Originally published in Volume 43 Issue 6 of Artificial Organs, 23 April 2019
I graduated from Tufts University School of Medicine in 1966. During my student years, I had little academic exposure to the developing field of artificial organs. I was not even sure what the term “artificial organs” meant. Little did I anticipate that my future career would be intimately tied to the field of artificial organs.
The 1950s and 1960s ushered in the clinical application of artificial organ technology with renal dialysis, the heart lung machine, the defibrillator, the pacemaker, assisted circulation, and much more.1
My early years in medicine were spent in surgical training with Dr Adrian Kantrowitz. As a young physician I found these times very exciting. Those were the days of the pioneering implants of the mechanical auxiliary ventricle, the intra-aortic balloon pump (IAPB), and the first cardiac transplant done in the United States.2, 3
Dr Kantrowitz involved his clinical house staff in many of his research projects. I was a first-year surgical resident and my assignment was the IABP. One afternoon Dr Kantrowitz called me and said, “Steve, we’re ready for a clinical patient.” I explained the function of the IABP to my medical resident colleagues, and how it might salvage a patient with cardiogenic shock. At 4 AM my phone rang “Steve, we have a 48-year-old woman in cardiogenic shock, let’s try the pump you told us about.” As directed by Dr Kantrowitz, Drs. Tjonneland, Butner, and I inserted the first IABP. It functioned quite well, and the patient survived.2
Shortly after Christiaan Barnard performed his historic heart transplant in Cape Town, South Africa, Dr Kantrowitz performed the second transplant on a 3-week-old baby. The transplant was carried out in the middle of the night using my newborn son’s bassinette. Let me explain. A donor was found but all the stores were closed, and the only bassinettes available had been used in the animal lab. I rushed to the house staff quarters and commandeered my son’s bassinette (Figure 1).
Figure 1
Figure 2
The Vietnam War interrupted my surgical training. I spent 1968-1969 in Vietnam as a company surgeon with the 101st Airborne Division, and part of 1970 attached to the 5th Special Forces, Saigon. Figure 3 shows me holding a remnant of a 122 MM rocket that blew up my aid station, and in Figure 4, I was on a beach, near Hue City, with a surfboard. War was hell, but someone had to surf. I spent the remainder of 1970 stateside at the Walter Reed Army Institute of Research. I continued as a reservist until my retirement in 1993. I continued to participate in activities to support our veterans. I served on the Board of the Vietnam Memorial Reception Center, (the WALL) and on a congressionally mandated Department of Defense Wounded Warrior Recovering Task Force.6
Figure 3
Figure 4
Following discharge from active duty in 1970, I rejoined Dr Kantrowitz to complete my surgical training. During those years I was able to spend time in the research lab. One project, which was published in 1976,7 investigated the use of a catheter mounted artificial aortic valve to treat aortic valve insufficiency. I found it unfortunate that in 1976, no commercial entity expressed interest in developing a transcatheter aortic valve.
From 1972 to 1974, I trained in cardio-pulmonary surgery at the University of Oregon under Dr Albert Starr. Dr Starr, with engineer Lowell Edwards, co-invented a mechanical heart valve. In 1960, heart valve pioneer Dr Starr successfully implanted his ball cage valve in a patient with end stage mitral stenosis.8
In July of 1974, I moved my family to Des Moines, Iowa, to establish a cardiac surgical program. I was busy from the day I arrived. At my retirement in 1999, the practice had grown to 55 cardiac physicians staffing numerous cardiac centers in Iowa, South Dakota, and Idaho.
My primary goal in treating patients was to identify and treat the cause of a disease and not just the symptoms. Such was the case with acute myocardial infarction (AMI). Traditional medical thearpy for AMI treated only symptoms and sequelae, but not the occluded coronary artery. We initiated a program to treat acute coronary artery occlusion with emergency coronary artery bypass surgery, analogous to treating a gunshot wound of the abdomen or a ruptured abdominal aortic aneurysm. We demonstrated that acute and timely intervention during an evolving AMI salvaged myocardium, and significantly reduced morbidity and mortality.9 Timely percutaneous intervention for unstable coronary artery disease is now the established standard of care.
I integrated my interests with artificial organs into my clinical practice. In 1975, I implanted a “permanent” balloon pump in two patients. The pump was inserted retroperitoneally into the iliac artery and exteriorized the Dacron velour covered pneumatic drive line through the iliac crest. The bone minimized drive-line movement, and its vascularity resisted, in theory, ascending infection. Both patients were discharged home but returned as outpatients for IABP, as you would treat a dialysis patient. One died at 3 months from documented ventricular tachycardia, the second at 5 months from progressive heart failure and chronic obstructive pulmonary disease. At postmortem there was no evidence of driveline infection and both drivelines were solidly healed into the iliac crest.10 I learned to bring the driveline through the bone rather than through a soft tissue skin button from Dr William Dobell, who pioneered artificial vision technology. Dr Dobell’s team placed an electrode on a patients visual cortex which was then connected to an external, artificial eye. The visual cortex coaxial cable was exteriorized through the patients occipital bone. None of the exit sites became infected.11
Another project was with the Datascope Corporation to test a percutaneous IABP.12 Percutaneous insertion eliminated the need for surgical insertion and permitted the larger community of cardiologists to apply IABP technology.
I implanted a permanent pump of my own design in two patients in 1976. This Parallel Aortic Pump, or PAP,13 sandwiched a100cc bladder between a semi rigid outer and compressible, inner, vascular graft. The vascular graft/pump was anastomosed to the aorta just below the left subclavian artery then to the descending aorta at the diaphragm. The velour covered driveline was exited through the iliac crest. Using a modified IAPB console, the PAP bladder was pneumatically compressed during diastole and actively deflated during systole (Figure 5).
Figure 5
In 1983, I described the technology for percutaneous femoral-femoral bypass, or PBY.14 We designed the PBY for use by invasive cardiologists to support hemodynamically unstable patients undergoing procedures. This technically simple system used femoral-femoral veno-arterial pumping without an oxygenator. An oxygen saturation probe was placed on the left index finger of the patient so as not to flow desaturated venous blood retrograde beyond the left subclavian artery. We could usually achieve 1.5-2.5 L flow. If an IABP was previously implanted, pulsatility significantly augmented the hemodynamic support.15, 16 PBY was used to temporally support a patient during transport from the catherization laboratory to the cardiac operating room. Following publication14 of the PBY paper, and unknownst to me, the PBY design was commercialized. Lesson learned: patent your ideas!
In addition to our own devices, our team participated in numerous clinical trials of ventricular assist devices (VADs), the total artificial heart (Jarvik) and the innovative nonpulsatile Wampler Hemopump.17 The Hemopump was the precursor to many of our modern day VADs that use nonpulsatile flow to support circulation. As a testimony to the scientific acceptance of the “continuous flow” concept, I recently counted approximately 50 VAD designs in the literature, many of which have been commercialized.
In the mid-1980s, our research team designed a “disposable heart-lung machine.” It utilized an off-the-shelf oxygenator fitted with three disposable pumps.18 The concept was to have a portable, pre-primed heart-lung machine “in a box.” The system worked quite well in the animal laboratory, but like my prototype TAV and PBY, I did not have an industrial partner.
The book and movie, “The Hunt for Red October,” described a submarine with a top-secret, silent, magneto-hydrodynamic (MHD), propulsion system. MHD propels fluids with magnetic pulses. Our research team created a shoe box sized MHD propulsion unit (Figure 6) that increased blood flow in a mock circulation loop from 2 to 4 L/min. Approximately one month following publication, we were visited by representatives of the Department of Defense (DoD). They were curious as to how we were able to use MHD to propel blood when government scientists, after millions of dollars and nearly 15 years of research, could barely get it to work. We spent some time collaborating with the government scientists working at the DoD’s Argon Laboratory located near Chicago. My only comment was that the government MHD project expected to propel sea water from a static state of no flow, being hampered by inertia. Our MHD experiment was jump-started as we simply boosted the flow from 2 to 4 L/min. I was never made aware of the outcome of the government research and we discontinued our project due to lack of funding.
Figure 6
In the mid 1990s the Iowa Pork Producers funded a porcine to bovine cross species transplant research project. Following the removal and preservation of the piglet heart, its vascular system was flushed clear with saline. The calf’s blood was then circulated through the pig carcass to “biologically” filter out the calf’s preformed xeno-reactive antibodies. With 6 h of filtering the implanted piglet heart survived up to 10 h.19
The first American Society for Artificial Internal Organs (ASAIO) I attended was in 1967, in Atlantic City. I was a first-year surgical resident and was overwhelmed and awed to be in the company of those artificial organ pioneers. Little did I know that 25 years later I would be honored by being selected as the 1992 ASAIO president.
In 1996, my name was put forward as a candidate for the Commissioner of the FDA. I was not selected but welcomed and deeply appreciated the broad support I received from multiple sectors, including the ASAIO. In 1998, as the representative for ASAIO, I testified before the Committee on Commerce as a witness on the implementation of the Food and Drug Administration Modernization Act of 1997.20
In 1998, I retired from my active surgical practice after undergoing a third spine surgery within 5 years. I was strongly advised not to return to the operating room as I might spend my “golden years” in a wheelchair. In 1999, I took the position as Director of Research and Education at the National Library of Medicine (NLM), National Institutes of Health (NIH). While at the NLM, I remained an active member of the ASAIO History Group. This Group was a joint undertaking between ASAIO, NLM, and the Smithsonian Institute. I had the opportunity to support the group’s activities through the NIH grant process. I continued my new career at the NLM wearing various hats; and retired in late 2015.
The integration of artificial organs into clinical medicine has been successful in managing acute, chronic, debilitating, and fatal illnesses. The artificial heart, VADs, renal dialysis, the cardiac pacemaker, artificial joints, cochlear implants, and intraocular lenses have significantly improved the quality of and extended functional life. A next step for us is to achieve total implantability of selected, life sustaining artificial organs. The goal of total implantability can be achieved with the use of a nuclear power source.21
The 21st Century is emerging as the bio-molecular century. The progress with hybrid tissue scaffolding, 3-D tissue printing, nanotechnology, robotics, genetics, and artificial intelligence will result in quantum scientific advances and discoveries. We will grow organs using genetic cloning, stem cells and biohybrid technologies. Cell lines will be created to regenerate replacement parts. These discoveries will be led by scientists in collaboration with industry, government, academic health centers, and research institutes.
