Héctor Alfonso Alvarez Covarrubias

Background and aims: The peripheral vessel tortuosity index (TI) was proposed to discriminate procedural success in patients undergoing transcatheter endovascular aortic replacement but not in those undergoing transcatheter aortic valve implantation (TAVI). We aimed to investigate the TI and its prognostic relevance in patients undergoing transfemoral (Tf) TAVI. Methods: Retrospective, observational single-center study, including patients undergoing Tf-TAVI from April 2011 to January 2023 at the TUM University Hospital, German Heart Centre, and available computed tomography angiography (CTA). Peripheral vessel measurements were performed using dedicated software (3mensio, Pie Medical). TI was determined dividing true central lumen vessel length from centerline reconstruction and direct distance from the aorto-iliac bifurcation to the epigastric artery. TI was dichotomized based on severity according to EVAR guidelines, where a TI of 1.5 is considered discriminatory for nonsevere tortuosity [< 1.5 for low TI (LTI)] and > 1.5 for high TI (HTI)]. Valve Academic Research Consortium 3 definitions were applied to describe procedural and follow-up outcomes. Mortality at 6-month follow-up was evaluated. Results: We included 2002 patients. Overall age was 81 years [77, 85], 45.2% were female, EuroScore II was 4.22 [2.39, 7.60]. Age ( p < 0.001), female sex ( p < 0.001), diabetes ( p < 0.001), peripheral artery disease ( p = 0.002), myocardial infarction ( p = 0.013), and creatinine ( p = 0.001) were associated with tortuosity. Adjusted 6-month analysis showed that TI > 1.50 was associated with increased mortality [hazard ratio (HR) 1.679, 95% CI (1.098–2.567), p = 0.017]. Conclusions: TI > 1.50 may determine a higher-risk population in patients undergoing Tf-TAVI. Further study is required to validate our findings. Graphical Tortuosity index as a risk factor for mortality at 6 months after transcatheter aortic valve implantation.

Background: The Systemic Immune-Inflammation Index (SII), calculated as neutrophils × platelets / lymphocytes, reflects the interplay between systemic inflammation and immune status. Its prognostic relevance in patients undergoing transcatheter aortic valve implantation (TAVI) remains poorly understood. Aim: To evaluate the prognostic significance of preprocedural SII in patients undergoing TAVI. Methods: This retrospective cohort study included 1822 patients undergoing TAVI for severe aortic stenosis between 2014 and 2023 at two TAVI centers in Germany. Patients were divided into derivation and validation cohorts. Preprocedural SII was calculated from differential blood counts. In the derivation cohort, patients were stratified into tertiles based on preprocedural SII. Using receiver operating characteristics (ROC) analysis an optimized cut-off value for the validation cohort was identified to stratify patients into high- and low-risk groups. A generalized linear model (GLM) was used to identify clinical predictors of SII. Results: In the derivation cohort, multivariate analysis showed that SII was independently associated with both major adverse cardiovascular events (MACE) (hazard ration [HR]: 1.0001 [1.00001; 1.00002], p  = 0.020) and stroke (HR: 1.0003 [1.00002; 1.00004], p < 0.001). In the GLM, SII positively correlated with age ( p = 0.013) and C-reactive protein ( p < 0.001), and inversely with mean aortic gradient ( p = 0.022) and hemoglobin ( p = 0.011). In the external validation cohort, high risk patients (cut-off > 1204) showed an increased risk for one-year all-cause mortality (HR: 2.19 [1.59; 3.02], p  < 0.001). Conclusion: Higher preprocedural SII was independently associated with increase rates of MACE and stroke at one-year following TAVI. A SII cut-off of 1204 effectively stratifies patients into high- and low-risk groups and may provide additional value for preprocedural risk stratification. Graphical

BACKGROUND: Differences between balloon- and self-expandable transcatheter heart valves (BE-THVs and SE-THVs, respectively) may influence the outcomes of transcatheter aortic valve replacement for bicuspid aortic valve (BAV) stenosis. METHODS: Consecutive patients undergoing transcatheter aortic valve replacement with BE-THV or SE-THV for computed tomography–diagnosed bicuspid aortic valve stenosis at 29 centers were included. The primary outcome was death or stroke. After propensity score matching in 10 data sets generated by multiple imputation, outcomes from transcatheter aortic valve replacement to 3-year follow-up were computed by multivariable binomial logistic mixed-effects models, multivariable linear mixed-effects models, or multivariable frailty models accounting for center-related influences and residual confounding effects (doubly robust adjustment). The results were replicated by inverse probability of treatment weighting and multivariable adjustment. RESULTS: A total of 1443 consecutive patients with bicuspid aortic valve stenosis undergoing BE-THV (n=860) or SE-THV (n=583) implantation were included. In-hospital and 30-day death or stroke did not significantly differ between BE-THV and SE-THV groups (5.1% versus 6.1%; hazard ratio after propensity score matching, 1.02 [95% CI, 0.51–2.02]). BE-THV implantation was associated with higher annulus rupture and mean transvalvular gradient compared with SE-THV implantation. In contrast, SE-THV implantation was associated with higher additional valve implantation and paravalvular regurgitation compared with BE-THV implantation. The results were consistent across the statistical methods used and between early- and new-generation THVs. At 30 days, pacemaker implantation was lower in the BE-THV group compared with the SE-THV group (11.9% versus 18.6%; hazard ratio after propensity score matching, 0.58 [95% CI, 0.36–0.93]). This result did not depend on the statistical method used. At 3 years, consistent with the 1- and 2-year analyses, death or stroke was not significantly different between the BE-THV and SE-THV groups (23.7% versus 26.2%; hazard ratio after propensity score matching, 0.99 [95% CI, 0.65–1.51]). Death or stroke across major clinical, anatomical, functional, and procedural conditions was consistent with the main analysis. After inverse probability of treatment weighting and multivariable adjustment, these conclusions remained unchanged. CONCLUSIONS: In patients undergoing transcatheter aortic valve replacement for bicuspid aortic valve stenosis, death or stroke does not significantly differ between those receiving a BE-THV and those receiving an SE-THV over a follow-up of 3 years. BE-THV is associated with higher transvalvular mean gradient and more frequent annulus rupture, whereas SE-THV is associated with more frequent moderate to severe aortic regurgitation, additional THV implantation, and permanent pacemaker implantation.

Background: Several treatment strategies are available for patients with mitral valve regurgitation (MR). However, evidence regarding their comparative effectiveness remains limited. We sought to compare the performance of different treatment strategies for personalized treatment of patients with MR. Methods: We performed a pairwise and network meta-analyses of randomized trials comparing treatment strategies for patients with MR. Patients were divided in two groups: transcatheter mitral valve repair (TMVR, including edge-to-edge repair and indirect percutaneous annuloplasty) and control (surgery or optimal medical therapy). The primary outcome of this analysis was all-cause death. Main secondary outcomes were re-hospitalization for heart failure and re-intervention. Results: A total of seven trials with 2324 participants, with mainly functional MR (TMVR, n = 1373-control, n = 951) were available for the quantitative synthesis. The median follow-up duration was 14 months. Compared to control therapy, TMVR significantly reduced all-cause death (RR 0.77, 95% CI 0.65–0.91, p = 0.002) and re-hospitalization for heart failure (RR 0.67, 95% CI 0.49–0.91, p = 0.01). Among TMVR strategies, the edge-to-edge repair with MitraClip ranked as possibly the best option to reduce all-cause death. Conclusions: In symptomatic patients with significant MR, TMVR is associated with a significant reduction of all-cause death, and re-hospitalization for heart failure, mainly in patients with functional MR. Additional comparative studies are needed to investigate the best TMVR treatment option, for patients with degenerative MR.

Background and aims: Vascular complications occur in a non-negligible proportion of transfemoral transcatheter aortic valve implantation (Tf-TAVI) procedures. There is only limited evidence regarding the efficacy and safety of covered balloon-expandable (CBE) stents in the management of Tf-TAVI related vascular complications. We aimed to investigate the efficacy and safety of CBE stent implantation to treat access-related vascular complications in patients undergoing Tf-TAVI. Methods: The present retrospective analysis included patients undergoing CBE stent implantation following Tf-TAVI from April 2012 to January 2023 at our centre. The primary endpoint was technical success defined as successful device delivery and implantation at the intended location with angiographic confirmation of vessel patency and absence of residual bleeding. Clinical outcomes and color Doppler ultrasonography findings were evaluated at discharge, 30 days and longest available follow-up. Results: Among 3331 Tf-TAVI procedures, 93 patients (2.8%) required covered stent implantation for the treatment of access related vascular complications. Technical success was achieved in 92 patients (98.9%). BeGraft and Atrium Advanta V12 CBE stents were implanted in 76 (81.7%) and 17 (18.3%) patients, respectively. Median clinical follow-up was 455 [304; 798] days, with both in-hospital and 30-days mortality equaling 4.3% and 1-year mortality 15.1%. Pre-discharge Doppler ultrasonography was performed in 98.9% patients, with normal findings in 79.8% and minor findings (such as pseudoaneurysm, non-flow-limiting dissection, arterio-venous fistula) in the remaining patients. Clinical follow-up was available in 96.2% patients; no cases of new-onset claudication, need for repeat surgical or transcatheter vascular interventions were recorded. Follow-up Doppler ultrasonography (54.4% patients) showed persistent patency and no signs of stent failure in all patients. Conclusions: CBE stent implantation for the treatment of access site related vascular complications after Tf-TAVI is associated with excellent technical success rates, optimal short- to mid-term patency rates as well as satisfactory long-term clinical outcomes.

Aims: We aimed to evaluate transcatheter mitral valve implantation (TMVI) using predominantly balloon‐expandable transcatheter heart valves (THV) in patients with a landing zone for a percutaneously delivered prosthesis.Background: Patients with a degenerated mitral valve bioprosthesis, annuloplasty ring, and mitral annulus calcification (MAC) considered at high surgical risk currently represent a treatment challenge. TMVI is an alternative treatment option.Methods: Retrospective analysis of patients with symptomatic degenerated mitral valve bioprosthesis, or annuloplasty ring, and MAC treated with TMVI between November 2011 and April 2021. Endpoints were defined according to Mitral Valve Academic Research Consortium (MVARC) criteria and included device and procedure success at 30 days as well as mortality at 30 days and 1 year after the procedure.Results: A total of 77 patients underwent TMVI (valve in valve [ViV = 56], valve in ring [ViR = 11], and valve in MAC [ViMAC = 10]). There was a trend toward higher technical success (all = 93.5%, ViV = 96.4%, ViR = 90.9%, ViMAC = 80%, p = 0.06) and lower 30‐day (all = 11.7%, ViV = 10.7%, ViR = 9.1%, ViMAC = 20%, p = 0.49) and 1‐year mortality (all = 26%, ViV = 23.2%, ViR = 27.3%, ViMAC= 40%, p = 0.36) after ViV and ViR compared to ViMAC.Conclusion: TMVI represents a reasonable treatment option in selected patients with MAC or who are poor candidates for redo mitral valve surgery. Technical success and survival up to 1 year were not significantly dependent on the subgroup in which TMVI was performed.

Objectives: To investigate the feasibility and safety of percutaneous transluminal angioplasty (PTA) of the iliofemoral arteries (IFA) before transfemoral transcatheter aortic valve implantation (Tf‐TAVI) in patients with advanced peripheral artery disease (PAD).Background: Although Tf‐TAVI represents the access of choice, alternative vascular access routes are preferred for patients displaying advanced PAD. PTA of the IFA represents a less invasive option, broadening the spectrum of patients eligible for Tf‐TAVI.Methods: All patients requiring PTA of the IFA before Tf‐TAVI, between 2012 and 2021, were included. Primary efficacy endpoint was the rate of successful transcatheter heart valve (THV) delivery and implantation. Primary safety endpoint was the rate of PTA and access‐site‐related vascular complications, procedural‐ and in‐hospital complications.Results: Among 2726 Tf‐TAVI procedures, 59 patients required IFA predilation. Successful THV delivery and implantation was achieved in 57 (96.6%) patients, respectively. Sheath placement was achieved in 59 (100%) patients with only one minor dissection and no major vascular complications following iliofemoral PTA. Regarding access site complications, two (3.4%) vessel perforations and one (1.7%) vessel rupture were observed, with eight (13.5%) patients requiring unplanned endovascular interventions. There was one intraprocedural death due to THV‐induced vessel laceration, while in‐hospital all‐cause mortality was 8.5% in the present high‐risk patient cohort.Conclusions: Predilation of IFA is safe and effective in patients with advanced PAD. Careful preprocedural planning is paramount in improving procedural safety and efficacy. This strategy has the potential to broaden the spectrum of patients eligible for Tf‐TAVI.

Aims: To quantify extra-valvular cardiac damage associated with severe aortic valve stenosis (AS), a novel staging model was proposed. This study aimed to validate this model in patients undergoing transcatheter aortic valve replacement (TAVR) as well as to assess its prognostic impact.Methods and results: Based on echocardiographic findings, the following stages were applied: isolated AS (stage 0), left ventricular (LV) damage (stage 1), left atrial or mitral valve damage (stage 2), pulmonary hypertension or tricuspid regurgitation (stage 3), or right ventricular dysfunction (stage 4). The primary endpoint was 2-year all-cause mortality. The distribution across stages was 0.8% at stage 0, 7.5% at stage 1, 63.3% at stage 2, 18.3% at stage 3, and 10.1% at stage 4. All-cause mortality increased at all stages 1–4 (12.1%, 18.2%, 26.6%, and 28.2%; p = 0.023). In the multivariate model, the stage of cardiac damage, age, New York Heart Association (NYHA) class III/IV, peripheral artery disease, and previous pacemaker were independent predictors of the primary endpoint.Conclusions: Patients treated for severe AS show a high prevalence of extra-valvular cardiac damage. An increase in stage is associated with higher 2-year all-cause mortality. The application of this staging model may add value to current treatment algorithms.