Long Term Single Center Results after 3 Years of TA-TAVI with Edwards Sapien XT Prosthesis

Objective: Since 2008 transapical valve implementation (TA-TAVI) became an alternative to standard (AVR) or minimal invasive aortic valve replacement (MIS-AVR) in elderly patients with high co-morbidities or critical preoperative state. Nevertheless, the long term benefit of this procedure is controversially discussed. Aim of this single center study was to evaluate the 6-month results after TA-TAVI with the Edwards Sapien XT-Prosthesis.

Methods: 106 patients with severe aortic stenosis and age ≥75 years (EuroSCORE II 7.9 ± 6.1%, STS-Score 14.5 ± 11.9) were included over 3 years. Pre-, peri- and postoperative data were monitored by a study nurse. Routinely a TEE-valve-evaluation was performed during the TA-TAVI procedure respectively on POD 5. Renal function was monitored daily until POD 8. Six month after discharge patients were re-evaluated regarding the valve function, the renal status and the occurrence of major adverse cardiac or cerebral events.

Results: Postoperative average Δp_max was 19.9 ± 12.1 with Δp_mean of 10.9 ± 7.7 mm Hg. 35% of the patients presented a paravalvular leakage grade I, 3.7% presented a central leakage. Mean operation time was 115 ± 55 minute, fluoroscopy time 6.7 ± 5.5 minute with 77.8 ± 26.1 ml radio-contrast media. Periprocedural hemodynamic instability occurred in n = 10 (9.4%), with a conversion rate to standard AVR or MIS-AVR of 8.5%. Two patients (1.9%) died periprocedurally: one caused by annulus rupture, the other by an uncontrollable bleeding from the apex. Mean ICU-stay was 3.2 ± 3.8 days, with a total in hospital-stay of 12.1 ± 7.3 days. Three re-thoracotomies for bleeding (2.8%), one coronary stenting (1%) and n = 8 pacemaker implantations were needed. An acute kidney injury after TA-TAVI occurred in n = 19 (18%) patients (14% stage 1; 4% stage 2). The perioperative stroke rate was 3%. In the 6-month follow up, the renal insufficiency increased to n = 26 (24%), the stroke-rate to n = 7 (6.6%) and one myocardial infarction occurred (1%). The postoperative mortality after 6 month was 19%.

Conclusion: TA-TAVI with first generation Edwards Sapien XT prosthesis may be conducted safely. Due to its simple implantation the periprocedural complication rate is low. Nevertheless the pravalvular leakage rate with 35% is remarkable and could be responsible for the increased 6-month mortality in the long-term follow up. Therefore, even in elderly patients MIS-AVR should be considered as a surgical alternative, since the latest still yields excellent results.