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Jeffrey P. Carpenter Robert Cuff Clifford Buckley Christopher Healey Sajjad Hussain Michel M.P.J. Reijnen Jose Trani Dittmar Böckler 《Journal of vascular surgery》2017,65(2):330-336.e4
Objective
The Nellix EndoVascular Aneurysm Sealing (EVAS) System (Endologix, Inc, Irvine, Calif) is a novel approach to abdominal aortic aneurysm (AAA) treatment whereby polymer is used to fill the AAA sac. We report 1-year results of the investigational device exemption pivotal trial.Methods
Eligible patients were treated at 30 sites in the United States and Europe. Inclusion criteria required an asymptomatic infrarenal AAA, with a neck length ≥10 mm and ≤60° angle, iliac artery blood lumen diameter 9 to 35 mm, access artery diameter ≥6 mm, and serum creatinine ≤2 mg/dL. Follow-up included computed tomography angiography scans at 30 days, 6 months, and 1 year that were evaluated by a core laboratory. The primary safety end point was 30-day major adverse events (MAEs), which were compared with a performance goal of <56% (the Society for Vascular Surgery open repair control group rate). The primary effectiveness end point was treatment success at 1 year, which was compared with a performance goal of >80%. Treatment success required procedural technical success and absence of AAA rupture during follow-up, conversion to open surgical repair, endoleak (type I or III) at 1 year, migration >10 mm causing complications or requiring secondary intervention, aneurysm enlargement, or secondary procedures through 1 year for resolution of endoleak, device obstruction or occlusion, or device defect.Results
Of 150 treated patients, 149 (99.3%) completed 1-year follow-up. The MAEs rate at 30 days was 2.7% (95% confidence interval, 0.7%-6.7%), satisfying the primary safety end point (<56%). The 1-year treatment success was 94% (95% confidence interval, 88.6%-97.4%), achieving the primary effectiveness end point (>80%). At 1 year, key secondary outcomes included 6.7% MAEs, 4.7% serious device-related events, 1.3% AAA-related mortality, 3.7% secondary interventions, and 0.7% surgical conversions. MAEs through 1 year included death (n = 6), stroke (n = 3), bowel ischemia (n = 2), renal failure (n = 2), respiratory failure (n = 2), and myocardial infarction (n =1). One iatrogenic AAA rupture occurred and one AAA rupture was reported during follow-up. AAA sac enlargement (>5 mm) was 1.5% at 1 year. Endoleaks were present in four patients (3.1%) at 1 year (1 type Ib and 3 type II). Migration >10 mm occurred in three patients (2.3%), but none required secondary intervention.Conclusions
Outcomes with this novel endovascular therapy for AAA, the Nellix EVAS System, are encouraging. The primary safety and effectiveness end points have been met. Low morbidity, low mortality, and high procedural and treatment success were achieved despite the inevitability of a learning curve and unique risks associated with a new device and technique. Long-term follow-up is in progress. 相似文献2.
Louise L. Blankensteijn Martijn L. Dijkstra Ignace F.J. Tielliu Michel M.P.J. Reijnen Clark J. Zeebregts 《Journal of vascular surgery》2017,65(2):303-310
Objective
The fenestrated Anaconda endograft (Vascutek, Renfrewshire, Scotland) was introduced in 2010 and showed promising short-term results with high technical success and low morbidity rates. The aim of this study was to present the midterm results, with a minimum of 12 months follow-up, for all patients treated with the fenestrated Anaconda endograft in The Netherlands.Methods
Patients treated with the fenestrated Anaconda endograft between May 2011 and February 2015 were included. Follow-up consisted of computed tomography angiography at 1 month and 1 year, and duplex ultrasound yearly thereafter with additional computed tomography angiography if indicated using a standard protocol.Results
A total of 60 patients were included; 48 patients (80.0%) were treated for juxtarenal aneurysms, and 12 (20.0%) were short-neck infrarenal aneurysms. Mean aneurysm size was 64 ± 9 mm. A total of 140 fenestrations were incorporated. Median follow-up was 16.4 months (interquartile range, 11.9-27.4). The 30-day mortality was 3.4% (n = 2). Kaplan-Meier estimates for 1-year, 2-year, and 3-year survival were 91.4%, 89.5%, and 86.3%, respectively, without aneurysm-related mortality during follow-up. Main body primary and secondary endograft patencies were 98.3% and 100%, respectively. Target vessel primary and secondary patencies were 95.0% and 98.6%, respectively. Early type IA endoleaks occurred in seven patients (11.7%) and spontaneously resolved in all patients. At 1-year follow-up 4 (6.7%) type II endoleaks persisted. One patient experienced aneurysm rupture because of a late type III endoleak attributable to a dislodged renal stent and subsequently underwent successful conversion to open surgery.Conclusions
The fenestrated Anaconda is a viable treatment option for complex abdominal aortic aneurysms. Acceptable mortality and morbidity and low reintervention rates contribute to good midterm results. Occurrence of early type I endoleak was relatively common, but these resolved spontaneously in all patients. 相似文献3.
Gabriele Piffaretti Walter Dorigo Patrizio Castelli Carlo Pratesi Raffaele Pulli 《Journal of vascular surgery》2018,67(5):1463-1471.e1
Objective
The aim of the study was to retrospectively analyze early and follow-up results of above-the-knee femoropopliteal bypasses (AKb) performed with a bioactive heparin-bonded expanded polytetrafluoroethylene (HB-ePTFE) graft in patients with peripheral arterial obstructive disease in a multicentric retrospective registry involving seven Italian vascular centers.Methods
During a 14-year period ending in March 2016, an HB-ePTFE graft was used in 1401 interventions performed for peripheral arterial obstructive disease. Comorbidities, risk factors, and follow-up outcomes were collected in a multicenter registry with a dedicated database. A post hoc analysis of the database was performed to identify 364 (25.9%) patients who underwent AKb. Early (intraoperative and <30 days) results were analyzed in terms of death, thrombosis, amputations, reinterventions, and the occurrence of major local and systemic complications. Follow-up results were analyzed by life-table analysis (Kaplan-Meier test) in terms of primary and secondary graft patency, assisted primary patency, limb preservation, and amputation-free survival. The analysis of follow-up results was stopped in December 2016.Results
In 61 (16.7%) patients, AKb was performed after the failure of a previous ipsilateral revascularization. Critical limb ischemia was present in 164 (45%) cases; the remaining patients had life-limiting intermittent claudication. Perioperative mortality occurred in three (0.8%) patients: in the hospital (n = 2) due to acute myocardial infarction and after discharge (n = 1) due to fatal arrhythmia. Early thromboses occurred in six (1.6%) patients; all these patients had primary AKb for critical limb ischemia. The cumulative rate of perioperative amputations was 0.5% (2 cases), whereas the cumulative rate of early reinterventions was 3% (11 cases). Median duration of follow-up was 28 months (range, 1-168 months); the median cumulative follow-up index for survival was 0.75 (range, 0.05-1). Estimated survival at 5 years was 75.3% (standard error [SE], 0.03). Estimated 5-year primary patency was 64% (SE, 0.04); the corresponding figure in terms of assisted primary patency was 65% (SE, 0.035). Secondary patency rate at 5 years was 74.5% (SE, 0.03). The rate of limb preservation at 5 years was 95% (SE, 0.02); the corresponding figure in terms of amputation-free survival was 74% (SE, 0.04).Conclusions
In an era of endovascular enthusiasm, with conflicting results for the treatment of long or complex lesions of the superficial femoral artery, AKb with the use of HB-ePTFE graft remains an effective option, with low rate of perioperative complications and satisfactory long-term results. 相似文献4.
Arnoud V. Kamman Jan Brunkwall Eric L. Verhoeven Robin H. Heijmen Santi Trimarchi 《Journal of vascular surgery》2017,65(4):964-971.e3
Background
The high-risk patient cohort of uncomplicated type B aortic dissections (uTBADs) needs to be clarified. We compared uTBAD patients treated with best medical treatment (BMT), with and without aortic growth, from the Acute Dissection Stent Grafting or Best Medical Treatment (ADSORB) trial database. Furthermore, we looked for trends in outcome for aortic growth and remodeling after BMT and thoracic endovascular aortic repair (TEVAR) and BMT (TEVAR+BMT).Methods
BMT patients with available baseline and a 1-year follow-up arterial computed tomography scan were identified. True lumen and false lumen diameter was assessed at baseline and at follow-up. Patients with false lumen growth (group I) and without false lumen growth (group II) were compared. Predictors of false lumen and total lumen (aortic) growth were identified. Lastly, BMT outcomes were compared with BMT+TEVAR for false lumen thrombosis and change in false lumen and total aortic diameter in four sections: 0 to 10 cm (A), 10 to 20 cm (B), 20 to 30 cm (C), and 30 to 40 cm (D) from the left subclavian artery.Results
The dissection was significantly longer in group I than in group II (43.2 ± 4.9 cm vs 30.4 ± 8.8 cm; P = .002). The number of vessels originating from the false lumen at baseline was identified as an independent predictor of false lumen growth (odds ratio, 22.1; 95% confidence interval, 1.01-481.5; P = .049). Increasing age was a negative predictor of total aortic diameter growth (odds ratio, 0.902; 95% confidence interval, 0.813-1.00; P = .0502). The proximal sections A and B showed complete thrombosis in 80.6% in the BMT+TEVAR group compared with 9.5% in the BMT group. In these sections, changes from patent to partial or partial to complete thrombosis were observed in 90.3% of the TEVAR+BMT group vs 31.0% in the BMT group. In sections C and D, the change in thrombosis was 74.1% for the TEVAR+BMT group vs 20.6% for the BMT group. The false lumen diameter increase at section C was larger in the BMT group. Total lumen diameter decreased in sections A and B in the TEVAR+BMT group compared with an increase in the BMT group (–4.8 mm vs +2.9 mm, and –1.5 mm vs +3.8 mm, respectively). Sections C and D showed minimal and comparable expansion in both treatment groups.Conclusions
The new imaging analysis of the ADSORB trial patients identified the number of vessels originating from the false lumen as an independent predictor of false lumen growth in uTBAD patients. Increasing age was a negative predictor of aortic growth. Our analysis may help to identify which uTBAD patients are at higher risk and should receive TEVAR or be monitored closely during follow-up. 相似文献5.
Sara L. Zettervall Peter A. Soden Dominique B. Buck Jack L. Cronenwett Phillip P. Goodney Mohammad H. Eslami Jason T. Lee Marc L. Schermerhorn 《Journal of vascular surgery》2017,65(5):1305-1312
Objective
Limited data exist comparing perioperative morbidity and mortality after open and endovascular abdominal aortic aneurysm (AAA) repair (EVAR) among regions of the United States. This study evaluated the regional variation in mortality and perioperative outcomes after repair of AAAs.Methods
The Vascular Quality Initiative (VQI) was used to identify patients undergoing open AAA repair and EVAR between 2009 and 2014. Ruptured and intact aneurysms were evaluated separately, and the analysis of intact aneurysms was limited to infrarenal AAAs. All 16 regions of the VQI were deidentified, and those with <100 open repairs were combined to eliminate the effect of low-volume regions. Regional variation was evaluated using χ2 and Fisher exact tests. Regional rates were compared against current quality benchmarks.Results
Perioperative outcomes from 14 regions were compared. After open repair of intact aneurysms, no significant variation was seen in 30-day or in-hospital mortality; however, multiple regions exceeded the Society for Vascular Surgery benchmark for in-hospital mortality after open repair of intact aneurysms of <5% (range, 0%-7%; P = .55). After EVAR, all regions met the Society for Vascular Surgery benchmark of <3% (range, 0%-1%; P = .75). Significant variation in in-hospital mortality existed after open (14%-63%; P = .03) and endovascular (3%-32%; P = .03) repair of ruptured aneurysms across the VQI regional groups. After repair of intact aneurysms, wide variation was seen in prolonged length of stay (>7 days for open repair: 32%-53%, P = .54; >2 days for EVAR: 16-43%, P < .01), transfusion (open: 10%-35%, P < .01; EVAR: 7%-18%, P < .01), use of vasopressors (open: 19%-37%, P < .01; EVAR: 3%-7%, P < .01), and postoperative myocardial infarction (open: 0%-13%, P < .01; EVAR: 0%-3%, P < .01). After open repair, worsening renal function (6%-18%; P = .04) and respiratory complications (6%-20%; P = .20) were variable across regions. The frequency of endoleak at completion of EVAR also had considerable variation (15%-38%; P < .01).Conclusions
Despite limited variation, multiple regions do not meet current benchmarks for in-hospital mortality after open AAA repair for intact aneurysms. Significant regional variation exists in perioperative outcomes and length of stay, and mortality is widely variable after repair for rupture. These data identify important areas for quality improvement initiatives and clinical practice guidelines. 相似文献6.
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K.Y. Kim J.-H. Cho H.-Y. Jung J.-Y. Choi S.-H. Park C.-D. Kim Y.-L. Kim H. Ro S. Lee S.-Y. Han C.W. Jung J.B. Park M.S. Kim J. Yang C. Ahn 《Transplantation proceedings》2017,49(5):1038-1042
Background
A higher body mass index (BMI) before kidney transplantation (KT) is associated with increased mortality and allograft loss in kidney transplant recipients (KTRs). However, the effect of changes in BMI after KT on these outcomes remains uncertain. The aim of this study was to investigate the effect of baseline BMI and changes in BMI on clinical outcomes in KTRs.Methods
A total of 869 KTRs were enrolled from a multicenter observational cohort study from 2012 to 2015. Patients were divided into low and high BMI groups before KT based on a BMI cutoff point of 23 kg/m2. Differences in acute rejection and cardiovascular disease (CVD) between the 2 groups were analyzed. In addition, clinical outcomes across the 4 BMI groups divided by BMI change 1 year after KT were compared. Associations between BMI change and laboratory findings were also evaluated.Results
Patients with a higher BMI before KT showed significantly increased CVD after KT (P = .027) compared with patients with a lower BMI. However, among the KTRs with a higher baseline BMI, only persistently higher BMI was associated with increased CVD during the follow-up period (P = .003). Patients with persistently higher BMI had significantly decreased high-density lipoprotein cholesterol and increased hemoglobin, triglyceride, and hemoglobin A1c levels. Baseline BMI and post-transplantation change in BMI were not related to acute rejection in KTRs.Conclusions
BMI in the 1st year after KT as well as baseline BMI were associated with CVD in KTRs. More careful monitoring of obese KTRs who do not undergo a reduction in BMI after KT is required. 相似文献12.
Peter A. Soden Sara L. Zettervall Katie E. Shean Sarah E. Deery Jeffrey A. Kalish Christopher T. Healey Nikhil Kansal Marc L. Schermerhorn 《Journal of vascular surgery》2017,65(3):711-719.e1
Background
Isolated common femoral endarterectomy was recently reported to have a 30-day mortality of 3.4%. The effect of adjunctive femoral endarterectomy at the time of lower extremity bypass is not well described, and therefore, the purpose of this study was to determine its associated perioperative and long-term risk.Methods
Vascular Study Group of New England registry data were used to identify patients undergoing initial lower extremity bypass from 2003 to 2015. After univariate analysis, multivariable logistic regression was used to identify the independent association of endarterectomy with adverse perioperative events. Kaplan-Meier and Cox hazard models were used for the 1-year analysis.Results
After exclusions, 4496 patients were identified as undergoing infrainguinal bypass (33% with endarterectomy). There was no difference in the proportion with chronic limb-threatening ischemia (CLI; 68% vs 67%; P = .24) or tissue loss of those with CLI (65% vs 63%; P = .34) between the adjunctive endarterectomy group and bypass alone, respectively. Patients undergoing adjunctive endarterectomy were older (mean 68 years vs 67 years; P = .02), more likely white (95% vs 93%; P = .02), smokers (91% vs 87%; P = .001), and more often had prior coronary artery bypass grafting/percutaneous coronary intervention (34% vs 31%; P = .02). The endarterectomy cohort had similar 30-day mortality (CLI: 2.6% vs 2.9%; P = .60; claudication: 0.2% vs 0.4%; P = 1.0) despite a longer operative time (median, 268 minutes vs 210 minutes; P < .001) and increased blood loss (median, 250 mL vs 180 mL; P < .001). Patients with CLI undergoing adjunctive endarterectomy had more in-hospital myocardial infarctions (MIs; 6.2% vs 3.8%; P = .003) and transfusions (11% vs 6.8%; P < .001). At 1-year, this group had a suggestion of improved freedom from major amputation (91% vs 87%; P = .049) and amputation-free survival (80% vs 76%; P = .03) that did not reach significance after adjustment. For patients with claudication and adjunctive endarterectomy, rates of MI (2.4% vs 0.9%; P = .02), renal dysfunction (3.6% vs 1.4%; P = .01), surgical site infection (SSI; 5.0% vs 2.6%; P = .02), and transfusion (4.6% vs 1.8%; P = .002) were higher. After adjustment, all patients undergoing adjunctive endarterectomy were at increased risk of MI (odds ratio [OR], 1.6; 95% confidence interval [CI], 1.1-2.2), SSI (OR, 1.5; 95% CI, 1.1-2.0), and bleeding requiring transfusion (OR, 1.8; 95% CI, 1.4-2.3). There were no differences in 1-year survival for CLI or claudication groups and no difference in all 1-year end points for patients with claudication.Conclusions
Adjunctive femoral endarterectomy with bypass is safe, with no difference in perioperative or 1-year mortality compared with bypass. However, surgeons should be aware that adjunctive endarterectomy is associated with an increased risk of bleeding, SSI, and MI, likely from these patients' disease burden and presumed more extensive atherosclerosis. 相似文献13.
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Saurabh Saluja Benedict Nwomeh Samuel R.G. Finlayson AiXuan L. Holterman Randeep S. Jawa Sudha Jayaraman Catherine Juillard Sanjay Krishnaswami Swagoto Mukhopadhyay Jennifer Rickard Thomas G. Weiser George P. Yang Mark G. Shrime 《Surgery》2018,163(2):463-466
Global surgery is an emerging academic discipline that is developing in tandem with numerous policy and advocacy initiatives. In this regard, academic global surgery will be crucial for measuring the progress toward improving surgical care worldwide. However, as a nascent academic discipline, there must be rigorous standards for the quality of work that emerges from this field. In this white paper, which reflects the opinion of the Global Academic Surgery Committee of the Society for University Surgeons, we discuss the importance of research in global surgery, the methodologies that can be used in such research, and the challenges and benefits associated with carrying out this research. In each of these topics, we draw on existing examples from the literature to demonstrate our points. We conclude with a call for continued, high-quality research that will strengthen the discipline's academic standing and help us move toward improved access to and quality of surgical care worldwide. 相似文献
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Naoya Yokota Tetsuhiko Go Atsushi Fujiwara Ayumu Kato Yasuhiro Otsuki Hiroyasu Yokomise 《The Annals of thoracic surgery》2021,111(2):436-439
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Joep G.J. Wijnand Martin Teraa Hendrik Gremmels Femke C.C. van Rhijn-Brouwer Gert J. de Borst Marianne C. Verhaar 《Journal of vascular surgery》2018,67(2):656-661
Background
Critical limb ischemia (CLI) represents the most severe form of peripheral artery disease and has an immense impact on quality of life, morbidity, and mortality. A considerable proportion of CLI patients are ineligible for revascularization, leaving amputation as the only option. Mesenchymal stromal cells (MSCs), because of their vasculoregenerative and immunomodulatory characteristics, have emerged as a potential new treatment.Methods
The primary objective of this trial is to investigate whether intramuscular administration of allogeneic bone marrow (BM)-derived MSCs is safe and potentially effective. The SAIL (allogeneic mesenchymal Stromal cells for Angiogenesis and neovascularization in no-option Ischemic Limbs) trial is a double-blind, placebo-controlled randomized clinical trial to investigate the effect of allogeneic BM-MSCs in patients with CLI who are not eligible for conventional revascularization. A total of 66 patients will be included and randomized (1:1) to undergo 30 intramuscular injections with either BM-MSCs (5 × 106 MSCs per injection) or placebo in the ischemic lower extremity. Primary outcome, that is, therapy success, a composite outcome consisting of mortality, limb status, clinical status, and changes in pain score, will be assessed at 6 months. All study-related procedures will take place in the University Medical Center Utrecht in The Netherlands.Conclusions
If our results indicate that intramuscular allogeneic BM-MSC therapy for CLI is safe and potentially effective, this will have important consequences for treatment of patients with CLI. A large multicenter clinical trial with longer follow-up focusing on hard end points should then be initiated to confirm these findings. 相似文献18.
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