Late Third Transcatheter Aortic Valve Replacement for Treatment of Persistent Paravalvular Regurgitation.

Paravalvular regurgitation remains a frequent finding after transcatheter aortic valve replacement and is associated with unfavorable outcomes if more-than-mild grade. In this case, a patient underwent a third transcatheter aortic valve replacement procedure for worsening symptoms due to severe paravalvular regurgitation. The case underlines the role of preprocedural planning in achieving treatment success.

Coronary Cannulation Following TAVR Using Self-Expanding Devices With Commissural Alignment: The RE-ACCESS 2 Study.

BACKGROUND: Coronary re-engagement after transcatheter aortic valve replacement (TAVR) using self-expanding transcatheter heart valves (THVs) systematically implanted using commissural alignment (CA) techniques has been poorly investigated. OBJECTIVES: The aim of this study was to evaluate unsuccessful coronary cannulation, and its predictors, after TAVR using self-expanding devices implanted using CA techniques. METHODS: RE-ACCESS 2 (Reobtain Coronary Ostia Cannulation Beyond Transcatheter Aortic Valve Stent 2) was an investigator-driven, single-center, prospective study that enrolled consecutive TAVR patients receiving Evolut and ACURATE THVs implanted using CA techniques. The primary endpoint was unsuccessful coronary cannulation after TAVR. The secondary endpoint was the identification of postprocedural predictors of unfeasible, selective coronary ostia re-engagement on computed tomographic angiography performed after TAVR. RESULTS: Among 127 patients enrolled from September 2021 to December 2022, 7 (5.5%) had unsuccessful coronary cannulation after TAVR, and 6 of them received Evolut THVs (7.5% vs 2.3%; P = 0.26). Failure of left coronary artery cannulation was similar between Evolut and ACURATE THVs (2.5% vs 2.1%; P = 1.00), whereas that of right coronary artery cannulation was prevalent in the Evolut group (6.3% vs 0.0%; P = 0.16). Coronary overlap was associated with the inability to selectively cannulate the right coronary artery (OR: 5.6; 95% CI: 1.2-25.8; P = 0.03), but not in ACURATE recipients (P = 0.39). Severe misalignment of Evolut THVs was associated with the inability to selectively cannulate both coronary arteries (OR: 24.7; 95% CI: 1.9-312.9; P = 0.01). CONCLUSIONS: Unsuccessful coronary cannulation after TAVR using self-expanding THVs implanted using CA techniques was reported in 5.5% of cases, with the majority involving the Evolut THV. Commissural misalignment affected coronary cannulation after TAVR mostly in Evolut recipients.

Evolut PRO and SAPIEN ULTRA Performance in Small Aortic Annuli: The OPERA-TAVI Registry.

BACKGROUND: The performance of latest iteration transcatheter aortic valve replacement platforms in patients with small aortic anatomy remains underexplored. OBJECTIVES: The aim of this study was to evaluate effectiveness and performance between the self-expanding (SE) Evolut PRO and PRO+ and the balloon-expandable (BE) SAPIEN ULTRA in patients with small aortic annuli. METHODS: Data from the OPERA-TAVI (Comparative Analysis of Evolut PRO vs. SAPIEN 3 ULTRA Valves for Transfemoral Transcatheter Aortic Valve Implantation) registry were used, with 1:1 propensity score matching. Primary endpoints included 1-year effectiveness composite (all-cause mortality, disabling stroke, or heart failure hospitalization) and 30-day device-related (hemodynamic structural valve dysfunction and nonstructural valve dysfunction) outcomes. RESULTS: Among 3,516 patients, 251 matched pairs with aortic annular area <430 mm2 were assessed. The 1-year primary effectiveness outcome did not differ significantly between cohorts (SE 10.8% vs BE 11.2%; P = 0.91). The 30-day device-oriented composite outcome was more favorable in the Evolut PRO group (SE 4.8% vs BE 10.4%; P = 0.027). Notably, SE valve recipients showed higher rates of disabling stroke (SE 4.0% vs BE 0.0%; P < 0.01) and paravalvular leaks (mild or greater: SE 48.5% vs BE 18.6% [P < 0.001]; moderate: SE 4.5% vs BE 1.2% [P = 0.070]). The BE group had higher rates of prosthesis-patient mismatch (moderate or greater: SE 16.0% vs BE 47.1% [P < 0.001]; severe: SE 1.3% vs BE 5.7% [P = 0.197]) and more patients with residual mean gradients >20 mm Hg (SE 1.0% vs BE 13.5%; P < 0.001). CONCLUSIONS: In patients with small aortic annuli, transcatheter aortic valve replacement with latest iteration devices is safe. SE platforms are associated with more favorable device performance in terms of hemodynamic structural and nonstructural dysfunction. Randomized data are needed to validate these findings and guide informed device selection.

Sex-Related Outcomes of Transcatheter Aortic Valve Implantation With Self-Expanding or Balloon-Expandable Valves: Insights from the OPERA-TAVI Registry.

Evidence regarding gender-related differences in response to transcatheter aortic valve implantation according to the valve type is lacking. This study aimed to evaluate the impact of gender on the treatment effect of Evolut PRO/PRO+ (PRO) or SAPIEN 3 Ultra (ULTRA) devices on clinical outcomes. The Comparative Analysis of Evolut PRO vs SAPIEN 3 Ultra Valves for Transfemoral Transcatheter Aortic Valve Implantation (OPERA-TAVI) is a multicenter, multinational registry including patients who underwent the latest-iteration PRO or ULTRA implantation. Overall, 1,174 of 1,897 patients were matched based on valve type and compared according to gender, whereas 470 men and 630 women were matched and compared according to valve type. The 30-day and 1-year outcomes were evaluated. In the PRO and ULTRA groups, men had a higher co-morbidity burden, whereas women had smaller aortic root. The 30-day (device success [DS], early safety outcome, permanent pacemaker implantation, patient-prosthesis mismatch, paravalvular regurgitation, bleedings, vascular complications, and all-cause death) and 1-year outcomes (all-cause death, stroke, and heart failure hospitalization) did not differ according to gender in both valve groups. However, the male gender decreased the likelihood of 30-day DS with ULTRA versus PRO (p for interaction = 0.047). A higher risk of 30-day permanent pacemaker implantation and 1-year stroke and a lower risk of patient-prosthesis mismatch was observed in PRO versus ULTRA, regardless of gender. In conclusion, gender did not modify the treatment effect of PRO versus ULTRA on clinical outcomes, except for 30-day DS, which was decreased in men (vs women) who received ULTRA (vs PRO).

One-year clinical outcomes of transcatheter aortic valve implantation with the latest iteration of self-expanding or balloonexpandable devices: insights from the OPERA-TAVI registry.

BACKGROUND: Midterm comparative analyses of the latest iterations of the most used Evolut and SAPIEN platforms for transcatheter aortic valve implantation (TAVI) are lacking. AIMS: We aimed to compare 1-year clinical outcomes of TAVI patients receiving Evolut PRO/PRO+ (PRO) or SAPIEN 3 Ultra (ULTRA) devices in current real-world practice. METHODS: Among patients enrolled in the OPERA-TAVI registry, patients with complete 1-year follow-up were considered for the purpose of this analysis. One-to-one propensity score matching was used to compare TAVI patients receiving PRO or ULTRA devices. The primary endpoint was a composite of 1-year all-cause death, disabling stroke and rehospitalisation for heart failure. Five prespecified subgroups of patients were considered according to leaflet and left ventricular outflow tract calcifications, annulus dimensions and angulation, and leaflet morphology. RESULTS: Among a total of 1,897 patients, 587 matched pairs of patients with similar clinical and anatomical characteristics were compared. The primary composite endpoint did not differ between patients receiving PRO or ULTRA devices (Kaplan-Meier [KM] estimates 14.0% vs 11.9%; log-rank p=0.27). Patients receiving PRO devices had higher rates of 1-year disabling stroke (KM estimates 2.6% vs 0.4%; log-rank p=0.001), predominantly occurring within 30 days after TAVI (1.4% vs 0.0%; p=0.004). Outcomes were consistent across all the prespecified subsets of anatomical scenarios (all pinteraction>0.10). CONCLUSIONS: One-year clinical outcomes of patients undergoing transfemoral TAVI and receiving PRO or ULTRA devices in the current clinical practice were similar, but PRO patients had higher rates of disabling stroke. Outcomes did not differ across the different anatomical subsets of the aortic root.

Long-term outcomes of concomitant transcatheter aortic valve implantation and percutaneous coronary intervention.

BACKGROUND: The safety of concomitant percutaneous coronary intervention (PCI) during transcatheter aortic valve implantation (TAVI) setting is still highly debated. This study aimed to assess the safety and the effectiveness of TAVI and PCI performed in the same session compared with TAVI alone. METHODS: Patients with severe aortic stenosis and coronary artery disease (CAD) (N.=786) who underwent TAVI from June 2007 to April 2021 were divided into two groups: patients who underwent TAVI alone (N.=633) and patients treated with TAVI and concomitant PCI (N.=153). The propensity-score matching adjustment was used to account for baseline confounding variables. RESULTS: A total of 302 TAVI with CAD patients (151 matched pairs), undergoing either isolated TAVI or TAVI+PCI were compared. In-hospital death (6% vs. 4%; P=0.427), stroke (2% vs. 0.7%; P=0.314), myocardial infarction (MI) (0% vs. 0.7%; P=0.317), major and life-threatening bleeding (14.6% vs. 15.9%; P=0.749), and acute kidney injury (9.3% vs. 10.6%; P=0.700) were similar for both groups. At 3 years, the rates of all-cause death (25.2% vs. 19.2%; P=0.615), the composite endpoints of all-cause death and MI (27.2% vs. 21.2%; P=0.699) and all-cause death, MI, and stroke (28.5% vs. 22.5%; P=0.739) were also comparable between the two groups. Achieving complete coronary revascularization in the TAVI setting did not impact on long-term mortality (P=0.257). CONCLUSIONS: In patients with severe aortic stenosis and CAD, concomitant TAVI and PCI was as safe and effective as TAVI alone up to 3-year follow-up.

Treatment in patients with severe asymptomatic aortic stenosis: is it best not to wait?

New insights into the natural history and pathophysiology of patients with aortic stenosis (AS), coupled with the dramatic evolution of transcatheter aortic valve implantation (TAVI), are fuelling intense interest in the management of asymptomatic patients with severe AS. This patient presenting for elective intervention poses a unique challenge. These patients are not traditionally offered surgical aortic valve replacement or TAVI given their lack of symptoms; however, they are at increased risk given the severity of their AS. Furthermore, clinical experience has shown that symptoms can be challenging to ascertain in many sedentary, deconditioned, and/or elderly patients. In addition, evolving data based on imaging and biomarker evidence of adverse ventricular remodelling, hypertrophy, inflammation, or fibrosis may radically transform existing clinical decision paradigms. However, management of asymptomatic severe AS is otherwise controversial and the decision to intervene requires careful assessment of the benefits and risks in an individual patient. Further randomized trials [EARLY TAVI (NCT03042104), AVATAR (NCT02436655), EVOLVED (NCT03094143)] will help determine future recommendations.

Transcatheter Aortic Valve Replacement With the Latest-Iteration Self-Expanding or Balloon-Expandable Valves: The Multicenter OPERA-TAVI Registry.

BACKGROUND: The latest iterations of devices for transcatheter aortic valve replacement (TAVR) have brought refinements to further improve patient outcomes. OBJECTIVES: This study sought to compare early outcomes of patients undergoing TAVR with the self-expanding (SE) Evolut PRO/PRO+ (Medtronic, Inc) or balloon-expandable (BE) Sapien 3 ULTRA (Edwards Lifesciences) devices. METHODS: The OPERA-TAVI (Comparative Analysis of Evolut PRO vs Sapien 3 Ultra Valves for Transfemoral Transcatheter Aortic Valve Implantation) registry collected data from 14 high-volume centers worldwide on patients undergoing TAVR with SE or BE devices. After excluding patients who were not eligible for both devices, patients were compared using 1:1 propensity score matching. The primary efficacy and safety outcomes were Valve Academic Research Consortium-3 device success and early safety, respectively. RESULTS: Among 2,241 patients eligible for the present analysis, 683 pairs of patients were matched. The primary efficacy outcome did not differ between patients receiving SE or BE transcatheter aortic valves (SE: 87.4% vs BE: 85.9%; P = 0.47), but the BE device recipients showed a higher rate of the primary safety outcome (SE: 69.1% vs BE: 82.6%; P < 0.01). This finding was driven by the higher rates of permanent pacemaker implantation (SE: 17.9% vs BE: 10.1%; P < 0.01) and disabling stroke (SE: 2.3% vs BE: 0.7%; P = 0.03) in SE device recipients. On post-TAVR echocardiography, the rate of moderate to severe paravalvular regurgitation was similar between groups (SE: 3.2% vs BE: 2.3%; P = 0.41), whereas lower mean transvalvular gradients were observed in the SE cohort (median SE: 7.0 vs BE: 12.0 mm Hg; P < 0.01). CONCLUSIONS: The OPERA-TAVI registry showed that SE and BE devices had comparable Valve Academic Research Consortium-3 device success rates, but the BE device had a higher rate of early safety. The higher permanent pacemaker implantation and disabling stroke rates in SE device recipients drove this composite endpoint.

[Evolution of transcatheter aortic valve implantation from a high-volume Italian center: report of 2058 procedures over 15-year experience]. / Evoluzione dell'impianto transcatetere di valvola aortica in un centro italiano ad alto volume: report di 2058 procedure in 15 anni di esperienza.

BACKGROUND: To assess the longitudinal changes in transcatheter aortic valve implantation (TAVI) practice and patients' outcomes in a high-volume Italian center. METHODS: We analyzed all patients undergoing TAVI at our Institution from June 2007 to August 2021. We stratified the overall population considering four time periods according to procedural advancements and changes in clinical practice: period 1 (2007-2009, n=107) vs period 2 (2010-2014, n=449) vs period 3 (2015-2019, n=864) vs period 4 (2019-2021, n=638). Baseline and procedural characteristics, and in-hospital outcomes among the four groups were compared. RESULTS: A total of 2058 patients underwent TAVI receiving all the available devices. Patients had a median age of 82 years (78-85) with no differences among time periods. A stepwise reduction of median Society of Thoracic Surgeons mortality risk score (3.7 [2.8-5.3] vs 3.6 [2.6-5.4] vs 3.6 [2.5-5.5] vs 3.3 [2.2-4.9]; p=0.01) was observed. In-hospital all-cause-death (7.5% vs 5.1% vs 2.9% vs 3.0%; p<0.05), major stroke (4.7% vs 0.7% vs 1.0% vs 0.8%; p<0.05), major vascular complications (17.8% vs 8.7% vs 10.5% vs 5.8%; p<0.05) and permanent pacemaker implantation (23.4% vs 12.0% vs 8.7% vs 8.8%; p<0.05) rates significantly lowered over time. Device success markedly improved (80.4% vs 87.1% vs 95.0% vs 96.3%; p<0.05) with significant improvement of paravalvular regurgitation after TAVI (moderate-to-severe 16.8% vs 8.1% vs 0.7% vs 0.2%; mild 61.4% vs 38.2% vs 38.5% vs 25.6%; p<0.05). CONCLUSIONS: All-cause death and in-hospital outcomes of patients undergoing TAVI significantly improved accordingly to technical advancements and changes in clinical practice over 15-year experience.

Intentional Misalignment of a Transcatheter Aortic Valve to Preserve Reaccess to Coronaries of Anomalous Origin.

Achieving patient-specific commissural alignment of transcatheter aortic valves is particularly important to ensure coronary reaccess after transcatheter aortic valve implantation. Nevertheless, in case of uncommon origin of coronary arteries, commissural alignment could be counterproductive. This case shows how alignment techniques could serve to intentionally misalign the neocommissures in this subset of patients. (Level of Difficulty: Intermediate.).

Transcatheter aortic valve implantation during COVID-19 pandemic: An optimized model to relieve healthcare system overload.

BACKGROUND: The coronavirus 2019 (COVID-19) pandemic upset healthcare systems and their logistics worldwide. We sought to assess safety and effectiveness of an optimized logistics for transcatheter aortic valve implantation (TAVI) pathway developed during the COVID-19 pandemic. METHODS: This is a retrospective analysis. An optimized TAVI logistics based on performing TAVI work-up and procedure during the same hospitalization was used during the COVID-19 pandemic. In-hospital and 30-day outcomes of patients treated during the pandemic were compared with an historical cohort of patients undergoing TAVI with staged work-up before the pandemic within an homogeneous timeframe. RESULTS: Of 536 patients, 227 (42.4%) underwent TAVI during the COVID-19 pandemic with a reduction of 26.5% compared to the pre-pandemic period (n = 309). The median age was 81 (77-85) years and STS score was 3.4 (2.2-5.6)%. Lower rates of in-hospital major vascular complications (2.2% vs. 8.7%; p < 0.01) and life-threatening bleeding (0.4% vs. 4.2%; p = 0.01) were reported in the COVID-19 period, whereas no difference in acute kidney injury (7.0% vs. 7.4%, p = 0.85) rate was reported between COVID-19 and pre-COVID-19 periods. No difference in 30-day rates of all-cause death (4.0 vs. 4.5, p = 0.75) and of major adverse cardiovascular events (4.0 vs. 6.1, p = 0.26) were reported between COVID-19 and pre-COVID-19 periods. CONCLUSIONS: The use of optimized single-hospitalization logistics for TAVI workup and procedure developed during the COVID-19 pandemic, showed to be as safe and effective as the two-stage TAVI pathway previously adopted, allowing the minimization of potential exposure to COVID-19 infection and shortening times to treatment for severely symptomatic patients.

An upfront combined strategy for endovascular haemostasis in transfemoral transcatheter aortic valve implantation.

BACKGROUND: Vascular complications still represent an important issue after transcatheter aortic valve implantation (TAVI). AIMS: The aim of this study was to evaluate the effectiveness of upfront use of an adjunctive Angio-Seal (AS) plug-based system on top of suture-based devices (SBDs) for endovascular haemostasis after transfemoral (TF) TAVI. METHODS: From January 2019 to April 2020, 332 consecutive patients with preprocedural computed tomography angiography (CTA) assessment underwent fully percutaneous TF-TAVI. The primary outcomes were 30-day major vascular complications and major or life-threatening (LT) bleeding due to endovascular closure system failure. A total of 246 TF-TAVI patients (123 pairs), undergoing either isolated SBD or SBD+AS, were matched using the propensity-score method. RESULTS: At 30 days, patients receiving SBD+AS had lower rates of major/LT bleeding (1.6% vs 8.9%, odds ratio [OR] 0.17, 95% confidence interval [CI]: 0.04-0.78; p<0.01) and major vascular complications (1.6% vs 8.9%, OR 0.17, 95% CI: 0.04-0.78; p<0.01). In addition, the use of SBD+AS was associated with a significant cost saving related to the vascular event (mean difference -315.3 € per patient, 95% CI: -566.4 € to -64.1 €; p=0.01), and a higher probability of next-day discharge (NDD) after TAVI (30.9% vs 16.3%, OR 2.30, 95% CI: 1.25-4.25; p<0.01). No difference in all-cause 30-day mortality was observed (3.3% vs 1.6% for SBD and SBD+AS groups, respectively, OR 0.49, 95% CI: 0.09-2.74; p=0.41). CONCLUSIONS: An upfront combined strategy with an additional AS plug-based device on top of SBDs was shown to reduce major vascular complications and major/LT bleeding due to closure system failure after TF-TAVI. This approach was associated with a cost saving and with a higher probability of NDD compared to the use of isolated SBD. Visual summary. Effectiveness of the upfront combined strategy for endovascular haemostasis in transfemoral transcatheter aortic valve implantation using Angio-Seal on top of a suture-based device (SBD) versus the isolated use of SBD. LT: life-threatening; TF-TAVI: transfemoral transcatheter aortic valve implantation.

Coronary Cannulation After Transcatheter Aortic Valve Replacement: The RE-ACCESS Study.

OBJECTIVES: The aims of this study were to investigate the feasibility of coronary ostia cannulation after transcatheter aortic valve replacement (TAVR) and to assess potential predictors of coronary access impairment. BACKGROUND: Certain data concerning the feasibility and reproducibility of coronary cannulation after TAVR are lacking. METHODS: RE-ACCESS (Reobtain Coronary Ostia Cannulation Beyond Transcatheter Aortic Valve Stent) was an investigator-driven, single-center, prospective, registry-based study that enrolled consecutive patients undergoing TAVR using all commercially available devices. All patients underwent coronary angiography before and after TAVR. The primary endpoint was the rate of unsuccessful coronary ostia cannulation after TAVR. Secondary endpoints were the identification of factors associated with the inability to selectively cannulate coronary ostia after TAVR. RESULTS: Among 300 patients enrolled in the RE-ACCESS study from December 2018 to January 2020, a total of 23 cases (7.7%) of unsuccessful coronary cannulation after TAVR were documented. This issue occurred in 22 of 23 cases with the use of Evolut R/PRO transcatheter aortic valves (TAVs) (17.9% vs. 0.4%; p < 0.01). In multivariate analysis, the use of Evolut R/PRO TAVs (odds ratio [OR]: 29.6; 95% confidence interval [CI]: 2.6 to 335.0; p < 0.01), the TAV-sinus of Valsalva relation (OR: 1.1 per 1-mm increase; 95% CI: 1.0 to 1.2; p < 0.01), and the mean TAV implantation depth (OR: 1.7 per 1-mm decrease; 95% CI: 1.3 to 2.3; p < 0.01) were found to be independent predictors of unsuccessful coronary cannulation after TAVR. A model combining these factors was demonstrated to predict with very high accuracy the risk for unsuccessful coronary cannulation after TAVR (area under the curve: 0.94; p < 0.01). CONCLUSIONS: Unsuccessful coronary cannulation following TAVR was observed in 7.7% of patients and occurred almost exclusively in those receiving Evolut TAVs. The combination of Evolut TAV, a higher TAV-sinus of Valsalva relation, and implantation depth predicts with high accuracy the risk for unsuccessful coronary cannulation after TAVR. (Reobtain Coronary Ostia Cannulation Beyond Transcatheter Aortic Valve Stent [RE-ACCESS]; NCT04026204).