Rates Of Paravalvular Leak Research Articles

Effects of aortic valve calcification on transcatheter aortic valve replacement for low-flow, low-gradient aortic stenosis.

Patients with low-flow, low-gradient (LFLG) aortic stenosis (AS) have precarious hemodynamics and are a fragile population for intervention. Quantification of aortic valve calcification (AVC) severity is a critical component of the evaluation for transcatheter aortic valve replacement (TAVR); this study aims to further clarify its utility for risk stratification in LFLG AS. This retrospective study evaluated 467 patients with LFLG AS undergoing TAVR at a large quaternary-care hospital from January 2019 to December 2021. AVC was quantified with Agatston scores using pre-operative computed tomography angiograms. Primary endpoint was a composite of all-cause mortality and heart failure rehospitalization rates. 51 patients (10.9%) had mild calcification, 137 (29.3%) had moderate, and 279 (59.7%) had severe. Increased AVC severity correlated with increased AS severity by aortic valve area (0.69cm2 for mild AVC vs. 0.63cm2 for severe; p≤0.001), peak velocity (3.1m/s vs. 3.9m/s; p≤0.001), and mean gradient (21mmHg vs. 36mmHg; p≤0.001). Kaplan-Meier analysis showed increased reductions in the primary composite endpoint (p=0.023) and heart failure rehospitalization rates (p=0.005) for patients with greater AVC severity undergoing TAVR. Multivariate adjustments confirmed a significant reduction in heart failure rehospitalizations when comparing TAVR outcomes between mild and severe AVC (HR 0.40, 95% CI 0.18-0.91; p=0.028). Between the 3 groups, there were no significant differences in adjusted rates of paravalvular leak or other periprocedural complications. Increased AVC in LFLG AS does not correlate clinically with more severe AS by echocardiography. Patients with more severe AVC have less heart failure rehospitalizations and derive greater benefit from TAVR.

Supra-Annular Versus Intra-Annular Self-Expanding Valves in Small Aortic Annulus: A Propensity Score-Matched Study

BackgroundTranscatheter aortic valve replacement (TAVR) with self-expanding valves (SEVs) may have different outcomes with supra-annular valves (SAVs) or intra-annular valves (IAVs) in patients with small aortic annuli (SAA), but this topic remains underexplored. We aimed to evaluate outcomes between different SEVs, namely SAVs (CoreValve/Evolut R/PRO/PRO+/FX) vs. IAVs (Portico/Navitor). MethodsSingle-center data with patients with SAA (maximum diameter <23 mm) who underwent TAVR from 2013 to 2023 with SEVs, followed by 1:1 propensity score matching (PSM). ResultsWe obtained 86 PSM pairs with median age of 83.0 years (SAVs) and 82.0 years (IAVs), with women representing 77.6% of the PSM cohort. After TAVR, we did not find statistically significant differences for the following outcomes: Valve Academic Research Consortium-3 periprocedural mortality, technical success, device success, clinical efficacy, and rates of paravalvular leak were not statistically significantly different, but we found higher rates of permanent pacemaker implantation in the IAV group (1.2 vs. 8.1%; p = 0.029). Despite the larger indexed effective orifice area with SAVs (median 1.0 vs. 0.8 cm2/m2, p = 0.001), we did not find statistically significant differences between the groups in terms of residual mean gradients >20 mmHg (0.0 vs. 2.3%, p = 0.155), and severe prosthesis-patient mismatch (2.3 vs. 5.8%, p = 0.390). No statistically significant difference was observed in survival (log-rank p = 0.950) and stroke (p = 0.6547) between patients who received SAVs and IAVs. For patients with SAA, TAVR with SEV devices is safe. ConclusionsIAVs and SAVs are associated with comparable device performance in terms of hemodynamic structural and nonstructural dysfunction. Randomized data are needed to validate these findings and guide informed device selection.

And the beat goes on.

Key points Technical advancements in devices and the development of techniques to optimize valve implantation have been the cornerstone of improvement in outcomes of TAVR. While device success and the rate of paravalvular leak have decreased over time, the rate of permanent pacemaker implantation following self‐expanding valve systems remains high. Reduction in the rate of permanent pacemaker implantation compared to surgical aortic valve replacement remains a high priority.

Do we still need intra-procedural TTE during Transcatheter aortic valve replacement? A high volume, single center experience

BackgroundTranscatheter aortic valve implantation (TAVI) has undergone significant advances in recent years, with the development of improved pre-planning tools and devices. These advances have led to a reduction in the rate of paravalvular leak (PVL), a complication that is associated with poor outcomes even when mild. As some centers around the world are moving to solely fluoroscopy-focused implantation, we aimed to describe the clinical impact of intra-procedural transthoracic echocardiography (TTE) during TAVI in a high volume hospital. MethodsObservational study during a 3-month period. A limited TTE examination was performed immediately after deployment to assess the existence of PVL and grade its severity. Complete TTE was performed a day after the procedure. In case of ≥mild PVL after valve deployment, a decision was made according to the severity of the PVL, patient anatomy and extent of annular calcification to preform balloon post-dilation. If done, an additional limited TTE was performed to assess possible complication and the degree of PVL post dilatation. Results115 patient were included in the study. Intra-procedural TTE identified 16 patients (14 %) with at least mild PVL, three of them with moderate (3 %). Post balloon dilatation was performed in 10 patients (9 % of the cohort) with significant improvement in the degree of PVL. ConclusionIntra-procedural TTE immediately after TAVI deployment can accurately identify PVL, allowing operators to perform post balloon dilatation with improvement in early echocardiographic results. Our findings support the routine use of TTE during procedures, without relying solely on fluoroscopy.

Conduction disorders following transcatheter aortic valve replacement using acurate Neo2 transcatheter heart valve: A propensity matched analysis

BackgroundThe ACURATE neo2 transcatheter aortic valve was developed to improve paravalvular leak (PVL) rates while maintaining low rates of conduction disturbances and permanent pacemaker implantation (PPMI) seen with its predecessor. We aimed to compare conduction disturbances rates of transcatheter aortic valve replacement (TAVR) using ACURATE Neo2 with other commonly used valves. MethodsA retrospective analysis of the Israeli TAVR registry between the years 2014–2023 was performed to compare conduction disturbances and PVL rates, and procedural outcomes, among patients treated with ACURATE neo2, Edwards Sapien 3 (S3), and Evolut PRO valves. Propensity score matching was performed to compare groups with similar characteristics. ResultsFollowing exclusion of patients with non-femoral access, unknown valve type, older-generation valves, and less commonly used valves or (n = 4387), our analysis included 3208 patients undergoing TAVR using ACURATE neo2, Edwards S3, and Evolut PRO valves. Propensity matched groups comprised 169 patients each. Rates of any conduction disturbances [left bundle branch block (LBBB), atrioventricular block, or PPMI] were lower in the ACURATE neo2 group compared to both other valves [15.8 %, S3–37.5 % (p < 0.001), Evolut PRO-27.5 % (p = 0.02)] as were LBBB rates [9.0 %, S3–31.3 % (p < 0.001); Evolut PRO-20.1 % (p = 0.01). Atrioventricular block and PPMI rates were lower without statistical significance, as were rates of above-moderate PVL. ConclusionsIn this analysis, TAVR using ACURATE neo2 was associated with a lower composite rate of conduction disturbances in comparison to the Evolut PRO and Edwards S3 valves, mainly due to lower left bundle branch block rates, with non-significantly lower rates of PPMI and PVL.

Outcomes of Pledgeted versus Nonpledgeted Suture Technique for Isolated Aortic Valve Replacement

Objective: To compare outcomes of pledgeted versus nonplegdeted suture techniques for aortic valve replacement (AVR). Methods: This was a retrospective study utilizing an institutional database of AVRs performed at our center between 2010 and 2020. All patients who underwent isolated surgical AVR were included, while those who underwent concomitant procedures were excluded. Patients were dichotomized into those who underwent pledgeted vs. nonpledgeted AVR, and 1:1 propensity score matching (PSM) was employed. Clinical and echocardiographic outcomes were compared. Kaplan-Meier survival estimation and Cox regression were performed. Cumulative incidence functions were generated for all-cause readmissions and for heart-failure readmissions. Freedom from major adverse cardiac and cerebrovascular events (MACCE) were also analyzed and compared using Kaplan-Meier methods. Results: A total of 2240 patients were identified. PSM yielded 892 matched pairs. Mean gradient was significantly higher in the pledgeted group (p &lt; 0.001), but patients in this group had a smaller median valve size implanted. There were no significant differences in paravalvular leak rates. Kaplan-Meier survival estimates, cumulative incidence of readmissions, and freedom from MACCE were not significantly different between groups. Conclusion: Long-term survival, readmission rates, and freedom from MACCE are comparable after pledgeted and nonpledgeted AVR. There were no differences in paravalvular leak rates between the two techniques.

Experience with the ACURATE neo and neo2 transcatheter aortic valves in Spain. The PRECISA (PRospective Evaluation Complementing Investigation with ACURATE devices) registry.

Previous studies have documented a high rate of implantation success with the ACURATE neo2 valve, as well as a reduction in paravalvular leak (PVL) compared to its predecessor, the ACURATE neo. However, there are no studies that have reviewed and compared the long-term clinical and hemodynamic outcomes of these patients. This study aimed to evaluate the results of the ACURATE neo transcatheter aortic valve in a real-world context, and to compare the results of the outcomes of both generations of this device (ACURATE neo and ACURATE neo2), with a specific focus on procedural success, safety, and long-term effectiveness. A prospective study including all consecutive patients treated with the ACURATE neo device in seven hospitals was conducted (Clinical Trials Identification Number: NCT03846557). The primary endpoint consisted of a composite of adverse events, including mortality, aortic insufficiency, and other procedural complications. As the second-generation device (ACURATE neo2) replaced the ACURATE neo during the study period, hemodynamic and clinical results before admission, at 30 days, and at 1 year of follow-up were compared between the two generations. A total of 296 patients underwent transcatheter aortic valve implantation with the ACURATE device, with 178 patients receiving the ACURATE neo and 118 patients receiving the ACURATE neo2. In the overall population, the absence of device success occurred in 14.5%. The primary reason for the absence of device success was the presence of para-valvular regurgitation ≥ 2. There were no instances of coronary occlusions, valve embolization, annulus rupture, or procedural deaths. ACURATE neo2 was associated with a significantly higher device success rate (91.7% vs. 82%, p = 0.04), primarily due to a significantly lower rate of para-valvular regurgitation, which remained significant at 1 year. The use of ACURATE neo and neo2 transcatheter aortic valves is associated with satisfactory clinical results and an extremely low rate of complications. The ACURATE neo2 enables a significantly higher device success rate, primarily attributed to a significant reduction in the rate of PVL.

Three-year clinical outcomes after transcatheter aortic valve implantation in patients with bicuspid aortic disease: Comparison between self-expanding and balloon-expandable valves.

Bicuspid aortic valve (BAV) stenosis is a complex anatomical scenario for transcatheter aortic valve implantation (TAVI). Favorable short-term clinical outcomes have been reported with TAVI in this setting, but long-term data are scarce. We retrospectively included, in a single-center registry, patients with BAV stenosis who underwent TAVI before 2020. We compared patients treated with self-expanding valves (SEV) versus balloon-expandable valves (BEV). The primary endpoint was a composite of all-cause mortality, stroke and need for aortic valve (AV) reintervention at 3 years. Secondary endpoints included each component of the primary endpoint, cardiovascular mortality, permanent pacemaker implantation (PPI) rate, mean gradient and ≥moderate paravalvular leak (PVL) rate. A total of 150 consecutive patients (SEV = 83, BEV = 67) were included. No significant differences were reported between SEV and BEV groups for the primary composite endpoint (SEV 35.9% vs. BEV 32%, p = 0.66), neither for clinical secondary endpoints (all-cause mortality SEV 28.1% vs. BEV 28%, p = 0.988; cardiovascular mortality SEV 14.1% vs. BEV 20%, p = 0.399; stroke SEV 12.5% vs. BEV 6%, p = 0.342; need for AV reintervention SEV 0% vs. BEV 0%; PPI SEV 28.1% vs. BEV 24%, p = 0.620). A lower mean gradient persisted up to 3 years in the SEV group (SEV 8.8 ± 3.8 mmHg vs. BEV 10.7 ± 3.2 mmHg, p = 0.063), while no significant difference was found in the rate of ≥ moderate PVL (SEV 3/30 vs. BEV 0/25, p = 0.242). In this single center registry, we observed favorable 3-year clinical outcomes in nonselected BAV patients treated with different generation devices, without significant differences between patients receiving SEV or BEV.

TAVR-in-TAVR with a balloon-expandable valve for paravalvular leak.

Paravalvular leak (PVL) is a severe complication of transcatheter aortic valve replacement (TAVR) that can lead to poor outcomes. TAVR-in-TAVR is a promising treatment for PVL; however, reports on its safety or efficacy are limited. In this study, we aimed to investigate the clinical outcomes of TAVR-in-TAVR using balloon-expandable prostheses for PVLs after TAVR. We retrospectively analyzed data from patients who underwent TAVR-in-TAVR using balloon-expandable Sapien prostheses for PVL after an initial TAVR at our institution. The procedural success, in-hospital complications, all-cause mortality, and echocardiographic data for up to 2 years post-surgery were evaluated. In total, 31 patients with a mean age of 81.1 ± 7.9 years and mean Society of Thoracic Surgeons score of 8.8 ± 5.4% were identified. The procedural success rate of TAVR-in-TAVR was 96.8% (30/31). No in-hospital deaths, cardiac tamponade, or conversion to sternotomy occurred. Re-intervention was performed in only one patient (3.2%) during hospitalization. The all-cause mortality rates at 30 days and 2 years were 0% and 16.1%, respectively. A significant reduction in the PVL rate was observed at 30 days compared with that at baseline (p < 0.01). Our findings suggest that TAVR-in-TAVR using balloon-expandable prostheses is safe and effective for PVL after TAVR with low complication rates and acceptable long-term outcomes. Further studies with larger sample sizes are needed to confirm our findings.

Real-World Outcomes for the Fifth-Generation Balloon Expandable Transcatheter Heart Valve in the United States

BackgroundThe fifth-generation SAPIEN 3 Ultra Resilia valve (S3UR) incorporates several design changes as compared with its predecessors, the SAPIEN 3 (S3) and SAPIEN 3 Ultra (S3U) valves, including bovine leaflets treated with a novel process intended to reduce structural valve deterioration via calcification, as well as a taller external skirt on the 29-mm valve size to reduce paravalvular leak (PVL). The clinical performance of S3UR compared with S3 and S3U in a large patient population has not been previously reported. ObjectivesThe aim of this study was to compare S3UR to S3/S3U for procedural, in-hospital, and 30-day clinical and echocardiographic outcomes after transcatheter aortic valve replacement (TAVR). MethodsPatients enrolled in the STS/ACC TVT (Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy) Registry between January 1, 2021, and June 30, 2023, who underwent TAVR with S3UR or S3U/S3 valve platforms were propensity-matched and evaluated for procedural, in-hospital, and 30-day clinical and echocardiographic outcomes. Results10,314 S3UR patients were propensity matched with 10,314 patients among 150,539 S3U/S3 patients. At 30 days, there were no statistically significant differences in death, stroke, or bleeding, but a numerically higher hospital readmission rate in the S3UR cohort (8.5% vs 7.7%; P = 0.04). At discharge, S3UR patients exhibited significantly lower mean gradients (9.2 ± 4.6 mm Hg vs 12.0 ± 5.7 mm Hg; P < 0.0001) and larger aortic valve area (2.1 ± 0.7 cm2 vs 1.9 ± 0.6 cm2; P < 0.0001) than patients treated with S3/S3U. The 29-mm valve size exhibited significant reduction in mild PVL (5.3% vs 9.4%; P < 0.0001). ConclusionsS3UR TAVR is associated with lower mean gradients and lower rates of PVL than earlier generations of balloon expandable transcatheter heart valve platforms.

Comparing two-year outcomes of balloon-expandable Myval and self-expanding Evolut R in severe aortic valve stenosis

BackgroundThe new balloon-expandable (BE) Myval transcatheter heart valves (THV) has shown promising early results with low paravalvular leak (PVL) and permanent pacemaker implantation (PPI) rates. Limited data are available regarding its long-term performance. We aimed to compare the 2-year clinical and echocardiographic outcomes of transcatheter aortic valve replacement (TAVR) using the self-expanding (SE) Evolut R and the BE Myval THVs. MethodsThe EVAL study included 166 patients with severe aortic valve stenosis who underwent TAVR either with SE Evolut R (n = 108) or BE Myval (n = 58) THV. Primary objectives include comparison on clinical efficacy (freedom from all-cause mortality, stroke, and cardiovascular hospitalization), echocardiographic performance and PPI rates between the two THVs. ResultsAt 2-year the BE Myval group showed higher clinical efficacy (86% vs. 66%,HR:2.62, 95%CI 2.2–5.1;p = 0.006), with fewer cardiac hospitalizations (3.4% vs. 13.9%,p = 0.03). No significant differences in all-cause mortality, cardiovascular mortality, or stroke rates were observed. The proportion of patients with ≥moderate PVL was significantly lower in the BE Myval compared to the SE Evolut R group (4%vs. 22%,p = 0.008). The mean transvalvular gradient was significantly higher in the SE group compared to the BE group (9.5 ± 4.3 vs. 6.9 ± 2.2 mmHg,p < 0.001), however there was no difference in the percentage of patients with a mean gradient ≥20 mmHg between the two groups. ConclusionsBoth THVs offer similar 2-year clinical outcomes. The BE Myval THV demonstrated advantages with higher clinical efficacy and lower PVL incidence. Longer follow-up and randomized trials are needed to validate these results and assess Myval's sustained performance and durability.

Five-Year Outcomes After Bicuspid Aortic Valve Replacement With a Novel Tissue Bioprosthesis

BackgroundThis study investigated the safety and effectiveness of surgical aortic valve replacement with RESILIA tissue (Edwards Lifesciences) through 5 years in patients with native bicuspid aortic valves. Outcomes were compared with those for patients with tricuspid aortic valves. MethodsOf 689 patients from the COMMENCE (ProspeCtive, nOn-randoMized, MulticENter) trial who received the study valve, 645 had documented native valve morphology and core laboratory-evaluable echocardiograms from any postoperative visit, which were used to model hemodynamic outcomes over 5 years. Linear mixed-effects models were used to estimate longitudinal changes in mean gradient and effective orifice area. ResultsPatients with native bicuspid aortic valves (n = 214) were more than a decade younger than those with tricuspid aortic valves (n = 458; 59.8 ± 12.4 years vs 70.2 ± 9.5 years; P < .001). The bicuspid aortic valve cohort exhibited no structural valve deterioration over 5 years, and rates of paravalvular leak and transvalvular regurgitation were low (0.7% and 2.9%, respectively [all mild] at 5 years). These outcomes mirrored those in patients with native tricuspid aortic valves. The model-estimated postoperative mean gradient and effective orifice area, as well as the rate of change of these outcomes, adjusted for age, body surface area, and bioprosthesis size, did not differ between the 2 cohorts. ConclusionsAmong patients with bicuspid aortic valves, RESILIA tissue valves demonstrated excellent outcomes to 5 years, including no structural valve deterioration and very low rates of paravalvular and transvalvular regurgitation. These results are encouraging for RESILIA tissue durability in young patients.

Short- and Long-term Clinical Outcomes of Balloon-expandable Versus Self-expanding Valves in Patients Undergoing Transcatheter Aortic Valve Replacement: A Meta-analysis

Background: Distinct clinical differences exist between balloon-expandable valves (BEVs) and self-expanding valves (SEVs) used in transcatheter aortic valve replacement (TAVR) for aortic stenosis. However, randomised data on comparative outcomes are limited. The aim of this meta-analysis was to analyse the differences in short- and longer-term clinical outcomes between the two valve designs. Methods: A comprehensive literature search for all studies up to and including April 2020 on the clinical outcomes of BEVs versus SEVs was performed. Study outcomes were divided into short term (in-hospital or 30 days), intermediate term (1 year) and long term (3 years). The primary outcome was all-cause mortality. Secondary endpoints were stroke or transient ischaemic attack (TIA), life-threatening or major bleeding, at least moderate paravalvular leak (PVL), permanent pacemaker (PPM) implantation, aortic valve area (AVA) and aortic valve mean pressure gradient (AV MPG). Results: A total of 41 studies (BEV, n=23,892; SEV, n=22,055) were included. At in-hospital/30 days, all-cause mortality favoured BEV (OR 0.85; 95% CI [0.75–0.96]). BEV had lower rates of PVL (OR 0.42; 95% CI [0.35–0.51]) and PPM (OR 0.56; 95% CI [0.44–0.72]), but smaller AVA (mean −0.09 cm2; 95% CI [−0.17, 0.00]) and higher AV MPG (mean 2.54 mmHg; 95% CI [1.84–3.23]). There were no significant differences in the incidence of stroke/TIA or bleeding between the two valve designs. At 1 year a lower PPM implantation rate (OR 0.44; 95% CI [0.37–0.52]), fewer PVLs (OR 0.26; 95% CI [0.09–0.77]), smaller AVA (mean −0.23 cm2; 95% CI [−0.35, −0.10]) and higher AV MPG (mean 6.05 mmHg; 95% CI [1.74–10.36]) were observed with BEV. No significant differences were observed in mortality, stroke/TIA or bleeding. There was no significant difference in mortality at 3 years between the two valve designs. Conclusion: In the short–intermediate term, SEVs had better valve haemodynamics but had higher PVL and PPM implantation rates than BEVs. However, there were no differences in intermediate–long-term mortality, stroke or TIA, or bleeding complications. A better understanding of these differences will enable TAVR operators to tailor their valve choice based on individual patient profile.

Comparison of Paravalvular Leak in SAPIEN 3 and EVOLUT PRO Valves in Transcatheter Aortic Valve Replacement: A Multicenter Registry

Paravalvular leak (PVL), conduction disturbances, and vascular complications remain the most common complications after TAVR. To address these adverse outcomes, the third generation of transcatheter heart valves has been developed. The last generation prosthesis provides an outer pericardial wrap for enhanced sealing and PVL prevention. This study aimed to compare the incidence and severity of PVL and 1-year survival after TAVR using SAPIEN 3 with those using EVOLUT PRO. An observational retrospective analysis was conducted in 1,481 patients who underwent TAVR for symptomatic severe aortic stenosis in 6 different European centers. The primary end point was to assess the frequency and severity of PVL at 30 days after TAVR. The secondary end point was to compare 1-year survival using EVOLUT PRO with that using SAPIEN 3. SAPIEN 3 transcatheter heart valve was implanted in 78.3% of study participants (n=1,160) whereas EVOLUT PRO was implanted in 21.7% (n=321). PVL is more commonly observed in patients treated with EVOLUT PRO at prehospital discharge (55.1% vs 37.3%) and at 1-month (51% vs 41.4%) and 1-year (51.3% vs 39.3%) follow-up. This difference mainly concerns low-grade (mild/trace) PVL. The frequency of high-degree (moderate/severe) PVL was almost similar in both groups throughout the study period (5.3% vs 5.8% before hospital discharge, 4% vs 3.1% at 1 month, and 3.2% vs 4.9% at 1 year). No significant difference in survival over 1 year has been observed (hazard ratio 0.73 [0.33 to 1.63], p=0.442) (Graphical abstract). In conclusion, the detection rate of PVL after TAVR with third-generation heart valves remains high, and there are no major differences between the devices regarding the frequency of significant (moderate/severe) PVL and survival.

Real-Life Performance and Clinical Outcomes of Portico Transcatheter Aortic Valve with FlexNav Delivery System: One-Year Data from a Single-Center Experience.

Significant progress has been made in both valves and delivery systems (DSs) for transcatheter aortic valve replacement (TAVR) procedures. We aimed to present one-year real-life data regarding TAVR procedures using Portico transcatheter heart valves (THVs) with new-generation, low-profile FlexNav DSs. This retrospective, single-center study enrolled 169 consecutive patients (mean age: 75.8 years, 68% females) with severe aortic stenosis undergoing TAVR with Portico THVs and FlexNav DSs between 2020 and 2021. We evaluated safety and efficacy outcomes, following the VARC-3 consensus, periprocedurally and at 30 days and 1 year. Procedural success was observed in 95.9% of cases, and no procedural mortality occurred. At 30 days, the rates of all-cause mortality, cardiovascular mortality, and neurological events were 4.7%, 3.6%, and 3.0%, respectively. Additionally, major vascular complications, acute kidney injury, and bleeding were recorded at rates of 11.2%, 14.8%, and 7.7%, respectively. The 1-year data showed all-cause mortality, cardiovascular mortality, and neurological event rates of 10.7%, 8.3%, and 7.7%, respectively. The moderate paravalvular leak and permanent pacemaker rates at 1 year were 2.6% and 12.2%, respectively. This real-life data provided evidence of positive outcomes and high technical success with Portico THVs and FlexNav DSs. Furthermore, we found low rates of mortality and neurological events, with satisfactory hemodynamic and functional results.

Mini-Aortic Valve Replacement versus Transcatheter Aortic Valve Implantation: A Propensity-Matched Study

Background. Total sternotomy for aortic valve replacement has been superseded by less invasive approaches such as mini-sternotomy or transcatheter procedures. There has been an exponential uptake in transcatheter aortic valve implantation (TAVI) in younger and lower risk patients following recent randomized trials. This study aims to compare the outcomes of patients with aortic stenosis treated with minimally invasive approaches: mini-sternotomy for aortic valve replacement (mini-AVR) and TAVI implantation. Methods. Between January 2015 and December 2021, a total of 1437 TAVI and 176 mini-AVR patients from 2 tertiary centers fulfilled the criteria and were included in the propensity matching model. Results. A total of 256 TAVIs and 146 mini-AVR were included in the matched cohort. There was no significant difference in 30-day mortality in the two groups (TAVI vs. mini-AVR 2.7% vs. 2.8%, p = 0.935 ). TAVI confers slightly lower gradients in the follow-up echo when compared with mini-AVR (peak gradient 20 ± 8.7 mmHg vs. 24.5 ± 10 mmHg, p &lt; 0.001 ; mean gradient 10.9 ± 5.6 mmHg vs. 13.2 ± 5.7 mmHg, p &lt; 0.001 ). On the other hand, mini-AVR exhibits remarkably lower rates of paravalvular leak (mild leak 8% vs. 41.5%, p &lt; 0.001 ; moderate leak 2.8% vs. 0%, p &lt; 0.001 ) and of need for permanent pacemaker implantation (2% vs. 12.2%, p &lt; 0.001 ). Unsurprisingly, TAVI has lower in-hospital stay 3 (2 to 6) days vs. 10 (8 to 13) days, p &lt; 0.001 ). Conclusions. For eligible aortic stenosis patients in the 7th decade of life, mini-AVR remains an excellent therapeutic option.

Transcatheter aortic valve replacement with the self-expanding ACURATE Neo2 in patients with horizontal aorta: Insights from the ITAL-neo registry

BackgroundHorizontal aorta (HA), defined by an aortic angulation (AA) ≥48°, is associated with worse outcomes particularly after self-expanding (SE) trans-catheter heart valve (THV) implantation. Although the SE ACURATE Neo THV demonstrated favorable procedural success rates in patients with HA, it remains associated with a non-negligible rate of moderate or greater paravalvular leak (PVL). ObjectivesAim of the study was to assess the performance of ACURATE Neo2 in the setting of HA. MethodsWe performed a multicenter cohort analysis on patients with severe aortic valve stenosis and HA undergoing transcatheter aortic valve replacement (TAVR) with the Neo or Neo2 THV enrolled in the ITAL-neo registry. The primary endpoint was a composite of early safety and clinical efficacy at 30 days according to the Valve Academic Research Consortium-3 (VARC-3). Secondary endpoints included the occurrence of moderate or severe PVL and 90-day clinical outcomes. ResultsAmong 900 patients included in the ITAL-neo registry, 407 exhibited HA; of these, 300 received a Neo THV and 107 a Neo2 THV. HA, irrespective of the THV implanted, emerged as an independent risk factor for developing ≥ moderate PVL. Technical and device success at 30-day follow-up was comparable between groups. However, Neo2 was associated with a significantly lower rate of ≥moderate PVL vs. Neo: (5% vs. 15%; p < 0.001), which was confirmed also at 90-day follow-up. Additionally, no correlation was found between ≥moderate PVL and AA in the Neo2 group, while PVL degree increased proportionally to the AA in the Neo cohort. ConclusionIn patients with HA, the new generation Acurate Neo2 THV was associated with a comparable device success rate and a significantly lower rate of ≥moderate PVL, when compared with its predecessor.

Evolut PRO/PRO+ versus Evolut R system for transcatheter aortic valve replacement

BackgroundThe self-expanding CoreValve Evolut PRO/PRO+ transcatheter aortic valve was designed to overcome the limitations of its forerunner, Evolut R. Evolut PRO/PRO+ offers the lowest delivery profile for 23–29 mm valves, with an external tissue wrap on all valve sizes. We compared safety and efficacy of Evolut PRO/PRO+ and Evolut R. MethodsWe analyzed 300 patients enrolled in the EPROMPT Registry against a historical control cohort of 242 patients who received Evolut R. The two arms were matched (1:1) via propensity-score methodology by accounting for differences in Society of Thoracic Surgeons Predicted Risk of Mortality scores, yielding 440 patients. The endpoints included in-hospital safety clinical outcomes, all-cause mortality, and echocardiographic parameters at 30 days and 1 year. ResultsAfter propensity-score matching, cardiac death (0.5% vs. 0.5%, p = 0.995), stroke (1.6% vs. 2.8%, p = 0.410), life-threatening bleeding (1.1% vs. 3.3%, p = 0.139), major vascular complications (0.5% vs. 0.9%, p = 0.653), and pacemaker implantation (16.9% vs. 13.6%, p = 0.345) were comparable between the Evolut PRO/PRO+ and Evolut R groups. Likewise, the rates of all-cause mortality were similar both at 30 days (0.5% vs. 1.4%, p = 0.315) and 1 year (1.8% vs. 4.1%, p = 0.159). The rates of moderate paravalvular leak (5.7% vs. 2.6%, p = 0.402), and mean gradient (7.27 ± 3.25 mmHg vs. 8.84 ± 4.36 mmHg, p = 0.105) were also comparable between groups at 1 year. ConclusionOur largest-to-date observational study suggests that the Evolut PRO/PRO+ system is safe and effective in treating severe aortic stenosis, with commensurate 30-day and 1-year mortality and similar 1-year echocardiographic hemodynamic outcomes in comparison to Evolut R.

One-year outcomes after transcatheter aortic valve implantation with the latest-generation SAPIEN balloon-expandable valve: the S3U registry.

Initial data about the performance of the new-generation SAPIEN 3 Ultra (S3U) valve are highly promising. However, evidence about the longer-term performance and safety of the S3U is scarce. We aimed to investigate the 1-year clinical and echocardiographic outcomes of transcatheter aortic valve implantation (TAVI) using the S3U compared with its predecessor, the SAPIEN 3 valve (S3). The SAPIEN 3 Ultra registry included consecutive patients who underwent transfemoral TAVI at 12 European centres with the S3U or S3 between October 2016 and December 2020. One-to-one propensity score (PS) matching was performed to account for differences in baseline characteristics. The primary outcomes of interest were all-cause death and the composite of all-cause death, disabling stroke and hospitalisation for heart failure at 1 year. The overall study cohort encompassed 1,692 patients treated with either the S3U (n=519) or S3 (n=1,173). The PS-matched population had a total of 992 patients (496 per group). At 1 year, the rate of death from any cause was 4.9% in the S3U group and 6.3% in the S3 group (p=0.743). Similarly, there were no significant differences in the rates of the primary composite outcome (9.5% in the S3 group and 6.6% in the S3U group; p=0.162). The S3U was associated with lower rates of mild paravalvular leak (PVL) compared with the S3 (odds ratio 0.63, 95% confidence interval: 0.44 to 0.88; p<0.01). No significant differences in transprosthetic gradients were observed between the two groups. Compared with the S3, the S3U transcatheter heart valve was associated with similar 1-year clinical outcomes but reduced rates of mild PVL.

Explant vs Redo-TAVR After Transcatheter Valve Failure: Mid-Term Outcomes From the EXPLANTORREDO-TAVR International Registry

BackgroundValve reintervention after transcatheter aortic valve replacement (TAVR) failure has not been studied in detail. ObjectivesThe authors sought to determine outcomes of TAVR surgical explantation (TAVR-explant) vs redo-TAVR because they are largely unknown. MethodsFrom May 2009 to February 2022, 396 patients in the international EXPLANTORREDO-TAVR registry underwent TAVR-explant (181, 46.4%) or redo-TAVR (215, 54.3%) for transcatheter heart valve (THV) failure during a separate admission from the initial TAVR. Outcomes were reported at 30 days and 1 year. ResultsThe incidence of reintervention after THV failure was 0.59% with increasing volume during the study period. Median time from index-TAVR to reintervention was shorter in TAVR-explant vs redo-TAVR (17.6 months [IQR: 5.0-40.7 months] vs 45.7 months [IQR: 10.6-75.6 months]; P < 0.001], respectively. TAVR-explant had more prosthesis–patient mismatch (17.1% vs 0.5%; P < 0.001) as the indication for reintervention, whereas redo-TAVR had more structural valve degeneration (63.7% vs 51.9%; P = 0.023), with a similar incidence of ≥moderate paravalvular leak between groups (28.7% vs 32.8% in redo-TAVR; P = 0.44). There was a similar proportion of balloon-expandable THV failures (39.8% TAVR-explant vs 40.5% redo-TAVR; P = 0.92). Median follow-up was 11.3 (IQR: 1.6-27.1 months) after reintervention. Compared with redo-TAVR, TAVR-explant had higher mortality at 30 days (13.6% vs 3.4%; P < 0.001) and 1 year (32.4% vs 15.4%; P = 0.001), with similar stroke rates between groups. On landmark analysis, mortality was similar between groups after 30 days (P = 0.91). ConclusionsIn this first report of the EXPLANTORREDO-TAVR global registry, TAVR-explant had a shorter median time to reintervention, with less structural valve degeneration, more prosthesis–patient mismatch, and similar paravalvular leak rates compared with redo-TAVR. TAVR-explant had higher mortality at 30 days and 1 year, but similar rates on landmark analysis after 30 days.