ABSTRACT
The current document commissioned by the Society for Cardiovascular Angiography and Interventions (SCAI) and endorsed by the American College of Cardiology, the American Heart Association, and Heart Rhythm Society represents a comprehensive update to the 2012 and 2016 consensus documents on patient-centered best practices in the cardiac catheterization laboratory. Comprising updates to staffing and credentialing, as well as evidence-based updates to the pre-, intra-, and post-procedural logistics, clinical standards and patient flow, the document also includes an expanded section on CCL governance, administration, and approach to quality metrics. This update also acknowledges the collaboration with various specialties, including discussion of the heart team approach to management, and working with electrophysiology colleagues in particular. It is hoped that this document will be utilized by hospitals, health systems, as well as regulatory bodies involved in assuring and maintaining quality, safety, efficiency, and cost-effectiveness of patient throughput in this high volume area.
Subject(s)
American Heart Association , Cardiology , Angiography , Cardiac Catheterization , Consensus , Humans , Laboratories , Treatment Outcome , United StatesABSTRACT
PURPOSE OF REVIEW: We provide a concise update on the contemporary management of cardiogenic shock in the setting of acute coronary syndrome (ACS). Early shock recognition, optimal selection and initiation of mechanical circulatory support (MCS), early coronary revascularization, and a team-based, protocol-driven approach are the current pillars of management. RECENT FINDINGS: Cardiogenic shock complicates approximately 5-10% of ACS cases and continues to have high mortality. Early use of mechanical circulatory may prevent the downward spiral of shock and has significantly increased over time, supported mainly by registry data. In the CULPRIT-SHOCK trial, culprit-only revascularization was associated with a lower 30-day incidence of all-cause death or severe renal failure, compared with immediate multivessel PCI. Routine revascularization of non-infarct related artery lesion(s) during primary PCI for cardiogenic shock is, therefore, not recommended. The routine use of an intra-aortic balloon pump (IABP) was not associated with improved outcomes in the IABP-SHOCK II trial. A team-based and protocol-driven approach may further improve outcomes. Recent advances in coronary revascularization and use of MCS, implementation of shock teams and standardized protocols may improve outcomes of cardiogenic shock in ACS patients.
Subject(s)
Acute Coronary Syndrome , Myocardial Infarction , Percutaneous Coronary Intervention , Shock, Cardiogenic , Acute Coronary Syndrome/therapy , Humans , Intra-Aortic Balloon Pumping , Myocardial Infarction/therapy , Shock, Cardiogenic/therapy , Treatment OutcomeABSTRACT
PURPOSE OF REVIEW: This article reviews the latest data on unprotected left main (ULM) percutaneous coronary intervention (PCI) versus coronary artery bypass graft (CABG) surgery, with a focus on the NOBLE and EXCEL trials. RECENT FINDINGS: In EXCEL trial, the primary endpoint at 3 years was 15.4% in the PCI group and 14.7% in the CABG group (p = 0.02 for non-inferiority of PCI versus CABG). In NOBLE, the primary endpoint at 5 years was 28% and 18% for PCI and CABG, respectively (HR 1.51, CI 1.13-2.0, which did not meet the criteria for non-inferiority of PCI to CABG; p for superiority of CABG was 0.0044). Higher repeat revascularization and non-procedural myocardial infarction were noted in PCI group but there was no difference in all-cause or cardiac mortality between the two groups. A heart team approach with appropriate patient selection, careful assessment of LM lesions, and meticulous procedural technique makes PCI a valid alternative to CABG for ULM stenosis.
Subject(s)
Coronary Artery Bypass , Coronary Stenosis/surgery , Percutaneous Coronary Intervention , Drug-Eluting Stents , Humans , Randomized Controlled Trials as Topic , Treatment OutcomeABSTRACT
UNLABELLED: Concepts of cardiopulmonary support (CPS), extracorporeal membrane oxygenation (ECMO), and ventricular support (VS) have been thoroughly studied and refined. These perfusion adjuncts often require multiple devices, skill sets, and significant financial burden to purchase, maintain, deploy, and use. We describe a novel system that is rapidly deployable, user-friendly, portable, safe, and economical. Over a 1-year period we have used a multi-functional life support system (MLS) in the cardiac catheterization laboratory, cardiovascular intensive care unit, and cardiac surgical suites. Further, we have conducted multiple transports within the hospital and one to an alternate facility. Applications have included ECMO, cardiopulmonary resuscitation-supported cardiogenic shock, high risk percutaneous coronary intervention (PCI), valvuloplasty, right ventricular assist device transition to ECMO post cardiotomy, left ventricular assist device transition to ECMO, ventricular septal defect closure, and ECMO transition to conventional cardiopulmonary bypass (CPB). Duration of support has ranged from approximately 39 minutes to several days. KEYWORDS: extracorporeal membrane oxygenation (ECMO), percutaneous ventricular assist device, cardiopulmonary support, portable cardiopulmonary life support, ventricular assist.
Subject(s)
Life Support Systems/instrumentation , Aged , Cardiopulmonary Bypass , Equipment Design , Extracorporeal Membrane Oxygenation , Heart-Assist Devices , Humans , Middle AgedABSTRACT
Transradial coronary intervention (TRI) lowers bleeding and mortality compared with transfemoral coronary intervention (TFI). There are limited data on outcomes as TFI operators transition to a default TRI practice. The aim of this study was to assess TFI and TRI outcomes before, during, and after the year TRI was first learned by femoral operators. Patients undergoing percutaneous coronary intervention (PCI) at a Veterans Affairs Medical Center from 2006 to 2012 were included. In 2009, TRI was learned by all operators and then used as the default PCI approach from 2010 to 2012. Baseline characteristics and outcomes were collected. Predictors of major bleeding, major adverse cardiovascular events (MACE), and mortality were determined by multivariable analysis; 1192 veterans were included. TRI rates were 9% (2006-2008), 65% (2009), and 90% (2010-2012). Incidence of 1-year MACE and mortality was 5.4% and 3.9%, respectively, in 2009, and 5.6% and 3%, respectively, during 2010 to 2012. Major bleeding remained at <1%. Age, glycoprotein IIb/IIIa inhibitors, and ST-elevation myocardial infarction were independently associated with major bleeding, whereas TRI was protective. Transition to default TRI is feasible over a short time period and associated with low rates of MACE and mortality and very low rate of major bleeding.
Subject(s)
Femoral Artery/surgery , Myocardial Infarction/surgery , Percutaneous Coronary Intervention , Radial Artery/surgery , Aged , Female , Hemorrhage/complications , Humans , Male , Middle Aged , Myocardial Infarction/mortality , Percutaneous Coronary Intervention/methods , Risk Factors , Time Factors , Treatment OutcomeABSTRACT
INTRODUCTION: Bivalirudin and heparin are the two most commonly used anticoagulants used during Percutaneous Coronary Intervention (PCI). The results of Randomized Controlled Trials (RCTs) comparing bivalirudin versus heparin monotherapy in the era of radial access are controversial, questioning the positive impact of bivalirudin on bleeding. The purpose of this systematic review is to summarize the results of RCTs comparing the efficacy and safety of bivalirudin versus heparin with or without Glycoprotein IIb/IIIa Inhibitors (GPI). METHODS: This systematic review was performed in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses PRISMA statements for reporting systematic reviews. We searched the National Library of Medicine PubMed, Clinicaltrial.gov and the Cochrane Central Register of Controlled Trials to include clinical studies comparing bivalirudin with heparin in patients undergoing PCI. Sixteen studies met inclusion criteria and were reviewed for the summary. FINDINGS: Several RCTs and meta-analyses have demonstrated the superiority of bivalirudin over heparin plus routine GPI use in terms of preventing bleeding complications but at the expense of increased risk of ischemic complications such as stent thrombosis. The hypothesis of post- PCI bivalirudin infusion to mitigate the risk of acute stent thrombosis has been tested in various RCTs with conflicting results. In comparison, heparin offers the advantage of having a reversible agent, of lower cost and reduced incidence of ischemic complications. CONCLUSION: Bivalirudin demonstrates its superiority over heparin plus GPI with better clinical outcomes in terms of less bleeding complications, thus making it as anticoagulation of choice particularly in patients at high risk of bleeding. Further studies are warranted for head to head comparison of bivalirudin to heparin monotherapy to establish an optimal heparin dosing regimen and post-PCI bivalirudin infusion to affirm its beneficial effect in reducing acute stent thrombosis.
Subject(s)
Acute Coronary Syndrome/drug therapy , Anticoagulants/therapeutic use , Antithrombins/therapeutic use , Heparin/therapeutic use , Peptide Fragments/therapeutic use , Percutaneous Coronary Intervention/methods , Female , Hirudins , Humans , Male , Randomized Controlled Trials as Topic , Recombinant Proteins/therapeutic use , Treatment OutcomeABSTRACT
BACKGROUND: Limited data exist on current cardiogenic shock (CS) management strategies. METHODS: A 48-item open- and closed-ended question survey on the diagnosis and management of CS. RESULTS: A total of 211 respondents (3.2%) completed the survey, including 64% interventional cardiologists, 14% general cardiologists, 11% advanced heart failure cardiologists, 5% intensivists, 3% cardiothoracic surgeons; the remainder were internists, emergency medicine, and other physicians. Nearly half (45%) reported practicing at sites without advanced heart failure support/resources, with neither durable ventricular assist devices nor heart transplant available; 16% practice at sites without on-site cardiac surgery and 6% do not offer 24/7 percutaneous coronary intervention (PCI) coverage. The majority (70%) practice in closed intensive care units with multidisciplinary rounding (73%), cardiologists frequently involved in patient care (89%), and involving cardiology-intensivist co-management (41%). Over half (55%) reported use of CS protocols, 61% reported routine arterial line use, 25% reported routine use of pulmonary artery catheter use to guide management and 9% did not. The preferred vasopressor and/or inotrope was norepinephrine (68%). For coronary angiography and PCI, 53% use transradial access, 72% only revascularize the culprit vessel, and 44% institute mechanical circulatory support (MCS) prior to revascularization. Percutaneous MCS availability was as follows: intra-aortic balloon pump (92%), Impella (78%), peripheral veno-arterial extracorporeal membrane oxygenation (66%), and TandemHeart (28%). Most respondents (58%) do not use a scoring system for risk stratification and most (62%) reported that CS-specific cardiac rehabilitation programs were unavailable at their sites. CONCLUSION: Wide variation exists in the care delivered and/or resources available for patients with CS. Our survey suggests opportunities for standardization of care.
Subject(s)
Heart-Assist Devices , Percutaneous Coronary Intervention , Shock, Cardiogenic , Humans , Intra-Aortic Balloon Pumping , Shock, Cardiogenic/diagnosis , Shock, Cardiogenic/therapy , Surveys and QuestionnairesABSTRACT
BACKGROUND: Low-density lipoproteins (LDLs) are removed by extracorporeal filtration during LDL apheresis. It is mainly used in familial hyperlipidemia. The PREMIER trial (Plaque Regression and Progenitor Cell Mobilization With Intensive Lipid Elimination Regimen) evaluated LDL apheresis in nonfamilial hyperlipidemia acute coronary syndrome patients treated with percutaneous coronary intervention. METHODS: We randomized 160 acute coronary syndrome patients at 4 Veterans Affairs centers within 72 hours of percutaneous coronary intervention to intensive lipid-lowering therapy (ILLT) comprising single LDL apheresis and statins versus standard medical therapy (SMT) with no LDL apheresis and statin therapy alone. Trial objectives constituted primary safety and primary efficacy end points and endothelial progenitor cell colony-forming unit mobilization in peripheral blood. RESULTS: Mean LDL reduction at discharge was 53% in ILLT and 17% in SMT groups (P<0.0001) from baseline levels of 116.3±34.3 and 110.7±32 mg/dL (P=0.2979), respectively. The incidence of the primary safety end point of major peri-percutaneous coronary intervention adverse events was similar in both groups (ILLT, 3; SMT, 0). The primary efficacy end point, percentage change in total plaque volume at 90 days by intravascular ultrasound, on average decreased by 4.81% in the ILLT group and increased by 2.31% in the SMT group (difference of means, -7.13 [95% CI, -14.59 to 0.34]; P=0.0611). The raw change in total plaque volume on average decreased more in the ILLT group than in the SMT group (-6.01 versus -0.95 mm3; difference of means, -5.06 [95% CI, -11.61 to 1.48]; P=0.1286). Similar results were obtained after adjusting for participating sites, age, preexisting coronary artery disease, diabetes mellitus, baseline LDL levels, and baseline plaque burden. There was robust endothelial progenitor cell colony-forming unit mobilization from baseline to 90 days in the ILLT group (P=0.0015) but not in SMT (P=0.0844). CONCLUSIONS: PREMIER is the first randomized clinical trial to demonstrate safety and a trend for early coronary plaque regression with LDL apheresis in nonfamilial hyperlipidemia acute coronary syndrome patients treated with percutaneous coronary intervention. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01004406 and NCT02347098.
Subject(s)
Acute Coronary Syndrome/therapy , Blood Component Removal , Coronary Artery Disease/therapy , Endothelial Progenitor Cells/pathology , Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use , Hyperlipidemias/therapy , Lipoproteins, LDL/blood , Percutaneous Coronary Intervention , Plaque, Atherosclerotic , Acute Coronary Syndrome/diagnostic imaging , Acute Coronary Syndrome/pathology , Aged , Biomarkers/blood , Blood Component Removal/adverse effects , Combined Modality Therapy , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/pathology , Female , Humans , Hydroxymethylglutaryl-CoA Reductase Inhibitors/adverse effects , Hyperlipidemias/blood , Hyperlipidemias/diagnosis , Male , Middle Aged , Percutaneous Coronary Intervention/adverse effects , Pilot Projects , Time Factors , Treatment Outcome , United States , United States Department of Veterans AffairsABSTRACT
BACKGROUND: Pre-procedural anemia is associated with increased bleeding and mortality post-percutaneous coronary intervention (PCI). The effect of trans-radial PCI (TR-PCI) in improving outcomes compared to trans-femoral PCI (TF-PCI) in anemic patients is not known. OBJECTIVE: The aim of this study was to evaluate the association between arterial access site (radial versus femoral) and outcomes in anemic Veterans undergoing PCI. METHODS: Patients with baseline anemia, undergoing PCI at Veterans Affairs (VA) facilities between 2009 and 2015, were divided into two groups based on primary radial or femoral access. The association between anemia and access site with in-hospital and one-year adverse outcomes was evaluated using multivariable analysis. RESULTS: 7330 veterans were included in the analysis, with 1712 (23%) treated via radial access. Baseline anemia was independently associated with in-hospital major bleeding (OR 3.8, 95% CI 2.5-5.6 for moderate anemia, OR 18.6, 95% CI 11.6-29.7 for severe anemia), and in-hospital mortality (OR 3.2, 95% CI 1.8-5.8 for moderate anemia, OR 7.9, 95% CI 3.7-16.8 for severe anemia). Anemia was also associated with increased one-year MACE and mortality. PCI performed via radial access was not associated with different outcomes compared with femoral access in the presence of anemia. Comparable results were noted when analysis was restricted to only patients with acute coronary syndrome (ACS). CONCLUSIONS: Moderate and severe anemia were strongly associated with increased in-hospital and one-year mortality in a large healthcare system, though there was no interaction between arterial access site for PCI and clinical outcomes among patients with moderate or severe anemia.
Subject(s)
Anemia/epidemiology , Catheterization, Peripheral , Coronary Artery Disease/therapy , Femoral Artery , Hemorrhage/epidemiology , Percutaneous Coronary Intervention , Radial Artery , Aged , Anemia/diagnosis , Anemia/mortality , Catheterization, Peripheral/adverse effects , Catheterization, Peripheral/mortality , Coronary Artery Disease/diagnosis , Coronary Artery Disease/mortality , Female , Hemorrhage/mortality , Hospital Mortality , Humans , Male , Middle Aged , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/mortality , Punctures , Retrospective Studies , Risk Assessment , Risk Factors , Severity of Illness Index , Time Factors , Treatment Outcome , United States/epidemiology , United States Department of Veterans Affairs , Veterans Health ServicesABSTRACT
BACKGROUND: The ideal treatment strategy for patients with cryptogenic stroke and patent foramen ovale (PFO) is not yet clear. Previous randomized controlled trials (RCTs) comparing transcatheter PFO closure with medical therapy in patients with cryptogenic stroke to prevent recurrent ischemic stroke showed mixed results. This meta-analysis aims to compare rates of recurrent stroke, transient ischemic attack (TIA) and all-cause mortality with PFO closure and medical therapy vs. medical therapy alone. METHODS: PubMed and the Cochrane Center Register of Controlled Trials were searched for studies published through June 2018, comparing PFO closure plus medical therapy versus medical therapy alone. Six RCTs (nâ¯=â¯3750) comparing PFO closure with medical therapy were included in the analysis. End points were recurrent stroke, TIA and all-cause mortality. The odds ratios (OR) with 95% confidence interval (CI) were computed and pâ¯<â¯0.05 was considered as a level of significance. RESULTS: A total of 1889 patients were assigned to PFO closure plus medical therapy and 1861 patients were assigned to medical therapy only. Risk of recurrent stroke was significantly lower in the PFO closure plus medical therapy group compared to medical therapy alone. (OR 0.47, 95% CI 0.33-0.67, pâ¯<â¯0.0001). Rate of TIA was similar between the two groups (OR 0.76, 95% CI 0.52-1.14), pâ¯=â¯0.18). There was no difference in all-cause mortality between two groups (OR 0.73, CI 0.33-1.58, pâ¯=â¯0.42). Patients undergoing PFO closure were more likely to develop transient atrial fibrillation than medical therapy alone (OR: 5.85; CI: 3.06-11.18, pâ¯≤0.0001) whereas the risk of bleeding was similar between the groups (OR: 0.93; CI: 0.55-1.57, pâ¯=â¯0.78). CONCLUSIONS: The results of this meta-analysis suggest that transcatheter closure of PFO plus medical therapy is superior to medical therapy alone for the prevention of recurrent cryptogenic stroke. However, PFO closure in these patients has not been shown to reduce the risk of recurrent TIA or all-cause mortality. There is a higher rate of transient atrial fibrillation post PFO closure device placement, the long-term effects of which have yet to be studied.
Subject(s)
Cardiac Catheterization , Cardiovascular Agents/therapeutic use , Foramen Ovale, Patent/therapy , Stroke/prevention & control , Adolescent , Adult , Cardiac Catheterization/adverse effects , Cardiac Catheterization/instrumentation , Cardiac Catheterization/mortality , Cardiovascular Agents/adverse effects , Combined Modality Therapy , Female , Foramen Ovale, Patent/complications , Foramen Ovale, Patent/diagnostic imaging , Humans , Ischemic Attack, Transient/etiology , Male , Middle Aged , Randomized Controlled Trials as Topic , Recurrence , Risk Assessment , Risk Factors , Stroke/diagnosis , Stroke/etiology , Time Factors , Treatment Outcome , Young AdultABSTRACT
BACKGROUND: Drug eluting stents (DES) are preferred over bare metal stents (BMS) for native coronary artery revascularization unless contraindicated. However, the preferred stent choice for saphenous venous graft (SVG) percutaneous coronary interventions (PCI) is unclear due to conflicting results. METHODS: PubMed, Clinical trials registry and the Cochrane Center Register of Controlled Trials were searched through June 2018. Seven studies (nâ¯=â¯1639) comparing DES versus BMS in SVG-PCI were included. Endpoints were major adverse cardiac events (MACE), cardiovascular mortality, all-cause mortality, myocardial infarction (MI), target vessel revascularization (TVR), target lesion revascularization (TLR), in-stent thrombosis, binary in-stent restenosis, and late lumen loss (LLL). RESULTS: Overall, during a mean follow up of 32.1â¯months, there was no significant difference in the risk of MACE, cardiovascular mortality, all-cause mortality, MI, stent thrombosis, TVR and TLR between DES and BMS. However, short-term follow up (mean 11â¯months) showed lower rate of MACE (OR 0.66 [0.51, 0.85]; pâ¯=â¯0.002), TVR (OR 0.47 [0.23, 0.97]; pâ¯=â¯0.04) and binary in-stent restenosis (OR 0.14 [0.06, 0.37]; pâ¯<â¯0.0001) in DES as compared with BMS. This benefit was lost on long-term follow up with a mean follow up 35.5â¯months. CONCLUSION: In this meta-analysis of SVG-PCI, DES use was associated with similar MACE, cardiovascular mortality, all-cause mortality, MI, in-stent thrombosis, TVR and TLR compared with BMS during long-term follow up. There was high incidence of MACE noted in both DES and BMS suggesting a need for exploring novel strategies to treat SVG disease to improve clinical outcomes.
Subject(s)
Coronary Artery Bypass/adverse effects , Coronary Artery Disease/surgery , Drug-Eluting Stents , Graft Occlusion, Vascular/therapy , Metals , Percutaneous Coronary Intervention/instrumentation , Saphenous Vein/transplantation , Stents , Coronary Artery Bypass/mortality , Coronary Artery Disease/mortality , Coronary Artery Disease/physiopathology , Coronary Thrombosis/etiology , Coronary Thrombosis/mortality , Graft Occlusion, Vascular/etiology , Graft Occlusion, Vascular/mortality , Graft Occlusion, Vascular/physiopathology , Humans , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/mortality , Prosthesis Design , Randomized Controlled Trials as Topic , Risk Assessment , Risk Factors , Saphenous Vein/diagnostic imaging , Saphenous Vein/physiopathology , Time Factors , Treatment Outcome , Vascular PatencyABSTRACT
BACKGROUND: Previous studies comparing outcomes between culprit vessel only percutaneous coronary intervention (CV-PCI) versus multivessel percutaneous coronary intervention (MV-PCI) in patients with cardiogenic shock in the setting of acute myocardial infarction have shown conflicting results. This meta-analysis investigates the optimal approach for management of these patients considering recently published data. METHODS: Electronic databases including MEDLINE, ClinicalTrials.gov and the Cochrane Library were searched for all clinical studies published until May 1, 2018, which compared outcomes in patients presenting with acute myocardial infarction and cardiogenic shock. Studies comparing CV-PCI versus MV-PCI in patients with multivessel coronary artery disease were screened for inclusion in final analysis. The primary end point was in-hospital/30â¯day mortality. Secondary endpoints included long term (>6â¯months) mortality, renal failure requiring renal replacement therapy, stroke, bleeding, and recurrent myocardial infarction. Odds ratio (OR) with 95% of confidence interval (CI) were computed and p values <0.05 were considered significant. RESULTS: Patient who underwent CV-PCI had significantly lower short-term mortality (in-hospital or 30-day mortality) (OR: 0.73, CI: 0.61-0.87, pâ¯=â¯0.0005), and lower odds of severe renal failure requiring renal replacement therapy (OR: 0.76, CI: 0.59-0.98, pâ¯=â¯0.03). There was no statistically significant difference in long-term mortality, stroke, bleeding, and recurrent myocardial infarction between two groups. CONCLUSION: This meta-analysis showed lower short-term mortality and decreased odds of renal failure requiring renal replacement therapy with CV-PCI compared to MV-PCI. However, subgroup analysis including studies exclusively assessing STEMI patients revealed no statistically significant difference in outcomes. Further randomized trials are needed to confirm these findings and evaluate long term results.
Subject(s)
Coronary Artery Disease/therapy , Myocardial Infarction/therapy , Percutaneous Coronary Intervention , Shock, Cardiogenic/therapy , Aged , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/mortality , Coronary Artery Disease/physiopathology , Female , Hospital Mortality , Humans , Male , Middle Aged , Myocardial Infarction/diagnostic imaging , Myocardial Infarction/mortality , Myocardial Infarction/physiopathology , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/mortality , Recurrence , Renal Insufficiency/mortality , Renal Insufficiency/therapy , Renal Replacement Therapy , Risk Factors , Shock, Cardiogenic/diagnostic imaging , Shock, Cardiogenic/mortality , Shock, Cardiogenic/physiopathology , Time Factors , Treatment OutcomeABSTRACT
BACKGROUND: Studies have shown reduction in major bleeding with trans-radial intervention (TRI) compared with trans-femoral intervention (TFI), and with use of bivalirudin compared with heparin+glycoprotein IIb/IIIa inhibitors (GPI). We compared major bleeding, mortality and the interaction between arterial access site and the anticoagulant used for PCI in Veterans. METHODS: A retrospective cohort of 1192 consecutive patients who underwent PCI at a VA hospital between 2006 and 2012 was divided into TFI-heparin (n=192), TFI-bivalirudin (n=272), TRI-heparin (n=274) and TRI-bivalirudin (n=454) groups. Primary outcomes were in-hospital major bleeding, in-hospital and 1-year all-cause mortality. Secondary outcomes were in-hospital MI, in-hospital and 1-year MACE and net adverse cardiovascular events (NACE - composite of major bleeding+MACE). RESULTS: Femoral access was associated with a significantly increased risk of major bleeding compared with radial access (OR 11.87, p<0.001). Correspondingly, radial access was protective against major bleeding compared with femoral access (OR 0.128, p<0.01), but did not lower mortality or MACE by itself. Severe anemia was the only predictor of in-hospital all-cause mortality (OR=27.62, p<0.008). Presence of anemia and age>70 predicted 1-year mortality, whereas major bleeding and anemia predicted 1-year MACE. An interaction was noted between anticoagulant and access site, such that heparin showed significantly greater major bleeding in the femoral group compared with the radial group. Bivalirudin resulted in similar risk of bleeding, regardless of access site. There was a synergistic interaction between radial access and heparin (HR 0.38, p<0.05), but not radial access and bivalirudin, on reduction in 1-year NACE. CONCLUSION: Radial access for PCI is associated with reduction in major bleeding, but does not have an effect on in-patient or 1-year MACE and mortality. Major bleeding is associated with poor short and intermediate term outcomes. In addition, anemia is strongly associated with increased in-patient and 1-year mortality. There is a differential effect of heparin but not bivalirudin on major bleeding, depending on the access site. There is no synergism between radial access and bivalirudin in lowering the composite outcome of MACE and major bleeding at 1year.
Subject(s)
Anticoagulants/adverse effects , Catheterization, Peripheral/methods , Femoral Artery , Hemorrhage/prevention & control , Heparin/adverse effects , Hirudins/adverse effects , Peptide Fragments/adverse effects , Percutaneous Coronary Intervention/methods , Radial Artery , Veterans Health , Aged , Anticoagulants/administration & dosage , Catheterization, Peripheral/adverse effects , Catheterization, Peripheral/mortality , Cause of Death , Databases, Factual , Female , Hemorrhage/chemically induced , Hemorrhage/mortality , Heparin/administration & dosage , Hirudins/administration & dosage , Hospital Mortality , Humans , Male , Middle Aged , Peptide Fragments/administration & dosage , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/mortality , Recombinant Proteins/administration & dosage , Recombinant Proteins/adverse effects , Retrospective Studies , Risk Factors , Time Factors , Treatment Outcome , United States , United States Department of Veterans AffairsABSTRACT
STUDY OBJECTIVES: Obstructive sleep apnea (OSA) is strongly associated with cardiovascular disease, including stroke and acute coronary syndromes. Plasminogen activator inhibitor-1 (PAI-1), the principal inhibitor of tissue-type plasminogen activator (t-PA), has a pronounced circadian rhythm and is elevated in both OSA and cardiovascular disease and may be an important link between the two conditions. Endothelial dysfunction is one of the underlying pathophysiological mechanisms of cardiovascular disease, and may be altered in OSA. Our primary aim was to compare circadian variability of PAI-1 and t-PA in patients with OSA and normal controls by determining the amplitude (peak level) and mesor (rhythm adjusted mean) of PAI-1 and t-PA in serial blood samples over a 24-h period. The secondary aim was to measure markers of endothelial function (brachial and radial artery flow) in patients with OSA compared with normal controls. SETTING: Cross-sectional cohort study. PATIENTS OR PARTICIPANTS: Subjects age 18 y or older, with a body mass index of 25-45 kg/m(2), with or without evidence of untreated OSA. INTERVENTIONS: Plasma samples were collected every 2 h, in OSA patients and matched controls, over a 24-h period. PAI-1 and t-PA antigen and activity were measured. The presence or absence of OSA (apnea-hypopnea index of 5 or greater) was confirmed by overnight polysomnography. Endothelial function was measured via brachial artery flow mediated vasodilatation and computerized arterial pulse waveform analysis. MEASUREMENTS AND RESULTS: The rhythm-adjusted mean levels of PAI-1 antigen levels in the OSA group (21.8 ng/mL, 95% confidence level [CI], 18 to 25.7) were significantly higher as compared to the non-OSA group (16 ng/mL, 95% CI, 12.2 to 19.8; P = 0.03). The rhythm-adjusted mean levels of PAI-1 activity levels in the OSA group (23.9 IU/mL, 95% CI, 21.4 to 26.5) were also significantly higher than in the non-OSA group (17.2 IU/ mL, 95% CI, 14.6 to 19.9; P < 0.001).There were strong correlations between amplitude of PAI-1 activity and severity of OSA as measured by AHI (P = 0.02), and minimum oxygen levels during sleep (P = 0.04). Endothelial function parameters did not differ significantly between the two groups. CONCLUSION: The presence of obstructive sleep apnea adversely affects circadian fibrinolytic balance with higher mean plasminogen activator inhibitor-1 activity and antigen, and significantly lower mean tissue-type plasminogen activator activity compared with controls. This perturbation may be an important mechanism for increased cardiovascular events in patients with obstructive sleep apnea. Intermittent hypoxia and changes in circadian clock gene activity in obstructive sleep apnea may be responsible for these findings and warrant further study. Favorable changes in fibrinolytic balance may underlie the reduction in cardiovascular events observed with the treatment of obstructive sleep apnea.
Subject(s)
Circadian Rhythm/physiology , Sleep Apnea, Obstructive/blood , Sleep Apnea, Obstructive/physiopathology , Biomarkers/blood , Body Mass Index , Cardiovascular Diseases/blood , Cardiovascular Diseases/complications , Cardiovascular Diseases/physiopathology , Case-Control Studies , Cross-Sectional Studies , Endothelial Cells/physiology , Female , Humans , Male , Middle Aged , Plasminogen Activator Inhibitor 1/blood , Polysomnography , Sleep/physiology , Sleep Apnea, Obstructive/complications , Tissue Plasminogen Activator/antagonists & inhibitors , Tissue Plasminogen Activator/bloodABSTRACT
Patients with non-ST segment elevation acute coronary syndromes (NSTEACS) are at high risk for subsequent thrombotic events. Combination antithrombotic management with anticoagulant and antiplatelet medications can improve outcomes in these high-risk patients. If an early invasive strategy is planned, unfractionated heparin or bivalirudin are the anticoagulants of choice, whereas in those in whom an early conservative strategy is planned enoxaparin or fondaparinux may be preferred. All patients with NSTEACS should receive aspirin and continue it indefinitely unless they cannot tolerate it. A second antiplatelet agent should be administered both for an early invasive or early conservative strategy.
ABSTRACT
BACKGROUND: High-risk percutaneous coronary interventions (PCI), refractory cardiogenic shock and in-lab cardiac arrest are all associated with significant mortality. Percutaneous left ventricular assist devices (pLVAD) and CPS (cardiopulmonary support) have been used to support such patients. However, the extent to which the use of these devices can improve outcomes in this patient subset is not known. METHODS: We evaluated clinical features, efficacy and safety outcomes in a retrospective cohort of 39 patients, treated either with pLVAD or CPS for support of high-risk PCI, cardiogenic shock or in-lab cardiac arrest. The Tandem-Heart and a new versatile Multifunctional Percutaneous Heart (MPH) system, with both CPS and LVAD capability, were used and assessed. RESULTS: 19 patients received the TandemHeart and 20 received the MPH system. The MPH system was used as a pLVAD in 12 and to provide CPS in 8 patients. Procedural efficacy was 100%. Emergent institution of CPS, in the setting of cardiac arrest, was able to support 7 out of 8 patients and resulted in a 50% survival to hospital discharge rate. Overall, in-hospital death and 30-day major adverse cardiac event rates were 28.2% and 35.9%, respectively. The risk of vascular complications and bleeding was relatively small. CONCLUSIONS: pLVADs are effective in supporting patients during high-risk cardiac (coronary and structural heart) interventions, with a low risk of device-related complications. Further, the expeditious use of CPS in the catheterization laboratory can improve survival in a selected subset of patients with refractory cardiogenic shock and cardiac arrest.
Subject(s)
Advanced Cardiac Life Support/instrumentation , Angioplasty, Balloon, Coronary/adverse effects , Heart Arrest/therapy , Heart-Assist Devices , Life Support Care/methods , Shock, Cardiogenic/therapy , Adult , Advanced Cardiac Life Support/adverse effects , Aged , Cohort Studies , Coronary Disease/therapy , Female , Heart Arrest/mortality , Heart-Assist Devices/adverse effects , Humans , Life Support Care/instrumentation , Male , Middle Aged , Myocardial Infarction/therapy , Retrospective Studies , Risk Factors , Shock, Cardiogenic/mortality , Survival Rate , Treatment OutcomeABSTRACT
The conversion of atrial fibrillation (AF) to normal sinus rhythm should be attempted in patients who present with this condition, as long as the cure is not worse than the disease itself. In young patients with normal hearts, AF has a small impact on morbidity and mortality. The primary indication for conversion in this population is often symptoms. In contrast, in patients with diseased hearts or who are older than 65 years, maintaining sinus rhythm may have a favorable impact on stroke risk, ventricular function, and symptoms. In the absence of normal sinus rhythm, these patients should receive anticoagulants. Rate control is the preferred first-line strategy for asymptomatic patients and patients presenting with a history of long-standing, persistent AF, making conversion and maintenance of sinus rhythm unlikely. Rate control may be used in patients who develop AF during an acute systemic illness, which will likely terminate with time or therapy. Conversion to sinus rhythm should be considered in patients with a first episode of AF, as unconverted AF tends to perpetuate itself. Conversion can be attempted if the duration of AF is less than 48 hours or if the patient has received anticoagulants when the duration is not known. Other indications for cardioversion are prolonged episodes in patients with otherwise infrequent episodes of paroxysmal AF, and in patients who refuse to take anticoagulants or in whom anticoagulation is contraindicated. After the patient is converted to sinus rhythm, the decision to initiate chronic drug therapy should be based on the presence of other cardiac and medical diseases that increase the risk of recurrence and serious symptoms in case of recurrence (such as hypertrophic cardiomyopathy or mitral stenosis). It is acceptable to manage patients with new-onset AF and normal cardiac function with cardioversion alone and not initiate chronic antiarrhythmic therapy afterwards. However, in patients with abnormal hearts (coronary artery disease, hypertensive or mitral valvular heart disease, and cardiomyopathy) AF is likely to recur, and such patients should be placed on antiarrhythmic medication.