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Background This pre-clinical study evaluated the efficacy of a novel shielding system to reduce scatter radiation in the cardiac catheterization laboratory. Methods Using a scatter radiation phantom in a standard cardiac catheterization laboratory, a radiation physicist recorded radiation measurements at 20 reference points on the operator side of the table. Measurements were made with fluoroscopy and cine with the C-arm in the posterior-anterior (PA) and 40 degrees left anterior oblique (LAO) orientations. Scatter radiation doses were compared with and without use of the shielding system. Results Use of the shielding system was associated with >94.2% reduction in scatter radiation across all reference points in the PA and LAO projections with fluoroscopy and cine. With the shielding system, dose reductions at the location of the primary operator ranged from 97.8% to 99.8%. At locations of maximum scatter radiation, use of the shielding system resulted in dose reductions ranging from 97.8% to 99.8% with fluoroscopy and from 97.9% to 99.8% with cine. Conclusions In this pre-clinical study, a novel radiation shielding system was observed to dramatically reduce scatter radiation doses. Based on these results, clinical testing is warranted to determine whether the shielding system will enable operators and staff to perform interventional procedures with less radiation exposure that may obviate the need to wear standard lead apparel. Indexing words Radiation safety; occupational health; occupational hazard.

Background Supersaturated oxygen (SSO2 ) has recently been approved by the U.S. Food and Drug Administration for administration after primary percutaneous coronary intervention (pPCI) in patients with anterior ST-segment elevation myocardial infarction (STEMI) based on its demonstration of infarct size reduction in the IC-HOT study. Objectives To describe the 1-year clinical outcomes of intracoronary SSO2 treatment after pPCI in patients with anterior STEMI. Methods IC-HOT was a prospective, open-label, single-arm study in which 100 patients without cardiogenic shock undergoing successful pPCI of an occluded left anterior descending coronary artery were treated with a 60-min SSO2 infusion. One-year clinical outcomes were compared with a propensity-matched control group of similar patients with anterior STEMI enrolled in the INFUSE-AMI trial. Results Baseline and postprocedural characteristics were similar in the two groups except for pre-PCI thrombolysis in myocardial infarction 3 flow, which was less prevalent in patients treated with SSO2 (9.6% vs. 22.9%, p = .02). Treatment with SSO2 was associated with a lower 1-year rate of the composite endpoint of all-cause death or new-onset heart failure (HF) or hospitalization for HF (0.0% vs. 12.3%, p = .001). All-cause mortality, driven by cardiovascular mortality, and new-onset HF or HF hospitalization were each individually lower in SSO2 -treated patients. There were no significant differences between groups in the 1-year rates of reinfarction or clinically driven target vessel revascularization. Conclusions Infusion of SSO2 following pPCI in patients with anterior STEMI was associated with improved 1-year clinical outcomes including lower rates of death and new-onset HF or HF hospitalizations.

Objectives The aim of this study was to evaluate institutional variability in high radiation doses during percutaneous coronary intervention (PCI). Background It is unknown whether radiation safety practices are optimally applied across institutions performing PCI. Methods Using data from a large statewide registry, PCI discharges between July 1, 2016, and March 31, 2018, with a procedural air kerma (AK) recorded were analyzed. PCI procedures were grouped by the performing hospital, and institutional frequency of procedural AK ≥5 Gy was calculated. Fitted hierarchical Bayesian modeling was performed to identify variables independently associated with an AK ≥5 Gy. The performing hospital was included as a random effect in the hierarchical model. Results Among 36,201 PCI procedures at 28 hospitals, procedural AK was ≥5 Gy in 1,477 cases (4.1%), ≥10 Gy in 185 (0.5%), and ≥15 Gy in 105 (0.3%). The institutional frequency of procedural AK ≥5 Gy ranged from 0.0% to 10.9%. Bayesian modeling identified body mass index, dyslipidemia, diabetes, prior coronary bypass surgery, use of mechanical circulatory support, and the performing hospital as independent predictors of an AK ≥5 Gy. The median odds ratio for the performing hospital, representing an estimate of the contribution of interhospital variability in determining the odds of having a procedural AK ≥5 Gy, was 3.08 (95% confidence interval: 3.01 to 3.16). Conclusions Wide variability exists in the institutional frequency of procedural AK ≥5 Gy during PCI. After accounting for patient characteristics and procedural variables, the performing hospital appears to be a major factor in determining patient radiation dose in contemporary PCI.

Background Autopsy studies suggest that implanting stents in lipid-rich plaque (LRP) may be associated with adverse outcomes. Objectives The purpose of this study was to evaluate the association between LRP detected by near-infrared spectroscopy (NIRS) and clinical outcomes in patients with coronary artery disease treated with contemporary drug-eluting stents. Methods In this prospective, multicenter registry, NIRS was performed in patients undergoing coronary angiography and possible percutaneous coronary intervention (PCI). Lipid core burden index (LCBI) was calculated as the fraction of pixels with the probability of LRP >0.6 within a region of interest. MaxLCBI4mm was defined as the maximum LCBI within any 4-mm-long segment. Major adverse cardiac events (MACE) included cardiac death, myocardial infarction, definite or probable stent thrombosis, or unplanned revascularization or rehospitalization for progressive angina or unstable angina. Events were subcategorized as culprit (treated) lesion–related, nonculprit (untreated) lesion–related, or indeterminate. Results Among 1,999 patients who were enrolled in the COLOR (Chemometric Observations of Lipid Core Plaques of Interest in Native Coronary Arteries Registry), PCI was performed in 1,621 patients and MACE occurred in 18.0% of patients, of which 8.3% were culprit lesion–related, 10.7% were nonculprit lesion–related, and 3.1% were indeterminate during 2-year follow-up. Complications from NIRS imaging occurred in 9 patients (0.45%), which resulted in 1 peri-procedural myocardial infarction and 1 emergent coronary bypass. Pre-PCI NIRS imaging was obtained in 1,189 patients, and the 2-year rate of culprit lesion–related MACE was not significantly associated with maxLCBI4mm (hazard ratio of maxLCBI4mm per 100: 1.06; 95% confidence interval: 0.96 to 1.17; p = 0.28) after adjusting clinical and procedural factors. Conclusions Following PCI with contemporary drug-eluting stents, stent implantation in NIRS-defined LRPs was not associated with increased periprocedural or late adverse outcomes compared with those without significant lipid.

Aim To compare the efficacy and safety of P2Y12 inhibitor or aspirin monotherapy for secondary prevention in patients with atherosclerotic cardiovascular disease (ASCVD). Methods and results Medline, Embase, and Cochrane Central databases were searched to identify randomized trials comparing monotherapy with a P2Y12 inhibitor versus aspirin for secondary prevention in patients with ASCVD (cardiovascular, cerebrovascular, or peripheral artery disease). The primary outcome was major adverse cardiac events (MACE). Secondary outcomes were myocardial infarction (MI), stroke, all-cause mortality, and major bleeding. A random-effects model was used to calculate risk ratios (RR) and the corresponding 95% confidence interval (CI) and heterogeneity among studies was assessed using the Higgins I2 value. A total of 9 eligible trials (5 with clopidogrel and 4 with ticagrelor) with 61 623 patients were included in our analyses. Monotherapy with P2Y12 inhibitors significantly reduced the risk of MACE by 11% (0.89, 95% CI 0.84–0.95, I2 = 0%) and MI by 19% (0.81, 95% CI 0.71–0.92, I2 = 0%) compared with aspirin monotherapy. There was no significant difference in the risk of stroke (0.85, 95% CI 0.73–1.01), or all-cause mortality (1.01, 95% CI 0.92–1.11). There was also no significant difference in the risk of major bleeding with P2Y12 inhibitor monotherapy compared with aspirin (0.94, 95% CI 0.72–1.22, I2 = 42.6%). Results were consistent irrespective of the P2Y12 inhibitor used. Conclusion P2Y12 inhibitor monotherapy for secondary prevention is associated with a significant reduction in atherothrombotic events compared with aspirin alone without an increased risk of major bleeding.

To compare the efficacy and safety of P2YMedline, Embase, and Cochrane Central databases were searched to identify randomized trials comparing monotherapy with a P2YP2Y

Objectives This study sought to describe the association between trends in primary and secondary vascular access sites and vascular access site complications (VASCs) among patients who underwent percutaneous coronary intervention (PCI) in Michigan. Background The frequency of transradial PCI has increased. As a result, there is concern that operators may lose femoral-access proficiency resulting in a paradoxical increase in PCI complications. Anecdotally, an increase in secondary access use during PCI has also been observed. Methods Data from the BMC2 (Blue Cross Blue Shield of Michigan Cardiovascular Consortium) registry was queried to evaluate the use of transradial and transfemoral PCI and their associated VASCs. Results From 2013 to 2017, transradial PCI increased from 25.9% to 45.2% and the overall use of secondary vascular access increased from 4.9% to 8.7% with minimal change in overall VASCs (1.2% to 1.4%). The use of secondary vascular access was associated with increased VASCs (odds ratio [OR]: 5.82; 95% confidence interval [CI]: 5.26 to 6.43). Although, patients treated by operators in the highest tertile of radial use were more likely to experience femoral VASCs (adjusted OR: 1.51; 95% CI: 1.08 to 2.13), treatment by these operators was associated with an overall reduction in all VASCs (adjusted OR: 0.62; 95% CI: 0.46 to 0.83). Conclusions Despite increased use of transradial PCI, there has been no significant decrease in VASCs. This is in part attributable to an increased incidence of femoral VASCs and increasing use of secondary vascular access. An overall reduction in VASCs was observed in the highest radial use operators. Further strategies are needed to reduce VASCs in the transradial era.

Objectives. We sought to assess if ineligibility to coronary artery bypass grafting (CABG) constitutes a risk factor in patients who underwent a nonemergent unprotected left main coronary artery (ULMCA) percutaneous coronary intervention (PCI) with prophylactic Impella® heart pump support. Background. ULMCA PCI in patients not deemed eligible for CABG is associated with significantly worse outcomes compared to ULMCA PCI in eligible patients. Methods. Patients from the cVAD Registry and the PROTECT II trial who underwent a nonemergent ULMCA PCI were identified. We compared in-hospital mortality and major adverse cardiac and cerebrovascular event (MACCE) rates as well as 30-day survival and MACCE rates between CABG ineligible and CABG eligible patients. Results. A total of 331 patients were included (293 Impella 2.5®, 38 Impella CP®); 227 were ineligible for CABG and 104 were eligible. Baseline characteristics were remarkable for a trend toward higher rate of chronic obstructive pulmonary disease in the ineligible patients. In-hospital mortality (3.52% vs. 5.77%; p=0.383) and MACCE (6.61% vs. 7.69%; p=0.816) rates as well as 30-day survival (92.0% vs. 93.4%; Log-Rank p-value =0.781) and MACCE (88.1% vs. 90.1%; Log-Rank p-value=0.648) rates were not different between the two groups. Conclusions. The results of our study suggest that prophylactic Impella support appears to mitigate the risks inherent to surgical ineligibility in patients undergoing a nonemergent ULMCA PCI. Our results require further investigation.

Background: Uncertainty exists over whether stents commonly used for percutaneous coronary intervention have comparable short- and long-term safety. The objective of this study was to determine the outcomes of patients treated with bioabsorbable polymer everolimus-eluting (BP-EES; Synergy, Boston Scientific), durable polymer everolimus-eluting (DP-EES; XIENCE, Abbott Vascular), or durable polymer zotarolimus-eluting (DP-ZES; Resolute, Medtronic) stents in routine clinical practice. Methods: All percutaneous coronary intervention cases from 48 hospitals performed after the introduction of the BP-EES stent in 2015 until the first quarter of 2018 were included. Propensity-matched multivariable analysis was used to adjust for differences in baseline characteristics and procedural variables. After matching, we performed pair-wise comparisons between DP-EES and BP-EES, DP-EES and DP-ZES, and BP-EES and DP-ZES for in-hospital postpercutaneous coronary intervention outcomes. We also evaluated 2-year postdischarge mortality in a subset of patients who could be matched to Medicare data. Results: During the study period, 53 724 percutaneous coronary intervention cases were performed. A total of 59% of patients were treated with DP-EES stents, 14% with BP-EES stents, and 27% with DP-ZES stents. Although baseline characteristics of patients differed between stent types, these differences were attenuated after matching. In the matched cohort, there was no difference in in-hospital mortality, stent thrombosis, or postprocedural stroke (a falsification end point) between BP-EES, DP-EES, and DP-ZES. After matching, there was no difference in 2-year postdischarge mortality (DP-EES versus BP-EES hazard ratio 0.91, P =0.50; DP-EES versus DP-ZES hazard ratio 1.03, P =0.77; BP-EES versus DP-ZES hazard ratio 1.20, P =0.29). Conclusions: Our data suggest similar risk-adjusted in-hospital outcomes among drug-eluting stent platforms commonly used in clinical practice. The absence of a difference in 2-year mortality between BP-EES, DP-EES, and DP-ZES suggests that stent choice decisions could be made based on other factors, including durability, availability, and cost.

BACKGROUND Transfemoral venous access (TFV) is the cornerstone of minimally invasive cardiac procedures. Although the presence of inferior vena cava filters (IVCFs) was considered a relative contraindication to TFV procedures, small experiences have suggested safety. We conducted a systematic review of the available literature on cardiac procedural success of TFV with IVCF in-situ. METHODS Two independent reviewers searched PubMed, EMBASE, SCOPUS, and Google Scholar from inception to October 2020 for studies that reported outcomes in patients with IVCFs undergoing TFV for invasive cardiac procedures. We investigated a primary outcome of acute procedural success and reviewed the pooled data for patient demographics, procedural complications, types of IVCF, IVCF dwell time, and procedural specifics. RESULTS Out of the 120 studies initially screened, 8 studies were used in the final analysis with a total of 100 patients who underwent 110 procedures. The most common IVCF was the Greenfield Filter (36%), 60% of patients were males and the mean age was 67.8 years. The overall pooled incidence of acute procedural success was 95.45% (95% confidence interval = 89.54-98.1) with no heterogeneity (I2 = 0%, p = 1) and there were no reported filter-related complications. CONCLUSION This systematic review is the largest study of its kind to demonstrate the safety and feasibility of TFV access in a variety of cardiac procedures in the presence of IVCF.

In asymptomatic severe aortic (AR) and mitral regurgitation (MR), left ventricular (LV) dimension criteria were established to guide timing of valve replacement to prevent irreversible LV dysfunction. Given both lesions are primary LV volume overload ''leaks'', it might be expected that both lesions would induce similar impact on the LV and result in equivalent dimension criteria for intervention. However, the dimension-based intervention criteria for AR versus MR (developed through natural history studies), differ markedly. The pathophysiological foundations for such discordance have neither been fully elucidated nor emphasized. This case-based treatise compares the two regurgitant lesions with respect to: (a) ''total regurgitant circuits''; (b) ''driving pressures'' resulting in LV volume overload from each respective ''leak''; and (c) volume and afterload wall stresses imposed on the LV.Key points The ''total circuits'' of volume overload differ: The AR circuit includes the LV and systemic vasculature, whereas MR includes the LV ejecting into the left atrium/pulmonary veins and systemic circulation. The ''driving pressure'' of regurgitation and afterload are high with AR and low with MR. Differing ''total circuits'' and ''driving pressures'' impose disparate wall stresses upon the LV. Parallel and serial sarcomere replication occurs in AR, while only serial replication occurs in MR. It therefore follows that for regurgitation of similar severities, AR results in greater LV dilation at the point of irreversible myocardial dysfunction compared to MR. These considerations may explain, at least in part, the disparate dimension criteria employed for valve intervention for severe AR vs MR.

Introduction Severe acute respiratory syndrome coronavirus‐2 (SARS‐CoV‐2)–infected patients commonly have elevated troponin and D‐dimer levels, but limited imaging exists to support most likely etiologies in efforts to avoid staff exposure. The purpose of this study was to report transthoracic echocardiographic (TTE) findings in SARS‐CoV‐2 patients with correlating troponin and D‐dimer levels. Methods We identified 66 SARS‐CoV‐2 patients (mean age 60 ± 15.7 years) admitted within a large, eight‐hospital healthcare system over a 6‐week period with a TTE performed. TTE readers were blinded to laboratory data with intra‐observer and inter‐observer analysis assessed. Results Sixty‐six of 1780 SARS‐CoV‐2 patients were included and represented a high‐risk population as 38 (57.6%) were ICU‐admitted, 47 (71.2%) had elevated D‐dimer, 41 (62.1%) had elevated troponin, and 25 (37.9%) died. Right ventricular (RV) dilation was present in 49 (74.2%) patients. The incidence and average D‐dimer elevation was similar between moderate/severe vs. mild/no RV dilation (69.6% vs 67.6%, P = 1.0; 3736 ± 2986 vs 4141 ± 3351 ng/mL, P = .679). Increased left ventricular (LV) wall thickness was present in 46 (69.7%) with similar incidence of elevated troponin and average troponin levels compared to normal wall thickness (66.7% vs 52.4%, P = .231; 0.88 ± 1.9 vs 1.36 ± 2.4 ng/mL, P = .772). LV dilation was rare (n = 6, 9.1%), as was newly reduced LV ejection fraction (n = 2, 3.0%). Conclusion TTE in SARS‐CoV‐2 patients is scarce, technically difficult, and reserved for high‐risk patients. RV dilation is common in SARS‐CoV‐2 but does not correlate with elevated D‐dimer levels. Increased LV wall thickness is common, while newly reduced LV ejection fraction is rare, and neither correlates with troponin levels.

Objective To evaluate the impact of COVID‐19 pandemic migitation measures on of ST‐elevation myocardial infarction (STEMI) care. Background We previously reported a 38% decline in cardiac catheterization activations during the early phase of the COVID‐19 pandemic mitigation measures. This study extends our early observations using a larger sample of STEMI programs representative of different US regions with the inclusion of more contemporary data. Methods Data from 18 hospitals or healthcare systems in the US from January 2019 to April 2020 were collecting including number activations for STEMI, the number of activations leading to angiography and primary percutaneous coronary intervention (PPCI), and average door to balloon (D2B) times. Two periods, January 2019–February 2020 and March–April 2020, were defined to represent periods before (BC) and after (AC) initiation of pandemic mitigation measures, respectively. A generalized estimating equations approach was used to estimate the change in response variables at AC from BC. Results Compared to BC, the AC period was characterized by a marked reduction in the number of activations for STEMI (29%, 95% CI:18–38, p

Coronavirus disease 2019 is a global pandemic affecting >3 million people in >170 countries, resulting in >200 000 deaths; 35% to 40% of patients and deaths are in the United States. The coronavirus disease 2019 crisis is placing an enormous burden on health care in the United States, including residency and fellowship training programs. The balance between mitigation, training and education, and patient care is the ultimate determinant of the role of cardiology fellows in training during the coronavirus disease 2019 crisis. On March 24, 2020, the Accreditation Council for Graduate Medical Education issued a formal response to the pandemic crisis and described a framework for operation of graduate medical education programs. Guidance for deployment of cardiology fellows in training during the coronavirus disease 2019 crisis is based on the principles of a medical mission, and adherence to preparation, protection, and support of our fellows in training. The purpose of this review is to describe our departmental strategic deployment of cardiology fellows in training using the Accreditation Council for Graduate Medical Education framework for pandemic preparedness.

OBJECTIVES We applied the cardiovascular angiography and interventions (SCAI) shock staging system to patients presenting with acute myocardial infarction and cardiogenic shock (AMI-CS) who were enrolled in the National Cardiogenic Shock Initiative (NCSI). BACKGROUND The SCAI shock staging system provides a framework for evaluation of patients with CS based on clinical and hemodynamic parameters, but has not been validated in patients with AMI-CS managed with a contemporary treatment algorithm that incorporates early use of Impella. METHODS Consecutive patients enrolled in NCSI were identified, all of whom were managed with invasive hemodynamic guidance and supported with Impella. Patients were retrospectively categorized into appropriate SCAI shock stages, and outcomes were assessed accordingly. RESULTS A total of 300 patients were included in the analysis; 182 patients (61%) presented in Stage C shock, 25 (8%) in Stage D, and 93 (31%) in Stage E. Survival to hospital discharge was 76, 76, and 58%, respectively (p = .006). Survival was

OBJECTIVES The objective of this study was to determine the long-term major adverse cardiac events (MACE) in patients treated with intracoronary brachytherapy (ICBT) for coronary in-stent restenosis (ISR). BACKGROUND ICBT was commonly used to treat coronary ISR prior to the availability of drug-eluting stents (DES). The long-term outcomes of ICBT for ISR remain unknown. METHODS Six hundred and eighty consecutive patients who underwent ICBT treated for ISR between September 1998 and April 2005 were included in the study. Clinical and angiographic data were collected and the long-term MACE were measured for all-cause death, myocardial infarction (MI), and target vessel revascularization (TVR) at 10-year follow-up. RESULTS Patients were 63 ± 11 years old (66% male). The majority of patients were treated with a bare metal stent 670/680 (99%) prior to ICBT. Significant baseline clinical findings include high incidence of smokers 479/680 (70%), hyperlipidemia 638/680 (94%), and multivessel disease 526/680 (77%). The majority of target lesions were diffuse 407/680 (60%), and either in the left anterior descending 258/680 (38%) or right coronary artery 215/680 (32%). At 10-year follow-up, the rate of death was 25%, MI was 22.4%, and TVR was 48%. CONCLUSION MACE at 10-year follow-up following ICBT for ISR indicates steady rate of death and MI and declining rate of TVR after 5 years.

Background In the randomized AMIHOT-II trial, supersaturated oxygen [SSO2 ] delivered into the left anterior descending (LAD) artery via an indwelling intracoronary infusion catheter following primary percutaneous coronary intervention (PCI) significantly reduced infarct size in patients with anterior ST-segment elevation myocardial infarction (STEMI) but resulted in a numerically higher incidence of safety events. Objectives The IC-HOT study evaluated the safety of SSO2 therapy selectively delivered to the left main coronary artery (LMCA) for 60 minutes after PCI in patients with anterior STEMI. Methods SSO2 therapy was administered to the LMCA after stent implantation in 100 patients with anterior STEMI and proximal or mid-LAD occlusion presenting within 6 hours of symptom onset. The primary endpoint was the 30-day composite rate of net adverse clinical events (NACE) (death, reinfarction, clinically driven target vessel revascularization, stent thrombosis, severe heart failure, or TIMI major/minor bleeding) compared against an objective performance goal of 10.7%. Cardiac magnetic resonance imaging was performed at 4 and 30 days to assess infarct size. Results SSO2 delivery was successful in 98% of patients. NACE at 30 days occurred 7.1% of patients (meeting the primary safety endpoint of the study); there were no deaths, only one stent thrombosis and one case of severe heart failure. Median [interquartile range] infarct size was 24.1% [14.4%, 31.6%] at 4 days and 19.4% [8.8%, 28.9%] at 30 days. Conclusion Following primary PCI in acute anterior STEMI, infusion of SSO2 via the LMCA was feasible and was associated with a favorable early safety profile.

The Impella percutaneous ventricular assist device (PVAD) rapidly deploys mechanical circulatory support (MCS) in patients with acute myocardial infarction complicated by cardiogenic shock (AMICS). We present findings from a quality improvement (IQ) registry for US patients with AMICS who received Impella devices.From January 2009 to December 2016, 46,949 patients from 1010US hospitals were entered into the IQ registry; of these, 15,259 had AMICS. Limited de-identified patient information, product performance, and survival to explantation were recorded. Of those with AMICS, 51% survived to explantation of PVAD. There was a significant difference between survival at explantation with quintile volume at hospitals (range: 0-100%; 30% survival rate in lowest quintile vs. 76% in top quintile; P.0001). Use of the Impella device as first-line treatment pre-PCI was associated with a 59% survival rate, compared with 52% when used as a salvage strategy (P.001). The survival rate among those who received hemodynamic monitoring with pulmonary artery catheters was 63% as compared with 49% in those who did not (P.0001). Overall institutional Impella volume was related to survival (56% survival at sites with7/year vs. 51% at sites with ≤1; P.001).In this early clinical experience with Impella support for AMICS, wide variation in outcomes existed across centers. Survival was higher when Impella was used as first support strategy, when invasive hemodynamic monitoring was used, and at centers with higher Impella implantation volume.

Incomplete revascularization is associated with worse outcomes as the number of untreated vessels increases [(1)][1]. Impella (Abiomed, Danvers, Massachusetts) and intra-aortic balloon pumps (IABP) were compared in the PROTECT-II randomized trial (A Prospective, Multi-center, Randomized

Objectives: This study sought to examine the relationship between temperature at reperfusion and infarct size. Background: Hypothermia consistently reduces infarct size when administered prior to reperfusion in animal studies, however, clinical results have been inconsistent. Methods: We performed a patient-level pooled analysis from six randomized control trials of endovascular cooling during primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) in 629 patients in which infarct size was assessed within 1 month after randomization by either single-photon emission computed tomography (SPECT) or cardiac magnetic resonance imaging (cMR). Results: In anterior infarct patients, after controlling for variability between studies, mean infarct size in controls was 21.3 (95%CI 17.4-25.3) and in patients with hypothermia

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.

The role and timing of percutaneous mechanical circulatory support (MCS) devices in the treatment of acute myocardial infarction complicated by cardiogenic shock (AMICS) are not well understood. We sought to evaluate patient characteristics and predictors of outcomes in patients presenting with AMICS supported with an axial flow percutaneous MCS device; 287 consecutive unselected patients enrolled in the catheter-based ventricular assist device registry presenting with AMICS who underwent percutaneous coronary intervention (PCI) were included in this analysis. All patients were supported with either the Impella 2.5 or Impella CP. Mean patient age was 66 ± 12.5 years, 76% were men, and mean left ventricular ejection fraction was 25 ± 12%. Before receiving MCS, 80% of patients required inotropes or vasopressors and 40% were supported with intra-aortic balloon pump; 9% of patients were under active cardiopulmonary resuscitation at the time of MCS implantation. Survival to discharge was 44%. In a multivariate analysis, early implantation of a MCS device before PCI (p = 0.04) and before requiring inotropes and vasopressors (p = 0.05) was associated with increased survival. Survival was 66% when MCS was initiated1.25 hours from shock onset, 37% when initiated within 1.25 to 4.25 hours, and 26% when initiated after 4.25 hours (p = 0.017). Survival was 68%, 46%, 35%, 35%, and 26% for patients requiring 0, 1, 2, 3, and ≥4 inotropes before MCS support, respectively (p 0.001). In conclusion, MCS implantation early after shock onset, before initiation of inotropes or vasopressors and before PCI, is independently associated with improved survival in patients presenting with AMICS.

Objectives We sought to evaluate the incidence, risk factors, in-hospital, and long-term outcomes and predictors of mortality of coronary artery perforations (CAP) in the contemporary percutaneous coronary intervention (PCI) era. Background CAP is a rare but serious complication of PCI associated with increased risk of morbidity and mortality. Methods We included 181,590 procedures performed across 47 hospitals in Michigan from January 1, 2010 to December 31, 2015. Endpoints evaluated included the incidence of CAP and its association with in-hospital outcomes. Logistic regression analysis was utilized to determine independent risk factors for CAP and to examine whether the effect of CAP on mortality varied by gender. Results CAP occurred in 625 (0.34%) patients. Independent predictors for CAP included older age, peripheral arterial disease, presence of left ventricular dysfunction or cardiomyopathy, lower body mass index, pre-PCI insertion of a mechanical ventricular support device, treatment of complex lesions (Type C), and treatment of chronic total occlusions, the latter of which was the strongest predictor of perforation (adjusted odds ratio (OR) 7.01, P

The COVID-19 pandemic has significantly affected the U.S. health care system. To preserve resources, including personal protective equipment and hospital beds to care for COVID-19 patients, the Centers for Disease Control and Prevention recommended deferral of elective cardiac procedures ([1][1])

Contrast-induced acute kidney injury (CI-AKI) is a common complication in patients undergoing cardiac catheterization and percutaneous coronary interventions (PCIs), is associated with a high morbidity and mortality, and is a major contributor to health care cost. There seems to be a nonlinear

Background: Invasive fractional flow reserve (FFR INV ) is the standard technique for assessing myocardial ischemia. Pressure distortions and measurement location may influence FFR INV interpretation. We report a technique for performing invasive fractional flow reserve (FFR INV ) by minimizing pressure distortions and identifying the proper location to measure FFR INV . Methods: FFR INV recordings were obtained prospectively during manual hyperemic pullback in 100 normal and diseased coronary arteries with single stenosis, using 4 measurements from the terminal vessel, distal-to-the-lesion, proximal vessel, and guiding catheter. FFR INV profiles were developed by plotting FFR INV values ( y -axis) and site of measurement ( x -axis), stratified by stenosis severity. FFR INV ≤0.8 was considered positive for lesion-specific ischemia. Results: Erroneous FFR INV values were observed in 10% of vessels because of aortic pressure distortion and in 21% because of distal pressure drift; these were corrected by disengagement of the guiding catheter and re-equalization of distal pressure/aortic pressure, respectively. There were significant declines in FFR INV from the proximal to the terminal vessel in normal and stenotic coronary arteries ( P INV was 41% when measured from the terminal vessel and 20% when measured distal-to-the-lesion ( P INV 20 to 30 mm distal-to-the-lesion (rather than from the terminal vessel) can reduce errors in measurement and optimize the assessment of lesion-specific ischemia. Conclusions: Meticulous technique (disengagement of the guiding catheter, FFR INV pullback) is required to avoid erroneous FFR INV , which occur in 31% of vessels. Even with optimal technique, FFR INV values are influenced by stenosis severity and the site of pressure measurement. FFR INV values from the terminal vessel may overestimate lesion-specific ischemia, leading to unnecessary revascularization.

Background Troponin release in ST‐segment–elevation myocardial infarction ( STEMI ) has predictable kinetics with early levels reflective of ischemia duration. Little research has examined the value of admission troponin levels in STEMI patients undergoing primary percutaneous coronary intervention. We investigated the relationship between troponin on presentation and mortality in a large, real‐world cohort of STEMI patients undergoing primary percutaneous coronary intervention. Methods and Results We used multivariable adaptive regression modeling to examine the association between admission troponin levels and in‐hospital mortality for patients who underwent primary percutaneous coronary intervention for STEMI . We adjusted for known clinical risk factors using a validated mortality risk model derived from the NCDR (National Cardiovascular Data Registry) CathPCI database, and this same model was used to calculate patients’ predicted mortality based on clinical and demographic factors. Patients were then stratified by troponin groups to compare predicted versus observed mortality. Of the 14 061 patients included in the cohort, 47.2% had initial troponin levels that were undetectable or within the reference range. Admission troponin was an independent predictor of in‐hospital mortality, and any value above the reference range was associated with increased mortality (1.8% versus 5.1%, [standardized difference, 18.2%]). Patients with the highest predicted risk for mortality (13% predicted) in the highest admission troponin grouping experienced an observed mortality of 19.5%. Patients in low troponin groupings consistently demonstrated lower than predicted mortality based on their clinical and demographic risk profile. Conclusions Nearly half of patients undergoing primary percutaneous coronary intervention had normal troponin on presentation and had a relatively good outcome. Mortality increases with elevated admission troponin levels, regardless of baseline clinical risk. The substantial number of patients who present with markedly elevated troponin and their relatively worse outcomes highlights the need for continued improvement in prehospital STEMI detection and care.

Among patients with coronary artery disease, participation in outpatient cardiac rehabilitation (CR) is associated with improved quality of life and reduced rates of readmission and cardiovascular mortality [(1)][1]. For these reasons, CR is recommended in international guidelines [(2,3)][2].

The National Cardiogenic Shock Initiative is a single-arm, prospective, multicenter study to assess outcomes associated with early mechanical circulatory support (MCS) in patients presenting with acute myocardial infarction and cardiogenic shock (AMICS) treated with percutaneous coronary intervention (PCI).Between July 2016 and February 2019, 35 sites participated and enrolled into the study. All centers agreed to treat patients with AMICS using a standard protocol emphasizing invasive hemodynamic monitoring and rapid initiation of MCS. Inclusion and exclusion criteria mimicked those of the "SHOCK" trial with an additional exclusion criteria of intra-aortic balloon pump counter-pulsation prior to MCS.A total of 171 consecutive patients were enrolled. Patients had an average age of 63 years, 77% were male, and 68% were admitted with AMICS. About 83% of patients were on vasopressors or inotropes, 20% had a witnessed out of hospital cardiac arrest, 29% had in-hospital cardiac arrest, and 10% were under active cardiopulmonary resuscitation during MCS implantation. In accordance with the protocol, 74% of patients had MCS implanted prior to PCI. Right heart catheterization was performed in 92%. About 78% of patients presented with ST-elevation myocardial infarction with average door to support times of 85 ± 63 min and door to balloon times of 87 ± 58 min. Survival to discharge was 72%. Creatinine ≥2, lactate4, cardiac power output (CPO)0.6 W, and age ≥ 70 years were predictors of mortality. Lactate and CPO measurements at 12-24 hr reliably predicted overall mortality postindex procedure.In contemporary practice, use of a shock protocol emphasizing best practices is associated with improved outcomes.

In patients with acute right ventricular infarction (RVI), global right ventricular (RV) performance is dependent on compensatory left ventricular (LV)-septal contractile contributions. This study was designed to assess the influence of depressed left ventricular ejection fraction (LVEF) on hemodynamics and clinical outcomes in patients with RVI.We retrospectively identified 338 patients with acute inferior ST elevation myocardial infarction (STEMI) undergoing a primary percutaneous coronary intervention. RVI was determined echocardiographically by right ventricular free wall motion abnormalities and depressed global RV performance (fractional area change); LV function was similarly calculated. RVI was documented in 185 (55%) cases. Compared with those with inferior myocardial infarction alone, patients with RVI suffered more hemodynamic compromise (need for inotropes or vasopressors 39 vs. 15%, P0.0001, and intra-aortic balloon pump 32 vs. 13%, P0.0001) and higher in-hospital mortality (14 vs. 3%, P=0.0006). In cases without RVI, the status of LV function did not influence in-hospital mortality (ejection fraction≤40%=7.3% vs. ejection fraction40%=1.8, P=0.12). In contrast, in patients with RVI, LVEF was an important determinant of outcome: those with LVEF ≤ 40% suffered more hemodynamic compromise (need for inotropes or vasopressors 63 vs. 30%, P0.0001, and intra-aortic balloon pump 59 vs. 22%, P0.0001) and had markedly higher in-hospital mortality (33 vs. 7%, P0.0001).In patients with acute inferior myocardial infarction complicated by RVI, depressed LVEF is associated with greater hemodynamic compromise and higher in-hospital mortality. These findings may have clinical implications for supportive efforts in such cases.

Coronary artery calcium (CAC) scoring is a noninvasive modality that can identify the presence of coronary artery disease (CAD), and provide additional risk stratification. In prior observational studies, a normal calcium score has been associated with a very low risk and thus considered a “

Objectives This study sought to examine the feasibility, safety, clinical outcomes, and costs associated with computed tomography–derived fractional flow reserve (FFRCT) in acute chest pain (ACP) patients in a coronary computed tomography angiography (CTA)–based triage program. Background FFRCT is useful in determining lesion-specific ischemia in patients with stable ischemic heart disease, but its utility in ACP has not been studied. Methods ACP patients with no known coronary artery disease undergoing coronary CTA and coronary CTA with FFRCT were studied. FFRCT ≤0.80 was considered positive for hemodynamically significant stenosis. Results Among 555 patients, 297 underwent coronary CTA and FFRCT (196 negative, 101 positive), whereas 258 had coronary CTA only. The rejection rate for FFRCT was 1.6%. At 90 days, there was no difference in major adverse cardiac events (including death, nonfatal myocardial infarction, and unexpected revascularization after the index visit) between the coronary CTA and FFRCT groups (4.3% vs. 2.7%; p = 0.310). Diagnostic failure, defined as discordance between the coronary CTA or FFRCT results with invasive findings, did not differ between the groups (1.9% vs. 1.68%; p = NS). No deaths or myocardial infarction occurred with negative FFRCT when revascularization was deferred. Negative FFRCT was associated with higher nonobstructive disease on invasive coronary angiography (56.5%) than positive FFRCT (8.0%) and coronary CTA (22.9%) (p Conclusions In ACP, FFRCT is feasible, with no difference in major adverse cardiac events and costs compared with coronary CTA alone. Deferral of revascularization is safe with negative FFRCT, which is associated with higher nonobstructive disease on invasive angiography.

The outcomes for patients transferred with cardiogenic shock and later treated with revascularization and Impella support have not previously been studied. To evaluate these outcomes, patients in cardiogenic shock were recruited from the catheter-based ventricular assist device registry, a prospective registry enrolling patients who underwent percutaneous coronary intervention with hemodynamic support using Impella 2.5 or CP. Analysis was performed on subgroups of patients who were characterized as those directly admitted to a tertiary care hospital (direct), or those transferred from an outside hospital (transfer). Patients who were transferred with acute myocardial infarction with cardiogenic shock (AMICS) more often presented in shock were in shock longer than 24 hours, and were more likely to be on intra-aortic balloon pump but were less likely to sustain cardiac arrest. The number of pressors, EF, diseased, and treated vessels were similar between the 2 groups. Despite baseline differences, the mortality was similar in the transfer versus direct patients (47.0% vs 53.5% p = 0.19). In a multivariate model, the factors independently associated with 30-day mortality in AMICS treated with revascularization and Impella support were cardiopulmonary resuscitation (CPR) (p0.01), age (p0.01), and ST-segment elevation myocardial infarction (STEMI) (p = 0.02). Whether the patient was transferred or directly admittedly with AMICS was not an independent predictor of death. In conclusion, these findings suggest that considerations should be given to transfer patients with AMICS to allow them to be treated in a contemporary manner.

BACKGROUND The risk of contrast-induced acute kidney injury (CI-AKI) increases in a nonlinear fashion with increasing volume of contrast media. Prior studies recommend limiting contrast volume to less than three times the estimated creatinine clearance (CC). Recently, a number of operators have reported successful percutaneous coronary intervention (PCI) using even lower volumes of contrast. OBJECTIVES To evaluate the prevalence and outcomes associated with ultra-low contrast volume among patients undergoing PCI. METHODS We assessed the prevalence and outcomes associated with use of ultra-low contrast volume among 75 393 patients undergoing PCI in Michigan between July 2014 and June 2017 in the BMC2 (Blue Cross Blue Shield of Michigan Cardiovascular Consortium) registry. Ultra-low contrast volume was defined as contrast volume less than or equal to the patient's estimated CC. Patients receiving dialysis at the time of the procedure were excluded. RESULTS Ultra-low contrast volume was used in 13% of procedures with the majority of these patients being at low risk of renal complications. Compared with patients who received a contrast volume between one and three times the CC, use of ultra-low volume of contrast was associated with a significantly lower incidence of AKI (aOR 0.682, 95% CI 0.566-0.821, P

Background: Assessments of healthcare value have largely focused on measuring outcomes of care at a given level of cost with less attention paid to appropriateness. However, understanding how appropriateness relates to outcomes and costs is essential to determining healthcare value. Methods AND RESULTS: In a retrospective cohort study design, administrative data from fee-for-service Medicare patients undergoing percutaneous coronary intervention (PCI) in Michigan hospitals between June 30, 2010, and December 31, 2014, were linked with clinical data from a statewide PCI registry to calculate hospital-level measures of (1) appropriate use criteria scores, (2) 90-day risk-standardized readmission and mortality rates, and (3) 90-day risk-standardized episode costs. We then used Spearman correlation coefficients to assess the relationship between these measures. A total of 29 839 PCIs were performed at 33 PCI hospitals during the study period. A total of 13.3% were for ST-segment–elevation myocardial infarction, 25.0% for non–ST-segment–elevation myocardial infarction, 47.1% for unstable angina, 9.8% for stable angina, and 4.7% for other. The overall hospital-level mean appropriate use criteria score was 8.4±0.2. Ninety-day risk-standardized readmission occurred in 23.7%±3.7% of cases, 90-day risk-standardized mortality in 4.3%±0.6%, and mean risk-standardized episode costs were $26 159±$1074. Hospital-level appropriate use criteria scores did not correlate with 90-day readmission, mortality, or episode costs. Conclusions: Among Medicare patients undergoing PCI in Michigan, we found hospital-level appropriate use criteria scores did not correlate with 90-day readmission, mortality, or episode costs. This finding suggests that a comprehensive understanding of healthcare value requires multidimensional consideration of appropriateness, outcomes, and costs.

Background High-risk percutaneous coronary intervention (PCI) supported by percutaneous left ventricular assist devices offers a treatment option for patients with severe symptoms, complex and extensive coronary artery disease, and multiple comorbidities. The extrapolation from clinical trial to real-world practice has inherent uncertainties. We compared the characteristics, procedures, and outcomes of high-risk PCI supported by a microaxial pump (Impella 2.5) in a multicenter registry versus the randomized PROTECT II trial (NCT00562016). Methods The USpella registry is an observational multicenter voluntary registry of Impella technology. A total of 637 patients treated between June 2007 and September 2013 were included. Of them, 339 patients would have met enrollment criteria for the PROTECT II trial. These were compared with 216 patients treated in the Impella arm of PROTECT II. Results Compared to the clinical trial, registry patients were older (70 ± 11.5 vs 67.5 ± 11.0 years); more likely to have chronic kidney disease (30% vs 22.7%), prior myocardial infarction (69.3% vs 56.5%), or prior bypass surgery (39.4% vs. 30.2%); and had similar prevalence of diabetes, peripheral vascular disease, and prior stroke. Registry patients had more extensive coronary artery disease (2.2 vs 1.8 diseased vessels) and had a similar Society of Thoracic Surgeons predicted risk of mortality. At hospital discharge, registry patients experienced a similar reduction in New York Heart Association class III to IV symptoms compared to trial patients. Registry patients had a trend toward lower in-hospital mortality (2.7% vs 4.6, P = .27). Conclusions USpella provides a real-world and contemporary estimation of the type of procedures and outcomes of high-risk patients undergoing PCI supported by Impella 2.5. Despite the higher risk of registry patients, clinical outcomes appeared to be favorable and consistent compared with the randomized trial.

Objective To assess the impact of simulation training on complications associated with femoral arterial access obtained by first year cardiology fellows. Background: Prior studies demonstrate a higher incidence of arterial access related complications among patients undergoing invasive cardiac procedures. Methods First year cardiology fellows at four teaching hospitals in Michigan tracked their femoral access experience and any associated complications between July 2011 and June 2013. Fellows starting their academic training in July 2012 were first trained on a specially developed simulator before starting their rotation in the catheterization laboratory. The primary outcome was access proficiency, defined as five successful femoral access attempts without any complication or need to seek help from a more experienced team member. Results A total of 1,278 femoral access attempts were made by 21 fellows in 2011–2012 compared with 869 femoral access attempts made by 21 fellows in 2012–2013. There was a lower rate of access related complications in patients undergoing access attempts by first year fellows in year 2 compared with year 1 (2.1% versus 4.5%, P = 0.003) . The number of procedures to achieve procedural proficiency was significantly higher in year 1 compared with year 2 (median 20 versus 10, P = 0.007). Conclusions Incorporation of simulation in the training of first year fellows was associated with an improvement in proficiency and a clinically meaningful reduction in vascular complications. © 2015 Wiley Periodicals, Inc.

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

Objectives We sought to evaluate the feasibility and safety of catheter-based supersaturated oxygen (SSO2) delivery via the left main coronary artery (LMCA) following primary percutaneous coronary intervention (PCI). Background: In the multicenter, randomized AMIHOT-II trial, SSO2 delivered into the proximal or mid left anterior descending (LAD) artery via an indwelling intracoronary infusion catheter in patients with acute anterior ST-segment elevation myocardial infarction (STEMI) following primary PCI significantly reduced infarct size but resulted in a numerically higher incidence of safety events. Methods: Patients with acute anterior STEMI presenting within 6 hr of symptom onset were enrolled at three centers. Following successful LAD stenting, SSO2 was infused into the LMCA via a diagnostic catheter for 60 min. The primary safety endpoint was the 30-day rate of target vessel failure (composite of death, reinfarction, or target vessel revascularization). Cardiac magnetic resonance imaging (cMRI) was performed at 3–5 and 30 days to assess infarct size. Results: Twenty patients with acute anterior STEMI were enrolled. The infarct lesion was located in the proximal LAD in 7 cases (35%) and the mid LAD in 13 cases (65%). Following primary PCI, SSO2 was delivered successfully in all cases. Target vessel failure within 30 days occurred in 1 patient (5%). Median [interquartile range] infarct size was 13.7% [5.4–20.6%] at 3–5 days and 9.6% [2.1–14.5%] at 30 days. Conclusions: Following primary PCI in acute anterior STEMI, infusion of SSO2 via the LMCA is feasible, and is associated with a favorable early safety and efficacy profile. © 2015 Wiley Periodicals, Inc.