CORRESPONDENCE: LETTER TO THE EDITOR
Reply
Krischan D. Sjauw, MD,
Annemarie E. Engström, MD,
Jose P.S. Henriques, MD, PhD* on behalf of the Europella Registry Investigators
* Department of Cardiology, Academic Medical Center–University of Amsterdam, Meibergdreef 9, Amsterdam, Noord Holland 1105AZ, the Netherlands (Email: j.p.henriques{at}amc.uva.nl).
We thank Drs. Garratt and Holmes for their interest in our report (1), and we could not agree more with their statement that the Impella 2.5 or any other mechanical cardiac-assist device only has merit in the setting of elective high-risk percutaneous coronary intervention (PCI) if there are more benefits than iatrogenic adverse events to expect. However, we do not agree with the raised concerns with regard to the 30-day mortality rate of 5.5% in the Europella registry (1).
Drs. Garratt and Holmes state that an overall mortality risk that matches or exceeds the risk predicted without special support questions the magnitude of benefit achieved through use of Impella. However, the mortality rates mentioned by Drs. Garratt and Holmes are far from comparable with the mortality rate reported in the Europella registry. First, the deduction from the cited study of Romagnoli et al. (2) that a EuroSCORE (European System for Cardiac Operative Risk Evaluation) of 8 corresponds with a 30-day mortality risk of about 5% in unsupported elective PCI is invalid. This single-center study only shows that the EuroSCORE has good discriminative power to predict mortality in the included cohort of PCI patients. Only if both studies had included approximately similar patients, a crude comparison of mortality rates would have been reasonable. However, the case mix of patients in the study of Romagnoli et al. (2) was completely different than the Europella registry (e.g., both emergent and elective patients; lower age; considerably lower frequencies of diabetes, hypertension, renal failure, peripheral vascular disease, and stroke; normal left ventricular ejection fraction in 75% of patients; and only 2.3% had left main disease). Moreover, due to lack of angiographic parameters of coronary anatomy, patients with identical "surgical" EuroSCOREs may have completely different mortality rates.
The Europella registry included a selected group of high-risk patients from multiple centers with high morbidity, poor left ventricular ejection fraction, and complex 3-vessel and left main disease seldom included in previous trials. Therefore, as part of the "real-world" design of the SYNTAX (Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery) trial (3) (eligibility for coronary artery bypass graft [CABG] or PCI judged in the "Heart-Team Conference"), the SYNTAX registry for CABG ineligible patients in our opinion included the most comparable patient population; indeed, only 43% of the patients were formally refused for CABG in the Europella registry, but all were judged poor candidates for CABG and conventional ("unsupported") PCI. It is true that only a 12-month mortality rate is reported in the SYNTAX registry, but as mentioned, better comparable figures are lacking.
Finally, it must be clear that the case mix included in the SYNTAX trial (all patients equally eligible for CABG and PCI, left ventricular ejection fraction <30% only in 1.3% of patients, lower comorbidity profile, mean EuroSCORE of 3.8) differs too much from the Europella registry for a valid comparison of mortality rates.
In conclusion, we think that the mortality rate of 5.5% is within the expected mortality range for this high-risk patient group, which a priori were at high risk for mortality and prone for periprocedural complications due to its high comorbidity and extensive coronary artery disease profile. Use of Impella resulted in a high procedural success rate with a relatively low periprocedural complication rate. Notwithstanding, we also eagerly await the results of the randomized 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.
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References
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1. Sjauw KD, Konorza T, Erbel R, et al. Supported high-risk percutaneous coronary intervention with the Impella 2.5 device. The Europella registry. J Am Coll Cardiol 2009;54:2430-2434.[Abstract/Free Full Text]2. Romagnoli E, Burzotta F, Trani C, et al. EuroSCORE as a predictor of in-hospital mortality after percutaneous coronary intervention Heart 2009;95:43-48.[Abstract/Free Full Text] 3. Serruys PW, Morice MC, Kappetein AP, et al. SYNTAX Investigators Percutaneous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease N Engl J Med 2009;360:961-972.[CrossRef][Medline]
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