Hasenfuß, G. et al. (2016) A transcatheter intracardiac shunt device for heart failure with preserved ejection fraction (REDUCE LAP-HF): a multicentre, open-label, single-arm, phase 1 trial. Lancet, 387(10025), pp. 1298-1304.There may be differences between this version and the published version. You are advised to consult the publisher's version if you wish to cite from it.http://eprints.gla.ac.uk/123112/
AimsTo assess the feasibility, short-term durability and clinical outcomes of MitraClip w therapy for mitral regurgitation (MR) in patients with end-stage heart failure and a severely reduced left ventricular (LV) ejection fraction.
Methods and resultsWe analysed retrospectively collected data from seven European centres. Included in the study were 50 heart failure patients [mean age 70 + 11 years, 38 men (76%)] with a LV ejection fraction ≤25% and MR of at least grade 3+. All patients had functional MR, were in New York Heart Association (NYHA) functional class III or IV, and their mean logistic EuroSCORE was 34%. The patients underwent a total of 53 MitraClip w procedures; one or more clips were implanted in 50 procedures (48 patients), for an acute procedural success rate of 94%. Severity of MR was reduced in all successfully treated patients, 44 (92%) were discharged with MR ≤2+. Thirty-day mortality was 6%; cumulative survival at 6 months was 81.2%. Clinical and echocardiographic 6-month follow-up data were obtained from 32 and 31 successfully treated patients, respectively. At 6 months, MR ≤2+ was present in 27 (87%) of 31 patients, and 23 (72%) of 32 patients were in NYHA functional class I or II. Six-minute walk distance improved significantly, and significant reductions in LV volumes indicative of reverse LV remodelling were concordant with significant reductions in N-terminal pro-brain natriuretic peptide plasma levels.
ConclusionMitraClip w therapy reduces functional MR in patients with end-stage heart failure and marked LV dysfunction and entails clinical benefit at 6 months.--
FMR treatment with the MitraClip in CRT nonresponders was feasible, safe, and demonstrated improved functional class, increased LVEF, and reduced ventricular volumes in about 70% of these study patients.
Background-The strategy for treating patients with severe asymptomatic carotid artery stenosis and cardiac disease remains unresolved. Staged or combined carotid endarterectomy in these patients offers the potential benefit of decreased neurological morbidity during and after cardiac surgery; however, in high-risk patients with severe coronary artery disease, chronic obstructive pulmonary disease, or renal impairment, the incidence of death and stroke is significantly higher. Methods and Results-We report the results of a prospective, single-center study designed to evaluate the feasibility and safety of carotid artery angioplasty and stenting (CAS) before cardiac surgery in neurologically asymptomatic patients. The periprocedural and long-term outcomes of 356 consecutive patients who underwent CAS before cardiac surgery were analyzed. The procedural success rate of CAS was 97.7%. The death and stroke rate from time of CAS to 30 days after cardiac surgery was 4.8% (nϭ17). The myocardial infarction rate from time of CAS to 30 days after cardiac surgery was 2.0% (nϭ7), and the combined death, stroke, and myocardial infarction rate was 6.7% (nϭ24). Distal embolic protection devices were used in 40% of the cases. Conclusions-This large cohort of asymptomatic patients who underwent staged CAS and cardiac surgery experienced a low periprocedural complication rate. The high rate of freedom from death and stroke during the 5 years of follow-up supports the long-term durability of this approach. Our findings suggest that this new strategy may become a valuable alternative in the treatment of patients with combined carotid and cardiac disease.
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