Since the late 1960s, there has been a dream to develop an artificial heart which would alleviate the suffering and mortality of patients with severe heart disease. Devices were initially used for patients waiting for transplant, and in 2001, the Heartmate Vented Electric (VE) left ventricular assist device (LVAD) (Thermo Cardiosystems, Inc, Woburn, Massachusetts) was shown to be superior to medical therapy for transplant ineligible patients.1 Given the intense interest and commercial support for this endeavor, we might have thought that now more than 20 years later, we would have solved most of the issues surrounding LVAD therapy but unfortunately, we still have much work to do. There are many creative types of mechanical circulatory support devices which have been designed, but currently, there is one remaining device which is commercially available, the Heartmate 3 (now owned by Abbott, Abbott Park, Illinois).

One of the creative devices to be trialed in humans with heart failure is the Jarvik 2000, which entered trials in the 2000s but which never achieved approval in the United States.2 The lessons from this device are valuable despite the lack of long-term success with this specific platform. In this issue, Selzman et al.3 present the final results of the pivotal trial of the Jarvik 2000 device, which was conducted between 2005 and 2012. The trial enrolled 150 patients who were listed for heart transplantation at multiple U.S. centers. This was a single arm unblinded trial with a primary endpoint of survival while still listed for transplantation or induction of anesthesia for transplantation at 180 days post-Jarvik LVAD implant. There was no comparator arm, and the prespecified performance goal was 57% survival at 180 days. The trial enrolled slowly, taking 7 years to complete. During a similar time frame, the Heartmate 2 and Heartware LVAD trials were conducted and ultimately received commercial approvals.

The major issue with the pump was related to hemolysis and thrombosis, and engineering analysis identified issues with the bearings for the pump, which were based on a pin-shaped design. This was changed to a “cone” style bearing near the end of the trial with a significant improvement in hemocompatibility. Selzman et al.3 report that the 180-day survival (while listed or transplanted) was 64% among patients with the original pin-bearing ventricular assist device (VAD) (n = 128) and 91% (n = 22) for those with the cone-bearing VAD, both of which met the prespecified endpoints for trial success.

The Jarvik device had several novel features which have not been duplicated in current LVADs. The device was quite small, mostly intracardiac, with a driveline which could be implanted behind the ear via a tunneled line from the abdomen.4–6 This reduced the risk of driveline infection and allowed a detachable connection to the pump via the “ear post.” Given its small size, there were reports of usage of two pumps for biventricular support, which was uncommon at the time7 as well as use in complex congenital heart disease.8,9 In addition, the Jarvik 2000 controller had a speed setting which was visible to the patient and intended for patients to modulate their own device speed depending on activity.10 The Jarvik was designed as an “assist device” to augment the native cardiac output at a time when the Heartmate VE promoted complete replacement of cardiac output with a device which could produce 6–8 L per minute of flow.

The failure of the Jarvik pump to move from trials to approved use illustrates the treacherous pathway which must be traversed for future devices which may be developed. The key points are as follows:

A good idea is not enough: The Jarvik device was clearly ahead of its time. A small axial flow pump was studied when the competing pumps were larger and more “powerful.” Competing firms had high levels of surgical implant support staff, training courses to teach techniques and field engineers to support sites with post-implant patients. It is also essential to achieve “critical mass” with large sites which are leading the field to promote confidence and inspire others to join the effort. The Heartmate pump team achieved these goals better than the Jarvik team. “More is better”: The appeal of a pump which offered partial assistance was lower when compared to a pump which offered higher flow. The Heartmate VE pump operated with a large blood chamber and a “fill to empty” cycle where the device received the left ventricular inflow and ejected it when the device was nearly full, resulting in full decompression of the heart, easily measured blood pressure and a logical solution to patients with severely low cardiac output. Other pumps have been developed as partial assist devices and have not been successful either.11,12 Disruptive ideas need many champions: The post-auricular connection for the Jarvik is a novel approach which might have markedly reduced drive line infection which remains a significant issue with current VAD therapy. However, it was not simple, and working on the skull behind the ear was foreign to cardiothoracic surgeons. Removal of the connector post-transplant also involved extra steps, which hindered adoption.6 The patient-controlled speed setting was also counter-intuitive. Clinicians are more accustomed to full control of pump settings and the idea that patients would shift their VAD into different speeds like a car shifting gears was not perceived as a completely safe or appropriate possibility. It also reinforced the idea that the Jarvik device was not particularly powerful. In summary, the rapid embrace of new ideas requires multiple enthusiastic supporters to lead and promote the concepts. Otherwise, it is far more common to reject the new idea and cling to the status quo. Competition is inherently good: Consumer technology such as personal computers have directly benefited from competition. The Apple Macintosh platform led to the development of Microsoft Windows, although arguably the first few versions were limited and inferior. Without competition, we might all still be on text-based systems, and the graphical user interface which is now routine might not have developed. In the medical field, the Heartmate 3 currently stands as the only commercially available LVAD. While outcomes are excellent,13,14 rivaling transplant in ways that were unthinkable when the Jarvik Pivotal trial conducted, the lack of competition is a profound contributor to inertia in the field. The recent report of the Society for Thoracic Surgeons INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) database shows that the number of VAD implants in the United States has dramatically fallen since 2018 when stable VAD patients were reduced in priority to receive transplantation.15 It is increasingly less likely that another company will invest in VAD technology when the current device which has excellent outcomes has a shrinking utilization despite excellent data supporting its use.

While guideline-directed medical therapy for heart failure has greatly expanded and outcomes have markedly improved, heart disease and heart failure remain leading causes of death. The unmet need continues to grow for a solution to these problems. Neither transplantation nor VAD therapy are likely to move beyond their narrow niches in their current iterations.

The future belongs to a new generation of “forgettable” devices which can be applied to sicker and more frail patients with lower maintenance. Whether we ever see a VAD which is more like a defibrillator with intermittent remote monitoring remains to be seen. It seems like an impossible notion in the year 2023, but then again, the concept that private companies would routinely send rockets into space seemed impossible as well 20 years ago. The SpaceX (Hawthorne, California) of VAD technology may be out there somewhere, someday in the future. For our patients’ sake, let’s hope that the vision of VAD therapy as a large-scale solution for end-stage heart failure is eventually realized.

1. Rose EA, Gelijns AC, Moskowitz AJ, et al.: Long-term use of a left ventricular assist device for end-stage heart failure. N Engl J Med 345: 1435–1443, 2001. 2. Frazier OH, Shah NA, Myers TJ, Robertson KD, Gregoric ID, Delgado R: Use of the flowmaker (Jarvik 2000) left ventricular assist device for destination therapy and bridging to transplantation. Cardiology 101: 111–116, 2004. 3. Selzman CH, Feller ED, Walker JC, et al.: The Jarvik 2000 left ventricular assist device: Results of the United States bridge to transplant trial. ASAIO J 69: 174–182, 2023. 4. Martin-Suarez S, Fiorentino M, Loforte A, Masetti M, Potena L, Pacini D: Longest reported support (7.5 years) with postauricular type of Jarvik 2000 axial-flow left ventricular assist device. J Artif Organs 24: 503–506, 2021. 5. Carrozzini M, Bejko J, Gregori D, Gerosa G, Bottio T: How to implant the Jarvik 2000 post-auricular driveline: Evolution to a novel technique. J Artif Organs 22: 188–193, 2019. 6. Gallo M, Bortolussi G, Bejko J, Tarzia V, Gerosa G, Bottio T: How to remove the retroauricular driveline in the Jarvik 2000 after heart transplantation. Int J Artif Organs 39: 45–47, 2016. 7. Frazier OH, Myers TJ, Gregoric I: Biventricular assistance with the Jarvik FlowMaker: A case report. J Thorac Cardiovasc Surg 128: 625–626, 2004. 8. Tanoue Y, Fujino T, Tatewaki H, Shiose AJ: Axial flow ventricular assist device in right single ventricle after Fontan operation. J Artif Organs 22: 338–340, 2019. 9. Tanoue Y, Jinzai Y, Tominaga RJ: Axial-flow ventricular assist device placement to a systemic morphologic right ventricle in congenitally corrected transposition of the great arteries. J Artif Organs 19: 97–99, 2016. 10. Healy AH, Koliopoulou A, Drakos SG, McKellar SH, Stehlik J, Selzman CH: Patient-controlled conditioning for left ventricular assist device-induced myocardial recovery. Ann Thorac Surg 99: 1794–1796, 2015. 11. Meyns B, Ector J, Rega F, et al.: First human use of partial left ventricular heart support with the Circulite synergy micro-pump as a bridge to cardiac transplantation. Eur Heart J 29: 2582, 2008. 12. Barbone A, Pini D, Rega F, Ornaghi D, Vitali E, Meyns B: Circulatory support in elderly chronic heart failure patients using the CircuLite® Synergy® system. Eur J Cardiothorac Surg 44: 207–212, discussion 212, 2013. 13. Mehra MR, Nayak A, Morris AA, et al.: Prediction of survival after implantation of a fully magnetically levitated left ventricular assist device. JACC Heart Fail 10: 948–959, 2022. 14. Mehra MR, Goldstein DJ, Cleveland JC, et al.: Five-year outcomes in patients with fully magnetically levitated vs axial-flow left ventricular assist devices in the MOMENTUM 3 randomized trial. JAMA 328: 1233–1242, 2022. 15. Yuzefpolskaya M, Schroeder SE, Houston BA, et al.: The Society of Thoracic Surgeons Intermacs 2022 annual report: Focus on 2018 heart transplant allocation system [published online ahead of print November 30, 2022]. Ann Thorac Surg doi:10.1016/j.athoracsur.2022.11.023.