Technical success and associated economic implications of conventional re-entry devices in subintimal recanalization of femoro-popliteal chronic total occlusions

PURPOSERe-entry devices contribute to the high success rate of subintimal recanalization of chronic total occlusions (CTO). However, to date, there are no studies comparing the available conventional re-entry devices concerning the impact of their technical success on economic aspects, as these devices differ greatly in their acquisition costs. This prospective observational study intends to contribute to this question.METHODSPrior to the start of the prospective study, all previous applications of the Outback® in femoro-popliteal CTO since its introduction to our hospital were analyzed retrospectively (n = 31). From June 2018 until January 2020, all patients with femoro-popliteal CTO treated with clear subintimal recanalization were included (n = 109). In the case of failed spontaneous re-entry, either the OffRoad® (study arm I, n = 20) or the Enteer® catheter (study arm II, n = 20) was used. If assisted re-entry failed, the Outback® device was used as a bailout. Baseline demographic and clinical data, morphologic characteristics, and technical success were documented. Additional per-patient costs due to the use of re-entry devices were analyzed.RESULTSA retrospective evaluation of all Outback® applications revealed a technical success rate of 97% (30/31). In the prospective study, 63% (68/109) were successfully treated without using re-entry devices. The overall procedural success was 95% (103/109). In study arm I, the OffRoad® achieved a success rate of 45% (9/20), with a subsequent successful application of the Outback® in 80% (8/10) of the failed cases. In study arm II, the Enteer® was successfully employed in 60% (12/20) of cases, and the Outback® was then used successfully in a further 62% (5/8) of cases. Too large a distance between the device and the target lumen was a knockout criterion for all tested devices, leading to a subgroup analysis with the exclusion of three cases, resulting in a success rate of 47% for the OffRoad® and 67% for the Enteer® device. Furthermore, in severe calcification, only the Outback® reliably enabled revascularization. Significant savings of almost €600 were only achieved in study arm II according to German prices.CONCLUSIONWith proper patient selection, a gradual approach with the Enteer® as the primarily used device, with the Outback® used additionally in case of failure, leads to significant savings and can be recommended. In severe calcification, the Outback® should be used as the primary device

Targeted tibio-peroneal re-entry during subintimal revascularization using the Outback® catheter

Background!#!Re-entry devices are used regularly in subintimal recanalization of chronic occlusions of the iliac and femoro-popliteal arteries and significantly contribute to the high success rate of these interventions. However, the use in tibio-peroneal arteries has only been described in few cases so far. The present work is a retrospective evaluation of the Outback® re-entry device for gaining targeted true lumen access at the level of the tibio-peroneal arteries.!##!Methods!#!From 9/2017 until 10/2020 the Outback® catheter was used in case of failed spontaneous re-entry at the level of the tibio-peroneal arteries in 14 patients either instead of the usual retrograde approach via a pedal/distal-crural access (n = 11) or in combination with it (n = 3). Baseline demographic and clinical data, morphologic characteristics of the occlusions, procedural succedss, as well as the Society of Vascular Surgery (SVS) runoff score before and after revascularization were documented.!##!Results!#!All patients (median age: 78 years; range: 66-93) suffered from peripheral artery occlusive disease Rutherford stage 4 to 6 with a median lesion length of 12 cm (range: 7-35). Technical and procedural success was achieved in all 14 patients. The mean re-entry accuracy was 0.25 cm (range: 0-0.8). The SVS runoff score improved from a median of 14.5 (interquartile range IQR: 10.8-16.4) to 7 (IQR: 6.3-7) (p < 0.01).!##!Conclusions!#!The use of the Outback® catheter for targeted tibio-peroneal re-entry is associated with a high technical and procedural success rate and should be considered in case of otherwise failed ante- and retrograde recanalization

Epidemiology of cardiac amyloidosis in Germany: a retrospective analysis from 2009 to 2018

Background Improved imaging modalities contributed to increasing awareness of cardiac amyloidosis. Contemporary data on frequency trends in Germany are lacking. Methods In a retrospective study using health claims data of a German statutory health insurance, patients with diagnostic codes of amyloidosis and concomitant heart failure between 2009 and 2018 were identified. Results Prevalence increased from 15.5 to 47.6 per 100,000 person-years, and incidence increased from 4.8 to 11.6 per 100,000 person-years, with a continuous steepening in the slope of incidence trend. In patients with amyloidosis and heart failure age and proportion of men significantly increased, whereas the frequency of myeloma and nephrotic syndrome significantly decreased over time. Median (IQR) survival time after first diagnosis was 2.5 years (0.5-6 years), with a 9% (95% CI 2-15%, p = 0.008) reduced risk of death in the second compared to the first 5 years of observation. In the 2 years prior and 1 year after diagnosis, mean total health care costs were 6568 euro, 11,872 euro and 21,955 euro per person and year. Conclusion The rise in cardiac amyloidosis has continuously accelerated in the last decade. Considering the adverse outcome and high health care burden, further effort should be put on early detection of the disease to implement available treatment

SARS-CoV-2 Seroprevalence among Health Care Workers—A Voluntary Screening Study in a Regional Medical Center in Southern Germany

Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) is associated with a potentially severe clinical manifestation, coronavirus disease 2019 (COVID-19), and currently poses a worldwide challenge. Health care workers (HCWs) are at the forefront of any health care system and thus especially at risk for SARS-CoV-2 infection due to their potentially frequent and close contact with patients suffering from COVID-19. Serum samples from 198 HCWs with direct patient contact of a regional medical center and several outpatient facilities were collected during the early phase of the pandemic (April 2020) and tested for SARS-CoV-2-specific antibodies. Commercially available IgA- and IgG-specific ELISAs were used as screening technique, followed by an in-house neutralization assay for confirmation. Neutralizing SARS-CoV-2-specific antibodies were detected in seven of 198 (3.5%) tested HCWs. There was no significant difference in seroprevalence between the regional medical center (3.4%) and the outpatient institution (5%). The overall seroprevalence of neutralizing SARS-CoV-2-specific antibodies in HCWs in both a large regional medical center and a small outpatient institution was low (3.5%) at the beginning of April 2020. The findings may indicate that the timely implemented preventive measures (strict hygiene protocols, personal protective equipment) were effective to protect from transmission of an airborne virus when only limited information on the pathogen was available

Primary prophylaxis of invasive fungal infections in patients with haematologic malignancies. 2014 update of the recommendations of the Infectious Diseases Working Party of the German Society for Haematology and Oncology

Invasive fungal infections cause substantial morbidity and mortality in immunocompromised patients, particularly in those with haematological malignancies and recipients of allogeneic haematopoietic stem cell transplantation. Difficulties in diagnosing invasive fungal infections and subsequent delays in treatment initiation lead to unfavourable outcomes and emphasise the importance of prophylaxis. Since the recommendations of the Infectious Diseases Working Party of the German Society for Haematology and Oncology in 2009, results of 14 additional clinical studies have been published comprising 2,899 patients and initiating this update. Key recommendations for adult patients are as follows: Posaconazole remains the drug of choice during remission-induction chemotherapy in acute myeloid leukaemia, myelodysplastic syndrome and allogeneic haematopoietic stem cell transplantation with graft versus host disease (AI). In the pre-engraftment period of allogeneic transplantation, several antifungals are appropriate and can be recommended with equal strength: voriconazole (BI), micafungin (BI), fluconazole (BI) and posaconazole (BII). There is poor evidence regarding antifungal prophylaxis in the post-engraftment period of allogeneic haematopoietic stem cell transplantation if no steroids for treatment of graft versus host disease are required. Aerosolised liposomal amphotericin B inhalation in conjunction with fluconazole can be used in patients with prolonged neutropenia (BII)

Antimykotische Prophylaxe bei Patienten mit hämatologischen Neoplasien oder nach allogener Stammzelltransplantation

Invasive Pilzinfektionen sind eine wesentliche Ursache für Morbidität und Mortalität bei immunsupprimierten Patienten, insbesondere bei Patienten mit hämatologischen Neoplasien nach intensiver Chemotherapie und/oder allogener Stammzelltransplantation. Schwierigkeiten in der frühzeitigen Diagnose von invasiven Pilzinfektionen und Verzögerungen in der Einleitung wirksamer Therapie tragen zur ungünstigen Prognose der Patienten bei. Eine Strategie zur Verbesserung der Prognose ist Prophylaxe unter Berücksichtigung der individuellen Risikofaktoren und der verfügbaren medikamentösen Optionen. Die Leitlinie ‚Antimykotische Prophylaxe bei Patienten mit hämatologischen Neoplasien‘ wurde von der Arbeitsgemeinschaft Infektionen der DGHO (AGIHO) für die Diagnostik und Therapie dieser Patienten erstellt [1]. Grundlagen sind eine systematische Literaturrecherche, die einheitliche Bewertung der Evidenzstärke [2] und ein Konsensfindungsprozess. Dies ist die Kurzfassung dieser Empfehlungen

Antimykotische Prophylaxe bei Patienten mit hämatologischen Neoplasien oder nach allogener Stammzelltransplantation

Invasive Pilzinfektionen sind eine wesentliche Ursache für Morbidität und Mortalität bei immunsupprimierten Patienten, insbesondere bei Patienten mit hämatologischen Neoplasien nach intensiver Chemotherapie und/oder allogener Stammzelltransplantation. Schwierigkeiten in der frühzeitigen Diagnose von invasiven Pilzinfektionen und Verzögerungen in der Einleitung wirksamer Therapie tragen zur ungünstigen Prognose der Patienten bei. Eine Strategie zur Verbesserung der Prognose ist Prophylaxe unter Berücksichtigung der individuellen Risikofaktoren und der verfügbaren medikamentösen Optionen. Die Leitlinie ‚Antimykotische Prophylaxe bei Patienten mit hämatologischen Neoplasien‘ wurde von der Arbeitsgemeinschaft Infektionen der DGHO (AGIHO) für die Diagnostik und Therapie dieser Patienten erstellt [1]. Grundlagen sind eine systematische Literaturrecherche, die einheitliche Bewertung der Evidenzstärke [2] und ein Konsensfindungsprozess. Dies ist die Kurzfassung dieser Empfehlungen