Abstract 19282: Safety and Utility of the CardioMEMs Device in Pulmonary Arterial Hypertension
Introduction: Pulmonary arterial hypertension (PAH) remains fatal requiring better methods for outcome prediction. Although invasive hemodynamics are valuable prognostically, their routine use is impractical. The CardioMEMS™ HF System (CMHFS) is indicated for wireless monitoring of PA pressure in heart failure (HF) patients (pts).
Hypothesis: Use of CMHFS in PAH pts will be safe and result in more efficient and timely responses to therapy (Rx).
Methods: 17 PAH pts with NYHA class III/IV sxs and a recent hospitalization (HOS) for HF were enrolled. 14 implants were performed and device mPAP, sPAP, dPAP, HR, and CO (sensor pressure based algorithm), total pulmonary resistance (TPR), stroke volume (SV) were collected daily. BNP levels, NYHA class (FC) and HF HOS events were collected at preimplant, implant, and 1, 4, 6, 12 months (mos). All pts were treated with FDA approved Rx and Rx changes were not mandated by the protocol. Pts were analyzed as a group and by predefined management profiles based on number of PAH specific drug changes: Highly (>8; n=9), Moderately/mildly (0-8; n=5).
Results: Pts consisted of 45% newly diagnosed pts. All pts were female, aged 57 ± 9 with IPAH (50%), scleroderma-related PAH (50%) with a mPAP 45 ± 14 mmHg and pulmonary vascular resistance of 7.5 ± 4 WU. There were no peri-procedural complications or device related SAE’s post implant. Device related information was used to optimize PAH-specific Rx. Mean duration of follow-up was 14 ±.6 mos. Annualized HF HOS for the total cohort fell from ≥ 1 HFH/pt-yr prior to implant to 0.453 (CI 0.182 to 0.934) after implant. FC improved from baseline (3.13) after 1 mo (-0.83, p=0.0004) and through last follow-up (-1.01, p=0.0004). BNP levels <340 pg/ml were maintained or achieved in 75% of pts after 1 mo. mPAP and TPR improved significantly overtime (p=0.04; p=0.01, respectively) and as early as 1 mo (-6.5 mmHg, p=0.0337; -2.1 WU, p=0.04, respectively) and maximal by 12 mo (-10 mmHg, p=0.002; -2.9 WU, p=0.006). CO and SV improved overall at 4 mo (+ 1.2 l, p=0.01; + 10 cc, p=0.02, respectively), but the effect was isolated to those highly managed (p<0.05, all time points).
Conclusions: Use of CMHFS in PAH pts appears safe, may reduce HOS, and allows rapid optimization of hemodynamics and functional outcome.
Author Disclosures: R. Benza: None. P. Correa-jaque: None. V. Franco: None. M. Doyle: None. J.A. White: Employment; Significant; Employee of St. Jude Medical. G. Ginn: Employment; Significant; Employee of St. Jude Medical. R. biederman: None.
- © 2016 by American Heart Association, Inc.