A Prospective, Randomized Clinical Trial of Hemodynamic Support With Impella 2.5 Versus Intra-Aortic Balloon Pump in Patients Undergoing High-Risk Percutaneous Coronary Intervention

Abstract

Background— Although coronary artery bypass grafting is generally preferred in symptomatic patients with severe, complex multivessel, or left main disease, some patients present with clinical features that make coronary artery bypass grafting clinically unattractive. Percutaneous coronary intervention with hemodynamic support may be feasible for these patients. Currently, there is no systematic comparative evaluation of hemodynamic support devices for this indication. Methods and Results— We randomly assigned 452 symptomatic patients with complex 3-vessel disease or unprotected left main coronary artery disease and severely depressed left ventricular function to intra-aortic balloon pump (IABP) (n=226) or Impella 2.5 (n=226) support during nonemergent high-risk percutaneous coronary intervention. The primary end point was the 30-day incidence of major adverse events. A 90-day follow-up was required, as well, by protocol. Impella 2.5 provided superior hemodynamic support in comparison with IABP, with maximal decrease in cardiac power output from baseline of −0.04±0.24 W in comparison with −0.14±0.27 W for IABP ( P =0.001). The primary end point (30-day major adverse events) was not statistically different between groups: 35.1% for Impella 2.5 versus 40.1% for IABP, P =0.227 in the intent-to-treat population and 34.3% versus 42.2%, P =0.092 in the per protocol population. At 90 days, a strong trend toward decreased major adverse events was observed in Impella 2.5–supported patients in comparison with IABP: 40.6% versus 49.3%, P =0.066 in the intent-to-treat population and 40.0% versus 51.0%, P =0.023 in the per protocol population, respectively. Conclusions— The 30-day incidence of major adverse events was not different for patients with IABP or Impella 2.5 hemodynamic support. However, trends for improved outcomes were observed for Impella 2.5–supported patients at 90 days. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00562016.

2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure

“…W metaanalizie 3 badań klinicznych z randomizacją, w których porównano przezskórne MCS z IABP w grupie 100 pacjentów we wstrzą-sie kardiogennym, przezskórne MCS okazały się bezpieczne i charakteryzowały się lepszym profilem hemodynamicznym, nie poprawiały jednak śmiertelności 30-dniowej, a ich zastosowanie wiązało się z większą częstością powikłań krwotocznych [596]. W randomizowanym badaniu przeprowadzonym wśród pacjentów poddawanych PCI wysokiego ryzyka u chorych z dysfunkcją skurczową LV (badanie PROTECT II) liczba zdarzeń niepożądanych w ciągu 30 dni nie różniła się między pacjentami z IABP oraz MCS [597]. Na podstawie tych wyników czasowe przezskórne stosowanie MCS nie może być zalecane w terapii wstrząsu kardiogennego jako metoda o potwierdzonej i udokumentowanej skuteczności.…”

2015 SCAI/ACC/HFSA/STS clinical expert consensus statement on the use of percutaneous mechanical circulatory support devices in cardiovascular care (Endorsed by the American heart assocation, the cardiological society of India, and sociedad latino Americana de cardiologia intervencion; Affirmation of value by the canadian association of interventional cardiology–association canadienne de cardiologie d'intervention)

“…The PROTECT 2 trial is the largest single randomized clinical trial of HR-PCI using MCS ever performed and enrolled 452 symptomatic patients with complex three-vessel disease or unprotected left main coronary artery disease and severely depressed left ventricular function to IABP (n 5 226) or Impella 2.5 (n 5 226) support for HR PCI [95]. The primary end point was a 30-day composite of 11 adverse events and was not significantly different between groups (Impella 35.1% vs. 40.1% IABP, P 5 0.227) in the intent-totreat population.…”

“…For recurrent, refractory, ventricular arrhythmias, ECMO may be required for biventricular failure. Prophylactic use for high risk PCI Particularly in patients with severe LV dysfunction (EF <20-30%) and complex coronary artery disease involving a large territory (sole-remaining vessel, left main or three vessel disease) [94,95,98]. High-risk or complex ablation of ventricular tachycardia Similar to HR-PCI, complex VT ablation can be made feasible with percutaneous support.…”

Passion: A day in the life of an interventionalist

“…A week later, the cath techs were still kidding with one another over "The Big Throw-Up". We all have had this experience: saving a life (or at least relieving suffering), experiencing the gratitude of patient and family, the pride of working as part of a high-performing team, and having lots of fun and laughter along the way.Interventional journal club started at 7:30 a.m. We discussed PROTECT II [1], and talked to the fellows about how they will need to safely introduce new technologies into their labs over the coming decades. It was exciting to remind the fellows that, just as new technologies emerged requiring new skills over recent decades, they will have the opportunity to master new technologies and learn new skills over their careers.…”

“…Interventional journal club started at 7:30 a.m. We discussed PROTECT II [1], and talked to the fellows about how they will need to safely introduce new technologies into their labs over the coming decades. It was exciting to remind the fellows that, just as new technologies emerged requiring new skills over recent decades, they will have the opportunity to master new technologies and learn new skills over their careers.…”