Impact of cancer history on outcomes after HeartMate 3 left ventricular assist device implantation in the momentum 3 studies
J K Raikhelkar, G T Sayer, M R Mehra, D J Goldstein, J C Cleveland, M K Kanwar, U P Jorde, S A Hall, I Gosev, E J Molina, K J Clerkin, S Porter, N Chakouri, N UrielAbstract
Background
A rising number of heart failure (HF) patients are living as cancer survivors (CS) due to advances in oncologic therapies and an aging population. Prior studies of left ventricular assist devices (LVADs) have shown worse clinical outcomes among CS compared with those without a history of cancer. However, the outcomes of CS receiving a HeartMate 3 (HM3) LVAD remain poorly characterized.
Purpose
This study evaluated clinical outcomes after HM3 implantation among patients with a history of cancer in the contemporary LVAD era.
Method
This study included all subjects implanted with the HM3 LVAD from the MOMENTUM 3 pivotal IDE (N=515) and Continued Access Protocol (N=1685) trials. Patients were stratified by cancer history into 3 groups, those without a history of cancer (No Cancer; NC), those with active cancer (AC), and those with resolved cancer (RC). Patients with non-melanoma skin cancers were included in the NC group given their benign course. Clinical outcomes at 2 years including survival, disabling stroke, device exchange, right HF, driveline infection, and gastrointestinal (GI) bleeding were analyzed from the time of HM3 implant using Kaplan-Meier methods. Cox proportional hazards modeling was used to identify independent predictors of GI bleeding.
Results
In this cohort, 1,938 patients comprised the NC group, 209 were in the RC group and 53 had AC at the time of LVAD implantation. Prostate cancer was the most common malignancy across both AC and RC groups (35.8% and 24.0%, respectively), followed by lymphoma (13.2% and 17.3%, respectively) and breast cancer (13.2% and 17.8%, respectively). Compared to the NC group, RC and AC group patients were older (64.1±10.7 and 64.8±8.5 vs 59.2±12.4 years), had a lower body mass index (27.6±6.0 and 26.8±5.8 vs 29.4±6.7 kg/m2), and were more frequently implanted with destination therapy intent (84.7% and 92.5% vs 70.4%). There were no significant differences in survival, disabling stroke, device exchange, right heart failure, or driveline infection between all 3 groups (Table 1). There was a significant difference in risk of GI bleeding between all three groups, with the highest rate among the AC group (47.0% [33.7%, 62.4%]), intermediate rate among the RC group (40.0% [33.2%, 47.7%]), and the lowest rate among the NC group (31.2% [29.0%, 33.6%]; p=0.0009) (Figure 1A). The Cox proportional hazards modeling identified a history of cancer, older age, hypertension, and destination therapy intent as independent predictors of increased risk of GI bleeding (Figure 1B).
Conclusion
In patients implanted with the HM3 LVAD in the contemporary era, a history of cancer did not adversely affect survival or major adverse events. However, a history of cancer (whether active or resolved) at the time of implantation was associated with significantly higher risk of GI bleeding. LVAD therapy is thus a viable treatment option for these patients, albeit with a mild increased risk of GI bleeding.For image description, please refer to the figure legend and surrounding text.For image description, please refer to the figure legend and surrounding text.