Transaortic transcatheter aortic valve implantation - rationale and design of the multicenter, multinational prospective ROUTE registry.

BACKGROUND: Transaortic transcatheter aortic valve implantation (TAo-TAVI) is a recently developed approach that provides an alternative delivery route for valve replacement in patients with vascular abnormalities or existing comorbidities. While initial studies have shown the principal efficacy and safety, the real world effectiveness and safety of this approach remains to be fully assessed. METHODS/DESIGN: In this regard, the Registry Of the Utilization of the TAo-TAVI approach using the Edwards SAPIEN Valve (ROUTE) represents the first multicenter, multinational prospective documentation of the course and outcome of patients with severe calcific aortic stenosis (AS) undergoing TAo-TAVI. ROUTE commenced in February 2013 with the goal of consecutively enrolling 300 patients at up to 22 sites across Europe. The primary objective of ROUTE is to determine the 30-day mortality associated with TAo-TAVI using the Edwards SAPIEN THV (Edwards Lifesciences, Irvine, CA). In addition, ROUTE aims to quantify complications, predictors of patient outcome and the value of CT guided valve sizing. DISCUSSION: Findings from this landmark registry will provide important information regarding procedural success rates and early mortality in patients undergoing TAo-TAVI. TRIAL REGISTRATION: Identifier: NCT01991431.

Left bundle-branch block induced by transcatheter aortic valve implantation increases risk of death.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is a novel therapy for treatment of severe aortic stenosis. Although 30% to 50% of patients develop new left bundle-branch block (LBBB), its effect on clinical outcome is unclear. METHODS AND RESULTS: Data were collected in a multicenter registry encompassing TAVI patients from 2005 until 2010. The all-cause mortality rate at follow-up was compared between patients who did and did not develop new LBBB. Of 679 patients analyzed, 387 (57.0%) underwent TAVI with the Medtronic CoreValve System and 292 (43.0%) with the Edwards SAPIEN valve. A total of 233 patients (34.3%) developed new LBBB. Median follow-up was 449.5 (interquartile range, 174-834) days in patients with and 450 (interquartile range, 253-725) days in patients without LBBB (P=0.90). All-cause mortality was 37.8% (n=88) in patients with LBBB and 24.0% (n=107) in patients without LBBB (P=0.002). By multivariate regression analysis, independent predictors of all-cause mortality were TAVI-induced LBBB (hazard ratio [HR], 1.54; confidence interval [CI], 1.12-2.10), chronic obstructive lung disease (HR, 1.56; CI, 1.15-2.10), female sex (HR, 1.39; CI, 1.04-1.85), left ventricular ejection fraction ≤50% (HR, 1.38; CI, 1.02-1.86), and baseline creatinine (HR, 1.32; CI, 1.19-1.43). LBBB was more frequent after implantation of the Medtronic CoreValve System than after Edwards SAPIEN implantation (51.1% and 12.0%, respectively; P<0.001), but device type did not influence the mortality risk of TAVI-induced LBBB. CONCLUSIONS: All-cause mortality after TAVI is higher in patients who develop LBBB than in patients who do not. TAVI-induced LBBB is an independent predictor of mortality.

The Impella 2.5 and 5.0 devices for ST-elevation myocardial infarction patients presenting with severe and profound cardiogenic shock: the Academic Medical Center intensive care unit experience.

OBJECTIVE: Cardiogenic shock remains an important therapeutic challenge, with high in-hospital mortality rates. Mechanical circulatory support may be beneficial in these patients. Since the efficacy of the intra-aortic balloon pump seems limited, new percutaneously placed mechanical left ventricular support devices, such as the Impella system, have been developed for this purpose. Our current purpose was to describe our experience with the Impella system in patients with ST-elevation myocardial infarction presenting in profound cardiogenic shock, who were admitted to our intensive care unit for mechanical ventilation. METHODS: From January 2004 through August 2010, a total of 34 ST-elevation myocardial infarction patients with profound cardiogenic shock were admitted to our intensive care unit and treated with either the Impella 2.5 or the Impella 5.0 device. Baseline and follow-up characteristics were collected retrospectively. MEASUREMENTS AND MAIN RESULTS: Within the study cohort, 25 patients initially received treatment with the Impella 2.5, whereas nine patients received immediate Impella 5.0 support. Eight out of 25 patients in the Impella 2.5 group were upgraded to 5.0 support. After 48 hrs, 14 of 25 patients in the 2.5 group were alive, five of whom had been upgraded. In the 5.0 group, eight out of nine patients were alive. After 30 days, six of 25 patients in the 2.5 group were alive, three of whom had been upgraded. In the 5.0 group, three of nine patients were alive at 30 days. CONCLUSIONS: In ST-elevation myocardial infarction patients with severe and profound cardiogenic shock, our initial experience suggests improved survival in patients who received immediate Impella 5.0 treatment, as well as in patients who were upgraded from 2.5 to 5.0 support, when compared to patients who received only Impella 2.5 support.

Transcatheter Aortic Valve Replacement Using Transaortic Access: Experience From the Multicenter, Multinational, Prospective ROUTE Registry.

OBJECTIVES: The Registry of the Utilization of the TAo-TAVR approach using the Edwards SAPIEN Valve (ROUTE) was established to assess the effectiveness and safety of the use of transaortic (TAo) access for transcatheter aortic valve replacement (TAVR) procedures (NCT01991431). BACKGROUND: TAVR represents an alternative to surgical valve replacement in high-risk patients. Whereas the transfemoral access route is used commonly as the first-line approach, transapical access is an option for patients not suitable for transfemoral treatment mainly due to anatomic conditions. TAo-TAVR has been shown to be a viable alternative surgical access route; however, only limited data on its effectiveness and safety has been published. METHODS: ROUTE is a multicenter, international, prospective, observational registry; data were collected from 18 centers across Europe starting in February 2013. Patients having severe calcific aortic stenosis were documented if they were scheduled to undergo TAo-TAVR using an Edwards SAPIEN XT or a SAPIEN 3 valve. The primary endpoint was 30-day mortality. Secondary endpoints were intraprocedural or in hospital and 30-day complication rates. RESULTS: A total of 301 patients with a mean age of 81.7 ± 5.9 years and an Society of Thoracic Surgeons score of 9.0 ± 7.6% were included. Valve success was documented in 96.7%. The 30-day mortality was 6.1% (18/293) (procedure-related mortality: 3.1%; 9 of 293). The Valve Academic Research Consortium-2 defined complications included myocardial infarction (1.0%), stroke (1.0%), transient ischemic attack (0.3%), major vascular complications (3.4%), life-threatening bleeding (3.4%), and acute kidney injury (9.5%). In 3.3% of patients, paravalvular regurgitation was classified as moderate or severe (10 of 300). Twenty-six patients (8.8%) required permanent pacemaker implantation. CONCLUSIONS: TAo access for TAVR seems to be a safe alternative to the transapical procedure.