individualized preprocedural CT planning of the initial TAVR and guide lifetime management for future coronary access after redo-TAVR. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02701283.

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Clinical Impact of Standardized TAVR Technique and Care Pathway

Cited by 39 publications

References 18 publications

Cusp‐overlap versus coplanar view in transcatheter aortic valve implantation with self‐expandable valves: A meta‐analysis of comparative studies

Cusp‐overlap versus coplanar view in transcatheter aortic valve implantation with self‐expandable valves: A meta‐analysis of comparative studies

Cusp-overlap view reduces conduction disturbances and permanent pacemaker implantation after transcatheter aortic valve replacement even with balloon-expandable and mechanically-expandable heart valves

Feasibility of Coronary Access Following Redo-TAVR for Evolut Failure: A Computed Tomography Simulation Study

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