Search

Background: There is speculation that the volume of percutaneous coronary interventions (PCIs) has been decreasing over the past several years. Published studies of PCI volume have evaluated regional or hospital trends, but few have captured national data. This study describes the use of coronary angiography and revascularization methods in Medicare patients from 2001 to 2009.Methods and Results: This retrospective study used data from the Centers for Medicare & Medicaid Services from 2001 to 2009. The annual number of coronary angiograms, PCI, intravascular ultrasound, fractional flow reserve, and coronary artery bypass graft (CABG) surgery procedures were determined from billing data and adjusted for the number of Medicare recipients. From 2001 to 2009, the average year-to-year increase for PCI was 1.3% per 1000 beneficiaries, whereas the mean annual decrease for CABG surgery was 5%. However, the increase in PCI volume occurred primarily from 2001 to 2004, as there was a mean annual rate of decline of 2.5% from 2004 to 2009; similar trends were seen with diagnostic angiography. The use of intravascular ultrasound and fractional flow reserve steadily increased over time.Conclusions: This study confirms recent speculation that PCI volume has begun to decrease. Although rates of CABG have waned for several decades, all forms of coronary revascularization have been declining since 2004. [ABSTRACT FROM AUTHOR]

The prevalence of calcification in obstructive coronary artery disease is on the rise. Percutaneous coronary intervention of these calcified lesions is associated with increased short-term and long-term risks. To optimize percutaneous coronary intervention results, there is an expanding array of treatment modalities geared toward calcium modification prior to stent implantation. The Society for Cardiovascular Angiography and Interventions, herein, puts forth an expert consensus document regarding methods to identify types of calcified coronary lesions, a central algorithm to help guide use of the various calcium modification strategies, tips for when using each treatment modality, and a look at future studies and trials for treating this challenging lesion subset., (© 2023 The Author(s).)

Background: Intravascular lithotripsy (IVL) safely and effectively modifies calcified coronary lesions during percutaneous coronary interventions (PCI). Data regarding its utility in modifying calcified left main coronary artery (LMCA) disease are limited. This study aimed to evaluate short-term outcomes of IVL-assisted LMCA PCI., Methods: This retrospective multicenter all-comers study analyzed patients who underwent intravascular imaging-guided, IVL-assisted PCI for calcified LMCA disease. Clinical and procedural characteristics were obtained, including intravascular imaging measurements. Technical success was defined as successful stent deployment with <30% residual diameter stenosis. Major adverse cardiac events (MACE) was a composite of all-cause death, myocardial infarction, and target vessel revascularization evaluated immediately postprocedure and at 30-day follow-up., Results: Among 184 patients treated at 7 centers from 2019-2023, IVL-assisted LMCA PCI achieved 99.4% technical success. Calcium fracture was identified in 136/165 cases (82.4%) on post-IVL imaging. Pretreatment minimal luminal area increased significantly compared to post-PCI minimal stent area (MSA) (4.1 ± 1.3 to 9.3 ± 2.5 mm 2 , respectively; P < .001). There was a direct correlation between IVL balloon size and the final MSA ( P = .002). In-hospital MACE was 4.4% and 30-day MACE was 8.8%. In multivariate logistic regression, presentation with troponin-positive myocardial infarction was the sole predictor of 30-day MACE., Conclusions: IVL-assisted PCI for calcified LMCA lesions was safe and resulted in high technical success rates, confirming its utility as an effective treatment in this challenging lesion subset., (© 2023 The Author(s).)

Background: Intravascular lithotripsy (IVL) for calcified lesion preparation prior to drug-eluting stent placement has high procedural success and safety, especially in women, whereas other atheroablative approaches are associated with increased procedural complications. We sought to investigate long-term sex-based outcomes of IVL-facilitated stenting., Methods: We performed a patient-level pooled analysis of the single-arm Disrupt CAD III and IV studies. Patient baseline, procedural characteristics, and outcomes were examined according to sex at 30 days and 1 year. The primary end point was major adverse cardiac events (a composite of cardiac death, all myocardial infarction, or target vessel revascularization). Target lesion failure was defined as cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization., Results: A total of 448 patients, 106 (24%) women, were included. Women were older and less likely to be smokers. Women had smaller reference vessel diameters (2.8 mm vs 3.1 mm), shorter lesion length (23.6 mm vs 27.1 mm), and shorter total calcified length (44.4 mm vs 49.3 mm) compared with men. Post-IVL angiographic outcomes and complications were similar between women and men. At 1 year, major adverse cardiac event rates (12.3% vs 13.2%, P = .52) were not different between women and men. There were no differences between women and men (10.4% vs 11.2%; P = .43) in target lesion failure at 1 year., Conclusions: Use of IVL in the treatment of severely calcified lesions is associated with low rates of adverse clinical events and with similar safety and effectiveness in women and men at 1 year., (© 2023 The Author(s).)

Background: Coronary intravascular lithotripsy (IVL) safely facilitates successful stent implantation in severely calcified lesions. This analysis sought to determine the relative impact of lesion calcium eccentricity on the safety and effectiveness of IVL using high-resolution optical coherence tomography imaging., Methods: Individual patient-level data (n=262) were pooled from 4 distinct international prospective studies (Disrupt CAD I, II, III, and IV) and analyzed by an independent optical coherence tomography core laboratory. IVL performance in eccentric versus concentric calcification was analyzed by dividing calcified lesions into quartiles (≤180° [most eccentric], 181°-270°, 271°-359°, and 360° [concentric]) by maximum continuous calcium arc., Results: In the 230 patients with clear imaging field on optical coherence tomography, there were no differences in preprocedure minimum lumen area, diameter stenosis, or maximum calcium thickness. The calcium length and volume index increased progressively with increasing mean and maximum continuous calcium arc (ie, concentricity). Conversely, the minimum calcium thickness decreased progressively with increasing concentricity. Post-procedure, the number of calcium fractures, fracture depth, and fracture width increased with increasing concentricity, with a 4-fold increase in the number of fractures in lesions with 360° of calcium arc compared with ≤180°. This increase in IVL-induced calcium fracture with increasing calcium burden and concentricity facilitated stent expansion and luminal gain such that there were no significant differences across quartiles., Conclusions: IVL induced calcium fractures proportional to the magnitude of coronary artery calcium, including in eccentric calcium, leading to consistent improvements in stent expansion and luminal gain in both eccentric and concentric calcified coronary lesions., Competing Interests: Disclosures Dr Ali reports institutional grants from Abbott, Abiomed, Acist Medical, Boston Scientific, Cardiovascular Systems, Inc, Medtronic, Opsens Medical, Philips, and Shockwave Medical; personal fees from Amgen, AstraZeneca, and Boston Scientific; and equity from Elucid, Lifelink, Spectrawave, Shockwave, and Vital Connect. Dr Kereiakes reports personal consulting fees from Shockwave Medical, Elixir Medical, and Boston Scientific. Dr Hill reports speaker honoraria and institutional grants from Abbott, Abiomed, Boston Scientific, and Shockwave Medical and equity from Shockwave. Dr Saito is a consultant for Japan Lifeline. Dr Di Mario reports research grants from Amgen, Behring, Chiesi, Daiichi Sanyo, Edwards, Medtronic, and Shockwave Medical. Dr Honton reports speaker honoraria from Shockwave Medical. Dr Gonzalo reports research grant from Abbott and consultancy and speaker fees from Abbott, Boston Scientific, Philips, and Shockwave. Dr Riley reports honoraria from Boston Scientific, Asahi Intecc, and Medtronic. Dr Maehara reports grant support from Abbott Vascular and Boston Scientific and consultant fees from Abbott Vascular, Boston Scientific, and Conavi Medical, Inc. M. Matsumura reports consulting fees from Terumo and Boston Scientific. Dr Stone has received speaker honoraria from Medtronic, Pulnovo, Infraredx, Abiomed, and Abbott; has served as a consultant to Valfix, TherOx, Robocath, HeartFlow, Ablative Solutions, Vectorious, Miracor, Neovasc, Ancora, Elucid Bio, Occlutech, CorFlow, Apollo Therapeutics, Impulse Dynamics, Cardiomech, Gore, Amgen, Adona Medical, and Millennia Biopharma; and has equity/options from Ancora, Cagent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, and Valfix, Xenter. Dr Stone’s daughter is an employee at IQVIA. Institutional disclosure: Dr Stone’s employer, Mount Sinai Hospital, receives research support from Abbott, Abiomed, Bioventrix, Cardiovascular Systems, Inc, Phillips, Biosense Webster, Shockwave, Vascular Dynamics, Pulnovo, and V-Wave. Dr Shlofmitz reports speaker honoraria from Shockwave Medical. The other author reports no conflicts.

Coronary angiography has historically served as the gold standard for diagnosis of coronary artery disease and guidance of percutaneous coronary intervention (PCI). Adjunctive use of contemporary intravascular imaging (IVI) technologies has emerged as a complement to conventional angiography-to further characterize plaque morphology and optimize the performance of PCI. IVI has utility for preintervention lesion and vessel assessment, periprocedural guidance of lesion preparation and stent deployment, and postintervention assessment of optimal endpoints and exclusion of complications. The role of IVI in reducing major adverse cardiac events in complex lesion subsets is emerging, and further studies evaluating broader use are underway or in development. This paper provides an overview of currently available IVI technologies, reviews data supporting their utilization for PCI guidance and optimization across a variety of lesion subsets, proposes best practices, and advocates for broader use of these technologies as a part of contemporary practice., Competing Interests: Funding Support and Author Disclosures Dr Truesdell has served as a consultant for/on the Speakers Bureau of Abiomed Inc and Shockwave Medical Inc. Dr Kaul has served as a consultant for Shockwave Medical Inc and Cardiovascular Systems Inc. Dr Riley has served as a consultant for Boston Scientific and Abbott Vascular. Dr Young has served as a consultant for/on the Advisory Board of Medtronic Inc. Dr Batchelor has served as a consultant for Boston Scientific, Abbott Vascular, Medtronic, Idorsia, and V Wave; and has received research grant support from Boston Scientific and Abbott Vascular. Dr Maehara has served as a consultant for Boston Scientific, Philips, and Shockwave Medical; and has served on the Advisory Board of SpectraWave. Dr Welt has served on the Advisory Board of Medtronic Inc; and has minor equity in Xenter Inc. Dr Kirtane has received institutional funding to Columbia University and/or Cardiovascular Research Foundation from Medtronic, Boston Scientific, Abbott Vascular, Amgen, Cardiovascular Systems Inc, Philips, ReCor Medical, Neurotronic, Biotronik, Chiesi, Bolt Medical, Magenta Medical, Canon, SoniVie, and Merck; in addition to research grants, institutional funding includes fees paid to Columbia University and/or Cardiovascular Research Foundation for consulting and/or speaking engagements in which Dr Kirtane controlled the content; has received consulting fees from IMDS; and has received travel expenses/meals from Medtronic, Boston Scientific, Abbott Vascular, Cardiovascular Systems Inc, Siemens, Philips, ReCor Medical, Chiesi, OpSens, Zoll, and Regeneron. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023. Published by Elsevier Inc.)

Intravascular lithotripsy (IVL) uses acoustic shock waves in a balloon-based delivery system to modify severely calcified atherosclerotic coronary vascular lesions in preparation for stent implantation. IVL results in circumferential and longitudinal calcium fracture, which improves transmural vessel compliance and facilitates subsequent stent expansion without requiring high-pressure balloon dilation. Clinical trials have demonstrated IVL to be safe (low rates of major adverse cardiac events in hospital and to 1 year; low rates of severe angiographic complications), effective (high rates of procedural success), and easy to use (little or no learning curve) when applied in the treatment of severely calcified coronary arteries., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: Coronary artery calcification increases the procedural complexity of percutaneous coronary intervention and is associated with worse outcomes, especially in women. Intravascular lithotripsy (IVL) has been demonstrated to be safe and effective for vessel preparation in severely calcified stenotic lesions before stent implantation. Sex-based outcomes of IVL-facilitated stenting have not been defined., Methods: We performed a patient-level pooled analysis of the 4 prospective, single-arm Disrupt CAD studies that evaluated the safety and efficacy of IVL-facilitated stenting. Patient baseline and procedural characteristics and clinical outcomes were examined based on sex. The primary safety end point was 30-day major adverse cardiovascular events, defined as the composite of cardiac death, myocardial infarction, or target vessel revascularization. The primary efficacy end point was procedural success, defined as stent delivery with residual in-stent stenosis ≤30% without in-hospital major adverse cardiovascular events., Results: A total of 628 patients were included, of which 144 (22.9%) were women. Women were older ( P < .001) and more likely to have hyperlipidemia ( P = .03), renal insufficiency ( P = .05), and prior myocardial infarction ( P = .05). Women had smaller mean reference vessel diameter (2.7 ​ ± ​0.4 ​mm vs 3.0 ​ ± ​0.5 ​mm, P < .001), shorter lesion length (22.4 ​ ± ​10.3 ​mm vs 25.0 ​ ± ​11.7 ​mm, P = .01), and less side branch involvement (22.9% vs 32.4%, P = .03). Severe coronary calcification defined by angiography, stent delivery success, lesion predilatation, post-IVL dilatation, and poststent dilatation was similar between groups. There were no significant differences between women and men in the primary safety end point (8.3% vs 7.1%, P = .61; adjusted odds ratio 1.66; 95% confidence interval 0.78, 3.34; P = .17) or the primary efficacy end point (91.7% vs 92.6%, P = .72; adjusted odds ratio 0.58; 95% confidence interval 0.29, 1.24; P = .15). Post-IVL serious angiographic complications (flow-limiting dissection, perforation, abrupt closure, slow flow, no reflow) were similar for women and men (1.6% vs 2.3%, P = .75)., Conclusions: Despite more comorbidities and smaller vessel size, IVL-facilitated stenting of severely calcified lesions achieves similar safety and efficacy in women and men., (© 2021 The Author(s).)

Background: Coronary calcification impairs stent delivery and optimal expansion, a significant predictor of subsequent stent thrombosis and restenosis. Current calcium ablative technologies may be limited by guidewire bias and periprocedural complications. Intravascular lithotripsy (IVL) delivers acoustic pressure waves to modify calcium, enhance vessel compliance, and optimize stent deployment. The Disrupt CAD III study demonstrated high (92.4%) procedural success and low (7.8%) 30-day major adverse cardiac event (MACE) rates following IVL, but longer term follow-up is required to determine the durability of clinical benefit and the late impact of optimized stent implantation associated with IVL. This analysis evaluates 1-year outcomes from the Disrupt CAD III study., Methods: Disrupt CAD III (NCT03595176) was a prospective, single-arm approval study designed to assess the safety and effectiveness of IVL as an adjunct to coronary stenting in de novo , severely calcified coronary lesions ( n  = 384). MACE was defined as the composite of cardiac death, myocardial infarction (MI), or ischemia-driven target vessel revascularization; target lesion failure was defined as cardiac death, MI, or ischemia-driven target lesion revascularization (ID-TLR)., Results: At 1 year, MACE occurred in 13.8% of patients (cardiac death: 1.1%, MI: 10.5%, ischemia-driven target vessel revascularization: 6.0%) and target lesion failure occurred in 11.9% (ID-TLR: 4.3%), both driven by non-Q-wave MI (9.2%). Stent thrombosis (definite or probable) occurred in 1.1% of patients (including 1 event [0.3%] beyond 30 ​days)., Conclusions: Disrupt CAD III represents the largest long-term (1-year) analysis of coronary IVL to date. IVL treatment prior to coronary stent implantation in severely calcified lesions was associated with low 1-year rates of MACE, ID-TLR, and stent thrombosis., (© 2021 The Author(s).)

The authors developed a global chronic total occlusion crossing algorithm following 10 steps: 1) dual angiography; 2) careful angiographic review focusing on proximal cap morphology, occlusion segment, distal vessel quality, and collateral circulation; 3) approaching proximal cap ambiguity using intravascular ultrasound, retrograde, and move-the-cap techniques; 4) approaching poor distal vessel quality using the retrograde approach and bifurcation at the distal cap by use of a dual-lumen catheter and intravascular ultrasound; 5) feasibility of retrograde crossing through grafts and septal and epicardial collateral vessels; 6) antegrade wiring strategies; 7) retrograde approach; 8) changing strategy when failing to achieve progress; 9) considering performing an investment procedure if crossing attempts fail; and 10) stopping when reaching high radiation or contrast dose or in case of long procedural time, occurrence of a serious complication, operator and patient fatigue, or lack of expertise or equipment. This algorithm can improve outcomes and expand discussion, research, and collaboration., Competing Interests: Funding Support and Author Disclosures Dr Wu has received research funding from Abiomed, OrbusNeich, Asahi Intecc; has received consulting honoraria from Boston Scientific and Abbott Vascular; is a member of the board of directors for APCTO Club; and holds stock in Abbott Vascular. Dr Brilakis has received consulting and speaker honoraria from Abbott Vascular, the American Heart Association (associate editor, Circulation), Amgen, Biotronik, Boston Scientific, Cardiovascular Innovations Foundation (board of directors), ControlRad, CSI, Ebix, Elsevier, GE Healthcare, InfraRedx, Medtronic, Siemens, and Teleflex; has received research support from Regeneron and Siemens; is an owner of Hippocrates; and is a shareholder in MHI Ventures. Dr Mashayekhi has received consulting, speaker, and proctoring honoraria from Abbott Vascular, Asahi Intecc, AstraZeneca, Biotronik, Boston Scientific, Cardinal Health, Daiichi-Sankyo, Medtronic, Teleflex, and Terumo. Dr Tsuchikane is a consultant for Boston Scientific, Asahi Intecc, Nipro, and Kaneka. Dr Avran has received consulting, speaker, and proctoring honoraria from Asahi Intecc, Biotronik, Boston Scientific, Terumo, Alvimedica, and OrbusNeich. Dr Azzalini has received consulting fees from Abiomed and Teleflex. Dr Buller is global medical director of Teleflex. Dr Burke is a shareholder in Egg Medical and MHI Ventures. Dr Croce has received grants from Abbott, Takeda, Teleflex, and CSI; has received consulting honoraria from Abbott, BSCI, Biotronik, Philips, Abiomed, CSI, Takeda, and Cordis; and holds stock in Dyad Medical. Dr Damas de los Santos is a proctor, speaker, and consultant for Boston Scientific, Terumo, Abbott Vascular, and Biotronik. Dr Dens has consultancy contracts with Abbott, Boston Scientific, IMDS, Terumo, Topmedical (a distributor for Asahi); and is a chronic total occlusion proctor for Boston Scientific and Topmedical (Asahi). Dr di Mario has received research grants from Abbott, Amgen, Behring, Daiichi-Sankyo, Edwards, Medtronic, and Shockwave Medical. Dr Egred has received chronic total occlusion proctorship fees, speaker fees, honoraria, and grants from Abbott Vascular, Boston Scientific, Philips, Spectranetics, Vascular Perspectives, Merrill, Biotronik, and AstraZeneca. Dr Elbarouni has received speaker fees from Teleflex and Bayer. Dr ElGuindy has received consulting, speaker, and proctoring honoraria from Medtronic, Boston Scientific, Asahi Intecc, and Terumo. Dr Escaned has received personal fees from Abbott, Boston Scientific, Terumo, and Phillips. Dr Furkalo has a proctoring agreement with Medtronic; and has received speaker honoraria from Sanofi. Dr Garbo is a proctor and consultant for Philips Volcano, Boston Europe, Terumo Italy, and Europe Teleflex. Dr Hall has received speaker honoraria from Medtronic, OpSens Medical, and the Cardiovascular Innovations Foundation. Dr Hanna Quesada has received honoraria from Boston Scientific. Dr Harb is a consultant for Medtronic and Cardinal Health; and has received speaker honoraria from Cardinal Health and Terumo. Dr Harding has received speaker and consultancy fees from Boston Scientific, Medtronic, Bio-Excel, and Asahi Intecc. Dr Hatem is a member of the Speakers Bureau for Abbott, Boston Scientific, and Teleflex. Dr Hoye has received speaker fees from AstraZeneca and Sanofi. Dr Jaber has received proctoring fees from Abbott; and has received consulting, advisory board, and institutional funds from Medtronic. Dr Jaffer conducts sponsored research for Canon, Siemens, Teleflex, and Shockwave; is a consultant for Boston Scientific, Siemens, Biotronik, and Magenta Medical; and holds equity interest in Intravascular Imaging. Dr Jussila has a proctoring contract with Boston Scientific and EPS Vascular. Dr Kalyanasundaram has received fees from Abbott Vascular, Boston Scientific, Asahi Intecc, and Terumo. Dr Kandzari has received institutional research grant support from Abbott, Biotronik, Boston Scientific, Cardiovascular Systems, Medtronic, Teleflex, and OrbusNeich; Dr Karmpaliotis has received honoraria from Abbott Vascular and Boston Scientific; and holds equity in Saranas, Soundbite, and Traverse Vascular. Dr Kassem has received speaker honoraria from Boston Scientific, Abbott Vascular, GE, and Abiomed. Dr Khatri has received institutional research grant from Asahi Intecc and honoraria or consulting fees from Abbott Vascular, Boston Scientific, and Terumo. Dr Kornowski is a founder of NitiLoop. Dr Lamelas has received proctoring fees from Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Lim has received educational support and honoraria from Asahi Intecc, Boston Scientific, Abbott Vascular, Kaneka, Biotronik, Alvimedica, Terumo, and Medtronic. Dr Lo has received speaker and proctoring honoraria from Bio-Excel, Boston Scientific, Abbott, and Terumo; and is a member of Medtronic’s advisory board. Dr Lombardi has received royalties and is a consultant for Asahi Intecc; is a consultant for Abiomed, Boston Scientific, Medtronic, Siemens, and Teleflex; and his spouse is an employee of Philips. Dr Maran is a consultant for Boston Scientific, Medtronic, and Philips. Dr Moses has received funding from Orchestra Biomedical and Ostial Corporation. Dr Munawar has received speaker and proctorship honoraria from Asahi Intecc, Terumo, Boston Scientific, Abbott Vascular, Toray, and Phillips. Dr Oksnes has proctoring contracts with Boston Scientific and EPS Vascular. Dr Olivecrona has received lecture honoraria from Abbott and Biotronik; and has received proctoring honoraria from EPS Vascular and Terumo. Dr Patel is a consultant for Abbott Vascular, Terumo, and Chiesi; and is a proctor for Medtronic. Dr Quadros has received honoraria from Boston Scientific; and has received research funding from Boston and Terumo. Dr Abi Rafeh is a proctor and consultant for Boston Scientific, Abbott, and Shockwave Medical. Dr Råmunddal has received consulting honoraria from EPS Vascular, Boston Scientific, and Abbott Vascular. Dr Riley is an advisory board and Speakers Bureau member for and has received consulting honoraria from Boston Scientific, Asahi Intecc, and Medtronic. Dr Saghatelyan has received proctoring and speaker honoraria from Asahi Intecc and Terumo. Dr Spaedy is a consultant for Boston Scientific and Abbott Vascular. Dr Stone has received speaker or other honoraria from Cook and Terumo; is a consultant to Valfix, TherOx, Vascular Dynamics, Robocath, HeartFlow, Gore, Ablative Solutions, Miracor, Neovasc, V-Wave, Abiomed, Ancora, MAIA Pharmaceuticals, Vectorious, Reva, Matrizyme, Cardiomech, Elucid Bio, and Occlutech; and holds equity or options with Ancora, Cagent, Applied Therapeutics, the Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, the MedFocus family of funds, and Valfix. Dr Tammam has a proctorship agreement with Terumo. Dr Tremmel has received honoraria from Abbott Vascular and Boston Scientific. Dr Wollmuth has received consulting, speaker, and proctoring honoraria from Abbott Vascular, Abiomed, Asahi Intecc, Biotronik, Boston Scientific, Cardiovascular Systems, Medtronic, and Philips. Dr Ybarra has received consulting and speaker fees from Abbott Vascular Canada and SoundBite Medical Solutions. Dr Yeh has received research grants from Abbott Vascular, AstraZeneca, Cook, BD Bard, Boston Scientific, Medtronic, and Philips; and is a consultant for Abbott Vascular, AstraZeneca, Boston Scientific, Edwards Lifesciences, Medtronic, Shockwave Medical, and Zoll. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this pooled analysis was to assess the cumulative safety and effectiveness of coronary intravascular lithotripsy (IVL)., Background: The clinical outcomes of IVL to optimize target lesion preparation in severely calcified de novo coronary stenoses have been examined in 4 prospective studies (Disrupt CAD I [NCT02650128], Disrupt CAD II [NCT03328949], Disrupt CAD III [NCT03595176], and Disrupt CAD IV [NCT04151628])., Methods: Patient data were pooled from the Disrupt CAD studies, which shared uniform study criteria, endpoint definitions and adjudication, and procedural follow-up. The primary safety endpoint was freedom from major adverse cardiovascular events (composite of cardiac death, all myocardial infarction, or target vessel revascularization) at 30 days. The primary effectiveness endpoint was procedural success, defined as stent delivery with a residual stenosis ≤30% by quantitative coronary angiography without in-hospital major adverse cardiovascular events. Secondary outcomes included serious angiographic complications, target lesion failure, cardiac death, and stent thrombosis at 30 days., Results: Between December 2015 and April 2020, 628 patients were enrolled at 72 sites from 12 countries. Presence of severe calcification was confirmed in 97.0% of target lesions with an average calcified segment length of 41.5 ± 20.0 mm. The primary safety and effectiveness endpoints were achieved in 92.7% and 92.4% of patients, respectively. At 30 days, the rates of target lesion failure, cardiac death, and stent thrombosis were 7.2%, 0.5%, and 0.8%. Rates of post-IVL and final serious angiographic complications were 2.1% and 0.3%, with no IVL-associated perforations, abrupt closure, or episodes of no reflow., Conclusions: In the largest cohort of patients treated with coronary IVL assessed to date, coronary IVL safely facilitated successful stent implantation in severely calcified coronary lesions with a high rate of procedural success., Competing Interests: Funding Support and Author Disclosures Dr. Kereiakes is a consultant for SINO Medical Sciences Technologies, Boston Scientific, Elixir Medical, Svelte Medical Systems, Caliber Therapeutics/Orchestra BioMed, and Shockwave Medical; and is a stockholder in Ablative Solutions. Dr. Riley has received honoraria from Boston Scientific, Asahi Intecc, and Medtronic. Dr. Di Mario has received research grants from Amgen, Behring, Chiesi, Daiichi-Sanyo, Edwards Lifesciences, Medtronic, Shockwave, and Volcano Philips. Dr. Shlofmitz is a speaker for Shockwave Medical. Dr. Saito is a consultant for Terumo and Japan Lifeline. Dr. Ali has received grants from the National Heart, Lung, and Blood Institute, Abbott Vascular, and Cardiovascular Systems; has received personal fees from Amgen, AstraZeneca, and Boston Scientific; and holds equity in Shockwave Medical. Dr. Price has received consulting and speaker honoraria from Abbott Vascular, Boston Scientific, Biosense Webster, Medtronic, Shockwave Medical, and W.L. Gore. Dr. Hill has received fees and grant support from Abbott Vascular, Boston Scientific, Abiomed, and Shockwave Medical; and is a stockholder in Shockwave Medical. Dr. Stone has received speaker honoraria from Cook Medical and Terumo; is a consultant for Valfix Medical, TherOx, Vascular Dynamics, Robocath, HeartFlow, Gore, Ablative Solutions, Miracor, Neovasc, V-Wave, Abiomed, Ancora, MAIA Pharmaceuticals, Vectorious, Reva, and CardioMech; and has equity and options from Ancora, Qool Therapeutics, Cagent, Applied Therapeutics, the BioStar family of funds, SpectraWave, Orchestra BioMed, Aria, Cardiac Success, and Valfix. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Objectives: We sought to assess in-hospital and long-term outcomes of retrograde compared with antegrade-only percutaneous coronary intervention for chronic total occlusion (CTO PCI)., Background: Procedural and clinical outcomes following retrograde compared with antegrade-only CTO PCI remain unknown., Methods: Using the core-lab adjudicated OPEN-CTO registry, we compared the outcomes of retrograde to antegrade-only CTO PCI. Primary endpoints included were in-hospital major adverse cardiac and cerebrovascular events (MACCE) (all-cause death, stroke, myocardial infarction [MI], emergency cardiac surgery, or clinically significant perforation) and MACCE at 1-year (all-cause death, MI, stroke, target lesion revascularization, or target vessel reocclusion)., Results: Among 885 single CTO procedures from the OPEN-CTO registry, 454 were retrograde and 431 were antegrade-only. Lesion complexity was higher (J-CTO score: 2.7 vs. 1.9; p < .001) and technical success lower (82.4 vs. 94.2%; p < .001) in retrograde compared with antegrade-only procedures. All-cause death was higher in the retrograde group in-hospital (2 vs. 0%; p = .003), but not at 1-year (4.9 vs. 3.3%; p = .29). Compared with antegrade-only procedures, in-hospital MACCE rates (composite of all-cause death, stroke, MI, emergency cardiac surgery, and clinically significant perforation) were higher in the retrograde group (10.8 vs. 3.3%; p < .001) and at 1-year (19.5 vs. 13.9%; p = .03). In sensitivity analyses landmarked at discharge, there was no difference in MACCE rates at 1 year following retrograde versus antegrade-only CTO PCI. Improvements in Seattle Angina Questionnaire Quality of Life scores at 1-year were similar between the retrograde and antegrade-only groups (29.9 vs 30.4; p = .58)., Conclusions: In the OPEN-CTO registry, retrograde CTO procedures were associated with higher rates of in-hospital MACCE compared with antegrade-only; however, post-discharge outcomes, including quality of life improvements, were similar between technical modalities., (© 2020 Wiley Periodicals LLC.)

Background: Patients with coronary chronic total occlusions (CTO) often have multivessel coronary artery disease. We utilized the OPEN CTO study to evaluate patients who underwent single-vessel versus multivessel percutaneous coronary intervention (PCI) during CTO PCI., Methods: Patients were considered to have undergone single-vessel CTO PCI if they underwent target-vessel only CTO PCI. Patients who underwent multivessel PCI during their index CTO PCI procedure were considered to have undergone multivessel PCI. The additional lesions treated in the multivessel group could be either a separate CTO lesion in a separate epicardial vessel or PCI attempt of any non-CTO stenosis during the same index procedure. Multivariate regression models were used to evaluate predictors of technical success, in-hospital major adverse cardiac and cerebrovascular events (MACCE), and health status measures., Results: Eighty hundred twenty-one patients underwent single-vessel CTO PCI and 179 (17.9%) underwent multivessel PCI during their CTO PCI procedure. Baseline comorbidities, index CTO lesion complexity, and successful crossing strategies used were similar between the two groups. Total procedural time (142.6 versus 115.9 minutes, P < 0.01) and contrast administered (293.8 versus 255.0 ml, P < 0.01) were increased in the multivessel CTO PCI group. Single-vessel versus multivessel PCI during these cases did not affect the likelihood of achieving technical success [odds ratio (OR) 1.05, 95% confidence interval (CI) 0.63-1.75] nor the risk for MACCE (OR 1.23, 95% CI 0.72-2.11). Quality of life (QOL) metrics were similar between the two groups at baseline and 30-day follow-up., Conclusion: There were no significant differences in technical success, in-hospital MACCE rates, or QOL metrics at 30-day follow-up for patients who underwent single-vessel versus multivessel PCI during CTO PCI., (Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Coronary calcification hinders stent delivery and expansion and is associated with adverse outcomes. Intravascular lithotripsy (IVL) delivers acoustic pressure waves to modify calcium, enhancing vessel compliance and optimizing stent deployment., Objectives: The purpose of this study was to assess the safety and effectiveness of IVL in severely calcified de novo coronary lesions., Methods: Disrupt CAD III (NCT03595176) was a prospective, single-arm multicenter study designed for regulatory approval of coronary IVL. The primary safety endpoint was freedom from major adverse cardiovascular events (cardiac death, myocardial infarction, or target vessel revascularization) at 30 days. The primary effectiveness endpoint was procedural success. Both endpoints were compared with a pre-specified performance goal (PG). The mechanism of calcium modification was assessed in an optical coherence tomography (OCT) substudy., Results: Patients (n = 431) were enrolled at 47 sites in 4 countries. The primary safety endpoint of the 30-day freedom from major adverse cardiovascular events was 92.2%; the lower bound of the 95% confidence interval was 89.9%, which exceeded the PG of 84.4% (p < 0.0001). The primary effectiveness endpoint of procedural success was 92.4%; the lower bound of the 95% confidence interval was 90.2%, which exceeded the PG of 83.4% (p < 0.0001). Mean calcified segment length was 47.9 ± 18.8 mm, calcium angle was 292.5 ± 76.5°, and calcium thickness was 0.96 ± 0.25 mm at the site of maximum calcification. OCT demonstrated multiplane and longitudinal calcium fractures after IVL in 67.4% of lesions. Minimum stent area was 6.5 ± 2.1 mm 2 and was similar regardless of demonstrable fractures on OCT., Conclusions: Coronary IVL safely and effectively facilitated stent implantation in severely calcified lesions., Competing Interests: Author Disclosures This study was supported by Shockwave Medical, Inc. Dr. Hill has received fees and grant support from Abbott Vascular, Boston Scientific, Abiomed, and Shockwave Medical; and is a stockholder in Shockwave Medical. Dr. Kereiakes has served as a consultant for SINO Medical Sciences Technologies, Inc., Boston Scientific, Elixir Medical, Svelte Medical Systems, Inc., Caliber Therapeutics/Orchestra Biomed, and Shockwave Medical; and is a stockholder in Ablative Solutions, Inc. Dr. Shlofmitz has served as a speaker for Shockwave Medical, Inc. Dr. Riley has received honoraria from Boston Scientific, Asahi Intecc, and Medtronic. Dr. Price has received personal fees from ACIST Medical, AstraZeneca, Abbott Vascular, Boston Scientific, Chiesi USA, Medtronic, and W.L. Gore. Dr. Herrmann has received research funding from Abbott, Boston Scientific, Medtronic, and Shockwave Medical; and is a consultant for Abbott, Medtronic, and Shockwave. Dr. Bachinsky has served as a consultant, served on the Speakers Bureau, and received research grant support from Abbott Vascular, Boston Scientific, BD Bard Vascular, Medtronic, and Shockwave Medical. Dr. Waksman has served on the Advisory Board of Amgen, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, and Pi-Cardia Ltd; has served as a consultant for Amgen, Biotronik, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, and Pi-Cardia Ltd.; has received grant support from AstraZeneca, Biotronik, Boston Scientific, Chiesi; has served as a speaker for AstraZeneca and Chiesi; and is a stockholder in MedAlliance. Dr. Stone has served as a speaker for Cook Medical; has served as a consultant for Valfix Medical, TherOx, Vascular Dynamics, Robocath, HeartFlow, Gore, Ablative Solutions, Miracor, Neovasc, V-Wave, Abiomed, Ancora, MAIA Pharmaceuticals, Vectorious, Reva, and Cardiomech; and has equity/options from Ancora, Qool Therapeutics, Cagent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, and Valfix., (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Both the prevalence and complexity of coronary artery disease are on the rise in the United States, leading to a resurgence in novel techniques and equipment utilized to treat complex coronary disease. However, declining percutaneous coronary intervention (PCI) volumes and lack of formal post-graduate education opportunities have created a gap in treatment delivery for this patient population. Several complex, high-risk, and indicated PCI (CHIP) fellowships have been developed in an attempt to bridge this disparity. We present data from the first year of practice from a former CHIP fellow during development of a formal complex coronary therapeutics program., Methods: Data was prospectively collected for PCIs performed during the first 12 months of practice for the lead author and compared to procedures performed in the 12 months prior to the study period., Results: Out of 371 PCIs performed during the study period, 53.4% (198/371) were considered complex, including 126 chronic total occlusion (CTO) procedures. Compared to the previous 12 months, there was a significant increase in the number and complexity (median J-CTO score 2.1 vs. 1.3, p .04) of CTOs performed during the study period. CTO procedural characteristics and complication rates were similar to those previously published in large U.S. registries, with technical success in 93.4% (118/126) and procedural success in 85.7% (108/126)., Conclusion: Following dedicated CHIP fellowship training and establishment of a formal CHIP program, procedural success and complication rates were achieved similar to those published in prior studies evaluating CTO PCI at high volume centers., (© 2019 Wiley Periodicals, Inc.)

Objective: Use of point-of-care (POC) troponin (cTn) testing in the Emergency Department (ED) is well established. However, data examining POC cTn measurement in the prehospital setting, during ambulance transport, are limited. The objective of this study was to prospectively test the performance of POC cTn measurement by paramedics to detect myocardial infarction (MI) among patients transported to the ED for acute chest pain. Methods: A prospective cohort study of adults with non-traumatic chest pain was conducted in three Emergency Medical Services agencies (December 2016 to January 2018). Patients with ST-elevation MI on ECG were excluded. During ambulance transport paramedics initiated intravenous access, collected blood, and used a POC device (i-STAT; Abbott Laboratories) to measure cTn. Following ED arrival, participants received standard evaluations including clinical blood draws for cTn measurement in the hospital central lab (AccuTnI +3 assay; Beckman Coulter, or cTnI-Ultra assay; Siemens). Blood collected during ambulance transport was also analyzed for cTn in the central lab. Index visit MI was adjudicated by 3 experts using central lab cTn measures from the patient's clinical blood draws. Test characteristics (sensitivity, specificity, and predictive values) for detection of MI were calculated for POC and central lab cTn measurement of prehospital blood and compared with McNemar's test. Results: During the study period prehospital POC cTn results were obtained on 421 patients, of which 5.0% (21/421) had results >99th percentile upper reference limit. MI was adjudicated in 16.2% (68/421) during the index visit. The specificity and positive predictive value of the POC cTn measurement were 99.2% (95% CI 97.5-99.8%) and 85.7% (95% CI 63.7-97.0%) for MI. However, the sensitivity and NPV of prehospital POC cTn were 26.5% (95% CI 16.5-38.6%) and 87.5% (95% CI 83.9-90.6%). Compared to POC cTn, the central lab cTn measurement of prehospital blood resulted in a higher sensitivity of 67.9% (95% CI 53.7-80.1%, p  < 0.0001), but lower specificity of 92.4% (95% CI 88.4-95.4%, p  = 0.0001). Conclusions: Prehospital POC i-STAT cTn measurement in patients transported with acute chest pain was highly specific for MI but had low sensitivity. This suggests that prehospital i-STAT POC cTn could be useful to rule-in MI, but should not be used to exclude MI.

Clinical Trial Registration: clinicaltrials.gov (NCT02709135)., Competing Interests: Abbott Point of Care provided a research grant to support the work presented in this manuscript. Dr. Stopyra received research funding from Abbott Point of Care and Roche Diagnostics. Dr. Mahler receives additional research funding from Roche Diagnostics, Ortho Clinical Diagnostics, Siemens, Creavo Medical Technologies, the Donaghue Foundation, AHRQ, PCORI, and NHLBI (1 R01 HL118263-01, L30 HL120008). Dr. Mahler also serves as the chief medical officer of Impathiq, Inc. Dr. Miller also receives research funding / support from Siemens, Abbott Point of Care, and 1 R01 HL118263 These commercial affiliations do not alter our adherence to PLOS ONE policies on sharing data and materials.

Complications of percutaneous coronary intervention (PCI) may have significant impact on patient survival and healthcare costs. PCI procedural complexity and patient risk are increasing, and operators must be prepared to recognize and treat complications, such as perforations, dissections, hemodynamic collapse, no-reflow, and entrapped equipment. Unfortunately, few resources exist to train operators in PCI complication management. Uncertainty regarding complication management could contribute to the undertreatment of patients with high-complexity coronary disease. We, therefore, coordinated the Learning From Complications: How to Be a Better Interventionalist courses to disseminate the collective experience of high-volume PCI operators with extensive experience in chronic total occlusion and high-risk PCI. From these conferences in 2018 and 2019, we developed algorithms that emphasize early recognition, effective treatment, and team-based care of PCI complications. We think that an algorithmic approach will result in a logical and systematic response to life-threatening complications. This construct may be useful for operators who plan to perform complex PCI procedures.

Improved technical equipment, dissemination of best practices, and the importance of complete coronary revascularization have led to a renewed interest in coronary chronic total occlusion (CTO) PCI. In particular, the hybrid algorithm has been associated with increasing procedural success rates in the US. However, the hybrid algorithm only covers overarching strategies in the overall approach to these lesions. Several technical challenges can occur during execution of these approaches, each of which has several potential solutions. A systematic or algorithmic approach to dealing with these challenges could contribute to improved procedural efficiency and higher procedural success. While there have been isolated attempts in the past to codify approaches to each of these situations, there has not been a contemporary, comprehensive review of the potential solutions to these problems. We present 10 common problems encountered during CTO PCI and a consensus hierarchical approach to them., (© 2018 Wiley Periodicals, Inc.)

Objective: The objective was to determine the impact of the HEART Pathway on health care utilization and safety outcomes at 1 year in patients with acute chest pain., Methods: Adult emergency department (ED) patients with chest pain (N = 282) were randomized to the HEART Pathway or usual care. In the HEART Pathway arm, ED providers used the HEART score and troponin measures (0 and 3 hours) to risk stratify patients. Usual care was based on American College of Cardiology/American Heart Association guidelines. Major adverse cardiac events (MACE-cardiac death, myocardial infarction [MI], or coronary revascularization), objective testing (stress testing or coronary angiography), and cardiac hospitalizations and ED visits were assessed at 1 year. Randomization arm outcomes were compared using Fisher's exact tests., Results: A total of 282 patients were enrolled, with 141 randomized to each arm. MACE at 1 year occurred in 10.6% (30/282): 9.9% in the HEART Pathway arm (14/141; 10 MIs, four revascularizations without MI) versus 11.3% in usual care (16/141; one cardiac death, 13 MIs, two revascularizations without MI; p = 0.85). Among low-risk HEART Pathway patients, 0% (0/66) had MACE, with a negative predictive value (NPV) of 100% (95% confidence interval = 93%-100%). Objective testing through 1 year occurred in 63.1% (89/141) of HEART Pathway patients compared to 71.6% (101/141) in usual care (p = 0.16). Nonindex cardiac-related hospitalizations and ED visits occurred in 14.9% (21/141) and 21.3% (30/141) of patients in the HEART Pathway versus 10.6% (15/141) and 16.3% (23/141) in usual care (p = 0.37, p = 0.36)., Conclusions: The HEART Pathway had a 100% NPV for 1-year safety outcomes (MACE) without increasing downstream hospitalizations or ED visits. Reduction in 1-year objective testing was not significant., (© 2018 by the Society for Academic Emergency Medicine.)

Aims: Contemporary coronary chronic total occlusion (CTO) PCI has been associated with increased success rates. However, the rate of periprocedural complications for hybrid CTO PCI remains incompletely defined. We leveraged the OPEN CTO study in order to describe the prevalence, predictors, and health status outcomes of complications during contemporary CTO PCI., Methods and Results: Baseline demographics, procedural characteristics and rates of in-hospital complications were prospectively collected for 1,000 consecutive procedures at 12 expert US centres from 02/2014 to 07/2015. Multivariable logistic regression was used to evaluate the association of pre-specified anatomic and physiologic variables with complications. Patient-reported health status measures over the year following CTO PCI were also compared between those with and those without periprocedural complications. The overall complication rate was 9.7% (n=97/1,000). The most common adverse events were perforation (8.8%), periprocedural myocardial infarction (2.6%), arrhythmia requiring treatment (1.2%), cardiogenic shock (1.1%), and in-hospital death (0.9%). Independent predictors of complications during CTO PCI were: use of the retrograde approach (OR 1.98, 95% CI: 1.32-2.99), age (OR 1.30, 95% CI: 1.07-1.58 per 10-year increment), and J-CTO score (OR 1.20, 95% CI: 1.03-1.41 per one point increment). Mean health status scores over 12 months were worse for patients who experienced complications compared to those who did not, even after adjusting for baseline health status., Conclusions: Complication rates for CTO PCI are more frequent than those reported for non-CTO PCI and were independently associated with retrograde approach, increasing age, and increasing lesion complexity. In addition, these periprocedural complications were also associated with worse long-term health status outcomes.

Introduction: Patients with coronary chronic total occlusions (CTO) often have concurrent higher-risk anatomy and physiology (significant calcium, left ventricular dysfunction, multivessel disease) that increase their procedural risk. We present a retrospective multicenter case series describing use of the Impella percutaneous ventricular assist device (p-VAD) during CTO PCI., Methods: We performed a retrospective analysis of self-reported data from five large referral centers from 2013 to 2017 and identified patients that underwent elective, hemodynamically supported CTO PCI with the Impella p-VAD device (2.5 or CP). Preprocedural demographics, procedural invasive hemodynamics and characteristics, and in-hospital outcomes were reported., Results: About 57 patients (2% of the overall CTO volume of these centers) were included in this retrospective cohort. The primary indication in the majority (78.9%) of cases was chronic angina; in 21.1% the primary indication was for chronic congestive heart failure because of an ischemic cardiomyopathy. The median LVEF was 20% (15%, 30%) and 63.2% were surgical turndowns. Significant proportions of the group underwent multivessel PCI (91.2%), intervention on an unprotected left main or last remaining conduit vessel (35.1%), and/or atherectomy (17.5%). Technical success was 87.7%. In-hospital procedural complications included: vascular injury (5.3%), all-cause death (5.3%), major bleeding (3.5%), stroke (1.8%), and coronary perforation resulting in tamponade (1.8%)., Conclusion: Impella-assisted CTO PCI can be performed with high technical success rates. However, assiduous attention to appropriate case selection is critical, given the periprocedural complication rates reported in this patient population., (© 2018 Wiley Periodicals, Inc.)

Objectives: To evaluate the outcomes of subadventitial stenting (SS) around occluded stents for recanalizing in-stent chronic total occlusions (IS-CTOs)., Background: There is little evidence on the outcomes of SS for IS-CTO., Methods: We examined the outcomes of SS for IS-CTO PCI at 14 centers between July 2011 and June 2017, and compared them to historical controls recanalized using within-stent stenting (WSS). Target-vessel failure (TVF) on follow-up was the endpoint of this study, and was defined as a composite of cardiac death, target-vessel myocardial infarction, and target-vessel revascularization., Results: During study period, 422 IS-CTO PCIs were performed, of which 32 (7.6%) were recanalized with SS, usually when conventional approaches failed. The most frequent CTO vessel was the right coronary artery (72%). Mean J-CTO score was 3.1 ± 0.9. SS was antegrade in 53%, and retrograde in 47%. Part of the occluded stent was crushed in 37%, while the whole stent was crushed in 63%. Intravascular imaging was used in 59%. One patient (3.1%) suffered tamponade. Angiographic follow-up was performed in 10/32 patients: stents were patent in six cases, one had mild neointimal hyperplasia, and three had severe restenosis at the SS site. Clinical follow-up was available for 29/32 patients for a mean of 388 ± 303 days. The 24-month incidence of TVF was 13.8%, which was similar to historical controls treated with WSS (19.5%, P = 0.49)., Conclusions: SS is rarely performed, usually as last resort, to recanalize complex IS-CTOs. It is associated with favorable acute and mid-term outcomes, but given the small sample size of our study additional research is warranted., (© 2018 Wiley Periodicals, Inc.)

An initial electrocardiogram (ECG) and serial troponin measurements are both independently and incrementally predictive of acute coronary syndrome in patients presenting with undifferentiated chest pain in the Emergency Department (ED). However, it is unclear if serial (ECGs) add significant to the contemporary diagnostic evaluation of this patient group. The ASAP CATH study was a single center, prospective study that enrolled patients presenting to an ED with undifferentiated chest pain. In addition to standard clinical evaluation, serial ECGs were performed at 90-minute intervals to evaluate whether serial changes suggestive of ischemia developed (Q waves, ST elevation or depression, or T-wave inversion). Total 365 subjects were enrolled from March 2014 to May 2015. Serial ECG changes developed in 6.6% (n = 24 of 365), the most common being the development of T-wave inversion (66.7%, n = 16 of 24). The sensitivity and positive predictive value of serial ECG changes were poor (<30%), with a less areas under the curve (0.55) compared with serial troponins alone (0.83). The addition of serial ECG changes to Thrombolysis In Myocardial Infarction risk scoring showed a decrease in the net reclassification index for major adverse cardiovascular events (-0.04, p <0.1) and was not significant for the prediction of major adverse cardiovascular events and/or acute coronary syndrome in 30 days (-0.003, p = 0.94). In conclusion, routine serial ECG evaluation for patients presenting with undifferentiated chest pain in the ED may not significantly improved diagnostic prognosis beyond current standard evaluation modalities., (Copyright © 2018. Published by Elsevier Inc.)

Background: Animal studies suggest that monocyte chemoattractant protein-1 (MCP-1) is a promising biomarker for coronary artery atherosclerosis (CAA), but human studies have been inconclusive., Objective: To determine potential relationships between plasma MCP-1 and CAA in patients with acute chest pain., Methods: A secondary analysis of 150 patients enrolled in emergency department chest pain risk stratification clinical investigations was conducted. Participants with stored blood and known coronary phenotypes (determined by coronary angiography) were selected using stratified randomization such that 50 patients were included into 3 groups: (1) no angiographic evidence of CAA, (2) nonobstructive CAA, and (3) obstructive CAA (stenosis ≥ 70%). Plasma MCP-1 levels were determined by enzyme-linked immunosorbent assay. The association between MCP-1 and obstructive CAA or any CAA was modeled using logistic regression. Variables in the unreduced model included age, sex, race, prior diagnosis of CAA or acute coronary syndrome, hyperlipidemia, hypertension, diabetes, smoking, and cardiac troponin I measurement., Results: Among the 150 participants, 65.3% (98/150) had invasive coronary angiography and 34.7% (52/150) had coronary computed tomographic angiography. Myocardial infarction occurred in 27.3% (41/150) and coronary revascularization occurred in 26% (39/150) of the participants. Each 10 pg/mL increase in MCP-1 measurement was associated with an odds ratio of 1.12 (95% confidence interval, 1.06-1.19) for obstructive CAA. MCP-1 remained a significant predictor of obstructive CAA and any CAA after adjustment for age, sex, race, traditional cardiac risk factors, and cardiac troponin I., Conclusions: MCP-1 is independently associated with CAA among emergency department patients with chest pain.

Background: The no objective testing rule (NOTR) is a decision aid designed to safely identify emergency department (ED) patients with chest pain who do not require objective testing for coronary artery disease., Objectives: The objective was to validate the NOTR in a cohort of U.S. ED patients with acute chest pain and compare its performance to the HEART Pathway., Methods: A secondary analysis of 282 participants enrolled in the HEART Pathway randomized controlled trial was conducted. Each patient was classified as low risk or at risk by the NOTR. Sensitivity for major adverse cardiac events (MACE) at 30 days was calculated in the entire study population. NOTR and HEART Pathways were compared among patients randomized to the HEART Pathway in the parent trial using McNemar's test and the net reclassification improvement (NRI)., Results: Major adverse cardiac events occurred in 22/282 (7.8%) participants, including no deaths, 16/282 (5.6%) with myocardial infarction (MI), and 6/282 (2.1%) with coronary revascularization without MI. NOTR was 100% (95% confidence interval [CI] = 84.6%-100%) sensitive for MACE and identified 78/282 patients (27.7%, 95% = CI 22.5-33.3%) as low risk. In the HEART Pathway arm (n = 141), both NOTR and HEART Pathway identified all patients with MACE as at risk. Compared to NOTR, the HEART Pathway was able to correctly reclassify 27 patients without MACE as low risk, yielding a NRI of 20.8% (95% CI = 11.3%-30.2%)., Conclusions: Within a U.S. cohort of ED patients with chest pain, the NOTR and HEART Pathway were 100% sensitive for MACE at 30 days. However, the HEART Pathway identified more patients suitable for early discharge than the NOTR., (© 2017 by the Society for Academic Emergency Medicine.)

This review explores the usefulness of multivessel revascularization with percutaneous coronary intervention in patients with multivessel obstructive coronary artery disease (CAD) presenting with and without cardiogenic shock. We also evaluate the literature regarding complete versus incomplete revascularization for patients with cardiogenic shock, acute coronary syndromes, and stable coronary artery disease., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Objectives: The HEART Pathway combines a decision aid and serial contemporary cardiac troponin I (cTnI) measures to achieve >99% sensitivity for major adverse cardiac events (MACE) at 30days and early discharge rates >20%. However, the impact of integrating high-sensitivity troponin (hs-cTn) measures into the HEART Pathway has yet to be determined. In this analysis we compare test characteristics of the HEART Pathway using hs-cTnI, hs-cTnT, or cTnI., Design & Methods: A secondary analysis of participants enrolled in the HEART Pathway RCT was conducted. Each patient was risk stratified by the cTn-HEART Pathway (Siemens TnI-Ultra at 0- and 3-h) and a hs-cTn-HEART Pathway using hs-cTnI (Abbott) or hs-cTnT (Roche) at 3-h. The early discharge rate, sensitivity, specificity, and negative predictive value (NPV) for MACE (death, myocardial infarction, or coronary revascularization) at 30days were calculated., Results: hs-cTnI measures were available on 133 patients. MACE occurred in 11/133 (8%) of these patients. Test characteristics for the HEART Pathway using serial cTnI vs 3hour hs-cTnI were the same: sensitivity (100%, 95%CI: 72-100%), specificity (49%, 95%CI: 40-58%), NPV (100%, 95%CI: 94-100%), and early discharge rate (45%, 95%CI: 37-54%). The HEART Pathway using hs-cTnT missed one MACE event (myocardial infarction): sensitivity (91%, 95%CI: 59-100%), specificity (48%, 95%CI: 39-57%), NPV (98%, 95%CI: 91-100%), and early discharge rate (45%, 95%CI: 37-54%)., Conclusions: There was no difference in the test characteristics of the HEART Pathway whether using cTnI or hs-cTnI, with both achieving 100% sensitivity and NPV. Use of hs-cTnT with the HEART Pathway was associated with one missed MACE., (Copyright © 2017 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.)