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• Patients experiencing loss of pulse pressure (LOPP) during high-risk percutaneous coronary intervention (HR-PCI) are transiently dependent on mechanical circulatory support (MCS) devices. • LOPP during HR-PCI with Impella was common and occurred more frequently in patients with cardiomyopathy and low systolic blood pressure. LOPP was strongly associated with higher 90-day major adverse cardiac and cerebrovascular events, acute kidney injury, and mortality. • The ongoing randomized PROTECT-IV trial will determine whether Impella CP support during HR-PCI improves early and late clinical outcomes compared with the standard of care. The trial includes a right heart catheterization substudy that should help to define the role of invasive hemodynamics in stratifying and managing patients undergoing HR-PCI. Patients experiencing loss of pulse pressure (LOPP) during high-risk percutaneous coronary intervention (HR-PCI) are transiently dependent on mechanical circulatory support devices. We sought to define the frequency and clinic outcomes of patients who experience LOPP during HR-PCI. Patients enrolled in the PROTECT III study and had automated Impella controller logs capturing real-time hemodynamics were included in this analysis. A LOPP event was defined as a mean pulse pressure on Impella of <20 mm Hg for ≥5 seconds during PCI. Clinical characteristics and outcomes were then compared between those with and without LOPP. Logistic regression identified clinical and hemodynamic predictors of LOPP. We included 302 patients, of whom 148 patients (49%) experienced LOPP. Age, sex, and comorbidities were similar in patients with and without LOPP. Mean baseline systolic blood pressure (118.6 mm Hg vs 129.8 mm Hg; P <.001) and mean arterial pressure (86.9 mm Hg vs 91.6 mm Hg; P =.011) were lower in patients with LOPP, whereas heart rate (78 bpm vs 73 bpm; P =.012) was higher. Anatomical complexity was similar between groups. Patients with LOPP were more likely to experience major adverse cardiac and cerebrovascular events (23.5% vs 8.8%; P =.002), acute kidney injury (10.1% vs 2.6%; P =.030), and death (20.2% vs 7.9%; P =.008) within 90 days. A low baseline systolic blood pressure and cardiomyopathy were the strongest predictors of LOPP (P =.003 and P =.001, respectively). LOPP on Impella during HR-PCI was common and occurred more frequently in patients with cardiomyopathy and a low systolic blood pressure. LOPP was strongly associated with higher 90-day major adverse cardiac and cerebrovascular events, acute kidney injury, and mortality. Condensed Abstract We sought to define the frequency and clinic outcomes of patients who experience LOPP during high-risk percutaneous coronary intervention (HR-PCI). We included 302 patients, of whom 148 (49%) experienced LOPP. Patients with LOPP were more likely to experience major adverse cardiac and cerebrovascular events (23.5% vs 8.8%; P =.002), acute kidney injury (10.1% vs 2.6%; P =.030), and death (20.2% vs 7.9%; P =.008) within 90 days. A low baseline systolic blood pressure and cardiomyopathy were the strongest predictors of LOPP (P =.003 and P =.001, respectively). [ABSTRACT FROM AUTHOR]

Right ventricular dysfunction (RVD) complicates 30%–40% of cases in acute myocardial infarction (AMI) and cardiogenic shock (CS). There are sparse data on the effects of RVD on outcomes and the impact of providing early left ventricular (LV) mechanical circulatory support (MCS) on RV function and hemodynamics. Between July 2016 and December 2020, 80 sites participated in the study. All centers agreed to treat patients with AMI-CS using a standard protocol emphasizing invasive hemodynamic monitoring and rapid initiation of LV-MCS. RVD was defined as a right atrial (RA) pressure of >12 mm Hg and a pulmonary artery pulsatility index (PAPI) of <1 within 24 hours of the index procedure. The primary outcome was survival to discharge. In a subgroup analysis, data available from the Automated Impella Controller console was used to analyze diastolic suction alarms from LV placement signal and its relation to RVD. A total of 361 patients were included in the analysis, of whom 28% had RVD. The median age was 64 years (interquartile range 55–72 years), 22.7% were female and 75.7% were White. There was no difference in age, sex, or comorbidities between those with or without RVD. Patients with RVD had a higher probability of active CPR during LV-MCS implant (14.7% vs 6.3%), Society for Cardiovascular Angiography and Interventions stage E shock (39.2% vs 23.2%), and higher admission lactate levels (5.1 mg/dL vs 3.0 mg/dL). Survival to discharge was significantly lower among those with RVD (61.8% vs 73.4%, odds ratio 0.89, 95% confidence interval 0.36–0.95, P =.031). This association remained significant in the multivariate analysis. There was no significant difference in hemodynamic variables within 24 hours of LV-MCS support among those with or without RVD. At 24 hours, patients with a CPO of >0.6 W and a PAPi of >1 had a trend toward better survival to discharge compared with those with a CPO of ≤0.6 W and a PAPi of ≤1 (77.1% vs 54.6%, P =.092). Patients with RVD were significantly more likely to have diastolic suction alarms within 24 hours of LV-MCS initiation. RVD in AMI-CS is common and associated with worse survival to discharge. Early LV-MCS decreases filling pressures rapidly within the first 24 hours and decreases the rate of RVD. Achieving a CPO of >0.6 W and a PAPi of >1 within 24 hours is associated with high survival. Diastolic suction alarms may have usefulness as an early marker of RVD. [ABSTRACT FROM AUTHOR]

With an aging population and an increase in the comorbidity burden of patients undergoing percutaneous coronary intervention (PCI), the management of coronary calcification for optimal PCI is critical in contemporary practice. This study sought to examine the trends and outcomes of coronary intravascular lithotripsy (IVL), rotational/orbital atherectomy, or both among patients who underwent PCI in Michigan. We included all PCIs between January 1, 2021, and June 30, 2022, performed at 48 Michigan hospitals. Outcomes included in-hospital major adverse cardiac events (MACEs) and procedural success. IVL was used in 1,090 patients (2.57%), atherectomy was used in 1,743 (4.10%) patients, and both were used in 240 patients (0.57% of all PCIs). IVL use increased from 0.04% of PCI cases in January 2021 to 4.28% of cases in June 2022, ultimately exceeding the rate of atherectomy use. The rate of MACEs (4.3% vs 5.4%; P = 0.23) and procedural success (89.4% vs 89.1%; P = 0.88) were similar among patients treated with IVL compared with atherectomy, respectively. Only 15.6% of patients treated with IVL in contemporary practice were similar to the population enrolled in the pivotal IVL trials. Among such patients (n = 169), the rate of MACEs (0.0%) and procedural success (94.7%) were similar to the outcomes reported in the pivotal IVL trials. Since its introduction in February 2021, coronary IVL use has steadily increased, exceeding atherectomy use in Michigan by February 2022. Contemporary use of IVL and atherectomy is generally associated with high rates of procedural success and low rates of complications. [Display omitted] [ABSTRACT FROM AUTHOR]

BACKGROUND: Prior studies have found that patients with chronic kidney disease (CKD) have worse outcomes following percutaneous coronary intervention (PCI). There are no data about patients with advanced CKD undergoing Impellasupported high-risk PCI. We, therefore, aimed to evaluate angiographic characteristics and clinical outcomes in patients with CKD who received Impella-supported high-risk PCI as part of the catheter-based ventricular assist device PROTECT III study (A Prospective, Multi-Center, Randomized Controlled Trial of the IMPELLA RECOVER LP 2.5 System Versus Intra Aortic Balloon Pump [IABP] in Patients Undergoing Non Emergent High Risk PCI). METHODS: Patients enrolled in the PROTECT III study were analyzed according to their baseline estimated glomerular filtration rate (eGFR). The primary outcome was 90-day major adverse cardiovascular and cerebrovascular events (the composite of all-cause death, myocardial infarction, stroke/transient ischemic attack, and repeat revascularization). RESULTS: Of 1237 enrolled patients, 1052 patients with complete eGFR baseline assessment were evaluated: 586 with eGFR =60 mL/min per 1.73 m2, 190 with eGFR =45 to <60, 105 with eGFR =30 to <45, and 171 with eGFR <30 or on dialysis. Patients with lower eGFR (all groups with eGFR <60) were more frequently females and had a higher prevalence of hypertension, diabetes, anemia, and peripheral artery disease. The baseline Synergy Between PCI With Taxus and Cardiac Surgery score was similar between groups (28.2±12.6 for all groups). Patients with lower eGFR were more likely to have severe coronary calcifications and higher usage of atherectomy. There were no differences in individual PCI-related coronary complications between groups, but the rates of overall PCI complications were less frequent among patients with lower eGFR. Major adverse cardiovascular and cerebrovascular events at 90 days and 1-year mortality were significantly higher among patients with eGFR <30 mL/min per 1.73 m2 or on dialysis. CONCLUSIONS: Patients with advanced CKD undergoing Impella-assisted high-risk PCI tend to have higher baseline comorbidities, severe coronary calcification, and higher atherectomy usage, yet CKD was not associated with a higher rate of immediate PCI-related complications. However, 90-day major adverse cardiovascular and cerebrovascular events and 1-year mortality were significantly higher among patients with eGFR<30 mL/min per 1.73 m2 or on dialysis. Future studies of strategies to improve intermediate and long-term outcomes of these high-risk patients are warranted. [ABSTRACT FROM AUTHOR]

Left ventricular (LV) systolic dysfunction worsens outcomes in patients undergoing percutaneous coronary intervention (PCI). The objective of this study, therefore, was to evaluate outcomes of pLVAD-supported high-risk PCI (HRPCI) patients according to LV ejection fraction (LVEF). Patients from the PROTECT III study undergoing pLVAD-supported HRPCI were stratified according to baseline LVEF: severe LV dysfunction (LVEF <30%), mild and moderate LV dysfunction (LVEF ≥30% to <50%), or preserved LV function (LVEF ≥50%). Major adverse cardiovascular and cerebrovascular events (MACCE: composite of all-cause death, myocardial infarction, stroke/transient ischemic attack, and repeat revascularization), and PCI-related complications were assessed at 90 days and mortality was assessed at 1-year. From March 2017 to March 2020, 940 patients had evaluable baseline LVEF recorded in the study database. Patients with preserved LV function were older, more frequently presented with myocardial infarction, and underwent more left main PCI and atherectomy. Immediate PCI-related coronary complications were infrequent (2.7%, overall), similar between groups (P = 0. 98), and not associated with LVEF. Unadjusted 90-day MACCE rates were similar among LVEF groups; however, as a continuous variable, LVEF was associated with both 90-day MACCE (adj.HR per 5% 0.89, 95% CI [0.80, 0.98], P = 0. 018) and 1-year mortality (adj.HR per 5% 0.84 [0.78, 0.90], P < 0. 0001). Patients who underwent pLVAD-supported HRPCI exhibited low incidence of PCI-related complications, regardless of baseline LVEF. However, LVEF was associated with 90-day MACCE and 1-year mortality. [Display omitted] [ABSTRACT FROM AUTHOR]

This study sought to evaluate the differences in cardiogenic shock patient characteristics in trial patients and real-life patients. Cardiogenic shock (CS) is a leading cause of mortality in patients presenting with acute myocardial infarction (AMI). However, the enrollment of patients into clinical trials is challenging and may not be representative of real-world patients. We performed a systematic review of studies in patients presenting with AMI-related CS and compared patient characteristics of those enrolled into randomized controlled trials (RCTs) with those in registries. We included 14 RCTs (n = 2,154) and 12 registries (n = 133,617). RCTs included more men (73% vs 67.7%, P < 0.001) compared with registries. Patients enrolled in RCTs had fewer comorbidities, including less hypertension (61.6% vs 65.9%, P < 0.001), dyslipidemia (36.4% vs 53.6%, P < 0.001), a history of stroke or transient ischemic attack (7.1% vs 10.7%, P < 0.001), and prior coronary artery bypass graft surgery (5.4% vs 7.5%, P < 0.001). Patients enrolled in RCTs also had lower lactate levels (4.7 ± 2.3 mmol/L vs 5.9 ± 1.9 mmol/L, P < 0.001) and higher mean arterial pressure (73.0 ± 8.8 mm Hg vs 62.5 ± 12.2 mm Hg, P < 0.001). Percutaneous coronary intervention (97.5% vs 58.4%, P < 0.001) and extracorporeal membrane oxygenation (11.6% vs 3.4%, P < 0.001) were used more often in RCTs. The in-hospital mortality (23.9% vs 38.4%, P < 0.001) and 30-day mortality (39.9% vs 45.9%, P < 0.001) were lower in RCT patients. RCTs in AMI-related CS tend to enroll fewer women and lower-risk patients compared with registries. Patients enrolled in RCTs are more likely to receive aggressive treatment with percutaneous coronary intervention and extracorporeal membrane oxygenation and have lower in-hospital and 30-day mortality. [Display omitted] [ABSTRACT FROM AUTHOR]

Acute myocardial infarction and cardiogenic shock (AMI-CS) is associated with significant morbidity and mortality. Early mechanical revascularization improves survival, and development of STEMI systems of care has increased the utilization of revascularization in AMI-CS from 19% in 2001 to 60% in 2014. Mechanical circulatory support devices are increasingly used to support and prevent hemodynamic collapse. These devices provide different levels of univentricular and biventricular support, have different mechanisms of actions, and provide different physiologic effects. Herein, the authors review the definition, incidence, pathophysiology, and treatment of AMI-CS. [ABSTRACT FROM AUTHOR]

Mechanical circulatory support devices are increasingly used for the treatment of acute myocardial infarction complicated by cardiogenic shock. These devices provide different levels of univentricular and biventricular support, have different mechanisms of actions, and provide different physiologic effects. Institutions require expert teams to safely implant and manage these devices. This article reviews the mechanism of action, physiologic effects, and data as they relate to the utilization of these devices. [ABSTRACT FROM AUTHOR]

Despite early reperfusion and coordinated systems of care, cardiogenic shock (CS) remains the number one cause of morbidity and in-hospital mortality following acute myocardial infarction (AMI). CS is a complex clinical syndrome that begins with hemodynamic instability and can progress to multi-organ failure and profound hemo-metabolic compromise. To improve outcomes, a clear understanding of the treatment objectives in CS and developing time-sensitive management strategies aimed at stabilizing hemodynamics and restoring myocardial perfusion are critical. Left ventricular (LV) load has been identified as an independent predictor of heart failure and mortality following AMI. Decades of preclinical and clinical research have identified several effective LV unloading strategies. Recent initiatives from single and multi-center registries and more recently the Door to Unload (DTU)-STEMI pilot study have provided valuable insight to developing a standardized treatment approach to AMI, based on early invasive hemodynamics and tailored circulatory support to unload the LV. To follow is a review of the pathophysiology and prevalence of shock, limitations of current therapies, and the pre-clinical and translational basis for incorporating LV unloading into contemporary AMI and shock care. [ABSTRACT FROM AUTHOR]

This study sought to compare outcomes of patients enrolled in the NCSI (National Cardiogenic Shock Initiative) trial who were treated using a revascularization strategy of percutaneous coronary intervention (PCI) of multivessel PCI (MV-PCI) versus culprit-vessel PCI (CV-PCI). In patients with multivessel disease who present with acute myocardial infarction and cardiogenic shock (AMICS), intervening on the nonculprit vessel is controversial. There are conflicting published reports and lack of evidence, particularly in patients treated with early mechanical circulatory support (MCS). From July 2016 to December 2019, patients who presented with AMICS to 57 participating hospitals were included in this analysis. All patients were treated using a standard shock protocol emphasizing early MCS, revascularization, and invasive hemodynamic monitoring. Patients with multivessel coronary artery disease (MVCAD) were analyzed according to whether CV-PCI or MV-PCI was undertaken during the index procedure. Of 198 patients with MVCAD, 126 underwent MV-PCI (64%) and 72 underwent CV-PCI (36%). Demographics between the cohorts were similar with respect to age, sex, history of diabetes, prior PCI or coronary artery bypass grafting, and prior history of myocardial infarction. Patients who underwent MV-PCI had a trend toward more severe impairment of cardiac output and worse lactate clearance on presentation, and cardiac performance was significantly worse at 12 h. However, 24 h from PCI, the hemometabolic derangements were similar. Survival and rates of acute kidney injury were not significantly different between groups (69.8% MV-PCI vs. 65.3% CV-PCI; p = 0.51; and 29.9% vs. 34.2%; p = 0.64, respectively). In patients with MVCAD presenting with AMICS treated with early MCS, revascularization of nonculprit lesions was associated with similar hospital survival and acute kidney injury when compared with culprit-only PCI. Selective nonculprit PCI can be safety performed in AMICS in patients supported with mechanical circulatory support. [ABSTRACT FROM AUTHOR]

Supplemental Digital Content is available in the text. Background: Ventricular septal defect (VSD) is a lethal complication of acute myocardial infarction (AMI) and is often associated with cardiogenic shock. The optimal form of percutaneous mechanical circulatory support (MCS) for AMI-VSD is unknown. Methods and Results: We used a previously validated cardiovascular model to simulate AMI-VSD with parameters adjusted to replicate average hemodynamics reported in the literature, including a pulmonary-to-systemic blood flow ratio of 3.0. We then predicted effects of different types of percutaneous MCS (including intra-aortic balloon pumping, Impella, TandemHeart, and extracorporeal membrane oxygenation) on pressures and flows throughout the cardiovascular system. The simulation replicated all major hemodynamic parameters reported in the literature with AMI-VSD. Inotropes and vasopressors worsened left-to-right shunting, whereas vasodilators decreased shunting at the expense of worsening hypotension. All MCS devices increased forward blood flow and arterial pressure but other effects varied among devices. Impella 5.0 provided the greatest degree of pulmonary capillary wedge pressure reductions and decreased left-to-right shunting. Extracorporeal membrane oxygenation worsened pulmonary capillary wedge pressure and shunting, which could be improved by adding Impella or passive left ventricular vent. Pulmonary-to-systemic blood flow ratio could not be reduced below 2.0, and pulmonary flows remained high with all forms of MCS. Conclusions: Although no form of percutaneous MCS normalized hemodynamics in AMI-VSD, pulmonary capillary wedge pressure and shunting were worsened by extracorporeal membrane oxygenation and improved by Impella. Accordingly, based on hemodynamics alone, Impella provides the optimal form of support in AMI-VSD. However, other factors, including team experience, device availability, potential for tissue ingestion, and clinical characteristics, need to be considered when choosing a percutaneous MCS device for AMI-VSD. [ABSTRACT FROM AUTHOR]