Long-term post-LVAD surgery outcome in patients with and without pre-operative hemodynamic guided optimization
Authors: Veenis J.F , Radhoe S.P , Manintveld O.C , Bekkers J.A , Birim O , Constantinescu A.A , Caliskan K , Van Mieghem N.M.D.A , Brugts J.J 
Published: November 2020

Abstract

Background/Introduction
Despite improved surgical techniques and pump designs, LVAD therapy remains associated with high mortality and morbidity. CardioMEMS guided hemodynamic optimization shortly pre-LVAD surgery could improve the long-term post-surgery outcomes.

Purpose
The aim of this analysis was to investigate the feasibility of pre-operative optimization using the hemodynamic monitoring provided by the CardioMEMS in patients with an LVAD surgery, to improve the long-term outcome compared to a cohort of historical controls.

Methods
Ten consecutive chronic heart failure patients, with an INTERMACS Class 2–5, scheduled for (semi-) elective HeartMate 3 (HM3) LVAD surgery were enrolled in the HEMO-VAD pilot study. All patients received a CardioMEMS device prior to LVAD surgery. The daily hemodynamic readings were used to guide the patient optimization process pre- and post-operatively. Aims of hemodynamic optimization were the normalization of the mean pulmonary artery pressure (mPAP), decongesting of the right ventricle (RV) and optimization of the renal function. Patients were categorized into optimized patients (mPAP ≤25mmHg) and non-optimized mPAP (mPAP &gt;25mmHg). Additionally, a historical cohort, consisting of 24 (semi-) elective HM3 LVAD recipients were included in this analysis. The outcome of this analysis was the event-free survival of the combined endpoint of all-cause mortality, RV failure, acute kidney injury (AKI) and/or renal replacement therapy (RRT) during the first 12 months post-LVAD surgery (time to first event analysis).

Results
The median age was 60.3 [51.6–66.3], 58.7 [53.4–61.9] and 60.1 [53.5–65.2] years in the optimized patients, non-optimized patients and historical controls, respectively (p=0.90). Of the optimized patients, 66.7% were men, compared to 75.0% and 100.0% of the non-optimized patients and historical controls, respectively (p=0.02). During the first year post-LVAD surgery, the combined endpoint occurred in 19 patients, five (83%) events occurred in the non-optimized patients, and 14 (58%) events in the historical controls, while no (0%) events occurred in the optimized patients (p=0.018) (Figure).

Conclusion(s)
This analysis demonstrated the feasibility of hemodynamic guided optimization pre-LVAD surgery using the CardioMEMS. The hemodynamic optimized patients were at very low risk for all-cause mortality, right-sided HF, and AKI/RRT compared to non-optimized patients or historical controls.
Figure 1. Event-free survival for the combined endpoint (all-cause mortality, right ventricular failure, and acute kidney injury and/or renal replacement therapy).

Funding Acknowledgement
Type of funding source: Public hospital(s). Main funding source(s): This work was supported by Abbott with an independent research grant, partially covering personnel costs. This study was investigator-initiated and was designed, conducted, interpreted and reported independently of the funder