Correction to: FMTVDM-TFM©â„—: True quantification requires standardization of the tool being used to measure, with a known, unchanging standard to produce accurate, consistent and reproducible quantified measurements.

The Editor wishes to clarify that the authors of the above named Letter provided ICMJE Conflict of Interest forms at the time of submission, and that the Journal omitted to include the resulting statement in the published Letter.

Long-term quality of life and risk factors for recurrence after laparoscopic repair of paraesophageal hernia.

IMPORTANCE: Laparoscopic repair of paraesophageal hernia (PEH) has been shown to result in excellent relief of symptoms and improved quality of life (QOL) despite a relatively high radiographically identified recurrence rate. OBJECTIVE: To assess potential risk factors for recurrence and long-term change in QOL after laparoscopic repair of PEH. DESIGN, SETTING, AND PARTICIPANTS: This was a prospective study of 111 patients who underwent elective laparoscopic repair of type III PEH with biological mesh buttressed over a primary cruroplasty from April 3, 2009, through July 31, 2014, at the Department of Surgery, Johns Hopkins University of Medicine. We administered a modified version of a validated gastroesophageal reflux disease-specific QOL tool to patients before and at 2, 12, and 36 months after the procedure. Higher QOL scores represent greater severity of symptoms. An upper gastrointestinal tract barium-contrast radiographic examination was performed at 1 year to assess for recurrence. Demographic factors, comorbidities, and preoperative radiographic findings were analyzed as possible indicators for recurrence using logistic regression. MAIN OUTCOMES AND MEASURES: Quality of life, measured by the gastroesophageal reflux disease-specific QOL tool, and recurrence, defined as a PEH of greater than 2 cm. RESULTS: Median patient age was 61 years, 63.1% of patients were women, and 81.1% of patients were white. Four patients required reoperation, of which only 1 was for symptomatic recurrent PEH. The mean follow-up time for the 36-month QOL assessment was 43.5 months. The overall preoperative and 2-, 12-, and 36-month QOL scores were 28.50, 10.18, 9.74, and 10.58, respectively (P < .001). Recurrences were found in 19 of the 70 patients (27%) who completed the 1-year radiographic examination. Compared with baseline, all individual symptoms improved significantly except for early satiety (mean [SD] score, 3.18 [1.88] at baseline vs 2.07 [1.70] at the 36-month follow-up; P = .07), nausea (1.69 [1.63] vs 0.77 [1.25]; P = .08), pain with swallowing (1.06 [1.50] vs 0.53 [0.90]; P = .73), and bloating/gas (3.28 [1.71] vs 2.23 [1.72]; P = .05) at the 36-month QOL assessment. Although not statistically significant, preoperative hernias containing most of the stomach were more likely to recur after repair when compared with those involving gastric cardia and fundus (odds ratio, 3.74 [95% CI, 0.93-15.14]; P = .06). CONCLUSIONS AND RELEVANCE: Overall, laparoscopic repair of PEH with biological mesh results in excellent long-term QOL. The cause of recurrence is likely multifactorial and individualized to each patient. Further evaluation of novel techniques and unidentified patient factors is needed.

Defining recurrence after paraesophageal hernia repair: correlating symptoms and radiographic findings.

BACKGROUND: Laparoscopic repair of paraesophageal hernia (PEH) has been shown to result in excellent relief of symptoms and improved quality of life (QOL) despite a high radiographically identified recurrence rate. Because there is no uniform definition of PEH recurrence, it is difficult to compare studies reporting on this. This study attempts to introduce consistency to the definition of PEH recurrence based on correlation of symptoms and radiographic findings. METHODS: This is an analysis of data derived from an ongoing prospective study. From April 2009 to December 2012, we enrolled 101 patients who underwent elective laparoscopic PEH repair with bioprosthesis buttressed over a primary cruroplasty. A validated gastroesophageal reflux disease-specific QOL tool was administered to patients before, and at 2 and 12 months postoperatively. Upper gastrointestinal barium contrast examination (UGI) was performed at 1 year. RESULTS: Of 101 patients, 13 were not available for follow-up, 58 reached the 1-year milestone for interval UGI, and 1 patient required reoperation for symptomatic recurrent PEH. There was no relationship between total QOL score and radiographic recurrent hernia (RRH); however, significant deterioration in many symptoms was seen in RRH > 2 cm. Based on these findings, we defined recurrence as RRH > 2 cm and calculated our recurrence rate as 28% (n = 16). CONCLUSION: Our analysis of symptom scores after laparoscopic PEH repair suggests that significant worsening occurs with RRH > 2 cm. Given that there is no consistent description of recurrent PEH, we suggest this as a possible standardized definition. Overall, patients with recurrent PEHs continue to experience excellent QOL and rarely require reoperation.

Safety of ephedra and related anorexic medications.

BACKGROUND: The increasing incidence of obesity, anorexia and bulimia has resulted in an increased interest in anorexic medications that can modify human eating behaviors. History and medical research is replete with consequences of addressing behavioral disorders with pharmacologic approaches to intervention in the absence of cognitive therapies such as self-efficacy counseling, which we and others have shown to be extremely effective at modifying behaviors previously thought to be resistant to such treatment. This paper looks at some of the ramifications of using anorexic medications, including ephedra, in modern society's efforts to address weight-related health problems. METHODS: A review of the medical literature about ephedra and related anorexic medications was undertaken as they are linked to eating disorders. The findings included limited evidence of clinical benefit from such medications with concerns over side effects such as cardiovascular, gastrointestinal, CNS and other potential problems. We provide information about current recommendations for using these medications along with concerns for their use. CONCLUSION: This paper is a review of ephedra and similar anorexic medications and nonprescription substances used in the treatment of obesity and other eating disorders along with some of the potential and proven consequences of such treatment.

What is the relationship between myocardial perfusion imaging and coronary artery disease risk factors and markers of inflammation?

The treatment of coronary artery disease (CAD) is clinically measured by monitoring changes in venous lipids and inflammatory markers. There is currently no established quantified relationship between coronary flow reserve and markers of inflammatory CAD. A total of 120 men and women underwent quantified measurement of coronary blood flow using SPECT imaging at baseline and 1 year later. They had fasting venous blood work obtained at baseline and 1 year later. These markers of lipids and inflammation included, total cholesterol, low-density lipoprotein cholesterol, very low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides, lipoprotein-a, homocysteine, fibrinogen, C-reactive protein, and interleukin-6. Regression analysis reveals no general statistical relationship between these markers and coronary blood flow as measured by myocardial perfusion imaging. However, when changes in indices are considered and changes in risk factors are compared with changes in ischemia, blood factor based estimates yield an adjusted R2 = 0.31, R = 0.57, P < .0001. Initial levels of coronary ischemia cannot be diagnostically inferred from baseline values in lipid and inflammatory markers of coronary artery disease. When change in coronary blood flow is quantified using SPECT imaging, 6 independent underlying blood factors provided statistically useful information in identifying changes in coronary blood flow. Although the relationship of changes is statistically significant ( P < .0001), quantification of coronary blood flow by SPECT imaging provides physiologic status information, which cannot be inferred from fasting markers of lipids and inflammation status.

Blood glucose and cerebrovascular disease in nondiabetic patients.

The objective of this study was to determine if elevations in blood glucose, in a range classified as impaired fasting glucose, are associated with a greater incidence of cerebrovascular disease in nondiabetic patients. Morning blood glucose determinations were evaluated with respect to subsequent stroke using records from 28 477 nondiabetic patients. Strokes and transient ischemic attacks (TIA) were identified from ICD-9 coding for a new event more than a year after baseline glucose determinations. Of the patients studied, 593 suffered stroke or TIA over a total risk analysis time of 100 982 years. Higher baseline morning glucose (100 to 126 mg/dL vs under 100 mg/dL) was associated with 31% more diagnoses (2.4% vs 1.8%, P < .001). Incidence rate was 5.3 per 1000 patient-years for those patients with glucose over 100 mg/dL and 3.9 per 1000 patient-years for those with glucose under 100 mg/dL (P <.001). Kaplan-Meier analysis showed that elevated baseline glucose was associated with a progressive, increased risk with time. A Cox proportional hazards model with adjustment for age, body mass index, sex, creatinine, lipids, smoking, and medications showed that elevated fasting glucose was associated with an increased hazard for a new event (hazard ratio 1.24, 95% CI 1.05-1.46, glucose over 100 mg/dL vs under 100 mg/dL). Thus, patients with higher baseline blood glucose levels in the absence of diabetes and after adjustment for covariants have a significantly greater risk for development of cerebrovascular disease.

The longitudinal effects of fenfluramine-phentermine use.

The use of previous anorectic medications and the combined use of the anorectic medications fenfluramine and phentermine (Fen-Phen) have been associated with varying degrees of valvular regurgitation and pulmonary hypertension. More recent reports have suggested a lower incidence of both than was previously reported. Comparisons of patients with similar body mass index (BMI) have been missing as well as information regarding chamber dimensions and pressures. Using transthoracic 2D, M-mode, and Doppler echocardiography, 57 men and women (30 Fen-Phen and 27 BMI-matched individuals/BMIMCG) were studied to determine their chamber dimensions, wall motion, diastolic function, valvular abnormalities, left ventricular ejection fractions (LVEFs), and pulmonary artery pressures (pAPs). The 30 Fen-Phen subjects were studied shortly after discontinuing the medications and again 6 to 12 months later. The results in these subjects were then compared with the valvular findings of 660 randomly selected cardiac patients with non-Fen-Phen-induced heart disease (NFPHD). Valvular regurgitation was greatest among patients who had recently discontinued the use of Fen-Phen (EFP) with 57% of all valves having regurgitation, 87.5% of which were "mild." These same individuals also had the largest left ventricles at end (LVEDD) diastole (5.03 +/-0.22 cm) and systole (LVESD). The LVESDs were statistically larger (p

The effect of high-, moderate-, and low-fat diets on weight loss and cardiovascular disease risk factors.

Over 60% of Americans are overweight and a number of popular diets have been advocated, often without evidence, to alleviate this public health hazard. This study was designed to investigate the effects of several diets on weight loss, serum lipids, and other cardiovascular disease risk factors. One hundred men and women followed one of four dietary programs for 1 year: a moderate-fat (MF) program without calorie restriction (28 patients); a low-fat (LF) diet (phase I) (16) ; a MF, calorie-controlled (phase II) diet (38 patients); and a high-fat (HF) diet (18 subjects) [corrected]. Weight, total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), triglycerides (TG), homocysteine (Ho), and lipoprotein(a) [Lp(a)], were measured every 4th month. The TC/HDL-C ratio was calculated and fibrinogen levels were measured at baseline and after one year. The MF diet resulted in a 2.6% (NS) decrease in weight compared with 18.4% (p=0.045) decrease in patients on phase I, 12.6% (p=0.0085) decrease in patients on phase II, and 13.7% (p=0.025) decrease in those on the HF diet. TC was reduced by 5% (NS) in the MF group, 39.1% (p=0.0005) in the phase I group, and 30.4% (p=0.0001) in the phase II group. HF group had a 4.3% (NS) increase in TC. LDL-C was reduced by 6.1% (NS) on MF, 52.0% (p=0.0001) on phase I, and 38.8% (p=0.0001) on phase II. Patients on HF had a 6.0% (NS) increase in LDL-C. There were nonsignificant reductions in HDL-C in those on MF (-1.5%) and HF (-5.8%). Patients on phase I showed an increase in HDL-C of 9.0% (NS), while those on phase II diet had a 3.6% increase (NS) in HDL-C. TC/HDL-C increased (9.8%) only in patients following the high-fat diets (NS). Patients on MF had a 5.3% (NS) reduction in TC/HDL-C, while those on LF had significant reductions on the phase I ( -45.8%; p=0.0001) diet and phase II diet (-34.7%; p=0.0001). TG levels increased on both the MF (1.0%) and HF (5.5%) diets, although neither was statistically significant. People following the phase I and II diets showed reductions of 37.3% and 36.9%, respectively. Ho levels increased by 9.7% when people followed the MF diet and by 12.4% when they followed the HF diet. Patients following the phase I and phase II diets showed reductions of 13.6% and 14.6%, respectively. Only those following phase II diets showed a tendency toward significant improvement (p=0.061). Lp(a) levels increased by 4.7% following the MF (NS) diet and by 31.0% (NS) on the HF diet. Patients following phase I showed a 7.4% (NS) reduction and a 10.8% reduction (NS) following phase II. Fibrinogen levels increased only in individuals following HF diets (11.9%), while patients following MF (-0.6%), phase I (-11.0%), and phase II (-6.3%) diets showed nonsignificant reductions in fibrinogen. Patients on MF demonstrated nonsignificant reductions in weight, LDL-C, TC, HDL-C, TC/HDL-C ratios, and fibrinogen and nonsignificant increases in TGs, Lp(a), and homocysteine. There was significant weight loss in patients on phase I and II and HF diets after 1 year. Reductions in TC, LDL-C, TGs, and TC/HDL ratios were significant only in patients either following a LF diet or a MF, calorically reduced diet. Only patients following HF diets showed a worsening of each cardiovascular disease risk factor (LDL-C, TG, TC, HDL-C, TC/HDL ratio, Ho, Lp(a), and fibrinogen), despite achieving statistically significant weight loss.

High-dose dipyridamole and gated sestamibi SPECT imaging provide diagnostic resting and stress ejection fractions useful for predicting extent of coronary artery disease.

A decline in ejection fraction at stress compared with rest images has been associated with increased severity of coronary artery disease (CAD) and suggests a poorer prognosis. Myocardial perfusion imaging (MPI) using high-dose dipyridamole (HDD) has been shown to more accurately detect CAD than either standard dose dipyridamole (SDD) or exercise-induced stress (EST), but has not been looked at to determine its usefulness in detecting changes in stress and rest ejection fractions. To determine the relationship between changes in left ventricular ejection fraction (LVEF) and the severity of CAD, 36 Individuals underwent gated single photon emission computed tomography (SPECT) MPI using HDD. In each case resting and stress LVEFs were determined along with MPI results. Subjects with single-vessel CAD demonstrated an increase in LVEF from 77.8% (sd +/-8.8%) to 85.6% (sd +/-8.4%) resulting in a statistically significant increase in LVEF of 7.8% (p = 0.009). Patients with two-vessel disease showed a smaller increase from 73.2% (sd + 8.3%) to 79.8% (sd + 9.8%) following HDD stress. This increase was statistically (p = 0.008) significant. Patients with triple-vessel CAD showed a reduction in LVEF from 67.4% (sd +/-14.07) to 65.1% (sd +/-16.5%) which represented a decrease in LVEF of 2.7% and approached (p = 0.25) but did not reach statistical significance. Both the resting and stress LVEFs were statistically lower (p<0.05) in patients with triple-vessel CAD. Changes in resting LVEF (REF) and HDD pharmacologically induced stress LVEF (SEF) provide a valuable diagnostic marker as to the number of significantly diseased coronary arteries and can be acquired from gated SPECT sestamibi images.

A tête-à-tête comparison of ejection fraction and regional wall motion abnormalities as measured by echocardiography and gated sestamibi SPECT.

Determination of ejection fraction and regional wall motion abnormalities (RWMAs) consistent with stunned, hibernating, or infarcted myocardium can be noninvasively determined by both echocardiography and nuclear cardiac imaging. Prior comparisons between the 2 methods have been limited to Tc 99m pertechnetate or to stress images with attention to RWMAs only. To determine the relationship between results seen with echocardiography and gated single photon emission computed tomography (SPECT) using sestamibi, 26 individuals with varying degrees of coronary artery disease were prospectively studied with both techniques. Five individuals had single-vessel disease, 10 had 2-vessel disease, and 11 had triple-vessel disease. Each individual underwent 2-D, M-mode, and Doppler echocardiography (echo) as well as gated SPECT imaging using rest and stress (high-dose dipyridamole/HDD) sestamibi imaging. The results were statistically different when ejection fractions (EFs) and RWMAs were compared. There were no statistical differences between EFs determined at rest when either echo or nuclear imaging was used. However, patients with EFs <70-80% were overestimated by echo, with echo underestimating EFs >70-80% (p=0.001). There was a high correlation (r=0.76) between resting echocardiographic EFs and SPECT resting gated sestamibi images in patients with single-vessel disease, and a moderate correlation (r=0.68 and r=0.68) in patients with 2- and 3-vessel disease, respectively. Differences in the detection of RWMAs were statistically different for patients with 2-vessel disease (p=0.04) and approached significance in 3-vessel disease (p=0.56) with more RWMA being detected by resting gated SPECT imaging than by echo. Greater differences in RWMAs were seen in patients with 1-, 2-, and 3-vessel disease when resting echo was compared with HDD gated SPECT sestamibi imaging. These differences were statistically greater in 2- (p=0.0027) and 3- (p=0.0003) vessel disease. Differences between stress and resting images are expected in individuals with severe coronary artery disease. Comparison of noninvasive assessment of EFs and RWMAs by gated SPECT sestamibi and echocardiography showed different results when looking at EFs, with echo reporting greater EFs for people with EFs <70-80%. Patients with two and 3-vessel disease were statistically more likely to have RWMAs detected by gated SPECT sestamibi than by echo.

Mitochondrial uptake of sestamibi distinguishes between normal, inflammatory breast changes, pre-cancers, and infiltrating breast cancer.

The evaluation of breast tissue using nuclear imaging is dependent upon the delivery and uptake of the isotope by breast tissue. This is dependent upon blood flow to the breast and functioning mitochondria. This 2-part study investigated (1) differences in uptake of sestamibi when blood flow is enhanced (breast enhanced scintigraphy test [BEST]), and (2) differences in isotope uptake in normal (Nl) breast tissue, inflammatory changes in breast tissue (ICB), and breast cancer (CA). In the first part of the study, 10 women were compared using both Miraluma and BEST imaging; in the second part, 195 people were studied using BEST imaging only. The results were compared with histopathologic specimens. Little difference was noted between Miraluma and BEST imaging in the first part. Women with ICB showed a statistically significant (P <.05) increase in isotope uptake using BEST imaging. This difference was even more significant (P <.005) in women with CA. During the second part of the study, BEST imaging demonstrated an exponential increase in tracer uptake. When maximal count activity was compared, there was a statistically significant (P <.001) difference between Nl and ICB, between ICB and atypia (A), and between A and CA. BEST imaging demonstrated significant increases in isotope delivery when compared with Miraluma imaging. These differences allowed differentiation of breast tissue, including the detection of early changes in breast tissue.

Breast enhanced scintigraphy testing distinguishes between normal, inflammatory breast changes, and breast cancer: a prospective analysis and comparison with mammography.

The detection of breast cancer has primarily focused on anatomic findings, whereas assessment of physiologic information using nuclear imaging has been used for the detection of heart disease. Using this approach, the authors developed a method (breast enhanced scintigraphy test [BEST]) for differentiation of breast tissue by enhancing the delivery of isotope. To determine if this technique could distinguish between normal (Nl), inflammatory changes of the breast (ICB), and breast cancer (CA), 100 women were prospectively studied using BEST imaging, and results were compared with mammography and pathology findings using either biopsy or ductoscopy approaches. Mammography demonstrated a sensitivity and specificity of 69% and 84%, respectively. Using BEST imaging, maximal count activity (MCA) was able to distinguish between Nl, ICB, and CA. The results of 2-tailed t test analysis demonstrated statistically significant differences between Nl and ICB MCA (P