Background Assessing haemodynamic congestion based on filling pressures instead of clinical congestion can be a way to further improve quality of life (QoL) and clinical outcome by intervening... Show moreBackground Assessing haemodynamic congestion based on filling pressures instead of clinical congestion can be a way to further improve quality of life (QoL) and clinical outcome by intervening before symptoms or weight gain occur in heart failure (HF) patients. The clinical efficacy of remote monitoring of pulmonary artery (PA) pressures (CardioMEMS; Abbott Inc., Atlanta, GA, USA) has been demonstrated in the USA. Currently, the PA sensor is not reimbursed in the European Union as its benefit when applied in addition to standard HF care is unknown in Western European countries, including the Netherlands. Aims To demonstrate the efficacy and cost-effectiveness of haemodynamic PA monitoring in addition to contemporary standard HF care in a high-quality Western European health care system. Methods The current study is a prospective, multi-centre, randomised clinical trial in 340 patients with chronic HF (New York Heart Association functional class III) randomised to HF care including remote monitoring with the CardioMEMS PA sensor or standard HF care alone. Eligible patients have at least one hospitalisation for HF in 12 months before enrolment and will be randomised in a 1:1 ratio. Minimum follow-up will be 1 year. The primary endpoint is the change in QoL as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ). Secondary endpoints are the number of HF hospital admissions and changes in health status assessed by EQ-5D-5L questionnaire including health care utilisation and formal cost-effectiveness analysis. Conclusion The MONITOR HF trial will evaluate the efficacy and cost-effectiveness of haemodynamic monitoring by CardioMEMS in addition to standard HF care in patients with chronic HF. Clinical Trial Registration number NTR7672. Show less
Pressure-Volume Loop Analyses during CRT Implants. Introduction: cardiac resynchronization therapy (CRT) may improve prognosis in patients with chronic right ventricular (RV) pacing, and optimal... Show morePressure-Volume Loop Analyses during CRT Implants. Introduction: cardiac resynchronization therapy (CRT) may improve prognosis in patients with chronic right ventricular (RV) pacing, and optimal lead position can decrease nonresponders. We evaluated the clinical and echocardiographic response to CRT in patients with previous chronic RV pacing, using pressure-volume loop analyses to determine the optimal left ventricular (LV) lead position during implantation. Methods and Results: In this single-blinded, randomized, controlled crossover study, 40 patients with chronic RV apical pacing and symptoms of heart failure, decreased LV ejection fraction (LVEF) or dyssynchrony were included. During implantation, stroke work (SW), LVEF, cardiac output, and LV dP/dt(max) were assessed by a conductance catheter. Clinical and echocardiographic response was studied during a 3-month period of RV pacing (RV period, LV lead inactive) and a 3-month period of biventricular pacing (CRT period). At the optimal LV lead position, SW (37 ± 41%), LVEF (16 ± 13%), cardiac output (29 ± 16%), and LV dP/dt(max) increased (11 ± 11%) significantly during biventricular pacing compared to baseline. Additional benefit could be achieved by pressure-volume loop guided selection of the best left-sided pacing location. RV outflow tract pacing did not improve hemodynamics. During follow-up, symptoms improved during CRT, VO(2,max) increased 10% and significant improvements in LVEF, LV volumes, and mitral regurgitation were observed as compared to the RV period. Conclusions: CRT in patients with chronic RV pacing causes significant improvement of both LV function as measured by pressure-volume loops during implantation and clinical and echocardiographic improvement during follow-up. Pressure-volume loops during implantation may facilitate selection of the most optimal pacing site. (J Cardiovasc Electrophysiol, Vol. pp. 1-7). Show less
