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Background: 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., Objectives: 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., Methods: 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., Results: 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., Conclusions: 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., Competing Interests: Funding Support and Author Disclosures Support for the Blue Cross Blue Shield of Michigan Cardiovascular Consortium and the Michigan Value Collaborative is provided by Blue Cross Blue Shield of Michigan and Blue Care Network as part of the Blue Cross Blue Shield of Michigan Value Partnerships program. Although Blue Cross Blue Shield of Michigan and BMC2 work collaboratively, the opinions, beliefs, and viewpoints expressed by the author do not necessarily reflect the opinions, beliefs, and viewpoints of BCBSM or any of its employees. Further, BCBSM does not have access to BMC2 data, and all patient episodes occurring at engaged hospitals are included in the data registries, regardless of payer. Dr Madder has received research support, consulting fees, speaker honoraria, and serves on the Advisory Board of Corindus, a Siemens Healthineers Company; has received research support, consulting fees, and speaker honoraria from Infraredx; has received speaker honoraria from Abbott Vascular; and serves on the Advisory Board of Spectrawave and Medtronic. Dr Basir is a consultant for Abiomed, Cardiovascular Systems, Chiesi, Saranas, and Zoll. Dr Kaki serves on the Speakers Bureau of Abiomed, Abbott, CSI, Medtronic, Shockwave, and Terumo. Dr Azzalini has received consulting fees from Teleflex, Abiomed, GE Healthcare, Asahi Intecc, Philips, Abbott Vascular, Reflow Medical, and Cardiovascular Systems, Inc. Dr Gurm has received research support from Blue Cross and Blue Shield of Michigan; is the co-founder of, owns equity in, and is a consultant to Amplitude Vascular Systems; owns equity in Jiaxing Bossh Medical Technology Partnership; is a consultant for Osprey Medical; and is the chair of the Clinical Events Committee for the PERFORMANCE trial sponsored by Contego Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Published by Elsevier Inc.)

Background: Mortality is the most devastating complication of percutaneous coronary interventions (PCI). Identifying the most common causes and mechanisms of death after PCI in contemporary practice is an important step in further reducing periprocedural mortality., Objectives: To systematically analyze the cause and circumstances of in-hospital mortality in a large, multi-center, statewide cohort., Methods: In-hospital deaths after PCI occurring at 39 hospitals included in the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2) between 2012 and 2014 were retrospectively reviewed using validated methods. A priori PCI-related mortality risk was estimated using the validated BMC2 model., Results: A total of 1,163 deaths after PCI were included in the study. Mean age was 71±13 years, and 507 (44%) were women. Left ventricular failure was the most common cause of death (52% of cases). The circumstance of death was most commonly related to prior acute cardiovascular condition (61% of cases). Procedural complications were considered contributing to mortality in 235 (20%) cases. Death was rated as not preventable or slightly preventable in 1,045 (89.9%) cases. The majority of the deaths occurred in intermediate or high-risk patients, but 328 (28.2%) deaths occurred in low-risk patients (<5% predicted risk of mortality). PCI was considered rarely appropriate in 30% of preventable deaths., Conclusions: In-hospital mortality after PCI is rare, and primarily related to pre-existing critical acute cardiovascular condition. However, approximately 10% of deaths were preventable. Further research is needed to characterize preventable deaths, in order to develop strategies to improve procedural safety., Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: Dr. Azzalini received consulting fees from Teleflex, Abiomed, GE Healthcare, Asahi Intecc, Philips, Abbott Vascular, Reflow Medical, and Cardiovascular Systems, Inc.; is on the advisory board of GE Healthcare; and owns equity in Reflow Medical. Devraj Sukul reports no relevant financial disclosures. Hitinder Gurm receives research support from Blue Cross and Blue Shield of Michigan. He is the co-founder of, owns equity in, and is a consultant to Amplitude Vascular Systems. He also owns equity in Jiaxing Bossh Medical Technology Partnership and is a consultant for Osprey Medical. He is the chair of the Clinical Events Committee for the PERFORMANCE trial sponsored by Contego Medical. All other authors have nothing to disclose. This does not alter our adherence to PLOS ONE policies on sharing data and materials., (Copyright: © 2024 Moroni et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background and Aims: Predicting personalized risk for adverse events following percutaneous coronary intervention (PCI) remains critical in weighing treatment options, employing risk mitigation strategies, and enhancing shared decision-making. This study aimed to employ machine learning models using pre-procedural variables to accurately predict common post-PCI complications., Methods: A group of 66 adults underwent a semiquantitative survey assessing a preferred list of outcomes and model display. The machine learning cohort included 107 793 patients undergoing PCI procedures performed at 48 hospitals in Michigan between 1 April 2018 and 31 December 2021 in the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2) registry separated into training and validation cohorts. External validation was conducted in the Cardiac Care Outcomes Assessment Program database of 56 583 procedures in 33 hospitals in Washington., Results: Overall rate of in-hospital mortality was 1.85% (n = 1999), acute kidney injury 2.51% (n = 2519), new-onset dialysis 0.44% (n = 462), stroke 0.41% (n = 447), major bleeding 0.89% (n = 942), and transfusion 2.41% (n = 2592). The model demonstrated robust discrimination and calibration for mortality {area under the receiver-operating characteristic curve [AUC]: 0.930 [95% confidence interval (CI) 0.920-0.940]}, acute kidney injury [AUC: 0.893 (95% CI 0.883-0.903)], dialysis [AUC: 0.951 (95% CI 0.939-0.964)], stroke [AUC: 0.751 (95%CI 0.714-0.787)], transfusion [AUC: 0.917 (95% CI 0.907-0.925)], and major bleeding [AUC: 0.887 (95% CI 0.870-0.905)]. Similar discrimination was noted in the external validation population. Survey subjects preferred a comprehensive list of individually reported post-procedure outcomes., Conclusions: Using common pre-procedural risk factors, the BMC2 machine learning models accurately predict post-PCI outcomes. Utilizing patient feedback, the BMC2 models employ a patient-centred tool to clearly display risks to patients and providers (https://shiny.bmc2.org/pci-prediction/). Enhanced risk prediction prior to PCI could help inform treatment selection and shared decision-making discussions., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Improved radiation safety practices are needed across hospitals performing percutaneous coronary intervention (PCI). This study was performed to assess the temporal trend in PCI radiation doses concurrent with the conduct of a statewide radiation safety initiative., Methods: A statewide initiative to reduce PCI radiation doses was conducted in Michigan between 2017 and 2021 and included focused radiation safety education, reporting of institutional radiation doses, and implementation of radiation performance metrics for hospitals. Using data from a large statewide registry, PCI discharges between July 1, 2016, and July 1, 2022, having a procedural air kerma (AK) recorded were analyzed for temporal trends. A multivariable regression analysis was performed to determine whether declines in procedural AK over time were attributable to changes in known predictors of radiation doses., Results: Among 131 619 PCI procedures performed during the study period, a reduction in procedural AK was observed over time, from a median dose of 1.46 (0.86-2.37) Gy in the first year of the study to 0.97 (0.56-1.64) Gy in the last year of the study ( P <0.001). The proportion of cases with an AK ≥5 Gy declined from 4.24% to 0.86% over the same time period ( P <0.0001). After adjusting for variables known to impact radiation doses, a 1-year increase in the date of PCI was associated with a 7.61% (95% CI, 7.38%-7.84%) reduction in procedural AK ( P <0.0001)., Conclusions: Concurrent with the conduct of a statewide initiative to reduce procedural radiation doses, a progressive and significant decline in procedural radiation doses was observed among patients undergoing PCI in the state of Michigan., Competing Interests: Disclosures Dr Madder received speaker honoraria from Abbott Vascular, Corindus, and Infraredx; has served as a consultant to Abbott Vascular, Angiowave Imaging, Corindus, Infraredx, and SpectraWAVE; received research support from Corindus and Infraredx; and serves on the advisory boards of Medtronic and SpectraWAVE. Dr Sukul receives salary support for his role in the Blue Cross Blue Shield of Michigan Cardiovascular Collaborative. Dr Gurm receives research support from Blue Cross Blue Shield of Michigan. He is a co-founder of, owns equity in, and is a consultant to Amplitude Vascular Systems. He also owns equity in Jiaxing Bossh Medical Technology Partnership and is a consultant for Osprey Medical. He is the chair of the Clinical Events Committee for the PERFORMANCE trial (Protection Against Emboli During Carotid Artery Stenting Using a 3-in-1 Delivery System Comprised of a Post-Dilation Balloon, Integrated Embolic Filter, and a Novel Carotid Stent II) sponsored by Contego Medical. The other authors report no conflicts.

Contrast media use is ubiquitous in the catheterization laboratory. Contrast-associated acute kidney injury (CA-AKI) is a key concern among patients undergoing coronary angiography and percutaneous coronary interventions. The risk of CA-AKI can be minimized by careful attention to hydration status and renal function-based contrast dosing in all patients. In patients with Stage IV chronic kidney disease, ultra low contrast procedure (contrast dose ≤ GFR) may be especially beneficial., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Objective: To assess the feasibility and treatment effect of pulsatile intravascular lithotripsy (PIVL) on calcified lesions in a cadaveric model of peripheral artery disease., Background: PIVL represents a novel potential approach to intravascular lithotripsy for the treatment of vascular calcification., Methods: In this preclinical device-feasibility study, technical success, calcium morphology and luminal expansion before and after PIVL treatment were evaluated in surgically isolated, perfused atherosclerotic lower-leg arteries and in perfused whole cadaveric lower legs. Analytical methods included micro-computed tomography (μCT), intravascular optical coherence tomography, digital subtraction angiography, and quantitative coronary analysis., Results: Treatment delivery was successful in all whole-leg specimens (N = 6; mean age 74.2, 66 % female) and in the 8 excised vessels with diameter appropriate to the PIVL balloon (2 vessels exceeding diameter specifications were excluded). There were no vessel perforations. After PIVL, excised vessels showed extensive evidence of new, full-thickness fractures in lesions with calcium arc exceeding 152° and with calcium wall thickness between 0.24 mm and 1.42 mm. PIVL fractures were observed in intimal nodules, sheets, shingles, and medial plates. Vessels within whole-leg specimens also showed full-thickness fracturing and a mean of 1.9 ± 0.9 mm in acute luminal gain, 101.6 ± 99.5 % gain in total minimum cross-sectional area, and a 31.7 ± 13.4 % relative reduction in stenosis (P < 0.001 for all analyses)., Conclusions: In a cadaveric model, PIVL treatment was technically feasible, fractured both circumferential and eccentric calcium lesions, and resulted in acute luminal gain. A clinical feasibility study of PIVL is currently enrolling., Competing Interests: Declaration of competing interest RV is a consultant for Abbott Vascular, Boston Scientific, Celonova, OrbusNeich Medical, Terumo Corporation, W. L. Gore, Edwards Lifesciences, Cook Medical, CSI, ReCor Medical, SinoMedical Sciences Technology, Surmodics, Bard BD and a scientific Advisory Board Member of Medtronic and Xeltis. AF has received research grants from AVS, Shockwave, Boston Scientific, Angiodynamics, and Cardiovascular Systems Inc. He is on an advisory board for Boston scientific and consults for Angiodynamics; RSC is the chief technology officer, co-founder, a board member, and holds an equity position in AVS; HSG receives research support from Blue Cross and Blue Shield of Michigan. He is the co-founder of, owns equity in, and is a consultant to AVS. He also owns equity in Jiaxing Bossh Medical Technology Partnership and is a consultant for Osprey Medical. He is the chair of the Clinical Events Committee for the PERFORMANCE trial sponsored by Contego Medical; JCG Is a consultant for AVS. The remaining authors declare no conflicts of interest., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

A miniature grinding wheel (0.85 mm diameter) was fabricated by nickel (Ni)-diamond electroplating on a thin (0.65 mm outer diameter) flexible hollow stainless steel drive shaft to remove the calcified plaque in coronary and peripheral arteries by atherectomy procedure. To coat electrically nonconductive diamond grits, the drive shaft was submerged in a pile of diamond grit during Ni electroplating. The electroplating current density and temperature were investigated for better surface finishing and Faraday efficiency. The electroplating time to obtain the designed coating thickness was modeled based on Faraday's law of electrolysis and the geometry of drive shaft, wheel, and diamond grit. To validate the miniature wheel performance in atherectomy, grinding experiments were conducted on an atherectomy cardiovascular simulator with a calcified plaque surrogate. The wheel motion, material removal rate, and wheel surface wear were studied via high-speed camera imaging and laser confocal microscopy. The grinding wheel with 80,000 rpm rotational speed had an orbital speed of 14,300 rpm around the 1.5 mm diameter plaque surrogate lumen. After grinding for 120 s, the plaque surrogate inner diameter was enlarged to 3.03 mm, and no wear or loss of diamond abrasive was observed on the grinding wheel. This study demonstrated that the proposed electroplating process for fabricating miniature grinding wheels could effectively remove the calcified plaque surrogate. This research could lead to a more effective and safer atherectomy device with sub-mm miniature diamond wheels to treat lesions deep in coronary and peripheral arteries., Competing Interests: Declaration of Competing Interest None declared, (Copyright © 2023 IPEM. Published by Elsevier Ltd. All rights reserved.)

Background: International registry comparisons provide insight into regional differences in clinical practice patterns, procedural outcomes, and general trends in population health and resource utilization in percutaneous coronary intervention (PCI). We sought to compare data from a state-wide PCI registry in the United States with a national registry from the United Kingdom (UK)., Methods: We analyzed all PCI cases from the Blue Cross Blue Shield of Michigan Cardiovascular Consortium and the British Cardiovascular Intervention Society registries from 2010 to 2017. Procedural characteristics and in-hospital outcomes were stratified by PCI indication., Results: A total of 248,283 cases were performed in Michigan and 773,083 in the United Kingdom during the study period. The proportion of patients with a prior diagnosis of diabetes in Michigan was nearly double that in the United Kingdom (38.9% vs. 21.0%). PCI for ST-elevation myocardial infarction was more frequent in the UK (25% UK vs. 14.3% Michigan). Radial access increased in both registries, reaching 86.8% in the United Kingdom versus 45.1% in Michigan during the final study year. Mechanical support utilization was divergent, falling to 0.9% of cases in the United Kingdom and rising to 3.95% of cases in Michigan in 2017. Unadjusted crude mortality rates were similar in the two cohorts, with higher rates of post-PCI transfusion and other complications in the Michigan population., Conclusions: In a real-world comparison using PCI registries from the US and UK, notable findings include marked differences in the prevalence of diabetes and other comorbidities, a greater proportion of primary PCI with more robust adoption of transradial PCI in the United Kingdom, and divergent trends in mechanical support with increasing use in Michigan., (© 2023 Wiley Periodicals LLC.)

Left ventricular end-diastolic pressure (LVEDP) is an important hemodynamic marker of left ventricular performance and affects coronary perfusion. We evaluated the association of LVEDP with patient outcomes after elective or urgent percutaneous coronary intervention (PCI). We included n = 49,600 patients undergoing elective or urgent PCI. Patients were divided according to LVEDP tertile for descriptive analysis. The primary end point was in-hospital mortality. A recursive partitioning tree model for mortality was built to guide decision-making in patients with high LVEDP undergoing nonemergent PCI. Overall, n = 18,099 patients had an LVEDP <13 mm Hg, n = 15,416 had an LVEDP 13 to 18 mm Hg, and n = 16,085 had an LVEDP >18 mm Hg. Patients in the high LVEDP tertile had a worse clinical and angiographic/procedural profile and experienced a higher incidence of in-hospital post-PCI adverse outcomes, including death (LVEDP <13 mm Hg 0.3% vs LVEDP 13 to 18 mm Hg 0.4% vs LVEDP >18 mm Hg 0.8%, p <0.001). An elevated LVEDP was an independent predictor of adverse outcomes including mortality. An LVEDP ≥26 mm Hg was identified as a marker of high mortality (1.5%) in patients who underwent elective PCI, with rates varying from 0.5% to 10.4%, based upon a clinical profile defined by hemoglobin, systolic blood pressure, renal and left ventricular function, and atrial fibrillation. In conclusion, an elevated LVEDP is observed in 1/3 of the patients who underwent elective or urgent PCI and is associated with higher rates of in-hospital adverse outcomes, including death. Patients with an LVEDP ≥26 mm Hg who underwent elective PCI had markedly higher mortality rates, suggesting that such patients may warrant further optimization before PCI., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: Intracoronary imaging (ICI) during percutaneous coronary intervention (PCI) improves outcomes, yet hospital- and physician-level variabilities in ICI and its impact on ICI use in contemporary PCI remain unknown. This study was performed to evaluate hospital- and physician-level use of ICI to optimize PCI., Methods: Using data from a large statewide registry, patients undergoing PCI between July 2019 and March 2021 were studied. The primary measure of interest was ICI (intravascular ultrasound or optical coherence tomography) optimization during PCI. A fitted hierarchical Bayesian model identified variables independently associated with ICI optimization. The performing hospital and physician were included as random effects in the model., Results: Among 48 872 PCIs, ICI optimization was performed in 8094 (16.6%). Median [interquartile range] hospital- and physician-level frequencies of ICI were 8.8% [3.1%, 16.0%] and 6.1% [1.1%, 25.0%], respectively. Bayesian modeling identified left main PCI (adjusted odds ratio [aOR], 4.41; 95% credible interval [3.82, 5.10]), proximal left anterior descending artery PCI (aOR, 2.28 [2.00, 2.59]), PCI for in-stent restenosis (aOR, 1.55 [1.40, 1.72]), and surgical consult prior to PCI (aOR, 1.21 [1.07, 1.37]) as independent predictors of ICI optimization. The hospital-level median odds ratio, an estimate of the contribution of inter-hospital variability in odds of ICI use, was 3.48 (2.64, 5.04). Physician-level median odds ratio was 3.81 (3.33, 4.45)., Conclusions: Substantial hospital- and physician-level variation in ICI was observed. Except for performance of left main PCI, the hospital and physician performing the PCI were more strongly associated with ICI optimization than any patient or procedural factors.

Background: The COVID-19 pandemic has severely impacted healthcare delivery and patient outcomes globally., Aims: We aimed to evaluate the influence of the COVID-19 pandemic on the temporal trends and outcomes of patients undergoing percutaneous coronary intervention (PCI) in Michigan., Methods: We compared all patients undergoing PCI in the BMC2 Registry between March and December 2020 ("pandemic cohort") with those undergoing PCI between March and December 2019 ("pre-pandemic cohort"). A risk-adjusted analysis of in-hospital outcomes was performed between the pre-pandemic and pandemic cohort. A subgroup analysis was performed comparing COVID-19 positive vs. negative patients during the pandemic., Results: There was a 15.2% reduction in overall PCI volume from the pre-pandemic (n = 25,737) to the pandemic cohort (n = 21,822), which was more pronounced for stable angina and non-ST-elevation acute coronary syndromes (ACS) presentations, and between February and May 2020. Patients in the two cohorts had similar clinical and procedural characteristics. Monthly mortality rates for primary PCI were generally higher in the pandemic period. There were no significant system delays in care between the cohorts. Risk-adjusted mortality was higher in the pandemic cohort (aOR 1.26, 95% CI 1.07-1.47, p = 0.005), a finding that was only partially explained by worse outcomes in COVID-19 patients and was more pronounced in subjects with ACS. During the pandemic, COVID-19 positive patients suffered higher risk-adjusted mortality (aOR 5.69, 95% CI 2.54-12.74, p<0.001) compared with COVID negative patients., Conclusions: During the COVID-19 pandemic, we observed a reduction in PCI volumes and higher risk-adjusted mortality. COVID-19 positive patients experienced significantly worse outcomes., Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: Dr. Azzalini received consulting fees from Teleflex, Abiomed, Asahi Intecc, Abbott Vascular, Philips, GE Healthcare, and Cardiovascular Systems, Inc. Dr. Sukul receives salary support from the Blue Cross Blue Shield of Michigan for his role in BMC2. Dr. Gurm receives research support from Blue Cross and Blue Shield of Michigan, and Michigan Translational Research and Commercialization for Life Sciences Innovation Hub. He is the co-founder of, owns equity in, and is a consultant to Amplitude Vascular Systems. He also owns equity in Jiaxing Bossh Medical Technology Partnership and is a consultant for Osprey Medical. He is the chair of the Clinical Events Committee for the PERFORMANCE trial sponsored by Contego Medical. The other authors have no disclosures. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Background: Mortality related to percutaneous coronary intervention (PCI) has gradually declined during the last decade. However, the causes and circumstances of death remain largely undescribed in contemporary practice., Methods: We retrospectively evaluated all patients undergoing PCI at our institution from July 2013 to March 2021. Three cardiologists independently determined the causes and circumstances of death, and evaluated the preventability of death using validated methods., Results: During study period, 4334 patients underwent 5506 PCIs, of whom 166 patients suffered in-hospital death (3.0%). Ninety-three percent of deceased patients initially presented with acute coronary syndrome, and 45% with cardiogenic shock. Left ventricular failure was the most common cause of death (39.7%), followed by neurologic compromise after cardiac arrest (16.8%) and infections (13.8%). The circumstance of death was most commonly acute cardiac (51.8%), followed by non-cardiac (19.2%) and non-procedural complications (17.4%). Death was attributed to a procedural complication in only 12% of cases. Reviewers determined that 90% of cases as being unpreventable or slightly preventable. Inter-reviewer agreement was substantial (the three reviewers agreed in >80% of cases for cause and preventability of death)., Conclusion: Mortality after PCI is uncommon, largely unpreventable, and most often related to pre-existing, acute cardiovascular conditions. Procedural complications account for a minority of cases of death, and future effort should focus on the treatment of acute cardiovascular conditions, in particular cardiogenic shock, to decrease acute mortality after PCI., Competing Interests: Declaration of competing interest Lorenzo Azzalini reports a relationship with Teleflex that includes: consulting or advisory. Lorenzo Azzalini reports a relationship with AbioMed Inc. that includes: consulting or advisory. Lorenzo Azzalini reports a relationship with Asahi Intecc USA Incorporation that includes: consulting or advisory. Lorenzo Azzalini reports a relationship with Philips Healthcare US that includes: consulting or advisory. Lorenzo Azzalini reports a relationship with Abbott Vascular that includes: consulting or advisory. Lorenzo Azzalini reports a relationship with Cardiovascular Systems Inc. that includes: consulting or advisory. Hitinder S Gurm reports a relationship with Blue Cross Blue Shield of Michigan that includes: funding grants. Hitinder S Gurm reports a relationship with Michigan Translational Research and Commercialization for Life Sciences Innovation Hub that includes: funding grants. Hitinder S Gurm reports a relationship with Amplitude Vascular Systems that includes: consulting or advisory and equity or stocks. Hitinder S Gurm reports a relationship with Jiaxing Bossh Medical Technology Partnership that includes: equity or stocks. Hitinder S Gurm reports a relationship with Osprey Medical Inc. that includes: consulting or advisory. Hitinder S Gurm reports a relationship with Contego Medical that includes: consulting or advisory. Antonio Abbate reports a relationship with Astra Zeneca that includes: consulting or advisory. Antonio Abbate reports a relationship with Effetti Srl that includes: consulting or advisory. Antonio Abbate reports a relationship with Implicit Bioscience Inc. that includes: consulting or advisory. Antonio Abbate reports a relationship with Kiniksa Pharmaceuticals Ltd. that includes: consulting or advisory. Antonio Abbate reports a relationship with Janssen Pharmaceuticals Inc. that includes: consulting or advisory. Antonio Abbate reports a relationship with Merck & Co Inc. that includes: consulting or advisory. Antonio Abbate reports a relationship with Novartis that includes: consulting or advisory. Antonio Abbate reports a relationship with Novo Nordisk Inc. that includes: consulting or advisory. Antonio Abbate reports a relationship with Olatec that includes: consulting or advisory. Antonio Abbate reports a relationship with Serpin Pharma that includes: consulting or advisory., (Copyright © 2022. Published by Elsevier Inc.)

Background: Acute kidney injury (AKI) after contrast-guided interventions is associated with adverse outcomes, but the role of contrast in the context of renal function is less well described for patients undergoing transcatheter aortic valve replacement (TAVR)., Methods: Patients from the Michigan TAVR registry between January 2016 and December 2019 were included. AKI was defined using Valve Academic Research Consortium 2 definitions. An integer cut point for the ratio of contrast volume (CV) to renal function (estimated glomerular filtration rate [eGFR]) as a predictor of AKI was calculated., Results: Of 7112 cases, AKI occurred in 629 (8.8%) patients. Unadjusted mortality was higher among patients with AKI (32.5% vs 9.0%, P  ​< ​.0001). AKI remained significantly associated with the risk of mortality after multivariable adjustment (hazard ratio = 4.50, P  ​< ​.001). Procedural characteristics associated with AKI included CV/eGFR >2 (adjusted odds ratio [aOR] = 1.36, P = .003, 95% CI = 1.10-1.67), CV/eGFR >3 (aOR = 1.38, P  ​= ​.009, 95% CI = 1.09-1.77), and use of general anesthesia (aOR = 1.67, P  ​< ​.0001, 95% CI = 1.38-2.03)., Conclusions: CV in the context of renal function administrated during TAVR is a robust tool to predict AKI. AKI after TAVR is associated with an increased risk of mortality. Incorporation of thresholds of >2× and > 3× eGFR into procedural planning should be considered as a quality initiative., Competing Interests: S. Gualano, W. Merhi, C. Schwartz, and F. Shannon have no disclosures. S. Chetcuti has been a consultant and proctor for Medtronic, with research support from 10.13039/100004374Medtronic, Gore, 10.13039/100008497Boston Scientific, 10.13039/100006520Edwards Lifesciences, and JenaValve. D. Sukul receives research funding from 10.13039/100001502Blue Cross Blue Shield of Michigan. H. Patel is a consultant for Medtronic and WL Gore. H. Gurm receives research funding from 10.13039/100001502Blue Cross Blue Shield of Michigan and the 10.13039/100000002National Institutes of Health Center for Accelerated Innovation and is a consultant for Osprey Medical. W. O’Neill is a consultant for Abbott, Edwards Lifesciences, Boston Scientific, and Abiomed, with research grant support from Abiomed, 10.13039/100001316Abbott, 10.13039/100006520Edwards Lifesciences, and 10.13039/100004374Medtronic. P. Grossman is a consultant for Medtronic Cardiovascular, has research support from 10.13039/100004374Medtronic Cardiovascular, 10.13039/100006520Edwards Life Sciences, and 10.13039/100016476Cardiovascular Systems Incorporated, has registry support from 10.13039/100001502Blue Cross Blue Shield of Michigan, and has research support from 10.13039/100000002National Institutes of Health. None of the authors have any conflicts directly relevant to this study.

Background: Despite its established benefit and strong endorsement in international guidelines, cardiac rehabilitation (CR) use remains low. Identifying determinants of CR referral and use may help develop targeted policies and quality improvement efforts. We evaluated the variation in CR referral and use across percutaneous coronary intervention (PCI) hospitals and operators., Methods: We performed a retrospective observational cohort study of all patients who underwent PCI at 48 nonfederal Michigan hospitals between January 1, 2012 and March 31, 2018 and who had their PCI clinical registry record linked to administrative claims data. The primary outcomes included in-hospital CR referral and CR participation, defined as at least one outpatient CR visit within 90 days of discharge. Bayesian hierarchical regression models were fit to evaluate the association between PCI hospital and operator with CR referral and use after adjusting for patient characteristics., Results: Among 54 217 patients who underwent PCI, 76.3% received an in-hospital referral for CR, and 27.1% attended CR within 90 days after discharge. There was significant hospital and operator level variation in in-hospital CR referral with median odds ratios of 3.88 (95% credible interval [CI], 3.06-5.42) and 1.64 (95% CI, 1.55-1.75), respectively, and in CR participation with median odds ratios of 1.83 (95% CI, 1.63-2.15) and 1.40 (95% CI, 1.35-1.47), respectively. In-hospital CR referral was significantly associated with an increased likelihood of CR participation (adjusted odds ratio, 1.75 [95% CI, 1.52-2.01]), and this association varied by treating PCI hospital (odds ratio range, 0.92-3.75) and operator (odds ratio range, 1.26-2.82)., Conclusions: In-hospital CR referral and 90-day CR use after PCI varied significantly by hospital and operator. The association of in-hospital CR referral with downstream CR use also varied across hospitals and less so across operators suggesting that specific hospitals and operators may more effectively translate CR referrals into downstream use. Understanding the factors that explain this variation will be critical to developing strategies to improve CR participation overall.

Objectives: To examine the association of operator sex with appropriateness and outcomes of percutaneous coronary intervention (PCI)., Background: Recent studies suggest that physician sex may impact outcomes for specific patient cohorts. There are no data evaluating the impact of operator sex on PCI outcomes., Methods: We studied the impact of operator sex on PCI outcome and appropriateness among all patients undergoing PCI between January 2010 and December 2017 at 48 non-federal hospitals in Michigan. We used logistic regression models to adjust for baseline risk among patients treated by male versus female operators in the primary analysis., Results: During this time, 18 female interventionalists and 385 male interventionalists had performed at least one PCI. Female interventionalists performed 6362 (2.7%) of 239,420 cases. There were no differences in the odds of mortality (1.48% vs. 1.56%, adjusted OR [aOR] 1.138, 95% CI: 0.891-1.452), acute kidney injury (3.42% vs. 3.28%, aOR 1.027, 95% CI: 0.819-1.288), transfusion (2.59% vs. 2.85%, aOR 1.168, 95% CI: 0.980-1.390) or major bleeding (0.95% vs. 1.07%, aOR 1.083, 95% CI: 0.825-1.420) between patients treated by female versus male interventionalist. While the absolute differences were small, PCIs performed by female interventional cardiologists were more frequently rated as appropriate (86.64% vs. 84.45%, p-value <0.0001). Female interventional cardiologists more frequently prescribed guideline-directed medical therapy., Conclusions: We found no significant differences in risk-adjusted in-hospital outcomes between PCIs performed by female versus male interventional cardiologists in Michigan. Female interventional cardiologists more frequently performed PCI rated as appropriate and had a higher likelihood of prescribing guideline-directed medical therapy., (© 2021 Wiley Periodicals LLC.)

Objectives: The collateral effect of the COVID-19 pandemic on interventional stroke care is not well described. We studied this effect by utilizing stroke device sales data as markers of interventional stroke case volume in the United States., Methods: Using a real-time healthcare device sales registry, this observational study examined trends in the sales of thrombectomy devices and cerebral aneurysm coiling from the same 945 reporting hospitals in the U.S. between January 22 and June 31, 2020, and for the same months in 2018 and 2019 to allow for comparison. We simultaneously reviewed daily reports of new COVID-19 cases. The strength of association between the cumulative incidence of COVID-19 and procedural device sales was measured using Spearman rank correlation coefficient (CC)., Results: Device sales decreased for thrombectomy (- 3.7%) and cerebral aneurysm coiling (- 8.5%) when comparing 2019-2020. In 2020, thrombectomy device sales were negatively associated with the cumulative incidence of COVID-19 (CC - 0.56, p < 0.0001), with stronger negative correlation during April (CC - 0.97, p < 0.0001). The same negative correlation was observed with aneurysm treatment devices (CC - 0.60, p < 0.001), with stronger correlation in April (CC - 0.97, p < 0.0001)., Conclusions: The decline in sales of stroke interventional equipment underscores a decline in associated case volumes. Future pandemic responses should consider strategies to mitigate such negative collateral effects., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Potent antithrombotic agents are routinely prescribed after percutaneous coronary intervention (PCI) to reduce ischemic complications. However, in patients who are at an increased bleeding risk, this may pose significant risks. We sought to evaluate the association between a history of gastrointestinal bleeding (GIB) and outcomes after PCI. We linked clinical registry data from PCIs performed at 48 Michigan hospitals between 1/2013 and 3/2018 to Medicare claims. We used 1:5 propensity score matching to adjust for patient characteristics. In-hospital outcomes included bleeding, transfusion, stroke or death. Post-discharge outcomes included 90-day all-cause readmission and long-term mortality. Of 30,206 patients, 1.1% had a history of GIB. Patients with a history of GIB were more likely to be older, female, and have more cardiovascular comorbidities. After matching, those with a history of GIB (n = 312) had increased post-procedural transfusions (15.7% vs 8.4%; p < 0.001), bleeding (11.9% vs 5.2%; p < 0.001), and major bleeding (2.8% vs 0.6%; p = 0.004). Ninety-day readmission rates were similar among those with and without a history of GIB (34.3% vs 31.3%; p = 0.318). There was no significant difference in post-discharge survival (1 year: 78% vs 80%; p = 0.217; 5 years: 54% vs 51%; p = 0.189). In conclusion, after adjusting for baseline characteristics, patients with a history of GIB had increased risk of post-PCI in-hospital bleeding complications. However, a history of GIB was not significantly associated with 90-day readmission or long-term survival., (Published by Elsevier Inc.)

Objectives: The aim of this study was to evaluate the association between reported marijuana use and post-percutaneous coronary intervention (PCI) in-hospital outcomes., Background: Marijuana use is increasing as more states in the United States legalize its use for recreational and medicinal purposes. Little is known about the frequency of use and relative safety of marijuana among patients presenting for PCI., Methods: The authors analyzed Blue Cross Blue Shield of Michigan Cardiovascular Consortium PCI registry data between January 1, 2013, and September 30, 2016. One-to-one propensity matching and multivariable logistic regression were used to adjust for differences between patients with or without reported marijuana use, and rates of post-PCI complications were compared., Results: Among 113,477 patients, 3,970 reported marijuana use. Compared with those without reported marijuana use, patients with reported marijuana use were likely to be younger (53.9 years vs 65.8 years), to use tobacco (73.0% vs 26.8%), to present with ST-segment elevation myocardial infarction (27.3% vs 15.9%), and to have fewer cardiovascular comorbidities. After matching, compared with patients without reported marijuana use, those with reported marijuana use experienced significantly higher risks for bleeding (adjusted odds ratio [aOR]: 1.54; 95% confidence interval [CI]: 1.20-1.97; P < 0.001) and cerebrovascular accident (aOR: 11.01; 95% CI: 1.32-91.67; P = 0.026) and a lower risk for acute kidney injury (aOR: 0.61; 95% CI: 0.42-0.87; P = 0.007). There were no significant differences in risks for transfusion and death., Conclusions: A modest fraction of patients undergoing PCI used marijuana. Reported marijuana use was associated with higher risks for cerebrovascular accident and bleeding and a lower risk for acute kidney injury after PCI. Clinicians and patients should be aware of the higher risk for post-PCI complications in these patients., Competing Interests: Funding Support and Author Disclosures The BMC2 coordinating center is supported by a grant from Blue Cross Blue Shield of Michigan to the University of Michigan. The sponsor had no role in the study design or decision to publish this work. Dr Yoo has received support from the Fogarty International Center and the National Institute of Mental Health of the National Institutes of Health under award D43 TW010543. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Mr Seth, Drs Sukul and Gurm have received salary support from Blue Cross Blue Shield of Michigan for their roles in the BMC2. However, the opinions, beliefs and viewpoints expressed by the authors do not necessarily reflect those of Blue Cross Blue Shield of Michigan or any of its employees. Dr Gurm has received research support from Blue Cross Blue Shield of Michigan, the National Institutes of Health Center for Accelerated Innovations, and the Michigan Translational Research and Commercialization for Life Sciences Innovation Hub; is a cofounder of, owns equity in, and is a consultant to Calcium Solution; owns equity in Jiaxing Bossh Medical Technology Partnership; and is a consultant for Osprey Medical. Dr Vaduganathan is supported by the KL2/Catalyst Medical Research Investigator Training Award from Harvard Catalyst (National Institutes of Health/National Center for Advancing Translational Sciences award UL 1TR002541); receives research grant support from Amgen; serves on advisory boards for Amgen, AstraZeneca, Baxter Healthcare, Bayer, Boehringer Ingelheim, Cytokinetics, and Relypsa; and has participated on clinical endpoint committees for studies sponsored by Galmed, Novartis, and the National Institutes of Health. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Published by Elsevier Inc.)

Background Contrast-induced acute kidney injury (CI-AKI) is a serious complication after percutaneous coronary intervention. The mainstay of CI-AKI prevention is represented by intravenous hydration. Tailoring infusion rate to patient volume status has emerged as advantageous over fixed infusion-rate hydration strategies. Methods and Results A systematic review and network meta-analysis with a frequentist approach were conducted. A total of 8 randomized controlled trials comprising 2312 patients comparing fixed versus tailored hydration strategies to prevent CI-AKI after percutaneous coronary intervention were included in the final analysis. Tailored hydration strategies included urine flow rate-guided, central venous pressure-guided, left ventricular end-diastolic pressure-guided, and bioimpedance vector analysis-guided hydration. Primary endpoint was CI-AKI incidence. Safety endpoint was incidence of pulmonary edema. Urine flow rate-guided and central venous pressure-guided hydration were associated with a lower incidence of CI-AKI compared with fixed-rate hydration (odds ratio [OR], 0.32 [95% CI, 0.19-0.54] and OR, 0.45 [95% CI, 0.21-0.97]). No significant difference in pulmonary edema incidence was observed between the different hydration strategies. P score analysis showed that urine flow rate-guided hydration is advantageous in terms of both CI-AKI prevention and pulmonary edema incidence when compared with other approaches. Conclusions Currently available hydration strategies tailored on patients' volume status appear to offer an advantage over guideline-supported fixed-rate hydration for CI-AKI prevention after percutaneous coronary intervention. Current evidence suggests that urine flow rate-guided hydration as the most convenient strategy in terms of effectiveness and safety.

[Figure: see text].

Background: Transthoracic echocardiograms (TTEs) account for approximately half of U.S. spending on cardiac imaging. We developed an electronic medical record (EMR)-based decision-support algorithm for TTE ordering and hypothesized that it would increase the appropriateness of TTE orders., Methods: This prospective observational study was performed at the Veterans Affairs Ann Arbor Healthcare System. From October to December 2016 (preintervention), consecutive TTEs ordered in the inpatient, outpatient, and emergency department settings were included. In May 2017, a decision-support algorithm was incorporated into the EMR, giving immediate feedback to providers. Chart review was performed for TTEs ordered from June to August 2017 (early intervention) and from June to August 2018 (late intervention). Appropriateness was determined based on the 2011 appropriate use criteria for echocardiography., Results: Appropriate TTE orders increased from 87.6% preintervention to 94.5% at early intervention (z = 0.00018) but decreased to 90.0% at late intervention (z = 0.51, compared with preintervention). Among patients with no previous TTEs in our system, 95.3% of TTEs were appropriate, compared with 87.7% of TTEs for patients with prior TTEs within 30 days prior (odds ratio = 2.85; 95% CI, 1.18-6.31; P = .005)., Conclusions: The EMR algorithm initially increased the percentage of appropriate TTEs, but this effect decayed over time. Further study is needed to develop EMR-based interventions that will have lasting impacts on provider ordering patterns., (Copyright © 2020 American Society of Echocardiography. Published by Elsevier Inc. All rights reserved.)

Background: Cardiac rehabilitation (CR) is associated with improved outcomes for patients with coronary artery disease (CAD). However, CR enrollment remains low and there is a dearth of real-world data on hospital-level variation in CR enrollment. We sought to explore determinants of hospital variability in CR enrollment during CAD episodes of care: medical management of acute myocardial infarction (AMI-MM), percutaneous coronary intervention (PCI), and coronary artery bypass grafting (CABG)., Methods: A cohort of 71 703 CAD episodes of care were identified from 33 hospitals in the Michigan Value Collaborative statewide multipayer registry (2015 to 2018). CR enrollment was defined using professional and facility claims and compared across treatment strategies: AMI-MM (n=18 678), PCI (n=41 986), and CABG (n=11 039). Hierarchical logistic regression was used to estimate effects of predictors and hospital risk-adjusted rates of CR enrollment., Results: Overall, 20 613 (28.8%) patients enrolled in CR, with significant differences by treatment strategy: AMI-MM=13.4%, PCI=29.0%, CABG=53.8% ( P <0.001). There were significant differences in CR enrollment across age groups, comorbidity status, and payer status. At the hospital-level, there was over 5-fold variation in hospital risk-adjusted CR enrollment rates (9.8%-51.6%). Hospital-level CR enrollment rates were highly correlated across treatment strategy, with the strongest correlation between AMI-MM versus PCI (R 2 =0.72), followed by PCI versus CABG (R 2 =0.51) and AMI-MM versus CABG (R 2 =0.46, all P <0.001)., Conclusions: Substantial variation exists in CR enrollment during CAD episodes of care across hospitals. However, within-hospital CR enrollment rates were significantly correlated across all treatment strategies. These findings suggest that CR enrollment during CAD episodes of care is the product of hospital-specific rather than treatment-specific practice patterns.

Background The relationship between local hospital culture and transfusion rates following endovascular and surgical cardiovascular procedures has not been well studied. Methods and Results Patients undergoing coronary revascularization, aortic valve replacement, lower extremity peripheral vascular intervention, or carotid artery revascularization from up to 852 US hospitals in the Nationwide Readmissions Database were identified. Crude and risk-standardized red blood cell transfusion rates were determined for each procedure. Pearson correlation coefficients were calculated between respective procedural transfusion rates. Median odds ratios were estimated to reflect between-hospital variability in red blood cell transfusion rates following the same procedure for a given patient. There was wide variation in red blood cell transfusion rates across different procedures, from 2% following carotid endarterectomy to 29% following surgical aortic valve replacement. For surgical and endovascular modalities, transfusion rates at the same hospital were highly correlated for aortic valve replacement ( r =0.67; P <0.001), moderately correlated for coronary revascularization ( r =0.56; P <0.001) and peripheral vascular intervention ( r =0.51; P <0.001), and weakly correlated for carotid artery revascularization ( r =0.19, P <0.001). Median odds ratios were all >2, highest for coronary artery bypass graft surgery and surgical aortic valve replacement, indicating substantial site variation in transfusion rates. Conclusions After adjustment for patient-related factors, wide variation in red blood cell transfusion rates remained across surgical and endovascular procedures employed for the same cardiovascular condition. Transfusion rates following these procedures are highly correlated at individual hospitals and vary widely across hospitals. In aggregate, these findings suggest that local institutional culture significantly influences the decision to transfuse following invasive cardiovascular procedures and highlight the need for randomized data to inform such decisions.

Introduction: Non-primary percutaneous coronary intervention (non-PPCI) recently received certificate of need approval in the state of Michigan at sites without cardiac surgery on-site (cSoS). This requires quality oversight through participation in the BMC2 registry. While previous studies have indicated the safety of this practice, real-world comprehensive outcomes, case volume changes, economic impacts, and readmission rates at diverse healthcare centers with and without cSoS remain poorly understood., Methods: Consecutive patients undergoing non-PPCI at 47 hospitals (33 cSoS and 14 non-cSoS) in Michigan from April 2016 to March 2018 were included. Using propensity-matching, patients were analyzed to assess outcomes and trends in non-PPCI performance at sites with and without cSOS., Results: Of 61,864 PCI's performed, 50,817 were non-PPCI, with 46,096 (90.7%) performed at sites with cSoS and 4,721 (9.3%) at sites without cSoS. From this cohort, 4,643 propensity-matched patients were analyzed. Rates of major adverse cardiac events (2.6% vs. 2.8%; p = 0.443), in-hospital mortality (0.6% vs. 0.5%; p = 0.465), and several secondary clinical and quality outcomes showed no clinically significant differences. Among a small subset with available post-discharge data, there were no differences in 90-day readmission rates, standardized episode costs, or post-discharge mortality. Overall PCI volume remained stable, with a near three-fold rise in non-PPCI at sites without cSoS., Conclusions: Non-PPCI at centers without cardiac SoS was associated with similar comprehensive outcomes, quality of care, 90-day episode costs, and post-discharge mortality compared with surgical sites. Mandatory quality oversight serves to maintain appropriate equivalent outcomes and may be considered for other programs, including the performance of non-PPCI at ambulatory surgical centers in the near future., Competing Interests: Dr. Hitinder S. Gurm receives research funding from BCBSM and the National Institutes of Health and is a consultant for Osprey Medical. This does not alter our adherence to PLOS ONE policies on sharing data and materials. The other authors do not have any direct onflicts or competing interest that could affect the study or its data presentation.

Background: An inverse relationship has been described between procedural success and outcomes of all major cardiovascular procedures. However, this relationship has not been studied for percutaneous coronary intervention (PCI) of chronic total occlusion (CTO)., Methods: We analyzed the data on patients enrolled in Blue Cross Blue Shield of Michigan Cardiovascular Consortium registry in Michigan (January 1, 2010 to March 31, 2018) to evaluate the association of operator and hospital experience with procedural success and outcomes of patients undergoing CTO-PCI. CTO-PCI was defined as intervention of a 100% occluded coronary artery presumed to be ≥3 months old., Results: Among 210 172 patients enrolled in the registry, 7389 (3.5%) CTO-PCIs were attempted with a success rate of 53%. CTO-PCI success increased with operator experience (45% and 65% in the lowest and highest experience tertiles) and was the highest for highly experienced operators at higher experience centers and the lowest for inexperienced operators at low experience hospitals. Multivariable logistic regression models (with spline transformed prior operator and institutional experience) demonstrated a positive relationship between prior operator and site experience and procedural success rates (likelihood ratio test=141.12, df=15, P <0.001) but no relationship between operator and site experience and major adverse cardiac event (likelihood ratio test=19.12, df=15, P =0.208)., Conclusions: Operator and hospital CTO-PCI experiences were directly related to procedural success but were not related to major adverse cardiac event among patients undergoing CTO-PCIs. Inexperienced operators at high experience centers had significantly higher success but not major adverse cardiac event rates compared with inexperienced operators at low experience centers. These data suggested that CTO-PCI safety and success could potentially be improved by selective referral of these procedures to experienced operators working at highly experienced centers.

Contrast-induced acute kidney injury is a common complication in patients undergoing invasive procedures and is associated with increased mortality and morbidity. There is no effective approach to the management of this complication, and prevention remains of paramount importance. The 3 pillars of prevention are identification of high-risk patients, appropriate hydration before and after contrast exposure, eGFR-based contrast dosing and use of ultra-low contrast volume in high-risk patients. Most evidence supporting these practices is derived from patients undergoing coronary angiography or percutaneous coronary intervention but these basic principles can be applied to most patients undergoing contrast-based procedures in the catheterization laboratory., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background Patient selection and outcomes for percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) have changed over the past decade. However, there is limited information on outcomes for both revascularization strategies in the same population. The study evaluated temporal changes in risk profile, procedural characteristics, and clinical outcomes for PCI- and CABG-treated patients. Methods and Results We analyzed all PCI and isolated CABG between 2005 and 2017 in nonfederal hospitals in Washington State. Descriptive analysis was performed to evaluate temporal changes in risk profile and, risk-adjusted in-hospital mortality. Over the study period, 178 474 PCI and 36 592 CABG procedures were performed. PCI and CABG volume decreased by 2.9% and 22.6%, respectively. Compared with 2005-2009, patients receiving either form of revascularization between 2014 and 2017 had a higher prevalence of comorbidities including diabetes mellitus and hypertension and dialysis. Presentation with ST-segment-elevation myocardial infarction (17% versus 20%) and cardiogenic shock (2.4% versus 3.4%) increased for patients with PCI compared with CABG. Conversely, clinical acuity decreased for patients receiving CABG over the study period. From 2005 to 2017, mean National Cardiovascular Data Registry CathPCI mortality score increased for patients treated with PCI (20.1 versus 22.4, P <0.0001) and decreased for patients treated with CABG (18.8 versus 17.8, P <0.0001). Adjusted observed/expected in-hospital mortality ratio increased for PCI (0.98 versus 1.19, P <0.0001) but decreased for CABG (1.21 versus 0.74, P <0.0001) over the study period. Conclusions Clinical acuity increased for patients treated with PCI rather than CABG. This resulted in an increase in adjusted observed/expected mortality ratio for patients undergoing PCI and a decrease for CABG. These shifts may reflect an increased use of PCI instead of CABG for patients considered to be at high surgical risk.

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., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Contrast-induced acute kidney injury (CI-AKI) is a potentially serious complication following coronary angiography and percutaneous coronary intervention (PCI). The incidence of CI-AKI is particularly high in patients with advanced chronic kidney disease (defined as an estimated glomerular filtration rate <30 ml/min/1.73 m 2 ). Although much effort has been dedicated to the identification and implementation of preventive measures for this complication at the pre-intervention stage, much less has been investigated on the procedural strategies and techniques to decrease the risk of CI-AKI during PCI. The mainstay of such approaches relies on the minimization of contrast volume by means of specific strategies or dedicated devices. Invasive imaging, such as intravascular ultrasound or non-contrast-based optical coherence tomography, is another pillar of any ultra-low-contrast-volume PCI protocol. Finally, an array of miscellaneous ancillary measures can be implemented to decrease the risk of CI-AKI, which includes the use of radial access, remote ischemic conditioning, and hemodynamic support in high-risk patients. The present review analyzes the technical aspects as well as the scientific evidence supporting these novel techniques, with the goal to improve the outcomes of patients at high risk for CI-AKI undergoing PCI., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

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.

Objective: To evaluate contrast media (CM) volume (CMV) saved using the DyeVert™ Plus Contrast Reduction System (DyeVert Plus System, Osprey Medical) in patients undergoing diagnostic coronary angiogram (CAG) and/or percutaneous coronary interventional (PCI) procedures performed with manual injections., Background: Current guidelines advocate for monitoring and minimization of the total volume of CM in chronic kidney disease (CKD) patients undergoing invasive cardiac procedures. The DyeVert Plus System is an FDA cleared device designed to reduce CMV delivered during angiography and permit real-time CMV monitoring., Methods: We performed a multicenter, single-arm, observational study. Eligible subjects were ≥ 18 years old with baseline estimated glomerular filtration rate (eGFR) 20-60 mL/min/1.73 m 2 . The primary endpoint was % CMV saved over the total procedure. A secondary objective was to evaluate adverse events (AEs) related to DyeVert Plus System or to CM use., Results: A total of 114 subjects were enrolled at eight centers. Mean age was 72 ± 9 years, 72% were male, and mean body mass index was 29 ± 5. Baseline eGFR was 43 ± 11 mL/min/1.73 m 2 . CAG-only was performed in 65% of cases. One hundred and five subjects were evaluable for the primary endpoint. Mean CMV attempted was 112 ± 85 mL (range 22-681) and mean CMV delivered was 67 ± 51 mL (range 12-403), resulting in an overall CMV savings of 40.1 ± 8.8% (95% CI 38.4, 41.8; P < 0.0001) per procedure. Image quality was maintained in all but one case where the system was turned off for one injection. No DyeVert Plus System-related AEs were reported. Acute kidney injury (AKI; defined as serum creatinine rise of >0.3 mg/dL from baseline) was reported in 11 cases with seven occurring in subjects with baseline eGFR < 30 and three AKI events were attributed to CM. AKI rates increased as CMV/eGFR ratios increased., Conclusions: These data suggest DyeVert Plus System use in CKD patients undergoing CAG and/or PCI results in clinically meaningful CMV savings while maintaining image quality., (© 2018 Wiley Periodicals, Inc.)