Pub Date : 2025-01-24DOI: 10.1177/15266028251313952
Moritz Staudacher, Heike Schulze-Bauer, Julian Veser, Clemens Hoebaus, Bernhard Zierfuss, Markus Müller, Michael E Gschwandtner, Andrea Willfort-Ehringer, Sabine Steiner, Oliver Schlager
Purpose: To report the occurrence of acute postrenal kidney failure caused by external ureteral obstruction after iliac venous stent placement.
Case report: A 73-year-old male patient presented with a chronic swelling and feeling of heaviness of his right leg. The presence of venous thrombosis was excluded by duplex ultrasound (DUS). However, DUS revealed a high-grade non-thrombotic stenosis of the right external iliac vein which was confirmed by computed tomography venography. This stenosis was attributed to local scarring following prostatectomy, lymphadenectomy, and adjuvant radiation therapy for prostate cancer 7 years before. According to the clinical presentation, the patient underwent catheter-based revascularization by implantation of a dedicated venous stent in the external iliac vein. One day after this procedure, the patient experienced acute kidney failure, which was attributable to an incipient right-sided grade II hydronephrosis. Subsequent ureterorenoscopy demonstrated a stenotic lesion of the intermediate part of the ureter at the same level as the venous stent. Finally, ureteral stent placement resulted in the restoration of urinary drainage as well as resolution of acute kidney failure. This case report highlights the importance of considering nonvascular complications after venous stent placement and it stresses the importance of postprocedural clinical and laboratory surveillance and follow-up.
Clinical impact: In recent years the number of endovenous stent implantations has significantly increased. In patients with clinically relevant iliofemoral obstructions, endovenous stent placement potentially reduces related symptoms and improves quality of life. However, endovenous stent placement may have an impact on peri-vascular structures, such as the ureters. This case report highlights the awareness of potential nonvascular complications, which might be caused by iliofemoral stent implantation.
{"title":"Acute Kidney Injury Due to Ureter Compression Following Iliac Venous Stenting.","authors":"Moritz Staudacher, Heike Schulze-Bauer, Julian Veser, Clemens Hoebaus, Bernhard Zierfuss, Markus Müller, Michael E Gschwandtner, Andrea Willfort-Ehringer, Sabine Steiner, Oliver Schlager","doi":"10.1177/15266028251313952","DOIUrl":"https://doi.org/10.1177/15266028251313952","url":null,"abstract":"<p><strong>Purpose: </strong>To report the occurrence of acute postrenal kidney failure caused by external ureteral obstruction after iliac venous stent placement.</p><p><strong>Case report: </strong>A 73-year-old male patient presented with a chronic swelling and feeling of heaviness of his right leg. The presence of venous thrombosis was excluded by duplex ultrasound (DUS). However, DUS revealed a high-grade non-thrombotic stenosis of the right external iliac vein which was confirmed by computed tomography venography. This stenosis was attributed to local scarring following prostatectomy, lymphadenectomy, and adjuvant radiation therapy for prostate cancer 7 years before. According to the clinical presentation, the patient underwent catheter-based revascularization by implantation of a dedicated venous stent in the external iliac vein. One day after this procedure, the patient experienced acute kidney failure, which was attributable to an incipient right-sided grade II hydronephrosis. Subsequent ureterorenoscopy demonstrated a stenotic lesion of the intermediate part of the ureter at the same level as the venous stent. Finally, ureteral stent placement resulted in the restoration of urinary drainage as well as resolution of acute kidney failure. This case report highlights the importance of considering nonvascular complications after venous stent placement and it stresses the importance of postprocedural clinical and laboratory surveillance and follow-up.</p><p><strong>Clinical impact: </strong>In recent years the number of endovenous stent implantations has significantly increased. In patients with clinically relevant iliofemoral obstructions, endovenous stent placement potentially reduces related symptoms and improves quality of life. However, endovenous stent placement may have an impact on peri-vascular structures, such as the ureters. This case report highlights the awareness of potential nonvascular complications, which might be caused by iliofemoral stent implantation.</p>","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"15266028251313952"},"PeriodicalIF":1.7,"publicationDate":"2025-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143034146","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-22DOI: 10.1177/15266028241312356
Emilien C J Wegerif, Michael J Nugteren, Isa F van Galen, Constantijn E V B Hazenberg, Michiel A Schreve, George P Akkersdijk, Bram Fioole, Maurice Pierie, Olaf Schouten, Daniel A F van den Heuvel, Olaf J Bakker, Jan-Willem Hinnen, Bart A N Verhoeven, Jan M M Heyligers, Maarten K Dinkelman, Gert J de Borst, Çağdaş Ünlü
Objective: There is a lack of consensus regarding the optimal antithrombotic therapy (ATT) after popliteal and infrapopliteal (PIP) endovascular therapy (EVT). Currently, dual antiplatelet therapy (DAPT) for 3 months and single antiplatelet therapy (SAPT) are the most prescribed regimens in the Netherlands. Thus far, no randomized comparison has been performed on the optimal ATT approach. Therefore, this study compared the efficacy and safety of 3-month DAPT with SAPT following PIP EVT.
Design: Retrospective analysis of prospectively collected data from a multicenter registry.
Methods: The Dutch chronic lower limb-threatening ischemia registry (THRILLER) collected prospective data on patients enrolled between January 2021 and October 2023. As for ATT, only patients prescribed antiplatelet therapy (APT), were included in this analysis. The primary efficacy outcome was a composite of 3-month major adverse cardiovascular events (MACEs, ie, myocardial infarction, cerebrovascular event, cardiovascular death), major adverse limb events (MALEs, ie, major amputation, reintervention), and non-cardiovascular death. Secondary efficacy outcomes were 3-month MACE, MALE, and all-cause mortality. The primary safety outcome was major bleeding according to the 'Thrombolysis In Myocardial Infarction' (TIMI) classification. Descriptive statistics and Cox proportional hazard models were applied.
Results: In total, 460 of 840 THRILLER patients used DAPT or SAPT as ATT and were therefore included in the analysis. Of these, 322 (70%) received DAPT and 138 (30%) received SAPT. In total, 73 (15.9%) primary efficacy outcomes were observed of which 21 (15.2%) events in the SAPT group and 52 (16.1%) events in the DAPT group. No significant differences were observed between SAPT and DAPT for the primary efficacy outcomes or any of the secondary efficacy outcomes. In both groups, one case of major bleeding was observed.
Conclusion: The findings suggest that 3 months of DAPT is not superior to SAPT. A well-powered randomized trial is warranted to assess the efficacy and safety of post-procedural DAPT in chronic limb-threatening ischemia (CLTI) patients undergoing PIP EVT.
Clinical impact: This manuscript reports on the efficacy and safety outcomes of 3 months of DAPT versus SAPT, which are commonly chosen therapies following popliteal and infrapopliteal endovascular therapy. No significant difference was found between the two groups regarding major adverse cardiovascular events, all-cause death, major amputation, or major bleeding. Therefore, 3 months of DAPT does not seem superior to SAPT. These results suggest that SAPT appears to be a sufficient alternative when considering 3 months of DAPT. Further research should verify these outcomes and focus on the efficacy and safety of prolonged DAPT suppletion after endovascular therapy.
{"title":"Short-Term Outcomes of Dual Versus Single Antiplatelet Therapy Following Popliteal and Infrapopliteal Endovascular Therapy: Data From Dutch Chronic Lower Limb-Threatening Ischemia Registry (THRILLER).","authors":"Emilien C J Wegerif, Michael J Nugteren, Isa F van Galen, Constantijn E V B Hazenberg, Michiel A Schreve, George P Akkersdijk, Bram Fioole, Maurice Pierie, Olaf Schouten, Daniel A F van den Heuvel, Olaf J Bakker, Jan-Willem Hinnen, Bart A N Verhoeven, Jan M M Heyligers, Maarten K Dinkelman, Gert J de Borst, Çağdaş Ünlü","doi":"10.1177/15266028241312356","DOIUrl":"https://doi.org/10.1177/15266028241312356","url":null,"abstract":"<p><strong>Objective: </strong>There is a lack of consensus regarding the optimal antithrombotic therapy (ATT) after popliteal and infrapopliteal (PIP) endovascular therapy (EVT). Currently, dual antiplatelet therapy (DAPT) for 3 months and single antiplatelet therapy (SAPT) are the most prescribed regimens in the Netherlands. Thus far, no randomized comparison has been performed on the optimal ATT approach. Therefore, this study compared the efficacy and safety of 3-month DAPT with SAPT following PIP EVT.</p><p><strong>Design: </strong>Retrospective analysis of prospectively collected data from a multicenter registry.</p><p><strong>Methods: </strong>The Dutch chronic lower limb-threatening ischemia registry (THRILLER) collected prospective data on patients enrolled between January 2021 and October 2023. As for ATT, only patients prescribed antiplatelet therapy (APT), were included in this analysis. The primary efficacy outcome was a composite of 3-month major adverse cardiovascular events (MACEs, ie, myocardial infarction, cerebrovascular event, cardiovascular death), major adverse limb events (MALEs, ie, major amputation, reintervention), and non-cardiovascular death. Secondary efficacy outcomes were 3-month MACE, MALE, and all-cause mortality. The primary safety outcome was major bleeding according to the 'Thrombolysis In Myocardial Infarction' (TIMI) classification. Descriptive statistics and Cox proportional hazard models were applied.</p><p><strong>Results: </strong>In total, 460 of 840 THRILLER patients used DAPT or SAPT as ATT and were therefore included in the analysis. Of these, 322 (70%) received DAPT and 138 (30%) received SAPT. In total, 73 (15.9%) primary efficacy outcomes were observed of which 21 (15.2%) events in the SAPT group and 52 (16.1%) events in the DAPT group. No significant differences were observed between SAPT and DAPT for the primary efficacy outcomes or any of the secondary efficacy outcomes. In both groups, one case of major bleeding was observed.</p><p><strong>Conclusion: </strong>The findings suggest that 3 months of DAPT is not superior to SAPT. A well-powered randomized trial is warranted to assess the efficacy and safety of post-procedural DAPT in chronic limb-threatening ischemia (CLTI) patients undergoing PIP EVT.</p><p><strong>Clinical impact: </strong>This manuscript reports on the efficacy and safety outcomes of 3 months of DAPT versus SAPT, which are commonly chosen therapies following popliteal and infrapopliteal endovascular therapy. No significant difference was found between the two groups regarding major adverse cardiovascular events, all-cause death, major amputation, or major bleeding. Therefore, 3 months of DAPT does not seem superior to SAPT. These results suggest that SAPT appears to be a sufficient alternative when considering 3 months of DAPT. Further research should verify these outcomes and focus on the efficacy and safety of prolonged DAPT suppletion after endovascular therapy.</p>","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"15266028241312356"},"PeriodicalIF":1.7,"publicationDate":"2025-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143015380","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-18DOI: 10.1177/15266028241312346
Adeline Demierre, Kaliska Pedrazzoli, Daniel Hayoz, Rolf P Engelberger, Daniel Périard
<p><strong>Purpose: </strong>Angioplasty of lower extremity arteries with calcification may result in flow-limiting dissection requiring bail-out stenting with unfavorable long-term outcomes. Vessel preparation prior to angioplasty may improve immediate results of the angioplasty and long-term patency. This prospective study assessed the 12-month outcomes of patients who underwent novel vessel preparation catheter, the FLEX Vessel Prep™ System (FLEX VP), prior to drug-coated balloon angioplasty (DCB-PTA).</p><p><strong>Materials and methods: </strong>This investigator-initiated single-arm prospective trial enrolled patients with symptomatic lower extremity peripheral artery disease with de novo, restenotic, or in-stent stenosis of the superficial femoral or popliteal arteries. Target lesions were prepared using FLEX VP that created 12 longitudinal micro-incisions before drug-coated balloon angioplasty.</p><p><strong>Results: </strong>Forty-three lesions in 41 patients were treated in this study with an average lesion length of 118 mm (10-291 mm), average stenosis of 82% (40-100%), and an occlusion rate of 27.9% with an average occlusion length of 89 mm (10-272 mm). Calcification was observed in 85.7% of the lesions, with 66.7% of lesions demonstrating grade 3 or 4 of the Peripheral Arterial Calcification Scoring System. After FLEX VP and DCB-PTA, 92.7% of patients were absent of flow-limiting dissections. Stenting occurred in 39% (16/41) patients (median stent length 40 mm) for residual stenosis (15 patients) and flow-limiting dissection (1 patient). There was one death prior to the 12-month follow-up, not related to the index procedure. Freedom from clinically driven target lesion revascularization at 12 months was 97.5% (39/40). Rutherford classification shifted from 41.5% Class ≥3 at baseline to 95% Class ≤1 at 12 months. There were no amputations at 12 months.</p><p><strong>Conclusion: </strong>Vessel preparation with longitudinal micro-incisions of complex and calcified lesions prior to angioplasty was associated with few flow-limiting dissections. The majority of stents were placed to treat focal residual stenosis, using the shortest available stent length at the time of the study (40 mm) for the majority. Only one stent was needed to treat a flow-limiting dissection. The 97.5% freedom from clinically driven target lesion revascularization (CDTLR) and symptom relief at 12 months suggest that vessel preparation via FLEX VP provides value in maintaining long-term outcomes in patients with highly calcified superficial femoral artery (SFA) or popliteal lesions.</p><p><strong>Clinical impact: </strong>Vessel preparation with longitudinal micro-incisions is a short and efficient intervention associated with promising clinical outcomes and patency rate 12 months after treatment of long and calcified occlusions or stenosis of the femoral and popliteal arteries. This innovative vessel preparation provides post-procedure less residual stenosis and mo
目的:下肢动脉钙化血管成形术可能导致血流受限夹层,需要置入术,长期预后不利。血管成形术前的血管准备可以改善血管成形术的即时效果和长期通畅。这项前瞻性研究评估了在药物包被球囊血管成形术(DCB-PTA)之前接受新型血管准备导管FLEX血管准备™系统(FLEX VP)的患者12个月的结果。材料和方法:这项由研究者发起的单臂前瞻性试验纳入了伴有新生、再狭窄或支架内股浅动脉或腘动脉狭窄的有症状的下肢外周动脉疾病患者。在药物包被球囊血管成形术之前,使用FLEX VP制备了12个纵向微切口的靶病变。结果:本研究共治疗41例患者43个病变,平均病变长度为118 mm (10-291 mm),平均狭窄率为82%(40-100%),平均闭塞长度为89 mm (10-272 mm),闭塞率为27.9%。85.7%的病变出现钙化,其中66.7%的病变表现为外周动脉钙化评分系统3级或4级。经FLEX VP和DCB-PTA治疗后,92.7%的患者未出现限流性夹层。39%(16/41)的患者(支架中位长度40 mm)因残留狭窄(15例)和限流夹层(1例)植入支架。12个月随访前有1例死亡,与指标程序无关。12个月时免于临床驱动的靶病变血运重建的比例为97.5%(39/40)。卢瑟福分类从基线时的41.5%≥3级转移到12个月时的95%≤1级。12个月时没有截肢。结论:血管成形术前对复杂和钙化病变进行纵向微切口血管准备与少量限流夹层相关。大多数支架放置用于治疗局灶性残留狭窄,大多数使用研究时可用的最短支架长度(40 mm)。只需要一个支架来治疗限制血流的夹层。临床驱动靶病变血运重建术(CDTLR)的97.5%的自由度和12个月后的症状缓解表明,通过FLEX VP进行血管准备对于维持高度钙化的股浅动脉(SFA)或腘窝病变患者的长期预后有价值。临床影响:纵向微切口血管制备是一种短而有效的干预措施,在治疗长且钙化的股动脉和腘动脉闭塞或狭窄12个月后具有良好的临床结果和通畅率。这种创新的血管制备提供了更少的术后残留狭窄和更有利的解剖形态,减少了支架的放置,特别是支架的长度。通过纵向切口制备血管也有利于抗再狭窄药物在病灶内的最佳分布,从而防止因再狭窄而进一步干预。
{"title":"The BEnefit of LONGitudinal Micro-Incisions Prior to Paclitaxel-Coated Balloon Angioplasty (BELONG Study) in Patients With Lower Extremity Arterial Disease: Clinical Outcomes at 12 Months.","authors":"Adeline Demierre, Kaliska Pedrazzoli, Daniel Hayoz, Rolf P Engelberger, Daniel Périard","doi":"10.1177/15266028241312346","DOIUrl":"https://doi.org/10.1177/15266028241312346","url":null,"abstract":"<p><strong>Purpose: </strong>Angioplasty of lower extremity arteries with calcification may result in flow-limiting dissection requiring bail-out stenting with unfavorable long-term outcomes. Vessel preparation prior to angioplasty may improve immediate results of the angioplasty and long-term patency. This prospective study assessed the 12-month outcomes of patients who underwent novel vessel preparation catheter, the FLEX Vessel Prep™ System (FLEX VP), prior to drug-coated balloon angioplasty (DCB-PTA).</p><p><strong>Materials and methods: </strong>This investigator-initiated single-arm prospective trial enrolled patients with symptomatic lower extremity peripheral artery disease with de novo, restenotic, or in-stent stenosis of the superficial femoral or popliteal arteries. Target lesions were prepared using FLEX VP that created 12 longitudinal micro-incisions before drug-coated balloon angioplasty.</p><p><strong>Results: </strong>Forty-three lesions in 41 patients were treated in this study with an average lesion length of 118 mm (10-291 mm), average stenosis of 82% (40-100%), and an occlusion rate of 27.9% with an average occlusion length of 89 mm (10-272 mm). Calcification was observed in 85.7% of the lesions, with 66.7% of lesions demonstrating grade 3 or 4 of the Peripheral Arterial Calcification Scoring System. After FLEX VP and DCB-PTA, 92.7% of patients were absent of flow-limiting dissections. Stenting occurred in 39% (16/41) patients (median stent length 40 mm) for residual stenosis (15 patients) and flow-limiting dissection (1 patient). There was one death prior to the 12-month follow-up, not related to the index procedure. Freedom from clinically driven target lesion revascularization at 12 months was 97.5% (39/40). Rutherford classification shifted from 41.5% Class ≥3 at baseline to 95% Class ≤1 at 12 months. There were no amputations at 12 months.</p><p><strong>Conclusion: </strong>Vessel preparation with longitudinal micro-incisions of complex and calcified lesions prior to angioplasty was associated with few flow-limiting dissections. The majority of stents were placed to treat focal residual stenosis, using the shortest available stent length at the time of the study (40 mm) for the majority. Only one stent was needed to treat a flow-limiting dissection. The 97.5% freedom from clinically driven target lesion revascularization (CDTLR) and symptom relief at 12 months suggest that vessel preparation via FLEX VP provides value in maintaining long-term outcomes in patients with highly calcified superficial femoral artery (SFA) or popliteal lesions.</p><p><strong>Clinical impact: </strong>Vessel preparation with longitudinal micro-incisions is a short and efficient intervention associated with promising clinical outcomes and patency rate 12 months after treatment of long and calcified occlusions or stenosis of the femoral and popliteal arteries. This innovative vessel preparation provides post-procedure less residual stenosis and mo","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"15266028241312346"},"PeriodicalIF":1.7,"publicationDate":"2025-01-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143015383","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-15DOI: 10.1177/15266028241312572
Omar El Shazly, Florent Porez, Ramzi Ramadan, Thomas Le Houérou, Antoine Gaudin, Alessandro Costanzo, Dominique Fabre, Julien Guihaire, Stéphan Haulon
Introduction: Management of patients with large aortic arch aneurysms who are considered high risk for frozen elephant trunk technique have been challenging, especially when they have a dilated ascending aorta (AA) that precludes total endovascular branched repair (arch BEVAR). A viable option in our armamentarium is wrapping of the AA (AW), and zone 0 Ishimaru TEVAR.
Methods: Retrospective analysis of our aortic database from 2013 to 2024 to select high-risk patients with aortic arch aneurysm that had an AW and TEVAR. We performed CTA analysis before and after wrapping and TEVAR, and last available CTA. The primary end points were 30-day mortality and stroke.
Results: A total of 12 patients had AA wrap and TEVAR, with supra-aortic vessels (SAVs) debranching (open or endovascular). In 9 patients, the indication for treatment was a large arch atherosclerotic aneurysm, and in 3 patients a dissecting arch aneurysm depicted during follow-up of AW initially performed for acute type A dissection (51.5 months on average between the wrap and the TEVAR). Average age was 72.9 years. Ascending aorta wrap and TEVAR were performed concomitantly in 3/12 patients, including 2 patients with rupture. It was staged in the other 9 patients. The average diameter of the AA pre-wrap was 47.7 (41.3-57), and post-wrap 35.6 (31.9-43) mm. The wrap provided an average seal length of 68.5 (38.4-97.4) mm. A total of 34 SAV were successfully debranched. No type 1 or 3 endoleaks were depicted on completion angiogram. Within the first 30 days, no strokes were diagnosed, and 1 patient with Horton disease died of cardiac arrest on postoperative day 7. Three patients required early reinterventions, including redosternotomy in 2 patients. Mean follow-up (FU) was 28 months (1-75). During FU, 1 patient developed a left vertebral artery steal phenomenon requiring a carotid subclavian bypass, and another patient died of an unknown cause.
Conclusion: Ascending aorta wrap technique with debranching of the SAVs and zone 0 TEVAR might be a good option in patients at high risk for open replacement of the AA and with unfavorable proximal seal zone for a total endovascular repair.
Clinical impact: In the current study, we describe the treatment of aortic arch aneurysms in patients considered at high risk for open replacement of the aortic arch and also not candidate for complete endovascular arch repair (arch BEVAR). Ascending aorta wrap with surgical or endovascular debranching of SAVs and zone 0 TEVAR was performed in 12 patients with favorable outcomes. It should thus be considered a treatment option in this subset of fragile patients with unfavorable proximal seal zone for total endovascular repair. This technique does not require cardiopulmonary bypass (CPB) support, neither aortic cross-clamping.
{"title":"Hybrid Arch Aneurysm Repair With Ascending Aortic Wrap and TEVAR.","authors":"Omar El Shazly, Florent Porez, Ramzi Ramadan, Thomas Le Houérou, Antoine Gaudin, Alessandro Costanzo, Dominique Fabre, Julien Guihaire, Stéphan Haulon","doi":"10.1177/15266028241312572","DOIUrl":"https://doi.org/10.1177/15266028241312572","url":null,"abstract":"<p><strong>Introduction: </strong>Management of patients with large aortic arch aneurysms who are considered high risk for frozen elephant trunk technique have been challenging, especially when they have a dilated ascending aorta (AA) that precludes total endovascular branched repair (arch BEVAR). A viable option in our armamentarium is wrapping of the AA (AW), and zone 0 Ishimaru TEVAR.</p><p><strong>Methods: </strong>Retrospective analysis of our aortic database from 2013 to 2024 to select high-risk patients with aortic arch aneurysm that had an AW and TEVAR. We performed CTA analysis before and after wrapping and TEVAR, and last available CTA. The primary end points were 30-day mortality and stroke.</p><p><strong>Results: </strong>A total of 12 patients had AA wrap and TEVAR, with supra-aortic vessels (SAVs) debranching (open or endovascular). In 9 patients, the indication for treatment was a large arch atherosclerotic aneurysm, and in 3 patients a dissecting arch aneurysm depicted during follow-up of AW initially performed for acute type A dissection (51.5 months on average between the wrap and the TEVAR). Average age was 72.9 years. Ascending aorta wrap and TEVAR were performed concomitantly in 3/12 patients, including 2 patients with rupture. It was staged in the other 9 patients. The average diameter of the AA pre-wrap was 47.7 (41.3-57), and post-wrap 35.6 (31.9-43) mm. The wrap provided an average seal length of 68.5 (38.4-97.4) mm. A total of 34 SAV were successfully debranched. No type 1 or 3 endoleaks were depicted on completion angiogram. Within the first 30 days, no strokes were diagnosed, and 1 patient with Horton disease died of cardiac arrest on postoperative day 7. Three patients required early reinterventions, including redosternotomy in 2 patients. Mean follow-up (FU) was 28 months (1-75). During FU, 1 patient developed a left vertebral artery steal phenomenon requiring a carotid subclavian bypass, and another patient died of an unknown cause.</p><p><strong>Conclusion: </strong>Ascending aorta wrap technique with debranching of the SAVs and zone 0 TEVAR might be a good option in patients at high risk for open replacement of the AA and with unfavorable proximal seal zone for a total endovascular repair.</p><p><strong>Clinical impact: </strong>In the current study, we describe the treatment of aortic arch aneurysms in patients considered at high risk for open replacement of the aortic arch and also not candidate for complete endovascular arch repair (arch BEVAR). Ascending aorta wrap with surgical or endovascular debranching of SAVs and zone 0 TEVAR was performed in 12 patients with favorable outcomes. It should thus be considered a treatment option in this subset of fragile patients with unfavorable proximal seal zone for total endovascular repair. This technique does not require cardiopulmonary bypass (CPB) support, neither aortic cross-clamping.</p>","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"15266028241312572"},"PeriodicalIF":1.7,"publicationDate":"2025-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142984760","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-13DOI: 10.1177/15266028241309543
Matthew Joe Grima, Michaela Zammit, Kevin Cassar
Purpose: The use of surgeon-modified fenestrated endograft to treat a bleeding complication in the common iliac artery.
Technique: An Endurant limb graft was modified on back table in theater after planning the fenestration using a semi-automated centerline. The Endurant stent was planned to land flush at the aortic bifurcation. The Endurant limb was partially deployed until the fenestration opened facing the anastomosis to enable rotation and axial movement of the stent graft, if needed. By obtaining access from the contralateral common femoral artery, the fenestration was cannulated using up-and-over technique and bypass graft cannulated. The Endurant stent graft was then fully deployed. Through a separate puncture in the ipsilateral sheath, the fenestration was re-cannulated using a hydrophilic wire, and a balloon-expandable covered stent was introduced through a 7F sheath and then flared in a kissing fashion along with the Endurant stent. The distal part of the Endurant limb was extended with a bare metal stent into the external iliac artery. Control angiography was satisfactory, and bleeding was controlled.
Conclusion: Surgeon-modified stent graft in the iliac arteries can be used even in the context of non-aneurysmal disease to treat patients in high-risk emergency situations and could be part of the armamentarium of the vascular surgeon.
Clinical impact: Physician-modified endografts are increasingly being used by vascular surgeons and interventional radiologists to treat patients with complex aorto-iliac aneurysms in whom custom-made endograft provided by the manufacturer is too expensive to produce and/or patient requires urgent surgery. Data on the use of physician-modified endografts to treat non-aneurysmal disease is lacking. This technical note highlights the use of physician-modified endograft to treat a patient with bleeding complication from the distal anastomosis of an iliac artery to coeliac trunk bypass graft in whom open surgery posed unacceptable high morbidity and mortality risks. This technical note continues to add more information and knowledge to the vascular surgery / interventional radiology communities on the use of physician-modified endografts and also adds another tool in the armamentarium of teams involved.
{"title":"A Bleed From the Distal Anastomosis Site of a Bypass Graft From the Left Common Iliac Artery to the Celiac Trunk Treated With a Surgeon-Modified Fenestrated Endograft.","authors":"Matthew Joe Grima, Michaela Zammit, Kevin Cassar","doi":"10.1177/15266028241309543","DOIUrl":"https://doi.org/10.1177/15266028241309543","url":null,"abstract":"<p><strong>Purpose: </strong>The use of surgeon-modified fenestrated endograft to treat a bleeding complication in the common iliac artery.</p><p><strong>Technique: </strong>An Endurant limb graft was modified on back table in theater after planning the fenestration using a semi-automated centerline. The Endurant stent was planned to land flush at the aortic bifurcation. The Endurant limb was partially deployed until the fenestration opened facing the anastomosis to enable rotation and axial movement of the stent graft, if needed. By obtaining access from the contralateral common femoral artery, the fenestration was cannulated using up-and-over technique and bypass graft cannulated. The Endurant stent graft was then fully deployed. Through a separate puncture in the ipsilateral sheath, the fenestration was re-cannulated using a hydrophilic wire, and a balloon-expandable covered stent was introduced through a 7F sheath and then flared in a kissing fashion along with the Endurant stent. The distal part of the Endurant limb was extended with a bare metal stent into the external iliac artery. Control angiography was satisfactory, and bleeding was controlled.</p><p><strong>Conclusion: </strong>Surgeon-modified stent graft in the iliac arteries can be used even in the context of non-aneurysmal disease to treat patients in high-risk emergency situations and could be part of the armamentarium of the vascular surgeon.</p><p><strong>Clinical impact: </strong>Physician-modified endografts are increasingly being used by vascular surgeons and interventional radiologists to treat patients with complex aorto-iliac aneurysms in whom custom-made endograft provided by the manufacturer is too expensive to produce and/or patient requires urgent surgery. Data on the use of physician-modified endografts to treat non-aneurysmal disease is lacking. This technical note highlights the use of physician-modified endograft to treat a patient with bleeding complication from the distal anastomosis of an iliac artery to coeliac trunk bypass graft in whom open surgery posed unacceptable high morbidity and mortality risks. This technical note continues to add more information and knowledge to the vascular surgery / interventional radiology communities on the use of physician-modified endografts and also adds another tool in the armamentarium of teams involved.</p>","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"15266028241309543"},"PeriodicalIF":1.7,"publicationDate":"2025-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142973082","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-26DOI: 10.1177/15266028241309267
Siem A Willems, Saskia G Dolfing, Rob C van Wissen, Rutger W van der Meer, Jan van Schaik, Joost R van der Vorst, Abbey Schepers, Jaap F Hamming, Jeroen J W M Brouwers
Introduction: Identifying peripheral arterial disease (PAD) remains challenging with currently used bedside tests. The maximal systolic acceleration (ACCmax) is a promising noninvasive parameter measured by duplex ultrasonography and reflects the arterial perfusion proximal to its measurement point. The principal aim of this study was to analyze the diagnostic accuracy of the ACCmax for detecting significant stenosis in different arterial segments, which could be useful in clinical decision-making.
Materials and methods: A retrospective cohort study was conducted in a tertiary referral hospital. Patients aged 18 years and older who underwent ACCmax measurement(s) alongside computed tomography angiography (CTA) of the abdominal aorta and lower extremities were qualified for inclusion. A significant stenosis was defined as a lumen reduction of more than 50% on CTA. Diagnostic accuracy of the ACCmax was investigated for the aortoiliac and popliteal arterial pathways.
Results: A total of 196 patients (373 limbs) were included in the study. Diagnostic performance of the ACCmax (cut-off value of 7.70 m/s2) to detect a significant stenosis in the aortoiliac pathway showed a sensitivity of 89%, specificity of 97%, positive likelihood ratio of 29.23 and negative likelihood ratio of 0.12 (area under the curve [AUC] 0.941). For the popliteal pathway (cut-off value of 6.30 m/s2), these results were 90%, 95%, 17.14 and 0.12, respectively, with an AUC of 0.958.
Conclusion: The ACCmax showed a promising diagnostic accuracy for detecting a significant stenosis in the aortoiliac and popliteal pathway.
Clinical impact: The maximal systolic acceleration (ACCmax) is a promising non-invasive parameter measured by duplex ultrasonography to diagnose peripheral arterial disease (PAD) and reflects the arterial perfusion proximal to its measurement point. This study focused on its diagnostic accuracy to detect a significant stenosis in the aortoiliac and popliteal pathway, which revealed to be promising with excellent sensitivity and specificity. These findings suggest that ACCmax measurements could play a key role in developing a new diagnostic approach for PAD.
{"title":"Diagnostic Performance of the Maximal Systolic Acceleration for Detecting a Significant Stenosis in the Aortoiliac and Popliteal Pathway: A Retrospective Cohort Study.","authors":"Siem A Willems, Saskia G Dolfing, Rob C van Wissen, Rutger W van der Meer, Jan van Schaik, Joost R van der Vorst, Abbey Schepers, Jaap F Hamming, Jeroen J W M Brouwers","doi":"10.1177/15266028241309267","DOIUrl":"https://doi.org/10.1177/15266028241309267","url":null,"abstract":"<p><strong>Introduction: </strong>Identifying peripheral arterial disease (PAD) remains challenging with currently used bedside tests. The maximal systolic acceleration (ACC<sub>max</sub>) is a promising noninvasive parameter measured by duplex ultrasonography and reflects the arterial perfusion proximal to its measurement point. The principal aim of this study was to analyze the diagnostic accuracy of the ACC<sub>max</sub> for detecting significant stenosis in different arterial segments, which could be useful in clinical decision-making.</p><p><strong>Materials and methods: </strong>A retrospective cohort study was conducted in a tertiary referral hospital. Patients aged 18 years and older who underwent ACC<sub>max</sub> measurement(s) alongside computed tomography angiography (CTA) of the abdominal aorta and lower extremities were qualified for inclusion. A significant stenosis was defined as a lumen reduction of more than 50% on CTA. Diagnostic accuracy of the ACC<sub>max</sub> was investigated for the aortoiliac and popliteal arterial pathways.</p><p><strong>Results: </strong>A total of 196 patients (373 limbs) were included in the study. Diagnostic performance of the ACC<sub>max</sub> (cut-off value of 7.70 m/s<sup>2</sup>) to detect a significant stenosis in the aortoiliac pathway showed a sensitivity of 89%, specificity of 97%, positive likelihood ratio of 29.23 and negative likelihood ratio of 0.12 (area under the curve [AUC] 0.941). For the popliteal pathway (cut-off value of 6.30 m/s<sup>2</sup>), these results were 90%, 95%, 17.14 and 0.12, respectively, with an AUC of 0.958.</p><p><strong>Conclusion: </strong>The ACC<sub>max</sub> showed a promising diagnostic accuracy for detecting a significant stenosis in the aortoiliac and popliteal pathway.</p><p><strong>Clinical impact: </strong>The maximal systolic acceleration (ACC<sub>max</sub>) is a promising non-invasive parameter measured by duplex ultrasonography to diagnose peripheral arterial disease (PAD) and reflects the arterial perfusion proximal to its measurement point. This study focused on its diagnostic accuracy to detect a significant stenosis in the aortoiliac and popliteal pathway, which revealed to be promising with excellent sensitivity and specificity. These findings suggest that ACC<sub>max</sub> measurements could play a key role in developing a new diagnostic approach for PAD.</p>","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"15266028241309267"},"PeriodicalIF":1.7,"publicationDate":"2024-12-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142899956","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Objective: This study offers a retrospective assessment of a single-center experience using cerebrospinal fluid catheters to reduce the risk of perioperative spinal cord injury in patients undergoing single-staged complex endovascular juxtarenal or thoracoabdominal aortic aneurysm repair.
Results: A total of 97 patients were included. On average, 70.7%±14.4% of the aortic segment between the left subclavian artery and the aortic bifurcation was covered during the procedures. Of the 53 patients receiving cerebrospinal fluid drainage, 77.4% were prophylactic and 22.6% were in symptomatic patients. The overall spinal cord injury rate was 12.4%, with 8.3% experiencing transient spinal cord injury with immediate improvement after cerebrospinal fluid drainage, and 4.1% of patients suffering permanent spinal cord injury: 2 (2.1%) with minor deficits and 2 (2.1%) with paraplegia. The mean intraoperatively administered heparin dosage was 7500 international units, and an additional intravenous bolus of acetylsalicylic acid was given in 69 cases (71.1%), whereas the cerebrospinal fluid drain was in situ.
Conclusions: The evaluation of the employed in-house protocol for single-staged complex endovascular juxtarenal and thoracoabdominal aortic aneurysm repair, focusing on cerebrospinal fluid catheter management in conjunction with necessary anticoagulant and antiplatelet medication, indicated that the use of a cerebrospinal fluid catheter is a feasible approach for spinal cord injury risk reduction in selected high-risk patients.
Clinical impact: This study highlights the effectiveness of cerebrospinal fluid drainage (CSFD) in reducing spinal cord injury (SCI) rates from 12.4% to 4.1% during single-staged complex endovascular repair of juxtarenal and thoracoabdominal aortic aneurysms. Implementing CSFD within a standardized protocol achieved a 99.7% target visceral and renal vessel patency without major CSFD-related bleeding complications. These findings emphasize CSFD as a feasible and effective tool for SCI prevention in selected high-risk patients. While supporting on-demand catheter placement, this study underscores the potential of selective prophylactic CSFD use, contributing to safer, evidence-based strategies in managing high-risk aortic repairs.
{"title":"Preventing Spinal Cord Injury in Single-Staged Juxtarenal and Thoracoabdominal Endovascular Aortic Aneurysm Repair: An Evaluation of Cerebrospinal Fluid Catheter Drainage.","authors":"Corinna Walter, Kornelia Hirsch, Sabine Heil, Fadi Taher, Jürgen Falkensammer, Burkhard Gustorff, Afshin Assadian","doi":"10.1177/15266028241309252","DOIUrl":"https://doi.org/10.1177/15266028241309252","url":null,"abstract":"<p><strong>Objective: </strong>This study offers a retrospective assessment of a single-center experience using cerebrospinal fluid catheters to reduce the risk of perioperative spinal cord injury in patients undergoing single-staged complex endovascular juxtarenal or thoracoabdominal aortic aneurysm repair.</p><p><strong>Results: </strong>A total of 97 patients were included. On average, 70.7%±14.4% of the aortic segment between the left subclavian artery and the aortic bifurcation was covered during the procedures. Of the 53 patients receiving cerebrospinal fluid drainage, 77.4% were prophylactic and 22.6% were in symptomatic patients. The overall spinal cord injury rate was 12.4%, with 8.3% experiencing transient spinal cord injury with immediate improvement after cerebrospinal fluid drainage, and 4.1% of patients suffering permanent spinal cord injury: 2 (2.1%) with minor deficits and 2 (2.1%) with paraplegia. The mean intraoperatively administered heparin dosage was 7500 international units, and an additional intravenous bolus of acetylsalicylic acid was given in 69 cases (71.1%), whereas the cerebrospinal fluid drain was in situ.</p><p><strong>Conclusions: </strong>The evaluation of the employed in-house protocol for single-staged complex endovascular juxtarenal and thoracoabdominal aortic aneurysm repair, focusing on cerebrospinal fluid catheter management in conjunction with necessary anticoagulant and antiplatelet medication, indicated that the use of a cerebrospinal fluid catheter is a feasible approach for spinal cord injury risk reduction in selected high-risk patients.</p><p><strong>Clinical impact: </strong>This study highlights the effectiveness of cerebrospinal fluid drainage (CSFD) in reducing spinal cord injury (SCI) rates from 12.4% to 4.1% during single-staged complex endovascular repair of juxtarenal and thoracoabdominal aortic aneurysms. Implementing CSFD within a standardized protocol achieved a 99.7% target visceral and renal vessel patency without major CSFD-related bleeding complications. These findings emphasize CSFD as a feasible and effective tool for SCI prevention in selected high-risk patients. While supporting on-demand catheter placement, this study underscores the potential of selective prophylactic CSFD use, contributing to safer, evidence-based strategies in managing high-risk aortic repairs.</p>","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"15266028241309252"},"PeriodicalIF":1.7,"publicationDate":"2024-12-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142900007","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-26DOI: 10.1177/15266028241307574
David Barillà, Giuseppe Roscitano, Graziana Derone, Vittorio Virga, Nunzio Montelione, Andrea Cutrupi, Francesco Costa, Maria Giulia Pascucci, Antonio Versace, Giampiero Vizzari, Francesco Spinelli, Efrem Civilini, Francesco Stilo, Antonio Micari
<p><strong>Introduction: </strong>Initial surgical revascularization has a recognized primary role in patients with critical limb-threatening ischemia with a high-quality great saphenous vein for conduit. However, approximately one-third of lower extremity vein grafts develop lesions threatening graft patency. Traditional treatments have limitations, highlighting the need for innovative solutions. The advantage of drug-coated balloons (DCBs) in treating native femoropopliteal occlusive disease is well established for its anti-restenotic features. This study evaluates the use of DCBs in maintaining the patency of autologous vein infrainguinal bypass grafts.</p><p><strong>Methods: </strong>This retrospective multicenter cohort study included consecutive patients who underwent DCB angioplasty of infrainguinal bypass vein graft stenoses from January 2010 to December 2022 in 4 tertiary Vascular Surgery referral Centers. The primary endpoints were assisted primary patency rate, amputation, and death. All endpoints were assessed at baseline, at 1, 3, and 6 months, and every 6 months after the procedure. Follow-up was mainly performed via duplex ultrasound, by hand of an experienced independent operator.</p><p><strong>Results: </strong>In total, 296 patients received an endovascular procedure for primary patency loss of a pre-existing infrainguinal saphenous vein bypass graft. Of these, 86 cases (29%) were treated with a paclitaxel-coated balloon. The mean age of patients was 72 (67-75) years, most being males (62%, n=53). The median time from the primary revascularization to reintervention with DCB was 2.58 (95% confidence interval [CI]: 2.31-3.10) years. The DCB angioplasty involved the proximal anastomosis in 20%, the graft in 51%, the distal anastomosis in 33%, and the outflow region in 28% of cases. During a median follow-up of 5 years (3.93-7.01), a 69% assisted primary patency rate was recorded. Limb salvage was achieved in 100% of cases at 1 year and in 90% of cases at 3 years. Only 6 cases of major amputation were recorded in a median follow-up time of 10 years. Overall survival reached 84% at 5 years, calculated on a median follow-up of 9.4 (95% CI: 8.7-10.1) years.</p><p><strong>Conclusion: </strong>Results suggest that DCBs may have a transformative impact on vascular care, reducing the need for repeated reinterventions, and thus improving the quality of life for patients with peripheral bypass grafts.</p><p><strong>Clinical impact: </strong>This study proposes a groundbreaking shift in the management of lower extremity vein graft lesions. By demonstrating the efficacy of drug-coated balloons (DCBs) in maintaining patency of infrainguinal vein bypass grafts, it offers clinicians a novel strategy to address a significant clinical challenge. Unlike traditional treatments with their limitations, DCBs present a promising alternative, potentially reducing the burden of repeated reinterventions. This innovation signifies a tangible improvement in p
{"title":"Drug-Coated Balloons in Autologous Vein Peripheral-Distal Bypass Graft Maintenance: Advancements and Potential Impact.","authors":"David Barillà, Giuseppe Roscitano, Graziana Derone, Vittorio Virga, Nunzio Montelione, Andrea Cutrupi, Francesco Costa, Maria Giulia Pascucci, Antonio Versace, Giampiero Vizzari, Francesco Spinelli, Efrem Civilini, Francesco Stilo, Antonio Micari","doi":"10.1177/15266028241307574","DOIUrl":"https://doi.org/10.1177/15266028241307574","url":null,"abstract":"<p><strong>Introduction: </strong>Initial surgical revascularization has a recognized primary role in patients with critical limb-threatening ischemia with a high-quality great saphenous vein for conduit. However, approximately one-third of lower extremity vein grafts develop lesions threatening graft patency. Traditional treatments have limitations, highlighting the need for innovative solutions. The advantage of drug-coated balloons (DCBs) in treating native femoropopliteal occlusive disease is well established for its anti-restenotic features. This study evaluates the use of DCBs in maintaining the patency of autologous vein infrainguinal bypass grafts.</p><p><strong>Methods: </strong>This retrospective multicenter cohort study included consecutive patients who underwent DCB angioplasty of infrainguinal bypass vein graft stenoses from January 2010 to December 2022 in 4 tertiary Vascular Surgery referral Centers. The primary endpoints were assisted primary patency rate, amputation, and death. All endpoints were assessed at baseline, at 1, 3, and 6 months, and every 6 months after the procedure. Follow-up was mainly performed via duplex ultrasound, by hand of an experienced independent operator.</p><p><strong>Results: </strong>In total, 296 patients received an endovascular procedure for primary patency loss of a pre-existing infrainguinal saphenous vein bypass graft. Of these, 86 cases (29%) were treated with a paclitaxel-coated balloon. The mean age of patients was 72 (67-75) years, most being males (62%, n=53). The median time from the primary revascularization to reintervention with DCB was 2.58 (95% confidence interval [CI]: 2.31-3.10) years. The DCB angioplasty involved the proximal anastomosis in 20%, the graft in 51%, the distal anastomosis in 33%, and the outflow region in 28% of cases. During a median follow-up of 5 years (3.93-7.01), a 69% assisted primary patency rate was recorded. Limb salvage was achieved in 100% of cases at 1 year and in 90% of cases at 3 years. Only 6 cases of major amputation were recorded in a median follow-up time of 10 years. Overall survival reached 84% at 5 years, calculated on a median follow-up of 9.4 (95% CI: 8.7-10.1) years.</p><p><strong>Conclusion: </strong>Results suggest that DCBs may have a transformative impact on vascular care, reducing the need for repeated reinterventions, and thus improving the quality of life for patients with peripheral bypass grafts.</p><p><strong>Clinical impact: </strong>This study proposes a groundbreaking shift in the management of lower extremity vein graft lesions. By demonstrating the efficacy of drug-coated balloons (DCBs) in maintaining patency of infrainguinal vein bypass grafts, it offers clinicians a novel strategy to address a significant clinical challenge. Unlike traditional treatments with their limitations, DCBs present a promising alternative, potentially reducing the burden of repeated reinterventions. This innovation signifies a tangible improvement in p","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"15266028241307574"},"PeriodicalIF":1.7,"publicationDate":"2024-12-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142900004","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-23DOI: 10.1177/15266028241307848
Blair E Warren, Kong Teng Tan, Arash Jaberi, Laura Donahoe, Marc de Perrot, Micheal C McInnis, John T Granton, Sebastian Mafeld
Background: Pulmonary embolism (PE) is an important cause of death and disability. Advances in catheter-directed therapies have led to the use of devices, such as the Inari FlowTriever and Penumbra Indigo system for aspiration thrombectomy (AT) for both massive and sub-massive PE. However, limited data exist on causes of procedural mortality.
Methods: Analysis of the Food and Drug Administration's (FDA) Manufacture and User Facility Device Experience (MAUDE) database was performed. Data for the Inari FlowTriever and Penumbra Indigo aspiration thrombectomy systems were evaluated for mortality events and classified by cause of death from January 1, 2015, to December 31, 2023.
Results: The review identified 26 mortality events related to the Inari FlowTriever and 28 related to the Penumbra Indigo device. Pulmonary vascular perforation (n=26) and right heart injury/tamponade (n=9) were the most common source of mortality. Clot migration (n=4) and acute right heart failure (n=5) were less frequently observed.
Conclusions: This study reveals more mortality events than have been captured in the literature to date. Vascular perforation and cardiac injury are the most common and also potentially preventable sources of mortality. Strategies to mitigate complications related to aspiration thrombectomy are described.
Clinical impact: Analysis of mortality in aspiration thrombectomy (AT) for acute pulmonary embolism is necessary to better understand the safety profile of this procedure. This analysis of the MAUDE database reports the largest single cohort of 54 deaths. Potentially preventable procedure-related mortality in AT has been documented to be the result of vascular perforation and cardiac perforation with tamponade. Preparation for emergent pericardiocentesis should be considered in mechanical thrombectomy. Clot migration may result from thrombus maceration or migration of clot in transit, thus, careful pre-procedure examination for clot in transit with echocardiography is suggested.
{"title":"Procedure-Related Mortality in Aspiration Thrombectomy for Pulmonary Embolism: A MAUDE Database Analysis of the Inari FlowTriever and Penumbra Indigo Systems.","authors":"Blair E Warren, Kong Teng Tan, Arash Jaberi, Laura Donahoe, Marc de Perrot, Micheal C McInnis, John T Granton, Sebastian Mafeld","doi":"10.1177/15266028241307848","DOIUrl":"https://doi.org/10.1177/15266028241307848","url":null,"abstract":"<p><strong>Background: </strong>Pulmonary embolism (PE) is an important cause of death and disability. Advances in catheter-directed therapies have led to the use of devices, such as the Inari FlowTriever and Penumbra Indigo system for aspiration thrombectomy (AT) for both massive and sub-massive PE. However, limited data exist on causes of procedural mortality.</p><p><strong>Methods: </strong>Analysis of the Food and Drug Administration's (FDA) Manufacture and User Facility Device Experience (MAUDE) database was performed. Data for the Inari FlowTriever and Penumbra Indigo aspiration thrombectomy systems were evaluated for mortality events and classified by cause of death from January 1, 2015, to December 31, 2023.</p><p><strong>Results: </strong>The review identified 26 mortality events related to the Inari FlowTriever and 28 related to the Penumbra Indigo device. Pulmonary vascular perforation (n=26) and right heart injury/tamponade (n=9) were the most common source of mortality. Clot migration (n=4) and acute right heart failure (n=5) were less frequently observed.</p><p><strong>Conclusions: </strong>This study reveals more mortality events than have been captured in the literature to date. Vascular perforation and cardiac injury are the most common and also potentially preventable sources of mortality. Strategies to mitigate complications related to aspiration thrombectomy are described.</p><p><strong>Clinical impact: </strong>Analysis of mortality in aspiration thrombectomy (AT) for acute pulmonary embolism is necessary to better understand the safety profile of this procedure. This analysis of the MAUDE database reports the largest single cohort of 54 deaths. Potentially preventable procedure-related mortality in AT has been documented to be the result of vascular perforation and cardiac perforation with tamponade. Preparation for emergent pericardiocentesis should be considered in mechanical thrombectomy. Clot migration may result from thrombus maceration or migration of clot in transit, thus, careful pre-procedure examination for clot in transit with echocardiography is suggested.</p>","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"15266028241307848"},"PeriodicalIF":1.7,"publicationDate":"2024-12-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142878574","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-23DOI: 10.1177/15266028241306068
Giovanni Federico Torsello, Konstantinos Stavroulakis, Gregory Chlouverakis, Giovanni Battista Torsello
Background: To compare the performance of a new-generation cobalt-chromium balloon-expandable bare metal stent with a stainless steel platform for the treatment of iliac occlusive disease.
Methods: Consecutive patients treated for symptomatic iliac occlusive disease between 2014 and 2021 with the cobalt-chromium Dynetic-35 or the stainless steel Dynamic platform were retrospectively evaluated. Outcome measures included technical success, device- or procedure-related death, clinically-driven target lesion revascularization (CD-TLR), primary patency, and major index limb amputation up to 12 months.
Results: In total, 222 Cobalt chromium (CC) stents were used in 159 patients (34.6% female; mean age 66.9 ± 9.5 years) for the treatment of 216 lesions, while 234 iliac lesions of 182 patients (34.6% female; mean age 66.3 ± 9.9 years) were treated with 252 stainless steel (SS) stents. The mean lesion length (30.2 ± 12.8 mm vs 28.7 ± 22.5 mm, p=0.36) and the mean calcification grade (2.0 vs 1.9, p=0.07) did not differ significantly between the 2 groups. Patients treated by the CC platform were more frequently on statins (p<0.001), whereas more active smokers and subjects with higher Rutherford class underwent a SS deployment (p<0.001). Technical success was significantly higher in the SS group (100% vs 97.3%; p=0.01). This was due to longitudinal deformation or stent dislocation after passing the Dynetic-35 with endovascular material. After 1 year, no difference was found following CC and SS stent deployment in terms of device- or procedure-related deaths (0.6% vs 1.1%, p=0.99), target limb amputations (1.9% vs 1.6%, p=0.99), primary patency (91.3% vs 93.5%), and CD-TLR (6.5% vs 2.8% p=0.07).
Conclusions: Through 1 year, cobalt-chromium and stainless steel balloon-expandable stents are safe and effective in the treatment of iliac occlusive disease. Enhanced attention should be given passing the cobalt-chromium stent with endovascular devices to avoid procedural complications.
Clinical impact: Stents with a thin-strut structure improve the flexibility and deliverability. The lower profile also increases the applicability lowering the risk of vascular access complications. In this study newer-generation cobalt chromium balloon-expandable stent did not confer advantages over stainless steel bare metal stent. On contrary, the technical success was inferior to stainless steel stents as longitudinal deformation or dislocation of the Dynetic-35 occurred. Therefore, enhanced attention should be given passing a Cobalt chromium stent with wires, catheters or sheaths to avoid stent deformation.
背景:比较新一代钴铬球囊可膨胀裸金属支架与不锈钢支架治疗髂闭塞性疾病的效果。方法:回顾性评估2014 - 2021年间连续使用钴铬Dynetic-35或不锈钢Dynamic平台治疗症状性髂闭塞疾病的患者。结局指标包括技术成功、器械或手术相关死亡、临床驱动的靶病变血运重建术(CD-TLR)、原发性通畅和长达12个月的主要下肢截肢。结果:159例患者共使用222个钴铬(CC)支架(女性34.6%;平均年龄66.9±9.5岁)治疗病变216例,而234例髂病变182例(女性34.6%;平均年龄66.3±9.9岁),采用252不锈钢(SS)支架治疗。两组患者的平均病变长度(30.2±12.8 mm vs 28.7±22.5 mm, p=0.36)和平均钙化程度(2.0 vs 1.9, p=0.07)差异无统计学意义。结论:经过1年时间,钴铬和不锈钢球囊扩张支架治疗髂闭塞性疾病是安全有效的。通过血管内装置置入钴铬支架时应给予高度重视,以避免手术并发症。临床影响:支架采用薄支架结构,可提高灵活性和可移植性。较低的轮廓也增加了适用性,降低了血管通路并发症的风险。在本研究中,新一代钴铬球囊膨胀支架并不比不锈钢裸金属支架具有优势。相反,由于dynamic -35发生纵向变形或错位,技术上的成功不如不锈钢支架。因此,通过带金属丝、导管或护套的钴铬支架时应格外注意,以避免支架变形。
{"title":"Cobalt Chromium or Stainless Steel Balloon-Expandable Bare Metal Stents for Iliac Occlusive Disease?","authors":"Giovanni Federico Torsello, Konstantinos Stavroulakis, Gregory Chlouverakis, Giovanni Battista Torsello","doi":"10.1177/15266028241306068","DOIUrl":"https://doi.org/10.1177/15266028241306068","url":null,"abstract":"<p><strong>Background: </strong>To compare the performance of a new-generation cobalt-chromium balloon-expandable bare metal stent with a stainless steel platform for the treatment of iliac occlusive disease.</p><p><strong>Methods: </strong>Consecutive patients treated for symptomatic iliac occlusive disease between 2014 and 2021 with the cobalt-chromium Dynetic-35 or the stainless steel Dynamic platform were retrospectively evaluated. Outcome measures included technical success, device- or procedure-related death, clinically-driven target lesion revascularization (CD-TLR), primary patency, and major index limb amputation up to 12 months.</p><p><strong>Results: </strong>In total, 222 Cobalt chromium (CC) stents were used in 159 patients (34.6% female; mean age 66.9 ± 9.5 years) for the treatment of 216 lesions, while 234 iliac lesions of 182 patients (34.6% female; mean age 66.3 ± 9.9 years) were treated with 252 stainless steel (SS) stents. The mean lesion length (30.2 ± 12.8 mm vs 28.7 ± 22.5 mm, p=0.36) and the mean calcification grade (2.0 vs 1.9, p=0.07) did not differ significantly between the 2 groups. Patients treated by the CC platform were more frequently on statins (p<0.001), whereas more active smokers and subjects with higher Rutherford class underwent a SS deployment (p<0.001). Technical success was significantly higher in the SS group (100% vs 97.3%; p=0.01). This was due to longitudinal deformation or stent dislocation after passing the Dynetic-35 with endovascular material. After 1 year, no difference was found following CC and SS stent deployment in terms of device- or procedure-related deaths (0.6% vs 1.1%, p=0.99), target limb amputations (1.9% vs 1.6%, p=0.99), primary patency (91.3% vs 93.5%), and CD-TLR (6.5% vs 2.8% p=0.07).</p><p><strong>Conclusions: </strong>Through 1 year, cobalt-chromium and stainless steel balloon-expandable stents are safe and effective in the treatment of iliac occlusive disease. Enhanced attention should be given passing the cobalt-chromium stent with endovascular devices to avoid procedural complications.</p><p><strong>Clinical impact: </strong>Stents with a thin-strut structure improve the flexibility and deliverability. The lower profile also increases the applicability lowering the risk of vascular access complications. In this study newer-generation cobalt chromium balloon-expandable stent did not confer advantages over stainless steel bare metal stent. On contrary, the technical success was inferior to stainless steel stents as longitudinal deformation or dislocation of the Dynetic-35 occurred. Therefore, enhanced attention should be given passing a Cobalt chromium stent with wires, catheters or sheaths to avoid stent deformation.</p>","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"15266028241306068"},"PeriodicalIF":1.7,"publicationDate":"2024-12-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142878557","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}