Aim
Heart failure with preserved ejection fraction (HFpEF) is associated with increased sympathetic nervous system (SNS) tone. Attenuating the SNS with renal denervation (RDT) might be helpful and there are no data currently in humans with HFpEF.
Methods and results
In this single‐centre, randomized, open‐controlled study we included 25 patients with HFpEF [preserved left ventricular (LV) ejection fraction, left atrial (LA) dilatation or LV hypertrophy and raised B‐type natriuretic peptide (BNP) or echocardiographic assessment of filling pressures]. Patients were randomized (2:1) to RDT with the Symplicity™ catheter or continuing medical therapy. The primary success criterion was not met in that there were no differences between groups at 12 months for Minnesota Living with Heart Failure Questionnaire score, peak oxygen uptake (VO2) on exercise, BNP, E/e′, LA volume index or LV mass index. A greater proportion of patients improved at 3 months in the RDT group with respect to VO2 peak (56% vs. 13%, P = 0.025) and E/e′ (31% vs. 13%, P = 0.04). Change in estimated glomerular filtration rate was comparable between groups. Two patients required plain balloon angioplasty during the RDT procedure to treat renal artery wall oedema.
Conclusion
This study was terminated early because of difficulties in recruitment and was underpowered to detect whether RD improved the endpoints of quality of life, exercise function, biomarkers, and left heart remodelling. The procedure was safe in patients with HFpEF, although two patients did require intraprocedure renal artery dilatation.
Aims
The CardioMEMS HF System Post‐Market Study (COAST) was designed to evaluate the safety, effectiveness, and feasibility of haemodynamic‐guided heart failure (HF) management using a small sensor implanted in the pulmonary artery of New York Heart Association (NYHA) Class III HF patients in the UK, Europe, and Australia.
Methods and results
COAST is a prospective, international, multicentre, open‐label clinical study (NCT02954341). The primary clinical endpoint compares annualized HF hospitalization rates after 1 year of haemodynamic‐guided management vs. the year prior to sensor implantation in patients with NYHA Class III symptoms and a previous HF hospitalization. The primary safety endpoints assess freedom from device/system‐related complications and pressure sensor failure after 2 years. Results from the first 100 patients implanted at 14 out of the 15 participating centres in the UK are reported here. At baseline, all patients were in NYHA Class III, 70% were male, mean age was 69 ± 12 years, and 39% had an aetiology of ischaemic cardiomyopathy. The annualized HF hospitalization rate after 12 months was 82% lower [95% confidence interval 72–88%] than the previous 12 months (0.27 vs. 1.52 events/patient‐year, respectively, P < 0.0001). Freedom from device/system‐related complications and pressure sensor failure at 2 years was 100% and 99%, respectively.
Conclusions
Remote haemodynamic‐guided HF management, using frequent assessment of pulmonary artery pressures, was successfully implemented at 14 specialist centres in the UK. Haemodynamic‐guided HF management was safe and significantly reduced hospitalization in a group of high‐risk patients. These results support implementation of this innovative remote management strategy to improve outcome for patients with symptomatic HF.
Clinical registration number: http://ClinicalTrials.gov identifier: NCT02954341.
Aortic stenosis is one of the most common forms of acquired valvular heart disease. The development of symptoms, namely syncope, angina, or heart failure, in patients with severe aortic stenosis predicts a high likelihood of mortality. Aortic valve replacement is the current standard of care. In truly asymptomatic patients, the risk of sudden death is perceived to be low; therefore many advocate conservative management of these patients until symptoms develop. Emerging data suggest that certain markers may identify subsets of asymptomatic patients who are at a high risk of cardiac events. This review critically appraises the growing plethora of adverse prognostic markers that have been identified and evaluates how these parameters may influence clinical practice and potentially identify patients in whom early surgical intervention is warranted.
The funders of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication. Disclosure of potential conflict of interest: M. H. Shamji has received grants from ALK-Abell o, Regeneron, Merck, ASIT Biotech.sa, and the Immune Tolerance Network and has received personal fees from ASIT Biotech.sa, ALK-Abell o, Allergopharma, and UCB. E. N.
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