cVAD Registry Research Articles

Elevated Central Venous Pressure As A Trigger For Right Heart Failure Evaluation In Patients Receiving Left-sided Mechanical Support For Cardiogenic Shock

Right ventricular failure (RVF) is associated with increased mortality among patients receiving left ventricular mechanical circulatory support (LV-MCS) for cardiogenic shock and requires prompt recognition and management. Increased central venous pressure (CVP) is an indicator of potential RVF. We analyzed the association between hemodynamic parameters and clinical outcomes among 132 patients with cardiogenic shock due to acute myocardial infarction in the cVAD registry who had a CVP measured during left-sided Impella support. CVP was significantly higher among patients who died in the hospital (14.0 vs 11.7 mmHg, p=0.014), and a CVP > 12 identified patients at significantly higher risk for in-hospital mortality (65% vs 45%, p=0.02). CVP remained significantly associated with in-hospital mortality even after adjustment in a multivariable model (adjusted OR 1.10 [95% CI 1.02-1.18] per 1 mmHg increase). LV-MCS suction events were non-significantly more frequent among patients with high versus low CVP (62.11 vs 7.14 events, p=0.067). CVP is a single, readily accessible hemodynamic parameter which predicts a higher rate of short-term mortality and may identify sub-clinical RVF in patients receiving LV-MCS for cardiogenic shock.

Improvement in left ventricular function following higher-risk percutaneous coronary intervention in patients with ischemic cardiomyopathy.

Surgical revascularization is associated with improved ventricular function and clinical outcomes among patients with ischemic cardiomyopathy. There are less extensive data on changes in ventricular function among patients with ischemic cardiomyopathy undergoing percutaneous coronary intervention (PCI). Accordingly, we sought to assess the extent and predictors of change in left ventricular ejection fraction (ΔLVEF) among patients undergoing hemodynamically-supported PCI. We assessed ΔLVEF following hemodynamically-supported PCI (with Impella or intra-aortic balloon counterpulsation) among patients enrolled in the PROTECT II trial and cVAD registry. The ΔLVEF was compared among patients with paired echocardiography at baseline and at least 30 days of follow-up. Independent correlates of ΔLVEF (modeled continuously and with an absolute ΔLVEF≥5%) were assessed using multivariable models. Among the 689 patients with paired echocardiographic data included in the analysis, the mean LVEF improved from 24.8 ± 9.9% to 31.4 ± 13.3% after PCI, for a net increase of 6.5 ± 10.8% (p < .001). A total of 395 (57%) patients had ΔLVEF ≥ 5% following hemodynamically-supported PCI. The number of vessels treated was associated with ΔLVEF (ΔLVEF 5.5% with 1 vessel, 6.6% with 2 vessels, and 8.3% with 3 vessels, p for trend = .046). A lower baseline LVEF, absence of a history of congestive heart failure or aldosterone receptor antagonist use, and a greater number of vessels treated were independent correlates of LVEF improvement. Among patients with severe left ventricular systolic dysfunction and paired echocardiographic assessments, an improvement in LVEF was observed following hemodynamically-supported PCI.

Nonemergent Percutaneous Coronary Intervention on an Unprotected Left Main Coronary Artery Supported with Impella® Heart Pump in Patients Ineligible for Surgical Revascularization.

Objectives We sought to assess if ineligibility to coronary artery bypass grafting (CABG) constitutes a risk factor in patients who underwent a nonemergent unprotected left main coronary artery (ULMCA) percutaneous coronary intervention (PCI) with prophylactic Impella® heart pump support. Background ULMCA PCI in patients not deemed eligible for CABG is associated with significantly worse outcomes compared to ULMCA PCI in eligible patients. Methods Patients from the cVAD Registry and the PROTECT II trial who underwent a nonemergent ULMCA PCI were identified. We compared in-hospital mortality and major adverse cardiac and cerebrovascular event (MACCE) rates as well as 30-day survival and MACCE rates between CABG ineligible and CABG eligible patients. Results A total of 331 patients were included (293 Impella 2.5®, 38 Impella CP®); 227 were ineligible for CABG and 104 were eligible. Baseline characteristics were remarkable for a trend toward higher rate of chronic obstructive pulmonary disease in the ineligible patients. In-hospital mortality (3.52% vs. 5.77%; p=0.383) and MACCE (6.61% vs. 7.69%; p=0.816) rates as well as 30-day survival (92.0% vs. 93.4%; Log-Rank p-value =0.781) and MACCE (88.1% vs. 90.1%; Log-Rank p-value=0.648) rates were not different between the two groups. Conclusions The results of our study suggest that prophylactic Impella support appears to mitigate the risks inherent to surgical ineligibility in patients undergoing a nonemergent ULMCA PCI. Our results require further investigation.

Prevalence and Clinical Correlates of Extended Mechanical Support in Patients Undergoing High-Risk Percutaneous Coronary Intervention in Current Clinical Practice: Insights from the cVAD Registry.

High-risk percutaneous coronary interventions (HR-PCI) are prone to hemodynamic instability, resulting in poor outcomes. Acute mechanical circulatory support (AMCS) devices are used during HR-PCI to improve outcomes. However, the clinical criteria for extended AMCS have not been well characterized. The aim of this study was to describe the prevalence and clinical correlates of extended AMCS in patients undergoing elective or urgent HR-PCI. We retrospectively analyzed 507 patients enrolled in the catheter-based ventricular assist device (cVAD) registry who underwent elective or urgent HR-PCI with prophylactic use of Impella. The study population was divided into two groups: Impella support removed immediately after PCI (Group A, n = 464) and extended support after PCI (Group B, n = 43). Multivariable regression analysis was used to identify independent predictors of extended AMCS. Baseline characteristics were similar between the groups. Non-ST-elevation myocardial infarction in 26.3% in Group A vs 41.8% in Group B (p = 0.03). PCI of left main was common in Group A (p = 0.02), whereas the right coronary artery was common in Group B (p < 0.001). The mean duration of Impella support 1.1 ± 0.6 h in Group A vs 11.4 ± 16.8 h in Group B (p < 0.001). Death and vascular complications were higher with extended Impella support. Revascularization of chronic total occlusion (CTO) was an independent predictor of extended Impella support (OR 3.2, 95% CI 1.20-8.53). About 9% of patients enrolled in the cVAD registry undergoing elective or urgent HR-PCI received extended Impella support. In-hospital mortality was about 12% in patients requiring extended Impella support. CTO was associated with a higher likelihood of extended AMCS. The hemodynamic benefits of extended AMCS support must be weighed in terms of risk of complications.

Outcomes Among Patients Transferred for Revascularization With Impella for Acute Myocardial Infarction With Cardiogenic Shock from the cVAD Registry

The outcomes for patients transferred with cardiogenic shock and later treated with revascularization and Impella support have not previously been studied. To evaluate these outcomes, patients in cardiogenic shock were recruited from the catheter-based ventricular assist device registry, a prospective registry enrolling patients who underwent percutaneous coronary intervention with hemodynamic support using Impella 2.5 or CP. Analysis was performed on subgroups of patients who were characterized as those directly admitted to a tertiary care hospital (direct), or those transferred from an outside hospital (transfer). Patients who were transferred with acute myocardial infarction with cardiogenic shock (AMICS) more often presented in shock were in shock longer than 24 hours, and were more likely to be on intra-aortic balloon pump but were less likely to sustain cardiac arrest. The number of pressors, EF, diseased, and treated vessels were similar between the 2 groups. Despite baseline differences, the mortality was similar in the transfer versus direct patients (47.0% vs 53.5% p = 0.19). In a multivariate model, the factors independently associated with 30-day mortality in AMICS treated with revascularization and Impella support were cardiopulmonary resuscitation (CPR) (p <0.01), age (p <0.01), and ST-segment elevation myocardial infarction (STEMI) (p = 0.02). Whether the patient was transferred or directly admittedly with AMICS was not an independent predictor of death. In conclusion, these findings suggest that considerations should be given to transfer patients with AMICS to allow them to be treated in a contemporary manner.

Abstract 17310: Outcome of Octogenarians Undergoing High Risk Percutaneous Coronary Intervention With Percutaneous Mechanical Circulatory Support

Introduction: The procedural risks of high risk percutaneous coronary intervention (HRPCI) using mechanical circulatory support (MCS) for octogenarians have not been well established. Hypothesis: We sought to study the outcome of octogenarians (≥80 years) undergoing HRPCI with MCS compared with those who are &lt;80 years old Methods: Using the cVAD Registry, we identified a total of 1,273 complex high-risk indicated patients who underwent PCI with MCS using Impella 2.5 or Impella CP. Patients without cardiogenic shock who underwent elective or urgent intervention were included. A total of 259 (20.2%) were octogenarians and (79.6%) were &lt; 80 years old Results: octogenarians were older (84±3 vs. 65±8, p&lt;0.001), had less diabetes (39% vs. 55%, p&lt;0.001), higher STS score (9.1±8 vs. 4.6±6, P&lt;0.001) and higher baseline ejection fraction (35±116 vs. 27±15, P&lt;0.001). Despite higher STS score, octogenarians had no difference in in-hospital mortality, stroke, myocardial infarction or need for recurrent revascularization compared with non-octogenarians (p value insignificant for all comparisons). Ejection fraction improved in both octogenarians and younger patients at the time of discharge (28% to 32% and 31% to 38%, respectively, p&lt;0.0001) as well as NYHA class post PCI (NYHA Class III/IV 73% to 50% in octogenarians and younger patients, p&lt;0.001). Freedom from death and MACE 30 days follow up, was similar as well in octogenarians and younger patients (figure) Conclusions: the use of percutaneous circulatory support for HRPCI is reasonable and feasible in a selected octogenarian population with similar outcomes as those of younger selected patients. Irrespective of age, the use of Impella 2.5 was an independent predictor of favorable outcomes.

The Impella Microaxial Flow Catheter Is Safe and Effective for Treatment of Myocarditis Complicated by Cardiogenic Shock: An Analysis From the Global cVAD Registry

BackgroundMyocarditis complicated by cardiogenic shock remains a complex problem. The use of acute mechanical circulatory support devices for cardiogenic shock is growing. We explored the utility of Impella transvalvular microaxial flow catheters in the setting of myocarditis with cardiogenic shock. Methods and ResultsWe retrospectively analyzed data from 21 sites within the cVAD registry, an ongoing multicenter voluntary registry at sites in North America and Europe that have used Impella in patients with myocarditis. Myocarditis was defined by endomyocardial biopsy (n = 11) or by clinical history without angiographic evidence of coronary disease (n = 23). A total of 34 patients received an Impella 2.5, CP, 5.0, or RP device for cardiogenic shock complicating myocarditis. Baseline characteristics included age 42 ± 17 years, left ventricular ejection fraction (LVEF) 18% ± 10%, cardiac index 1.82 ± 0.46 L·min−1·m−2, pulmonary capillary wedge pressure 25 ± 7 mm Hg, and lactate 27 ± 31 mg/dL. Before Impella placement, 32% (n = 11) of patients required intra-aortic balloon pump. Mean duration of Impella support was 91 ± 74 hours; 21 of 34 patients (62%) survived the index hospitalization and were discharged with an improved mean LVEF of 37.32% ± 20.31% (P = .001); 15 patients recovered with successful support, 5 patients were transferred to another hospital on initial Impella support, 1 patient underwent orthotopic heart transplantation. Ten patients required transition to another mechanical circulatory support device. ConclusionsThis is the largest analysis of Impella-supported myocarditis cases to date. The use of Impella appears to be safe and effective in the settings of myocarditis complicated by cardiogenic shock.

TCT-694 Outcome of High Risk Percutaneous Coronary Intervention in Octogenarians: Insight from the from the cVAD Registry

TCT-694 Outcome of High Risk Percutaneous Coronary Intervention in Octogenarians: Insight from the from the cVAD Registry

Comparison of Outcomes of Percutaneous Coronary Intervention on Native Coronary Arteries Versus on Saphenous Venous Aorta Coronary Conduits in Patients With Low Left Ventricular Ejection Fraction and Impella Device Implantation Achieved or Attempted (from the PROTECT II Randomized Trial and the cVAD Registry)

Patients with prior coronary artery bypass grafting (CABG) represent a high-risk cohort given associated medical conditions and worse outcome of saphenous vein graft compared with native vessel percutaneous coronary intervention (PCI). The goal of the current analysis was to compare clinical outcomes in 591 patients with and without prior CABG and multivessel coronary artery disease or unprotected left main disease and severely reduced left ventricular systolic function underwent Impella supported PCI from the PROTECT II randomized trial and the cVAD Registry. Patients with prior CABG surgery (n = 201) were compared with those without prior CABG surgery (n = 390). The primary end point of this analysis was overall mortality at 30 days. Patients with prior CABG surgery had greater Society of Thoracic Surgery mortality score compared with patients without prior CABG surgery, 7.6 ± 6.4 versus 5.1 ± 5.5, respectively, p <0.001. Saphenous vein graft PCI was performed in 17% of patients with prior CABG surgery. Number of vessels treated was lower in patients with prior CABG surgery compared with patients without prior CABG surgery, 1.66 ± 0.56 versus 1.89 ± 0.64, respectively, p <0.001. Achievement of TIMI 3 flow post PCI and overall PCI success was similar in the two groups. Overall mortality at 30 days was similar in patients with prior CABG surgery compared with patients without prior CABG surgery, 6.75% versus 6.61%, respectively, p = 1.0. In conclusion, in this high-risk cohort of patients underwent hemodynamically supported PCI, prior CABG surgery was not associated with worse outcome. The use of hemodynamic support appears to mitigate the increased risk of PCI associated with prior CABG.

TCT-513 The Impella Micro-axial Flow Catheter is Safe and Effective for Treatment of Myocarditis Complicated by Cardiogenic Shock: An Analysis from the Global cVAD Registry

Myocarditis complicated by cardiogenic shock (Myo-CS) remains a complex clinical problem. The use of acute circulatory support devices for CS is growing. We explored the clinical utility of Impella micro-axial flow catheters in the setting of Myo-CS. We retrospectively analyzed data from 21 sites

The cVAD registry for percutaneous temporary hemodynamic support: A prospective registry of Impella mechanical circulatory support use in high-risk PCI, cardiogenic shock, and decompensated heart failure

The current catheter-based ventricular assist devices registry is an international database documenting outcomes with temporary Impella hemodynamic support. The registry has supported 8 publications and 4 Food and Drug Administration premarket approvals since its inception in 2009. The current registry is more robust containing outcomes up to 1 year postprocedure.

367 - The Impella Micro-Axial Flow Catheter is Safe and Effective for Treatment of Myocarditis Complicated by Cardiogenic Shock: An Analysis from the Global cVAD Registry

367 - The Impella Micro-Axial Flow Catheter is Safe and Effective for Treatment of Myocarditis Complicated by Cardiogenic Shock: An Analysis from the Global cVAD Registry

Impella 2.5 initiated prior to unprotected left main PCI in acute myocardial infarction complicated by cardiogenic shock improves early survival.

To assess post-procedural outcomes when Impella 2.5 percutaneous left ventricular assist device (pLVAD) support is initiated either prior to or after percutaneous coronary intervention (PCI) on unprotected left main coronary artery (ULMCA) culprit lesion in the context of acute myocardial infarction cardiogenic shock (AMICS). Initiation of Impella 2.5 pLVAD prior to PCI is associated with significant survival benefit in the setting of AMICS. Outcomes of those presenting with a ULMCA culprit lesion in this setting have not been well characterized. Thirty-six consecutive patients in the cVAD Registry supported with Impella 2.5 pLVAD for AMICS who underwent PCI on ULMCA culprit lesion were included in our multicenter study. The average age was 69.8 ± 14.2 years, 77.8% were male, 72.7% were in CS at admission, 44.4% sustained one or multiple cardiac arrests, and 30.6% had anoxic brain injury. Baseline characteristics were comparable between the Pre-PCI group (n = 20) and Post-PCI group (n = 16). Non-ST segment elevation myocardial infarction and greater coronary disease burden were significantly more frequent in the Pre-PCI group but they had significantly better survival to discharge (55.0% vs 18.8%, P = 0.041). Kaplan-Meier 30-day survival analysis showed very poor survival in Post-PCI group (48.1% vs 12.5%, Log-Rank P = 0.004). Initiation of Impella 2.5 pLVAD prior to as compared with after PCI of ULMCA for AMICS culprit lesion is associated with significant early survival. As previously described, patients supported after PCI appear to have very poor survival at 30 days.

Outcomes of hemodynamic support with Impella in very high-risk patients undergoing balloon aortic valvuloplasty: Results from the Global cVAD Registry

BackgroundReports on the role of hemodynamic support devices in patients with severe aortic stenosis (AS) and left ventricular (LV) dysfunction undergoing balloon aortic valvuloplasty (BAV) are limited. MethodsPatients were identified from the cVAD registry, an ongoing multicenter voluntary registry at selected sites in North America that have used Impella in >10 patients. ResultsA total of 116 patients with AS who underwent BAV with Impella support were identified. Mean age was 80.41±9.03years and most patients were male. Mean STS score was 18.77%±18.32, LVEF was 27.14%±16.07, and 42% underwent concomitant PCI. In most cases Impella was placed electively prior to BAV, whereas 26.7% were placed as an emergency. The two groups had similar baseline characteristics except for higher prevalence of CAD and lower LVEF in the elective group, and higher STS score in the emergency group. Elective strategy was associated higher 1-year survival compared to emergency placement (56% vs. 29.2%, p=0.003). One-year survival was higher when BAV was used as a bridge to definitive therapy as opposed to palliative treatment (90% vs. 28%, p<0.001). On multivariate analysis, STS score and aim of BAV (bridge to definitive therapy vs. palliative indication) were independent predictors of mortality. ConclusionIn this large cohort of patients with AS and severe LV dysfunction undergoing BAV, our results demonstrates feasibility and promising long-term outcomes using elective Impella support with the intention to bridge to a definitive therapy.

TCT-124 Predictors of the Need for Continuous Impella Support in High Risk Percutaneous Coronary Intervention

Percutaneous left ventricular assist devices like Impella can be used during high-risk percutaneous coronary intervention (HRPCI) for hemodynamic support. The predictors for the need of continuous support post HRPCI have not been studied. Patients enrolled in the cVAD registry who underwent

TCT-127 Prior Coronary Artery Bypass Graft Surgery and Hemodynamically Supported High Risk Percutaneous Coronary Intervention: Observations from The PROTECT II Randomized Trial and The cVAD Registry

Patients with prior coronary artery bypass graft (CABG) surgery represent a high risk cohort given associated medical conditions and worse outcome of saphenous vein graft (SVG) compared to native vessel percutaneous coronary intervention (PCI). The use of hemodynamic support in patients with prior

TCT-121 Mechanical Circulatory Support in Acute Myocardial Infarction Complicated by Cardiogenic Shock: Insights from the cVAD Registry

The role and timing of percutaneous mechanical circulatory support devices in the treatment of acute myocardial infarction complicated by cardiogenic shock (AMICS) is not well understood. We therefore sought to evaluate patient characteristics and predictors of outcomes in patients presenting with

TCT-136 Outcomes of Hemodynamic Support with Impella in very high-risk patients undergoing Balloon Aortic Aortic Valvuloplasty: Results From the Global cVAD Registry

TCT-136 Outcomes of Hemodynamic Support with Impella in very high-risk patients undergoing Balloon Aortic Aortic Valvuloplasty: Results From the Global cVAD Registry

TCT-24 Global cVAD Registry: A global initiative in percutaneous circulatory support From the cVAD Steering Committee on behalf of all cVAD Investigators

Percutaneous circulatory support has an exponential growth within the last decade. In the era of evidence based medicine and appropriate use, having a systematic, standardized conduit for clinical data in “real world” medical setting becomes paramount. Objective: To build a comprehensive

Women With Cardiogenic Shock Derive Greater Benefit From Early Mechanical Circulatory Support: An Update From the cVAD Registry.

The aim of this analysis was to assess survival differences between men and women supported with Impella 2.5 (Abiomed Inc., Danvers) in the setting of acute myocardial infarction (AMI) complicated by cardiogenic shock (CS). Data on sex differences in outcomes of CS with mechanical circulatory support are sparse. Patients enrolled in the cVAD Registry who underwent percutaneous coronary intervention (PCI) and Impella 2.5 support for CS complicating an AMI were included. Differences between men and women were examined. In total, 180 patients were analyzed. Women (n = 49, 27.2%) were older (71.0 ± 12.8 years vs 63.8 ± 13.0, P = 0.001), smaller (BSA 1.82 ± 0.22 vs 2.04 ± 0.24 m(2) , P < 0.001), and had a higher STS mortality risk score than men (27.9 ± 17.0 vs. 20.8 ± 16.8 P = 0.01). There was no difference in survival to discharge (P = 0.3). Patients receiving the Impella 2.5 pre-PCI had significantly lower inpatient mortality than those who received support post-PCI (P = 0.003). However, the magnitude of the survival benefit was significantly greater in women who received the Impella pre-PCI as compared to men. Overall, 68.8% of women survived with pre-PCI Impella 2.5 versus 24.2% post-PCI (P = 0.005) whereas 54.2% of men survived with pre-PCI Impella 2.5 versus 40.3% post-PCI (P = 0.1, p-interaction = 0.07). No differences in timing to intervention were found between men and women. Early initiation of hemodynamic support prior to PCI with Impella 2.5, in the setting of AMI complicated by CS, was associated with a greater survival benefit to hospital discharge in women compared to men, despite a higher predicted risk of mortality and a greater revascularization failure rate for women. (J Interven Cardiol 2016;29:248-256).