Patient Assisted Intervention for Neuropathy: Comparison of Treatment in Real Life Situations (PAIN-CONTRoLS): Bayesian Adaptive Comparative Effectiveness Randomized Trial.

Importance: Cryptogenic sensory polyneuropathy (CSPN) is a common generalized slowly progressive neuropathy, second in prevalence only to diabetic neuropathy. Most patients with CSPN have significant pain. Many medications have been tried for pain reduction in CSPN, including antiepileptics, antidepressants, and sodium channel blockers. There are no comparative studies that identify the most effective medication for pain reduction in CSPN. Objective: To determine which medication (pregabalin, duloxetine, nortriptyline, or mexiletine) is most effective for reducing neuropathic pain and best tolerated in patients with CSPN. Design, Setting, and Participants: From December 1, 2014, through October 20, 2017, a bayesian adaptive, open-label randomized clinical comparative effectiveness study of pain in 402 participants with CSPN was conducted at 40 neurology care clinics. The trial included response adaptive randomization. Participants were patients with CSPN who were 30 years or older, with a pain score of 4 or greater on a numerical rating scale (range, 0-10, with higher scores indicating a higher level of pain). Participant allocation to 1 of 4 drug groups used the utility function and treatment's sample size for response adaptation randomization. At each interim analysis, a decision was made to continue enrolling (up to 400 participants) or stop the whole trial for success (80% power). Patient engagement was maintained throughout the trial, which helped guide the study and identify ways to communicate and disseminate information. Analysis was performed from December 11, 2015, to January 19, 2018. Interventions: Participants were randomized to receive nortriptyline (n = 134), duloxetine (n = 126), pregabalin (n = 73), or mexiletine (n = 69). Main Outcomes and Measures: The primary outcome was a utility function that was a composite of the efficacy (participant reported pain reduction of ≥50% from baseline to week 12) and quit (participants who discontinued medication) rates. Results: Among the 402 participants (213 men [53.0%]; mean [SD] age, 60.1 [13.4] years; 343 White [85.3%]), the utility function of nortriptyline was 0.81 (95% bayesian credible interval [CrI], 0.69-0.93; 34 of 134 [25.4%] efficacious; and 51 of 134 [38.1%] quit), of duloxetine was 0.80 (95% CrI, 0.68-0.92; 29 of 126 [23.0%] efficacious; and 47 of 126 [37.3%] quit), pregabalin was 0.69 (95% CrI, 0.55-0.84; 11 of 73 [15.1%] efficacious; and 31 of 73 [42.5%] quit), and mexiletine was 0.58 (95% CrI, 0.42-0.75; 14 of 69 [20.3%] efficacious; and 40 of 69 [58.0%] quit). The probability each medication yielded the highest utility was 0.52 for nortriptyline, 0.43 for duloxetine, 0.05 for pregabalin, and 0.00 for mexiletine. Conclusions and Relevance: This study found that, although there was no clearly superior medication, nortriptyline and duloxetine outperformed pregabalin and mexiletine when pain reduction and undesirable adverse effects are combined to a single end point. Trial Registration: ClinicalTrials.gov Identifier: NCT02260388.

Patient Body Mass Index and Physician Radiation Dose During Coronary Angiography.

BACKGROUND: Consistent with the increasing prevalence of obesity in the general population, obesity has become more prevalent among patients undergoing cardiac catheterization. This study evaluated the association between patient body mass index (BMI) and physician radiation dose during coronary angiography. METHODS AND RESULTS: Real-time radiation exposure data were collected during consecutive coronary angiography procedures. Patient radiation dose was estimated using dose area product. Physician radiation dose in each case was recorded by a dosimeter worn by the physician and is reported as the personal dose equivalent (Hp10). Patient BMI was categorized as <25.0, 25.0 to 29.9, 30.0 to 34.9, 35.0 to 39.9, and ≥40. Among 1119 coronary angiography procedures, significant increases in dose area product and physician radiation dose were observed across increasing patient BMI categories ( P<0.001). Compared with a BMI <25, a patient BMI ≥40 was associated with a 2.1-fold increase in patient radiation dose (dose area product, 91.8 [59.6-149.2] versus 44.5 [25.7-70.3] Gy×cm2; P<0.001) and a 7.0-fold increase in physician radiation dose (1.4 [0.2-7.1] versus 0.2 [0.0-2.9] µSv; P<0.001). By multiple regression analysis, patient BMI remained independently associated with physician radiation dose (dose increase, 5.2% per unit increase in BMI; 95% CI, 3.0%-7.5%; P<0.0001). CONCLUSIONS: Among coronary angiography procedures, increasing patient BMI was associated with a significant increase in physician radiation dose. Additional studies are needed to determine whether patient obesity might have adverse effects on physicians, in the form of increased radiation doses during coronary angiography.

Impact of patient obesity on radiation doses received by scrub technologists during coronary angiography.

BACKGROUND: The impact of patient obesity on scrub technologist radiation dose during coronary angiography has not been adequately studied. METHODS: Real-time radiation exposure data were prospectively collected during consecutive coronary angiography cases. Patient radiation dose was estimated by dose area product (DAP). Technologist radiation dose was recorded by a dosimeter as the personal dose equivalent (Hp (10)). Patients were categorized according to their body mass index (BMI): <25.0, lean; 25.0-29.9, overweight; ≥30.0, obese. The study had two phases: in Phase I (N = 351) standard radiation protection measures were used; and in Phase II (N = 268) standard radiation protection measures were combined with an accessory lead shield placed between the technologist and patient. RESULTS: In 619 consecutive coronary angiography procedures, significant increases in patient and technologist radiation doses were observed across increasing patient BMI categories (p < 0.001 for both). Compared to lean patients, patient obesity was associated with a 1.7-fold increase in DAP (73.0 [52.7, 127.5] mGy × cm2 vs 43.6 [25.1, 65.7] mGy × cm2, p < 0.001) and a 1.8-fold increase in technologist radiation dose (1.1 [0.3, 2.7] µSv vs 0.6 [0.1, 1.6] µSv, p < 0.001). Compared to Phase I, use of an accessory lead shield in Phase II was associated with a 62.5% reduction in technologist radiation dose when used in obese patients (p < 0.001). CONCLUSIONS: During coronary angiography procedures, patient obesity was associated with a significant increase in scrub technologist radiation dose. This increase in technologist radiation dose in obese patients may be mitigated by use of an accessory lead shield.

Radiation Exposure Among Scrub Technologists and Nurse Circulators During Cardiac Catheterization: The Impact of Accessory Lead Shields.

OBJECTIVES: This study was performed to determine if the use of an accessory lead shield is associated with a reduction in radiation exposure among staff members during cardiac catheterization. BACKGROUND: Accessory lead shields that protect physicians from scatter radiation are standard in many catheterization laboratories, yet similar shielding for staff members is not commonplace. METHODS: Real-time radiation exposure data were prospectively collected among nurses and technologists during 764 consecutive catheterizations. The study had 2 phases: in phase I (n = 401), standard radiation protection measures were used, and in phase II (n = 363), standard radiation protection measures were combined with an accessory lead shield placed between the staff member and patient. Radiation exposure was reported as the effective dose normalized to dose-area product (EDAP). RESULTS: Use of an accessory lead shield in phase II was associated with a 62.5% lower EDAP per case among technologists (phase I: 2.4 [4.3] µSv/[mGy × cm2] × 10-5; phase II: 0.9 [2.8] µSv/[mGy × cm2] × 10-5; p < 0.001) and a 63.6% lower EDAP per case among nurses (phase I: 1.1 [3.1] µSv/[mGy × cm2] × 10-5; phase II: 0.4 [1.8] µSv/[mGy × cm2] × 10-5; p < 0.001). By multivariate analysis, accessory shielding remained independently associated with a lower EDAP among both technologists (34.2% reduction; 95% confidence interval: 20.1% to 45.8%; p < 0.001) and nurses (36.4% reduction; 95% confidence interval: 19.7% to 49.6%; p < 0.001). CONCLUSIONS: The relatively simple approach of using accessory lead shields to protect staff members during cardiac catheterization was associated with a nearly two-thirds reduction in radiation exposure among nurses and technologists.

Percutaneous coronary intervention using a combination of robotics and telecommunications by an operator in a separate physical location from the patient: an early exploration into the feasibility of telestenting (the REMOTE-PCI study).

AIMS: The present study explores the feasibility of telestenting, wherein a physician operator performs stenting on a patient in a separate physical location using a combination of robotics and telecommunications. METHODS AND RESULTS: Patients undergoing robotic stenting were eligible for inclusion. All manipulations of guidewires, balloons, and stents were performed robotically by a physician operator located in an isolated separate room outside the procedure room housing the patient. Communication between the operating physician and laboratory personnel was via telecommunication devices providing real-time audio and video connectivity. Among 20 patients who consented to participate, technical success, defined as successful advancement and retraction of guidewires, balloons, and stents by the robotic system without conversion to manual operation, was achieved in 19 of 22 lesions (86.4%). Procedural success, defined as <30% residual stenosis upon completion of the procedure in the absence of death or repeat revascularisation prior to hospital discharge, was achieved in 19 of 20 patients (95.0%). There were no deaths or repeat revascularisations prior to hospital discharge. CONCLUSIONS: To the best of our knowledge, the present study is the first to explore the feasibility of telestenting. Additional studies are required to determine if future advancements in robotics will facilitate telestenting over greater geographic distances.

Screening for retinopathy of prematurity in a provincial hospital in Port Elizabeth, South Africa.

UNLABELLED:  Background. Retinopathy of prematurity (ROP) is an emerging public health problem in many middle-income countries where improved neonatal survival rates coupled with inadequate health resources have created a new epidemic. There are limited available data on the magnitude of the problem, and screening in South African (SA) hospitals has not been uniformly practised. OBJECTIVE: To describe the results of various interventions implemented over a 6-year period while developing a new ROP screening service in a provincial hospital in Port Elizabeth, SA. METHOD: A retrospective case folder review of ROP screening at Dora Nginza Hospital, Port Elizabeth, SA, over the 6-year period 2009 - 2014 was conducted. RESULTS: A total of 919 new cases were seen. Fifteen patients received treatment for type 1 ROP (T1ROP), 223 had type 2 (T2) or earlier ROP, 1 had stage 4 ROP and 6 had stage 5 ROP. The combination of healthcare worker education, improved equipment and human resources and the introduction of dual responsibility for case referrals resulted in an increase in the number of new infants screened from 33 in year 1 to 292 in year 6. The number of infants who were screened late decreased from 33/33 (100%) in year 1, prior to the interventions, to 23/292 in the final year (7.9%). Improved oxygen delivery and adequate oxygen saturation monitoring contributed to a decrease in the incidence of T1ROP from 1.5% to 1% over 1 year and in the incidence of T2 or earlier ROP from 30.3% to 24%. CONCLUSIONS: Better management of ROP can be achieved through adequate provision of healthcare professionals and material resources coupled with education and a well-supported referral system. A close working relationship between paediatricians and ophthalmologists results in a more efficient screening programme.

Combined Near-Infrared Spectroscopy and Intravascular Ultrasound Imaging of Pre-Existing Coronary Artery Stents: Can Near-Infrared Spectroscopy Reliably Detect Neoatherosclerosis?

BACKGROUND: Neoatherosclerosis is an emerging phenomenon in which lipid-rich plaques (LRPs) develop within pre-existing stents. This study was undertaken to describe near-infrared spectroscopy (NIRS) and intravascular ultrasound findings in pre-existing stents and to compare NIRS findings in pre-existing stents, in which an increased lipid signal has been speculated to indicate neoatherosclerosis, and NIRS findings in a control group of freshly implanted stents, in which any lipid signal originates from fibroatheroma under the stent. METHODS AND RESULTS: At the site of LRP detected by NIRS in a cohort of pre-existing stents, intravascular ultrasound was used to determine the presence of neointimal tissue. The lipid-core burden index and maximum lipid-core burden index in 4 mm were measured within stented segments. Findings were compared between pre-existing stents and a control group of freshly implanted stents. Among 60 pre-existing stents implanted 5.5±4.0 years earlier, NIRS detected LRP in 33%. At the site of LRP, intravascular ultrasound found no neointimal tissue in 35% of cases. NIRS findings in pre-existing stents were indistinguishable from those of freshly implanted stents (lipid-core burden index: 50±72 versus 42±58; P=0.40 and maximum lipid-core burden index in 4 mm: 156±184 versus 155±203; P=0.69). CONCLUSIONS: The detection of LRP in a pre-existing stent by NIRS alone is not reliable evidence of neoatherosclerosis, as the lipid signal may originate from fibroatheroma underlying the stent. By identifying the presence or absence of neointimal tissue at the site of LRP detected by NIRS, intravascular ultrasound may provide some insight into the potential source of the lipid signal in pre-existing stents. REGISTRATION INFORMATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01694368.

Large lipid-rich coronary plaques detected by near-infrared spectroscopy at non-stented sites in the target artery identify patients likely to experience future major adverse cardiovascular events.

AIMS: A recent study demonstrated that intracoronary near-infrared spectroscopy (NIRS) findings in non-target vessels are associated with major adverse cardiovascular and cerebrovascular events (MACCE). It is unknown whether NIRS findings at non-stented sites in target vessels are similarly associated with future MACCE. This study evaluated the association between large lipid-rich plaques (LRP) detected by NIRS at non-stented sites in a target artery and subsequent MACCE. METHODS AND RESULTS: This study evaluated 121 consecutive registry patients undergoing NIRS imaging in a target artery. After excluding stented segments, target arteries were evaluated for a large LRP, defined as a maximum lipid core burden index in 4 mm (maxLCBI4 mm) ≥400. Excluding events in stented segments, Cox regression analysis was performed to evaluate for an association between a maxLCBI4 mm ≥400 and future MACCE, defined as all-cause mortality, non-fatal acute coronary syndrome, and cerebrovascular events. NIRS detected a maxLCBI4 mm ≥400 in a non-stented segment of the target artery in 17.4% of patients. The only baseline clinical variable marginally associated with MACCE was ejection fraction (HR 0.96, 95% CI 0.93-1.00, P = 0.054). A maxLCBI4 mm ≥400 in a non-stented segment at baseline was significantly associated with MACCE during follow-up (HR 10.2, 95% CI 3.4-30.6, P < 0.001). CONCLUSION: Detection of large LRP by NIRS at non-stented sites in a target artery was associated with an increased risk of future MACCE. These findings support ongoing prospective studies to further evaluate the ability of NIRS to identify vulnerable patients.

Use of a variable long-pulse alexandrite laser in the treatment of facial telangiectasia.

BACKGROUND: The alexandrite laser selectively targets melanin and hemoglobin. We used the alexandrite laser with variable pulse widths to treat facial telangiectasia. METHODS: Nineteen patients were enrolled in this study, which consisted of two parts: a series of test spots over a range of pulse durations (3-80 ms) and treatment over a larger area based on the pulse width-specific outcomes from the test spots. The final follow-up visit was 12 weeks after irradiation. RESULTS: The 40-ms pulse width achieved the optimal balance of pain tolerance, epidermal tolerance, and vessel reduction. Mean fluence was 88 J/cm(2), with a 6-mm spot. Overall, a 48% reduction in vessels was noted after one treatment. Side effects were minimal. CONCLUSIONS: In fair-skinned patients with large telangiectasia, the alexandrite laser is a good option for vessel reduction.

Effect of monopolar radiofrequency treatment over soft-tissue fillers in an animal model: part 2.

BACKGROUND AND OBJECTIVE: Monopolar radiofrequency (RF) treatment is used by physicians to heat skin and promote tissue tightening and contouring. Cosmetic fillers are used to soften deep facial lines and wrinkles. Patients who have had dermal fillers implanted may also benefit from or are candidates for monopolar RF skin tightening. This study examined the effect of RF treatment on various dermal filler substances. This is the second part of a two-part study. STUDY DESIGN/MATERIALS AND METHODS: A juvenile farm pig was injected with dermal fillers including cross-linked human collagen (Cosmoplast), polylactic acid (PLA) (Sculptra), liquid injectable silicone (Silikon 1000), calcium hydroxylapatite (CaHA) (Radiesse), and hyaluronic acid (Restylane). Skin injected with dermal fillers was RF-treated using a 1.5-cm2 treatment tip and treatment levels typically used in the clinical setting. Fillers were examined histologically 5 days, 2 weeks, or 1 month after treatment. Histological specimens were scored for inflammatory response, foreign body response, and fibrosis in order to assess the effect of treatment on early filler processes, such as inflammation and encapsulation. RESULTS: Each filler substance produced a characteristic inflammatory response. No immediate thermal effect of RF treatment was observed histologically. RF treatment resulted in statistically significant increases in the inflammatory, foreign body, and fibrotic responses associated with the filler substances. CONCLUSIONS: Monopolar RF treatment levels that are typically used in the clinical setting were employed in this animal study. RF treatment resulted in measurable and statistically significant histological changes associated with the various filler materials. Additional clinical and histological studies are required to determine the optimal timing of monopolar RF treatment and filler placement for maximal potential aesthetic outcome.