Bioresorbable scaffolds (BRS) were developed as an innovative solution to overcome the limitations of metallic stents. While polymeric BRS initially demonstrated comparable clinical outcomes to drug-eluting stent (DES) in clinical trials, subsequent large-scale studies revealed that patients implanted with polymeric BRS experienced higher rates of scaffold thrombosis (ScT) and target lesion failure compared to those with metallic stents. Resorbable magnesium scaffolds (RMS) have emerged as a promising alternative owing to magnesium's natural degradability and favorable mechanical properties. Learning from the mechanism of polymeric BRS failure and through continuous improvements, recent clinical trials have shown promising clinical performance for RMS technology. However, comparative studies between RMS and DES have continued to highlight the remaining challenges with RMS, particularly in regard to late lumen loss. Recent advancements in third-generation RMS show improvements in strut thickness and homogeneous degradation, which enhances sustained structural integrity throughout the degradation process. Based on encouraging results from a first-in-human trial of the latest version of RMS, a randomized controlled trial has been initiated to compare the outcomes between metallic stents and the latest RMS, with patient enrollment already underway. This review aims to explore the limitations of polymeric BRS and provide an overview of the current developments and future potential of magnesium-based BRS.
{"title":"Current situation and overview of resorbable magnesium scaffolds: a perspective for overcoming the remaining issues of polymeric bioresorbable scaffold.","authors":"Masaru Seguchi, Kenichi Sakakura, Yousuke Taniguchi, Hideo Fujita","doi":"10.1007/s12928-024-01070-w","DOIUrl":"https://doi.org/10.1007/s12928-024-01070-w","url":null,"abstract":"<p><p>Bioresorbable scaffolds (BRS) were developed as an innovative solution to overcome the limitations of metallic stents. While polymeric BRS initially demonstrated comparable clinical outcomes to drug-eluting stent (DES) in clinical trials, subsequent large-scale studies revealed that patients implanted with polymeric BRS experienced higher rates of scaffold thrombosis (ScT) and target lesion failure compared to those with metallic stents. Resorbable magnesium scaffolds (RMS) have emerged as a promising alternative owing to magnesium's natural degradability and favorable mechanical properties. Learning from the mechanism of polymeric BRS failure and through continuous improvements, recent clinical trials have shown promising clinical performance for RMS technology. However, comparative studies between RMS and DES have continued to highlight the remaining challenges with RMS, particularly in regard to late lumen loss. Recent advancements in third-generation RMS show improvements in strut thickness and homogeneous degradation, which enhances sustained structural integrity throughout the degradation process. Based on encouraging results from a first-in-human trial of the latest version of RMS, a randomized controlled trial has been initiated to compare the outcomes between metallic stents and the latest RMS, with patient enrollment already underway. This review aims to explore the limitations of polymeric BRS and provide an overview of the current developments and future potential of magnesium-based BRS.</p>","PeriodicalId":9439,"journal":{"name":"Cardiovascular Intervention and Therapeutics","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2024-12-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142871488","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 : 2024-12-19DOI: 10.1007/s12928-024-01073-7
Tineke H Pinxterhuis, Eline H Ploumen, Marlies M Kok, Carl E Schotborgh, Rutger L Anthonio, Ariel Roguin, Peter W Danse, Edouard Benit, Adel Aminian, Marc Hartmann, Gerard C M Linssen, Robert H Geelkerken, Carine J M Doggen, Clemens von Birgelen
Patients undergoing percutaneous coronary intervention (PCI) may experience bleeding events. Bleeding risk is increased in patients with comorbid peripheral arterial disease (PADs). To evaluate whether PCI patients with PADs have worse outcome after bleeding, we assessed pooled patient-level data of 5,989 randomized all-comer trial participants and identified those who had a bleeding (BIO-RESORT:NCT01674803, BIONYX:NCT02508714). Major adverse cardiac events (MACE) and mortality were assessed from bleeding until 3 years after PCI. Of all 313 PCI patients with bleeding events, patients with PADs (n = 34, 10.9%) were older and had more complex lesions than those without PADs (n = 279, 89.1%). In patients with PADs, bleeding occurred more often during the first year after PCI (79.4% vs. 57.3%, p = 0.013). The proportion of major bleeding, and the severity and location of bleeding were similar between both groups. Multivariate analysis found no statistically significant between-group difference in MACE (43.1% vs. 34.7%, p = 0.53; adj.HR:0.86, 95%CI 0.45-1.63, p = 0.64) and mortality (33.5% vs. 22.3%, p = 0.12; adj.HR:1.45, 95%CI 0.73-2.91, p = 0.29). Bleeding occurred significantly more often during the first year after PCI in all-comer patients with concomitant PADs than in those without PADs, while we observed no significant between-group difference in bleeding severity and location, and the risk of adverse events after bleeding.
接受经皮冠状动脉介入治疗(PCI)的患者可能会出现出血事件。合并外周动脉疾病(pad)的患者出血风险增加。为了评估PCI合并pad患者出血后的预后是否更差,我们评估了5,989名随机试验参与者的患者水平数据,并确定了出血患者(BIO-RESORT:NCT01674803, BIONYX:NCT02508714)。主要不良心脏事件(MACE)和死亡率从出血到PCI术后3年进行评估。在所有313例发生出血事件的PCI患者中,有pad的患者(n = 34, 10.9%)比没有pad的患者(n = 279, 89.1%)年龄更大,病变更复杂。在pad患者中,PCI术后第一年出血发生率更高(79.4% vs. 57.3%, p = 0.013)。两组患者大出血比例、严重程度及出血部位相似。多因素分析发现,组间MACE差异无统计学意义(43.1%比34.7%,p = 0.53;adj.HR: 0.86, 95% ci 0.45 - -1.63, p = 0.64)和死亡率(33.5%比22.3%,p = 0.12;[j] hr:1.45, 95%CI 0.73 ~ 2.91, p = 0.29)。合并pad的所有患者在PCI术后第一年出血的发生率明显高于未合并pad的患者,但我们观察到出血严重程度和部位以及出血后不良事件的风险在组间无显著差异。
{"title":"Clinical outcome after bleeding events following coronary stenting in patients with and without comorbid peripheral arterial disease.","authors":"Tineke H Pinxterhuis, Eline H Ploumen, Marlies M Kok, Carl E Schotborgh, Rutger L Anthonio, Ariel Roguin, Peter W Danse, Edouard Benit, Adel Aminian, Marc Hartmann, Gerard C M Linssen, Robert H Geelkerken, Carine J M Doggen, Clemens von Birgelen","doi":"10.1007/s12928-024-01073-7","DOIUrl":"https://doi.org/10.1007/s12928-024-01073-7","url":null,"abstract":"<p><p>Patients undergoing percutaneous coronary intervention (PCI) may experience bleeding events. Bleeding risk is increased in patients with comorbid peripheral arterial disease (PADs). To evaluate whether PCI patients with PADs have worse outcome after bleeding, we assessed pooled patient-level data of 5,989 randomized all-comer trial participants and identified those who had a bleeding (BIO-RESORT:NCT01674803, BIONYX:NCT02508714). Major adverse cardiac events (MACE) and mortality were assessed from bleeding until 3 years after PCI. Of all 313 PCI patients with bleeding events, patients with PADs (n = 34, 10.9%) were older and had more complex lesions than those without PADs (n = 279, 89.1%). In patients with PADs, bleeding occurred more often during the first year after PCI (79.4% vs. 57.3%, p = 0.013). The proportion of major bleeding, and the severity and location of bleeding were similar between both groups. Multivariate analysis found no statistically significant between-group difference in MACE (43.1% vs. 34.7%, p = 0.53; adj.HR:0.86, 95%CI 0.45-1.63, p = 0.64) and mortality (33.5% vs. 22.3%, p = 0.12; adj.HR:1.45, 95%CI 0.73-2.91, p = 0.29). Bleeding occurred significantly more often during the first year after PCI in all-comer patients with concomitant PADs than in those without PADs, while we observed no significant between-group difference in bleeding severity and location, and the risk of adverse events after bleeding.</p>","PeriodicalId":9439,"journal":{"name":"Cardiovascular Intervention and Therapeutics","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2024-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142853001","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":"Detection and nanagement of stent under-expansion in self-expanding TAVR using a steep right anterior oblique view.","authors":"Umihiko Kaneko, Daisuke Hachinohe, Ryo Horita, Ryo Otake, Kazuki Mizutani, Ken Kobayashi","doi":"10.1007/s12928-024-01078-2","DOIUrl":"https://doi.org/10.1007/s12928-024-01078-2","url":null,"abstract":"","PeriodicalId":9439,"journal":{"name":"Cardiovascular Intervention and Therapeutics","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2024-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142853034","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 : 2024-12-19DOI: 10.1007/s12928-024-01074-6
Anna Pfenniger, Thorald Stolte, Jakob Johannes Reichl, Gregor Leibundgut, Max Wagener, Christoph Kaiser, Jasper Boeddinghaus, Felix Mahfoud, Thomas Nestelberger
Transcatheter aortic valve implantation (TAVI) is recommended for treatment of high-risk aortic stenosis patients. While measuring mean transaortic valve gradient (MG) is crucial in evaluating procedural success, echocardiographic measurements often overestimate direct invasive measurements. This study aimed to examine the discordance between echocardiographic and invasive MGs in TAVI patients and assess their prognostic value on long-term outcomes. This prospective registry included consecutive TAVI patients at a tertiary university hospital. Transthoracic or transoesophageal echocardiography was performed pre-TAVI, at discharge, 1 month, 1, and 5 years with invasive MG measurements obtained peri-procedurally. The primary endpoints were 5-year all-cause mortality and major adverse cardiac events. Among 1353 patients from 2011 to 2023, non-invasive MGs exceeded invasive MGs pre- and post-implantation (43 [36, 52] mmHg vs. 40 [30, 50] mmHg, p < 0.001; 9 [6, 12] mmHg vs. 4 [2, 7] mmHg, p < 0.001) Pre-procedural MGs correlated better than post-procedural MGs (r = 0.70, p < 0.001 vs. r = 0.23, p < 0.001), particularly in self-expandable valves and smaller sinus of Valsalva diameter (SOVd) (r = 0.33, p < 0.001; r = 0.46, p < 0.001 vs R = 0.06, p = 0.701). Non-invasive MG remained stable from discharge (9 [6, 12] mmHg) to 5 years (9 [7, 12] mmHg). While structural valve deterioration and patient-prosthesis mismatch showed no impact, extreme invasive MGs (< 3 or > 6 mmHg) predicted worse outcomes (mortality hazard: 1.25 [1.06, 1.88] and 0.85 [0.8, 0.95], respectively), unlike non-invasive measurements. In conclusion, invasive as compared with non-invasive MGs correlated better before than after valve implantation, whereas invasive MGs were always lower than non-invasive MGs. Lower invasive MGs after TAVI appeared to be associated with favourable long-term outcomes.
经导管主动脉瓣植入术(TAVI)被推荐用于治疗高危主动脉瓣狭窄患者。虽然测量平均经主动脉瓣梯度(MG)是评估手术成功的关键,超声心动图测量往往高估直接侵入性测量。本研究旨在探讨TAVI患者超声心动图与有创心电图的不一致性,并评估其对长期预后的预测价值。这项前瞻性登记包括一家三级大学医院的连续TAVI患者。经胸或经食管超声心动图分别在tavi前、出院时、1个月、1年和5年进行,并在术中进行有创MG测量。主要终点是5年全因死亡率和主要心脏不良事件。在2011年至2023年的1353例患者中,与非侵入性测量不同,非侵入性mg值高于植入前和植入后的有创mg值(43 [36,52]mmHg vs. 40 [30,50] mmHg, p 6 mmHg)预测的结果更差(死亡率风险分别为1.25[1.06,1.88]和0.85[0.8,0.95])。综上所述,瓣膜置入术前有创性与无创性心电图相关性好于瓣膜置入术后,但有创性心电图始终低于无创性。TAVI后较低的侵袭性mg似乎与良好的长期预后有关。
{"title":"Comparison of invasive and non-invasive gradients before and after TAVI and their implications on clinical outcomes.","authors":"Anna Pfenniger, Thorald Stolte, Jakob Johannes Reichl, Gregor Leibundgut, Max Wagener, Christoph Kaiser, Jasper Boeddinghaus, Felix Mahfoud, Thomas Nestelberger","doi":"10.1007/s12928-024-01074-6","DOIUrl":"https://doi.org/10.1007/s12928-024-01074-6","url":null,"abstract":"<p><p>Transcatheter aortic valve implantation (TAVI) is recommended for treatment of high-risk aortic stenosis patients. While measuring mean transaortic valve gradient (MG) is crucial in evaluating procedural success, echocardiographic measurements often overestimate direct invasive measurements. This study aimed to examine the discordance between echocardiographic and invasive MGs in TAVI patients and assess their prognostic value on long-term outcomes. This prospective registry included consecutive TAVI patients at a tertiary university hospital. Transthoracic or transoesophageal echocardiography was performed pre-TAVI, at discharge, 1 month, 1, and 5 years with invasive MG measurements obtained peri-procedurally. The primary endpoints were 5-year all-cause mortality and major adverse cardiac events. Among 1353 patients from 2011 to 2023, non-invasive MGs exceeded invasive MGs pre- and post-implantation (43 [36, 52] mmHg vs. 40 [30, 50] mmHg, p < 0.001; 9 [6, 12] mmHg vs. 4 [2, 7] mmHg, p < 0.001) Pre-procedural MGs correlated better than post-procedural MGs (r = 0.70, p < 0.001 vs. r = 0.23, p < 0.001), particularly in self-expandable valves and smaller sinus of Valsalva diameter (SOVd) (r = 0.33, p < 0.001; r = 0.46, p < 0.001 vs R = 0.06, p = 0.701). Non-invasive MG remained stable from discharge (9 [6, 12] mmHg) to 5 years (9 [7, 12] mmHg). While structural valve deterioration and patient-prosthesis mismatch showed no impact, extreme invasive MGs (< 3 or > 6 mmHg) predicted worse outcomes (mortality hazard: 1.25 [1.06, 1.88] and 0.85 [0.8, 0.95], respectively), unlike non-invasive measurements. In conclusion, invasive as compared with non-invasive MGs correlated better before than after valve implantation, whereas invasive MGs were always lower than non-invasive MGs. Lower invasive MGs after TAVI appeared to be associated with favourable long-term outcomes.</p>","PeriodicalId":9439,"journal":{"name":"Cardiovascular Intervention and Therapeutics","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2024-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142853005","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":"Successful transcatheter edge-to-edge repair with PASCAL devices in a patient with large prolapse and deep cleft.","authors":"Hiroshi Ohara, Mike Saji, Takayuki Yabe, Shintaro Dobashi, Shojiro Hirano, Takanori Ikeda","doi":"10.1007/s12928-024-01077-3","DOIUrl":"10.1007/s12928-024-01077-3","url":null,"abstract":"","PeriodicalId":9439,"journal":{"name":"Cardiovascular Intervention and Therapeutics","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2024-12-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142827369","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}
Primary percutaneous coronary intervention (PCI) is the cornerstone of treatment for ST-segment elevation myocardial infarction (STEMI). Previous studies suggest that direct transport by ambulance to a primary PCI facility is associated with better clinical outcomes in patients with STEMI. However, those studies included seriously ill patients for whom direct transport is the only option. We included 462 patients with STEMI who were supposed to select either direct transport by ambulance or indirect transport via primary care doctor, and compared the clinical outcomes between the direct transfer group (n = 172) and the indirect transfer group (n = 290). The primary endpoint was major adverse cardiovascular events (MACE), which was defined as the composite of all-cause death, non-fatal myocardial infarction, re-admission for heart failure, and target vessel revascularization. The median follow-up duration was 540 days (86-1266 days). Age was significantly higher in the indirect transfer group [72.0 (64-80) years] than in the direct transfer group [69.5 (58.3-77) years] (p = 0.013). Onset to balloon time was significantly shorter in the direct transport group (p < 0.001). The Kaplan-Meier curves revealed that MACE were similarly observed between the two groups (31.4% vs. 27.2%; p = 0.330). After adjusting for potential confounders, indirect transfer was not associated with MACE (adjusted hazard ratio: 0.740, 95% confidence interval: 0.485-1.128, p = 0.161). In conclusion, indirect transfer was not associated with poor clinical outcomes in patients with STEMI who were supposed to select either direct transport or indirect transport.
{"title":"Comparison of clinical outcomes between direct and indirect transfer in patients with ST-segment elevation myocardial infarction.","authors":"Yoshiaki Hai, Kenichi Sakakura, Hiroyuki Jinnouchi, Yousuke Taniguchi, Kei Yamamoto, Takunori Tsukui, Masashi Hatori, Taku Kasahara, Yusuke Watanabe, Shun Ishibashi, Masaru Seguchi, Hideo Fujita","doi":"10.1007/s12928-024-01075-5","DOIUrl":"https://doi.org/10.1007/s12928-024-01075-5","url":null,"abstract":"<p><p>Primary percutaneous coronary intervention (PCI) is the cornerstone of treatment for ST-segment elevation myocardial infarction (STEMI). Previous studies suggest that direct transport by ambulance to a primary PCI facility is associated with better clinical outcomes in patients with STEMI. However, those studies included seriously ill patients for whom direct transport is the only option. We included 462 patients with STEMI who were supposed to select either direct transport by ambulance or indirect transport via primary care doctor, and compared the clinical outcomes between the direct transfer group (n = 172) and the indirect transfer group (n = 290). The primary endpoint was major adverse cardiovascular events (MACE), which was defined as the composite of all-cause death, non-fatal myocardial infarction, re-admission for heart failure, and target vessel revascularization. The median follow-up duration was 540 days (86-1266 days). Age was significantly higher in the indirect transfer group [72.0 (64-80) years] than in the direct transfer group [69.5 (58.3-77) years] (p = 0.013). Onset to balloon time was significantly shorter in the direct transport group (p < 0.001). The Kaplan-Meier curves revealed that MACE were similarly observed between the two groups (31.4% vs. 27.2%; p = 0.330). After adjusting for potential confounders, indirect transfer was not associated with MACE (adjusted hazard ratio: 0.740, 95% confidence interval: 0.485-1.128, p = 0.161). In conclusion, indirect transfer was not associated with poor clinical outcomes in patients with STEMI who were supposed to select either direct transport or indirect transport.</p>","PeriodicalId":9439,"journal":{"name":"Cardiovascular Intervention and Therapeutics","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2024-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142805793","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":"Effect of cutting frequency in the jet stream atherectomy system on lumen area acquisition.","authors":"Naoya Kurata, Osamu Iida, Motoki Yasunaga, Taku Toyoshima, Takafumi Masai, Yoshiharu Higuchi","doi":"10.1007/s12928-024-01069-3","DOIUrl":"https://doi.org/10.1007/s12928-024-01069-3","url":null,"abstract":"","PeriodicalId":9439,"journal":{"name":"Cardiovascular Intervention and Therapeutics","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2024-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142784150","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}