Abstract
Background
Patients undergoing percutaneous coronary intervention (PCI) who are at high risk for cardiovascular collapse during the procedure may benefit from prophylactic circulatory support. The objective was to evaluate the safety and feasibility of prophylactic use of the Impella 2.5 during high-risk PCI.
Methods and materials
We used the Impella 2.5 for partial circulatory support during 60 consecutive elective high-risk PCI cases over 20 months. All patients either were deemed inoperable by the cardiac surgeons or were offered bypass surgery but declined.
Results
The patients had multiple risk factors including hypertension (95%), diabetes (52%), chronic pulmonary disease (23%), prior myocardial infarction (62%) and prior bypass surgery (18%). Forty-five percent presented with acute coronary syndrome. The mean left ventricular ejection fraction was 23%±15%. Nearly all patients had multivessel disease (93%), and 60% had left main disease. The average SYNTAX score was 30±9. Despite lesion complexity and high-risk factors, we achieved an angiographic success rate of 96%. Left main lesions were treated in 55% of the patients, and 83% of patients had multiple lesions treated. There was one procedural death. At 30 days postintervention, mortality was 5%, and rates of myocardial infarction, stroke, target vessel revascularization and urgent bypass surgery were 0%.
Conclusions
The single-center experience reported here demonstrates that use of the Impella 2.5 during high-risk PCI in the “real world” — outside the controlled environment of a clinical trial — is safe and feasible.
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Introduction
A subset of patients undergoing percutaneous coronary intervention (PCI) is at high risk for cardiovascular collapse during the procedure due to poor left ventricular function, a substantial percentage of myocardium at risk, planned multivessel intervention and/or complex target lesions . These patients may benefit from prophylactic circulatory support during the intervention.
The Impella 2.5 (Abiomed Inc., Danvers, MA, USA) is a microaxial intravascular blood pump capable of pumping up to 2.5 L/min of blood directly from the left ventricle to the ascending aorta. The Impella is inserted percutaneously via the femoral artery and is positioned with the blood inlet area in the left ventricle and the blood outlet area in the ascending aorta above the aortic valve. The inlet and outlet areas are connected by a 12-Fr cannula that crosses the aortic valve. The PROTECT I clinical trial, concluded in 2007, demonstrated the safety and feasibility of Impella 2.5 use during high-risk PCI . The device proved easy to implant, performed well and was associated with a low rate of adverse events. Earlier studies conducted in Europe drew similar conclusions , as did the recently published Europella Registry study . A randomized clinical trial has recently concluded, comparing the efficacy of Impella 2.5 support to that of intraaortic balloon pumping during high-risk PCI.
In May 2008, the Impella 2.5 was cleared for use by the Food and Drug Administration for partial circulatory support for periods up to 6 h. Since that time, we have integrated the Impella 2.5 into our high-risk PCI practice at Harper University Hospital. We report here our “real-world” experience using the Impella 2.5 during 60 consecutive elective high-risk PCI cases.
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