CLASSICS IN THORACIC SURGERY
Origins of Intraaortic Balloon Pumping Adrian Kantrowitz, MD Wayne State University College of Medicine and Sinai Hospital, Detroit, Michigan
In 1968, the Journal of the American Medical Association published a paper on the “Initial clinical experience with intraaortic balloon pumping in cardiogenic shock,” which gave the results of the first clinical use of the procedure developed in our laboratory. For more than 2 years, our group was the only one using intraaortic
balloon pumping clinically. Later, intraaortic balloon pumping was used by others, and despite poor clinical salvage, the hemodynamic benefit was demonstrated convincingly. At the present time, approximately 70,000 balloon pump procedures are performed annually. (Ann Thorac Surg 1990;50:6724)
I
that the device would be occlusive in the aorta, and the use of carbon dioxide suggested that the shuttle gas was probably moved too slowly through the narrow catheter. At any rate, after their initial papers, neither group reported any further studies. By early 1967, we had enough experience in the experimental animal to show clearly the advantages of a nondistensible polyurethane balloon. The use of helium as the shuttle gas gave us sufficient transit speed to assure appropriate timing. Our experimental results in dogs were published in the Transactions of the American Society of Artificial Internal Organs early in 1967 [5]. We believed that the evidence was strong enough to warrant a clinical trial in a small number of carefully selected patients who were in cardiogenic shock, which at the time was almost always fatal. We then secured approval from the Medical Research Committee of Maimonides Hospital for the use of IABP in a limited number of human subjects. On June 29, 1967, we were called to examine a patient whose course is described in a 1968 article in the Journal of the American Medical Association [6]. (Follow-up data are given in reference [7].)The patient was a 45-year-old woman who was comatose, anuric, cold, and cyanotic; her blood pressure was unobtainable. The patient was clearly near death. We inserted the balloon pump and she was pumped for about 7 hours; her condition stabilized, and the pump was removed (Figs 1, 2). The patient recovered and was subsequently discharged from the hospital. Two other patients, however, did not fare that well. Both died; in 1 patient, we were unable to pass the balloon pump either from the femoral artery or from the axillary artery. If our results with the first patient had not been successful, I feel fairly certain that we would not have had much support for attempting this procedure in other patients at Maimonides Hospital. I do not believe that would have meant the end of IABP, but it certainly could have delayed it for some years. The editors of the Journal of the American Medical Association have my gratitude and respect for accepting our paper for publication despite the meager clinical experience with just 3 patients. By 1969, we received many inquiries from colleagues eager to try IABP. We thought that the only way to get il
ntraaortic balloon pumping (IABP)was a product of an endeavor begun more than three decades ago to explore first the concept and then the uses of diastolic augmentation. In 1951, I worked at Western Reserve University as a research fellow in the Department of Cardiovascular Physiology under the direction of Dr Carl Wiggers. My brother, Arthur, (then on the Cornell physics faculty and later at the AVCO Corporation) and I performed a series of experiments that demonstrated some of the principles of diastolic augmentation [l]. This eventually led to a cooperative effort between my research group at Maimonides Hospital in Brooklyn and the AVCO-Everett Research Laboratory in Massachusetts. We were trying to develop a permanent mechanical assist device that would provide diastolic augmentation for the relief of chronic left ventricular failure. In 1966, after several years of animal studies, we implanted such an avalvular pump into the aorta of 2 patients with chronic, terminal left ventricular failure. One patient survived only 24 hours; the second survived 11 days, then died of cerebral embolus [2]. However, in terms of hemodynamic support, the experience with this device was impressive. This experience also pointed to further problems that had to be overcome before a permanent left ventricular assist device could become a reality. We believed it was reasonable, and probably easier, to achieve a temporary assist device based on the principle of diastolic augmentation. Arthur and I had some differences as to how best to approach development of such a device. He decided that he preferred to work with a group at the Massachusetts General Hospital. I would continue to work independently with my group of engineering and surgical research associates at Maimonides Hospital. This resulted then in two parallel, but entirely separate, efforts. Moulopolous, Topaz, and Kolff [3] had reported on their early experiments with an intraaortic balloon pump in 1962. At about the same time, Clauss and his colleagues [4] reported on similar experiments. Both groups used a latex balloon (condom) on a small plastic catheter, driven with carbon dioxide. The use of a latex balloon ensured Address reprint requests to Dr Kantrowitz, Sinai Hospital, 6767 West Outer Dr,Detroit, MI 48235.
0 1990 by The Society of Thoracic Surgeons
0003-4975/90/$3.50
Ann Thorac Surg 1990;50:6724
CLASSICS KANTROWITZ INTRAAORTIC BALLOON PUMPING
Balloon Out A t 6124
9 o r R A Peak Pressure
rnrn Hg
'1
673
Fig 1 . Graph of physiologic data recorded during pumping (case 1). Note increase in venous oxygen (0,) percent saturation to normal levels after termination of pumping. (Low 12:30 PM value probably resulted from technical error.) Pumping rapidly restored urina y output, which had been zero for several hours. (Reprinted by permission from Journal of the American Medical Association 1968;203:13540. 0 1968, American Medical Association.)
60
t
5ot
0
t 4c L Venous O2 % Sat.
80-.
..I-
::[ 1
9
I
-u
_-i
10
II
12
Noon
I
2
3
4
5
6
/%/?7ponnpU/?7poff
clear-cut answer on the clinical usefulness of this device was to organize a cooperative trial in which a considerable number of patients could be treated under a common protocol. Cardiologists and surgeons responded enthusiastically to my invitation to discuss a multicenter trial. They came from nine hospital and university medical centers: Albany, Barnes, Baylor, Peter Bent Brigham, Cedar-Sinai, Cornell, Duke, St. Vincent's (New York), and State University of New York (Downstate). The study
7
CASE I K F JUNE 29,1967
participants prepared a common protocol and obtained approval from their respective institutional research committees. However, the members of the Maimonides Research Committee expressed doubt that the balloon pump really worked and vetoed the protocol. Maimonides was a community hospital. Its resources were already stressed by being the site of the first heart transplantation in the United States and of the first implantation of a permanent left ventricular assist device, Fig 2. Electrocardiogram (ECG), right radial artery pressure, and central aortic pressure from pressure transducer (case 1). A, Recorded during initiation of balloon pumping. 8, Recorded 15 minutes later. Component of radial artery pressure curve due to natural heart (1). Component due to balloon pumping (2). (Reprinted by permission from Journal of the American Medical Association 1968;203:13540. 0 1968, American Medical Association.)
674
CLASSICS KANTROWITZ INTRAAORTIC BALLOON PUMPING
both by our group. A yet more difficult atmosphere in the hospital was created by the Research Committee action on the IABP protocol. The Board of Trustees, in their wisdom, encouraged me to look for a more hospitable environment. In 1970, I left Brooklyn and came to Sinai Hospital of Detroit with our entire research group and a large portion of the surgical residency staff, 25 individuals in all. The John A. Hartford Foundation generously provided support for the cooperative study. Within a month, we started a clinical open heart surgery program and secured Research Committee approval to pursue, with the rest of the cooperating groups, further patient studies using IABP. Scheidt and co-workers [8] reported on the 87 patients treated in our cooperative study in the New England Journal of Medicine in 1973. About 2% years after our initial 1968 publication in the Journal of the American Medical Association, other groups began to report their early clinical experience. By that time, we had treated 30 patients with IABP [9]. At the April 1970 meeting of the American Society of Artificial Internal Organs, the group from the Albert Einstein College of Medicine described their use of a balloon pump in the treatment of 4 patients in cardiogenic shock. Only 1 patient survived [lo]. In May 1970, the Massachusetts General Hospital-AVCO group reported their results in treating their first 8 patients in cardiogenic shock with IABP. They also had only one survivor [ll].So, after 2% years of clinical experience with rather poor clinical results, it is not clear why the balloon pump effort just did not disappear. In retrospect, even though there was low salvage of patients in cardiogenic shock, the beneficial hemodynamic effects of IABP had been demonstrated convincingly and, therefore, it promised to be useful in other acute low-output left ventricular problems. Any new idea, if it is to succeed, requires the courage and depth of understanding of its inventor to pursue the thought to its conclusion. The least challenges in the development of IABP were solving the many technical problems. More formidable were the intrainstitutional political agendas and their obstructive consequences. That IABP was not aborted in its infancy is witness to the remarkable support to us from the National Institutes of Health, from the John A. Hartford Foundation, from many residency and research staff members, and from independent-minded colleagues and investigators in the cooperative study, all of whom participated in this excit-
Ann Thorac Surg 1990;50:672 4
ing adventure. Certainly in part because of their conviction, at the present time, some 23 years after the first clinical trials of IABP, there are approximately 70,000 such procedures performed annually. A more complete description of these and related events appeared in the March 1987 issue of the Transactions of the American Society of Artificial Internal Organs as an article in the Moment in History series [12].
References 1. Kantrowitz A, Kantrowitz A. Experimental augmentation of coronary flow by retardation of the arterial pressure pulse. Surgery 1953;34:678-87. 2. Kantrowitz A, Akutsu T, Chaptal P-A, Krakauer J, Kantrowitz A, Jones RT. A clinical experience with an implanted mechanical auxiliary ventricle. JAMA 1966;197525-9. 3. Moulopolous SD, Topaz W, Kolff WJ. Diastolic balloon pumping (with carbon dioxide) in aorta: mechanical assistance to failing circulation. Am Heart J 1962;63:669-75. 4. Clauss RH, Missier P, Reed GE, Tice D. Assisted circulation by counter-pulsation with an intraaortic balloon. Methods and effects. In: Digest, 15th Annual Conference on Engineering in Medicine and Biology. Chicago: Northwestern University 1962;4:44. 5. Schilt W, Freed PS, Khalil G, Kantrowitz A. Temporary non-surgical intraarterial cardiac assistance. Trans Am SOC Artif Intern Organs 1967;13:322-7. 6. Kantrowitz .4, Tjonneland S, Freed PS, Phillips SJ, Butner AN, Sherman JL Jr. Initial clinical experience with intraaortic balloon pumping in cardiogenic shock. JAMA 1968;203:135-40. 7. Kantrowitz A, Tjonneland S , Freed PS, Phillips SJ, Butner AN, Sherman JL Jr. Intraaortic balloon pumping [Letter]. JAMA 1968;203:988. 8. Scheidt S, Wilner G, Mueller H, et al. Intra-aortic balloon counterpulsation in cardiogenic shock. Report of a cooperative clinical trial. N Engl J Med 1973;288:979-84. 9. Kantrowitz A, Krakauer JS, Rosenbaum A, et al. Phase-shift balloon pumping in medically refractory cardiogenic shock: results in 27 patients. Arch Surg 1969;99:73943. 10. Bregman D, Kripke DC, Goetz RH. The effect of synchronous unidirectional intraaortic balloon pumping on hemodynamics and coronary blood flow in cardiogenic shock. Trans Am SOCArtif Intern Organs 1970;16:43946. 11. Buckley MJ, Leinbach RC, Kastor JA, et al. Hemodynamic evaluation of intraaortic balloon pumping in man. Circulation 1970;46(Suppl2):13&4. 12. Kantrowitz A. A moment in history: introduction of left ventricular assistance. Trans Am SOCArtif Intern Organs 1987;19:3947.
Origins of Intraaortic Balloon Pumping Adrian Kantrowitz, MD Wayne State University College of Medicine and Sinai Hospital, Detroit, Michigan
In 1968, the Journal of the American Medical Association published a paper on the “Initial clinical experience with intraaortic balloon pumping in cardiogenic shock,” which gave the results of the first clinical use of the procedure developed in our laboratory. For more than 2 years, our group was the only one using intraaortic
balloon pumping clinically. Later, intraaortic balloon pumping was used by others, and despite poor clinical salvage, the hemodynamic benefit was demonstrated convincingly. At the present time, approximately 70,000 balloon pump procedures are performed annually. (Ann Thorac Surg 1990;50:6724)
I
that the device would be occlusive in the aorta, and the use of carbon dioxide suggested that the shuttle gas was probably moved too slowly through the narrow catheter. At any rate, after their initial papers, neither group reported any further studies. By early 1967, we had enough experience in the experimental animal to show clearly the advantages of a nondistensible polyurethane balloon. The use of helium as the shuttle gas gave us sufficient transit speed to assure appropriate timing. Our experimental results in dogs were published in the Transactions of the American Society of Artificial Internal Organs early in 1967 [5]. We believed that the evidence was strong enough to warrant a clinical trial in a small number of carefully selected patients who were in cardiogenic shock, which at the time was almost always fatal. We then secured approval from the Medical Research Committee of Maimonides Hospital for the use of IABP in a limited number of human subjects. On June 29, 1967, we were called to examine a patient whose course is described in a 1968 article in the Journal of the American Medical Association [6]. (Follow-up data are given in reference [7].)The patient was a 45-year-old woman who was comatose, anuric, cold, and cyanotic; her blood pressure was unobtainable. The patient was clearly near death. We inserted the balloon pump and she was pumped for about 7 hours; her condition stabilized, and the pump was removed (Figs 1, 2). The patient recovered and was subsequently discharged from the hospital. Two other patients, however, did not fare that well. Both died; in 1 patient, we were unable to pass the balloon pump either from the femoral artery or from the axillary artery. If our results with the first patient had not been successful, I feel fairly certain that we would not have had much support for attempting this procedure in other patients at Maimonides Hospital. I do not believe that would have meant the end of IABP, but it certainly could have delayed it for some years. The editors of the Journal of the American Medical Association have my gratitude and respect for accepting our paper for publication despite the meager clinical experience with just 3 patients. By 1969, we received many inquiries from colleagues eager to try IABP. We thought that the only way to get il
ntraaortic balloon pumping (IABP)was a product of an endeavor begun more than three decades ago to explore first the concept and then the uses of diastolic augmentation. In 1951, I worked at Western Reserve University as a research fellow in the Department of Cardiovascular Physiology under the direction of Dr Carl Wiggers. My brother, Arthur, (then on the Cornell physics faculty and later at the AVCO Corporation) and I performed a series of experiments that demonstrated some of the principles of diastolic augmentation [l]. This eventually led to a cooperative effort between my research group at Maimonides Hospital in Brooklyn and the AVCO-Everett Research Laboratory in Massachusetts. We were trying to develop a permanent mechanical assist device that would provide diastolic augmentation for the relief of chronic left ventricular failure. In 1966, after several years of animal studies, we implanted such an avalvular pump into the aorta of 2 patients with chronic, terminal left ventricular failure. One patient survived only 24 hours; the second survived 11 days, then died of cerebral embolus [2]. However, in terms of hemodynamic support, the experience with this device was impressive. This experience also pointed to further problems that had to be overcome before a permanent left ventricular assist device could become a reality. We believed it was reasonable, and probably easier, to achieve a temporary assist device based on the principle of diastolic augmentation. Arthur and I had some differences as to how best to approach development of such a device. He decided that he preferred to work with a group at the Massachusetts General Hospital. I would continue to work independently with my group of engineering and surgical research associates at Maimonides Hospital. This resulted then in two parallel, but entirely separate, efforts. Moulopolous, Topaz, and Kolff [3] had reported on their early experiments with an intraaortic balloon pump in 1962. At about the same time, Clauss and his colleagues [4] reported on similar experiments. Both groups used a latex balloon (condom) on a small plastic catheter, driven with carbon dioxide. The use of a latex balloon ensured Address reprint requests to Dr Kantrowitz, Sinai Hospital, 6767 West Outer Dr,Detroit, MI 48235.
0 1990 by The Society of Thoracic Surgeons
0003-4975/90/$3.50
Ann Thorac Surg 1990;50:6724
CLASSICS KANTROWITZ INTRAAORTIC BALLOON PUMPING
Balloon Out A t 6124
9 o r R A Peak Pressure
rnrn Hg
'1
673
Fig 1 . Graph of physiologic data recorded during pumping (case 1). Note increase in venous oxygen (0,) percent saturation to normal levels after termination of pumping. (Low 12:30 PM value probably resulted from technical error.) Pumping rapidly restored urina y output, which had been zero for several hours. (Reprinted by permission from Journal of the American Medical Association 1968;203:13540. 0 1968, American Medical Association.)
60
t
5ot
0
t 4c L Venous O2 % Sat.
80-.
..I-
::[ 1
9
I
-u
_-i
10
II
12
Noon
I
2
3
4
5
6
/%/?7ponnpU/?7poff
clear-cut answer on the clinical usefulness of this device was to organize a cooperative trial in which a considerable number of patients could be treated under a common protocol. Cardiologists and surgeons responded enthusiastically to my invitation to discuss a multicenter trial. They came from nine hospital and university medical centers: Albany, Barnes, Baylor, Peter Bent Brigham, Cedar-Sinai, Cornell, Duke, St. Vincent's (New York), and State University of New York (Downstate). The study
7
CASE I K F JUNE 29,1967
participants prepared a common protocol and obtained approval from their respective institutional research committees. However, the members of the Maimonides Research Committee expressed doubt that the balloon pump really worked and vetoed the protocol. Maimonides was a community hospital. Its resources were already stressed by being the site of the first heart transplantation in the United States and of the first implantation of a permanent left ventricular assist device, Fig 2. Electrocardiogram (ECG), right radial artery pressure, and central aortic pressure from pressure transducer (case 1). A, Recorded during initiation of balloon pumping. 8, Recorded 15 minutes later. Component of radial artery pressure curve due to natural heart (1). Component due to balloon pumping (2). (Reprinted by permission from Journal of the American Medical Association 1968;203:13540. 0 1968, American Medical Association.)
674
CLASSICS KANTROWITZ INTRAAORTIC BALLOON PUMPING
both by our group. A yet more difficult atmosphere in the hospital was created by the Research Committee action on the IABP protocol. The Board of Trustees, in their wisdom, encouraged me to look for a more hospitable environment. In 1970, I left Brooklyn and came to Sinai Hospital of Detroit with our entire research group and a large portion of the surgical residency staff, 25 individuals in all. The John A. Hartford Foundation generously provided support for the cooperative study. Within a month, we started a clinical open heart surgery program and secured Research Committee approval to pursue, with the rest of the cooperating groups, further patient studies using IABP. Scheidt and co-workers [8] reported on the 87 patients treated in our cooperative study in the New England Journal of Medicine in 1973. About 2% years after our initial 1968 publication in the Journal of the American Medical Association, other groups began to report their early clinical experience. By that time, we had treated 30 patients with IABP [9]. At the April 1970 meeting of the American Society of Artificial Internal Organs, the group from the Albert Einstein College of Medicine described their use of a balloon pump in the treatment of 4 patients in cardiogenic shock. Only 1 patient survived [lo]. In May 1970, the Massachusetts General Hospital-AVCO group reported their results in treating their first 8 patients in cardiogenic shock with IABP. They also had only one survivor [ll].So, after 2% years of clinical experience with rather poor clinical results, it is not clear why the balloon pump effort just did not disappear. In retrospect, even though there was low salvage of patients in cardiogenic shock, the beneficial hemodynamic effects of IABP had been demonstrated convincingly and, therefore, it promised to be useful in other acute low-output left ventricular problems. Any new idea, if it is to succeed, requires the courage and depth of understanding of its inventor to pursue the thought to its conclusion. The least challenges in the development of IABP were solving the many technical problems. More formidable were the intrainstitutional political agendas and their obstructive consequences. That IABP was not aborted in its infancy is witness to the remarkable support to us from the National Institutes of Health, from the John A. Hartford Foundation, from many residency and research staff members, and from independent-minded colleagues and investigators in the cooperative study, all of whom participated in this excit-
Ann Thorac Surg 1990;50:672 4
ing adventure. Certainly in part because of their conviction, at the present time, some 23 years after the first clinical trials of IABP, there are approximately 70,000 such procedures performed annually. A more complete description of these and related events appeared in the March 1987 issue of the Transactions of the American Society of Artificial Internal Organs as an article in the Moment in History series [12].
References 1. Kantrowitz A, Kantrowitz A. Experimental augmentation of coronary flow by retardation of the arterial pressure pulse. Surgery 1953;34:678-87. 2. Kantrowitz A, Akutsu T, Chaptal P-A, Krakauer J, Kantrowitz A, Jones RT. A clinical experience with an implanted mechanical auxiliary ventricle. JAMA 1966;197525-9. 3. Moulopolous SD, Topaz W, Kolff WJ. Diastolic balloon pumping (with carbon dioxide) in aorta: mechanical assistance to failing circulation. Am Heart J 1962;63:669-75. 4. Clauss RH, Missier P, Reed GE, Tice D. Assisted circulation by counter-pulsation with an intraaortic balloon. Methods and effects. In: Digest, 15th Annual Conference on Engineering in Medicine and Biology. Chicago: Northwestern University 1962;4:44. 5. Schilt W, Freed PS, Khalil G, Kantrowitz A. Temporary non-surgical intraarterial cardiac assistance. Trans Am SOC Artif Intern Organs 1967;13:322-7. 6. Kantrowitz .4, Tjonneland S, Freed PS, Phillips SJ, Butner AN, Sherman JL Jr. Initial clinical experience with intraaortic balloon pumping in cardiogenic shock. JAMA 1968;203:135-40. 7. Kantrowitz A, Tjonneland S , Freed PS, Phillips SJ, Butner AN, Sherman JL Jr. Intraaortic balloon pumping [Letter]. JAMA 1968;203:988. 8. Scheidt S, Wilner G, Mueller H, et al. Intra-aortic balloon counterpulsation in cardiogenic shock. Report of a cooperative clinical trial. N Engl J Med 1973;288:979-84. 9. Kantrowitz A, Krakauer JS, Rosenbaum A, et al. Phase-shift balloon pumping in medically refractory cardiogenic shock: results in 27 patients. Arch Surg 1969;99:73943. 10. Bregman D, Kripke DC, Goetz RH. The effect of synchronous unidirectional intraaortic balloon pumping on hemodynamics and coronary blood flow in cardiogenic shock. Trans Am SOCArtif Intern Organs 1970;16:43946. 11. Buckley MJ, Leinbach RC, Kastor JA, et al. Hemodynamic evaluation of intraaortic balloon pumping in man. Circulation 1970;46(Suppl2):13&4. 12. Kantrowitz A. A moment in history: introduction of left ventricular assistance. Trans Am SOCArtif Intern Organs 1987;19:3947.
