Clinical characteristics and outcomes of patients requiring prolonged mechanical circulatory support after high-risk percutaneous coronary intervention.

BACKGROUND: There are limited data on the clinical characteristics and outcomes of patients who require prolonged mechanical circulatory support (MCS) after Impella-supported high-risk percutaneous coronary intervention (HR-PCI). AIMS: The aim of this study is to describe the contemporary clinical characteristics, outcomes, and predictors associated with prolonged MCS support after assisted HR-PCI. METHODS: Patients enrolled in the prospective, multicentre, clinical endpoint-adjudicated PROTECT III study who had undergone HR-PCI using Impella were evaluated. Patient and procedural characteristics and outcomes for those who received prolonged MCS beyond the duration of their index procedure were compared to those in whom MCS was successfully weaned and explanted at the conclusion of the index PCI. RESULTS: Among 1,155 patients who underwent HR-PCI with Impella between 2017 and 2020 and had sufficient data to confirm the duration of Impella support, 16.5% received prolonged MCS (mean duration 25.2±31.1 hours compared with 1.8±5.8 hours for those who only received intraprocedural MCS). Patients receiving prolonged support presented with more urgent indications (e.g., acute coronary syndromes [ACS], lower ejection fraction [EF], elevated baseline heart rate and lower systolic blood pressure). Use of the Impella CP, intraprocedural complications, periprocedural complications and in-hospital mortality were all more common amongst the prolonged MCS group. Prolonged MCS was associated with increased rates of major adverse cardiovascular and cerebrovascular events, cardiovascular death, and all-cause mortality at 90-day follow-up. CONCLUSIONS: Patients receiving prolonged MCS after Impella-supported HR-PCI presented with more ACS, reduced EF and less favourable haemodynamics. Additionally, they were more likely to experience intraprocedural and periprocedural complications as well as increased in-hospital and post-discharge mortality.

Early Utilization of Mechanical Circulatory Support in Acute Myocardial Infarction Complicated by Cardiogenic Shock: The National Cardiogenic Shock Initiative.

BACKGROUND: Acute myocardial infarction complicated by cardiogenic shock (AMI-CS) is associated with significant morbidity and mortality. Mechanical circulatory support (MCS) devices increase systemic blood pressure and end organ perfusion while reducing cardiac filling pressures. METHODS AND RESULTS: The National Cardiogenic Shock Initiative (NCT03677180) is a single-arm, multicenter study. The purpose of this study was to assess the feasibility and effectiveness of utilizing early MCS with Impella in patients presenting with AMI-CS. The primary end point was in-hospital mortality. A total of 406 patients were enrolled at 80 sites between 2016 and 2020. Average age was 64±12 years, 24% were female, 17% had a witnessed out-of-hospital cardiac arrest, 27% had in-hospital cardiac arrest, and 9% were under active cardiopulmonary resuscitation during MCS implantation. Patients presented with a mean systolic blood pressure of 77.2±19.2 mm Hg, 85% of patients were on vasopressors or inotropes, mean lactate was 4.8±3.9 mmol/L and cardiac power output was 0.67±0.29 watts. At 24 hours, mean systolic blood pressure improved to 103.9±17.8 mm Hg, lactate to 2.7±2.8 mmol/L, and cardiac power output to 1.0±1.3 watts. Procedural survival, survival to discharge, survival to 30 days, and survival to 1 year were 99%, 71%, 68%, and 53%, respectively. CONCLUSIONS: Early use of MCS in AMI-CS is feasible across varying health care settings and resulted in improvements to early hemodynamics and perfusion. Survival rates to hospital discharge were high. Given the encouraging results from our analysis, randomized clinical trials are warranted to assess the role of utilizing early MCS, using a standardized, multidisciplinary approach.

Unloading the Left Ventricle Before Reperfusion in Patients With Anterior ST-Segment-Elevation Myocardial Infarction.

BACKGROUND: In ST-segment-elevation myocardial infarction (STEMI), infarct size correlates directly with heart failure and mortality. Preclinical testing has shown that, in comparison with reperfusion alone, mechanically unloading the left ventricle (LV) before reperfusion reduces infarct size and that 30 minutes of unloading activates a cardioprotective program that limits reperfusion injury. The DTU-STEMI pilot trial (Door-To-Unload in STEMI Pilot Trial) represents the first exploratory study testing whether LV unloading and delayed reperfusion in patients with STEMI without cardiogenic shock is safe and feasible. METHODS: In a multicenter, prospective, randomized exploratory safety and feasibility trial, we assigned 50 patients with anterior STEMI to LV unloading by using the Impella CP followed by immediate reperfusion (U-IR) versus delayed reperfusion after 30 minutes of unloading (U-DR). The primary safety outcome was a composite of major adverse cardiovascular and cerebrovascular events at 30 days. Efficacy parameters included the assessment of infarct size by using cardiac magnetic resonance imaging. RESULTS: All patients completed the U-IR (n=25) or U-DR (n=25) protocols with respective mean door-to-balloon times of 72 versus 97 minutes. Major adverse cardiovascular and cerebrovascular event rates were not statistically different between the U-IR versus U-DR groups (8% versus 12%, respectively, P=0.99). In comparison with the U-IR group, delaying reperfusion in the U-DR group did not affect 30-day mean infarct size measured as a percentage of LV mass (15±12% versus 13±11%, U-IR versus U-DR, P=0.53). CONCLUSIONS: We report that LV unloading using the Impella CP device with a 30-minute delay before reperfusion is feasible within a relatively short time period in anterior STEMI. The DTU-STEMI pilot trial did not identify prohibitive safety signals that would preclude proceeding to a larger pivotal study of LV unloading before reperfusion. An appropriately powered pivotal trial comparing LV unloading before reperfusion to the current standard of care is required. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT03000270.

Barriers to Early Discharge after Elective Percutaneous Coronary Intervention (BED PCI): A Single-Center Study.

OBJECTIVE: To identify patient characteristics and procedural factors that may play a role in hindering same-day discharge (SDD) practices. BACKGROUND: Multiple studies have shown the safety and cost effectiveness of SDD following elective percutaneous coronary intervention (PCI), but factors that hinder SDD practices have not been thoroughly studied. MATERIAL AND METHODS: A retrospective comparative analysis of elective PCI patients who had an overnight stay (OS) (n=345) vs. SDD patients (n=222) was conducted to identify significant differences between the two groups in baseline patient characteristics, procedural, and postprocedural factors. RESULTS: Comparing OS to SDD patients, OS patients had a lower prevalence of radial access (20.29% vs. 39.64%, P<0.0001); a higher incidence of suboptimal angiographic results (14.49% vs. 1.80%, P=0.0027); CRCL values lower than 60mL/min (26.38% vs. 15.32%, P=0.0019); and greater femoral vascular site hemostasis with manual compression (69.09% vs. 36.57%, P=0.0027). OS patients received larger sheath sizes (P=0.0209), more bivalirudin (45.80% vs. 36.70%) and glycoprotein IIb/IIIa inhibitors (5.51% vs. 2.25%), but less heparin (51.30% vs. 53.21%). Chest pain (8.12% vs. 0.92%, P=0.0042) and vascular access site concerns (20.58% vs. 0%, P=0.0027) were more common among OS patients. CONCLUSIONS: Pre-, peri-, and post-procedural factors play a role in SDD eligibility. Understanding factors that limit as well as those that facilitate SDD may enable institutions to establish or enhance a SDD program.

Percutaneous coronary intervention using a combination of robotics and telecommunications by an operator in a separate physical location from the patient: an early exploration into the feasibility of telestenting (the REMOTE-PCI study).

AIMS: The present study explores the feasibility of telestenting, wherein a physician operator performs stenting on a patient in a separate physical location using a combination of robotics and telecommunications. METHODS AND RESULTS: Patients undergoing robotic stenting were eligible for inclusion. All manipulations of guidewires, balloons, and stents were performed robotically by a physician operator located in an isolated separate room outside the procedure room housing the patient. Communication between the operating physician and laboratory personnel was via telecommunication devices providing real-time audio and video connectivity. Among 20 patients who consented to participate, technical success, defined as successful advancement and retraction of guidewires, balloons, and stents by the robotic system without conversion to manual operation, was achieved in 19 of 22 lesions (86.4%). Procedural success, defined as <30% residual stenosis upon completion of the procedure in the absence of death or repeat revascularisation prior to hospital discharge, was achieved in 19 of 20 patients (95.0%). There were no deaths or repeat revascularisations prior to hospital discharge. CONCLUSIONS: To the best of our knowledge, the present study is the first to explore the feasibility of telestenting. Additional studies are required to determine if future advancements in robotics will facilitate telestenting over greater geographic distances.

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. © 2015 Wiley Periodicals, Inc.

Radial PCI and the obesity paradox: Insights from Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2).

OBJECTIVE: To examine if transradial approach (TRA) negates the increased risk associated with femoral access in lean and morbidly obese patients undergoing percutaneous coronary intervention (PCI). BACKGROUND: Patients at extremes of body mass are at increased risk of bleeding after PCI. TRA has been associated with lower overall rates of bleeding compared to femoral approach. METHODS AND RESULTS: We studied patients undergoing emergent and elective PCI from 2010 to 2012 across 47 hospitals in Michigan who participate in the Blue Cross Blue Shield of Michigan Cardiovascular Consortium PCI registry. The primary outcomes were the incidences of bleeding and postprocedure transfusion. Propensity matching (PM) was used to adjust for nonrandomized use of TRA. TRA was used in 10,235 procedures. In PM analyses, use of TRA was associated with a reduction in bleeding (0.80 vs. 1.9%, odds ratio [OR] = 0.41, 95% confidence interval [CI] = 0.32-0.54, P < 0.001) and need for transfusion (1.4 vs. 2.5%, OR = 0.56, 95% CI = 0.45-0.69, P < 0.001) compared with femoral access. The absolute difference in bleeding and transfusion associated with TRA was largest in patients with lean body mass (BMI < 25 kg/m(2)) and morbid obesity (BMI ≥ 40 kg/m(2)): Lean patients undergoing TRA had a rate of bleeding of 1.2 versus 2.8% for femoral access (OR = 0.43, 95% CI = 0.24-0.77, P = 0.002); and rate of transfusion of 2.4 versus 3.9% (OR = 0.61, 95% CI = 0.40-0.94, P = 0.019). The morbidly obese had a rate of bleeding of 0.8% for TRA versus 2.4% for femoral access (OR = 0.33, 95% CI = 0.44-0.72, P = 0.004); and rate of transfusion of 1.7 versus 3.0%, (OR = 0.55, 95% CI = 0.30-1.0, P = 0.051). CONCLUSIONS: Compared with the femoral approach, TRA is associated with a reduction in bleeding across all patients undergoing PCI and the absolute benefit was greatest in those with extremely low or high BMI.

Detection by intracoronary near-infrared spectroscopy of lipid core plaque at culprit sites in survivors of cardiac arrest.

With an estimated 300,000 cases occurring per year in the United States alone, sudden cardiac death remains a major public health problem and in many cases is the first manifestation of coronary artery disease. Autopsy studies have established that the causative event in many cases of sudden death is rupture of an intracoronary lipid core plaque with subsequent thrombus formation. Until recently, identification of lipid core plaque in vivo has not been possible; however, a combined near-infrared spectroscopy (NIRS) and intravascular ultrasound (IVUS) catheter has become available that can detect lipid core plaque in patients undergoing coronary angiography. In this report, we present findings in 5 patients who experienced a documented sudden cardiac arrest, were successfully resuscitated, and then were studied with intracoronary NIRS-IVUS to assess the extent and location of lipid core plaque. Although the detection of lipid core plaque at the culprit site in victims of sudden death is not novel, the novelty of the present report is that NIRS permitted identification of the large lipid core plaque underlying sudden cardiac arrest in vivo, a finding in striking accord with prior autopsy observations implicating ruptured lipid core plaque in the pathogenesis of sudden cardiac death.

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.

Differences in the outcome of patients undergoing percutaneous coronary interventions at teaching versus non-teaching hospitals.

BACKGROUND: Teaching hospitals have superior outcomes for major medical conditions including cardiovascular disease compared to non-teaching hospitals. This may not be applicable to invasive cardiac procedures given a potential increase in complications due to trainee participation. METHODS: We assessed the impact of hospital teaching status on the outcome of 89,048 patients who underwent percutaneous coronary intervention (PCI). Teaching hospitals were defined as trainee involvement in greater than 50% of PCIs conducted at that hospital and corresponded to teaching status granted by national accreditation agencies. Unadjusted and risk adjusted analyses were used to determine differences in process of care, morbidity and mortality. RESULTS: Of 89,048 patients studied, 30,870 received their PCI at teaching hospitals and 58,178 at non-teaching hospitals. Risk-adjusted analysis showed no significant difference in death, in-hospital myocardial infarction, contrast induced nephropathy or gastrointestinal bleeding between teaching and non-teaching hospitals. PCI at teaching hospitals was associated with a lower rate of emergency coronary artery bypass grafting (OR, 0.63; 95% CI, 0.49-0.83; P = .0009) and an increased rate of vascular complications (OR, 1.33; 95% CI, 1.21-1.46; P < .0001). CONCLUSIONS: General outcomes of patients undergoing PCI are similar across hospital types. However, PCI at teaching hospitals is associated with increased risk of vascular complications and reduced risk of emergency coronary artery bypass grafting compared to non-teaching hospitals.

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

OBJECTIVE: To assess clinical outcomes of same-day discharge (SDD) patients after elective percutaneous coronary intervention (PCI). BACKGROUND: An overnight stay after PCI has been the standard approach in the majority of institutions. Data supporting SDD while maintaining patient safety, based on contemporary United States practice, have not been well established. METHODS: Using institutional pre-, peri-, and post-procedural guidelines, short-term clinical outcomes of 200 consecutive patients discharged on the same day after elective PCI were prospectively studied. Major adverse cardiac events (MACE), access site and vascular complications, readmissions, and emergency room (ER) visits were assessed within 24 hrs and at 7-day post-SDD. MACE included cerebral vascular accidents, death, myocardial infarction, target vessel revascularization, pulmonary embolism, and emergent coronary artery bypass grafting. RESULTS: The mean age of the population was 63.2 years; 75% were males. Of 200 patients, 75.5% were accessed femorally and 24.5% had radial access. Intra-procedural anticoagulation included bivalirudin alone (47%), bivalirudin with glycoprotein (GP) IIb/IIIa inhibitors (3.5%), heparin alone (37%), and heparin with GP IIb/IIIa inhibitors (12.5%). No major bleeding or MACE was reported within 24 hrs or at 7 days. Within 7 days, 8 (4%) patients experienced minor bleeding, 4 (2%) were readmitted, and 3 (1.5%) had ER visits only. Pseudoaneurysm occurred in 1 (0.5%) patient. CONCLUSIONS: Our institution-specific guidelines identify low-risk PCI patients who can be safely considered candidates for SDD with virtually no short-term adverse consequences.