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.

Acute and late outcomes of Transcatheter Aortic Valve Implantation (TAVI) for the treatment of severe symptomatic aortic stenosis in patients at high- and low-surgical risk.

BACKGROUND: This prospective study examines the impact of EuroSCORE and transfemoral (TF) or transapical (TA) delivery approach on mortality at 30 days and 1 year in patients with severe aortic stenosis implanted with either the Edwards SAPIEN Transcatheter Heart Valve (THV) or Medtronic CoreValve. METHODS AND RESULTS: TAVI was successfully performed in 293 (97.7%) of 300 patients (TF: 174, TA: 126, mean EuroSCORE 24.0). The mortality at 30 days and after 1 year was 6.0% and 17.3%. Mortality depends significantly on the logistic EuroSCORE with a 30-day odds ratio (OR) of 1.92 (95% CI 1.41 to 2.62, P < 0.001) and after 1 year of 1.67 (95% CI 1.34 to 2.08, P < 0.001). Mortality in patients with a logistic EuroSCORE <15 (n = 113) or ≥15 (n = 187) at 30 days was 0.9% versus 9.1% and after 1 year 7.1% versus 23.5% demonstrating significantly less mortality (P < 0.001) in patients with lower logistic EuroSCOREs. In this specific setup of our center there was no significant difference (P = 0.553) in mortality regarding the technical approach for TA (4.0% and 15.9%) and for TF (7.5% and 18.4%). Severe cardiac complications occurred in 20 patients (6.7%) with a 30-day mortality of 45.0%. CONCLUSION: The mortality in patients undergoing TAVI correlates significantly with the logistic EuroSCORE. Patients with a logistic EuroSCORE <15 can be implanted, with a low 30-day mortality and good long-term outcome over 1 year.

Clinical impact of a new left bundle branch block following TAVI implantation: 1-year results of the TAVIK cohort.

BACKGROUND: Compared with surgical aortic valve replacement, transcatheter aortic valve implantation (TAVI) is associated with a higher risk of developing a new conduction disorder that necessitates permanent pacemaker implantation (PM). The most frequently observed conduction disorder is left bundle branch block (LBBB), which impairs left ventricular function. OBJECTIVES: The primary objective of this study was to assess the incidence and prognostic significance of persistent new-onset LBBB following TAVI. Factors predictive of persistent new-onset LBBB were also explored. METHODS: This study included a total of 793 patients who underwent TAVI between May 2008 and April 2012. Patients were divided into two groups: those with persistent new-onset LBBB and those without persistent new-onset LBBB. Follow-up was conducted within 1-year of TAVI. RESULTS: Persistent new-onset LBBB was observed in 31.1 % (n = 197) out of 634 eligible patients. At 30 days and 1-year post-TAVI, the all-cause mortality rate was higher in patients with persistent new-onset LBBB (6.1 %, n = 12 and 20.8 %, n = 41, respectively) than in patients without new-onset LBBB (3.3 %, n = 10 and 13.0 %, n = 57, respectively; p = 0.014 and p = 0.010 for the two time points). Multivariate regression analyses revealed, that persistent new-onset LBBB was an independent predictor of all-cause mortality at 1 year (HR 1.84, 95 %CI 1.35-2.02). PM implantation was observed slightly more frequently in patients with persistent new-onset LBBB (14.2 %) than in those without (9.4 %; HR 1.60, 95 %CI 0.96-2.67). Risk factors for pacemaker (PM) were baseline RBBB (HR 6.23, 95 %CI 3.76-10.33), chronic atrial fibrillation (HR 1.75, 95 %CI 1.10-2.56) and the Medtronic CoreValve implantation (HR 2.40, 95 %CI 1.55-3.75). At 1-year follow-up, the mean survival of patients with PM (81.2 %) was slightly lower, but not significantly different from that of patients without PM (85.0 %; p = 0.377). Upon multivariable logistic binary regression analysis Medtronic CoreValve was associated with an increase rate of persistent new-onset LBBB (HR 2.52, 95 %CI 1.67-3.80) and PM implantation. Mortality during 1 year of follow-up, however, was neither increased in the total population (p = 0.232), nor in a subgroup of those with LBBB in a comparison of Medtronic CoreValve and Edwards SAPIEN. CONCLUSION: This study demonstrated that persistent new-onset LBBB was associated with increased mortality in patients undergoing TAVI. Compared with the Edwards SAPIEN valve, implantation of the Medtronic CoreValve resulted in a higher rate of both persistent new-onset LBBB and PM but not death.

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.