Ce Clin. Cardiol. 30, 223-228 (2007) Clinical Investigations Portable Enhanced External Counterpulsation for Acute Coronary Syndrome and Cardiogenic Shock: A Pilot Study Jostiva COHEN, mp," WILLIAM Grossman, M.D," ANDREW D, MICHAELS, MD. Mas. ‘Division of Cardiology, Department of Medicine, University of California xt San Francisco Medical Center, San Francisco, California, USA; "Division of Cardiology, Department of Medicine, University of Utah, Salt Lake City, Utah, US, Summary Background: Enhanced external _counterpulsation (BECP) currently is used as an outpatient therapy for patients with refractory chronic angina. Hypothesis: We sought to determine the safety and feasibility of a portable ECP unit to treat patients with acute coronary syndrome andor cardiogenie shock in the coronary care unit (CCU), Methods: Ten patients with acute coronary syndrome and/or cardiogenic shock who were not considered can- didates for invasive intra-aortic balloon counterpulsation (IABP) by the treating cardiologist were prospectively enrolled in this single-center study. Each patient received 2-4 one-hour EECP treatments performed at the bedside in the CCU. Anticoagulation or recent femoral access ‘was not an exclusion criterion Results: ‘The mean age was S819 years (range 28-81), and half were women. Patients had either acute coronary syndrome alone (n= 4), cardiogenic shock alone (n= 3), or both (n=3). The cardiac indica- tions for study enrollment included: acute inferior wall Address for reprints ‘Andrew D. Michaels, M.D., MLAS. Division of Cardiology University of Utah Health Science Center 30 North 1900 East, Room 4A100 Salk Lake City Utah 84132-2401 usa, ema: andzew.michaels@hse.utahedu Received: October 9, 2006 ‘Accepted with revision: November 30, 2006 Poblished online in Wiley InterScience (ws interscenee ily com, DOLI0.1o02/te-20078 (© 2007 Wiley Periodical, Ine ‘ST-segment elevation myocardial infaretion with cardio genic shock (n = 2), non-ST-segment elevation myocar- dial infarction with postinfaretion angina (n= 2) or heat failure (n = 1), unstable angina with refractory test angina (n = 2), cardiogenic shock from ischemic car diomyopathy with severe mitral regurgitation (n= 1), and cardiogenic shock from nonischemic cardiomyopa- thy (n = 2). No adverse events were recorded during or as 2 consequence of FECP therapy, including no bleed: ing complications, no heart failure exacerbations, and no skin breakdown. The portable EECP unit did not interfere with ongoing critical care nursing. Conclusions: EECP is safe and feasible for acute bed- side therapy of critically ill patients with acute coronary syndrome and/or cardiogenic shock who are not candi- dates for IABP. Key words: coronary artery disease, heart failure, exter= nal counterpulsation, acute coronary syndrome, cardio- ‘genic shock Clin. Cardiol, 2007; 30: 223-228, © 2007 Wiley Periodicals, Inc. Introduction In current clinical practice, enhanced external counter pulsation (EECP) is used for the outpatient treatment of refractory angina and heart failure. EECP bas an antiang- inal effect in outpatients with exercise-induced myocar- dial ischemia.'~* EECP increases diastolic aortic pres- sure, thereby increasing coronary artery perfusion, Cuff deflation at the onset of systole decreases left ventricular afterload by systolic unloading.® These acute hemody- namie effects achieved with EECP are comparable 10 those with invasive intra-aortic balloon counterpulsation, (ABP)! While the use of IABP in acute coronary syndromes (ACS) and cardiogenic shock is well-established, there are situations when its application is limited due to woney InterScience*24 lin. Cardiol. Vol. the potential complications of lower extremity ischemia, bleeding, and infecton."* For patients with IABP contra indications, FECP presents a potential noninvasive me thod for inereasing coronary perfusion and ventricular unloading While early EECP devices using « hydraulic water ‘compression system showed limited efficacy for cardio genic shock?" and acute myocardial infarction, there have been no studies using the pneumatic BECP devices in these clinical situations. This pilot study sought to determine the safety and feasibility of a portable ECP device to treat acutely ill patients in the coronary care unit (CCU) with ACS and/or cardiogenic shock Methods ‘This single-center study enrolled adult CCU patients admitted with ACS (Braunwald class IITB/C unstable angina," non-ST-segment elevation myocardial infare- tion, or ST-segment elevation myocardial infarction) and/or cardiogenic shock who were not candidates for IABP by the (eating cardiology team, Exclusion crite- ria inchided severe aortic insufficiency, supraventicular tachyarrhythmias, thrombophlebitis, active femoral site bleeding or hematoma, and uncontrolled hypertension (180/100 mmHg). Recent femoral vascular access and decompensated heart failure if the patient was intubated were not exclusion criteria, Patients or the surrogate decision-maker gave written informed consent prior to BECP, and the protocol was approved by the Committee con Human Research, Study Procedures EECP treatment was performed in the CCU portable prototype model, Vasomedical, Ine., Westbury, NY). Patients received 2~4 one-hour BECP treatments ‘over 24 h. Three seis of disposable lower-extremity pneu- matic cuffs were connected by air hoses to the portable ‘compressor unit (Fig. 1) in the CCU bed, The BECP device sequentially inflated the cuffs timed with the patient's cardiac cycle measured by electrocardiogra- phy. At the onset of systole, compressed air is released {o reduce systolic aortic pressure. Counterpulsation was performed at cuff inflation pressures ranging from 80 to 300 mmHg. Noninvasive finger plethysmography was used to monitor the arterial waveforms, If systemic arte- rial and pulmonary artery catheters were used clinically, hemodynamic data was recorded before, during, and after ‘each EECP treatment. Urine output prior to and during EECP was assessed using a Foley catheter. Patients were asked to report the severity of chest pain and dyspnea on 2 0-10 scale before and during each EECP treatment. ‘The cuff inflation pressure was statted at low pressure (80 mmHg) and increased gradually over the I-h treatment 30, May 2007 course as tolerated. Monitoring of the femoral access sites for vascular injury was performed. Statistical Analysis Continuous variables are presented as means stan- dard deviations. Paired tests were used to compare continuous variables prior to and 30-min after initiation of EECP. Two-tailed probability (p) values <0.05 were ‘considered significant. Statistical computations were per- formed using Stata version 9.2 (Stata Corporation, Col: lege Station, TX). Results Baseline Characteristies ‘Ten patients were enrolled (Tuble 1). The mean age was 58 + 19 years (range 28-81), and half were women, Patients had either ACS alone (n = 4), cardiogenic shock alone (n = 3), or both (n = 3). The cardiac indications for study enrollment included: acute inferior wall ST segment elevation myocardial infarction with cardio- genic shock (n = 2), non-ST-segment elevation myocar dial infaretion with postinfarction angina (n = 2) or heart failure (n = 1), class IIB unstable angina with refractory rest angina (n= 2), cardiogenic shock from ischemic cardiomyopathy with severe mitral regurgitation (n = 1), ‘and cardiogenic shock from nonischemic cardiomyopa- thy (n = 2), Two subjects had severe mitral regurgitation, ‘Two others were intubated prior to study enrollment, ‘and were continued on mechanical ventilation during the study period, ‘The decision not to treat the patients with IABP was made at the treating physicians’ discretion. Reasons for selecting patients included preference for a noninvasive approach (n = 6), severe iliac tortuosity (n = 1), abdom- inal aortic wleer (n = 1), recent abdominal aortic surgery (n= 1), and concem for infection one day following biventricular pacemaker implantation (n = 1). Seven patients had femoral arterial access within 48 bh of BECP. Four patients had current femoral arterial and/or femoral venous sheaths in place during ECP treatment, EECP Therapy Patients received an average of 2.5 +:0.7 h of EECP. therapy (range 2-4 h; Table 2). Patients were treated With antiplatelet and antithrombin agents including un- fractionated intravenous heparin (n = 7), glycoprotein MBANA receptor blockers (n= 5), aspirin (n= 8), and clopidogrel (n = 7; Table 2). Arterial pressure was mea sured invasively in four patients, and noninvasively in sixs patients. During treatment, there was a. signif cant increase in mean arterial pressure measured 30-min after starting EECP compared to baseline (p = 0.0002; Clinical Cardiology DOK:10.1002/elea J. Cohen etal: BCP for ACS and shock 25 Fic. 1 Portable enhanced external counterpulsation on a critically ill patient in the coronary care unit. This patient remained in cardiogenic shock after successful right coronary artery stenting for acute inferior ST-segment elevation inyocardial faretion. An intra-aortic balloon pump was not possible die to severe bilateral iliae artery tortuosity TABLE 1 Baseline demographics and clinieal characteristics Age Curent LVEF Mitr Patient (years) Sex ACS Shock Diahetes_HTN CAD PVD smoker Dyslipidemia (%) regurgitation 1 4 MY ON YoY Y oN oN Y 1“ Mid 2 4° MY ON NN Yo oN ON y 5 Trace 3 6 oM Y ¥ YoY oy on y¥ y 40 Mile 4 sR oY ON NY oy oY oN y 10 Moderate 5 7% Mo Y ¥ YoY oy oy oN y 33 ‘Trace 6 2M oN OY YoY N oN oN N 21 Mid 7 mF Y ON YoY Y oN oN y 54 None 5 6 Mo NY N oN Y¥ YON y 41 Severe 9 2% FON Y N oN Y oN ON N 39 Severe 10 6 oF YON NY Y oN ON y 35 ‘Trace Abbreviations: ACS = acute coronary syndrome, HTN = hypertension; CAD = coronary artery disease, PVD = peripheral vascular Gisease, LVEF = left ventricular ejection fraction ‘Table 3). There were no significant changes in heart was not a candidate for further coronary revasculariza- rate, pulse oximetry, or urine output. While there was tion, and was treated with intravenous antianginal agents no significant change in chest pain severity, the sever- with continued rest angina in the CCU, After two one- ity of dyspnea improved during FECP (p = 0.036). No. hour EECP treatments, the patient's angina appeared less EECP-related adverse events were recorded during or as frequent and less severe ({rom 8/10 down to 3/10), The consequence of EECP therapy, including no bleeding patient was discharged with the plan to continue EECP complications, no heart failure exacerbations, and no skin a8 an outpatient breakdown from the pneumatic cuffs Potential concerns stch as excessive noise from the air compressor units, ‘moving the TS3 device into the CCU rooms, or inter- ference with ongoing critical care nursing did not oceur during this study, ECP in Acute Myocardial Infarction Patient 2 was a 45-year-old man who presented with ‘an acute non-ST-elevation myocardial infarction. Urgent coronary angiography revealed critical stenoses of the BECP in Unstable Angina left main, left anterior descending, and right coro- nary arteries with thrombolysis in- myocardial infa Patient 4 was an S1-year-old woman hospitalized tion (TIMI) THT flow. He was referred for coronary with Braunwald class IB unsiable angina. Angiography artery bypass grafting, but the timing of surgery was showed occlusion of all native coronary arteries and all delayed due 1 the patient's clopidogrel exposure, He rafts from her two prior coronary bypass surgeries, She was admitted to the CCU where he developed recurrent Clinical Cardiology DOI:10.1002/cle226 Clin. Cardio. ‘Tame 2 BECP therapy Vol. 30, May 2007 Max EECP ECP Femoral _—_‘Femor uration pressure arterisl_-—venous-—_Device GP IBAA Antithrombotic Patient (hrs) (mmHg) __aceess_access_closure__Asprin Clopidogrel inhibitor medications 1 3 280 Recent 6F None Angioseal—Y y Y URH 2 2 280 Current 6F Current 8F «None y y UFH 3 3 280 Recent 6F Current 7F-Angioseal y y None 4 1 160 None None. == None y N LMWH 5 2 160 Current 6F Curent §F None = y Y UH 6 4 300 None Cuntent 7F_—None ON N N None 7 2 160 Recent 6F None Perclose = y Y None 8 2 160 Recent 8 —-None-~—=sNone = N N UFA 9 2 300 Recent $F None —None.= NY y N UEH 10 2 280 None None None N N UPR Abbreviations: GP UB/NA = glycoprotein IB/IIIA, UFH (enoxaparin). LMWH unfractionated heparin, L low molecular weight heparin ‘TaBLe 3 Hemodynamic and Clinical EMects during the first hour of EECP Pulse Mean arterial Heart Rate oximetry Urine output Chest severity Dyspnea severity pressure (img) (opm) saturation (%) efhour) (0-10 scale) (0-10 seale) Patient Prior During Prior During Prior During Prior During Prior During ‘Prior During 1 ee ee 3 0 ° 2 rn ee) 1 1 0 0 3 68 74107, 1B Ska 0 ° 4 2 4 Cn 5 0 0 5 7 77 689993028 nuh new Totub—Intub 6 4 60) 00979720100 ntu—Entub—Intub——Intub 1 so 9 BOK 0 0 5 4 8 no HRS DD ° 6 3 9 6 68] TS HSS a ° 7 3 lo 2 97 5 S79 HSS 0 2 1 Total 78416 85416" 8020 SIEI9 9642 9 4 4b 23 13421 11419 30429 16-4167 Abbreviations: Intub = intubated patient. * denotes paired test p-value <0.001 compared to baseline. + denotes paired test p-value =0.05 compared to baseline. angina. His angina improved after treatment with EECP therapy. Patient 5 was a 76-year-old man with history of three. vessel coronary artery disease and diabetes who under- went EECP in the CCU 16 h after right coronary artery stenting for acute inferior ST-segment elevation myocar dial infarction (Fig, 1). The patient remained in cardio- genic shock from extensive right ventricular infarction, and was hypotensive despite dopamine and dobutamine. ‘The patient did not receive an IABP dve to severe bilat- cal iliac artery tortuosity. He was discharged from the hospital on day 6, and did well at 8-month follow-up. ECP in Cardiogenic Shock Patient 6 was a 32-year-old man with nonischemi car~ diomyopathy with a left ventricular ejection fraction of 219, One day prior to enrollment, he underwent biven- tricular pacemaker defibrillator implantation, Shortly thereafter, he was intubated for pulmonary edema, He remained hypotensive with poor urine output despite treatment with intravenous furosemide, dopamine, dobu- tamine, and norepinephrine. He started EECP 16 h after intubation, and subsequently his urine output increased from 20 co/h to 100 cefh, beginning 30-min after initia tion of EECP. He was extubated 3 days later, but died two weeks later from a respiratory arrest, Patient 8 had low urine output (20 cofh) prior to EECP. This patient hhad cardiogenic shock from an ischemic cardiomyopa- thy and severe mitral regurgitation. This subject had no improvement in urine output during ECP. Patient 9 was a 28-year-old woman on intravenous milrinone and furosemide awaiting heart transplantation for dilated cardiomyopathy. She tolerated EECP well Clinical Cardiology DOL:10,1002/eleJ. Cohen et al: ECP for ACS and shock 227 100 nm Hg Fic. 2 Radial arterial tracing from patient 9 at baseline (a) and during enhanced external counterpulsation at a cuff inflation pressure of 300 mmHg (b). The patient is a 28-year-old woman on intravenous milrinone and furosemide who was awaiting heart transplantation for dilated cardiomyopathy. ‘with improvement in her hemodynamics (Fig. 2). She underwent orthotopic heart transplantation and was doing well at 9-month follow-up. Both patients with severe ‘mitral regurgitation reported an improvement in their rest «dyspnea during FECP. Discussion In current practice, FECP is limited to the outpa- tient management of refractory angina and heart fail- ture. EECP systems are essentially fixed in place and cannot routinely be transported. This pilot study demon- strated the safety and feasibility of a portable prototype BECP system to provide bedside treatment to critically ill CCU patients. Observations suggested that acute inpa- tient EECP therapy may improve cardiovascular perfor- mance and possibly clinical outcomes in patients with ACS andor cardiogenic shock, Research regarding the hemodynamic and clinical effects of external counterpulsation began in the 1960s using hydraulic-driven, water-filled compression cham- bers. Soro first applied extemal counterpulsation in man. Among 20 patients with cardiogenic shock treated with external counterpulsation, the mortality rate ‘of 65% was reported to be lower than historical rates for Tapp." Extemal counterpulsation prevented the hypotension caused by nitroprusside vasodilator therapy, provid. ing left ventricular systolic unloading pharmacologi- cally while maintaining coronary perfusion by external ccounterpulsation.!> In a multicenter study, 258 acute myocardial infaretion patients were randomized to exter: ‘nal counterpulsation within 24 h of presentation or usual care.!? External counterpulsation patients had a trend toward lower hospital mortality rate (8.4%) eom- pared with controls (14.7%; p = 0.12). Counterpulsation patients had lower rates of recurrent angin, heat failure, and ventricular fibrillation, ‘There were limitations of early external counterpulsa- tion devices?" The leg compression bags were not sufficiently powerful to provide effective systolic unload- ing. Studies of cardiac metabotism showed that IABP, decreased myocardial oxygen consumption, while exter- nal counterpulsation increased consumption, In studies ‘measuring coronary sinus blood flow during atrial pac- ing, early external counterpulsation devices had no acute beneficial metabolic or hemodynamic effeets,'6"7 ‘The modern pneumatic cuff EECP system augments intracoronary pressure and flow. Improving coronary perfusion pressure in addition to left ventricular systolic unloading makes EECP a potentially useful hemody. namic assist device. A recent trial showed that EECP was superior to medical therapy alone in stable outpa- tients with left ventricular systolic dysfunction, resulting in improved exercise tolerance, heart failure class, and quality of Tife."® In two of our patients with severe mitral regurgitation, patient-reported severity of dysp- nea improved during EECP. In this pilot study, we ‘observed no harmful effect from increased venous return in patients with heart failure. This study is limited by its small size and single- center design. As a safety and feasibility study, it was not designed to evaluate the efficacy of portable EECP com- pared to other treatments, We could not report changes in aortic and diastolic arterial pressure because six of the ten subjects had noninvasive measures of systemic pres- sure, The subjective measures of chest pain and dyspnea severity were aimed at assessing safety. 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Hust, M.D. Clinical Investigations EEOP for ACS Portable Enhanced External Counterpulsation for Acute Coronary Syndrome and Cardiogenie Shock: A Pilot Study JosHus Conn, M.D, WILLIAM GROSSMAN, MED, ANDREW. MicHAFLs, MiD- M.A AMI, PCI Stent and QT QT Dispersion and Prognosis after Coronary Stent Placement in Acute Dispersion Myocardial Infaretion Hiovast Uta, MD,, ToMostice Havasin, MID, KESTSUMURA, M.D., KA7Uakt Karta, MD, IOMICHI YosHIMARU, MLD., YASUNOR! NAKAYAMA, M.D, Miwon Yostvaia, MD. Prognosis, Effort Tolerance Submaximal Effort Tolerance as a Predictor of All-Cause Mortality in and Cardiac Rehabilitation Patients Undergoing Cardiac Rehabilitation PAUL FELERSTADT, MID, ANDREW Cit, BS., PAUL KUGHELD, M.D. ACS, Diabetes and Characteristics and In-hospital Mortality of Diabetics and Nondiabetics with In-Hospital Mortality ‘An Acute Coronary Syndrome; The GREECS Study Ciaistos Prrsavos, PHLD., M.D, Georoin KOURLABA, MSC., | Demtosrienes B. PaNaciotakos, PH.D., CHRISTODOULOS STEFANADIS, PHLD., M.D. Biomarkers in Ischemic and ‘Troponin, B-Type Natriuretic Peptides and Outcomes in Severe Heart Dilated Cardiomyopathies Failure: Differences Between Ischemic and Dilated Cardiomyopat \Wavne L. MILLER, M.D., PH.D, KaREN A. HARTMAN, BS.N., CCRC. Many F Bursrrr, PH.D,, orm C. Burner, JR. M.D, ALLAN S, JAFFE, M.D. (see inside for complete Table of Contents) May 2007 fualluailihtatluontlin teo7k | ras. TECHIES ae cove JENILEY]? | sentibo HERIPL Eso caves 2007] |acoumica