Commissural alignment may impact device performance and clinical outcomes in patients undergoing balloon-expandable transcatheter aortic valve replacement (TAVR), according to a new RESOLVE study analysis.
The study – led by Matthias Raschpichler, MD, from Cedars-Sinai Medical Center, Los Angeles, and Leipzig Heart Center, Germany – was published Monday online ahead of the June 13 issue of JACC: Cardiovascular Interventions.
TAVR with most available transcatheter heart valve (THV) systems – including SAPIEN 3, Evolut R/ Pro, Lotus and Portico valves – is generally performed with no technique or technology available to control the rotational alignment of the bioprosthesis to native aortic valve commissures (aka commissural alignment), the researchers added.
However, the issue of commissural alignment has recently gained attention over its influence on coronary access after TAVR.
It has also been found that, based on post-TAVR computed tomography (CT), commissural misalignment (CMA) of THVs is associated with higher rates of mild central bioprosthetic aortic regurgitation, raising concerns about the overall impact of commissural alignment on clinical outcomes and prosthesis performance.
Yet data on the impact of CMA on clinical and hemodynamic outcomes in the TAVR setting remain scarce, said the researchers.
The current study, therefore, set out to investigate the impact of commissural alignment on the clinical and hemodynamic outcomes of the balloon-expandable SAPIEN 3 and SAPIEN 3 Ultra THVs in a retrospective analysis of 324 consecutive severe tricuspid AS patients undergoing TAVR at Cedars-Sinai Medical Center in the RESOLVE registry.
At baseline, 153 of the patients had devices aligned to commissures, while 171 had CMA (defined as a neocommissure position >30° compared with native commissures on CT scan). The vast majority (97.8%) received transfemoral TAVR procedures.
Median age was 82 years (83 years in the aligned group vs. 82 in CMA), most were male (36.7% female), and the median Society of Thoracic Surgeons score was 3.9%.
At baseline, those with CMA tended to be less likely to have suffered a stroke (3.53% vs. 6.54%; P = 0.23) and had lower rates of diabetes (23.5% vs. 32.7%; P = 0.07), but had higher rates of transient ischemic attack (8.77% vs. 2.61; P = 0.02) and coronary artery disease (57.8% vs. 48.3%; P = 0.09).
CMA was also associated with a smaller aortic valve area (P = 0.05) and THV size ≤23 mm (P = 0.02).
The researchers found that TAVR resulting in CMA was associated with the use of moderate sedation (used in 5.2% of CMA patients vs. 0.71% of non-CMA; P = 0.03) and small THV size (33.3% vs. 21.6%, respectively; P = 0.02). Misaligned THVs were also associated with deeper implantation around the left coronary cusp (3.2 mm vs. 2.5 mm; P = 0.02).
Rates of hypoattenuated leaflet thickening (HALT) or hypoattenuation affecting motion (HAM) did not differ between groups.
Clinical and hemodynamic outcome and sinus rhythm
At 30 days, aortic regurgitation rates deemed greater than mild (5.6%) and a residual aortic valve gradient ≥ 30 mm Hg (7.4%) were not different between CMA and non-CMA patients, the researchers said.
However, commissural orientation was independently associated with a relative aortic valve mean gradient increase >50% from discharge to 30 days (per increase of 10° misalignment; odds ratio [OR]: 1.3; 95% confidence interval [CI]: 1.0-1.4; P = 0.01).
TIA or stroke occurred in four patients total (1.3%), of whom three had CMA (P = 0.40), and life-threatening bleeding occurred in three patients, all of whom had CMA. A major vascular complication occurred in six patients, of whom five had CMA (P = 0.20), “thus, the endpoint of early safety (excluding periprocedural mortality) was met in 11 patients (3.8%); 9 of these patients had CMA (P = 0.07).”
This reached significance in patients with sinus rhythm, the researchers added (OR: 0.16; 95% CI: 0.01-0.90; P = 0.04).
Nevertheless, the long-term composite outcome of death or stroke was not different between groups (log-rank P = 0.29), and there were no cases of coronary obstruction requiring intervention or valve-related dysfunction requiring a repeated procedure.
“Our study provides evidence that commissural alignment is associated with improved outcomes,” said the researchers. “The composite endpoint of early safety was observed almost 4 times more frequently in patients with CMA (5.7% vs 1.5%, P = 0.07) because all its components were more common in these patients.
“However, these events were moderately associated; in 3 of 6 patients, a major vascular complication resulted in at least major bleeding.”
The researchers went on to call for further studies providing long-term hemodynamic and clinical follow-up to confirm their findings.
The findings are the first to demonstrate that CMA was predictive of an increase in aortic valve gradient early after balloon-expandable TAVR, Gilbert H.L. Tang, MD, MSc, MBA, from Mount Sinai Health System, New York, and Syed Zaid, MD, from Houston Methodist DeBakey Heart and Vascular Center, said in an accompanying editorial. But the study “likely raises more questions than it provides answers for now.”
“It is clear that CMA adversely impacts to the potential to perform coronary access and redo TAVR after index TAVR. The question is whether CMA also impacts valve hemodynamics and durability,” the editorialists added.
They stressed that only longitudinal multimodality imaging studies analyzed by a core lab “can better answer this question.”
Raschpichler M, Flint N, Yoon S-H, et al. Commissural Alignment After Balloon-Expandable Transcatheter Aortic Valve Replacement Is Associated With Improved Hemodynamic Outcomes. JACC Cardiovasc Interv 2022;15:1126-1136.
Tang GHL, Zaid S. Commissural (Mis)Alignment in TAVR and Hemodynamic Impact: More Questions Raised Than Answered. JACC: Cardiovasc Interv 2022;15:1137-1139.
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