Safety of in-hospital insertable cardiac monitor procedures performed outside the traditional settings: results from the Reveal LINQ in-office 2 international study

Duration; Holding area; Insertable cardiac monitorDuració; Sala d'espera; Monitor cardíac inseribleDuración; Sala de espera; Monitor cardíaco insertableBACKGROUND: Historically, the majority of insertable cardiac monitor (ICM) procedures were performed in the cardiac catheterization (cath) lab, electrophysiology (EP) lab, or operating room (OR). The miniaturization of ICMs allows the procedure to be relocated within the hospital without compromising patient safety. We sought to estimate the rate of untoward events associated with procedures performed within the hospital but outside the traditional settings and to characterize resource utilization, procedure time intervals, and physician experience. METHODS: The Reveal LINQ in-Office 2 (RIO 2) International study was a single arm, multicenter, prospective study. Patients indicated for an ICM and willing to undergo device insertion outside the cath/EP lab or OR were eligible and followed for 90 days after insertion. RESULTS: A total of 191 patients (45.5% female aged 63.8 ± 26.9 years) underwent successful Reveal LINQ ICM insertion at 17 centers in Europe, Canada and Australia. The median total visit duration was 106 min (interquartile range [IQR]: 55-61). Patient preparation and patient education accounted for 10 min (IQR: 5-20) and 10 min (IQR: 8-15) of total visit duration, respectively. Preparation and education occurred in the procedure room for 90.6 and 60.2% of patients, respectively. There were no untoward events (0.0, 95% CI: 0.0-2.1%) though four patients presented with procedure-related adverse events that did not require invasive intervention. Physicians rated procedure location as convenient or very convenient. CONCLUSIONS: The Reveal LINQ™ ICM insertion can be safely and efficiently performed in the hospital outside the cath/EP lab or OR. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT02412488 ; registered on April 9, 2015.This study was sponsored by Medtronic, Inc

Albiglutide and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease (Harmony Outcomes): a double-blind, randomised placebo-controlled trial

Background: Glucagon-like peptide 1 receptor agonists differ in chemical structure, duration of action, and in their effects on clinical outcomes. The cardiovascular effects of once-weekly albiglutide in type 2 diabetes are unknown. We aimed to determine the safety and efficacy of albiglutide in preventing cardiovascular death, myocardial infarction, or stroke. Methods: We did a double-blind, randomised, placebo-controlled trial in 610 sites across 28 countries. We randomly assigned patients aged 40 years and older with type 2 diabetes and cardiovascular disease (at a 1:1 ratio) to groups that either received a subcutaneous injection of albiglutide (30–50 mg, based on glycaemic response and tolerability) or of a matched volume of placebo once a week, in addition to their standard care. Investigators used an interactive voice or web response system to obtain treatment assignment, and patients and all study investigators were masked to their treatment allocation. We hypothesised that albiglutide would be non-inferior to placebo for the primary outcome of the first occurrence of cardiovascular death, myocardial infarction, or stroke, which was assessed in the intention-to-treat population. If non-inferiority was confirmed by an upper limit of the 95% CI for a hazard ratio of less than 1·30, closed testing for superiority was prespecified. This study is registered with ClinicalTrials.gov, number NCT02465515. Findings: Patients were screened between July 1, 2015, and Nov 24, 2016. 10 793 patients were screened and 9463 participants were enrolled and randomly assigned to groups: 4731 patients were assigned to receive albiglutide and 4732 patients to receive placebo. On Nov 8, 2017, it was determined that 611 primary endpoints and a median follow-up of at least 1·5 years had accrued, and participants returned for a final visit and discontinuation from study treatment; the last patient visit was on March 12, 2018. These 9463 patients, the intention-to-treat population, were evaluated for a median duration of 1·6 years and were assessed for the primary outcome. The primary composite outcome occurred in 338 (7%) of 4731 patients at an incidence rate of 4·6 events per 100 person-years in the albiglutide group and in 428 (9%) of 4732 patients at an incidence rate of 5·9 events per 100 person-years in the placebo group (hazard ratio 0·78, 95% CI 0·68–0·90), which indicated that albiglutide was superior to placebo (p<0·0001 for non-inferiority; p=0·0006 for superiority). The incidence of acute pancreatitis (ten patients in the albiglutide group and seven patients in the placebo group), pancreatic cancer (six patients in the albiglutide group and five patients in the placebo group), medullary thyroid carcinoma (zero patients in both groups), and other serious adverse events did not differ between the two groups. There were three (<1%) deaths in the placebo group that were assessed by investigators, who were masked to study drug assignment, to be treatment-related and two (<1%) deaths in the albiglutide group. Interpretation: In patients with type 2 diabetes and cardiovascular disease, albiglutide was superior to placebo with respect to major adverse cardiovascular events. Evidence-based glucagon-like peptide 1 receptor agonists should therefore be considered as part of a comprehensive strategy to reduce the risk of cardiovascular events in patients with type 2 diabetes. Funding: GlaxoSmithKline

Cumulative Troponin T Release after Acute Myocardial Infarction. Influence of Reperfusion

Peer Reviewe

Estimation of Myocardial Infarct Size from Plasma Myoglobin or Fatty Acid-Binding Protein. Influence of Renal Function

Peer Reviewe

Multimodality treatment for anaplastic thyroid carcinoma - Treatment outcome in 75 patients

Purpose: To retrospectively analyze the outcome of patients with anaplastic thyroid carcinoma (ATC) treated in the Erasmus MC. Material and methods: Seventy-five ATC-patients were treated between 1972 and 2003. Mean age was 68 years. Tumor stage was IVA in 9%, IVB in 51%, and IVC in 40%. Thirty-six patients underwent up-front surgery, with 53% resulting in R0/R1 resection. Before 1988 adjuvant treatment consisted of conventional radiotherapy (RT) and/or chemotherapy (CT). As of 1988, 30 eligible patients were enrolled in a newly designed protocol. This consists of locoregional RT in 46 fractions of 1.1 Gy, given twice daily, followed by prophylactic irradiation of the lungs (PLI) in 5 daily fractions of 1.5 Gy. During radiation, low-dose Doxorubicine (15 mg/m(2)) is administered weekly and is followed by adjuvant Doxorubicine (50 mg/m(2)) 3-weekly up to a cumulative dose of 550 mg/m(2). Twenty-five ineligible patients were treated conventionally. Results: Overall median survival was 3 months, 1-year OS 9%. Locoregional control was significantly higher in patients who had undergone R0/R1 resection or chemoradiation, with best results for patients who underwent both (complete remission in 89%). However, the survival benefit of patients who reached CR remained borderline (median OS 7 months, 1-year OS 32%). Three patients survived for more than 5 years; all had undergone R0/R1 surgical resection and chemoradiation. Acute toxicity in the protocol group was significantly higher than in the nonprotocol group, with 46% versus 11% grade 3 pharyngeal and/or esophageal toxicity. Conclusion: Despite the ultimately dismal prognosis of ATC-patients, multimodality treatment significantly improved local control and improved the median survival. (C) 2009 Elsevier Ireland Ltd. All rights reserved. Radiotherapy and Oncology 92 (2009) 100-10

Tailored Telemonitoring in patients with heart failure: results from a multicentre randomized controlled trial (the TEHAF-study)

Recent increases in heart failure tend to overload the healthcare system. Consequently, there is a need for innovative strategies to reduce heart failure hospitalizations. A multicentre randomized controlled trial was carried out to test the hypothesis that telemonitoring reduces heart failure hospitalizations during 1 year follow-up. The mean age of the 382 participating patients was 71.5 (3293) years; the mean left ventricular ejection fraction was 0.38, and in 61 it was 0.45. Mean time to first heart failure-related hospitalization was 161 days for the intervention group and 139 days for the usual-care group; hospitalizations occurred in 18 (9.1) compared with 25 (13.5) patients, with a total number of 24 and 43 hospitalizations, respectively [KaplanMeier P 0.151, hazard ratio (HR) 0.65, 95 confidence interval (CI) 0.351.17]. Subgroup analysis of the primary endpoint showed benefits for three subgroups: duration of heart failure, having a pacemaker, and co-habiting. The combined endpoint of heart failure admission and all-cause mortality was similar for both groups (KaplanMeier P 0.641, HR 0.89, 95 CI 0.691.83). No differences were found regarding secondary endpoints, except for the reduced number of face to face contacts with the heart failure nurse (MannWhitney P 0.001). Mortality was 18 (9.1) in the intervention group and 12 (6.5) in the usual-care group (MannWhitney P 0.34, Cox regression analysis P 0.82). No significant differences were found regarding the primary endpoint, possibly caused by a relative underpowering of the population combined with well-treated study groups. However, telemonitoring tends to reduce heart failure (re)admissions and significantly decreases contacts with specialized nurses. Further research with pre-specified groups, as found in the subgroup analysis, is needed. Trial registration: NCT00502255

Effects of tailored telemonitoring on heart failure patients' knowledge, self-care, self-efficacy and adherence: A randomized controlled trial

10.1177/1474515113487464European Journal of Cardiovascular Nursing133243-252EJCN

Anaemia and renal dysfunction are independently associated with BNP and NT-proBNP levels in patients with heart failure

Background: Anaemia may affect 13-type natriuretic peptide (BNP) and N-terminal proBNP (NT-proBNP) levels, but this has not been well described in heart failure (1417) patients without the exclusion of patients with renal dysfunction. Aims: To study the influence of both anaemia and renal function on BNP and NT-proBNP levels in a large group of hospitalised HF patients. Methods and results: We studied 541 patients hospitalised for HF (mean age 71 +/- 11 years, 62% male, and left ventricular ejection fraction 0.33 +/- 0.14). Of these patients, 30% (n= 159) were anaemic (women: Hb <7.5 mmol/l, men: Hb <8.1 mmol/1). Of the 159 anaemic patients, 73% had renal dysfunction (eGFR <60 ml/min/1.73 m(2)) and of the non-anaemic patients, 57% had renal dysfunction. BNP and NT-proBNP levels were measured in all patients before discharge. In multivariable analyses both plasma haemoglobin and eGFR were independently related to the levels of BNP and NT-proBNP (standardised beta's of -0.16, -0.14 [BNP] and -0.19, -0.26 [NT-proBNP] respectively, P-values <0.01). Conclusion: Anaemia and renal dysfunction are related to increased BNP and NT-proBNP levels, independent of the severity of HE These results indicate that both anaemia and renal dysfunction should be taken into consideration during the interpretation of BNP and NT-proBNP levels in HF patients. (c) 2007 European Society of Cardiology. Published by Elsevier B.V. All rights reserved