Cost savings for pVAD compared to ECMO in the management of acute myocardial infarction complicated by cardiogenic shock: An episode-of-care analysis.

BACKGROUND: Acute myocardial infarction complicated by cardiogenic shock (AMICS) occurs in up to 10% of acute myocardial infarction admissions and is associated with high mortality, frequent adverse outcomes, prolonged hospitalizations, extensive medical resource utilization, and major cost. Using hospital cost data for Medicare Fee-for-Service (FFS) patients with AMICS, we sought to evaluate in hospital and 45-day outcomes and cost, comparing patients treated with percutaneous ventricular assist device (pVAD) versus extracorporeal membrane oxygenation (ECMO). The goal of this study was to better understand clinical and economic outcomes of AMICS to help clinicians and hospitals optimize outcomes most economically for AMICS patients. METHODS: A retrospective claims analysis identified patients from the full census Medicare Standard Analytic Files compiled by the Center for Medicare and Medicaid (CMS) including: Inpatient, Outpatient, Skilled Nursing Facility and Home Health files for Medicare FFS beneficiaries. Study costs were defined as the total costs incurred by providers for treating a population with AMICS. Medicare FFS beneficiaries who experienced an inpatient admission during the index period (January 1, 2015 to March 31, 2017) with a diagnosis of AMICS were eligible for study inclusion and were identified by the presence of appropriate International Classification of Diseases, Ninth and Tenth Versions (ICD-9 and ICD-10) diagnosis and procedure codes. To create a matched sample and control for any baseline differences, a 1:1 Propensity Score Matching (PSM) was performed based on criteria such as age, gender, race, geographic distribution, and 11 high-cost comorbidities (e.g., congestive HF, coronary artery disease, diabetes, etc.). Index length of stay (LOS), index costs, discharge disposition (including mortality), post-index utilization, and episode-of-care (EOC) costs were reviewed. EOC was defined as index admission for all patients plus a 45-day post index period for patients who survived the index admission. RESULTS: Each cohort included 338 patients. Index in-hospital mortality rates were 53% for pVAD versus 64% for ECMO (178 vs. 217; p = .0023), and total EOC in-hospital mortality rates were 66% for pVAD versus 74% for ECMO (222 vs. 250; p = .0160). Index LOS for pVAD was 27% lower versus ECMO (12.12 vs. 16.59; p = .0006). The index LOS for patients discharged alive was 25% lower for pVAD versus ECMO (17.73 vs. 23.62; p = .0016). For patients that experienced in-hospital mortality during their index stay, pVAD had a 44% lower LOS compared to ECMO (7.08 vs. 12.66; p < .0001). Following index hospitalization, the average cost savings with additional inpatient care was 31% lower for pVAD patients ($62,188 vs. $90,087; p = NS). During the EOC, pVAD patients incurred 32% lower costs compared to ECMO patients ($117,849 vs. $172,420; <.0001). CONCLUSIONS: This study of Medicare FFS patients demonstrates that hospitals utilizing pVAD for appropriately selected AMICS patients have reduced mortality rates and reduced index LOS with lower index facility costs and lower post index 45-day costs. The study results offer hospitals and clinicians an opportunity to improve clinical outcomes and reduce total EOC costs in treating patients with AMI complicated by CS.

Expanding opportunities for stent optimization.

Restenosis is reduced but continues to impact optimal late PCI outcomes. FFR post stenting can predict late need for repeat revascularization. Intraluminal Intensity of Blood Speckle measured via Intravascular Ultrasound may provide another method to predict target vessel revascularization.

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

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. CONDENSED ABSTRACT: 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.

Stent "Hygiene".

Studies demonstrate ideal Stent expansion with prolonged inflations. Longer inflations, a mediator of greater stent expansion, lower immediate, subacute, and late stent failure. Research should focus on components of stent deployment that optimize early and late stent outcomes.

A comprehensive meta-analysis of randomized controlled trials comparing drug-eluting stents with bare-metal stents in saphenous vein graft interventions.

BACKGROUND: Several large randomized controlled trials (RCTs) have proven the superiority of drug-eluting stents (DESs) over bare-metal stents (BMSs) for native coronary stenosis. However, RCTs comparing DESs with BMSs for SVG lesions have predominantly been small in size and have yielded conflicting results. Therefore, we conducted an updated comprehensive meta-analysis of RCTs comparing DESs versus BMSs for SVG interventions using the largest sample size to date. METHODS: Scientific databases and websites were searched to find RCTs. Data from six RCTs involving 1,582 patients were included. Pooled risk ratios (RRs) were calculated using random-effects models. The primary outcome of this meta-analysis was target vessel revascularization (TVR). The secondary outcomes were major adverse cardiac events (MACEs), myocardial infarction (MI), stent thrombosis, all-cause mortality, and cardiac mortality. RESULTS: Data from six RCTs involving 1,582 patients were included. Saphenous vein graft interventions with DESs reduced TVR (RR, 0.52; 95% CI, 0.30-0.88; P = 0.017) and MACE rate (RR, 0.60; 95% CI, 0.42-0.87; P = 0.007) compared to BMSs. No difference between the stents were found in rates of MI (RR, 0.69; 95% CI, 0.43-1.10; P = 0.123), stent thrombosis (RR, 0.61; 95% CI, 0.27-1.41; P = 0.255), all-cause mortality (RR, 1.13; 95% CI, 0.74-1.71; P = 0.554), or cardiac mortality. CONCLUSION: For SVG intervention, the MACE rate was lower for DESs compared to BMSs, driven primarily by decreased non-MI-related TVR. Rates of MI, all-cause mortality, cardiac mortality, and stent thrombosis were not different between the stents.

Hemodynamic Support Devices for Shock and High-Risk PCI: When and Which One.

PURPOSE OF REVIEW: This article addresses evolving devices and uses of hemodynamic support in the management of high-risk PCI and AMI with cardiogenic shock. RECENT FINDINGS: Recent publications question the benefit of Intra-aortic Balloon Pump support for AMI Shock. Furthermore, in high-risk PCI, the Impella support system provides better late outcomes than does the intra-aortic balloon pump. We have entered a new era in which larger, higher flow devices that increase cardiac output while unloading the left ventricle provide better outcome. The current PCI population is higher risk, and often without surgical options. Hemodynamic support, most often utilizing Impella support, improves outcomes via providing the hemodynamic stability to allow complete revascularization and optimal lesion treatment. Regarding shock, preliminary data suggests that a concept of early left ventricular unloading before PCI maybe the critical factor for improving the outcome for acute myocardial infarction complicating myocardial infarction.

"Real-World" Comparison of Prasugrel With Ticagrelor in Patients With Acute Coronary Syndrome Treated With Percutaneous Coronary Intervention in the United States.

OBJECTIVES: The 30-day clinical outcomes with prasugrel or ticagrelor were compared using a US payer database in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI). BACKGROUND: Prasugrel and ticagrelor demonstrated superior efficacy with increased non-coronary artery bypass graft major bleeding compared with clopidogrel in randomized clinical trials. No direct randomized or observational studies have compared clinical outcomes between prasugrel and ticagrelor. METHODS: Patients hospitalized for ACS-PCI between August 1, 2011 and April 30, 2013 and prescribed prasugrel or ticagrelor were selected. Drug treatment cohorts were propensity matched based upon demographic and clinical characteristics. The primary objective compared 30-day net adverse clinical events (NACE) in prasugrel- and ticagrelor-treated patients using a prespecified 20% noninferiority margin. Secondary objectives included comparisons of major adverse cardiovascular events (MACE) and major bleeding. RESULTS: Data were available for 16,098 patients (prasugrel, n = 13,134; ticagrelor, n = 2,964). In unmatched cohorts, prasugrel-treated patients were younger with fewer comorbidities than ticagrelor-treated patients, and 30-day NACE rates were 5.6 and 9.3%, respectively (P < 0.001). Following propensity matching, NACE was noninferior (P < 0.001) and 22% lower in prasugrel-treated than in ticagrelor-treated patients (RR, 0.78; 95% CI, 0.64-0.94). A 30-day adjusted MACE (RR, 0.80; 95% CI, 0.64-0.98) and major bleeding (RR, 0.65; 95% CI, 0.45-0.95) were also lower in prasugrel-treated patients compared with ticagrelor-treated patients. CONCLUSIONS: In this "real-world," retrospective, observational study, physicians appear to preferentially use prasugrel in younger patients with lower risk of bleeding or comorbidities compared with ticagrelor. Following adjustment, clinical outcomes associated with prasugrel use appear as good, if not better, than those associated with ticagrelor in ACS-PCI patients. © 2015 Wiley Periodicals, Inc.

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.

Buzzing the plaque: Coronary rotational atherectomy in its third decade.

Rotational atherectomy enhances successful stenting in high risk, limited option PCI. Independent risk factors for mortality, not surprisingly, include older age, reduced LVEF, renal insufficiency and diabetes. These results support the continued importance of rotational atherectomy to support the growing frequency of high risk, no option PCI patients often with complex calcified lesions.

Longitudinal Geographic Miss (LGM) in Robotic Assisted Versus Manual Percutaneous Coronary Interventions.

OBJECTIVES: To evaluate the impact of robotic-assisted percutaneous coronary intervention (RA-PCI) versus manual PCI (M-PCI) on the incidence of Longitudinal Geographic Miss (LGM). BACKGROUND: The safety and feasibility of RA-PCI has been established in preclinical animal trials and human clinical trials. Patients with LGM have been shown to have worse clinical outcomes including significantly increased incidences of MACE. METHODS: Patients with significant coronary artery disease underwent RA-PCI in the PRECISE study (n=164) and standard M-PCI in the STLLR trial (n = 1,509). Longitudinal geographic miss was defined as cases where the entire length of the injured or stenotic segment was not fully covered by the total length of the stent. The incidence of LGM was compared between RA-PCI and M-PCI cohorts. RESULTS: The RA-PCI cohort had a significantly greater prevalence of previous MI, previous coronary revascularization, and unstable angina. The robotic cohort exhibited a lower incidence of LGM when compared to the M-PCI patients, 12.2% to 43.1%, respectively (P < 0.0001). To account for the differences in baseline characteristics between the two studies, a propensity score analysis was conducted. The propensity modeling showed similar rates of LGM in both a larger group of patients that met key PRECISE study inclusion/exclusion criteria adjusted for propensity score (9.3% vs 55.0%; P < 0.0001) and in a smaller, matched on propensity score, subset of patients (10.3% vs 64.1%; P < 0.0001). CONCLUSION: Robotic-assisted PCI had significantly lower incidence of LGM compared to standard M-PCI. Reducing LGM potentially improves long-term clinical outcomes through reduction in MACE.

Cardiovascular safety of varenicline: patient-level meta-analysis of randomized, blinded, placebo-controlled trials.

Smoking is a major modifiable risk factor for cardiovascular (CV) disease. Varenicline is a pharmacological aid for smoking cessation. To explore the CV safety of varenicline, we investigated the incidence of CV events in varenicline-treated subjects across all phase 2-4 randomized placebo-controlled clinical trials of ≥12-week treatment duration conducted in smokers aged ≥18 years and sponsored by the drug manufacturer. This manuscript reports a subject-level meta-analysis of time to major adverse cardiovascular events (MACE; defined as CV-related death, nonfatal myocardial infarction, nonfatal stroke) and time to MACE+ (defined as MACE plus worsening or any procedure for peripheral vascular disease, hospitalization for angina, or performance of coronary revascularization). All events were adjudicated by an independent adjudication committee, blind to treatment assignment. Events were assessed during treatment and up to 30 days after the last treatment dose. The primary analytical method was a stratified logrank time-to-event analysis; secondary analyses were meta-analyses of incidence rate ratios and rate differences. Overall, 7002 subjects were included (varenicline: 4190; placebo: 2812) from 15 studies. MACE were reported by 13 varenicline subjects (0.31%) and 6 placebo subjects (0.21%) [hazard ratio, 1.95; 95% confidence interval (CI): 0.79-4.82; P = 0.15; risk difference, 0.006 events per subject-year; 95% CI: -0.003, 0.015, P = 0.19]. MACE+ were reported by 26 varenicline subjects (0.62%) and 12 placebo subjects (0.43%) (hazard ratio, 1.74; 95% CI: 0.91-3.34, P = 0.10; risk difference, 0.010; 95% CI: -0.002, 0.022, P = 0.11). This subject-level meta-analysis of MACE or MACE+ up to 30 days posttreatment in placebo-controlled clinical trials of varenicline found a trend toward increased incidence of these events in varenicline-treated patients that did not reach statistical significance. The overall number of events was low and the absolute risk of CV events with varenicline was small.

Patterns of Care and Outcomes of Ambulatory Endovascular Interventions in Lower Extremity Peripheral Arterial Disease.

Lower extremity endovascular intervention (LE-EVI) is gaining popularity as the primary treatment modality for patients with symptomatic peripheral artery disease refractory to noninvasive management. We examined the contemporary patterns of care, regional variation, and outcomes of ambulatory LE-EVI in the United States. The National Ambulatory Surgery Sample was analyzed to identify 266,563 records with peripheral artery disease and LE-EVI between January 1, 2016 and December 31, 2017. The mean age of the study cohort was 68.9 years and 40.5% were women. The majority of the endovascular interventions were performed at large (58.1%), urban teaching (64.1%), private not-for-profit (76.8%) centers, and the southern region accounted for most cases (43%). Periprocedural major adverse renal and cardiovascular events and other complications were 0.5% and 3.3%, respectively. Most patients (97.6%) were discharged home after the procedure. Age, female gender, uncontrolled hypertension, ischemic heart disease, heart failure, arrhythmia, chronic kidney disease, malnutrition, non-Medicare insurance, private for-profit, urban teaching facilities, and southern and midwest regions were associated with higher odds of major adverse renal and cardiovascular events. The mean charges per patient encounter were $56,500, with significant differences across various patient and facility characteristics. In conclusion, our study demonstrates the use, patterns of care, financial aspect, and overall safety of ambulatory LE-EVIs in a real-world setting.

Best Practices for Cardiac Catheterization Laboratory Morbidity and Mortality Conferences.

Cardiac catheterization laboratory (CCL) morbidity and mortality conferences (MMCs) are a critical component of CCL quality improvement programs and are important for the education of cardiology trainees and the lifelong learning of CCL physicians and team members. Despite their fundamental role in the functioning of the CCL, no consensus exists on how CCL MMCs should identify and select cases for review, how they should be conducted, and how results should be used to improve CCL quality. In addition, medicolegal ramifications of CCL MMCs are not well understood. This document from the American College of Cardiology's Interventional Section attempts to clarify current issues and options in the conduct of CCL MMCs and to recommend best practices for their conduct.