Louis E. Samuels
Louis E. Samuels Division of Cardiothoracic Surgery, Department of Surgery, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.
Louis E. Samuels was born and raised in New York, attending the U. of Rochester where he received his undergraduate degree in Biology and Anthropology. He moved to Philadelphia attending Hahnemann University for Medical School. Dr. Samuels did his General Surgery and Cardiothoracic Surgery Residencies at Hahnemann Hospital, and in 1995 he became full-time faculty at Hahnemann. Dr. Samuels was appointed Director of Cardiac Transplantation and Mechanical Circulatory Support in 1999, and in 2001, he and his team performed the world’s fifth totally implantable electric artificial heart. In 2013, Dr. Samuels was recruited to the Main Line Health System and established a heart transplant and Mechanical Circulatory Support Program at Lankenau Medical Center. He was recruited back to Philadelphia in 2016 where he became Professor of Surgery at Thomas Jefferson University. At present, Dr. Samuels is the Chief of Cardiac Surgery for the Jefferson-Einstein Medical Center in North Philadelphia.
Abstract: The quest to replace the natural heart with an artificial one as a permanent system is among the remaining holy grails in medicine and surgery. Beginning in 1969, when the first total artificial heart (TAH) was implanted into a human, to the present, several types have been developed—the AbioCor was among them. On November 5th, 2001, our team at Hahnemann University Hospital in Philadelphia, Pennsylvania placed the world’s fifth AbioCor. Excerpts of that moment in time were recorded and serve as a memorial to the past and a testimony to the present and future quest of this elusive holy grail.
It was on November 5, 2001, that the team at Hahnemann University Hospital in Philadelphia, PA, placed the world’s fifth totally implantable electric artificial heart, the AbioCor (Abiomed, Inc., Danvers, MA). It was a journey like none other in my career, chronicled in a daily log that captured the moments in real time. We felt that this new technology was going to change the world and that we had finally developed a human heart replacement that would make cardiac transplantation obsolete. This sentiment was expressed in a news clip from ABC News Business Now in which David Lederman and Robert Kung, the President, and Chief Engineer of Abiomed, respectively, described their device in the context of the heart failure epidemic. Although far from the first to replace a natural heart with a synthetic one, everything about my participation in this trial seemed as though we were still navigating unchartered space. This article describes portions of the experience we encountered and concludes with the reality that we are still exploring.
Sitting on my office shelf is a book that summarizes an artificial heart conference that took place in Washington, DC, from June 9–13, 1969 (Figure 1A)—I was 8 years old when this book was published. It was given to me by the Chairman of Cardiothoracic Surgery at Hahnemann University Hospital (Dr. Stanley Brockman) under whom I trained from 1992 to 1995. Although not a transplant or artificial heart surgeon in his own right, Dr. Brockman was among those from the generation of surgeons who were. Various milestones occurred in 1969. As a native New Yorker, the Jets won the Superbowl on January 12 with Joe Namath under center; On October 16, the Mets won the World Series with Tom Seaver on the mound; and from August 15 to August 18, the Woodstock music festival was held in the town of Bethel amidst the Catskill mountains. In the background, far from home, was the Viet Nam War. Even further from home was the lunar landing on July 20, but on April 4, 1969, the first total artificial heart (TAH) was placed into a human by Dr. Denton Cooley in Houston at the Texas Heart Institute. This event, as historic as it was, set into motion a 40-year feud between the two “Titans of Texas” as described by Dr. Coselli in his editorial.1 In summary, 1969 was a year of some small steps and some giant leaps.
FIGURE 1 (A) Artificial Heart Program Conference. National Heart Institute. Artificial Heart Program. Frank W. Hastings, M.D. Chief. Lowell T. Harmison, Ph.D., Assistant Chief. Proceedings. Washington, DC, June 9–13, 1969. Edited by Ruth Johnsson Hegyeli, M.D. For sale by the Superintendent of Documents, US Government Printing Office, Washington, DC 20402—Price $10.00. (B) Chapter 79, Page 938: Energy transmission through the intact skin. L Heimlich and F. Christiansen. Biomedical Systems Department, Hamilton Standard, Division of United Aircraft, Farmington, CT and T. Sato, Yale University, New Haven, CT. Artificial Heart Program Conference. [Colour figure can be viewed at wileyonlinelibrary.com]
The 1969 artificial heart conference was sponsored by the US Department of Health, Education, and Welfare (a Public Health Service of the National Institutes of Health) and made possible by the efforts of Dr. Frank W. Hastings who was appointed head of the US Government’s artificial heart program in 1964. The New York Times obituary had this (among other things) to say about Dr. Hastings:
Dr. Hastings, who was trained as a surgeon, had made significant contributions of his own to the development of artificial hearts and other man-made internal organs as well as synthetic replacements for bone, tendon, and skin.
(original context from March 17, 1971, Page 48)
A casual look through this book is daunting—the table of contents (Table 1) and pages filled with highly technical descriptions of work done on benches and animal laboratories all over the country: Ohio, Pennsylvania, Michigan, California, Virginia, Massachusetts, New Jersey, Maryland, North Carolina, Florida, Vermont, New York, Illinois, Minnesota, Colorado, Texas, Mississippi, Washington, Connecticut, Indiana, and Utah. A deeper analysis of its contents is profound and yes, intimidating, with research done by the same kind of minds that constituted NASA. In addition to the many University bioengineering laboratories, numerous partnering corporations were involved in the pursuit of a total heart replacement system (Table 2).
The illustrations, figures, and images in this 92-chapter collection represented the state of the art as it existed in 1969. Much to my astonishment, several of the products that we use now were described more than 50 years earlier, including a transcutaneous energy transfer (TET) system (Figure 1B). It was remarkable for me to discover that this method of conveying energy invisibly across the skin was discussed and illustrated on page 938 in Chapter 79. In the year 2000, when the AbioCor clinical trial appeared on my radar, I was intrigued by the prospect of a driveline-free device. I had no idea that the concept was conceived of and described half a century earlier.
TABLE 1 Table of contents of Artificial Heart Program Conference. National Heart Institute. Artificial Heart Program. Frank W. Hastings, M.D. Chief. Lowell T. Harmison, Ph.D., Assistant Chief. Proceedings. Washington, DC, June 9–13, 1969.
TABLE 2 Corporations involved in the Artificial Heart Program Conference. National Heart Institute. Artificial Heart Program. Frank W. Hastings, M.D. Chief. Lowell T. Harmison, Ph.D., Assistant Chief. Proceedings. Washington, DC, June 9–13, 1969.
The American company, Abiomed, Inc. was determined to create a completely implantable electric TAH and insisted on doing so on American soil. David Lederman, the company’s founder and CEO, and Bob Kung, the chief engineer and designer of the AbioCor, sought centers and people from around the United States whose passion and commitment to artificial heart technologies matched their own. My program at Hahnemann University Hospital (Philadelphia, PA) was fortunate to be awarded one of the five sites. The other four were the Texas Heart Institute (Houston, TX), Jewish Hospital (Louisville, KY), UCLA (Los Angeles, CA) and Massachusetts General Hospital/ Women’s and Brigham (Boston, MA). Collaborating with my colleagues from these institutions was among the highlights of my career: Laman Gray, Rob Dowling, Hillel Laks, Dan Marelli, Greg Couper, Gus Vlahakes, Steven Etoch, and of course, Bud Frazier—a melting pot of multi-generational artificial heart surgeons.
Preparation for the AbioCor trial was a monumental task. The regulatory process alone was Herculean as the FDA, the IRB, and so many other layers of oversight went into the planning stages. At Hahnemann, we expanded our animal lab facility to accommodate 300-pound Yorkshire pigs in which to conduct Mock implants. Matt Thomas, a college graduate who I hired as a research assistant, was integral in the laboratory and in so many other capacities related to the trial and other projects. Matt went to become a successful cardiac surgeon in its aftermath.
On July 2, 2001, the team at Jewish Hospital in Louisville, KY (Drs. Laman Gray and Rob Dowling) placed the first AbioCor. The same team at Jewish Hospital implanted the second device on September 13, 2001. The third implant took place at The Texas Heart Institute (Drs. Bud Frazer and Steven Etoch) on September 26, 2001. The fourth patient was implanted at UCLA Medical Center (Drs. Hillel Lakes and Dan Marelli) on October 17, 2001. On November 5, 2001, our team placed the fifth AbioCor.
Our patient, a 51-year-old man with a dilated cardiomyopathy, underwent extensive screening for the device. He was ineligible for cardiac transplant for several reasons including irreversible pulmonary hypertension. Although initially scheduled for mid-November, his condition deteriorated and the surgical date was moved up to the first week of November. The operation was formidable, the right atrium so massive that it had to be plicated in order to accommodate the artificial atrial cuff (Figure 2A). My fellow and future colleague, John Entwistle, was instrumental in helping to tailor the fixed dimensions of the artificial heart with the remnants of the native structures (Figure 2B). The postoperative X-ray demonstrating all the internal components was surreal (Figure 2C). Equally extraordinary were the monitoring displays and the electrocardiogram postoperatively (Figure 3A, B). A timeline of the operation is shown below:
07:25 Transported to OR
07:35 Induction/Intubation
08:50 Sternotomy
10:18 On CPB
13:35 Off CPB
13:55 Protamine
14:05 Additional Protamine
15:00 ETT with copious secretions
16:00 Sternum closed
17:15 Transported to CT-ICU
*No blood products given in OR
SBP 116/86 RAP 15 LAP 13 Flow 3.5 Rate 105 No Drips
FIGURE 2 (A) Massive right atrium of the AbioCor recipient heart. (B) Myself with Dr. John Entwistle postoperatively in the CT-ICU at Hahnemann University Hospital following the AbioCor implant. Pre and postimplant chest X-rays in background. (C) X-Ray of internal AbioCor components. [Color figure can be viewed at wileyonlinelibrary.com]
Postoperatively, the first of two life-threatening conditions occurred—pulmonary edema with hypoxia/hypercarbia/ acidosis. Although the device was working well, serial arterial blood gases and the chest radiograph were alarming:
18:00
SBP 138/96, RAP 17, LAP 15, Flow 5.3, Rate 125 Diprivan, Nimbex, Nipride
7.16/60/60/21/-8/79% PC-26, 100%, PEEP 16
FIGURE 3 (A) Monitoring of the hemodynamics (pre and postimplant). (B) EKGs (pre and postimplant). [Color figure can be viewed at wileyonlinelibrary.com]
At this point, bi-femoral veno-venous ECMO was instituted and eventually discontinued at noon on the third postoperative day (POD) with the patient neurologically intact.
The next significant event occurred on POD #6—a Sunday. Taken from my daily journal—
November 11, 2001 (POD#6, Sun)
Unable to establish TET coupling. External TET removed to change from black pouch to Duoderm and Velcro pouch. RF box atop abdomen in proximity to antennae. No other changes in console. Tried repositioning with no coupling. Moderate hematoma at internal TET site. Wound opened sterilly and hematoma evacuated. Still unable to establish coupling. Tried backup console with no success. New external TET coil brought and coupling established. Reason for inability to couple with initial TET coil still unclear. Bob Kung made aware. Wound closed.
This event was not a trivial one given the fact that the internal battery supplies power to the pump for only 20 minutes when not linked to the TET system. As the seconds and minutes went by, my natural heart was racing to prevent the patient’s artificial heart from stopping. Like the countdown on a ticking time bomb, I was only a few minutes away from a complete pump shutdown. Afterwards, I couldn’t help but ask myself why there wasn’t a direct electrical connection option as an emergency bailout in the event of a TET failure. Something to consider for the future.
As nightmarish as the first few hours and days were, the next several were thankfully favorable.
Over the course of the next two days, the CXR steadily improved to nearly baseline by the morning of POD#3. In addition, the secretions diminished considerably. By the afternoon, the patient, whose neurologic status had fully recovered and was anxious to get the ETT out, was checked for weaning parameters. Remarkably, the parameters were very good. So, we extubated him and he did well. For the history books, his first words were not what we expected. Prior to extubation, he had received a rectal suppository. So, when he could talk, he said “No one’s stickin’ anything up my butt again.”
Bob Kung and his team from Abiomed were present and on-site daily during the first week, and it was a memorable moment to witness the creator and his creation together conversing (Figure 4). Mr. Quinn’s management was overseen by Elena Casanova (AKA Elena Holmes), a nurse practitioner who remained with the patient wherever he was stationed (Figure 5): the CT-ICU, the hospital lobby, his Baptist church, the Hawthorne Suites, or excursions to his west Philadelphia home.
Mr. Quinn’s impressive story made local and national media, appearing in the Philadelphia Inquirer, The New York Times, the Oprah Show, The Early Show, and so forth. The glory of his success was tempered by the realities of the marriage between man and machine with the humbling realization that this unnatural relationship was not without complications: stroke, bleeding, and eventual death from an intracranial hemorrhage. His device was discontinued on August 26, 2002, nearly 10 months from the implant date. Considered a clinical success, the case became a medico-legal and ethical nightmare resulting in a settled award between the company and the Quinn family.
FIGURE 4 James Quinn, recipient of the AbioCor TAH with Bob Kung, the AbioCor inventor, conversing in the CT-ICU at Hahnemann University Hospital postoperatively. [Color figure can be viewed at wileyonlinelibrary.com]
FIGURE 5 Elena Holmes, myself, and James Quinn in the lobby of Hahnemann University Hospital. [Color figure can be viewed at wileyonlinelibrary.com]
FIGURE 6 Photograph of Dr. Willem Kolff with Dr. Denton Cooley and the artificial heart of the 1960s; inserted photograph of Dr. Kolff with me and the AbioCor. [Color figure can be viewed at wileyonlinelibrary.com]
The AbioCor received FDA approval to conduct its pivotal clinical trial in 20012 A total of 14 patients were part of this trial, all in the United States. The initial experience from the trial centers was published in the Annals of Thoracic Surgery and the Journal of Thoracic and Cardiovascular Surgery in 2003 and 2004, respectively.3,4 We published our case report and concluded with the question of whether fixed pulmonary hypertension is an indication or a contraindication to total artificial heart replacement.5 In 2006, the device received FDA human device exemption (HDE) status.6 Although optimism for success was growing dimmer, one further implant was performed in 2009 by the Robert Wood Johnson Team (Mark Anderson, MD) in New Jersey.7 The AbioCor was abandoned despite some limited interest in refining the technology designed to be considerably smaller by combining the original AbioCor ventricles with the Penn State energy converter—AbioCor II.8 It never materialized.
My memories of the preparation and participation in the AbioCor trial remain forever cemented in my mind with the hope that one day we may overcome the barriers that continue to plague this quest. I still marvel at an actual AbioCor pump housed in a Lucite container on my bookshelf—a gift from the company—and remember handing it to Willem Kolff who visited me after the implant. He cradled it like a baby, the image captured in a photograph that I inserted into a black-and-white image of Drs. Kolff and Cooley with the artificial heart of their era (Figure 6). That singular moment illustrates the essence of our specialty—in this case, the pursuit of a total heart replacement system—and the passage of the proverbial torch from one generation to the next. I look forward to seeing the next generation of artificial heart surgeons and privately chuckle at the prospect of visiting one of them someday and holding the latest version for someone to capture in a photograph.
REFERENCES
1. Coselli JS. Nothing like a good feud to spark competition: first use of the total artificial heart. Artif Organs. 2022;46:8–14.
2. Nose Y. Implantable total artificial heart developed by Abiomed gets FDA approval for clinical trials. Artif Organs. 2001;25(6):429.
3. Dowling RD, Gray LA, Etoch SW, Laks H, Marelli D, Samuels L, et al. The AbioCor implantable replacement heart. Ann Thorac Surg. 2003;75:S93–9.
4. Dowling RD, Gray LA, Etoch SW, Laks H, Marelli D, Samuels L, et al. Initial experience with the AbioCor implantable replacement heart system. J Thorac Cardiovasc Surg. 2004;127:131–41.
5. Samuels L, Entwistle J, Holmes E, Fitzpatrick J, Wechsler A. Use of the AbioCor replacement heart as destination therapy for end-stage heart failure with irreversible pulmonary hypertension. J Thorac Cardiovasc Surg. 2004;128:643–5.
6. Nose Y. FDA approval of totally implantable permanent total artificial heart for humanitarian use. Artif Organs. 2007;31(1):1–3.
7. Rothman C. Surgeons perform first artificial heart implant in New Jersey. NJ.com. New Jersey On-Line, LLC; 2009. https://www.nj.com/news/2009/06/first_artif icial_heart_impla nt.html
8. Juretich JT, Corbett SC, Ritchie G, Kung RT. Development progress on a second generation total artificial heart. ASAIO J.
2006 Mar 1;52(2):48A.
Correspondence
Louis E. Samuels, MD, Division of Cardiothoracic Surgery, Department of Surgery, Thomas Jefferson University, 1025 Walnut Street, Suite 607, Philadelphia, PA 19107, USA.
Email: louis.samuels@jefferson.edu