Search Results (108)

This is a single-center study about upward facing in branched endovascular aortic repair. Background: The evolution of branched endovascular aortic repair (BEVAR) has introduced upward-facing branches as a novel approach to facilitate exclusive transfemoral access in complex aortic aneurysm repair. This study evaluates the feasibility, safety, and early outcomes of custom-made BEVAR devices incorporating upward-facing branches in patients with cranially oriented renal arteries. The investigation further aims to analyze the technical success and mid-term outcomes related to these novel devices, as well as to identify any challenges or complications specific to the use of upward-facing branches in clinical practice. Methods: We retrospectively analyzed 17 patients treated at a single center between January 2020 and December 2024 using custom-made Cook Medical branched stent grafts with at least one upward-facing branch. Demographics, comorbidities, target vessel details, bridging stent graft (BSG) configurations, and procedure-related complications were collected. The primary endpoints were technical success and branch patency. Secondary endpoints included short- and mid-term branch-related complications. Results: The cohort had a mean age of 70 years, with hypertension (88%) and coronary artery disease (47%) being common comorbidities. Technical success was achieved in 100% of cases. The left renal artery was the most frequently targeted vessel (63.2%). Most upward-facing branches were bridged using a combination of balloon-expandable and self-expandable stents. One patient (5.9%) experienced a renal bleeding complication requiring embolization. There were no cases of primary stent occlusion or dislocation. At a mean follow-up of 14 months, one asymptomatic occlusion of an upward-facing branch was detected in computed tomography angiography. No further upward-facing branch-related complications occurred, and 1-year follow-up was available in 41.2% of patients. Conclusions: In our single-center study including 17 patients, upward-facing branches in BEVAR demonstrate high technical success and a low complication rate, offering a promising alternative to traditional access strategies. These findings support broader adoption in select anatomical scenarios, pending larger comparative studies and longer-term data collection. Full article

Background/Objectives: This study aimed to assess the effectiveness and clinical relevance of intraprocedural invasive measurements—specifically intraprocedural mean pressure gradients (IC MPGs) and diastolic delta (DD)—in comparison with echocardiography for evaluating transcatheter heart valve (THV) performance across different prosthesis types. Particular attention was paid to comparing outcomes between balloon-expandable (BE) and self-expandable (SE) valves, with further stratification by aortic annulus size. Methods: A retrospective analysis was performed on 926 patients who underwent transcatheter aortic valve replacements (TAVRs) between 2012 and 2021. Patients were categorized into BE (n = 301) and SE (n = 625) valve groups. Intraprocedural MPG was measured immediately before and after valve deployment. Postprocedural echocardiographic MPG (EC MPG) and the degree of aortic regurgitation were assessed within five days after implantation. Aortic annuli were classified as small (≤23 mm) or large (≥24 mm). Results: After implantation, EC MPG was consistently higher than IC MPG, with only a weak correlation observed between the two modalities. SE valves were generally associated with lower EC MPG than BE valves. DD was higher in the BE group; however, no significant correlation was found between DD and echocardiographically assessed aortic regurgitation. Conclusions: Intraprocedural invasive measurements offer a reliable and immediate assessment of prosthesis function during TAVR but tend to underestimate gradients compared to echocardiography. Newer SE valves show performance comparable to BE valves, particularly in small annuli, supporting their use in challenging anatomies. DD appears to lack a diagnostic value for postprocedural aortic regurgitation. Full article

Transcatheter aortic valve implantation (TAVI) has transformed the treatment of aortic valve stenosis, offering a less invasive alternative to surgical valve replacement, particularly in elderly and high-risk populations. As TAVI expands into younger, lower-risk patients, the choice of transcatheter heart valve has become increasingly important to optimize both immediate and long-term outcomes. Currently, Self-Expandable Valves (SEVs) and Balloon-Expandable Valves (BEVs) are the two most widely used platforms, each characterized by distinct design features, implantation techniques, and hemodynamic profiles. While no definitive evidence supports the overall superiority of one valve type over the other, accumulating clinical data highlight specific advantages and limitations depending on anatomical and procedural contexts. This review aims to present and critically discuss the current evidence, clinical considerations, and evolving concerns surrounding the use of SEVs versus BEVs, with a particular focus on challenging scenarios such as valve-in-valve procedures and long-term valve strategy planning. Full article

Background and Objectives: Transcatheter heart valve (THV) selection is challenging as self-expanding valves (SEVs) are associated with lower post-procedural mean aortic gradients, while balloon-expandable valves (BEVs) have lower rates of paravalvular leak (PVL) and permanent pacemaker implantation (PPI). We aimed to compare the 30-day and 1-year outcomes following Myval BEV (Meril Life Sciences, Vapi, Gujarat, India) and intra-annular Portico SEV (Abbott, St. Paul, MN, USA) implantation. Materials and Methods: We retrospectively analyzed the data from the all-comer TAVI registry of the University Medical Centre Ljubljana, Slovenia, from October 2017 to August 2023. Safety and efficacy outcomes following Myval BEV and Portico SEV implantation were compared overall and after propensity score matching. Results: Of the total 1152 THVs implanted, 97 patients (8%) received a Myval BEV and 47 (4%) a Portico SEV. After propensity score matching, there were no significant differences between the two patient cohorts regarding 30-day (Myval 0.0% vs. Portico 2.9%, p = 1.000) and 1-year mortality (Myval 0.0% vs. Portico 5.9%, p = 0.492). Likewise, the rates of new PPI, device failure (mean aortic gradient and more than mild PVL), and periprocedural in-hospital complications were comparable between the two groups. Conclusions: In this retrospective analysis of two intra-annular THVs, the Myval BEV was associated with comparable short- and mid-term outcomes as the Portico SEV. Full article

The main objective of this study was to compare the long-term outcomes of transcatheter aortic valve implantation (TAVI) in patients with severe aortic stenosis, focusing on differences between self-expanding valve (SEV) versus balloon-expandable valve (BEV) prostheses and the influence of balloon pre- and post-dilatation on clinical results. The secondary objective was to report the long-term outcomes after TAVI in Romania. All patients who underwent a TAVI procedure for severe AS between November 2016 and May 2025 at a tertiary center in Romania were included in the present study. A total of 702 patients were included, of which 455 (64.8%) and 247 (35.1%) patients received a BEV (Sapien3 platform) and a SEV (Accurate, Boston, Portico, Evolut, or Navitor platforms), respectively. Pre-dilatation was performed in 514 (73.2%) cases, and post-dilatation was performed in 189 (26.9%) cases. There were 10.5 and 7.8 all-cause and cardiovascular-cause mortality event rates per 100 patient years, respectively. In regard to the univariable Cox regression, a BEV has significantly lower mortality than an SEV (HR = 0.67[0.46–0.96], p = 0.03), pre-dilatation did not influence mortality (HR = 0.71[0.48–1.04], p = 0.08), and post-dilatation significantly increased mortality (HR = 1.51[1.05–2.19], p = 0.03). In regard to the multivariable Cox regression, survival was not influenced by pre-dilatation or the valve platform, while post-dilatation had a trend towards higher mortality (p = 0.06). The BEV and SEV have similar survival rates, with no heterogeneity among a large number of TAVI platforms. While pre-dilatation had no impact on mortality, post-dilatation was associated with a trend towards increased mortality (p = 0.06), which was independent of the transprosthetic gradient. Survival after TAVI in Romania is comparable to that reported in Western registries. Full article

Background: Left bundle branch block (LBBB) following trans-catheter aortic valve implantation (TAVI) has been excluded from same-day discharge. Early identification of patients with stable LBBB can help facilitate same-day discharge. We aim to assess the role of 6-hour ECG to determine development of LBBB in patients undergoing TAVI. Methods: This is a prospective single-centre study of patients who have LBBB following elective TAVI procedures. All patients underwent ECGs pre-TAVI, as well as immediately, 6 h, and 24 h post-TAVI. Changes in ECG were compared at 6 and 24 h with the one immediately post TAVI. Results: The study included 115 patients with uncomplicated procedures. The mean age was 81 ± 7 years, with 54% male. A self-expanding valve was used in 67% of patients. Following TAVI, prolongations of PR interval and QRS duration were dynamic and reduced at 6 h. The change in PR interval at 6 and 24 h was comparable [−11 (−20 to 3) vs. −2 (−24 to 16) ms, p = 0.18]. Similarly, there was no statistical difference in the change of QRS duration at 6 and 24 h compared to the ECG immediately post-TAVI [−10 (−40 to −2) vs. −7 (−34 to 0) ms, p = 0.055]. Changes in ECG were also comparable in patients undergoing balloon-expandable and self-expanding valves. Conclusions: The current study supports that 6-hour ECG has the potential to reduce the need for prolonged continuous monitoring post-TAVI. ECG at 6 h can help optimise patient flow and facilitate early discharge. Future studies with larger sample sizes are required to confirm our findings. Full article

Background/Objective: Bridging stent optimal choice in fenestrated and branched endovascular aortic repair (f/bEVAR) is under investigation. This systematic review and meta-analysis studied the outcomes of the BeGraft peripheral and peripheral PLUS as bridging stents in f/bEVAR. Methods: The methodology was pre-registered to the PROSPERO (CRD420251007695). Following the PRISMA guidelines and PICO model, the PubMed, Cochrane and Embase databases were searched for observational studies and randomized control trials, in English, from 2015 to 2025, reporting on f/bEVAR patients using the second-generation BeGraft peripheral or the BeGraft peripheral PLUS balloon expandable covered stent (BECS; Bentley InnoMed, Hechingen, Germany) for bridging. The ROBINS-I assessed the risk of bias and GRADE the quality of evidence. Target vessel technical success, occlusion/stenosis, endoleak Ic/IIIc, reintervention and instability during follow-up were primary outcomes, assessed using proportional meta-analysis. Results: Among 1266 studies, eight were included (1986 target vessels; 1791 bridged via BeGraft); all retrospective, except one. The ROBINS-I showed that seven were at serious risk of bias. According to GRADE, the quality of evidence was “very low” for primary outcomes. Target vessel technical success was 99% (95% CI 98–100%; I² = 12%). The mean follow-up was 20.2 months. Target-vessel instability was 3% (95% CI 2–5%; I² = 44%), occlusion/stenosis was 1% (95% CI 1–4%; I² = 8%) and endoleak Ic/IIIc was 1% (95% CI 0–3%; I² = 0%). The estimated target-vessel reintervention was 2% (95% CI 2–4%; I² = 12%). Celiac trunk, superior mesenteric and renal artery instability were 1% (95% CI 0–16%; I² = 0%;), 1% (95% CI 0–5%; I² = 14%) and 4% (95% CI 2–7%; I² = 40%), respectively. Conclusions: The BeGraft peripheral and peripheral PLUS BECS performed with high technical success and low instability when used for bridging in f/bEVAR. Cautious interpretation is required due to the very low quality of evidence. Full article

Background/Objectives: Currently, the transfemoral approach is recognized as the primary method for accessing transcatheter aortic valve implantation (TAVI). However, alternative techniques are needed when the transfemoral access is not suitable. We proposed that a modified transaxillary approach through the distal left axillary artery is both viable and safe for conducting TAVI, potentially offering benefits for patients. Methods: From December 2018 to February 2024, a total of 24 patients (7 women, average age 77.9 ± 8 years) received TAVI using transaxillary access via the left axillary artery. The participants suffered from symptomatic severe aortic stenosis and were deemed TAVI candidates with iliofemoral anatomy unsuitable for a transfemoral route. The patient group displayed a high perioperative risk profile, with significant peripheral artery disease or severe obstructive infrarenal aortic conditions. The implantation of the aortic prosthesis was carried out through the left distal axillary artery. A balloon-expandable valve was used in every instance. Results: In the examined cohort, the 30-day mortality rate was 4.2%. A new pacemaker was necessary for four patients (16.7%). One case exhibited a new moderate neurological dysfunction. Additionally, one patient required surgical revision of the access point due to ischemia. Conclusions: Our findings indicate that transaxillary TAVI via the distal left axillary artery has yielded encouraging outcomes. This approach is practicable and safe, does not prolong the procedure, minimizes surgical trauma, ensures excellent access regardless of chest anatomy, and is sparing for the brachial plexus. As a single-center pilot study, our findings require confirmation in larger, prospective cohorts with extended follow-up to fully validate the safety and long-term efficacy of this technique. Full article

Drug-coated balloons (DCBs) have emerged as a promising alternative therapeutic strategy to traditional drug-eluting stent (DES) implantation in various coronary artery lesion scenarios, aiming to minimize complications associated with permanent metallic scaffolds, such as chronic inflammation, delayed vessel healing, and stent thrombosis. This review systematically evaluates the current clinical evidence supporting the use of DCBs across diverse anatomical and clinical contexts, including small-vessel disease, in-stent restenosis, bifurcation lesions, diffuse coronary lesions, acute coronary syndromes, and chronic total occlusions, as well as in special patient populations such as individuals with diabetes mellitus or at high bleeding risk. The literature analysis incorporated recent randomized controlled trials, observational studies, and real-world registries, highlighting the clinical efficacy, safety profiles, and specific advantages of DCB angioplasty. The findings consistently demonstrated non-inferior clinical outcomes of DCBs compared to DESs across multiple lesion types, with particular benefits observed in special populations, including reduced restenosis rates and comparable major adverse cardiac events (MACEs). Nevertheless, clinical data gaps remain, emphasizing the need for larger, longer-term randomized trials to refine patient selection and procedural techniques. In conclusion, DCB angioplasty represents a viable and effective alternative to conventional stenting, particularly advantageous in complex lesions and specific patient subsets, pending further definitive evidence. Full article

Pulmonary disfunction is frequent in repaired congenital heart diseases. Both pulmonary regurgitation and pulmonary stenosis are possible complications over time. In the past, the surgical approach was the only feasible management but exposed the patient to a redo-surgery with its consequent risks. Nowadays, the development of novel devices and techniques has made possible a transcatheter pulmonary valve implantation. The Melody Transcatheter Pulmonary Valve (TPV) (Medtronic Inc., Minneapolis, MN, USA) and the Edwards Sapien XT and S3 Transcatheter Heart Valve (Edwards Lifesciences LLC, Irvine, CA, USA) are balloon-expandable valvular bioprostheses approved for pulmonary position. Venus P-Valve (Venus Medtech, Shanghai, China) and Harmony TPV (Medtronic Inc., Minneapolis, MN, USA) are self-expandable pulmonary valves. Alterra Adaptive Prestent (Edwards Lifesciences LLC, Irvine, CA, USA) is an hourglass self-expandable stent that reduces the size of large right ventricular outflow tracts, creating a suitable landing zone to implant an Edwards Sapien S3 THV 29 mm. Novel stents and percutaneous valves are being planned and experimented with to widen the field of transcatheter approach. The aim of this review is to describe both the current approaches, strategies, and techniques as well as the future perspective to deal with the patients with significant pulmonary stenosis and/or regurgitation. Full article

Bicuspid aortic valve (BAV) is the most common congenital heart disease, affecting 0.5–2% of the population and often leading to early aortic valve degeneration. While surgical aortic valve replacement (SAVR) remains the gold standard for treating severe bicuspid aortic stenosis (AS), transcatheter aortic valve implantation (TAVI) is emerging as a viable alternative in selected BAV anatomies. Initial experiences with first-generation transcatheter heart valves (THVs) showed the feasibility of this technique, but were associated with lower device success rates and higher complications, such as paravalvular leak (PVL) and pacemaker implantation. Advancements in second- and third- generation THVs, together with better pre-procedural imaging assessment and growing operator experience, have significantly enhanced TAVI outcomes in BAV patients, with results now comparable to those seen in tricuspid aortic valves (TAVs). Proper patient selection, pre-procedural sizing, and device implantation are key to improving TAVI success in BAV. Recent registry data on contemporary THV platforms demonstrate improved procedural success, hemodynamic performance, and the safety of TAVI in BAV. However, higher rates of PVL, pacemaker implantation, and strokes remain concerns. Ongoing advancements in THV design and procedural techniques will further enhance outcomes for this challenging population. Up to the present, there are no dedicated THVs for BAV, but the latest-generation THVs offer promising results. Full article

Aims: The aim of this paper is to report 30-day and 1-year outcome data regarding the first 200 patients who underwent the TAVR procedure using the Myval THV system at our single centre. Methods: From November 2019 to October 2022, 200 consecutive patients underwent TAVR procedure. Outcomes were analysed according to the VARC-2 definitions, and device performance was assessed via transthoracic echocardiography. Data collection was approved by the local Ethical Committee. Results: The mean age of the cohort was 75.3 ± 6.9 years, and 122 (61%) participants were male. The mean EuroSCORE II and STS was 5.4 ± 5.4 and 5.8 ± 3.8, respectively. The proportion of patients with a bicuspid aortic valve was 18%. The transfemoral access approach was the most common (surgical vs. percutaneous: 1% vs. 98%), and in two patients, surgical subclavian access was used. VARC-2 outcomes were as follows: 99% device success, 2% STROKE, 5% and 4.5% major and minor vascular complications, respectively, and a 29.5% rate of new permanent pacemaker implantation. At discharge, the incidence of aortic regurgitation grade II or above was 5.5% without relevant PVL (grade II or above 0.5%). In-hospital mortality was only 1%. At 1 year, the all-cause mortality rate was 8.5% (cardiac origin in three cases), and two patients had valve-related dysfunction requiring surgical aortic replacement. Conclusions: Our results showed excellent 30-day and 1-year outcomes regarding patient survival, technical success, and valve-related adverse events using the Myval transcatheter heart valve system. The limitations of our study comprise a single-centre design with retrospective data collection. Full article

Abstract: Background: Transcatheter aortic valve implantation (TAVI) is the treatment of choice for symptomatic aortic stenosis in patients with moderate to high surgical risk. When transfemoral access is unsuitable, alternative routes such as transapical (TAP) or transaxillary (TAX) routes must be considered. This study compares the in-hospital mortality and clinical outcomes of TAP vs. TAX TAVI. Methods: We conducted a retrospective analysis of 76 patients who underwent TAP or TAX TAVI between 2018 and 2021 at our department. Inverse probability of treatment weighting (IPTW) was used to account for baseline differences. Results: Among 1901 TAVI procedures, a total of 76 was selected of which TAP was performed in 34.2% (n = 26), and TAX in 65.8% (n = 50) of cases. Self-expanding CoreValve Evolut R valve prostheses were used in 96% of TAX cases, while balloon-expandable Edwards SAPIEN 3 valve prostheses were exclusively implanted in TAP cases. After IPTW adjustment, baseline characteristics, including EuroSCORE II, LVEF, and NYHA class, were comparable. TAX was associated with a higher pacemaker implantation rate (22.6% vs. 0%; p = 0.032), while TAP had a higher incidence of late bacteremia (13.4% vs. 1.6%; p = 0.027) and longer hospitalization (19 [13, 28] vs. 10 [8, 21] days; p = 0.016). In-hospital (0% vs. 2.1%; p = 0.388), 30-day (3.4% vs. 3.5%; p = 0.957), and 3-year mortality (6.7% vs. 4.8%; p = 0.709) were similar. Device implantation success was 100% in both groups. Major bleeding and vascular complications were rare. Balloon predilatation was more frequent in TAX (57.6% vs. 13.3%; p = 0.002). Rates of mild and moderate aortic regurgitation did not differ. Conclusions: In patients unsuitable for transfemoral TAVI, TAP was associated with lower pacemaker rates but longer hospitalization and increased late bacteremia compared to TAX. Both approaches showed comparable safety and efficacy, emphasizing the need for individualized access selection. Full article

Background: Over the last two decades, therapy for benign esophageal strictures has shifted from empirical dilatations and surgery to evidence-based and complex endoscopic and surgical procedures, aiming to achieve long-term esophageal patency. Aim: The purpose of our study is to provide descriptive evidence regarding the appropriate tailored medical, endoscopic, and surgical management of benign esophageal strictures. Methods: This retrospective study includes patients with benign esophageal strictures; the data collected encompass the complete patient profiles, detailed etiologic and anatomic workups of the strictures, comprehensive imaging, as well as management and follow-up details. Technical and clinical success rates, adverse events, stricture patency, and the need for additional therapy have been evaluated. Results: Most of the strictures (80.2%) were complex, requiring advanced techniques for management. The primary treatment involved endoscopic dilation, performed with Savary-Gillard bougie dilators in 76.7% of cases and pneumatic balloon dilators in 23.3% of cases. Clinical success was achieved in 95.3% of patients, with a significant improvement in the Ogilvie dysphagia score. Patients with caustic strictures required repeated dilations over the years, compared to shorter intervals for peptic strictures. Adverse events were minimal (e.g., perforation 2.3% and bleeding 4.7%) and managed predominantly endoscopically. Refractory strictures (16.3%) required advanced interventions, including fully covered self-expandable metallic stents (fc-SEMS) and corticosteroid injections. Conclusions: Both our data and the current literature support the use of tailored endoscopic strategies as the first-choice options for managing benign esophageal strictures. Our results strongly suggest against one-size-fits-all therapeutic alternatives. Full article

Background: Prosthesis-patient mismatch (PPM) has been demonstrated to affect the outcome of both surgical (SAVR) and transcatheter aortic valve replacement (TAVR) patients. Supra-annular transcatheter valves (SAV) appear to offer a superior solution to intra-annular valves (IAV) in this regard. However, data on the comparison of the intra-annular self-expanding (SE) NAVITOR and the intra-annular balloon-expandable (BE) Sapien 3 Ultra in small annuli are limited. Methods: A total of 179 patients with severe native aortic valve stenosis were treated with either the SE NAVITOR (SEV; n = 104) or the BE Sapien 3 Ultra (BEV; n = 75) between March 2019 and June 2024. We compared the clinical and hemodynamic outcomes of the cohort according to the implanted prostheses. BMI-adjusted PPM was defined in accordance with the VARC-3 recommendations. Results: The device success at 30 days was superior in patients treated with the NAVITOR prosthesis (94.2% vs. 80.0%, p < 0.001), mainly driven by a higher rate of elevated gradients in the BEV group. The post-procedural mean gradient (8.0 mmHg vs. 13.0 mmHg, p < 0.001) as well as the rate of moderate to severe prosthesis patient mismatch (12.2% vs. 33.3%, p = 0.002) was higher in BEV recipients while the rate of more than moderate paravalvular leakage (PVL) or Valve in Valve (VinV) due to PVL (1.0% vs. 1.3%, p = 1.000) was similar between both groups. Pacemaker implantations were numerically more common after SEV (18.4% vs. 8.5%, p = 0.110). There was a trend towards higher thirty-day all-cause mortality among patients treated with SAV (3.8% vs. 1.3%, p = 0.401). Conclusion: The NAVITOR system may offer a more favorable hemodynamic profile compared to the Sapien 3 Ultra device in patients with small aortic annuli. Full article