Reticulocytes in donor blood units enhance red blood cell alloimmunization.

Although red blood cell (RBC) transfusions save lives, some patients develop clinically-significant alloantibodies against donor blood group antigens, which then have adverse effects in multiple clinical settings. Few effective measures exist to prevent RBC alloimmunization and/or eliminate alloantibodies in sensitized patients. Donor-related factors may influence alloimmunization; thus, there is an unmet clinical need to identify which RBC units are immunogenic. Repeat volunteer blood donors and donors on iron supplements have elevated reticulocyte counts compared to healthy non-donors. Early reticulocytes retain mitochondria and other components, which may act as danger signals in immune responses. Herein, we tested whether reticulocytes in donor RBC units could enhance RBC alloimmunization. Using a murine model, we demonstrate that transfusing donor RBC units with increased reticulocyte frequencies dose-dependently increased RBC alloimmunization rates and alloantibody levels. Transfusing reticulocyte-rich RBC units was associated with increased RBC clearance from the circulation and a robust proinflammatory cytokine response. As compared to previously reported post-transfusion RBC consumption patterns, erythrophagocytosis from reticulocyte-rich units was increasingly performed by splenic B cells. These data suggest that reticulocytes in a donated RBC unit impact the quality of blood transfused, are targeted to a distinct compartment, and may be an underappreciated risk factor for RBC alloimmunization.

Impact of diabetes mellitus on procedural and one year clinical outcomes following treatment of severely calcified coronary lesions with the orbital atherectomy system: A subanalysis of the ORBIT II study.

OBJECTIVES: The goal of the study was to investigate the safety and efficacy of the coronary orbital atherectomy system to treat severe coronary artery calcification (CAC) prior to stent placement in diabetic and non-diabetic patients. BACKGROUND: The ORBIT II study reported the safety and efficacy of orbital atherectomy treatment in 443 patients with severe CAC. Percutaneous coronary intervention in diabetic patients is associated with an increased risk of major adverse cardiac events (MACE) compared with non-diabetics. The outcomes of diabetic patients who undergo orbital atherectomy are unknown. METHODS: Patients were sub-grouped as either diabetic (160/443, 36.1%) or non-diabetic (283/443, 63.9%). The MACE rate, defined as cardiac death, myocardial infarction (MI; CK-MB > 3X ULN), and target vessel revascularization, was examined at 30 days and 1 year after treatment. RESULTS: Procedural success was similar in the diabetic and non-diabetic groups (89.3 vs. 88.6%, P = 0.88). There was no significant difference in the 30-day and 1-year MACE rates between the diabetic and non-diabetic groups (30 day: 8.8 vs. 11.3%; P = 0.40; 1 year: 17.1 vs. 16.7%, P = 0.97). The individual components of cardiac death (3.9 vs. 2.9%, P = 0.58), MI (9.4 vs. 11.3%, P = 0.52), and target vessel revascularization (5.9 vs. 5.8%, P = 0.99) were also similar in both groups at 1 year. CONCLUSIONS: The rates of adverse clinical events in diabetic patients who underwent orbital atherectomy were low and similar to non-diabetic patients. This study suggests orbital atherectomy is a reasonable treatment strategy for diabetic patients with severe CAC.

Gender differences in acute and 30-day outcomes after orbital atherectomy treatment of de novo, severely calcified coronary lesions.

OBJECTIVES: The aim of this analysis is to evaluate potential differences according to gender in terms of acute and 30-day clinical outcomes in patients enrolled in the ORBIT II trial with de novo, severely calcified coronary lesions treated with orbital atherectomy to facilitate stent delivery. BACKGROUND: Previous studies have shown an increased risk of safety events in females compared to males undergoing percutaneous coronary intervention. METHODS: ORBIT II, a prospective, nonrandomized, multicenter, single arm study conducted in the US evaluated the safety and efficacy of the coronary OAS to facilitate stent placement in de novo, severely calcified coronary lesions in 443 subjects (286 males and 157 females). The rate of major adverse cardiac events (MACE) defined as a composite of myocardial infarction, target vessel revascularization, and cardiac death was evaluated in-hospital and 30-days postprocedure. For this analysis, the ORBIT II safety and efficacy results were stratified by gender. RESULTS: At baseline, females were significantly older than males and had a lower mean estimated glomerular filtration rate. Males had a higher rate of previous coronary artery bypass grafting and history of smoking. The rates of successful stent delivery and <50% residual stenosis were similar in males and females. In-hospital and 30-day MACE rates did not differ by gender. CONCLUSIONS: Despite females being older, having smaller arteries, and more renal dysfunction, preparation of severely calcified coronary lesions with orbital atherectomy to facilitate stent deployment results in similar rates of in-hospital and 30-day MACE, irrespective of gender.

Two-year outcomes after treatment of severely calcified coronary lesions with the orbital atherectomy system and the impact of stent types: Insight from the ORBIT II trial.

OBJECTIVES: We report 2-year outcomes of the Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions (ORBIT II) trial, with emphasis on the impact of stent type. BACKGROUND: The ORBIT II trial demonstrated the safety and efficacy of the Diamondback 360° Coronary Orbital Atherectomy System (OAS; Cardiovascular Systems, Inc., St. Paul, MN) in the treatment of de novo, severely calcified coronary lesions. METHODS: ORBIT II was a single-arm trial that enrolled 443 subjects with severely calcified lesions at 49 US sites. All patients were intended to be treated with OAS before stent implantation. The primary safety endpoint was 30-day major adverse cardiac events (MACE: Cardiac death, myocardial infarction, or target vessel revascularization). For the purpose of this study, we divided patients into three groups according to the type of stent implanted (i.e., bare metal stent [BMS], first-generation drug-eluting stent [DES], or second-generation DES). The 2-year MACE rate and its components were compared between groups. RESULTS: In the ORBIT II study cohort, 2-year rates of MACE, cardiac death, and target vessel revascularization were 19.4%, 4.3%, and 8.1%, respectively. Two year data were available in 419 of 443 patients (94.6%) with median follow up time of 25.1 months. Stent-type data were available in 435 of the 443 patients (98.2%). Six patients received stents of more than one type and were excluded from the stent type comparisons. Among the 429 patients included in the stent comparison analyses, 43 patients (10.0%) received BMS, 74 (17.2%) received first-generation DES, and 312 (72.7%) received second-generation DES. The 1 and 2-year target lesion revascularization rates were lower among patients receiving first-generation (1.4% and 6.3%) and second-generation (3.9% and 5.0%) DES compared to patients receiving BMS (15.3% and 15.3%), respectively (1 year: P = 0.007; 2 year: P = 0.047). Higher diameter stenosis and the use of BMS were independently associated with the occurrence of MACE and TVR at 2 years. CONCLUSIONS: OAS remained safe and effective for patients with de novo, severely calcified lesions at 2 years in the ORBIT II study. Adverse ischemic events were significantly higher with BMS compared with DES. © 2016 Wiley Periodicals, Inc.

Serial Vascular Responses of Balloon-Expandable Stent With Biodegradable Film-Type Graft in a Rabbit Iliac Artery Dissection Model (BioGard Study).

BACKGROUND AND OBJECTIVES: Arterial dissection during endovascular therapy rarely occurs but can be lethal. A fabric-based covered graft stents yield poor clinical outcomes. A novel balloon-expandable stent with biodegradable film graft for overcoming these issues was evaluated in a rabbit iliac artery model. METHOD: Eighteen rabbits with iliac artery dissections were induced by balloon over-inflation on angiography (Ellis type 2 or 3) and treated using the test device (3.0×24 mm). Subsequently, survived twelve animals underwent histologic examinations and micro-computed tomography (CT) at 0, 2, 4, and 8 weeks and 3, 6, 9, and 12 months and angiography at one-year. RESULTS: There were no adverse cardiovascular events during the one-year. Early-stage histologic examination revealed complete sealing of disrupted vessels by the device, exhibiting mural hematoma, peri-stent red thrombi, and dense infiltration of inflammatory cells. Mid- and long-term histologic examination showed patent stents with neointimal hyperplasia over the stents (% area stenosis: 11.8 at 2 weeks, 26.1 at 1 month, 29.7 at 3 months, 49.2 at 9 months, and 51.0 at 1 year), along with mild peri-strut inflammatory response (Grade: 1-2 at mid-term and 0-1 at long-term). The graft film became scarcely visible after six months. Both CT and angiography revealed no instances of thrombotic occlusion or in-stent restenosis (% diameter stenosis: 5.7 at 2 weeks, 12.3 at 1 month, 14.2 at 3 months, 25.1 at 9 months, and 26.6 at 1 year). CONCLUSIONS: The novel balloon-expandable stent with a biodegradable film graft demonstrates feasibility in managing severe artery dissection and preventing lethal vascular events in animal model.

Reticulocytes in donor RBC units enhance RBC alloimmunization.

Although red blood cell (RBC) transfusions save lives, some patients develop clinically-significant alloantibodies against donor blood group antigens, which then have adverse effects in multiple clinical settings. Few effective measures exist to prevent RBC alloimmunization and/or eliminate alloantibodies in sensitized patients. Donor-related factors may influence alloimmunization; thus, there is an unmet clinical need to identify which RBC units are immunogenic. Repeat volunteer blood donors and donors on iron supplements have elevated reticulocyte counts compared to healthy non-donors. Early reticulocytes retain mitochondria and other components, which may act as danger signals in immune responses. Herein, we tested whether reticulocytes in donor RBC units could enhance RBC alloimmunization. Using a murine model, we demonstrate that transfusing donor RBC units with increased reticulocyte frequencies dose-dependently increase RBC alloimmunization rates and alloantibody levels. Transfusing reticulocyte-rich RBC units was associated with increased RBC clearance from the circulation and a robust proinflammatory cytokine response. As compared to previously reported post-transfusion RBC consumption patterns, erythrophagocytosis from reticulocyte-rich units was increasingly performed by splenic B cells. These data suggest that reticulocytes in a donated RBC unit impact the quality of blood transfused, are targeted to a distinct compartment, and may be an underappreciated risk factor for RBC alloimmunization.

Low-Dose Dietary Fish Oil Improves RBC Deformability without Improving Post-Transfusion Recovery in Mice.

Long-chain polyunsaturated fatty acids (LC-PUFAs) are important modulators of red blood cell (RBC) rheology. Dietary LC-PUFAs are readily incorporated into the RBC membrane, improving RBC deformability, fluidity, and hydration. Female C57BL/6J mice consumed diets containing increasing amounts of fish oil (FO) ad libitum for 8 weeks. RBC deformability, filterability, and post-transfusion recovery (PTR) were evaluated before and after cold storage. Lipidomics and lipid peroxidation markers were evaluated in fresh and stored RBCs. High-dose dietary FO (50%, 100%) was associated with a reduction in RBC quality (i.e., in vivo lifespan, deformability, lipid peroxidation) along with a reduced 24 h PTR after cold storage. Low-dose dietary FO (6.25-12.5%) improved the filterability of fresh RBCs and reduced the lipid peroxidation of cold-stored RBCs. Although low doses of FO improved RBC deformability and reduced oxidative stress, no improvement was observed for the PTR of stored RBCs. The improvement in RBC deformability observed with low-dose FO supplementation could potentially benefit endurance athletes and patients with conditions resulting from reduced perfusion, such as peripheral vascular disease.

Deuterated Linoleic Acid Attenuates the RBC Storage Lesion in a Mouse Model of Poor RBC Storage.

Background: Long-chain polyunsaturated fatty acids (PUFAs) are important modulators of red blood cell (RBC) rheology. Dietary PUFAs are readily incorporated into the RBC membrane, improving RBC deformability, fluidity, and hydration. However, enriching the lipid membrane with PUFAs increases the potential for peroxidation in oxidative environments (e.g., refrigerated storage), resulting in membrane damage. Substitution of bis-allylic hydrogens with deuterium ions in PUFAs decreases hydrogen abstraction, thereby inhibiting peroxidation. If lipid peroxidation is a causal factor in the RBC storage lesion, incorporation of deuterated linoleic acid (DLA) into the RBC membrane should decrease lipid peroxidation, thereby improving RBC lifespan, deformability, filterability, and post-transfusion recovery (PTR) after cold storage. Study Design and Methods: Mice associated with good (C57BL/6J) and poor (FVB) RBC storage quality received diets containing 11,11-D2-LA Ethyl Ester (1.0 g/100 g diet; deuterated linoleic acid) or non-deuterated LA Ethyl Ester (control) for 8 weeks. Deformability, filterability, lipidomics, and lipid peroxidation markers were evaluated in fresh and stored RBCs. Results: DLA was incorporated into RBC membranes in both mouse strains. DLA diet decreased lipid peroxidation (malondialdehyde) by 25.4 and 31% percent in C57 mice and 12.9 and 79.9% in FVB mice before and after cold storage, respectively. In FVB, but not C57 mice, deformability filterability, and post-transfusion recovery were significantly improved. Discussion: In a mouse model of poor RBC storage, with elevated reactive oxygen species production, DLA attenuated lipid peroxidation and significantly improved RBC storage quality.

A randomized comparison of estimated radiation exposure between Low and conventional dose protocol during invasive coronary angiography (ERICA trial): Pilot study.

PURPOSE: Radiation exposure during coronary angiography is potentially harmful to patients and operators. However, there are limited data on the effects of a low-dose radiation angiography. We evaluated the feasibility and effectiveness of a reduced radiation dose protocol during invasive coronary angiography. METHODS: One hundred three consecutive patients who underwent coronary angiography were enrolled and randomized to low- or conventional dose protocols (LDP versus CDP). The LDP consists of 10 frames per second during fluoroscopy and half the radiation dose of CDP during cineangiography. Image quality was assessed using a Likert rating scale by an independent radiologist. The radiation dose was estimated with dose-area product (DAP) and air-kerma (AK). RESULTS: Body weight and waist circumference are well correlated with the level of DAP and AK. Exposure time and total images and frame counts in cineangiography were similar in both groups. There was a marked reduction of the estimated radiation dose (DAP and AK) in the LDP group compared to the CDP group without significant compromise in image quality (total DAP: LDP 1980.1 ±â€¯1163.7 vs. CDP 3434.2 ±â€¯2188.1 µGym2 p = 0.001; total AK: 279.6 ±â€¯159.3 vs. 493.8 ±â€¯280.6 mGy, p < 0.001). CONCLUSION: The LDP reduced the total estimated radiation dose compared to the CDP without a significant loss of diagnostic information. A LDP may be a viable strategy to protect patients and medical staff from the hazards of radiation in the cardiac catheterization laboratory.

Blood-sparing removal technique of extracorporeal membrane oxygenation circuit in a Jehovah Witness patient: Case report.

RATIONALE: Percutaneous cardiopulmonary support (PCPS) using extracorporeal membrane oxygenation (ECMO) is widely used in the critical patients with cardiopulmonary collapse. It is a representative blood-consuming procedure. In limited situations in which the option of blood transfusion is unavailable, there is no general agreement as to whether ECMO is contraindicated. PATIENT CONCERNS: A 61-year-old male Jehovah Witness with acute respiratory collapse and loss of consciousness was rushed to our emergency room. Throughout his hospital course, the patient's family refused any type of blood transfusion even at the risk of death. DIAGNOSIS: The clinical situations were secondary to a massive pulmonary thromboembolism INTERVENTIONS:: The patient underwent veno-venous ECMO via both femoral veins. The patient was recovered by intensive medical care although the level of hemoglobin (Hb) and hematocrit (Hct) was gradually decreased from 15.8 g/dl and 46.8% to 11.7 g/dl and 36.5%, respectively. OUTCOMES: On hospital day 3, ECMO was successfully removed using a blood-sparing ECMO removal technique involving the recycling of blood within the circuit by continuous saline infusion. There was no significant change in level of Hb/Hct and hemodynamic profile. At 2 days after ECMO removal, the level of Hb/Hct was elevated up to 9.2 g/dl and 30.0%, respectively without any transfusion. LESSONS: Our blood-sparing removal technique of ECMO appears to be feasible and led to no significant adverse impact on hemodynamic status. The technique might be helpful for critical patients who cannot receive blood transfusion due to any cause.

Rationale and Design for a Randomized Comparison of Efficacy and Safety between Aspirin and Clopidogrel in Atrial Fibrillation Patients with Low Stroke Risk: CESAC-AF trial.

BACKGROUND: Atrial fibrillation (AF) increases the risk of thromboembolic stroke. An oral anticoagulant should be administrated to prevent stroke in patients with moderate stroke risk (ie, CHA2DS2-VASc score>2). If the stroke risk is low (i.e. the score=1), however, antiplatelet agent such as aspirin is widely used. Aspirin can cause peptic ulcer disease (PUD) while its alternative, clopidogrel, theoretically does not. OBJECTIVE: To elucidate the efficacy and safety between aspirin and clopidogrel, a multicenter randomized controlled trial was designed in AF patients with low stroke risk. METHODS: According to sample size estimation based on previous literature, a total of 1560 AF patients with low stroke risk will be randomly assigned into 4 different groups dependent upon initial esophagogastroduodenoscopy (EGD) results: two mono-antiplatelet treatment groups with either aspirin 100mg or clopidogrel 75mg for 1year; two antiplatelet agent and proton pump inhibitor (PPI) combination groups. Follow-up EGD will be performed at 1year. RESULTS: The clinical follow-up will be performed for 1year after enrollment. The primary efficacy endpoint is to compare the annual stroke rate between aspirin and clopidogrel treatment groups. The primary safety endpoint is to compare the prevalence of drug-induced gastrointestinal (GI) and intracranial hemorrhage and upper-GI response including PUD based on EGD after 1year. CONCLUSIONS: This trial will determine whether clopidogrel is noninferior in stroke prevention and superior in reduction of GI events including PUD to aspirin in AF patients with low stroke risk. (ClinicalTrials.gov: NCT02960126).

Orbital Atherectomy for Treating De Novo Severely Calcified Coronary Narrowing (1-Year Results from the Pivotal ORBIT II Trial).

Percutaneous coronary intervention of severely calcified lesions has historically been associated with major adverse cardiac event (MACE) rates as high as 30%. In the ORBIT II (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) trial, treatment of de novo severely calcified lesions with the Diamondback 360° Coronary Orbital Atherectomy System (OAS) resulted in low rates of procedural and 30-day adverse ischemic events. The long-term results from this trial have not been reported. We sought to determine the 1-year outcomes after orbital atherectomy of severely calcified coronary lesions. ORBIT II was a single-arm trial enrolling 443 subjects at 49 US sites with severely calcified lesions usually excluded from randomized trials. OAS utilizes a centrifugal differential sanding mechanism of action for plaque modification prior to stent implantation. After OAS drug-eluting stents were implanted in 88.2% of the patients. The primary safety end point was 30-day MACE, the composite of cardiac death, myocardial infarction, or target vessel revascularization [TVR]. The present analysis reports the 1-year follow-up results from ORBIT II. One-year data were available in 433 of 443 patients (97.7%), with median follow-up time of 16.7 months. The 1-year MACE rate was 16.4%, including cardiac death (3.0%), myocardial infarction (9.7%), and target vessel revascularization (5.9%). The 1-year target lesion revascularization rate was 4.7%, and stent thrombosis occurred in 1 patient (0.2%). Independent predictors of 1-year MACE and target vessel revascularization were diameter stenosis at baseline and the use of bare-metal stents. In patients with severely calcified lesions who underwent percutaneous coronary intervention, the use of OAS was associated with low rates of 1-year adverse ischemic events compared with historical controls. This finding has important clinical implications for the selection of optimum treatment strategies for patients with severely calcified lesions.

Pivotal trial to evaluate the safety and efficacy of the orbital atherectomy system in treating de novo, severely calcified coronary lesions (ORBIT II).

OBJECTIVES: The ORBIT II (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) trial evaluated the safety and efficacy of the coronary Orbital Atherectomy System (OAS) to prepare de novo, severely calcified coronary lesions for stent placement. BACKGROUND: Despite advances in interventional techniques, treatment of calcified coronary lesions remains a challenge. Stent placement in these lesions may result in stent underexpansion, malapposition, and procedural complications. METHODS: ORBIT II is a prospective, multicenter, nonblinded clinical trial that enrolled 443 consecutive patients with severely calcified coronary lesions at 49 U.S. sites from May 25, 2010, to November 26, 2012. Investigators used the centrifugal action of the OAS diamond-coated crown to modify calcified lesions prior to stent placement. RESULTS: The pre-procedure mean minimal lumen diameter of 0.5 mm increased to 2.9 mm after the procedure. The primary safety endpoint was 89.6% freedom from 30-day major adverse cardiac events compared with the performance goal of 83%. The primary efficacy endpoint (residual stenosis <50% post-stent without in-hospital major adverse cardiac events) was 88.9% compared with the performance goal of 82%. Stent delivery occurred successfully in 97.7% of cases with <50% stenosis in 98.6% of subjects. Low rates of in-hospital Q-wave myocardial infarction (0.7%), cardiac death (0.2%), and target vessel revascularization (0.7%) were reported. CONCLUSIONS: The ORBIT II coronary OAS trial met both the primary safety and efficacy endpoints by significant margins. Preparation of severely calcified plaque with the OAS not only helped facilitate stent delivery, but improved both acute and 30-day clinical outcomes compared with the outcomes of historic control subjects in this difficult-to-treat patient population. (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions [ORBIT II]; NCT01092416).

U.S. veterans' experience with rebetron in a nonstudy environment: success or failure?

OBJECTIVE: The aim of this study is to report the clinical response observed in a U.S. veteran population with hepatitis C to combination therapy with Rebetron (interferon/ribavirin) outside of a controlled study environment. METHODS: Ninety-nine consecutive patients with hepatitis C who met the approved guidelines for treatment were offered treatment with Rebetron. Ninety-four patients initiated therapy. All patients received formal instruction on the use of the drug, as well as the side effects and were instructed to report any side effects. Follow-up was scheduled twice a month for the first month, then monthly unless adverse events were observed. RESULTS: Ninety-four of 99 patients initiated therapy. Thirty-two patients were lost to follow-up or did not tolerate therapy. Ethnic distribution comprised 56 whites, 42 African Americans, one Hispanic. Of the 56 whites who started therapy, 39 completed treatment. Sustained viral response (SVR) for all genotypes was observed in 10 of 39 (26%). In the African American patients, 22 of 42 (52%) completed therapy, but a SVR was noted in none. The only Hispanic patient did not respond to therapy. In the veteran population, favorable factors associated with achieving SVR included having genotype other than 1, absence of cirrhosis, and ethnicity. Factors contributing to the low response rates were difficulty in adhering to therapy as well as a predominance of genotype 1. CONCLUSIONS: Using an intention-to-treat analysis, only 10% of veterans achieved SVR. These findings highlight the need to develop a multidisciplinary team to address the complexity of treating the veteran patient with hepatitis C.

Endoscopic removal of large colonic lipomas.

BACKGROUND: Colonic lipomas are benign adipose tumors that rarely cause symptoms. Removal of lipomas 2 cm or greater in diameter has been associated with a greater risk of perforation. Experience with the evaluation and removal of large colonic lipomas with the assistance of EUS to reduce the risk of perforation is reported. METHODS: Four patients with large colonic lipomas were evaluated and treated with endoscopic methods. EUS was performed to confirm that the lesion was a lipoma superficial to the muscularis propria. Saline or epinephrine solution was injected at the base of the tumor, which was then resected electrosurgically with a snare. OBSERVATIONS: All 4 lesions were successfully removed and histopathologically confirmed to be lipomas (mean maximal diameter 2.8 cm). There were no complications of any procedure. One patient was hospitalized overnight because of abdominal pain that resolved without complication. CONCLUSIONS: Large colonic lipomas can be removed safely by electrosurgical snare resection after injection of the base with epinephrine or saline solution. EUS should be used to ensure that the lipoma does not extend into the muscularis propria. Clinical judgment is important in assessing the need to remove these lesions.

Accuracy of esophagoscopy performed by a non-physician endoscopist with a 4-mm diameter battery-powered endoscope.

BACKGROUND: A cost-effective technique is needed for screening of a broad population at risk for esophageal cancer. A solution would be to have non-physician endoscopists perform esophagoscopy with small-caliber battery-powered endoscopes. METHODS: In a prospective blinded study, the diagnostic accuracy of sedated esophagoscopy performed by a trained nurse practitioner with a battery-powered 4-mm diameter endoscope was compared with that for a sedated standard video-endoscopy performed by a gastroenterologist. Patients were recruited to undergo peroral esophagoscopy by the nurse practitioner followed by sedated standard endoscopy by the supervising gastroenterologist, each blinded to the findings of the other. Major esophageal findings of nurse practitioner and gastroenterologist were compared. RESULTS: Findings in 40 patients were analyzed. In 4 patients both endoscopists could not assess the presence or absence of columnar-lined esophagus because of severe erosive esophagitis (n = 3) or severe candida-esophagitis (n = 1). By using sedated standard endoscopy as the standard, on a per finding basis, esophagoscopy by the nurse practitioner had a sensitivity for columnar-lined esophagus of 89%: 95% CI [75%, 97%] and specificity of 96%: 95% CI [84%, 99%]. The missed columnar epithelium was a 3 x 3-mm island. For all lesions, the sensitivity of endoscopy performed by the nurse practitioner with the battery-powered endoscope was 75%: 95% CI [67%, 82%] and specificity 98%: 95% CI [96%, 99%]. The nurse practitioner missed all of 4 rings (3 considered clinically irrelevant). CONCLUSION: Esophagoscopy with a battery-powered 4-mm diameter endoscope by a non-physician endoscopist is feasible and accurate in detecting esophageal pathologies. It may be an efficient screening method for the detection of columnar-lined esophagus. There was a distinct underestimate of the presence of esophageal rings.

Tele-endoscopy: a way to provide diagnostic quality for remote populations.

BACKGROUND: Flexible endoscopy plays an important role in digestive health. However, access to endoscopy is limited in many rural areas throughout the world. Training non-physician personal to perform diagnostic endoscopy and to transmit images to a central hospital, where experienced endoscopists can review the procedures, may improve digestive health for patients in remote areas. The aim of this study was to evaluate the diagnostic quality and accuracy of upper-GI tele-endoscopy. METHODS: Fifty patients scheduled for EGD underwent upper-GI tele-endoscopy. The procedures were observed simultaneously by the endoscopist and a gastroenterologist observing from a remote station connected by 4 integrated services digital network telephone lines. The interpretation of the findings by both were compared and concordance for diagnosis of major and minor lesions was analyzed. RESULTS: Tele-endoscopic image quality was adequate to support diagnosis of abnormal lesions by the remote observer. Technical issues included worsening image quality caused by mild pixelation during rapid endoscope movement and rare loss of the telephone lines. The endoscopist identified 47 different major and 44 minor findings in the 50 patients. The observer missed one major lesion (columnar-lined esophagus) because of suspected inflammation and described 10 non-existing major lesions (sensitivity 98%: 95% CI[89%, 99%], specificity 80%: 95% CI[66%, 90%]). Some of the differences were because of interobserver variability. CONCLUSIONS: Upper-GI tele-endoscopy by using telephone lines has good diagnostic quality and is highly sensitive with regard to major findings. The misinterpretation of certain findings (esophageal ring, gastric erosions) may be caused by interobserver variability. The data strongly suggest that endoscopist and observer see similar endoscopic views.

A prospective, blinded study of diagnostic esophagoscopy with a superthin, stand-alone, battery-powered esophagoscope.

OBJECTIVES: A more widely available, well-tolerated, and cost-effective technique is needed to screen a broad population at risk for esophageal cancer. An ideal solution might be to perform unsedated esophagoscopy with an entirely self-contained, small-caliber endoscope. In a prospective, blinded study in three phases, we compared the feasibility, patient tolerance, and diagnostic accuracy of esophagoscopy performed with a prototype, superthin, battery-powered esophagoscope (BPE) with standard video esophagogastroduodenoscopy (SVE). METHODS: In phase I, 10 healthy volunteers underwent both peroral and transnasal esophagoscopy with BPE to evaluate the technical feasibility of the examination. For phases II and III, patients were recruited to have BPE before SVE. In phase II, both procedures were performed with conscious sedation. In phase III, the BPE was performed with only topical anesthesia. Two endoscopists assessed the technical performance of the endoscope and patient tolerance and recorded the esophageal findings independently. RESULTS: In phase I, all endoscopists reported adequate visualization of the esophagus in the 10 volunteers. A total of 181 patients were evaluated in phases II and III (89 in phase II, 92 in phase III). The sensitivity for detecting columnar lined esophagus was 94% in phase II and 95% in phase III. The sensitivity for all esophageal findings was 87% and 86% in phases II and III, respectively. The technical performance of the endoscope was significantly worse for BPE compared with the SVE. The patient tolerance as evaluated by the endoscopist was similar for both procedures. Ninety-five percent of the patients undergoing unsedated BPE were willing to have the procedure repeated under similar circumstances. CONCLUSIONS: Unsedated esophagoscopy with a 3.1-mm, battery-powered, stand-alone esophagoscope is feasible, well tolerated, and accurate in detecting esophageal pathologies. It might be an efficient and cost-effective screening tool for the detection of columnar lined esophagus.

Cost-effectiveness of screening a population with chronic gastroesophageal reflux.

BACKGROUND: Persons with chronic esophageal reflux are at increased risk for the development of Barrett's esophagus and adenocarcinoma. Recently developed ultrathin endoscopes are less expensive and better tolerated than standard endoscopes, they can be used without sedation, and are sensitive and specific for Barrett's esophagus. The cost-effectiveness of one-time screening strategies were evaluated for 50-year-old patients with chronic reflux: no screening, standard endoscopy, and screening by an ultrathin endoscope. METHODS: Markov models were created to simulate the clinical course for patients with chronic reflux. Costs and quality-adjusted life-years were estimated from cancer registry data, published medical data, and expert opinion. RESULTS: Under baseline assumptions, no screening resulted in average costs of $11,785 per person and 19.3226 quality-adjusted life-years. Ultrathin endoscopy screening resulted in costs of $12,119 per person and 19.3326 quality-adjusted life-years, yielding a marginal cost-effectiveness ratio of $55,764 per quality-adjusted life-year. Using standard endoscopy yielded costs of $12,332 with only slightly greater effectiveness, yielding a marginal cost-effectiveness ratio of $709,260 when compared with ultrathin endoscopy and $86,833 compared with no screening. Results were most sensitive to variation in the incidence of cancer in the population with Barrett's esophagus. CONCLUSIONS: Screening for Barrett's esophagus with ultrathin endoscopy is more cost-effective than standard endoscopy, and both strategies appear to improve quality-adjusted life-years among patients with chronic reflux at costs that are similar to those of other accepted preventive measures.

High-resolution chromoendoscopy for classifying colonic polyps: a multicenter study.

BACKGROUND: Chromoendoscopy may reliably separate adenomatous from nonadenomatous polyps. The aim of this multicenter trial was to determine the accuracy of high-resolution chromoendoscopy for the determination of colonic polyp histology. METHODS: This multicenter trial included 4 academic centers and a primary care practice. In 299 patients referred for routine colonoscopy or sigmoidoscopy, 520 polyps 10 mm in size were sprayed with indigo carmine dye. Using a high-resolution endoscope, the endoscopist predicted the histology of each polyp based on its surface characteristics. Hyperplastic polyps had a "pitted" surface pattern of orderly arranged "dots" that resembled surrounding normal mucosa. Adenomatous polyps had at least one surface "groove" or "sulcus." Each polyp was subsequently resected for histopathologic evaluation. RESULTS: The resected polyps were comprised by 193 adenomas (37%), 225 hyperplastic polyps (43%), and 102 "other" types (20%). Forty polyps (7.7%) could not be classified by high resolution chromoendoscopy with indigo carmine dye. For the remaining polyps, the sensitivity, specificity, and negative predictive value of indigo carmine dye staining for adenomatous polyps were, respectively, 82%, 82%, and 88%. The results were consistent among the academic centers and the primary care practice. CONCLUSIONS: High-resolution chromoendoscopy with indigo carmine dye demonstrates morphologic detail of diminutive colorectal polyps that can reliably be used to separate adenomatous from nonadenomatous polyps.