Original article
Adult cardiac
Medium Term Outcomes of Transapical Aortic Valve Implantation: Results From the Italian Registry of Trans-Apical Aortic Valve Implantation

Presented at the Forty-ninth Annual Meeting of The Society of Thoracic Surgeons, Los Angeles, CA, Jan 26–30, 2013.
https://doi.org/10.1016/j.athoracsur.2013.04.094Get rights and content

Background

Transcatheter aortic valve implantation (TAVI) has been proposed as a therapeutic option for high-risk or inoperable patients with severe symptomatic aortic valve stenosis. The aim of this multicenter study was to assess early and medium term outcomes of transapical aortic valve implantation (TA-TAVI).

Methods

From April 2008 through June 2012, a total of 774 patients were enrolled in the Italian Registry of Trans-Apical Aortic Valve Implantation (I-TA). Twenty-one centers were included in the I-TA registry. Outcomes were also analyzed according to the impact of the learning curve (first 50% cases versus second 50% cases of each center) and of the procedural volume (high-volume versus low-volume centers).

Results

Mean age was 81.0 ± 6.7 years, mean logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) I, EuroSCORE II, and The Society of Thoracic Surgeons risk score were 25.6% ± 16.3%, 9.4% ± 11.0%, and 10.6% ± 8.5%, respectively. Median follow-up was 12 months (range, 1 to 44). Thirty-day mortality was 9.9% (77 patients). Overall 1-, 2-, and 3-year survival was 81.7% ± 1.5%, 76.1% ± 1.9%, and 67.6% ± 3.2%, respectively. Thirty-day mortality of the first 50% patients of each center was higher when compared with the second half (p = 0.04) but 3-year survival was not different (p = 0.64). Conversely, 30-day mortality at low-volume centers versus high-volume centers was similar (p = 0.22). At discharge, peak and mean transprosthetic gradients were 21.0 ± 10.3 mm Hg and 10.2 ± 4.1 mm Hg, respectively. These values remained stable 12 and 24 months after surgery.

Conclusions

Transapical TAVI provides good results in terms of early and midterm clinical and hemodynamic outcomes. Thus it appears to be a safe and effective alternative treatment for patients who are inoperable or have high surgical risk.

Section snippets

Patients and Methods

This study represents an update of our previously published paper with data from the Italian Registry of Trans-Apical Aortic Valve Implantation (I-TA) [5]. The I-TA registry is a prospective, independent, and spontaneous registry with the participation of the majority of Italian cardiac surgery centers who started a TA-TAVI program. All patients undergoing TA-TAVI at each center were enrolled in this registry. From April 2008 through June 2012, 774 patients underwent TA-TAVI at 21 centers.

Results

Preoperative clinical variables of patients are listed in Table 1. Mean age was 81.0 ± 6.7 years, mean logistic EuroSCORE I was 25.6% ± 16.3%; EuroSCORE II, 9.4% ± 11.0%; and STS score, 10.6% ± 8.5%. New York Heart Association (NYHA) functional class III or IV was assigned to 621 patients (80.2%). Nearly 50% of patients had severe peripheral vascular disease. There were 167 patients (21.6%) who had already undergone cardiac surgery, and 139 patients (18.0%) who had percutaneous coronary

Comment

This study shows the results of transapical TAVI in a “real world” population. Our main findings are that transapical TAVI can be performed with an acceptable mortality rate, safety at 30 days, efficacy at 1 year, as well as 3-year survival and freedom from cardiovascular mortality, in particular if we consider the high surgical risk of these patients. All-cause mortality was 9.9%; this value is similar to that reported by other registries 9, 10, 11. The 30-day combined safety endpoint is a

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