Assessing the institutional learning curve for pararenal aortic repair using the fenestrated Anaconda endograft.

OBJECTIVE: Custom-made fenestrated aortic endografts allow exclusion of pararenal aortic aneurysms while maintaining blood flow to aortic branches. Meticulous device planning and precise deployment of the main body are essential to allow successful cannulation of the fenestrations. This study investigates whether a learning curve can be observed with more reliable cannulation and connection of fenestrations over time at a single department of vascular and endovascular surgery with multiple surgeons trained to use the device. METHODS: A retrospective analysis of data from all patients undergoing primary fenestrated endovascular aneurysm repair during the study period was performed. Outcome measures included case volume and average number of fenestrations over time, average fluoroscopy dose area product per calendar year and primary unconnected fenestration and 30-day mortality rates. RESULTS: Between 1 January 2013 and 31 December 2016, 89 patients with no history of endovascular aneurysm repair underwent fenestrated endovascular aneurysm repair at our institution. The number of fenestrations per case increased over time, averaging 2.6 in 2013 and 3.3 in 2016. Primary unconnected fenestration and 30-day mortality rates were 5.6%. Primary-assisted technical success was 93.3%, secondary-assisted technical success was 94.4%. Fluoroscopy dose area product declined over the study period. Thirty-day mortality and primary unconnected fenestration rates did not significantly change over the study period. CONCLUSION: Albeit the reduction in lethal complications and primary technical success rates were not statistically significant, a lower percentage of unconnected fenestrations and 30-day mortality per calendar year were observed over time. At the same time, an increasing complexity of performed cases, as reflected by an increasing number of fenestrations per case, was observed. Complications associated with this complex endovascular procedure are potentially lethal and remain an unfortunate reality and may not be entirely dependent on overcoming a learning curve. A higher volume of cases performed over the study period and a reduction in fluoroscopy use can be considered a representation of the institutional development and learning curve for the Anaconda fenestrated endograft at a department with prior complex endovascular aortic repair experience, but due to limitations of the current retrospective observation, deserve further consideration in future trials, ideally designed in a prospective fashion.

Randomized controlled trial comparing the combination of a polymeric membrane dressing plus negative pressure wound therapy against negative pressure wound therapy alone: The WICVAC study.

Negative pressure wound therapy (NPWT) is the treatment of choice for chronic wounds; yet, it is associated with considerable workload. Prompted by its nonadhesive and wound-healing properties, this study investigated the effect of an additional polymeric membrane interface dressing (PMD; PolyMem WIC) in NPWT. From October 2011 to April 2013, 60 consecutive patients with chronic leg wounds or surgical site infections after revascularization of lower extremities were randomly allocated to either treatment with conventional NPWT (control arm) or NPWT with an additional PMD (intervention arm). The primary outcome was wound healing achieved within 30 days, the secondary endpoints included: number of days between dressing changes, wound-related pain, cost efficiency, and occurrence of adverse events (ClinTrials.gov Identifier: NCT02399722). Forty-seven patients completed follow-up. No difference in wound healing was observed (p > 0.05) between both study arms. The additional PMD allowed significantly longer wearing times (days) between dressing changes (intervention: 8.8 ± 0.5, control: 4.8 ± 0.2; p < 0.001). Pain was slightly higher in patients randomized to NPWT alone (VAS score: 4.8 ± 2.9) compared to NPWT + PMD (VAS score: 3.0 ± 2.9, p = 0.063). No wound infections were observed. Costs were reduced by 34% per patient in the intervention arm. These results suggest that the combination of NPWT and an additional interface PMD is a safe and economic method for the treatment of chronic wounds, which requires significantly fewer dressing changes for a comparable wound healing.

A prospective, randomised study of a novel transforming methacrylate dressing compared with a silver-containing sodium carboxymethylcellulose dressing on partial-thickness skin graft donor sites in burn patients.

This prospective, randomised study compares a new transforming methacrylate dressing (TMD) with a silver-containing carboxymethylcellulose dressing (CMC-Ag) after application to split-thickness skin graft (STSG) donor sites. This was an unblinded, non-inferiority, between-patient, comparison study that involved patients admitted to a single-centre burn unit who required two skin graft donor sites. Each patient's donor sites were covered immediately after surgery: one donor site with TMD and the other with CMC-Ag. The donor sites were evaluated until healing or until 24 days post-application, whichever came first. Study endpoints were time to healing, daily pain scores, number of dressing changes, patient comfort and physicians' and patients' willingness to use the dressings in the future. Nineteen patients had both the dressings applied. No statistically significant difference was noted in time to healing between the two dressings (14·2 days using TMD compared with 13·2 days using CMC-Ag). When pain scores were compared, TMD resulted in statistically significantly less pain at three different time periods (2-5 days, 6-10 days and 11-15 days; P < 0·001 at all time periods). Patients also reported greater comfort with TMD (P < 0·001). Users rated TMD as being less easy to use because of the time and technique required for application. Reductions in pain and increased patient comfort with the use of the TMD dressing, compared with CMC-Ag, were seen as clinical benefits as these are the major issues in donor site management.

Homocysteine improves risk stratification in patients undergoing endarterectomy for asymptomatic internal carotid artery stenosis.

BACKGROUND AND PURPOSE: A limited life expectancy reduces the benefit from carotid endarterectomy (CEA) for treatment of asymptomatic internal carotid artery stenosis. The aim of this study was to assess homocysteine as stratifying biomarker to improve prediction of postoperative survival. METHODS: This was a prospective, nonrandomized case series from 2003 to 2012. Two hundred and fourteen consecutive patients (<75 years, n=130; ≥75 years, n=84) undergoing CEA for their asymptomatic internal carotid artery stenosis were observed for 8.5 years for the occurrence of death after CEA as primary end point (EC-nr: 04-067-0604). Homocysteine and major cardiovascular risk factors were used for computation of prognostic indices. Cumulative survival of prognostic indices-based quintiles was estimated by Kaplan-Meier curves. RESULTS: Total homocysteine had a significant effect on postoperative survival (P<0.0001). Total homocysteine-based quintiles of prognostic indices showed a better prediction of the survival of the patients than age alone. This caused reclassification of 17 patients (20.2%)>75 years as fit for surgery, but also indicated a high risk for 19 patients (14.6%)<75 years. In the majority (79.8%) of patients aged>75 years, statistically, CEA could not be advised because of a significantly reduced 5-year survival rate. CONCLUSIONS: High plasma homocysteine levels suggest that older patients with asymptomatic carotid stenosis might rather benefit from intensive medical therapy than from CEA.

N-terminal pro B-type natriuretic peptide (NT pro-BNP) is a predictor of long-term survival in male patients of 75 years and older with high-grade asymptomatic internal carotid artery stenosis.

BACKGROUND: Carotid endarterectomy (CEA) is commonly performed for asymptomatic high-grade internal carotid artery (ICA) stenosis to prevent stroke. However, despite advancing age of the society, for patients older than 75 years, there is no recommendation by the European guidelines for CEA, as this age group might not benefit from this intervention due to a limited life expectancy. OBJECTIVE: We assessed N-terminal pro B-type natriuretic peptide (NT pro-BNP) as a predictive marker for long-term survival in this particular patient population in order to stratify patients for an improved surgical outcome. METHODS: In a nonrandomized single-center clinical trial, we prospectively studied mortality rates of 205 consecutive patients (80 women, 125 men; mean age, 75 ± 10 years) with asymptomatic high-grade ICA stenosis in relation to preoperative plasma NT pro-BNP levels. We estimated cumulative survival over 5 years by Kaplan-Meier curves and established a proportional hazard-model by Cox regression. RESULTS: In male patients, higher levels of preoperative NT pro-BNP levels were associated with a significantly increased long-term mortality. Those 75 years or older had the same survival rate as younger patients, if NT pro-BNP levels were low, making them thus eligible for CEA. CONCLUSIONS: The results of our study suggest that preoperative plasma levels of NT pro-BNP are a valuable tool for the stratification of male patients. Male patients older than 75 years with low levels of NT pro-BNP should be referred for carotid revascularization, as they will most likely enjoy the benefit of surgery.