Pub Date : 2023-06-01DOI: 10.23736/S0021-9509.23.12534-1
Giovanni A Chiariello, Emmanuel Villa, Piergiorgio Bruno, Annalisa Pasquini, Marialisa Nesta, Francesco Ferraro, Serena D'Avino, Valerio Sanesi, Claudia Vecchio, Antonio Messina, Margherita Dalla Tomba, Maria Calabrese, Abdallah Raweh, Luca Montini, Giovanni Troise, Massimo Massetti
Background: The increasing use of biological substitutes for surgical aortic valve replacement (AVR), has led to the development of new bioprostheses with improved hemodynamics and expected durability.
Methods: In this observational retrospective two-center cohort study, two innovative bioprostheses, INSPIRIS Resilia and AVALUS were analyzed. We analyzed early and 2.4-year follow-up results in terms of safety, clinical outcome and hemodynamic performance.
Results: From November 2017 to February 2021, 148 patients underwent AVR with INSPIRIS Resilia (N.=74) or AVALUS (N.=74) bioprosthesis. The 30-day and mid-term mortality was comparable (1% vs. 3%, P=0.1 and 7% vs. 4%, P=0.4, respectively). Valve-related mortality was observed in one AVALUS patient. Three (4%) patients of the AVALUS group developed prosthetic endocarditis and two of them died after reoperation. No other cases of prosthetic endocarditis were observed. No cases of structural valve degeneration or significant paravalvular leak were detected at follow-up. Median follow-up peak pressure gradient was 21 vs. 23 mmHg (P=0.4) and the mean pressure gradient was 12 vs. 13 mmHg (P=0.9) for Inspiris and AVALUS, respectively. The effective orifice area (EOA) and indexed EOA were 1.5 cm2 vs. 1.4 cm2 (P=0.4) and 0.8 vs. 0.7 cm2/m2 (P=0.5), respectively. Indexed left ventricular mass regression was -33 vs. -52 g/m2 for the Inspiris and AVALUS groups, respectively, (R2-adjusted =0.14; P<0.01).
Conclusions: INSPIRIS Resilia and AVALUS bioprostheses were reliable with comparable results in safety, clinical outcome and hemodynamic performance. After statistical adjustment, AVALUS was associated with better left ventricular mass reduction. Long-term follow-up would provide definitive comparative results.
{"title":"Two innovative aortic bioprostheses evaluated in the real-world setting. First results from a two-center study.","authors":"Giovanni A Chiariello, Emmanuel Villa, Piergiorgio Bruno, Annalisa Pasquini, Marialisa Nesta, Francesco Ferraro, Serena D'Avino, Valerio Sanesi, Claudia Vecchio, Antonio Messina, Margherita Dalla Tomba, Maria Calabrese, Abdallah Raweh, Luca Montini, Giovanni Troise, Massimo Massetti","doi":"10.23736/S0021-9509.23.12534-1","DOIUrl":"https://doi.org/10.23736/S0021-9509.23.12534-1","url":null,"abstract":"<p><strong>Background: </strong>The increasing use of biological substitutes for surgical aortic valve replacement (AVR), has led to the development of new bioprostheses with improved hemodynamics and expected durability.</p><p><strong>Methods: </strong>In this observational retrospective two-center cohort study, two innovative bioprostheses, INSPIRIS Resilia and AVALUS were analyzed. We analyzed early and 2.4-year follow-up results in terms of safety, clinical outcome and hemodynamic performance.</p><p><strong>Results: </strong>From November 2017 to February 2021, 148 patients underwent AVR with INSPIRIS Resilia (N.=74) or AVALUS (N.=74) bioprosthesis. The 30-day and mid-term mortality was comparable (1% vs. 3%, P=0.1 and 7% vs. 4%, P=0.4, respectively). Valve-related mortality was observed in one AVALUS patient. Three (4%) patients of the AVALUS group developed prosthetic endocarditis and two of them died after reoperation. No other cases of prosthetic endocarditis were observed. No cases of structural valve degeneration or significant paravalvular leak were detected at follow-up. Median follow-up peak pressure gradient was 21 vs. 23 mmHg (P=0.4) and the mean pressure gradient was 12 vs. 13 mmHg (P=0.9) for Inspiris and AVALUS, respectively. The effective orifice area (EOA) and indexed EOA were 1.5 cm<sup>2</sup> vs. 1.4 cm<sup>2</sup> (P=0.4) and 0.8 vs. 0.7 cm<sup>2</sup>/m<sup>2</sup> (P=0.5), respectively. Indexed left ventricular mass regression was -33 vs. -52 g/m<sup>2</sup> for the Inspiris and AVALUS groups, respectively, (R<sup>2</sup>-adjusted =0.14; P<0.01).</p><p><strong>Conclusions: </strong>INSPIRIS Resilia and AVALUS bioprostheses were reliable with comparable results in safety, clinical outcome and hemodynamic performance. After statistical adjustment, AVALUS was associated with better left ventricular mass reduction. Long-term follow-up would provide definitive comparative results.</p>","PeriodicalId":50245,"journal":{"name":"Journal of Cardiovascular Surgery","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9930744","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: A modified aortic arch "island anastomosis" with a stent graft technique was used in 33 patients with acute type A aortic dissection. We retrospectively reviewed our experience of this procedure and the short-term follow-up results.
Methods: This retrospective analysis included 33 patients with acute type A aortic dissection undergoing the modified aortic arch island anastomosis with stent graft procedure. Postoperatively, computed tomography angiography images were obtained before discharge and at 12 months.
Results: All patients underwent successful surgery without intraoperative death. Three patients received dialysis because of postoperative renal insufficiency, 1 patient received tracheotomy because of postoperative respiratory insufficiency, and 5 patients had postoperative delirium. Surgery caused stroke in 1 patient. No paraplegia was found, and no re-exploration for bleeding was performed. One patient died in the hospital due to multiple organ failure, and the other patients were discharged as expected. Only 1 patient had a proximal endoleak, and the patient was stable under close follow-up. The diameter of the descending thoracic aorta was smaller at 12 months postoperatively than preoperatively (34.5±2.5 mm versus 36.7±2.9 mm, P<0.05). The average diameter of the true lumen of the descending thoracic aorta was larger at 12 months postoperatively than preoperatively (24.1±3.1 mm versus 14.9±2.3 mm, P<0.05).
Conclusions: The modified aortic arch island anastomosis with stent graft technique is a feasible and safety surgical strategy for acute type A aortic dissection. Short-term outcomes are satisfactory.
背景:对33例急性A型主动脉夹层患者采用改良的主动脉弓“岛状吻合”支架移植技术。我们回顾性地回顾了我们的手术经验和短期随访结果。方法:回顾性分析33例急性A型主动脉夹层行改良型主动脉弓岛状吻合支架手术的患者。术后分别在出院前和12个月时进行计算机断层血管造影。结果:所有患者手术成功,无术中死亡。术后肾功能不全3例透析,呼吸功能不全1例气管切开术,术后谵妄5例。手术引起脑卒中1例。无截瘫,无再次探查出血。1例患者因多器官功能衰竭在医院死亡,其余患者均顺利出院。仅有1例发生近端内漏,密切随访后病情稳定。术后12个月胸降主动脉直径明显小于术前(34.5±2.5 mm vs 36.7±2.9 mm)。结论:改良主动脉弓岛状吻合支架技术是治疗急性a型主动脉夹层的一种安全可行的手术策略。短期结果令人满意。
{"title":"A modified aortic arch \"island anastomosis\" with stent graft technique for acute type A aortic dissection: a retrospective analysis.","authors":"Junbo Feng, Yuntao Hu, Ya-Peng Wang, Juntao Li, Peng Peng, Shenglin Ge","doi":"10.23736/S0021-9509.23.12123-9","DOIUrl":"https://doi.org/10.23736/S0021-9509.23.12123-9","url":null,"abstract":"<p><strong>Background: </strong>A modified aortic arch \"island anastomosis\" with a stent graft technique was used in 33 patients with acute type A aortic dissection. We retrospectively reviewed our experience of this procedure and the short-term follow-up results.</p><p><strong>Methods: </strong>This retrospective analysis included 33 patients with acute type A aortic dissection undergoing the modified aortic arch island anastomosis with stent graft procedure. Postoperatively, computed tomography angiography images were obtained before discharge and at 12 months.</p><p><strong>Results: </strong>All patients underwent successful surgery without intraoperative death. Three patients received dialysis because of postoperative renal insufficiency, 1 patient received tracheotomy because of postoperative respiratory insufficiency, and 5 patients had postoperative delirium. Surgery caused stroke in 1 patient. No paraplegia was found, and no re-exploration for bleeding was performed. One patient died in the hospital due to multiple organ failure, and the other patients were discharged as expected. Only 1 patient had a proximal endoleak, and the patient was stable under close follow-up. The diameter of the descending thoracic aorta was smaller at 12 months postoperatively than preoperatively (34.5±2.5 mm versus 36.7±2.9 mm, P<0.05). The average diameter of the true lumen of the descending thoracic aorta was larger at 12 months postoperatively than preoperatively (24.1±3.1 mm versus 14.9±2.3 mm, P<0.05).</p><p><strong>Conclusions: </strong>The modified aortic arch island anastomosis with stent graft technique is a feasible and safety surgical strategy for acute type A aortic dissection. Short-term outcomes are satisfactory.</p>","PeriodicalId":50245,"journal":{"name":"Journal of Cardiovascular Surgery","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9930743","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-06-01DOI: 10.23736/S0021-9509.22.12311-6
Ozan Yazar, Gabriela Pilz da Cunha, Michiel W de Haan, Barend M Mees, Geert W Schurink
Background: The impact of stent-graft complexity on clinical outcome after fenestrated endovascular aortic aneurysm repair (FEVAR) has been conflicting in the literature. The objective of this study was to compare mid-term results of stent-grafts with renal fenestrations alone with more complex stent-grafts including mesenteric fenestrations.
Methods: A single center retrospective study was conducted on 154 patients, who underwent FEVAR from 2006 to 2020 at our institution.
Results: There were 54 (35.1%) patients in the renal FEVAR group and 100 (64.9%) patients in the complex FEVAR group. Median follow-up of the total group was 25 months (IQR 7-45). There were no significant differences in technical success and perioperative mortality. Intraoperative complications (4% vs. 18%, P=0.001), operative time (145 min vs. 191 min, P=0.001), radiation dose (119372 mGy*cm2 vs. 159573 mGy*cm2, P=0.004) and fluoroscopy time (39 min vs. 54 min, P=0.007) were significantly lower in the renal FEVAR group. During follow-up target vessel instability, endoleaks and reinterventions were not significantly different between the two groups.
Conclusions: In this single center retrospective study, renal FEVAR was a safe and effective treatment for patients with juxtarenal AAA demonstrating fewer intraoperative complications and similar mid-term outcomes as complex FEVAR. If the anatomy is compatible for renal FEVAR, it might be unnecessary to expose patients to potentially more complications by choosing a complex FEVAR strategy.
背景:支架移植复杂性对开窗血管内动脉瘤修复(FEVAR)后临床结果的影响在文献中一直存在矛盾。本研究的目的是比较单独肾开孔支架移植和更复杂的包括肠系膜开孔支架移植的中期结果。方法:对我院2006 ~ 2020年收治的154例FEVAR患者进行单中心回顾性研究。结果:肾性FEVAR组54例(35.1%),复合性FEVAR组100例(64.9%)。全组中位随访25个月(IQR 7-45)。技术成功率和围手术期死亡率无显著差异。肾脏FEVAR组术中并发症(4% vs. 18%, P=0.001)、手术时间(145 min vs. 191 min, P=0.001)、放射剂量(119372 mGy*cm2 vs. 159573 mGy*cm2, P=0.004)、x线检查时间(39 min vs. 54 min, P=0.007)均显著降低。在随访中,两组间靶血管不稳定、内漏和再干预均无显著差异。结论:在本单中心回顾性研究中,肾性FEVAR是一种安全有效的治疗肾旁AAA患者的方法,术中并发症较少,中期预后与复杂FEVAR相似。如果解剖结构与肾脏FEVAR相匹配,可能没有必要通过选择复杂的FEVAR策略使患者暴露于潜在的更多并发症。
{"title":"Impact of stent-graft complexity on mid-term results in fenestrated endovascular aortic repair of juxtarenal and suprarenal abdominal aortic aneurysms.","authors":"Ozan Yazar, Gabriela Pilz da Cunha, Michiel W de Haan, Barend M Mees, Geert W Schurink","doi":"10.23736/S0021-9509.22.12311-6","DOIUrl":"https://doi.org/10.23736/S0021-9509.22.12311-6","url":null,"abstract":"<p><strong>Background: </strong>The impact of stent-graft complexity on clinical outcome after fenestrated endovascular aortic aneurysm repair (FEVAR) has been conflicting in the literature. The objective of this study was to compare mid-term results of stent-grafts with renal fenestrations alone with more complex stent-grafts including mesenteric fenestrations.</p><p><strong>Methods: </strong>A single center retrospective study was conducted on 154 patients, who underwent FEVAR from 2006 to 2020 at our institution.</p><p><strong>Results: </strong>There were 54 (35.1%) patients in the renal FEVAR group and 100 (64.9%) patients in the complex FEVAR group. Median follow-up of the total group was 25 months (IQR 7-45). There were no significant differences in technical success and perioperative mortality. Intraoperative complications (4% vs. 18%, P=0.001), operative time (145 min vs. 191 min, P=0.001), radiation dose (119372 mGy*cm<sup>2</sup> vs. 159573 mGy*cm<sup>2</sup>, P=0.004) and fluoroscopy time (39 min vs. 54 min, P=0.007) were significantly lower in the renal FEVAR group. During follow-up target vessel instability, endoleaks and reinterventions were not significantly different between the two groups.</p><p><strong>Conclusions: </strong>In this single center retrospective study, renal FEVAR was a safe and effective treatment for patients with juxtarenal AAA demonstrating fewer intraoperative complications and similar mid-term outcomes as complex FEVAR. If the anatomy is compatible for renal FEVAR, it might be unnecessary to expose patients to potentially more complications by choosing a complex FEVAR strategy.</p>","PeriodicalId":50245,"journal":{"name":"Journal of Cardiovascular Surgery","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9557810","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-06-01DOI: 10.23736/S0021-9509.22.12538-3
Hozan Mufty, Inge Fourneau
Vascular graft infection (VGI) remains one of the most difficult topics within the field of vascular surgery. Despite many preventive measures, infection risk remains present. Mortality and morbidity rates are high, both for peripheral and aortic VGI. Articles reporting on the treatment of VGI are often small, heterogenous or even under reported, which is especially the case for the outcome of different bypass materials that can be used for peripheral VGI. This is one of the reasons why the evidence of which type of vascular graft that should be used in the current guidelines of the European Society of Vascular surgery on the treatment of aortic graft infection is limited to Level C,Class IIa. Nowadays, many types of grafts are being used to treat VGI such as autologous veins, cryopreserved allografts, rifampicin-soaked grafts and silver coated grafts. The antimicrobial effect of silver has been translated to vascular grafts from other disciplines. Nowadays it is commercially off the shelf available and often used in the daily practice, both in the prevention as in the treatment of VGI. The aim of this review was to report on the antimicrobial working mechanism of silver, to report on possible side effects and to summarize in vitro, in vivo and clinical evidence of silver coated vascular grafts, both in the treatment and prevention of VGI.
{"title":"Is silver still the Holy Grail for vascular grafts?","authors":"Hozan Mufty, Inge Fourneau","doi":"10.23736/S0021-9509.22.12538-3","DOIUrl":"https://doi.org/10.23736/S0021-9509.22.12538-3","url":null,"abstract":"<p><p>Vascular graft infection (VGI) remains one of the most difficult topics within the field of vascular surgery. Despite many preventive measures, infection risk remains present. Mortality and morbidity rates are high, both for peripheral and aortic VGI. Articles reporting on the treatment of VGI are often small, heterogenous or even under reported, which is especially the case for the outcome of different bypass materials that can be used for peripheral VGI. This is one of the reasons why the evidence of which type of vascular graft that should be used in the current guidelines of the European Society of Vascular surgery on the treatment of aortic graft infection is limited to Level C,Class IIa. Nowadays, many types of grafts are being used to treat VGI such as autologous veins, cryopreserved allografts, rifampicin-soaked grafts and silver coated grafts. The antimicrobial effect of silver has been translated to vascular grafts from other disciplines. Nowadays it is commercially off the shelf available and often used in the daily practice, both in the prevention as in the treatment of VGI. The aim of this review was to report on the antimicrobial working mechanism of silver, to report on possible side effects and to summarize in vitro, in vivo and clinical evidence of silver coated vascular grafts, both in the treatment and prevention of VGI.</p>","PeriodicalId":50245,"journal":{"name":"Journal of Cardiovascular Surgery","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9556269","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-06-01DOI: 10.23736/S0021-9509.23.12668-1
Gianmarco de Donato, Edoardo Pasqui, Maria A Ruffino, Massimo Sponza, Angelo Spinazzola, Giuseppe Guzzardi, Francesco Intrieri, Daniele Savio, Giancarlo Palasciano
Background: Penumbra/Indigo aspiration thrombectomy Systems (Penumbra Inc.) in patients with acute lower limb ischemia (ALLI) is becoming a fundamental alternative to surgical and intra-arterial thrombolysis. The INDIAN UP trial represents the second phase of the Italian national multicenter trial evaluating the safety and effectiveness of the device in the treatment of ALLI.
Methods: To assess vessel patency, the TIPI (Thrombo-aspiration In Peripheral Ischemia), is used. The TIPI flow in three different moments: at presentation, immediately after thromboaspiration, and after all adjuvant procedures. The primary outcome is the technical success of the thrombo-aspiration with the investigative system, defined as near complete or complete revascularization TIPI 2 - 3. Safety and clinical success rate were collected at one month follow-up.
Results: A total of 250 patients were enrolled. The mean age was 72.2±13.1 years and 72.1% were male. Rutherford grade on enrolment was I in 10.8%, IIa in 34.9%, and IIb in 54.4%. Primary technical success (TIPI 2-3 flow) was achieved in 90.8% of patients. Adjunctive procedures were needed in 158 cases. After all interventions, assisted primary technical success was 96.4%. No systemic bleeding complications or device related serious adverse events were reported. At one month follow up, survival rate was 97.2%, limb salvage was 97.6%. Primary patency was 89.6% and 13 (5.4%) reinterventions were registered.
Conclusions: The updated results of the INDIAN UP trial have confirmed the high value of the mechanical thromboaspiration device Indigo Penumbra in the treatment of ALLI in a large variety of clinical and anatomical settings.
{"title":"Mechanical thrombectomy in acute limb ischemia: ad Interim results of the INDIAN UP Trial.","authors":"Gianmarco de Donato, Edoardo Pasqui, Maria A Ruffino, Massimo Sponza, Angelo Spinazzola, Giuseppe Guzzardi, Francesco Intrieri, Daniele Savio, Giancarlo Palasciano","doi":"10.23736/S0021-9509.23.12668-1","DOIUrl":"https://doi.org/10.23736/S0021-9509.23.12668-1","url":null,"abstract":"<p><strong>Background: </strong>Penumbra/Indigo aspiration thrombectomy Systems (Penumbra Inc.) in patients with acute lower limb ischemia (ALLI) is becoming a fundamental alternative to surgical and intra-arterial thrombolysis. The INDIAN UP trial represents the second phase of the Italian national multicenter trial evaluating the safety and effectiveness of the device in the treatment of ALLI.</p><p><strong>Methods: </strong>To assess vessel patency, the TIPI (Thrombo-aspiration In Peripheral Ischemia), is used. The TIPI flow in three different moments: at presentation, immediately after thromboaspiration, and after all adjuvant procedures. The primary outcome is the technical success of the thrombo-aspiration with the investigative system, defined as near complete or complete revascularization TIPI 2 - 3. Safety and clinical success rate were collected at one month follow-up.</p><p><strong>Results: </strong>A total of 250 patients were enrolled. The mean age was 72.2±13.1 years and 72.1% were male. Rutherford grade on enrolment was I in 10.8%, IIa in 34.9%, and IIb in 54.4%. Primary technical success (TIPI 2-3 flow) was achieved in 90.8% of patients. Adjunctive procedures were needed in 158 cases. After all interventions, assisted primary technical success was 96.4%. No systemic bleeding complications or device related serious adverse events were reported. At one month follow up, survival rate was 97.2%, limb salvage was 97.6%. Primary patency was 89.6% and 13 (5.4%) reinterventions were registered.</p><p><strong>Conclusions: </strong>The updated results of the INDIAN UP trial have confirmed the high value of the mechanical thromboaspiration device Indigo Penumbra in the treatment of ALLI in a large variety of clinical and anatomical settings.</p>","PeriodicalId":50245,"journal":{"name":"Journal of Cardiovascular Surgery","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9930745","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-06-01DOI: 10.23736/S0021-9509.23.12651-6
Tom LE Corvec, Brenda Brancaccio, Edoardo Pasqui, Benoît Decante, Gianmarco de Donato, Yann Gouëffic
Background: Surgical training and evaluation of medical devices require simulation models. The aim of this study was to assess a 3D-printed model as a training model for peripheral endovascular procedures, including thromboaspiration in acute limb ischemia (ALI).
Methods: The 3D-simulation model was modeled from an aorta and lower limbs CT scan by segmentation of the arterial light. The 3D simulator was printed in multimaterial with photo-polymerizable resins (Polyjet). The simulator consisted of interchangeable cartridges intended to reproduce the lower limb vasculature. The simulator was connected to a pump to obtain a pulsative flow. A gelled product was positioned in a cartridge just above a stenosis in order to simulate an ALI by in-situ thrombosis. Vascular interventionalists should perform a thrombo-aspiration (Indigo®, Penumbra Inc., Alameda, CA, USA) by crossover in an experimental hybrid room (Discovery®, General Electric, Boston, MA, USA). The analysis of the results was based on the feedback of vascular interventionalists using a Likert Psychometric Scale.
Results: A total of 6 vascular surgeons performed two training sessions in real-life conditions. Access to the target lesion was achieved by cross-over or antegrade approach with an 8 F - 45 cm introducer. An angiogram was used to localize the thrombus. Due to the flow, a part of the thrombus was migrating from femoropopliteal segment to below the knee level. Thromboaspiration was realized by Indigo (Penumbra Inc.) CAT-8 and -6 with separators. The average score out of 5 was 4.5 (±0.55) regarding anatomical reproducibility, 4.3 (±0.82) for navigation, and 4.5 (±0.84) for aspiration. The didactical evaluation showed a score of 4.3 (±0.52) for improving technical skills. The improvement of the confidence score in the simulator was +1.2 (±1.72).
Conclusions: The 3D-simulation model for peripheral endovascular procedures provides a realistic training for thromboaspiration. This model could mimic different types of peripheral arterial pathologies and participate to the vascular interventionalists training.
{"title":"3D-printed model of simulation for acute thrombus removal in peripheral arteries.","authors":"Tom LE Corvec, Brenda Brancaccio, Edoardo Pasqui, Benoît Decante, Gianmarco de Donato, Yann Gouëffic","doi":"10.23736/S0021-9509.23.12651-6","DOIUrl":"https://doi.org/10.23736/S0021-9509.23.12651-6","url":null,"abstract":"<p><strong>Background: </strong>Surgical training and evaluation of medical devices require simulation models. The aim of this study was to assess a 3D-printed model as a training model for peripheral endovascular procedures, including thromboaspiration in acute limb ischemia (ALI).</p><p><strong>Methods: </strong>The 3D-simulation model was modeled from an aorta and lower limbs CT scan by segmentation of the arterial light. The 3D simulator was printed in multimaterial with photo-polymerizable resins (Polyjet). The simulator consisted of interchangeable cartridges intended to reproduce the lower limb vasculature. The simulator was connected to a pump to obtain a pulsative flow. A gelled product was positioned in a cartridge just above a stenosis in order to simulate an ALI by in-situ thrombosis. Vascular interventionalists should perform a thrombo-aspiration (Indigo<sup>®</sup>, Penumbra Inc., Alameda, CA, USA) by crossover in an experimental hybrid room (Discovery<sup>®</sup>, General Electric, Boston, MA, USA). The analysis of the results was based on the feedback of vascular interventionalists using a Likert Psychometric Scale.</p><p><strong>Results: </strong>A total of 6 vascular surgeons performed two training sessions in real-life conditions. Access to the target lesion was achieved by cross-over or antegrade approach with an 8 F - 45 cm introducer. An angiogram was used to localize the thrombus. Due to the flow, a part of the thrombus was migrating from femoropopliteal segment to below the knee level. Thromboaspiration was realized by Indigo (Penumbra Inc.) CAT-8 and -6 with separators. The average score out of 5 was 4.5 (±0.55) regarding anatomical reproducibility, 4.3 (±0.82) for navigation, and 4.5 (±0.84) for aspiration. The didactical evaluation showed a score of 4.3 (±0.52) for improving technical skills. The improvement of the confidence score in the simulator was +1.2 (±1.72).</p><p><strong>Conclusions: </strong>The 3D-simulation model for peripheral endovascular procedures provides a realistic training for thromboaspiration. This model could mimic different types of peripheral arterial pathologies and participate to the vascular interventionalists training.</p>","PeriodicalId":50245,"journal":{"name":"Journal of Cardiovascular Surgery","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9562873","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-06-01DOI: 10.23736/S0021-9509.22.12195-6
Eduard Charchyan, Denis Breshenkov, Yuriy Belov
Background: The aim of this study was to assess predictors of technical complexity of minimally invasive aortic root repairs (MIARR) performed through J-shaped mini-sternotomies in patients with aortic root aneurysm.
Methods: This study included 49 patients with aortic root aneurysm who underwent MIARR via an upper median J-shaped mini-sternotomy between January 2017 and April 2020. Preoperative high-resolution computed tomographic images synchronised with electrocardiography were mandatory for inclusion. Predictors of technical complexity were identified, and a scoring system was created. The correlation between technical complexity and intraoperative/postoperative parameters was explored.
Results: There was a significant association between technical complexity and increased procedure time (Spearmen's ρ=-0.45, P=0.001), blood loss (Spearmen's ρ=-0.384, P=0.006), cardiopulmonary bypass time (Spearmen's ρ=-0.301, P=0.035), and postoperative bleeding (Spearmen's ρ=-0.265, P=0.066). The anatomical aorta-sternal relationship (distance of >22.1 mm in the axial plane between the midline of the sternotomy plane and the left coronary), distance between the sternal notch and the aortic valve annulus (>14.5 cm in the sagittal plane), distance between the skin and the left coronary artery (>9.53 cm in the axial plane), obesity (Body Mass Index >30), and-diameter at the brachiocephalic trunk level (>37 mm), were strongly associated with procedural complexity. Overall test accuracy was 75.5%, sensitivity was 73.1%, and specificity 78.3%. Finally, we created an online calculator that surgeons can use to determine the probability of a technically difficult of MIARR based on these factors.
Conclusions: This novel scoring system can be used to assess the technical complexity of minimally invasive aortic root repairs and to aid in preoperative planning.
{"title":"Preoperative assessment of the technical complexity of minimally invasive aortic root repair.","authors":"Eduard Charchyan, Denis Breshenkov, Yuriy Belov","doi":"10.23736/S0021-9509.22.12195-6","DOIUrl":"https://doi.org/10.23736/S0021-9509.22.12195-6","url":null,"abstract":"<p><strong>Background: </strong>The aim of this study was to assess predictors of technical complexity of minimally invasive aortic root repairs (MIARR) performed through J-shaped mini-sternotomies in patients with aortic root aneurysm.</p><p><strong>Methods: </strong>This study included 49 patients with aortic root aneurysm who underwent MIARR via an upper median J-shaped mini-sternotomy between January 2017 and April 2020. Preoperative high-resolution computed tomographic images synchronised with electrocardiography were mandatory for inclusion. Predictors of technical complexity were identified, and a scoring system was created. The correlation between technical complexity and intraoperative/postoperative parameters was explored.</p><p><strong>Results: </strong>There was a significant association between technical complexity and increased procedure time (Spearmen's ρ=-0.45, P=0.001), blood loss (Spearmen's ρ=-0.384, P=0.006), cardiopulmonary bypass time (Spearmen's ρ=-0.301, P=0.035), and postoperative bleeding (Spearmen's ρ=-0.265, P=0.066). The anatomical aorta-sternal relationship (distance of >22.1 mm in the axial plane between the midline of the sternotomy plane and the left coronary), distance between the sternal notch and the aortic valve annulus (>14.5 cm in the sagittal plane), distance between the skin and the left coronary artery (>9.53 cm in the axial plane), obesity (Body Mass Index >30), and-diameter at the brachiocephalic trunk level (>37 mm), were strongly associated with procedural complexity. Overall test accuracy was 75.5%, sensitivity was 73.1%, and specificity 78.3%. Finally, we created an online calculator that surgeons can use to determine the probability of a technically difficult of MIARR based on these factors.</p><p><strong>Conclusions: </strong>This novel scoring system can be used to assess the technical complexity of minimally invasive aortic root repairs and to aid in preoperative planning.</p>","PeriodicalId":50245,"journal":{"name":"Journal of Cardiovascular Surgery","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9558060","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-06-01DOI: 10.23736/S0021-9509.23.12688-7
Gianmarco de Donato, Edoardo Pasqui
{"title":"The long journey of acute limb ischemia management: from the disappointing observation of a medical student to precision medicine and the tailored endovascular treatment.","authors":"Gianmarco de Donato, Edoardo Pasqui","doi":"10.23736/S0021-9509.23.12688-7","DOIUrl":"https://doi.org/10.23736/S0021-9509.23.12688-7","url":null,"abstract":"","PeriodicalId":50245,"journal":{"name":"Journal of Cardiovascular Surgery","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9577051","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Acute limb ischemia still represents a challenge for the contemporary vascular surgeon, representing an immediate threat for patients' limb but potentially also for the proper patient life in some settings. Technology recently evolved and focused on the treatment of such complex situation. Several devices are available as of today allowing a complete acute limb ischemia endovascular management, aiming to remove intraluminal material while leaving the possibility for treating the underlying pathology when needed. In this review, proper specific device characteristics, indications and advantages are reported and discussed. Despite the broad spectrum of different available devices could appear as potentially confounding, each device has its own features, indications, weak and strength point. Ideally the modern endovascular surgeon should master every single tool, tailoring revascularization strategy and timing for the proper patient and arterial segment to be treated, maximizing the benefits coming from technological improvements.
{"title":"Endovascular thrombectomy devices for acute limb ischemia management.","authors":"Giacomo Isernia, Edoardo Pasqui, Gianmarco de Donato, Gianluigi Fino, Massimo Lenti, Gianbattista Parlani, Gioele Simonte","doi":"10.23736/S0021-9509.23.12696-6","DOIUrl":"https://doi.org/10.23736/S0021-9509.23.12696-6","url":null,"abstract":"<p><p>Acute limb ischemia still represents a challenge for the contemporary vascular surgeon, representing an immediate threat for patients' limb but potentially also for the proper patient life in some settings. Technology recently evolved and focused on the treatment of such complex situation. Several devices are available as of today allowing a complete acute limb ischemia endovascular management, aiming to remove intraluminal material while leaving the possibility for treating the underlying pathology when needed. In this review, proper specific device characteristics, indications and advantages are reported and discussed. Despite the broad spectrum of different available devices could appear as potentially confounding, each device has its own features, indications, weak and strength point. Ideally the modern endovascular surgeon should master every single tool, tailoring revascularization strategy and timing for the proper patient and arterial segment to be treated, maximizing the benefits coming from technological improvements.</p>","PeriodicalId":50245,"journal":{"name":"Journal of Cardiovascular Surgery","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9561987","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-06-01DOI: 10.23736/S0021-9509.22.12171-3
Bahaa Nasr, Mélanie Carret, Kevin Pluchon, Eric Bezon
Background: Endarterectomy with prosthetic patch angioplasty is the preferred treatment for common femoral artery occlusive disease. Eversion endarterectomy was described as a promising alternative. the aim of this study was to compare the eversion endarterectomy and patch angioplasty outcomes for patients with de novo femoral bifurcation atherosclerotic lesions. this study was a single-center, retrospective analysis of prospectively collected registry data, non-randomized cohort. Patients treated by eversion endarterectomy and patch angioplasty for de novo femoral bifurcation atheromatous lesions were evaluated.
Methods: Between January 2016 and June 2019, all patients with de novo femoral bifurcation atheromatous lesions with a stenosis ≥70% were included in a prospective single-center database. Patients undergoing eversion endarterectomy and patch angioplasty were propensity-matched by age, sex, preexisting comorbidities, and lesion characteristics.
Results: There were 51 eversion endarterectomy and 137 patch angioplasty cases. One-to-one propensity matching yielded 51 pairs of patients. In the matched population, intermittent claudication was the most common clinical presentation (68% for both groups; P=0.83). There was no difference in femoral bifurcation lesion types between the two groups (P=0.11). Univariate analysis found no significant difference between the groups in terms of 30-d morbidity and mortality (10% and 16%; P=0.55). At 24 months, there was no significant difference in primary sustained clinical improvement (72% and 86%; P=0.22), primary patency rate (90% and 98%; P=0.48), and freedom from target lesion revascularization (100% and 98%; P=0.31) between the groups.
Conclusions: This propensity-score analysis did not show any advantage for the EE. The EPPA should be the first line treatment of de novo femoral tripod occlusive disease. Results show that patch angioplasty treatment for de novo femoral bifurcation atheromatous could improve the daily practice with a good clinical improvement and primary patency.
{"title":"Common femoral artery endarterectomy by eversion versus prosthetic patch angioplasty: a propensity-matched study.","authors":"Bahaa Nasr, Mélanie Carret, Kevin Pluchon, Eric Bezon","doi":"10.23736/S0021-9509.22.12171-3","DOIUrl":"https://doi.org/10.23736/S0021-9509.22.12171-3","url":null,"abstract":"<p><strong>Background: </strong>Endarterectomy with prosthetic patch angioplasty is the preferred treatment for common femoral artery occlusive disease. Eversion endarterectomy was described as a promising alternative. the aim of this study was to compare the eversion endarterectomy and patch angioplasty outcomes for patients with de novo femoral bifurcation atherosclerotic lesions. this study was a single-center, retrospective analysis of prospectively collected registry data, non-randomized cohort. Patients treated by eversion endarterectomy and patch angioplasty for de novo femoral bifurcation atheromatous lesions were evaluated.</p><p><strong>Methods: </strong>Between January 2016 and June 2019, all patients with de novo femoral bifurcation atheromatous lesions with a stenosis ≥70% were included in a prospective single-center database. Patients undergoing eversion endarterectomy and patch angioplasty were propensity-matched by age, sex, preexisting comorbidities, and lesion characteristics.</p><p><strong>Results: </strong>There were 51 eversion endarterectomy and 137 patch angioplasty cases. One-to-one propensity matching yielded 51 pairs of patients. In the matched population, intermittent claudication was the most common clinical presentation (68% for both groups; P=0.83). There was no difference in femoral bifurcation lesion types between the two groups (P=0.11). Univariate analysis found no significant difference between the groups in terms of 30-d morbidity and mortality (10% and 16%; P=0.55). At 24 months, there was no significant difference in primary sustained clinical improvement (72% and 86%; P=0.22), primary patency rate (90% and 98%; P=0.48), and freedom from target lesion revascularization (100% and 98%; P=0.31) between the groups.</p><p><strong>Conclusions: </strong>This propensity-score analysis did not show any advantage for the EE. The EPPA should be the first line treatment of de novo femoral tripod occlusive disease. Results show that patch angioplasty treatment for de novo femoral bifurcation atheromatous could improve the daily practice with a good clinical improvement and primary patency.</p>","PeriodicalId":50245,"journal":{"name":"Journal of Cardiovascular Surgery","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9913823","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}