BACKGROUNDExtracorporeal cardiopulmonary resuscitation (CPR) restores perfusion and oxy-genation in a patient who does not have spontaneous circulation. The evidencewith regard to the effect of... Show moreBACKGROUNDExtracorporeal cardiopulmonary resuscitation (CPR) restores perfusion and oxy-genation in a patient who does not have spontaneous circulation. The evidencewith regard to the effect of extracorporeal CPR on survival with a favorable neu-rologic outcome in refractory out-of-hospital cardiac arrest is inconclusive.METHODSIn this multicenter, randomized, controlled trial conducted in the Netherlands, weassigned patients with an out-of-hospital cardiac arrest to receive extracorporealCPR or conventional CPR (standard advanced cardiac life support). Eligible patientswere between 18 and 70 years of age, had received bystander CPR, had an initialventricular arrhythmia, and did not have a return of spontaneous circulationwithin 15 minutes after CPR had been initiated. The primary outcome was sur-vival with a favorable neurologic outcome, defined as a Cerebral PerformanceCategory score of 1 or 2 (range, 1 to 5, with higher scores indicating more severedisability) at 30 days. Analyses were performed on an intention-to-treat basis.RESULTSOf the 160 patients who underwent randomization, 70 were assigned to receiveextracorporeal CPR and 64 to receive conventional CPR; 26 patients who did notmeet the inclusion criteria at hospital admission were excluded. At 30 days, 14 pa-tients (20%) in the extracorporeal-CPR group were alive with a favorable neuro-logic outcome, as compared with 10 patients (16%) in the conventional-CPR group(odds ratio, 1.4; 95% confidence interval, 0.5 to 3.5; P = 0.52). The number of seri-ous adverse events per patient was similar in the two groups.CONCLUSIONSIn patients with refractory out-of-hospital cardiac arrest, extracorporeal CPR andconventional CPR had similar effects on survival with a favorable neurologic out-come. (Funded by the Netherlands Organization for Health Research and Develop-ment and Maquet Cardiopulmonary [Getinge]; INCEPTION ClinicalTrials.govnumber, NCT03101787.) Show less
Jaegere, P.P.T. de; Weger, A. de; Heijer, P. den; Verkroost, M.; Baan, J.; Kroon, T. de; ... ; Bruinsma, G.J.B.B. 2020
The current paper presents a position statement of the Dutch Working Group of Transcatheter Heart Valve Interventions that describes which patients with aortic stenosis should be considered for... Show moreThe current paper presents a position statement of the Dutch Working Group of Transcatheter Heart Valve Interventions that describes which patients with aortic stenosis should be considered for transcatheter aortic valve implantation and how this treatment proposal/decision should be made. Given the complexity of the disease and the assessment of its severity, in particular in combination with the continuous emergence of new clinical insights and evidence from physiological and randomised clinical studies plus the introduction of novel innovative treatment modalities, the gatekeeper of the treatment proposal/decision and, thus, of qualification for cost reimbursement is the heart team, which consists of dedicated professionals working in specialised centres. Show less
Bol, M.E.; Suverein, M.M.; Lorusso, R.; Delnoij, T.S.R.; Bruinsma, G.J.B.B.; Otterspoor, L.; ... ; Poll, M.C.G. van de 2019
Background Return of spontaneous circulation occurs in less than 10% of patients with cardiac arrest undergoing cardiopulmonary resuscitation (CPR) for more than 15 minutes. Studies suggest that... Show moreBackground Return of spontaneous circulation occurs in less than 10% of patients with cardiac arrest undergoing cardiopulmonary resuscitation (CPR) for more than 15 minutes. Studies suggest that extracorporeal life support during cardiopulmonary resuscitation (ECPR) improves survival rate in these patients. These studies, however, are hampered by their non-randomized, observational design and are mostly single-center. A multicenter, randomized controlled trial is urgently warranted to evaluate the effectiveness of ECPR.Hypothesis We hypothesize that early initiation of ECPR in refractory out-of-hospital cardiac arrest (OHCA) improves the survival rate with favorable neurological status.Study design The INCEPTION trial is an investigator-initiated, prospective, multicenter trial that will randomly allocate 110 patients to either continued CPR or ECPR in a 1: 1 ratio. Patients eligible for inclusion are adults (<= 70 years) with witnessed OHCA presenting with an initial rhythm of ventricular fibrillation (VF) or ventricular tachycardia (VT), who received bystander basic life support and who fail to achieve sustained return of spontaneous circulation within 15 minutes of cardiopulmonary resuscitation by emergency medical services. The primary endpoint of the study is 30-day survival rate with favorable neurological status, defined as 1 or 2 on the Cerebral Performance Category score. The secondary endpoints include 3, 6 and 12-month survival rate with favorable neurological status and the cost-effectiveness of ECPR compared to CCPR.Summary The INCEPTION trial aims to determine the clinical benefit for the use of ECPR in patients with refractory OHCA presenting with VF/VT. Additionally, the feasibility and cost-effectiveness of ECPR will be evaluated. Show less
