scholarly journals Efficacy and Safety of Endovascular Cooling After Cardiac Arrest

Stroke ◽  
2006 ◽  
Vol 37 (7) ◽  
pp. 1792-1797 ◽  
Author(s):  
Michael Holzer ◽  
Marcus Müllner ◽  
Fritz Sterz ◽  
Oliver Robak ◽  
Andreas Kliegel ◽  
...  
2021 ◽  
Vol 11 (4) ◽  
pp. 254
Author(s):  
Mezin Öthman ◽  
Erik Widman ◽  
Ingela Nygren ◽  
Dag Nyholm

Patients in fluctuating stages of Parkinson’s disease (PD) require device-aided treatments. Continuous infusion of levodopa–carbidopa intestinal gel (LCIG) is a well-proven option in clinical practice. We now report the first clinical experience of levodopa–entacapone–carbidopa intestinal gel (LECIG) therapy. An observational study of the first patients to start LECIG in our clinic was performed. Twenty-four patients (11 females, 13 males) were included. The median age was 71.5 years, and the median duration since PD diagnosis was 15.5 years. The median treatment duration was 305 days. Median doses were: 6.0 mL as morning dose, 2.5 mL/h as infusion rate, and 1.0 mL as extra dose. Half of the patients were switched directly from LCIG. These patients express improvements in the size and weight of the pump. Furthermore, most of them considered the new pump to be improved regarding user-friendliness. Six patients discontinued LECIG, three due to diarrhea, one due to hallucinations and two deceased (one cardiac arrest and one COVID-19). LECIG has shown to be possible to use in patients with PD, efficacy and safety as expected. Patients are generally happy with the size and usability of the pump, but some technical improvements of the software are warranted, as well as larger, prospective studies.


Critical Care ◽  
2015 ◽  
Vol 19 (1) ◽  
pp. 85 ◽  
Author(s):  
Sang Oh ◽  
Joo Oh ◽  
Young-Min Kim ◽  
Kyu Park ◽  
Seung Choi ◽  
...  

Circulation ◽  
2020 ◽  
Vol 142 (21) ◽  
pp. 2002-2012 ◽  
Author(s):  
Karl B. Kern ◽  
Peter Radsel ◽  
Jacob C. Jentzer ◽  
David B. Seder ◽  
Kwan S. Lee ◽  
...  

Background: The benefit of emergency coronary angiography after resuscitation from out-of-hospital cardiac arrest is uncertain for patients without ST-segment elevation. The aim of this randomized trial was to evaluate the efficacy and safety of early coronary angiography and to determine the prevalence of acute coronary occlusion in resuscitated patients with out-of-hospital cardiac arrest without ST-segment elevation. Methods: Adult (>18 years) comatose survivors without ST-segment elevation after resuscitation from out-of-hospital cardiac arrest were prospectively randomized in a 1:1 fashion under exception to informed consent regulations to early coronary angiography versus no early coronary angiography in this multicenter study. Early angiography was defined as ≤120 minutes from arrival at the percutaneous coronary intervention–capable facility. The primary end point was a composite of efficacy and safety measures, including efficacy measures of survival to discharge, favorable neurologic status at discharge (Cerebral Performance Category score ≤2), echocardiographic measures of left ventricular ejection fraction >50%, and a normal regional wall motion score of 16 within 24 hours of admission. Adverse events included rearrest, pulmonary edema on chest x-ray, acute renal dysfunction, bleeding requiring transfusion or intervention, hypotension (systolic arterial pressure ≤90 mm Hg), and pneumonia. Secondary end points included the incidence of culprit vessels with acute occlusion. Results: The study was terminated prematurely before enrolling the target number of patients. A total of 99 patients were enrolled from 2015 to 2018, including 75 with initially shockable rhythms. Forty-nine patients were randomized to early coronary angiography. The primary end point of efficacy and safety was not different between the 2 groups (55.1% versus 46.0%; P =0.64). Early coronary angiography was not associated with any significant increase in survival (55.1% versus 48.0%; P =0.55) or adverse events (26.5% versus 26.0%; P =1.00). Early coronary angiography revealed a culprit vessel in 47%, with a total of 14% of patients undergoing early coronary angiography having an acutely occluded culprit coronary artery. Conclusions: This underpowered study, when considered together with previous clinical trials, does not support early coronary angiography for comatose survivors of cardiac arrest without ST elevation. Whether early detection of occluded potential culprit arteries leads to interventions that improve outcomes requires additional study. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02387398.


Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 3307-3307
Author(s):  
Dorte Tholstrup ◽  
Peter de Nully Brown ◽  
Mads Hansen ◽  
Jesper Jurlander

Abstract The outcome of advanced diffuse large cell B-cell lymphoma (DLBCL) has been improved by the “dose-densified” biweekly CHOP-14 regimen. The German NHL-B2 trial has demonstrated favourable efficacy and safety in elderly patients with performance status ≤ 3 and normal organ function. However, a considerable proportion of patients are not eligible for clinical trials due to high age, poor performance, concomitant disease and/or organ dysfunction. The efficacy and safety of CHOP-14 is unknown in this group of very poor risk patients. CHOP-14 was introduced as standard treatment for advanced DLBCL (CSII-IV and/or LDH above UNV and/or bulky tumor ≥ 7.5 cm) at our institution in 2002. Seventy consecutive patients with DLBCL have been treated with 6-8 series CHOP-14 in the period March 2002 to December 2003. Patients with residual disease following chemotherapy were subsequently treated with involved field radiation. In order to estimate the efficacy and safety of CHOP-14 in very poor risk patients, we divided this population into two cohorts; A: standard risk: pts. aged 60–75 years with PS ≤ 3 or pts. aged < 60 years regardless of PS and B: very poor risk: pts. aged 60–75 years with PS = 4 or pts. aged > 75 years regardless of PS. Patient characteristics Age PS ≥ LDH UNV Bulky CS III/IV Extranodal IPI 4–5 B-symptoms; A: 22/44 (50%), B: 15/26 (58%) A (n=44) 60 (26–73) 0 (0–4) 26 (59%) 19 (43%) 25 (57%) 24 (55%) 2 (5%) B (n=26) 76 (64–83) 2 (0–4) 22 (85%) 14 (54%) 21 (81%) 19 (73%) 17 (65%) The response rates in the two cohorts (A vs. B) were CR/Cru: 82% vs. 62% (p=0.06); PR: 2% vs. 8% (p=0.55); NC/PD: 11% vs. 8% (ns). Two year EFS was 66% vs. 37% (p=0.027) and the two year OS was 71% vs. 57% (p=0.04). Concerning toxicity 30/44 (68%) vs. 23/26 (88%) (p=0.08) required hospitalisation for one or more of the following reasons: 50% vs. 65% (p=0.21) due to infection; 9% vs. 15% (p=0.42) due to Pneumocystis Carinii pneumonia; 27% vs. 31% (p=0.75) due to reduced PS mainly caused by malnutrition. The median total number of days in hospital were 8 (1–162) vs. 39 (1–228) days (p=0.002). The therapy-associated deaths without progression were 2/44 (5%) in cohort A (1 cardiac arrest, 1 ileus) compared to 3/26 (12%) in cohort B (1 cardiac arrest, 1 PCP, 1 unknown) (ns). In 3 additional patients in cohort B, treatment was stopped early due to severe infection, resulting in progression and subsequently death. In general dose erosion was minimal, except for vincristin that was reduced due to neuropathy in 20/44 (45%) vs. 10/26 (38%) (p=0.57) of the patients after a median of 5 vs. 4 cycles. The median delay in treatment schedule (schedule erosion) was 8 days (0–95 days) vs. 14 days (0–67 days) (p=0.06). Given the dismal prognosis of the patients in cohort B, the two-year survival rate of 57% is encouraging. However, the increased toxicity with infections and malnutrition, warrants for careful attention to this high risk group of patients, preferably within clinical trials focused on prevention and treatment of infections, improvement of the nutritional status and quality of life.


2020 ◽  
Vol 36 (4) ◽  
pp. 363-371
Author(s):  
Pamela Aidelsburger ◽  
Janine Seyed-Ghaemi ◽  
Christian Guinin ◽  
Andreas Fach

ObjectivesTo assess the effectiveness, efficacy, and safety of a wearable cardioverter-defibrillator (WCD) in adult persons with high risk for sudden cardiac arrest and for which an implantable cardioverter is currently not applicable.MethodsWe performed a systematic literature search in Medline, Embase, Cochrane Library, and CRD-databases. Study selection was performed by two reviewers independently. Data were presented quantitatively; due to heterogeneity of studies no meta-analysis was performed.ResultsOne randomized-controlled trial (RCT), one non-randomized comparative trial, and forty-four non-comparative trials were included. The RCT reported an overall mortality of 3.1 percent in the WCD group versus 4.9 percent in controls (relative risk [RR]: .64; 95 percent confidence interval [CI], .43–.98, p = .04), but no significant effect on arrhythmia-related mortality. The RR for arrhythmia-related mortality amounted to .67 (95 percent CI, .37–1.21, p = .18) as assessed in the RCT. Appropriate shocks were observed in 1.3 percent of patients in both comparative studies, and inappropriate shocks in .6 percent of patients in the RCT. Termination of ventricular tachycardia (VT) or ventricular fibrillation (VF) was successful in 75 to 100 percent of appropriate shocks in all studies. Adverse events assessed in the RCT showed a lower incidence of shortness of breath (38.8 percent vs. 45.3 percent; p = .004), higher incidence of rash at any location (15.3 percent vs. 7.1 percent; p < .001), and higher incidence of itching at any location (17.2 percent vs. 6.4 percent; p < .001) for WCD.ConclusionsAvailable evidence demonstrates that the WCD detects and terminates VT/VF events reliably and shows a high rate of appropriate shocks in mixed patient populations. Data of large registries confirm that the WCD is a safe intervention.


Circulation ◽  
2018 ◽  
Vol 138 (Suppl_2) ◽  
Author(s):  
Fabrizio Assis ◽  
Emma G Bigelow ◽  
Raghuram Chava ◽  
Sunjeet Sidhu ◽  
Aravindan Kolandaivelu ◽  
...  

Background: Targeted temperature management (TTM) is recommended as a standard of care for post cardiac arrest patients. Current TTM methods have significant limitations to be used in an ambulatory setting. We explored the efficacy and safety of a novel non-invasive transnasal evaporative cooling device (CoolStat™). Methods: Eleven pigs underwent hypothermia therapy using a transnasal cooling device (CoolStat™). CoolStat™ induces evaporative cooling by blowing de-humidified ambient air over the nose in a unidirectional fashion. CoolStat’s efficacy and safety were assessed by applying different cooling strategies (Groups A, B and C). In group A (efficacy study; n=5, TTM for 8h), time to achieve brain target temperature, and the percentage of time in which the temperature ranged within 0.5 o C after reaching the target temperature were investigated. In the safety assessment (Groups B and C), two worst-case therapy situations were reproduced: in group B (n=3), continuous maximum air flow (65L/min) was applied without temperature control and, in group C (n=3), subjects underwent 24-hour TTM (prolonged therapy). Hemodynamic and respiratory parameters, nasal mucosa integrity (endoscopic assessment) and other therapy-related adverse effects were evaluated. Results: Efficacy study. CoolStat™ cooling therapy successfully induced and sustained managed hypothermia in all subjects. Brain target temperature was achieved in 0.5±0.6h and kept within a ±0.5 o C range for the therapy duration (99.9±0.1%). All animals completed the safety studies. Maximum air flow (Group B) and 24-hour (Group C) therapies were well-tolerated and no significant damage was observed on nasal mucosa for neither of the groups. Conclusion: CoolStat™ was able to efficiently induce and maintain hypothermia using unidirectional high flow of dry air into the nostrils of porcine models. CoolStat therapy was well-tolerated and might account for early hypothermia in cardiac arrest settings.


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