Commentary: The safety and efficacy of balloon-expandable vs. self-expanding trans-catheter aortic valve replacement in high-risk patients with severe symptomatic aortic stenosis.
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SUBMITTER: Reardon MJ
PROVIDER: S-EPMC10773742 | biostudies-literature | 2023
REPOSITORIES: biostudies-literature
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Commentary: The safety and efficacy of balloon-expandable vs. self-expanding trans-catheter aortic valve replacement in high-risk patients with severe symptomatic aortic stenosis.
Reardon Michael J MJ Bajwa Tanvir T Popma Jeffrey J JJ
Frontiers in cardiovascular medicine 20231218
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Project description:AimTransfemoral Trans-catheter Aortic Valve Replacement (TF-TAVR) is a safe and effective therapy compared with surgical aortic valve replacement (SAVR) in patients across all risk profiles using balloon-expandable valves (BEV) and self-expanding valves (SEV). Our aim was to compare safety and efficacy of BEV vs. SEV in high-risk patients undergoing TF-TAVR.Methods and resultsWe searched PubMed, EMBASE, Clinicaltrials.gov, Scopus, and Web of sciences for studies on patients with severe aortic stenosis undergoing TAVR. Primary outcome was 30-day all-cause mortality. Secondary outcomes defined by Valve Academic Research Consortium 2 (VARC-2) criteria were also examined. Six studies with 2,935 patients (1,439 to BEV and 1,496 to SEV) were included. BEV was associated with lower risk of all-cause mortality (2.2% vs. 4.5%; RR: 0.51; 95% CI: 0.31-0.82; p < 0.006) and cardiovascular mortality [(2.5% vs. 4.3%; RR: 0.54; 95% CI: 0.32-0.90; p = 0.01) at 30 days compared with SEV. Implantation of more than one valve per procedure (0.78% vs. 5.11%; RR: 0.15; 95% CI: 0.07-0.31; p < 0.00001), and moderate/severe AR/PVL (2.5% vs. 9.01%; RR: 0.3; 95% CI: 0.17-0.48); p < 0.00001) were also lower in the BEV arm.ConclusionBEV TAVR is associated with reduced all-cause mortality (High level of GRADE evidence), cardiovascular mortality (very low level) at 30 days compared with SEV TAVR in high surgical risk patients. Data are necessary to determine if the difference in outcomes persists in longer-term and if the same effects are seen in lower-risk patients.Systematic review registrationidentifier, CRD42020181190.
| S-EPMC10283153 | biostudies-literature
Project description:The safety and effectiveness of the fully repositionable LOTUS valve system as compared with the balloon-expandable Edwards SAPIEN 3 prosthesis for the treatment of aortic stenosis has not been evaluated to date. All patients undergoing transcatheter aortic valve implantation with the Edwards SAPIEN 3 or the LOTUS valve system were included into the Swiss Transcatheter Aortic Valve Implantation Registry. An adjusted analysis was performed to compare the early clinical safety outcome according to the Valve Academic Research Consortium-2 definition. Between February 2014 and September 2015, 140 and 815 patients were treated with the LOTUS and the Edwards SAPIEN 3 valve, respectively. There was no difference in crude and adjusted analyses of the early safety outcome between patients treated with LOTUS (14.3%) and those treated with Edwards SAPIEN 3 (14.6%) (crude hazard ratio, 0.97; 95% CI, 0.61-1.56 [P=0.915]; adjusted hazard ratio, 1.03; 95% CI, 0.64-1.67 [P=0.909]). More than mild aortic regurgitation was <2% for both devices. A total of 34.3% of patients treated with LOTUS and 14.1% of patients treated with Edwards SAPIEN 3 required a permanent pacemaker (HR, 2.76; 95% CI, 1.97-3.87 [P<0.001]). The repositionable LOTUS valve system and the balloon-expandable Edwards SAPIEN 3 prosthesis appeared comparable in regard to the Valve Academic Research Consortium-2 early safety outcome, and the rates of more than mild aortic regurgitation were exceedingly low for both devices. The need for new permanent pacemaker implantation was more frequent among patients treated with the LOTUS valve.
| S-EPMC5210340 | biostudies-literature
Project description:We present the case of an 82-year-old man whose left coronary ostium became obstructed 15 months after transcatheter aortic valve replacement (TAVR) with a balloon-expandable valve. The patient underwent TAVR for symptomatic severe aortic stenosis with no complications. Fifteen months after the initial TAVR, the patient complained of chest pain while exercising, and the exercise stress myocardial perfusion scintigraphy demonstrated the development of regional myocardial ischemia in the region of the left coronary artery. Coronary angiography implied severe stenosis in the ostium of the left coronary artery. Computed tomography angiography and intravascular ultrasonography indicated a soft tissue component along with stent struts, which was considered to cause delayed coronary obstruction. Our report emphasizes the importance of having a low threshold for clinically suspecting delayed coronary obstruction in patients who have undergone TAVR, even after several years of the procedure. <Learning objective:Delayed coronary obstruction (DCO) should be suspected in patients presenting with new ischemic symptoms after transcatheter aortic valve replacement (TAVR). DCO may occur even in the case of TAVR with a balloon-expandable prosthetic valve, on antithrombotic regimens, and several years after the initial procedure.>.
| S-EPMC8766574 | biostudies-literature
Project description:Background The incidence of conduction abnormalities requiring permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR) with early and later generation prostheses remains debated. Methods and Results Based on the administrative hospital-discharge database, we collected information for all patients treated with TAVR between 2010 and 2019 in France. We compared the incidence of PPI after TAVR according to the type and generation of valve implanted. A total of 49 201 patients with aortic stenosis treated with TAVR using the balloon-expandable (BE) Edwards SAPIEN valve (early Sapien XT and latest Sapien 3) or the self-expanding (SE) Medtronic CoreValve (early CoreValve and latest Evolut R) were found in the database. Mean (SD) follow-up was 1.2 (1.5 years) (median [interquartile range] 0.6 [0.1-2.0] years). PPI after the procedure was reported in 13 289 patients, among whom 11 010 (22.4%) had implantation during the first 30 days. In multivariable analysis, using early BE TAVR as reference, adjusted odds ratio (95% CI) for PPI during the first 30 days was 0.88 (0.81-0.95) for latest BE TAVR, 1.40 (1.27-1.55) for early SE TAVR, and 1.17 (1.07-1.27) for latest SE TAVR. Compared with early BE TAVR, the adjusted hazard ratio for PPI during the whole follow-up was 1.01 (0.95-1.08) for latest BE TAVR, 1.30 (1.21-1.40) for early SE TAVR, and 1.25 (1.18-1.34) for latest SE TAVR. Conclusions In patients with aortic stenosis treated with TAVR, our systematic analysis at a nationwide level found higher rates of PPI than previously reported. BE technology was independently associated with lower incidence rates of PPI both at the acute and chronic phases than SE technology. Recent generations of TAVR were not independently associated with different rates of PPI than early generations during the overall follow-up.
| S-EPMC7428568 | biostudies-literature
Project description:Background No data currently exist comparing the contemporary iterations of balloon-expandable (BE) Edwards SAPIEN 3/Ultra and the self-expanding (SE) Medtronic Evolut PRO/R34 valves. The aim of the study was the comparison of these transcatheter heart valves with emphasis on patients with small aortic annulus. Methods and Results In this retrospective registry, periprocedural outcomes and midterm all-cause mortality were analyzed. A total of 1673 patients (917 SE versus 756 BE) were followed up for a median of 15 months. A total of 194 patients died (11.6%) during follow-up. SE and BE groups showed similar survival at 1 (92.6% versus 90.6%) and 3 (80.3% versus 85.2%) years (Plog-rank=0.136). Compared with the BE group, patients treated with the SE device had lower peak (16.3±8 mm Hg SE versus 21.9±8 mm Hg BE) and mean (8.8±5 mm Hg SE versus 11.5±5 mm Hg BE) gradients at discharge. Conversely, the BE group demonstrated lower rates of at least moderate paravalvular regurgitation postoperatively (5.6% versus 0.7% for SE and BE valves, respectively; P<0.001). In patients treated with small transcatheter heart valves (≤26 mm for SE and ≤23 mm for BE; N=284 for SE and N=260 for BE), survival was higher among patients treated with SE valves at both 1 (96.7% SE versus 92.1% BE) and 3 (91.8% SE versus 82.2% BE) years (Plog-rank=0.042). In propensity-matched patients treated with small transcatheter heart valve, there remained a trend for higher survival among the SE group at both 1 (97% SE versus 92.3% BE) and 3 years (91.8% SE versus 78.7% BE), Plog-rank=0.096). Conclusions Real-world comparison of the latest-generation SE and BE devices demonstrated similar survival up to 3 years' follow-up. In patients with small transcatheter heart valves, there may be a trend for improved survival among those treated with SE valves.
| S-EPMC10382012 | biostudies-literature
Project description:Background and objectivesTranscatheter aortic valve replacement (TAVR) has been reported as a good alternative for surgical aortic valve replacement in patients with small aortic annulus. Head-to-head comparisons of different transcatheter aortic valves in these patients are insufficient. We compared the outcomes after TAVR between two different types of recent transcatheter aortic valves (self-expanding vs. balloon-expandable) in patients with small aortic annulus.MethodsA total of 70 patients with severe aortic stenosis and small annulus (mean diameter ≤23 mm or minimal diameter ≤21 mm on computed tomography) underwent TAVR with either a self-expanding valve with supra-annular location (n=45) or a balloon-expandable valve with intra-annular location (n=25). The echocardiographic hemodynamic parameters after TAVR and 1-year follow-up were compared.ResultsBetween the self-expanding and balloon-expandable valve-treated patients, the clinical outcomes including permanent pacemaker implantation (11.1% vs. 8.0%), acute kidney injury stage 2 or 3 (4.4% vs. 4.0%), and major vascular complication (4.4% vs. 0.0%) were similar without all-cause mortality, stroke, and life-threatening bleeding during 30-day follow-up. Compared with the balloon-expandable valve-treated patients, the self-expanding valve-treated patients presented larger effective orifice area (EOA) (1.46±0.28 vs. 1.75±0.42 cm², p=0.002) and indexed EOA (0.95±0.21 vs. 1.18±0.28 cm²/m², p=0.001), whereas mean aortic valve gradient (11.7±2.9 vs. 8.9±5.2 mmHg, P=0.005) and incidence of ≥moderate prosthesis-patient mismatch (36.0% vs. 8.9%, p=0.009) were lower. These hemodynamic differences were maintained at 1-year follow-up.ConclusionsTAVR with self-expanding valves was associated with superior hemodynamic outcomes compared with balloon-expandable valves in patients with small aortic annulus.
| S-EPMC7925971 | biostudies-literature
Project description:Bicuspid aortic valve (BAV) remains challenging in transcatheter aortic valve replacement (TAVR) because of unfavorable anatomy. New-generation balloon-expandable valve (BEV) appears to be a valid alternative to surgery, especially in some Asian countries with a higher prevalence of BAV. This tutorial review summarizes current thinking about how to plan and implant BEV in BAVs using versatile techniques. First, the authors depict the main morphological characteristics of BAVs and their effects on the TAVR procedure. Next, the authors provide preprocedural analysis on sizing, obtaining the optimal deployment projection, and how to simplify valve-crossing. Finally, the authors provide step-by-step guidance on how to deploy the BEVs with evolved iterations in terms of specific anatomies, calcified annulus, and giant annulus.
| S-EPMC9627836 | biostudies-literature
Project description:Transcatheter aortic valve implantation has emerged as a valuable option to treat patients with symptomatic severe aortic stenosis, who are not being considered for surgery because of significant comorbidities. Concerns exist over treating patients who have previously undergone mitral valve surgery for possible interference between the percutaneous aortic valve and the mitral prosthesis or ring.At our centre, from May 2008 to December 2012, 172 patients (76 male) with severe symptomatic aortic stenosis were eligible for transcatheter aortic valve implant. Nine patients, affected by severe aortic stenosis, had previously undergone mitral valve surgery (4 mono-leaflet, 3 bileaflet, 1 bioprosthesis, 1 mitral ring); they were considered high-risk surgical candidates following joint evaluation by cardiac surgeons and cardiologist and had undergone TAVI.Seven patients underwent standard femoral retrograde CoreValve(®) (Medtronic Inc., Minneapolis, USA) implantation, two patients underwent a direct aortic implantation through a mini-thoracotomy. All patients experienced immediate improvement of their haemodynamic status. No deformation of the nitinol tubing of the CoreValve, nor distortion or malfunction of the mechanical valve or mitral ring, occurred as assessed by echographical and fluoroscopic evaluation. No major postoperative complications occurred. In all patients , echocardiography indicated normal valve function during follow-up.Our experience confirms the feasibility of CoreValve implantation in patients with mechanical mitral valves or mitral annuloplasty ring.
| S-EPMC3686371 | biostudies-other
Project description: Not available
| S-EPMC8302989 | biostudies-literature
Project description:BackgroundThere is no evidence of hemodynamic performance during exercise in patients with aortic stenosis (AS) after transcatheter aortic valve implantation (TAVI). This study aimed to investigate the changes in kinematic hemodynamics during exercise and determine the impact of prosthesis-patient mismatch (PPM) on the hemodynamics of transcatheter heart valves using exercise stress echocardiography (ESE) in AS patients after TAVI.Methods and resultsThis study enrolled 77 consecutive patients (mean age 82 ± 5 years, 50.6% male) who underwent ESE 3-6 months after TAVI with a balloon-expandable valve. The effective orifice area index at rest was significantly correlated with the mean pressure gradient (PG) during exercise (p <0.001). The patients were divided into two groups according to the presence of PPM (PPM and non-PPM groups). During exercise, the patients with PPM had a higher left ventricular ejection fraction (74.6 ± 6.1% vs. 69.7 ± 9.6%, p = 0.048), a lower stroke volume index (47.2 ± 14.0 ml/m2 vs. 55.6 ± 14.5 ml/m2, p = 0.037), a significantly higher mean transvalvular PG (21.9 ± 9.1 mmHg vs. 12.2 ± 4.9 mmHg, p = 0.01) and an increased mean PG from rest to exercise (5.7 ± 3.5 mmHg vs. 2.3 ± 2.8 mmHg, p <0.001) compared with patients without PPM. Patients with PPM had a higher pulmonary artery systolic pressure (SPAP) during exercise (57.3 ± 13.8 mmHg vs. 49.7 ± 10.9 mmHg, p = 0.021) and a higher incidence of exercise-induced pulmonary hypertension (43.8 vs. 15.0%, p = 0.037) than patients without PPM. PPM was strongly associated with exercise-induced pulmonary hypertension (hazard ratio: 3.570, p = 0.013).ConclusionsAS patients with PPM after TAVI showed a disproportionate increase in the transvalvular PG and SPAP during exercise, and PPM was associated with exercise-induced pulmonary hypertension.
| S-EPMC8841769 | biostudies-literature