Endoscopic pyloromyotomy for the treatment of severe and refractory gastroparesis: a pilot, randomised, sham-controlled trial.

OBJECTIVE: Endoscopic pyloromyotomy (G-POEM) is a minimally invasive treatment option with promising uncontrolled outcome results in patients with gastroparesis. DESIGN: In this prospective randomised trial, we compared G-POEM with a sham procedure in patients with severe gastroparesis. The primary outcome was the proportion of patients with treatment success (defined as a decrease in the Gastroparesis Cardinal Symptom Index (GCSI) by at least 50%) at 6 months. Patients randomised to the sham group with persistent symptoms were offered cross-over G-POEM. RESULTS: The enrolment was stopped after the interim analysis by the Data and Safety Monitoring Board prior to reaching the planned sample of 86 patients. A total of 41 patients (17 diabetic, 13 postsurgical, 11 idiopathic; 46% male) were randomised (21 G-POEM, 20-sham). Treatment success rate was 71% (95% CI 50 to 86) after G-POEM versus 22% (8-47) after sham (p=0.005). Treatment success in patients with diabetic, postsurgical and idiopathic gastroparesis was 89% (95% CI 56 to 98), 50% (18-82) and 67% (30-90) after G-POEM; the corresponding rates in the sham group were 17% (3-57), 29% (7-67) and 20% (3-67).Median gastric retention at 4 hours decreased from 22% (95% CI 17 to 31) to 12% (5-22) after G-POEM and did not change after sham: 26% (18-39) versus 24% (11-35). Twelve patients crossed over to G-POEM with 9 of them (75%) achieving treatment success. CONCLUSION: In severe gastroparesis, G-POEM is superior to a sham procedure for improving both symptoms and gastric emptying 6 months after the procedure. These results are not entirely conclusive in patients with idiopathic and postsurgical aetiologies. TRIAL REGISTRATION NUMBER: NCT03356067; ClinicalTrials.gov.

Slow QT interval adaptation to heart rate changes in normal ambulatory subjects.

BACKGROUND: Clinical formulas for QT correction utilize instantaneous HR. We showed previously that longer-term HR affects QT duration. We extend these findings, identifying more accurate models of QT behavior. METHOD: Multiple models of QT dependence on HR were tested in 2 independent populations. Holter recordings were analyzed in population A (healthy volunteers, n = 14, 6 males, age 26.9 ± 12.3 yr). The hypotheses generated in population A were tested in an independent group population B, healthy volunteers, n = 15, 9 males, age 52.9 ± 15.6 yr). Linear models of QT interval dependence on a weighted average of RR intervals in the preceding 3 minutes were compared to models based on the immediately preceding RR interval (instantaneous HR). RESULTS: In population A, linear models based on RR intervals over the preceding minute performed better than the best nonlinear model based on the single RR interval immediately preceding the QT interval. Linear models including HR values preceding the QT interval by more than 60 s further improved model fit. This model hierarchy was confirmed in population B. Linear formula for QT correction based on exponential decay of HR effect with 60 s time constant outperformed Bazett and Fridericia formulas in both populations. CONCLUSIONS: QT duration in normal ambulatory subjects is affected by noninstantaneous HR, including HR history dating back more than 60 s. Exponential decay of this "memory effect" with time constant of 1 minute provides an accurate description of QT adaptation. This may be of clinical importance when HR is not steady.

Use of fuzzy edge single-photon emission computed tomography analysis in definite Alzheimer's disease--a retrospective study.

BACKGROUND: Definite Alzheimer's disease (AD) requires neuropathological confirmation. Single-photon emission computed tomography (SPECT) may enhance diagnostic accuracy, but due to restricted sensitivity and specificity, the role of SPECT is largely limited with regard to this purpose. METHODS: We propose a new method of SPECT data analysis. The method is based on a combination of parietal lobe selection (as regions-of-interest (ROI)), 3D fuzzy edge detection, and 3D watershed transformation. We applied the algorithm to three-dimensional SPECT images of human brains and compared the number of watershed regions inside the ROI between AD patients and controls. The Student's two-sample t-test was used for testing domain number equity in both groups. RESULTS: AD patients had a significantly reduced number of watershed regions compared to controls (p < 0.01). A sensitivity of 94.1% and specificity of 80% was obtained with a threshold value of 57.11 for the watershed domain number. The narrowing of the SPECT analysis to parietal regions leads to a substantial increase in both sensitivity and specificity. CONCLUSIONS: Our non-invasive, relatively low-cost, and easy method can contribute to a more precise diagnosis of AD.

QT interval variability and adaptation to heart rate changes in patients with long QT syndrome.

BACKGROUND: Increased QT variability (QTV) has been reported in conditions associated with ventricular arrhythmias. Data on QTV in patients with congenital long QT syndrome (LQTS) are limited. METHODS: Ambulatory electrocardiogram recordings were analyzed in 23 genotyped LQTS patients and in 16 healthy subjects (C). Short-term QTV was compared between C and LQTS. The dependence of QT duration on heart rate was evaluated with three different linear models, based either on the RR interval preceding the QT interval (RR(0)), the RR interval preceding RR(0) (RR(-1)), or the average RR interval in the 60-second period before QT interval (mRR). RESULTS: Short-term QTV was significantly higher in LQTS than in C subjects (14.94 +/- 9.33 vs 7.31 +/- 1.29 ms; P < 0.001). It was also higher in the non-LQT1 than in LQT1 patients (23.00 +/- 9.05 vs 8.74 +/- 1.56 ms; P < 0.001) and correlated positively with QTc in LQTS (r = 0.623, P < 0.002). In the C subjects, the linear model based on mRR predicted QT duration significantly better than models based on RR(0) and RR(-1). It also provided better fit than any nonlinear model based on RR(0). This was also true for LQT1 patients. For non-LQT1 patients, all models provided poor prediction of QT interval. CONCLUSIONS: QTV is elevated in LQTS patients and is correlated with QTc in LQTS. Significant differences with respect to QTV exist among different genotypes. QT interval duration is strongly affected by noninstantaneous heart rate in both C and LQT1 subjects. These findings could improve formulas for QT interval correction and provide insight on cellular mechanisms of QT adaptation.

Role of quantitative bone scanning in the assessment of bone turnover in patients with Charcot foot.

OBJECTIVE: To assess the new quantitative bone scan parameters as markers of Charcot neuroosteoarthropathy (CNO) activity. RESEARCH DESIGN AND METHODS: Forty-two patients with acute (n = 21) and nonacute (n = 21) CNO underwent quantitative bone scanning. Patients with acute CNO were followed for 3-12 months and bone scans were repeated after treatment. New quantitative parameters were assessed and compared with markers of bone turnover and with skin temperature difference (STD). RESULTS: Significant correlations between quantitative bone scan parameters and bone turnover markers were observed (all P < 0.05). These parameters decreased after treatment of CNO, and its reduction to the baseline value correlated with differences of bone turnover markers and STD (all P < 0.05). CONCLUSIONS: Our study suggests that bone scanning can be used not only for diagnosis of CNO but also for monitoring disease activity by quantitative bone scan parameters.

Heart rate dependence of the QT interval duration: differences among congenital long QT syndrome subtypes.

INTRODUCTION: The heart rate dependence of QT interval duration is abnormal in patients with congenital long QT syndrome. Patients with LQT1 have a defective I(Ks) current, a major determinant of QT response to heart rate. METHODS AND RESULTS: We studied the heart rate dependence of QT interval duration in different long QT syndrome genotypes and control subjects using computerized QT measurements obtained from Holter recordings. The dependence of QT duration on heart rate is steeper in long QT syndrome than in control subjects (0.347 +/- 0.263 vs 0.162 +/- 0.083 at heart rate 100 beats/min; P < 0.05). In addition, QT interval is significantly longer in LQT2 and LQT3 than in LQT1 patients at slow (533 +/- 23 ms vs 468 +/- 30 ms at heart rate 60 beats/min; P < 0.0001) but not at rapid heart rate. The heart rate dependence of QT interval is steeper in LQT2 and LQT3 than in LQT1 (0.623 +/- 0.245 vs 0.19 +/- 0.079 at heart rate 100 beats/min; P < 0.05). For a given heart rate, the QT intervals vary more in LQT2 and LQT3 than in LQT1 patients (25.98 +/- 11.18 ms vs 14.39 +/- 1.55 ms; P < 0.01). CONCLUSION: Individual long QT syndrome genotypes differ with respect to QT interval dependence on heart rate. These differences may relate to the propensity of LQT2 and LQT3 patients to develop arrhythmias during bradycardia.