Immanuel Klinikum Bernau

Interventional closure of symptomatic paravalvular leaks (PVL) after valve replacement has developed to an attractive treatment option for patients at high operative risk. However, prospective and long-term data are sparse. We analysed data from a multicentre prospective registry on interventional PVL closure. 41 patients with symptomatic PVL were included in the plug registry at nine German hospitals from 2014 until 2020. In total 50 interventions with 67 plug implantations were recorded, 46.3% of procedures were performed for aortic and 53.7% for mitral PVLs. In 82% of patients PVL closure was performed once, in 16% twice and 2% underwent three procedures. Indication for PVL closure was symptomatic heart failure with NYHA class ≥ II (63.4%), haemolysis (4.9%), or NYHA class ≥ II and haemolysis (31.7%). PVL closure was completely successful in 76%, partially successful in 10% and failed in 14%. Acute improvement of one NYHA class was achieved in 56.4% and of two NYHA classes in 15.4%. Postprocedural no residual severe aortic PVL was described and residual severe mitral PVL was seen in 4.8%. Postinterventional complications occurred in 21.9%. In-hospital mortality rate was 4.9%. A follow-up was performed after 30days, 12months, 3 and 5years. Calculated mortality rates were 10.1% at 1-year-, 18.5% at 3-year- and 32.5% at 5-year-follow-up. The estimated rates for mortality and/or reintervention (surgical or interventional) were 25.6% at 1-year, 36.8% at 3-year and 45.1% at 5-year follow-up. The multicentre German Plug-Registry describes a high procedural success rate with clinical improvement in most patients and acceptable long-term outcomes after percutaneous PVL closure. NCT03179969.

Approximately 40% of patients with heart failure (HF) who are eligible for cardiac resynchronization therapy (CRT) either fail to respond or are untreatable due to anatomical constraints. To assess the safety and efficacy of a novel, leadless, left ventricular (LV) endocardial pacing system for patients at high risk for a CRT upgrade or whose coronary sinus (CS) lead placement/pacing with a conventional CRT system failed. The SOLVE-CRT study was a prospective multicenter trial enrolling January 2018 through July 2022, with follow-up at 6 months. Data were analyzed from January 17, 2018, through February 15, 2023. The trial combined data from an initial randomized, double-blind study (n = 108) and a subsequent single-arm part (n = 75). It took place at 36 centers across Australia, Europe, and the US. Participants were nonresponders, previously untreatable (PU), or high-risk upgrades (HRU). All participants contributed to the safety analysis. The primary efficacy analysis (n = 100) included 75 PU-HRU patients from the single-arm part and 25 PU-HRU patients from the randomized treatment arm. Patients were implanted with the WiSE CRT System (EBR Systems) consisting of a leadless LV endocardial pacing electrode stimulated with ultrasound energy delivered by a subcutaneously implanted transmitter and battery. The primary safety end point was freedom from type I complications. The primary efficacy end point was a reduction in mean LV end systolic volume (LVESV). The study included 183 participants; mean age was 68.1 (SD, 10.3) years and 141 were male (77%). The trial was terminated at an interim analysis for meeting prespecified stopping criteria. In the safety population, patients were either New York Heart Association Class II (34.6%) or III (65.4%). The primary efficacy end point was met with a 16.4% (95% CI, -21.0% to -11.7%) reduction in mean LVESV (P = .003). The primary safety end point was met with an 80.9% rate of freedom from type I complications (P < .001), which included 12 study device system events (6.6%), 5 vascular events (2.7%), 3 strokes (1.6%), and 7 cardiac perforations which mostly occurred early in the study (3.8%). The SOLVE-CRT study has demonstrated that leadless LV endocardial pacing with the WiSE CRT system is associated with a reduction in LVESV in patients with HF. This novel system may represent an alternative to conventional CRT implants in some HF patient populations. ClinicalTrials.gov Identifier: NCT0292203.

Introduction: The percutaneous Kirschner-wire fixation is a minimally invasive operative technique in pediatric fracture treatment. The advantage of the K-wire technique is that it requires little instrumentation and removing the wire is easy. The disadvantage is that it requires plaster cast or brace. Objective: Our aim was to examine the following: did exposed wires have more septic complications, were the total hospital stays and the number of narcosis during metal removal lower, than in the case of buried wires? Method: A retrospective observational cohort study was enrolled in Heim Pál National Pediatric Institute between 2017 and 2021. Patients under 18 years were included with fractures treated via closed reduction and percutaneous K-wiring. Exclusion criteria were the open reduction, other surgery at the same time, open fractures, if the wire removal was fractionated, documentation was missing or the treatment was started/finished in other hospital. Patients were grouped according to the position of the wires (buried or exposed). The observed parameters were the type of anaesthesia during the wire removal, the cumulative length of hospital stay, the rate of infective complications. For statistical analysis, the t-probe and the chi2-test were used. Results: In the study period, 427 patients with the average age of 10 years were included. The wires were buried in 138/427 and exposed in 289/427 cases. The cumulative length of hospital stay was 3.44 days in average in buried cases and 1.92 days in exposed cases (p = 0.0158). During wire removal, general anaesthesia was needed in 33/138 cases in buried wire patients and 19/289 in exposed wire patients (p<0.0001). Infective complication was observed in 6/138 buried and 16/289 exposed wire patients (p = 0.6). Discussion: Using exposed K-wires, the cumulative length of hospital stay is shorter, needing general anaesthesia during the implant removal is less according to buried wires. There is no difference in infective complications between the two techniques. Conclusion: Using exposed K-wires is feasible: in the majority of the cases, the implant removal does not needi general anaesthesia, so the cumulative hospital stay can be reduced. Orv Hetil. 2024; 165(23): 908–912.

Funding AcknowledgementsType of funding sources: None.BackgroundBoth, the prevalence of obesity and incidence of cardiac implantable electronic device (CIED)-related complications are increasing worldwide. Transvenous laser lead extraction is a way to meet the rising complexity of cases, but knowledge about the impact of body-mass-index (BMI) on this procedure is limited.Methods and ResultsAll patients in the GALLERY (GermAn Laser Lead Extraction RegistrY) database were stratified by BMI in accordance to the World Health Organization (WHO) definition. Patient characteristics, as well as procedural outcomes were analyzed. Within the group of obese patients (BMI ≥30kg/m2), predictors for adverse outcomes (procedural failure, complications, all-cause mortality) were assessed.A total of 2524 patients were divided into 5 groups (Underweight: BMI <18.5 kg/m2, Regular weight: BMI 18.5-24.5 kg/m2; Overweight: BMI 25.0-29.9 kg/m2, Obese 1: 30.0-34.9 kg/m2, Obese 2: BMI >35.0 kg/m2). Most patients (46.6%) were overweight (BMI 25.0-29.9kg/m2). The prevalence of metabolic comorbidities, such as arterial hypertension (84.2%; p<0.001), chronic kidney disease (36.8%; p=0.020) and diabetes mellitus (51.1%; p<0.001) were highest amongst patients in group Obese 2. In this patient group (Obese 2), systemic infection was the leading extraction indication (39.8%; p<0.001). There were no differences in minor (p=0.839) or major (p=0.426) complications, procedure-related- (p=0.533) and all-cause mortality (p=0.333) between groups. Rates for clinical procedural success (p=0.504) were indifferent between groups. Procedural time (p=0.450) and postoperative period of hospitalization (p=0.09) were not significantly different between groups. Multivariate analyses of groups Obese 1+2 revealed lead age ≥10 years as predictor or procedural failure (OR: 2.99; 95% CI: 1.06-8.45; p=0.038). Lead age ≥10 years (OR: 3.25; 95% CI: 1,31-8.10; p=0.011) and the presence of abandoned leads (OR: 3.08; 95% CI: 1.03-9.22; p=0.044) were identified as predictors of procedural complications, whereas a patient age ≥75 years seemed to be protective against complications (OR: 0.27; 95% CI: 0.08-0.93; p=0.039). Chronic kidney disease (OR: 3.20; 95% CI: 1.32-7.80; p=0.010) and periprocedural complications (OR: 5.33; 95% CI: 1.55-18.32; p=0.008) were identified as predictors of all-cause mortality. After adjustment, systemic infection (OR: 17.68; 95% CI: 4.03-77.49; p<0.001) remained the sole predictor for all-cause mortality.ConclusionLaser lead extraction (LLE) in obese patients did not show higher rates of complications. Procedural time as well as duration of hospitalization was not prolonged. With considerate planning and in experienced centers, LLE is a safe and efficacious option for this patient collective. Systemic infection is the main driver of mortality in obese patients with BMI ≥ 30 kg/m2.

Review question / Objective: How is the recurrence of atrial fibrillation after catheter ablation therapy defined and monitored in randomized-controlled clinical studies in the past ten years? Do the monitoring characteristics have an impact on the ablation efficacy outcomes?

Purpose Somatic illnesses are often accompanied by (psychological) capacity impairments which impact on everyday life and work. The question is whether different somatic illnesses are associated with different capacity impairments, and whether impairment is more severe in cases of comorbid mental disorders. Materials and Methods Patients with neurological (N = 318), cardiological (N = 307) and orthopedic illness (N = 311) with and without comorbid mental illness according to MINI were investigated in a rehabilitation hospital. Psychological capacity impairments were assessed with the Mini-ICF-APP observer rating. Results The "baseline rate" of capacity impairment in patients without mental illnesses was 40.7% in orthopedic, in 36% of cardiology patients (36.1%) and in 74.9% of neurology patients. Patients with additional comorbid mental disorders had stronger impairments than those without mental illness. The most heavily impaired group overall were neurology patients with comorbid mental illness. Conclusions Somatic patients also have psychological impairments; these are more pronounced in the case of comorbid mental illnesses. It should be clearly explored whether psychological symptoms and impairment are an expression of the somatic illness per se, or due to a comorbid mental illness. Rehabilitation diagnostics should consider capacity impairments routinely in order to make indications for capacity trainings or context adjustment.

Background: Primary objective of this present trial was to define the maximum tolerable dose of lapatinib in combination with oxaliplatin, 5-fluorouracil, and folinic acid (OFF) in refractory pancreatic cancer. The secondary objective was to assess the safety and efficacy of lapatinib plus OFF. Methods: We conducted a phase I trial using an accelerated dose escalation design in patients with refractory pancreatic cancer. Lapatinib was given on days 1 to 42 in combination with folinic acid 200 mg/m2 day + 5-fluorouracil 2000 mg/m2 (24 h) on days 1, 8, 15, and 22, and oxaliplatin 85 mg/m2 days 8 and 22 of a 43-day cycle (OFF). Toxicity and efficacy were evaluated. Results: In total, eighteen patients were enrolled: dose level 1 (1000 mg) was assigned to seven patients, dose level 2 (1250 mg), five patients; and dose level 3 (1500 mg), six patients. Dose-limiting toxicities were diarrhea and/or neutropenic enterocolitis observed in two of six patients: one diarrhea III°, one diarrhea IV°, as well as neutropenic enterocolitis. The maximum tolerable dose of lapatinib was 1250 mg OD. Conclusions: The combination of lapatinib 1250 mg OD with platinum-containing chemotherapy is safe and feasible in patients with refractory pancreatic cancer and warrants further investigation.

BackgroundIron deficiency (ID) is a common co‐morbidity in patients with cardiovascular disease and contributes to impaired functional capacity. The relevance of ID in patients in recovery after acute stroke is not known. We assessed the prevalence of ID and anaemia in relation to functional capacity and to recovery during early rehabilitation after stroke.MethodsThis observational study enrolled consecutively 746 patients with ischaemic or haemorrhagic stroke at in‐patient early rehabilitation (age 68 ± 13 years, female 47%, ischaemic stroke 87%). Functional capacity was assessed before and after rehabilitation using Barthel index (reha‐BI), motricity index (MI), trunk control test (TCT), and functional ambulatory category (FAC). ID was defined as ferritin <100 μg/L or as transferrin saturation (TSAT) < 20% if ferritin was 100‐ < 300 μg/L or if CrP > 5 mg/L. Anaemia was defined as Hb < 12 g/dL (women) and <13 g/dL (men).ResultsThe prevalence of ID and anaemia before rehabilitation were 45% and 46%, respectively, and remained high at discharge (after 27 ± 17 days) at 40% and 48%, respectively. Patients with ID had lower functional capacity compared with patients without ID (reha‐BI 20 [±86] vs. 40 [±80], MI 64 [±66] vs. 77 [±41], TCT 61 [±76] vs. 100 [±39], FAC 1 [±4] vs. 4 [±4]; median [IQR], all P < 0.001). ID was related to inflammation (OR 2.68 [95% CI 1.98–3.63], P < 0.001), female sex (OR 2.13 [95% CI 1.59–2.85], P < 0.001), haemorrhagic stroke (OR 1.70 [95% CI 1.11–2.61], P = 0.015), initial treatment on stroke unit (OR 3.59 [95% CI 1.08–11.89], P < 0.001), and anaemia (OR 2.94 [95% CI 2.18–3.96], P < 0.001), while age, BMI, and renal function were not related to ID. In adjusted analysis, ID was associated with low functional capacity in all functional scores: reha‐BI (OR 1.66 [95% CI 1.08–2.54], P = 0.02), motricity index (OR 1.94 [95% CI 1.36–2.76], P < 0.001), trunk control test (OR 2.34 [95% CI] 1.64–3.32, P < 0.001) and functional ambulatory category (OR 1.77 [95% CI 1.2–2.63], P < 0.02). Functional capacity improved during rehabilitation regardless of presence of ID, but functional outcome remained significantly lower in patients with ID at the end of rehabilitation (rehab BI and MI, both P < 0.001).ConclusionsIron deficiency and anaemia are common and persistent findings in patients after acute stroke. ID and anaemia are independently related to lower functional capacity after acute stroke and to poor functional outcome after rehabilitation. Regular assessment of iron status may identify patients at risk of low functional recovery.

Abstract Funding Acknowledgements Type of funding sources: None. Background Leading right heart failure due to tricuspid regurgitation results in retrograde hepatic venous congestion with subsequent gastropathy and hyperemia of the gastric mucosa. Due to increased portal pressure as well as possible cirrhosis cardiaque, the risk for esophageal varices is greatly increased. In addition, associated with atrial dilatation, these patients usually suffer from atrial fibrillation and receive an oral anticoagulation/ direct anticoagulation (OAC/DOAC) as insult prophylaxis. Heparinization with a target ACT &amp;gt; 250 seconds is necessary during transfemoral transcatheter tricuspid repair (TTTR). Alternation between transgastric and midesophageal view with the transesophageal ultrasound probe is usually performed to better guide TTTR. Sufficient wall contact is crucial for good imaging. All of these conditions increase the risk for periprocedural gastric and/or esophageal injury. Purpose The aim of this study was to assess the incidence and risk factors for mechanical irritation and bleeding caused by the TEE probe manipulation in the setting of TTTR. Methods In this prospective cohort study patients received gastroscopy preinterventional and on the first day after TTTR. Statistical analysis was performed with IBM SPSS.28, t-Test was used to compare patients with and without postinterventional lesions. Results From December 2020 to July 2021, 18 patients with indication for TTTR were included in this study. The mean age of the patients was 77.8 (± 7.5) years. Thirteen patients (72.2%) had antral gastritis and 4 patients (22.2%) had corpus gastritis preinterventionally. Esophageal varices were not detectable in any patient. Postinterventionally, 10 patients (55.6%) showed lesions (hematoma or coagulated pressure points) (Fig. 1), and 2 patients (11%) required interventional treatment with hemoclips. The main lesion sites were midesophageal at 20-25 cm, 1 lesion at the Z-line. A mean of 5.7 (± 2.5) position changes took place; the mean procedural duration was 88 (± 27.8) min. The number of clips placed (p = 0.64), the procedural duration (p = 0.99) and the number of position changes (p = 0.48) did not differ between the group of patients with and without injuries after TTTR (Tab 1). Conclusion More than 50% of patients with TTTR showed postprocedural injuries (lesions) of the esophagus. Contrary to our assumption, mainly lesions midesophageal could be detected. Due to the procedure as well as the severe underlying disease, gastrointestinal bleeding is a potential complication in the context of a TTTR. Consideration should be given to implementing regular control gastroscopy after TTTR to reduce the procedure-related complication rate. Due to the high incidence of procedure-related lesions, further research in larger patient collectives is necessary. Abstract Figure. Abstract Figure.