Transfemoral-only transcatheter aortic valve replacement: A single center experience of 400 consecutive patients.

BACKGROUND: In transcatheter aortic valve replacement (TAVR), transfemoral (TF) access offers several advantages over alternative access routes. Advances in sheaths and valve delivery technology have catalyzed the feasibility of TF-TAVR, even in challenging anatomies. AIMS: Report procedural characteristics and outcomes of a TAVR program aiming for a 100% TF access rate. METHODS: Consecutive patients undergoing TAVR were enrolled in a prospective registry. Equipment used to facilitate TF-access in challenging anatomies included low-profile sheaths, dilatators, peripheral balloons, covered and uncovered self-expanding and balloon-expandable stents, and intravascular lithotripsy (IVL). RESULTS: A total of 400 patients with a mean age of 81 ± 6 years (42% female) were analyzed. Minimal iliofemoral artery diameter (MLD) of the main access side was <5 mm in 42 (10.5%), extreme tortuosity was present in 65 (16.3%), and severe calcification in 59 (14.8%). TF-access was successful in 399 (99.8%) patients. A transaxillary access was used in one patient. In multivariable analysis, an MLD < 5 mm was the strongest predictor for vascular complications (11.9% vs. 3.9%, OR: 3.86, 95% CI: 1.38-10.8, p = 0.01). Such patients also had more major/life-threatening bleeding (14.2% vs. 3.1%, p < 0.001) and required more planned and unplanned peripheral interventions to enable TF access (35.8% vs. 3.4%, p < 0.001). CONCLUSION: Our study shows that utilization of dedicated sheaths, peripheral balloons, stents, and IVL enables TAVR via TF access in >99% of patients. However, rates of vascular and bleeding complications in patients with narrow iliofemoral arteries (MLD < 5 mm) were high.

Outcomes following coronary chronic total occlusion revascularization with drug-coated balloons.

OBJECTIVES: Despite the introduction of improved drug eluting stents (DES), the rate of repeat revascularization procedures following percutaneous coronary interventions (PCI) in coronary chronic total occlusions (CTO) remains high. By leaving vessels uncaged and limiting length of stented segments, drug-coated balloons (DCB) represent an appealing alternative to DES for CTO-PCI. Since data supporting the use of DCBs in CTO-PCI is scarce, we compared the outcomes of patients undergoing CTO-PCI involving DCBs vs DES only. METHODS: From 2 prospective registries, outcomes of patients undergoing CTO-PCI involving DCBs and those undergoing PCI with DES only were compared. Outcomes included major adverse cardiac and cerebrovascular events (MACCE) and cardiovascular death (CV-death). RESULTS: Overall, 157 patients were studied; 112 (71%) underwent CTO-PCI involving DCBs and 45 (29%) were treated with DES only. Mean J-CTO score was 1.84 ± 0.7. Most CTO-lesions involved the right coronary artery, 88 (56%), and 26 (17%) cases were in-stent occlusions. In the DCB group, 46 (41%) lesions were treated with DCBs alone. Mean lengths of the stented segments in the DCB vs DES cohorts were 59 ± 28 mm vs 87 ± 37 mm (P less than .001), respectively. After 12 months, the MACCE rate was higher in the DES only vs DCB group (26% vs 11%, P=.03). Length of the stented segment was an independent predictor for MACCE (HR 1.15 [95% CI, 1.05-1.26] per 10-mm stent length). CONCLUSIONS: Revascularization of CTO lesions involving DCBs appears safe and potentially lowers MACCE rates compared to treatment with DES alone. Importantly, using DCBs for CTO treatment may reduce total stent length, which determines PCI outcomes.

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.

A fully automated artificial intelligence-driven software for planning of transcatheter aortic valve replacement.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is increasingly performed for the treatment of aortic stenosis. Computed tomography (CT) analysis is essential for pre-procedural planning. Currently available software packages for TAVR planning require substantial human interaction. We describe development and validation of an artificial intelligence (AI) powered software to automatically rend anatomical measurements and other information required for TAVR planning and implantation. METHODS: Automated measurements from 100 CTs were compared to measurements from three expert clinicians and TAVR operators using commercially available software packages. Correlation coefficients and mean differences were calculated to assess precision and accuracy. RESULTS: AI-generated annular measurements had excellent agreements with manual measurements by expert operators yielding correlation coefficients of 0.97 for both perimeter and area. There was no relevant bias with a mean difference of -0.07 mm and - 1.4 mm2 for perimeter and area, respectively. For the ascending aorta measured 5 cm above the annular plane, correlation coefficient was 0.95 and mean difference was 1.4 mm. Instruction for use-based sizing yielded agreement with the effective implant size in 87-88 % of patients for self-expanding valves (perimeter-based sizing) and in 88 % for balloon-expandable valves (area-based sizing). CONCLUSIONS: A fully automated software enables accurate and precise anatomical segmentation and measurements required for TAVR planning without human interaction and with high reliability.

Long-Term Outcomes After Transcatheter Aortic Valve Implantation in Patients With Chronic Inflammatory Disease.

BACKGROUND: Chronic inflammatory disease (CID) accelerates atherosclerosis and the development of aortic stenosis. Data on long-term outcomes after transcatheter aortic valve implantation (TAVI) in those patients are missing. The aim of this study was to investigate the clinical long-term outcomes of patients with and without autoimmune-related CID undergoing TAVI for the treatment of severe aortic stenosis. METHODS AND RESULTS: From a prospective registry, consecutive patients with TAVI were included. Baseline clinic and imaging data (echocardiographic and computed tomography) were analyzed. Long-term (up to 5 years) clinical and echocardiographic outcomes were studied. Of 1000 consecutive patients (mean age 81±6 years, 46% female), 107 (11%) had CID; the most frequent entities included polymyalgia rheumatica (31%) and rheumatoid arthritis (28%). Patients with CID were predominantly female (60% versus 44%, P=0.002) and more often had pulmonary disorders (21% versus 13%, P=0.046) and atrial fibrillation (32% versus 20%, P=0.003). The presence of CID was associated with a higher rate of postinterventional infection (5% versus 1%, P=0.007) and further emerged as a risk factor for rehospitalization for bleeding or infection (hazard ratio, 1.93 and 1.62, respectively). Premature valve degeneration, endocarditis, and all-cause mortality were not increased among patients with CID. CONCLUSIONS: This real-world analysis found that patients with CID undergoing TAVI were associated with a higher risk of postinterventional infectious complications and rehospitalization due to infection. However, valve durability and survival seem not to differ between patients with TAVI with versus without CID.

Amplatzer or Figulla Flex II Occluder: a comparative study of outcomes after transcatheter patent foramen ovale closure.

OBJECTIVES: Percutaneous closure of a patent foramen ovale (PFO) for the prevention of recurrent paradoxical thromboembolic events has been shown to be safe and effective in randomized controlled trials. However, it remains uncertain if differences in the structure and design of the occluder devices impact the outcomes. The aim of this study was to compare results of percutaneous PFO closure using 2 widely used double-disc occluders. METHODS: Consecutive patients who underwent percutaneous PFO closure with the Abbott Amplatzer occluder (APO) or the Occlutech Figulla-Flex-II occluder (OPO) at the Heart Center Lucerne between February 2017 and December 2022 were included in a registry. The primary endpoint was effective closure of the PFO, defined as a residual shunt grade 0 or 1, assessed by contrast echocardiogram at 6-month follow-up. Secondary endpoints included procedural efficacy/safety and major adverse cardiovascular events during the hospital stay and at 6-month follow-up. RESULTS: One hundred ninety-three consecutive patients (mean age 51.7 ± 12.5 years; 39% women; Risk of Paradoxical Embolism (RoPE) score = 7, IQR = 6-8) underwent percutaneous PFO closure with the APO (120 patients, 62.2%) or the OPO (73 patients, 37.8%). Main indications for closure were crypotogenic stroke in 168 patients (87.1%) and peripheral embolism in 13 patients (6.7%). At baseline, right-to-left shunt (RLS) greater than or equal to grade 2 was present in 189 patients (97.9%). Immediate procedural success was 99.5%. In 1 patient, an air embolism occurred during positioning of the APO occluder with transient chest pain and electrocardiogram changes, but without further sequelae to the patient. At 6-month follow-up, effective closure was achieved in 185 patients (95.8%; APO: 96.6% vs OPO: 94.5%, P = .30). Rates of atrial fibrillation and recurrent thromboembolic events were 4.2 and 0.5%, respectively. CONCLUSIONS: PFO closure is safe and effective when performed with either the self-expanding Abbott Amplatzer or Occlutech Figulla Flex II PFO occluder.

Non-Vitamin K Antagonist Versus Vitamin K Antagonist Oral Anticoagulant Agents After Transcatheter Aortic Valve Replacement.

BACKGROUND: Studies comparing long-term outcomes between non-vitamin K antagonist (VKA) oral anticoagulant agents (direct oral anticoagulant agents [DOACs]) and VKA anticoagulant agents after transcatheter aortic valve replacement (TAVR) are scarce, with conflicting results. OBJECTIVES: The aim of this study was to examine the periprocedural, short-term, and long-term safety and effectiveness of DOACs vs VKAs in patients undergoing TAVR via femoral access with concomitant indications for oral anticoagulation. METHODS: Consecutive patients undergoing transfemoral TAVR in the prospective national SwissTAVI Registry between February 2011 and June 2021 were analyzed. Net clinical benefit (a composite of all-cause mortality, myocardial infarction, stroke, and life-threatening or major bleeding) and the primary safety endpoint (a composite of life-threatening and major bleeding) were compared between the VKA and DOAC groups at 30 days, 1 year, and 5 years after TAVR. RESULTS: After 1:1 propensity score matching, 1,454 patients were available for analysis in each group. There was no significant difference in the rate of the net clinical benefit and the safety endpoints between the groups as assessed at 30 days and 1 and 5 years post-TAVR between VKAs and DOACs. VKAs were associated with significantly higher rates of 1- year (HR: 1.28; 95% CI: 1.01-1.62) and 5-year (HR: 1.25; 95% CI: 1.11-1.40) all-cause mortality. Long-term risk for disabling stroke was significantly lower in the VKA group after excluding periprocedural events (HR: 0.64; 95% CI: 0.46-0.90). CONCLUSIONS: At 5 years after TAVR, VKAs are associated with a higher risk for all-cause mortality, a lower risk for disabling stroke, and a similar rate of life-threatening or major bleeding compared with DOACs. (SwissTAVI Registry; NCT01368250).

ACURATE neo2 Transcatheter aortic valve implantation without balloon aortic valvuloplasty - direct ACURATE neo2.

BACKGROUND: ACURATE neo2 (Neo2) implantation is performed after systematic Balloon Aortic Valvuloplasty (BAV) in most patients. No reports exist about the feasibility and safety of direct Neo2 transcatheter aortic valve implantation (TAVI) in comparison to the standard practice. AIM: We aimed to identify the patients' baseline anatomical characteristics, procedural, and early post-procedural outcomes in patients treated using Neo2 with and without BAV. METHODOLOGY: This is a retrospective multicentre analysis of 499 patients with severe aortic stenosis who underwent TAVI using Neo2. The comparison was done according to the performance or omission of BAV. Echocardiography and computed tomography were analysed by an independent Core Lab. Propensity score matching (PSM) was performed based on the annular diameter and AV calcium volume, which identified 84 matched pairs. RESULTS: Among the cohort included, 391 (78%) patients received BAV (BAV-yes) and 108 (22%) were not attempted (BAV-no or Direct TAVI). Patients in BAV-no cohort had smaller annular diameter (22.6 vs 23.4 mm; p < 0.001) and lower calcium volume (163 vs 581 mm3; p < 0.001) compared to BAV-yes cohort. In the matched cohort, VARC-3 device technical success was similar (95%) and all other outcome measures were statistically comparable between cohorts. CONCLUSION: Direct TAVI using ACURATEneo2 without pre-TAVI balloon aortic valvuloplasty in patients with mild or less valve calcifications might be feasible and associated with comparable early outcomes compared to patients with similar anatomical features undergoing systematic balloon valvuloplasty.

Comparison of Mid-Term Prognosis in Intermediate-to-Low-Risk Contemporary Population with Guidelines-Oriented Age Cutoff.

BACKGROUND: Current European guidelines support transcatheter aortic valve implantation (TAVI) in intermediate-to-low-risk patients ≥75 years-old, but its prognostic relevance is unknown. METHODS: Intermediate-to-low-risk (The Society of Thoracic Surgeons score <8%) patients enrolled in the HORSE registry were included. We compared the populations aged under 75 with those over 75. The primary endpoint was all-cause mortality. RESULTS: A total of 2685 patients were included: 280 (8.6%) < 75 and 2405 ≥ 75 years. Through a mean follow-up of 437 ± 381 days, 198 (8.2%) and 23 (8.2%) patients died in the two arms without statistically significant differences (log-rank p = 0.925). At Cox regression analysis, age did not predict the occurrence of all-cause death, neither as a continuous variable (HR 1.01, 95% CI 0.99-1.04, p = 0.294) nor dichotomizing according to the prespecified cutoff of 75 years (HR 0.97, 95% CI 0.63-1.51, p = 0.924). Time-to-event ROC curves showed low accuracy of age to predict all-cause mortality (area under the curve of 0.54 for both 1-year and 2-year outcomes). CONCLUSIONS: TAVI has comparable benefits across age strata for intermediate-to-low-risk patients. The age cutoff suggested by the current guidelines is not predictive of the risk of adverse events during hospital stays or of all-cause mortality through a mid-term follow-up.

Relevance of Motion Artifacts in Planning Computed Tomography on Outcomes After Transcatheter Aortic Valve Implantation.

Background: Motion artifacts in planning computed tomography (CT) for transcatheter aortic valve implantation (TAVI) can potentially skew measurements required for procedural planning. Whether such artifacts may affect safety or efficacy has not been studied. Methods: We conducted a retrospective analysis of 852 consecutive patients (mean age, 82 years; 47% women) undergoing TAVI-planning CT at a tertiary care center. Two independent observers divided CTs according to the presence of motion artifacts at the annulus level (Motion vs. Normal group). Endpoints included surrogate markers for inappropriate valve selection: annular rupture, valve embolization or misplacement, need for a new permanent pacemaker, paravalvular leak (PVL), postprocedural transvalvular gradient, all-cause death. Results: Forty-six (5.4%) patients presented motion artifacts on TAVI-planning CT (Motion group). These patients had more preexisting heart failure, moderate-severe mitral regurgitation, and atrial fibrillation. Interobserver variability of annular measurement (Normal vs. Motion group) did not differ for mean annular diameter but was significantly different for perimeter and area. Presence of motion artifacts on planning CT did not affect the prevalence of PVL (≥moderate PVL 0% vs. 2.5% p = 0.5), mean transvalvular gradient (6±3 mmHg vs 7±5 mmHg, p = 0.1), or the need for additional valve implantation (0% vs. 2.8%, p = 0.6). One annular rupture occurred (Normal group). Pacemaker implantation, procedural duration, hospital stay, 30-day outcomes, and all-cause mortality did not differ between the groups. Conclusions: Motion artifacts on planning CT were found in about 5% of patients. Measurements for valve selection were possible without the need for repeat CT, with mean diameter-derived annulus measurement being the most accurate. Motion artifacts were not associated with worse outcomes.

The Allegra transcatheter heart valve: Long-term clinical and echocardiographic outcomes.

OBJECTIVES: The Allegra-THV is a novel, self-expanding THV with supra-annular bovine leaflets. The valve is available in 3 different sizes and is delivered through an 18 French sheath. To determine the safety and efficacy of the Allegra transcatheter heart valve (THV; Biosensors) for the treatment of severe aortic valve stenosis under real-world conditions. METHODS: Consecutive patients undergoing transcatheter aortic valve replacement (TAVR) at the Heart-Centre Lucerne with the Allegra-THV were included. Echocardiographic data were collected at baseline, before discharge, and at 1-year follow-up; clinical outcomes were recorded for up to 3 years. Clinical endpoints were defined according to the definitions of the Valve-Academic-Research-Consortium. RESULTS: One hundred-three patients (age 81 ± 7 years, 63% women) were enrolled. Median European System for Cardiac Operative Risk Evaluation II score was 4.1% (IQR 1.8%-4.2%). Mean aortic valve gradient was 6.9 ± 3.3 mm Hg and 7.7 ± 3.3 mm Hg, and an effective orifice area was 2.1 ± 0.5 cm2 and 2.0 ± 0.5 cm2 at 30 days and 1-year follow-up, respectively. More than mild paravalvular leak was observed in 2.0% of patients at 30 days and 3.3% at 1 year. At 1-year follow-up, 14.7% of patients required implantation of a new permanent pacemaker, 1 patient had endocarditis with an uneventful clinical course and good THV-function after antibiotic therapy, and no thrombosis, structural-valve-detoriation (SVD), or non-SVD had occurred. At 3-year follow-up, rates of all-cause and cardiovascular mortality were 31.4% and 18.8%, respectively. CONCLUSIONS: Transfemoral implantation of the Allegra-THV resulted in favorable clinical and echocardiographic outcomes at up to 3-year follow-up. Head-to-head randomized clinical trials are necessary to determine if the Allegra-THV valve performs as well as current generation valves.

Long-Term Risk of Stroke After Transcatheter Aortic Valve Replacement: Insights From the SwissTAVI Registry.

BACKGROUND: Stroke after transcatheter aortic valve replacement (TAVR) is associated with considerable morbidity and mortality. Predictors of stroke and the long-term risk after TAVR remain incompletely understood. OBJECTIVES: The authors sought to investigate the short- and long-term incidence and predictors of stroke after TAVR in the SwissTAVI Registry. METHODS: Between February 2011 and June 2021, consecutive patients undergoing TAVR were included. Standardized stroke ratios (SSRs) were calculated to compare trends in stroke of TAVR patients with an age- and sex-matched general population in Switzerland derived from the 2019 Global Burden of Disease study. RESULTS: A total of 11,957 patients (81.8 ± 6.5 years of age, 48.0% female) were included. One-third of the patients (32.3%) had a history of atrial fibrillation, and 11.8% had a history of cerebrovascular accident. The cumulative 30-day incidence rate of stroke was 3.0%, with 69% of stroke events occurring within the first 48 hours after TAVR. The incidence of stroke was 4.3% at 1 year, and 7.8% at 5 years. Compared with an age- and sex-adjusted general population, the risk of stroke was significantly higher in the TAVR population during the first 2 years after TAVR: first year: SSR 7.26 (95% CI: 6.3-8.36) and 6.82 (95% CI: 5.97-7.79) for males and females, respectively; second year: SSR 1.98 (95% CI: 1.47-2.67) and 1.48 (95% CI: 1.09-2.02) for males and females, respectively; but returned to a comparable level to that observed in the matched population thereafter. CONCLUSIONS: Compared with an age- and sex-matched population, TAVR patients experienced a higher risk of stroke for up to 2 years after the procedure, and a comparable risk thereafter. (SwissTAVI Registry; NCT01368250).

Restoration of Life Expectancy After Transcatheter Edge-to-Edge Mitral Valve Repair.

BACKGROUND: Survival data after mitral transcatheter edge-to-edge repair (TEER) are scarce, and its impact on predicted life expectancy is unknown. OBJECTIVES: The aim of this study was to estimate the impact of TEER on postprocedural life expectancy among patients enrolled in the MitraSwiss registry through a relative survival (RS) analysis. METHODS: Consecutive TEER patients 60 to 89 years of age enrolled between 2011 and 2018 (N = 1140) were evaluated. RS was defined as the ratio between post-TEER survival and expected survival in an age-, sex- and calendar period-matched group derived from the Swiss national 2011 to 2019 mortality tables. The primary aim was to assess 5-year survival and RS after TEER. The secondary aim was to assess RS according to the etiology of mitral regurgitation, age class and sustained procedural success over time. RESULTS: Overall, 5-year survival after TEER was 59.3% (95% CI: 54.9%-63.4%), whereas RS reached 80.5% (95% CI: 74.6%-86.0%). RS was 91.1% (95% CI: 82.5%-98.6%) in primary mitral regurgitation (PMR) and 71.5% (95% CI: 63.0%-79.3%) in secondary mitral regurgitation (SMR). Patients 80 to 89 years of age (n = 579) showed high 5-year RS (93.0%; 95% CI: 83.3%-101.9%). In this group, restoration of predicted life expectancy was achieved in PMR with a 5-year RS of 100% (95% CI: 87.9%-110.7%), whereas sustained procedural success increased the RS rate to 90.6% (95% CI: 71.3%-107.3%) in SMR. CONCLUSIONS: Mitral TEER in patients 80 to 89 years of age is able to restore predicted life expectancy in PMR, whereas in SMR with sustained procedural success, high RS estimates were observed. Our analysis suggests that successful, sustained mitral regurgitation reduction is key to survival improvement, particularly in patients 80 to 89 years of age.

The Early neo2 Registry: Transcatheter Aortic Valve Implantation With ACURATE neo2 in a European Population.

Background ACURATE neo2 is a transcatheter aortic valve implantation system consisting of a self-expanding bioprosthetic valve with supra-annular leaflet position and featuring innovations to facilitate placement accuracy and reduce paravalvular regurgitation. Methods and Results The goal of the Early neo2 (Early neo2 Registry of the ACURATE neo2 TAVI Prosthesis) was to gather real-life data on safety and efficacy in a European transcatheter aortic valve implantation population treated with ACURATE neo2. Data were collected from 554 consecutive patients treated with ACURATE neo2 at 12 European sites (mean age, 82 years; 66% women; mean European System for Cardiac Operative Risk Evaluation II, 4.5%±3.8%) between September 2020 and March 2021. The composite primary end point was the occurrence of any of the following: postoperative (in-hospital) paravalvular regurgitation grade ≥2, in-hospital acute kidney injury stage 3, postoperative pacemaker implantation, 30-day death, and 30-day stroke. The primary end point occurred in 12.6% of patients. The 30-day rates for all-cause death and all stroke were 1.3% and 2.7%, respectively, and 1.5% of patients exhibited stage 3 acute kidney injury. A total of 34 patients (6.2%) received a postoperative permanent pacemaker. Per core laboratory-adjudicated echocardiographic analysis, mean postoperative aortic valve gradient was 7.6±3.3 mm Hg, and 2.8% of patients exhibited paravalvular regurgitation grade ≥2. Conclusions In this report of postmarket use of the ACURATE neo2 valve in a real-world transcatheter aortic valve implantation population, patients exhibited favorable postoperative hemodynamics and clinical outcomes and a low rate of postoperative pacemaker implantation.

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.

Final 3-Year Outcomes of a Randomized Trial Comparing a Self-Expanding to a Balloon-Expandable Transcatheter Aortic Valve.

BACKGROUND: In the SCOPE I trial (Safety and Efficacy of the Symetis ACURATE Neo/TF Compared to the Edwards SAPIEN 3 Bioprosthesis), transcatheter aortic valve implantation with the self-expanding ACURATE neo (NEO) did not meet noninferiority compared with the balloon-expandable SAPIEN 3 (S3) device regarding a composite end point at 30 days due to higher rates of prosthetic valve regurgitation and acute kidney injury. Data on long-term durability of NEO are scarce. Here, we report whether early differences between NEO and S3 translate into differences in clinical outcomes or bioprosthetic valve failure 3 years after transcatheter aortic valve implantation. METHODS: Patients with severe aortic stenosis were randomized to transfemoral transcatheter aortic valve implantation with NEO or S3 at 20 European centers. Clinical outcomes at 3 years are compared using Cox proportional or Fine-Gray subdistribution hazard models by intention-to-treat. Bioprosthetic valve failure is reported for the valve-implant cohort. RESULTS: Among 739 patients, 84 of 372 patients (24.3%) had died in the NEO and 85 of 367 (25%) in the S3 group at 3 years. Comparing NEO with S3, the 3-year rates of all-cause death (hazard ratio, 0.98 [95% CI, 0.73-1.33]), stroke (subhazard ratio, 1.04 [95% CI, 0.56-1.92]), and hospitalization for congestive heart failure (subhazard ratio, 0.74 [95% CI, 0.51-1.07]) were similar between the groups. Aortic valve reinterventions were required in 4 NEO and 3 S3 patients (subhazard ratio, 1.32 [95% CI, 0.30-5.85]). New York Heart Association functional class ≤II was observed in 84% (NEO) and 85% (S3), respectively. Mean gradients remained lower after NEO at 3 years (8 versus 12 mm Hg; P<0.001). CONCLUSIONS: Early differences between NEO and S3 did not translate into significant differences in clinical outcomes or bioprosthetic valve failure throughout 3 years. REGISTRATION: URL: https://clinicaltrials.gov, Unique identifier: NCT03011346.

Clinical Outcomes in High-Gradient, Classical Low-Flow, Low-Gradient, and Paradoxical Low-Flow, Low-Gradient Aortic Stenosis After Transcatheter Aortic Valve Implantation: A Report From the SwissTAVI Registry.

Background In view of the rising global burden of severe symptomatic aortic stenosis, its early recognition and treatment is key. Although patients with classical low-flow, low-gradient (C-LFLG) aortic stenosis have higher rates of death after transcatheter aortic valve implantation (TAVI) when compared with patients with high-gradient (HG) aortic stenosis, there is conflicting evidence on the death rate in patients with severe paradoxical low-flow, low-gradient (P-LFLG) aortic stenosis. Therefore, we aimed to compare outcomes in real-world patients with severe HG, C-LFLG, and P-LFLG aortic stenosis undergoing TAVI. Methods and Results Clinical outcomes up to 5 years were addressed in the 3 groups of patients enrolled in the prospective, national, multicenter SwissTAVI registry. A total of 8914 patients undergoing TAVI at 15 heart valve centers in Switzerland were analyzed for the purpose of this study. We observed a significant difference in time to death at 1 year after TAVI, with the lowest observed in HG (8.8%) aortic stenosis, followed by P-LFLG (11.5%; hazard ratio [HR], 1.35 [95% CI, 1.16-1.56]; P<0.001) and C-LFLG (19.8%; HR, 1.93 [95% CI, 1.64-2.26]; P<0.001) aortic stenosis. Cardiovascular death showed similar differences between the groups. At 5 years, the all-cause death rate was 44.4% in HG, 52.1% in P-LFLG (HR, 1.35 [95% CI, 1.23-1.48]; P<0.001), and 62.8% in C-LFLG aortic stenosis (HR, 1.7 [95% CI, 1.54-1.88]; P<0.001). Conclusions Up to 5 years after TAVI, patients with P-LFLG have higher death rates than patients with HG aortic stenosis but lower death rates than patients with C-LFLG aortic stenosis.