Supported High-Risk Percutaneous Coronary Intervention With the Impella 2.5 Device

Sjauw, Krischan D.; Konorza, Thomas; Erbel, Raimund; Danna, Paolo; Viecca, Maurizio; Minden, H; Butter, Christian; Engstrøm, Thomas; Hassager, Christian; Machado, Francisco Pereira; Pedrazzini, Giovanni; Wagner, Daniel R.; Schamberger, Rainer; Kerber, Sebastian; Mathey, D; Schofer, Joachim; Engström, Annemarie E.; Henriques, José P.S.

doi:10.1016/j.jacc.2009.09.018

Cited by 214 publications

(160 citation statements)

References 10 publications

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“…It is likely that staging of these procedures reflects the high degree of coronary and patient complexity being treated in contemporary PCI practice, 4 including the need for careful evaluation of therapeutic options or medical stabilization and application of adjunctive therapies such as ventricular support devices. 22 However, given the high degree of hospitallevel variability in multivessel disease management noted in our analysis, it appears that local practice patterns may be an important driver of the decisions surrounding staging of procedures as well.…”

Section: Staged Revascularizationmentioning

confidence: 83%

Repeat Revascularization After Contemporary Percutaneous Coronary Intervention

Stolker

Cohen

Kennedy

et al. 2012

Circ: Cardiovascular Interventions

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Background-Although drug-eluting stents and intensive secondary prevention have contributed to improved outcomes after percutaneous coronary intervention (PCI), repeat revascularization remains relatively common in contemporary practice. We used data from the multicenter Evaluation of Drug-Eluting Stents and Ischemic Events registry to evaluate the relative frequency and timing of staged revascularization, target lesion revascularization (TLR), and other nontarget revascularization during the first year after contemporary PCI. Methods and Results-Patients with staged revascularization, TLR, and other unplanned procedures (elsewhere in the target vessel or in other coronary arteries) were evaluated in time-dependent models using Kaplan-Meier life-table estimation.Predictors of TLR and unplanned revascularization at nontarget sites were identified using logistic regression. Between July 2004 to June 2007, 10 144 patients undergoing PCI were enrolled at 55 US hospitals, of whom 86% were treated with at least 1 drug-eluting stent. Twelve percent required repeat revascularization within the first year (3% staged; 9% unplanned). More than 75% of staged revascularizations were performed <30 days after index PCI, although there was significant variation in this practice across hospitals (range, 0%-54%). TLR occurred in 4.5% of patients, with higher hazard rates between 2 to 9 months after PCI, whereas the risk of unplanned non-TLR (4.4% cumulative incidence) was constant over time. Conclusions-Among unselected patients undergoing PCI in the drug-eluting stent era, the incidence of repeat revascularization at 1 year is ≈12%. Among unplanned procedures, only half are performed for TLR. To achieve further improvements in PCI outcomes, future efforts should concentrate as much on identifying ischemia-producing lesions and intensifying secondary prevention therapies as on the prevention of restenosis. (Circ Cardiovasc Interv. 2012;5:772-782.)

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Section: Staged Revascularizationmentioning

confidence: 83%

Repeat Revascularization After Contemporary Percutaneous Coronary Intervention

Stolker

Cohen

Kennedy

et al. 2012

Circ: Cardiovascular Interventions

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“…Similarly, we did not observe any aortic or mitral valve dysfunction or left ventricular injury, which confirms the safety profile of the Impella 2.5 device with respect to ventricular and valve function and integrity, consistent with previous reports. 7,12,17,18 Analysis of the Kaplan-Meier event curves suggests that the use of a 30-day end point is not sufficient in this population. Other investigations of PCI in severely compromised patients such as the Should We Emergently Revascularize Occluded Coronaries for Cardiogenic Shock (SHOCK) trial 19 and the BCIS-1 study 16 found that event curves continue to diverge over time.…”

Section: Discussionmentioning

confidence: 98%

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

et al. 2012

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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.

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“…Short-term circulatory support with the device has been demonstrated to be safe and feasible in high-risk percutaneous coronary intervention (PCI) as well as in the setting of hemodynamically stable large anterior ST-elevation myocardial infarction. [14][15][16][17] In patients with CS, a small randomized clinical trial of Impella-2.5 versus IABP demonstrated an improvement in cardiac index in Impella-treated patients. 18 The purpose of the multicenter Impella-EUROSHOCK-registry was to assess procedural safety and outcome of Impella-2.5-support in a large cohort of patients with acute CS.…”

mentioning

confidence: 99%

Percutaneous Left-Ventricular Support With the Impella-2.5–Assist Device in Acute Cardiogenic Shock

Lauten

Engström

Jung

et al. 2013

Circ: Heart Failure

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293

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Background-Acute cardiogenic shock after myocardial infarction is associated with high in-hospital mortality attributable to persisting low-cardiac output. The Impella-EUROSHOCK-registry evaluates the safety and efficacy of the Impella-2.5-percutaneous left-ventricular assist device in patients with cardiogenic shock after acute myocardial infarction. Methods and Results-This multicenter registry retrospectively included 120 patients (63.6±12.2 years; 81.7% male) with cardiogenic shock from acute myocardial infarction receiving temporary circulatory support with the Impella-2.5-percutaneous left-ventricular assist device. The primary end point evaluated mortality at 30 days. The secondary end point analyzed the change of plasma lactate after the institution of hemodynamic support, and the rate of early major adverse cardiac and cerebrovascular events as well as long-term survival. Thirty-day mortality was 64.2% in the study population. After Impella-2.5-percutaneous left-ventricular assist device implantation, lactate levels decreased from 5.8±5.0 mmol/L to 4.7±5.4 mmol/L (P=0.28) and 2.5±2.6 mmol/L (P=0.023) at 24 and 48 hours, respectively. Early major adverse cardiac and cerebrovascular events were reported in 18 (15%) patients. Major bleeding at the vascular access site, hemolysis, and pericardial tamponade occurred in 34 (28.6%), 9 (7.5%), and 2 (1.7%) patients, respectively. The parameters of age >65 and lactate level >3.8 mmol/L at admission were identified as predictors of 30-day mortality. After 317±526 days of follow-up, survival was 28.3%. Conclusions-In patients with acute cardiogenic shock from acute myocardial infarction, Impella 2.5-treatment is feasible and results in a reduction of lactate levels, suggesting improved organ perfusion. However, 30-day mortality remains high in these patients. This likely reflects the last-resort character of Impella-2.5-application in selected patients with a poor hemodynamic profile and a greater imminent risk of death. Carefully conducted randomized controlled trials are necessary to evaluate the efficacy of Impella-2.5-support in this high-risk patient group. (Circ Heart Fail. 2013;6:23-30.)Key Words: cardiogenic shock ■ Impella-2.5-device ■ mechanical circulatory support ■ percutaneous left-ventricular assist device

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Supported High-Risk Percutaneous Coronary Intervention With the Impella 2.5 Device

Abstract: This large multicenter registry supports the safety, feasibility, and potential usefulness of hemodynamic support with Impella 2.5 in high-risk PCI.

Cited by 214 publications

References 10 publications

Repeat Revascularization After Contemporary Percutaneous Coronary Intervention

Repeat Revascularization After Contemporary Percutaneous Coronary Intervention

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

Percutaneous Left-Ventricular Support With the Impella-2.5–Assist Device in Acute Cardiogenic Shock

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