LEFT VENTRICULAR ASSIST
The current practice of intra-aortic balloon counterpulsation: results from the Benchmark Registry
James J. Ferguson, III, MD, FACC*,*,
Marc Cohen, MD, FACC ,
Robert J. Freedman, Jr, MD, FACC ,
Gregg W. Stone, MD, FACC ,
Michael F. Miller, PhD||,
Debra L. Joseph, BSN¶ and
E. Magnus Ohman, MD, FACC#
* Texas Heart Institute, Houston, Texas, USA
Hahnemann University Hospital, Philadelphia, Pennsylvania, USA
Tulane University Medical Center, New Orleans, Louisiana, USA
Cardiology Research Foundation, Washington, DC, USA
|| M. F. Miller Statistical Services, Langhorne, Pennsylvania, USA
¶ Datascope Corp., Fairfield, New Jersey, USA
# University of North Carolina, Chapel Hill, North Carolina, USA
Manuscript received May 22, 2001;
accepted July 23, 2001.
* Reprint requests and correspondence to: Dr. James J. Ferguson III, Texas Heart Institute Cardiology Research, MC1-191, 1101 Bates Street, Houston, Texas 77030 USA jferguson{at}heart.thi.tmc.edu
 |
Abstract
|
|---|
OBJECTIVES
This study presents clinical data from the first large registry of aortic counterpulsation, a computerized database that incorporates prospectively gathered data on indications for intra-aortic balloon counterpulsation (IABP) use, patient demographics, concomitant medication and in-hospital outcomes and complications.
BACKGROUND
The intra-aortic balloon pump (IABP) is widely used to provide circulatory support for patients experiencing hemodynamic instability due to myocardial infarction, cardiogenic shock, or in very high risk patients undergoing angioplasty or coronary artery bypass grafting.
METHODS
Between June 1996 and August 2000, 203 hospitals worldwide (90% U.S., 10% non-U.S.) collected 16,909 patient case records (68.8% men, 31.2% women; mean age 65.9 ± 11.7 years).
RESULTS
The most frequent indications for use of IABP were as follows: to provide hemodynamic support during or after cardiac catheterization (20.6%), cardiogenic shock (18.8%), weaning from cardiopulmonary bypass (16.1%), preoperative use in high risk patients (13.0%) and refractory unstable angina (12.3%). Major IABP complications (major limb ischemia, severe bleeding, balloon leak, death directly due to IABP insertion or failure) occurred in 2.6% of cases; in-hospital mortality was 21.2% (11.6% with the balloon in place). Female gender, high age and peripheral vascular disease were independent predictors of a serious complication.
CONCLUSIONS
This registry provides a useful tool for monitoring the evolving practice of IABP. In the modern-day practice of IABP, complication rates are generally low, although in-hospital mortality remains high. There is an increased risk of major complications in women, older patients and patients with peripheral vascular disease.
|
Abbreviations and Acronyms
| | AMI | = acute myocardial infarction | | BSA | = body surface area | | CABG | = coronary artery bypass graft | | IAB | = intra-aortic balloon | | IABP | = intra-aortic balloon pump | | LOS | = length of stay | | PVD | = peripheral vascular disease |
|
The intra-aortic balloon pump (IABP) is the most widely used of all circulatory assist devices today (1). The IABP was first employed 30 years ago as a treatment of last resort for a mortally ill patient suffering from cardiogenic shock (2,3). Today, this treatment modality is routinely used in a wide range of serious cardiovascular conditions, ranging from hemodynamic stabilization in patients suffering from complications of acute myocardial infarction (AMI) or cardiogenic shock, to very high risk patients undergoing angioplasty or coronary artery bypass grafting (CABG) (46).
As potential clinical applications of counterpulsation continue to expand, there is an increasing need to prospectively document the current clinical experience with IABP. No study has extensively documented the indications, clinical outcomes, patient hemodynamics, concomitant medications, complications, risk factors and insertion techniques associated with IABP. Therefore, a comprehensive, prospective, multicenter computerized database program was developed: the Benchmark Counterpulsation Outcomes Registry. The present report summarizes the development and implementation of the registry, and reviews cumulative data compiled from 17,540 IABP records from 16,909 patients between the initiation of data collection in June 1996 and August 2000.
 |
Methods
|
|---|
The Benchmark Counterpulsation Outcomes Registry was started in June 1996, initially included 22 contributing clinical centers, and presently includes 243 institutions in 18 countries. An independent steering committee (Appendix A) designed and implemented the investigator-initiated registry. Datascope Corp. (Fairfield, New Jersey) provided funding for the database, and the sites included in the registry were institutions that used intra-aortic balloons (IABs) manufactured by Datascope Corp. Patient populations included all patients in participating institutions who received IABP between June 1996 (or time of institution enrollment) and August 2000. Concomitant medications and procedures were left to the discretion of the treating physician.
Figure 1 outlines data handling within the registry. Participating sites were provided with a computer for entering data on all consecutive IABP cases. Database software (Lotus Notes platform) was custom-written so investigators could easily enter clinical data relating to indications of IABP, details of the balloon insertion, patient hemodynamics, concomitant medications, complications and in-hospital outcomes. Site data were forwarded via modem to a single registry storage location and handled on a central file server. Continuous updates, individual site data and registry information were available on-line at the participating sites. More complex data queries were performed by request at the central storage facility.

View larger version (22K):
[in this window]
[in a new window]
|
Figure 1 Data handling in the Benchmark Registry. Data from consecutive patients are collected at participating centers, entered into a computer on-site and subsequently transferred to a central storage facility. Individual site and overall registry data are available to the participants, as well as customized queries of the database.
|
|
Statistics.
Descriptive summaries included frequency and percent distributions for the categorical variables, and the sample mean, standard deviation, minimum, median and maximum for the quantitative assessments. Logistic regression methodology was used to study effects of demographic, medical history and preprocedure factors on the occurrence of a major IABP complication. A full model containing all selected factors was first obtained, then a reduced model was generated containing only those factors that individually tested as statistically significant (p 0.05) within the model. The reduced model also had to fit as well as the full model as measured by the reduction in the likelihood ratio chi-square statistic. All analyses were performed using SAS, version 8, using the Windows 98 operating system from an IBM-compatible PC.
End points.
We collected data on four primary end points: ischemia, bleeding, IABP failure and in-hospital mortality. Major limb ischemia was defined as a loss of pulse or sensation, or abnormal limb temperature or pallor, requiring surgical intervention. Minor ischemia was defined as decreased arterial flow as manifested by diminished pulse that resolves with balloon removal, and not resulting in any impairment of body function.
An association with hemodynamic compromise, required blood transfusion or surgical intervention defined severe bleeding. Nonsevere bleeding involved minor hematomas and oozing from puncture site, and did not require blood transfusion or surgical intervention. The IAB failure was defined as poor augmentation, inability to deploy or any IAB leak suggested by blood inside the catheter tubing, gas loss or catheter alarm. All-cause hospital mortality was defined as mortality occurring from any cause during IABP or after IABP. Mortality directly related to IABP was also tabulated. A secondary endpoint was major IAB-related complications, defined as any major limb ischemia, severe bleed, IAB leak or mortality directly attributed to IABP.
Registry validation.
In order to maximize the reliability of the registry from which these data were gathered, an external audit (data validation) of the Benchmark Registry was undertaken (StatTrade, Inc., Morrisville, Pennsylvania) that was sponsored by Datascope. Randomly selected database case histories from 21 hospitals with 2,339 patient records were audited and compared to actual local site records. The audit involved 485 (20.7%) records entered in 1999. Seventy items were checked from each record, resulting in an audit of 33,950 entries. Check-box items had at least a 95% accuracy (lower 95% confidence bound), and dates had at least a 90% accuracy. In addition, virtually all IABP cases were being reported by each participating hospital.
 |
Results
|
|---|
Clinical variables and indications.
Between June 1996 and September 2000, 16,909 individual IABP patients were enrolled in the database. Of the enrolled patients, 68.8% were male, 31.2% were female and the mean age was 65.9 years (Table 1). From the perspective of clinical history, 25.6% of patients had diabetes, 11.9% had peripheral vascular disease (PVD), 30.6% had experienced a prior myocardial infarction and 14.6% had undergone prior CABG surgery. In 15.4% of patients, the presenting symptoms involved the left main coronary artery, while 28.5% had triple-vessel disease. Some of the patients only underwent diagnostic catheterization procedures (9.3%) or percutaneous coronary intervention procedures (23.0%); the majority of procedures were surgical (60.7%; 89.4% of the surgical patients were undergoing CABG). Of the total 16,909 patients, 13,020 (77%) underwent cardiac catheterization and 4,833 (28.6%) underwent percutaneous coronary intervention. Of the 9,179 patients undergoing CABG surgery, 1,672 (18.2%) underwent CABG alone, 6,655 (72.5%) underwent diagnostic catheterization and CABG, and 852 (9.3%) underwent percutaneous coronary intervention and CABG.
The most frequent indication for use of IABP was to provide hemodynamic support during or after cardiac catheterization (20.6% of patients) (Table 2). Other common clinical indications included cardiogenic shock (18.8%), weaning from cardiopulmonary bypass (16.1%), refractory unstable angina (12.3%) and preoperative use in high risk patients (13.0%).
Balloon insertion.
Balloon insertions were performed in the catheterization laboratory or procedure room (63.0%), the operating room (24.0%), the intensive care unit (4.0%), the emergency department (0.2%) and other locations (8.8%). Patients received either 40 ml (77.3%), 34 ml (21.5%) or other size balloons (1.2%). Insertion technique involved a sheath in 79.7% of patients, and employed a 9.5F (78.4%) or an 8F catheter (21.6%; 8F devices have been available since June 1, 1997). The insertion was accomplished percutaneously in 95.4% of cases. The approach was right femoral (63.3%), left femoral (35.6%) or an alternate approach (1.1%). The mean duration of IABP in the overall registry cohort was 53 h (median = 41 h, most frequent time = 24 h, range from 5 min to 89 days).
In-hospital balloon-related complications.
The incidence of balloon-related complications in the overall registry cohort was low (Table 3). Major complications of balloon counterpulsation were defined as severe bleeding, major limb ischemia, balloon leak or in-hospital mortality related to IABP. A total of 2.6% of all patients experienced at least one major complication.
Limb ischemia (defined as reduced arterial flow as manifested by diminished pulse) occurred in 2.9% of cases, but major limb ischemia (loss of pulse, loss of sensation, abnormal limb temperature or pallor requiring surgical intervention, arterial repair or amputation) was reported in only 0.9% of patients. Balloon leak occurred in 1.0% of cases. The incidence of severe bleeding (bleeding at the balloon insertion site leading to hemodynamic compromise and requiring a transfusion or surgical intervention) was 0.8%. Of the balloon insertions, 2.6% were unsuccessful due to a balloon leak, poor inflation of a balloon, poor augmentation or difficulties associated with balloon insertion (Table 4). The incidence of in-hospital mortality related to IABP was 0.05%. Not surprisingly, overall in-hospital mortality in this seriously ill population was high (21.2%, 11.6% with the IAB in place). The mean length of stay (LOS) in this cohort was 14 days (median = 10 days, most frequent LOS = 7 days, range from 1 day to 384 days).
Multivariate logistic regression analysis was used to identify significant independent predictors of a major complication of IABP, including death related to IABP, major limb ischemia, severe bleeding or balloon leak. Of the 15 variables screened, only female gender, PVD, small body surface area (BSA) (<1.65 m2) and higher age ( 75 years) significantly increased the risk of a major complication. Table 5 identifies the risk factors in order by odds ratio.
 |
Discussion
|
|---|
The major finding of this study is that the incidence of major balloon-related complications is encouragingly low (2.8%). Advances such as percutaneous insertion and smaller-diameter catheters have considerably reduced the incidence of serious vascular complications (723). In addition, the incidence of unsuccessful IABP due to balloon leak, poor inflation, poor augmentation or insertion difficulty was extremely low (2.3%), and to our knowledge, no previous study has examined this issue.
Complications and risk factors.
The overall complication rates noted in this real-world observational experience compare favorably with other published observational experiences (Table 6) (2426). Both major limb ischemia (0.9%) and major bleeding (0.8%) are lower than in the previously reported experiences; this may be due to use of smaller catheters and advances in the use of heparin and glycoprotein inhibitors. Use of the IABP has been shown to reduce recurrent ischemia (24) and improve overall clinical outcomes (4). In the present study, the actual number of deaths attributable to IABP failure or insertion is approximately 5 in 10,000, with a low incidence of other balloon-related complications, suggesting that IABP is a low risk therapeutic option in a high risk patient cohort. In fact, previous studies report low balloon-related mortality, and there seems to be less balloon-related mortality over time (Table 6) (27).
Sheathless insertion techniques have not replaced the traditional insertion techniques, although this may change in the future. The Benchmark experience to date has only recently (since June 1997) included 8F devices, but usage rates of these smaller catheters are expected to increase as more centers seek to reduce access site injury.
Previous studies have implicated patient size, diabetes and PVD as major IABP risk factors, but have generally been small and retrospective in nature. Multivariate logistic regression (not stepwise) on the present data establish that female gender, PVD, BSA (<1.65 m2) and age ( 75 years) remain the four prominent, independent predictors of a serious IABP complication. These four high risk groups may become a focus of efforts to improve clinical outcomes and to reduce IABP complications.
Indications.
The American College of Cardiology/American Heart Association guideline indications for IABP use include preparation for angiography and revascularization in cardiogenic shock that has not quickly reversed, acute mitral regurgitation or ventricular septal defect, refractory post-MI angina, refractory ventricular arrhythmias with hemodynamic instability, hemodynamic instability, poor left ventricular function or recurrent ischemia (28). However, no study other than this one has examined indications for IABP use. The data from this registry suggest that the most frequent indication for IABP was to provide hemodynamic support in the catheterization laboratory, and the most frequent site of IAB insertion was in the catheterization laboratory. Thus, IABP appears to have been embraced as an adjunctive technique in patients undergoing invasive cardiac procedures. The mean duration of hemodynamic support was 53 h, verifying the use of IABP for short-term hemodynamic support. The IABP was also widely used in patients with cardiogenic shock and in patients undergoing high risk surgical procedures. Interestingly, although CABG is considered a primary indication for IABP use, only 13% of patients received an IABP because they were undergoing a CABG procedure (Table 2). However, of the patients who received an IABP, more than half underwent CABG even if it was not the primary indication.
Registry information.
The National Registry of Myocardial Infarction is an ongoing, prospective registry that provides a framework for this registry (29). The ongoing Benchmark Counterpulsation Outcomes Registry provides prospective data on all patients who receive IAB counterpulsation (IABP) support at over 243 hospitals in 18 countries. The database has considerable potential for examining current practice patterns, documenting outcome, and trending use and outcomes over time. For example, the impact of such advances as the recently released 8F balloon catheter system can be rigorously and prospectively evaluated through use of the IABC registry data. In addition, data from this registry will be used as a complement to standards based assessment (Appendix B).
Study limitations.
The limitations of the present study are those inherent in any large-scale retrospective observational registry. This is not a randomized trial; rather, it is a detailed description of ongoing and evolutionary clinical practice. Most of the data were collected prospectively, however, some were collected based on review of patient charts and records. The data have not been 100% validated, but in contrast to other large-scale observational registries, the Benchmark registry has gone to considerable effort to validate the data. Finally, given the large number of participating clinical institutions, there are site-to-site variations in personnel and resources allocated to the registry, individual practice patterns and patient populations.
Retrospective analyses of risk factors should be regarded with caution because there is not necessarily a cause and effect relationship with the risk factors associated with major complications. However, the data strongly suggest the need for greater care and clinical attention in treating patients who are small, female, have PVD or who are at least 75 years of age, in view of their increased risk for experiencing a major complication of IABP.
Summary.
In this analysis if 16,909 patients enrolled form June 1996 to August 2000, the incidence of major complications was relatively low (2.8%) as were incidences of unsuccessful IABP (2.3%). In addition, the most frequent indication for use of IABP was for hemodynamic support in the catheterization laboratory, while use of IABP during CABG procedures remained relatively low. Female gender, small BSA, high age and PVD were independent predictors of a serious complication of IABP. Appendix C
 |
Appendix A
|
|---|
Steering Committee.
James J. Ferguson III, MD (Chairman)
Texas Heart Institute, Houston, TX
Jan T. Christenson, MA, MD, PhD
Dept. of Cardiovascular and Thoracic Surgery University of Geneva Hospital, Geneva, Switzerland
Marc Cohen, MD
MCP Hahnemann University, Philadelphia, PA
Robert Freedman, Jr, MD
Freedman Memorial Cardiology Associates, Alexandria, LA
Christine Kopistansky, RN, BSN
MCP Hahneman University, Philadelphia, PA
Michael F. Miller, PhD
M.F. Miller Statistical Services, Langhorne, PA
E. Magnus Ohman, MD
University of North Carolina, Chapel Hill, NC
Ramachandra C. Reddy, MD
SUNY Health Science Center at Brooklyn, Brooklyn, NY
Gregg W. Stone, MD
Cardiovascular Research Foundation, New York, NY
Philip M. Urban, MD
The Cardiovascular Surgery Unit, Hospital de la Tour, Meyrin-Geneva, Switzerland
 |
Appendix B
|
|---|
The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has recently introduced the ORYXtm initiative to integrate performance measures into the accreditation process and establish a data-driven continuous survey to complement standards-based assessment. The JCAHO has accepted the Benchmark Counterpulsation Outcomes Registry as having met the initial criteria for inclusion in the ORYXtm initiative, which measures clinical performance as a part of the future accreditation process. A total of 8 Benchmark measures of clinical outcome have been accepted by the Joint Commission for accreditation purposes in connection with the ORYXtm initiative.
 |
Appendix C
|
|---|
Participating sites.
Australia (1 participant)
Alfred Hospital; Prahran, Victoria, Australia
Belgium (5 participants)
Centre Hospitalier Sart Tilman; Liege, Belgium
Clinique Universitaire; Yvoir, Belgium
Hopital de la Citadelle; Liege, Belgium
Universitair Ziekenhuis Antwerpen; Eilegem, Belgium
Universitair Ziekenhuis; Gent, Belgium
Brazil (1 participant)
Hospital Sao Mateus S/C Ltda.; Papicua, Forteleza, Brazil
Canada (11 participants)
Centre Hospitalier de la Vallee de lOutaouais; Hull, Quebec, Canada
CHUM-Campus Notre Dame; Montreal, Quebec, Canada
Foothills Provincial General; Calgary, Canada
Hopital St-Luc; Montreal, Quebec, Canada
Institut De Cardiologie De Montreal; Montreal, Canada
Kingston General Hospital; Kingston, Ontario, Canada
London Health Service University Campus-Windemer; London ON, Canada
London Health Services Victoria Campus-South St.; London ON, Canada
Royal University Hospital; Saskatoon, Saskatchewan, Canada
Sudbury Regional Hospital; Sudbury, Ontario, Canada
Vancouver Hospital & Health Sciences Center; Vancouver, British Columbia, Canada
Denmark (1 participant)
Skeijby Universitetshospital; Aarhus, Denmark
France (10 participants)
Centre Medico-Chirurgical PARLY II; France
CHR Rennes; France
CHU Bon Secours, METZ; METZ Cedex, France
CHU Michallon Grenoble; Grenoble, Cedex, France
CHU Toulouse Hopital Rangueil; Toulouse, France
Hopital de la Timone; Marseille, France
Hopital Louis Pradel; Bron, France
Hopital Pastuer; Nice, France
Hopital Saint Joseph; Marseille, France
Institut Jacques Cartier; Massy, France
Germany (15 participants)
Berufsgenossenschaftliche Kliniken Bergmannsheil Universitatsklinik; Bochum, Germany
Friedrich-Schiller-Universität Jena-Klinik für Innere Medizin 3-; Jena, Germany
Herzzentrum Frankfurt AG; Franfurt, Germany
Herzzentrum Lahr/Baden; Lahr, Germany
Kaiser Wilhelm-Krankenhaus; Duisburg, Germany
Klinikum der Phillipps-Universität Marburg/Lahn; Marburg, Germany
Klinikum Karlsburg Klinik für Anästhesiologie und Intensivmedizin; Karlsburg, Mecklenburg-Vorpommern, Germany
Klinikum Krefeld; Krefeld, Germany
Kreiskrankenhaus Vöklingen; Vöklingen, Germany
Medizinische Einrichtungen der RWTH; Aachen, Germany
Städtische Kliniken Dortmund Klinik für Thorax-, Herz- und Gefässchirurgie Prof. Dr. med. M.-J. Polonius; DORTMUND, Germany
Uniklinik Bonn; Bonn, Germany
Universitätsklinik Göttingen; Göttingen, Germany
University-Hospital Luebeck; Luebeck, Germany
University of Gießen; Gießen, Germany
Ireland (1 participant)
Mater Misecordiae Hospital; Dublin, Ireland
Italy (4 participants)
Centro Cuore Columbus; Milan, Italy
Ospedale Clinicizzato San Donato; San Donato Milanese, Italy
Ospedale di Mirano; Mirano (Venezia), Italy
Poliambulanza; Brescia, Italy
Netherlands (6 participants)
Academisch Ziekenhuis Masstricht; Maastricht, Netherlands
Academisch Ziekenhuis Vrije Universiteit; HV Amsterdam, Netherlands
Leids Universtaire Medische Centrum (LUMC); Za Leiden, Netherlands
Medische Centrum Alkmaar; JD ALKMAAR, Netherlands
Medische Spectrum Twente; JX ENSCHEDE, Netherlands
Weezenlanden Hospital; JW Zwolle., Netherlands
New Zealand (1 participant)
Green Lane Hospital; Epsom Auckland, New Zealand
Poland (1 participant)
Gornoslaskie Centrum; Poland
Scotland (1 participant)
Aberdeen Royal Infirmary; Aberdeen, Scotland
South Africa (2 participants)
Morningside Hospital; Johannesburg, South Africa
Union Hospital; Johannesburg, South Africa
Sweden (1 participant)
University Hospital; Lund, Sweden
Switzerland (2 participants)
Inselspital; Bern, Switzerland
La Tour Hospital; Meyrin, Geneva, Switzerland
United Kingdom (14 participants)
Bristol Royal Infirmary; Bristol, United Kingdom
Cardiothoracic Center Liverpool; Liverpool, United Kingdom
Freeman Hospital; Newcastle Upon Tyne, United Kingdom
Glenfield Hospital; Leicester, United Kingdom
Harefield; Harefield, United Kingdom
Hull Royal Infirmary; Hull, United Kingdom
Morriston; Swansea, United Kingdom
Nottingham City; Nottingham, United Kingdom
Royal Sussex County; Brighton East Sussex, United Kingdom
South Cleveland Hospital; Middlesborough, Cleveland, United Kingdom
The London Chest Hospital; London, United Kingdom
The Royal Brompton Hospital; London, United Kingdom
Walsgrave; Walsgrave, United Kingdom
Wythenshaw Hospital; Wythenshaw, Manchester, United Kingdom
United States (166 participants)
Alabama
(6 Participants)
Baptist Medical Center; Montgomery, AL
Carraway Methodist Med. Center; Birmingham, AL
Jackson Hospital and Clinic; Montgomery, AL
Shelby Medical Center; Alabaster, AL
South Baldwin Hospital; Foley, AL
University of Alabama Hospital; Birmingham, AL
Arkansas
(4 Participants)
Baptist Memorial Medical Ctr.; North Little Rock, AR
Northwest Medical Center; Springdale, AR
St. Vincent Infirmary-Med. Ctr.; Little Rock, AR
Univ. Hospital & Amb. Care Ctr.; Little Rock, AR
California
(10 Participants)
Downey Community Hospital; Downey, CA
Good Samaritan Hospital; Los Angeles, CA
Grossmont Hospital; La Mesa, CA
Holy Cross Medical Center; Mission Hills, CA
Kaweah Delta District Hospital; Visalia, CA
Long Beach Memorial Med. Ctr.; Long Beach, CA
Providence of St. Josephs Medical Center; Burbank, CA
Santa Barbara Cottage Hospital; Santa Barbara, CA
Sharp Memorial Hospital; San Diego, CA
St. Johns Regional Medical Ctr.; Oxnard, CA
Colorado
(2 Participants)
St. Anthony Hospital Central; Denver, CO
St. Marys Hospital and Med. Ctr.; Grand Junction, CO
Connecticut
(2 Participants)
Bridgeport Hospital; Bridgeport, CT
St. Vincents Medical Center; Bridgeport, CT
Florida
(15 Participants)
Broward General Medical Center; Ft. Lauderdale, FL
Charlotte Regional Med. Ctr.; Punta Gorda, FL
Columbia West Florida; Pensacola, FL
Florida Hospital-Orlando; Orlando, FL
Florida Medical Center; Ft. Lauderdale, FL
Largo Medical Center Hospital; Largo, FL
Lucerne Medical Center; Orlando, FL
Munroe Regional Medical Center; Ocala, FL
Naples Community Hospital; Naples, FL
North Ridge Medical Center; Ft. Lauderdale, FL
Sarasota Memorial Hospital; Sarasota, FL
Shands Hosp. at the Univ. of FL; Gainesville, FL
St. Josephs Hospital; Tampa, FL
Tallahassee Memorial Hospital; Tallahassee, FL
Veterans Affairs Medical Center; Gainesville, FL
Georgia
(2 Participants)
Atlanta Medical Center; Atlanta, GA
Medical Center of Central Georgia; Macon, GA
Hawaii
(1 Participant)
Kaiser Foundation Hospital; Honolulu, HI
Idaho
(1 Participant)
St. Alphonsus Regional Med. Ctr.; Boise, ID
Illinois
(14 Participants)
Bromenn Regional Medical Ctr.; Normal, IL
E H S Christ Hospital & Med. Ctr.; Oak Lawn, IL
Gottlieb Memorial Hospital; Melrose Park, IL
Illini Hospital; Silvis, IL
La Grange Memorial Hospital; La Grange, IL
Mercy Ctr. for Health Care Services; Aurora, IL
Methodist Med. Ctr. of Illinois; Peoria, IL
Mt. Sinai Hosp. Med. Center; Chicago, IL
Northwest Community Hospital; Arlington Heights, IL
Proctor Hospital; Peoria, IL
St. Francis Medical Center; Peoria, IL
St. Joseph Medical Center; Joliet, IL
Trinity Medical Center; Rock Island, IL
Westlake Community Hospital; Melrose Park, IL
Indiana
(3 Participants)
Bloomington Hospital; Bloomington, IN
Greater Lafayette Health Service, Inc.; Lafayette, IN
Witham Memorial Hospital; Lebanon, IN
Iowa
(5 Participants)
Allen Memorial Hospital; Waterloo, IA
Mercy Medical Center; Cedar Rapids, IA
Mercy Medical Center; Dubuque, IA
St. Lukes Methodist Hospital; Cedar Rapids, IA
Univ. of Iowa Hospitals; Iowa City, IA
Kansas
(1 Participant)
Hutchinson Community Hospital; Hutchinson, MN
Louisiana
(3 Participants)
Ochsner Foundation Hospital; New Orleans, LA
St. Frances Cabrini Hospital; Alexandria, LA
Terrebonne General Medical Ctr.; Houma, LA
Maine
(1 Participant)
Maine Medical Center; Portland, ME
Maryland
(1 Participant)
Washington Adventist Hospital; Takoma Park, MD
Massachusetts
(2 Participants)
New England Medical Center; Boston, MA
St. Elizabeths Medical Center; Brighton, MA
Michigan
(13 Participants)
Bronson Methodist Hospital; Kalamazoo, MI
Genesys Health Park; Grand Blanc, MI
Henry Ford Hospital; Detroit, MI
Ingham Regional; Lansing, MI
Mercy Hospital; Muskegon, MI
Mount Clemens General Hospital; Mt. Clemens, MI
Munson Medical Center; Traverse City, MI
Northern Michigan Hospital; Petoskey, MI
Sparrow Hospital; Lansing, MI
Spectrum Health Downtown; Grand Rapids, MI
St. Joseph Mercy Hospital; Ann Arbor, MI
St. Joseph Mercy Hospital; Pontiac, MI
William Beaumont Hosp. Royal Oak; Royal Oak, MI
Minnesota
(4 Participants)
Fairview Southdale Hospital; Minneapolis, MN
Fairview University Hospital; Minneapolis, MN
Hennepin County Med. Center; Minneapolis, MN
North Memorial Medical Center; Robbinsdale, MN
Mississippi
(1 Participant)
St. Dominic-Jackson Mem. Hosp.; Jackson, MS
Nebraska
(1 Participant)
Nebraska Health Systems-University; Omaha, NE
New Hampshire
(2 Participants)
Catholic Medical Center; Manchester, NH
Exeter Hospital; Exeter, NH
New Jersey
(7 Participants)
Cooper Hospital/Univ. Med. Ctr.; Camden, NJ
Hackensack Medical Center; Hackensack, NJ
Jersey Shore Medical Center; Neptune, NJ
Newark Beth Israel Med. Center; Newark, NJ
Our Lady of Lourdes Med. Ctr.; Camden, NJ
Passaic General; Passaic, NJ
St. Josephs Hosp. and Med. Center; Paterson, NJ
New Mexico
(1 Participant)
San Juan Regional Medical Ctr.; Farmington, NM
New York
(11 Participants)
Albany Medical Center Hospital; Albany, NY
Arnot-Ogden Medical Center; Elmira, NY
Beth Israel Medical Center; New York, NY
Buffalo General Hospital; Buffalo, NY
Long Island Jewish Med. Ctr.; New York, NY
Millard Fillmore Hospital; Buffalo, NY
St. Elizabeth Hospital; Utica, NY
St. Josephs Hospital Health Ctr.; Syracuse, NY
St. Peters Hospital; Albany, NY
University Hospital Brooklyn; Brooklyn, NY
Winthrop-University Hospital; Mineola, NY
North Carolina
(3 Participants)
Frye Regional Medical Center; Hickory, NC
Moore Regional Hospital; Pinehurst, NC
Wake County Medical Center; Raleigh, NC
Ohio
(8 Participants)
Lima Memorial Hospital; Lima, OH
Miami Valley Hospital; Dayton, OH
Northside Medical Center; Youngstown, OH
Ohio State Univ. Hospital; Columbus, OH
St. Ritas Medical Center; Lima, OH
St. Vincent Mercy Medical Center-Cardiac Cath. Lab; Toledo, OH
St. Vincent Mercy Medical Center-Perfusion; Toledo, OH
University Hospital; Cleveland, OH
Oklahoma
(4 Participants)
Integris Baptist Med. Ctr.; Oklahoma City, OK
Midwest City Regional Hospital; Midwest City, OK
St. Anthony Hospital; Oklahoma City, OK
St. Francis Hospital; Tulsa, OK
Pennsylvania
(9 Participants)
Altoona Hospital; Altoona, PA
Doylestown Hospital; Doylestown, PA
Hahnemann Univ. Hospital; Philadelphia, PA
Hamot Medical Center; Erie, PA
Lancaster General Hospital; Lancaster, PA
Medical College of PA Hospital; Philadelphia, PA
Robert Packer Hospital; Sayre, PA
St. Francis Medical Center; Pittsburgh, PA
UPMC Lee Regional; Johnstown, PA
Rhode Island
(1 Participant)
Miriam Hospital; Providence, RI
South Carolina
(3 Participants)
Carolinas Hosp. Syst./Florence; Florence, SC
Grand Strand General Hospital; Myrtle Beach, SC
Hilton Head Hospital; Hilton Head, SC
Tennessee
(3 Participants)
Erlanger Medical Center; Chattanooga, TN
Univ. of Tenn. Mem. Hospital; Knoxville, TN
Vanderbilt University Medical Center; Nashville, TN
Texas
(12 Participants)
Baptist Hospital Southeast Texas; Beaumont, TX
Bayshore Medical Center (PerStat Medical Systems); Clear Lake, TX
Columbia Medical Center West; El Paso, TX
Harris Methodist/H E B North; Bedford, TX
Heart Hospital of Austin; Austin, TX
Houston Northwest Medical Ctr.; Houston, TX
Mc Allen Heart Hospital; Mc Allen, TX
Medical City Dallas Hospital; Dallas, TX
Osteopathic Med. Ctr. of Texas; Ft. Worth, TX
Santa Rosa Northwest Hospital; San Antonio, TX
Seton Medical Center; Austin, TX
St. Lukes Episcopal Hospital; Houston, TX
Virginia
(3 Participants)
Henrico Doctors Hospital; Richmond, VA
Sentara Norfolk General Hosp.; Norfolk, VA
Southside Regional Medical Ctr.; Petersburg, VA
Washington
(1 Participant)
Providence Yakima Medical Center; Yakima, WA
West Virginia
(2 Participants)
Charleston Area Med. Ctr.-Gen. Div.; Charleston, WV
St. Marys Hospital; Huntington, WV
Wisconsin
(3 Participants)
Appleton Medical Center; Appleton, WI
Mercy Hospital of Janesville; Janesville, WI
St. Marys Medical Center; Racine, WI
Wyoming
(1 Participant)
Wyoming Medical Center; Casper, WY
 |
Acknowledgments
|
|---|
The authors thank Karen Staman for her editorial assistance.
 |
Footnotes
|
|---|
The Benchmark Registry and this analysis were supported by a grant from Datascope Corp., Fairfield, New Jersey.
 |
References
|
|---|
1. Mahaffey KW, Kruse KR, Ohman EM. Perspectives on the use of intra-aortic balloon counterpulsation in the 1990s. Topol EJ. Textbook of Interventional Cardiology. Update 21. Philadelphia, PA: WB Saunders; 1996. p. 303321
2. Bregman D, Casarella WJ. Percutaneous intraaortic balloon pumping: initial clinical experience. Ann Thorac Surg. 1980;29:153155[Abstract]
3. Subramanian VA, Goldstein JE, Sos JA, et al. Preliminary clinical experience with percutaneous intra-aortic balloon pumping. Circulation 1980;62 Suppl I:I1239.
4. Ohman EM, George BS, White CJ, et al. Use of aortic counterpulsation to improve sustained coronary artery patency during acute myocardial infarction. Circulation. 1994;90:792799[Abstract/Free Full Text]
5. Voudris V, Marco J, Morice M, et al. "High-risk" percutaneous transluminal coronary angioplasty with preventive intra-aortic balloon counterpulsation. Cathet Cardiovasc Diagn. 1990;19:160164[Medline]
6. Hochman JS, Boland J, Sleeper LA, et al. Current spectrum of cardiogenic shock and effect of early revascularization on mortality: results of an international registry. Circulation. 1995;91:873881[Abstract/Free Full Text]
7. Makhoul RG, Cole CW, McCann RI. Vascular complications of the intra-aortic balloon pump: an analysis of 436 patients. Am Surg. 1993;59:564568[Medline]
8. Barnett MG, Swartz MT, Peterson GJ, et al. Vascular complications from intra-aortic balloons: risk analysis. J Vasc Surg. 1994;19:8189[Medline]
9. Patel JJ, Kopistansky C, Boston B, et al. Prospective evaluation of complications associated with percutaneous intraaortic balloon counterpulsation. Am J Cardiol. 1995;76:12051207[CrossRef][Medline]
10. Cohen M, Dawson MS, Kopistansky C, McBride R. Sex and other predictors of intra-aortic balloon pump complications: prospective study of 1,119 consecutive patients. Am Heart J. 2000;139:282287[Medline]
11. Gottlieb SO, Brinker JA, Borkon AM, et al. Identification of patients at high risk for complications of intra-aortic balloon counterpulsation: a multivariate risk factor analysis. Am J Cardiol. 1984;53:11351139[CrossRef][Medline]
12. Alderman JD, Gabliani GI, McCabe CH, et al. Incidence and management of limb ischemia with percutaneous wire-guided intraaortic balloon catheters. J Am Coll Cardiol. 1987;9:524530[Abstract]
13. Iverson LIG, Herfindahl G, Ecker RR, et al. Vascular complications of intra-aortic balloon counterpulsation. Am J Surg. 1987;154:100103
14. Skillman JJ, Kim D, Baim DS. Vascular complications of percutaneous femoral cardiac interventions. Arch Surg. 1988;123:12071212[Abstract/Free Full Text]
15. Funk M, Gleason J, Foell D. Lower limb ischemia related to use of the intra-aortic balloon pump. Heart Lung. 1989;18:542552[Medline]
16. Miller JS, Dodson TF, Salam AA, Smith RB III. Vascular complications following intra-aortic balloon pump insertion. Am Surg. 1992;58:232238[Medline]
17. Eltchaninoff H, Dimas AP, Whitlow PL. Complications associated with percutaneous placement and use of intra-aortic balloon counterpulsation. Am J Cardiol. 1993;71:328332[CrossRef][Medline]
18. Nash IS, Lorell BH, Fishman RF, et al. A new technique for sheathless percutaneous intra-aortic balloon catheter insertion. Cathet Cardiovasc Diagn. 1991;23:5760[Medline]
19. Tatar H, Cicek S, Demirkilic U, et al. Vascular complications of intra-aortic balloon pumping: unsheathed versus sheathed insertion. Ann Thorac Surg. 1993;55:15181521[Abstract]
20. Gol MK, Bayazit M, Emir M, et al. Vascular complications related to percutaneous insertion of intra-aortic balloon pumps. Ann Thorac Surg. 1994;58:14761480[Abstract]
21. Colyer WR Jr, Moore JA, Burket MW, Cooper CJ. Intra-aortic balloon pump insertion after percutaneous revascularization in patients with severe peripheral vascular disease. Cathet Cardiovasc Diagn. 1997;42:16[Medline]
22. Kvilekval KHV, Mason RA, Newton GB, et al. Complications of percutaneous intra-aortic balloon pump use in patients with peripheral vascular disease. Arch Surg. 1991;126:62123
23. Winters KJ, Smith SC, Kopistansky C, et al. Reduction in ischemic vascular complications and balloon leak with a hydrophilic-coated intra-aortic balloon catheter. Cathet Cardiovasc Intervent. 1999;46:357362[CrossRef][Medline]
24. Stone GW, Marsalese D, Brodie BR, et al. A prospective, randomized evaluation of prophylactic intra-aortic balloon counterpulsation in high risk patients with acute myocardial infarction treated with primary angioplasty. Second Primary Angioplasty in Myocardial Infarction (PAMI-II) Trial Investigators. J Am Coll Cardiol. 1997;29:14591467[Abstract]
25. Arafa OE, Pedersen TH, Svennevig JL, et al. Vascular complications of the intra-aortic balloon pump in patients undergoing open heart operations: 15-year experience. Ann Thorac Surg. 1999;67:645651[Abstract/Free Full Text]
26. Busch T, Sirbu H, Zenker D, Dalichau H. Vascular complications related to intra-aortic balloon counterpulsation: an analysis of ten years experience. Thorac Cardiovasc Surg. 1997;45:5559[Medline]
27. Pi K, Block PC, Warner MG, Diethrich EB. Major determinants of survival and nonsurvival of intra-aortic balloon pumping. Am Heart J. 1995;130:849853[CrossRef][Medline]
28. Ryan TJ, Anderson JL, Antman EM, et al. ACC/AHA guidelines for the management of patients with acute myocardial infarction. J Am Coll Cardiol. 1996;28:13281419[CrossRef][Medline]
29. Rogers WJ, Canto JG, Lambrew CT, et al. Temporal trends in the treatment of over 1.5 million patients with myocardial infarction in the U.S. from 1990 through 1999: the National Registry of Myocardial Infarction 1, 2 and 3. J Am Coll Cardiol. 2000;36:20562063[Abstract/Free Full Text]
This article has been cited by other articles:

|
 |

|
 |
 
C. Kolyva, G. M. Pantalos, G. A. Giridharan, J. R. Pepper, and A. W. Khir
Discerning aortic waves during intra-aortic balloon pumping and their relation to benefits of counterpulsation in humans
J Appl Physiol,
November 1, 2009;
107(5):
1497 - 1503.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
C. A. den Uil, S. D.A. Valk, J. M. Cheng, A. P. Kappetein, A. J.J.C. Bogers, R. T. van Domburg, and M. L. Simoons
Prognosis of patients undergoing cardiac surgery and treated with intra-aortic balloon pump counterpulsation prior to surgery: a long-term follow-up study
Interactive CardioVascular and Thoracic Surgery,
August 1, 2009;
9(2):
227 - 231.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
C. Diez, R.-E. Silber, M. Wachner, M. Stiller, and H.-S. Hofmann
EuroSCORE directed intraaortic balloon pump placement in high-risk patients undergoing cardiac surgery - retrospective analysis of 267 patients
Interactive CardioVascular and Thoracic Surgery,
June 1, 2008;
7(3):
389 - 395.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
J. T Christenson, J. Sierra, J.-A. Romand, M. Licker, and A. Kalangos
Long Intraaortic Balloon Treatment Time Leads to More Vascular Complications
Asian Cardiovasc Thorac Ann,
October 1, 2007;
15(5):
408 - 412.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
E. Nikolsky, R. Mehran, G. Dangas, M. Fahy, Y. Na, S. J. Pocock, A. M. Lincoff, and G. W. Stone
Development and validation of a prognostic risk score for major bleeding in patients undergoing percutaneous coronary intervention via the femoral approach
Eur. Heart J.,
August 2, 2007;
28(16):
1936 - 1945.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
F. Onorati, L. Cristodoro, P. Mastroroberto, A. di Virgilio, A. Esposito, M. Bilotta, and A. Renzulli
Should We Discontinue Intraaortic Balloon During Cardioplegic Arrest? Splanchnic Function Results of a Prospective Randomized Trial
Ann. Thorac. Surg.,
December 1, 2005;
80(6):
2221 - 2228.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
M. B. Reid and D. Cottrell
Nursing Care of Patients Receiving: Intra-aortic Balloon Counterpulsation
Crit. Care Nurse,
October 1, 2005;
25(5):
40 - 49.
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
C. F. Azevedo, L. C. Amado, D. L. Kraitchman, B. L. Gerber, T. Edvardsen, N. F. Osman, C. E. Rochitte, K. C. Wu, and J. A.C. Lima
The effect of intra-aortic balloon counterpulsation on left ventricular functional recovery early after acute myocardial infarction: a randomized experimental magnetic resonance imaging study
Eur. Heart J.,
June 2, 2005;
26(12):
1235 - 1241.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
I. R. Ramnarine, A. D. Grayson, W. C. Dihmis, N. K. Mediratta, B. M. Fabri, and J. A.C. Chalmers
Timing of intra-aortic balloon pump support and 1-year survival
Eur. J. Cardiothorac. Surg.,
May 1, 2005;
27(5):
887 - 892.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
J. Mand'ak, V. Lonsky, J. Dominik, and P. Zacek
Vascular Complications of the Intra-aortic Balloon Counterpulsation
Angiology,
January 1, 2005;
56(1):
69 - 74.
[Abstract]
[PDF]
|
 |
|

|
 |

|
 |
 
P. Tozzi, A.F. Corno, L.V. Lapanashvili, and L.K. von Segesser
Muscular counterpulsation: preliminary results of a non-invasive alternative to intra-aortic balloon pump
Eur. J. Cardiothorac. Surg.,
October 1, 2004;
26(4):
726 - 729.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
H. Aydin, O. Kandemir, S. Gunaydin, and Y. Zorlutuna
A peeled off and entrapped intraaortic balloon catheter in the femoral artery: an unusual complication
Interactive CardioVascular and Thoracic Surgery,
June 1, 2004;
3(2):
314 - 316.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
G H Linley, E W Bakker, R de Vroege, and J J Spijkstra
When the blood-back detection system fails: an IABP case report
Perfusion,
December 1, 2003;
18(6):
369 - 371.
[Abstract]
[PDF]
|
 |
|

|
 |

|
 |
 
M. Cohen, P. Urban, J. T. Christenson, D. L. Joseph, R. J. Freedman Jr, M. F. Miller, E.M. Ohman, R. C. Reddy, G. W. Stone, J. J. Ferguson III, et al.
Intra-aortic balloon counterpulsation in US and non-US centres: results of the Benchmark(R) Registry
Eur. Heart J.,
October 1, 2003;
24(19):
1763 - 1770.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
E. W. Chen, J. G. Canto, L. S. Parsons, E. D. Peterson, K. A. Littrell, N. R. Every, C. M. Gibson, J. S. Hochman, E. M. Ohman, M. Cheeks, et al.
Relation Between Hospital Intra-Aortic Balloon Counterpulsation Volume and Mortality in Acute Myocardial Infarction Complicated by Cardiogenic Shock
Circulation,
August 26, 2003;
108(8):
951 - 957.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
A. W. Khir, S. Price, M. Y. Henein, K. H. Parker, and J. R. Pepper
Intra-aortic balloon pumping: effects on left ventricular diastolic function
Eur. J. Cardiothorac. Surg.,
August 1, 2003;
24(2):
277 - 282.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
G. W. Stone, E. M. Ohman, M. F. Miller, D. L. Joseph, J. T. Christenson, M. Cohen, P. M. Urban, R. C. Reddy, R. J. Freedman, K. L. Staman, et al.
Contemporary utilization and outcomes of intra-aortic balloon counterpulsation in acute myocardial infarction: The benchmark registry
J. Am. Coll. Cardiol.,
June 4, 2003;
41(11):
1940 - 1945.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
V. S. Mahadevan, D. McCarty, and A. A. J. Adgey
Platelet GPIIb/IIIa receptor blockers for failed thrombolysis in acute myocardial infarction, alone or as adjunct to other rescue therapies
Eur. Heart J.,
October 1, 2002;
23(19):
1490 - 1491.
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
J. T. Christenson, M. Cohen, J. J. Ferguson III, R. J. Freedman, M. F. Miller, E. M. Ohman, R. C. Reddy, G. W. Stone, and P. M. Urban
Trends in intraaortic balloon counterpulsation complications and outcomes in cardiac surgery
Ann. Thorac. Surg.,
October 1, 2002;
74(4):
1086 - 1090.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
P. Naughton and C. A. Bashour
Mechanical Support After Cardiac Surgery
Seminars in Cardiothoracic and Vascular Anesthesia,
September 1, 2002;
6(3):
237 - 257.
[Abstract]
[PDF]
|
 |
|

|
 |

|
 |
 
P. Menon, P. Totaro, A. Youhana, and V. Argano
Reduced vascular complication after IABP insertion using smaller sized catheter and sheathless technique
Eur. J. Cardiothorac. Surg.,
September 1, 2002;
22(3):
491 - 492.
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
Z. S. Meharwal and N. Trehan
Vascular complications of intra-aortic balloon insertion in patients undergoing coronary reavscularization: analysis of 911 cases
Eur. J. Cardiothorac. Surg.,
April 1, 2002;
21(4):
741 - 747.
[Abstract]
[Full Text]
[PDF]
|
 |
|
|