Santiago Garcia MD , Ibrahim Sultan MD , William Rollefson MD , Brandon M. Jones MD , Rishi Puri MD, PhD , Amar Krishnaswamy MD , Gilbert H.L. Tang MD, MSc, MBA , Sahil Khera MD, MPH , Hemal Gada MD , Mathew Williams MD , Atman P. Shah MD , Deepak Talreja MD , Pradeep Yadav MD , Vinod Thourani MD
{"title":"Early U.S. Real-World Experience With a Novel Intra-Annular Self-Expanding Valve for Transcatheter Aortic Valve Replacement","authors":"Santiago Garcia MD , Ibrahim Sultan MD , William Rollefson MD , Brandon M. Jones MD , Rishi Puri MD, PhD , Amar Krishnaswamy MD , Gilbert H.L. Tang MD, MSc, MBA , Sahil Khera MD, MPH , Hemal Gada MD , Mathew Williams MD , Atman P. Shah MD , Deepak Talreja MD , Pradeep Yadav MD , Vinod Thourani MD","doi":"10.1016/j.jcin.2025.10.053","DOIUrl":"10.1016/j.jcin.2025.10.053","url":null,"abstract":"<div><h3>Background</h3><div>A novel intra-annular, self-expanding transcatheter heart valve was introduced in the U.S. market in 2023 for treating native aortic stenosis in high- or extreme-risk patients.</div></div><div><h3>Objectives</h3><div>The authors sought to report early real-world experience with the Navitor valve (Abbott Structural Heart) from the STS/ACC TVT Registry (Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry).</div></div><div><h3>Methods</h3><div>Baseline, procedural, and follow-up data were prospectively collected and retrospectively analyzed. The primary outcome was a composite of all-cause mortality or stroke at 30 days. Additional safety and effectiveness outcomes were reported per registry definitions.</div></div><div><h3>Results</h3><div>A total of 2,958 aortic stenosis patients were treated between January 2023 and December 2024. Mean age was 81.4 ± 7.6 years; 62.4% were female. Mean STS score was 6.6% ± 5.4%. Technical success rate was 97.9%, with in-hospital mortality rate at 1.3%. Thirty-day all-cause mortality or stroke rate was 5.2% (2.8% mortality, 2.7% stroke). Major vascular complications and new permanent pacemaker implantation (PPI) occurred in 1.8% and 17.8%, respectively. At 30 days, mean transvalvular gradient was 7.3 ± 3.8 mm Hg; aortic valve area was 1.98 ± 0.64 cm<sup>2</sup>; moderate or greater PVL occurred in 1.8%. Analysis of case volume showed reduced PPI rate with site experience beyond 20 cases for Navitor Classic (19.4% vs 13.5%; <em>P =</em> 0.0039) and Vision (19.1% vs 10.6%; <em>P =</em> 0.047). Kansas City Cardiomyopathy Questionnaire Overall Summary score improved by 23.8 points from 52.1 ± 24.8 at baseline to 75.9 ± 22.6 at 30 days (<em>P <</em> 0.0001).</div></div><div><h3>Conclusions</h3><div>Early U.S. experience with the Navitor valve demonstrates favorable early clinical and hemodynamic outcomes, with improved PPI rate associated with procedural experience.</div></div>","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":"19 7","pages":"Pages 801-809"},"PeriodicalIF":11.4,"publicationDate":"2026-04-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145948691","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Hanna Ratcovich MD, PhD , Lene Holmvang MD, DMSc , Golnaz Sadjadieh MD, PhD , Reza Jabbari MD, PhD , Charlotte Glinge MD, PhD , Muhammad Sabbah MD, PhD , Karsten Tange Veien MD , Matti Niemela MD , Phillip Freeman MD, PhD , Rickard Linder MD, PhD , Rikke Sørensen MD, PhD , Dan Ioanes MD , Christian Juhl Terkelsen MD, PhD, DMSc , Julia Ellert-Gregersen MD, PhD , Evald Christiansen MD, PhD , Ashkan Eftekhari MD, PhD , Jarkko Piuhola MD, PhD , Olli Kajander MD, PhD , Sasha Koul MD, PhD , Mikko Savontaus MD , Jacob Lønborg MD, PhD, DMSc
{"title":"Percutaneous Coronary Intervention in Frail Patients Undergoing Transcatheter Aortic Valve Replacement","authors":"Hanna Ratcovich MD, PhD , Lene Holmvang MD, DMSc , Golnaz Sadjadieh MD, PhD , Reza Jabbari MD, PhD , Charlotte Glinge MD, PhD , Muhammad Sabbah MD, PhD , Karsten Tange Veien MD , Matti Niemela MD , Phillip Freeman MD, PhD , Rickard Linder MD, PhD , Rikke Sørensen MD, PhD , Dan Ioanes MD , Christian Juhl Terkelsen MD, PhD, DMSc , Julia Ellert-Gregersen MD, PhD , Evald Christiansen MD, PhD , Ashkan Eftekhari MD, PhD , Jarkko Piuhola MD, PhD , Olli Kajander MD, PhD , Sasha Koul MD, PhD , Mikko Savontaus MD , Jacob Lønborg MD, PhD, DMSc","doi":"10.1016/j.jcin.2025.12.028","DOIUrl":"10.1016/j.jcin.2025.12.028","url":null,"abstract":"<div><h3>Background</h3><div>Frailty is an important predictor of outcomes in patients with coronary artery disease (CAD) and following transcatheter aortic valve replacement (TAVR). The NOTION-3 (Third Nordic Aortic Valve Intervention) trial demonstrated that performing percutaneous coronary intervention (PCI) in addition to TAVR reduced the risk for major adverse cardiac events (MACE). Whether this benefit applies to frail patients remains uncertain.</div></div><div><h3>Objectives</h3><div>The aim of this study was to evaluate efficacy and safety of PCI in frail TAVR patients with CAD.</div></div><div><h3>Methods</h3><div>NOTION-3 was an international, open-label, randomized superiority trial enrolling patients with CAD and severe aortic stenosis undergoing TAVR. Patients were randomized 1:1 to PCI or conservative treatment. Frailty was assessed post hoc using a calculated frailty score derived from baseline data on symptom-related limitations, daily function, and quality of life. Primary endpoint was a composite of all-cause mortality, myocardial infarction (MI), and urgent coronary revascularization. Safety endpoints included bleeding and acute kidney injury.</div></div><div><h3>Results</h3><div>Frailty data were available for 407 patients (90%), of whom 130 (32%) were frail. During median follow-up of 2 years (Q1-Q3: 1-4 years), PCI reduced MACE in nonfrail patients (15% vs 33%; HR: 0.42; 95% CI: 0.25-0.69; <em>P</em> < 0.001), as well as death of any cause (<em>P</em> = 0.019), MI (<em>P</em> = 0.004), and urgent revascularization (<em>P</em> = 0.005). No differences were observed in frail patients. In contrast, frail patients undergoing PCI had more bleeding events (HR: 2.51; 95% CI: 1.23-5.11; <em>P</em> = 0.011).</div></div><div><h3>Conclusions</h3><div>In nonfrail patients with CAD undergoing TAVR, PCI lowered the risk for MACE, all-cause mortality, and MI compared to conservative treatment. In frail patients, PCI increased bleeding without clinical benefit. These findings require confirmation in larger prospective studies.</div></div>","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":"19 7","pages":"Pages 828-839"},"PeriodicalIF":11.4,"publicationDate":"2026-04-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147664888","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Lukas Stolz MD , Karl-Patrik Kresoja MD , Jennifer von Stein MD , Vera Fortmeier MD , Christoph Pauschinger MD , Wolfgang Rottbauer MD , Mohammad Kassar MD , Bjoern Goebel MD , Paolo Denti MD , Paul Achouh MD , Tienush Rassaf MD , Manuel Barreiro-Perez MD , Peter Boekstegers MD , Andreas Rück MD , Monika Zdanyte MD , Marianna Adamo MD , Flavien Vincent MD, PhD , Philipp Schlegel MD , Sebastian Rosch MD , Mirjam G. Wild MD , Anke von Peter MD
{"title":"Applying the 2025 ESC/EACTS Recommendations for the Treatment of Severe Tricuspid Regurgitation to Real-World Practice","authors":"Lukas Stolz MD , Karl-Patrik Kresoja MD , Jennifer von Stein MD , Vera Fortmeier MD , Christoph Pauschinger MD , Wolfgang Rottbauer MD , Mohammad Kassar MD , Bjoern Goebel MD , Paolo Denti MD , Paul Achouh MD , Tienush Rassaf MD , Manuel Barreiro-Perez MD , Peter Boekstegers MD , Andreas Rück MD , Monika Zdanyte MD , Marianna Adamo MD , Flavien Vincent MD, PhD , Philipp Schlegel MD , Sebastian Rosch MD , Mirjam G. Wild MD , Anke von Peter MD","doi":"10.1016/j.jcin.2026.02.024","DOIUrl":"10.1016/j.jcin.2026.02.024","url":null,"abstract":"<div><h3>Background</h3><div>According to the 2025 ESC/EACTS guidelines for the management of valvular heart disease, transcatheter tricuspid valve interventions (TTVI) have received a Class IIa recommendation (Level of Evidence: A) for the treatment of patients with severe symptomatic tricuspid regurgitation. However, in patients with severe left ventricular dysfunction (LVD) or right ventricular dysfunction (RVD) or precapillary pulmonary hypertension (pcPH), optimal medical therapy (OMT) is preferred because of the potential risk for futility.</div></div><div><h3>Objectives</h3><div>The aim of this study was to evaluate clinical and symptomatic outcomes in such “OMT candidate” patients.</div></div><div><h3>Methods</h3><div>Using data from EuroTR (European Registry of Transcatheter Repair for Tricuspid Regurgitation), guideline-based thresholds for LVD, RVD, and pcPH were applied to patients undergoing tricuspid valve transcatheter edge-to-edge repair (T-TEER). Patients meeting ≥1 exclusion criterion (“OMT candidates”) were compared with those meeting current recommendations (“TTVI appropriate”) regarding NYHA functional class improvement and 2-year survival free from heart failure hospitalization (HFH).</div></div><div><h3>Results</h3><div>Among 1,626 T-TEER patients, 213 (13.1%) met ≥1 exclusion criterion (4.2% of those with LVD, 6.8% of those with RVD, and 3.6% of those with pcPH). Severe LVD, RVD, and pcPH were each associated with significantly lower 1-year HFH-free survival (LVD, 54.6% vs 72.9% [<em>P</em> < 0.001]; RVD, 59.0% vs 73.2% [<em>P</em> = 0.003]; pcPH, 56.2% vs 73.4% [<em>P</em> = 0.021]; median survival follow-up 446 days [Q1-Q3: 192-805 days]). Despite higher NYHA functional class at baseline and follow-up, the rate of ≥1-class improvement was comparable across subgroups (LVD, 51.1% vs 59.4% [<em>P</em> = 0.25]; RVD, 59.7% vs 59.0% [<em>P</em> = 0.90]; pcPH, 51.3% vs 59.4% [<em>P</em> = 0.31]). Overall, “OMT candidates” had lower HFH-free survival than “TTVI-appropriate” patients (58.7% vs 74.3%; <em>P</em> < 0.001) but showed comparable symptomatic relief (≥1 NYHA functional class in 56.2% vs 59.5%; <em>P</em> = 0.68).</div></div><div><h3>Conclusions</h3><div>T-TEER may provide symptomatic benefit in selected high-risk patients with severe LVD, RVD, or pcPH. In the absence of randomized evidence, multidisciplinary evaluation at experienced heart valve centers remains essential to balance potential benefit against procedural futility. Further studies are warranted to refine patient selection and optimize outcomes in this challenging cohort.</div></div>","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":"19 7","pages":"Pages 843-853"},"PeriodicalIF":11.4,"publicationDate":"2026-04-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147638850","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}