P1712The Impella percutaneous mechanical circulatory support device in cardiogenic shock: a single-center, real-world, observational experience
Authors: Pazzanese V , Ancona M B , Bertoldi L F , Pagnesi M , Marini C , Gramegna M , Montorfano M , Chieffo A , Pappalardo F , Camici P G 
Published: October 2019

Background

The Impella () percutaneous mechanical circulatory support device is a catheter-based, impeller-driven, axial-flow pump. It reduces left ventricular (LV) stroke work and myocardial oxygen demand while increasing systemic and coronary perfusion in the setting of cardiogenic shock (CS).

Purpose

The aim of the study was to evaluate clinical characteristics and outcomes of patients with CS treated with Impella at our center.

Methods

Our single-center, real-world, observational registry included all consecutive patients with CS treated with Impella 2.5, CP, 5.0, or RP at our center from February 2013 to June 2018. Indication for Impella implantation was CS, defined as hypotension (systolic blood pressure <90 mmHg) despite adequate filling status with signs of hypoperfusion.

Results

A total of 130 patients were included in the registry, mean age was 61±12 years, and 79.2% were males. A history of prior MI, chronic heart failure, and chronic kidney disease was present in 28.9%, 26.1%, and 18.3%, respectively. The etiologies of CS were the following: fulminant myocarditis in 6.1% of the patients, acute coronary syndromes in 59.2%, peri-procedural CS during ventricular tachycardia ablation in 7.7% and acute heart failure in 27%. Out-of-hospital cardiac arrest was present in 30.4% of the patients; 60.2% were in INTERMACS I class at presentation. At admission, mean arterial pressure (MAP) was 65±18 mmHg, serum lactate was 6.7±5.5 mmol/L, mean left ventricular ejection fraction 21.4±11.7%, right ventricular dysfunction was indeed present in 48.6% of the patients. Inotropic drugs support was used in 66.4% of the patients. Impella 2.5, CP, and 5.0 were implanted in 76.1%, 15.4%, and 1.5% of the patients, respectively. Impella RP was also used in 11.5% of patients.The mean duration of support was 135±167 hours. Of note, extra-corporeal membrane oxygenation (ECMO) and intra-aortic balloon pump (IABP) were implanted before Impella insertion in 42.8% and 46.7% of the patients, respectively. Escalation to ECMO, ventricular assist device, or heart transplantation was needed in 35.8% of the patients. During hospital stay, acute kidney injury occurred in 56.7% of the patients; need of renal replacement therapy (RRT) 31.7%; access site-related bleeding 14.3%; life-threatening bleeding 31.5%; acute limb ischemia 14.5%; hemolysis 33.3%. The rate of all-cause mortality at 30 day was 39.7%. Need of RRT was the only independent predictor of 30-day mortality (OR 6.56; CI 1.71–25.15; p=0.006).

Conclusion

Our single-center, real-world, observational experience reports acceptable clinical outcomes after Impella implantation in a particularly complex population of patients with CS (INTERMACS class I in 60.2% of patients, prior use of ECMO in 42.8% of patients). All-cause mortality at 30 days was 39.7%, and need of RRT was the only independent predictor for 30-day mortality.