Pub Date : 2024-08-28DOI: 10.1016/j.carrev.2024.08.018
Antonio L Bartorelli, Giovanni Monizzi, Luca Grancini, Emanuele Gallinoro, Angelo Mastrangelo, Vincenzo Mallia, Franco Fabbiocchi
Background: Coronary bifurcation lesions (CBL) comprise 15 %-20 % of percutaneous coronary procedures and remain a challenge despite advances in stent and interventional techniques. The BioMime™ Branch sirolimus-eluting coronary side-branch stent (BBSES) is specifically designed for CBL treatment in conjunction with a standard drug-eluting stent (DES). We report the first single-center experience of treating complex CBL with the novel BBSES.
Methods: This is a retrospective, single-center study involving consecutive prospectively identified patients who underwent treatment of true CBL with the BBSES. The protocol included BBSES+DES implantation in the CBL and simultaneous final kissing balloon inflation.
Results: Fifty-eight CBL were treated in 58 consecutive patients (89.6 % men, mean age 69.0 ± 9.5 years) presenting primarily with stable angina (84.4 %) and true (Medina 1,1,1,) CBL. Procedural success was 100 % without major adverse cardiac events (MACE). At a median follow-up of 18 months, one sudden death was reported that was accounted as possible late stent thrombosis. One patient had spontaneous myocardial infarction due to subacute thrombosis of a DES implanted in the main vessel proximally to the BBSES before the index procedure. Another patient was hospitalized for atrial fibrillation.
Conclusions: This is the first clinical experience to date of true CBL treatment with the BBSES demonstrating high procedural success, no in-hospital MACE and sustained clinical results at a median follow-up of 18 months.
{"title":"Coronary bifurcation lesion treatment with the BioMime™ Branch sirolimus-eluting coronary side-branch stent system: A single-center experience.","authors":"Antonio L Bartorelli, Giovanni Monizzi, Luca Grancini, Emanuele Gallinoro, Angelo Mastrangelo, Vincenzo Mallia, Franco Fabbiocchi","doi":"10.1016/j.carrev.2024.08.018","DOIUrl":"https://doi.org/10.1016/j.carrev.2024.08.018","url":null,"abstract":"<p><strong>Background: </strong>Coronary bifurcation lesions (CBL) comprise 15 %-20 % of percutaneous coronary procedures and remain a challenge despite advances in stent and interventional techniques. The BioMime™ Branch sirolimus-eluting coronary side-branch stent (BBSES) is specifically designed for CBL treatment in conjunction with a standard drug-eluting stent (DES). We report the first single-center experience of treating complex CBL with the novel BBSES.</p><p><strong>Methods: </strong>This is a retrospective, single-center study involving consecutive prospectively identified patients who underwent treatment of true CBL with the BBSES. The protocol included BBSES+DES implantation in the CBL and simultaneous final kissing balloon inflation.</p><p><strong>Results: </strong>Fifty-eight CBL were treated in 58 consecutive patients (89.6 % men, mean age 69.0 ± 9.5 years) presenting primarily with stable angina (84.4 %) and true (Medina 1,1,1,) CBL. Procedural success was 100 % without major adverse cardiac events (MACE). At a median follow-up of 18 months, one sudden death was reported that was accounted as possible late stent thrombosis. One patient had spontaneous myocardial infarction due to subacute thrombosis of a DES implanted in the main vessel proximally to the BBSES before the index procedure. Another patient was hospitalized for atrial fibrillation.</p><p><strong>Conclusions: </strong>This is the first clinical experience to date of true CBL treatment with the BBSES demonstrating high procedural success, no in-hospital MACE and sustained clinical results at a median follow-up of 18 months.</p>","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2024-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142113445","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}
Pub Date : 2024-08-28DOI: 10.1016/j.carrev.2024.08.019
Andrew Sharp, Sripal Bangalore
{"title":"Editorial: Improving outcomes in High Risk PE - a glimpse of the future?","authors":"Andrew Sharp, Sripal Bangalore","doi":"10.1016/j.carrev.2024.08.019","DOIUrl":"https://doi.org/10.1016/j.carrev.2024.08.019","url":null,"abstract":"","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2024-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142298651","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}
Pub Date : 2024-08-24DOI: 10.1016/j.carrev.2024.08.017
Axel Rentzsch, Eva Metz, Ruben Mühl-Benninghaus, Alexander Maßmann, Stephanie Bettink, Bruno Scheller, Lilia Lemke, Ali Awadelkareem, Toshiki Tomori, Ayman Haidar, Matthias W Laschke, Michael D Menger, Cenk Aktas, Matthias Hannig, Norbert Pütz, Thomas Büttner, David Scheschkewitz, Michael Veith, Hashim Abdul-Khaliq
Background: Intima proliferation and in-stent restenosis is a challenging situation in interventional treatment of small vessel obstruction. Al/Al2O3 nanowires have been shown to accelerate vascular endothelial cell proliferation and migration in vitro, while suppressing vascular smooth muscle cell growth. Moreover, surface modification of Al/Al2O3 nanowires with poly[bis(2,2,2-trifluoromethoxy)phosphazene (PTFEP) coating enables further advantages such as reduced platelet adhesion. Therefore, the study's goal was to compare the biocompatibility of novel Al/Al2O3 + PTFEP coated nanowire bare-metal stents to uncoated control stents in vivo using optical coherence tomography (OCT), quantitative angiography and histomorphometric assessment.
Methods: 15 Al/Al2O3 + PTFEP coated and 19 control stents were implanted in the cervical arteries of 9 Aachen minipigs. After 90 days, in-stent stenosis, thrombogenicity, and inflammatory response were assessed. Scanning electron microscopy was used to analyse the stent surface.
Results: OCT analysis revealed that neointimal proliferation in Al/Al2O3 + PTFEP coated stents was significantly reduced compared to control stents. The neointimal area was 1.16 ± 0.77 mm2 in Al/Al2O3 + PTFEP coated stents vs. 1.98 ± 1.04 mm2 in control stents (p = 0.004), and the neointimal thickness was 0.28 ± 0.20 vs. 0.47 ± 0.10 (p = 0.003). Quantitative angiography showed a tendency to less neointimal growth in coated stents. Histomorphometry showed no significant difference between the two groups and revealed an apparent inflammatory reaction surrounding the stent struts.
Conclusions: At long-term follow-up, Al/Al2O3 + PTFEP coated stents placed in peripheral arteries demonstrated good tolerance with no treatment-associated vascular obstruction and reduced in-stent restenosis in OCT. These preliminary in vivo findings indicate that Al/Al2O3 + PTFEP coated nanowire stents may have translational potential to be used for the prevention of in-stent restenosis.
{"title":"In vivo biocompatibility of a new hydrophobic coated Al/Al<sub>2</sub>O<sub>3</sub> nanowire surface on stents.","authors":"Axel Rentzsch, Eva Metz, Ruben Mühl-Benninghaus, Alexander Maßmann, Stephanie Bettink, Bruno Scheller, Lilia Lemke, Ali Awadelkareem, Toshiki Tomori, Ayman Haidar, Matthias W Laschke, Michael D Menger, Cenk Aktas, Matthias Hannig, Norbert Pütz, Thomas Büttner, David Scheschkewitz, Michael Veith, Hashim Abdul-Khaliq","doi":"10.1016/j.carrev.2024.08.017","DOIUrl":"https://doi.org/10.1016/j.carrev.2024.08.017","url":null,"abstract":"<p><strong>Background: </strong>Intima proliferation and in-stent restenosis is a challenging situation in interventional treatment of small vessel obstruction. Al/Al<sub>2</sub>O<sub>3</sub> nanowires have been shown to accelerate vascular endothelial cell proliferation and migration in vitro, while suppressing vascular smooth muscle cell growth. Moreover, surface modification of Al/Al<sub>2</sub>O<sub>3</sub> nanowires with poly[bis(2,2,2-trifluoromethoxy)phosphazene (PTFEP) coating enables further advantages such as reduced platelet adhesion. Therefore, the study's goal was to compare the biocompatibility of novel Al/Al<sub>2</sub>O<sub>3</sub> + PTFEP coated nanowire bare-metal stents to uncoated control stents in vivo using optical coherence tomography (OCT), quantitative angiography and histomorphometric assessment.</p><p><strong>Methods: </strong>15 Al/Al<sub>2</sub>O<sub>3</sub> + PTFEP coated and 19 control stents were implanted in the cervical arteries of 9 Aachen minipigs. After 90 days, in-stent stenosis, thrombogenicity, and inflammatory response were assessed. Scanning electron microscopy was used to analyse the stent surface.</p><p><strong>Results: </strong>OCT analysis revealed that neointimal proliferation in Al/Al<sub>2</sub>O<sub>3</sub> + PTFEP coated stents was significantly reduced compared to control stents. The neointimal area was 1.16 ± 0.77 mm<sup>2</sup> in Al/Al<sub>2</sub>O<sub>3</sub> + PTFEP coated stents vs. 1.98 ± 1.04 mm<sup>2</sup> in control stents (p = 0.004), and the neointimal thickness was 0.28 ± 0.20 vs. 0.47 ± 0.10 (p = 0.003). Quantitative angiography showed a tendency to less neointimal growth in coated stents. Histomorphometry showed no significant difference between the two groups and revealed an apparent inflammatory reaction surrounding the stent struts.</p><p><strong>Conclusions: </strong>At long-term follow-up, Al/Al<sub>2</sub>O<sub>3</sub> + PTFEP coated stents placed in peripheral arteries demonstrated good tolerance with no treatment-associated vascular obstruction and reduced in-stent restenosis in OCT. These preliminary in vivo findings indicate that Al/Al<sub>2</sub>O<sub>3</sub> + PTFEP coated nanowire stents may have translational potential to be used for the prevention of in-stent restenosis.</p>","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2024-08-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142113447","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}
Pub Date : 2024-08-22DOI: 10.1016/j.carrev.2024.08.015
Ezequiel J Molina
{"title":"Improving outcomes with standardized care in high-risk patients supported with a percutaneous microaxial flow pump.","authors":"Ezequiel J Molina","doi":"10.1016/j.carrev.2024.08.015","DOIUrl":"https://doi.org/10.1016/j.carrev.2024.08.015","url":null,"abstract":"","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2024-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142056904","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}
Pub Date : 2024-08-22DOI: 10.1016/j.carrev.2024.08.016
Gauravpal S Gill, Shikha Shailly, Teja Chakrala, Anirudh Palicherla, Pramod K Ponna, Venkata Mahesh Alla, Arun Kanmanthareddy
Background: Chronic kidney disease (CKD) and end stage renal disease (ESRD) are associated with increased risk of bleeding events, including hemorrhagic stroke, and periprocedural and gastrointestinal bleeding among patients with atrial fibrillation who are on anticoagulation. Safety of percutaneous left atrial appendage occlusion (LAAO) among this patient population has been uncertain with studies showing contradictory results.
Methods: PubMed and Google Scholar databases were queried for studies comparing outcomes among patients with and without significant CKD, and with and without ESRD who underwent LAAO device implantation. Data on outcomes from the selected studies were extracted and analyzed using random effects model. Heterogeneity was assessed using I2 test.
Results: Data from eleven studies with 61,724 patients with and without kidney disease were included in the final analyses. There was an increased risk of in-hospital mortality (OR 2.76, 95 % CI [1.15-6.64]; p = 0.02) and peri-procedural bleeding (1.51 [1.33-1.71]; p < 0.01) associated with kidney disease. There was no significant difference in risk of stroke (1.19 [0.70-2.03]; p = 0.53), pericardial effusion (1.22 [0.77-1.92]; p = 0.40), vascular complications (1.18 [0.92-1.52]; p = 0.20), or device related thrombus (1.13 [0.53-2.40]; p = 0.75).
Conclusions: This study shows an increased risk of complications among patients with kidney disease, who undergo LAAO device implantation. These findings suggest the need for studies with randomized control design specifically designed to compare outcomes with LAAO versus anticoagulation in the CKD and ESRD populations.
{"title":"Adverse outcomes with left atrial appendage occlusion device implantation in chronic and end stage kidney disease: A systemic review and meta-analysis.","authors":"Gauravpal S Gill, Shikha Shailly, Teja Chakrala, Anirudh Palicherla, Pramod K Ponna, Venkata Mahesh Alla, Arun Kanmanthareddy","doi":"10.1016/j.carrev.2024.08.016","DOIUrl":"https://doi.org/10.1016/j.carrev.2024.08.016","url":null,"abstract":"<p><strong>Background: </strong>Chronic kidney disease (CKD) and end stage renal disease (ESRD) are associated with increased risk of bleeding events, including hemorrhagic stroke, and periprocedural and gastrointestinal bleeding among patients with atrial fibrillation who are on anticoagulation. Safety of percutaneous left atrial appendage occlusion (LAAO) among this patient population has been uncertain with studies showing contradictory results.</p><p><strong>Methods: </strong>PubMed and Google Scholar databases were queried for studies comparing outcomes among patients with and without significant CKD, and with and without ESRD who underwent LAAO device implantation. Data on outcomes from the selected studies were extracted and analyzed using random effects model. Heterogeneity was assessed using I<sup>2</sup> test.</p><p><strong>Results: </strong>Data from eleven studies with 61,724 patients with and without kidney disease were included in the final analyses. There was an increased risk of in-hospital mortality (OR 2.76, 95 % CI [1.15-6.64]; p = 0.02) and peri-procedural bleeding (1.51 [1.33-1.71]; p < 0.01) associated with kidney disease. There was no significant difference in risk of stroke (1.19 [0.70-2.03]; p = 0.53), pericardial effusion (1.22 [0.77-1.92]; p = 0.40), vascular complications (1.18 [0.92-1.52]; p = 0.20), or device related thrombus (1.13 [0.53-2.40]; p = 0.75).</p><p><strong>Conclusions: </strong>This study shows an increased risk of complications among patients with kidney disease, who undergo LAAO device implantation. These findings suggest the need for studies with randomized control design specifically designed to compare outcomes with LAAO versus anticoagulation in the CKD and ESRD populations.</p>","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2024-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142082143","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}
Pub Date : 2024-08-22DOI: 10.1016/j.carrev.2024.08.013
Giulio Piedimonte, Enrico Cerrato, Cristina Rolfo, Ivan J Nunez Gil, Lorenzo Azzalini, Riccardo Mangione, Francesco Maiellaro, Alberto Boi, Donovan Riganelli, Andrea Sardone, Francesco Bruno, Fernando Scudiero, Giampiero Vizzari, Gabriele Carciotto, Dario Calderone, Marco Borgi, Francesco Paolo Cancro, Ivan Sanchez, Massimo Leoncini, Emanuele Sagazio, Francesco Colombo, Gabriele Rosso, Tania Chechi, Simone Zecchino, Marco Pavani, Alfonso Franzè, Greca Zanda, Manuel Bosco, Jose Maria De La Torre Hernandez, Antonio Micari, Gennaro Galasso, Francesco Versaci, Corrado Tamburino, Giuseppe Patti, Alessio La Manna, Francesco Tomassini, Ferdinando Varbella
Background: The optimal strategy during percutaneous coronary intervention (PCI) of aneurysmatic right coronary artery (ARCA) remains uncertain and has never been tested in the acute setting.
Objectives: To compare the in-hospital and long-term outcomes of immediate and staged PCI strategies for ARCA as culprit lesions during acute coronary syndrome (ACS).
Methods: Among 102.376 PCIs performed in 18 European centers, a total of 85 patients presenting with acute coronary syndrome undergoing ARCA PCI were finally included in the analysis. PCI strategy (stenting performed during the immediate vs staged procedure) and pharmacological approach adopted were collected. The primary outcome was procedural success (technical success without in-hospital MACE).
Results: The primary outcome occurred in 48.2 % of cases, with no significant differences observed between the immediate and staged PCI groups (50.9 % vs 43.3 %, p = 0.504). Patients in the staged-PCI group had a significantly higher rate of intravenous anticoagulant use (83.3 % vs 48.1 %, p = 0.002), BARC type 3 and 5 bleedings (12.9 % vs 1.9 %, p = 0.037), and longer in-hospital stay (7.40 ± 5.11 vs 9.5 ± 5.25 days, p = 0.049). After multivariate analysis, no independent predictors for procedural success were found in either group. Target lesion failure occurred in 24.1 % of cases without differences between groups at a median follow-up of three years.
Conclusions: Among patients undergoing ARCA PCI in the setting of ACS, immediate or staged PCI were associated with similar in-hospital and long-term outcomes. However, staged PCI was associated with a higher risk of major bleeding events and longer length of stay compared to immediate PCI strategy.
背景:动脉瘤右冠状动脉(ARCA)经皮冠状动脉介入治疗(PCI动脉瘤性右冠状动脉(ARCA)经皮冠状动脉介入治疗(PCI)的最佳策略仍不确定,且从未在急性病例中进行过测试:目的:比较急性冠状动脉综合征(ACS)期间作为罪魁祸首的ARCA立即和分阶段PCI策略的院内和长期疗效:在欧洲18个中心进行的102376例PCI手术中,共有85例急性冠状动脉综合征患者接受了ARCA PCI治疗,最终纳入分析。分析收集了患者的 PCI 策略(即刻手术与分阶段手术中的支架植入)和采用的药物治疗方法。主要结果是手术成功率(技术成功且无院内MACE):结果:48.2%的病例获得了主要结果,立即PCI组和分期PCI组之间没有观察到显著差异(50.9% vs 43.3%,P = 0.504)。分期 PCI 组患者的静脉抗凝剂使用率(83.3% vs 48.1%,p = 0.002)、BARC 3 型和 5 型出血率(12.9% vs 1.9%,p = 0.037)和住院时间(7.40 ± 5.11 vs 9.5 ± 5.25 天,p = 0.049)均明显更高。经过多变量分析,两组患者均未发现手术成功的独立预测因素。靶病变失败发生率为24.1%,中位随访三年,两组间无差异:结论:在接受ARCA PCI治疗的ACS患者中,立即或分期PCI与相似的院内和长期预后相关。然而,与立即PCI策略相比,分期PCI与更高的大出血风险和更长的住院时间相关。
{"title":"Percutaneous coronary interventions for aneurysmatic right coronary artery in acute coronary syndrome: RIGHTMARE registry outcomes.","authors":"Giulio Piedimonte, Enrico Cerrato, Cristina Rolfo, Ivan J Nunez Gil, Lorenzo Azzalini, Riccardo Mangione, Francesco Maiellaro, Alberto Boi, Donovan Riganelli, Andrea Sardone, Francesco Bruno, Fernando Scudiero, Giampiero Vizzari, Gabriele Carciotto, Dario Calderone, Marco Borgi, Francesco Paolo Cancro, Ivan Sanchez, Massimo Leoncini, Emanuele Sagazio, Francesco Colombo, Gabriele Rosso, Tania Chechi, Simone Zecchino, Marco Pavani, Alfonso Franzè, Greca Zanda, Manuel Bosco, Jose Maria De La Torre Hernandez, Antonio Micari, Gennaro Galasso, Francesco Versaci, Corrado Tamburino, Giuseppe Patti, Alessio La Manna, Francesco Tomassini, Ferdinando Varbella","doi":"10.1016/j.carrev.2024.08.013","DOIUrl":"https://doi.org/10.1016/j.carrev.2024.08.013","url":null,"abstract":"<p><strong>Background: </strong>The optimal strategy during percutaneous coronary intervention (PCI) of aneurysmatic right coronary artery (ARCA) remains uncertain and has never been tested in the acute setting.</p><p><strong>Objectives: </strong>To compare the in-hospital and long-term outcomes of immediate and staged PCI strategies for ARCA as culprit lesions during acute coronary syndrome (ACS).</p><p><strong>Methods: </strong>Among 102.376 PCIs performed in 18 European centers, a total of 85 patients presenting with acute coronary syndrome undergoing ARCA PCI were finally included in the analysis. PCI strategy (stenting performed during the immediate vs staged procedure) and pharmacological approach adopted were collected. The primary outcome was procedural success (technical success without in-hospital MACE).</p><p><strong>Results: </strong>The primary outcome occurred in 48.2 % of cases, with no significant differences observed between the immediate and staged PCI groups (50.9 % vs 43.3 %, p = 0.504). Patients in the staged-PCI group had a significantly higher rate of intravenous anticoagulant use (83.3 % vs 48.1 %, p = 0.002), BARC type 3 and 5 bleedings (12.9 % vs 1.9 %, p = 0.037), and longer in-hospital stay (7.40 ± 5.11 vs 9.5 ± 5.25 days, p = 0.049). After multivariate analysis, no independent predictors for procedural success were found in either group. Target lesion failure occurred in 24.1 % of cases without differences between groups at a median follow-up of three years.</p><p><strong>Conclusions: </strong>Among patients undergoing ARCA PCI in the setting of ACS, immediate or staged PCI were associated with similar in-hospital and long-term outcomes. However, staged PCI was associated with a higher risk of major bleeding events and longer length of stay compared to immediate PCI strategy.</p>","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2024-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142056843","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}
Pub Date : 2024-08-22DOI: 10.1016/j.carrev.2024.08.007
Enrico Poletti, Ignacio Amat-Santos, Enrico Criscione, Antonio Popolo Rubbio, Mario García-Gómez, Mateusz Orzalkiewicz, Manuel Pan, Antonio Sisinni, Mattia Squillace, Bruno García Del Blanco, Francesco Bruno, Vasileios Panoulas, Radoslaw Pracon, Ole De Backer, Maurizio Taramasso, Giuliano Costa, Marco Barbanti, Nicolas M Van Mieghem, Damiano Regazzoli, Antonio Mangieri, Andrea Scotti, Azeem Latib, Francesco Saia, Francesco Bedogni, Luca Testa
Background: The off-label utilization of transcatheter heart valve (THV) devices for the treatment of inoperable or high-surgical risk patients with pure native aortic valve regurgitation (NAVR) has demonstrated suboptimal outcomes, both with self- and balloon-expandable (BE) devices. The aim of this study is to compare the use of different BE scaffolds in treating pure NAVR.
Methods: Consecutive patients with pure severe NAVR who were deemed to be at high-risk and were treated with last-generation BE-THVs among seventeen Centers in Europe and US. Technical and device success rates were the primary objectives.
Results: Between February 2018 and July 2023, among 144 patients, 41 (28 %) received a MyVal device and 103 (72 %) were treated with a Sapien THV. Patients treated with a MyVal THV had an extra-large annulus more frequently compared to the Sapien group (49%vs.20 %, p < 0.001). Technical and device success rates were 90 % and 81 %, respectively, p > 0.1. The rate of THV migration/embolization (MyVal 4.9%vs. Sapien 11 %, p = 0.4) and second valve needed (4.9%vs.7.8 %, p = 0.7) were numerically lower in the MyVal group, whereas the rate of at least moderate paravalvular leak (15%vs.7.8 %, p = 0.2) and permanent pacemaker implantation (25%vs.18 %, p = 0.16) were numerically higher in the Myval group.
Conclusions: Off-label use of BE devices for pure NAVR represents a potential alternative in high-risk patients in the absence of dedicated devices. However, BE in NAVR is associated with suboptimal outcomes. The availability of larger THV sizes may introduce transcatheter aortic valve replacement as an effective treatment for patients traditionally deemed unsuitable.
Non-standard abbreviations and acronyms: AR = aortic regurgitation, BE = balloon-expandable, NAVR = native aortic valve regurgitation, PM = pacemaker, TAVR = transcatheter aortic valve replacement, THV = transcatheter heart valve, TVEM = transcatheter valve embolization and migration, VARC-3 = Valve Academic Research Consortium 3.
{"title":"Performance of balloon-expandable transcatheter bioprostheses in inoperable patients with pure aortic regurgitation of a native valve: The BE-PANTHEON international project.","authors":"Enrico Poletti, Ignacio Amat-Santos, Enrico Criscione, Antonio Popolo Rubbio, Mario García-Gómez, Mateusz Orzalkiewicz, Manuel Pan, Antonio Sisinni, Mattia Squillace, Bruno García Del Blanco, Francesco Bruno, Vasileios Panoulas, Radoslaw Pracon, Ole De Backer, Maurizio Taramasso, Giuliano Costa, Marco Barbanti, Nicolas M Van Mieghem, Damiano Regazzoli, Antonio Mangieri, Andrea Scotti, Azeem Latib, Francesco Saia, Francesco Bedogni, Luca Testa","doi":"10.1016/j.carrev.2024.08.007","DOIUrl":"https://doi.org/10.1016/j.carrev.2024.08.007","url":null,"abstract":"<p><strong>Background: </strong>The off-label utilization of transcatheter heart valve (THV) devices for the treatment of inoperable or high-surgical risk patients with pure native aortic valve regurgitation (NAVR) has demonstrated suboptimal outcomes, both with self- and balloon-expandable (BE) devices. The aim of this study is to compare the use of different BE scaffolds in treating pure NAVR.</p><p><strong>Methods: </strong>Consecutive patients with pure severe NAVR who were deemed to be at high-risk and were treated with last-generation BE-THVs among seventeen Centers in Europe and US. Technical and device success rates were the primary objectives.</p><p><strong>Results: </strong>Between February 2018 and July 2023, among 144 patients, 41 (28 %) received a MyVal device and 103 (72 %) were treated with a Sapien THV. Patients treated with a MyVal THV had an extra-large annulus more frequently compared to the Sapien group (49%vs.20 %, p < 0.001). Technical and device success rates were 90 % and 81 %, respectively, p > 0.1. The rate of THV migration/embolization (MyVal 4.9%vs. Sapien 11 %, p = 0.4) and second valve needed (4.9%vs.7.8 %, p = 0.7) were numerically lower in the MyVal group, whereas the rate of at least moderate paravalvular leak (15%vs.7.8 %, p = 0.2) and permanent pacemaker implantation (25%vs.18 %, p = 0.16) were numerically higher in the Myval group.</p><p><strong>Conclusions: </strong>Off-label use of BE devices for pure NAVR represents a potential alternative in high-risk patients in the absence of dedicated devices. However, BE in NAVR is associated with suboptimal outcomes. The availability of larger THV sizes may introduce transcatheter aortic valve replacement as an effective treatment for patients traditionally deemed unsuitable.</p><p><strong>Non-standard abbreviations and acronyms: </strong>AR = aortic regurgitation, BE = balloon-expandable, NAVR = native aortic valve regurgitation, PM = pacemaker, TAVR = transcatheter aortic valve replacement, THV = transcatheter heart valve, TVEM = transcatheter valve embolization and migration, VARC-3 = Valve Academic Research Consortium 3.</p>","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2024-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142093978","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}
Pub Date : 2024-08-22DOI: 10.1016/j.carrev.2024.08.006
Shreyash M Manegaonkar, Rishi Sukhija, Mohamed A Effat, Marepalli Rao, Rupak K Banerjee
Background: Evaluating the severity of aortic stenosis (AS) can be challenging, particularly in patients with low-gradient (LG, Δp < 40 mmHg) AS.
Objective: This study aims to improve the accuracy of assessing severity of AS using a novel functional index- Aortic Valve Coefficient (AVC). The AVC is defined as ratio of mean transvalvular pressure-drop (Δp) to the proximal dynamic pressure (1/2 × blood density × VLVOT2; VLVOT: left ventricular outflow tract peak velocity).
Hypothesis: AVC, developed from fundamental fluid dynamic principles, is a better index for accessing AS severity as it incorporates square of VLVOT and downstream pressure recovery.
Methods: This pilot prospective study enrolled 47 patients undergoing TAVR for AS. Using cardiac-catheterization-measured Δp and echocardiography-Doppler-derived VLVOT, AVC was evaluated. Pre- and post-TAVR pressure-velocity measurements were obtained, resulting in a dataset with 78 data points, including 32 data points specifically linked to LG AS. Linear regression analysis was performed to correlate AVC with Δp, VLVOT and aortic-valve-area. Welch 2-sample t-test was carried out to compare the means of AVC against aortic-valve-area.
Results: Moderate correlation (r = 0.85) was observed between AVC and aortic-valve-area indicating AVC could be a prospective index. However, correlation decreased (r = 0.75) in LG AS patients, indicating increased discordancy. Comparing AVC and aortic-valve-area in LG AS patients with left ventricular ejection fraction (LVEF) < 50 % and LVEF ≥50 %, t-test showed that AVC values are significantly different (p < 0.05) as compared to aortic-valve-area (p = 0.48).
Conclusion: AVC, a novel index, has the potential to improve assessment of AS severity and clinical decision making for treating patients with AS.
Condensed abstract: Complex hemodynamics, such as paradoxical "low-flow low-gradient (LG)" Aortic stenosis (AS) can be difficult to diagnose. Currently, mean transvalvular pressure-drop and flow-derived aortic-valve-area assess AS severity. Aortic valve coefficient (AVC) is a novel index which combines both pressure-drop and flow measurements to assess the severity of AS. A total of 47 patients (72 data points) were studied undergoing TAVR. In LG AS patients, t-test comparing left ventricular ejection fraction (LVEF) < 50 % and LVEF ≥50 % showed that AVC are significantly different (p < 0.05) as compared to aortic-valve-area (p = 0.48). Therefore, AVC could be a better index.
背景:评估主动脉瓣狭窄(AS)的严重程度具有挑战性,尤其是在低梯度(LG,Δp)患者中:本研究旨在使用一种新型功能性指标--主动脉瓣系数(AVC)来提高评估主动脉瓣狭窄严重程度的准确性。AVC 的定义是平均跨瓣压降(Δp)与近端动态压力(1/2 × 血液密度 × VLVOT2;VLVOT:左室流出道峰值速度)之比:假设:根据流体动力学基本原理开发的AVC是评估强直性脊柱炎严重程度的更好指标,因为它包含了VLVOT的平方和下游压力恢复:这项试验性前瞻性研究招募了 47 名因 AS 而接受 TAVR 的患者。方法:这项试验性前瞻性研究共纳入了 47 名因 AS 而接受 TAVR 的患者,使用心脏导管测量的 Δp 和超声心动图-多普勒衍生的 VLVOT 对 AVC 进行了评估。TAVR前和TAVR后的压力-速度测量结果产生了一个包含78个数据点的数据集,其中包括32个与LG AS特别相关的数据点。进行了线性回归分析,将 AVC 与 Δp、VLVOT 和主动脉瓣面积相关联。对 AVC 与主动脉瓣面积的平均值进行了韦尔奇 2 样本 t 检验:结果:AVC 与主动脉瓣面积之间存在适度的相关性(r = 0.85),表明 AVC 可以作为一种前瞻性指标。然而,LG AS 患者的相关性降低(r = 0.75),表明不一致性增加。比较左心室射血分数(LVEF)的 LG AS 患者的 AVC 和主动脉瓣面积 结论:AVC作为一项新指标,有可能改善对AS严重程度的评估和治疗AS患者的临床决策。主动脉瓣狭窄(AS)很难诊断。目前,平均跨瓣压降和血流衍生的主动脉瓣面积可评估主动脉瓣狭窄的严重程度。主动脉瓣系数(AVC)是一种新型指数,它结合了压降和血流测量来评估主动脉瓣狭窄的严重程度。共对 47 名接受 TAVR 的患者(72 个数据点)进行了研究。在LG AS患者中,比较左心室射血分数(LVEF)的t检验结果为:LVEF(左心室射血分数)高于AVC(左心室射血分数)。
{"title":"A novel functional index, aortic-valve-coefficient, for assessing aortic-stenosis in patients undergoing TAVR: A prospective-pilot study.","authors":"Shreyash M Manegaonkar, Rishi Sukhija, Mohamed A Effat, Marepalli Rao, Rupak K Banerjee","doi":"10.1016/j.carrev.2024.08.006","DOIUrl":"https://doi.org/10.1016/j.carrev.2024.08.006","url":null,"abstract":"<p><strong>Background: </strong>Evaluating the severity of aortic stenosis (AS) can be challenging, particularly in patients with low-gradient (LG, Δp < 40 mmHg) AS.</p><p><strong>Objective: </strong>This study aims to improve the accuracy of assessing severity of AS using a novel functional index- Aortic Valve Coefficient (AVC). The AVC is defined as ratio of mean transvalvular pressure-drop (Δp) to the proximal dynamic pressure (1/2 × blood density × V<sub>LVOT</sub><sup>2</sup>; V<sub>LVOT</sub>: left ventricular outflow tract peak velocity).</p><p><strong>Hypothesis: </strong>AVC, developed from fundamental fluid dynamic principles, is a better index for accessing AS severity as it incorporates square of V<sub>LVOT</sub> and downstream pressure recovery.</p><p><strong>Methods: </strong>This pilot prospective study enrolled 47 patients undergoing TAVR for AS. Using cardiac-catheterization-measured Δp and echocardiography-Doppler-derived V<sub>LVOT</sub>, AVC was evaluated. Pre- and post-TAVR pressure-velocity measurements were obtained, resulting in a dataset with 78 data points, including 32 data points specifically linked to LG AS. Linear regression analysis was performed to correlate AVC with Δp, V<sub>LVOT</sub> and aortic-valve-area. Welch 2-sample t-test was carried out to compare the means of AVC against aortic-valve-area.</p><p><strong>Results: </strong>Moderate correlation (r = 0.85) was observed between AVC and aortic-valve-area indicating AVC could be a prospective index. However, correlation decreased (r = 0.75) in LG AS patients, indicating increased discordancy. Comparing AVC and aortic-valve-area in LG AS patients with left ventricular ejection fraction (LVEF) < 50 % and LVEF ≥50 %, t-test showed that AVC values are significantly different (p < 0.05) as compared to aortic-valve-area (p = 0.48).</p><p><strong>Conclusion: </strong>AVC, a novel index, has the potential to improve assessment of AS severity and clinical decision making for treating patients with AS.</p><p><strong>Condensed abstract: </strong>Complex hemodynamics, such as paradoxical \"low-flow low-gradient (LG)\" Aortic stenosis (AS) can be difficult to diagnose. Currently, mean transvalvular pressure-drop and flow-derived aortic-valve-area assess AS severity. Aortic valve coefficient (AVC) is a novel index which combines both pressure-drop and flow measurements to assess the severity of AS. A total of 47 patients (72 data points) were studied undergoing TAVR. In LG AS patients, t-test comparing left ventricular ejection fraction (LVEF) < 50 % and LVEF ≥50 % showed that AVC are significantly different (p < 0.05) as compared to aortic-valve-area (p = 0.48). Therefore, AVC could be a better index.</p>","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2024-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142113444","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}
Pub Date : 2024-08-22DOI: 10.1016/j.carrev.2024.08.012
Placido Maria Mazzone, Davide Capodanno
{"title":"C-reactive protein and TAVR: Impact of inflammation on patient outcomes.","authors":"Placido Maria Mazzone, Davide Capodanno","doi":"10.1016/j.carrev.2024.08.012","DOIUrl":"https://doi.org/10.1016/j.carrev.2024.08.012","url":null,"abstract":"","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2024-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142082144","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}
Pub Date : 2024-08-22DOI: 10.1016/j.carrev.2024.08.014
David Gittess, R David Anderson
{"title":"Editorial response to \"Outcomes in transcatheter aortic valve replacement (TAVR) patients requiring red blood cell transfusion: A nationwide perspective\".","authors":"David Gittess, R David Anderson","doi":"10.1016/j.carrev.2024.08.014","DOIUrl":"https://doi.org/10.1016/j.carrev.2024.08.014","url":null,"abstract":"","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2024-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142082145","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}