Characterization and Management of Stable Coronary Artery Disease in Patients Undergoing Transcatheter Aortic Valve Implantation.

Background/Objectives: To date, data regarding the characteristics and management of obstructive, stable coronary artery disease (CAD) encountered in patients undergoing transcatheter aortic valve implantation (TAVI) are sparse. The aim of the study was to analyze granular details, treatment, and outcomes of patients undergoing TAVI with obstructive, stable CAD from real-world practice. Methods: REVASC-TAVI (Management of myocardial REVASCularization in patients undergoing Transcatheter Aortic Valve Implantation with coronary artery disease) is an investigator-initiated, multicenter registry, which collected data from patients undergoing TAVI with obstructive stable CAD found during the pre-TAVI work-up. Results: A total of 2025 patients from 30 centers worldwide with complete follow-up were included in the registry. Most patients had single-vessel CAD (56.1%). An involvement of proximal coronary tracts was detected in 62.5% of cases, with 12.0% of patients having CAD in left main (LM). Most patients received percutaneous coronary intervention (PCI) (n = 1617, 79.9%), especially those with proximal CAD (90.4%). At 2 years, the rates of all-cause death [Kaplan-Meier (KM) estimates 20.1% vs. 18.8%, plog-rank = 0.86] and of the composite of all-cause death, stroke, myocardial infarction, and rehospitalization for heart failure (KM estimates 29.7% vs. 27.5%, plog-rank = 0.82) did not differ between patients undergoing PCI and those who were not. Conclusions: Patients undergoing TAVI with obstructive CAD more commonly had a single-vessel disease and an involvement of proximal coronary tracts. They were commonly treated with PCI, with similar outcomes compared to those treated conservatively.

Incidence, Predictors, and Outcomes of Paravalvular Regurgitation after TAVR in Sievers Type-1 Bicuspid Aortic Valves.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve (BAV) stenosis is technically challenging and is burdened by an increased risk of paravalvular regurgitation (PVR). OBJECTIVES: To identify the incidence, predictors, and clinical outcomes of PVR following TAVR in Sievers type 1 BAV stenosis. METHODS: Consecutive patients with severe Sievers type 1 BAV stenosis undergoing TAVR with current generation transcatheter heart valves (THVs) in 24 international centres were enrolled. PVR was graded as none/trace, mild, moderate, and severe according to echocardiographic criteria. The endpoint of major adverse events (MAE), defined as a composite of all-cause death, stroke, or hospitalization for heart failure, was assessed at the last available follow-up. RESULTS: A total of 946 patients were enrolled. PVR occurred in 423 patients (44.7%): mild, moderate, and severe in 387 (40.9%), 32 (3.4%), and 4 (0.4%) patients, respectively. Independent predictors of moderate or severe PVR were larger virtual raphe ring (VRR) perimeter (ORadj 1.07, 95% CI 1.02-1.13), severe annular or left ventricular outflow tract (LVOT) calcification (ORadj 5.21, 95% CI 1.45-18.77), self-expanding valve (ORadj 9.01, 95% CI 2.09-38.86), and intentional supra-annular THV positioning (ORadj 3.31, 95% CI 1.04-10.54). At a median follow-up of 1.3 [IQR 0.5-2.4] years, moderate or severe PVR was associated with an increased risk of MAE (HRadj 2.52, 95% CI 1.24-5.09). CONCLUSIONS: After TAVR with current-generation THVs in Sievers type 1 BAV stenosis, moderate or severe PVR occurred in about 4% of cases and was associated with an increased risk of MAE during follow-up.

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.

Outcomes and predictors of left ventricle recovery in patients with severe left ventricular dysfunction undergoing transcatheter aortic valve implantation.

BACKGROUND: Data on the likelihood of left ventricle (LV) recovery in patients with severe LV dysfunction and severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI) and its prognostic value are limited. AIMS: We aimed to assess the likelihood of LV recovery following TAVI, examine its association with midterm mortality, and identify independent predictors of LV function. METHODS: In our multicentre registry of 17 TAVI centres in Western Europe and Israel, patients were stratified by baseline LV function (ejection fraction [EF] >/≤30%) and LV response: no LV recovery, LV recovery (EF increase ≥10%), and LV normalisation (EF ≥50% post-TAVI). RESULTS: Our analysis included 10,872 patients; baseline EF was ≤30% in 914 (8.4%) patients and >30% in 9,958 (91.6%) patients. The LV recovered in 544 (59.5%) patients, including 244 (26.7%) patients whose LV function normalised completely (EF >50%). Three-year mortality for patients without severe LV dysfunction at baseline was 29.4%. Compared to this, no LV recovery was associated with a significant increase in mortality (adjusted hazard ratio 1.32; p<0.001). Patients with similar LV function post-TAVI had similar rates of 3-year mortality, regardless of their baseline LV function. Three variables were associated with a higher likelihood of LV recovery following TAVI: no previous myocardial infarction (MI), estimated glomerular filtration rate >60 mL/min, and mean aortic valve gradient (mAVG) (expressed either as a continuous variable or as a binary variable using the standard low-flow, low-gradient aortic stenosis [AS] definition). CONCLUSIONS: LV recovery following TAVI and the extent of this recovery are major determinants of midterm mortality in patients with severe AS and severe LV dysfunction undergoing TAVI. Patients with no previous MI and those with an mAVG >40 mmHg show the best results following TAVI, which are at least equivalent to those for patients without severe LV dysfunction. (ClinicalTrials.gov: NCT04031274).

Comparison of two self-expanding transcatheter heart valves for degenerated surgical bioprostheses: the AVENGER multicentre registry.

BACKGROUND: There is a lack of comparative data on transcatheter aortic valve implantation (TAVI) in degenerated surgical prostheses (valve-in-valve [ViV]). AIMS: We sought to compare outcomes of using two self-expanding transcatheter heart valve (THV) systems for ViV. METHODS: In this retrospective multicentre registry, we included consecutive patients undergoing transfemoral ViV using either the ACURATE neo/neo2 (ACURATE group) or the Evolut R/PRO/PRO+ (EVOLUT group). The primary outcome measure was technical success according to Valve Academic Research Consortium (VARC)-3. Secondary outcomes were 30-day all-cause mortality, device success (VARC-3), coronary obstruction (CO) requiring intervention, rates of severe prosthesis-patient mismatch (PPM), and aortic regurgitation (AR) ≥moderate. Comparisons were made after 1:1 propensity score matching. RESULTS: The study cohort comprised 835 patients from 20 centres (ACURATE n=251; EVOLUT n=584). In the matched cohort (n=468), technical success (ACURATE 92.7% vs EVOLUT 88.9%; p=0.20) and device success (69.7% vs 73.9%; p=0.36) as well as 30-day mortality (2.8% vs 1.6%; p=0.392) were similar between the two groups. The mean gradients and rates of severe PPM, AR ≥moderate, or CO did not differ between the groups. Technical and device success were higher for the ACURATE platform among patients with a true inner diameter (ID) >19 mm, whereas a true ID ≤19 mm was associated with higher device success - but not technical success - among Evolut recipients. CONCLUSIONS: ViV TAVI using either ACURATE or Evolut THVs showed similar procedural outcomes. However, a true ID >19 mm was associated with higher device success among ACURATE recipients, whereas in patients with a true ID ≤19 mm, device success was higher when using Evolut.

Risk Score for Prediction of Dialysis After Transcatheter Aortic Valve Replacement.

BACKGROUND: Dialysis is a rare but serious complication after transcatheter aortic valve replacement. We analyzed the large multicenter TRITAVI (transfusion requirements in transcatheter aortic valve implantation) registry in order to develop and validate a clinical score assessing this risk. METHODS AND RESULTS: A total of 10 071 consecutive patients were enrolled in 19 European centers. Patients were randomly assigned (2:1) to a derivation and validation cohort. Two scores were developed, 1 including only preprocedural variables (TRITAVIpre) and 1 also including procedural variables (TRITAVIpost). In the 6714 patients of the derivation cohort (age 82±6 years, 48% men), preprocedural factors independently associated with dialysis and included in the TRITAVIpre score were male sex, diabetes, prior coronary artery bypass graft, anemia, nonfemoral access, and creatinine clearance <30 mL/min per m2. Additional independent predictors among procedural features were volume of contrast, need for transfusion, and major vascular complications. Both scores showed a good discrimination power for identifying risk for dialysis with C-statistic 0.78 for TRITAVIpre and C-statistic 0.88 for TRITAVIpost score. Need for dialysis increased from the lowest to the highest of 3 risk score groups (from 0.3% to 3.9% for TRITAVIpre score and from 0.1% to 6.2% for TRITAVIpost score). Analysis of the 3357 patients of the validation cohort (age 82±7 years, 48% men) confirmed the good discrimination power of both scores (C-statistic 0.80 for TRITAVIpre and 0.81 for TRITAVIpost score). Need for dialysis was associated with a significant increase in 1-year mortality (from 6.9% to 54.4%; P=0.0001). CONCLUSIONS: A simple preprocedural clinical score can help predict the risk of dialysis after transcatheter aortic valve replacement.

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.

Long-term outcomes following transcatheter aortic valve implantation with the Portico self-expanding valve.

AIM: Transcatheter aortic valve implantation (TAVI) is a mainstay in the management of severe aortic valve stenosis in elderly patients, but there is uncertainty on their long-term effectiveness. We aimed to assess the long-term outcome of patients undergoing TAVI with the Portico valve. METHODS: We retrospectively collected the data on patients in whom TAVI with Portico was attempted from 7 high-volume centres. Only patients theoretically eligible for 3 or more years of follow-up were included. Clinical outcomes, including death, stroke, myocardial infarction, reintervention for valve degeneration and hemodynamic valve performance were systematically assessed. RESULTS: A total of 803 patients were included, with 504 (62.8%) women, mean age of 82 years, median EuroSCORE II of 3.1%, and 386 (48.1%) subjects at low/moderate risk. The median follow-up was 3.0 years (3.0; 4.0). The composite of death, stroke, myocardial infarction, and reintervention for valve degeneration occurred in 37.5% (95% confidence interval: 34.1-40.9%), with all-cause death in 35.1% (31.8-38.4%), stroke in 3.4% (1.3-3.4%), myocardial infarction in 1.0% (0.3-1.5%), and reintervention for valve degeneration in 1.1% (0.6-2.1%). The mean aortic valve gradient at follow-up was 8.1 ± 4.6 mmHg, and at least moderate aortic regurgitation was present in 9.1% (6.7-12.3%). Independent predictors of major adverse events or death were: peripheral artery disease, chronic obstructive pulmonary disease, estimated glomerular filtration rate, atrial fibrillation, prior pacemaker implantation, EuroSCORE II, and reduced left ventricular ejection fraction (all p < 0.05). CONCLUSIONS: Portico use is associated with favorable long-term clinical outcomes. Clinical outcomes were largely impacted by baseline risk factors and surgical risk.

Features and outcomes of bailout repeat transcatheter aortic valve implantation (TAVI): the Bailout Acute TAVI-in-TAVI to Lessen Events (BATTLE) international registry.

AIM: Transcatheter aortic valve implantation (TAVI) is a mainstay in the management of severe aortic stenosis in patients with intermediate to prohibitive surgical risk. When a single TAVI device fails and cannot be retrieved, TAVI-in-TAVI must be performed acutely, but outcomes of bailout TAVI-in-TAVI have been incompletely appraised. We aimed at analyzing patient, procedural and outcome features of patients undergoing bailout TAVI-in-TAVI in a multicenter registry. METHODS: Details of patients undergoing bailout TAVI-in-TAVI, performed acutely or within 24 h of index TAVI, in 6 international high-volume institutions, were collected. For every case provided, 2 same-week consecutive controls (prior TAVI, and subsequent TAVI) were provided. Outcomes of interest were procedural and long-term events, including death, myocardial infarction, stroke, access site complication, major bleeding, and reintervention, and their composite (i.e. major adverse events [MAE]). RESULTS: A total of 106 patients undergoing bailout TAVI-in-TAVI were included, as well as 212 controls, for a total of 318 individuals. Bailout TAVI-in-TAVI was less common in younger patients, those with higher body mass index, or treated with Portico/Navitor or Sapien devices (all p < 0.05). Bailout TAVI-in-TAVI was associated with higher in-hospital rates of death, emergency surgery, MAE, and permanent pacemaker implantation (all p < 0.05). Long-term follow-up showed that bailout TAVI-in-TAVI was associated with higher rates of death and MAE (both < 0.05). Similar findings were obtained at adjusted analyses (all p < 0.05). However, censoring early events, outlook was not significantly different when comparing the two groups (p = 0.897 for death, and p = 0.645 for MAE). CONCLUSIONS: Bail-out TAVI-in-TAVI is associated with significant early and long-term mortality and morbidity. Thus, meticulous preprocedural planning and sophisticated intraprocedural techniques are of paramount importance to avoid these emergency procedures.

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.

Mid-term outcomes and hemodynamic performance of transcatheter aortic valve implantation in bicuspid aortic valve stenosis: Insights from the bicuSpid TAvi duraBILITY (STABILITY) registry.

BACKGROUND: Limited data are available on transcatheter heart valves (THVs) durability in bicuspid aortic valve (BAV) stenosis. AIMS: To evaluate evaluating 4-year clinical and echocardiographic outcomes of patients with BAV undergoing transcatheter aortic valve implantation (TAVI). METHODS: The bicuSpid TAvi duraBILITY (STABILITY) registry is an Italian multicentre registry including all consecutive patients with BAV and severe aortic stenosis (AS), treated by means of TAVI between January 2011 and December 2017. Outcomes of interest were all-cause death at 4-year, over time changes in echocardiographic measurements, and THV durability according to the valve aortic research consortium (VARC)-3 update definitions. RESULTS: Study population included 109 patients (50% females; mean age 78 ± 7.5 years) with a mean Society of Thoracic Surgeons Predicted Risk of Mortality score of 5.1 ± 4.3%. Median follow-up (FU) duration was 4.1 years [interquartile range: 2.8-5.1]. The overall cumulative incidence of all-cause death by Kaplan-Meier estimates at 4 years was 32%. Compared to baseline, a significant decrease in transprosthetic mean gradient was obtained after TAVI (54 ± 16 vs. 10 ± 5 mmHg; p < 0.001), whereas a significant increase was observed at 4-year (13 ± 6.4 mmHg, p = 0.03). Cumulative incidence of hemodynamic valve dysfunction (HVD) was 4%. Six patients met HVD criteria: three moderate and three severe HVD. All three cases of severe HVD were clinically relevant (bioprosthetic valve failure [BVF]) with two patients receiving a reintervention (TAVI in TAVI), and one patient experiencing a valve-related death due to endocarditis. CONCLUSIONS: The STABILITY registry suggests that in patients with severe AS and BAV undergoing TAVI, postprocedural clinical benefits might last, over time, up to 4-year FU. The low rates of severe HVD and BVF may support the hypothesis of good THV durability also in BAV recipient.

Prosthesis-patient mismatch after transcatheter implantation of contemporary balloon-expandable and self-expandable valves in small aortic annuli.

BACKGROUND: Evidence of clinical impact of PPM after TAVI is conflicting and might vary according to the type of valve implanted. AIMS: To assess the clinical impact of prosthesis-patient mismatch (PPM) after transcatheter aortic valve implantation (TAVI) with balloon-expandable (BEV) and self-expandable valves (SEV) in patients with small annuli. METHODS: TAVI-SMALL 2 enrolled 628 patients in an international retrospective registry, which included patients with severe aortic stenosis and small annuli (annular perimeter <72 mm or area <400 mm2 ) treated with transfemoral TAVI at 16 high-volume centers between 2011 and 2020. Analyses were performed comparing patients with less than moderate (n = 452), moderate (n = 138), and severe PPM (n = 38). Primary endpoint was incidence of all-cause mortality. Predictors of all-cause mortality and PPM were investigated. RESULTS: At a median follow-up of 380 days (interquartile range: 210-709 days), patients with severe PPM, but not moderate PPM, had an increased risk of all-cause mortality when compared with less than moderate PPM (log-rank p = 0.046). Severe PPM predicted all-cause mortality in patients with BEV (hazard ratio [HR]: 5.20, 95% confidence interval [CI]: 1.27-21.2) and intra-annular valves (IAVs, HR: 4.23, 95% CI: 1.28-14.02), and it did so with borderline significance in the overall population (HR: 2.89, 95% CI: 0.95-8.79). Supra-annular valve (SAV) implantation was the only predictor of severe PPM (odds ratio: 0.33, 95% CI: 0.13-0.83). CONCLUSIONS: Patients with small aortic annuli and severe PPM after TAVI have an increased risk of all-cause mortality at early term follow-up, especially after IAV or BEV implantation. TAVI with SAV protected from severe PPM.

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

BACKGROUND: Horizontal 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). OBJECTIVES: Aim of the study was to assess the performance of ACURATE Neo2 in the setting of HA. METHODS: We 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. RESULTS: Among 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. CONCLUSION: In 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.

Transcatheter Aortic Valve Replacement for Pure Native Aortic Valve Regurgitation: The PANTHEON International Project.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) in patients with pure severe native aortic valve regurgitation (NAVR) has been associated with suboptimal results. The available evidence concerns mostly outdated transcatheter heart valves (THVs). OBJECTIVES: The aim of this study was to investigate the performance of new-generation THVs in patients treated for pure severe NAVR. METHODS: The PANTHEON (Performance of Currently Available Transcatheter Aortic Valve Platforms in Inoperable Patients With Pure Aortic Regurgitation of a Native Valve) study retrospectively included patients who underwent TAVR with currently available devices (both self-expanding [SE] and balloon expandable [BE]) for severe NAVR. Technical and device success rates as well as a composite of all-cause mortality and heart failure rehospitalization at 1 year were evaluated. The rate and clinical consequences of acute transcatheter valve embolization or migration (TVEM) were also considered. RESULTS: A total of 201 patients were included. Overall technical and device success rates were 83.6% and 76.1%, respectively, and did not differ between SE and BE devices. These figures were due mostly to TVEM occurrence (14.6% vs 16.1%; P = 0.47) and residual moderate or greater aortic regurgitation (9.2% vs 10.1%; P = 0.87). Patients who experienced TVEM compared with those without TVEM had a significantly higher incidence of the composite endpoint at 1 year (25.7% vs 15.8%; P = 0.05). CONCLUSIONS: Despite improved THV platforms and techniques, TAVR for pure severe NAVR remains a challenging procedure, with significant risk for TVEM. SE and BE platforms demonstrated comparable performance in this setting. (Performance of Currently Available Transcatheter Aortic Valve Platforms in Inoperable Patients With Pure Aortic Regurgitation of a Native Valve [PANTHEON]; NCT05319171).

Incidence, Predictors, and Prognostic Impact of New Permanent Pacemaker Implantation After TAVR With Self-Expanding Valves.

OBJECTIVES: The authors sought to evaluate the incidence, predictors, and outcomes of new permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR) with contemporary self-expanding valves (SEV). BACKGROUND: Need for PPI is frequent post-TAVR, but conflicting data exist on new-generation SEV and on the prognostic impact of PPI. METHODS: This study included 3,211 patients enrolled in the multicenter NEOPRO (A Multicenter Comparison of Acurate NEO Versus Evolut PRO Transcatheter Heart Valves) and NEOPRO-2 (A Multicenter Comparison of ACURATE NEO2 Versus Evolut PRO/PRO+ Transcatheter Heart Valves 2) registries (January 2012 to December 2021) who underwent transfemoral TAVR with SEV. Implanted transcatheter heart valves (THV) were Acurate neo (n = 1,090), Acurate neo2 (n = 665), Evolut PRO (n = 1,312), and Evolut PRO+ (n = 144). Incidence and predictors of new PPI and 1-year outcomes were evaluated. RESULTS: New PPI was needed in 362 patients (11.3%) within 30 days after TAVR (8.8%, 7.7%, 15.2%, and 10.4%, respectively, after Acurate neo, Acurate neo2, Evolut PRO, and Evolut PRO+). Independent predictors of new PPI were Society of Thoracic Surgeons Predicted Risk of Mortality score, baseline right bundle branch block and depth of THV implantation, both in patients treated with Acurate neo/neo2 and in those treated with Evolut PRO/PRO+. Predischarge reduction in ejection fraction (EF) was more frequent in patients requiring PPI (P = 0.014). New PPI was associated with higher 1-year mortality (16.9% vs 10.8%; adjusted HR: 1.66; 95% CI: 1.13-2.43; P = 0.010), particularly in patients with baseline EF <40% (P for interaction = 0.049). CONCLUSIONS: New PPI was frequently needed after TAVR with SEV (11.3%) and was associated with higher 1-year mortality, particularly in patients with EF <40%. Baseline right bundle branch block and depth of THV implantation independently predicted the need of PPI.

Financial Burden of Transcatheter Aortic Valve Implantation.

Given the increasing population eligible for transcatheter aortic valve implantation (TAVI), resource utilization has become an important focus in this setting. We aimed to estimate the change in the financial burden of TAVI therapy over 2 different periods. A probabilistic Markov model was developed to estimate the cost consequences of increased center experience and the introduction of newer-generation TAVI devices compared with an earlier TAVI period in a cohort of 6,000 patients. The transition probabilities and hospitalization costs were retrieved from the OBSERVANT (Observational Study of Effectiveness of AVR-TAVI procedures for severe Aortic steNosis Treatment) and OBSERVANT II (Observational Study of Effectiveness of TAVI with new generation deVices for severe Aortic stenosis Treatment) studies, including 1,898 patients treated with old-generation devices and 1,417 patients treated with new-generation devices. The propensity score matching resulted in 853 pairs, with well-balanced baseline risk factors. The mean EuroSCORE II (6.6% vs 6.8%, p = 0.76) and the mean age (82.0 vs 82.1 y, p = 0.62) of the early TAVI period and new TAVI period were comparable. The new TAVI period was associated with a significant reduction in rehospitalizations (-30.5% reintervention, -25.2% rehospitalization for major events, and -30.8% rehospitalization for minor events) and a 20% reduction in 1-year mortality. These reductions resulted in significant cost savings over a 1-year period (-€4.1 million in terms of direct costs and -€19.7 million considering the additional cost of the devices). The main cost reduction was estimated for rehospitalization, accounting for 79% of the overall cost reduction (not considering the costs of the devices). In conclusion, the introduction of new-generation TAVI devices, along with increased center experience, led to significant cost savings at 1-year compared with an earlier TAVI period, mainly because of the reduction in rehospitalization costs.

Safety and Effectiveness of Concomitant Mitral Transcatheter Edge-to-Edge Repair and Left Atrial Appendage Closure.

BACKGROUND: Concomitant mitral transcatheter edge-to-edge repair (M-TEER) and left atrial appendage closure (LAAC) showed to be a feasible approach to optimize the treatment of patients eligible for both procedures, but mid-term outcomes are unclear. METHODS: We retrospectively analyzed consecutive patients undergoing M-TEER and enrolled in the local prospective Getting Reduction of Mitral Insufficiency by Percutaneous Clip Implantation (GRASP) registry. We compared patients undergoing isolated M-TEER (n = 58, 58.5%) with those undergoing concomitant M-TEER and LAAC (n = 41, 41.5%) from January 2018 to December 2022. The primary endpoint was a composite of all-cause death, stroke or systemic embolism, hospitalization for heart failure, and bleeding at 1 year. The co-primary endpoint was procedural success. RESULTS: The primary endpoint was similar between patients undergoing concomitant M-TEER+LAAC or isolated M-TEER (Kaplan Meier (KM) estimates 36.6% vs. 44.8%; plog-rank = 0.75). Procedural success was also similar (92.7% vs. 94.8%; p = 0.69). At 1- year, minor bleeds were lower in patients undergoing concomitant M-TEER and LAAC (KM estimates 0.0% vs. 18.9%; plog-rank < 0.01). CONCLUSION: In patients with concomitant MR and AF and eligible for M-TEER and LAAC treatment, a combined approach of M-TEER and LAAC was as safe as an M-TEER-alone strategy and associated with lower minor bleeding at 1 year.