Remote Hemodynamic-Guided Therapy of Patients With Recurrent Heart Failure Following Cardiac Resynchronization Therapy

Abstract

Background Patients with recurring heart failure (HF) following cardiac resynchronization therapy fare poorly. Their management is undecided. We tested remote hemodynamic-guided pharmacotherapy. Methods and Results We evaluated cardiac resynchronization therapy subjects included in the CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in New York Heart Association Class III Heart Failure Patients) trial, which randomized patients with persistent New York Heart Association Class III symptoms and ≥1 HF hospitalization in the previous 12 months to remotely managed pulmonary artery (PA) pressure-guided management (treatment) or usual HF care (control). Diuretics and/or vasodilators were adjusted conventionally in control and included remote PA pressure information in treatment. Annualized HF hospitalization rates, changes in PA pressures over time (analyzed by area under the curve), changes in medications, and quality of life (Minnesota Living with Heart Failure Questionnaire scores) were assessed. Patients who had cardiac resynchronization therapy (n=190, median implant duration 755 days) at enrollment had poor hemodynamic function (cardiac index 2.00±0.59 L/min per m2), high comorbidity burden (67% had secondary pulmonary hypertension, 61% had estimated glomerular filtration rate <60 mL/min per 1.73 m2), and poor Minnesota Living with Heart Failure Questionnaire scores (57±24). During 18 months randomized follow-up, HF hospitalizations were 30% lower in treatment (n=91, 62 events, 0.46 events/patient-year) versus control patients (n=99, 93 events, 0.68 events/patient-year) (hazard ratio, 0.70; 95% CI, 0.51-0.96; P=0.028). Treatment patients had more medication up-/down-titrations (847 versus 346 in control, P<0.001), mean PA pressure reduction (area under the curve -413.2±123.5 versus 60.1±88.0 in control, P=0.002), and quality of life improvement (Minnesota Living with Heart Failure Questionnaire decreased -13.5±23 versus -4.9±24.8 in control, P=0.006). Conclusions Remote hemodynamic-guided adjustment of medical therapies decreased PA pressures and the burden of HF symptoms and hospitalizations in patients with recurring Class III HF and hospitalizations, beyond the effect of cardiac resynchronization therapy. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT00531661.

Keywords: cardiac resynchronization therapy; heart failure; hemodynamic; hemodynamic monitoring; pulmonary artery pressure; remote monitoring.

Conflict of interest statement

Niraj Varma reports consulting Fees/Honoraria from St. Jude Medical, Boston Scientific, Biotronik, Medtronic. Robert Bourge reports grant support and consulting fees from Abbott (CardioMEMS). Lynne Stevenson is an unpaid consultant for Abbott and Biotronik and Chair of the DSMB for LivaNova. Mariarosa Rosa Costanzo reports consulting Fees/Honoraria from Abbott, Medtronic, Boston Scientific, and grant support from Abbott to the Advocate Heart Institute for the CardioMEMS postapproval study and GUIDE‐HF clinical trial. Philip B. Adamson reports salary support from Abbott. Greg Ginn reports salary support from Abbott. John Henderson reports salary support from Abbott. David Shavelle reports grant support from Abbott for CardioMEMS clinical trials.

Figures

Figure 1. Hospitalization rates over time using a Nelson‐Aalen cumulative hazard rate.

Heart failure hospitalization rates were 30% lower in the CRT‐D treatment group (hazard ratio, 0.70; 95% CI, 0.51–0.96; P=0.028) compared with the control group managed by standard clinical methods. CRT‐D indicates cardiac resynchronization therapy with implantable cardioverter‐defibrillator.

Figure 2. Frequency of increases and decreases in medical management of CRT patients involved in the CHAMPION Trial.

Medication changes in the PA pressure guided heart failure group (treatment group, red bars, n=91) are compared with the standard of care heart failure management only group (control group, blue bars, n=99). ACEI indicates angiotensin converting enzyme inhibitor; ARB, angiotensin receptor blocker; CHAMPION, CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in New York Heart Association Class III Heart Failure Patients; CRT, cardiac resynchronization therapy; HF, heart failure; and PA, pulmonary artery.

Figure 3. Pulmonary artery pressure changes over time compared with each patient's baseline (BL) pressure defined as the average pressure from the first week postsensor implantation through 6 months of follow‐up (x‐axis, time in months).

An area under the curve analysis was performed to quantify the time pressures were below the patient's baseline with units of mm Hg‐day (y‐axis). The treatment group experienced significant reductions in pulmonary artery pressures over time (P=0.0023). AUC indicates area under the curve; and PAP, pulmonary artery pressure.