Article

High-Risk PCI in acute coronary syndromes with Impella LP 2.5 device support

Authors:
  • Elisabeth Hospital Essen, Germany
  • Klinikum Westfalen
  • KMG Klinik Silbermühle GmbH
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Abstract

To evaluate feasibility, safety, efficacy as well as acute and short-term outcome of hemodynamically supported percutaneous coronary intervention (PCI) by a percutaneous, catheter-based left ventricular assist device (LVAD) (Impella LP 2.5, Abiomed Europe GmbH, Aachen, Germany) in a high-risk patient population with acute coronary syndrome. Although hemodynamic support by intraaortic balloon pump favorably affects myocardial oxygen supply and demand, it has modest effects on cardiac output, providing passive support only. In contrast, the Impella LP 2.5 microaxial pump, which is placed within the left ventricular outflow tract and actively ejects blood into the ascending aorta, might offer additional hemodynamic support and thereby procedural safety during PCI. Thirty-eight consecutive high-risk patients (mean age, 69.7 ± 10.3 years, logistic EuroSCORE, 22.4 ± 14.9%) with unstable angina pectoris or non-ST-segment elevation myocardial infarction and severe three-vessel-disease were included in the study. Clinical and laboratory examinations were performed at baseline as well as at 6, 24 and 48 h after the procedure and 30 days after discharge. Device insertion and explantation was feasible in all patients without vascular complications and continuous hemodynamic stability was obtained during PCI. PCI was uneventfully performed in all but one patient for technical reasons. One non procedure-related death occurred 7 days after the intervention, accounting for a total 30-day mortality of 2.86%. Other major cardiac or cerebrovascular events did not occur. LVAD support using a percutaneous microaxial flow pump is a promising and safe approach for high-risk PCI providing good short-term results.

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... In addition to the PROTECT II trial, 10 observational studies met the inclusion criteria. Seven of these studies were noncomparative 5,[20][21][22][23][24][25] ; one compared Impella 2.5 with IABP 11 ; one compared Impella 2.5 with TandemHeart 8 ; and one compared Impella with either IABP or TandemHeart. 26 Researchers reported various outcomes for benefits and harms. ...
... The remaining four noncomparative observational studies were single-centre retrospective chart reviews or observational studies with a sample size of 20 to 60 patients. 5,20,21,23 The study by Alasnag et al 20 was on elective PCI, and the study by Iliodromitis et al 23 was on emergency PCI only. The other two noncomparative studies did not specify whether the PCI was elective or emergency or both. ...
... Eight noncomparative observational studies on using Impella 2.5 to support high-risk PCI reported mortality rates. 5,8,20,[22][23][24][25][26] The 30-day mortality rates ranged from 0% to 10%. The study that reported a 10% mortality rate 5 had a smaller sample (n = 20) than other studies. ...
Article
Background: Percutaneous coronary intervention (PCI)-using a catheter to place a stent to keep blood vessels open-is increasingly used for high-risk patients who cannot undergo surgery. Cardiogenic shock (when the heart suddenly cannot pump enough blood) is associated with a high mortality rate. The percutaneous ventricular assist device can help control blood pressure and increase blood flow in these high-risk conditions. This health technology assessment examined the benefits, harms, and budget impact of the Impella percutaneous ventricular assist device in high-risk PCI and cardiogenic shock. We also analyzed cost-effectiveness of the Impella device in high-risk PCI. Methods: We performed a systematic search of the literature for studies examining the effects of the Impella percutaneous ventricular assist device in high-risk PCI and cardiogenic shock, and appraised the evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria, focusing on hemodynamic stability, mortality, major adverse cardiac events, bleeding, and vascular complications. We developed a Markov decision-analytical model to assess the cost- effectiveness of Impella devices versus intra-aortic balloon pumps (IABPs), calculated incremental cost-effectiveness ratios (ICERs) using a 10-year time horizon, and conducted sensitivity analyses to examine the robustness of the estimates. The economic model was conducted from the perspective of the Ontario Ministry of Health and Long-Term Care. Results: Eighteen studies (one randomized controlled trial and 10 observational studies for high-risk PCI, and one randomized controlled trial and six observational studies for cardiogenic shock) were included in the clinical review. Compared with IABPs, Impella 2.5, one model of the device, improved hemodynamic parameters (GRADE low-very low) but showed no significant difference in mortality (GRADE low), major adverse cardiac events (GRADE low), bleeding (GRADE low), or vascular complications (GRADE low) in high-risk PCI and cardiogenic shock. No randomized controlled trials or prospective observational studies with a control group have studied Impella CP and Impella 5.0 (other models of the device) in patients undergoing high-risk PCI or patients with cardiogenic shock. The economic model predicted that treatment with the Impella device would have fewer quality-adjusted life-years (QALYs) and higher costs than IABP in high-risk PCI patients. These observations were consistent even when uncertainty in model inputs and parameters was considered. We estimated that adopting Impella would increase costs by $2.9 to $11.5 million per year. Conclusions: On the basis of evidence of low to very low quality, Impella 2.5 devices were associated with improved hemodynamic stability, but had mortality rates and safety profile similar to IABPs in high-risk PCI and cardiogenic shock. Our cost-effectiveness analysis indicated that Impella 2.5 is likely associated with greater costs and fewer quality-adjusted life years than IABP.
... Twelve studies (54.5%) reported major bleeding events without specifying the bleeding site. 7,11,16,[19][20][21][24][25][26][29][30][31] Five studies (22.7%) reported that no major bleeding complications occurred. 14,15,18,23,32 The remaining five studies (22.7%) reported on bleeding complications and specified the bleeding site. ...
... Transfusion rates in the four studies in which the majority of transfusions were stated as being performed in the setting of baseline anaemia ranged from 5.0% to 34.3%. 12,23,26,32 Few studies included in our review reported on haemolysis (9 of 23 studies). Of these, 3 studies reported 0% haemolysis rates, 1 ...
... Bleeding complications over time demonstrated that the variability in bleeding risk seen across centres has not changed meaningfully over the last 15 years ( Figure 1). 7,[11][12][13][14][15][16][18][19][20][21][22][23][24][25][26][27][28][29][30][31][32] Given the broad scope of bleeding complications (comprising both access and non-access-related bleeding during PCI), often complicated by pre-existing anaemia and the inclusion of some urgent HR-PCI patient populations, this variability is not surprising. Likewise, many series reported relatively low numbers of cases over extended time periods, suggesting that any advantages of increased operator skill, using best practices accrued through increasing experience, could not be ascertained. ...
... Historical cohort. The historical control patients were identified from 2 studies: the Europella Registry 9 and a historical cohort from our tertiary center 20 . The study cohort was compared to the Europella registry (n = 144) with respect for serious adverse vascular events that required the transfusion of erythrocyte concentrates or interventional/surgical treatment. ...
... In our study, we used fluoroscopic-and angiographic-guided femoral access, which is known to reduce femoral complications 21 . We compared our study cohort to that included in a historical Essen cohort that included patients undergoing high-risk PCI with Impella support 20 . In this cohort, Impella was placed without www.nature.com/scientificreports ...
Article
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Mechanical circulatory support (MCS) devices are increasingly used to provide hemodynamic stability for patients with severe coronary artery disease, comorbidities, and/or impaired hemodynamics during high-risk percutaneous coronary interventions (PCI). Vascular access site complications, particularly those due to the use of large-bore sheaths, may limit outcomes in these patients. The aim of this study was to investigate the incidence and predictors of vascular complications in protected high-risk PCIs. Therefore, we included patients undergoing high-risk PCI with an Impella device from January 2016 to August 2018. Vascular complications were graded according to ‘Valve Academic Research Consortium-2’, a definition routinely used in transcatheter valve implantation procedures. In total, 61 patients (mean age 72 ± 11 years, 79% male, SYNTAX score 33 ± 7) were included, and angiographic- and fluoroscopic-guided vascular access was used for Impella implantation in all patients. Major vascular complications occurred in 5 male patients (8%). All major vascular complications were treated conservatively without the need for surgical intervention, and only one patient received a transfusion of three erythrocyte concentrates. Regression analysis revealed that patients with peripheral arterial disease of the lower extremities are at higher risk of major vascular complications. In conclusion, the utilization of Impella using a standardized protocol for angiographic- and fluoroscopic-guided vascular access was associated with a low rate of vascular complications.
... Veno-arterial ECMO has also been successfully used in a provisional setting for high-risk percutaneous coronary intervention [30]. However, in elective high-risk coronary interventions a percutaneous microaxial pump appears to be equally effective with lower procedural risk [31]. Veno-arterial ECMO can be useful for preconditioning the patient prior to implantation of a permanent left ventricular assist device (LVAD) [32], or in a bridge-totransplantation setting. ...
Article
Full-text available
Extracorporeal membrane oxygenation (ECMO) has revolutionized treatment of severe isolated or combined failure of lung and heart. Due to remarkable technical development the frequency of use is growing fast, with increasing adoption by interventional cardiologists independent of cardiac surgery. Nevertheless, ECMO support harbors substantial risk such as bleeding, thromboembolic events and infection. Percutaneous ECMO circuits usually comprise cannulation of two large vessels ('dual' cannulation), either veno-venous for respiratory and veno-arterial for circulatory support. Recently experienced centers apply more advanced strategies by cannulation of three large vessels ('triple' cannulation), resulting in veno-veno-arterial or veno-arterio-venous cannulation. While the former intends to improve drainage and unloading, the latter represents a very potent method to provide circulatory and respiratory support at the same time. As such triple cannulation expands the field of application at the expense of increased complexity of ECMO systems. Here, we review percutaneous dual and triple cannulation strategies for different clinical scenarios of the critically ill. As there is no unifying terminology to date, we propose a nomenclature which uses "A" and all following letters for supplying cannulas and all letters before "A" for draining cannulas. This general and unequivocal code covers both dual and triple ECMO cannulation strategies (VV, VA, VVA, VAV). Notwithstanding the technical evolution, current knowledge of ECMO support is mainly based on observational experience and mostly retrospective studies. Prospective controlled trials are urgently needed to generate evidence on safety and efficacy of ECMO support in different clinical settings.
... Impella use is steadily becoming more widespread. Its use has been described in the management of postcardiomiotomy heart failure and during high-risk percutaneous coronary interventions [4]. There is one reported pediatric case where an Impella 5.0 was used as a bridge to full recovery from fulminant viral myocarditis [5]. ...
Article
Full-text available
A 31-year-old male was transferred to our hospital with severe heart failure due to viral myocarditis. He progressed to multiorgan failure requiring intubation and maximal doses of multiple vasopressors. Circulatory support was provided with an Impella device as a bridge to an extracorporeal membrane oxygenation (ECMO) system. On full mechanical cardiovascular support, the patient's hemodynamic status improved and ECMO and Impella were explanted after 48 hours. Three days later, he was extubated and continued on to a full recovery. There are no specific therapies for fulminant myocarditis but first-line treatment is supportive care. ECMO is commonly used in patients with severe heart failure. In severe systolic dysfunction, left ventricular decompression is required to reduce myocardial wall stress, decrease myocardial oxygen requirements, and enhance the chances of recovery. The Impella, an active support system, is less invasive than classical decompressive techniques and is associated with lower requirements for blood products with fewer thromboembolic complications. This is the only case reported of the contemporary use of Impella and ECMO as a bridge to full recovery in an adult with myocarditis. It also presents a novel use of the Impella device in decompressing the left ventricle of an adult patient on ECMO.
... Six hundred fifty-eight duplicated articles were additionally excluded. After the review of 161 full-length articles, we subsequently excluded 67 articles because the data on AKI incidence and its associated mortality was not available, 28 articles because they were not observational studies or clinical trials, and 10 articles because they investigated AKI in shortterm LVAD use, not implantable LVAD [79][80][81][82][83][84][85][86][87][88]. Therefore, 56 cohort studies with a total of 63,663 adult patients were included in this meta-analysis. ...
Article
Full-text available
Background: We aimed to evaluate the acute kidney injury (AKI) incidence and its associated risk of mortality in patients with implantable left ventricular assist devices (LVAD). Methods: A systematic literature search in Ovid MEDLINE, EMBASE, and Cochrane Databases was conducted through January 2020 to identify studies that provided data on the AKI incidence and AKI-associated mortality risk in adult patients with implantable LVADs. Pooled effect estimates were examined using random-effects, generic inverse variance method of DerSimonian-Laird. Results: Fifty-six cohort studies with 63,663 LVAD patients were enrolled in this meta-analysis. The pooled incidence of reported AKI was 24.9% (95%CI: 20.1%–30.4%) but rose to 36.9% (95%CI: 31.1%–43.1%) when applying the standard definition of AKI per RIFLE, AKIN, and KDIGO criteria. The pooled incidence of severe AKI requiring renal replacement therapy (RRT) was 12.6% (95%CI: 10.5%–15.0%). AKI incidence did not differ significantly between types of LVAD (p = .35) or indication for LVAD use (p = .62). While meta-regression analysis did not demonstrate a significant association between study year and overall AKI incidence (p = .55), the study year was negatively correlated with the incidence of severe AKI requiring RRT (slope = −0.068, p < .001). The pooled odds ratios (ORs) of mortality at 30 days and one year in AKI patients were 3.66 (95% CI, 2.00–6.70) and 2.22 (95% CI, 1.62–3.04), respectively. The pooled ORs of mortality at 30 days and one year in severe AKI patients requiring RRT were 7.52 (95% CI, 4.58–12.33) and 5.41 (95% CI, 3.63–8.06), respectively. Conclusion: We found that more than one-third of LVAD patients develop AKI based on standard definitions, and 13% develop severe AKI requiring RRT. There has been a potential improvement in the incidence of severe AKI requiring RRT for LVAD patients. AKI in LVAD patients was associated with increased 30-day and 1 year mortality.
... Patients with complex coronary artery disease or unprotected left-main coronary artery as well as severe left main coronary stenosis occasionally present with hemodynamic instability or suffer from such comorbidities that they are considered ineligible for coronary artery bypass graft (CABG). Correspondingly, they are at increased risk for [17,[28][29][30][31][32][33][34][35][36][37], (b) pooled data from 11 trials [5-7, 15, 19, 38-43], (c) pooled data from 11 trials [44][45][46][47][48][49][50][51][52][53][54], and (d) pooled data from 10 trials [55][56][57][58][59][60][61][62][63][64]. ...
Article
Full-text available
The development of ventricular assist devices has broadened the means with which one can treat acute heart failure. Percutaneous ventricular assist devices (pVAD) have risen from recent technological advances. They are smaller, easier, and faster to implant, all important qualities in the setting of acute heart failure. The present paper briefly describes the functioning and assets of the most common devices used today. It gives an overview of the current evidence and indications for left ventricular assist device use in cardiogenic shock and high-risk percutaneous coronary intervention. Finally, extracorporeal life support devices are dealt with in the setting of hemodynamic support.
... Additional studies prove that patients with complex anatomy (e.g. LM culprit lesion) have a high mortality rate after PCI, and thanks to such evidences cardiac protection devices(50,51) have started to get their central role. Another interesting study of ventricular assist devices has investigated the role ECMO has in patients at very high risk for coronary artery bypass grafting, demonstrating that elective high-risk PCI supported by ECMO is a feasible alternative for patients who are at very high risk for CABG(52).Many studies have also stressed on the role diabetes mellitus has on PCI outcome:Kappetein et al. informed that, in diabetic patients, 5 years rates are significantly higher for MACCE and repeat revascularization (53); according to this study, Armstrong et al.underlined the major diabetes role on higher rates of restenosis and stent thrombosis(54).Another multi-factorial phenomenon in the spectrum of high-risk PCI, which has a great impact on patient outcome, should be specified: the no-reflow. ...
Article
Before the percutaneous spread, the mortality rate of patients with coronary heart disease not suitable for cardiac surgery was markedly high. This limit has been progressively exceeded with the advent of minimally invasive approaches, which, although was initially intended exclusively for low risk patients, was then employed in complex patients often too compromised to undergo cardiac surgery. Given to the rising of high-risk population, due to an increase of patients with multiple chronic conditions linked to the best care offered, we are witnessing an expansion of the high-risk percutaneous coronary interventions (PCI) population. Despite defining what high-risk is remains still unclear, all proposed definitions of high-risk PCI combine features related to three clinical areas: 1) patient risk factors and comorbidities (incorporating those which preclude surgical or percutaneous revascularization such as diabetes, COPD, CKD, lung disease, frailty, advanced age); 2) location of the disease and complexity of coronary anatomy (including multi-vessel disease, left main disease, CTO, bifurcations); 3) hemodynamic clinical status (ventricular dysfunction, concomitant valvular disease or unstable characteristics). Since cardiologists have ascertained the encouraging results in terms of efficacy and rewards compared to the low-risks patients, the important role of treating high-risk patients is becoming more and more relevant to the point that current guidelines have now changed the appropriateness of percutaneous interventions indications. Considering the complexity in managing higher-risk patients with coronary artery disease, the next step to ensure the best care for this type of patients is to create a team-based model of cooperation in order to properly establish the right treatment for the right patient.
... In the original PROTECT I trial, the incidence of bleeding was greater compared to PROTECT II with a hematoma incidence of 40%, however, this study included a small number of patients (2). In addition, several other studies have demonstrated bleeding complications associated with Impella use during PCI in high-risk patients ranging from 6% to 40% (2,(14)(15)(16)(17). Further, the incidence of bleeding is high with prolonged use of a hemodynamic support device (18). ...
Article
High-risk candidates for percutaneous coronary intervention (PCI) may include patients with severe multi-vessel coronary artery disease, unprotected left main coronary artery stenosis, or last patent conduit with a stenosis, especially in patients with a left ventricular (LV) ejection fraction of ≤35% (1-4). In addition, the condition and co-morbidities of the patient should be taken into consideration. Traditionally, revascularization in these patients could be better accomplished with coronary artery bypass graft (CABG) surgery; however, sometimes these patients are high-risk surgical candidates, have advanced age and/or have poor distal targets for bypass surgery (5). PCI in these patients is a viable option, however, episodic interruption of blood flow to the target coronary artery in these high-risk patients during contrast dye injections, balloon inflation and stent implantation may result in a decrease in LV performance raising procedural morbidity and/or mortality (3,4,6). Currently, it is thought that hemodynamic support devices like the Impella (Abiomed, Danvers, Massachusetts) percutaneous left ventricular assist device (PLVAD) or intra-aortic balloon pump (IABP) may provide support during high-risk PCI (2,3,7-9).
Article
Morbidity and mortality in patients with cardiogenic shock remain high despite the recent advances in therapy. New temporary ventricular assist devices (VADs) that are rapidly applied to normalize cardiac output in patients with severe heart failure are being used more frequently. Bridge to decision describes the temporary use of a VAD to stabilize critically ill patients until complete diagnostic tests are performed and decisions about more definitive therapy are made. The CentriMag, TandemHeart, and Impella VADs offer versatility for use in many patients and in multiple hospital settings. These VADs provide continuous blood flow, altering the usual assessment of arterial blood pressure. Patients are usually immobilized during support to prevent dislodgement of cannulas. Anticoagulation therapy is commonly required, and bleeding is a frequent complication. Infection prevention measures must be used to avoid septic complications. In the past 10 years, clinical experience with these devices has expanded, but they remain underused.
Article
Objective: Compare vascular complications and incidence of bleeding of Impella 2.5 and intra-aortic balloon pump (IABP) in high-risk percutaneous coronary interventions (PCI). Background: Large arterial sheath size for device insertion is associated with vascular and/or bleeding complications; gastrointestinal bleeding may also occur with anti-coagulation use. Methods: Patients with an acute coronary syndrome receiving Impella 2.5 or IABP during high-risk PCI were studied (13 Impella; 62 IABP). Vascular complications and incidence of bleeding were compared. Results: Post-procedure hematocrit was similar between groups. Blood transfusion occurred in 38.4% and 32.2% of patients in the Impella and IABP groups, respectively (P = NS); 65.3%, 30.7% and 3.8% of bleeding were due to vascular access site/procedure related, gastrointestinal and genitourinary, respectively. There was no statistical significant difference in vascular complications between the Impella and IABP groups (15.3% and 6.4% of patients, respectively); mesenteric ischemia (n = 1) and aortic rupture (n = 1) were only in the IABP group. In-hospital and one-year mortality were not statistically significant between groups. Conclusion: Impella can be used as safely as IABP during high-risk PCI with similar vascular and bleeding complications. Importantly, approximately one third of bleeding was from the gastrointestinal system warranting careful prophylactic measures and monitoring.
Article
Background: Although controversial, using prophylactic intra-aortic balloon pump (IABP) in patients undergoing high-risk percutaneous coronary intervention (PCI) has been reported to be effective by numerous registry studies. However, conflicting findings were observed in observational studies (Obs.) and randomised controlled trials (RCTs). Objective: The purpose of this meta-analysis was to assess the impact of IABP on in-hospital deaths, major adverse cardiovascular events (MACCE), access-site complications and stroke in high-risk PCI cases from Obs. and RCTs published from 1st January, 1990 to 31st March, 2012 and indexed in PubMed. Methods and results: We retrieved 1125 studies from the database; 11 studies compared the effects of IABP support, i.e., prophylactic administration (P-IABP) vs. no support (No-IABP), in high-risk patients undergoing PCI. These studies were included in the meta-analysis. We then calculated risk ratios (RRs) and risk differences (RDs) between the two groups of patients (P-IABP vs. No-IABP). We did not observe significant in-hospital mortality, MACCE, access-site complications or stroke differences in the RRs and RDs of the two groups. Conclusions: The results suggest that PCI plus P-IABP support does not result in reduced in-hospital mortality or MACCE nor in significant higher access-site complications or stroke incidence compared with PCI alone in patients at high risk for peri-procedural PCI complications.
Article
Objective: A new and smaller percutaneous ventricular assist device (pVAD, Impella, Abiomed, Danvers, MA) has been developed to provide circulatory support in hemodynamically unstable patients and to prevent hemodynamic collapse during high-risk percutaneous coronary interventions (PCI). The objective of the study was to assess the cost-effectiveness of this specific device compared to the intra-aortic balloon pump (IABP) from the European perspective. Additional analysis on extracorporeal membrane oxygenation was conducted for observational purposes only, given its use in some European countries. Methods: A combination of a decision tree and Markov model was developed to assess the cost-effectiveness of the small, pVAD. The short-term (30-day) effectiveness and safety (early survival, risk of bleeding, and stroke) were modeled, as well as long-term risk of major adverse cardiovascular events (recurrent myocardial infarction, stroke, and heart failure). The short-term effectiveness and safety data for the device were obtained from two registries (the Europella and USpella), both of which are large multi-center studies in high-risk patient groups. Probabilities of long-term major adverse cardiovascular events were obtained from various published clinical studies. The economic analysis was conducted from a German statutory health insurance perspective and only direct medical costs were included. Cost-effectiveness was estimated over a 10-year time horizon. Results: Compared with IABP, the pVAD generated an incremental quality-adjusted life-year (QALY) of 0.22 (with Euro-registry data) and 0.27 (with US-registry data). The incremental cost-effectiveness ratio (ICER) of the device varied between €38,069 (with Euro-registry data) and €31,727 (with US-registry data) per QALY compared with IABP. Key limitations: Unadjusted, indirect comparisons of short-term effectiveness and safety between the interventions were used in the model. Cost and utility data were retrieved from various sources. Therefore, differences in patient populations may bias the estimated cost-effectiveness. Conclusions: Compared with IABP, the pVAD is a cost-effective intervention for high-risk PCI patients, with ICERs well-below the conventional cost-effectiveness threshold.
Article
Objectives: This study evaluates the cost-effectiveness of percutaneous cardiac assist device (pVAD) therapy in the emergent setting compared with traditional surgical hemodynamic support alternatives. Background: Previous research has demonstrated the cost-effectiveness of pVAD hemodynamic support for patients undergoing high-risk percutaneous coronary intervention. For patients in cardiogenic shock (CS), use of pVAD therapy has been shown to reduce length of stay (LOS). Methods: National utilization and outcome data from the 2010-2011 MedPAR and state-sponsored all-payer databases were collected for patients with an acute myocardial infarction complicated by CS who were treated with either a pVAD (n = 883) or with traditional surgical hemodynamic support alternatives (ECMO and extracorporeal VAD) (n = 305). Results: Discharge survival was greater with pVADs than with surgical alternatives (56% versus 42%, P < 0.001) and was achieved with a strong trend toward reduced LOS (13.2 and 17.9 days, respectively, P = 0.055) and a significantly lower cost of the index admission ($90,929 and $144,257, respectively, P < 0.001). Cost-effectiveness analysis based on the national data demonstrated that pVAD achieved better outcomes at lower cost. Data were also collected for similar patients who underwent protocol-guided pVAD therapy (using Impella 2.5) at PinnacleHealth, between 2009 and 2011 (n = 30). At this site, the survival rate increased to 60%, length of hospitalization was shortened by six days, and admission costs were lowered by $53,850 relative to the surgical alternatives strategy. Conclusions: For patients in CS requiring emergent hemodynamic support, pVAD therapy offers a less invasive alternative that can be deployed sooner, resulting in better outcomes, shorter LOS, lower costs and with no incremental cost and a survival benefit when compared to traditional surgical hemodynamic support alternatives. PVAD therapy (and Impella 2.5 in particular) is emerging as a dominant strategy for this challenging patient population. © 2013 Wiley Periodicals, Inc.
Article
Widespread utilization of mechanical circulatory support (MCS) for high-risk percutaneous coronary intervention (PCI) remains controversial, with a lack of randomized supporting evidence and associated risk of device-related complications. We investigated whether high-risk PCI of native coronary arteries without elective MCS in patients with acute coronary syndrome (ACS) is safe and feasible. We performed a single-center, retrospective analysis for ACS patients meeting American College of Cardiology high-risk criteria: unprotected left main disease, last remaining conduit, ejection fraction <35%, 3-vessel coronary artery disease, severe aortic stenosis, or severe mitral regurgitation. Patients with cardiogenic shock and those undergoing PCI of the bypass grafts were excluded. Major in-hospital and 30-day cardiovascular outcomes were assessed. From 2003 through 2018, 499 patients (847 lesions) with unstable angina pectoris (UAP), 1218 patients (1807 lesions) with non-ST-elevation myocardial infarction (NSTEMI), and 868 patients (1260 lesions) with ST-segment elevation myocardial infarction (STEMI) underwent high-risk PCI. Procedural success was achieved in 97.2% of UAP, 98.3% of NSTEMI, and 96.6% of STEMI patients. In-hospital and 30-day all-cause mortality were as follows: UAP, 2%; NSTEMI, 2.1%; and STEMI 4.7%. Bailout intra-aortic balloon pump was required in 1.6% of UAP, 3.1% of NSTEMI, and 10.3% of STEMI patients. Major complications for UAP, NSTEMI, and STEMI were, respectively: target lesion revascularization (2.3%, 1.4%, and 1.5%), stroke or transient ischemic attack (0.8%, 0.6%, and 1.3%), acute renal failure (8.2%, 7.2%, and 10.2%), major bleeding (1.6%, 3.1%, and 8.5%). In conclusion, our results show that high-risk PCI without elective MCS is safe and feasible in most ACS patients, challenging professional societies’ current recommendations. A randomized trial comparing unprotected versus protected high-risk PCI for non-shock ACS patients is warranted.
Article
Full-text available
PROTECT I and II trials have tested the efficacy of Impella in patents with high-risk percutaneous coronary intervention (PCI). However, patients with severe hemodynamic instability such as cardiac arrest, ST-segment elevated myocardial infarction (STEMI), or cardiogenic shock were excluded. The objective was to investigate the efficacy of Impella in sicker patient population who were not included in PROTECT trials. These patients merit high-risk PCI who had cardiogenic shock and unstable or decompensated heart failure (HF). From December 2010 to March 2012, 10 consecutive patients with extremely high surgical risk and hemodynamic instability underwent urgent PCI with Impella 2.5 support (Abiomed Inc., Danvers, MA). These patients were presented with advance HF and/or cardiogenic shock. Among the 10 included patients, 3 patients were with cardiac arrest and 1 patient was with acute myocardial infarction. All patients had successful Impella implantation and remained hemodynamically stable during high-risk PCI. Among the 10 patients 2 patients (20%) died within 1 month and 1 patient developed limb ischemia. In high-risk population nonrandomizable to PROTECT trials with advance HF/cardiogenic shock, Impella could be an important tool for hemodynamic support to PCI or could be a bridge to left ventricle assist device to achieve good recovery. Larger studies need to be conducted on this high-risk population.
Impella 2.5 has been shown to reduce major adverse events for patients undergoing elective high-risk percutaneous coronary intervention. We performed a single-center retrospective study to compare the costs and resource use of Impella 2.5 and intra-aortic balloon pump (IABP) support. All high-risk patients who received Impella 2.5 (n = 35) and IABP (n = 295) support from December 2008 to July 2011 were included. Propensity score matching identified a balanced 1:1 matched cohort (35 Impella vs 35 IABP) based on indications for implantation, preimplantation hemodynamics, and age. Diagnostic, procedural, financial, and resource use data were collected. As compared with IABP, Impella offered a more predictable course of treatment/resource consumption and was not associated with any extreme cost outliers (17.1% vs 0.0%, respectively; P = 0.025). The mean admission and 90-day episode of care total costs for Impella were 5.5% ($67,681 vs $71,608, P = 0.79) and 4.2% ($70,680 vs $73,476, P = 0.85) lesser than that for IABP, respectively. Although not statistically significant, Impella patients had a trend toward lower rehospitalization rates (11.4% vs 20%), lesser mean index length of hospital stay (11.2 vs 13.7), and 90-day (11.7 vs 14.2) episode of care length of hospital stay. Impella support was associated with consistent course of treatment/resource consumption with significantly fewer 90-day extreme cost outliers than was IABP. The lower index and 90-day follow-up cost trends observed for Impella were driven by shorter length of hospital stay and fewer rehospitalizations. As providers strive to improve quality of care by reducing variability, these findings have implications for the development of hemodynamic support algorithms.
Article
SUMMARY Efficient therapy of cardiogenic shock and optimal protection in high-risk percutaneous coronary intervention are still orphaned to ideal management. Intra-aortic balloon pump and the newer percutaneous ventricular assist devices, such as TandemHeart and Impella Recover LP 2.5, have diversified the therapeutic arsenal with which one can tackle these clinical dilemmas. This article describes the characteristics of these three devices as well as the clinical evidence available for optimal and adapted use.
Article
High-risk percutaneous coronary intervention (PCI) is often offered to patients with extensive coronary artery disease, decreased left ventricular function and comorbid conditions that increase surgical risk. In these settings, percutaneous left ventricular assist devices (PVADs) can be used for hemodynamic support. To assess the effects of PVAD use on mortality, MI and complication rates in patients undergoing high-risk PCI we systematically searched the electronic databases, MEDLINE, PUBMED, EMBASE and Cochrane for prospective controlled trials and cohort studies of patients that received hemodynamic support with PVADs for high-risk PCI. The primary outcome measures were 30-day all-cause mortality, 30-day myocardial infarction (MI) rates, peri-procedural major bleeding and vascular complications. We included 12 studies with 1346 participants that underwent Impella 2.5L device placement and 8 cohort studies with 205 patients that received TandemHeart device for high-risk PCI. Short-term mortality was 3.5% and 8% and major bleeding rates were 7.1% and 3.6% with Impella and TandemHeart respectively. Both devices are associated with comparable peri-procedural outcomes in patients undergoing high-risk PCI.
Article
Background: Small randomized controlled trials (RCTs) and observational studies have examined the effectiveness and safety of the Impella device, a percutaneous left ventricular assist device, in the setting of high-risk percutaneous coronary intervention (PCI). However, data are sparse and results are conflicting. Our objective was to evaluate the effectiveness and safety of the Impella device in high-risk patients undergoing PCI via a systematic review of the literature. Methods: We searched Medline, EMBASE, and the Cochrane Library for RCTs and observational studies that evaluated the Impella device in high-risk patients undergoing PCI. Inclusion was restricted to studies in which ≥10 patients received the Impella device; both uncontrolled and controlled (versus intra-aortic-balloon pump [IABP]) studies were included. Results: A total of 20 studies (4 RCTs, 2 controlled observational studies, and 14 uncontrolled observational studies; 1,287 patients) were included, with follow-up ranging from 1 to 42 months. The use of Impella resulted in improved procedural and hemodynamic characteristics in controlled and uncontrolled studies. In controlled studies, the 30-day rates of all-cause mortality and MACE were similar across groups. In most uncontrolled studies, the 30-day rates of all-cause mortality were generally low (range: 3.7%-10%), though rates of MACE were slightly higher (range: 5%-20%). Conclusion: The Impella device was found to improve procedural and hemodynamic parameters, but only limited randomized data are available regarding clinical outcomes associated with its use. Large, multicenter RCTs are needed to definitively establish the effectiveness of the Impella device among high-risk PCI patients.
Article
We report a case of a patient successfully treated with an Impella Recover LP 2.5 (ABIOMED, Danvers, MA) left ventricular assist device, in the setting of cardiogenic shock secondary to severe acute mitral regurgitation associated with an acute myocardial infarction.
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To construct a scoring system for the prediction of early mortality in cardiac surgical patients in Europe on the basis of objective risk factors. The EuroSCORE database was divided into developmental and validation subsets. In the former, risk factors deemed to be objective, credible, obtainable and difficult to falsify were weighted on the basis of regression analysis. An additive score of predicted mortality was constructed. Its calibration and discrimination characteristics were assessed in the validation dataset. Thresholds were defined to distinguish low, moderate and high risk groups. The developmental dataset had 13,302 patients, calibration by Hosmer Lemeshow Chi square was (8) = 8.26 (P < 0.40) and discrimination by area under ROC curve was 0.79. The validation dataset had 1479 patients, calibration Chi square (10) = 7.5, P < 0.68 and the area under the ROC curve was 0.76. The scoring system identified three groups of risk factors with their weights (additive % predicted mortality) in brackets. Patient-related factors were age over 60 (one per 5 years or part thereof), female (1), chronic pulmonary disease (1), extracardiac arteriopathy (2), neurological dysfunction (2), previous cardiac surgery (3), serum creatinine >200 micromol/l (2), active endocarditis (3) and critical preoperative state (3). Cardiac factors were unstable angina on intravenous nitrates (2), reduced left ventricular ejection fraction (30-50%: 1, <30%: 3), recent (<90 days) myocardial infarction (2) and pulmonary systolic pressure >60 mmHg (2). Operation-related factors were emergency (2), other than isolated coronary surgery (2), thoracic aorta surgery (3) and surgery for postinfarct septal rupture (4). The scoring system was then applied to three risk groups. The low risk group (EuroSCORE 1-2) had 4529 patients with 36 deaths (0.8%), 95% confidence limits for observed mortality (0.56-1.10) and for expected mortality (1.27-1.29). The medium risk group (EuroSCORE 3-5) had 5977 patients with 182 deaths (3%), observed mortality (2.62-3.51), predicted (2.90-2.94). The high risk group (EuroSCORE 6 plus) had 4293 patients with 480 deaths (11.2%) observed mortality (10.25-12.16), predicted (10.93-11.54). Overall, there were 698 deaths in 14,799 patients (4.7%), observed mortality (4.37-5.06), predicted (4.72-4.95). EuroSCORE is a simple, objective and up-to-date system for assessing heart surgery, soundly based on one of the largest, most complete and accurate databases in European cardiac surgical history. We recommend its widespread use.
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To make a prospective assessment of the clinical and prognostic correlates of angiographically diffuse non-obstructive coronary lesions. Angiographic vessel and extent scores were calculated in 228 clinically stable patients (mean (SD) age, 60 (11) years; 43 women, 185 men) undergoing prospective follow up for the composite end point of death and myocardial infarction. The effect on outcome of clinical variables (age, sex, previous myocardial infarction, diabetes mellitus, smoking habit, systemic hypertension, hypercholesterolaemia, ejection fraction) and angiographic variables (vessel and extent score) was evaluated by Cox's proportion hazard model. The vessel score was 3 in 34 patients (15%), 2 in 78 (34%), 1 in 87 (38%), and 0 in 29 (13%). Median extent score was 60 (range 6-110; first quartile 40, third quartile 70). Forty one events (nine deaths and 32 myocardial infarcts) occurred over a median follow up period of 30 months. Age and extent score were the only multivariate predictors of outcome, but the latter provided 28% additional prognostic information after adjustment for the most predictive variables (gain in chi2 = 7, p < 0.01). A vessel score of 3 was associated with worse survival, while no significant discrimination was possible among the other groups. However, assignment of patients to two groups according to an ROC curve derived cut off value for the extent score made it possible to obtain significant discrimination of survival even in cases with vessel scores of 0 to 2. Age and diabetes were clinical markers of a higher extent score. The angiographic extent score is a powerful marker of adverse outcome independent of severity and the number of flow limiting coronary lesions, and may reflect the link between clinical risk profile and diffusion of coronary atherosclerosis. Thus it should be of clinical value for targeting aggressive preventive measures.
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Mortality in cardiogenic shock (CS) following acute myocardial infarction (AMI) remains unacceptably high despite percutaneous coronary intervention (PCI) of the infarcted artery and use of intra-aortic balloon pump (IABP) counterpulsation. A newly developed percutaneous left ventricular assist device (VAD) (Tandem Heart, Cardiac Assist, Pittsburgh, PA, USA) with active circulatory support might have positive haemodynamic effects and decrease mortality. Patients in CS after AMI, with intended PCI of the infarcted artery, were randomized to either IABP (n=20) or percutaneous VAD support (n=21). The primary outcome measure cardiac power index, as well as other haemodynamic and metabolic variables, could be improved more effectively by VAD support from 0.22 [interquartile range (IQR) 0.19-0.30] to 0.37 W/m2 (IQR 0.30-0.47, P<0.001) when compared with IABP from 0.22 (IQR 0.18-0.30) to 0.28 W/m2 (IQR 0.24-0.36, P=0.02; P=0.004 for intergroup comparison). However, complications like severe bleeding (n=19 vs. n=8, P=0.002) or limb ischaemia (n=7 vs. n=0, P=0.009) were encountered more frequently after VAD support, whereas 30 day mortality was similar (IABP 45% vs. VAD 43%, log-rank, P=0.86). Haemodynamic and metabolic parameters can be reversed more effectively by VAD than by standard treatment with IABP. However, more complications were encountered by the highly invasive procedure and by the extracorporeal support.
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Retrospective studies and post hoc analyses have suggested that mild elevations in the creatine kinase-MB (CK-MB) isoenzyme following percutaneous coronary intervention (PCI) may be associated with an increased risk of death in the long term. However, this finding is still controversial, and the prognostic significance of elevations of more sensitive markers of myocardial damage, such as the cardiac troponins, has not been established. In this multicentre prospective cohort study, we evaluated the influence of post-procedural elevations of CK-MB and troponin I (cTnI) on long-term mortality. The CK-MB and PCI study included 3494 consecutive patients undergoing PCI from February 2000 to October 2000 in 16 Italian tertiary centres. Blood samples were collected at baseline, and at 8-12 and 18-24 h after the procedure, and were analysed in a core biochemistry laboratory. CK-MB elevation was detected in 16% of the patients, and was associated with increased 2-year mortality [7.2 vs. 3.8%; odds ratio (OR): 1.9; 95% confidence interval (CI): 1.3-2.8; P<0.001). The degree of CK-MB elevation (peak CK-MB ratio) independently predicted the risk of death (adjusted OR per unit: 1.04; 95% CI: 1.01-1.07; P=0.009). A cTnI elevation was detected in 44.2% of the cases and was not associated with a significant increase in mortality (4.9 vs. 4.0%; OR: 1.2; 95% CI: 0.9-1.7; P=0.2). Post-procedural elevations of CK-MB, but not cTnI, influence 2-year mortality.
Article
Objective: To compare a restrictive red blood cell transfusion strategy with a more liberal strategy in volume-resuscitated critically ill patients with cardiovascular disease. Setting: Twenty-two academic and three community critical care units across Canada. Study Design: Randomized controlled clinical trial. Study Population: Three hundred fifty-seven critically ill patients with cardiovascular diseases from the Transfusion Requirements in Critical Care trial who had a hemoglobin concentration of <90 g/L within 72 hrs of admission to the intensive care unit. Interventions: Patients were randomized to a restrictive strategy to receive allogeneic red blood cell transfusions at a hemoglobin concentration of 70 g/L (and maintained between 70 and 90 g/L) or a liberal strategy to receive red blood cells at 100 g/L land maintained between 100 and 120 gill. Results: Baseline characteristics in the restrictive (n = 160) and the liberal group (n = 197) were comparable, except for the use of cardiac and anesthetic drugs (p < .02), Average hemoglobin concentrations (85 +/- 6.2 vs. 103 +/- 6.7 g/L; p < .01) and red blood cell units transfused (2.4 +/- 4.1 vs. 5.2 +/- 5.0 red blood cell units; p < .01) were significantly lower in the restrictive compared with the liberal group. Overall, all mortality rates were similar in both study groups, including 30-day (23% vs. 23%; p 1.00), 60-day, hospital, and intensive care unit rates. Changes in multiple organ dysfunction from baseline scores were significantly less in the restrictive transfusion group overall (0.2 +/- 4.2 vs. 1.3 +/- 4.4; p = .02). In the 257 patients with severe ischemic heart disease, there were no statistically significant differences in all survival measures, but this is the only subgroup where the restrictive group had lower but nonsignificant absolute survival rates compared with the patients in the liberal group. Conclusion: A restrictive red blood cell transfusion strategy generally appears to be safe in most critically ill patients with cardiovascular disease, with the possible exception of patients with acute myocardial infarcts and unstable angina.
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A series of recent studies identified coronary microemboli-zation as a potential cause of regional myocardial contractile dysfunction in the absence of an atherosclerotic obstruction of an epicardial coronary artery that could account for such dysfunction. This review attempts to provide evidence for coronary microembolization and analyzes its sources and consequences.
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To assess the effects of invasive procedures, hemostatic and clinical variables, the timing of beta-blocker therapy, and the doses of recombinant plasminogen activator (rt-PA) on hemorrhagic events. A multicenter, randomized, controlled trial. Hospitals participating in the Thrombolysis in Myocardial Infarction, Phase II trial (TIMI II). Patients received rt-PA, heparin, and aspirin. The total dose of rt-PA was 150 mg for the first 520 patients and 100 mg for the remaining 2819 patients. Patients were randomly assigned to an invasive strategy (coronary arteriography with percutaneous angioplasty [if feasible] done routinely 18 to 48 hours after the start of thrombolytic therapy) or to a conservative strategy (coronary arteriography done for recurrent spontaneous or exercise-induced ischemia). Eligible patients were also randomly assigned to either immediate intravenous or deferred beta-blocker therapy. Patients were monitored for hemorrhagic events during hospitalization. In patients on the 100-mg rt-PA regimen, major and minor hemorrhagic events were more common among those assigned to the invasive than among those assigned to the conservative strategy (18.5% versus 12.8%, P less than 0.001). Major or minor hemorrhagic events were associated with the extent of fibrinogen breakdown, peak rt-PA levels, thrombocytopenia, prolongation of the activated partial thromboplastin time (APTT) to more than 90 seconds, weight of 70 kg or less, female gender, and physical signs of cardiac decompensation. Immediate intravenous beta-blocker therapy had no important effect on hemorrhagic events when compared with delayed beta-blocker therapy. Intracranial hemorrhages were more frequent among patients treated with the 150-mg rt-PA dose than with the 100-mg rt-PA dose (2.1% versus 0.5%, P less than 0.001). The extent of the plasmin-mediated hemostatic defect was also greater in patients receiving the 150-mg dose. Increased morbidity due to hemorrhagic complications is associated with an invasive management strategy in patients with acute myocardial infarction. Our findings show the complex interaction of several factors in the occurrence of hemorrhagic events during thrombolytic therapy.
Article
JID: 8200291; 2008/11/17 [received]; 2008/11/17 [accepted]; 2008/11/28 [aheadofprint]; ppublish
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After myocardial infarction (MI), biomarkers can be helpful to identify patients who might benefit from more intensive therapies. The prothrombin time-derived fibrinogen (PTDF) assay is widely available and relatively inexpensive. We determined whether PTDF predicts events in patients with MI and compared this assay with brain natriuretic peptide (BNP) and C-reactive protein (CRP). We retrospectively analyzed data from 915 patients admitted with MI. Follow-up was collected at 1 year for major adverse cardiac events (MACE) defined as death from any cause, nonfatal MI or death, target vessel revascularization, or coronary artery bypass grafting. Patients in the fourth quartile of PTDF were older and had more risk factors but fewer ST-elevation MI and lower peak troponin values. The fourth quartiles of PTDF, CRP, and BNP were associated with increased MACE compared with the first quartiles with hazard ratios of 2.08 (1.30-3.33), 1.94 (1.22-3.07), and 2.56 (1.57-4.18), respectively, findings that remained significant after adjustment. When outcomes by strata of PTDF were examined, CRP failed to add additional prognostic value. Higher BNP levels predicted MACE in the upper but not lower stratum of PTDF. In patients with MI, PTDF is a predictor of MACE at 1 year, with equivalent value compared to BNP and CRP. With low PTDF levels, neither BNP nor CRP adds prognostic value. At elevated PTDF values, higher BNP, but not CRP, identifies a higher-risk population. Therefore, PTDF can be substituted for CRP, with BNP being useful in the presence of elevated PTDF.
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The diagnosis coronary artery disease is classically based on patient's symptoms and morphology, as analyzed by angiography. The importance of risk factors for the development of coronary atherosclerosis and disturbance of coronary vasomotion is clearly established. However, microembolization of the coronary circulation has also to be taken into account. Microembolization may occur as a single or as multiple, repetitive events, and it may induce inflammatory responses. Spontaneous microembolization may occur, when the fibrous cap of an atheroma or fibroatheroma (Stary i.v. and Va) ruptures and the lipid pool with or without additional thrombus formation is washed out of the atheroma into the microcirculation. Such events with progressive thrombus formation are known as cyclic flow variations. Plaque rupture occurs more frequently than previously assumed, i.e. in 9% of patients without known heart disease suffering a traffic accident and in 22% of patients with hypertension and diabetes. Also, in patients dying from sudden death microembolization is frequently found. Patients with stable and unstable angina show not only signs of coronary plaque rupture and thrombus formation, but also microemboli and microinfarcts, the only difference between those with stable and unstable angina being the number of events. Appreciation of microembolization may help to better understand the pathogenesis of ischemic cardiomyopathy, diabetic cardiomyopathy and acute coronary syndromes, in particular in patients with normal coronary angiograms, but plaque rupture detected by intravascular ultrasound. Also, the benefit from glycoprotein IIb/IIIa receptor antagonist is better understood, when not only the prevention of thrombus formation in the epicardial atherosclerotic plaque, but also that of microemboli is taken into account. Microembolization also occurs during PTCA, inducing elevations of troponin T and I and elevations of the ST segment in the EKG. Elevated baseline coronary blood flow velocity, as a potential consequence of reactive hyperemia in myocardium surrounding areas of microembolization, is more frequent in patients with high frequency rotablation than in patients with stenting and in patients with PTCA. The hypothesis of iafrogenic microembolization during coronary interventions is now supported by the use of aspiration and filtration devices, where particles with a size of up to 700 microns have been retrieved. In the experiment, microembolization is characterized by perfusion-contraction mismatch, as the proportionate reduction of flow and function seen with an epicardial stenosis is lost and replaced by contractile dysfunction in the absence of reduced flow. The analysis of the coronary microcirculation, in addition to that of the morphology and function of epicardial coronary arteries, and in particular appreciation of the concept of microembolization will further improve the understanding of the pathophysiology and clinical symptoms of coronary artery disease.
Article
This retrospective multicenter registry evaluated the safety and feasibility of left ventricular (LV) support with the Impella 2.5 (Abiomed Europe GmbH, Aachen, Germany) during high-risk percutaneous coronary intervention (PCI). Patients with complex or high-risk coronary lesions, such as last remaining vessel or left main lesions, are increasingly being treated with PCI. Because periprocedural hemodynamic compromise and complications might occur rapidly, many of these high-risk procedures are being performed with mechanical cardiac assistance, particularly in patients with poor LV function. The Impella 2.5, a percutaneous implantable LV assist device, might be a superior alternative to the traditionally used intra-aortic balloon pump. The Europella registry included 144 consecutive patients who underwent a high-risk PCI. Safety and feasibility end points included incidence of 30-day adverse events and successful device function. Patients were older (62% >70 years of age), 54% had an LV ejection fraction < or = 30%, and the prevalence of comorbid conditions was high. Mean European System for Cardiac Operative Risk Evaluation score was 8.2 (SD 3.4), and 43% of the patients were refused for coronary artery bypass grafting. A PCI was considered high-risk due to left main disease, last remaining vessel disease, multivessel coronary artery disease, and low LV function in 53%, 17%, 81%, and 35% of the cases, respectively. Mortality at 30 days was 5.5%. Rates of myocardial infarction, stroke, bleeding requiring transfusion/surgery, and vascular complications at 30 days were 0%, 0.7%, 6.2%, and 4.0%, respectively. This large multicenter registry supports the safety, feasibility, and potential usefulness of hemodynamic support with Impella 2.5 in high-risk PCI.
Article
We studied online left ventricular (LV) dynamic effects of mechanical LV unloading directly after percutaneous coronary intervention (PCI). Limited clinical information is available on the direct LV dynamic consequences of LV unloading in patients undergoing high-risk PCI and primary PCI for acute ST-elevation myocardial infarction. The effects of the Impella LP2.5 device on LV dynamics were studied in 11 patients (elective high-risk PCI, n = 6; primary PCI, n = 5). LV pressure and volume were continuously assessed by a pressure-conductance catheter at 4 different support levels of the Impella, from 0 L/min at baseline to 2.5 L/min at maximal support. The response to increased LV unloading was not different between both groups of patients. The pooled data showed no change on global and systolic LV function during increased LV unloading, while diastolic function showed improvement as indicated by an increased LV compliance in all patients. There was a decrease in end-diastolic pressure from 22 +/- 12 to 13 +/- 9 mm Hg (P = 0.0001), in end-diastolic elastance from 0.134 +/- 0.060 to 0.091 +/- 0.064 mm Hg/mL (P = 0.009), and in end-diastolic wall stress from 84 +/- 50 to 47 +/- 39 mm Hg (P = 0.004). LV unloading decreases end-diastolic wall stress and improves diastolic compliance dose-dependently. Our results indicate beneficial LV unloading effects of Impella during high-risk and primary PCI.
Article
Increases of creatine kinase (CK) and CK-MB cardiac enzymes after nonemergent percutaneous coronary intervention (PCI) have been associated with an increased risk of cardiovascular events during follow-up. However, there are limited data about the incidence and prognostic significance of an isolated increase of cardiac troponin I (cTnI) without an increase in CK-MB after PCI. The aim of this study was to evaluate the impact of an isolated cTnI increase on long-term survival in patients undergoing nonemergent PCI with normal CK-MB levels after PCI. Using the 2004/2005 Cornell Angioplasty Registry, we evaluated the clinical outcomes in 1,601 patients (undergoing elective or urgent PCI) with normal preprocedure cTnI and CK-MB and normal CK-MB levels after the procedure. Patients were divided into 2 groups based on the presence of cTnI increase after PCI. The mean follow-up period was 24.6 +/- 7.6 months. An increase in cTnI was observed in 831 patients (51.9%). Drug-eluting stents were used in 87% of patients and glycoprotein IIb/IIIa inhibitors were administered in 48% of patients. Incidence of in-hospital major adverse cardiovascular events was low, 0.1% versus 0% (p = 1.000), in patients with versus without cTnI increases, respectively. By 2 years of follow-up, Kaplan-Meier survival rates were 94.1% versus 96.4% (log-rank p = 0.020) in those with versus without cTnI increases, respectively. By multivariate Cox regression analysis, an increase in cTnI after PCI (hazard ratio 1.62, 95% confidence interval 1.01 to 2.59, p = 0.047) was an independent predictor of increased long-term mortality. In conclusion, an isolated increase in cTnI after nonemergent PCI is common, not associated with more frequent adverse in-hospital outcomes compared to patients with normal cTnI, and provides long-term prognostic information regarding mortality.
Article
Coronary artery bypass grafting (CABG) with extracorporeal circulation (ECC) is the gold standard for surgical coronary re-vascularisation. Recently, minimised extracorporeal circulation system (MECC) has been postulated a safe and advantageous alternative for multi-vessel CABG. Between January 2004 and December 2007, 244 high-risk patients (logistic EuroScore (ES)>10%) underwent CABG in our institution. ECC was used in 139 (57%) and MECC in 105 (43%) patients. Demographic data including age (MECC: 73.4+/-7.4 years; ECC: 73.3+/-6.4 years), ES (MECC: 19.2+/-9.8%; ECC: 21.4+/-11.9%), left-ventricular ejection fraction (MECC: 45.6+/-16.1%; ECC: 43.1+/-15.3%), diabetes mellitus (MECC: 14.3%; ECC: 15.1%) and COPD (MECC: 6.7%; ECC: 7.9%) did not differ between the two groups. Preoperative end-stage renal failure was an exclusion criterion. The clinical course and serological/haematological parameters in the ECC and MECC patients were compared in a retrospective manner. Although the numbers of distal anastomoses did not differ between the two groups (MECC: 3.0+/-0.9; ECC: 2.9+/-0.9), ECC time was significantly shorter in the MECC group (MECC: 96+/-33 min; ECC: 120+/-50 min, p<0.01). Creatinine kinase (CK) levels were significantly lower 6 h after surgery in the MECC group (MECC: 681+/-1505 U l(-1); ECC: 1086+/-1338 U l(-1), p<0.05) and the need of red blood cell transfusion was significantly less after MECC surgery (MECC: 3 [range: 1-6]; ECC: 5 [range: 2-9] p<0.05). Moreover, 30-day mortality was significantly lower in the MECC group as compared to the ECC group (MECC: 12.4%; ECC: 26.6, p<0.01). MECC is a safe alternative for CABG surgery. A lower 30-day mortality, lower transfusion requirements and less renal and myocardial damage encourage the use of MECC systems, especially in high-risk patients.
Article
We sought to evaluate the safety and feasibility of the Impella 2.5 system (Abiomed Inc., Danvers, Massachusetts) in patients undergoing high-risk percutaneous coronary intervention (PCI). The Impella 2.5 is a miniaturized percutaneous cardiac assist device, which provides up to 2.5 l/min forward flow from the left ventricle into the systemic circulation. In a prospective, multicenter study, 20 patients underwent high-risk PCI with minimally invasive circulatory support employing the Impella 2.5 system. All patients had poor left ventricular function (ejection fraction <or=35%) and underwent PCI on an unprotected left main coronary artery or last patent coronary conduit. Patients with recent ST-segment elevation myocardial infarction or cardiogenic shock were excluded. The primary safety end point was the incidence of major adverse cardiac events at 30 days. The primary efficacy end point was freedom from hemodynamic compromise during PCI (defined as a decrease in mean arterial pressure below 60 mm Hg for >10 min). The Impella 2.5 device was implanted successfully in all patients. The mean duration of circulatory support was 1.7 +/- 0.6 h (range: 0.4 to 2.5 h). Mean pump flow during PCI was 2.2 +/- 0.3 l/min. At 30 days, the incidence of major adverse cardiac events was 20% (2 patients had a periprocedural myocardial infarction; 2 patients died at days 12 and 14). There was no evidence of aortic valve injury, cardiac perforation, or limb ischemia. Two patients (10%) developed mild, transient hemolysis without clinical sequelae. None of the patients developed hemodynamic compromise during PCI. The Impella 2.5 system is safe, easy to implant, and provides excellent hemodynamic support during high-risk PCI. (The PROTECT I Trial; NCT00534859).
Article
The purpose of this study was to evaluate secular trends and factors associated with major femoral bleeding after percutaneous coronary intervention (PCI) in routine clinical practice during the past decade and to assess the impact of these complications on outcomes including mortality. Significant changes in patient demographic data, adjunctive pharmacotherapy, and access site management have occurred during the coronary stent era. Trends in major vascular complications after PCI during this time have not been well characterized. Consecutive patients who underwent transfemoral PCI from 1994 to 2005 at the Mayo Clinic (n = 17,901) were studied. Patients were divided into 3 groups: Group 1 (1994 to 1995, n = 2,441); Group 2 (1996 to 1999, n = 6,207); and Group 3 (2000 to 2005, n = 9,253). The incidence of major femoral bleeding complications decreased (from 8.4% to 5.3% to 3.5%; p < 0.001). Reductions in sheath size, intensity and duration of anticoagulation with heparin, and procedure time were observed (p < 0.001), and multivariate analysis confirmed each as an independent predictor of complications (p < 0.001). Adverse outcomes of major femoral bleeding included prolonged hospital stay (mean 4.5 vs. 2.7 days; p < 0.0001) and increased requirement for blood transfusion (39% vs. 4.7%; p < 0.0001). Major femoral bleeding and blood transfusion were both associated with decreased long-term survival, driven by a significant increase in 30-day mortality (p < 0.001 for both). We noted a marked decline in the incidence of major femoral bleeding after PCI over the past decade. Mortality associated with these bleeding complications and with blood transfusion remains a significant issue.
Article
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Article
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). 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. 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. 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. 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).
Article
This study describes the impact of clinical, angiographic, and demographic characteristics on the long-term survival of Coronary Artery Surgery Study (CASS) patients while they were under medical treatment. Revascularization rates for the population are also provided. All CASS patients who had not received heart surgery before enrollment (23,467 patients) were included in this survival analysis while they were under medical treatment or surveillance. Follow-up time ranged from 0 to 17 years (median, 12 years). Long-term vital status is known for 95.8% of these patients. Log-rank tests, Kaplan-Meier survival curves, and Cox proportional-hazards regression are used to describe and assess the impact of patient characteristics on survival. Characteristics that had a significant impact on survival, in order of observed explanatory power, are age, number of diseased vessels, congestive heart failure score, smoking history, ejection fraction, sex, presence of left main coronary artery disease, presence of diabetes, left ventricular wall motion score, presence of other illnesses, history of myocardial infarction, and presence of left main equivalent disease. Overall, 12-year survival for patients with zero-, one-, two- and three-vessel disease is 88%, 74%, 59%, and 40%, respectively. Twelve-year survival for patients with at least one diseased vessel and ejection fractions in the ranges of 50% to 100%, 35% to 49%, and 0% to 34% is 73%, 54%, and 21%, respectively. High myocardial jeopardy, high anginal class, and two or three proximal diseased vessels characterize the profile of patients most likely to have received surgical treatment during follow-up. These results contribute to the understanding of the natural history of coronary artery disease and are also of historical interest. The poor survival of patients with three-vessel disease and low ejection fractions continues to emphasize the importance of considering revascularization for these patients.
Article
The aim of this study was to assess the risk of intra-aortic balloon counterpulsation and to identify clinical and procedural variables that would predict complications. We analysed 381 consecutive patients who were treated between 1977 and 1995 at our catheterization laboratory and/or medical intensive care unit. The complications considered relevant were limb ischaemia requiring catheter removal, vascular injury, bleeding requiring transfusion, embolic events, and infection. In eight patients the balloon could not be inserted. The rate of complications for the remaining 373 patients was 12.9%. Between 1977 and 1980, surgical insertion was performed using a 12 French catheter with a complication rate of 30.4% (seven of 23 patients). Percutaneous implantation, performed after 1981, had an overall complication rate of 11.7% (41 of 350 patients). Using thinner catheters for percutaneous placement was associated with a reduction in the rate of complications, from 20.7% (17 of 82 patients) for 12 French catheters to 9.9% (10 of 101 patients) for 10.5 French catheters (P = 0.04), and 8.4% (14 of 167 patients) for 9.5 French catheters (P = 0.006). Multivariate logistic regression analysis identified duration of counterpulsation > 48 h (odds ratio 3.6), catheter size (odds ratio 3.4 for 12 French catheters), peripheral vascular disease (odds ratio 2.7), and shock (odds ratio 2.0) as independent risk factors for counterpulsation-associated complications. When considering 9.5 French catheters only (167 patients, all after 1992), the sole remaining independent risk factor was duration of counterpulsation > 48 h (odds ratio 3.8). Those patients with 9.5 French catheters in whom counterpulsation did not exceed 48 h had a low complication rate of 3.9%. The rate of percutaneous intra-aortic balloon counterpulsation complications was thus significantly reduced by employing thinner catheters. It was at an acceptable level for 9.5 French catheters, where a long duration of counterpulsation emerged as the most significant factor associated with complications. Whether using even thinner catheters in combination with a sheathless implantation technique further minimizes the risk of counterpulsation remains to be seen.
Article
This study presents clinical data from the first large registry of aortic counterpulsation, a computerized database that incorporates prospectively gathered data on indications for intra-aortic balloon counterpulsation (IABP) use, patient demographics, concomitant medication and in-hospital outcomes and complications. The intra-aortic balloon pump (IABP) is widely used to provide circulatory support for patients experiencing hemodynamic instability due to myocardial infarction, cardiogenic shock, or in very high risk patients undergoing angioplasty or coronary artery bypass grafting. Between June 1996 and August 2000, 203 hospitals worldwide (90% U.S., 10% non-U.S.) collected 16,909 patient case records (68.8% men, 31.2% women; mean age 65.9 +/- 11.7 years). The most frequent indications for use of IABP were as follows: to provide hemodynamic support during or after cardiac catheterization (20.6%), cardiogenic shock (18.8%), weaning from cardiopulmonary bypass (16.1%), preoperative use in high risk patients (13.0%) and refractory unstable angina (12.3%). Major IABP complications (major limb ischemia, severe bleeding, balloon leak, death directly due to IABP insertion or failure) occurred in 2.6% of cases; in-hospital mortality was 21.2% (11.6% with the balloon in place). Female gender, high age and peripheral vascular disease were independent predictors of a serious complication. This registry provides a useful tool for monitoring the evolving practice of IABP. In the modern-day practice of IABP, complication rates are generally low, although in-hospital mortality remains high. There is an increased risk of major complications in women, older patients and patients with peripheral vascular disease.
Article
World Heart Day is September 29, 2002. This occasion provides an opportunity to recognize our successes in science and clinical care, to survey the present and future challenges at home and abroad, and to seek opportunities for international partnerships in addressing the burgeoning global epidemic of cardiovascular disease. The final decades of the twentieth century represented a period of unprecedented success for the cardiovascular biomedical enterprise in advancing the knowledge of cardiovascular disease. Scientific progress in understanding the mechanisms of cardiovascular diseases fueled the proliferation of new methods for prevention and treatment, clinical trials to critically test these interventions, and evidence-based practice guidelines to distill these scientific advances broadly into clinical practice. Despite major steps forward in the fight against cardiovascular disease, there is compelling evidence in the United States that we have not been fully effective in translating, disseminating, and expediting the adoption of scientific advances to improve outcomes for our society. We have failed to develop public health infrastructures and healthcare systems in parallel with the scientific progress to implement effective, evidence-based prevention and treatment strategies. Hence, we have not realized the potential of our scientific discoveries for improved cardiovascular health. A recent Institute of Medicine report1 underscored this dilemma, indicating that “between the care we have and the care we could have lies not just a gap, but a chasm.” The chasm may impede our efforts to achieve the Healthy People 2010 Objectives for the US population, as established by the Department of Health and Human Services.2 The US healthcare system is facing serious access and quality issues. Large segments of the US population do not have access to mainstream health care. These include the uninsured, a segment of the population that includes not only the unemployed but also many self-employed and low-wage earners. It …
Article
We sought to investigate the effect of a catheter-mounted microaxial blood pump (Impella, Aachen, Germany) on myocardial infarct size. The small rotary blood pump Impella provides unloading of the left ventricle and is introducible via the femoral artery. Myocardial infarction was induced by occlusion of major branches of the left anterior descending coronary artery for 60 min followed by 120 min of reperfusion in 26 sheep. The animals were allocated to four groups: group 1 had no support; group 2 was fully supported with the pump during ischemia and reperfusion; group 3 was supported during reperfusion only; and group 4 was partially supported during reperfusion. Infarct size, hemodynamics, myocardial oxygen consumption, lactate extraction, and myocardial flow were analyzed. Infarct size was significantly reduced in the pump-supported animals (percent area at risk in group 1: 67.2 +/- 4.6%; group 2: 18.1 +/- 10%; group 3: 41.6 +/- 5.8%; group 4: 54 +/- 8%; p = 0.00001). The pump produced 4.1 +/- 0.1 l/min at full support and 2.4 +/- 0.1 l/min at partial support. The pump significantly increased the diastolic and mean blood pressures (groups 2, 3, and 4) and significantly decreased the left ventricular end-diastolic pressure (groups 2 and 3). During ischemia, myocardial flow was not influenced by pump support. At reperfusion, the fully supported group had significantly higher myocardial flow. Pump support reduced myocardial oxygen consumption significantly, and this reduction correlates strongly with the reduction in infarct size (r = 0.9). Support by a microaxial blood pump reduces myocardial oxygen consumption during ischemia and reperfusion and leads to a reduction of infarct size. This reduction in infarct size correlates with the degree of unloading during reperfusion.
Article
In most patients, severity of valvular aortic stenosis can be accurately assessed non-invasively by echocardiography. However, retrograde catheterisation of the aortic valve is often undertaken. This procedure has a potential risk of neurological complications, with an unknown incidence of clinically silent embolism. We aimed to establish the frequency of clinically apparent and silent cerebral embolism after this procedure. We prospectively randomised 152 consecutive patients with valvular aortic stenosis at a German university hospital to receive either cardiac catheterisation with (n=101) or without (n=51) passage through the aortic valve. Patients underwent cranial MRI and neurological assessment within 48 h before and after the procedure to assess cerebral embolism. Controls were 32 patients without valvular aortic stenosis who underwent coronary angiography and laevocardiography. 22 of 101 patients (22%) who underwent retrograde catheterisation of the aortic valve had focal diffusion-imaging abnormalities in a pattern consistent with acute cerebral embolic events after the procedure; three of these patients (3%) had clinically apparent neurological deficits. By contrast, none of the patients without passage of the valve, or any of the controls, had evidence of cerebral embolism as assessed by MRI. Patients with valvular aortic stenosis who undergo retrograde catheterisation of the aortic valve have a substantial risk of clinically apparent cerebral embolism, and frequently have silent ischaemic brain lesions. Patients should be informed about these risks, and this procedure should be used only in patients with unclear echocardiographical findings when additional information is necessary for clinical management.
Article
Outcome studies of percutaneous coronary intervention (PCI) with conventional balloon angioplasty have established increased in-hospital and 1-year mortality in patients with left ventricular (LV) dysfunction compared with others. It is unclear whether recent PCI practice innovations, including stents and adjunctive pharmacotherapy, have made PCI safer and more effective in patients with LV dysfunction. We evaluated the influence of LV ejection fraction (EF) indexes on in-hospital and 1-year outcomes in 1,458 patients within the National Heart, Lung, and Blood Institute-sponsored Dynamic Registry. Patients (n = 300) with acute myocardial infarction were excluded. The remaining 1,158 patients were subdivided into 3 categories: group 1, EF <or=40% (n = 166); group 2, EF 41% to 49% (n = 126); and group 3, EF >or=50% (n = 866). We determined the frequency of individual and composite adverse events (death/myocardial infarction [MI]/coronary artery bypass grafting) at discharge and 1 year. In the Dynamic Registry patients, mean EF in the 3 groups was 32%, 45%, and 62% and in-hospital mortality was 3.0%, 1.6%, and 0.1%, respectively (p <0.001). The composite end point of death/MI was also significant, but other in-hospital adverse events did not differ between groups. The respective mortality rates were 11.0%, 4.5%, and 1.9% (p <0.001) after 1 year. The composite end points of death/MI and death/MI/coronary artery bypass grafting also occurred more frequently in group 1 patients. Thus, significant LV dysfunction was still associated with increased in-hospital and 1-year mortality in patients having contemporary PCI.
Article
In the setting of an acute coronary syndrome (ACS), anemia has the potential to worsen myocardial ischemia; however, data relating anemia to clinical outcomes in ACS remain limited. We examined the association between baseline hemoglobin values and major adverse cardiovascular events through 30 days in 39,922 patients enrolled in clinical trials of ACS. After adjustment for differences in baseline characteristics and index hospitalization treatments, a reverse J-shaped relationship between baseline hemoglobin values and major adverse cardiovascular events was observed. In patients with ST-elevation myocardial infarction, when those with hemoglobin values between 14 and 15 g/dL were used as the reference, cardiovascular mortality increased as hemoglobin levels fell below 14 g/dL, with an adjusted OR of 1.21 (95% CI 1.12 to 1.30, P<0.001) for each 1-g/dL decrement in hemoglobin. At the other end of the range of hemoglobin, patients with hemoglobin values >17 g/dL also had excess mortality (OR 1.79, 95% CI 1.18 to 2.71, P=0.007). In patients with non-ST-elevation ACS, with those with hemoglobin 15 to 16 g/dL used as the reference, the likelihood of cardiovascular death, myocardial infarction, or recurrent ischemia increased as the hemoglobin fell below 11 g/dL, with an adjusted OR of 1.45 (95% CI 1.33 to 1.58, P<0.001) for each 1 g/dL decrement in hemoglobin. Patients with hemoglobin values >16 g/dL also had an increased rate of death or ischemic events (OR 1.31, 95% CI 1.03 to 1.66, P=0.027). Anemia is a powerful and independent predictor of major adverse cardiovascular events in patients across the spectrum of ACS.
Article
A number of techniques have been proposed for circulatory support during high-risk percutaneous coronary interventions (PCI), but no single approach has achieved wide acceptance so far. We report on a patient with severe left ventricular (LV) impairment who underwent a PCI with the use of a new left ventricular assist device, the Impella Recover LP 2.5 system. The effects on global cardiac output were determined by thermodilution (TD) and LV pressure-volume loops obtained by conductance catheter. The activation of the pump resulted in a rapid and sustained unloading effect of the LV. At the same time, the continuous expulsion of blood into ascending aorta throughout the cardiac cycle produced by the pump resulted in an increase of systemic overall CO, measured by the TD technique, of 1.43 L/min. The procedure was uncomplicated and the patient remained uneventful at follow-up. Our single experience gives new input for future trials to assess the effect of the Impella Recover LP 2.5 assist device on outcome in this subset of patients.
Article
To compare 19 risk score algorithms with regard to their validity to predict 30-day and 1-year mortality after cardiac surgery. Risk factors for patients undergoing heart surgery between 1996 and 2001 at a single centre were prospectively collected. Receiver operating characteristics (ROC) curves were used to describe the performance and accuracy. Survival at 1 year and cause of death were obtained in all cases. The study included 6222 cardiac surgical procedures. Actual mortality was 2.9% at 30 days and 6.1% at 1 year. Discriminatory power for 30-day and 1-year mortality in cardiac surgery was highest for logistic (0.84 and 0.77) and additive (0.84 and 0.77) European System for Cardiac Operative Risk Evaluation (EuroSCORE) algorithms, followed by Cleveland Clinic (0.82 and 0.76) and Magovern (0.82 and 0.76) scoring systems. None of the other 15 risk algorithms had a significantly better discriminatory power than these four. In coronary artery bypass grafting (CABG)-only surgery, EuroSCORE followed by New York State (NYS) and Cleveland Clinic risk score showed the highest discriminatory power for 30-day and 1-year mortality. EuroSCORE, Cleveland Clinic, and Magovern risk algorithms showed superior performance and accuracy in open-heart surgery, and EuroSCORE, NYS, and Cleveland Clinic in CABG-only surgery. Although the models were originally designed to predict early mortality, the 1-year mortality prediction was also reasonably accurate.
Article
Intra-aortic balloon pump (IABP) has been shown to support patients who are at high risk for percutaneous coronary interventions (PCIs) or becoming hemodynamically unstable during PCI, but the longer term outcomes of these strategies are unknown. This study investigated the outcomes of high-risk patients who received a prophylactic IABP (P-IABP) versus patients who required rescue IABP (R-IABP) because of intraprocedural complications. Clinical outcomes of 68 consecutive patients (69 procedures) who underwent high-risk PCI with P-IABP support were compared with those of 46 patients who required R-IABP. Patients who presented with cardiogenic shock or acute ST-segment elevation myocardial infarction, and those who were on mechanical ventilators were excluded. Clinical baseline characteristics were similar between groups except for more diabetics and patients with hypercholesterolemia in the P-IABP group. The procedural success was higher in the P-IABP group, with lower in-hospital mortality and major complications, than in the R-IABP group. At 6 months, the mortality and major adverse cardiac event rates were lower in the P-IABP group (8% vs 29%, p < 0.01, and 12% vs 32%, p = 0.02, respectively). Multivariate analysis showed that prophylactic insertion of an IABP is the only independent predictor of survival at 6 months. The incidence of vascular complications was low and comparable except for more major bleeding (15% vs 3%, p = 0.03) in the R-IABP group. In conclusion, patients who undergo high-risk PCI and then receive P-IABP support have favorable outcomes compared with those who require R-IABP for intraprocedural complications. Therefore, in high-risk patients undergoing PCI, liberal use of a P-IABP should be considered.
Article
Despite major advances in the treatment of heart failure, cardiogenic shock (CGS) remains associated with substantial mortality. Recent data suggest that the TandemHeart percutaneous ventricular assist device (pVAD) may be useful in the management of CGS. The aim of this prospective randomized study was to test the hypothesis that the TandemHeart (pVAD) provides superior hemodynamic support compared with intraaortic balloon pumping (IABP). Forty-two patients from 12 centers presenting within 24 hours of developing CGS were included in the study and treated in an initial roll-in phase (n = 9) or randomized to treatment with IABP (n = 14) or TandemHeart pVAD (n = 19). Thirty patients (71%) had persistent CGS despite having an IABP in place at the time of study enrollment. Cardiogenic shock was due to myocardial infarction in 70% of the patients and decompensated heart failure in most of the remaining patients. The mean duration of support was 2.5 days. Compared with IABP, the TandemHeart pVAD achieved significantly greater increases in cardiac index and mean arterial blood pressure and significantly greater decreases in pulmonary capillary wedge pressure. Overall 30-day survival and severe adverse events were not significantly different between the 2 groups. In patients presenting within 24 hours of the development of CGS, TandemHeart significantly improves hemodynamic parameters, even in patients failing IABP. Larger-scale studies are required to assess the influence of improved hemodynamics on survival.
Article
Although most clinical trials of coronary stents have measured nominally identical safety and effectiveness end points, differences in definitions and timing of assessment have created confusion in interpretation. The Academic Research Consortium is an informal collaboration between academic research organizations in the United States and Europe. Two meetings, in Washington, DC, in January 2006 and in Dublin, Ireland, in June 2006, sponsored by the Academic Research Consortium and including representatives of the US Food and Drug Administration and all device manufacturers who were working with the Food and Drug Administration on drug-eluting stent clinical trial programs, were focused on consensus end point definitions for drug-eluting stent evaluations. The effort was pursued with the objective to establish consistency among end point definitions and provide consensus recommendations. On the basis of considerations from historical legacy to key pathophysiological mechanisms and relevance to clinical interpretability, criteria for assessment of death, myocardial infarction, repeat revascularization, and stent thrombosis were developed. The broadly based consensus end point definitions in this document may be usefully applied or recognized for regulatory and clinical trial purposes. Although consensus criteria will inevitably include certain arbitrary features, consensus criteria for clinical end points provide consistency across studies that can facilitate the evaluation of safety and effectiveness of these devices.
Article
We studied the effects of LV unloading by the Impella on coronary hemodynamics by simultaneously measuring intracoronary pressure and flow and the derived parameters fractional flow reserve (FFR), coronary flow velocity reserve (CFVR), and coronary microvascular resistance (MR). Patients with compromised left ventricular (LV) function undergoing high-risk percutaneous coronary intervention (PCI) may benefit from LV unloading. Limited information is available on the effects of LV unloading on coronary hemodynamics. Eleven patients (mean LV ejection fraction of 35 +/- 11%) underwent PCI during LV support by the LV unloading device (Impella Recover LP2.5). Intracoronary measurements were performed in a nonstenotic coronary artery after the PCI, before and after adenosine-induced hyperemia at four different support levels (0-2.5 L/min). Aortic and coronary pressure increased with increasing support levels, whereas FFR remained unchanged. Baseline flow velocity remained unchanged, while hyperemic flow velocity and CFVR increased significantly with increasing support levels (61 +/- 24 to 72 +/- 27 cm/sec, P = 0.001 and 1.88 +/- 0.52 to 2.34 +/- 0.63, P < 0.001 respectively). The difference between baseline MR and hyperemic MR significantly increased with increasing support levels (1.28 +/- 1.32 to 1.89 +/- 1.43 mm Hg cm(-1) sec, P = 0.005). Unloading of the LV by the Impella increased aortic and intracoronary pressure, hyperemic flow velocity and CFVR, and decreased MR. The Impella-induced increase in coronary flow, probably results from both an increased perfusion pressure and a decreased LV volume-related intramyocardial resistance.
Long-term survival of medically treated patients in the Coronary Artery Surgery Study (CASS) Registry
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Emond M, Mock MB, Davis KB, et al. Long-term survival of medically treated patients in the Coronary Artery Surgery Study (CASS) Registry. Circulation 1994;90:2645–57.
Use of Impella Recover LP 2.5 in elective high risk percutaneous coronary interventionElectronic publication ahead of print]. Use of Impella Recover LP 2.5 in elective high risk percutaneous coronary intervention
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Ferreiro JL, Gomez-Hospital JA, Cequier AR, et al. Use of Impella Recover LP 2.5 in elective high risk percutaneous coronary intervention. Int J Cardiol 2009 Sep 2. [Electronic publication ahead of print]. Use of Impella Recover LP 2.5 in elective high risk percutaneous coronary intervention. (19732979[uid]).