A Prospective Clinical Study to EvaluAte the AbiliTy of the CloudCath System to Detect Peritonitis During In-Home Peritoneal Dialysis (CATCH).

Introduction: Peritonitis is the leading complication of peritoneal dialysis (PD). Patients are instructed to seek care promptly for signs (cloudy effluent) or symptoms (abdominal pain), and earlier treatment improves outcomes. The CloudCath Peritoneal Dialysis Drain Set Monitoring (CloudCath) system monitors turbidity in dialysis effluent and sends notifications of changes signaling possible peritonitis. Methods: We conducted this single-arm, open-label, multicenter study of CloudCath system use during PD. We deactivated system notifications to participants and investigators, who followed standard-of-care for peritonitis signs and symptoms. Effectiveness endpoints measured time between CloudCath system notifications and peritonitis events using International Society of Peritoneal Dialysis (ISPD) criteria. Results: Two hundred forty-three participants used the CloudCath system for 178.8 patient-years. Of 71 potential peritonitis events, 51 events (0.29 per patient-year) met ISPD white blood cell (WBC) count criteria. The system triggered notifications for 41 of 51 events (80.4%), with a median lead time of 2.6 days (10%-90% range, -1.0 to 15.7; P < 0.0001). Excluding 6 peritonitis events that occurred when the system was not in use, the system triggered notifications for 41 of 45 events (91.1%), with a median lead time of 3.0 days (10%-90% range, -0.5 to 18.8; P < 0.0001). Of the 0.78 notifications per patient-year, the majority were peritonitis events or nonperitonitis events such as exit site and tunnel infections or catheter/cycler issues. Conclusion: The CloudCath system detected peritonitis events during PD several days earlier than the current standard-of-care and has the capacity to send notifications that could expedite peritonitis diagnosis and treatment.

The EVEREST II Trial: design and rationale for a randomized study of the evalve mitraclip system compared with mitral valve surgery for mitral regurgitation.

BACKGROUND: Mitral valve surgery is the standard of care for patients with symptomatic mitral regurgitation (MR) or asymptomatic MR with evidence of left ventricular dysfunction or dilation. Whether an endovascular approach to repair can offer comparable effectiveness with improved safety remains to be determined in randomized trials. STUDY DESIGN: The EVEREST II Trial is a multicenter, randomized controlled trial to evaluate the benefits and risks of endovascular mitral valve repair using the MitraClip device compared with open mitral valve surgery (control) in patients with moderate or severe MR. Using a 2:1 randomization ratio, the trial is enrolling up to 186 MitraClip-treated subjects and 93 control subjects. Trial end points include a primary efficacy end point: the proportion of patients free from death, surgery for valve dysfunction, and with moderate-severe (3+) or severe (4+) MR at 12 months; the primary safety end point includes the proportion of patients with death, myocardial infarction, reoperation, nonelective cardiovascular surgery, stroke, renal failure, deep would infection, ventilation >48 hours, gastrointestinal complication, new permanent atrial fibrillation, septicemia, or transfusion of >or=2 U at 30 days or hospital discharge, whichever is longer. CONCLUSIONS: This randomized controlled trial is designed to evaluate the performance of endovascular mitral repair in comparison to open mitral valve surgery in patients with significant MR.

The amplitude of force variability is correlated in the knee extensor and elbow flexor muscles.

The purpose of this study was to determine motor output variability for different muscles in the same individuals. Ten young (21.7 +/- 3.4 years) and ten elderly (72.1 +/- 3.9 years) men underwent assessment of maximal isometric (MVC) and dynamic (1-RM) strength, and performed constant-force (2-50% MVC), constant-load (5-50% 1-RM load), and unloaded postural contractions as steadily as possible with the first dorsal interosseus (FDI), elbow flexors (EF), and knee extensors (KE). The coefficient of variation (CV) of force for isometric contractions and the standard deviation (SD) of acceleration for concentric, eccentric, and postural contractions were calculated. The 1-RM load, the CV of force for four of five isometric target forces, and the SD of acceleration during postural contractions were correlated between the EF and KE muscles. MVC force, 1-RM load, and SD of acceleration during postural contractions were not correlated between the FDI/EF or FDI/KE. The CV of force was correlated between the FDI/EF and FDI/KE for two of five isometric target forces. The SD of acceleration during concentric and eccentric contractions was not correlated between muscles. The normalized fluctuations during isometric contractions were greater for the FDI compared with the EF and KE. Elderly adults displayed greater fluctuations only for the FDI during low-force isometric and postural contractions. The dominant frequency of fluctuations was similar for the EF and KE muscles. The correlated fluctuations for the EF and KE muscles, within subjects, suggests that the two motor neuron pools transform the various neural inputs similarly.