Pub Date : 2023-10-01Epub Date: 2023-06-29DOI: 10.23736/S0021-9509.23.12695-4
Daniela Toro, Thomas Ohrlander, Timothy Resch
Endovascular treatment of complex aortic aneurysms (cAAA) including thoracoabdominal aortic aneurysms is becoming more common. Most patients require custom made devices and until recently the off the shelf (OTS) options were limited. The aim of this manuscript was to describe a new inner branch OTS device and its clinical applications. A review of the current literature on the ENSIDE device from Artivion was performed and the authors' experience presented. The short outcomes of this particular OTS device are acceptable and the anatomical suitability on par with other similar devices. The preloaded configuration of the device can offer benefits in complex anatomy. New OTS devices for cAAA can provide treatment in emergent or urgent situations in many patients. Long term follow-up is needed and caution must be made against excessive use in less extensive aneurysms due to the risk of spinal cord ischemia.
{"title":"Experience with inner branch off the shelf device for thoracoabdominal aneurysms.","authors":"Daniela Toro, Thomas Ohrlander, Timothy Resch","doi":"10.23736/S0021-9509.23.12695-4","DOIUrl":"10.23736/S0021-9509.23.12695-4","url":null,"abstract":"<p><p>Endovascular treatment of complex aortic aneurysms (cAAA) including thoracoabdominal aortic aneurysms is becoming more common. Most patients require custom made devices and until recently the off the shelf (OTS) options were limited. The aim of this manuscript was to describe a new inner branch OTS device and its clinical applications. A review of the current literature on the ENSIDE device from Artivion was performed and the authors' experience presented. The short outcomes of this particular OTS device are acceptable and the anatomical suitability on par with other similar devices. The preloaded configuration of the device can offer benefits in complex anatomy. New OTS devices for cAAA can provide treatment in emergent or urgent situations in many patients. Long term follow-up is needed and caution must be made against excessive use in less extensive aneurysms due to the risk of spinal cord ischemia.</p>","PeriodicalId":50245,"journal":{"name":"Journal of Cardiovascular Surgery","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2023-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9695213","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 : 2023-08-01DOI: 10.23736/S0021-9509.22.12535-8
Sébastien Vedani, Didem Haligür, Silvan Jungi, Michel J Bosiers
Calcification represent one the most important predictors of treatment failure of endovascular therapy for peripheral arterial disease, since it restricts wall expansion and acts as a barrier for drug uptake. It also increases complications after PTA like dissection, perforation, and embolization with poor outcomes. Intravascular lithotripsy (IVL) is a novel approach for the treatment of vascular calcifications with the goal to optimize outcome in patients with PAD and heavy calcifications. This review gives an overview of the currently published articles regarding the use of IVL within the vascular field. In conclusion, IVL is a safe and effective approach in the treatment of highly calcified arteries with excellent results and low rates of related complications, such as embolization, dissection, and perforation. However, it seems to require adjunctive therapies to enhance long-term patency as well as an adequate sizing (1.1:1 ratio). Its use to facilitate access of large-bore devices seems to be valuable by changing vessel compliance and achieving luminal gain. Further studies are nonetheless mandatory.
{"title":"Intravascular lithotripsy: a powerful tool to treat peripheral artery calcifications.","authors":"Sébastien Vedani, Didem Haligür, Silvan Jungi, Michel J Bosiers","doi":"10.23736/S0021-9509.22.12535-8","DOIUrl":"https://doi.org/10.23736/S0021-9509.22.12535-8","url":null,"abstract":"<p><p>Calcification represent one the most important predictors of treatment failure of endovascular therapy for peripheral arterial disease, since it restricts wall expansion and acts as a barrier for drug uptake. It also increases complications after PTA like dissection, perforation, and embolization with poor outcomes. Intravascular lithotripsy (IVL) is a novel approach for the treatment of vascular calcifications with the goal to optimize outcome in patients with PAD and heavy calcifications. This review gives an overview of the currently published articles regarding the use of IVL within the vascular field. In conclusion, IVL is a safe and effective approach in the treatment of highly calcified arteries with excellent results and low rates of related complications, such as embolization, dissection, and perforation. However, it seems to require adjunctive therapies to enhance long-term patency as well as an adequate sizing (1.1:1 ratio). Its use to facilitate access of large-bore devices seems to be valuable by changing vessel compliance and achieving luminal gain. Further studies are nonetheless mandatory.</p>","PeriodicalId":50245,"journal":{"name":"Journal of Cardiovascular Surgery","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2023-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9743849","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: The Misago iliac stent has not been compared with other stents. This study aimed to evaluate the 2-year clinical outcomes between the Misago stent and other self-expandable nitinol stents for symptomatic chronic aortoiliac disease.
Methods: This retrospective, single-center observational study enrolled 138 patients (180 limbs; Rutherford classification, between categories 2 and 6) treated with a Misago stent (N.=41) or self-expandable nitinol stent (N.=97) between January 2019 and December 2019. The primary endpoint was patency for up to 2 years. The secondary endpoints were technical success, procedure-related complications, freedom from target lesion revascularization, overall survival, and freedom from major adverse limb events. Multivariate Cox proportional hazards analysis was used to investigate predictors of restenosis.
Results: The mean follow-up duration was 710±201 days. The 2-year primary patency rate was comparable between the groups (Misago, 89.6% and self-expandable nitinol stent, 91.0%, P=0.883). The technical success rate was 100% in both groups, and procedure-related complications were equivalent between the groups (1.7% and 2.4%, respectively; P=0.773). Freedom from target lesion revascularization was not significantly different between the groups (97.6% and 94.4%, respectively; P=0.890). The overall survival rate and freedom from major adverse limb events were not significantly different between the groups (77.2% and 70.8%, respectively, P=0.209; 66.9% and 58.4%, respectively, P=0.149). Statin therapy was positively associated with primary patency.
Conclusions: The Misago stent for aortoiliac lesions demonstrated comparable and acceptable clinical results of safety and efficacy for up to 2 years compared with other self-expandable stents. Statin use predicted the prevention of patency loss.
{"title":"Comparative 2-year outcomes of the Misago stent versus other self-expandable nitinol stents for the endovascular treatment of aortoiliac disease.","authors":"Takuya Haraguchi, Tsujimoto Masanaga, Tsutomu Fujita, Ryo Otake, Daisuke Hachinohe, Umihiko Kaneko, Yoshifumi Kashima, Katsuhiko Sato","doi":"10.23736/S0021-9509.23.12500-6","DOIUrl":"https://doi.org/10.23736/S0021-9509.23.12500-6","url":null,"abstract":"<p><strong>Background: </strong>The Misago iliac stent has not been compared with other stents. This study aimed to evaluate the 2-year clinical outcomes between the Misago stent and other self-expandable nitinol stents for symptomatic chronic aortoiliac disease.</p><p><strong>Methods: </strong>This retrospective, single-center observational study enrolled 138 patients (180 limbs; Rutherford classification, between categories 2 and 6) treated with a Misago stent (N.=41) or self-expandable nitinol stent (N.=97) between January 2019 and December 2019. The primary endpoint was patency for up to 2 years. The secondary endpoints were technical success, procedure-related complications, freedom from target lesion revascularization, overall survival, and freedom from major adverse limb events. Multivariate Cox proportional hazards analysis was used to investigate predictors of restenosis.</p><p><strong>Results: </strong>The mean follow-up duration was 710±201 days. The 2-year primary patency rate was comparable between the groups (Misago, 89.6% and self-expandable nitinol stent, 91.0%, P=0.883). The technical success rate was 100% in both groups, and procedure-related complications were equivalent between the groups (1.7% and 2.4%, respectively; P=0.773). Freedom from target lesion revascularization was not significantly different between the groups (97.6% and 94.4%, respectively; P=0.890). The overall survival rate and freedom from major adverse limb events were not significantly different between the groups (77.2% and 70.8%, respectively, P=0.209; 66.9% and 58.4%, respectively, P=0.149). Statin therapy was positively associated with primary patency.</p><p><strong>Conclusions: </strong>The Misago stent for aortoiliac lesions demonstrated comparable and acceptable clinical results of safety and efficacy for up to 2 years compared with other self-expandable stents. Statin use predicted the prevention of patency loss.</p>","PeriodicalId":50245,"journal":{"name":"Journal of Cardiovascular Surgery","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2023-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9743896","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 : 2023-08-01DOI: 10.23736/S0021-9509.23.12595-X
Maya R Chilbert, Sara Salah, Brian Kersten, Lindsay Nitsche, Nicole Castoro, Awad El-Ashry
Background: Evidence surrounding P2Y12 platelet reactivity units (PRU) impact on bleeding outcomes in patients undergoing coronary artery bypass is varied. This study sought to assess whether on-pump CABG procedures result in increased bleeding in patients with high compared to low PRUs.
Methods: This retrospective cohort study compared those with a PRU level ≤237 (low PRU group) to >237 (high PRU group). The primary outcome assessed massive or severe bleeding in accordance with universal definition of perioperative bleeding criteria. Secondary outcomes assessed mortality, length of stay and relevant bleeding related outcomes (e.g., rates of moderate or lower classifications of bleeding, chest tube output, blood product receipt).
Results: A total of 69 patients were included, 47 in the low and 22 in the high PRU groups. Patients were a median (IQR) 66 (62-74) years and 84.1% (N.=58) were male. Most patients received clopidogrel prior to procedure (39 [83%] in low and 18 [81.8%] in high PRU group; P=1.0000). The rate of the primary outcome was 14.9% (N.=7) in patients with a low PRU and 18.2% (N.=4) in patients with a high PRU; P=0.7345. The rate of moderate bleeding was 59.6% (N.=28) in the low and 27.3% (N.=6) in the high PRU group (P=0.0124). Packed red blood cells (PRBCs) were administered to more patients in the low (23 [48.9%]) than the high PRU group (2 [22.7%]; P=0.0388). There were no differences in other blood product requirement, chest tube output, factor products administered, mortality, or length of stay.
Conclusions: This study determined that low preoperative P2Y12 PRU levels may influence moderate bleeding in patients undergoing cardiac surgery, but not massive or severe bleeding.
{"title":"Effect of P2Y12 platelet reactivity level on peri- and postoperative outcomes of cardiac surgery patients.","authors":"Maya R Chilbert, Sara Salah, Brian Kersten, Lindsay Nitsche, Nicole Castoro, Awad El-Ashry","doi":"10.23736/S0021-9509.23.12595-X","DOIUrl":"https://doi.org/10.23736/S0021-9509.23.12595-X","url":null,"abstract":"<p><strong>Background: </strong>Evidence surrounding P2Y12 platelet reactivity units (PRU) impact on bleeding outcomes in patients undergoing coronary artery bypass is varied. This study sought to assess whether on-pump CABG procedures result in increased bleeding in patients with high compared to low PRUs.</p><p><strong>Methods: </strong>This retrospective cohort study compared those with a PRU level ≤237 (low PRU group) to >237 (high PRU group). The primary outcome assessed massive or severe bleeding in accordance with universal definition of perioperative bleeding criteria. Secondary outcomes assessed mortality, length of stay and relevant bleeding related outcomes (e.g., rates of moderate or lower classifications of bleeding, chest tube output, blood product receipt).</p><p><strong>Results: </strong>A total of 69 patients were included, 47 in the low and 22 in the high PRU groups. Patients were a median (IQR) 66 (62-74) years and 84.1% (N.=58) were male. Most patients received clopidogrel prior to procedure (39 [83%] in low and 18 [81.8%] in high PRU group; P=1.0000). The rate of the primary outcome was 14.9% (N.=7) in patients with a low PRU and 18.2% (N.=4) in patients with a high PRU; P=0.7345. The rate of moderate bleeding was 59.6% (N.=28) in the low and 27.3% (N.=6) in the high PRU group (P=0.0124). Packed red blood cells (PRBCs) were administered to more patients in the low (23 [48.9%]) than the high PRU group (2 [22.7%]; P=0.0388). There were no differences in other blood product requirement, chest tube output, factor products administered, mortality, or length of stay.</p><p><strong>Conclusions: </strong>This study determined that low preoperative P2Y12 PRU levels may influence moderate bleeding in patients undergoing cardiac surgery, but not massive or severe bleeding.</p>","PeriodicalId":50245,"journal":{"name":"Journal of Cardiovascular Surgery","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2023-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9760513","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 : 2023-08-01DOI: 10.23736/S0021-9509.23.12666-8
Arsalan Wafi, Mohamed S Hosny, Sanjay Patel, Lukla Biasi, Athanasios Saratzis, Hany Zayed
Aortoiliac occlusive disease (AIOD) secondary to peripheral arterial disease remains a challenging condition to manage due to anatomical complexities and comorbidities. Operative morbidity and mortality rates are high, and best-practice guidelines have traditionally been limited by a paucity of good quality evidence to aid decision-making. The advent of endovascular technology has enabled the clinician in providing a less invasive option in patients unsuitable for open surgery, but durability of endovascular approaches has remained questionable. However, emerging data on the contemporary management of aortoiliac occlusive disease is demonstrating comparable success rates between open and endovascular surgery. The purpose of this review is to provide an overview on the evolution of techniques, the contemporary management, limitations in the body of evidence and future treatment adjuncts aimed at improving success of intervention in aortoiliac occlusive disease.
{"title":"Contemporary approaches for the management of aorto-iliac occlusive disease.","authors":"Arsalan Wafi, Mohamed S Hosny, Sanjay Patel, Lukla Biasi, Athanasios Saratzis, Hany Zayed","doi":"10.23736/S0021-9509.23.12666-8","DOIUrl":"https://doi.org/10.23736/S0021-9509.23.12666-8","url":null,"abstract":"<p><p>Aortoiliac occlusive disease (AIOD) secondary to peripheral arterial disease remains a challenging condition to manage due to anatomical complexities and comorbidities. Operative morbidity and mortality rates are high, and best-practice guidelines have traditionally been limited by a paucity of good quality evidence to aid decision-making. The advent of endovascular technology has enabled the clinician in providing a less invasive option in patients unsuitable for open surgery, but durability of endovascular approaches has remained questionable. However, emerging data on the contemporary management of aortoiliac occlusive disease is demonstrating comparable success rates between open and endovascular surgery. The purpose of this review is to provide an overview on the evolution of techniques, the contemporary management, limitations in the body of evidence and future treatment adjuncts aimed at improving success of intervention in aortoiliac occlusive disease.</p>","PeriodicalId":50245,"journal":{"name":"Journal of Cardiovascular Surgery","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2023-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9756407","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 : 2023-08-01DOI: 10.23736/S0021-9509.23.12607-3
Marc Bosiers, Gianmarco DE Donato, Giovanni Torsello, Pierre Galvagni Silveira, Koen Deloose, Dierk Scheinert, Pierfrancesco Veroux, Jeroen Hendriks, Lieven Maene, Koen Keirse, Tulio Navarro, Joren Callaert, Hans-Henning Eckstein, Jörg Tessarek, Alessia Giaquinta, Wouter van den Eynde, Jürgen Verbist, Jasmin Wahl-Gravsen
Background: To report the 3-year safety and effectiveness results of a multicenter, prospective, randomized controlled trial comparing the ZILVER PTX paclitaxel-eluting stent to surgical bypass and to conduct a health economic analysis up to 3-year follow-up of the two treatment modalities.
Methods: This is a study in symptomatic TransAtlantic Inter-Society Consensus (TASC) C and D femoropopliteal lesions comparing endovascular ZILVER PTX stenting vs. surgical bypass surgery using a prosthetic graft (ClinicalTrials.gov identifier NCT01952457). Between October 2013 and July 2017, 220 patients (mean age 68.6±10.5 years; 159 men) were enrolled and randomized to the ZILVER PTX treatment group (113, 51.40%) or the bypass treatment group (107, 48.60%). One of the secondary outcomes was primary patency at 3-year, defined as no evidence of binary restenosis or occlusion within the target lesion or bypass graft based on a duplex ultrasound peak systolic velocity ratio <2.4 and no clinically-driven target lesion revascularization (TLR) in endovascular cases or reintervention to restore flow in the bypass. An economic analysis was conducted to analyze the cost differences between ZILVER PTX and bypass, which shows the perspective of the public authority/organization that pays for healthcare in the two countries (payor), Germany and USA.
Results: The 3-year primary patency rate was 53.30% (95% CI 61.40% to 45.20%) for the ZILVER PTX group vs. 58.20% (95% CI 67.10% to 49.30%) for the bypass arm (P=0.9721). Freedom from TLR at 3-year was 62.80% (95% CI 72.60% to 53%) for the ZILVER PTX group vs. 65.30% (95% CI 75.40% to 55.20%) for the bypass group (P=0.635). There was also no significant difference (P=0.358) in survival rate at 3-year between the ZILVER PTX group 78.50%, (95% CI to 87.70% to 69.30%) and the bypass group 87.40% (95% CI 97.6% to 77.2%). None of the deaths was categorized as related to the procedure or device. The economic analysis, taking into account procedural-, hospitalization- and reintervention costs, showed a clear cost-benefit for Zilver PTX in both investigated countries up to 3-year follow-up: Germany (Bypass €9446 per patient versus ZILVER PTX €5755) and USA (Bypass $26,373 per patient versus ZILVER PTX $19,186).
Conclusions: The non-inferior safety and effectiveness results of the ZILVER PTX stent were associated with lower costs for the payer and confirmed that ZILVER PTX stent treatment can be considered as a valid alternative for bypass surgery in long and complex femoropopliteal lesions.
背景:报告一项多中心、前瞻性、随机对照试验的3年安全性和有效性结果,比较ZILVER PTX紫杉醇洗脱支架与外科搭桥手术,并对两种治疗方式进行长达3年的随访健康经济分析。方法:这是一项针对症状性跨大西洋社会共识(TASC) C和D股动脉病变的研究,比较血管内ZILVER PTX支架置入与使用假体移植物的外科搭桥手术(ClinicalTrials.gov标识符NCT01952457)。2013年10月至2017年7月,220例患者(平均年龄68.6±10.5岁;纳入159名男性患者,随机分为ZILVER PTX治疗组(113人,51.40%)和旁路治疗组(107人,48.60%)。其中一个次要结果是3年的原发性通畅,定义为基于双超声峰值收缩速度比的目标病变或旁路移植术内没有二元再狭窄或闭塞的证据。结果:3年的原发性通畅率ZILVER PTX组为53.30% (95% CI 61.40%至45.20%),而旁路臂组为58.20% (95% CI 67.10%至49.30%)(P=0.9721)。ZILVER PTX组3年TLR自由度为62.80% (95% CI 72.60% - 53%),而旁路组为65.30% (95% CI 75.40% - 55.20%) (P=0.635)。3年生存率在ZILVER PTX组78.50% (95% CI为87.70% ~ 69.30%)和旁路组87.40% (95% CI为97.6% ~ 77.2%)之间也无显著差异(P=0.358)。没有一例死亡被归类为与手术或设备有关。经济分析,考虑到手术、住院和再干预成本,显示Zilver PTX在两个调查国家的3年随访中具有明显的成本效益:德国(旁路治疗每位患者9446欧元,而Zilver PTX为5755欧元)和美国(旁路治疗每位患者26,373美元,而Zilver PTX为19,186美元)。结论:ZILVER PTX支架的安全性和有效性与支付者较低的费用相关,证实了ZILVER PTX支架治疗可以被认为是长而复杂的股腘病变旁路手术的有效替代方案。
{"title":"ZILVERPASS Study: ZILVER PTX Stent vs. Bypass Surgery in Femoropopliteal Lesions, 3 year results and economic analysis.","authors":"Marc Bosiers, Gianmarco DE Donato, Giovanni Torsello, Pierre Galvagni Silveira, Koen Deloose, Dierk Scheinert, Pierfrancesco Veroux, Jeroen Hendriks, Lieven Maene, Koen Keirse, Tulio Navarro, Joren Callaert, Hans-Henning Eckstein, Jörg Tessarek, Alessia Giaquinta, Wouter van den Eynde, Jürgen Verbist, Jasmin Wahl-Gravsen","doi":"10.23736/S0021-9509.23.12607-3","DOIUrl":"https://doi.org/10.23736/S0021-9509.23.12607-3","url":null,"abstract":"<p><strong>Background: </strong>To report the 3-year safety and effectiveness results of a multicenter, prospective, randomized controlled trial comparing the ZILVER PTX paclitaxel-eluting stent to surgical bypass and to conduct a health economic analysis up to 3-year follow-up of the two treatment modalities.</p><p><strong>Methods: </strong>This is a study in symptomatic TransAtlantic Inter-Society Consensus (TASC) C and D femoropopliteal lesions comparing endovascular ZILVER PTX stenting vs. surgical bypass surgery using a prosthetic graft (ClinicalTrials.gov identifier NCT01952457). Between October 2013 and July 2017, 220 patients (mean age 68.6±10.5 years; 159 men) were enrolled and randomized to the ZILVER PTX treatment group (113, 51.40%) or the bypass treatment group (107, 48.60%). One of the secondary outcomes was primary patency at 3-year, defined as no evidence of binary restenosis or occlusion within the target lesion or bypass graft based on a duplex ultrasound peak systolic velocity ratio <2.4 and no clinically-driven target lesion revascularization (TLR) in endovascular cases or reintervention to restore flow in the bypass. An economic analysis was conducted to analyze the cost differences between ZILVER PTX and bypass, which shows the perspective of the public authority/organization that pays for healthcare in the two countries (payor), Germany and USA.</p><p><strong>Results: </strong>The 3-year primary patency rate was 53.30% (95% CI 61.40% to 45.20%) for the ZILVER PTX group vs. 58.20% (95% CI 67.10% to 49.30%) for the bypass arm (P=0.9721). Freedom from TLR at 3-year was 62.80% (95% CI 72.60% to 53%) for the ZILVER PTX group vs. 65.30% (95% CI 75.40% to 55.20%) for the bypass group (P=0.635). There was also no significant difference (P=0.358) in survival rate at 3-year between the ZILVER PTX group 78.50%, (95% CI to 87.70% to 69.30%) and the bypass group 87.40% (95% CI 97.6% to 77.2%). None of the deaths was categorized as related to the procedure or device. The economic analysis, taking into account procedural-, hospitalization- and reintervention costs, showed a clear cost-benefit for Zilver PTX in both investigated countries up to 3-year follow-up: Germany (Bypass €9446 per patient versus ZILVER PTX €5755) and USA (Bypass $26,373 per patient versus ZILVER PTX $19,186).</p><p><strong>Conclusions: </strong>The non-inferior safety and effectiveness results of the ZILVER PTX stent were associated with lower costs for the payer and confirmed that ZILVER PTX stent treatment can be considered as a valid alternative for bypass surgery in long and complex femoropopliteal lesions.</p>","PeriodicalId":50245,"journal":{"name":"Journal of Cardiovascular Surgery","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2023-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9756408","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 : 2023-08-01DOI: 10.23736/S0021-9509.23.12565-1
Piergiorgio Bruno, Maria Grandinetti, Piero Farina, Serena D'Avino, Francesca Graziani, Maria Calabrese, Rosa Lillo, Annalisa Pasquini, Giovanni Alfonso Chiariello, Federico Cammertoni, Marialisa Nesta, Natalia Pavone, Massimo Massetti
Background: In patients undergoing mitral valve surgery, restrictive suture annuloplasty (De Vega) for less-than-severe functional tricuspid regurgitation has been proven to be safe and effective. The aim of this study is to determine whether the adjunct of the plication of the posterior tricuspid leaflet with the same running suture (bicuspidized De Vega or "De Kay") is equally safe and effective.
Methods: Single center, retrospective study on patients submitted to suture repair of the tricuspid valve during mitral valve surgery, with either conventional or De Kay, between January 2014 and December 2020. Comparison was based on degree of residual tricuspid valve regurgitation and right ventricular assessment at discharge.
Results: Over the course of the study period, 255 patients undergoing mitral valve surgery had a dilated (>40 mm or >20 mm/m2) tricuspid valve annulus, with less-than-severe tricuspid regurgitation. Conventional De Vega was employed in 166 patients (65.1%) and De Kay in the remaining 89 (34.9%). At discharge the adjunct of postero-septal commissure plication has similar outcomes to the classic De Vega repair. It seems to preserve right ventricular function.
Conclusions: De Kay repair guarantees the same tricuspidal regurgitation reduction as compared with conventional De Vega early after surgery.
{"title":"Comparison of De-Kay repair versus De Vega suture for functional tricuspid regurgitation: a preliminary experience.","authors":"Piergiorgio Bruno, Maria Grandinetti, Piero Farina, Serena D'Avino, Francesca Graziani, Maria Calabrese, Rosa Lillo, Annalisa Pasquini, Giovanni Alfonso Chiariello, Federico Cammertoni, Marialisa Nesta, Natalia Pavone, Massimo Massetti","doi":"10.23736/S0021-9509.23.12565-1","DOIUrl":"https://doi.org/10.23736/S0021-9509.23.12565-1","url":null,"abstract":"<p><strong>Background: </strong>In patients undergoing mitral valve surgery, restrictive suture annuloplasty (De Vega) for less-than-severe functional tricuspid regurgitation has been proven to be safe and effective. The aim of this study is to determine whether the adjunct of the plication of the posterior tricuspid leaflet with the same running suture (bicuspidized De Vega or \"De Kay\") is equally safe and effective.</p><p><strong>Methods: </strong>Single center, retrospective study on patients submitted to suture repair of the tricuspid valve during mitral valve surgery, with either conventional or De Kay, between January 2014 and December 2020. Comparison was based on degree of residual tricuspid valve regurgitation and right ventricular assessment at discharge.</p><p><strong>Results: </strong>Over the course of the study period, 255 patients undergoing mitral valve surgery had a dilated (>40 mm or >20 mm/m<sup>2</sup>) tricuspid valve annulus, with less-than-severe tricuspid regurgitation. Conventional De Vega was employed in 166 patients (65.1%) and De Kay in the remaining 89 (34.9%). At discharge the adjunct of postero-septal commissure plication has similar outcomes to the classic De Vega repair. It seems to preserve right ventricular function.</p><p><strong>Conclusions: </strong>De Kay repair guarantees the same tricuspidal regurgitation reduction as compared with conventional De Vega early after surgery.</p>","PeriodicalId":50245,"journal":{"name":"Journal of Cardiovascular Surgery","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2023-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9745874","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 : 2023-08-01DOI: 10.23736/S0021-9509.23.12649-8
Palma M Shaw
{"title":"Editorial on current management of complex aorto-iliac occlusive disease.","authors":"Palma M Shaw","doi":"10.23736/S0021-9509.23.12649-8","DOIUrl":"https://doi.org/10.23736/S0021-9509.23.12649-8","url":null,"abstract":"","PeriodicalId":50245,"journal":{"name":"Journal of Cardiovascular Surgery","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2023-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10148027","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 : 2023-08-01DOI: 10.23736/S0021-9509.22.12462-6
Paolo Spath, Jan Stana, Giulia Marazzi, Sven Peterss, Carlota Fernandez-Prendes, Nikolaos Tsilimparis
Complicated acute nonA-nonB dissection with malperfusion is associated with a high in-hospital mortality up to 67%. Therefore, rapid identification and treatment are critical for clinical outcomes. We report the urgent treatment of a complicated subacute aortic dissection treated with a physician-modified-endograft (PMEG) fenestrated-TEVAR (f-TEVAR) for the left common carotid artery (LCCA). A 49-year-old male patient with acute non-A non-B aortic dissection with complete true lumen collapse and associated mesenteric and renal ischemia, was referred to another vascular center for abdominal pain and received exclusively medical treatment. After 15 days of persistent pain, the patient self-referred to our center and was treated with endovascular repair. The proximal entry tear was located at the level of the left subclavian artery: a PMEG f-TEVAR was performed with fenestration for LCCA in conjunction with carotid-subclavian bypass. In addition, spot stenting of the left renal artery was performed to resolve renal malperfusion. The final angiography showed satisfactory result. The patient soon reported significant pain relief. Follow-up at 30-days was satisfactory, with no need for further intervention. A physician-modified fenestrated-TEVAR can be used in emergency setting to treat acute non-A-non-B aortic dissection in conjunction with multiorgan malperfusion, with satisfactory results even after initial delayed treatment.
{"title":"Emergent physician modified carotid fenestrated TEVAR for the treatment of a complicated acute type nonA-nonB aortic dissection with undetected multiorgan malperfusion.","authors":"Paolo Spath, Jan Stana, Giulia Marazzi, Sven Peterss, Carlota Fernandez-Prendes, Nikolaos Tsilimparis","doi":"10.23736/S0021-9509.22.12462-6","DOIUrl":"https://doi.org/10.23736/S0021-9509.22.12462-6","url":null,"abstract":"<p><p>Complicated acute nonA-nonB dissection with malperfusion is associated with a high in-hospital mortality up to 67%. Therefore, rapid identification and treatment are critical for clinical outcomes. We report the urgent treatment of a complicated subacute aortic dissection treated with a physician-modified-endograft (PMEG) fenestrated-TEVAR (f-TEVAR) for the left common carotid artery (LCCA). A 49-year-old male patient with acute non-A non-B aortic dissection with complete true lumen collapse and associated mesenteric and renal ischemia, was referred to another vascular center for abdominal pain and received exclusively medical treatment. After 15 days of persistent pain, the patient self-referred to our center and was treated with endovascular repair. The proximal entry tear was located at the level of the left subclavian artery: a PMEG f-TEVAR was performed with fenestration for LCCA in conjunction with carotid-subclavian bypass. In addition, spot stenting of the left renal artery was performed to resolve renal malperfusion. The final angiography showed satisfactory result. The patient soon reported significant pain relief. Follow-up at 30-days was satisfactory, with no need for further intervention. A physician-modified fenestrated-TEVAR can be used in emergency setting to treat acute non-A-non-B aortic dissection in conjunction with multiorgan malperfusion, with satisfactory results even after initial delayed treatment.</p>","PeriodicalId":50245,"journal":{"name":"Journal of Cardiovascular Surgery","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2023-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9755335","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 : 2023-08-01DOI: 10.23736/S0021-9509.23.12697-8
Margaret C Tracci, Jeanette E Paterson
The surgical management of aortic occlusive disease can be significantly complicated by the extension of disease, or occlusion, to the level of the renal arteries. The juxtarenal occlusion necessitates careful consideration of operative exposure, technique, and the method and extent of reconstruction. While endovascular techniques have revolutionized the management of occlusive disease of the distal aorta and iliacs, both the presence of bulky, eccentric or exophytic calcification and thrombus at the level of the renal arteries increase the technical difficulty and risk of perforation, stent compromise, or embolization. Disease extending to the visceral segment often necessitates the application of lessons learned in an earlier era and techniques less familiar to the modern surgeon. We will focus on direct, rather than extraanatomic surgical reconstruction.
{"title":"Open surgical techniques for the management of complex juxtarenal aortic occlusions.","authors":"Margaret C Tracci, Jeanette E Paterson","doi":"10.23736/S0021-9509.23.12697-8","DOIUrl":"https://doi.org/10.23736/S0021-9509.23.12697-8","url":null,"abstract":"<p><p>The surgical management of aortic occlusive disease can be significantly complicated by the extension of disease, or occlusion, to the level of the renal arteries. The juxtarenal occlusion necessitates careful consideration of operative exposure, technique, and the method and extent of reconstruction. While endovascular techniques have revolutionized the management of occlusive disease of the distal aorta and iliacs, both the presence of bulky, eccentric or exophytic calcification and thrombus at the level of the renal arteries increase the technical difficulty and risk of perforation, stent compromise, or embolization. Disease extending to the visceral segment often necessitates the application of lessons learned in an earlier era and techniques less familiar to the modern surgeon. We will focus on direct, rather than extraanatomic surgical reconstruction.</p>","PeriodicalId":50245,"journal":{"name":"Journal of Cardiovascular Surgery","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2023-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9745876","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}