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A Multidisciplinary Network To Save the Lives of Severe, Persistent Cardiogenic Shock Patients

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A Multidisciplinary Network To Save the Lives of Severe, Persistent Cardiogenic Shock Patients
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   2005;80:543-547  Ann Thorac Surg Arusoglu, Michiel Morshuis, Hendrik Milting, Gero Tenderich and Reiner Koerfer Aly El-Banayosy, Dagmar Cobaugh, Armin Zittermann, Lukasz Kitzner, Latif   Shock PatientsA Multidisciplinary Network To Save the Lives of Severe, Persistent Cardiogenic  http://ats.ctsnetjournals.org/cgi/content/full/80/2/543located on the World Wide Web at: The online version of this article, along with updated information and services, is Print ISSN: 0003-4975; eISSN: 1552-6259. Southern Thoracic Surgical Association. Copyright © 2005 by The Society of Thoracic Surgeons. is the official journal of The Society of Thoracic Surgeons and the The Annals of Thoracic Surgery  by on June 2, 2013 ats.ctsnetjournals.orgDownloaded from   A Multidisciplinary Network To Save the Lives ofSevere, Persistent Cardiogenic Shock Patients Aly El-Banayosy,  MD,  Dagmar Cobaugh,  MD,  Armin Zittermann,  PhD, Lukasz Kitzner,  MD,  Latif Arusoglu,  MD,  Michiel Morshuis,  MD,  Hendrik Milting,  PhD, Gero Tenderich,  MD,  and Reiner Koerfer,  MD Department of Cardiothoracic Surgery, Heart Center North-Rhine Westfalia, Ruhr University of Bochum, Bad Oeynhausen, Germany Background.  Severe, persistent cardiogenic shock isassociated with very high morbidity and lethality. Wetherefore tried to improve the outcome of these patientsusing a network between local hospitals and a special-ized heart center that has facilities for transplantationand ventricular assist device (VAD) implantation.  Methods.  Between 1998 and 2000, 50 patients, who werein cardiogenic shock (mean age 49 years, SD 14) despitehigh doses of at least three inotropic agents, were admit-ted to our specialized heart center. During the first 12hours, we tried to stabilize the patient’s condition, toreduce inotropic support agents, and to keep cardiacindex above 2.4 L · min  1 · m  2 . According to this strat-egy, patients were allocated to medical treatment only,emergency VAD therapy, urgent VAD implantation, orheart transplantation. To assess variables potentiallyinfluencing patients’ outcome, we performed univariateand multivariate analyses. Results.  Early in-hospital mortality was 36% and latemortalitywas10%.Overallsurvivalat1,6,and12monthsof follow-up was 70%, 56%, and 52%, respectively. Evenwhen the heart transplant patients were excluded, overall12-months survival after cardiogenic shock was still 50%.Higher age, and the absence of sinus rhythm were theonly independent risk factors for 12-month mortality. Conclusions.  Our data show that a network betweencardiology departments of local hospitals and specializedheart centers can be life-saving for severe, persistentcardiogenic shock patients.(Ann Thorac Surg 2005;80:543–7)© 2005 by The Society of Thoracic Surgeons A variety of cardiovascular conditions such as myo-cardial infarction, dilatative cardiomyopathy, andmyocarditis can lead to cardiogenic shock. According tothe SHOCK trial [1] , clinical criteria for cardiogenic shock  are a systolic blood pressure less than 90 mm Hg for 30minutes before inotropes/vasopressors, the requirementof vasopressors or intra-aortic balloon pumping to main-tain systolic blood pressure at 90 mm Hg or more,evidence of decreased organ perfusion, and heart rate of 60 beats per minutes or less. Hemodynamic criteria forcardiogenic shock are a pulmonary capillary wedge pres-sure of 15 mm Hg or more and a cardiac index of 2.2.L · min  1 · m  2 or less [1]. In earlier studies, unaccept- ably high morbidity and mortality rates of cardiogenicshock patients have been reported, irrespective of theetiology and despite advanced interventive measures[2–7]. Although the overall incidence of cardiogenicshock remains unchanged, mortality rates from this clin-ical entity appear to be declining [8, 9]. In the SHOCK trial, 1-year survival was 34% and 47%, respectively,depending on the strategy of emergency therapy [1].Usually, patients with acute cardiogenic shock aretransported to local hospitals. However, a significantpercentage of the patients remain in cardiogenic shock,despite therapy with inotropic support agents and intra-aortic balloon pumping (IABP). Therefore, these patients(designated severe, persistent cardiogenic shock pa-tients) often need a ventricular assist device (VAD) sys-tem and sometimes need heart transplantation to savethem. However, most local clinics do not have the possi-bility to implant VAD systems or to perform heart trans-plantation. Consequently, these patients usually die inthe local hospital. A network between cardiologists fromlocal hospitals and specialized heart centers with experi-ence in the management of severe, persistent cardiogenicshock patients including heart transplantation and VADprograms might improve the outcome of these patients.Since 1994, we have established a network at the HeartCenter Northrhine Westfalia, Germany, for further treat-ment and diagnosis of severe persistent cardiogenic shock patients [10]. The present investigation was aimed at eval- uating 1-year survival of the patients who were admitted toour hospital. Moreover, we assessed the impact of variablespotentially influencing patients’ outcome. Material and Methods  Multidisciplinary Network and Management Protocol Our network consists of 20 cardiologic clinics includingseveral university hospitals. All these other clinics haveheart failure programs and heart failure cardiologists by Accepted for publication March 7, 2005.Address reprint requests to Dr El-Banayosy, Department of Cardiotho-racic Surgery, Heart Center North-Rhine Westfalia, Ruhr University of Bochum, Georgstrasse 11, D-32545 Bad Oeynhausen, Germany; e-mail:abanayosy@hdz-nrw.de. © 2005 by The Society of Thoracic Surgeons 0003-4975/05/$30.00Published by Elsevier Inc doi:10.1016/j.athoracsur.2005.03.039      C     A     R     D     I     O     V     A     S     C     U     L     A     R  by on June 2, 2013 ats.ctsnetjournals.orgDownloaded from   themselves. Only severe, persistent cardiogenic shock patients who have already received multiple medicationsincluding high doses of at least three inotropic supportagents and several interventive measures are admitted tous (Fig 1). The severe, persistent cardiogenic shock pa- tients who are hemodynamically stable are transferred toour center by regular ambulance or helicopter. For thepatients who are hemodynamically unstable, however, amobile specialized mechanical circulatory support teamat our clinic is responsible for the transport of theseselected patients from the emergency hospital to ourspecialized center. The team consists of a cardiac sur-geon, an emergent interventional cardiologist, an inten-sivist, and a VAD coordinator.Severe, persistent cardiogenic shock patients needrapid intervention to restore adequate circulation. This isa key for successful management. The management atour specialized heart center includes an evaluation pro-tocol during the first 6 hours after admission and adecision-making protocol from 6 hours until 12 hoursafter admission. EVALUATION AND DECISION-MAKING PROTOCOL.  Directly afteradmission we try to stabilize the hemodynamics toachieve a cardiac index greater than 2.4L · min  1 · m  2  , a mean arterial pressure greater than60 mm Hg, and a urine output greater than 30 mL/h.This strategy is performed in two ways: First, weimplant IABP in all patients admitted without pump.Second, we try to modify inotropic support agents andvasoactive drugs. In the meantime, social history, andbrain, kidney, liver and gastrointestinal functions areassessed by routine clinical methods to evaluate thosepatients who are candidates for VAD therapy and forcardiac transplantation. Since all admitted patients are onvery high doses of inotropic support agents and vasoactivedrugs, our main effort is to reduce these high doses from 6hours until 12 hours after admission and to keep cardiacindex above 2.4 L · min  1 · m  2 . When this is not possible,an emergent VAD system is applied.  Patients From January 1998 to December 2000, 50 patients withsevere, persistent cardiogenic shock despite apparentlymaximal medical treatment were referred to our inten-sive care unit for further diagnoses and treatment. Noneof the patients died during transfer. Moreover, none of the patients has been rejected because of severity of illness. The patients’ mean age was 49 years (SD 14).Characteristics of that cohort are presented in Table 1.The majority of the patients were male (76%). In mostpatients, the etiology of cardiogenic shock was acutemyocardial infarction, followed by idiopathic dilatativecardiomyopathy, fulminate myocarditis, and ischemicdilated cardiomyopathy. Nineteen of the 22 patients withacute myocardial infarction have had an anterior wallinfarction. Fifteen of these 22 patients (68.2%) have hadrescue percutaneous transluminal coronary angioplasty(PTCA). Several patients had a history of concomitantchronic diseases such as hypertension, insulin-dependent diabetes mellitus, and stroke (Table 1). Somepatients have had previous concomitant cardiac proce-dures such as implantation of a defibrillator and cardiacsurgery. The vast majority of the patients needed emer-  Fig 1. Management protocol for severe, persistent cardiogenic shock patients. (  IABP  intra-aortic balloon pump;  VAD  ventricular assist device.) Table 1. Baseline Characteristics of the Patients Parameter Number PercentSexMale 38 76Female 12 24Etiology of cardiogenic shock Acute myocardial infarction 22 44Idiopathic dilatativecardiomyopathy12 24Fulminate myocarditis 9 18Ischemic dilated cardiomyopathy 7 14Concomitant diagnosesHistory of hypertension 12 24Insulin-dependent diabetesmellitus8 16Stroke 4 8Concomitant previous proceduresDefibrillator implantation 6 12Cardiac surgery 16 32Concomitant emergency proceduresCardiopulmonary resuscitation 4 8PTCA 15 30IABP 23 46CABG 8 16 Ventilatory support 43 86Continuous venovenoushemofiltration19 38 CABG    coronary artery bypass graft surgery; IABP    Intra-aorticballoon pump; PTCA    percutaneous transluminal coronaryangioplasty. 544  EL-BANAYOSY ET AL Ann Thorac SurgSEVERE CARDIOGENIC SHOCK 2005;80:543–7  C A R D I   O V A S  C U L  A R  by on June 2, 2013 ats.ctsnetjournals.orgDownloaded from   gency ventilatory support, nearly 50% required IABP,38% needed continuous venovenous hemofiltration, and16% depended on coronary artery bypass grafting. Fourpatients (8%) have already had cardiopulmonary resus-citation. Twenty-one patients (42%) were hemodynami-cally very unstable and needed the intervention of ourmechanical circulatory support team to secure the trans-port to our hospital. On admission, all patients were onhigh doses of at least three inotropic agents. Mean dosesof inotropic support agents were: adrenaline0.33   g · kg  1 · min  1 (SD 0.24   g · kg  1 · min  1 ), dopa-mine 8.8   g · kg  1 · min  1 (SD 5.5   g · kg  1 · min  1 ), do-butamine 8.6   g · kg  1 · min  1 (SD 4.2   g · kg  1 · min  1 ),and nor-adrenaline 0.25  g · kg  1 · min  1 (SD 0.34  g · kg  1 · min  1 ). Echocardiography of the patients re-vealed a mean left ventricular end diastolic diameter of 66 mm Hg (SD 12 mm Hg). Despite inotropic support,systolic arterial pressure was only 83 mm Hg (SD 13 mmHg), and mean arterial blood pressure was only 60 mmHg (SD 12 mm Hg) on admission. Left ventricular ejec-tion fraction was 24% (SD 13%), pulmonary artery pres-sure was 33 mm Hg (SD 11 mm Hg), pulmonary arterywedge pressure was 20 mm Hg (SD 7 mm Hg), andcardiac index was 2.6 L · min  1 · m  2 (SD 1.0L · min  1 · m  2 ).To assess variables potentially influencing patients’outcome, we performed univariate and multivariate anal-yses. Variables tested were as follows: absence of sinusrhythm on admission, sex, previous cardiac surgery, needfor cardiopulmonary resuscitation, renal replacementtherapy, left ventricular ejection fraction, pulmonary ar-tery pressure, left ventricular end diastolic diameter,pulmonary artery wedge pressure, cardiac index, percu-taneous cardiopulmonary bypass, etiology of cardiogenicshock, VAD therapy, acute myocardial infarction, insu-lin-dependent diabetes mellitus, hypertension, ventricu-lar tachycardia, IABP, mean arterial blood pressure onadmission, systolic arterial blood pressure, and ventila-tory support. Statistics Statistical evaluations were performed with the Statisti-cal Package for Social Sciences, version 11 (SPSS, Chi-cago, Illinois). Survival rates were calculated with theKaplan-Meier product-limit estimator. The log-rank testwas used to test for differences in survival rates of specificsubgroups. Associations of factors with long-term sur-vival were first tested in a univariate Cox regressionmodel. Every univariate variable showing marginal sig-nificance (  p  0.15) was then tested in a Cox multivariatemodel and removed stepwise if no significant influencewas proved. A  p  value less than 0.05 was consideredstatistically significant. Results The outcome of the patients is given in Figure 2. Accord- ing to our protocol and decision tree, we could classifyour patients into two groups. Group 1 (n    6) failed toshow improved hemodynamics with medical treatment.Therefore, patients received initial emergency VAD ther-apy. Four of these 6 patients died, while 2 patients couldbe transplanted later on. Group 2 (n  44) could initiallybe successfully stabilized with optimal medical treat-ment. Of these 44 patients, 9 patients died. Sixteenpatients could be weaned from inotropic support andrecovered from cardiogenic shock. They were dischargedat home. In 6 other patients who remained on low-doseinotropic support agents, heart transplantation becameavailable. Mean time until heart transplantation was 54  30 days (range, 26 to 94). Five of these 6 patients could bedischarged at home, and 1 patient died. Because hearttransplantation was initially not available, 13 patientswho could not be weaned from moderate inotropic sup-port received late urgent VAD therapy. Mean time until VAD implantation was 6  6 days (range, 1 to 21). Of the13 patients, 4 patients were transplanted later on, 5patients could be weaned later on, and 4 patients died.The VAD systems applied were Thoratec (Thoratec Inc,Pleasanton, CA) (n    6 LVAD; n    5 BiVAD), NovacorLVAS (World Heart Inc, Oakland, CA) (n    2), HeartMate 1 (Thoratec Inc) (n    2), and CardioWest TAH(SynCardia Systems Inc, Tucson AZ) (n  4). The criteriafor the selection of the type of the VAD system has beendescribed elsewhere [11, 12].Early in-hospital mortality was 36% (18 patients). Thecauses of death were multiple organ failure (16 patients)and mesenteric ischemia (2 patients). Sixteen patients(31%) with VAD implantation or heart transplantationand 16 patients (31%) with optimal medical treatmentsurvived their in-hospital stay (Fig 2). Late mortality rate after discharge, including after heart transplantation and VAD patients, was 10% (5 patients). The causes of latefollow-up deaths were cardiac failure (2 patients), pneu-monia (1 patient), renal failure (1 patient), and gastroin-testinal bleeding (1 patient). Overall survival at 1, 6, and12 months was 70%, 56%, and 52%, respectively (data notshown). Even when the heart transplant patients wereexcluded, survival rate at 12 months of follow-up was still50% (Fig 3). In a multivariate Cox proportional hazard analysis, ageand the absence of sinus rhythm were the only risk factors of 12-month mortality (Table 2). Our data dem-  Fig 2. Outcome of patients with severe, persistent cardiogenic shock.(  HTx  heart transplantation;  VAD  ventricular assist device.) 545 Ann Thorac Surg EL-BANAYOSY ET AL2005;80:543–7 SEVERE CARDIOGENIC SHOCK      C     A     R     D     I     O     V     A     S     C     U     L     A     R  by on June 2, 2013 ats.ctsnetjournals.orgDownloaded from   onstrate that the relative risk of death during 12 monthsof follow-up was approximately 2 times higher in theabsence of sinus rhythm, and increased by 7.1% witheach year of age. Comment Our multidisciplinary approach through a network in-cluding cardiologists and a specialized cardiac center wasbased on the assumption that such a network mightdecrease the fatal outcome of severe, persistent cardio-genic shock patients. In the present study, we coulddemonstrate that our approach indeed leads to the sur-vival of a significant number of patients with severepersistent cardiogenic shock. It should be mentioned thatthe status of this cohort was very precarious: On admis-sion, 46% of the patients required rescue IABP and 86%required ventilatory support. Moreover, 8% of the pa-tients needed reanimation and 16% needed percutane-ous cardiopulmonary bypass. Therefore, our data arevery encouraging. Our cohort of patients is not compa-rable with the patients of the SHOCK trial. One inclusioncriteria in that earlier study was a systolic blood pressureless than 90 mm Hg for 30 minutes before inotropes/vasopressors, or vasopressors or IAPB were required tomaintain systolic blood pressure at 90 mm Hg or higher[1]. In the patients of our study, however, systolic arterialblood pressure was only 83    13 mm Hg, although thepatients were on high doses of at least three inotropicsupport agents. Moreover, in the SHOCK trial all pa-tients of the revascularization treatment arm receivedemergency early PTCA/CABG, while in our study 68% of the patients with myocardial infarction needed rescuePTCA.In the SHOCK trial, overall survival at 1, 6, and 12months of follow-up was 53%, 50%, and 47%, respec-tively, in the emergency revascularization arm and 44%,37%, and 34%, respectively, in the initial medical stabili-zation arm [1, 13]. Compared with that earlier study, the overall survival at 1, 6, and 12 months in our study of 70%,56%, and 52% was excellent, given the precarious medi-cal status of our patients.One reason for the relatively low mortality of ourpatients is the possibility to perform VAD implantationsand heart transplantations at our heart center. Indeed, 11patients survived because of successful emergency orurgent VAD implantation and 11 patients survived be-cause heart transplantation became available (Fig 2). However, our data also demonstrate that the lives of 16patients could be saved with optimal medical treatmentonly. Obviously, we were able to accumulate a lot of experience through the network to successfully wean asignificant number of severe, persistent patients fromhigh inotropic support agents and to discharge them athome. We are planning to use our experience to teach thedoctors of the local hospitals to improve their medicaltreatment of severe, persistent cardiogenic shock pa-tients. Moreover, it is our strategy that only those severe,persistent cardiogenic shock patients are admitted to ourheart center, who presumably need VAD implantation orheart transplantation to rescue them.Cardiologists should use the possibility to send severe,persistent cardiogenic shock patients to a specializedcardiac center with VAD and heart transplantation facil-ities in order to improve the outcome of these patients.As early treatment is essential and sufficient time toobserve the patient and to make decisions about the besttherapeutic strategy is also important, the transport of severe, cardiogenic shock patients has to be performedvery rapidly and safely. A mobile specialized team withexperience in mechanical circulatory support should beresponsible for the transport of those patients to thespecialized center, who are hemodynamically very unsta-ble. In our opinion, an established network is an optimalguarantee for a successful therapy of severe, persistentcardiogenic shock patients and also for an optimal use of medical resources.In view of the disastrous condition of the patientsbefore transport, the survival rate of more than 50% 1year after the cardiogenic shock justifies the employmentof immense financial and staff resources. As expected,age was identified as a risk factor for mortality aftercardiogenic shock. Thus, our data demonstrate that theprocedure should be restricted to younger patients inwhom organ recovery is more likely. In Germany, forexample, approximately 12,000 patients less than 65 yearsof age died from cardiogenic shock due to myocardial  Fig 3. Overall 12-month survival of heart recipients and patientswithout heart transplantation. Table 2. Relative Risks and 95% Confidence Intervals (CI) for 12-Month Mortality According to Absence of Sinus Rhythm and Age  VariableRelative Risk [Exp (B)]95.0% CIfor Exp(B) SignificanceSinus rhythm (no) 3.18 1.127–8.95 0.029Age (per year) 1.071 1.024–1.12 0.003 Exp (B)  exponent of the B-coefficient. 546  EL-BANAYOSY ET AL Ann Thorac SurgSEVERE CARDIOGENIC SHOCK 2005;80:543–7  C A R D I   O V A S  C U L  A R  by on June 2, 2013 ats.ctsnetjournals.orgDownloaded from 
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