Background A small proportion of patients undergoing primary prophylactic implantation of implantable cardioverter defibrillators (ICDs) experiences malignant arrhythmias. We postulated that periodic repolarisation dynamics, a novel marker of sympathetic-activity-associated repolarisation instability, could be used to identify electrically vulnerable patients who would benefit from prophylactic implantation of ICDs by way of a reduction in mortality. Methods We did a prespecified substudy of EUropean Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators (EU-CERT-ICD), a prospective, investigator-initiated, non-randomised, controlled cohort study done at 44 centres in 15 EU countries. Patients aged 18 years or older with ischaemic or non-ischaemic cardiomyopathy and reduced left ventricular ejection fraction (<= 35%) were eligible for inclusion if they met guideline-based criteria for primary prophylactic implantation of ICDs. Periodic repolarisation dynamics from 24-h Holter recordings were assessed blindly in patients the day before ICD implantation or on the day of study enrolment in patients who were conservatively managed. The primary endpoint was all-cause mortality. Propensity scoring and multivariable models were used to assess the interaction between periodic repolarisation dynamics and the treatment effect of ICDs on mortality. Findings Between May 12, 2014, and Sept 7, 2018, 1371 patients were enrolled in our study. 968 of these patients underwent ICD implantation, and 403 were treated conservatively. During follow-up (median 2.7 years [IQR 2.0-3.3] in the ICD group and 1.2 years [0.8-2.7] in the control group), 138 (14%) patients died in the ICD group and 64 (16%) patients died in the control group. We noted a 43% reduction in mortality in the ICD group compared with the control group (adjusted hazard ratio [HR] 0.57 [95% CI 0.41-0.79]; p=0.0008). Periodic repolarisation dynamics significantly predicted the treatment effect of ICDs on mortality (adjusted p=0.0307). The mortality benefits associated with ICD implantation were greater in patients with periodic repolarisation dynamics of 7.5 deg or higher (n=199; adjusted HR 0.25 [95% CI 0.13-0.47] for the ICD group vs the control group; p<0.0001) than in those with periodic repolarisation dynamics less than 7.5 deg (n=1166; adjusted HR 0.69 [95% CI 0.47-1.00]; p=0.0492; P-interaction=0.0056). The number needed to treat was 18.3 (95% CI 10.6-4895.3) in patients with periodic repolarisation dynamics less than 7.5 deg and 3.1 (2.6-4.8) in those with periodic repolarisation dynamics of 7.5 deg or higher. Interpretation Periodic repolarisation dynamics predict mortality reductions associated with prophylactic implantation of ICDs in contemporarily treated patients with ischaemic or non-ischaemic cardiomyopathy. Periodic repolarisation dynamics could help to guide treatment decisions about prophylactic ICD implantation. Copyright (C) 2019 Elsevier Ltd. All rights reserved.
Die Lungenarterienembolie (LE) ist eine häufig auftretende Komplikation bei kritisch kranken Patienten. Das gleichzeitige Auftreten von LE und lebensbedrohlichen Blutungen ist ein therapeutisches Dilemma. Für diese Patientenpopulation stellen Vena-cava-Filter (VCF) eine therapeutische Option dar. Der Angel®-Katheter (Bio2 Medical Inc. San Antonio, TX, USA) ist ein neuartiger temporärer VCF, der bettseitig ohne Durchleuchtung implantiert wird.
PurposePulmonary embolism (PE) is a frequently occurring complication in critically ill patients. Simultaneous occurrence of PE and life-threatening bleeding, may render medical anticoagulation impossible. For these patients, inferior vena cava filters (IVCF) present a valuable therapeutic alternative. The Angel® catheter is a novel IVCF that provides temporary protection from PE and is implanted at bedside.The primary objective of the European Angel® catheter registry is to evaluate the safety and efficacy of this IVCF.Material and methodsThe European Angel® catheter registry is an observational, multi-centre registry. Patients from four countries and eight sites that have undergone Angel® catheter implantation between March 2013 and February 2017 were enrolled.ResultsA total of 114 critically ill patients were included. The main indication for implantation was a high-risk for PE in combination with contraindications for anticoagulation (69.3%). One clinically non-significant PE (0.9%) occurred in a patient with an indwelling Angel® catheter. No cases of catheter associated serious complications were observed.ConclusionData shows that the Angel® catheter is a safe and effective approach to overcome the acute phase of critically ill patients with a high risk for the development of PE or an established PE, when an anticoagulation therapy is contraindicated.
Zusammenfassung Hintergrund Die Lungenarterienembolie (LE) ist eine häufig auftretende Komplikation bei kritisch kranken Patienten. Das gleichzeitige Auftreten von LE und lebensbedrohlichen Blutungen ist ein therapeutisches Dilemma. Für diese Patientenpopulation stellen Vena-cava-Filter (VCF) eine therapeutische Option dar. Der Angel®-Katheter (Bio2 Medical Inc. San Antonio, TX, USA) ist ein neuartiger temporärer VCF, der bettseitig ohne Durchleuchtung implantiert wird. Methodik Das europäische Angel®-Katheter-Register ist eine multizentrische Beobachtungsstudie. In unserer Substudie wurden Patienten aus 3 deutschen Kliniken und 4 Intensivstationen eingeschlossen, die zwischen Februar 2016 und Dezember 2016 eine Angel®-Katheter-Implantation erhalten haben. Ergebnisse Es wurden 23 kritisch kranke Patienten (68 ± 9 Jahre, 43 % männlich) in die Studie eingeschlossen. Die Hauptindikation für die Implantation waren eine manifeste LE oder Patienten mit einem erhöhten Risiko für eine LE, in Kombination mit einer Kontraindikation für eine prophylaktische oder therapeutische Antikoagulation aufgrund eines erhöhten Risikos für eine Blutung (81 %) oder einer aktiven Blutung (13 %). In 100 % der Fälle gelang die Implantation problemlos. Während des Implantationszeitraums traten keine LE auf, wohingegen größere Thromben über 20 mm in 5 % der Fälle in der Kavographie festgestellt wurden. Die Entfernung des Filters gelang problemlos in 100 % der Fälle, während es in 3 % der Fälle zu einer Filterdislokation kam. Diskussion Die deutschen Daten aus dem europäischen Angel®-Katheter-Register zeigen, dass die Angel®-Katheter-Implantation eine sichere und effektive Möglichkeit ist, LE bei kritisch kranken Patienten, die eine nachgewiesene LE oder ein hohes Risiko für eine LE haben, zu verhindern, solange eine Antikoagulation kontraindiziert ist.
The hypothesis of an association between stroke mechanisms (cardiac sources of embolism, extracranial large-artery disease, hypertension) and cranial computerized tomography stroke patterns was tested in a prospective study. 200 consecutive patients with focal brain ischemia were investigated by echocardiography (transthoracic and transesophageal approach), Doppler sonography, electrocardiography, and cranial computerized tomography (rated masked). Except for low-flow infarcts and carotid artery stenoses the association between stroke mechanisms and stroke patterns was weak. Lacunes were found with almost equal frequencies in patients with cardiac sources of embolism, extracranial large-artery disease or no extracranial source (with or without hypertension). The predictive value of cranial computerized tomography stroke patterns for the finding of possible stroke mechanisms is low. An embolic etiology of lacunes cannot be excluded.
BACKGROUND AND AIMS:Implantable cardioverter defibrillator (ICD) remote follow-up and ICD remote monitoring (RM) are established means of ICD follow-up. The reduction of the number of in-office visits and the time to decision is proven, but the true clinical benefit is still unknown. Cost and cost-effectiveness of RM remain leading issues for its dissemination. The MONITOR-ICD study has been designed to assess costs, cost-effectiveness, and clinical benefits of RM versus standard-care follow-up in a prospective multicenter randomized controlled trial.METHODS AND RESULTS:Patients indicated for single- or dual-chamber ICD are eligible for the study and are implanted an RM-capable Biotronik ICD (Lumax VR-T or Lumax DR-T; Biotronik SE & Co KG, Berlin, Germany). Implantable cardioverter defibrillator programming and alert-based clinical responses in the RM group are highly standardized by protocol. As of December 2011, recruitment has been completed, and 416 patients have been enrolled. Subjects are followed-up for a minimum of 12months and a maximum of 24months, ending in January 2013. Disease-specific costs from a societal perspective have been defined as primary end point and will be compared between RM and standard-care groups. Secondary end points include ICD shocks (including appropriate and inappropriate shocks), cardiovascular hospitalizations and cardiovascular mortality, and additional health economic end points.CONCLUSIONS:The MONITOR-ICD study will be an important randomized RM study to report data on a primary economic end point in 2014. Its results on ICD shocks will add to the currently available evidence on clinical benefit of RM.
SummaryA recently developed multiparameter computer- aided expert system (TheMa) for guiding anticoagulation with phenprocoumon (PPC) was validated by a prospective investigation in 22 patients. The PPC-INR-response curve resulting from physician guided dosage was compared to INR values calculated by “twin calculation” from TheMa recommended dosage. Additionally, TheMa was used to predict the optimal time to perform surgery or invasive procedures after interruption of anticogulation therapy. Results: Comparison of physician and TheMa guided anticoagulation showed almost identical accuracy by three quantitative measures: Polygon integration method (area around INR target) 616.17 vs. 607.86, INR hits in the target range 166 vs. 161, and TTR (time in therapeutic range) 63.91 vs. 62.40 %. After discontinuation of anticoagulation therapy, calculating the INR phase-out curve with TheMa INR prognosis of 1.8 was possible with a standard deviation of 0.50 ± 0.59 days. Conclusion: Guiding anticoagulation with TheMa was as accurate as Physician guided therapy. After interruption of anticoagulant therapy, TheMa may be used for calculating the optimal time performing operations or initiating bridging therapy.
UNLABELLED:A recently developed multiparameter computer-aided expert system (TheMa) for guiding anticoagulation with phenprocoumon (PPC) was validated by a prospective investigation in 22 patients. The PPC-INR-response curve resulting from physician guided dosage was compared to INR values calculated by "twin calculation" from TheMa recommended dosage. Additionally, TheMa was used to predict the optimal time to perform surgery or invasive procedures after interruption of anticogulation therapy.RESULTS:Comparison of physician and TheMa guided anticoagulation showed almost identical accuracy by three quantitative measures: Polygon integration method (area around INR target) 616.17 vs. 607.86, INR hits in the target range 166 vs. 161, and TTR (time in therapeutic range) 63.91 vs. 62.40 %. After discontinuation of anticoagulation therapy, calculating the INR phase-out curve with TheMa INR prognosis of 1.8 was possible with a standard deviation of 0.50 ± 0.59 days.CONCLUSION:Guiding anticoagulation with TheMa was as accurate as Physician guided therapy. After interruption of anticoagulant therapy, TheMa may be used for calculating the optimal time performing operations or initiating bridging therapy.
Accidental malpositioning of a right ventricular (RV) electrode has not been previously reported in the context of cardiac resynchronization therapy (CRT). The case of a 75-year old male patient with dilative cardiomyopathy, left ventricular (LV) ejection fraction 23%, New York Heart Association functional heart failure status stage III, left bundle branch block (LBBB) with QRS width of 136 ms, and misplacement of the RV lead to the LV apex during implantation of a CRT defibrillator is described. Following unremarkable implantation, routine interrogation of the CRT device on the first day after the implantation revealed uneventful technical findings. The 12-lead surface electrocardiogram (ECG) showed biventricular stimulation featuring a narrow QRS complex with incomplete right bundle branch block (RBBB) and R>S in V1. The biplane postoperative chest X-ray was graded normal. On routine follow-up one month later, a transthoracic echocardiogram revealed an increased ejection fraction of 51% but the RV lead was placed in the LV apex. An additional transesophageal echocardiogram exhibited an Eustachian valve guiding the lead via the patent foramen ovale through the mitral valve into the LV apex. Operative revision was scheduled and the active fixation lead was uneventful removed from the LV. A new electrode was inserted and placed in the RV apex. Accidental malplacement of the RV electrode to the LV may be difficult to diagnose in the context of CRT patients as a stimulated biventricular ECG with incomplete RBBB appearance is expected in this situation. Careful analysis of lateral radiographic views during the operation is important to ensure correct lead positioning. As timely revision is the preferred procedure, early routine transthoracic echocardiography may be considered for detection of malplacement.
Cannabinoid hyperemesis syndrome inducing acute prerenal failure and electrolyte disturbance History and clinical findings: A 36-year-old patient presented to the psychiatric clinic with presumed worsening of a chronic psychosis. Investigations: Laboratory values revealed acute renal failure and electrolyte imbalance. A further diagnostic work-up including urine analysis as well as abdominal und retroperitoneal sonography was normal. Diagnosis, therapy and clinical course: By exact history taking the clinical diagnosis of a cannabinoid hyperemesis syndrome (CHS) was established. Symptomatic treatment with intravenous fluids and electrolytes together with strict cannabis abstinence completely resolved all symptoms and normalized all pathologic values. Conclusion: Recreational use of cannabis is widespread. It may induce a widely unknown syndrome characterized by nausea, vomiting and crampy abdominal pain accompanied by frequent hot showers or bathing. This syndrome should be recognized as a potential cause of acute prerenal failure.
A 41-year-old woman presented with acute angina in the emergency unit. Additionally, she reported pain in both legs and a weight loss of 5 kilograms within the last 10 days. ECG revealed an acute anterior myocardial infarction. However, immediate coronary angiography showed open arteries with minimal arteriosclerosis. A characteristic rise of cardiac enzymes together with an akinesis of the anterior wall and an adjacent mural thrombus was highly suggestive of a transient coronary thrombosis. Further investigations showed occlusion of multiple arteries in both legs and a splenic infarct. Although there was a typical risk profile including smoking, hyperlipidemia and regular estrogen medication, a further work-up was started. Urin analysis was decisive for the presence of proteinuria and a severe nephrotic syndrome. The definite diagnosis was made by direct biopsy of the kidney that revealed the characteristic findings of a minimal change glomerulopathy. Rapid remission could be induced by high-dose oral steroids. During routine work-up of coronary syndromes, especially in those with normal coronaries, rare but treatable causes of myocardial infarction and coagulopathy have to be thought of and should carefully be excluded.
There are few data about predictors of cardiovascular mortality and rehospitalization rate in patients with left ventricular systolic dysfunction (LVSD) after myocardial revascularization and optimization of pharmacological treatment.
Eine 41-jährige Patientin kommt mit ausgeprägtem thorakalem Druckgefühl in die Notaufnahme. Zusätzlich bestehen seit 5 Wochen Schmerzen in beiden Beinen sowie ein Gewichtsverlust von insgesamt 5 kg in den letzten 10 Tagen. Das EKG zeigt einen anterioren ST-Streckenhebungsinfarkt. In der sofort durchgeführten Koronarangiographie wurde eine relevante koronare Herzkrankheit ausgeschlossen, jedoch eine Vorderwandakinesie mit Thrombus nachgewiesen. Bei im Verlauf deutlich ansteigenden Herzenzymen wurde eine passagere Koronarthrombose als Infarktursache vermutet. Die zusätzliche Diagnostik zeigte multiple arterielle Gefäßverschlüsse in Milz und Unterschenkelarterien. Trotz einer typischen Risikokonstellation (Rauchen, Fettstoffwechselstörung, hormonelle Kontrazeption) erfolgte die Suche nach einer ursächlichen Grundkrankheit. Der Urinstatus gab den entscheidenden Hinweis auf das Vorliegen eines nephrotischen Syndroms. Mittels Nierenbiopsie konnte eine Minimal-change-Glomerulopathie nachgewiesen werden, welche die Hyperkoagulabilität erklären konnte. Mit einer systemischen Steroidtherapie war eine rasche Remission zu erzielen. Im Rahmen der Abklärung des akuten Koronarsyndroms müssen insbesondere bei normalen Koronargefäßen seltene, aber gut behandelbare Ursachen bedacht und sicher ausgeschlossen werden.
Ein 52-Jähriger Patient wird mit der Diagnose Niereninsuffizienz und Hyperkalzämie eingewiesen. Parathormon ist supprimiert, Parathormon-related-Peptid nicht erhöht, 1,25-Vitamin-D3 im Normbereich, löslicher Interleukin-2-Rezeptor und Angiotensinkonversionenzym sind deutlich erhöht. Erst die Nierenbiopsie zeigt epitheloidzellige Granulome und eine geringe bis mäßige Nephrokalzinose, sodass die Diagnose einer renalen Sarkoidose gestellt wird. Unter einer systemischen Steroidtherapie kommt es zu einer raschen Normalisierung von Serumkalzium und Retentionswerten. Als ungewöhnlich bei diesem Fall sind die mutmaßlich isolierte Nierensarkoidose und normale 1,25-Vitamin-D3-Spiegel bei schwerer Hyperkalzämie anzusehen.
Background: Diagnostic marker parameters are needed to enable timely identification of high risk patients after acute myocardial infarction (MI). We assessed risk factors for death and sudden death in stable revascularized patients undergoing guideline-based therapy during an in-patient rehabilitation program more than 3 weeks after acute myocardial infarction.Methods: During an in-patient rehabilitation program, 939 patients with a recent myocardial infarction were prospectively included. Besides demographic and clinical data, ejection fraction (EF), Holter ECG, standard 12-lead electrocardiogram ( ECG) and baseline laboratory values were determined. Patients were followed up for 18 months.Results: Among multiple variables, left bundle-branch block (LBBB) was the most significant parameter affecting the outcome (combination endpoint of death, resuscitation or ventricular tachycardia (VT)), hazard ratio 7.74 (3.2-18.7, P < 0.0001). 42% of the 24 patients with LBBB but only 11.5% of the 62 patients with a left ventricular EF <= 30% died during follow-up (P < 0.001).Conclusion: LBBB observed during a rehabilitation program following an acute MI indicates a grave prognosis with a high mortality rate (mainly caused by sudden death). Future studies are required to establish whether this simple marker characterizes a group of patients that will profit from preventive defibrillator implantation and/or biventricular pacing. (c) 2007 Elsevier Ireland Ltd. All rights reserved.
Drug Prescribing for Patients with Chronic Kidney Disease in General Practice: a Cross-Sectional Study