OBJECTIVES
The objective of this study was to evaluate the safety and performance of a novel, beating heart procedure that enables echocardiographic-guided beating heart implantation of expanded polytetrafluoroethylene (ePTFE) artificial cords on the posterior mitral leaflet of patients with degenerative mitral regurgitation.
METHODS
Two prospective multicentre studies enrolled 13 (first-in-human) and 52 subjects, respectively. Patients were treated with the HARPOON beating heart mitral valve repair system. The primary (30-day) end point was successful implantation of cord(s) with mitral regurgitation reduction to ≤moderate. An independent core laboratory analysed echocardiograms.
RESULTS
Of 65 patients enrolled, 62 (95%) achieved technical success, 2 patients required conversion to open surgery and 1 procedure was terminated. The primary end point was met in 59/65 (91%) patients. Among the 62 treated patients, the mean procedural time was 2.1 ± 0.5 h. Through discharge, there were no deaths, strokes or renal failure events. At 1 year, 2 of the 62 patients died (3%) and 8 (13%) others required reoperations. At 1 year, 98% of the patients with HARPOON cords were in New York Heart Association class I or II, and mitral regurgitation was none/trace in 52% (n = 27), mild in 23% (n = 12), moderate in 23% (n = 12) and severe in 2% (n = 1). Favourable cardiac remodelling outcomes at 1 year included decreased end-diastolic left ventricular volume (153 ± 41 to 119 ± 28 ml) and diameter (53 ± 5 to 47 ± 6 mm), and the mean transmitral gradient was 1.4 ± 0.7 mmHg.
CONCLUSIONS
This initial clinical experience with the HARPOON beating heart mitral valve repair system demonstrates encouraging early safety and performance.
Clinical registration numbers
NCT02432196 and NCT02768870.
People over 65 years of age constitute over 80% of patients with heart failure (HF) and the incidence of HF is 10 per 1,000 in people aged above 65 years. Approximately 25% of older patients with HF exhibit evidence of frailty. Frail patients with cardiovascular disease (CVD) have a worse prognosis than non-frail patients, and frailty is an independent risk factor for incident HF among older people. Planning the treatment of individuals with HF and concomitant frailty, one should consider not only the limitations imposed by frailty syndrome (FS) but also those associated with the underlying heart disease. It needs to be emphasized that all patients with HF and concomitant FS require individualized treatment.
Heart failure (HF) is a global health problem inherent in an ageing population with coexisting cardiovascular diseases. Based on the data from the National Health Fund (NFZ) currently, approximately 1.2 million Polish people suffer from HF, and 140,000 of them die annually. Recently Poland was ranked 5th among the European Union countries in terms of the number of patients with diagnosed HF and 1st in terms of the number of HF hospitalizations (547 per 100,000 population) among 34 countries associated in the Organization for Economic Cooperation and Development (OECD).
BACKGROUND A myocardial bridge (MB) is defined as a congenital anomaly, in which a segment of an epicardial coronary artery takes an intramuscular course. AIMS The aim of the study was to evaluate the prevalence of MB in coronary arteries among patients who were diagnosed using coronary angiography. METHODS Data were obtained from the National Polish Percutaneous Interventions Registry for patients hospitalized between January 1, 2014, and December 31, 2016, in invasive cardiology departments in Poland and divided into groups with and without MB. RESULTS The study included 298 558 patients. The non-MB group comprised 296 133 patients (99.19%; women, 38.01%), while the MB group included 2425 patients (0.81%; women, 39.98%). The most frequent location of MB was the left anterior descending artery (n = 2355; 97.11% of patients). The MB group less often had diabetes (14.68% vs 21.63%), previous stroke (1.61% vs 2.96%), previous myocardial infarction (10.97% vs 21.97%), kidney disease (2.8% vs 5.04%), previous coronary artery bypass graft (1.03% vs 5.64%), previous percutaneous coronary intervention (13.20% vs 25.86%) than the non-MB group (P <0.0001). The incidence of acute coronary syndromes was lower in the MB group (P <0.0001), while smoking was more common (18.76% vs 16.87%, P <0.01). CONCLUSIONS Patients with MB were younger and had fewer comorbidities and risk factors for atherosclerosis than patients without MB. The condition was more common among patients with stable coronary artery disease. Smoking and female sex appeared to be associated with a more clinically symptomatic presentation of MB.
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