Author + information
- Kirk N. Garratt, MSc, MD* ( and )
- David R. Holmes, MD
- ↵*Lenox Hill Hospital, 130 East 77th Street, 9th Floor, Black Hall, New York, New York 10075
We are concerned about the report from the Europella registry (1), which described the use of the Impella 2.5 device (ABIOMED Inc., Danvers, Massachusetts) in 144 European patients undergoing elective high-risk coronary intervention. If this device or any other has merit in an elective, high-risk population, it must produce fewer adverse events than would be expected without the device.
Most patients had multivessel disease; left main disease (LMD) was listed as a high-risk criterion for more than one-half of the patients. Reported 30-day mortality figures were 5.5% overall, with surprisingly little variation as a function of left ventricular ejection fraction. Mortality rates were much higher among LMD patients: 8.3% overall, and 12% for those with LMD and low left ventricular ejection fraction.
The mean EuroSCORE (European System for Cardiac Operative Risk Evaluation) of about 8 suggests a 30-day mortality risk of about 5% with unsupported percutaneous coronary intervention (2). The investigators note that in the SYNTAX (Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery) trial (3), 12-month mortality was 7.3% for patients who refused bypass surgery, but the 30-day risk for such patients was not reported in SYNTAX, and surgical turn-down was cited as a high-risk feature in fewer than one-half of the patients in the Impella registry. Overall 12-month mortality in SYNTAX was 4.3%, and for LMD patients it was 4.2%, which is roughly one-half the 30-day mortality for LMD patients treated with Impella in this registry. This is of concern as an overall mortality risk that matches or exceeds the risk predicted without special support and questions the magnitude of benefit achieved through use of Impella. Ease of use is an attractive feature of the Impella device, but ease should not drive its use in the absence of demonstrated efficacy. We anxiously await the completion of PROTECT II (A Prospective Multicenter, Randomized Controlled Trial of the Impella Recover LP 2.5 System versus Intra-Aortic Balloon Pump in Patients Undergoing Nonemergent High-Risk PCI) trial, which will clarify possible benefits of this intermediate support device in elective high-risk percutaneous coronary intervention.
- American College of Cardiology Foundation
- Sjauw K.,
- Konorza T.,
- Erbel R.,
- et al.
- Romagnoli E.,
- Burzotta F.,
- Trani C.