ISHLT Response to OPTN Escalation of Status for Time on Left Ventricular Assist Device

Published 19 March 2025

• OPTN Comment

The International Society for Heart and Lung Transplantation (ISHLT) welcomes the opportunity to comment on the OPTN proposal, “Escalation of Status for Time on Left Ventricular Assist Device.”

Previously, ISHLT provided input on the OPTN evaluation of continuous heart distribution, emphasizing the adverse impact of extended waiting periods due to the cumulative risks associated with long-term mechanical circulatory support. The Society highlighted the need for greater consideration of the wait time attribute for LVAD recipients, endorsing an annual increase in percentage points for time on an LVAD in continuous allocation models. Clinical evidence indicates that survival declines with the accumulation of adverse events post-LVAD, particularly within the first three years. Consequently, the ISHLT recommended incorporating wait time or comparable measures to better account for the impact of LVAD-related adverse events on waiting list mortality.

The proposed policy change introduces a step-down provision, granting Status 2 and 3 eligibility after seven and five years of MCS implantation, respectively. While the ISHLT strongly supports prioritizing these patients, we express concerns that this approach could inadvertently prioritize patients with extended waiting times over those with immediate urgency. The proposed policy should aim to enhance equity and efficiency in organ transplant prioritization by considering candidates with extended waiting periods while thoroughly evaluating clinical stability and complication risks. While stable candidates may demonstrate better post-transplant outcomes, prioritizing them over those with higher clinical need could disadvantage patients facing significant complications.

The ISHLT also underscores the need to reassess current medical urgency tier designations, as the existing framework may over-prioritize temporary MCS devices and disadvantage patients with challenging matching options or specific clinical conditions requiring long-term MCS, such as bridge-to-transplant or bridge-to-candidacy for left ventricular assist devices. These patients often face cumulative adverse events that progressively increase with longer MCS durations. Although these events may not meet existing prioritization criteria, they still present a substantial risk of death or disability. The ISHLT would like to once again encourage the OPTN to consider the mortality risk LVAD patients with cumulative complications face (stroke, GI bleed, infection, pump malfunction) and take this into account for the initial iteration of the heart continuous allocation score.

Moreover, providing robust supporting evidence for the proposed timeframes is critical to justify this approach and ensure it is both equitable and effective. The recent changes to the requirements for Status 2 patients with temporary MCS (proof of inotrope prior to IABP or percutaneous device support) may shift the current approach of programs towards favoring short-term MCS placement, thereby promoting LVAD support instead. While these adjustments in high urgency tiers under UNOS could further influence transplant strategies, the proposed policy remains relevant as a robust long-term strategy.

We recommend provisional implementation of the proposal with close monitoring and data analysis to evaluate changes in waitlist mortality. We believe utilization of post-implementation data analysis to further refine prioritization strategies could effectively address immediate needs while contributing to the development of future tools, such as a continuous allocation system.