Balloon-expandable transapical transcatheter aortic valve implantation with or without predilation of the aortic valve: results of a multicentre registry.

OBJECTIVES: To assess safety and efficacy of transapical transcatheter aortic valve implantation (TA-TAVI) in the absence of predilation using balloon aortic valvuloplasty (BAV). Predilation of the stenosed valve using BAV is a routine step in TA-TAVI; however, evidence supporting its clinical value is lacking, and several studies have linked it with higher complication rates. METHODS: A prospective, two-armed, multicentre registry (EASE-IT TA) to gather data on patients undergoing TA-TAVI with or without BAV, using the Edwards SAPIEN 3 valve was designed. The primary evaluation criterion was a composite of all-cause mortality, non-fatal stroke, non-fatal myocardial infarction, acute kidney injury and pacemaker implantation [per Valve Academic Research Consortium-2 (VARC-2)] within 30 days after TAVI. RESULTS: A total of 198 subjects underwent TA-TAVI, 61 with and 137 without BAV. Patient characteristics were comparable at baseline (mean ± SD: age 80.3 ± 5.7 years; logistic EuroSCORE 20.2 ± 12.6). Similar reductions in peak and mean transvalvular gradients were observed post-procedurally. There was a significant reduction of fluoroscopy time without BAV (4.7 vs 7.9 min; P = 0.039) and significantly decreased odds of catecholamine administration (17.5% vs 32.8%; P = 0.017). A decreased odds of the primary evaluation criterion in patients without BAV after 30 days (adjusted odds ratio 0.71; 95% confidence interval 0.34-1.82) and the same composite end-point after 6 months (adjusted odds ratio 0.74; 95% confidence interval 0.37-1.47) were not significant even after multivariable adjustment. CONCLUSIONS: TA-TAVI without BAV appears to be at least equal to its conventional counterpart in terms of efficacy and may offer advantages in terms of safety. Thus, there appears to be little justification for maintaining the BAV step in TA-TAVI for many patients.

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.

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.

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.

How to adapt the implantation technique for the new SAPIEN 3 transcatheter heart valve design.

The new balloon-expandable Edwards SAPIEN 3 THV has significant design improvements requiring adjustments in the implantation technique as compared to the previous generation SAPIEN XT. Basically, the new valve requires less oversizing due to the outer skirt, which, if positioned underneath the annulus, can reduce the occurrence and severity of paravalvular leak (PVL). As with any transcatheter vale, a thorough assessment of the device-landing-zone, the surrounding structures, and the distribution of calcifications is of vast importance. Once the SAPIEN 3 valve is positioned with the initial orientation of the middle balloon marker at the level of the leaflet hinge points, the outer skirt will remain under the annulus, despite the foreshortening of the lower inflow portion of the valve. If there is an incomplete apposition, the outer skirt can conform to the anatomy, close the gaps, and reduce the risk of PVL. When calcifications are located on the edges of the annulus, PVL is common with the SAPIEN XT THV but dramatically reduced with the SAPIEN 3 THV. If the calcification extends from the annulus into the entire LVOT, there is always an incomplete apposition of the either valve frame; however, the resulting PVL is reduced by the outer skirt of the SAPIEN 3. In 165 consecutive SAPIEN 3 patients, 89.7% (n = 145) had none or a trace PVL and there were no patients with moderate or severe PVL. The new generation SAPIEN 3 valve allows more challenging anatomies to be treated, requires less oversizing, and can reduce PVL.

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.