Strategies for avoiding typical drug–drug interactions and drug-related problems in patients with vascular diseases

Background and objectives: Drug–drug interactions and drug-related problems in patients with vascular diseases are common. To date, very few studies have focused on these important problems. The aim of the present study is to investigate the most common drug–drug interactions and DRPs in patients with vascular diseases. Materials and Methods: The medications of 1322 patients were reviewed manually in the time period from 11/2017 to 11/2018; the medications of 96 patients were entered into a clinical decision support system. Potential drug problems were identified, and a read-through consensus was reached between a clinical pharmacist and a vascular surgeon during the clinical curve visits; possible modifications were implemented. The focus was on additional dose adjustment and drug antagonization on drug interactions. Interactions were classified as contraindicated/high-risk combination (drugs must not be combined), clinically serious (interaction can be potentially life-threatening or have serious, possibly irreversible consequences), or potentially clinically relevant and moderate (interaction can lead to therapeutically relevant consequences). Results: A total of 111 interactions were observed. Of these, 6 contraindicated/high-risk combinations, 81 clinically serious interactions, and 24 potentially clinically relevant and moderate interactions were identified. Furthermore, 114 interventions were recorded and categorized. Discontinued use of the drug (36.0%) and drug dose adjustment (35.1%) were the most common interventions. Mostly, antibiotic therapy was continued unnecessarily (10/96; 10.4%), and the adjustment of the dosage to kidney function was overlooked in 40/96; 41.7% of the cases. In the most common cases, a dose reduction was not considered necessary. Here, unadjusted doses of antibiotics were found in 9/96, 9.3% of the cases. Notes for medical professionals summarized information that did not require direct intervention but rather increased attention on the part of the ward doctor. It was usually necessary to monitor laboratory parameters (49/96, 51.0%) or the patients for side effects (17/96, 17.7%), which were expected with the combinations used. Conclusions: This study could help identify problematic drug groups and develop prevention strategies for drug-related problems in patients with vascular diseases. A multidisciplinary collaboration between the different professional groups (clinical pharmacists and surgeons) might optimize the medication process. Collaborative care could have a positive impact on therapeutic outcomes and make drug therapy safer for patients with vascular diseases

Revascularization with BYCROSS atherectomy device - protocol of a prospective multicenter observational study

Background The BYCROSS™ device is a novel device intended for use in atherectomy of the peripheral arterial disease (PAD). With the BYCROSS™ atherectomy system, also prolonged calcifying lesions can be treated in a minimally invasive manner, which was previously reserved for bypass surgery. The aim of this study is to collect additional clinical data on safety and performance of the BYCROSS™ from patients undergoing revascularization of severely stenotic or occluded peripheral arterial vessels with the BYCROSS™. Methods and design This is an investigator-initiated national prospective multicenter observational study in patients with PAD. Sixty patients (20 per center) with PAD with stenosis higher than 80% or complete occlusion (de novo or recurrent stenosis) of vessels below the aortic bifurcation (min 3 mm vessel diameter) will be recruited. Three vascular surgery centers are participating in the study. The primary efficacy endpoint is procedural success, defined as passage of the occlusion through the BYCROSS device, and safety outcomes, explicated as freedom from device-related serious adverse events (SADEs). Secondary endpoints include primary and secondary patency rates, change in Rutherford classification, and freedom from amputation at 3 and 12 months. Discussion The BYCROSS atherectomy system may be a novel device for the minimally invasive treatment of prolonged calcified lesions previously reserved for bypass surgery. This national prospective multicenter observational study could represent another step in demonstrating the efficancy and safety of this device for treatment of PAD

German nation-wide in-patient treatment of abdominal aortic aneurysm — trends between 2005 and 2019 and impact of the SARS-CoV-2 pandemic

Purpose Aim of this study was to analyze hospitalizations due to ruptured and non-ruptured abdominal aortic aneurysms (rAAA, nrAAA) in Germany between 2005 and 2021 to determine long-term trends in treatment and the impact of the SARS-CoV-2 pandemic. Materials and Methods Fully anonymized data were available from the research data center (RDC) of the German Federal Statistical Office (Destatis). All German hospitalizations with the ICD-10 code “I71.3, rAAA” and “I71.4, nrAAA” in 2005 and 2010–2021 were analyzed. Results We report data of a total of 202,951 hospitalizations. The number of hospitalizations increased from 2005 to 2019 (14,075 to 16,051, + 14.0%). The rate of open repair (OR) constantly decreased, whereas the rate of endovascular aortic repair (EVAR) increased until 2019. During the pandemic, the number of hospitalizations due to nrAAA dropped from 13,887 (86.5%) in 2019 to 11,278 (85.0%) in 2021. The strongest decrease of hospitalizations for AAA was observed during the first wave of the SARS-CoV-2-pandemic in spring 2020 (-25.5%). Conclusion Over the past decades, we observed an increasing number of hospitalizations due to AAA accompanied by a shift from OR to EVAR especially for nrAAA. During the lockdown measures due to the SARS-CoV-2-pandemic, a decrease in hospitalizations for nrAAA (but not for rAAA) was shown in 2020 and furthermore in 2021 with no rebound of treatment of nrAAA suggesting an accumulation of untreated AAA with a potentially increased risk of rupture

Die Marginalvene – nach wie vor eine seltene Entität: Fallserie von 16 Patienten

BACKGROUND: The marginal vein (MV) is a congenital, predominantly venous vascular malformation, which is based on a lack of regression of the embryonic venous system in the lower extremities and is associated with a variety of complications. So far, no uniform treatment regimens have been described in the literature. OBJECTIVE: What are the treatment strategies and outcomes in patients with a MV? MATERIAL AND METHODS: In the period from 1 January 2008 to 31 December 2020, all patients treated at the University Hospital Augsburg with MV were retrospectively reviewed. RESULTS: The median age at the time of diagnosis was 14.8 years (3–42 years). Out of 16 patients 12 had a leg length difference, 75% of patients (12/16) already had chronic venous insufficiency (CVI) at the time of diagnosis of MV. Open surgical removal of MV was performed as first-line treatment in 31.3% (5/16) patients. The MV was primarily closed by endovenous laser therapy (EVLT) in 1/16 patients, 15/16 patients were treated with redo procedures and 2.6 ± 2.4 (mean±SD) redo procedures were performed per patient in follow-up. The mean follow-up was 8.1 years. DISCUSSION: In order to prevent/avoid progression of CVI and thrombosis prophylaxis, the MV should be closed/removed promptly after diagnosis. The use of conventional surgical techniques for the removal of MV seems to have an advantage over treatment with minimally invasive procedures in terms of the number of secondary interventions required

Valvulotomy of the great saphenous vein in ex situ non-reversed and in situ setting: a multicenter post-market study to assess the safety and efficacy of the AndraValvulotome™”

Purpose To evaluate the safety and technical success of the AndraValvulotome™ device (Andramed GmbH, Reutlingen, Germany) in patients with peripheral arterial disease (PAD) requiring bypass surgery using the great saphenous vein (GSV) as graft. Methods This was a multicenter, post-market observational study conducted in 2021 in 11 German centers. Safety and efficacy data were prospectively collected and analyzed. Primary endpoints were the absence of device-related serious adverse events until 30 ± 7 days follow-up, the clinical efficacy of valvulotomy, which was defined as pulsatile blood flow in the bypass and the number of insufficiently destroyed vein valves. Secondary endpoints were the number of valvulotomy passages, the primary patency rate of the venous bypass (determined by a color-duplex sonography showing a normal blood flow through the bypass and absence of stenosis or occlusion), and the primary technical success defined as the absence of product-specific (serious) adverse events and clinical efficacy. Results Fifty-nine patients were enrolled. The mean age of the patients was 71 years (46–91), and 74.6% were males. The vein material used for bypass grafting had a median length of 47.5 cm (range 20–70 cm) with a median diameter of 5.0 mm (range 3–6 mm) and 4.0 mm (range 2–6 mm) in the proximal and distal segments, respectively. The technical success rate was 96.6%. The primary patency rate was 89.9% at 30 days follow-up. The clinical efficacy was rated as very good in 81% of patients, fair in 17%, and poor in 2%. Between 1 and 5 (average 2.9) valvulotome passages were performed. One product-related serious adverse event was recorded (bypass vein dissection). Conclusion The AndraValvulotome™ can be considered a safe and effective device to disrupt venous valves during in situ non-reversed bypass surgeries using GSV grafts in patients with PAD

Incidence of incisional hernia after xiphopubic laparotomy during aortic aneurysm compared to benign colorectal surgery: a retrospective matched control cohort study

Hintergrund: Narbenhernien stellen nach Operationen ein unerwünschtes Ereignis dar. Dabei werden in der Literatur verschiedene Theorien zur Entstehung diskutiert. Sowohl beim Aortenaneurysma als auch bei der Narbenhernie soll das Kollagen ein entscheidender Faktor in der Entstehung. Historisch wird von ausgegangen das Patienten mit einem Aortenaneurysma auch ein erhöhtes Risiko für die Entwicklung einer Narbenhernie haben. Aus diesem Grund vergleichen wir die Inzidenzrate zwischen Patienten mit Aortenaneurysmen und Patienten mit einem kolorektalen Eingriff um Risikofaktoren zu identifizieren. Methoden: Diese Studie ist eine retrospektive „Matched Control“ Kohorten-Studie. Es wurden alle Patienten eingeschlossen die sich zwischen dem 01.01.2006 und dem 31.12.2008 an der chirurgischen Universitätsklinik Würzburg an einem Aortenaneurysma oder einem kolorektalen Eingriff unterzogen haben. Ergebnisse: In unserer Studie konnten wir eine Gesamtinzidenzrate von 17,2% nachweisen. In der Gruppe der Aortenaneurysmen bestand eine Inzidenzrate von 13,9%, in der Gruppe der Kolorektalen Eingriffe von 25,9%. Es bestand kein signifikanter Unterschied zwischen den beiden Gruppen bezüglich der Inzidenzrate von Narbenhernien Schlussfolgerung: Es besteht kein signifikanter Unterschied zwischen den beiden Vergleichsgruppen. In der Gruppe der Aortenaneurysmen war die Inzidenzrate sogar geringer.Background: Incisional hernias represent after surgeries an adverse event dar. Various theories on the development are discussed in the literature. Both the aortic aneurysm as well as the hernia , the collagen is a crucial factor in the development . Historically sumed that patients with aortic aneurysms have an increased risk for developing a hernia . For this reason, we compare the incidence rate between patients with aortic aneurysms and patients with colorectal intervention to identify risk factors. Methods: This study is a retrospective " Matched Control" cohort study. It all patients were included who 01.01.2006 and 31.12.2008 subjected between the Surgical University Clinic Würzburg on a aortic aneurysm or colorectal surgery. Results: In our study , we demonstrated an overall incidence rate of 17.2%. In the group of aortic aneurysms was an incidence rate of 13.9 % , in the group of colorectal surgery of 25.9 %. There was no significant difference between the two groups regarding the incidence of incisional hernias Conclusion: There is no significant difference between the two comparison groups. In the group of aortic aneurysms , the incidence rate was even lower

Atherektomie mit einem neuen System, das noch mehr kann

Zusammenfassung Die kathetergestützte Atherektomie wird hinsichtlich ihrer Indikation seit Jahren kontrovers diskutiert. Neuere Studiendaten zeigen, dass multifunktionelle Atherektomiesysteme mit geringem Materialaufwand auch für komplexe Läsionen eine Alternative zum Bypass darstellen können, obwohl der direkte Vergleich noch fehlt. Die Ergebnisse der ByCross-Zulassungsstudie wurden mit den technischen und klinischen Daten anderer Atherektomiesysteme in Bezug auf die Indikationsbreite, die herstellerseitigen Limitierungen, die technische Erfolgs- und Komplikationsrate und die jeweiligen Instruktionen für den Einsatz verglichen. Dabei war in allen rezenten Studien eine Residualstenose von ≤ 50% nach Atherektomie und ≤ 30% in der abschließenden Gefäßdarstellung als ein primärer Endpunkt und als Beweis des technischen Erfolges angegeben. Für die ByCross-Studie wurden deutlich komplexere, langstreckig schwer verkalkte Gefäßläsionen eingeschlossen als für andere Zulassungsstudien. Dies betrifft nicht nur die Läsionslänge (124,7 mm vs. 34 mm in der EASE-Studie oder 67,2 mm in der VISION-Studie) und den Stenosegrad (99,4% vs. 88,5% in der EASE- und 78,7% in der VISION-Studie). Auch der Kalzifizierungsgrad, der anhand des Peripheral Artery Calcification Severity Score (PACSS) definiert wurde, war höher als in anderen Studien. Dennoch lag die technische Erfolgsrate, wie vorgegeben, über 95%. Während das ByCross ohne vorherige Drahtpassage als Crossingsystem eingesetzt werden kann (26,82% der Fälle), ist die primäre intraluminale Passage des Drahtes für alle weiteren Systeme vorgeschrieben. Das ByCross hat einen größenvariablen Kopf, der einen Lumengewinn von 4,7 mm erlaubt, ohne dass Systeme ausgetauscht werden oder aufgrund von Laufzeitlimitierungen pausieren müssen. Das ByCross war das einzige System im Vergleich mit 0% Embolierate, was auf das Wirkprinzip und die hohe Aspirationskraft des Systems zurückführbar ist. Gefäßverletzungen traten ebenso nicht auf. Die 6-Monats-Ergebnisse zeigen den Langzeiterfolg des Verfahrens mit 0% Revaskularisationsrate. Atherektomiesysteme der neuesten Generation stellen eine sichere und effektive Erweiterung des endovaskulären Portfolios dar. Das ByCross-System hebt sich durch die breitere Zulassung und die Multifunktionalität als investmentfreie Atherektomie-, Thrombektomie- und Crossingdevice für iliakale wie femorodistale Gefäßläsionen deutlich von den anderen Systemen ab und kann in komplexen Verschlussmorphologien als Alternative zum Bypass gesehen werden