Atrial fibrillation (AF) is the most common arrhythmia, and its incidence is constantly increasing. It is associated with higher stroke risk and the presence of sleep disorders and dementia. The ...choice between rhythm and rate control in AF patients remains a debated topic, and it should be tailored on specific patient characteristics. In specific situations, electrical cardioversion (ECV) for rhythm control represents the preferred choice; in particular, in patients affected by cardiopathy and/or heart failure. Because of relevant AF social costs, there is a growing interest in developing new devices for large-scale screening and monitoring programs in patients affected or at risk of AF, to reduce the incidence of disabling events.
The aim of this study was to evaluate the feasibility of the use of a set-up for multi-parametric monitoring of candidates to AF ECV. In particular, new technologies were exploited for photoplethysmographic (PPG) and electroencephalographic (EEG) signal registration, integrated with clinical and instrumental data. We analyzed the effect of AF ECV on heart rate variability (HRV) and vascular age parameters derived from PPG signals registered with Empatica (CE 1876/MDD 93/42/EEC; Empatica S.r.l, Milan, Italy), and on EEG sleep pattern registered with Neurosteer (IEC 60601-1-2; Neurosteer Inc., Herzliya, Israel).
24 patients were enrolled, 75% males, mean age Formula: see text years. HRV analyses considering time frames registered before and after ECV showed a significant reduction of most variables (Formula: see text0.001), only LF/HF ratio did not differ significantly. Considering HRV parameters, comparisons between PPG signals registered during day or night before and after ECV showed a significant difference in SD1/SD2 ratio (p=0.035) and HF (Formula: see text). Regarding vascular age parameters, a significant reduction was observed in both turning point ratio (TPR) and a wave after ECV (Formula: see text). Moreover, we observed that patients with Mini-Mental State Examination (MMSE) ≤28 presented higher values of TPR (Formula: see text versus Formula: see text, Formula: see text) and CHA
2
DS
2
-VASc score (congestive heart failure, hypertension, age, diabetes mellitus, prior stroke or transient ischemic attack or thromboembolism, vascular disease, age, sex category) (Formula: see text versus Formula: see text, p=0.022). Considering sleep patterns, a tendency to higher coherence was observed in registrations acquired during AF than in presence of sinus rhythm, or considering signals registered before and after ECV for each patient.
In conclusion, the use of this new setup of multiparametric monitoring of candidates to ECV showed significant modifications on vascular age parameters derived from PPG signals measured before and after ECV. Moreover, a possible AF effect on sleep pattern registered with Neurosteer was noticed, but more data are necessary to confirm these preliminary results.
Hypoglycaemia unawareness and severe hypoglycaemia can increase fear of hypoglycaemia and the risk of subsequent hypoglycaemic events. We aimed to assess the safety and efficacy of insulin pump ...therapy with integrated continuous glucose monitoring (CGM) and a suspend-before-low feature (Medtronic MiniMed 640G with SmartGuard) in hypoglycaemia-prone adults with type 1 diabetes.
SMILE was an open-label randomised controlled trial done in people aged 24-75 years with type 1 diabetes for 10 years or longer, HbA
values of 5·8-10·0% (40-86 mmol/mol), and at high risk of hypoglycaemia (recent severe hypoglycaemia or hypoglycaemia unawareness defined by a Clarke or Gold score ≥4). Participants were enrolled from 16 centres (eg, clinics, hospitals, or university medical centres) in Canada, France, Italy, the Netherlands, and the UK. After baseline run-in phase (2 weeks), participants were randomly assigned to the MiniMed 640G pump (continuous subcutaneous insulin infusion) with self-monitoring of blood glucose (control group) or to the MiniMed 640G system with the suspend-before-low feature enabled (intervention group), for 6 months. The study statistician analysing the data was masked to group assignment until final database lock; because of the nature of the intervention, participants and treating clinicians could not be masked to group assignment. The primary outcome was the mean number of sensor hypoglycaemic events, defined as 55 mg/dL (3·1 mmol/L) or lower, and was analysed on an intention-to-treat basis in all randomly assigned participants. This trial is registered with ClinicalTrials.gov, number NCT02733991, and is completed.
Between Dec 7, 2016, and March 27, 2018, 153 participants with a mean age 48·2 12·4 years were randomly assigned: 77 to the control group (mean age 47·4 12·5 years) and 76 to the intervention group (mean age 49·0 12·2 years). After 6 months, the intervention group had significantly fewer hypoglycaemic events per participant per week (1·1 SD 1·2 vs 4·1 3·4 mean events, model-based treatment effect -2·9 95% CI -3·5 to -2·3; p<0·0001) and fewer severe hypoglycaemic events (instances requiring third-party assistance with carbohydrate or glucagon administration, or other resuscitative actions) overall (three vs 18; p=0·0036). The most common adverse events were hypoglycaemia (observed in ten 13% of 77 participants in the control group vs four 5% of 76 in the intervention group) and hyperglycaemia (observed in seven 9% of 77 vs seven 9% of 76). No serious adverse device effects or episodes of diabetic ketoacidosis were reported.
Insulin pump therapy with integrated CGM and a suspend-before-low feature reduced the frequency of sensor hypoglycaemic and severe hypoglycaemic events in hypoglycaemia-prone adults compared with use of continuous subcutaneous insulin infusion without real-time CGM. These results suggest that this technology could be beneficial in this high-risk population.
Medtronic International Trading Sàrl and Medtronic Canada.
ABSTRACT
Background: The prognosis of patients with untreated pulmonary arterial hypertension has historically been poor, but recent advances in our understanding of its pathobiology have led to the ...development of numerous therapeutic options over the last decade.
Methods: Systematic literature review of all randomised studies performed in patients with pulmonary arterial hypertension including long-term extension observations (Medline 1990–2007).
Findings: This article provides an overview of the currently available data on the short and long-term effects of emerging agents on exercise capacity, functional capacity, haemodynamics, quality of life, and survival in patients with pulmonary arterial hypertension. Prostanoids, endothelin receptor antagonists, and phosphodiesterase‐5 inhibitors have shown great promise in short-term randomised clinical trials, but the long-term effects of these classes of medication have not been well established to date.
Conclusion: Several long-term cohort studies have recently suggested that these drugs can maintain their beneficial effects on important clinical outcomes, but further studies will be needed before definitive conclusions can be drawn regarding the ultimate utility and optimal role of each agent in the therapeutic repertoire.
The pathophysiologic mechanisms of pulmonary arterial hypertension (PAH) are initiated by the progressive obstructive changes of the pulmonary resistance vessels which lead to the increase of the ...afterload of the right ventricle (RV) that responds with functional and structural adaptations. The RV remodelling compensates for a variable period of time but ultimately may fail leading to heart failure and death. The depression of myocardial contractility seems to be one of the primary events in the progression of heart failure in a chronically overloaded RV. However, afterload mismatch remains the leading determinant of heart failure in patients with both PAH and chronic thrombo-embolic pulmonary hypertension. Different therapies induce a variable degree of reverse remodelling on the heart changes typical of PAH. The extent of this effect is strictly related to the reduction of RV afterload. The best results are observed in patients who underwent lung transplantation, pulmonary endoarterectomy and in vasoreactive subjects responders to chronic treatment with calcium channel blocking agents. The RV reverse remodelling effects of the new targeted therapies in non-vasoreactive PAH patients appear to be only mild to moderate.
ABSTRACT
Background: Remodelling of the heart in patients with pulmonary arterial hypertension (PAH) involves both the right and left ventricles. The objective of the present study was to analyse the ...dimensions of the right and left ventricles as assessed by echocardiography, and to compare this with haemodynamics and exercise capacity in patients with PAH.
Materials and methods: Transthoracic echocardiogram, exercise capacity as assessed by the 6-minute walk test and right-heart catheterization were performed within 1 week in 66 consecutive patients with PAH. Univariate correlation and multiple regression analyses were performed to relate echocardiographic and clinical variables.
Results: Left ventricular end-diastolic area index had the best correlation with cardiac index (r = 0.62; p < 0.001) and 6-minute walk distance (r = 0.56; p < 0.001). The ratio of the right to left ventricular area correlated with right atrial pressure (r = 0.62; p < 0.001). Right ventricular percent change in area correlated with cardiac index (r = 0.51; p < 0.001). No correlations were observed between the right and left ventricular dimensions.
Conclusions: Left ventricular dimensions and the ratio of the right to left ventricular area correlated with resting haemodynamics and exercise capacity in patients with pulmonary arterial hypertension. These correlations were stronger than those observed with right ventricular dimensions alone. Left ventricular dimensions are important for the non-invasive evaluation of severity of patients with pulmonary arterial hypertension.
ABSTRACT
Background: The pathogenesis of idiopathic pulmonary arterial hypertension (IPAH) is unknown. Recent molecular and immunohistochemical evidence has demonstrated the presence of Kaposi's ...sarcoma-associated herpes virus (KSHV) at high frequency in lung tissue from patients with IPAH, suggesting a possible role for this virus in the pathogenesis of the disease.
Materials and methods: Eighty-seven patients with IPAH (n = 45) or other forms of pulmonary hypertension (n = 42) were prospectively assessed for serologic evidence of KSHV, Epstein–Barr virus (EBV) and human cytomegalovirus (HCMV) infection. Immunofluorescence assays specific for antibodies against latency-associated and lytic antigens of KSHV, as well as commercially available kits that detect antibodies against HCMV and EBV nuclear antigens, were employed.
Results: Only one patient with IPAH (2.2%) and one of the patients with other forms of pulmonary hypertension tested seropositive for KSHV. In contrast, 100% and more than 90% of patients with both forms of pulmonary hypertension were positive for EBV and HCMV antibodies, respectively.
Conclusions: Italian patients with IPAH do not exhibit serologic evidence of KSHV infection despite a normal ability to mount antibody-mediated responses toward human herpes viruses. KSHV is unlikely to play a role in the pathogenesis of IPAH.
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