Implementing an Innovative Cardiac Assist System in a Nonuniversity Hospital--Feasibility, Complications, and First Results.

To evaluate the feasibility of implementing a cardiac assist system in a nonuniversity hospital we analyzed 18 consecutive patients treated with venoarterial membrane oxygenation. The system was used electively in 5/18 (27.8%) patients during high-risk interventions. Thirteen patients (72.2%) were treated in emergency situations. The extracorporal system could be initiated successfully in all patients. Periprocedural complications were hemolysis in 3/18 (16.7%), disseminated intravascular coagulation in 2/18 (11.1%), cerebral ischemia in 1/18 (5.6%), and local infection in 2/18 (11.1%) patients. None of these led to a discontinuation of the therapy. All electively treated patients were successfully weaned from the extracorporeal system. In 9/13 (69.2%) emergency patients the system was removed successfully. The 60-day survival rate of the emergency patients was 53.8% (7/13). Our experience confirms that an innovative extracorporeal circulatory support system can be implemented in a nonuniversity hospital at a tolerable risk and a low complication and high procedural success rate.

First-in-man analysis of the i-cor assist device in patients with cardiogenic shock.

OBJECTIVE: In patients with refractory cardiogenic shock (CS) mechanical assistance by venous-arterial extracorporeal membrane oxygenation (VA-ECMO) therapy may be considered to reach haemodynamic stabilization. In this first-in-man study, we analysed the applicability of the new i-cor VA-ECMO assist device equipped with a diagonal pump system. METHODS AND RESULTS: In total, 15 patients with refractory CS were treated with the i-cor assist device in three tertiary care centres. In 71%, CS was due to acute myocardial infarction (AMI). At baseline, patients were hypotensive (systolic/diastolic blood pressure 97 ± 4/62 ± 4 mm Hg) despite high doses of catecholamines. Under ECMO therapy, a significant reduction in vasopressor therapy and serum lactate levels was observed (norepinephrine: 0.69 ± 0.1 µg/kg/min at baseline vs 0.21 ± 0.08 µg/kg/min on the last day of treatment, p<0.0001; serum lactate: 6.7 ± 1.4 mmol/l at baseline versus 1.3 ± 0.1 mmol/l on the last day, p<0.001). Inspiratory oxygen concentration was significantly reduced during the course of VA-ECMO support (80.4 ± 7.0% at baseline vs 42.7 ± 2.4% on final day; p<0.001). At baseline, three patients (20%) were on continuous haemodialysis treatment. Of the 12 patients without haemodialysis at baseline, only one patient required haemodialysis during the course of ECMO treatment. Glomerular filtration rate (GFR) significantly increased with treatment (41.2 ± 7.4 at baseline vs 69.0 ± 10.8 on last day; p=0.006). Bleeding at the insertion site was recorded in two patients (13.3%). Overall, 11 patients (73.3%) needed blood transfusion. Three patients (20%) developed signs of limb ischaemia that were fully reversible. Haemolysis was recorded in five patients (33%). None of the complications required the interruption of ECMO therapy. Overall mortality was 33.3% (five patients); two patients died during, and three patients after, ECMO therapy. CONCLUSION: This first-in-man analysis suggests that the i-cor ECMO device is successfully applicable in humans. The data set the stage for further evaluation of this novel system and provide the necessary basis to design randomised evaluations.