Chiostri, Marco

Gensini, Gian Franco

Giglioli, C.

Lazzeri, C.

Valente, S.

Zucchini, M.

English

Florence Research

Intra-aortic balloon pump in intensive cardiac care: A registry in FlorenceSerafina Valente ⁎, Chiara Lazzeri, Marco Chiostri, Mery Zucchini, Cristina Giglioli, Gian Franco GensiniDepartment of Heart and Vessels, Careggi Hospital Florence, Italya r t i c l e i n f oArticle history:Received 3 August 2010Accepted 23 October 2010Available online 19 November 2010The Intra-aortic Balloon Pump (IABP) is currently the mostcommonly used mechanical assist device to improve and supporthemodynamics in patients with cardiogenic shock; it is widely usedalso in high-risk patients undergoing percutaneous coronary inter-vention (PCI) or coronary artery bypass grafting (CABG) [1–9].However, the impact of IABP on prognosis is so far controversial [5,10].We assessed the in-hospital mortality and complications inpatients treated with IABP consecutively admitted to our IntensiveCardiac Care Unit (ICCU).From Jan. 1, 2005 to Dec. 31, 2008, 3500 patients were consecutivelyadmitted to our ICCU [11–13]. Among them, 414 (11.8%) underwent IABPduring their hospitalization and were prospectively enrolled in ourRegistry.Large ischemic risk area (LIRA)was defined as “ejection fraction lessthan 40% together with proximal occlusion of left descending anteriorcoronary artery associated or not with critical lesions in othercoronary arteries”. In these patients IABP was deployed after PCI.Patients were defined as “high risk” as if one ormore of the followingcriteria were present: ventricular ejection fraction (LVEF)<40%, killipclass 3, persistent malignant ventricular arrhythmias, acute mitralregurgitation and severe coronary artery disease (left main stem orthree vessel or vein graft disease).Major bleeding.Major bleeding was defined according to Replace 2[14]:Continuous data (Kolmogorov–Smirnov test ) were expressed asmean±SD, categorical data as frequencies and percentages. All datawere analysed by means of Fisher's exact test or Student's t test, whenappropriate. Variables resulted significantly different between sub-groups were entered as covariates in a backward stepwise logisticregression analysis. A p<0.05 was considered statistical significant(SPSS 13.0 statistical software; SPSS Inc., Chicago, ILL, USA).The mean age of patients in the study was 68.5±11.4 years; 69.6%were men. Hypertension was detectable in 51.4% (n=213), dyslipi-demia in 32.1% (n=133) and diabetes mellitus in 22.0% (n=91).About one fourth of patients (24.4%) showed prior myocardialinfarction and prior PCI in the 20.5%.Table 1 shows indications for IABP in our series. In the majority ofpatients (67.1%, n=278) IABP was the only device, while in theremaining (32.9%) it was associated to other devices. The device mostfrequently associated with IABP was mechanical ventilation (41.7%;invasive: 24.6%; non-invasive 17.1%). The continuous veno-venousrenal replacement therapy was used in 13.5% (n=56) of patients.Unfractioned heparin was used in 97.8% of patients. The majority ofpatients received dual antiplatelet therapy; acetylsalicylic acid(90.6%) and clopidogrel (83.8%). Therapy with glycoprotein IIb IIIainhibitors was administered in 59.7% of cases. Inotropic agents(epinephrine, norepinephrine, dopamine and dobutamine) wereused in 40.6% of patients, all with refractory cardiogenic shock.In our series, complications were 13.8% (57/414 patients) (Table 2).Thirtypatients (outof 57, 52.7.%) showed severebleeding, amongwhichhalf of patients exhibited unknown bleeding site while bleeding at theinsertion site occurred in 12 patients. The incidence of IABP-relatedcomplications did not differ betweenmales and females (10.6%@versus13.9% p=0.398). Patients who developed IABP-related complicationsshowed a higher median duration of the device (48 h; 25–75thpercentile 24–72 hversus 36 h;25–75thpercentile 24–48 h;p=0.007).In our population, 82 patients died (82/414:19.8%). Among patientswho died, IABP was implanted because of: cardiogenic shock in 59patients (72%), cardiac arrest in 8 patients (9.8%), periproceduralcomplications of PCI in 5 patients (6.1%), mechanical complication ofacute myocardial infarction in 4 patients (4.9%), large ischemic risk areain 3 patients (3.6%), acute pulmonary edema in 2 patients (2.4%) andbridge to CABG in 1 patient (1.2%).Among the 47 patientswhodeveloped IABP-related complications 22died; two deaths were due to IABP (intestinal ischemia in 1 patients and⁎ Corresponding author. Intensive Cardiac Care Unit, Heart and Vessels Department,Careggi Hospital, Viale Morgagni 85, 50134, Florence, Italy. Tel.: +39 055 794 7705;fax: +39 055 794 7706.E-mail address: seravalente@hotmail.com (S. Valente).Table 1IABP indications.Frequencies (%)Diagnosis IABP indicationSTEMI [latency<12 h](n=251 [60.6%])Large ischemic risk area 86 (34.3)Cardiogenic shock 73 (29.1)Hypotension 38 (15.1)Sudden death/VF 15 (6.0)In the caht lab 4 (26.7)Outside the cath lab 11 (73.3)PCI failure 14 (5.6)Acute pulmonary edema 11 (4.4)Mechanical complications 10 (4.0)Mitral regurgitation 6VSD 4Peri-procedural complications 2 (0.8)Pre-operative support 2 (0.8)STEMI [latency>12 h](n=38 [9.2%])Cardiogenic shock 16 (42.1)Large ischemic risk area 7 (18.4)Mechanical complications 6 (15.8)Mitral regurgitation 1VSD 5Hypotension 5 (13.2)Acute pulmonary edema 3 (7.9)Others 1UA/NSTEMI(n=109 [26.3%])Severe coronary arterydisease in high-risk patients28 (25.7)Hypotension 20 (18.3)Cardiogenic shock 16 (14.7)Peri-procedural complications 15 (13.8)Acute pulmonary edema 12 (11.0)Pre-operative support 10 (9.2)Sudden death/VF 8 (7.3)In the caht lab 4Outside the cath lab 4CHD with CABGindication (n=9 [2.2%])Election procedure 3 (33.3)Cardiogenic shock 3 (33.3)Refractory angina 2 (22.2)Peri-procedural complications 1 (11.1)Pulmonary embolism(n=5 [1.2%])Other (n=2 [0.5%])Cardiogenic shock 5 (100.0)STEMI: ST elevation myocardial infarction; VF: ventricular fibrillation; PCI:percutaneous coronary intervention; UA: unstable angina; NSTEMI: non ST elevationmyocardial infarction; VSD: ventricular septal defect; CHD: coronary heart disease.238 Letters to the EditorTable 2IABP complications.Complications (total) 57/414(13.8%)Strictly related to IABP Severe bleeding 30 (52.7%)Non specific site (acute anemia) 15 (50.0%)Bleeding at the insertion site 12 (40.0%)Retro-peritoneal hematoma 3 (10.0)Limb ischemia 10 (17.5%)Sistemic embolization (renal/mesentericinfarct)4 (7.0%)Pseudo aneurysm of femoral artery 3 (5.3%)Not strictly related toIABPGastrointestinal and urinary bleeding 10 (17.5%)severe bleeding associated with retroperitoneal hematoma in 1 patient).In ourpopulationoverall strictly IABP-relatedmortalitywas0.5% (2/414).At backward logistic regression analysis the following variableswereindependent predictors for in-ICCUmortality: killip class (OR 1.86; 95%CI 1.41–2.46; p<0.001); age (OR 1.04; 95%CI 1.01–1.08; p=0.018);aPTT max (OR 1.007; 95%CI 1.001–1.013; p=0.015); eGFR (OR 0.98;95%CI 0.96–0.99; p=0.037) and admission glycemia (OR 2.07; 95%CI1.39–3.07; p<0.001). Hosmer–Lemeshow test: 2.996; p=0.935.At backward logistic regression analysis the following variablesresulted as independent predictor for IABP-related complications(when adjusted for age and admission systolic blood pressure, andIABP duration): aPTT max (OR 1.008; 95%CI 1.002–1.013; p=0.010);admission glycemia (OR 1.68; 95%CI 1.21–2.34; p=0.002); minimumplatelet count (OR 0.991; 95%CI 0.985–0.997; p=0.005). Hosmer–Lemeshow test: 8.23; p=0.412.The main findings of our Registry are as follows: a) in our clinicalpractice the most frequent indications for IABP implantation are notincluded in guidelines; b) the incidence of “strictly IABP-related”mortality and complications are low and c) clinicians should carefullymonitor anticoagulation, since aPTT max is an independent predictorfor IABP-related complications.In our institution, the most frequent indication for IABP implanta-tion is represented by large ischemic risk area in STEMI patientstreated with primary PCI. So far, this indication is supportedmainly byexperimental data [15,16]. In a randomized experimental study,Azevedo et al. [16] demonstrated that IABP counterpulsation improvesthe time course of recovery of LV systolic function after reperfusedAMI. Using both tagged and contrast enhanced magnetic resonanceimaging, the Authors demonstrated that this beneficial effect is mainlydue to an acceleration of the functional recovery of non-infarcted,stunnedmyocardial regions. A series of 116 subjects at a single center,following successful PCI for anterior AMI and total occlusion receivedeither conventional treatment or an IABP. Those subjectswhohad IABPafter successful PTCA had lower rates of reinfarction (0/48) withrespect to patientswithout IABP 1/42 [17]. In our investigation, thoughour study design does not allowus to drawany conclusions in regard tobenefits (since the lack of randomization), IABP implantation inpatients with large ischemic risk area is safe since the incidence ofcomplications in this subgroup is low as well as its mortality.The most frequent and feared complication is represented bymajor bleeding and aPTT max resulted an independent predictor forIABP-related complications, thus underlining the importance of aclose monitoring of anticoagulation in these patients.In our series, the incidence of IABP-related complications is higherthan that reported in the Benchmark Registry [3], mainly because ofthe different definitions of severe bleeding and different inclusioncriteria for complication. [18–20].In our daily current practice, indications for IABP implantation arenot strictly those reported in guidelines. 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Intra-aorticballoon counterpulsation: variations in use and complications. Int J Cardiol 2004;94:255–9.[21] Coats AJ. Ethical authorship and publishing. Int J Cardiol 2009;131:149–50.0167-5273/$ – see front matter © 2010 Elsevier Ireland Ltd. All rights reserved.doi:10.1016/j.ijcard.2010.10.044239Letters to the Editor

Intra-aortic balloon pump in intensive cardiac care: a registry in Florence

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Intra-aortic balloon pump in intensive cardiac care: a registry in Florence

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