Dominik Liebetrau, Jörg Teßarek, Florian Elger, Viktoria Peters, Christian Scheurig-Münkler, Alexander Hyhlik-Dürr
{"title":"新型 BYCROSSTM 动脉粥样硬化切除术设备的技术方面--28 例患者的初步治疗结果。","authors":"Dominik Liebetrau, Jörg Teßarek, Florian Elger, Viktoria Peters, Christian Scheurig-Münkler, Alexander Hyhlik-Dürr","doi":"10.1024/0301-1526/a001151","DOIUrl":null,"url":null,"abstract":"<p><p><b></b> Purpose: Technical aspects are crucial for the planning and performing of the atherectomy to treat peripheral arterial disease. This report illustrates the use of a novel atherectomy device and investigates the feasibility, efficacy, and safety procedures involved in performing the atherectomy on 28 patients.</p><p><strong>Materials and methods: </strong>We performed a prospective analysis of patients who underwent an atherectomy with the BYCROSS<sup>TM</sup> Atherectomy device between August 2022 and September 2023 at a tertiary referral centre. Patients with a lesion below the aortic bifurcation (vessel diameter ≥ 3mm) having a de novo or restenotic (stent-included) present were recruited. Major adverse events (MAE) are defined as amputation, death, myocardial infarction, or angiographic distal embolization that require a separate intervention.</p><p><strong>Results: </strong>Of the 28 patients treated with the BYCROSS device, 23 were men with a mean age of 65.6 ± 9,6 years and a mean BMI of 24,6 ± 3.9 kg/m<sup>2</sup>. Most patients had a typical atherogenic risk profile as well as multiple preexisting comorbidities. In all patients, a symptomatic peripheral arterial disease (PAD) was the main reason for an intervention. The most common Rutherford category was 5 (12/28). The most common lesion region was the femoropopliteal segment (25/28) with 23 de novo stenosis. Mean lesion length was 218,0 ± 93,7 mm. The mean PACCS Score was 3,0 ± 1,0. Stenosis grade was by mean 99,3 ± 3,7%. Ankle Brachial Index (ABI) increased significantly after BYCROSS atherectomy (pre- 0,44 ± 0,43 vs. post-procedure 0,84 ± 0,30 P<0,001. Target lesion/vessel revascularization (TLR/TVR) within the first 30 days was 3,6% (1/28). 30-day MAE rate was 14,3% (vessel perforation in 3/28 patients, embolism in 1/28). There were no deaths, index limb amputations, or myocardial infarctions.</p><p><strong>Conclusion: </strong>The BYCROSS<sup>TM</sup> atherectomy system is a new device with numerous advantages in treating high-grade, calcifying stenosis and occlusion processes in PAD. Based on the above findings, the BYCROSS<sup>TM</sup> Atherectomy device represents a feasible, safe, and effective method for endovascular treatment of peripheral arterial disease.</p>","PeriodicalId":23528,"journal":{"name":"Vasa-european Journal of Vascular Medicine","volume":" ","pages":"388-396"},"PeriodicalIF":2.1000,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Technical aspects of the new BYCROSS<sup>TM</sup> atherectomy device - preliminary results after 28 patients.\",\"authors\":\"Dominik Liebetrau, Jörg Teßarek, Florian Elger, Viktoria Peters, Christian Scheurig-Münkler, Alexander Hyhlik-Dürr\",\"doi\":\"10.1024/0301-1526/a001151\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p><b></b> Purpose: Technical aspects are crucial for the planning and performing of the atherectomy to treat peripheral arterial disease. This report illustrates the use of a novel atherectomy device and investigates the feasibility, efficacy, and safety procedures involved in performing the atherectomy on 28 patients.</p><p><strong>Materials and methods: </strong>We performed a prospective analysis of patients who underwent an atherectomy with the BYCROSS<sup>TM</sup> Atherectomy device between August 2022 and September 2023 at a tertiary referral centre. Patients with a lesion below the aortic bifurcation (vessel diameter ≥ 3mm) having a de novo or restenotic (stent-included) present were recruited. Major adverse events (MAE) are defined as amputation, death, myocardial infarction, or angiographic distal embolization that require a separate intervention.</p><p><strong>Results: </strong>Of the 28 patients treated with the BYCROSS device, 23 were men with a mean age of 65.6 ± 9,6 years and a mean BMI of 24,6 ± 3.9 kg/m<sup>2</sup>. Most patients had a typical atherogenic risk profile as well as multiple preexisting comorbidities. In all patients, a symptomatic peripheral arterial disease (PAD) was the main reason for an intervention. The most common Rutherford category was 5 (12/28). The most common lesion region was the femoropopliteal segment (25/28) with 23 de novo stenosis. Mean lesion length was 218,0 ± 93,7 mm. The mean PACCS Score was 3,0 ± 1,0. Stenosis grade was by mean 99,3 ± 3,7%. Ankle Brachial Index (ABI) increased significantly after BYCROSS atherectomy (pre- 0,44 ± 0,43 vs. post-procedure 0,84 ± 0,30 P<0,001. Target lesion/vessel revascularization (TLR/TVR) within the first 30 days was 3,6% (1/28). 30-day MAE rate was 14,3% (vessel perforation in 3/28 patients, embolism in 1/28). There were no deaths, index limb amputations, or myocardial infarctions.</p><p><strong>Conclusion: </strong>The BYCROSS<sup>TM</sup> atherectomy system is a new device with numerous advantages in treating high-grade, calcifying stenosis and occlusion processes in PAD. Based on the above findings, the BYCROSS<sup>TM</sup> Atherectomy device represents a feasible, safe, and effective method for endovascular treatment of peripheral arterial disease.</p>\",\"PeriodicalId\":23528,\"journal\":{\"name\":\"Vasa-european Journal of Vascular Medicine\",\"volume\":\" \",\"pages\":\"388-396\"},\"PeriodicalIF\":2.1000,\"publicationDate\":\"2024-11-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Vasa-european Journal of Vascular Medicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1024/0301-1526/a001151\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/10/18 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q3\",\"JCRName\":\"PERIPHERAL VASCULAR DISEASE\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Vasa-european Journal of Vascular Medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1024/0301-1526/a001151","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/10/18 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"PERIPHERAL VASCULAR DISEASE","Score":null,"Total":0}
Technical aspects of the new BYCROSSTM atherectomy device - preliminary results after 28 patients.
Purpose: Technical aspects are crucial for the planning and performing of the atherectomy to treat peripheral arterial disease. This report illustrates the use of a novel atherectomy device and investigates the feasibility, efficacy, and safety procedures involved in performing the atherectomy on 28 patients.
Materials and methods: We performed a prospective analysis of patients who underwent an atherectomy with the BYCROSSTM Atherectomy device between August 2022 and September 2023 at a tertiary referral centre. Patients with a lesion below the aortic bifurcation (vessel diameter ≥ 3mm) having a de novo or restenotic (stent-included) present were recruited. Major adverse events (MAE) are defined as amputation, death, myocardial infarction, or angiographic distal embolization that require a separate intervention.
Results: Of the 28 patients treated with the BYCROSS device, 23 were men with a mean age of 65.6 ± 9,6 years and a mean BMI of 24,6 ± 3.9 kg/m2. Most patients had a typical atherogenic risk profile as well as multiple preexisting comorbidities. In all patients, a symptomatic peripheral arterial disease (PAD) was the main reason for an intervention. The most common Rutherford category was 5 (12/28). The most common lesion region was the femoropopliteal segment (25/28) with 23 de novo stenosis. Mean lesion length was 218,0 ± 93,7 mm. The mean PACCS Score was 3,0 ± 1,0. Stenosis grade was by mean 99,3 ± 3,7%. Ankle Brachial Index (ABI) increased significantly after BYCROSS atherectomy (pre- 0,44 ± 0,43 vs. post-procedure 0,84 ± 0,30 P<0,001. Target lesion/vessel revascularization (TLR/TVR) within the first 30 days was 3,6% (1/28). 30-day MAE rate was 14,3% (vessel perforation in 3/28 patients, embolism in 1/28). There were no deaths, index limb amputations, or myocardial infarctions.
Conclusion: The BYCROSSTM atherectomy system is a new device with numerous advantages in treating high-grade, calcifying stenosis and occlusion processes in PAD. Based on the above findings, the BYCROSSTM Atherectomy device represents a feasible, safe, and effective method for endovascular treatment of peripheral arterial disease.
期刊介绍:
Vasa is the European journal of vascular medicine. It is the official organ of the German, Swiss, and Slovenian Societies of Angiology.
The journal publishes original research articles, case reports and reviews on vascular biology, epidemiology, prevention, diagnosis, medical treatment and interventions for diseases of the arterial circulation, in the field of phlebology and lymphology including the microcirculation, except the cardiac circulation.
Vasa combines basic science with clinical medicine making it relevant to all physicians interested in the whole vascular field.