Commissural alignment after balloon-expandable transcatheter aortic valve replacement is associated with improved hemodynamic outcomes
Selected in JACC: Cardiovascular Interventions by A. Beneduce , S. Brugaletta
This study aimed at investigating the impact of commissural misalignment on clinical outcomes and hemodynamic performance of balloon-expandable devices.
References
Authors
Matthias Raschpichler, Nir Flint, Sung-Han Yoon, Danon Kaewkes, Chinar Patel, Chetana Singh, Vivek Patel, Mohammad Kashif, Michael A. Borger, Tarun Chakravarty, and Raj Makkar
Reference
J Am Coll Cardiol Intv. 2022 Jun, 15 (11) 1126–1136
Published
15 June 2022
Link
Read the abstractReviewers
Our Comment
Why this study – the rationale/objective?
With increasing studies supporting transcatheter aortic valve replacement (TAVR) in low-risk patients, lifetime management of aortic stenosis has become more important, taking into account possible re-intervention overtime.
Commissural alignment has gained momentum owing to (1) its relevance for coronary access and (2) recent studies suggesting increased leaflets stress in misaligned valves.
However, data on the impact of commissural misalignment (CMA) on clinical and hemodynamic outcomes after TAVR are limited. Current balloon-expandable (BE) platforms do not allow control on commissural alignment, resulting in random commissural orientation.
This study aimed at investigating the impact of CMA on clinical outcomes and hemodynamic performance of BE devices.
How was it executed? - the methodology:
Clinical data of consecutive patients who underwent BE TAVR at Cedars-Sinai Medical Center enrolled in the RESOLVE (Assessment of TRanscathetER and Surgical Aortic BiOprosthetic Valve Thrombosis and Its TrEatment With Anticoagulation) registry were retrospectively analyzed to evaluate CMA, which was defined as a neocommissure position > 30 compared with native commissures on computed tomography (CT).
What is the main result?
A total of 324 patients (36.6 % female, median Society of Thoracic Surgeons score of 3.9 %) undergoing TAVR with SAPIEN 3 or SAPIEN 3 Ultra BE platforms were included in the analysis.
The study showed that:
- CMA was present in 171 individuals (52.8 %).
- At 30 days, rates of aortic regurgitation greater than mild (5.6 %) and a residual AV gradient ≥ 20 mm Hg (7.4 %) were not different between CMA and non-CMA patients.
- Commissural orientation was independently associated with a relative AV mean gradient increase > 50 % from discharge to 30 days (per increase of 10° misalignment; OR: 1.3; 95 % CI: 1.0-1.4; P < 0.01).
- The long-term composite outcome of death or stroke was not different between groups (log-rank p = 0.29).
Main outcomes of aligned versus misaligned balloon-expandable TAVR (N = 324)
Source = JACC: Cardiovascular Interventions
Critical reading and the relevance for clinical practice:
As TAVR boundaries expand to younger patients, valve durability is a relevant issue and much efforts are pursued to obtain the best hemodynamic and improve long-term valve function.
This study suggests for the first time that commissural alignment may impact device performance in patients undergoing TAVR with BE valves.
The clinical relevance of early increase in valve gradient remains to be clarified, as there was no association with prosthesis dysfunction or hypo-attenuated leaflet thickening (HALT) at post-procedural CT.
Nevertheless, this study provides important insights supporting the need for improvement of BE technology, as commissural alignment is impossible with current-generation platforms.
Among latest device iterations of the SAPIEN X4 recently shown at TVT 2022 congress, a dedicated wheel will allow to orientate the valve inside the delivery system and obtain commissural alignment.
The journey towards TAVR technical refinement continues.
-> Do you have any tips & tricks about commissural alignment with current generation of BE TAVR?
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