Rates Of Paravalvular Leak Research Articles

Outcomes of Transcatheter Aortic Valve Replacement in Patients With Concomitant Aortic Regurgitation

BackgroundThis study sought to evaluate outcomes of transcatheter aortic valve replacement (TAVR) in patients with moderate or greater aortic regurgitation (AR). MethodsThis was an observational study using an institutional database of TAVRs from November 2012 to April 2022. The study compared outcomes of TAVR in patients with isolated aortic stenosis (AS) vs patients with AS and concomitant AR (moderate or greater). Those patients with trace or mild AR were excluded. Clinical and echocardiographic outcomes were compared, with end points established by the Valve Academic Research Consortium 3. Kaplan-Meier survival estimation and Cox regression for mortality were performed. Competing-risk cumulative incidence estimates for heart failure readmissions were also compared. ResultsOf 3295 patients, 605 (53.4%) had severe AS with no AR and 529 (46.6%) had severe AS with moderate or severe AR. There were no significant differences in in-hospital mortality, length of stay, stroke, myocardial infarction, permanent pacemaker requirement, transfusion requirement, minor or major vascular complications, or 30-day readmissions between the 2 groups (P > .05). There were also no significant differences in annular dissection or rupture, coronary obstruction, or device embolization. Mean gradient and paravalvular leak rates at 30 days and 1 year were similar between the groups. Survival estimates were comparable, and, on multivariable Cox regression, mixed aortic valvular disease was not associated with an increased hazard of death as compared with isolated AS (hazard ratio, 1.01; 95% CI, 0.81-1.25; P = .962). Cumulative incidence estimates for heart failure readmissions were comparable between groups. ConclusionsTAVR can be safely performed in patients with mixed valvular disease, with outcomes comparable to those in isolated AS.

Conventional Prostheses versus Sutureless Perceval for Aortic Valve Replacement: A Meta-Analysis.

Perceval sutureless valves have gained popularity. Whether this implant performs superior to the traditional sutured prosthesis remains unclear. This meta- analysis compared the Perceval implants versus the sutured conventional valves for aortic valve replacement (AVR). This meta-analysis was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The following databases were accessed: PubMed, Google Scholar, Web of Science, Scopus, and EMBASE. All clinical investigations comparing Perceval versus the conventional prostheses for AVR were considered. The Perceval group demonstrated higher rate of pacemaker implantation (P <0.00001). Aortic cross-clamp (ACC) time (P <0.00001) and cardiopulmonary bypass (CPB) time (P <0.00001) were shorter in the Perceval group. Similarity was found in mean and peak pressure gradient (P = 0.8 and P = 0.2, respectively), mean aortic valve area (P = 0.3), length of intensive care unit (P = 0.4) and hospital stay (P = 0.2), rate of revision (P = 0.11), hemorrhages (P = 0.05), paravalvular leak (P = 0.3), cerebrovascular complication (P = 0.7), and early mortality (P = 0.06). Given the shorter ACC time and CPB time, Perceval AVR can be an alternative in high-risk patients. The higher rate of pacemaker implantation following Perceval may limit its routine implantation.

Abstract 13931: Comparison of Inpatient Outcomes of Transcatheter Aortic Valve Replacement in Bicuspid versus Tricuspid Aortic Valve Stenosis: An Insight From National Inpatient Sample

Background: TAVR is increasingly performed in patients with severe aortic stenosis (AS), including those with bicuspid aortic valve (BAV). There is a paucity of data on the safety and efficacy of TAVR in the latter group since they were excluded from the landmark trials which established TAVR as a favorable alternative to surgery. Prior studies have shown higher rates of permanent pacemaker placement (PPM) and paravalvular leak (PL) but comparable rates of embolic stroke (ES) and mortality in BAV patients who underwent TAVR when compared to those with tricuspid aortic valve (TAV). We examined the impact of aortic valve anatomy on inpatient mortality and complication rates using current data from the largest inpatient database in the United States.Methods:We queried the 2016-2019 National Inpatient Sample database to identify all patients over 18 years of age who underwent TAVR for AS. Patients were stratified to BAV and TAV groups using ICD-10 codes. Greedy nearest neighbor propensity score matching was performed based on demographics, Charlson comorbidity index, hospital characteristics, insurance status, and median income. Outcomes of interest included rates of mortality, PPM, PL, ES, and length of hospital stay (LOS).Results:Of 192,100 AS patients who underwent TAVR, 0.5% had BAV. After propensity score matching, 995 BAV and 995 TAV patients were included in the final analysis. The overall mortality rate was 1.5% with no significant difference between the two groups [OR 1.00 (0.20-5.060), p=1.00]. Rates of PPM were 10.1% in BAV and 8.5% in TAV patients with no significant difference [OR 1.20 (0.61-2.37), p=0.61]. Rates of PL were 1% in BAV and 0.5% in TAV patients with no significant difference [OR 2.01 (0.18-22.65), p=0.57]. Rate of ES was 1.5% in BAV patients; however, direct comparison to its propensity-matched TAV cohort was not feasible since the latter group had no events in this analysis. There was no significant difference in the LOS between the two groups.Conclusion:Insight from this large database suggests that in the current era, TAVR has similar short-term outcomes in both BAV and TAV patients. Further studies with long-term follow-up on valve function and the need for reintervention will be needed, especially since this involves younger patients.

Similar clinical outcomes with transcatheter aortic valve implantation and surgical aortic valve replacement in octogenarians with aortic stenosis.

Transcatheter aortic valve implantation (TAVI) is the preferred treatment option for severe aortic stenosis in the elderly and in patients with comorbidities. We sought to compare outcomes after TAVI and surgical aortic valve replacement (SAVR) in octogenarians. In this retrospective cohort study conducted at our tertiary center, clinical data were gathered before and after TAVI and SAVR procedures performed from January 2013 to May 2019; follow-up completed in March 2021. The primary outcome was 1-year mortality. Patients were stratified according to Society of Thoracic Surgeons (STS) score and procedure type. Propensity score-based matching was also performed. Of 542 patients who matched the inclusion criteria, 273 underwent TAVI and 269 SAVR. TAVI patients were older (85.8 ± 3.0 vs. 82.2 ± 2.2 years; P < 0.001) and had a higher mean STS score (5.0 ± 4.0 vs. 2.8 ± 1.3; P < 0.001) and EuroSCORE II (5.3 ± 4.1 vs. 2.8 ± 6.0; P < 0.001). Rates of postoperative permanent pacemaker insertion (15.0% vs. 9.3%; P = 0.040) and paravalvular leak (9.9% vs. 0.8%; P < 0.001) were higher and acute kidney injury lower (8.8% vs. 32.7%; P < 0.001) after TAVI, with no difference between treatment groups for major bleeding (11.0% vs. 6.7%; P = 0.130) or 30-day mortality (5.5% vs. 3.7%; P = 0.315). A statistically significant difference was found between TAVI and SAVR in low- and intermediate-risk groups when it came to occurrence of paravalvular leak, acute kidney injury, and new onset AF (all P < 0.001). This analysis of an octogenarian "real-life" population undergoing TAVI or SAVR (with a biological valve) showed similar outcomes regarding clinical endpoints in low- and medium-risk (STS score) groups.

Impact of Nodular Calcifications in the Aortic Annulus and Left Ventricular Outflow Tract on TAVI Outcome with New-Generation Devices.

The impact of nodular calcifications in left ventricular outlow tract (LVOT) and aortic annulus on the procedural outcome of transcatheter aortic valve implantation (TAVI) with new-generation devices is yet to be elucidated. Similarly, computational simulations may provide a novel insight into the biomechanical features of TAVI devices and their interaction with nodular calcifications. This retrospective single-center study included 232 patients submitted to TAVI with Evolut-R (53.4%), Portico (33.6%) and Lotus (13.0%) devices with available preoperative computed tomography (CT) angiography and evidence of nodular calcifications in aortic annulus and/or LVOT. Calcification severity was defined moderate in presence of at least two nodules or one nodule 5 mm. Three virtual simulation models of aortic root presenting a nodular calcification of increasing size were implemented. Stress distribution, stent-root contact area and paravalvular orifice area were computed. At least moderate calcifications were found in 123 (53.0%) patients, with no sex differences. Among the moderate calcification group, lower device success rate was evident (87.8% vs. 95.4%; p = 0.039). Higher rates of moderate paravalvular leak (PVL) (11.4% vs. 3.7%; p = 0.028) and vascular complications (9.8% vs. 2.8%; p = 0.030) were also observed. Among the Evolut-R group, higher rates of at moderate PVL (12.1%) were observed compared to Portico (3.8%; p = 0.045) and Lotus (0.0%; p = 0.044) groups. Calcification of both annulus and LVOT (odds ratio [OR] 0.105; p = 0.023) were independent predictors of device success. On computational simulations, Portico exhibited homogeneous stress distribution by increasing calfications and overall a larger paravalvular orifice areas compared to Evolut-R and Lotus. Evolut-R showed higher values of average stress than Portico, although with a more dishomogeneous distribution leading to greater paravalvular orifice areas by severe calcifications. Lotus showed overall small paravalvular orifice areas, with no significant increase across the three models. At least moderate nodular calcifications in the annulus/LVOT region significantly affected TAVI outcome, as they were independent predictors of device success. Lotus and Portico seemed to perform better than Evolut-R as for device success and moderate PVL. Computational simulations revealed unique biomechanical features of the investigated devices in terms of stent compliance and radial force.

71-Year-Old Man With a New Heart Murmur

71-Year-Old Man With a New Heart Murmur

Transcatheter Aortic Valve Implantation for Severe Bicuspid Aortic Stenosis - 2 Years Follow up Experience From India.

Transcatheter Aortic Valve Implantation for Severe Bicuspid Aortic Stenosis - 2 Years Follow up Experience From India.

Comparison of clinical outcomes between use of overexpanding an undersized versus nominal-sized SAPIEN 3 ultra transcatheter heart valve in patients with borderline annulus area.

For patients with borderline annulus areas that fall between two valve sizes, overinflating a smaller balloon-expandable transcatheter heart valve (THV) may be preferable to nominal sizing of a larger THV. To evaluate the outcomes of nominal preparation versus over-expanding an under-sized SAPIEN 3 Ultra (S3U) transcatheter heart valve (OE-THV) in cases with borderline annuli. 958 patients that underwent TAVR with the S3U at four high-volume TAVR centers between January 2017 and December 2020 were retrospectively reviewed. 336 patients were identified as borderline annuli size, of which 146 (44%) received OE-THVs and 190 (56%) received nominal-sized THVs. The primary composite endpoint included: in-hospital mortality, aortic injury, moderate/severe paravalvular leak (PVL), permanent pacemaker implant (PPM), stroke, or conversion to surgery. Baseline characteristics were similar except for a larger percentage of females in the OE-THV (53.42% vs. 42.11%, p = 0.04). TAVR with OE-THV resulted a reduction in the primary composite endpoint (13.69% vs. 22.63%, p = 0.04). On subgroup analysis, there was no difference between 20 mm OE-THV versus 23 mm nominal or 23 mm OE-THV versus 26 mm nominal, but there was a reduction in the primary composite endpoint in patients with larger annuli that received a 26 mm OE-THV compared to the 29 mm nominally sized THV (9.7% vs. 27.4%, p = 0.02). At 1 month and 1 year follow-up, there was no significant difference in mortality, PVL rates, NYHA class, and/or KCCQ score. Overinflating a smaller-sized S3U THV may be a safer option in comparison to nominal sizing in patients with borderline annular area.

Long-Term Mortality After TAVI for Bicuspid vs. Tricuspid Aortic Stenosis: A Propensity-Matched Multicentre Cohort Study.

ObjectivesPatients with bicuspid aortic valve (BAV) stenosis were excluded from the pivotal trials of transcatheter aortic valve implantation (TAVI). We compared the in-hospital and long-term outcomes between patients undergoing TAVI for bicuspid and tricuspid aortic valve (TAV) stenosis.MethodsWe performed a retrospective registry-based analysis on patients who underwent TAVI for BAV and TAV at five different centers between January 2009 and August 2017. The primary outcome was long-term all-cause mortality. Secondary outcomes were in-hospital mortality, procedural complications, and valve performance.ResultsOf 1,451 consecutive patients who underwent TAVI, two propensity-matched cohorts consisting of 130 patients with BAV and 390 patients with TAV were analyzed. All-cause mortality was comparable in both groups up to 10 years following TAVI (HR 1.09, 95% CI: 0.77–1.51). Device success and in-hospital mortality were comparable between the groups (96 vs. 95%, p = 0.554 and 2.3 vs. 2.1%, p = 0.863, respectively). Incidence of procedural complications was similar in both groups, with a trend toward a higher rate of stroke in patients with BAV (5 vs. 2%, p = 0.078). Incidence of moderate or severe paravalvular leak (PVL) at discharge was comparable in both groups (2 vs. 2%, p = 0.846). Among patients with BAV, all-cause mortality was similar in self-expanding and balloon-expandable prostheses (HR 1.02, 95% CI: 0.52–1.99) and lower in new-generation devices compared to old-generation valves (HR 0.27, 95% CI 0.12–0.62).ConclusionPatients who had undergone TAVI for BAV had comparable mortality to patients with TAV up to 10 years after the procedure. The device success, in-hospital mortality, procedural complications, and PVL rate were comparable between the groups. The high rate of neurological complications (5%) in patients with BAV warrants further investigation.

Factibilidad del alineamiento comisural y coronario precisos con TAVI balón-expandible

Introduction and objectivesWe aimed to describe the feasibility and preliminary outcomes of commissural alignment (CA) for the balloon-expandable transcatheter heart valve. MethodsThe relationship among native commissures and transcatheter aortic valve implantation neocommissures was analyzed in 10 consecutive patients with tricuspid severe aortic stenosis undergoing transcatheter aortic valve implantation after guided implantation based on computed tomography analysis with a self-developed software. CA was predicted by in silico bio-modelling in the 10 patients and the calculated rotation was applied during crimping. Degrees of CA and coronary overlap (CO) were measured through 1-month follow up computed tomography. Transvalvular residual gradients and the rate of paravalvular leak were also analyzed. ResultsMean commissural misalignment was 16.7±8°. Four patients showed mild misalignment but none of them showed a moderate or severe degree of misalignment. The in silico model accurately predicted the final in vivo position with a correlation coefficient of 0.983 (95%CI, 0.966-0.992), P <.001. Severe CO with right coronary ostium occurred in 3 patients likely due to ostial eccentricity, and CO was not present with the left coronary artery in any of the patients. Mean transaortic gradient was 6.1±3.3mmHg and there were no moderate-severe paravalvular leaks. ConclusionsPatient-specific rotation during valve crimping based on preprocedural computed tomography is feasible with balloon-expandable devices and is associated with the absence of moderate or severe commissural misalignment and left main CO.Full English text available from:www.revespcardiol.org/en

Clinical outcomes following single access transfemoral transcatheter aortic valve implantation.

We describe the first experience using calcification of anatomical landmarks to obviate the need for transcatheter aortic valve implantation(TAVI) alignment aortography and secondary TAVI access. TAVI alignment conventionally involves secondary femoral access for contrast aortography using a second catheter. Secondary femoral access accounts for up to 25% of all vascular complications. Heavily calcified aortic leaflets are often visible fluoroscopically and can act as markers for TAVI alignment. We considered 100 consecutive patients for transfemoral TAVI. The first group was considered for a conventional dual access technique and the subsequent group was considered for a single access technique. Relevant baseline, and procedural and outcome measures were recorded. Baseline characteristics were comparable between groups. Balloon-expandable transcatheter heart valves(THV)were used in all cases. THV implantation was successful in 100% of cases with no procedural or in-hospital mortality. Procedural time and contrast use were lower in the single access group. There were no Valve Academic Research Consortium (VARC)-2major vascular complications with the single access technique. This is the first study describing the use of calcification of anatomical landmarks to obviate the need for secondary TAVI access. Notable observations included successful device implantation in all cases, no VARC-2 major vascular complications, comparable rates of paravalvular leak and permanent pacemaker requirement, shorter procedural times, and lower contrast use. Single access TAVI is a viable alternative technique to minimize vascular access, contrast use, and procedural duration in experienced centers and with selected patients, allowing successful device implantation and low complication rates while further streamlining TAVI workflow.

Very-long-term outcomes of mechanical valves in mitral position focusing on valve-related complications.

OBJECTIVESThis study aimed to examine very-long-term outcomes of a mechanical valve at the mitral position.METHODSThis study included all patients who underwent mitral valve replacement (MVR) using a mechanical valve including urgent operation at the Department of Cardiovascular Surgery, Hyogo Brain and Heart Center, Himeji, from January 1987 to December 2015.RESULTSFive hundred and eighty-three patients (277 men [47.51%]; age, 61 [54–67] years) were included in this study. The implanted valve models were as follows: SJM, 221 (37.91%); ATS, 35 (6.00%); On-X, 68 (11.66%); and Carbomedics 194, (33.28%).The median clinical follow-up duration was 13.3 (7.4–19.6) years. The survival rates at 10, 15, 20 and 25 years were 81.42%, 69.27%, 56.34% and 45.03%, respectively. Thromboembolism was observed in 38 patients, and the linearized ratio for each event was 0.626%/patient-year [95% confidence interval (CI), 0.443–0.859%]. Intracranial haemorrhage and gastrointestinal bleeding were observed in 26 and 9 patients, and the linearized ratio for each event was 0.425%/patient-year (95% CI, 0.277–0.006%) and 0.145%/patient-year (95% CI, 0.067–0.276%), respectively. Major paravalvular leak was observed in 32 patients, and the linearized ratio was 0.532%/patient-year (95% CI, 0.364%–0.751%). The cumulative incidence rate of major paravalvular leak at 10, 15, 20 and 25 years was 3.7%, 5.6%, 6.4% and 10.4%, respectively. Multivariable Cox regression analysis revealed that repeated MVR and male gender were associated with major paravalvular leak.CONCLUSIONSMale gender and repeated MVR were risk factors for paravalvular leak after mechanical MVR. Paravalvular leak could have occurred regardless of postoperative period even at 25 years after implantation. Lifelong clinical follow-up is considered necessary.

Feasibility of precise commissural and coronary alignment with balloon-expandable TAVI

Introduction and objectivesWe aimed to describe the feasibility and preliminary outcomes of commissural alignment (CA) for the balloon-expandable transcatheter heart valve. MethodsThe relationship among native commissures and transcatheter aortic valve implantation neocommissures was analyzed in 10 consecutive patients with tricuspid severe aortic stenosis undergoing transcatheter aortic valve implantation after guided implantation based on computed tomography analysis with a self-developed software. CA was predicted by in silico bio-modelling in the 10 patients and the calculated rotation was applied during crimping. Degrees of CA and coronary overlap (CO) were measured through 1-month follow up computed tomography. Transvalvular residual gradients and the rate of paravalvular leak were also analyzed. ResultsMean commissural misalignment was 16.7±8°. Four patients showed mild misalignment but none of them showed a moderate or severe degree of misalignment. The in silico model accurately predicted the final in vivo position with a correlation coefficient of 0.983 (95%CI, 0.966-0.992), P <.001. Severe CO with right coronary ostium occurred in 3 patients likely due to ostial eccentricity, and CO was not present with the left coronary artery in any of the patients. Mean transaortic gradient was 6.1±3.3mmHg and there were no moderate-severe paravalvular leaks. ConclusionsPatient-specific rotation during valve crimping based on preprocedural computed tomography is feasible with balloon-expandable devices and is associated with the absence of moderate or severe commissural misalignment and left main CO.

Comparison of In-Hospital Outcomes and Readmission Rates of Transcatheter Aortic Valve Implantation in Mixed Aortic Valve Disease Versus Pure Aortic Stenosis

Recently, transcatheter aortic valve implantation (TAVI) has been performed in patients with combined aortic stenosis (AS) and aortic regurgitation. We sought to evaluate in-hospital outcomes and readmission rates after TAVI in patients with mixed aortic valve disease (MAVD). A total of 100,573 TAVI procedures were identified between 2011 and 2017 using International Classification of Diseases, Ninth Revision and International Classification of Diseases, Tenth Revision procedure codes the from Nationwide Readmissions Database. We separated patients into 2 cohorts, those with MAVD and those with pure AS. The primary outcome was all-cause inpatient mortality after TAVI, and secondary outcomes included rates of 30- and 90-day readmissions and postprocedural complications. A total of 3,260 patients had MAVD (median age 83 years, 43.5% women). In-hospital mortality (2.5% vs 2.6%, p=0.531) and rates of paravalvular leak (1.0% vs 1.3%, p=0.056) were similar between the MAVD and pure AS groups. Major bleeding (7.4% vs 9.6%, p <0.001), 30-day readmission (0.5% vs 8.8%, p <0.001) and 90-day readmission rates (0.8% vs 16.0%, p <0.001), acute kidney injury (12.9% vs 15.1%, p <0.001), postoperative ischemic stroke (2.0% vs 5.7%, p <0.001), and mechanic circulatory support use (1.9% vs 4.5%, p <0.001) were less prevalent in the MAVD cohort. Using a multivariate logistic regression model to adjust for confounding factors, MAVD was not predictive of mortality in patients who underwent TAVI (adjusted odds ratio [adjOR] 1.25, 95% confidence interval [CI] 0.99 to 1.57, p=0.056); however, MAVD was associated with: decreased odds of 30-day readmission (adjOR 0.05, 95% CI 0.03 to 0.08, p <0.001), 90-day readmission rates (adjOR 0.04, 95% CI 0.03 to 0.06, p <0.001), and higher odds of pacemaker implantation (adjOR 1.46, 95% CI 1.29 to 1.65, p <0.001). In conclusion, despite differences in the aortic valve and left ventricular anatomy (pressure vs volume-related adaptive changes) in patients with MAVD and pure AS, TAVI appears safe and feasible. However, patients with MAVD were more likely to have permanent pacemakers implanted. The results of our study warrant further randomized controlled studies to confirm these findings.

Impact of Valve Size on Paravalvular Leak and Valve Hemodynamics in Patients With Borderline Size Aortic Valve Annulus.

BackgroundTranscatheter heart valve (THV) selection for transcatheter aortic valve implantation (TAVI) is crucial to achieve procedural success. Borderline aortic annulus size (BAAS), which allows a choice between two consecutive valve sizes, is a common challenge during device selection. In the present study, we evaluated TAVI outcomes in patients with BAAS according to THV size selection.MethodsWe performed a retrospective study including patients with severe aortic stenosis (AS) and BAAS, measured by multi-detector computed tomography (MDCT), undergoing TAVI with self-expandable (SE) or balloon-expandable (BE) THV from the Israeli multi-center TAVI registry. The aim was to evaluate outcomes of TAVI, mainly paravalvular leak (PVL) and valve hemodynamics, in patients with BAAS (based on MDCT) according to THV sizing selection in between 2 valve sizes. In addition, to investigate the benefit of shifting between different THV types (BE and SE) to avoid valve size selection in BAAS.ResultsOut of 2,352 patients with MDCT measurements, 598 patients with BAAS as defined for at least one THV type were included in the study. In BAAS patients treated with SE-THV, larger THV selection was associated with lower rate of PVL, compared to smaller THV (45.3 vs. 64.5%; pv = 0.0038). Regarding BE-THV, larger valve selection was associated with lower post-procedural transvalvular gradients compared to smaller THV (mean gradient: 9.9 ± 3.7 vs. 12.5 ± 7.2 mmHg; p = 0.019). Of note, rates of mortality, left bundle branch block, permanent pacemaker implantation, stroke, annular rupture, and/or coronary occlusion did not differ between groups.ConclusionBAAS is common among patients undergoing TAVI. Selection of a larger THV in these patients is associated with lower rates of PVL and optimized THV hemodynamics with no effect on procedural complications. Additionally, shift from borderline THV to non-borderline THV modified both THV hemodynamics and post-dilatation rates.

Generational Differences in Outcomes of Self-Expanding Valves for Transcatheter Aortic Valve Replacement.

The Medtronic Evolut Pro valve (EPV) is a new-generation self-expanding valve (SEV), particularly designed to reduce paravalvular leak (PVL) rates in transcatheter aortic valve replacement (TAVR). We aimed to compare the safety and efficacy of EPV with older-generation SEVs, in particular, postprocedural PVL and permanent pacemaker (PPM) implantation rates. We performed a retrospective, multicenter, propensity-matched analysis of the Israeli TAVR registry between September 2008 and June 2019. Two independent propensity score-matched comparisons were performed comparing EPV with the first-generation CoreValve (CV), and comparing EPV with the second-generation Evolut R valve (ERV). The registry included 2591 patients who were propensity-matched into 3 cohorts: EPV (n = 222), CV (n = 212), and ERV (n = 213). Moderate and above PVL rates were lower for EPV (angiographic PVL [aPVL], 0.6%; echocardiographic PVL [ePVL], 3.0%) as compared with CV (aPVL, 7.8% [P<.001] and ePVL, 11.6% [P<.01]), but not as compared with ERV (aPVL, 6.4% [P<.01] and ePVL, 4.4% [P=.57]). Lower rates of PPM were noted for EPV (16.3%) as compared with both CV (33.5%; P<.001) and ERV (24.4%; hazard ratio, 0.61; 95% confidence interval, 0.37-0.995; P=.046). Other safety and efficacy outcome rates were excellent, with significant improvements as compared with older-generation SEVs. The EPV demonstrates excellent procedural safety and efficacy outcomes. Moderate and above PVL rates were significantly reduced in comparison with CV; however, not significantly reduced as compared with ERV. The need for PPM implantation was lower as compared with both older-generation valves.

Comparison between Edwards SAPIEN 3 and Edwards SAPIEN 3 ULTRA in Transcatheter Aortic Valve Implantation (TAVI): The First Australian Experience

Edwards SAPIEN 3 ULTRA is the new iteration of SAPIEN 3 (S3) valve designed to reduce the rate of paravalvular leak (PVL). Studies from outside Australia reported a significant reduction in PVL. To date, there is no published Australian data.

Ellipticity Is Associated With Non-Cardiac Mortality Following Transcatheter Aortic Valve Implantation

Aortic annulus ellipticity may be associated with increased rates of paravalvular leak (PVL) following transcatheter aortic valve implantation (TAVI), without increased mortality, although studies are limited. We sought to determine the role of ellipticity on valvular and mortality outcomes.

90 Annular size and interaction with trans-catheter aortic valves for the treatment of severe bicuspid aortic valve stenosis: insights from the beat registry

Abstract Aims Transcatheter aortic valve replacement (TAVR) is safe and feasible in patients with bicuspid aortic valve (BAV), but whether annular size may influence TAVR results in BAV patients remains unclear. We aimed at evaluating the impact of aortic annular size on procedural and clinical outcomes of BAV patients undergoing TAVR, as well as potential interactions between annular dimension and trans-catheter heart valve (THV) type [balloon-expandable (BEV) vs. self-expanding (SEV)]. Methods and results BEAT is a multicentre registry of consecutive BAV stenosis undergoing TAVR. For this sub-study patients were classified according to annular dimension in small-annulus (area &amp;lt; 400 mm2 or perimeter &amp;lt;72 mm), medium-annulus (area ≥ 400 and &amp;lt; 575 mm2, perimeter ≥72 mm and&amp;lt; 85 mm), large-annulus (area ≥575 mm2 or perimeter ≥85 mm). Primary endpoint was Valve Academic Research Consortium-2 (VARC-2) device success. 45(15.5%) patients had small, 132(45.3%) medium, and 114(39.2%) large annuli. Compared with other groups, patients with large annuli were more frequently male, at younger age, had higher body mass index, larger aortic valve area, higher rate of moderate-severe calcification, lower mean trans-aortic valve gradient and lower left ventricular ejection fraction. In large-annuli SEVs were associated with a lower VARC-2 device success (75.9% vs. 90.6%, P = 0.049) driven by a higher rate of paravalvular valvular leak (PVL) compared to BEVs (20.7% vs. 1.2%, P &amp;lt; 0.001). However, no differences in clinical outcomes were observed according to annular size nor THV type. Conclusions TAVR in BAV patients is feasible irrespective of annular size. However in patients with large aortic annulus SEVs were associated with a significantly higher rate of PVLs compared to BEVs.

Annular size and interaction with trans-catheter aortic valves for treatment of severe bicuspid aortic valve stenosis: Insights from the BEAT registry

BackgroundTranscatheter aortic valve replacement (TAVR) is safe and feasible in patients with bicuspid aortic valve (BAV), but whether annular size may influence TAVR results in BAV patients remains unclear. We aimed at evaluating the impact of aortic annular size on procedural and clinical outcomes of BAV patients undergoing TAVR, as well as potential interactions between annular dimension and trans-catheter heart valve (THV) type (balloon-expandable (BEV) vs. self-expanding (SEV). MethodsBEAT is a multicenter registry of consecutive BAV stenosis undergoing TAVR. For this sub-study patients were classified according to annular dimension in small-annulus (area < 400 mm2 or perimeter <72 mm), medium-annulus (area ≥ 400 and < 575 mm2, perimeter ≥72 mm and< 85 mm), large-annulus (area ≥ 575 mm2 or perimeter ≥85 mm). Primary endpoint was Valve Academic Research Consortium-2 (VARC-2) device success. Results45(15.5%) patients had small, 132(45.3%) medium, and 114(39.2%) large annuli. Compared with other groups, patients with large annuli were more frequently male, younger, with higher body mass index, larger aortic valve area, higher rate of moderate-severe calcification, lower mean trans-aortic valve gradient and lower left ventricular ejection fraction. In large-annuli SEVs were associated with a lower VARC-2 device success (75.9% vs. 90.6%, p = 0.049) driven by a higher rate of paravalvular valvular leak (PVL) compared to BEVs (20.7% vs. 1.2%, p < 0.001). However, no differences in clinical outcomes were observed according to annular size nor THV type. ConclusionsTAVR in BAV patients is feasible irrespective of annular size. However in patients with large aortic annulus SEVs were associated with a significantly higher rate of PVLs compared to BEVs.