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Transfemoral Aortic Valve Implantation with the New Edwards Sapien 3 Valve for Treatment of Severe Aortic Stenosis-Impact of Valve Size in a Single Center Experience.

ABSTRACT: AIMS:The third generation Edwards Sapien 3 (Edwards Lifesciences Inc., Irvine, California) system was optimized to reduce residual aortic regurgitation and vascular complications. METHODS AND RESULTS:235 patients with severe symptomatic aortic stenosis were prospectively enrolled. Transcatheter aortic valve implantations (TAVI) were performed without general anesthesia by transfemoral approach. Patients were followed for 30 days. Patients received 23mm (N = 77), 26mm (N = 91) or 29mm (N = 67) valve based on pre-procedural 256 multislice computer tomography. Mean oversizing did not differ between the 3 valves. There was no residual moderate or severe aortic regurgitation. Rate of mild aortic regurgitation and regurgitation index did not differ between groups. There was no switch to general anesthesia or conversion to surgery. Rate of major vascular complication was 3.0% with no difference between valve and delivery sheath sizes. Within 30 days rates of all cause mortality (2.6%) and stroke (2.1%) were low. CONCLUSIONS:In patients with severe aortic stenosis transfemoral TAVI with the Edwards Sapien 3 valve without general anesthesia was associated with a high rate of device success, no moderate or severe residual aortic regurgitation, low rates of major vascular complication, mortality and stroke within 30 days with no difference between the 3 valve sizes. TRIAL REGISTRATION:ClinicalTrials.gov NCT02162069.

SUBMITTER: Wohrle J

PROVIDER: S-EPMC4803290 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

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Transfemoral Aortic Valve Implantation with the New Edwards Sapien 3 Valve for Treatment of Severe Aortic Stenosis-Impact of Valve Size in a Single Center Experience.

Wöhrle Jochen J Gonska Birgid B Rodewald Christoph C Seeger Julia J Scharnbeck Dominik D Rottbauer Wolfgang W

PloS one 20160322 3

<h4>Aims</h4>The third generation Edwards Sapien 3 (Edwards Lifesciences Inc., Irvine, California) system was optimized to reduce residual aortic regurgitation and vascular complications.<h4>Methods and results</h4>235 patients with severe symptomatic aortic stenosis were prospectively enrolled. Transcatheter aortic valve implantations (TAVI) were performed without general anesthesia by transfemoral approach. Patients were followed for 30 days. Patients received 23mm (N = 77), 26mm (N = 91) or 2 ...[more]

PMID: 27003573

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Project description:Objectives:The current 2017 ESC/EACTS guidelines recommend transcatheter aortic valve implantations (TAVIs) as the therapy of choice for inoperable patients with severe symptomatic aortic stenosis. Most of the TAVIs worldwide are performed under general anaesthesia (GA). Although conscious sedation (CS) concepts are increasingly applied in Europe, it is still a matter of debate which concept is associated with highest amount of safety for this high-risk patient population. The aim of this single center, before-and-after study was to investigate feasibility and safety of CS compared with GA with respect to peri-procedural complications and 30-day mortality in patients scheduled for transfemoral TAVI (TF-TAVI). Methods:From March 2012 until September 2014, patients scheduled for the TF-TAVI procedure were included in a prospective, observational manner. From the 200 patients finally included, 107 procedures were performed under GA, using either an endotracheal tube or a laryngeal mask, and balanced anaesthesia. CS was performed in 93 patients using low-dose propofol and remifentanil. Results:Conversion to GA was needed 4 times due to procedural-related complications (4.3%), in one patient due to ongoing agitation (1.1%). The CS-group showed significantly shorter key time courses: anaesthesia time (105 [95-120] minutes vs 115 [105-140] minutes, P-value = 0.009, Mann-Whitney-U-test) and length of stay in the intensive care unit (1.6 [1.0-1.5] d vs 2.1 [1.0-2.0] d, P-value = 0.002, Mann-Whitney-U-test). The lowest mean arterial pressure was significantly higher in the CS-group compared with the GA-group (74.3 mmHg vs 55.2 mmHg, P-value <0.0001, t-test). CS was associated with less requirements of norepinephrine (0.1 μg/kg vs 2.3 μg/kg, P-value <0.0001, Mann-Whitney-U-test). Conclusions:Our single-center data demonstrate that CS is a feasible and safe alternative, especially with respect to a higher degree of intra-procedural haemodynamic stability, and a reduced length of stay in the intensive care unit.

Project description:Off-pump transapical aortic valve implantation (TA-TAVI) through mini-thoracotomy was first performed in Vancouver, Canada in October 2005. The objective of this manuscript is to describe the Vancouver experience with 178 TA-TAVI cases in symptomatic severe aortic stenosis (AS) since 2005.Baseline characteristics and in-hospital outcomes were calculated for the overall cohort. To compare pre-procedure and post-procedure echocardiographic measurements, one way analysis of variance was utilized, followed by Tukey's HSD. In-hospital outcomes were compared between early and late cohorts using Z-test and chi-squared test as appropriate. Kaplan-Meier analysis was used to generate 3-year survival curves. The Log-rank test was used to compare survival between low-risk and high-risk groups, based on STS score.Between October 2005-March 2012, TA-TAVI was performed in 178 patients. Mean age was 80.5±8.6 years. Congestive heart failure and renal failure were more common in the late cohort, while previous myocardial infarction was more common in the early cohort (P<0.05). Eleven patients (6.2%) had significant intra-operative complications, including death (1.7%), conversion to CPB (3.9%), and valve embolization (1.1%). In-hospital survival was 87.9%. Mean length of hospital stay was 12.2±17.1 days. In-hospital incidence of stroke was 3.4%. Bleeding (20.2% vs. 4.7%) and vascular (14.6% vs. 3.5%) complications were more common in the early cohort. Echocardiography demonstrated a significant increase in aortic valve area and decrease in mean transvalvular gradient post-procedure. These improvements were maintained throughout the 3-year follow-up period. Overall survival was 72.1% at 6 months, 67.7% at 12 months, 55.5% at 24 months, and 47.3% at 36 months. Repeated Kaplan-Meier analysis for the 2 groups stratified by STS score, demonstrated improved survival in the low-risk group (Log-rank P=0.039).Among patients with symptomatic severe AS at high risk for conventional AVR, TA-TAVI is a reasonable therapeutic option with acceptable risk. Long-term survival appears to be superior in lower-risk patients.

Dataset Information

Transfemoral Aortic Valve Implantation with the New Edwards Sapien 3 Valve for Treatment of Severe Aortic Stenosis-Impact of Valve Size in a Single Center Experience.

Publications

Transfemoral Aortic Valve Implantation with the New Edwards Sapien 3 Valve for Treatment of Severe Aortic Stenosis-Impact of Valve Size in a Single Center Experience.

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