Sebastian Debus

Current practice of first-line treatment strategies in patients with critical limb ischemia.

OBJECTIVE Critical limb ischemia (CLI) is growing in global prevalence and is associated with high rates of limb loss and mortality. However, a relevant gap of evidence about the most optimal treatment strategy still exists. The aim of this study of the prospective, multicenter First-Line Treatments in Patients With Critical Limb Ischemia (CRITISCH) registry was to assess the current practice of all first-line treatments strategies in CLI patients in German vascular centers. METHODS Between January 2013 and September 2014, five first-line treatment strategies-endovascular revascularization (ER), bypass surgery (BS), femoral/profundal artery patchplasty (FAP), conservative treatment, and primary amputation-were determined among CLI patients in 27 vascular tertiary centers. The main composite end point was major amputation or death, or both, during the hospital stay. Secondary outcomes were hemodynamic failure, major adverse cardiovascular and cerebral events, and reintervention. Univariate logistic models were additionally built to preselect possible risk factors for either event, which were then used as candidates for a multivariate logistic model. RESULTS The study included 1200 consecutive patients. First-line treatment of choice was ER in 642 patients (53.4%), BS in 284 (23.7%), FAP in 126 (10.5%), conservative treatment in 118 (9.8%), and primary amputation in 30 (2.5%). The composite end point was met in 24 patients (4%) after ER, in 17 (6%) after BS, in 8 (6%) after FAP, and in 9 (8%) after conservative treatment (P = .172). The highest rate of in-hospital death was observed after primary amputation (10%) and of hemodynamic failure after conservative treatment (91%). Major adverse cardiovascular and cerebral events developed in 4% of patients after ER, in 5% after BS, in 6% after FAP, in 5% after conservative treatment, and in 13% after primary amputation. The reintervention rate was 8%, 14%, 6%, 5%, and 3% in each group, respectively. In the multivariate regression model, coronary artery disease (odds ratio [OR], 2.96; 95% confidence interval [CI], 1.42-6.17) and previous myocardial infarction (PMI) <6 months (OR, 3.67, 95% CI, 1.51-8.88) were identified as risk factors for the composite end point. Risk factors for amputation were dialysis (OR, 3.31, 95% CI, 1.44-7.58) and PMI (OR, 3.26, 95% CI, 1.23-8.36) and for death, BS compared with ER (OR, 3.32; 95% CI, 1.10-10.0), renal insufficiency without dialysis (OR, 6.34; 95% CI, 1.71-23.5), and PMI (OR, 7.41; 95% CI, 2.11-26.0). CONCLUSIONS The CRITISCH registry revealed ER as the most common first-line approach in CLI patients. Coronary artery disease and PMI <6 months were independent risk factors for the composite end point. Special attention should be also paid to CLI patients with renal insufficiency, with or without dialysis, and those undergoing BS.

Quality of Care in Chronic Leg Ulcer in the Community: Introduction of Quality Indicators and a Scoring System

Background: Treatment of chronic wounds is complex, particularly as a standard for the assessment and evaluation of quality of care is missing. Objectives: To develop indicators for quality of care in chronic wounds in general, and to evaluate the quality of care in leg ulcers in Hamburg, Germany, in particular. Methods: Twenty indicators were derived from a national Delphi expert consensus to compute a single index of quality of care. This index was applied in a cross-sectional study involving a large spectrum of care providers and leg ulcer patients in the community. Trained wound experts interviewed and examined the patients, who had to complete standardized questionnaires. Results: On average, 64% of the quality criteria were met in the consecutive sample of 502 patients with chronic leg ulcers of any origin; 75% of the patients were satisfied with their wound care. Predictors of quality of care are presented. Conclusions: This instrument is feasible, valid and ready for comparisons of patient groups, regions and care systems, and for optimization processes in wound care.

Thyrotropin-Releasing Hormone (TRH) Promotes Wound Re-Epithelialisation in Frog and Human Skin

There remains a critical need for new therapeutics that promote wound healing in patients suffering from chronic skin wounds. This is, in part, due to a shortage of simple, physiologically and clinically relevant test systems for investigating candidate agents. The skin of amphibians possesses a remarkable regenerative capacity, which remains insufficiently explored for clinical purposes. Combining comparative biology with a translational medicine approach, we report the development and application of a simple ex vivo frog (Xenopus tropicalis) skin organ culture system that permits exploration of the effects of amphibian skin-derived agents on re-epithelialisation in both frog and human skin. Using this amphibian model, we identify thyrotropin-releasing hormone (TRH) as a novel stimulant of epidermal regeneration. Moving to a complementary human ex vivo wounded skin assay, we demonstrate that the effects of TRH are conserved across the amphibian-mammalian divide: TRH stimulates wound closure and formation of neo-epidermis in organ-cultured human skin, accompanied by increased keratinocyte proliferation and wound healing-associated differentiation (cytokeratin 6 expression). Thus, TRH represents a novel, clinically relevant neuroendocrine wound repair promoter that deserves further exploration. These complementary frog and human skin ex vivo assays encourage a comparative biology approach in future wound healing research so as to facilitate the rapid identification and preclinical testing of novel, evolutionarily conserved, and clinically relevant wound healing promoters.

Registry and health insurance claims data in vascular research and quality improvement

The expansion of procedures in multidisciplinary vascular medicine has sparked a controversy regarding measures of quality improvement. In addition to primary registries, the use of health insurance claims data is becoming of increasing importance. However, due to the fact that health insurance claims data are not collected for scientific evaluation but rather for reimbursement purposes, meticulous validation is necessary before and during usage in research and quality improvement matters. This review highlights the advantages and disadvantages of such data sources. A recent comprehensive expert opinion panel examined the use of health insurance claims data and other administrative data sources in medicine. Results from several studies concerning the validity of administrative data varied significantly. Validity of these data sources depends on the clinical relevance of the diagnoses considered. The rate of implausible information was 0.04 %, while the validity of the considered diagnoses varied between 80 and 97 % across multiple validation studies. A matching study between health insurance claims data of the third-largest German health insurance provider, DAK-Gesundheit, and a prospective primary registry of the German Society for Vascular Surgery demonstrated a good level of validity regarding the mortality of endovascular and open surgical treatment of abdominal aortic aneurysm in German hospitals. In addition, a large-scale international comparison of administrative data for the same disorder presented important results in treatment reality, which differed from those from earlier randomized controlled trials. The importance of administrative data for research and quality improvement will continue to increase in the future. When discussing the internal and external validity of this data source, one has to distinguish not only between its intended usage (research vs. quality improvement), but also between the included diseases and/or treatment procedures. Linkage between primary registry data and administrative data could be a reasonable solution to some current major issues of validity.
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Hemodynamic impact of transseptal access to the ascending aorta in a porcine model.

Purpose To evaluate the hemodynamic impact of transseptal sheath access to the ascending aorta using increasing sheath diameters. Methods Transseptal puncture was performed in 6 pigs (62 ± 9 kg) facilitating guidewire passage across the left heart to the descending aorta to establish transseptal through-and-through access into the ascending aorta. Hemodynamic parameters were evaluated during 6- to 16-F sheath deployments and after sheath retraction according to a standardized protocol. Fluorescent microspheres were injected for quantitative assessment of myocardial and cerebral perfusion and left-right shunting volume. Results Cardiac output, heart rate, and central venous pressure (CVP) were stable throughout the study in all animals. The ratio between pulmonary artery pressure and mean arterial pressure was significantly higher during sheath deployment compared to after retraction (p<0.01), indicating transient mitral valve insufficiency. The ratio between left atrial pressure and CVP was significantly higher with the sheath in place (p<0.01), signaling transient left-right shunting; the hemodynamic alteration disappeared after sheath retraction. Myocardial perfusion (p=0.224), cerebral perfusion (p=0.209), and left-right shunting volume (p=0.111) were not significantly affected by the transseptal access. Conclusion Transseptal access to the ascending aorta in a porcine model is feasible without persisting hemodynamic impairment or severe influence on myocardial or cerebral perfusion even with up to 16-F sheaths. Potential adverse effects need to be addressed before clinical use of this alternative access to the ascending aorta, aortic arch, and its side branches.

New Advances in Endovascular Therapy: Endovascular Repair of a Chronic DeBakey Type II Aortic Dissection With a Scalloped Stent-Graft Designed for the Ascending Aorta.

Purpose: To describe the deployment into the ascending aorta of a fenestrated stent-graft with a scallop for the innominate artery. Technique: A 72-year-old multimorbid patient presented with a chronic DeBakey type II aortic dissection of the ventral ascending aorta with close proximity (16 mm) to the innominate artery. A 1-piece, 46-mm-diameter Zenith Ascend Thoracic Endovascular Graft with circumferential diameter-reducing sutures (ProForm) was custom made with a 15×30-mm scallop for the innominate artery. The stent-graft was loaded on a Z-Trak Plus Introducer System with a 20-F hydrophilic-coated sheath and successfully implanted under inflow occlusion in a procedure that lasted 35 minutes. Conclusion: The use of fenestrated stent-grafts in the ascending aorta is feasible, and a scallop in the distal stent-graft can extend coverage of the ascending aorta in pathologies close to the innominate artery. This technique broadens the range of endovascular options for patients not suitable for open surgery.

Quality Improvement in Vascular Surgery: The Role of Comparative Audit and Vascunet

Most nations with developed healthcare systems have a strong interest in audit, both for financial and clinical quality control. Whereas financial control has been a key political requirement for managing healthcare, the use of clinical outcome data has, until recently, taken more of a back seat. Clinical audit has a long history of describing outcomes and challenging established attitudes or practice. Responses to published audits vary. Some clinicians voice criticism of bias as a result of selective reporting, either from a few units, or because of incomplete datasets. Attitudes have gradually changed with improved understanding of the role of audit as a tool to examine and refine standards of practice. This has been accompanied by a growth in clinical audit across all branches of medicine. The turn of the century marked a shift towards more widespread clinical audit, with development of political interest in using quality to justify or contain costs. The advent of organisations such as the National Institute for Clinical Excellence (NICE) in the UK saw a growth in the use of research and audit to set standards both for outcomes and processes of care. A good example of this in vascular surgery is the NICE clinical guideline 68, which sets out clear standards for assessment, referral, and treatment of patients with TIA and minor stroke. These standards are incorporated into national audits in Europe and reporting now encompasses both outcomes and performance indicators such as timeliness of surgery and cranial nerve injury. Such reporting has driven improvement in quality of services by focussing clinicians on key components of highquality pathways of care. Vascunet was formed in 1997 as a collaboration of national registries in Europe, New Zealand, and the state of Victoria in Australia, with its first report produced in 2007. Since then, the Vascunet group have published comparative data on carotid surgery, abdominal aortic aneurysm, lower limb bypass, and popliteal artery aneurysm. One of the key features of these publications has been to describe the variation in clinical practice across neighbouring countries, notable examples being rates of surgery for asymptomatic stenosis and rates of lower limb bypass for intermittent claudication. Variation in outcomes is also reported at a national level. The value of such reporting was demonstrated by the 2008 Vascunet report. This demonstrated outlying mortality

2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with the European Society for Vascular Surgery (ESVS)

* Corresponding authors: Victor Aboyans, Department of Cardiology CHRU Dupuytren Limoges, 2 Avenue Martin Luther King, 87042 Limoges, France. Tel: þ33 5 55 05 63 10, Fax: þ335 55 05 63 34, Email: vaboyans@live.fr. Jean-Baptiste Ricco, Department of Vascular Surgery, University Hospital, rue de la Miletrie, 86021 Poitiers, France. Tel: þ33 549443846, Fax: þ33 5 49 50 05 50, Email: jeanbaptistericco@gmail.com

Association between statin therapy and amputation-free survival in patients with critical limb ischemia in the CRITISCH registry

Objective Secondary prevention in patients with critical limb ischemia (CLI) is crucial for the reduction of cardiovascular morbidity and mortality. Nonetheless, current recommendations are extrapolated from other high‐risk populations because of the lack of CLI‐dedicated trials. The aim of this explorative study was to evaluate the association of statin therapy with the outcomes of CLI patients. Methods The First‐Line Treatments in Patients With Critical Limb Ischemia (CRITISCH) registry is a prospective multicenter registry analyzing the effectiveness of all available treatment strategies in 1200 CLI patients. For the purposes of this analysis, patients were divided into two groups based on statin administration. Treatment crossovers and nonadherent patients were excluded from analysis. The primary composite end point of this study was the amputation‐free survival (AFS). Major adverse cardiovascular and cerebral events (MACCEs), time to death, and time to major amputation were also analyzed. Results Statin therapy was applied in 445 individuals (37%), 371 (31%) patients received no statins, and 384 subjects were excluded from analysis (treatment crossovers). Patients receiving statins were more likely to be younger (P < .001) and to have a history of coronary heart disease (P < .001) or previous intervention at index limb (P < .001). Patients receiving statin therapy had a lower hazard regarding AFS (hazard ratio [HR], 0.45; 95% confidence interval [CI], 0.34‐0.63; P < .001) and death (HR, 0.40; 95% CI, 0.24‐0.66; P < .001) as well as lower odds of MACCE (odds ratio, 0.41; 95% CI, 0.23‐0.69; P = .001). However, statin therapy was not associated with reduced amputation rates (HR, 1.02; 95% CI, 0.67‐1.56; P = .922). Statin effect on AFS was consistent among diabetics (HR, 0.47; 95% CI, 0.31‐0.70; P < .001), patients with chronic kidney disease (HR, 0.53; 95% CI, 0.32‐0.87; P = .012), and patients older than 75 years (HR, 0.40; 95% CI, 0.26‐0.60; P < .001). Statin administration was also associated with an improved AFS in patients with antiplatelet medication (HR, 0.64; 95% CI, 0.41‐0.99; P = .049) and without antiplatelet medication (HR, 0.26; 95% CI, 0.12‐0.57; P = .001) and after both endovascular therapy (HR, 0.51; 95% CI, 0.34‐0.76; P = .001) and bypass revascularization (HR, 0.38; 95% CI, 0.21‐0.68; P = .001). Conclusions Statin therapy in CLI patients is associated with an increased AFS and lower rates of mortality and MACCEs without improving, however, the salvage rates of the affected limb.

Right brachial access is safe for branched endovascular aneurysm repair in complex aortic disease

Background: The risk of perioperative cerebrovascular events in endovascular repair of thoracic and thoracoabdominal aneurysms is reported from 2% to 15%. The unavoidable use of an upper extremity access during branched endovascular aneurysm repair (b‐EVAR) may play a role in embolic brain injuries. For this reason, some advocate the use of a left‐sided upper access to avoid crossing the origin of supra‐aortic vessels. However, the assumption that right brachial access has a higher risk for stroke during b‐EVAR has not been confirmed in the literature. Methods: This study retrospectively analyzed all consecutive patients treated by b‐EVAR with right brachial access at a single institution. A through‐and‐through right‐brachiofemoral 0.014‐inch wire was used to stabilize the sheath across the arch in all cases. End point of the study was the incidence of cerebrovascular events. Results: We identified 61 patients (65.6% male) during a 4‐year period. Mean age at the time of surgery was 70.4 years (range, 53‐87 years). The most common indication for treatment was type II (32.8%), followed by type IV thoracoabdominal aortic aneurysms (23%). There were 20 urgent (32.8%) and 41 elective (67.2%) procedures. Two perioperative ischemic strokes occurred in the first postoperative day in two men (3.3%; 95% confidence interval, 0.397‐11.84). No further ischemic strokes occurred perioperatively. There was no statistically significant association between the occurrence of postoperative stroke and any of the perioperative characteristics. No significant association was found between the duration of the procedure and the end point. In both patients with embolic events, the use of a left arm approach would not have been feasible due to coverage of the left subclavian artery ostium. Conclusions: The postoperative stroke rate in b‐EVAR with the use of a right brachial access in our experience was in line with the literature for treatment of thoracic and thoracoabdominal aortic aneurysms. We conclude that the right brachial access with the use of a stabilizing through‐and‐through wire is a safe approach during b‐EVAR.