Self-expanding Aortic Bioprosthesis Research Articles

Next-day Discharge Following Transcatheter Aortic Valve Implantation With The Acurate neo/neo2 Self-expanding Aortic Bioprosthesis

Prior studies have shown the safety of early discharge (ED) pathways in selected patients and using selected transcatheter heart valves. Hence, we sought to evaluate the safety of next-day discharge (NDD) in patients who underwent transfemoral transcatheter aortic valve implantation (TF-TAVI) with the Acurate neo/neo2 (Boston Scientific, Marlborough, MA) self-expanding aortic bioprosthesis. Patients who underwent TF-TAVI between January 2018 and April 2023 were prospectively included. Patients were stratified into 3 groups according to discharge times within 24h (NDD), between 24-48h and those discharged >48h following TAVI. The primary outcome was the first unplanned readmission at 30 days after TAVI. Log-rank test was used to assess differences in the outcome of interest among groups. A total of 368 allcomers were included in this study. According to discharge times, 204 patients followed NDD, 69 patients 24-48h discharge and 95 patients >48h discharge following TAVI. The mean age was 84±6.3 years and 61% were female, without differences between groups. The mean STS-score was lower among those with NDD versus 24-48h and >48h (2.9±1.0, 3.2±1.2 and 3.4±1.4, respectively, P=0.014). There were no differences between the groups in terms of preprocedural right bundle branch block or pacemaker. The need for new permanent pacemaker implantation (PPI) was the leading postprocedural complication; it occurred more frequently among the >48h group compared with the 24-48h and <24h groups (24% versus 8.6% and 2.2%, P<0.001). There were 5 (1.4%) strokes and all of them occurred in the >48h group (P=0.005). At 30 days after discharge, there were no deaths, and no differences in all-cause readmissions (9.3% in <24h, 8.6% in 24-48h, and 19% in >48h, log-rank P=0.087). Readmission rates for new PPI requirement were 3.3% (n=6) in NDD, 0% in 24-48h and 1.6% (n=5) in >48h groups (P=0.27). In conclusion, in unselected patients undergoing TF-TAVI with the Acurate neo/neo2 self-expanding bioprosthesis, the NDD pathway is feasible and appears to be safe, without an increased risk of death or all-cause rehospitalization through 30 days after hospital discharge.

SINGLE ARTERIAL ACCESS FOR TRANSFEMORAL TRANSCATHETER AORTIC VALVE IMPLANTATION WITH THE ACURATE NEO SELF-EXPANDING AORTIC BIOPROSTHESIS: INSIGHTS FROM THE LONDON HEALTH SCIENCES CENTRE HEART TEAM

SINGLE ARTERIAL ACCESS FOR TRANSFEMORAL TRANSCATHETER AORTIC VALVE IMPLANTATION WITH THE ACURATE NEO SELF-EXPANDING AORTIC BIOPROSTHESIS: INSIGHTS FROM THE LONDON HEALTH SCIENCES CENTRE HEART TEAM

Complicated Interaction Between Balloon Expandable Sheath and Self-Expanding Aortic Bioprosthesis

An 83-year-old woman with severe symptomatic aortic stenosis, assessed by the heart team as high surgical risk, was referred for transcatheter aortic valve replacement (TAVR). Pre-procedural computed tomography demonstrated calcific trileaflet aortic stenosis with a perimeter-derived annular

Transaortic Transcatheter Aortic Valve Implantation: Learning Curve, Perioperative, and Midterm Follow-Up Results of a Single Center.

We present our initial institutional experience with transaortic (TAo) transcatheter aortic valve implantation (TAVI) using a self-expanding aortic bioprosthesis. A total of 106 patients underwent TAo TAVI with Medtronic CoreValve through a small partial upper sternotomy. We focus our analysis on the overall perioperative results, procedural learning curve (first 30 patients), and midterm follow-up outcomes. VARC-2 device success was achieved in 95 patients (89%), and there were no intraoperative deaths. Nine patients (8.4%) required a second valve and conversion to standard surgery was required in 2 patients (1.8%). The final aortic insufficiency was grade 0 in 65 patients (62%) and grade 1 in 39 (37%). Although patients treated in the TAo TAVI learning phase required a significantly longer radiation time and contrast agent use, device success (93.4% versus 88.2%, P = .7) and prostheses hemodynamics were similar. All-cause mortality at 30 days was 12% (13/106). At a median follow-up of 392 days (IQR: 216-494 days) estimated overall 1-year survival was 72%. No significant differences were reported in terms of 30-day and 1-year observed mortality, and estimated 1-year survival in the learning and later phase of TAo TAVI. TAo TAVI can be performed safely even in the very early phase of the learning curve. Although satisfactory results can be achieved from the beginning, a significant reduction in contrast agent use and radiological exposure are expected as the technique is mastered. Good hemodynamics have been documented and should be further improved with modifications achieved in the TAVI self-expandable valves technology.

740 - Coronary procedures in patients treated by TAVI with the self-expanding aortic bioprosthesis Medtronic CoreValve ©, not an easy matter

740 - Coronary procedures in patients treated by TAVI with the self-expanding aortic bioprosthesis Medtronic CoreValve ©, not an easy matter

2-Year Outcomes After Iliofemoral Self-Expanding Transcatheter Aortic Valve Replacement in Patients With Severe Aortic Stenosis Deemed Extreme Risk for Surgery

BackgroundWe reported favorable 1-year outcomes in patients unsuitable for surgery who underwent self-expanding transcatheter aortic valve replacement (TAVR) compared with an objective performance goal. Longer-term outcomes in these patients are not known. ObjectivesThis study sought to evaluate the 2-year safety and efficacy in patients with severe aortic stenosis (AS) at extreme risk of surgery treated with self-expanding TAVR. MethodsWe performed a prospective, multicenter, controlled, nonrandomized investigation of self-expanding TAVR in patients with severe AS and prohibitive surgical risk. We report the 2-year clinical outcomes in these patients. ResultsA total of 489 extreme-risk patients were treated transfemorally with a self-expanding aortic bioprosthesis at 41 centers. The rate of all-cause mortality or major stroke was 38.0% at 2 years (all-cause mortality, 36.5%; major stroke, 5.1%). The rates of all-cause mortality, cardiovascular mortality, and major stroke were 36.6%, 26.2%, and 5.1%, respectively, at 2 years. Between 1 and 2 years, the incremental all-cause mortality, cardiovascular mortality, and major stroke rates were 12.3%, 7.9%, and 0.8%, respectively. Multivariable predictors of all-cause mortality at 2 years included the presence of coronary artery disease and admission from an assisted living center. A Society of Thoracic Surgeons score >15% was also predictive of 2-year all-cause mortality. At 2 years, 94% of patients had New York Heart Association functional class I or II symptoms. The frequency of moderate or severe paravalvular regurgitation (4.3% at 1 year; 4.4% at 2 years) was unchanged between the first and second year. ConclusionsPatients with severe AS at extreme surgical risk treated with self-expanding TAVR continued to show good clinical outcomes and hemodynamic valve performance at 2 years. The presence of comorbid conditions rather than valve performance affected 2-year outcomes in these patients. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902)

Sutureless Aortic Valve Replacement With the Perceval S Prosthesis : a Canadian Multicenter Study

The Perceval S valve is a sutureless self-expanding aortic bioprosthesis that has recently been introduced as an alternative to standard aortic valve replacement (AVR) in elderly and high-risk surgical patients. The purpose of this multicenter study is to report the early Canadian experience with this new prosthesis.

Direct-aortic “evolute” self-expanding aortic bioprosthesis implantation

Direct-aortic “evolute” self-expanding aortic bioprosthesis implantation

Transcatheter aortic valve implantation with a self‐expanding nitinol bioprosthesis

To ascertain incidence and predictors of new permanent pacemaker (PPM) following transcatheter aortic valve implantation (TAVI) with the self-expanding aortic bioprosthesis. TAVI with the Medtronic Corevalve (MCV) Revalving System (Medtronic, Minneapolis, MN) has been associated with important post-procedural conduction abnormalities and frequent need for PPM. Overall, 73 consecutive patients with severe symptomatic AS underwent TAVI with the MCV at two institutions; 10 patients with previous pacemaker and 3 patients with previous aortic valve replacement were excluded for this analysis. Clinical, echocardiographic, and procedural data were collected prospectively in a dedicated database. A standard 12-lead ECG was recorded in all patients at baseline, after the procedure and predischarge. Decision to implant PPM was taken according to current guidelines. Logistic multivariable modeling was applied to identify independent predictors of PPM at discharge. Patients exhibited high-risk features as evidenced by advanced age (mean = 82.1 ± 6.2 years) and high surgical scores (logistic EuroSCORE 23.0 ± 12.8%, STS score 9.4 ± 6.9%). The incidence of new PPM was 28.3%. Interventricular septum thickness and logistic Euroscore were the baseline independent predictors of PPM. When procedural variables were included, the independent predictors of PPM were interventricular septum thickness (OR 0.52; 95% CI 0.32-0.85) and the distance between noncoronary cusp and the distal edge of the prosthesis (OR 1.37; 95% CI 1.03-1.83). Conduction abnormalities are frequently observed after TAVI with self-expandable bioprosthesis and definitive pacing is required in about a third of the patients, with a clear association with depth of implant and small interventricular septum thickness.

Preliminary feasibility and hemodynamic performance of a newly-developed self-expanding bioprosthesis and 16-F delivery system in transcatheter aortic valve implantation in sheep

We sought to evaluate the feasibility and hemodynamic performance of a new self-expanding bioprosthesis and 16-F delivery system in sheep. A 23-mm new self-expanding aortic bioprosthesis was implanted in sheep (n = 10) with a 16-F catheter via the right common carotid artery. Each sheep underwent angiography and coronary angiography before intervention, immediately and 1 h after stent implantation. Electrocardiographic monitoring was carried out during and 2 h after the procedure. Transthoracic echocardiography was employed to detect he-modynamic performance before intervention, immediately and 1 and 2 h after stent implantation. All sheep were euthanized 2 h after successful implantation for macroscopic inspection. In all cases, the new self-expanding aortic bioprosthesis was successfully delivered to the aortic root and released with a 16-F catheter. Successful implantation was achieved in 8 of 10 sheep. Hemodynamic performance and device position of successful implantation were stable 2 h after device deployment. Atrioventricular block was not observed. We conclude that it is feasible to implant the new self-expanding aortic valve with a 16-F delivery system into sheep hearts via the retrograde route.