Peripheral arterial disease (PAD) - A challenging manifestation of atherosclerosis.

The diagnosis of peripheral arterial disease (PAD) is not always evident as symptoms and signs may show great variation. As all grades of PAD are linked to both an increased risk for cardiovascular complications and adverse limb events, awareness of the condition and knowledge about diagnostic measures, prevention and treatment is crucial. This article presents in a condensed form information on PAD and its management.

[Diabetic foot syndrome-Part 2 : Revascularization, treatment alternatives, care structures, recurrency prophylaxis]. / Diabetisches Fußsyndrom ­ Teil 2 : Revaskularisation, Behandlungsalternativen, Versorgungsstrukturen, Rezidivprophylaxe.

Diabetic foot syndrome (DFS) is the most frequent reason for major amputations in Germany. The majority of foot lesions are triggered by repetitive pressure in diabetic polyneuropathy. Peripheral arterial occlusive disease (PAOD) impairs wound healing and is the main risk factor for amputations. The treatment of wounds and infections as well as timely revascularization are decisive. The use of endovascular and vascular surgical methods depends on the distribution pattern and length of the occlusion processes. Both procedures are complementary. Bypass surgery is of great importance for neuroischemic DFS. Multidisciplinary centers that provide revascularization in DFS can achieve an improvement of arterial blood flow in 90% of the cases and reduce the amputation rate by up to 80%. Due to the high recurrence rate of diabetic foot lesions, measures for secondary prophylaxis are of exceptional importance (podological and orthopedic technical care, foot surgery).

[Diabetic foot syndrome-Part 1 : Definition, pathophysiology, diagnostics and classification]. / Diabetisches Fußsyndrom ­ Teil 1 : Definition, Pathophysiologie, Diagnostik und Klassifikation.

There are ca. 8 million persons with diabetes mellitus living in Germany. A late sequelae of diabetes is the diabetic foot syndrome (DFS), the prevalence of which is greatly increasing. It comprises all alterations of the foot as a result of diabetic polyneuropathy as well as microvascular and macrovascular (peripheral arterial occlusive disease, PAOD) alterations. Many of the ca. 250,000 newly diagnosed diabetic foot ulcers per year become chronic wounds. Despite intensive efforts for prevention, early diagnosis and adequate wound care, ca. 13,000 persons with diabetes undergo major limb amputation in Germany every year. With consistent treatment in interdisciplinary centers and by exhausting all possible methods of wound treatment, pressure relief as well as arterial revascularization, the major amputation rate in patients with diabetic foot problems can be reduced by 80%. With a suitable strategy of prevention, the recurrence rate of foot ulcers would be reduced.

Big data in vascular surgery: registries, international collaboration and future directions.

Given the increasing availability of large data set, small single-institutional series raise decreasing attention. Rapid expansion of technology from electronic medical records to easily accessible internet access, and widespread use and acceptance of registries in the medical world has allowed for research and quality improvement efforts using 'big data'. Big data, although technically not defined, typically refers to large databases that can be used to investigate common or rare disease processes or outcomes, describe variation in clinical practices across and between different specialties at various practice location, whilst allowing important information about trends over time. Big data have allowed investigators to quickly assimilate cohorts of patients and/or procedures to answer current questions, with more complete population representation and improved generalizability whilst decreasing the likelihood of power problems and type II errors. On the other hand, pitfalls still exist with the growing problem of hypothesis fishing, lack of granularity and the fear by many clinicians that registry transparency may have already gone too far, where surgery groups or individual surgeon outcomes are readily available to patients and referring providers. Within vascular surgery specifically, big data have expanded over the last decade and now includes regional, national and global registries that have major benefits of gathering specific clinical and procedural information within vascular surgery. In this review, we highlight the main vascular surgery registries and recap a few success stories of how the registries have been leveraged to benefit discovery, quality improvement and ultimately patient care. Additionally, we outline future directions that will be imperative for continued expansion, acceptance and adoption of 'big data' utilization inpatients with vascular disease.

Erratum to: Complex endovascular treatment of intact aortic aneurysms. An analysis of health insurance claims data.

[This corrects the article DOI: 10.1007/s00772-018-0387-7.].

Complex endovascular treatment of intact aortic aneurysms: An analysis of health insurance claims data.

BACKGROUND: The complex endovascular repair of aortic aneurysms and dissections with fenestrated or branched stent grafts (FB-EVAR) remains challenging for interventional vascular surgery. To date, the evidence regarding treatment patterns and outcome measures consists of single center studies; however, it might be reasonable to validate results with multicenter real-world evidence. METHODS: Health insurance claims data from Germany's third largest insurance provider, DAK-Gesundheit, were used to determine outcomes following FB-EVAR of non-ruptured thoracic aorta (TA) or thoracoabdominal including pararenal abdominal (TAA) aorta. The study included patients operated between January 2008 and April 2017. RESULTS: Included were 984 patients (18.1% female) who underwent FB-EVAR. Patients with treatment of the TA were younger (71.7 vs. 73.2 years, p < 0.001) and more often female (38.5% vs. 17.0%, p < 0.001) as compared to patients with treatment of TAA. In the TA group peripheral arterial disease was less frequent compared to the TAA group (67.3% vs. 80.4%, p = 0.036). Mortality was significantly (p < 0.001) higher following repair of the TAA compared to the TA at discharge (17.3% vs. 4.6%), at 30 days (26.9% vs. 8.2%) and at 90 days (34.6% vs. 10.1%). Patients with treatment of the TAA suffered more often from stroke as compared to the TA group (7.7% vs. 1.2%, p = 0.002). CONCLUSION: In this large-scale German analysis of claims data, multicenter real-world evidence was different from single center studies regarding patient risk-factors and outcome measures. Validated multicenter registry studies could help to further investigate this topic in times of increasing procedures.

[Clinical registers in the twenty-first century : Balancing act between data protection and feasibility?] / Klinische Register im 21. Jahrhundert : Ein Spagat zwischen Datenschutz und Machbarkeit?

In the light of big data applications in modern medicine, the various forms of registries becoming increasingly more important. To meet the changing requirements in the field of digital healthcare, the European Commission proposed a comprehensive reform of data protection rules in the European Union (EU). After a transition phase the novel regulations will come into force from 25 May 2018 and then replace the existing Federal Data Protection Act. To conscientiously deal with this subject is of utmost importance before implementing registry-based projects in medical research or quality improvement. To protect patient rights in times of technical progress and increasing amounts of data, appropriate data protection strategies are needed. This article gives an overview on the background and developments in European data privacy law. It further aims to illustrate solutions to overcome new challenges associated with medical register projects.

Percutaneous endovascular treatment of infrainguinal PAOD: Results of the PSI register study in 74 German vascular centers.

BACKGROUND: The percutaneous infrainguinal stent (PSI) register study aimed to collate all percutaneous endovascular procedures for infrainguinal peripheral arterial occlusive disease (PAOD) conducted in 74 German vascular centers between September and November 2015 (3 months). In order to obtain representative results all consecutive treatment procedures had to be submitted by the participating trial centers. MATERIAL AND METHODS: This was a prospective, nonrandomized multicenter study design. All patients suffering from intermittent claudication (IC, Fontaine stage II) or critical limb ischemia (CLI, Fontaine stages III and IV) were included. Trial centers with less than 5 cases reported within the 3­month trial period or centers that could not ensure the submission of all treated patients were excluded. RESULTS: In the final assessment 2798 treated cases from 74 trial centers were reported of which 65 (87.8 %) centers were under the leadership of a vascular surgeon. Approximately 33 % of the interventions in centers under the leadership of vascular surgeons were conducted by radiologists. Risk factors, especially chronic renal disease, diabetes and cardiac risk factors were significantly different between patients with IC and CLI. Of the patients with Fontaine stage II PAOD 41.3 % had 3 patent crural vessels compared to only 10.8 % of patients with Fontaine stage IV. With respect to peri-interventional complications, percutaneous endovascular treatment of IC was a safe procedure with severe complications in less than 1 % and no fatalities. Only 4.5 % of the procedures were conducted under ambulatory conditions. In the supragenual region self-expanding bare metal stents, standard percutaneous transluminal angioplasty (PTA) and drug-coated balloons were the most frequently used procedures. For interventions below the knee, standard PTA was the most commonly employed treatment. CONCLUSION: The main aim of the PSI study was to obtain a realistic picture of percutaneous endovascular techniques used to treat suprapopliteal and infrapopliteal PAOD lesions and to describe the treatment procedures used by vascular specialists in Germany. To investigate the change in trends for treatment over time, this study has to be repeated in the future in order to test how quickly the results of randomized studies can be implemented in practice.

Editor's Choice - Assessment of International Outcomes of Intact Abdominal Aortic Aneurysm Repair over 9 Years.

BACKGROUND: Case mix and outcomes of complex surgical procedures vary over time and between regions. This study analyses peri-operative mortality after intact abdominal aortic aneurysm (AAA) repair in 11 countries over 9 years. METHODS: Data on primary AAA repair from vascular surgery registries in 11 countries for the years 2005-2009 and 2010-2013 were analysed. Multivariate adjusted logistic regression analyses were carried out to adjust for variations in case mix. RESULTS: A total of 83,253 patients were included. Over the two periods, the proportion of patients ≥80 years old increased (18.5% vs. 23.1%; p < .0001) as did the proportion of endovascular repair (EVAR) (44.3% vs. 60.6; p < .0001). In the latter period, 25.8% of AAAs were less than 5.5 cm. The mean annual volume of open repairs per centre decreased from 12.9 to 10.6 between the two periods (p < .0001), and it increased for EVAR from 10.0 to 17.1 (p < .0001). Overall, peri-operative mortality fell from 3.0% to 2.4% (p < .0001). Mortality for EVAR decreased from 1.5% to 1.1% (p < .0001), but the outcome worsened for open repair from 3.9% to 4.4% (p = .008). The peri-operative risk was greater for octogenarians (overall, 3.6% vs. 2.1%, p < .0001; open, 9.5% vs. 3.6%, p < .0001; EVAR, 1.8% vs. 0.7%, p < .0001), and women (overall, 3.8% vs. 2.2%, p < .0001; open, 6.0% vs. 4.0%, p < .0001; EVAR, 1.9% vs. 0.9%, p < .0001). Peri-operative mortality after repair of AAAs <5.5 cm was 4.4% with open repair and 1.0% with EVAR, p < .0001. CONCLUSIONS: In this large international cohort, total peri-operative mortality continues to fall for the treatment of intact AAAs. The number of EVAR procedures now exceeds open procedures. Mortality after EVAR has decreased, but mortality for open operations has increased. The peri-operative mortality for small AAA treatment, particularly open surgical repair, is still considerable and should be weighed against the risk of rupture.

[Vascular surgery in the elderly : What is possible? What is reasonable?] / Gefäßchirurgie bei alten Menschen : Was ist möglich? Was ist sinnvoll?

Nowadays vascular treatment of the elderly is a great challenge. Following the demographic change patients in the field of vascular surgery are becoming older and sicker. In addition to the actual main vascular pathology, the average patient arrives with a series of additional diagnoses that have an impact on the perioperative strategy, surgery and outcome of patients. This strategy becomes more and more challenging because on one hand there will be soon be no limits to treatment, which is attributable to the progress in endovascular surgery and on the other hand the question arises whether the feasible is reasonable? Within the scope of this article the problems of treatment of the elderly are presented and strategies and decisions for an individualized optimal therapy are proposed.

Radiation Dosage for Percutaneous PAD Treatment is Different in Cardiovascular Disciplines: Results From an Eleven Year Population Based Registry in the Metropolitan Area of Hamburg.

OBJECTIVE: The worldwide prevalence of peripheral artery disease (PAD) has evolved to an intervention as the primary treatment option and therefore radiation is used with escalating incidence. Dose area product (DAP) correlates well with the total energy imparted to the patient during fluoroscopic interventions. This study aims to determine whether there are any associations among stage of disease, gender, age, and expertise on the radiation dose in single endovascular treatments of PAD. METHODS: This study was a prospective, mandatory, population based cross-sectional registry design. In total, 24,000 invasive percutaneous endovascular treatments of PAD conducted in the metropolitan area of Hamburg (Germany) were consecutively collected between January 2004 and December 2015. DAP was analysed by discipline conducting the procedure, Fontaine classification, patient gender, and age. RESULTS: Statistically significant differences in median DAP values were found. The lowest median DAP values were observed in surgical centres (7.1 vs. 18.0 Gy*cm2, p<.001) and in endovascular revascularisations (ER) following multidisciplinary consultation (11.6 vs. 23.4 Gy*cm2, p<.001). Considering the treatment of intermittent claudication, men had statistically significantly higher DAP values compared with women. Furthermore, lower median DAP values were observed in higher age groups, with lowest dosages in octogenarians. CONCLUSION: This is the first large population based study on DAP during ER for PAD. Several significant differences in median DAP values were observed, although patient stratification was comparable. Pre-operative therapy strategy planning can lead to lower DAP values, emphasising the importance of further vascular research and quality improvement projects targeting this topic. To date, available evidence is limited and therefore there is no accepted range of DAP levels. However, the ever increasing use of fluoroscopic interventions means that further investigation into radiation exposure to patients and healthcare professionals is required in order to keep DAP levels low.

[Endovascular versus conventional vascular surgery--old-fashioned thinking? Part 2: carotid artery stenosis and peripheral arterial occlusive disease]. / Endovaskuläre vs. konventionelle Gefäßchirurgie--antiquiertes Denken? Teil 2: Karotisstenose und periphere arterielle Verschlusskrankheit.

Endovascular therapy has widely replaced conventional open vascular surgical reconstruction. For this reason, both techniques were widely considered to be competing approaches. Evidence-based data from randomized prospective trials, meta-analyses and clinical registries, however, demonstrated that both techniques should be used to complement each other. It became increasingly more evident that the use of either procedure depends on the underlying disease and the anatomical conditions, whereby a combination of both (hybrid approach) may be the preferred option in certain situations. This review focuses on the treatment of patients with carotid artery stenosis, intermittent claudication, critical limb ischemia and acute limb ischemia.

[Endovascular versus conventional vascular surgery - old-fashioned thinking? Part 1: interventions on the aorta]. / Endovaskuläre vs. konventionelle Gefäßchirurgie - antiquiertes Denken? Teil 1: Eingriffe an der Aorta.

Endovascular therapy has widely replaced conventional open vascular surgical reconstruction. For this reason both techniques were widely considered to be competing approaches. Evidence-based data from randomized prospective trials, meta-analyses and clinical registries, however, demonstrated that both techniques should be used to complement each other. It became increasingly more evident that the use of either procedure depends on the underlying disease and the anatomical conditions, whereby a combination of both (hybrid approach) may be the preferred option in certain situations. This review focuses on the treatment of complicated acute type B aortic dissection, descending thoracic aortic aneurysms, thoracoabdominal aortic aneurysms as well as asymptomatic and ruptured abdominal aortic aneurysms.

[Perioperative mortality following repair for abdominal aortic aneurysm in Germany : Comparison of administrative data of the DAK health insurance and clinical registry data of the German Vascular Society]. / Perioperative Letalität bei der Versorgung abdomineller Aortenaneurysmen in Deutschland : Ein Vergleich von Routinedaten der DAK-Gesundheit mit Registerdaten der DGG.

OBJECTIVE: This study determined whether the routine data of a single health insurance company (DAK health) can allow equivalent statements on hospital mortality of endovascular (EVAR) and open (OR) repair of intact (iAAA) and ruptured (rAAA) aortic aneurysms (AAA) in Germany in comparison to clinical registry surveys of the German Vascular Society (GVS). METHODS: The study compared two cohorts that were comparable in group sizes but not identical in terms of the duration of treatment and the selection of the centers. The GVS registry included 5080 patients with iAAA and 485 with rAAA and the DAK data consisted of 5182 patients with iAAA and 576 with rAAA. In GVS (in brackets DAK) 72.6 % (71.0 %) of patients with iAAA received EVAR and 27.4 % (29 %) OR, with rAAA 34.6 % (26.9 %) of patients received EVAR and 65.4 % (73.1 %) OR. Both cohorts were comparable with respect to patient age and gender distribution. RESULTS: Intact AAA: the hospital mortality rate in GVS (DAK in brackets) was 0.95 % (1.4 %) with EVAR and 4.7 % (5.5 %) with OR. For patients less than 80 years old the statements were almost identical when the hospital mortality in the GVS and DAK registers constituted 0.85 % and 0.9 % after EVAR and 3.8 % and 4.0 % after OR, respectively. Patients over 80 years old in particular had a benefit by EVAR as the hospital mortality in GVS (DAK in brackets) was 1.3 % (2.6 %) with EVAR vs. 13.9 % (17.4 %) with OR. A benefit by EVAR was also seen in women. Ruptured AAA: the hospital mortality rate in GVS (DAK in brackets) was 19.6 % (27.1 %) with EVAR and 38.5 % (42.0 %) with OR. Again, particularly patients over 80 years old showed an advantage with EVAR where the hospital mortality was 31.0 % (34.3 %) with EVAR vs. 56.7 % (61.3 %) with OR in this group. CONCLUSION: Hospital mortality is an important quality parameter of endovascular and open repair of iAAA and rAAA. Administrative data of a health insurance company can be used to provide representative and comprehensive statements on inhospital mortality.

[Complications following aortic reconstruction surgery]. / Komplikationen nach Rekonstruktion der Aorta.

BACKGROUND: The potential complications following aortic reconstruction surgery are diverse and potentially life-threatening. Besides the well known complications of open aortic repair (OAR) the spectrum of complications has been extended and shifted by the growing use of endovascular aortic repair (EVAR). AIM: The most common complications of open as well as endovascular aortic surgery are presented in a summarizing review. The focus is placed on the presentation of cardiovascular and nephrological complications, colonic ischemia, as well as aortic graft infections and graft fistulas. Spinal ischemia and endoleaks after EVAR are also discussed. Additionally epidemiological data, risk factors and basic therapeutic principles are outlined. CONCLUSION: Aortic reconstruction surgery can be associated with severe complications, the main features of which should be known by all surgical specialties.