Relevance of New Conduction Disorders After Implantation of the ACURATE Neo Transcatheter Heart Valve in the Aortic Valve Position

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The ACURATE neo transcatheter heart valve has been associated with very low rates of new conduction disorders (CDs). We assessed the clinical relevance of new CDs in patients undergoing transcatheter aortic valve replacement (TAVR) with this valve. Data of consecutive patients without a pre-existing left bundle branch block (LBBB) or a permanent pacemaker (PPM) undergoing TAVR with the ACURATE neo were analyzed from the prospective SwissTAVI registry. Patients with new CDs were compared with patients with an unchanged electrocardiogram (ECG). ACURATE neo was implanted in 203 patients (mean age 82 ± 6 years, 63% women), CDs occurred in 28 patients (22 [11%] developed a LBBB, 6 [3%] required a PPM). New CDs resulted in a longer median duration of hospitalization (7 vs 5 days, interquartile range 4 to 13 vs 3 to 8 days, p = 0.04). At 1-year follow-up, left ventricular ejection fraction was significantly lower in patients with new CDs comparedwith patients with an unchanged ECG (54% ± 13% vs 61% ± 9%, p <0.01). Kaplan-Meier estimates of survival at 1-year were 89% in patients with new CDs and 95% in patients with an unchanged ECG (hazard ratio 2.0, 95% confidence interval 0.7 to 6.2, p = 0.22). After TAVR with the self-expanding ACURATE neo valve, the rate of new CDs, including complete LBBB was low and very few patients required a new PPM. However, new CDs prolonged initial hospitalization and increased the risk for left ventricular-dysfunction at 1-year follow-up. Patients without new CDs had excellent outcomes with a very high survival rate at 1-year follow-up.

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Methods

Between June 2015 and June 2019, consecutive patients undergoing TAVR with the ACURATE neo or ACURATE neo 2 THV at the Heart Center Lucerne were enrolled in the prospective SwissTAVI registry. Data were collected throughout the initial hospital stay and follow-ups were conducted at 30 days and 1 year. The study complies with the declaration of Helsinki. Prospective data acquisition was approved by the local ethic committee. All patients provided written informed consent for the TAVR procedure,

Results

A total of 229 consecutive patients who underwent TAVR with ACURATE neo were enrolled. Of those, 26 patients with a pre-existing LBBB or PPM were excluded from the current analyses. Mean age of the study cohort was 82 ± 6 years and 128 (63%) were women. ECG at discharge showed a new LBBB in 22 (11%) patients and 6 (3%) patients had received a new PPM. These patients were compared with the remaining 175 (86%) patients with an unchanged ECG. Baseline characteristics and procedural details of the

Discussion

Evaluating data from a prospective registry, we assessed the impact of TAVR with the ACURATE neo valve on occurrence of CDs. We found (1) implantation of the ACURATE neo resulted in remarkably low rates of new CDs; (2) new CDs prolonged the median duration of hospitalization by 2 days; (3) patients with new CDs had a significantly lower LVEF at 1-year follow-up; and (4) patients without new CDs had excellent short- and midterm outcomes with a remarkably high 1-year survival rate of 95%.

Authorship Contribution

Conception and design or analysis and interpretation of data, or both: MB, ST. Drafting of the manuscript or revising it critically for important intellectual content: MB, MW, FM, MBo, BB, FC, RK, ST. Final approval of the manuscript submitted: all authors.

Disclosure

ST is a consultant and proctor for Boston Scientific and New Valve Technology, and has received institutional research grants from Boston Scientific and Fumedica AG. The other authors have no conflicts of interest to declare.

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Funding: There was no funding for this study.

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