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.

Treatment of Acute Myocardial Infarction and Cardiogenic Shock: Outcomes of the RECOVER III Postapproval Study by Society of Cardiovascular Angiography and Interventions Shock Stage.

BACKGROUND: The Society for Cardiovascular Angiography and Interventions proposed a staging system (A-E) to predict prognosis in cardiogenic shock. Herein, we report clinical outcomes of the RECOVER III study for the first time, according to Society for Cardiovascular Angiography and Interventions shock classification. METHODS AND RESULTS: The RECOVER III study is an observational, prospective, multicenter, single-arm, postapproval study of patients with acute myocardial infarction with cardiogenic shock undergoing percutaneous coronary intervention with Impella support. Patients enrolled in the RECOVER III study were assigned a baseline Society for Cardiovascular Angiography and Interventions shock stage. Staging was then repeated within 24 hours after initiation of Impella. Kaplan-Meier survival curve analyses were conducted to assess survival across Society for Cardiovascular Angiography and Interventions shock stages at both time points. At baseline assessment, 16.5%, 11.4%, and 72.2% were classified as stage C, D, and E, respectively. At ≤24-hour assessment, 26.4%, 33.2%, and 40.0% were classified as stage C, D, and E, respectively. Thirty-day survival among patients with stage C, D, and E shock at baseline was 59.7%, 56.5%, and 42.9%, respectively (P=0.003). Survival among patients with stage C, D, and E shock at ≤24 hours was 65.7%, 52.1%, and 29.5%, respectively (P<0.001). After multivariable analysis of impact of shock stage classifications at baseline and ≤24 hours, only stage E classification at ≤24 hours was a significant predictor of mortality (odds ratio, 4.8; P<0.001). CONCLUSIONS: In a real-world cohort of patients with acute myocardial infarction with cardiogenic shock undergoing percutaneous coronary intervention with Impella support, only stage E classification at ≤24 hours was significantly predictive of mortality, suggesting that response to therapy may be more important than clinical severity of shock at presentation.

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.

Improved outcomes in patients with severely depressed LVEF undergoing percutaneous coronary intervention with contemporary practices.

BACKGROUND: Contemporary practices for hemodynamically supported high-risk percutaneous coronary intervention have evolved over the last decade. This study sought to compare outcomes of the prospective, multicenter, PROTECT III study to historic patients treated with Impella in the PROTECT II randomized controlled trial. METHODS: Of 1,134 patients enrolled in PROTECT III from March 2017 to March 2020, 504 were "PROTECT II-like" (met eligibility for PROTECT II randomized controlled trial) and are referred to as PROTECT III for comparative analysis. Major adverse cardiac and cerebrovascular events (MACCE), comprising all-cause mortality, stroke/transient ischemic attack, myocardial infarction, and repeat revascularization, were compared at hospital discharge and 90 days. RESULTS: Compared with PROTECT II (N = 216), PROTECT III patients were less often Caucasian (77.1% vs 83.8%, P = .045), with less prior CABG (13.7% vs 39.4%; P < .001) and prior myocardial infarction (40.7% vs 69.3%; P < .001). More PROTECT III patients underwent rotational atherectomy (37.1% vs 14.8%, P < .001) and duration of support was longer (median 1.6 vs 1.3 hours; p<0.001), with greater improvement achieved in myocardial ischemia jeopardy scores (7.0±2.4 vs 4.4±2.9; P < .001) and SYNTAX scores (21.4±10.8 vs 15.7±9.5; P < .001). In-hospital bleeding requiring transfusion was significantly lower in PROTECT III (1.8% vs 9.3%; P < .001), as was procedural hypotension (2.2% vs 10.1%; P < .001) and cardiopulmonary resuscitation or ventricular arrhythmia (1.6% vs 6.9%; P < .001). At 90 days, MACCE was 15.1% and 21.9% in PROTECT III and PROTECT II, respectively (p=0.037). Following propensity score matching, Kaplan-Meier analysis showed improved 90-day MACCE rates in PROTECT III (10.4% vs 16.9%, P = .048). CONCLUSIONS: The PROTECT III study demonstrates improved completeness of revascularization, less bleeding, and improved 90-day clinical outcomes compared to PROTECT II for Impella-supported high-risk percutaneous coronary intervention among patients with severely depressed LVEF.

Pandemic-Associated Delays in Myocardial Infarction Presentation in Predominantly Rural Counties With Low COVID-19 Prevalence.

Fewer ST-elevation myocardial infarctions (STEMIs) presentations and increased delays in care occurred during the COVID-19 pandemic in urban areas. Whether these associations occurred in a more rural population has not been previously reported. Our objective was to evaluate the impact of COVID-19 on time-to-presentation for STEMI in rural locations. Patients presenting to a large STEMI network spanning 27 facilities and 13 predominantly rural counties between January 1, 2016 and April 30, 2020 were included. Presentation delays, defined as time from symptom onset to arrival at the first medical facility, classified as ≥12 and ≥24 hours from symptom onset were compared among patients in the pre-COVID-19 and the early COVID-19 eras. To account for patient-level differences, 2:1 propensity score matching was performed using binary logistic regression. Among 1,286 patients with STEMI, 1,245 patients presented in the pre-COVID-19 era and 41 presented during the early COVID-19 era. Presentation delays ≥12 hours (19.5% vs 4.0%) and ≥24 hours (14.6% and 0.2%) were more common in COVID-19 than pre-COVID-19 cohorts (p <0.001 for both), despite a low COVID-19 prevalence. Similar results were seen in propensity-matched comparisons (≥12 hours: 19.5% vs 2.4%, p = 0.002; ≥24 hours 14.6% vs 0.0%, p = 0.001). In a predominantly rural STEMI population, delays in seeking medical care after symptom onset were markedly more frequent during the COVID-19 era, despite low COVID-19 prevalence. Considering delays in reperfusion have multiple adverse downstream consequences, these findings may have important implications in rural communities during future pandemic resurgences.

Door-to-unload: left ventricular unloading before reperfusion in ST-elevation myocardial infarction.

ST-elevation myocardial infarction treatment in the modern era has focused on minimizing time of ischemia by reducing door-to-balloon time to limit infarct size and improve survival. Although there have been significant improvements in minimizing time to coronary reperfusion, the incidence of heart failure following a myocardial infarction has remained high. Preclinical studies have shown that unloading the left ventricle for 30 min prior to coronary reperfusion can reduce infarct size and promote myocardial recovery. The DTU-STEMI randomized prospective trial will test the hypothesis that left ventricular unloading for at least 30 min prior to coronary reperfusion will improve infarct size and heart failure-related events as compared with the current standard of care.

Lay abstract Improvements in the treatment of heart attacks over the years have focused on rapidly opening the blocked vessel to limit the amount of heart muscle damage. Although there have been significant improvements in minimizing the time to treatment using various options from medications to balloons and stents, there continues to be a high incidence of heart failure following a heart attack with larger heart attacks leading to more heart failure. Recent studies in animal models have shown that unloading the work of the heart with a temporary heart pump can decrease the size of the heart attack and improve heart muscle recovery. The door-to-unload research program continues to investigate the treatment strategy of unloading the heart for at least 30 min prior to opening the blocked vessel to improve patient outcomes.

Ventricular Septal Rupture in 2 Patients Presenting Late after Myocardial Infarction during the COVID-19 Pandemic.

Ventricular septal rupture (VSR) following myocardial infarction is rare in the reperfusion era. The decrease in patients presenting with myocardial infarction during the coronavirus-2019 (COVID-19) pandemic could result in more frequent VSR. This report describes two patients with VSR presenting late after myocardial infarction and treated at a single institution. (Level of Difficulty: Beginner.).

Implanted Monitor Alerting to Reduce Treatment Delay in Patients With Acute Coronary Syndrome Events.

BACKGROUND: Increased pre-hospital delay during acute coronary syndrome (ACS) events contributes to worse outcome. OBJECTIVES: The purpose of this study was to assess the effectiveness of an implanted cardiac monitor with real-time alarms for abnormal ST-segment shifts to reduce pre-hospital delay during ACS events. METHODS: In the ALERTS (AngeLmed Early Recognition and Treatment of STEMI) pivotal study, subjects at high risk for recurrent ACS events (n = 907) were randomized to control (Alarms OFF) or treatment groups for 6 months, after which alarms were activated in all subjects (Alarms ON). Emergency department (ED) visits with standard-of-care cardiac test results were independently adjudicated as true- or false-positive ACS events. Alarm-to-door (A2D) and symptom-to-door (S2D) times were calculated for true-positive ACS ED visits triggered by 3 possible prompts: alarm only, alarms + symptoms, or symptoms only. RESULTS: The Alarms ON group showed reduced delays, with 55% (95% confidence interval [CI]: 46% to 63%) of ED visits for ACS events <2 h compared with 10% (95% CI: 2% to 27%) in the Alarms OFF group (p < 0.0001). Results were similar when restricted to myocardial infarction (MI) events. Median pre-hospital delay for MI was 12.7 h for Alarms OFF and 1.6 h in Alarms ON subjects (p < 0.0089). Median A2D delay was 1.4 h for asymptomatic MI. Median S2D delay for symptoms-only MI (no alarm) in Alarms ON was 4.3 h. CONCLUSIONS: Intracardiac monitoring with real-time alarms for ST-segment shift that exceeds a subject's self-normative ischemia threshold level significantly reduced the proportion of pre-hospital delays >2 h for ACS events, including asymptomatic MI, compared with symptoms-only ED visits in Alarms OFF. (AngeLmed for Early Recognition and Treatment of STEMI [ALERTS]; NCT00781118).

Implantable Cardiac Alert System for Early Recognition of ST-Segment Elevation Myocardial Infarction.

BACKGROUND: Symptoms remain a poor prompt for acute coronary syndromes (ACS). Timely restoration of perfusion in ST-segment elevation myocardial infarction is associated with improved left ventricular function and survival. OBJECTIVES: This report details the results of ALERTS (AngelMed for Early Recognition and Treatment of STEMI), a multicenter, randomized trial of an implantable cardiac monitor that alerts patients with rapidly progressive ST-segment deviation. METHODS: High-risk ACS subjects (N = 907) were randomized to a control (alarms deactivated) or treatment group for 6 months, after which alarms were activated in all subjects. The primary safety endpoint was absence of system-related complications (>90%). The composite primary efficacy endpoint was cardiac/unexplained death, new Q-wave myocardial infarction, or detection to presentation time >2 h. RESULTS: Safety was met with 96.7% freedom from system-related complications (n = 30). The efficacy endpoint for a confirmed occlusive event within 7 days was not significantly reduced in the treatment compared with control group (16 of 423 [3.8%] vs. 21 of 428 [4.9%], posterior probability = 0.786). Within a 90-day window, alarms significantly decreased detection to arrival time at a medical facility (51 min vs. 30.6 h; Pr [pt < pc] >0.999). In an expanded analysis using data after the randomized period, positive predictive value was higher (25.8% vs. 18.2%) and false positive rate significantly lower in the ALARMS ON group (0.164 vs. 0.678 false positives per patient-year; p < 0.001). CONCLUSIONS: The implantable cardiac system detects early ST-segment deviation and alerts patients of a potential occlusive event. Although the trial did not meet its pre-specified primary efficacy endpoint, results suggest that the device may be beneficial among high-risk subjects in potentially identifying asymptomatic events. (AngelMed for Early Recognition and Treatment of STEMI [ALERTS]; NCT00781118).

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.

Outcomes After Percutaneous Coronary Intervention in Patients With a History of Cerebrovascular Disease: Insights From the Blue Cross Blue Shield of Michigan Cardiovascular Consortium.

BACKGROUND: Because of shared risk factors between coronary artery disease and cerebrovascular disease, patients with a history of transient ischemic attack (TIA) or stroke are at greater risk of developing coronary artery disease, which may require percutaneous coronary intervention (PCI). However, there remains a paucity of research examining outcomes after PCI in these patients. METHODS AND RESULTS: We analyzed consecutive patients who underwent PCI between January 1, 2013, and March 31, 2016, at 47 Michigan hospitals and identified those with a history of TIA/stroke. We used propensity score matching to adjust for differences in baseline characteristics and compared in-hospital outcomes between patients with and without a history of TIA/stroke. We compared rates of 90-day readmission and long-term mortality in a subset of patients. Among 98 730 patients who underwent PCI, 10 915 had a history of TIA/stroke. After matching (n=10 618 per group), a history of TIA/stroke was associated with an increased risk of in-hospital stroke (adjusted odds ratio, 2.04; 95% confidence interval, 1.41-2.96; P<0.001). There were no differences in the risks of other in-hospital outcomes. In a subset of patients with postdischarge data, a history of TIA/stroke was associated with increased risks of 90-day readmission (adjusted odds ratio, 1.22; 95% confidence interval, 1.09-1.38; P<0.001) and long-term mortality (hazard ratio, 1.23; 95% confidence interval, 1.07-1.43; P=0.005). CONCLUSIONS: A history of TIA/stroke was common in patients who underwent PCI and was associated with increased risks of in-hospital stroke, 90-day readmission, and long-term mortality. Given the devastating consequences of post-PCI stroke, patients with a history of TIA/stroke should be counseled on this increased risk before undergoing PCI.

Radiation Exposure Among Scrub Technologists and Nurse Circulators During Cardiac Catheterization: The Impact of Accessory Lead Shields.

OBJECTIVES: This study was performed to determine if the use of an accessory lead shield is associated with a reduction in radiation exposure among staff members during cardiac catheterization. BACKGROUND: Accessory lead shields that protect physicians from scatter radiation are standard in many catheterization laboratories, yet similar shielding for staff members is not commonplace. METHODS: Real-time radiation exposure data were prospectively collected among nurses and technologists during 764 consecutive catheterizations. The study had 2 phases: in phase I (n = 401), standard radiation protection measures were used, and in phase II (n = 363), standard radiation protection measures were combined with an accessory lead shield placed between the staff member and patient. Radiation exposure was reported as the effective dose normalized to dose-area product (EDAP). RESULTS: Use of an accessory lead shield in phase II was associated with a 62.5% lower EDAP per case among technologists (phase I: 2.4 [4.3] µSv/[mGy × cm2] × 10-5; phase II: 0.9 [2.8] µSv/[mGy × cm2] × 10-5; p < 0.001) and a 63.6% lower EDAP per case among nurses (phase I: 1.1 [3.1] µSv/[mGy × cm2] × 10-5; phase II: 0.4 [1.8] µSv/[mGy × cm2] × 10-5; p < 0.001). By multivariate analysis, accessory shielding remained independently associated with a lower EDAP among both technologists (34.2% reduction; 95% confidence interval: 20.1% to 45.8%; p < 0.001) and nurses (36.4% reduction; 95% confidence interval: 19.7% to 49.6%; p < 0.001). CONCLUSIONS: The relatively simple approach of using accessory lead shields to protect staff members during cardiac catheterization was associated with a nearly two-thirds reduction in radiation exposure among nurses and technologists.

Ninety-Day Readmission and Long-Term Mortality in Medicare Patients (≥65 Years) Treated With Ticagrelor Versus Prasugrel After Percutaneous Coronary Intervention (from the Blue Cross Blue Shield of Michigan Cardiovascular Consortium).

Ticagrelor and prasugrel were found to be superior to clopidogrel for the treatment of acute coronary syndrome (ACS) after percutaneous coronary intervention (PCI); however, the comparative effectiveness of these 2 drugs remains unknown. We compared postdischarge outcomes among older patients treated with ticagrelor versus prasugrel after PCI for ACS. We linked clinical data from PCIs performed in older patients (age ≥65) for ACS at 47 Michigan hospitals to Medicare fee-for-service claims from January 1, 2013, to December 31, 2014, to ascertain rates of 90-day readmission and long-term mortality. We used propensity score matching to adjust for the nonrandom use of ticagrelor and prasugrel at discharge. Logistic regression and Cox proportional hazards models were used to compare rates of 90-day readmission and long-term mortality, respectively. Patients discharged on ticagrelor (n = 1,243) were more frequently older, female, had a history of cerebrovascular disease, and presented with ST- or non-ST-elevation myocardial infarction compared with prasugrel (n = 1,014). After matching (n = 756 per group), there were no significant differences in the rates of 90-day readmission (16.7% ticagrelor vs 14.6% prasugrel; adjusted odds ratio 1.15, 95% confidence interval 0.86 to 1.55, p = 0.35) or 1-year mortality (5.4% ticagrelor vs 3.7% prasugrel; hazard ratio 1.3, 95% confidence interval 0.8 to 2.2, p = 0.31). In conclusion, we found no significant differences in the rates of 90-day readmission or long-term mortality between older patients treated with ticagrelor and patients treated with prasugrel after PCI for ACS. In the absence of randomized data to the contrary, these 2 treatments appear similarly effective.

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.

Impact of robotics and a suspended lead suit on physician radiation exposure during percutaneous coronary intervention.

BACKGROUND: Reports of left-sided brain malignancies among interventional cardiologists have heightened concerns regarding physician radiation exposure. This study evaluated the impact of a suspended lead suit and robotic system on physician radiation exposure during percutaneous coronary intervention (PCI). METHODS: Real-time radiation exposure data were prospectively collected from dosimeters worn by operating physicians at the head- and chest-level during consecutive PCI cases. Exposures were compared in three study groups: 1) manual PCI performed with traditional lead apparel; 2) manual PCI performed using suspended lead; and 3) robotic PCI performed in combination with suspended lead. RESULTS: Among 336 cases (86.6% manual, 13.4% robotic) performed over 30weeks, use of suspended lead during manual PCI was associated with significantly less radiation exposure to the chest and head of operating physicians than traditional lead apparel (chest: 0.0 [0.1] µSv vs 0.4 [4.0] µSv, p<0.001; head: 0.5 [1.9] µSv vs 14.9 [51.5] µSv, p<0.001). Chest-level radiation exposure during robotic PCI performed in combination with suspended lead was 0.0 [0.0] µSv, which was significantly less chest exposure than manual PCI performed with traditional lead (p<0.001) or suspended lead (p=0.046). In robotic PCI the median head-level exposure was 0.1 [0.2] µSv, which was 99.3% less than manual PCI performed with traditional lead (p<0.001) and 80.0% less than manual PCI performed with suspended lead (p<0.001). CONCLUSIONS: Utilization of suspended lead and robotics were observed to result in significantly less radiation exposure to the chest and head of operating physicians during PCI.

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.

Confirmation of the Intracoronary Near-Infrared Spectroscopy Threshold of Lipid-Rich Plaques That Underlie ST-Segment-Elevation Myocardial Infarction.

OBJECTIVE: In a previous exploratory analysis, intracoronary near-infrared spectroscopy (NIRS) found the majority of culprit lesions in ST-segment-elevation myocardial infarction (STEMI) to contain a maximum lipid core burden index in 4 mm (maxLCBI4mm) of >400. This initial study was limited by a small sample size, enrollment at a single center, and post hoc selection of the maxLCBI4mm ≥400 threshold. This study was designed a priori to substantiate the ability of NIRS to discriminate STEMI culprit from nonculprit segments and to confirm the performance of the maxLCBI4mm ≥400 threshold. APPROACH AND RESULTS: At 2 centers in the United States and Sweden, 75 STEMI patients underwent intracoronary NIRS imaging after establishing thrombolysis in myocardial infarction 3 flow, but before stenting. Blinded core laboratory analysis defined the culprit segment as the 10-mm segment distal to the proximal angiographic culprit margin. The remaining vessel was divided into contiguous 10-mm nonculprit segments. The maxLCBI4mm of culprit segments (median [interquartile range]: 543 [273-756]) was 4.4-fold greater than nonculprit segments (median [interquartile range]: 123 [0-307]; P<0.001). Receiver-operating characteristic analysis demonstrated that maxLCBI4mm differentiated culprit from nonculprit segments with high accuracy (c-statistic=0.83; P<0.001). A threshold maxLCBI4mm ≥400 identified STEMI culprit segments with a sensitivity of 64% and specificity of 85%. CONCLUSIONS: This study substantiates the ability of NIRS to accurately differentiate STEMI culprit from nonculprit segments and confirms that a threshold maxLCBI4mm ≥400 is detected by NIRS in the majority of STEMI culprits.

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.

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.

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.