Balloon-expandable Valve Research Articles

Right ventricular outflow tract obstruction associated with neointimal tissue accumulation and distortion of the Harmony TPV25 stent frame: Potential mechanisms and treatment.

The Harmony TPV25 transcatheter pulmonary valve (Medtronic Inc.) is constructed with a self-expanding stent frame comprising six zigged nitinol wires sewn together and covered with knitted polyester fabric, with flared inflow and outflow ends and a porcine pericardial valve sutured to the central portion of the device. It was approved for treatment of pulmonary regurgitation after prior right ventricular outflow tract repair in 2021. Early outcomes of this procedure have been excellent, but little is known about valve durability or ultimate mechanisms of dysfunction. We collected data on patients who underwent reintervention for TPV25 dysfunction and described findings related to distortion of the stent frame and tissue accumulation. We describe six patients who underwent valve-in-valve implant for TPV25 obstruction (peak catheterization gradient peak 28-73 mmHg) 10-28 months after implant. In all cases, there was tissue accumulation within the inflow and valve-housing segments of the device and deformation of the self-expanding valve frame characterized by variable circumferential narrowing at the junction between the valve housing and the inflow and outflow portions of the device, with additional geometric changes in all segments. All six patients underwent valve-in-valve implant that results in a final peak gradient ≤10 mmHg and no regurgitation. The occurrence of short-term Harmony TPV25 dysfunction in multiple patients with a similar appearance of frame distortion and tissue accumulation within the inflow and valve housing portions of the device suggests that this may be an important failure mechanism for this valve. Potential causes of the observed findings are discussed. It is possible to treat this mechanism of TPV25 dysfunction with valve-in-valve implant using balloon expandable transcatheter valves.

Redo-TAVI with SAPIEN 3 in SAPIEN XT or SAPIEN 3 - impact of pre- and post-dilatation on final THV expansion.

When a balloon-expandable transcatheter heart valve (THV) is chosen to treat a failed balloon-expandable THV, there is a risk of underexpansion with a potential impact on performance. We aimed to assess the impact of pre- and post-dilatation on the expansion of balloon-expandable THVs after redo-transcatheter aortic valve implantation (TAVI). Redo-TAVI was performed on the bench with a 23 mm SAPIEN 3 (S3) implanted within a 23 mm SAPIEN XT (SXT) or a 23 mm S3, both of which served as the "failed" THVs. Pre- and/or post-dilatation was performed using a 23 mm non-compliant TRUE balloon. Expansion of the index and redo-THVs were assessed before and after pre-/post-dilatation using microcomputed tomography (micro-CT), and THV hydrodynamic testing was conducted. Without pre- or post-dilatation, the S3 was underexpanded, for all combinations, particularly in the mid-portion of the THV (18.6 mm and 19.7 mm representing 81% and 86% of the nominal diameter inside the SXT and S3, respectively). Pre- and post-dilatation had an additive effect on diameter expansion of the redo-THV, which remained constrained in most combinations. The only combination to achieve nominal expansion was the S3 in S3 when both pre- and post-dilatation were performed. The S3 remained underexpanded inside the SXT despite pre- and post-dilatation (93% in the mid-portion). Improved redo-THV expansion was accompanied by 2.7 mm (12%) overexpansion of the index THV. While all samples had acceptable hydrodynamic performance, the underexpanded samples had worse leaflet pinwheeling. When performing redo-TAVI with a 23 mm S3 inside a 23 mm SXT or S3, only the S3 in S3 with the use of pre- and post-dilatation reached full expansion. This underlines the importance of CT assessment of THV expansion and the role of pre-/post-dilatation.

Feasibility of Coronary Access Following Redo-TAVR for Evolut Failure: A Computed Tomography Simulation Study.

Coronary accessibility following redo-transcatheter aortic valve replacement (redo-TAVR) is increasingly important, particularly in younger low-risk patients. This study aimed to predict coronary accessibility after simulated Sapien-3 balloon-expandable valve implantation within an Evolut supra-annular, self-expanding valve using pre-TAVR computed tomography (CT) imaging. A total of 219 pre-TAVR CT scans from the Evolut Low-Risk CT substudy were analyzed. Virtual Evolut and Sapien-3 valves were sized using CT-based diameters. Two initial Evolut implant depths were analyzed, 3 and 5 mm. Coronary accessibility was evaluated for 2 Sapien-3 in Evolut implant positions: Sapien-3 outflow at Evolut node 4 and Evolut node 5. With a 3-mm initial Evolut implant depth, suitable coronary access was predicted in 84% of patients with the Sapien-3 outflow at Evolut node 4, and in 31% of cases with the Sapien-3 outflow at Evolut node 5 (P<0.001). Coronary accessibility improved with a 5-mm Evolut implant depth: 97% at node 4 and 65% at node 5 (P<0.001). When comparing 3- to 5-mm Evolut implant depth, sinus sequestration was the lowest with Sapien-3 outflow at Evolut node 4 (13% versus 2%; P<0.001), and the highest at Evolut node 5 (61% versus 32%; P<0.001). Coronary accessibility after Sapien-3 in Evolut redo-TAVR relates to the initial Evolut implant depth, the Sapien-3 outflow position within the Evolut, and the native annular anatomy. This CT-based quantitative analysis may provide useful information to inform and refine individualized preprocedural CT planning of the initial TAVR and guide lifetime management for future coronary access after redo-TAVR. URL: https://www.clinicaltrials.gov; Unique identifier: NCT02701283.

Risk of Sinus Sequestration During Redo Transcatheter Aortic Valve Implantation: The Prevalence, Predictors, and Risk Stratification

The number of patients undergoing transcatheter aortic valve implantation (TAVI) with the potential for re-intervention is steadily increasing; however, there is a risk of sinus sequestration (SS) during a redo TAVI. The prevalence, predictors, and risk stratification of risk for SS remain uncertain. We analyzed computed tomography acquired from 263 patients who underwent TAVI between 2021 and 2022: balloon-expandable valve (BEV), 71%, and self-expandable valve (SEV), 29%. Patients were considered at risk of SS if they met 1) BEV frame > sino-tubular junction (STJ) or SEV neo-commissure > STJ and 2) valve-to-STJ < 2 mm. The risk of left, right, and any SS in 51%, 50%, and 65%, respectively, which did not differ between BEV and SEV. The predictors of any SS were the height of the left and right coronary cusp (Odds ratio [OR], 0.81 and 0.71; cut-off, 18.6 and 19.2 mm) and STJ minus annulus diameter (OR, 0.65; cut-off, 3.7 mm) in BEV, and STJ diameter (OR, 0.47; cut-off, 27.6 mm) in SEV. The number of predictors stratified the risk of any SS: low risk with BEV, at 0 predictors (14% at risk of SS); intermediate risk, 1 predictor (65%); high risk, 2 or 3 predictors (81% and 95%); low risk with SEV, 0 predictors (33%), vs. high risk, 1 predictor (91%). In conclusion, two-thirds of patients undergoing TAVI were at risk of SS. The height of the coronary cusp and the STJ diameter were associated with, and adequately stratified the risk of SS.

Implantation depth of balloon-expandable transcatheter heart valves and risks for permanent pacemaker implantation and midterm adverse events.

Permanent pacemaker implantation (PPI) remains a relevant complication after transcatheter aortic valve implantation (TAVI) and its impact on outcome remains controversial. This study aimed to analyze the effects of implantation depth on PPI at 30 days and assess its impact on outcome with the balloon-expandable Sapien 3 (S3) prosthesis. Between 2014 and 2018, 849 patients without previous pacemaker undergoing transfemoral TAVI with the S3 were included. Prosthesis implantation depth was measured and divided into Quintiles. An ordinal logistic regression was used to assess its association with PPI, while a multivariate logistic regression was performed to identify predictors of PPI. Survival analyses were performed with the Kaplan-Meier method and a multivariable Cox regression was performed to ascertain the impact of PPI on mortality. Overall, incidence of PPI at 30 days was 9.7%. Implantation depth decreased consistently from a median of 6.7 mm [5.55-8.00] in 2014 to 2.7 mm [2.30-3.50] in 2018 (p < 0.001). When considering Quintiles of implantation depth, incidence of PPI was significantly higher in upper Quintiles and risk for PPI was significantly lower for the 1. Quintile compared to the 5. Quintile (OR: 0.34, 95% CI: [0.16-0.73]; p = 0.003). In the adjusted multivariable logistic regression implantation depth persisted ad independent predictor of PPI at 30 days. Patients requiring PPI at 30 days displayed significantly higher mortality at 4 years compared to patients without PPI (49.5% vs. 40.0%; log-rank = 0.022). In a multivariate analysis, increased logistic EuroScore, diabetes mellitus, and history of atrial fibrillation, were independent predictors of all-cause mortality at 2 years. Higher prosthesis implantation relative to the virtual aortic annulus was significantly associated with reduced risk for PPI at 30 days. Patients with PPI at 30 days exhibited higher mortality during follow-up, however, only logistic EuroScore, diabetes mellitus, and history of atrial fibrillation were identified as independent predictors of mortality at 2 years.

Balloon- vs Self-Expanding Transcatheter Valves for Failed Small Surgical Aortic Bioprostheses: 1-Year Results of the LYTEN Trial

BackgroundData comparing valve systems in the valve-in-valve transcatheter aortic valve replacement (ViV-TAVR) field have been obtained from retrospective studies. ObjectivesThe authors sought to compare the 1-year hemodynamic performance and clinical outcomes between balloon-expandable valves (BEV) SAPIEN 3/ULTRA (Edwards Lifesciences) and self-expanding valves (SEV) Evolut R/PRO/PRO+ (Medtronic) in ViV-TAVR. MethodsPatients with a failed small (≤23 mm) surgical valve undergoing ViV-TAVR were randomized to receive a SEV or a BEV. Patients had a clinical and valve hemodynamic (Doppler echocardiography) evaluation at 1-year follow-up. Study outcomes were defined according to VARC-2/VARC-3 criteria. Intended performance of the valve was defined as mean gradient <20 mm Hg, peak velocity <3 m/s, Doppler velocity index ≥0.25 and less than moderate AR. ResultsA total of 98 patients underwent ViV-TAVR (46 BEV, 52 SEV). At 1-year follow-up, patients receiving a SEV had a lower mean transaortic gradient (22 ± 8 mm Hg BEV vs 14 ± 7 mm Hg SEV; P < 0.001), and a higher rate of intended valve performance (BEV: 30%, SEV:76%; P < 0.001). There were no cases of greater than mild aortic regurgitation. There were no differences in functional status (NYHA functional class >II, BEV: 7.3%, SEV: 4.1%; P = 0.505) or quality of life (Kansas City Cardiomyopathy Questionnaire, BEV: 77.9 ± 21.2, SEV: 81.8 ± 14.8; P = 0.334). No differences in all-cause mortality (BEV: 6.5%, SEV: 3.8; P = 0.495), heart failure hospitalization (BEV: 6.5%, SEV: 1.9%; P = 0.214), stroke (BEV: 0%, SEV: 1.9%; P = 0.369), myocardial infarction (BEV: 0%, SEV: 1.9%; P = 0.347), or pacemaker implantation (BEV: 2.2%, SEV: 1.9%; P = 0.898) were found. ConclusionsIn patients who underwent ViV-TAVR for failed small aortic bioprostheses, those receiving a SEV exhibited a better valve hemodynamic profile at 1-year follow-up. There were no differences between SEV and BEV regarding functional status, quality of life, or clinical outcomes.

Safety and Efficacy of TAVR With a Pressure Sensor and Pacing Guidewire: SAFE-TAVI Trial

BackgroundThe SavvyWire (OpSens Inc) is a 0.035-inch preshaped guidewire with dedicated pacing properties and a distal pressure sensor allowing for continuous hemodynamic pressure monitoring. ObjectivesThis study sought to determine the efficacy and safety of the guidewire during transcatheter aortic valve replacement (TAVR) procedures. MethodsThis prospective, multicenter clinical study included patients with severe aortic stenosis undergoing TAVR in 8 European centers. The primary efficacy endpoint was defined as effective left ventricular rapid pacing runs with the guidewire translating into a significant systemic pressure drop (below 60 mm Hg). The safety outcome included the absence of major procedural complications related to the guidewire. ResultsA total of 121 patients (mean age: 82.2 ± 5.9 years, 50% women) were included in the study, and 119 (98.3%) patients were finally treated with the study device. A balloon-expandable valve was implanted in 45 (37.8%) patients. Predilatation and postdilatation were performed in 89 (74.8%) and 14 (11.8%) patients, respectively. The primary efficacy endpoint was achieved in 116 (98.3%) patients, and the mean aortic systolic arterial pressure achieved during rapid pacing was 46.6 ± 11.3 mm Hg. Hemodynamic assessment with the use of the OptoMonitor 3 (OpSens Inc) without additional catheter exchange was achieved in 117 (99.2%) patients. The safety endpoint was achieved in 117 (99.2%) patients. No procedural mortality, stroke, or ventricular perforation was reported. ConclusionsThe use of the guidewire during TAVR procedures appeared to be efficacious and safe. This device could help minimize interventions during the procedure and improve the clinical decision making after transcatheter heart valve deployment. (SavvyWire Efficacy and Safety in Transcatheter Aortic Valve Implantation Procedures [SAFE-TAVI]; NCT05492383)

Single center experience with the balloon-expandable Myval transcatheter aortic valve system with the first 100 patients: 30-day and 1-year follow-up.

To report our single-center data, regarding the first 100 patients who underwent TAVR procedure with the new balloon-expandable MYVAL system. We report 30-day and 1-year outcomes in low to high-risk TAVR patient population. From November 2019 to July 2021, 100 consecutive patients underwent TAVR procedure. Patient outcome was classified according to the VARC-2 definitions. The device performance was assessed using transthoracic echocardiography. Data collection was allowed by the Local Ethical Committee. The mean age was 74.7 years, 63 (63%) were male. The mean Euroscore II and STS score were 4.8 ± 4.9 and 5.6 ± 3.9, respectively. Transfemoral access was the most frequent (surgical vs. percutaneous 2% vs. 97%) and in one patient surgical subclavian access was used. VARC-2 outcomes were as follows: device success 99%, STROKE 1%, major and minor vascular complication was 1% and 11%, respectively, the rate of new permanent pacemaker implantation was 30.7%. At discharge, the incidence of grade I, grade II aortic regurgitation was 39% and 1%, respectively, without relevant PVL. In-hospital mortality was only 1%. These results included a high proportion (17%) of patients with bicuspid aortic valves. At 1 year, the all-cause mortality rate was 7% (only two due to cardiac event) and only a single patient had valve-related dysfunction requiring surgical aortic replacement. TAVR procedure with MYVAL transcatheter heart valve system shows excellent 30-day and 1-year outcomes regarding patient survival, technical success, and valve-related adverse events. The limitations of our study comprise a single-center study with retrospective data collection.

Late Survival After Valve-in-Valve Transcatheter Aortic Valve Implantation With Balloon- Versus Self-Expandable Valves: Meta-Analysis of Reconstructed Time-to-Event Data

Valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) in patients with failed bioprostheses arose as an alternative to redo surgical aortic valve replacement. There is an increasing interest in exploring the differences between self-expanding valves (SEVs) and balloon-expandable valves (BEVs). Our study aimed to evaluate the all-cause mortality in ViV-TAVI with SEV versus BEV in patients with failed bioprostheses. We performed a study-level meta-analysis of reconstructed time-to-event data from Kaplan-Meier curves of studies published by March 30, 2023. A total of 5 studies met our eligibility criteria and included 1,454 patients who underwent ViV-TAVI (862 with SEV and 592 with BEV). Almost all BEVs were iterations of the Edwards BEVs (SAPIEN, SAPIEN XT, and SAPIEN 3) and almost all SEVs were iterations of the Medtronic SEVs (CoreValve/Evolut). During the first year after ViV-TAVI, 67 deaths (11.8%) occurred in patients treated with BEV compared with 92 deaths (11.1%) in patients treated with SEV (hazard ratio 0.92, 95% confidence interval 0.66 to 1.27, p=0.632). At 8 years of follow-up, the all-cause death was not statistically significantly different between the groups, with mortality rates of 65.4% in the group treated BEV and 58.8% in the group treated with SEV (hazard ratio 0.91, 95% confidence interval 0.75 to 1.09, p=0.302). The restricted mean survival time was overall 0.25 years greater with SEV than BEV, but this difference was not statistically significant (p=0.278), which indicates no lifetime gain or loss with SEV in comparison with BEV. There seems to be no difference in terms of all-cause death in ViV-TAVI with SEV versus BEV. Randomized controlled trials are warranted to validate our results.

Preemptive alcohol septal ablation prior to transcatheter mitral valve replacement.

Alcohol septal ablation (ASA) has been shown to increase the neo-left ventricular outflow tract (LVOT) area before transcatheter mitral valve replacement (TMVR) but there is little literature on its success and use with dedicated devices. To describe our experience with preemptive ASA to increase the predicted neo-LVOT area and its utility with both dedicated TMVR devices and balloon-expandable valves. All patients who underwent ASA for TMVR candidacy in our center between May 2018 and October 2022 and had computed tomography(CT) scans done before and after ASA were included. Each CT was assessed for the minimum predicted neo-LVOT area at end-systole, using a virtual valve of the desired TMVR device for each patient. The primary outcome was an increase in the predicted neo-LVOT area after ASA that was deemed sufficient for safe implantation of the desired TMVR device. The secondary outcome was the absence of acute LVOT obstruction after TMVR. A total of 12 patients underwent ASA and all but 1 (n = 11, 91.6%) achieved the primary outcome of having sufficient predicted neo-LVOT area to proceed with TMVR. The mean increase in neo-LVOT area after ASA was 126 ± 64 mm2 (median 119.5, interquartile range: 65.0-163.5 mm2 ). Two patients (16.7%) required a permanent pacemaker after ASA. Nine patients went on and underwent TMVR with their respective devices and none had LVOT obstruction after the procedure. Among the remaining three patients, one had insufficient neo-LVOT clearance after ASA, one had unrelated mortality before TMVR, and one had advanced heart failure before TMVR. In appropriately selected patients and at centers experienced with ASA, preemptive ASA can achieve sufficient neo-LVOT clearance for TMVR with a variety of devices in approximately 90% of patients.

Rationale and design of Non-antithrombotic Therapy After Transcatheter Aortic Valve Implantation (NAPT) Trial

BackgroundDespite the wide implementation of transcatheter aortic valve implantation (TAVI), the optimal antithrombotic therapy after TAVI has not been established yet. Owing to the accumulating evidence supporting the efficacy and safety of single antiplatelet therapy (SAPT) over dual antiplatelet therapy, the latest guideline recommends life-long SAPT. However, there is scarce evidence supporting SAPT compared with non-antithrombotic therapy. Given the vulnerability of patients undergoing TAVI in terms of high bleeding risk, the benefit of SAPT may be canceled out by its potential increased bleeding risk. Study design and objectivesNon-antithrombotic Therapy After Transcatheter Aortic Valve Implantation (NAPT) Trial is a prospective, randomized controlled, open-label blinded endpoint multicenter trial conducted in Japan, testing the non-inferiority of non-antithrombotic therapy compared with aspirin monotherapy in patients who underwent TAVI and had no indications for long-term oral anticoagulation therapy (OAC). Patients who successfully underwent trans-femoral TAVI for severe aortic stenosis with either balloon-expandable or self-expandable valves are eligible for inclusion. Key exclusion criteria are (i) occurrence of perioperative complications (ii) indications of taking antithrombotic drugs for other reasons; (iii) eGFR <30 ml/min/1.73 m2 or hemodialysis or peritoneal dialysis. A total of 360 patients will be randomized (1:1) to aspirin monotherapy vs. non-antithrombotic therapy. The primary outcome is a composite of all-cause mortality, myocardial infarction, stroke, and bleeding. All bleeding events based on the Valve Academic Research Consortium 3 are included as a component of the primary outcome. ConclusionThe NAPT trial will determine the non-inferiority of a non-antithrombotic therapy compared with aspirin monotherapy after TAVI.

Self-expanding and balloon-expandable valves in low risk TAVR patients

BackgroundRecent randomized studies have broadened the indication of transcatheter aortic valve replacement (TAVR) to also include low-surgical-risk patients. However, the data on self-expanding (SE) and balloon-expandable (BE) valves in low-risk patients remain sparse. MethodsThe current study is a post hoc analysis of combined data from both LRT 1.0 and 2.0 trials comparing BE and SE transcatheter heart valves. ResultsA total of 294 patients received a BE valve, and 102 patients received an SE valve. The 30-day clinical outcomes were similar across both groups except for stroke (4.9% vs. 0.7%, p = 0.014) and permanent pacemaker implantation (17.8% vs. 5.8%, p < 0.001), which were higher in the SE cohort than the BE cohort. No difference was observed in terms of paravalvular leak (≥moderate) between the groups (0% vs. 1.5%, p = 0.577). SE patients had higher aortic valve area (1.92 ± 0.43 mm2 vs. 1.69 ± 0.45 mm2, p < 0.001) and lower mean gradient (8.93 ± 3.53 mmHg vs. 13.41 ± 4.73 mmHg, p < 0.001) than BE patients. In addition, the rate of subclinical leaflet thrombosis was significantly lower in SE patients (5.6% vs. 13.8%, p = 0.038). ConclusionIn this non-randomized study assessing SE and BE valves in low-risk TAVR patients, SE valves are associated with better hemodynamics and lesser leaflet thrombosis, with increased rates of stroke and permanent pacemaker implantation at 30 days; however, this could be due to certain patient-dependent factors not fully evaluated in this study. The long-term implications of these outcomes on structural valve durability remain to be further investigated. Clinical Trial RegistryLRT 1.0: NCT02628899LRT 2.0: NCT03557242

Feasibility and Outcome of Transjugular Intracardiac Echocardiography–Guided Transcatheter Aortic Valve Replacement

BackgroundThere are limited data on the impact of intracardiac echocardiography (ICE)–guided transcatheter aortic valve replacement (TAVR) on the new permanent pacemaker implantation (PPMI) rate. ObjectivesThis study investigated the feasibility and outcome of transjugular ICE (TJ-ICE) –guided TAVR, by visualizing the relationship between the membranous septum (MS) and the transcatheter aortic valve (TAV). MethodsAmong patients with severe aortic stenosis who underwent TAVR between February 2017 and June 2020, this study enrolled a total of 163 patients with TJ-ICE–guided TAVR. MS length was measured by ICE. The primary endpoint of this study was the incidence of new PPMI at 30 days. ResultsThe mean age of the patients in this study was 84.9 ± 4.6 years, and 71.2% of the patients were female. Device success was 96.3% with TJ-ICE guidance. A TJ-ICE–related complication occurred in 1 case (0.6%). The median length of the MS was 5.8 mm (IQR: 5.0-6.9 mm). Excellent intraobserver (intraclass correlation coefficient [ICC]: 0.94; 95% CI:0.79-0.98; P < 0.001) and interobserver (ICC: 0.93; 95% CI: −0.05 to 0.98; P < 0.001) agreements were shown. The new PPMI rate was 6.7% at 30 days without a significant difference between balloon-expandable valves and self-expandable valves (3.4% vs 8.7%; P = 0.226). Patients with a TAV implantation depth less than MS length had a significantly lower incidence of new PPMI compared with patients with a TAV implantation depth greater than MS length (2.1% vs 13.4%; P = 0.005), regardless of baseline right bundle branch block presence (6.7% vs 66.7%; P = 0.004) or absence (1.2% vs 8.2%; P = 0.041). ConclusionsTJ-ICE–guided TAVR demonstrated remarkable feasibility and safety. The TJ-ICE–guided final TAV position had a significant impact on the new PPMI rate. (Tokai Valve Registry; UMIN000036671)

TCT-543 Comparison of Outcomes in Patients With Type-0 Bicuspid Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement With Self-Expanding Valves vs Balloon-Expandable Valves

TCT-543 Comparison of Outcomes in Patients With Type-0 Bicuspid Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement With Self-Expanding Valves vs Balloon-Expandable Valves

TCT-416 Long-Term Clinical Outcomes After Transcatheter Aortic Valve Replacement With Balloon-Expandable Versus Self-Expanding Valves

TCT-416 Long-Term Clinical Outcomes After Transcatheter Aortic Valve Replacement With Balloon-Expandable Versus Self-Expanding Valves

TCT-239 Survival Outcomes of TAVR and Self-Expandable Versus Balloon-Expandable Valves in Patients With Advanced Cardiac Dysfunction and Aortic Stenosis

TCT-239 Survival Outcomes of TAVR and Self-Expandable Versus Balloon-Expandable Valves in Patients With Advanced Cardiac Dysfunction and Aortic Stenosis

TCT-403 1-Year Clinical and Echocardiographic Outcomes of TAVI With the Latest SAPIEN 3 ULTRA Balloon-Expandable Valve: From the S3U Registry

TCT-403 1-Year Clinical and Echocardiographic Outcomes of TAVI With the Latest SAPIEN 3 ULTRA Balloon-Expandable Valve: From the S3U Registry

Long-Term Survival Outcomes After Transcatheter Aortic Valve Replacement: A Real-World Experience of a Large Tertiary Center

Transcatheter aortic valve replacement (TAVR) becomes the leading therapeutic choice for severe aortic stenosis. There is a growing body of knowledge on long-term survival outcomes, but available data from real-world observational studies are scarce. An observational cohort study was conducted on 705 consecutive patients who underwent TAVR at Strasbourg University Hospital between February 2010 and June 2017. We observed the living status (dead or alive) for each study participants by March 2023. The primary end point was to evaluate the all-cause mortality rate beyond 5years after TAVR, compare the survival outcomes according to valve type, and identify predictors of mortality. Of the 705 study participants, 91.8% of the TAVR procedures were performed through the common femoral artery and 60.6% were treated with a balloon-expandable valve. Over a mean study period of 5.4 ± 3years, the all-cause mortality rate was 45.8%. No difference in survival outcomes according to valve type was observed (p=0.449). All-cause mortality rate was associated with age ≥90years (hazard ratio [HR] 1.625, 1.109 to 2.380, p=0.013), female gender (HR 0.228, 0.176 to 0.294, p <0.001), diabetes mellitus (HR 1.356, 1.070 to 1.719, p=0.012), post-TAVR stroke (HR=2.867, 1.690 to 4.865, p <0.001), and post-TAVR acute kidney injury (HR 1.977, 1.445 to 2.703, p <0.001). In conclusion, the present real-world large tertiary center experience showed that more than half of patients who underwent TAVR are alive beyond 5years from procedure's date. All-cause mortality is mainly determined by advanced age and co-morbid conditions, and valve type has no advantage on the survival outcomes.

Impact of Prosthesis-Patient Mismatch After Transcatheter Aortic Valve Replacement

BackgroundData on the long-term impact of prosthesis-patient mismatch (PPM) on outcomes after transcatheter aortic valve replacement (TAVR) remain sparse. We therefore aimed to investigate the incidence, predictive factors, and long-term prognostic impact of PPM on bioprosthesis durability and mortality. MethodsThis was a single-centre retrospective study including 2117 patients who underwent TAVR for aortic stenosis from 2002 to 2022. Moderate PPM was defined by indexed effective orifice area (iEOA) > 0.65 and ≤ 0.85 cm2/m2 (> 0.55 and ≤ 0.70 cm2/m2 if BMI ≥ 30 kg/m2) and severe PPM by an iEOA ≤ 0.65 cm2/m2 (≤ 0.55 cm2/m2 If BMI ≥ 30 kg/m2). ResultsThere were 351 patients (16.6%) with PPM, including 39 patients (1.8%) with severe PPM and 312 patients (14.7%) with moderate PPM. The mean follow-up duration was 31.2 ± 26.5 months. Factors independently associated with the occurrence of PPM were body surface area (odds ratio [OR] 3.32, 95% confidence interval [CI] 1.32-8.35; P = 0.01), valve-in-valve TAVR (OR 6.12, 95% CI 2.29-16.08; P < 0.001), small annulus (OR 2.42, 95% CI 1.41-4.07; P = 0.001), and the use of a balloon-expandable valve (OR 4.17, 95% CI 2.17-8.33; P < 0.001). PPM was associated with increased risk of mortality (hazard ratio [HR] 1.3, 95% CI 1.1-1.5, P = 0.004) and valve thrombosis (HR 4.2, 95% CI 1.4-12.6, P = 0.01), and a trend towards increased risk of structural valve deterioration (HR 1.7, 95% CI 0.9-2.9; P = 0.08). ConclusionsThe results of this study suggest that PPM has a negative long-term impact on outcomes after TAVR. These findings emphasise the importance of preventing PPM.

Self-Expanding Transcatheter Aortic Valves Optimize Transvalvular Hemodynamics Independent of Intra- Versus Supra-Annular Design

This study sought to characterize transvalvular hemodynamics during the first 30days after transcatheter aortic valve implantation (TAVI) across various transcatheter heart valves (THVs), while adjusting for annular dimensions. This was an observational study of TAVIs from September 2021 to October 2022. The primary outcome was mean transvalvular pressure gradient (TVPG), measured using transthoracic echocardiography at day 0, day 1, and day 30 post-TAVI, and were compared across 3 THV, including the self-expandable intra-annular Portico (Abbott Vascular, Santa Clara, California) valve, the balloon-expandable SAPIEN 3 Ultra (Edwards Lifesciences, Irvine, California), and the self-expandable supra-annular Evolut Pro+ (Medtronic, Minneapolis, Minnesota). A total of 560 patients who underwent TAVI were identified, of which 106 (18.9%) received a Portico THV, 176 (31.4%) received a SAPIEN THV, and 278 (49.6%) received an Evolut THV. For Portico THV, the TVPG on day 0 increased from 6.0 (4.7 to 9.0) to 7.0 (6.0 to 10.0) by day 30 (p=0.009). For SAPIEN THV, the TVPG on day 0 increased from 6.5 (5.0 to 8.0) to 12.0 (9.0 to 15.0) by day 30 (p <0.001). For Evolut THV, the TVPG on day 0 increased from 6.0 (5.0 to 9.0) to 7.2 (5.0 to 10.0) by day 30 (p=0.001). Adjusting for time and annular diameter in a multivariable mixed effects model, the SAPIEN group had a significantly greater increase in TVPG over time than the Evolut reference group (p <0.001), while there was no difference in the change of TVPG over time for the Portico group vs. the Evolut group (p=0.874). In conclusion, compared with balloon-expandable valves, self-expanding THV may optimize transvalvular hemodynamics across all annular diameters, independent of their supra-annular and intra-annular design.