A comparison of transcatheter aortic valve implantation and surgical aortic valve replacement in 1,141 patients with severe symptomatic aortic stenosis and less than high risk.

OBJECTIVES: To assess outcomes for patients undergoing transcatheter aortic valve implantation (TAVI) versus surgical aortic valve replacement but with less than high risk. BACKGROUND: While there is abundant data for high risk patients there is insufficient data for reduced risk. METHODS: Patients undergoing TAVI or SAVR between 2007 and 2012 in Karlsruhe were considered. They were assessed by cardiac computed tomography, transoesophageal echocardiogram, and logistic EuroSCORE I (ES) and groups compared using Propensity Score Matching. RESULTS: The mean ES was 10.1±2.8 in the TAVI group (n = 419) and 5.7 ± 3.2 in the SAVR group (n = 722; P < 0.0001). Mean survival probability over 3 years was higher in patients undergoing surgery (P < 0.0001). A total of 432 patients were considered for the matched-pairs analysis based on propensity scores (216 in each group). Major vascular complications (10.6% vs. 0.0%; P < 0.0001), new pacemaker implantation (13.9% vs. 4.6%; P < 0.001) and moderate aortic insufficiency (3.2% vs. 0.5%; P = 0.03) were more frequent in patients undergoing TAVI. Major (20.8% vs. 4.2%; P < 0.0001) and life-threatening (14.5% vs. 2.3%; P < 0.0001) bleeding complications were more frequent in those undergoing surgery. Survival probability over 3 years in the propensity matched cohort was comparable between both groups (P = 0.16). CONCLUSIONS: In this large, single center, real world dataset there was no difference in mortality between patients undergoing TAVI or SAVR during a 3-year follow-up but there was a TAVI related increase in major vascular complications, new pacemaker implantation and aortic insufficiency and a SAVR related increased bleeding risk.

Feasibility of transcatheter aortic valve implantation in patients with coronary heights ≤7 mm: insights from the transcatheter aortic valve implantation Karlsruhe (TAVIK) registry.

OBJECTIVES: Transcatheter aortic valve implantation (TAVI) in patients with low coronary heights is generally denied but is not impossible. Information about these high-risk procedures is sparse. METHODS: Since May 2008, data of more than 3000 patients who had TAVI were prospectively collected in the institutional TAVI Karlsruhe registry. Characteristics, peri- and postoperative outcome of patients with low coronary heights of ≤7 mm were analysed according to the Valve Academic Research Consortium-2. RESULTS: Eighty-six patients with an average coronary height of 6.4 ± 1.1 mm (mean age 81.0 ± 5.3 years, logistic EuroSCORE I 19.6 ± 13.3%) were treated. TAVI was performed in 72 transfemoral (83.7%) and 14 transapical (16.3%) cases using 44 CoreValve/Evolut R (51.2%), 21 Sapien XT/S3 (24.4%), 14 ACURATE (16.3%), 5 Lotus (5.8%) and 2 Portico (2.3%) prostheses. Ten procedures were valve-in-valve (VinV) TAVI (VinV, 11.6%). The 72-h, 30-day, 1-year and follow-up (3.0 ± 1.6 years) mortality rates were 2.3%, 8.0%, 10.5% and 26.7%, respectively. Within 30 days, 4 cardiac deaths and 3 non-cardiac deaths occurred (4.7% and 3.5%). Three coronary obstructions (3.5%) occurred-2 during VinV TAVI. One patient was connected to extracorporeal circulation that could not be weaned later due to an unsuccessful percutaneous coronary intervention. Another patient, the only conversion (1.2%), required delayed surgical valve replacement. The third patient died of right heart failure after aortic dissection. The procedural success rate was 95.3%. VinV procedures were associated with increased follow-up deaths (P < 0.001; hazard ratio 7.96). CONCLUSIONS: Coronary-related complications in TAVI procedures in patients with coronary heights ≤7 mm occurred less frequently, but once they occurred, they were serious. These TAVI procedures are feasible, with a high procedural success rate, but meticulous preoperative planning should be mandatory. In VinV procedures, the follow-up mortality rate is increased; therefore, we do not recommend these procedures.

Long-term results of transapical versus transfemoral TAVI in a real world population of 1000 patients with severe symptomatic aortic stenosis.

BACKGROUND: Transapical transcatheter aortic valve implantation is generally perceived to be associated with increased morbidity compared with transfemoral transcatheter aortic valve implantation. We aimed to compare access-related complications and survival using propensity score matching. METHODS AND RESULTS: Prospective, single-center registry of 1000 consecutive patients undergoing transapical and transfemoral transcatheter aortic valve implantation between May 2008 and April 2012. Transapical was performed in 413 patients and transfemoral in 587 patients. Patients with transapical access were less often women and less had pulmonary hypertension. Further they had more peripheral arterial disease, coronary artery disease, carotid stenosis, and recurrent surgery and a higher logistic EuroSCORE I (24.3% ± 16.2% for transapical versus 22.2% ± 16.2% for transfemoral; P < 0.01). After building 2 propensity score-matched groups of 354 patients each with either access route (total 708 patients), baseline characteristics were comparable. In this analysis, there was no significant difference in 30 day mortality (5.9% transapical versus 8.5% transfemoral; P = 0.19), the rate of myocardial infarction (2.5% transapical versus 2.0% transfemoral; P = 0.61), stroke (2.0% transapical versus 2.3% transfemoral; P = 0.79), bleeding complications, pacemaker implantation rates, or moderate aortic insufficiency. Stage 1 renal complications were more common in transapical patients (odds ratio, 2.81; 95% confidence interval, 1.93-4.09), whereas major vascular complications were less common (odds ratio, 0.14; 95% confidence interval, 0.06-0.29). Survival probability over the long term was not statistically different (hazard ratio, 0.89; 95% confidence interval, 0.72-1.10; log-rank Test, P = 0.27). CONCLUSIONS: The data demonstrate that in an experienced multidisciplinary heart team, either access route can be performed with comparable results.

Ruptures of the device landing zone in patients undergoing transcatheter aortic valve implantation: an analysis of TAVI Karlsruhe (TAVIK) patients.

BACKGROUND: Aortic rupture of the device landing zone is a rare complication of transcatheter aortic valve implantation (TAVI) and it is associated with significant mortality. METHODS: This study reports on the experience of a single-center in a case series of more than 1,000 implants. We explored patient and procedural characteristics aiming at identifying variables that increase the risk for aortic root rupture. RESULTS: Among a total of 1,000 TAVI procedures, six patients (0.6 %) had a rupture of the device landing zone. Five of these patients received the balloon-expandable Edwards SAPIEN valve (5/813; 0.62 %) of which four had a supraannular and one a subannular rupture. One patient received the self-expanding Medtronic CoreValve (1/199; 0.5 %; p = n.s. vs. SAPIEN) and had an annular rupture. Factors that were associated with aortic rupture were: (1) the relative size of the valve compared with the aortic annulus and its geometric form; (2) the need for post-dilation of the new valve because of paravalvular leakage; and (3) the location and severity of calcification. We determined, to avoid aortic rupture, caution may be necessary in the presence of the following conditions: (1) flat sinuses of Valsalva and severe calcifications of either the body or the free edge of the aortic cusps (supraannular rupture); (2) an ellipsoid annulus and bulky calcifications on either the base of the cusps or the rim of the annulus (annular rupture); and (3) a narrow left-ventricular outflow tract (LVOT) and bulky calcification of the LVOT (subannular rupture). After considering these precautions, we observed no case of aortic root rupture in the following 600 cases. CONCLUSION: The data indicate that to reduce the frequency of aortic rupture, a careful pre-procedural planning appears essential to avoid this serious and potentially deleterious complication.