Cumulative complication rate in 111 consecutive patients treated by TAVI

Objectives: Transcatheter aortic valve implantation (TAVI) is a safe procedure for the treatment of patients with severe aortic stenosis uneligible for conventional surgery. The procedure is still refined, so the learning curve has not reached a plateau yet. The objective of this study was to evaluate the cumulative complication rate in 111 patients treated by TAVI in a single center.

Methods: From February 2011 until April 2012 111 consecutive TAVI procedures (transapical (TA) n = 50 and transfemoral (TF) n = 61) have been carried out exclusively using Edwards Sapien bioprostheses. We established a registry for all perioperative complications.

Results: Of these 111 consecutive patients 61% were females, mean age was 80.6 years ± 11.0, mean ejection fraction was 48.3%± 10.3, and mean logistic EuroScore was 21.2%± 13.8 (TA 22.7%± 18.8; TF 19.9%± 10.8). 23 mm valve size were implanted in 16 TA (32.0%) and 22 TF (36.1%) patients, 26 mm valve in 23 TA (46.0%) and 38 TF (62.3%) patients, and 29 mm valve in 11 TA (22.0%) and 1 TF (1.6%) patients.The 30 day mortality was 6.3% (8.0% TA; 4.9% TF), stroke rate was 1.8% (0% TA; 3.3% TF), new left bundle brunch block occurred in 13.5% (8.0% TA; 18.0% TF), and new pacemaker rate was 8.1% (4.0% TA; 11.5% TF). Femoral access site revisions were indicated in 4.5% (0.9% TA; 3.6% TF) while no thoracic access site revision was necessary. Post-procedural aortic regurgitation (AR) grade 0 – I was present in 89.2% (94.0% TA; 85.2% TF), AR grade >I – II+ in 10.8% (6.0% TA; 14.8% TF) and AR grade III and IV was not present in both groups. Intraoperative post-dilatation of the implanted valve was necessary in 27.9% (12.0% TA; 31.1% TF). A valve-in-valve procedure was performed in 3.6% (6.0% TA; 1.6% TF). An intraoperative “heart team” approach was realised in 97.3% (108/111 procedures). Statistical analysis revealed no significant differences between both groups in all observed items, except 29 mm valve size implanted (p = 0.001) due to technical reasons.

Conclusions: The very low peri-, and post-procedural cumulative complication rate in 111 consecutive patients emphasizes the importance of transcatheter aortic valve implantation in high risk patients. These excellent results can only be performed by implementation of a consistent “heart team” with continuous TAVI conferences. Because of our marginal stroke rate of 1.8% we are still in discussion about the need for protection devices to minimize neurological complications.