Abstract/Text: BACKGROUND: In patients with poor left ventricular function and high-risk coronary lesions, prolonged ischemia during percutaneous coronary intervention (PCI) may have major hemodynamic consequences. The Tandemheart is a percutaneous left ventricular assist device intended for short-term circulatory support.
METHODS AND RESULTS: The Tandem-heart incorporates 9-17 F. arterial cannulae and a unique 21 F. transseptal cannula and centrifugal bloodpump. Operating at 7500 rpm, the pump withdraws oxygenated blood from the left atrium and delivers up to 4 liters/min to the arterial circulation. As of May 2001, the Tandem-heart was electively employed in three male patients (ages 52, 54 and 56) scheduled for high-risk PCI. The mean time to initial circulatory support was less than 30 minutes. Systemic hemodynamics significantly improved prior to PCI in two patients. Pump flow after one hour ranged from 2.43 to 3.8 liters/min (mean 3.17 liters/min) and duration of support from 23 to 49 hours (mean 33 hours). Procedural success was 100%, with no significant hemolysis or bleeding. Successful weaning was completed in all patients, who have remained free of major cardiac events up to seven months post-PCI.
CONCLUSIONS: In this first clinical experience of elective use of Tandem-heart for circulatory support during high-risk PCI, the device was easily inserted and preserved hemodynamic stability, regardless of the intrinsic cardiac function, creating optimism for more widespread use for this and other indications.

Abstract/Text: BACKGROUND: We planned a study to assess the safety, feasibility, and efficacy of the Impella micro-axial blood pump in patients with cardiogenic shock.
METHODS: From January 2001 to September 2002 inclusive, 16 patients in cardiogenic shock (maximal inotropic support and with IABP in 11 cases) underwent left ventricle unloading with the Impella pump. 6 were placed via the femoral artery (patients in the coronary care unit) and 10 directly through the aorta (postcardiotomy heart failure). In three patients, the device was used in combination with ECMO. Mean age was 60 years (range 43 - 75), 11 were male.
RESULTS: A stable pump flow of 4.24 +/- 0.28 l/min was reached (3.3 +/- 1.9 l/min in patients with ECMO and Impella). Mean blood pressure before Impella) support was 57.4 +/- 13 mmHg, which increased to 74.9 +/- 13 mmHg after 6 hours and 80.6 +/- 17 mmHg (p = 0.003) after 24 hours. Cardiac output increased from 4.1 +/- 1.3 l/min to 5.5 +/- 1.3 (p = 0.003) and 5.9 +/-1.9 l/min (p = 0.01) at 6 and 24 hours. Mean pulmonary wedge pressure decreased from 29 +/- 10 mmHg to 17 +/- 5 mmHg and 18 +/- 7 mmHg at 6 (p = 0.04) and 24 hours. Blood lactate levels decreased significantly after 6 hours of support (from 2.7 +/- 1 to 1.3 +/- 0.5 mmol/l, p = 0.004). Device-related complications included three sensor failures (no clinical action), one pump displacement (replacement) and six incidences of haemolysis (peak free plasma haemoglobin > 100 mg/dl, no clinical action). Eleven patients (68 %) were weaned, six (37 %) survived.
CONCLUSIONS: Left ventricular unloading with the Impella pump via the transthoracic or femoral approach is feasible and safe. Support led to a decrease in pulmonary capillary wedge pressure, increase in cardiac output and mean blood pressure, and improved organ perfusion in patients with severe cardiogenic shock.

Abstract/Text: OBJECTIVES: This study aimed to report the in-hospital and 30-day event rates in patients undergoing non-emergent, high-risk percutaneous coronary intervention (PCI) and to evaluate whether the Impella Recover LP 2.5 device (Abiomed, Danvers, MA) demonstrates superiority over intra-aortic balloon pump (IABP) in the Protect II (A Prospective Feasibility Trial Investigating the Use of the Impella Recover LP 2.5 System in Patients Undergoing High Risk Percutaneous Coronary Intervention) study.
BACKGROUND: Patients undergoing non-emergent, high-risk PCI are often treated with prophylactic IABP for hemodynamic support.
METHODS: A cohort of 85 patients who met the inclusion/exclusion criteria of the Protect II study was included in this retrospective analysis. High-risk PCI was defined as intervention to the last patent coronary conduit or to an unprotected left main or in a patient with three-vessel disease with an ejection fraction of RESULTS: The overall in-hospital and 30-day event rates were low (15.3% and 21.3%, respectively) with a low major vascular complication rate (5.9%). Therefore, for the Impella Recover LP 2.5 device to demonstrate superiority over IABP with a treatment effect of 33.3% and 80% power, the Protect II trial will require a total of 908 patients. With the current sample size of 654 patients, the Protect II trial is underpowered, with only 66% power.
CONCLUSION: These data question the clinical benefit of the Protect II study, which is evaluating the relatively high-profile Impella LP 2.5 device over IABP for this high-risk population.

Abstract/Text: OBJECTIVES: The aim of this study was to test whether the left ventricular assist device (LVAD) Impella LP2.5 (Abiomed Europe GmbH, Aachen, Germany) provides superior hemodynamic support compared with the intra-aortic balloon pump (IABP).
BACKGROUND: Cardiogenic shock caused by left ventricular failure is associated with high mortality in patients with acute myocardial infarction (AMI). An LVAD may help to bridge patients to recovery from left ventricular failure.
METHODS: In a prospective, randomized study, 26 patients with cardiogenic shock were studied. The primary end point was the change of the cardiac index (CI) from baseline to 30 min after implantation. Secondary end points included lactic acidosis, hemolysis, and mortality after 30 days.
RESULTS: In 25 patients the allocated device (n = 13 IABP, n = 12 Impella LP2.5) could be safely placed. One patient died before implantation. The CI after 30 min of support was significantly increased in patients with the Impella LP2.5 compared with patients with IABP (Impella: DeltaCI = 0.49 +/- 0.46 l/min/m(2); IABP: DeltaCI = 0.11 +/- 0.31 l/min/m(2); p = 0.02). Overall 30-day mortality was 46% in both groups.
CONCLUSIONS: In patients presenting with cardiogenic shock caused by AMI, the use of a percutaneously placed LVAD (Impella LP 2.5) is feasible and safe, and provides superior hemodynamic support compared with standard treatment using an intra-aortic balloon pump. (Efficacy Study of LV Assist Device to Treat Patients With Cardiogenic Shock [ISAR-SHOCK]; NCT00417378).

Abstract/Text: OBJECTIVES: This study aimed to report the in-hospital and 30-day event rates in patients undergoing non-emergent, high-risk percutaneous coronary intervention (PCI) and to evaluate whether the Impella Recover LP 2.5 device (Abiomed, Danvers, MA) demonstrates superiority over intra-aortic balloon pump (IABP) in the Protect II (A Prospective Feasibility Trial Investigating the Use of the Impella Recover LP 2.5 System in Patients Undergoing High Risk Percutaneous Coronary Intervention) study.
BACKGROUND: Patients undergoing non-emergent, high-risk PCI are often treated with prophylactic IABP for hemodynamic support.
METHODS: A cohort of 85 patients who met the inclusion/exclusion criteria of the Protect II study was included in this retrospective analysis. High-risk PCI was defined as intervention to the last patent coronary conduit or to an unprotected left main or in a patient with three-vessel disease with an ejection fraction of RESULTS: The overall in-hospital and 30-day event rates were low (15.3% and 21.3%, respectively) with a low major vascular complication rate (5.9%). Therefore, for the Impella Recover LP 2.5 device to demonstrate superiority over IABP with a treatment effect of 33.3% and 80% power, the Protect II trial will require a total of 908 patients. With the current sample size of 654 patients, the Protect II trial is underpowered, with only 66% power.
CONCLUSION: These data question the clinical benefit of the Protect II study, which is evaluating the relatively high-profile Impella LP 2.5 device over IABP for this high-risk population.