Articles published on Paravalvular leak
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- Research Article
- 10.1080/14779072.2026.2698021
- Jun 30, 2026
- Expert review of cardiovascular therapy
- Vasiliki Androutsopoulou + 5 more
Transcatheter aortic valve replacement (TAVR) has transformed the management of severe aortic stenosis across all surgical risk strata. As its use expands to younger, lower-risk patients, the durability of transcatheter heart valves and the clinical consequences of prosthetic failure have become critically important. Despite a growing literature on reintervention strategies, systematic prevention of TAVR failure remains comparatively underemphasized. We searched PubMed and the Cochrane Library (2000-2026, English language) for studies on TAVR failure and its prevention. This review examines the mechanisms of TAVR failure, including structural valve deterioration, paravalvular leak, prosthesis-patient mismatch, subclinical leaflet thrombosis, valve endocarditis, and device migration; appraises current management, including valve-in-valve TAVR, redo surgical aortic valve replacement, and medical therapy; and reviews prevention strategies spanning patient selection, procedural optimization, antithrombotic management, structural surveillance, coronary access preservation, and lifetime planning. The evidence base has focused disproportionately on reintervention rather than prevention. Greater emphasis on structured lifetime management planning at index TAVR, individualized antithrombotic strategies, and evidence-based surveillance is needed. Several proposed measures, however, including routine anticoagulation for subclinical leaflet thrombosis and routine CT or artificial-intelligence-based surveillance, are not yet supported by outcome data and require prospective validation.
- New
- Research Article
- 10.1186/s44215-026-00265-2
- Jun 23, 2026
- General thoracic and cardiovascular surgery cases
- Koki Yokawa + 8 more
The graft insertion technique is an effective choice for redo aortic root reconstruction in cases with extensive annular destruction. Nevertheless, its impact on postoperative left ventricular outflow tract (LVOT) geometry and flow dynamics has not been investigated in detail. A 69-year-old woman who underwent aortic valve replacement for infective endocarditis developed prosthetic valve dehiscence with paravalvular leakage and a large aortic root pseudoaneurysm after 4 months. Because the native annulus was completely destroyed, redo aortic root replacement using the Bentall procedure with the graft insertion technique was performed. Intraoperative examination revealed no macroscopic evidence of active infection but raised concerns regarding potential LVOT narrowing after the insertion of the inverted graft. Postoperative contrast-enhanced computed tomography demonstrated significant LVOT narrowing, with a minimal diameter of 14mm, despite the implantation of a 19-mm bioprosthetic valve. Moreover, four-dimensional flow (4D-flow) magnetic resonance imaging (MRI) revealed accelerated systolic flow at the narrowed LVOT, indicating functional LVOT stenosis. This case emphasizes an important pitfall of the graft insertion technique-postoperative LVOT narrowing caused by the intraventricular portion of the inverted graft. Postoperative morphological and hemodynamic evaluation using advanced imaging modalities, including 4D-flow MRI, may be required to ensure the safety of this technique in complex aortic root reconstruction.
- Research Article
- 10.1186/s13019-026-04457-3
- Jun 22, 2026
- Journal of cardiothoracic surgery
- Si-Wen Wang + 4 more
Transcatheter mitral valve implantation (TMVI) device featuring an apical fixation design is now the most mature TMVI system and widely applied in routine clinical practice. Nevertheless, severe unique complications including left ventricular outflow tract (LVOT) obstruction, paravalvular leakage (PVL), and hemolysis can still occur with this device. A 75-year-old frail elderly female with severe mitral regurgitation (MR) and recurrent heart failure was admitted to our institution for treatment. TMVI was successfully completed. The patient was subsequently rehospitalized owing to decompensated heart failure, PVL and severe hemolysis due to late valve dislodgement. We then performed valve re-tensioning via the prior thoracotomy, which resolved PVL and relieved hemolysis. Subacute dislodgement of the prosthesis can still occur following TMVI with apical fixation design, leading to severe PVL and hemolysis. Accurate diagnosis using transesophageal echocardiography (TEE) combined with prompt re-tensioning is critical for the management of this complication.
- Research Article
- 10.1016/j.jcin.2026.04.035
- Jun 22, 2026
- JACC. Cardiovascular interventions
- Robert Kay + 5 more
Transcatheter Mitral Valve Replacement in MAC Complicated by Atrioventricular Disruption, Valve Migration, and Paravalvular Leak.
- Research Article
- 10.1016/j.jjcc.2026.06.013
- Jun 22, 2026
- Journal of cardiology
- Carlo Mannina + 17 more
Neutrophil-to-lymphocyte ratio in patients with low-flow aortic stenosis undergoing transcatheter aortic valve implantation.
- Research Article
- 10.3390/jcdd13060277
- Jun 19, 2026
- Journal of cardiovascular development and disease
- Eray Aksoy + 3 more
The continuous suture technique is not routinely used in surgical aortic valve replacement (SAVR), and data regarding its clinical outcomes remain limited. This retrospective observational study evaluated early and mid-term outcomes after continuous suture SAVR in a real-world cohort. Eighty-eight consecutive patients who underwent SAVR using a continuous suture technique between November 2015 and July 2024 were included. Both isolated and concomitant procedures were analyzed. The operative technique consisted of three 2-0 polypropylene sutures, one placed along each aortic cusp. Clinical outcomes, postoperative complications, and survival were assessed. The mean age was 62.22 ± 15.22 years, and 71.6% of patients were male. Bioprosthetic valves were implanted in 61.4% of cases, and the mean prosthesis size was 25.02 ± 0.93 mm. Concomitant procedures were performed in 86.4% of patients. There were no in-hospital deaths. New-onset atrial fibrillation occurred in 26.1% of patients, and permanent pacemaker implantation was required in 3.4%. The median cross-clamp time was 41.50 min. During a mean follow-up of 18.38 months, one- and three-year overall survival was 92.9%. No prosthetic valve dysfunction related to thrombus, pannus formation, or clinically significant paravalvular leak was observed. Continuous suture SAVR appears feasible and safe, with acceptable early and mid-term outcomes, although the retrospective, non-comparative design requires cautious interpretation.
- Research Article
- 10.1161/circinterventions.126.016616
- Jun 18, 2026
- Circulation. Cardiovascular interventions
- Sang-Yun Lee + 20 more
Patients with congenital or acquired right ventricular outflow tract dysfunction frequently require pulmonary valve replacement and are exposed to repeated surgical interventions due to prosthetic valve degeneration. The PULSTA self-expanding transcatheter pulmonary valve was designed to address a broad spectrum of native and surgically repaired right ventricular outflow tract anatomies. This study reports the midterm safety, hemodynamic performance, and durability outcomes of the prospective, multinational PULSTA CE approval trial (PULSTA Carpentier Edwards). This premarket, multicenter, nonrandomized study enrolled 58 patients across 11 centers in 6 countries. Successful PULSTA implantation was achieved in 57 patients (98.3%), including 4 valve-in-valve procedures. Patients were followed for a median duration of 4.1 years. Primary end points included procedural or device-related serious adverse events, hemodynamic improvement, and sustained valve function. At 6 months, cardiac magnetic resonance imaging demonstrated significant reverse right ventricular remodeling, with marked reductions in right ventricular end-diastolic volume index, end-systolic volume index, and pulmonary regurgitation fraction (all P<0.001). Valve performance remained stable throughout follow-up, with 93.8% of patients exhibiting mild or less pulmonary regurgitation at 4.1 years. Freedom from reintervention was 98.2% at 5 years. One patient required a PULSTA-in-PULSTA implantation due to paravalvular leakage, and one case of infective endocarditis was successfully managed with antibiotic therapy. No stent fractures or structural valve deterioration were observed. The PULSTA transcatheter pulmonary valve demonstrated high procedural success, durable valve function, and sustained hemodynamic benefits. Its adaptability to diverse right ventricular outflow tract anatomies and favorable safety profile supports its role as an effective therapeutic option for patients with right ventricular outflow tract dysfunction. URL: https://www.clinicaltrials.gov; Unique identifier: NCT03983512.
- Research Article
- 10.1186/s13019-026-04317-0
- Jun 15, 2026
- Journal of cardiothoracic surgery
- Shasha Chen + 8 more
Mid-term clinical evidence for the VitaFlow LibertyTM transcatheter aortic valve system in anatomically complex populations is limited. This was a prospective, multicenter, single-arm Objective Performance Criteria study performed at 22 Chinese sites, with follow-up at 30days, 6months, 1year, and annually through 5years. The prespecified primary endpoint of the parent study was 1-year all-cause mortality. Other clinical events were adjudicated according to Valve Academic Research Consortium-2 definitions. A total of 163 patients underwent transcatheter aortic valve replacement (TAVR) with the VitaFlow LibertyTM system. The mean age was 76.8 ± 5.0years, 65.0% were male, the mean STS-PROM score was 7.87 ± 2.70, and 46.6% had bicuspid aortic valve anatomy. At 2years, all-cause mortality was 13.5%, any stroke occurred in 7.6%, and new permanent pacemaker implantation was required in 19.5%. Mean aortic valve gradient improved from 59.22 ± 19.76mmHg at baseline to 9.04 ± 6.07mmHg at 2years, and effective orifice area improved from 0.57 ± 0.21 cm2 to 2.00 ± 0.51 cm2. Moderate paravalvular leak was present in 4.5% of patients at 2years. TAVR with the VitaFlow LibertyTM system demonstrated favorable 2-year safety and efficacy in a challenging population, with sustained hemodynamic performance. NCT04414878.
- Research Article
- 10.1002/ccd.70682
- Jun 8, 2026
- Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
- Ehsan Khalilipur + 11 more
Paravalvular leak (PVL) is a complication after prosthetic valve implantation, leading to issues like hemolysis and heart failure. While redo surgery is the standard treatment, it poses significant risks for high-risk patients. Transcatheter PVL closure has become a less invasive option, with improved efficacy from advanced imaging and device technologies. This study aims to evaluate the safety, efficacy, and technical strategies of transcatheter PVL closure, including novel approaches like the reverse loop and arteriovenous (AV) rail techniques in a prospective single-center cohort. Twenty-eight high-risk patients (mean age 57.2 ± 10.1 years) with significant aortic or mitral PVLs underwent transcatheter closure. Procedures were guided by multimodal imaging, assessing technical, procedural, and clinical success rates, along with 6-month outcomes in NYHA functional class and echocardiographic parameters. Out of 28 procedures, 27 were technically successful (96.4%), with clinical success achieved in 92.9% of patients. Most procedures used transfemoral access, treating aortic PVLs retrogradely and mitral PVLs through various routes. Advanced techniques like reverse loop (n = 4) and AV rail (n = 3) were utilized in complex cases. NYHA functional class improved significantly (p < 0.001), with no significant change in left ventricular ejection fraction. One patient required redo surgery, and one died from sepsis. Transcatheter PVL closure is a safe and effective alternative to redo surgery for selected high-risk patients. Advanced imaging and access techniques enhance procedural success, particularly in complex mitral PVLs. Further multicenter studies with long-term follow-up are needed to confirm these results and refine technique selection.
- Research Article
- 10.1097/crd.0000000000001333
- Jun 4, 2026
- Cardiology in review
- Ahmed K Abdelrahman + 8 more
The optimal transcatheter aortic valve replacement strategy in patients with a small aortic annulus (SAA) remains unclear. We performed a systematic review and meta-analysis comparing self-expanding valves (SEVs) to balloon-expandable valves (BEVs) in SAA patients. We searched PubMed, Embase, Web of Science, and Scopus for studies comparing SEVs and BEVs in patients with SAA defined by computed tomography. A random-effects model using the Der Simonian and Laird estimator was used to pool odds ratios (ORs) and mean differences (MDs). We identified 25 studies encompassing 13,846 patients (5633 BEV; 8213 SEV). SEVs demonstrated superior hemodynamics, including a larger indexed effective orifice area (MD: 0.20 cm2/m2; P < 0.00001), a lower mean transvalvular gradient (MD: -4.11 mm Hg; P < 0.00001), and a lower risk of severe patient-prosthesis mismatch (OR: 0.37; P < 0.00001). However, SEVs were associated with a higher risk of permanent pacemaker implantation (PPI) (OR: 1.63; P = 0.0008) and moderate or severe paravalvular leak (PVL) (OR: 2.26; P < 0.00001). There was no significant difference in all-cause mortality at 1 year (OR: 0.96; P = 0.55) or stroke at 30 days (OR: 1.34; P = 0.18). Notably, in a subgroup analysis restricted to patients with extra-small annuli (area <400 mm2 or diameter <23 mm), the hemodynamic advantages of SEVs persisted while the elevated risks of PPI and PVL were no longer statistically significant. In patients with SAA, SEVs provide better hemodynamics but carry safety concerns including higher risks of PVL and PPI in the overall population. These risks were not observed in the extra-small annulus subgroup. Valve selection should be individualized based on patient anatomy and procedural risk profile.
- Research Article
- 10.1016/j.hlc.2026.01.013
- Jun 3, 2026
- Heart, lung & circulation
- Pouya Nezafati + 2 more
Early Clinical Outcome of Perceval Aortic Valve Implantation in Townsville, Australia.
- Research Article
- 10.1093/icvts/ivag142
- Jun 2, 2026
- Interdisciplinary cardiovascular and thoracic surgery
- Younus Qamar + 9 more
This study examined the indications, frequency, and outcomes of cardiac surgery following transcatheter aortic valve replacement (TAVR) at a single institution. As TAVR volumes increase, understanding the nature and outcomes of subsequent cardiac operations is critical, particularly as the procedure expands to younger, lower-risk populations. We analyzed outcomes of 61 patients who underwent cardiac surgery after TAVR at our institution from August 2011 to September 2023, excluding periprocedural complications and staged procedures. Patients were stratified into two groups: those requiring surgical aortic valve replacement (SAVR) with or without concomitant procedures (n = 33) and those undergoing non-SAVR cardiac operations (n = 28). Data were collected from a prospectively maintained cardiovascular surgery database and electronic health records. Indications for surgery, operative characteristics, and outcomes were analyzed, with survival assessed using Kaplan-Meier estimates. The median interval between TAVR and cardiac surgery was 19 months. Indications for SAVR included infective endocarditis (36%), nonstructural valve deterioration (36%), structural valve deterioration (12%), and valve thrombosis (6%). Non-SAVR operations primarily addressed mitral valve disease (43%) and coronary artery disease (29%). Operative mortality was 6.6%, with no deaths in the endocarditis subgroup. Postoperative complications included prolonged mechanical ventilation (18%), new-onset renal failure (7%), and stroke (2%). Kaplan-Meier survival estimates were 83% at 1 year and 50% at 5 years. Although complex, cardiac operations in patients who have undergone TAVR can be performed with acceptable mortality rates. Structural valve deterioration, paravalvular leak, and endocarditis were the primary indications for SAVR, while mitral valve and coronary artery disease predominated in non-SAVR cases. These findings highlight the importance of considering nonaortic valve pathologies in TAVR planning, particularly as the procedure expands to younger, lower-risk populations.
- Research Article
- 10.1186/s44215-026-00263-4
- Jun 1, 2026
- General thoracic and cardiovascular surgery cases
- Hayate Nomura + 6 more
The Konno procedure is an effective option for performing aortic valve replacement in pediatric patients utilizing an aortoventriculoplasty patch with a right ventricular outflow patch. However, re-do procedures are technically demanding and carry a non-negligible risk of surgical complications when the prosthetic materials are infected. We report a case of a patient who successfully underwent a re-do Konno procedure and an aortic root replacement for prosthetic valve endocarditis involving an aortoventriculoplasty patch. A 21-year-old male patient had undergone multiple aortic valvular surgeries since childhood. The patient's subsequent clinical course was complicated by prosthetic valve endocarditis caused by Propionibacterium acnes that occurred at the age of 19years, which was treated with antibiotics. Due to the occurrence of a subdural hematoma associated with recurrent endocarditis and exacerbated residual paravalvular leak, the patient was referred to our hospital to receive the appropriate multidisciplinary care throughout the perioperative period. After managing the intracranial hemorrhage, aortic root replacement along with reconstruction of the Konno patch and right ventricular outflow tract was performed using a fresh autologous pericardium. Postoperative echocardiography revealed hemodynamic stability without residual paravalvular leakage. Computed tomography revealed the absence of pseudoaneurysms. The patient was discharged uneventfully after six weeks of antibiotic treatment. The re-do Konno procedure and aortic root replacement can be effective surgical options to resolve sustained infection with indwelling prosthetic materials.
- Research Article
- 10.1055/a-2679-5606
- Jun 1, 2026
- The Thoracic and cardiovascular surgeon
- Daniel Maldonado Gaekel + 8 more
In patients at elevated risk for redo mitral valve surgery, transcatheter mitral valve replacement (TMVR) can be taken into consideration as a less invasive alternative. However, long-term outcome data on mitral valve-in-ring (ViR) and valve-in-valve (ViV) procedures are scarce. We herein report the 3-year outcomes following these interventions. Between 2014 and 2023, 51 consecutive patients received ViR/ViV TMVR at our center. Baseline, periprocedural, and 3-year outcome parameters were analyzed according to M-VARC criteria. Among 51 patients (70.9 ± 13.6 years, Society of Thoracic Surgeons (STS) score 3.3 ± 2.3%, left ventricular ejection fraction (LVEF) 50 ± 12%), 19 underwent ViR and 32 underwent ViV TMVR. Follow-up ranged from 1 to 71 months. The 30-day mortality rate was 5.9% (3/51 patients). Over time, access shifted from transapical to transseptal (p for trend <0.01). Rehospitalization, neurological events, and myocardial infarction occurred in 2.0% (1/51 patients), 2.0% (1/51 patients), and 0.0% of the cases, respectively. No structural valve failure was observed. Functional failure was 3.9% of cases due to significant residual mitral valve regurgitation (MR). Most paravalvular leak occluder implantations were performed in ViR patients (6/9, 66.7%; four rigid rings and two semirigid rings). Three-year survival was 87.5% for ViR and 83.4% for ViV, with no difference between groups. Mitral ViR and ViV procedures demonstrate acceptable safety and clinical efficacy up to 3 years. Rigid annuloplasty rings are associated with an increased risk of significant residual regurgitation. Over the last decade, a clear transition from the transapical to the transseptal access has been observed, further reducing procedural trauma in this high-risk subset of patients.
- Research Article
- 10.1016/j.cjca.2025.12.006
- Jun 1, 2026
- The Canadian journal of cardiology
- Pasquale Paolisso + 12 more
Evolving Indications for Transcatheter Aortic Valve Implantation: Key Issues From Procedural Challenges to Lifetime Management.
- Research Article
- 10.1002/clc.70347
- Jun 1, 2026
- Clinical cardiology
- Haitao Xu + 4 more
Aortic valve replacement (AVR) with the INSPIRIS RESILIA aortic valve (Edwards Lifesciences, Irvine, CA) has established durability and promising outcomes. However, real-world safety and functional performance data remain limited. This study reported early outcomes in the Chinese population. This prospective, multicenter, single-arm, post-market, real-world study enrolled patients scheduled for elective AVR using the study valve. Safety outcomes included all-cause death, study valve-related death, structural valve deterioration (SVD), non SVD, reoperation on the study valve, major bleeding, and thromboembolic events. Effectiveness outcomes included valve hemodynamic performance and New York Heart Association (NYHA) class. A total of 250 patients underwent study valve implantation, with 238 completing 1-year follow-up (mean follow-up duration: 448.2 ± 162.50 days). The mean age was 58.5 ± 9.17 years, with 11.4% undergoing concomitant aortic root/annular enlargement. The 1-year freedom from all-cause death and freedom from reoperation on the study valve were 98.0% and 99.2%, respectively. All deaths were assessed as unrelated to the study device. Incidence of complications included thromboembolic events (2.4%), major bleeding (4.4%), endocarditis (0.4%), and new permanent pacemaker implantation (0.4%) at 1 year. Two patients (0.8%) required reoperation on the study valve. No SVD was observed. At 1-year post-operation, no severe aortic regurgitation (AR) occurred, while 1 patient (0.4%) developed moderate AR. Three patients (1.3%) had mild paravalvular leakage. Functional status improved with 100% of patients having a NYHA Class I/II at 1 year. INSPIRIS RESILIA aortic valve shows favorable 1-year safety profiles and stable hemodynamics in Chinese patients.
- Research Article
- 10.1016/j.cjca.2026.05.016
- May 29, 2026
- The Canadian journal of cardiology
- Marco Angelillis + 18 more
Computed Tomography Sizing Algorithm for Transcatheter Aortic Valve Implantation in Bicuspid valve: Results from the CASPER Registry.
- Research Article
- 10.3390/jcdd13060230
- May 28, 2026
- Journal of cardiovascular development and disease
- Ziyad Gunga + 8 more
An aorto-right ventricular fistula (ARVF) secondary to membranous septum rupture is an exceptionally rare complication after surgical aortic valve replacement (SAVR). While sutureless prostheses such as the Perceval valve have gained wide acceptance due to reduced cross-clamp times and procedural simplification, the reported adverse events predominantly include conduction disturbances and paravalvular leaks. Structural septal disruption remains sparsely described. We report a case of an early ARVF after Perceval implantation and review the pathophysiological and procedural mechanisms implicated in septal injury following sutureless and transcatheter aortic valve interventions. A 66-year-old woman with severe bicuspid aortic valve stenosis underwent SAVR via a median sternotomy using a Perceval XL prosthesis after meticulous annular decalcification and sizing. Immediate intraoperative transesophageal echocardiography (TEE) confirmed optimal seating without any paravalvular regurgitation. Within 24 h, the patient developed a complete atrioventricular block followed by cardiogenic shock. A repeat TEE revealed a large ARVF with significant left-to-right shunt. Emergent re-exploration identified a membranous septum tear. The Perceval prosthesis was explanted, the defect was closed with a reinforced patch repair, and a 27 mm Inspiris Resilia bioprosthesis was implanted. Peripheral veno-arterial ECMO support was required temporarily. The patient recovered and remained free of prosthetic dysfunction at the two-year follow-up. Membranous septum rupture after AVR has an estimated incidence of 0.4-1.5% in TAVR cohorts but is virtually unreported with Perceval valves. The mechanisms are thought to be chronic radial stress from oversized or malpositioned prostheses. Case reports with TAVR devices emphasize oversizing as a risk factor. Predictive factors for septal injury in sutureless AVR mirror those for conduction disturbances: valve oversizing, shallow infra-annular septal length, heavy calcification, and prior valve surgery. Preventive measures, such as strict sizing protocols, the avoidance of balloon dilation, and optimized implantation depth, have reduced conduction complications and may mitigate septal trauma. The treatment choice, whether percutaneous or surgical closure, depends on hemodynamic stability, defect size and anatomy, and operative risk. Early ARVF after Perceval implantation is exceedingly rare but potentially catastrophic. Strict adherence to sizing principles, awareness of septal anatomy, and prompt management, percutaneous in selected stable cases or surgical in acute large defects, are essential to optimize outcomes in sutureless AVR.
- Research Article
- 10.1186/s13019-026-04100-1
- May 24, 2026
- Journal of cardiothoracic surgery
- Tingting Tao + 4 more
Suturing and knot-tying during cardiac surgery remain challenging. Unexpectedly loosened knots are particularly stressful and can lead to poor outcomes if not properly handled. Herein, we describe four simple yet practical techniques to address unexpectedly loosened knots or paravalvular leaks caused by them during cardiac surgery. These techniques offer cardiac surgeons alternatives for managing unexpectedly loosened knots and their associated complications. By avoiding reintervention, we believe these techniques are highly beneficial in intraoperative emergencies.
- Research Article
- 10.4244/eij-d-26-00390
- May 20, 2026
- EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
- Matteo Casenghi + 38 more
Contemporary self-expanding transcatheter heart valves (THVs) differ in leaflet position and frame architecture. Comparative data between new-generation intra-annular (IA) and supra-annular (SA) platforms remain limited. We sought to compare 30-day and 1-year clinical and haemodynamic outcomes between contemporary intra-annular and supra-annular self-expanding THVs in a large multicentre real-world cohort. Consecutive patients undergoing transfemoral transcatheter aortic valve implantation with a Navitor/Navitor Vision (IA self-expanding valve [SEV]) or Evolut FX/FX+ (SA-SEV) between June 2021 and April 2025 were included. The primary endpoint was the composite of all-cause death, disabling stroke, or heart failure hospitalisation at 1 year. Propensity score matching (PSM) was performed to adjust for baseline differences. Among 2,607 patients (IA-SEV: 1,604; SA-SEV: 1,003), PSM yielded 892 well-balanced pairs. Valve Academic Research Consortium 3 device success was achieved in 91.1% of IA-SEV patients and 90.9% of SA-SEV patients (p=0.868). Permanent pacemaker implantation was more frequent with IA-SEVs (22.1% vs 16.3%; p=0.007), whereas major or life-threatening bleeding was more common with SA-SEVs (4.2% vs 2.6%; p<0.001). At 1 year, the primary endpoint occurred in 12.6% of IA-SEV patients and 11.3% of SA-SEV patients (p=0.422) with no difference between groups in the time-to-event analysis (hazard ratio [HR] 1.01, 95% confidence interval [CI]: 0.77-1.33; p=0.916). The mean transvalvular gradients and rates of moderate or severe paravalvular leak remained low and similar between the two groups at 1 year. Findings were consistent in the unmatched cohort (HR 1.02, 95% CI: 0.81-1.31; p=0.835). In this large real-world registry, contemporary IA-SEVs and SA-SEVs demonstrated overall similar clinical outcomes and sustained haemodynamic performance at 1-year follow-up, despite differences in procedure-related endpoints between the groups.