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BACKGROUND: Acute myocardial infarction complicated by cardiogenic shock (AMI-CS) is associated with significant morbidity and mortality. Mechanical circulatory support (MCS) devices increase systemic blood pressure and end organ perfusion while reducing cardiac filling pressures. METHODS AND RESULTS: The National Cardiogenic Shock Initiative (NCT03677180) is a single-arm, multicenter study. The purpose of this study was to assess the feasibility and effectiveness of utilizing early MCS with Impella in patients presenting with AMI-CS. The primary end point was in-hospital mortality. A total of 406 patients were enrolled at 80 sites between 2016 and 2020. Average age was 64±12 years, 24% were female, 17% had a witnessed out-of-hospital cardiac arrest, 27% had in-hospital cardiac arrest, and 9% were under active cardiopulmonary resuscitation during MCS implantation. Patients presented with a mean systolic blood pressure of 77.2±19.2 mm Hg, 85% of patients were on vasopressors or inotropes, mean lactate was 4.8±3.9 mmol/L and cardiac power output was 0.67±0.29 watts. At 24 hours, mean systolic blood pressure improved to 103.9±17.8 mm Hg, lactate to 2.7±2.8 mmol/L, and cardiac power output to 1.0±1.3 watts. Procedural survival, survival to discharge, survival to 30 days, and survival to 1 year were 99%, 71%, 68%, and 53%, respectively. CONCLUSIONS: Early use of MCS in AMI-CS is feasible across varying health care settings and resulted in improvements to early hemodynamics and perfusion. Survival rates to hospital discharge were high. Given the encouraging results from our analysis, randomized clinical trials are warranted to assess the role of utilizing early MCS, using a standardized, multidisciplinary approach.
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Corazón Auxiliar , Infarto del Miocardio , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Ácido Láctico , Infarto del Miocardio/complicaciones , Infarto del Miocardio/terapia , Choque Cardiogénico/diagnóstico , Choque Cardiogénico/etiología , Choque Cardiogénico/terapia , Resultado del TratamientoRESUMEN
Background: The Aortix percutaneous mechanical circulatory support (pMCS) 18F micromechanical axial impeller-driven pump is percutaneously placed and retrieved from the descending aorta above the renal arteries. Pump deployment and retrieval use defined steps to allow suture-mediated closure around the exiting power lead and for terminal hemostasis after device retrieval after therapy. The overall procedure was validated preclinically in ovine and porcine models and has since proven reliable in a recently completed IDE feasibility study (NCT04145635). This study describes the steps of a novel technique for reliable suture-mediated vessel closure when using the Aortix pMCS device. Methods: The principal steps associated with the procedure comprised ultrasound-guided access of the femoral artery, preclose placement of 4 Perclose (Abbott) sutures, achievement of intermediate hemostasis by locking 3 of the 4 sutures around the 6F exiting power lead, breaking the 3 locked sutures to permit vessel reentry for device removal, and finally, vessel closure using the fourth preclose suture along with 1 or more postclose suture(s) to close the femoral artery using a hybrid dual-sheath technique. Results: The standardized steps described have been developed and used over the course of 21 clinical cases by 12 operators who were initially procedurally naïve but experienced in large-bore access. Conclusions: Preclose and postclose suture-mediated closure is a reliable means of managing the exiting power lead of the Aortix pMCS and closing the large-bore arteriotomy after pump retrieval. The steps outlined in this study may have applicability to other procedures requiring large-bore access or using suture-mediated closure.
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OBJECTIVES: This study was designed to compare efficiency and quality metrics between percutaneous coronary intervention (PCI) procedures using optical coherence tomography (OCT) guided by a variable workflow versus a standardized workflow in a real-world population. BACKGROUND: The LightLab (LL) Initiative was designed to evaluate the impact of a standardized OCT workflow during PCI to address barriers to adoption. METHODS: The LL Initiative was a multicenter, prospective, observational study. PCI efficiency data were collected from 1/21/19 to 1/8/21 from 45 physicians at 17 US centers. OCT-guided PCIs were compared between baseline phase (variable workflow; N = 383) and the LL workflow utilization phase (N = 447). The LL workflow uses OCT to assess lesion Morphology, Length and Diameter, and then optimize outcomes by correcting for Medial dissection, stent mal-Apposition, and under-eXpansion (MLD MAX). Matching based on propensity scores was used to control for differences between PCIs. RESULTS: After propensity matching, 291 paired procedures were included. Integration of the LL versus variable workflow resulted in no difference in procedure time (51 min vs. 51 min, p = 0.93). There was a reduction in radiation exposure (1124 mGy vs. 1493 mGy, p < 0.0001) and contrast volume (160 cc vs. 172 cc, p < 0.001). The LL workflow decreased the proportion of underexpanded lesions (34% vs. 54%, p < 0.0001) and improved minimum stent expansion (85% vs. 79%, p < 0.0001). Number of noncompliant balloons used was reduced with the LL workflow. (2.0 vs. 1.7, p < 0.01). CONCLUSIONS: These data suggest that standardizing imaging with the LL workflow may overcome barriers to imaging and improve PCI outcomes without prolonging procedures.
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Enfermedad de la Arteria Coronaria , Intervención Coronaria Percutánea , Humanos , Angiografía Coronaria/métodos , Tomografía de Coherencia Óptica/métodos , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/métodos , Estudios Prospectivos , Flujo de Trabajo , Resultado del Tratamiento , Stents , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/terapia , Enfermedad de la Arteria Coronaria/patología , Vasos Coronarios/diagnóstico por imagen , Vasos Coronarios/patologíaRESUMEN
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.
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American Heart Association , Cardiología , Angiografía , Cateterismo Cardíaco , Consenso , Humanos , Laboratorios , Resultado del Tratamiento , Estados UnidosRESUMEN
Dorsal or distal transradial artery access has recently gained popularity due to several perceived benefits that include favorable ergonomics, the potential for rapid hemostasis and lower rates of vascular complications. Still, no vascular access site is free of complications and reports of hematoma and pseudoaneurysm formation related to distal radial artery access have been reported in the literature. We present a case of a 71-year-old male who developed an arteriovenous fistula (AVF) involving the distal left radial artery following repeated access of the artery. This rare complication is likely avoidable with a comprehensive understanding of the surrounding anatomy and proper procedural technique, including the routine use of ultrasound for access.
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Fístula Arteriovenosa , Intervención Coronaria Percutánea , Anciano , Fístula Arteriovenosa/diagnóstico por imagen , Fístula Arteriovenosa/etiología , Fístula Arteriovenosa/terapia , Angiografía Coronaria , Humanos , Masculino , Intervención Coronaria Percutánea/efectos adversos , Arteria Radial/diagnóstico por imagen , Arteria Radial/cirugía , Resultado del TratamientoRESUMEN
There is no recent comprehensive overview of contemporary clinical trials assessing short and long-term outcomes in patients with acute coronary syndrome (ACS). This paper reviews factors from recent clinical trials that influenced prognosis in patients with ACS. Cochrane and PubMed databases were screened systematically for clinical trials published in the English literature reporting on ACS prognosis. Two authors independently screened titles, abstracts, and full text. Studies meeting inclusion criteria evaluated the impact of modern practice on prognosis. In vitro and animal models studies, conference abstracts, imaging studies, and review articles were excluded. Disagreement in inclusion criteria was resolved by consensus. A large study of 8,859 patients showed no difference in all-cause mortality between 31 days and 2 years in patients with ST segment elevation myocardial infarction (STEMI) compared to those with non-ST segment elevation myocardial infarction (NSTEMI) or stable ischemic heart disease (SIHD). Other studies showed a significant increase in all-cause mortality in patients with STEMI within the first 30 days, with NSTEMI patients exhibiting a higher mortality rate compared to those with SIHD during the 2-year follow-up period. Our review found that women have a poorer short-term prognosis compared to men. Additionally, reports from patients receiving comprehensive and coordinated care showed longer survival rates. In view of the improved prognosis demonstrated for patients suffering from ACS, assessing prognosis in patients represents a formidable task in modern practice. Our review highlights the need for further evidence-based studies evaluating long-term outcomes on diagnostic and treatment strategies.
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Síndrome Coronario Agudo , Infarto del Miocardio con Elevación del ST , Síndrome Coronario Agudo/mortalidad , Síndrome Coronario Agudo/terapia , Anciano , Animales , Modelos Animales de Enfermedad , Supervivencia sin Enfermedad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Infarto del Miocardio con Elevación del ST/mortalidad , Infarto del Miocardio con Elevación del ST/terapia , Factores Sexuales , Tasa de Supervivencia , Factores de TiempoRESUMEN
BACKGROUND: The National Cardiogenic Shock Initiative is a single-arm, prospective, multicenter study to assess outcomes associated with early mechanical circulatory support (MCS) in patients presenting with acute myocardial infarction and cardiogenic shock (AMICS) treated with percutaneous coronary intervention (PCI). METHODS: Between July 2016 and February 2019, 35 sites participated and enrolled into the study. All centers agreed to treat patients with AMICS using a standard protocol emphasizing invasive hemodynamic monitoring and rapid initiation of MCS. Inclusion and exclusion criteria mimicked those of the "SHOCK" trial with an additional exclusion criteria of intra-aortic balloon pump counter-pulsation prior to MCS. RESULTS: A total of 171 consecutive patients were enrolled. Patients had an average age of 63 years, 77% were male, and 68% were admitted with AMICS. About 83% of patients were on vasopressors or inotropes, 20% had a witnessed out of hospital cardiac arrest, 29% had in-hospital cardiac arrest, and 10% were under active cardiopulmonary resuscitation during MCS implantation. In accordance with the protocol, 74% of patients had MCS implanted prior to PCI. Right heart catheterization was performed in 92%. About 78% of patients presented with ST-elevation myocardial infarction with average door to support times of 85 ± 63 min and door to balloon times of 87 ± 58 min. Survival to discharge was 72%. Creatinine ≥2, lactate >4, cardiac power output (CPO) <0.6 W, and age ≥ 70 years were predictors of mortality. Lactate and CPO measurements at 12-24 hr reliably predicted overall mortality postindex procedure. CONCLUSION: In contemporary practice, use of a shock protocol emphasizing best practices is associated with improved outcomes.
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Protocolos Clínicos , Corazón Auxiliar , Infarto del Miocardio sin Elevación del ST/terapia , Intervención Coronaria Percutánea , Infarto del Miocardio con Elevación del ST/terapia , Choque Cardiogénico/terapia , Anciano , Femenino , Hemodinámica , Humanos , Masculino , Persona de Mediana Edad , Infarto del Miocardio sin Elevación del ST/diagnóstico , Infarto del Miocardio sin Elevación del ST/mortalidad , Infarto del Miocardio sin Elevación del ST/fisiopatología , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/mortalidad , Estudios Prospectivos , Diseño de Prótesis , Recuperación de la Función , Factores de Riesgo , Infarto del Miocardio con Elevación del ST/diagnóstico , Infarto del Miocardio con Elevación del ST/mortalidad , Infarto del Miocardio con Elevación del ST/fisiopatología , Choque Cardiogénico/diagnóstico , Choque Cardiogénico/mortalidad , Choque Cardiogénico/fisiopatología , Factores de Tiempo , Resultado del Tratamiento , Estados UnidosRESUMEN
Relative bradycardia is the term used to describe the mechanism where there is dissociation between pulse and temperature. This finding is important to recognize since it may provide further insights into the potential underlying causes of disease. There is no known proposed mechanism to explain this phenomenon. We hypothesize that relative bradycardia is the central mechanism reflecting and influenced potentially by the direct pathogenic effect on the sinoatrial node as well as cross-talk between the autonomic nervous system and immune system. Cardiac pacemaker cells may act as a target for inflammatory cytokines leading to alteration in heart rate dynamics or their responsiveness to neurotransmitters during systemic inflammation. These factors account for the important role of how the host response to infectious and non-infectious causes influences the appearance of relative bradycardia. We propose several methods that may be useful to confirm the proposed theoretical framework to further enhance our understanding of this paradoxical phenomenon. This includes measuring, during the episode of relative bradycardia, proinflammatory and anti-inflammatory cytokines, monitoring heart rate variability (HRV), and assessing underlying comorbidities and outcomes in patients with the same disease.
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Bradicardia/diagnóstico , Bradicardia/terapia , Citocinas/metabolismo , Frecuencia Cardíaca , Neurotransmisores/metabolismo , Sistema Nervioso Autónomo , Comorbilidad , Endotelina-1/metabolismo , Humanos , Sistema Inmunológico , Inflamación , Interleucina-6/metabolismo , Lipopolisacáridos/metabolismo , Modelos Teóricos , NADPH Oxidasas/metabolismo , Óxido Nítrico/metabolismo , Pulso Arterial , Sepsis/fisiopatología , Nodo Sinoatrial , Temperatura , Resultado del Tratamiento , Factor de Necrosis Tumoral alfa/metabolismoRESUMEN
A 56-year-old healthy male with no obvious risk factors or significant past medical history was admitted to the emergency room with acute ischemic stroke. On his transthoracic echocardiography (TTE), an extremely large thrombus was detected at the apex involving the distal anterior wall. The thrombus was predominantly adherent but with a mobile tip. The patient was subsequently managed with dual antiplatelet therapy. In this report, we present an interesting case of an acute ischemic stroke secondary to a giant left ventricular thrombus in a patient with no past significant cardiac or neurologic medical history.
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Hospitalized patients are at risk of venous thromboembolism (VTE) and prophylaxis is often suboptimal due to difficulty in identifying at-risk patients. Simple and validated risk-assessment models (RAMs) are available to assist clinicians in identifying patients who have a high risk for developing VTE. Despite the well-documented association of immobility with increased risk of thrombosis, immobility is not consistently defined in clinical studies. We conducted a systematic review of published VTE RAMs and used objective criteria to determine how the term immobility is defined in RAMs. We identified 17 RAMs with six being externally validated. The concept of immobility is vaguely described in different RAMs, impacting the validity of these models in clinical practice. The wide variability in defining mobility in RAMs precluded its accurate clinical application, further limiting generalization of published RAMs. Externally validated RAMs with clearly defined qualitative or quantitative terms of immobility are needed to assess VTE risk in real-time at the point-of-care.
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Hospitalización , Hipocinesia , Modelos Cardiovasculares , Tromboembolia Venosa , Humanos , Hipocinesia/complicaciones , Hipocinesia/epidemiología , Hipocinesia/terapia , Factores de Riesgo , Tromboembolia Venosa/epidemiología , Tromboembolia Venosa/etiología , Tromboembolia Venosa/terapiaRESUMEN
Enhanced external counterpulsation (EECP) is a noninvasive technique for treatment of symptomatic coronary artery disease in patients not amenable to revascularization procedures. However, the mechanisms underlying the benefits of EECP remain unknown. We hypothesized that decreases in arterial stiffness and aortic wave reflection are a therapeutic target for EECP. Patients with coronary artery disease and chronic angina pectoris were randomized (2:1 ratio) to 35 1-hour sessions of EECP (n = 28) or sham EECP (n = 14). Central and peripheral arterial pulse-wave velocity and aortic wave reflection (augmentation index) were measured using applanation tonometry before, and after 17 and 35 1-hour treatment sessions. Wasted left ventricular pressure energy and aortic systolic tension-time index, markers of left-ventricular myocardial oxygen demand, were derived from the synthesized aortic pressure wave. Exercise duration, anginal threshold, and peak oxygen consumption were measured using a graded treadmill test. Central arterial stiffness and augmentation index were decreased after 17 and 35 sessions in the treatment group. Measurements of peripheral arterial stiffness were decreased after 35 sessions in the treatment group. Changes in aortic pressure wave reflection resulted in decreased measurements of myocardial oxygen demand and wasted left ventricular energy. No changes in central or peripheral arterial stiffness were observed in the sham group. Furthermore, measurements of exercise capacity were improved in the EECP group but unchanged in the sham group. In conclusion, EECP therapy decreases central and peripheral arterial stiffness, which may explain improvements in myocardial oxygen demand in patients with chronic angina pectoris after treatment.
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Angina de Pecho/terapia , Contrapulsación/métodos , Miocardio/metabolismo , Oxígeno/metabolismo , Angina de Pecho/fisiopatología , Arterias/fisiología , Arterias/fisiopatología , Enfermedad Crónica , Femenino , Humanos , Masculino , Persona de Mediana EdadRESUMEN
BACKGROUND: Mechanisms responsible for anti-ischemic benefits of enhanced external counterpulsation (EECP) remain unknown. This was the first randomized sham-controlled study to investigate the extracardiac effects of EECP on peripheral artery flow-mediated dilation. METHODS AND RESULTS: Forty-two symptomatic patients with coronary artery disease were randomized (2:1 ratio) to thirty-five 1-hour sessions of either EECP (n=28) or sham EECP (n=14). Flow-mediated dilation of the brachial and femoral arteries was performed with the use of ultrasound. Plasma levels of nitrate and nitrite, 6-keto-prostaglandin F(1α), endothelin-1, asymmetrical dimethylarginine, tumor necrosis factor-α, monocyte chemoattractant protein-1, soluble vascular cell adhesion molecule, high-sensitivity C-reactive protein, and 8-isoprostane were measured. EECP increased brachial (+51% versus +2%) and femoral (+30% versus +3%) artery flow-mediated dilation, the nitric oxide turnover/production markers nitrate and nitrite (+36% versus +2%), and 6-keto-prostaglandin F(1α) (+71% versus +1%), whereas it decreased endothelin-1 (-25% versus +5%) and the nitric oxide synthase inhibitor asymmetrical dimethylarginine (-28% versus +0.2%) in treatment versus sham groups, respectively (all P<0.05). EECP decreased the proinflammatory cytokines tumor necrosis factor-α (-16% versus +12%), monocyte chemoattractant protein-1 (-13% versus +0.2%), soluble vascular cell adhesion molecule-1 (-6% versus +1%), high-sensitivity C-reactive protein (-32% versus +5%), and the lipid peroxidation marker 8-isoprostane (-21% versus +1.3%) in treatment versus sham groups, respectively (all P<0.05). EECP reduced angina classification (-62% versus 0%; P<0.001) in treatment versus sham groups, respectively. CONCLUSIONS: Our findings provide novel mechanistic evidence that EECP has a beneficial effect on peripheral artery flow-mediated dilation and endothelial-derived vasoactive agents in patients with symptomatic coronary artery disease.
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Angina de Pecho/fisiopatología , Arteria Braquial/fisiología , Contrapulsación/métodos , Arteria Femoral/fisiología , Flujo Sanguíneo Regional/fisiología , Vasodilatación/fisiología , 6-Cetoprostaglandina F1 alfa/sangre , Anciano , Presión Sanguínea/fisiología , Proteína C-Reactiva/metabolismo , Enfermedad Crónica , Citocinas/sangre , Endotelina-1/sangre , Tolerancia al Ejercicio/fisiología , Humanos , Persona de Mediana Edad , Óxido Nítrico/sangre , Consumo de Oxígeno/fisiología , Factor de Necrosis Tumoral alfa/sangreRESUMEN
AIMS: Using intravascular ultrasound (IVUS), we sought to characterize coronary morphology in women with chest pain without major epicardial obstructive coronary artery disease (CAD). We have previously observed an unexpectedly high rate of adverse outcomes among women with chest pain and normal or insignificant obstructive CAD. Information about the presence and characteristics of coronary atherosclerosis in these women could provide insight into the mechanisms related to increased risk, as well as improved diagnosis, prevention, and treatment. METHODS: Women (n = 100) with suspected ischemia without obstructive CAD (>50% stenosis) underwent IVUS of a left coronary segment with measurements by a core lab masked to clinical and angiographic findings. RESULTS: Angiograhic core lab analysis found 69.6% of patients had no (≤20%) and 30.4% had minimal (20-<50%) CAD. IVUS segmental images were interpretable by the core lab in 92 women, with 19 (21%) having no atherosclerosis (intimal-medial thickness <0.5 mm). In the remaining 73 women (79%), percent atheroma volume was 27 ± 8% and mean maximum plaque thickness was 0.53 ± 0.22 mm. Thirty-eight women with atherosclerosis (53%) had ≥30% of interrogated vessel involved. The average vessel involvement was 40%, and the maximum plaque thickness was 1.27 mm. The number of risk factors strongly correlated with percent atheroma volume (r = 0.53, P < 0.0001) and percent vessel involvement (r = 0.51, P < 0.0001), with the strongest independent predictor of both being age. Remodeling was assessed in 59/73 women (81%), and 73% had evidence of positive remodeling. CONCLUSIONS: In symptomatic women without significant luminal obstructive CAD, we observed a high prevalence of atherosclerosis with positive remodeling and preserved lumen size. These findings may help explain increased risk and emphasize need for improved diagnostic and treatment options for women with concealed CAD.
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Dolor en el Pecho/etiología , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/epidemiología , Placa Aterosclerótica/diagnóstico por imagen , Placa Aterosclerótica/epidemiología , Anciano , Dolor en el Pecho/diagnóstico por imagen , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/complicaciones , Femenino , Humanos , Persona de Mediana Edad , National Heart, Lung, and Blood Institute (U.S.) , Placa Aterosclerótica/complicaciones , Factores de Riesgo , Ultrasonografía Intervencional , Estados UnidosRESUMEN
Cardiovascular disease is associated with chronic low-level inflammation, as evidenced by elevated circulating proinflammatory cytokines. Experimental evidence suggests that inflammation can be suppressed under conditions of high shear stress. This study was conducted to examine the effects of enhanced external counterpulsation (EECP), a noninvasive therapy that increases endothelial shear stress, on circulating levels of inflammatory biomarkers and adhesion molecules in patients with angina pectoris. Twenty-one patients were randomly assigned to either 35 1-hour treatments at cuff pressures of 300 mm Hg (EECP; n=12) or 75 mm Hg (sham; n=9). Plasma tumor necrosis factor-alpha, monocyte chemoattractant protein-1, and soluble vascular cell adhesion molecule-1 were measured before and after 35 1-hour sessions of treatment or sham. Patients in the EECP group demonstrated reductions in tumor necrosis factor-alpha (6.9+/-2.7 vs 4.9+/-2.5 pg/ml, p<0.01; -29%) and monocyte chemoattractant protein-1 (254.9+/-55.9 vs 190.4+/-47.6 pg/ml, p<0.01; -19%) after treatment, whereas there was no change in the sham group. Changes in soluble vascular cell adhesion molecule-1 were not observed in either group. In conclusion, 35 sessions of EECP decreased circulating levels of proinflammatory biomarkers in patients with symptomatic coronary artery disease.