David Wohns

The Current Use of Impella 2.5 in Acute Myocardial Infarction Complicated by Cardiogenic Shock: Results from the USpella Registry

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.

Real-world use of the Impella 2.5 circulatory support system in complex high-risk percutaneous coronary intervention: The USpella Registry

Objectives: We report on the real‐world, multicenter experience of the Impella 2.5 circulatory support system during high‐risk PCI, a subset of the larger USpella Registry. Background: Standard of care for most patients with compromised ventricular function with multivessel or high‐risk coronary lesions has been coronary artery bypass grafting. In poor operative candidates, high‐risk PCI is increasingly considered, despite an increased risk for periprocedural hemodynamic compromise. Methods: 175 consecutive patients who underwent high‐risk PCI with prophylactic support of the Impella 2.5 were evaluated. The primary safety endpoint was the incidence of major adverse cardiac events (MACE) at 30 days. Secondary endpoints included safety and efficacy related to the device and patient outcomes, including survival at 12 months. Results: Overall angiographic revascularization was successful in 99% of patients and in 90% of those with multivessel revascularization, resulting in a reduction of the mean SYNTAX score post‐PCI from 36 ± 15 to 18 ± 15 (P < 0.0001) and an improvement of the ejection fraction (from 31 ± 15% to 36 ± 14%, P < 0.0001). In 51% of patients, the functional status improved by one or more NYHA class (P < 0.001). At 30‐day follow‐up, the rate of MACE was 8%, and survival was 96%, 91%, and 88% at 30 days, 6 months, and 12 months, respectively. Conclusions: The use of Impella 2.5 in high‐risk PCI appeared feasible and safe in the real‐world setting. The utilization of the Impella 2.5 was successful, resulting in favorable short‐ and midterm angiographic, procedural and clinical outcomes.

Risk of Acute Kidney Injury After Percutaneous Coronary Interventions Using Radial Versus Femoral Vascular Access Insights From the Blue Cross Blue Shield of Michigan Cardiovascular Consortium

Background—Transradial percutaneous coronary intervention (PCI [TRI]) does not involve catheter manipulation in the descending aorta, whereas transfemoral PCI (TFI) does. Therefore, the risk of acute kidney injury (AKI) after PCI might be influenced by vascular access site. We compared risks of AKI and nephropathy requiring dialysis (NRD) among patients treated with TRI and TFI. Methods and Results—We included patients across 47 hospitals in Michigan. Primary end point was AKI (serum creatinine increase ≥0.5 mg/dL). Secondary end points were NRD and postprocedural bleeding. Odds ratios (OR) for study end points were calculated for the entire and propensity-matched population, reported as crude, and values adjusted for preprocedural calculated AKI risk. Between 2010 and 2012, a total of 82 225 PCI procedures were performed, of which 8915 were TRI. After adjustment, TRI was associated with a reduction in AKI (OR, 0.76, 95% confidence intervals [0.62–0.92]) and bleeding with a trend toward lower NRD risk. The propensity-matched population consisted of 8857 procedures per group. In this population, TRI was associated with lower adjusted odds of AKI (OR, 0.74; 95% confidence intervals [0.58–0.96]), and bleeding (OR, 0.47; 95% confidence intervals [0.36–0.63]), but no difference in NRD was observed. Although postprocedural bleeding was independently associated with AKI (OR, 2.86; 95% confidence intervals [1.75–4.66]) in the propensity-matched population, the lower odds of AKI was not mediated by a reduction in bleeding with TRI. Sensitivity analysis demonstrated that the observed association between access site and AKI could potentially be explained by a moderately strong unknown confounder. Conclusions—The risk of AKI was significantly lower after TRI compared with TFI. This finding needs to be evaluated in randomized controlled trials.

Contemporary Use of Prasugrel in Clinical Practice Insights From the Blue Cross Blue Shield of Michigan Cardiovascular Consortium

Background— Prasugrel is a recently approved thienopyridine for use in patients with acute coronary syndromes undergoing percutaneous coronary intervention. There are no data on contemporary use of prasugrel in routine clinical practice. Methods and Results— We assessed the patterns of prasugrel use among 55 821 patients who underwent percutaneous coronary intervention and were discharged alive from January 2010 to December 2011 at 44 hospitals participating in the Blue Cross Blue Shield of Michigan Cardiovascular Consortium. Potential inappropriate therapy was defined as use in patients who had a history of cerebrovascular disease, weighed <60 kg, or were aged ≥75 years old. Clopidogrel was prescribed to 83% (n=46 574) and 17% (n=9247) of patients received prasugrel on hospital discharge. A steady, linear increase in prasugrel use was seen during the study period, with discharge prescription increasing from 8.4% in quarter 1 of 2010 to 22.3% in quarter 4 of 2011. Of the total cohort, 69.1% of patients presented with acute coronary syndrome, and in this group, 17.2% received prasugrel. Among patients prescribed prasugrel, 28.3% (n=2614) received the medication for indications outside of acute coronary syndromes. One or more known contraindications to the drug were present in 6% to 10% of patients discharged on this agent. Conclusions— There has been a steady increase in the use of prasugrel with the drug being used in ≈22% of patients undergoing percutaneous coronary intervention by study end. Prasugrel use in patients with known contraindications is not uncommon and may be a suitable target for focused quality improvement efforts.

Large lipid-rich coronary plaques detected by near-infrared spectroscopy at non-stented sites in the target artery identify patients likely to experience future major adverse cardiovascular events

AIMS A recent study demonstrated that intracoronary near-infrared spectroscopy (NIRS) findings in non-target vessels are associated with major adverse cardiovascular and cerebrovascular events (MACCE). It is unknown whether NIRS findings at non-stented sites in target vessels are similarly associated with future MACCE. This study evaluated the association between large lipid-rich plaques (LRP) detected by NIRS at non-stented sites in a target artery and subsequent MACCE. METHODS AND RESULTS This study evaluated 121 consecutive registry patients undergoing NIRS imaging in a target artery. After excluding stented segments, target arteries were evaluated for a large LRP, defined as a maximum lipid core burden index in 4 mm (maxLCBI4 mm) ≥400. Excluding events in stented segments, Cox regression analysis was performed to evaluate for an association between a maxLCBI4 mm ≥400 and future MACCE, defined as all-cause mortality, non-fatal acute coronary syndrome, and cerebrovascular events. NIRS detected a maxLCBI4 mm ≥400 in a non-stented segment of the target artery in 17.4% of patients. The only baseline clinical variable marginally associated with MACCE was ejection fraction (HR 0.96, 95% CI 0.93-1.00, P = 0.054). A maxLCBI4 mm ≥400 in a non-stented segment at baseline was significantly associated with MACCE during follow-up (HR 10.2, 95% CI 3.4-30.6, P < 0.001). CONCLUSION Detection of large LRP by NIRS at non-stented sites in a target artery was associated with an increased risk of future MACCE. These findings support ongoing prospective studies to further evaluate the ability of NIRS to identify vulnerable patients.

The comparative efficacy of bivalirudin is markedly attenuated by use of radial access: insights from Blue Cross Blue Shield of Michigan Cardiovascular Consortium

AIM The purpose of our study was to evaluate the relative impact of bivalirudin on bleeding outcomes associated with trans-radial interventions (TRI) in real world practice. METHODS AND RESULTS Data for patients undergoing percutaneous coronary intervention (PCI) between January 2010 and March 2014 at the 47 hospitals participating in the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2) were utilized. Propensity matching was used within cohorts defined by access site. The impact of bivalirudin use on in-hospital outcomes was evaluated with Fishers exact tests. Among patients undergoing trans-femoral interventions (TFI), use of bivalirudin was associated with a reduction in bleeding compared with both glycoprotein IIb/IIIa inhibitors (GPI; 1.67 vs. 3.46%, absolute risk reduction (ARR) 1.79%, odds ratio, OR, 0.47, confidence interval, CI, 0.41-0.54, number needed to treat, NNT 56, P < 0.001) and heparin (1.26 vs. 1.76%, ARR 0.5%, OR 0.71, CI 0.61-0.82, NNT 197, P < 0.001). Among patients undergoing TRI, there was a more modest absolute reduction in bleeding with bivalirudin compared with GPI (0.79 vs. 1.41%, ARR 0.62%, OR 0.56, CI 0.34-0.90, NNT 161, P = 0.016) and no difference in bleeding compared with heparin (0.46 vs. 0.46%, OR 1, CI 0.54-1.84, P = 1). CONCLUSION Bivalirudin is markedly efficacious in reducing bleeding in patients undergoing TFI. The reduction in bleeding associated with bivalirudin use is minimal to absent in patients undergoing TRI. Given its lower cost and comparable outcomes, heparin should be the preferred anticoagulation strategy in those undergoing radial PCI.

Percutaneous left ventricular assist device for high-risk percutaneous coronary interventions: Real-world versus clinical trial experience.

BACKGROUND High-risk percutaneous coronary intervention (PCI) supported by percutaneous left ventricular assist devices offers a treatment option for patients with severe symptoms, complex and extensive coronary artery disease, and multiple comorbidities. The extrapolation from clinical trial to real-world practice has inherent uncertainties. We compared the characteristics, procedures, and outcomes of high-risk PCI supported by a microaxial pump (Impella 2.5) in a multicenter registry versus the randomized PROTECT II trial (NCT00562016). METHODS The USpella registry is an observational multicenter voluntary registry of Impella technology. A total of 637 patients treated between June 2007 and September 2013 were included. Of them, 339 patients would have met enrollment criteria for the PROTECT II trial. These were compared with 216 patients treated in the Impella arm of PROTECT II. RESULTS Compared to the clinical trial, registry patients were older (70 ± 11.5 vs 67.5 ± 11.0 years); more likely to have chronic kidney disease (30% vs 22.7%), prior myocardial infarction (69.3% vs 56.5%), or prior bypass surgery (39.4% vs. 30.2%); and had similar prevalence of diabetes, peripheral vascular disease, and prior stroke. Registry patients had more extensive coronary artery disease (2.2 vs 1.8 diseased vessels) and had a similar Society of Thoracic Surgeons predicted risk of mortality. At hospital discharge, registry patients experienced a similar reduction in New York Heart Association class III to IV symptoms compared to trial patients. Registry patients had a trend toward lower in-hospital mortality (2.7% vs 4.6, P = .27). CONCLUSIONS USpella provides a real-world and contemporary estimation of the type of procedures and outcomes of high-risk patients undergoing PCI supported by Impella 2.5. Despite the higher risk of registry patients, clinical outcomes appeared to be favorable and consistent compared with the randomized trial.

Impact of Automated Contrast Injector Systems on Contrast Use and Contrast-Associated Complications in Patients Undergoing Percutaneous Coronary Interventions

OBJECTIVES The purpose of this study was to assess the impact of manual versus automated contrast injection on renal complications in patients undergoing percutaneous coronary intervention (PCI). BACKGROUND Contrast volume is a major modifiable risk factor for contrast-induced nephropathy (CIN). Automated contrast injector systems (ACIS) are believed to be associated with a reduction in the total volume of contrast media use. METHODS We compared the outcome of 60,884 patients who underwent PCI at 28 hospitals in Michigan in 2008 to 2009 and assessed the outcome of those treated at hospitals that did not use ACIS (n = 24) and compared them with those that used ACIS (n = 4). Propensity matching was used to adjust for baseline differences. RESULTS The use of ACIS was associated with a statistically significant albeit clinically small difference in the average volume of contrast media use (mean 199 ± 84 ml vs. mean 204 ± 82 ml, p < 0.0001) with no difference in proportion of patients exceeding contrast volume/calculated creatinine clearance ratio of 3 (28.4% vs. 29.1%, p = 0.19). There was no difference in the incidence of CIN (3.11% vs. 3.42%, p = 0.15) or new need for dialysis (0.30% vs. 0.33%, p = 0.54), and these differences remained nonsignificant in propensity matched analysis. In fully adjusted, multivariate logistic analysis, patients treated with ACIS remained as likely to develop CIN (odds ratio: 0.96, 95% confidence interval: 0.83 to 1.11, p = 0.56) or new need for dialysis (odds ratio: 0.83, 95% confidence interval: 0.54 to 1.28, p = 0.40). CONCLUSIONS Compared with hospitals using manual injection, institutions having ACIS used slightly less amount of contrast with no reduction in CIN. Use of ACIS is unlikely to impact contrast-induced renal complications in patients undergoing PCI.

Assessment of clinical outcomes related to early discharge after elective percutaneous coronary intervention: COED PCI.

To assess clinical outcomes of same‐day discharge (SDD) patients after elective percutaneous coronary intervention (PCI).

A team-based approach to patients in cardiogenic shock

Cardiogenic shock is a common clinical condition with high in‐hospital mortality. Early application of appropriate interventions for cardiogenic shock—including medical therapies, revascularization, temporary hemodynamic support devices, and durable mechanical circulatory support—may improve outcomes. The number and complexity of therapies for cardiogenic shock are increasing, making time‐dependent decision‐making more challenging. A multidisciplinary cardiogenic shock team is recommended to guide the rapid and efficient use of these available treatments.