Cardiology

Kandzari, D.E., Kirtane, A.J., Windecker, S., Latib, A., Kedhi, E., Mehran, R., Price, M.J., Abizaid, A., Simon, D.I., Worthley, S.G., Zaman, A., Choi, J.W., Caputo, R., Kanitkar, M., McLaurin, B., Potluri, S., Smith, T., Spriggs, D., Tolleson, T., Nazif, T., Parke, M., Lee, L.C., Lung, T.H. and Stone, G.W. (2020). “One-Month Dual Antiplatelet Therapy Following Percutaneous Coronary Intervention With Zotarolimus-Eluting Stents in High-Bleeding-Risk Patients.” Circ Cardiovasc Interv 13(11): e009565.

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BACKGROUND: Despite treatment guidance endorsing shortened dual antiplatelet therapy (DAPT) duration in high bleeding risk (HBR) patients after drug-eluting stents, limited evidence exists to support these recommendations. The present study was designed to examine the safety and effectiveness of 1-month DAPT duration following percutaneous coronary intervention with zotarolimus-eluting stents in HBR patients. METHODS: Onyx ONE Clear was a prospective, multicenter, nonrandomized study evaluating the safety and effectiveness of 1-month DAPT followed by single antiplatelet therapy in HBR patients undergoing percutaneous coronary intervention with Resolute Onyx drug-eluting stents. The primary analysis of cardiac death or myocardial infarction between 1 month and 1 year was performed in the prespecified one-month clear population of patients pooled from the Onyx ONE US/Japan study and Onyx ONE randomized controlled trial. One-month clear was defined as DAPT adherence and without major adverse events during the first month following percutaneous coronary intervention. RESULTS: Among patients enrolled in Onyx ONE US/Japan (n=752) and Onyx ONE randomized controlled trial (n=1018), 1506 patients fulfilled one-month clear criteria. Mean HBR characteristics per patient was 1.6 with 44.7% having multiple risks. By 2 months and 1 year, respectively, 96.9% and 89.3% of patients were taking single antiplatelet therapy. Between 1 month and 1 year, the rate of the primary end point was 7.0%. The 1-sided upper 97.5% CI was 8.4%, less than the performance goal of 9.7% (P<0.001). CONCLUSIONS: Among HBR patients who were event free before DAPT discontinuation at 1 month, favorable safety and effectiveness through 1 year support treatment with Resolute Onyx drug-eluting stents as part of an individualized strategy for shortened DAPT duration following percutaneous coronary intervention. Registration: URL: https://www.clinicaltrials.gov; Unique identifier NCT03647475.

Xenogiannis, I., Choi, J.W., Alaswad, K., Khatri, J.J., Doing, A.H., Dattilo, P., Jaffer, F.A., Uretsky, B., Krestyaninov, O., Khelimskii, D., Patel, M., Mahmud, E., Potluri, S., Koutouzis, M., Tsiafoutis, I., Jaber, W., Samady, H., Jefferson, B.K., Patel, T., Megaly, M.S., Hall, A.B., Vemmou, E., Nikolakopoulos, I., Rangan, B.V., Abdullah, S., Garcia, S., Banerjee, S., Burke, M.N. and Brilakis, E.S. (2020). “Outcomes of subintimal plaque modification in chronic total occlusion percutaneous coronary intervention.” Catheter Cardiovasc Interv 96(5): 1029-1035.

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BACKGROUND: When crossing into the distal true lumen fails during chronic total occlusion (CTO) percutaneous coronary intervention (PCI), subintimal plaque modification (SPM) is often performed to restore antegrade flow and facilitate subsequent lesion recanalization. METHODS: Between January 2012 and May 4, 2019, 4,659 CTO PCIs were included in the PROGRESS-CTO registry, of which 935 (20%) had a prior unsuccessful attempt. Of those 935 patients, 119 (13%) had prior SPM. We analyzed the outcomes of the 58 SPM procedures for which data were available, as well as the outcomes of the 60 subsequent CTO PCI attempts. RESULTS: Mean patient age was 67 ± 9 years and 86% were men. Patients had high prevalence of cardiovascular risk factors such as dyslipidemia (91%), hypertension (93%) diabetes (48%), prior PCI (61%), and prior coronary artery bypass graft surgery (47%). The target CTO lesions often had proximal cap ambiguity (54%), moderate/severe calcification (73%), moderate/severe tortuosity (63%), and high J-CTO score (mean 3.2 ± 1.1). The technical and procedural success of subsequent CTO PCI were high (83% for both) with an acceptable rate of in-hospital major adverse cardiovascular events (3.3%). Technical and procedural success were higher for repeat attempts that were performed ≥60 days after the index CTO PCI (94% vs. 69%, p = .015). Median (interquartile range) subsequent procedure time was 147 (100, 215) min, contrast volume was 185 (150, 260) ml, and air kerma radiation dose was 2.5 (1.4, 4.2) Gray. CONCLUSION: Repeat CTO PCI attempts after SPM are associated with high likelihood for successful revascularization with acceptable risks.

Nguyen, M.L., Gause, E., Mills, B., Tonna, J.E., Alvey, H., Saczkowski, R., Grunau, B., Becker, L.B., Gaieski, D.F., Youngquist, S., Gunnerson, K., England, P., Hamilton, J., Badulak, J., Mandell, S.P., Bulger, E.M. and Johnson, N.J. (2020). “Traumatic and hemorrhagic complications after extracorporeal cardiopulmonary resuscitation for out-of-hospital cardiac arrest.” Resuscitation Oct 12;S0300-9572(20)30501-3. [Epub ahead of print].

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INTRODUCTION: Extracorporeal cardiopulmonary resuscitation (ECPR) is an emerging invasive rescue therapy for treatment of refractory out-of-hospital cardiac arrests (OHCA). We aim to describe the incidence of traumatic and hemorrhagic complications among patients undergoing ECPR for OHCA and examine the association between CPR duration and ECPR-related injuries or bleeding. METHODS: We examined prospectively collected data from the Extracorporeal Resuscitation Outcomes Database (EROD), which includes ECPR-treated OHCAs from participating hospitals (October 2014 to August 2019). The primary outcome was traumatic or hemorrhagic complications, defined any of the following: pneumothorax, pulmonary hemorrhage, major bleeding, cannula site bleeding, gastrointestinal bleeding, thoracotomy, cardiac tamponade, aortic dissection, or vascular injury during hospitalization. The primary exposure was the cardiac arrest to ECPR initiation interval (CA-ECPR interval), measured as the time from arrest to initiation of ECPR. Descriptive statistics were used to compare demographic, cardiac arrest, and ECPR characteristics among patients with and without CPR-related traumatic or bleeding complications. Multivariable logistic regression was used to examine the association between CA-ECPR interval and traumatic or bleeding complications. RESULTS: A total of 68 patients from 4 hospitals receiving ECPR for OHCA were entered into EROD and met inclusion criteria. Median age was 51 (interquartile range 38-58), 81% were male, 40% had body mass index > 30, and 70% had pre-existing medical comorbidities. A total of 65% had an initial shockable cardiac rhythm, mechanical CPR was utilized in at least 29% of patients, and 27% were discharged alive. The median time from arrest to ECPR initiation was 73 min (IQR 60-104). A total of 37% experienced a traumatic or bleeding complication, with major bleeding (32%), vascular injury (18%), and cannula site bleeding (15%) being the most common. Compared to patients with shorter CPR times, patients with a longer CA-ECPR interval had 18% (95% confidence interval – 2-42%) higher odds of suffering a mechanical or bleeding complication, but this did not reach statistical significance (p = 0.08). CONCLUSIONS: Traumatic injuries and bleeding complications are common among patients undergoing ECPR. Further study is needed to investigate the relation between arrest duration and complications. Clinicians performing ECPR should anticipate and assess for injuries and bleeding in this high-risk population.

Russell, D.W., Casey, J.D., Gibbs, K.W., Dargin, J.M., Vonderhaar, D.J., Joffe, A.M., Ghamande, S., Khan, A., Dutta, S., Landsperger, J.S., Robison, S.W., Bentov, I., Wozniak, J.M., Stempek, S., White, H.D., Krol, O.F., Prekker, M.E., Driver, B.E., Brewer, J.M., Wang, L., Lindsell, C.J., Self, W.H., Rice, T.W., Semler, M.W. and Janz, D. (2020). “Protocol and statistical analysis plan for the PREventing cardiovascular collaPse with Administration of fluid REsuscitation during Induction and Intubation (PREPARE II) randomised clinical trial.” BMJ Open 10(9): e036671.

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INTRODUCTION: Cardiovascular collapse is a common complication during tracheal intubation of critically ill adults. Whether administration of an intravenous fluid bolus prevents cardiovascular collapse during tracheal intubation remains uncertain. A prior randomised trial found fluid bolus administration to be ineffective overall but suggested potential benefit for patients receiving positive pressure ventilation during tracheal intubation. METHODS AND ANALYSIS: The PREventing cardiovascular collaPse with Administration of fluid REsuscitation during Induction and Intubation (PREPARE II) trial is a prospective, multi-centre, non-blinded randomised trial being conducted in 13 academic intensive care units in the USA. The trial will randomise 1065 critically ill adults undergoing tracheal intubation with planned use of positive pressure ventilation (non-invasive ventilation or bag-mask ventilation) between induction and laryngoscopy to receive 500 mL of intravenous crystalloid or no intravenous fluid bolus. The primary outcome is cardiovascular collapse, defined as any of: systolic blood pressure <65 mm Hg, new or increased vasopressor administration between induction and 2 min after intubation, or cardiac arrest or death between induction and 1 hour after intubation. The primary analysis will be an unadjusted, intention-to-treat comparison of the primary outcome between patients randomised to fluid bolus administration and patients randomised to no fluid bolus administration using a χ(2) test. The sole secondary outcome is 28-day in-hospital mortality. Enrolment began on 1 February 2019 and is expected to conclude in June 2020. ETHICS AND DISSEMINATION: The trial was approved by either the central institutional review board at Vanderbilt University Medical Center or the local institutional review board at each trial site. Results will be submitted for publication in a peer-reviewed journal and presented at scientific conferences. TRIAL REGISTRATION NUMBER: NCT03787732.

Thayer, K.L., Zweck, E., Ayouty, M., Garan, A.R., Hernandez-Montfort, J., Mahr, C., Morine, K.J., Newman, S., Jorde, L., Haywood, J.L., Harwani, N.M., Esposito, M.L., Davila, C.D., Wencker, D., Sinha, S.S., Vorovich, E., Abraham, J., O’Neill, W., Udelson, J., Burkhoff, D. and Kapur, N.K. (2020). “Invasive Hemodynamic Assessment and Classification of In-Hospital Mortality Risk Among Patients With Cardiogenic Shock.” Circ Heart Fail 13(9): e007099.

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BACKGROUND: Risk stratifying patients with cardiogenic shock (CS) is a major unmet need. The recently proposed Society for Cardiovascular Angiography and Interventions (SCAI) stages as an approach to identify patients at risk for in-hospital mortality remains under investigation. We studied the utility of the SCAI stages and further explored the impact of hemodynamic congestion on clinical outcomes. METHODS: The CS Working Group registry includes patients with CS from 8 medical centers enrolled between 2016 and 2019. Patients were classified by the maximum SCAI stage (B-E) reached during their hospital stay according to drug and device utilization. In-hospital mortality was evaluated for association with SCAI stages and hemodynamic congestion. RESULTS: Of the 1414 patients with CS, the majority were due to decompensated heart failure (50%) or myocardial infarction (MI; 35%). In-hospital mortality was 31% for the total cohort, but higher among patients with MI (41% versus 26%, MI versus heart failure, P<0.0001). Risk for in-hospital mortality was associated with increasing SCAI stage (odds ratio [95% CI], 3.25 [2.63-4.02]) in both MI and heart failure cohorts. Hemodynamic data was available in 1116 (79%) patients. Elevated biventricular filling pressures were common among patients with CS, and right atrial pressure was associated with increased mortality and higher SCAI Stage. CONCLUSIONS: Our findings support an association between the proposed SCAI staging system and in-hospital mortality among patient with heart failure and MI. We further identify that venous congestion is common and identifies patients with CS at high risk for in-hospital mortality. These findings provide may inform future management protocols and clinical studies.