Strategies for Reducing Vascular and Bleeding Risk for Percutaneous Left Ventricular Assist Device-supported High-risk Percutaneous Coronary Intervention.

In patients at high risk for haemodynamic instability during percutaneous coronary intervention (PCI), practitioners are increasingly opting for prophylactic mechanical circulatory support, such as the Impella® heart pump (Abiomed, Danvers, MA, USA). Though Impella-supported high-risk PCI (HRPCI) ensures haemodynamic stability during the PCI procedure, access-related complication rates have varied significantly in published studies. Reported variability in complication rates relates to many factors, including anticoagulation practices, access and closure strategy, post-procedure care and variations in event definitions. This article aims to outline optimal strategies to minimize vascular and bleeding complications during Impella-supported HRPCI based on previously identified clinical, procedural and postprocedural risk factors. Practices to reduce complications include femoral skills training, standardized protocols to optimize access, closure, anticoagulation management and post-procedural care, as well as the application of techniques and technological advances. Protocols integrating these strategies to mitigate access-related bleeding and vascular complications for Impella-supported procedures can markedly limit vascular access risk as a barrier to appropriate large-bore mechanical circulatory support use in HRPCI.

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.

A Review of Bleeding Risk with Impella-supported High-risk Percutaneous Coronary Intervention.

Complex, high-risk percutaneous coronary intervention (HR-PCI) is increasingly being performed, often with mechanical circulatory support (MCS), though to date, there are limited randomised data on the efficacy of MCS for HR-PCI. The majority of MCS is provided by intra-aortic balloon pumps, but increasingly Impella® (Abiomed, Danvers, MA, USA) heart pumps are being used. While the Impella pumps provide greater increases in cardiac output, these devices require large bore access, which has been associated with an increased risk of bleeding and vascular complications. Decisions regarding the use of Impella are often based on risk-benefit considerations, with Impella-related bleeding risk being a major factor that can impact decisions for planned use. While bleeding risk related to large bore access is a concern, published data on the risk have been quite variable. Thus, the goal of this article is to provide a comprehensive review of reports describing bleeding and vascular complications for Impella-supported HR-PCI.

Comparison of In-Hospital Outcomes in Patients Having Limb-Revascularization With Versus Without Atrial Fibrillation.

The impact of atrial fibrillation (AF) on clinical outcomes among patients with peripheral artery disease (PAD) who undergo limb revascularization procedures is not well understood. We aim to compare in-hospital outcomes for patients with and without AF who underwent limb revascularization. We identified patients with PAD aged ≥18 years that underwent limb revascularization using endovascular or surgical approaches in the National Inpatient Sample between 2002 and 2014. Multivariate logistic regression analysis was performed to examine in-hospital outcomes. A total of 2,283,568 patients underwent limb revascularization during the study duration and 294,469 (12.9%) had AF. Patients with AF were older (mean age 76.1 ± 10.0 years), more likely to be women and white, compared with non-AF group. Among patients who had surgical revascularization, AF was associated with a higher rates of in-hospital mortality (6.4% vs 2.5%, adjusted odds ratio [aOR]: 1.09 [95% confidence interval {CI}: 1.05 to 1.12]) and major amputation (5.2% vs 3.8%, aOR: 1.05 [95% CI: 1.02 to 1.08]), compared with non-AF group. Among patients who had endovascular intervention (EVI), AF was associated with a higher rates of in-hospital mortality (3.8% vs 1.6%, aOR: 1.29 [95% CI: 1.24 to 1.33]) and major amputation (5.2% vs 3.9%, aOR: 1.07 [95% CI: 1.04 to 1.10]), compared with non-AF group. Within study period, EVI utilization increased in patients with and without AF (Ptrend <0.001); whereas, surgical revascularization utilization decreased in patients with and without AF (Ptrend <0.001). In conclusion, among patients with PAD who undergo limb revascularization, AF appears to be associated with poor in-hospital outcomes.

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.

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.

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.

One-Year Clinical Effectiveness Comparison of Prasugrel with Ticagrelor: Results from a Retrospective Observational Study using an Integrated Claims Database.

BACKGROUND: No direct comparisons of ticagrelor and prasugrel with 1-year clinical follow-up have been reported. OBJECTIVES: Our objective was to compare 1-year clinical outcomes among patients with acute coronary syndrome (ACS) managed with percutaneous coronary intervention (PCI) and treated with either ticagrelor or prasugrel in a real-world setting. METHODS: This retrospective study included patients from a payer database who were aged ≥18 years and had ACS managed with PCI with no history of transient ischemic attack (TIA)/stroke. Data were propensity matched for prasugrel use with a 3:1 prasugrel:ticagrelor ratio. Post-discharge net adverse clinical event (NACE) rate at 1 year was evaluated for noninferiority using a pre-defined 20% margin. NACE was a composite of major adverse cardiovascular events (MACE) or rehospitalization for bleeding. RESULTS: In total, 15,788 ACS-PCI patients were included (prasugrel 12,797; ticagrelor 2991). Prasugrel-treated patients were younger; less likely to be female, have prior myocardial infarction (MI), diabetes, or non-ST-segment elevation MI (NSTEMI); and more likely to have unstable angina (UA) than ticagrelor-treated patients. Prior to matching, NACE and MACE (P < 0.01) were lower, with no difference in bleeding with prasugrel compared with ticagrelor. After matching, there was no significant difference in baseline characteristics. Noninferiority was demonstrated for NACE, MACE, and bleeding between prasugrel and ticagrelor. NACE and MACE were significantly lower with prasugrel use, primarily driven by heart failure, with no significant difference in all-cause death, MI, UA, revascularization, TIA/stroke, or bleeding. CONCLUSIONS: In this retrospective study, physicians preferentially used prasugrel rather than ticagrelor in younger ACS-PCI patients with lower risk of bleeding or comorbidities. After propensity matching, clinical outcomes associated with prasugrel were noninferior to those with ticagrelor.

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.

Meta-Analysis Comparing Coronary Artery Bypass Grafting to Drug-Eluting Stents and to Medical Therapy Alone for Left Main Coronary Artery Disease.

Historically, coronary artery bypass graft (CABG) surgery has been the standard revascularization method for unprotected left main coronary artery (LMCA) disease. Over the last decade, several randomized controlled trials (RCTs) have shown favorable results for percutaneous coronary intervention (PCI) with drug-eluting stent (DES) compared with CABG; however, no RCT has been conducted directly comparing DESs with medical therapy alone (MTA). Furthermore, the 2 most recently reported larger RCTs, using new-generation DESs reached somewhat conflicting conclusions comparing the 2 revascularization strategies. Therefore, we performed a traditional pairwise meta-analysis and Bayesian network meta-analysis to compare the efficacies of the 3 currently available treatment strategies (MTA, CABG, and DES) for unprotected LMCA disease. Scientific databases and websites were searched to find RCTs. Data from 8 trials including 4,850 patients were analyzed. Overall PCI increased the risk of major adverse cardiac and cerebrovascular events (MACCEs) driven by increased rate of revascularization compared with CABG, but no differences in all-cause mortality, cardiac mortality, and recurrent myocardial infarction were found. However, early (i.e., within 30 days) PCI decreased the risk of MACCEs and stroke compared with CABG. In the mixed-treatment comparison models, both CABG and DESs were associated with better survival compared with MTA, but no difference was found between them. In conclusion, in patients with unprotected LMCA disease, PCI with DESs yields similar all-cause and cardiac mortalities compared with CABG. Furthermore, CABG increases early (i.e., within 30 days) MACCE rates, driven by an increased risk of stroke. Over longer durations, PCI increases MACCE rates because of increased recurrent revascularization.