What happens when a disruptive technology gets disrupted?

Few innovations in modern medicine have had as significant an impact on patient outcomes as left ventricular assist devices (LVADs). According to most recent registry data, LVAD recipients – receiving any pump for any indication – now boast a median survival of more than 4 years [1]. This contrasts sharply with the dismal prognosis for advanced and end-stage heart failure on medical therapy alone, with survival beyond 6 to 9 months highly unlikely. The resultant transition in treatment approach to advanced heart failure, along with inevitable new challenges posed by physiologic changes while on LVAD support, certainly satisfy the criteria defining a “disruptive technology”, as described in The Innovator's Dilemma [2]. Indeed, several prior reviews and editorials have applied the moniker of ‘disruptive technology’ or ‘disruptive innovation’ to LVADs [3], [4]. Medtronic's announcement of its decision to remove the HeartWare Ventricular Assist Device (HVAD) from the market begs the question: what happens when a disruptive technology is itself disrupted?

Medtronic inherited the HVAD pump as part of its $1.1 billion acquisition of HeartWare International in 2016. The HVAD was the first centrifugal flow device to be widely implanted worldwide following FDA approval for bridge to transplant (BTT) and later, destination therapy (DT) implantation in 2012 and 2017 respectively. Although the HVAD was recognized to be a more hemocompatible device, promoting less hemolysis than its axial flow counterpart, it was initially associated with a higher incidence of neurologic adverse events [5]. This issue was addressed in part through a series of pump design enhancements, along with more stringent antithrombotic and antihypertensive medical management recommendations [6]. Although no randomized studies have been conducted to directly compare the HVAD with its centrifugal flow competitor the HeartMate 3 (Abbott Laboratories), published data from the ReVOLVE and LATERAL investigators both suggested improved survival and adverse event profiles for patients on long-term HVAD support [7], [8]. Therefore, Medtronic's field corrective action removing the HVAD from the market, which cited “a growing body of clinical comparisons” suggesting a higher frequency of neurological adverse events and worse survival with the HVAD when compared to the HeartMate 3, was certainly unexpected. Recent deaths associated with the December 2020 Urgent Medical Device Communication, regarding failure of the pump to restart following a controller exchange, were also cited as informing the decision. While the pump stoppage issue was initially determined to be confined to a subset of three lots, and the root cause identified, additional cases of delayed start or stoppage were noted outside of the initial lots, for which no root cause has been identified as of yet. Nevertheless, it is likely the decision was also influenced by a declining market share in the wake of the FDA approval for Abbott's HeartMate 3, coupled with the changes in the United Network for Organ Sharing (UNOS) heart allocation system which disincentivized BTT implantation.

While the Medtronic decision was no doubt undertaken with a great deal of thought and sensitivity, the unexpected removal of the HVAD from the market could have wide-ranging negative ramifications. Coverage in the lay press has the potential to diminish patient and referring provider trust in the field of mechanical circulatory support, particularly if the likely benefits of a traditionally underutilized, life-saving therapy in target populations are not well described. Due to its smaller size and unique properties of left ventricular unloading, the HVAD also provided clinicians with flexibility for novel implant techniques and the ability to more precisely pair patients with pumps. Additionally, as a unique, only-one-of-its-kind product of a large and well-funded medical device company, it created opportunities for research as well as support for therapy awareness and training opportunities for providers. Therefore, HVAD's disappearance from the market has the potential to hamper timely referrals for advanced heart failure therapies and diminish future evolution and education, while limiting patient and provider choice.

To meet this challenge, clinical and industry leaders would do well to reflect on earlier lessons from the infancy and adolescence of mechanical circulatory support. The earliest first generation pulsatile LVADs, as studied in the REMATCH trial, were associated with an initial mortality as high as 50%, yet still surpassing the outcomes of optimal medical management [9]. Nevertheless, the need for lifesaving device therapy to address rapid growth in the incidence of advanced heart failure, particularly in the face of stagnant availability of organs for heart transplantation, remained well recognized. The intellectual capital from these early endeavors undoubtedly spurred the development and approval of second-generation continuous flow devices, which doubled post implant life expectancy and transformed the landscape of implants within one year of FDA approval [10], [11]. The momentum associated with the successes of second generation pumps – undoubtedly along with concerns regarding a persistently high rate of adverse events related to suboptimal hemocompatibility – encouraged research and development of third generation centrifugal pumps such as Ventracor's Ventrassist device. Although Ventrassist reached the market before the HVAD, the company was forced to declare bankruptcy after only 400 pumps had been implanted, due to a combination of reported complications related to lead fractures and a failure to attract ongoing investment in the wake of the 2008 economic crisis [12]. Thoratec Inc., at the time the predominant industry player in LVAD development, purchased the intellectual property associated with Ventrassist following the company's demise, while also bidding to acquire HeartWare International for $282 million. This merger was successfully blocked by the US Federal Trade Commission (FTC), which cited the importance of competition in medical device development, particularly in “life saving devices such as the LVAD” [13], [14]. One could easily conclude that the LVAD community owes a vast body of research and numerous advancements to this decision protecting competition and its importance to scientific advancement.

While all LVAD enthusiasts are expecting that Abbott Laboratories will continue its support and development of the field, and equally hopeful that Medtronic will not allow its acquired and self-grown institutional knowledge to be lost, it is imperative that as providers, clinicians and scientists we return to the origins of mechanical circulatory support. Namely, a reinvestment into enhanced collaboration and investigator-initiated innovation of device therapy for advanced heart failure. In this fashion we can ensure not only the future health of our patients, but of the field itself. To the question of what happens when a disruptive technology is disrupted, then, the answer can and should be: a renewal. A renewal of focus and attention to the original goal of mechanical circulatory support; a life-saving solution to the epidemic of advanced heart failure.

Funding

None.

Declaration of competing interest

None.