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Currently available risk scores fail to accurately predict morbidity and mortality in patients with severe symptomatic aortic stenosis who undergo transcatheter aortic valve implantation (TAVI). In this context, biomarkers like matrix metalloproteinase-2 (MMP-2) and Galectin-3 (Gal-3) may provide additional prognostic information. Patients with severe aortic stenosis undergoing consecutive, elective, transfemoral TAVI were included. Baseline demographic data, functional status, echocardiographic findings, clinical outcomes and biomarker levels were collected and analysed. The study cohort consisted of 89 patients (age 80.4 ± 5.1 years, EuroScore II 7.1 ± 5.8%). During a median follow-up period of 526 d, 28 patients (31.4%) died. Among those who died, median baseline MMP-2 (alive: 221.6 [170.4; 263] pg/mL vs. deceased: 272.1 [225; 308.8] pg/mL, p < 0.001) and Gal-3 levels (alive: 19.1 [13.5; 24.6] pg/mL vs. deceased: 25 [17.6; 29.5] pg/mL, p = 0.006) were higher than in survivors. In ROC analysis, MMP-2 reached an acceptable level of discrimination to predict mortality (AUC 0.733, 95% CI [0.62; 0.83], p < 0.001), but the predictive value of Gal-3 was poor (AUC 0.677, 95% CI [0.56; 0.79], p = 0.002). Kaplan–Meier and Cox regression analyses showed that patients with MMP-2 and Gal-3 concentrations above the median at baseline had significantly impaired long-term survival (p = 0.004 and p = 0.02, respectively). In patients with severe aortic stenosis undergoing transfemoral TAVI, MMP-2 and to a lesser extent Gal-3, seem to have additive value in optimizing risk prediction and streamlining decision-making. [ABSTRACT FROM AUTHOR]

Coronary artery disease (CAD) is a common finding in patients suffering from aortic valve stenosis (AS), with a prevalence of over 50% in patients 70 years of age or older. Transcatheter aortic valve intervention (TAVI) is the standard treatment option for patients with severe AS and at least 75 years of age. Current guidelines recommend percutaneous coronary intervention (PCI) in patients planned for TAVI with stenoses of >70% in the proximal segments of non-left main coronary arteries and in >50% of left main stenoses. While the guidelines on myocardial revascularization clearly recommend functional assessment of coronary artery stenoses of less than 90% in the absence of non-invasive ischemia testing, a statement regarding invasive functional testing in AS patients with concomitant CAD is lacking in the recently published guideline on the management of valvular heart disease. This review aims to provide an overview of the hemodynamic background in AS patients, discusses and summarizes the current evidence of invasive functional testing in patients with severe AS, and gives a future perspective on the ongoing trials on that topic. [ABSTRACT FROM AUTHOR]

Background: Third-generation transcatheter heart valves (THVs) are designed to improve outcomes. Data on the new intra-annular self-expanding NAVITOR are scarce. Aims: The aim of this analysis was to compare outcomes between the PORTICO and the NAVITOR systems. Methods: Data from 782 patients with severe native aortic stenosis treated with PORTICO (n = 645) or NAVITOR (n = 137) from 05/2012 to 09/2022 were evaluated. The clinical and hemodynamic outcomes of 276 patients (PORTICO, n = 139; NAVITOR, n = 137) were evaluated according to VARC-3 recommendations. Results: Rates of postprocedural more-than-mild paravalvular leakage (PVL) were significantly lower for NAVITOR than for PORTICO (7.2% vs. 1.5%, p = 0.041). In addition, severe bleeding rates (27.3% vs. 13.1%, p = 0.005) and major vascular complications (5.8% vs. 0.7%, p = 0.036) were lower in the NAVITOR group. The mean gradients (7 vs. 8 mmHg, p = 0.121) and calculated aortic valve areas (1.90 cm2 vs. 1.99 cm2, p = 0.235) were comparable. Rates of PPI were similarly high in both groups (15.3 vs. 21.6, p = 0.299). Conclusions: The NAVITOR demonstrated favorable in-hospital procedural outcome data, with lower rates of relevant PVL, major vascular complications, and severe bleeding than its predecessor the PORTICO and preserved favorable hemodynamic outcomes. [ABSTRACT FROM AUTHOR]

Background: Severe calcification of the ascending aorta increases the peri-operative risk for neurological complications in patients with severe aortic stenosis. Transcatheter aortic valve implantation (TAVI) seems to be an optimal treatment option in these patients. However, the impact of the extent of aortic calcification on procedural and neurological outcomes during TAVI is unclear. Methods: Data from 3010 patients with severe native aortic valve stenosis treated with ACURATE neo/neo2 from May 2012 to July 2022 were evaluated and matched by 2-to-1 nearest-neighbor matching to identify one patient with porcelain aorta (PA) (n = 492) compared with two patients without PA (n = 984). PA was additionally subdivided into circumferential (classic PA) (n = 89; 3.0%) and non-circumferential (partial PA) (n = 403; 13.4%) calcification. We compared outcomes according to VARC-3 criteria among patients with and without PA and identified predictors for occurrence of stroke in the overall population. Results: Technical success (88.5% vs. 87.4%, p = 0.589) and device success at 30 days (82.3% vs. 81.5%, p = 0.755) after transcatheter ACURATE neo/neo2 implantation according to VARC-3 definition was high and did not differ between non-calcified aortas or PA. The rate of in-hospital complications according to VARC-3-definitions was low in both groups. Rates of all stroke (3.2% (n = 31) vs. 2.6% (n = 13), p = 0.705) or transitory ischemic attacks (1.1% vs. 1.2%, p = 1.000) did not differ significantly. Thirty-day all-cause mortality did not differ (3.0% vs. 3.2%, RR 1.1; p = 0.775). Overall device migration/embolization (OR 5.0 [ 2.10 ; 11.87 ] ), severe bleeding (OR 1.79 [ 1.11 ; 2.89 ] ), and major structural cardiac complications (OR 3.37 [ 1.32 ; 8.57 ] ) were identified as independent predictors for in-hospital stroke in a multivariate analysis after implantation of ACURATE neo/neo2. Conclusion: A porcelain aorta does not increase the risk of neurological complications after transfemoral ACURATE neo/neo2 implantation. Based on these findings, transfemoral ACURATE neo/neo2 implantation is safe in these particularly vulnerable patients. [ABSTRACT FROM AUTHOR]

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We introduce a novel approach that involves a s ing l e arter i al access and low contrast agent volu m e (SLIM). Transcatheter aortic valve implantation (TAVI) is subject to an ongoing process of refinement and simplification. Between January 2019 and November 2020, a total 888 patients with severe aortic stenosis underwent transfemoral TAVI using balloon-expandable or specific self-expanding devices. The study cohort comprised patients with attempted SLIM approach (n = 291). A matched cohort of patients who were treated in a standard fashion served as control group (n = 291). The SLIM approach was successful in 92.4% of attempted cases. In the SLIM group, utilization of contrast agent (23 [19–37] vs. 75 [52–100] ml; p < 0.001), rates of any acute kidney injury (5.5% vs. 12.7%; p = 0.002), complications at the secondary access (0.3% vs. 3.1%; p = 0.011) and length of hospital stay (7 [5–8] vs. 7 [6–9]) days; p = 0.039) were significantly reduced. All other procedural outcomes were similar between groups. Initial results of this novel, minimalistic approach demonstrate its feasibility and potential beneficial effects without compromising procedural safety. Further refinement of this approach is warranted. [Display omitted] • SLIM (single-arterial access; low contrast use) was successful in 92.4%. • Rates of acute kidney injury and access-site complications decreased. • Length of hospital stay was reduced. • SLIM did not compromise procedural success and safety. [ABSTRACT FROM AUTHOR]

Background: Rates of permanent pacemaker implantation (PPI) have been low using the self‐expanding ACURATE neo device, but data regarding risk factors of PPI for this specific device are scarce. Methods: The study cohort consisted of patients (n = 1000) with severe aortic stenosis undergoing transfemoral transcatheter aortic valve implantation (TAVI) using the ACURATE neo prosthesis in our center between May 2012 and December 2019. For the present analysis, we excluded patients with previous permanent pacemaker (n = 110), high‐grade AV block prior to TAVI (n = 3), and patients requiring conversion to surgical valve replacement (n = 4) or the implantation of a second prosthesis as valve‐in‐valve (n = 15). Preexisting conduction abnormalities were determined, and the implantation depth of the prosthesis was measured on final angiography. Differences across quartiles based on the original consecutive cohort were analyzed with respect to implantation depth and PPI rate. Predictors of PPI were identified using logistic regression. Results: The PPI rate was 10%. Preexisting AV block I°, right bundle branch block (RBBB), and the implantation depth were independent predictors of PPI. Across quartiles, the implantation depth differed significantly with lowest values in the last quartile, whereas differences of PPI rates across quartiles were not statistically significant, but showed a notable decrease in the last quartile. Conclusion: Preexisting RBBB, AV block I°, and low implantation depth were independent predictors of PPI following TAVI using the ACURATE neo device. Instead of deliberately aiming at a high position, avoidance of a low implantation depth may represent a reasonable compromise to reduce the rate of PPI without increasing the risk of malpositioning. [ABSTRACT FROM AUTHOR]

Background: Within the last years TAVI—especially transfemoral/transvascular TAVI—has proven to be a valuable therapeutic option for most patients suffering from AS. Here, we present the outcome of a complete dataset of all patients undergoing aortic valve replacement in Germany in 2018. Methods: The data of all aortic valve procedures performed in Germany in 2018 derive from the mandatory nationwide quality control program. Patients were stratified with a new version of the German Aortic valve score (AKL Score) divided in different risk stratification depending on the treatment with either a catheter based (TV-TAVI) or surgical (iSAVR) approach. In-hospital outcomes have been compared between the two approaches. Results: 19,317 transvascular (TV)–TAVI procedures were carried out. In contrast to this steady growth, the number of iSAVR andtransapical (TA) -TAVI procedures declined. In-hospital mortality after TV-TAVI (2.5%) was lower when compared to iSAVR (3.1%) as well as TA-TAVI (5.7%) in-hospital mortality after TV-TAVI was significantly lowest (Fig. 2) with an in-hospital mortality rate of 2.5%. TV-TAVI was the only approach with an observed vs. expected mortality ratio < 1 according to the used risk prediction model. Conclusion: TV-TAVI is more often performed and shows lower in-hospital mortality than iSAVR. TV-TAVI has replaced iSAVR as the gold-standard concerning in-hospital outcome in aortic stenosis management. [ABSTRACT FROM AUTHOR]

Abstract Background The ACURATE neo prosthesis is commonly implanted using introducer sheaths with inner diameters of up to 20 French. The use of only the expandable mesh component of the transGlide introducer system (Mesh only) would substantially decrease the inner diameter to 13 French. We sought to assess the feasibility and safety of using Mesh only for femoral access of the ACURATE neo device and to compare outcomes with patients in whom standard sheaths were used. Methods and results We retrospectively analyzed a total of 551 patients with severe aortic stenosis from 4 high volume centers in Germany and Switzerland undergoing transfemoral TAVI between February 2016 and February 2018 with implantation of the ACURATE neo device. The median age was 81.7 [78.3–85.2], 67.0% were female, the STS score was 4.2% [2.8–6.5]. The use of the Mesh only was feasible in all attempted cases (n = 272); in all other patients, a standard sheath was used. Major vascular complications at the main access-site (VARC-2) were less frequent in the Mesh only group than in the standard sheath group (1.5% vs. 7.9%; p < 0.001). In the multivariable analysis, the use of Mesh only was independently associated with less major vascular complications (odds ratio 0.10 [95% CI 0.02–0.48]; p = 0.004). Conclusions Transfemoral implantation of the ACURATE neo device using the Mesh only was associated with a lower rate of major access-related complications when compared to the standard of care. Graphical abstract Comparison of patients undergoing transfemoral aortic valve implantation with the ACURATE neo ™ prosthesis using the mesh of the transGlide® expandable introducer (n = 272) versus standard sheaths (n = 279). The mesh only has the smallest inner and outer diameter and insertion profile, which translates into a significant reduction of vascular complications at the main access site. Abbreviations: ID = inner diameter, OD = outer diameter, IP = insertion profile. Unlabelled Image Highlights Using solely the mesh of the transGlide® expandable introducer for implantation of the ACURATE neo ™ prosthesis is feasible and safe. • The use of the mesh only represents the approach with the lowest insertion profile • and significantly reduces major vascular complications. [ABSTRACT FROM AUTHOR]

Background The extent of aortic valve calcification is an important determinant of procedural success in transcatheter aortic valve implantation (TAVI). We sought to validate device landing zone calcium volume (DLZ-CV) measurements on contrast-enhanced multidetector computed tomography (MDCT) with non-contrast-enhanced scans as reference. Methods We determined DLZ-CV in 141 patients undergoing transfemoral TAVI. Non-contrast-enhanced images were analyzed using a threshold of 130 HU as reference (DLZ-CV 130 ). For contrast-enhanced scans, we applied various thresholds including 450 HU (DLZ-CV 450 ), 850 HU (DLZ-CV 850 ), mean aortic attenuation (Atten Ao ) + 2 SD (DLZ-CV 2SD ), Atten Ao  + 4 SD (DLZ-CV 4SD ), Atten Ao  + 4 SD + 5 mm 3 volume filter (DLZ-CV 4SD+ ), and based on visual estimation (DLZ-CV vis ). We compared DLZ-CV values between patients with versus without paravalvular leak (PVL), and between patients with versus without post-dilatation stratified by the type of prosthesis. Results All DLZ-CV measurements on contrast-enhanced scans significantly differed from DLZ-CV 130 (p < 0.001 for all comparisons). The best approximation to DLZ-CV 130 was achieved with DLZ-CV 4SD+ (508 mm 3 [332–772]; Pearson correlation: R = 0.87, p < 0.001; Bland-Altman: mean difference 1339 mm 3 [limits of agreement 79;2600]). Moreover, DLZ-CV 4SD+ allowed for discrimination of PVL ≥1° or the need for post-dilatation in patients receiving self-expanding prostheses. Procedural outcome using balloon-expandable prostheses was independent of DLZ-CV. Conclusion Measurement of DLZ-CV using contrast-enhanced scans with unadjusted thresholds results in incorrect estimation of the calcium volume. The use of a scan-specific individual HU threshold including a volume filter (DLZ-CV 4SD+ ) provides the best approximation to the reference and allows for discrimination of PVL ≥ 1° in patients receiving the Acurate neo prosthesis. [ABSTRACT FROM AUTHOR]

Aims We analysed the number of procedures, complications and in-hospital mortality rates of all patients undergoing transvascular transcatheter aortic valve implantation (TV-TAVI) in comparison to isolated surgical aortic valve replacement (iSAVR) from 2014 to 2016 in Germany. Methods and results All aortic valve procedures performed in Germany are mandatorily registered in a quality control program. More than 15 000 TV-TAVI procedures were performed in 2016 in Germany. Especially the number of post-procedural complications declined within the last few years, including new pacemaker implantations (2015: 12.6% vs. 2016: 11.4%, P=0.002) and vascular complications (2015: 8.5% vs. 2016: 7.1%; P< 0.001). Thus, in 2016 the overall in-hospital mortality rate after TV-TAVI was 2.6%, which is for the first time numerically below that of iSAVR, which was 2.9% (P=0.19). A stratified analysis according to the German aortic valve score shows a lower observed than expected in-hospital mortality rate for TV-TAVI (O/E 0.68). Additionally, the in-hospital mortality was significantly lower after TV-TAVI than after iSAVR in the very high- (11.3% vs. 23.6%; P< 0.001), in the high- (4.1% vs. 9.2%; P< 0.001) and in the intermediate-risk group (3.0% vs. 4.6%; P= 0.016) and was similar to that of iSAVR in low-risk patients (1.6% vs. 1.4%; P=0.4). Conclusion The overall in-hospital mortality after TV-TAVI was numerically lower than after iSAVR in 2016 for the first time. In the low risk group in-hospital mortality was similar, whereas in all other risk groups in-hospital mortality after TV-TAVI was significantly lower than after SAVR. This is likely to contribute to a redefinition of the standard of care in the future. [ABSTRACT FROM AUTHOR]

Aims Life-threatening complications occur during transcatheter aortic valve implantation (TAVI) which can require emergent cardiac surgery (ECS). Risks and outcomes of patients needing ECS during or immediately after TAVI are still unclear. Methods and results Incidence, risk factors, management and outcomes of patients requiring ECS during transfemoral (TF)-TAVI were analysed from a contemporary real-world multicentre registry. Between 2013 and 2016, 27 760 patients underwent TF-TAVI in 79 centres. Of these, 212 (0.76%) patients required ECS (age 82.4 ±6.3 years, 67.5% females, logistic EuroSCORE: 17.1%, STS-score 5.8%). The risk of ECS declined from 2013 (1.07%) to 2014 (0.70%) but remained stable since. Annual TF-TAVI numbers have more than doubled from 2013 to 2016. Leading causes for ECS were left ventricular perforation by the guidewire (28.3%) and annular rupture (21.2%). Immediate procedural mortality (<72 h) of TF-TAVI patients requiring ECS was 34.6%. Overall in-hospital mortality was 46.0% and highest in case of annular rupture (62%). Independent predictors of in-hospital mortality following ECS were age > 85 years [odds ratio (OR) 1.87, 95% confidence interval (95% CI) (1.02-3.45), P = 0.044], annular rupture [OR 1.96, 95% CI (0.94- 4.10), P = 0.060] and immediate ECS [OR 3.12, 95% CI (1.07-9.11), P = 0.037]. One year of survival of the 114 patients surviving the in-hospital period was only 40.4%. Conclusion Between 2014 and 2016, the need for ECS remained stable around 0.7%. Left ventricular guidewire perforation and annular rupture were the most frequent causes, accounting for almost half of ECS cases. Half of the patients could be salvaged by ECS--nevertheless, 1 year of all-cause mortality was high even in those ECS patients surviving the in-hospital period. [ABSTRACT FROM AUTHOR]

Aims: Approximately every fifth patient undergoing transcatheter aortic valve implantation (TAVI) requires a permanent pacemaker (PPM) after the procedure. The aim of this study was to analyse predictors of atrioventricular block III° (AVBIII) persistence with concurrent PPM dependency after TAVI. Methods and results: Between 2010 and 2015 a total of 1198 patients underwent TAVI at the Kerckhoff Heart and Thorax Center, Germany. After exclusion of patients with prior PPM ( n = 173) 14.7% ( n = 176) of the patients underwent PPM implantation after the procedure. Independent predictors of PPM implantation were pre-existing right bundle branch block (RBBB, p < 0.001) and implantation of a CoreValve prosthesis ( p < 0.001). A subgroup of patients with a newly implanted PPM ( n = 102) were followed-up for a median of 73 (IQR 62-85) days. The leading indication for PPM implantation was AVBIII in 74.5% (76/102). Of these patients only 22.4% (17/76) had persistent AVBIII at follow-up. Predictors of AVBIII persistence were prior RBBB ( p = 0.04), postdilatation ( p = 0.006) and higher mean aortic valve gradient prior to implantation ( p = 0.013). PPMs were implanted earlier in patients with persisting AVBIII [1 day (IQR0-2.5) vs. 4 days (IQR2-7); p < 0.001]. Early PPM implantation after TAVI was the only independent predictor of persistent AVBIII [OR 1.36 (95% 1.05-1.75); p = 0.02]. Conclusion: The long-term persistence of AVBIII is generally low after TAVI. Therefore, it may be wise to postpone the indication for PPM implantation for a couple of days. The only predictors of a lack of recovery of the AVB are prior RBBB, higher mean aortic valve gradients and postdilatation of the prosthesis. [ABSTRACT FROM AUTHOR]

Background The aim of the present study was to investigate whether transfemoral implantation of the Acurate neo transcatheter heart valve without pre-dilation is feasible. Methods Between December 2014 and December 2016, 294 patients were treated with the Acurate neo prosthesis at our center. Of these, 72 cases were performed without pre-dilation. The decision to omit pre-dilation was at the discretion of the operator, preferably in the case of mild to moderate aortic valve calcification (AVC). Propensity matching (1:1) resulted in 48 cases in each group. Main outcomes of interest were device success according to VARC-2 criteria, residual aortic regurgitation (AR) ≥ 2°, and rate of post-dilation. Results Median [IQR] age in patients without pre-dilation was 82.7 years [78.6–85.6], STS score was 4.6% [3.4–6.1], and AVC-score was 1436 AU [1043–1682] with mild and moderate AVC in 63.9% and 36.1% of cases, respectively. Device success was achieved in 94.4% of cases, post-dilation was necessary in 26.4%, and one (1.4%) patient had moderate AR. In the matched population, there were no differences regarding device success, rate of AR ≥ 2°, need for post-dilation, and post-procedural mean gradient, but the group without pre-dilation had shorter procedure (34.0 min [27.0–38.8] vs. 43.0 min [34.3–52.0]; p < 0.001) and fluoroscopy times (7.4 min [5.7–9.0] vs. 9.9 min [7.9–13.5]; p < 0.001). Conclusion In select patients with mild to moderate AVC, transfemoral implantation of the Acurate neo without pre-dilation is feasible and safe. This allows for a straightforward procedure that may be performed without rapid pacing in the majority of cases. [ABSTRACT FROM AUTHOR]

Patients with symptomatic aortic stenosis (AS) can have concomitant systolic heart failure (HF) that persists even after correction of afterload by transcatheter aortic valve implantation (TAVI). These patients qualify as potential candidates for prophylactic therapy with an implantable cardioverter defibrillator (ICD). We compared survival between patients with or without an ICD after successful TAVI. This retrospective study analyzed Kaplan-Meier survival data during a follow-up period of three years in two populations: (a) patients with a left ventricular ejection fraction (LVEF) ≤ 35% before TAVI (overall population); (b) patients with additionally documented LVEF ≤ 35% 3 months after TAVI (persistent LV dysfunction subpopulation). In the overall population, 53 patients with and 193 patients without an ICD had similar baseline characteristics and procedural success rates, and HF medication at discharge was comparable. Three-year mortality rates were 26.4% for patients with an ICD and 24.4% for patients without an ICD (p = 0.758). Cardiovascular death rates were similar between groups (p = 0.914), and deaths were most often attributed to worsening of HF. Survival rates in patients with persistent LV dysfunction with an ICD (n = 24) or without an ICD (n = 59) were similar between groups (p = 0.872), with cardiovascular deaths mostly qualified as worsening HF and none as sudden cardiac death. Patients of the overall study population with biventricular pacing devices showed only a tendency to have better outcomes (p = 0.298). ICD therapy in elderly patients with AS and LV dysfunction undergoing TAVI did not demonstrate a survival benefit during a 3-year follow-up period. [ABSTRACT FROM AUTHOR]

Para-valvular regurgitation (PVR) after transcatheter aortic valve (TAV) implantation is associated with increased mortality. Redo-TAVI may be applied to treat PVR, yet with unknown efficacy. We thought to assess redo-TAVI efficacy in reducing PVR using the Redo-TAVI registry (45 centers; 600 TAV-in-TAV cases). Patients were excluded if redo-TAVI was done urgently (N = 253), for isolated TAV stenosis (N = 107) or if regurgitation location at presentation remained undetermined (N = 123). The study group of patients with PVR (N = 70) were compared against patients with intra-valvular regurgitation (IVR) (N = 41). Echocardiographic examinations of 67 (60%) patients were reassessed in a core-lab for data accuracy validation. Core-lab examination validated the jet location in 66 (98.5%) patients. At 30 days, the rate of residual AR ≥ moderate was 7 (10%) in the PVR cohort vs. 1 (2.4%) in the IVR cohort, p = 0.137. The rate of procedural success was 53 (75.7%) vs. 33 (80.5%), p = 0.561; procedural safety 51 (72.8%) vs. 31 (75.6%), p = 0.727; and mortality 2 (2.9%) vs. 1 (2.4%), p = 0.896 at 30 days and 7 (18.6%) vs. 2 (11.5%), p = 0.671 at 1 year, respectively. Of patients with residual PVR ≥ moderate at 30 days, 5/7 occurred after implanting balloon-expandable in self-expanding TAV and 2/7 after balloon-expandable in balloon-expandable TAV. This study puts in perspective redo-TAVI efficacy and limitations to treat PVR after TAVI. Patient selection for this and other therapies for PVR needs further investigation. • Para-valvular regurgitation (PVR) after TAVI is associated with increased mortality. • Redo-TAVI reduced PVR in 90% of patients with PVR after TAVI. • AR persisted in 10% of patients with PVR vs. 2.4% with intra-valvular AR, p = 0.137. • Procedural success, safety and mortality were comparable. [ABSTRACT FROM AUTHOR]

Despite excellent procedural results in a broad clinical population, certain anatomical or clinical conditions are still challenging for transcatheter aortic valve replacement (TAVI). Whether the adherence to the instructions for use (IFU) or the use of a clinically suitable device is a prerequisite for procedural success has not been well characterized. The anatomical and clinical suitability of new-generation transcatheter heart valves (THV) was evaluated in an all-comers population (n = 540) at a high-volume center. Conformity with anatomical IFU criteria was evaluated in each implanted THV. In addition, the suitability of the implanted THV was verified in each case according to clinical and anatomical criteria, which had been previously defined according to the results of an international survey including 20 renowned TAVI operators. Furthermore, criteria of clinical suitability and adherence to IFU of each THV were applied to the overall cohort to analyze the proportion of patients in whom the use of the respective THV would have been judged to be unsuitable or off-label. An off-label use of THV based on anatomical considerations was found in 20% of all procedures, whereas the implantation of a THV deemed to be clinically unsuitable was noted in 16.3% of all procedures. Clinical suitability and conformity with IFU were present to a varying extent across the THV systems. Neither clinical suitability, nor conformity with IFU were associated with device failure or periprocedural mortality. On multivariable analysis, aortic tortuosity, mean transaortic gradient and ascending aorta diameter were identified as independent predictors of device failure (VARC-3). Off-label TAVI and the use of clinically unsuitable THVs were common, but did not affect procedural outcomes. The variety of clinical and anatomical coverage of the different THV systems emphasizes the importance of an individualized THV selection. • The majority of anatomical and clinical conditions in a contemporary TAVI population can be treated properly with new-generation THVs. • Vast differences exist in the anatomical coverage and clinical eligibility among all four THVs examined. • An off-label or clinically unsuitable THV use was common in this all-comers TAVI population. • Off-label use and the use of a "clinically unsuitable" THV were not associated with device failure after transfemoral TAVI. [ABSTRACT FROM AUTHOR]