[Vascular surgery in old people]. / Gefäßchirurgie bei alten Menschen.

The age pyramid in Germany is upside down. According to the Federal Statistical Office this development will continue in the coming years, which presents a challenge for surgeons to surgically treat increasingly more and increasingly older people. Particularly in vascular surgery, which is a surgery of old people, this fact represents a special challenge. The frailty of old people is, among other things, due to a series of comorbidities, which must be taken into consideration within the framework of surgical treatment. They can have an important influence on the perioperative planning, the operation, the postoperative treatment and the outcome of the patient. This treatment planning becomes more and more challenging, because due to the progress in endovascular surgery there will soon be no limits to what is feasible; however, the question arises whether the feasible is also reasonable? Within the scope of this article the authors try to give answers to the treatment of old patients in vascular surgery and to find strategies for planning and to establish an individualized optimal treatment.

Abdominal incision defect following AAA-surgery (AIDA): 2-year results of prophylactic onlay-mesh augmentation in a multicentre, double-blind, randomised controlled trial.

The reported incidence of incisional hernia following repair of abdominal aortic aneurysm (AAA) via midline laparotomy is up to 69%. This prospective, multicenter, double-blind, randomised controlled trial was conducted at eleven hospitals in Germany. Patients aged 18 years or older undergoing elective AAA-repair via midline incision were randomly assigned using a computer-generated randomisation sequence to one of three groups for fascial closure: with long-term absorbable suture (MonoPlus®, group I), long-term absorbable suture and onlay mesh reinforcement (group II) or extra long-term absorbable suture (MonoMax®, group III). The primary endpoint was the incidence of incisional hernia within 24 months of follow-up, analysed by intention to treat. Physicians conducting the postoperative visits and the patients were blinded. Between February 2011 and July 2013, 104 patients (69.8 ± 7.7 years) were randomised, 99 of them received a study intervention. The rate of incisional hernia within 24 months was not significantly reduced with onlay mesh augmentation compared to primary suture (p = 0.290). Furthermore, the rate of incisional hernia did not differ significantly between fascial closure with slow and extra long-term absorbable suture (p = 0.111). Serious adverse events related to study intervention occurred in five patients (5.1%) from treatment groups II and III. Wound healing disorders were more frequently seen after onlay mesh implantation on the day of discharge (p = 0.010) and three (p = 0.009) and six (p = 0.023) months postoperatively. The existing evidence on prophylactic mesh augmentation in patients undergoing AAA-repair via midline laparotomy probably needs critical review. As the implementation of new RCTs is considered difficult due to the increasing number of endovascular AAA treated, registry studies could help to collect and evaluate data in cases of open AAA-repair. Comparisons between prophylactic mesh implantation and the small bite technique are also required. Trial registration: ClinicalTrials.gov Identifier: NCT01353443. Funding Sources: Aesculap AG, Tuttlingen, Germany.

[Publication performance of university orthopedic trauma surgery in Germany]. / Zur Publikationsleistung der universitären Unfallchirurgie in Deutschland.

BACKGROUND: One of the performance criteria of a university hospital is its publication activities. The aim of this bibliometric study was a comparative benchmarking of the publication activities of German orthopedic trauma surgery university hospitals. MATERIAL AND METHODS: The publication performance of the leading groups, consisting of chief and senior physicians, section and division heads of 39 German orthopedic trauma surgery university hospitals, was recorded over a period of 10 years (1 January 2010-31 December 2019). All publications that were listed in PubMed and for which the appropriate persons were first or last author were considered. In addition, the impact factor (IF) was determined. RESULTS: A total of 4438 publications were recorded published by 381 surgeons. The share of publishing authors was 72.8%. The articles were published in 545 journals. The average IF of all publications was 1.81. The publication activities of hospitals showed a wide range, this applied to both the number of publications and the IF generated by the individual author. The publication activity ranged from an average of 16.4 publications per author in the top-ranked hospital to 1.5 publications in the last-placed hospital. The same result was seen with the total IFs. In the highest ranking hospital according to this criterion the individual surgeon achieved on average of 42.1 cumulative IFs compared with 1.7 IFs in the last placed hospital. CONCLUSION: The publication performance of German orthopedic trauma surgery university hospitals showed a high variance, as was also found in other disciplines. The causes must remain open, but a different research motivation cannot be ruled out.

Publication activity of chief and consultant general/visceral surgeons in German university hospitals-a ten-year analysis.

PURPOSE: The publication activity of 38 German general/visceral surgery university departments, documented by first or last authorship from staff surgeons (chief and consultants), was evaluated. METHODS: The observation period extended from 2007 to 2017 and all PubMed-listed publications were considered. Impact factor (IF) was evaluated through the publishing journal's 5-year IF in 2016, as was the IF for each individual publication. Ranking was expressed in quartiles. RESULTS: The staff surgeons of the 38 departments comprised 442 surgeons, of which only 351 (79.4%) were active as first or last authors. Four thousand six hundred and ninety-nine publications published in 702 journals were recorded. The four leading departments in publication number published as much as the last 20 departments (1330 vs. 1336 publications, respectively). The mean of the first (most active) department quartile was 19.6 publications, the second 15.4, the third 11.0, and the last quartile 7.6 per publishing surgeon. The total cumulative impact factor was 14,130. When examining the mean number of publications per publishing surgeons per the 10 year period, the mean of the first quartile was 57.9 cumulative IF, the second 45.0, the third 29.5, and the fourth quartile 17.1. With 352 (7.5%) publications, the most frequently used journal was Chirurg, followed by Langenbeck's Archives of Surgery with 274 (5.8%) publications. Pancreas-related topics led in terms of publication number and IF generated per individual publication. CONCLUSION: A significant difference in publication performance of individual departments was apparent that cannot be explained by staff number. This indicates that there are as yet unknown factors responsible for minor publication activity in many university departments.

Surgical publication activity in the English literature over a 10-year interval.

Background: Surgical publication activity in the English literature over a 10-year interval may have changed. This study sought to identify which countries make the most contributions and whether significant shifts have occurred in this time. Methods: Screening of 17 international journals in PubMed was performed for the time periods 2006-2007 and 2016-2017, for papers published by a first author belonging to a general surgical department. Data were collected by country regarding the total number of publications, cumulative impact factors (IFs), publications per inhabitant, IFs per inhabitant, and number of RCTs, meta-analyses and systematic reviews per country in both periods. Results: A total of 2247 and 3029 papers were found for 2006-2007 and 2016-2017 respectively. In 2006-2007, most papers (605, 26·9 per cent; 2697·3 IFs) came from the USA, followed by Japan (284, 12·6 per cent; 1042·1 IFs) and the UK (197, 8·8 per cent; 923·1 IFs). In 2016-2017, the USA led again with 898 papers (29·6 per cent; 4575·3 IFs), followed by Japan with 414 papers (13·7 per cent; 1556·6 IFs) and the Netherlands with 167 (5·5 per cent; 885·2 IFs). From the top 15 countries, Sweden, the Netherlands and Switzerland contributed the most articles per inhabitant during both time periods. During both periods, the UK published the most RCTs, meta-analyses and systematic reviews. Conclusion: Surgeons from the USA were the most productive in total number of publications during both time periods. However, smaller European countries were more active than the USA in relation to their population size.

Angioplasty in asymptomatic carotid artery stenosis vs. endarterectomy compared to best medical treatment: One-year interim results of SPACE-2.

BACKGROUND: Treatment of individuals with asymptomatic carotid artery stenosis is still handled controversially. Recommendations for treatment of asymptomatic carotid stenosis with carotid endarterectomy (CEA) are based on trials having recruited patients more than 15 years ago. Registry data indicate that advances in best medical treatment (BMT) may lead to a markedly decreasing risk of stroke in asymptomatic carotid stenosis. The aim of the SPACE-2 trial (ISRCTN78592017) was to compare the stroke preventive effects of BMT alone with that of BMT in combination with CEA or carotid artery stenting (CAS), respectively, in patients with asymptomatic carotid artery stenosis of ≥70% European Carotid Surgery Trial (ECST) criteria. METHODS: SPACE-2 is a randomized, controlled, multicenter, open study. A major secondary endpoint was the cumulative rate of any stroke (ischemic or hemorrhagic) or death from any cause within 30 days plus an ipsilateral ischemic stroke within one year of follow-up. Safety was assessed as the rate of any stroke and death from any cause within 30 days after CEA or CAS. Protocol changes had to be implemented. The results on the one-year period after treatment are reported. FINDINGS: It was planned to enroll 3550 patients. Due to low recruitment, the enrollment of patients was stopped prematurely after randomization of 513 patients in 36 centers to CEA (n = 203), CAS (n = 197), or BMT (n = 113). The one-year rate of the major secondary endpoint did not significantly differ between groups (CEA 2.5%, CAS 3.0%, BMT 0.9%; p = 0.530) as well as rates of any stroke (CEA 3.9%, CAS 4.1%, BMT 0.9%; p = 0.256) and all-cause mortality (CEA 2.5%, CAS 1.0%, BMT 3.5%; p = 0.304). About half of all strokes occurred in the peri-interventional period. Higher albeit statistically non-significant rates of restenosis occurred in the stenting group (CEA 2.0% vs. CAS 5.6%; p = 0.068) without evidence of increased stroke rates. INTERPRETATION: The low sample size of this prematurely stopped trial of 513 patients implies that its power is not sufficient to show that CEA or CAS is superior to a modern medical therapy (BMT) in the primary prevention of ischemic stroke in patients with an asymptomatic carotid stenosis up to one year after treatment. Also, no evidence for differences in safety between CAS and CEA during the first year after treatment could be derived. Follow-up will be performed up to five years. Data may be used for pooled analysis with ongoing trials.

[The publication performance of German academic vascular surgery-journals, focal topics and impact factors]. / Publikationsleistung der deutschen akademischen Gefäßchirurgie ­ Journale, Impactfaktoren und Schwerpunktthemen.

AIM: The aim of the present study was to describe the publication performance of the academic surgical management teams in Germany based on the preferred journals, their impact factors (IF) and the focal topics. METHODS: The publications of the vascular surgical management teams, consisting of chief and senior physicians, of 37 German university hospitals were analyzed. Reference date for all considerations (staffing and publications) was 1 July 2017. The publication period covered the last 10 years. The literature search was based on an evaluation of the PubMed database. RESULTS: A total of 1047 publications published in 197 journals were recorded. Among them were 3 German language journals with 136 (13.0%) publications but only 3.3% of all cumulative IFs. In 126 journals (64.0%) only one article was published and in 30 (15.2%) two articles. The three PubMed listed journals in which German university vascular surgeons published most frequently were the J Vasc Surg with 126 publications, Eur J Vasc Endovasc Surg with 94 and J Endovasc Ther with 88 publications. Of all 1047 publications 46.5% were published in an IF range under 2 and a total of 907/1047 publications (86.6%) in an IF range under 4. In 8.6% of the journals 44.1% of the IFs were generated. In terms of publication topics, thoracic and abdominal aorta were at the top of the list, accounting for almost half of all publications with 501 publications and with 52% of all 1252.08 accumulated IFs. CONCLUSION: A total of 78.6% of the publications in the 17 journals, in which more than 10 publications were made, came from independent institutions, 19.3% from the sections. None of the 91 publications in journals with an IF > 4 came from a subordinate organizational structure, indicating a gap between independent departments, sections and subordinate structures. The number of publications was based on the achievable IF of the individual topic and thus its attractiveness. Peripheral arterial disease was underrepresented in the publication topics in relation to the number of patients, with a share of 8.5.

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.].

[Modern wound treatment-from best practice to innovation]. / Moderne Wundbehandlung ­ von "best practice" zur Innovation.

According to the Research Group for Primary Medical Care (PMV), approximately 890,000 people in Germany were suffering from a chronic wound in 2012. This corresponds to a prevalence of 1.1%. Ulcus cruris, diabetic ulcers and decubital ulcers are among the most frequent causes of chronic wounds (57-80%). The guarantee for successful wound care is based on a good understanding of the physiology of the wound healing process. A disorder of the phase-like course can lead to complications, delays or suspension of wound healing. There are many reasons for pathological wound healing including infections, oxygen deficiency and non-phase-adapted wound care. In addition to established wound products, innovative products such as dermal matrixes, cold plasma therapy and platelet-rich plasma represent promising therapeutic alternatives for non-healing chronic wounds.

Staged procedures for prevention of spinal cord ischemia in endovascular aortic surgery.

BACKGROUND: Spinal cord ischemia with development of paraplegia is the most relevant complication of thoracoabdominal aortic surgery caused by compromising the segmental arteries. To prevent this devastating complication in endovascular aortic surgery, staging procedures have been developed to reinforce collateral blood flood to the spinal cord. RESULTS: In patients with a medium to high risk for spinal cord ischemia, staged aortic repair is recommended. The classical staged repair is the two-step repair with delayed implantation of the aortic stent grafts. Additionally, more recent methods for short-term salvage of segmental artery perfusion by leaving an endoleak have been developed. Perfusion branches, delayed bridging stents as well as the open branch technique are among these methods. The latest option of staged repair is minimally invasive segmental artery embolization. CONCLUSION: Besides the nonsurgical options for monitoring and therapy of spinal cord ischemia, various staging procedures are available, which can be implemented depending on the patient and the aortic anatomy. Evidence that underlines staged repair for endovascular treatment of thoracoabdominal aortic pathologies is mostly based on retrospective studies.

The marine Omega3 wound matrix for treatment of complicated wounds: A multicenter experience report.

INTRODUCTION: The Kerecis™ Omega3 Wound matrix is a decellularized skin matrix derived from fish skin and represents an innovative concept to achieve wound healing. The aim of this study was to report the cumulative experience of three centers for vascular surgery regarding use of the Omega3 Wound matrix in selected patients with complicated wounds. MATERIAL AND METHODS: In this study 23 patients with 25 vascular and/or diabetes mellitus-associated complicated wounds and partially exposed bony segments were treated with the Omega3 Wound matrix in three vascular centers. In several patients, conventional wound treatment with vacuum therapy had previously been carried out sometimes over several weeks without durable success. Following initial debridement in the operating room, the matrix was applied and covered with a silicone mesh. In the further course, wound treatment was conducted on an outpatient setting if possible. RESULTS: In total 25 wounds were treated with localization at the level of the thigh (n = 2), the distal calf (n = 7), the forefoot (n = 14) and the hand (n = 2). The time to heal varied between 9 and 41 weeks and between 3 and 26 wound matrices were applied per wound. Interestingly, a reduction of analgesics intake was noted when the treatment with the Omega3 Wound matrix was initiated. CONCLUSION: The novel Omega3 Wound matrix in this study represented an effective treatment option in 25 complicated wounds. Further studies are necessary to evaluate the impact of the wound matrix on stimulation of granulation tissue and re-epithelialization as well as the potential antinociceptive and analgetic effects.

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.

[Hemostyptics for treatment of junctional vascular injuries : Management of traumatic vascular injuries at the transition from trunk to extremities]. / Hämostyptika zur Behandlung der "junctional vascular injuries" : Versorgung traumatischer Gefäßverletzungen am Übergang vom Körperstamm zur Extremität.

BACKGROUND: Uncontrolled post-traumatic bleeding is still the leading cause of death among trauma patients. In situations of mass casualty incidents (MASCAL) and military conflicts the treatment of uncontrolled critical bleeding is a challenge and associated with a worse outcome due to the austere environment; however, even under optimal treatment circumstances in situations of individual medicine the severity of vascular trauma is underestimated. As a consequence, this leads to a poorer prognosis for patients with (vascular) injuries. From this perspective it was reasonable to intensify the training of physicians, paramedics (Advanced Trauma Life Support©) and first responders (Hartford consensus) for handling of critical bleeding in traumatized patients. Furthermore, the main emphasis of the revised S3 clinical guidelines on polytrauma/severely injured treatment from 2016 of the German Society for Trauma Surgery is on the preclinical treatment. Despite a renaissance and increasing use of tourniquets, the treatment of bleeding in the transition from the trunk to the extremities (junctional vascular injuries), which are inaccessible to placing a tourniquet, remains a problem. CONCLUSION: It was the military that in addition to the development of special tourniquets, intensified research programs and the implementation of hemostatic devices and dressings in this anatomical region. This article deals with junctional vascular injuries at the transition between the trunk and the extremities. In addition to the anatomical situation, this article gives the reader an overview of the currently available hemostyptics and their mode of action.

[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.

I-SWOT as instrument to individually optimize therapy of thoracoabdominal aortic aneurysms: Effective, norm-compliant and meeting the needs.

BACKGROUND: Guidelines summarize medical evidence, they identify the most efficient therapy under study conditions and recommend this therapy for use. The physician now has the challenge to translate a therapy that is efficient under laboratory conditions to a patient who is an individual person. To accomplish this task the physician has to make sure that (I) the ideal typical therapy is applicable and effective in this individual patient taking the special features into consideration, that (II) therapy is compliant with the norm including guidelines, laws and ethical requirements (conformity) and that (III) the therapy meets the patient's needs. OBJECTIVE: How can physicians together with the patients translate the medical evidence into an individually optimized therapy? MATERIAL AND METHODS: At the German Aortic Center in Hamburg we use I­SWOT as an instrument to identify such individually optimized therapy. With I­SWOT, we present an instrument with which we have developed an (I) efficient, (II) conform and (III) needs-oriented therapeutic strategy for individual patients. RESULTS: I-SWOT cross-tabulates strengths (S) and weaknesses (W) related to therapy with opportunities (O) and threats (T) related to individual patients. This I­SWOT matrix identifies four fundamental types of strategy, which comprise "SO" maximizing strengths and opportunities, "WT" minimizing weaknesses and threats, "WO" minimizing weaknesses and maximizing opportunities and "ST" maximizing strengths and minimizing threats. We discuss the case of a patient with asymptomatic thoracoabdominal aneurysm to show how I­SWOT is used to identify an individually optimized therapy strategy.

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.