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A multicenter study was undertaken to determine the failure rate of a specific polyurethane bipolar tined pacing lead, the Medtronic 4012 pacing lead. Six centers in the United States and Canada implanted 1,190 Medtronic 4012 pacing leads. The study was designed to determine the probability and clinical manifestations of lead failure. Only failures compatible with an insulation problem were included. The probability of a 4012 lead failure by Kaplan-Meier analysis was 20.9% at 6 years after implantation. Failures were manifested as sensing abnormalities, failure to capture, early battery depletion, and significant decrease in measured impedance compared with the previous impedance measurements. Of the 95 definite lead failures, 16 (16.8%) were associated with symptoms similar to those experienced before pacemaker placement. The observed failure rate is unacceptable, and strong consideration should be given to replacing the 4012 pacing lead in pacemaker-dependent patients and closely monitoring nondependent patients. [ABSTRACT FROM AUTHOR]

Objectives: Cardiovascular disease (CVD) risk calculators developed for the general population do not accurately predict CVD events in patients with RA. We sought to externally validate risk calculators recommended for use in patients with RA including the EULAR 1.5 multiplier, the Expanded Cardiovascular Risk Prediction Score for RA (ERS-RA) and QRISK2., Methods: Seven RA cohorts from UK, Norway, Netherlands, USA, South Africa, Canada and Mexico were combined. Data on baseline CVD risk factors, RA characteristics and CVD outcomes (including myocardial infarction, ischaemic stroke and cardiovascular death) were collected using standardized definitions. Performance of QRISK2, EULAR multiplier and ERS-RA was compared with other risk calculators [American College of Cardiology/American Heart Association (ACC/AHA), Framingham Adult Treatment Panel III Framingham risk score-Adult Treatment Panel (FRS-ATP) and Reynolds Risk Score] using c-statistics and net reclassification index., Results: Among 1796 RA patients without prior CVD [mean ( s . d .) age: 54.0 (14.0) years, 74% female], 100 developed CVD events during a mean follow-up of 6.9 years (12430 person-years). Estimated CVD risk by ERS-RA [mean ( s . d .) 8.8% (9.8%)] was comparable to FRS-ATP [mean ( s . d .) 9.1% (8.3%)] and Reynolds [mean ( s . d .) 9.2% (12.2%)], but lower than ACC/AHA [mean ( s . d .) 9.8% (12.1%)]. QRISK2 substantially overestimated risk [mean ( s . d .) 15.5% (13.9%)]. Discrimination was not improved for ERS-RA (c-statistic = 0.69), QRISK2 or EULAR multiplier applied to ACC/AHA compared with ACC/AHA (c-statistic = 0.72 for all) or for FRS-ATP (c-statistic = 0.75). The net reclassification index for ERS-RA was low (-0.8% vs ACC/AHA and 2.3% vs FRS-ATP)., Conclusion: The QRISK2, EULAR multiplier and ERS-RA algorithms did not predict CVD risk more accurately in patients with RA than CVD risk calculators developed for the general population., (© The Author 2017. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com)

Objective: This report summarizes the findings from a consensus process to identify potential classification criteria for polymyalgia rheumatica (PMR)., Methods: A 3-stage hybrid consensus approach was used to develop potential PMR classification criteria. The first stage consisted of a facilitated meeting of 27 international experts who anonymously rated the importance of 68 potential criteria. The second stage involved a meeting of the experts, who were provided with the results of the first round of ratings and were then asked to re-rate the criteria. In the third stage, the wider acceptance of the 43 criteria that received > 50% support at round 2 was evaluated using an extended mailed survey of 111 rheumatologists and 53 nonrheumatologists in the United States, Canada, and Northern and Western Europe., Results: A total of 68 and 50 criteria were identified and rated in round 1 and round 2, respectively. In round 2, 43 of the 50 items achieved at least 50% support, including 10 core criteria achieving 100% support. In round 3, over 70% of survey respondents agreed on the importance of 7 core criteria. These were age >or=50 years, duration >or=2 weeks, bilateral shoulder and/or pelvic girdle aching, duration of morning stiffness > 45 min, elevated erythrocyte sedimentation rate, elevated C-reactive protein, and rapid steroid response (> 75% global response within 1 wk to prednisolone/prednisone 15 20 mg daily). Among physical signs, more than 70% of survey respondents agreed on the importance of assessing pain and limitation of shoulder (84%) and/or hip (76%) on motion, but agreement was low for peripheral signs like carpal tunnel, tenosynovitis, and peripheral arthritis., Conclusion: There are differences in opinion as to what PMR is and how it should be treated. These findings make it important to develop classification criteria for PMR. The next step is to perform an international prospective study to evaluate the utility of candidate classification criteria for PMR in patients presenting with the polymyalgic syndrome.