Abstract The role and timing of percutaneous mechanical circulatory support (MCS) devices in the treatment of acute myocardial infarction complicated by cardiogenic shock (AMICS) is not well ...understood. We sought to evaluate patient characteristics and predictors of outcomes in patients presenting with AMICS supported with an axial flow percutaneous MCS device. 287 consecutive unselected patients enrolled in the cVAD Registry presenting with AMICS who underwent percutaneous coronary intervention (PCI) were included in this analysis. All patients were supported with either the Impella 2.5 or Impella CP. Mean patient age was 66±12.5 years, 76% were male, mean left ventricular ejection fraction was 25 ±12 %. Prior to receiving MCS, 80% of patients required inotropes or vasopressors and 40% were supported with intra-aortic balloon pump. 9% of patients were under active cardiopulmonary resuscitation at the time of MCS implantation. Survival to discharge was 44%. In a multivariate analysis early implantation of a MCS device prior to PCI (p=0.04) and prior to requiring inotropes and vasopressors (p=0.05) was associated with increased survival. Survival was 66% when MCS was initiated <1.25 hours from shock onset, 37% when initiated within 1.25-4.25 hours, and 26% when initiated after 4.25 hours (p=0.017). Survival was 68%, 46%, 35%, 35%, 26% for patients requiring 0, 1, 2, 3, ≥4 inotropes prior to MCS support respectively (P<0.001). In conclusion, MCS implantation early after shock onset, before initiation of inotropes or vasopressors and prior to PCI, is independently associated with improved survival in patients presenting with AMICS.
Abstract Background In patients with severe aortic stenosis at increased risk for surgery, self-expanding transcatheter aortic valve replacement (TAVR) is associated with improved 2-year survival ...compared with surgery. Objectives This study sought to determine whether this clinical benefit was sustained over time. Methods Patients with severe aortic stenosis deemed at increased risk for surgery by a multidisciplinary heart team were randomized 1:1 to TAVR or open surgical valve replacement (SAVR). Three-year clinical and echocardiographic outcomes were obtained in those patients with an attempted procedure. Results A total of 797 patients underwent randomization at 45 U.S. centers; 750 patients underwent an attempted procedure. Three-year all-cause mortality or stroke was significantly lower in TAVR patients (37.3% vs. 46.7% in SAVR; p = 0.006). Adverse clinical outcome components were also reduced in TAVR patients compared with SAVR patients, including all-cause mortality (32.9% vs. 39.1%, respectively; p = 0.068), all stroke (12.6% vs. 19.0%, respectively; p = 0.034), and major adverse cardiovascular or cerebrovascular events (40.2% vs. 47.9%, respectively; p = 0.025). At 3 years aortic valve hemodynamics were better with TAVR patients (mean aortic valve gradient 7.62 ± 3.57 mm Hg vs. 11.40 ± 6.81 mm Hg in SAVR; p < 0.001), although moderate or severe residual aortic regurgitation was higher in TAVR patients (6.8% vs. 0.0% in SAVR; p < 0.001). There was no clinical evidence of valve thrombosis in either group. Conclusions Patients with severe aortic stenosis at increased risk for surgery had improved 3-year clinical outcomes after TAVR compared with surgery. Aortic valve hemodynamics were more favorable in TAVR patients without differences in structural valve deterioration. (Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902 )
Abstract Background The U.S. pivotal trial for the self-expanding valve found that among patients with severe aortic stenosis at increased risk for surgery, the 1-year survival rate was 4.9 ...percentage points higher in patients treated with a self-expanding transcatheter aortic valve bioprosthesis than in those treated with a surgical bioprosthesis. Objectives Longer-term clinical outcomes were examined to confirm if this mortality benefit is sustained. Methods Patients with severe aortic stenosis who were at increased surgical risk were recruited. Eligible patients were randomly assigned in a 1:1 ratio to transcatheter aortic valve replacement with the self-expanding transcatheter valve (transcatheter aortic valve replacement TAVR group) or to aortic valve replacement with a surgical bioprosthesis (surgical group). The 2-year clinical and echocardiographic outcomes were evaluated in these patients. Results A total of 797 patients underwent randomization at 45 centers in the United States. The rate of 2-year all-cause mortality was significantly lower in the TAVR group (22.2%) than in the surgical group (28.6%; log-rank test p < 0.05) in the as-treated cohort, with an absolute reduction in risk of 6.5 percentage points. Similar results were found in the intention-to-treat cohort (log-rank test p < 0.05). The rate of 2-year death or major stroke was significantly lower in the TAVR group (24.2%) than in the surgical group (32.5%; log-rank test p = 0.01). Conclusions In patients with severe aortic stenosis who are at increased surgical risk, the higher rate of survival with a self-expanding TAVR compared with surgery was sustained at 2 years. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902 )
Transcatheter aortic-valve replacement with a new self-expanding prosthesis was compared with surgical aortic-valve replacement in patients with aortic stenosis who were at high surgical risk. The ...rate of death from any cause at 1 year was lower in the TAVR group.
Aortic stenosis is a debilitating disease in elderly persons that carries a dismal prognosis after symptom onset.
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Although surgical aortic-valve replacement remains the standard treatment for aortic stenosis,
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many patients are not suitable candidates for surgical replacement owing to an increased risk of death during surgery.
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,
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Transcatheter aortic-valve replacement (TAVR) with a balloon-expandable device improves survival, as compared with medical therapy, in patients with severe aortic stenosis who cannot undergo surgery.
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Balloon-expandable TAVR and surgical aortic-valve replacement are associated with similar survival rates at 1 year among patients considered to be at high surgical risk, although the frequency of . . .
Contrast-induced acute kidney injury (CI-AKI) is an important consideration in patients undergoing cardiac catheterization. There has been a continuous strive to decrease morbidity and improve ...procedural safety. This review will address the pathophysiology, predictors, and clinical management of CI-AKI with a concise overview of the pathophysiology and a suggested association with left atrial appendage closure. Minimizing contrast administration and intravenous fluid hydration are the cornerstones of an effective preventive strategy. A few adjunctive pharmacotherapies hold promise, but there are no consensus recommendations on prophylactic therapies.
Management of patients requiring temporary, mechanical hemodynamic support during high- risk percutaneous coronary intervention (PCI) or in cardiogenic shock is rapidly evolving. With the ...availability of the Impella 2.5, CP, 5.0, LD, and RP percutaneous mechanical circulatory support devices, there is a need for continued surveillance of outcomes.
Three factors underline the importance of a registry for these populations. First, large randomized trials of hemodynamic support, involving cardiogenic shock, are challenging to conduct. Second, there is increasing interest in the use of registries to provide “real-world” experience and to allow the flexibility to evaluate individual patient uses and outcomes. Third, current, large databases have not captured the specific impact of mechanical support treatment of cardiogenic shock.
The predecessor to the catheter-based ventricular assist devices registry, known as USpella, began in 2009 with paper data acquisition but beginning in 2011 transferred to electronic data capture, enrolling 3,339 patients through 2016. Throughout, registry data have been used to assess the outcomes of Impella therapy, leading to 8 publications and 4 Food and Drug Administration premarket approvals covering multiple indications and Impella devices.
Going forward, the registry will continue to assess not only in-hospital outcomes but long-term follow-up to 1 year. In addition, data management will be enhanced to assess quality and clinical experiences. The registry will also provide a mechanism for postmarketing surveillance.
This manuscript reviews the ongoing catheter-based ventricular assist devices registry design, management, and contributions of the registry data. The upgraded registry will provide a more robust opportunity to assess acute and late outcomes of current and future device use worldwide.
The current catheter-based ventricular assist devices registry is an international database documenting outcomes with temporary Impella hemodynamic support. The registry has supported 8 publications and 4 Food and Drug Administration premarket approvals since its inception in 2009. The current registry is more robust containing outcomes up to 1 year postprocedure.
Autopsy studies suggest that implanting stents in lipid-rich plaque (LRP) may be associated with adverse outcomes.
The purpose of this study was to evaluate the association between LRP detected by ...near-infrared spectroscopy (NIRS) and clinical outcomes in patients with coronary artery disease treated with contemporary drug-eluting stents.
In this prospective, multicenter registry, NIRS was performed in patients undergoing coronary angiography and possible percutaneous coronary intervention (PCI). Lipid core burden index (LCBI) was calculated as the fraction of pixels with the probability of LRP >0.6 within a region of interest. MaxLCBI4mm was defined as the maximum LCBI within any 4-mm-long segment. Major adverse cardiac events (MACE) included cardiac death, myocardial infarction, definite or probable stent thrombosis, or unplanned revascularization or rehospitalization for progressive angina or unstable angina. Events were subcategorized as culprit (treated) lesion–related, nonculprit (untreated) lesion–related, or indeterminate.
Among 1,999 patients who were enrolled in the COLOR (Chemometric Observations of Lipid Core Plaques of Interest in Native Coronary Arteries Registry), PCI was performed in 1,621 patients and MACE occurred in 18.0% of patients, of which 8.3% were culprit lesion–related, 10.7% were nonculprit lesion–related, and 3.1% were indeterminate during 2-year follow-up. Complications from NIRS imaging occurred in 9 patients (0.45%), which resulted in 1 peri-procedural myocardial infarction and 1 emergent coronary bypass. Pre-PCI NIRS imaging was obtained in 1,189 patients, and the 2-year rate of culprit lesion–related MACE was not significantly associated with maxLCBI4mm (hazard ratio of maxLCBI4mm per 100: 1.06; 95% confidence interval: 0.96 to 1.17; p = 0.28) after adjusting clinical and procedural factors.
Following PCI with contemporary drug-eluting stents, stent implantation in NIRS-defined LRPs was not associated with increased periprocedural or late adverse outcomes compared with those without significant lipid.
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Objectives
To evaluate the periprocedural characteristics and outcomes of patients supported with Impella 2.5 prior to percutaneous coronary intervention (pre‐PCI) versus those who received it after ...PCI (post‐PCI) in the setting of cardiogenic shock (CS) complicating an acute myocardial infarction (AMI).
Background
Early mechanical circulatory support may improve outcome in the setting of CS complicating an AMI. However, the optimal timing to initiate hemodynamic support has not been well characterized.
Methods
Data from 154 consecutive patients who underwent PCI and Impella 2.5 support from 38 US hospitals participating in the USpella Registry were included in our study. The primary end‐point was survival to discharge. Secondary end‐points included assessment of patients' hemodynamics and in‐hospital complications. A multivariate regression model was used to identify independent predictors for mortality.
Results
Both groups were comparable except for diabetes (P = 0.02), peripheral vascular disease (P = 0.008), chronic obstructive pulmonary disease (P = 0.05), and prior stroke (P = 0.04), all of which were more prevalent in the pre‐PCI group. Patients in the pre‐PCI group had more lesions (P = 0.006) and vessels (P = 0.01) treated. These patients had also significantly better survival to discharge compared to patients in the post‐PCI group (65.1% vs.40.7%, P = 0.003). Survival remained favorable for the pre‐PCI group after adjusting for potential confounding variables. Initiation of support prior to PCI with Impella 2.5 was an independent predictor of in‐hospital survival (Odds ratio 0.37, 95% confidence interval: 0.17–0.79, P = 0.01) in multivariate analysis. The incidence of in‐hospital complications included in the secondary end‐point was similar between the 2 groups.
Conclusions
The results of our study suggest that early initiation of hemodynamic support prior to PCI with Impella 2.5 is associated with more complete revascularization and improved survival in the setting of refractory CS complicating an AMI. (J Interven Cardiol 2014;27:1–11)
Objectives
To assess post‐procedural outcomes when Impella 2.5 percutaneous left ventricular assist device (pLVAD) support is initiated either prior to or after percutaneous coronary intervention ...(PCI) on unprotected left main coronary artery (ULMCA) culprit lesion in the context of acute myocardial infarction cardiogenic shock (AMICS).
Background
Initiation of Impella 2.5 pLVAD prior to PCI is associated with significant survival benefit in the setting of AMICS. Outcomes of those presenting with a ULMCA culprit lesion in this setting have not been well characterized.
Methods
Thirty‐six consecutive patients in the cVAD Registry supported with Impella 2.5 pLVAD for AMICS who underwent PCI on ULMCA culprit lesion were included in our multicenter study.
Results
The average age was 69.8 ± 14.2 years, 77.8% were male, 72.7% were in CS at admission, 44.4% sustained one or multiple cardiac arrests, and 30.6% had anoxic brain injury. Baseline characteristics were comparable between the Pre‐PCI group (n = 20) and Post‐PCI group (n = 16). Non‐ST segment elevation myocardial infarction and greater coronary disease burden were significantly more frequent in the Pre‐PCI group but they had significantly better survival to discharge (55.0% vs 18.8%, P = 0.041). Kaplan‐Meier 30‐day survival analysis showed very poor survival in Post‐PCI group (48.1% vs 12.5%, Log‐Rank P = 0.004).
Conclusions
Initiation of Impella 2.5 pLVAD prior to as compared with after PCI of ULMCA for AMICS culprit lesion is associated with significant early survival. As previously described, patients supported after PCI appear to have very poor survival at 30 days.
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