Michael Lauterbach

Venous thromboembolism (VTE) is a life-threatening disease with risk of recurrence. Oral anticoagulation (OAC) with vitamin K antagonists (VKA) is effective to prevent thromboembolic recurrence. We aimed to investigate the quality of OAC of VTE patients in regular medical care (RMC) compared to a telemedicine-based coagulation service (CS). The thrombEVAL study (NCT01809015) is a prospective, multi-center study to investigate OAC treatment (recruitment: January 2011–March 2013). Patients were evaluated using clinical visits, computer-assisted personal interviews, self-reported data and laboratory measurements according to standard operating procedures. Overall, 360 patients with VTE from RMC and 254 from CS were included. Time in therapeutic range (TTR) was higher in CS compared to RMC (76.9% (interquartile range [IQR] 63.2–87.1%) vs. 69.5% (52.3–85.6%), p < 0.001). Crude rate of thromboembolic events (rate ratio [RR] 11.33 (95% confidence interval [CI] 1.85–465.26), p = 0.0015), clinically relevant bleeding (RR 6.80 (2.52–25.76), p < 0.001), hospitalizations (RR 2.54 (1.94–3.39), p < 0.001) and mortality under OAC (RR 5.89 (2.40–18.75), p < 0.001) were consistently higher in RMC compared with CS. Patients in RMC had higher risk for primary outcome (clinically relevant bleedings, thromboembolic events and mortality, hazard ratio [HR] 5.39 (95%CI 2.81–10.33), p < 0.0001), mortality (HR 5.54 (2.22–13.84), p = 0.00025), thromboembolic events (HR 6.41 (1.51–27.24), p = 0.012), clinically relevant bleeding (HR 5.31 (1.89–14.89), p = 0.0015) and hospitalization (HR 1.84 (1.34–2.55), p = 0.0002). Benefits of CS care were still observed after adjusting for comorbidities and TTR. In conclusion, anticoagulation quality and outcome of VTE patients undergoing VKA treatment was significantly better in CS than in RMC. Patients treated in CS had lower rates of adverse events, hospitalizations and lower mortality. CS was prognostically relevant, beyond providing advantages of improved international ratio (INR) monitoring.

Oral anticoagulation (OAC) is effective at preventing and treating thromboses and thromboembolism in patients with normal renal function. We aimed to research the impact of severe renal failure (RF) on patient outcome and to determine the potential benefit of caring for these patients in a specialized coagulation service (CS). A total of 1516 usual medical care patients and 756 CS-managed patients of the thrombEVAL multicenter (21 centers), prospective, cohort study (NCT01809015) were analyzed in a 3-year follow-up. Patients with RF (serum creatinine >3 mg/dL, no renal replacement therapy) were compared to patients without RF in usual care and a CS. The fluctuations in the international normalized ratios were significantly lower in CS-managed patients, and regardless of treatment in usual care or a CS, the time in therapeutic range was significantly lower in RF patients. Cox regression-adjusted hazard ratios for long-term outcome (1.5, 95% CI: 1.22–1.83, p < 0.001), death (1.62, CI: 1.27–2.08, p < 0.001), and hospitalization (1.21, CI: 1.02–1.44, p = 0.032) were significantly higher in RF patients in usual care. Furthermore, there was a trend of more bleeding events in RF patients. CS-treated patients had significantly lower adjusted hazard ratios for death (0.24, CI: 0.14–0.39, p < 0.001), hospitalizations (0.41, CI: 0.34–0.5, p < 0.001), clinically relevant bleeding (0.29, CI: 0.18–0.47, p < 0.001), and major bleeding (0.33, CI: 0.18–0.59, p < 0.001). Thus, patients who required oral anticoagulation therapy benefitted significantly from being managed in a specialized coagulation service, regardless of their renal function.

Beta‐blocker overdose is potentially harmful due to the strong blood pressure‐lowering and heart rate‐lowering effects. However, conflicting data exist as to their differential toxicity, single‐substance exposures and the effect of co‐exposure with additional antihypertensive medication. For this, a 10‐year retrospective, explorative analysis of the Mainz Poison Center/Germany database with regard to circumstances of beta‐blocker exposure, doses, symptoms and treatment was carried out. Analyses were restricted to adult patients with single‐substance exposures and co‐exposures with one additional antihypertensive substance. Written follow‐up information was obtained in half the cases. A total of 2967 cases were analysed, of which 697 were single‐substance exposures. Metoprolol was most frequently reported followed by bisoprolol, atenolol, propranolol and sotalol. Metoprolol showed a linear dose‐symptom relationship, whereas propranolol and sotalol seemed to have a threshold dose beyond which symptoms aggravated. Symptoms did not differ substantially, except for more seizures being reported with propranolol, and more CNS depression/vomiting with sotalol. Activated charcoal was used in 38%, gastric lavage in 11%, temporary pacemaker in 3%, glucagon in 1%, intubation for respiratory insufficiency and cardiopulmonary resuscitation in 1% and 0.5%. All patients recovered. In 174 co‐exposure cases, the distribution of poisoning severity and rate of worsening of symptoms was comparable with single‐substance exposures except one patient deceased after bisoprolol and verapamil co‐exposure. In adults with beta‐blocker overdose, no significant differences in poisoning severity among beta‐blockers were detected, and no fatalities were observed with single‐substance exposures. Co‐exposures with other antihypertensives, sedatives or alcohol should be carefully attended to as fatalities might occur.

Introduction: Years after mitral valve surgery, progressive degeneration of reconstructed mitral valves or bioprostheses might lead to severe mitral valve regurgitation. Patients with significant comorbidity, or impaired left ventricular function are poor candidates for redo surgery at an acceptable risk at that later time point.Methods and results: This study reports the first‐in‐man transapical valve‐in‐ring implantations in the mitral position of the fully repositionable Lotus valve system approved for transcatheter aortic valve replacement in Europe. Transapical valve‐in‐ring implantations with this valve system were successfully performed in a 64‐year‐old female, and a 53‐year‐old male patient. Both patients were NHYA class IV, and carried an unacceptably high risk of cardiac surgery due to clinical condition and comorbidity. The first patient was successfully implanted a 25 mm valve, improved to NYHA class II, and was discharged 2 weeks after the procedure. The second patient required a short episode of cardiopulmonary resuscitation after valve implantation (27 mm), and was placed on veno‐venous ECMO for 24 hr to improve oxygenation. He developed stroke on day 7, and deceased from fatal, toxic rhabdomyolysis 13 days after the procedure.Conclusion: Transapical valve‐in‐ring implantation of the repositionable Lotus valve system in the mitral position is a feasible and promising option that merits further evaluation.

Loss of protective airway reflexes in patients with acute coma puts these patients at risk of aspiration pneumonia complicating the course of the primary disease. Available data vary considerably with regard to bacteriology, role of anaerobic bacteria, and antibiotic treatment. Our objective was to research the bacteriology of aspiration pneumonia in acute coma patients who were not pre-treated with antibiotics or hospitalized within 30 days prior to the event. We prospectively analyzed 127 patient records from adult patients admitted, intubated and ventilated to a tertiary medical intensive care unit with acute coma. Bacteriology and antibiotic resistance testing from tracheal aspirate sampled within 24 h after admission, blood cultures, ICU scores (APACHE II, SOFA), hematology, and clinical chemistry were assessed. Patients were followed up until death or hospital discharge. The majority of patients with acute coma suffered from acute cardiovascular disorders, predominantly myocardial infarction, followed by poisonings, and coma of unknown cause. In a majority of our patients, microaspiration resulted in overt infection. Most frequently S. aureus, H. influenzae, and S. pneumoniae were isolated. Anaerobic bacteria (Bacteroides spec., Fusobacteria, Prevotella spec.) were isolated from tracheal aspirate in a minority of patients, and predominantly as part of a mixed infection. Antibiotic monotherapy with a 2nd generation cephalosporin, or a 3rd generation gyrase inhibitor, was most effective in our patients regardless of the presence of anaerobic bacteria.

Transcatheter aortic valve implantation (TAVI) has emerged as a viable treatment option for high-risk patients with symptomatic, senile degenerative aortic stenosis. Since the first TAVI in 2002, the technology has evolved tremendously. With the downsizing of the device delivery catheter profile, vascular access site complications have decreased significantly. Current access routes are transfemoral, subclavian, transapical and transaortic, with most centres preferring a ‘transfemoral-first’ strategy. Other significant complications of TAVI are cerebrovascular events and conduction disturbances with the need for pacemaker implantation. The current TAVI devices with the largest number of implantations and the best evidence are the Medtronic CoreValve™ and the Edwards SAPIEN XT™. Both devices are already in their third generation. Navigation technology, such as the HeartNavigator, has been developed to facilitate the preparation of the procedure and the actual device implantation. The use of hybrid catheterisation labs for performing TAVI is becoming the standard of care due to the significant advantages with regard to safety and hygiene.