Michał Piotrowski , Julia Izabela Karpierz , Radosław Litwinowicz , Bogusław Kapelak , Krzysztof Bartuś
{"title":"Seven years of follow-up of first-in-human percutaneous epicardial-only left atrial appendage closure using Sierra device","authors":"Michał Piotrowski , Julia Izabela Karpierz , Radosław Litwinowicz , Bogusław Kapelak , Krzysztof Bartuś","doi":"10.1016/j.carrev.2025.08.001","DOIUrl":"10.1016/j.carrev.2025.08.001","url":null,"abstract":"<div><h3>Background</h3><div>It is estimated that at least one third of the population will suffer from atrial fibrillation in their lifetime. In order to prevent strokes and thromboembolism, anticoagulation treatment should be administered. In addition, exclusion of the left atrial appendage should be considered in certain cases to prevent fatal ischemic complications. In patients at high risk of intervention, the devices available to close the left atrial appendage are not suitable. In addition, their use is limited by the anatomy of the left atrial appendage, which may not be suitable for any of the available exclusion devices. The aim of this study is to present the long-term results of the Sierra Aegis Left Atrial Appendage Ligation System – a new, exclusively epicardial system for closure of the left atrial appendage - for the first time in a human study.</div></div><div><h3>Methods</h3><div>This was a prospective, first-in-human study investigating the efficacy and safety of the Sierra Aegis Left Atrial Appendage Ligation System for epicardial closure of the left atrial appendage. 7 patients (mean age: 57.3 ± 10.6 years, 71.4 % male) who underwent left atrial appendage exclusion with the Sierra system were followed for up to 7 years.</div></div><div><h3>Results</h3><div>No strokes, leaks, or other complications were observed in the study group during the 7-year follow-up period.</div></div><div><h3>Conclusions</h3><div>This 7-year follow-up of the first-in-human study of the Sierra Aegis Ligation System for left atrial appendage closure shows very good long-term results in terms of the efficacy and safety of this device when used in humans.</div></div>","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":"86 ","pages":"Pages 12-16"},"PeriodicalIF":1.9,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144800618","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
William Nicholson , Khaled I. Alnahhal , John Han , Jacob Borenstein , Keivan Ranjbar , Stephanie D. Talutis , Shivani Kumar , Payam Salehi
{"title":"Efficacy and safety of protamine sulfate following carotid artery stenting","authors":"William Nicholson , Khaled I. Alnahhal , John Han , Jacob Borenstein , Keivan Ranjbar , Stephanie D. Talutis , Shivani Kumar , Payam Salehi","doi":"10.1016/j.carrev.2025.08.011","DOIUrl":"10.1016/j.carrev.2025.08.011","url":null,"abstract":"<div><h3>Background</h3><div>protamine sulfate is used to reduce bleeding risk after Carotid Artery Stenting (CAS), but its efficacy in personalized patient settings remains underexplored. This study aims to identify factors associated with greater benefits from protamine sulfate following CAS.</div></div><div><h3>Methods</h3><div>A retrospective review of Vascular Quality Initiative (VQI) data (2016–2022) identified patients undergoing CAS, divided into Transfemoral CAS (TF-CAS) and Transcarotid artery revascularization (TCAR) groups. Multivariate analysis used to identify perioperative predictors of bleeding complications, and propensity score matching compared rates of death and thrombotic events (myocardial infarction (MI), stroke/transient ischemic attack (TIA)) between protamine and no protamine groups.</div></div><div><h3>Results</h3><div>Among 51,473 patients (36.9 % females), 56.4 % underwent TCAR (Protamine: 85.6 %; No protamine: 14.4 %), and 43.6 % underwent TF-CAS (Protamine: 18.9 %; No protamine: 81.1 %). Protamine significantly reduced bleeding complications in female patients and those on ACE inhibitors in both groups. In the TF-CAS group, protamine was associated with lower all-cause mortality (7.9 % vs. 11.5 %; <em>P</em> < .001) without an increase in MI (0.5 % vs. 0.9 %) or stroke/TIA (2.8 % vs. 2.9 %; <em>P</em> > .05). In the TCAR group, protamine had similar rates of all-cause mortality (7.7 % vs. 7.3 %), MI (0.4 % vs. 0.3 %), and stroke/TIA (2.4 % vs. 2.9 %; P > .05).</div></div><div><h3>Conclusions</h3><div>Protamine sulfate appears to be effective in reducing the bleeding complications in TCAR patients without increasing death or thrombotic complications. Its benefits are especially notable in females and those on ACE inhibitors, regardless of the CAS approach. Although protamine use in the TF-CAS cohort was associated with reduced all-cause mortality, it did not show an overall benefit in bleeding reduction. However, in TF-CAS, females and patients on ACE inhibitors did appear to benefit, supporting a more selective approach to its use.</div></div>","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":"86 ","pages":"Pages 88-93"},"PeriodicalIF":1.9,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145030838","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Atman P. Shah , James V. Freeman , Mohamad Alkhouli , Himanshu Agarwal , Megan Coylewright , Akash Makkar , Jordan Anderson , Ryan Gage , Xavier Freixa , Jens Erik Nielsen-Kudsk , Dhanunjaya Lakkireddy
{"title":"Outcomes for single antiplatelet, dual antiplatelet, or oral anticoagulation after Amulet: Insights from EMERGE LAA post-approval study","authors":"Atman P. Shah , James V. Freeman , Mohamad Alkhouli , Himanshu Agarwal , Megan Coylewright , Akash Makkar , Jordan Anderson , Ryan Gage , Xavier Freixa , Jens Erik Nielsen-Kudsk , Dhanunjaya Lakkireddy","doi":"10.1016/j.carrev.2025.07.012","DOIUrl":"10.1016/j.carrev.2025.07.012","url":null,"abstract":"<div><h3>Background</h3><div>Outcomes associated with different antithrombotic strategies after Amulet left atrial appendage occlusion (LAAO) are not well described.</div></div><div><h3>Objective</h3><div>This analysis compared outcomes from patients discharged on dual antiplatelet therapy (DAPT) versus single antiplatelet therapy (SAPT) or oral anticoagulation (OAC) following Amulet implant in the EMERGE LAA post-approval study.</div></div><div><h3>Methods</h3><div>Patients with a successful Amulet implant and discharged from the hospital between August 14, 2021 and December 15, 2023 and entered into the National Cardiovascular Data Registry (NCDR) LAAO Registry were included. A safety endpoint of all-cause death, stroke, major bleeding, or systemic embolism and effectiveness endpoint of ischemic stroke, systemic embolism, or cardiovascular death were assessed through 6 months as well as major adverse events.</div></div><div><h3>Results</h3><div>A total of 11,445 patients were included in this analysis with 9355 discharged on DAPT (81.7 %), 606 on SAPT (5.3 %), and 1484 on OAC (13.0 %). Patients in the SAPT group had more comorbid conditions and were at the greatest bleeding risk pre-Amulet implant. At 45-days, clinically relevant closure (≤3 mm peri-device leak) was achieved in >95 % of all patients. At 6 months, the safety endpoint rates were 8.8 %, 7.0 %, and 7.0 % in the DAPT, SAPT, and OAC groups, respectively (<em>p</em> = 0.045) and effectiveness endpoint rates were 2.1 %, 1.6 %, and 1.7 % in the DAPT, SAPT, and OAC groups, respectively (<em>p</em> = 0.511). Despite higher baseline bleeding risk, the SAPT group had numerically lower bleeding rates than the DAPT group through 6 months (DAPT 4.8 % vs. SAPT 3.9 %; HR 1.23 [0.78, 1.95]) with no difference in device-related thrombus rates (DAPT 0.8 % vs. 0.8 % SAPT; HR 0.91 [0.33, 2.50]). However, after adjusting for differences in baseline characteristics, no significant differences (<em>p</em> > 0.05) were noted for any clinical events between the three medication groups at 45 days or 6 months.</div></div><div><h3>Conclusion</h3><div>In the present cohort of patients treated with Amulet LAAO there were high rates of LAA complete closure, and SAPT emerged as a viable alternative to the current DAPT regimen potentially reducing the risk of bleeding complications in patients at high risk without compromising effectiveness.</div></div>","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":"86 ","pages":"Pages 1-9"},"PeriodicalIF":1.9,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144765637","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pedro E.P. Carvalho , Deniz Mutlu , Dimitrios Strepkos , Michaella Alexandrou , Eleni Kladou , Sandeep Jalli , Ozgur Selim Ser , Bavana V. Rangan , Emmanouil S. Brilakis , Yader Sandoval
{"title":"Physiology assessment in bifurcation percutaneous coronary intervention: Insights from PROGRESS-BIFURCATION registry","authors":"Pedro E.P. Carvalho , Deniz Mutlu , Dimitrios Strepkos , Michaella Alexandrou , Eleni Kladou , Sandeep Jalli , Ozgur Selim Ser , Bavana V. Rangan , Emmanouil S. Brilakis , Yader Sandoval","doi":"10.1016/j.carrev.2025.08.005","DOIUrl":"10.1016/j.carrev.2025.08.005","url":null,"abstract":"<div><div>Fractional flow reserve (FFR) and non-hyperemic pressure ratios (NHPR) are established physiologic indices that can help inform the need for percutaneous coronary intervention (PCI), however, their use in patients undergoing bifurcation PCI is uncertain. The PROGRESS-BIFURCATION study is an ongoing multi-center, international registry conducted across six centers. Among 2494 bifurcation lesions treated (2271 patients), only 158 (6.3 %) had pressure-wire based physiology assessment. Pre-PCI, 127 (5.1 %) lesions had assessments of the main vessel (MV), 32 (1.3 %) of the side branches (SB), and 18 (0.7 %) had assessments of both MV and SB. Post-PCI, 23 (0.9 %) had assessments of the MV, and 9 (0.4 %) of the SB. NHPR were used in 55 % and FFR in 45 % of cases. Technical and procedural success rates, as well as complication rates, were comparable between bifurcation PCIs performed with and without physiology assessments. However, the use of physiology assessment was associated with a lower incidence of in-hospital major adverse cardiac events (MACE) (0.0 % vs. 3.8 %; <em>p</em> = 0.02). Despite randomized controlled trials showing benefits of coronary physiology to inform the need for PCI and improve clinical outcomes, real-world adoption of physiology-based assessment in bifurcation PCI remains low.</div></div>","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":"86 ","pages":"Pages 29-31"},"PeriodicalIF":1.9,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144974245","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Comment on Steinke et al.: Long-term outcomes of coronary angiography in patients with and without diabetes","authors":"Parth Aphale , Himanshu Shekhar , Shashank Dokania","doi":"10.1016/j.carrev.2025.09.010","DOIUrl":"10.1016/j.carrev.2025.09.010","url":null,"abstract":"","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":"86 ","pages":"Page 99"},"PeriodicalIF":1.9,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145179148","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Marco Zuin , Giuseppe Marchese , Francesca Prevedello , Ervis Hiso , Andrea Bertolini , Marco Foroni , Gianluca Rigatelli
{"title":"Impact of double versus single stenting on myocardial work in complex left main bifurcation percutaneous coronary intervention","authors":"Marco Zuin , Giuseppe Marchese , Francesca Prevedello , Ervis Hiso , Andrea Bertolini , Marco Foroni , Gianluca Rigatelli","doi":"10.1016/j.carrev.2025.12.015","DOIUrl":"10.1016/j.carrev.2025.12.015","url":null,"abstract":"<div><h3>Background</h3><div>Provisional single stenting is the recommended default strategy for complex left main (LM) bifurcation lesions. However, double stenting may improve side branch patency in such cases, though its effect on myocardial performance remains uncertain<strong>.</strong> We compare 30-day changes in non-invasive myocardial work (MW) indices following double versus provisional single stenting in patients with complex LM bifurcations.</div></div><div><h3>Method</h3><div>In this prospective, single-center analysis, 282 patients with complex LM bifurcation lesions undergoing PCI between October 2023 and June 2025 were included. Patients were treated with either double stenting (culotte, nano-inverted-T, or TAP; <em>n</em> = 141) or provisional single stenting (n = 141) and matched 1:1 by propensity score. Echocardiography was performed at baseline and 30 days post-PCI. MW indices, including global work index (GWI), global constructive work (GCW), global wasted work (GWW), and global work efficiency (GWE), were derived from non-invasive pressure-strain analysis.</div></div><div><h3>Results</h3><div>Baseline characteristics and echocardiographic indices were comparable between groups. Both strategies improved GWI and GCW and reduced GWW (all <em>p</em> < 0.0001). However, double stenting was associated with greater improvements in all MW indices [ΔGWI 218.3 ± 93.3 vs. 117.2 ± 83.4 mmHg% and ΔGCW177.7 ± 75.4 vs. 99.7 ± 83.6 mmHg% (both <em>p</em> < 0.001); ΔGWW –44.9 ± 31.0 vs. –23.8 ± 32.1 mmHg% (p < 0.001), and ΔGWE +3.1 ± 1.9 vs. +1.4 ± 1.9 % (p < 0.001)].</div></div><div><h3>Conclusions</h3><div>In complex LM bifurcation lesions, double stenting leads to superior 30-day recovery of MW compared with provisional single stenting, suggesting enhanced left ventricular efficiency.</div></div>","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":"86 ","pages":"Pages 44-50"},"PeriodicalIF":1.9,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145846884","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Mick P.L. Renkens , Tsung-Ying Tsai , Pruthvi C. Revaiah , Shigetaka Kageyama , Johan H.C. Reiber , Robbert J. de Winter , Maik Grundeken , Nick S. Nurmohamed , Erik Stroes , Scot Garg , Clemens von Birgelen , Sjoerd Hofma , Mohammad Alkhalil , Liesbeth Rosseel , Faisal Sharif , Pieter C. Smits , Andreas Baumbach , Yoshinobu Onuma , Joanna J. Wykrzykowska , Patrick W. Serruys
{"title":"Impact of elevated lipoprotein(a) on epicardial coronary flow conductance and endoluminal atherosclerotic disease distribution","authors":"Mick P.L. Renkens , Tsung-Ying Tsai , Pruthvi C. Revaiah , Shigetaka Kageyama , Johan H.C. Reiber , Robbert J. de Winter , Maik Grundeken , Nick S. Nurmohamed , Erik Stroes , Scot Garg , Clemens von Birgelen , Sjoerd Hofma , Mohammad Alkhalil , Liesbeth Rosseel , Faisal Sharif , Pieter C. Smits , Andreas Baumbach , Yoshinobu Onuma , Joanna J. Wykrzykowska , Patrick W. Serruys","doi":"10.1016/j.carrev.2025.07.003","DOIUrl":"10.1016/j.carrev.2025.07.003","url":null,"abstract":"<div><h3>Background</h3><div>Elevated lipoprotein(a) [Lp(a)] is associated with accelerated progression of coronary plaques, a higher prevalence of thin-cap fibroatheroma, and an increased risk of spontaneous myocardial infarction. However, Lp(a)'s impact on coronary artery disease (CAD) and the resulting coronary flow dynamics have yet to be fully determined.</div></div><div><h3>Objective</h3><div>To evaluate the effects of elevated Lp(a) levels on epicardial coronary flow and endoluminal disease pattern (focal or diffuse).</div></div><div><h3>Methods</h3><div>In a propensity-score matched (PSM) cohort from the ongoing PIONEER IV trial (<span><span>NCT04923191</span><svg><path></path></svg></span>), participants with de novo CAD and elevated Lp(a) (>50 mg/dL or 120 nmol/L) were matched to controls based on traditional CAD risk factors. Epicardial flow velocity was assessed using the Quantitative Flow Ratio (QFR), with the virtual QFR-Pressure Pullback Gradient Index (QFR-PPGi) characterizing the endoluminal disease phenotype. A QFR ≤ 0.80 indicated significant epicardial flow limitation.</div></div><div><h3>Results</h3><div>Among 672 consecutively enrolled participants with available Lp(a) measurements, elevated levels were observed in 23 % (152/672). Complete risk profiles for traditional CAD risk factors were available for 391 participants with de novo CAD, of whom 75 had elevated Lp(a) levels. After propensity matching, 75 pairs (150 participants) were eligible for analyses. QFR analyses were completed in 392/450 (87 %) vessels. The median difference in baseline QFR between matched vessels was −0.045 (<em>p</em> = 0.005), while the mean difference in QFR-PPGi was −0.028 (<em>p</em> = 0.013). Vessels from participants with elevated Lp(a) demonstrated significantly higher rates of QFR ≤ 0.80 compared to matched controls (31 % vs. 19 %, absolute risk difference 12 %; 95 % CI: 2.7 %–21 %, <em>p</em> = 0.011).</div></div><div><h3>Conclusions</h3><div>Elevated plasma levels of Lp(a) were associated with increased epicardial flow limitation and a more diffuse endoluminal disease pattern.</div></div><div><h3>Condensed abstract</h3><div>In this PIONEER IV sub-study (<span><span>NCT04923191</span><svg><path></path></svg></span>), we investigated the effect of elevated lipoprotein(a) [Lp(a)] on epicardial coronary flow and endoluminal disease distribution. We analyzed 392 vessels from 75 propensity-matched pairs using Quantitative Flow Ratio (QFR) to assess flow limitation and the virtual QFR-Pressure Pullback Gradient Index (QFR-PPGi) to characterize disease distribution patterns (focal versus diffuse). Vessels exposed to elevated Lp(a) exhibited significantly higher rates of epicardial flow limitation (QFR ≤ 0.80) than controls (31 % vs. 19 %, absolute risk difference 12 %; 95 % CI: 2.7 %–21 %, <em>p</em> = 0.011). The median difference in baseline QFR between matched vessels was −0.045 (<em>p</em> = 0.005), while the mean difference in QFR-PPGi wa","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":"86 ","pages":"Pages 67-77"},"PeriodicalIF":1.9,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144660794","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}