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1.
J Am Med Dir Assoc ; 22(12): 2440-2446.e2, 2021 12.
Article in English | MEDLINE | ID: mdl-33984293

ABSTRACT

OBJECTIVES: Most transitional care initiatives to reduce rehospitalization have focused on the transition that occurs between a patient's hospital discharge and return home. However, many patients are discharged from a skilled nursing facility (SNF) to their homes. The goal was to evaluate the effectiveness of the Mayo Clinic Care Transitions (MCCT) program (hereafter called program) among patients discharged from SNFs to their homes. DESIGN: Propensity-matched control-intervention trial. INTERVENTION: Patients in the intervention group received care management following nursing stay (a home visit and nursing phone calls). SETTING AND PARTICIPANTS: Patients enrolled after discharge from an SNF to home were matched to patients who did not receive intervention because of refusal, program capacity, or distance. Patients were aged ≥60 years, at high risk for hospitalization, and discharged from an SNF. METHODS: Program enrollees were matched through propensity score to nonenrollees on the basis of age, sex, comorbid health burden, and mortality risk score. Conditional logistic regression analysis examined 30-day hospitalization and emergency department (ED) use; Cox proportional hazards analyses examined 180-day hospital stay and ED use. RESULTS: Each group comprised 160 patients [mean (standard deviation) age, 85.4 (7.4) years]. Thirty-day hospitalization and ED rates were 4.4% and 10.0% in the program group and 3.8% and 10.0% in the group with usual care (P = .76 for hospitalization; P > .99 for ED). At 180 days, hospitalization and ED rates were 30.6% and 46.3% for program patients compared with 11.3% and 25.0% in the comparison group (P < .001). CONCLUSIONS AND IMPLICATIONS: We found no evidence of reduced hospitalization or ED visits by program patients vs the comparison group. Such findings are crucial because they illustrate how aggressive stabilization care within the SNF may mitigate the program role. Furthermore, we found higher ED and hospitalization rates at 180 days in program patients than the comparison group.


Subject(s)
Patient Transfer , Transitional Care , Aged , Aged, 80 and over , Hospitalization , Humans , Patient Discharge , Patient Readmission , Retrospective Studies , Skilled Nursing Facilities
2.
Clin Interv Aging ; 14: 17-25, 2019.
Article in English | MEDLINE | ID: mdl-30587950

ABSTRACT

BACKGROUND: Care transitions programs are increasingly used to improve care and reduce re-admission of patients after hospitalization. To learn from the experience of patients who have participated in the Mayo Clinic Care Transitions (MCCT) program and to understand the patient experience, we sought perspectives of patients, caregivers, and providers who worked with participants of the MCCT program. METHODS: Investigators interviewed 17 patients and nine of their caregivers about their experience with the MCCT program. Eight health care providers described provider experiences with the MCCT program. Data from semistructured interviews were audio recorded, transcribed, and evaluated through content analysis. Inductive coding methods were used to elicit themes about patient experience with the MCCT program. RESULTS: Patients, caregivers, and providers emphasized that the MCCT program prevented hospitalizations and contributed to the health and quality of life of participants. All three stakeholder groups emphasized the value of the home visit and provision of the visit on a patient's "home turf" as central to the program. Patients appreciated speaking to a provider without the stress and exertion of a trip to the clinic. Caregivers appreciated improved communication provided in the home visit and felt that home visits gave them peace of mind. Patients, caregivers, and providers also identified the need for improved phone triage and communication. CONCLUSION: Patients, caregivers, and providers acknowledged the care transitions problem and emphasized the benefits of seeing patients on their home turf rather than in an office visit. This qualitative study of patient, caregiver, and provider experiences further validates the importance of the MCCT program.


Subject(s)
Aftercare/methods , Patient Transfer , Quality of Life , Aged , Aged, 80 and over , Caregivers , Communication , Female , Health Personnel , Hospitalization , House Calls , Humans , Interviews as Topic , Male , Middle Aged , Patient Satisfaction , Qualitative Research
3.
J Pain Symptom Manage ; 56(6): 928-935, 2018 12.
Article in English | MEDLINE | ID: mdl-30165123

ABSTRACT

CONTEXT: Identifying high-value health care delivery for patients with clinically complex and high-cost conditions is important for future reimbursement models. OBJECTIVES: The objective of this study was to assess the Medicare reimbursement savings of an established palliative care homebound program. METHODS: This is a retrospective cohort study involving 50 participants enrolled in a palliative care homebound program and 95 propensity-matched control patients at Mayo Clinic in Rochester, Minnesota, between September 1, 2012, and March 31, 2013. Total Medicare reimbursement was compared in the year before enrollment with the year after enrollment for participants and controls. RESULTS: No significant differences were observed in demographic characteristics or prognostic indices between the two groups. Total Medicare reimbursement per program participant the year before program enrollment was $16,429 compared with $14,427 per control patient, resulting in $2004 higher charges per program patient. In 12 months after program enrollment, mean annual payment was $5783 per patient among participants and $22,031 per patient among the matched controls. In the second year, the intervention group had a decrease of $10,646 per patient; the control group had an increase of $7604 per patient. The difference between the participant group and control group was statistically significant (P < 0.001) and favored the palliative care homebound program enrollees by $18,251 (95% CI, $11,268-$25,234). CONCLUSION: The Mayo Clinic Palliative Care Homebound Program reduced annual Medicare expenditures by $18,251 per program participant compared with matched control patients. This supports the role of home-based palliative medicine in delivering high-value care to high-risk older adults.


Subject(s)
Chronic Disease/therapy , Frail Elderly , Home Care Services , Palliative Care/methods , Aged, 80 and over , Chronic Disease/economics , Chronic Disease/epidemiology , Comorbidity , Female , Health Expenditures , Home Care Services/economics , Humans , Longitudinal Studies , Male , Medicare/economics , Palliative Care/economics , Patient Acceptance of Health Care , Propensity Score , Quality Improvement , Retrospective Studies , Risk , United States
4.
Med Care ; 56(8): 693-700, 2018 08.
Article in English | MEDLINE | ID: mdl-29939913

ABSTRACT

BACKGROUND: Care transitions programs have been shown to reduce hospital readmissions. OBJECTIVES: The main objective of this study was to evaluate effects of the Mayo Clinic Care Transitions (MCCTs) Program on potentially preventable and nonpreventable 30-day unplanned readmissions among high-risk elders. RESEARCH DESIGN: This was a retrospective cohort study of patients enrolled in MCCT following hospitalization and propensity score-matched controls receiving usual primary care. SUBJECTS: The subjects were primary care patients, who were 60 years or older, at high-risk for readmission, and hospitalized for any cause between January 1, 2011 and June 30, 2013. MEASURES: Hospital readmission within 30 days. The 3M algorithm was used to identify potentially preventable readmissions. Readmissions for ambulatory care sensitive conditions, a subset of preventable readmissions identified by the 3M algorithm, were also assessed. RESULTS: The study cohort included 365 pairs of MCCT enrollees and propensity score-matched controls. Patients were similar in age (mean 83 y) and other baseline demographic and clinical characteristics, including reason for index hospitalization. MCCT enrollees had a significantly lower all-cause readmission rate [12.4% (95% confidence interval: CI, 8.9-15.7) vs. 20.1% (15.8-24.1); P=0.004] resulting from a decrease in potentially preventable readmissions [8.4% (95% CI, 5.5-11.3) vs. 14.3% (95% CI, 10.5-17.9); P=0.01]. Few potentially preventable readmissions were for ambulatory care sensitive conditions (6.7% vs. 12.0%). The rates of nonpotentially preventable readmissions were similar [4.3% (95% CI, 2.2-6.5) vs. 6.7% (95% CI, 4.0-9.4); P=0.16]. Potentially preventable readmissions were reduced by 44% (hazard ratio, 0.56; 95% CI, 0.36-0.88; P=0.01) with no change in other readmissions. CONCLUSIONS: The MCCT significantly reduces preventable readmissions, suggesting that access to multidisciplinary care can reduce readmissions and improve outcomes for high-risk elders.


Subject(s)
Aftercare/organization & administration , Hospital Administration/statistics & numerical data , Patient Handoff/statistics & numerical data , Patient Readmission/statistics & numerical data , Academic Medical Centers , Aged , Cohort Studies , Female , Humans , Male , Middle Aged , Patient Discharge/statistics & numerical data , Patient Transfer , Retrospective Studies , Risk Factors , Sex Factors
5.
J Am Geriatr Soc ; 66(2): 321-326, 2018 02.
Article in English | MEDLINE | ID: mdl-29231962

ABSTRACT

OBJECTIVES: To assess the degree to which self-reported symptoms predict unplanned readmission or emergency department (ED) care within 30 days of high-risk, elderly adults enrolled in a posthospitalization care transition program (CTP). DESIGN: Retrospective cohort study. SETTING: Posthospitalization CTP at Mayo Clinic, Rochester, Minnesota, from January 1, 2013, through March 3, 2015. PARTICIPANTS: Frail, elderly adults (N = 230; mean age 83.5 ± 8.3, 46.5% male). MEASUREMENTS: Charlson Comorbidity Index (CCI) and self-reported symptoms, measured using the Edmonton Symptom Assessment System (ESAS), were ascertained upon CTP enrollment. RESULTS: Mean CCI was 3.9 ± 2.3. Of 51 participants returning to the hospital within 30 days of discharge, 13 had ED visits, and 38 were readmitted. Age, sex, and CCI were not significantly different between returning and nonreturning participants, but returning participants were significantly more likely to report shortness of breath (P = .004), anxiety (P = .02), depression (P = .02), and drowsiness (P = .01). Overall ESAS score was also a significant predictor of hospital return (P = .01). CONCLUSION: Four self-reported symptoms and overall ESAS score, but not CCI, ascertained after hospital discharge were strong predictors of hospital return within 30 days. Including symptoms in risk stratification of high-risk elderly adults may help target interventions and reduce readmissions.


Subject(s)
Emergency Service, Hospital , Frail Elderly/statistics & numerical data , Health Status Indicators , Hospitals , Patient Readmission/statistics & numerical data , Aged, 80 and over , Continuity of Patient Care , Female , Humans , Male , Minnesota , Patient Discharge , Retrospective Studies , Risk Factors , Surveys and Questionnaires
6.
ISRN Gastroenterol ; 2014: 494157, 2014.
Article in English | MEDLINE | ID: mdl-24944824

ABSTRACT

Objective. Guidelines on antiplatelet medication use during endoscopy are based on limited evidence. We investigate the risk of bleeding and ischemic events in patients undergoing endoscopic mucosal resection (EMR) of esophageal lesions in the setting of scheduled cessation and prompt resumption of clopidogrel. Design. Single centre retrospective review. Patients. Patients undergoing EMR of esophageal lesions. Interventions. Use of clopidogrel before EMR and resumption after EMR. Patients cease antiplatelets and anticoagulants 7 days before EMR and resume clopidogrel 2 days after EMR in average risk patients. Main Outcomes. Gastrointestinal bleeding (GIB) and ischemic events (IE) within 30 days of EMR. Results. 798 patients underwent 1716 EMR. 776 EMR were performed on patients on at least 1 antiplatelet/anticoagulant (APAC). 17 EMR were performed following clopidogrel cessation. There were 14 GIB and 2 IE. GIB risk in the setting of recent clopidogrel alone (0%) was comparable to those not on APAC (1.1%) (P = 1.0). IE risk on clopidogrel (6.3%) was higher than those not on APAC (0.1%) (P = 0.03). Limitations. Retrospective study. Conclusions. Temporary cessation of clopidogrel before EMR and prompt resumption is not associated with an increased risk of gastrointestinal bleeding but may be associated with increased ischemic events.

7.
Comput Inform Nurs ; 32(6): 257-66, 2014 Jun.
Article in English | MEDLINE | ID: mdl-24814998

ABSTRACT

Palliative care services for patients with life-limiting conditions enhance their quality of life. Most palliative care services, however, are located in hospitals with limited transitional care for patients who live in distant locations. The long-term goal of this program of research is to use existing technology for virtual visits to provide transitional care for patients initially hospitalized in an urban setting by a nurse practitioner located closer to patients' homes in distant, rural settings. The purpose of this proof-of-concept study was to determine the resources needed to use the system (efficiency) and the quality of the audio and visual components (effectiveness) to conduct virtual visits between a clinician at an academic center and community-dwelling adults living in rural locations. Guided by the Technology Acceptance Model, a mixed-methods field design was used. Because of the burden of testing technology with patients with life-limiting conditions, the sample included eight healthy adults. Participant satisfaction and perceptions of the ease of using the technology were also measured. Virtual visits were conducted using a 3G-enabled Apple iPad, cellular phone data service, and a Web-based video conference service. Participants and clinicians perceived the technology as easy to use. Observations revealed the importance of the visual cues provided by the technology to enhance communication, engagement, and satisfaction. Findings from this study will inform a subsequent study of technology-enhanced transitional care with palliative care patients.


Subject(s)
Palliative Care/trends , Rural Health Services , Telemedicine , Videoconferencing , Feasibility Studies , Female , Health Services Accessibility , Health Services Needs and Demand , Humans , Male , Middle Aged , Quality of Life
8.
J Pain Symptom Manage ; 47(5): 926-935.e6, 2014 May.
Article in English | MEDLINE | ID: mdl-24094703

ABSTRACT

The role of palliative medicine in the care of patients with advanced heart failure, including those who receive mechanical circulatory support, has grown dramatically in the last decade. Previous literature has suggested that palliative medicine providers are well poised to assist cardiologists, cardiothoracic surgeons, and the multidisciplinary cardiovascular team with promotion of informed consent and initial and iterative discussions regarding goals of care. Although preparedness planning has been described previously, the actual methods that can be used to complete a preparedness plan have not been well defined. Herein, we outline several key aspects of this approach and detail strategies for engaging patients who are receiving mechanical circulatory support in preparedness planning.


Subject(s)
Advance Care Planning , Heart Failure/therapy , Heart-Assist Devices , Palliative Care/methods , Palliative Medicine/methods , Physicians , Advance Care Planning/ethics , Aged , Comorbidity , Cost of Illness , Decision Making , Equipment Failure , Female , Heart Failure/epidemiology , Heart Failure/psychology , Heart-Assist Devices/adverse effects , Humans , Informed Consent , Male , Palliative Care/ethics , Palliative Medicine/ethics , Physicians/ethics , Quality of Life
9.
Clin Gastroenterol Hepatol ; 8(3): 248-53, 2010 Mar.
Article in English | MEDLINE | ID: mdl-19948247

ABSTRACT

BACKGROUND & AIMS: There is controversy over the outcomes of esophageal adenocarcinoma with superficial submucosal invasion. We evaluated the impact of depth of submucosal invasion on the presence of metastatic lymphadenopathy and survival in patients with esophageal adenocarcinoma. METHODS: Pathology reports of esophagectomy samples collected from 1997 to 2007 were reviewed. Specimens from patients with esophageal adenocarcinoma and submucosal invasion were reviewed and classified as superficial (upper 1 third, sm1) or deep (middle third, sm2 or deepest third, sm3) invasion. Outcomes studied were presence of metastatic lymphadenopathy and overall survival. Variables of interest were analyzed as factors that affect overall and cancer-free survival using Cox proportional hazards modeling. A multivariate model was constructed to establish independent associations with survival. RESULTS: The study included 80 patients; 31 (39%) had sm1 carcinoma, 23 (29%) had sm2 carcinoma, and 26 (33%) had sm3 carcinoma. Superficial and deep submucosal invasion were associated with substantial rates of metastatic lymphadenopathy (12.9% and 20.4%, respectively). The mean follow-up time was 40.5 +/- 4 months and the mean overall unadjusted survival time was 53.8 +/- 4.1 months. Factors significantly associated with reduced survival time included the presence of metastatic lymph nodes (hazard ratio [HR], 2.89; confidence interval [CI], 1.13-6.88) and esophageal cancer recurrence (HR 6.39, CI 2.40-16.14), but not depth of submucosal invasion. CONCLUSIONS: Patients with sm1 esophageal carcinoma have substantial rates of metastatic lymphadenopathy. Endoscopic treatment of superficial submucosal adenocarcinoma is not advised for patients that are candidates for surgery.


Subject(s)
Adenocarcinoma/mortality , Adenocarcinoma/pathology , Esophageal Neoplasms/pathology , Lymph Nodes/pathology , Neoplasm Metastasis , Aged , Esophagus/pathology , Female , Humans , Incidence , Male , Mucous Membrane/pathology , Retrospective Studies , Survival Analysis
10.
Gastrointest Endosc ; 71(4): 697-703, 2010 Apr.
Article in English | MEDLINE | ID: mdl-19959164

ABSTRACT

BACKGROUND: The incidence and risk factors for recurrence of dysplasia after ablation of Barrett's esophagus (BE) have not been well defined. OBJECTIVE: To determine the rate and predictors of dysplasia/neoplasia recurrence after photodynamic therapy (PDT) in BE. SETTING: Retrospective analysis of a prospective cohort of BE patients seen at a specialized BE unit. METHODS: Patients underwent a standard protocol assessment with esophagogastroduodenoscopy and 4-quadrant biopsies every centimeter at 3-month intervals after ablation. Recurrence was defined as the appearance of any grade of dysplasia or neoplasia after 2 consecutive endoscopies without dysplasia. Entry histology, demographics, length of BE, presence and length of diaphragmatic hernia, EMR, stricture formation, nonsteroidal anti-inflammatory drug use, smoking, and the presence of nondysplastic BE or squamous epithelium were assessed for univariate associations. Time-to-recurrence analysis was done by using Cox proportional hazards regression. A multivariate model was constructed to establish independent associations with recurrence. RESULTS: A total of 363 patients underwent PDT with or without EMR. Of these, 261 patients were included in the final analysis (44 lost to follow-up, 46 had residual dysplasia, and 12 had no dysplasia at baseline). Indication for ablation was low-grade dysplasia (53 patients, 20%), high-grade dysplasia (152 patients, 58%), and intramucosal cancer (56 patients, 21%). Median follow-up was 36 months (interquartile range 18-79 months). Recurrence occurred in 45 patients. Median time to recurrence was 17 months (interquartile range 8-45 months). Significant predictors of recurrence on the multivariate model were older age (hazard ratio [HR] 1.04, P=.029), presence of residual nondysplastic BE (HR 2.88, P=.012), and a history of smoking (HR 2.68, P=.048). LIMITATIONS: Possibility of missing prevalent dysplasia despite aggressive surveillance. CONCLUSION: Recurrence of dysplasia/neoplasia after PDT ablation is associated with advanced age, smoking, and residual BE.


Subject(s)
Adenocarcinoma/drug therapy , Adenocarcinoma/epidemiology , Barrett Esophagus/drug therapy , Barrett Esophagus/etiology , Endoscopy, Digestive System , Esophageal Neoplasms/drug therapy , Esophageal Neoplasms/epidemiology , Hematoporphyrin Photoradiation , Neoplasm Recurrence, Local/epidemiology , Precancerous Conditions/drug therapy , Precancerous Conditions/epidemiology , Adenocarcinoma/pathology , Adult , Aged , Aged, 80 and over , Barrett Esophagus/pathology , Biopsy , Combined Modality Therapy , Cross-Sectional Studies , Esophageal Neoplasms/pathology , Esophagus/pathology , Female , Follow-Up Studies , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Neoplasm Recurrence, Local/pathology , Precancerous Conditions/pathology , Risk Factors
11.
Gastroenterology ; 137(3): 815-23, 2009 Sep.
Article in English | MEDLINE | ID: mdl-19524578

ABSTRACT

BACKGROUND & AIMS: Endoscopic therapy is emerging as an alternative to surgical therapy in patients with mucosal (T1a) esophageal adenocarcinoma (EAC) given the low likelihood of lymph node metastases. Long-term outcomes of patients treated endoscopically and surgically for mucosal EAC are unknown. We compared long-term outcomes of patients with mucosal EAC treated endoscopically and surgically. METHODS: Patients treated for mucosal EAC between 1998 and 2007 were included. Patients were divided into an endoscopically treated group (ENDO group) and a surgically treated group (SURG group). Vital status information was queried using an institutionally approved internet research and location service. Statistical analysis was performed using Kaplan-Meier curves and Cox proportional hazard ratios. RESULTS: A total of 178 patients were included, of whom 132 (74%) were in the ENDO group and 46 (26%) were in the SURG group. The mean follow-up period was 64 months (standard error of the mean, 4.8 mo) in the SURG group and 43 months (standard error of the mean, 2.8 mo) in the ENDO group. Cumulative mortality in the ENDO group (17%) was comparable with the SURG group (20%) (P = .75). Overall survival also was comparable using the Kaplan-Meier method. Treatment modality was not a significant predictor of survival on multivariable analysis. Recurrent carcinoma was detected in 12% of patients in the ENDO group, all successfully re-treated without impact on overall survival. CONCLUSIONS: Overall survival in patients with mucosal EAC when treated endoscopically appears to be comparable with that of patients treated surgically. Recurrent carcinoma occurs in a limited proportion of patients, but can be managed endoscopically.


Subject(s)
Adenocarcinoma/surgery , Barrett Esophagus/complications , Esophageal Neoplasms/surgery , Esophagectomy , Esophagoscopy , Adenocarcinoma/drug therapy , Adenocarcinoma/etiology , Adenocarcinoma/mortality , Aged , Combined Modality Therapy , Disease-Free Survival , Esophageal Neoplasms/drug therapy , Esophageal Neoplasms/etiology , Esophageal Neoplasms/mortality , Female , Humans , Male , Mucous Membrane , Neoplasm Recurrence, Local , Photochemotherapy , Proton Pump Inhibitors/therapeutic use
13.
Gastroenterology ; 135(2): 370-9, 2008 Aug.
Article in English | MEDLINE | ID: mdl-18538141

ABSTRACT

BACKGROUND & AIMS: Photodynamic therapy (PDT) has been shown to be effective in the treatment of high-grade dysplasia (HGD)/mucosal carcinoma in Barrett's esophagus (BE). Substantial proportions of patients do not respond to PDT or progress to carcinoma despite PDT. The role of biomarkers in predicting response to PDT is unknown. We aimed to determine if biomarkers known to be associated with neoplasia in BE can predict loss of dysplasia in patients treated with ablative therapy for HGD/intramucosal cancer. METHODS: Patients with BE and HGD/intramucosal cancer were studied prospectively from 2002 to 2006. Biomarkers were assessed using fluorescence in situ hybridization performed on cytology specimens, for region-specific and centromeric probes. Patients were treated with PDT using cylindric diffusing fibers (wavelength, 630 nm; energy, 200 J/cm fiber). Univariate and multiple variable logistic regression was performed to determine predictors of response to PDT. RESULTS: A total of 126 consecutive patients (71 who underwent PDT and 55 patients who did not undergo PDT and were under surveillance, to adjust for the natural history of HGD), were included in this study. Fifty (40%) patients were responders (no dysplasia or carcinoma) at 3 months after PDT. On multiple variable analysis, P16 allelic loss (odds ratio [OR], 0.32; 95% confidence interval [CI], 0.10-0.96) predicted decreased response to PDT. BE segment length (OR, 0.71; 95% CI, 0.59-0.85), and performance of PDT (OR, 7.17; 95% CI, 2.50-20.53) were other independent predictors of loss of dysplasia. CONCLUSIONS: p16 loss detected by fluorescence in situ hybridization can help predict loss of dysplasia in patients with BE and HGD/mucosal cancer. Biomarkers may help in the selection of appropriate therapy for patients and improve treatment outcomes.


Subject(s)
Barrett Esophagus/drug therapy , Biomarkers, Tumor/genetics , Carcinoma/drug therapy , Esophageal Neoplasms/drug therapy , Gene Expression Regulation, Neoplastic , Photochemotherapy , Aged , Barrett Esophagus/genetics , Barrett Esophagus/pathology , Carcinoma/genetics , Carcinoma/pathology , Esophageal Neoplasms/genetics , Esophageal Neoplasms/pathology , Esophagus/drug effects , Esophagus/pathology , Female , Genes, p16 , Humans , In Situ Hybridization, Fluorescence , Loss of Heterozygosity , Male , Middle Aged , Odds Ratio , Patient Selection , Predictive Value of Tests , Prospective Studies , Proto-Oncogene Proteins c-myc/genetics , ROC Curve , Receptor, ErbB-2/genetics , Risk Assessment , Risk Factors , Treatment Outcome , Tumor Suppressor Protein p53/genetics
14.
Cancer ; 113(3): 470-6, 2008 Aug 01.
Article in English | MEDLINE | ID: mdl-18553366

ABSTRACT

BACKGROUND: Currently, histology is used as the endpoint to define success with photodynamic therapy (PDT) in patients with high-grade dysplasia (HGD). Recurrences despite 'successful' ablation are common. The role of biomarkers in assessing response to PDT remains undefined. The objectives of the current study were 1) to assess biomarkers in a prospective cohort of patients with HGD/mucosal cancer before and after PDT and 2) to correlate biomarker status after PDT with histology. METHODS: Patients who underwent PDT for HGD/mucosal cancer were studied prospectively. All patients underwent esophagogastroduodenoscopy, 4-quadrant biopsies every centimeter, endoscopic mucosal resection of visible nodules, and endoscopic ultrasound. Cytology samples were obtained by using standard cytology brushes. Biomarkers were assessed by using fluorescence in situ hybridization (FISH). The biomarkers that were assessed included loss of 9p21 (site of the p16 gene) and 17p13.1 (site of the p53 gene) loci; gains of the 8q24(c-myc), 17q (HER2-neu), and 20q13 loci; and multiple gains. Patients received PDT 48 hours after the administration of sodium porfimer. Demographic and clinical variables were collected prospectively. Patients were followed with endoscopy and repeat cytology for biomarkers. The McNemar test was used to compare biomarker proportions before and after PDT. RESULTS: Thirty-one patients were studied. The median patient age was 66 years (interquartile range [IQR], 56-73 years), and 28 patients (88%) were men. The mean Barrett segment length was 5 cm (standard error of the mean, 0.5 cm). Post-PDT biomarkers were obtained after a median duration of 9 months (IQR, 3-12 months). There was a statistically significant decrease in the proportion of several biomarkers assessed after PDT. Six patients without HGD after PDT still had positive FISH results for 1 or more biomarkers: of these, 2 patients (33%) developed recurrent HGD. CONCLUSIONS: In this initial study, histologic downgrading of dysplasia after PDT was associated with the loss of biomarkers that have been associated with progression of neoplasia in Barrett esophagus. Patients with persistently positive biomarkers appeared to be at a higher risk of recurrent HGD. These findings should be confirmed in a larger study.


Subject(s)
Barrett Esophagus/drug therapy , Barrett Esophagus/pathology , Biomarkers/analysis , Dihematoporphyrin Ether/therapeutic use , Photochemotherapy , Aged , Algorithms , Barrett Esophagus/metabolism , Carcinoma/drug therapy , Carcinoma/pathology , Esophageal Neoplasms/drug therapy , Esophageal Neoplasms/pathology , Female , Follow-Up Studies , Humans , In Situ Hybridization, Fluorescence , Male , Middle Aged , Recurrence
15.
Am J Gastroenterol ; 102(11): 2380-6, 2007 Nov.
Article in English | MEDLINE | ID: mdl-17640326

ABSTRACT

OBJECTIVES: Although EMR has been used for elimination of neoplasia in BE, the significance of positive carcinoma margins and depth of invasion on endoscopic resection pathology has not been assessed using a valid standard. The aim of this study was to assess the accuracy of tumor staging by EMR using esophagectomy as the standard. METHODS: Medical records of patients, who underwent endoscopic resection for esophageal carcinoma or high-grade dysplasia in BE followed by esophagectomy, were reviewed. Data were abstracted from a prospectively maintained EMR database. Endosonography and endoscopic resection were performed by a single experienced endoscopist. Two experienced GI pathologists interpreted all histological results. Standard statistical tests were used to compare continuous and categorical variables. RESULTS: Twenty-five patients were included in the study. Three patients had mucosal carcinoma and 16 had submucosal carcinoma following endoscopic resection. Surgical pathology staging was consistent with preoperative EMR staging in all patients. No patient with negative mucosal resection margins had residual tumor at the resection site at esophagectomy. In patients with submucosal carcinoma, 8 had residual carcinoma at the EMR site at surgery and 5 patients had metastatic lymphadenopathy. CONCLUSIONS: Tumor staging using EMR pathology is accurate when compared with surgical pathology following esophagectomy. Negative margins on EMR pathology correlate with absence of residual disease at the EMR site at esophagectomy. Submucosal carcinoma on EMR specimens was associated with a high prevalence of residual disease at surgery (50%) and metastatic lymphadenopathy (31%).


Subject(s)
Barrett Esophagus/pathology , Esophagoscopy , Esophagus/pathology , Aged , Barrett Esophagus/surgery , Chi-Square Distribution , Esophageal Neoplasms/pathology , Esophagectomy , Female , Humans , Intestinal Mucosa/pathology , Intestinal Mucosa/surgery , Lymphatic Metastasis , Male , Neoplasm Invasiveness/pathology , Neoplasm Staging , Precancerous Conditions/pathology , Precancerous Conditions/surgery , Statistics, Nonparametric
16.
Clin Gastroenterol Hepatol ; 5(6): 743-8, 2007 Jun.
Article in English | MEDLINE | ID: mdl-17545000

ABSTRACT

BACKGROUND & AIMS: Recent studies have shown a survival advantage using photodynamic therapy (PDT) in patients with unresectable cholangiocarcinoma. Factors associated with increased survival after PDT are unknown. METHODS: Twenty-five patients with cholangiocarcinoma who were treated with PDT at the Mayo Clinic Rochester from 1991 to 2004 were studied. Porfimer sodium (2 mg/kg) was administered intravenously to patients with Bismuth type I (3 patients), type III a/b (13 patients), and type IV (9 patients) tumors. Forty-eight hours later, PDT was administered using a 1.5- to 2.5-cm diffusing fiber that was advanced across the tumor by either retrograde (20 patients) or percutaneous (5 patients) cholangiography. Laser light was applied for a total energy of 180 J/cm2 in 1-3 applications. Patients received PDT treatments every 3 months. Plastic biliary stents (10-11.5 F) were inserted to decompress the biliary system after PDT. Survival analysis was performed using Kaplan-Meier curves and Cox proportional hazards models. RESULTS: Patients were 64 (standard error of the mean, +/-2.6) years of age; 20 (80%) were men. The median overall survival period was 344 days. The median survival period after PDT was 214 days. The 1-year survival rate was 30%. On multivariate analysis, the presence of a visible mass on imaging studies (hazard ratio, 3.55; 95% confidence interval, 1.21-10.38), and increasing time between diagnosis and PDT (hazard ratio, 1.13; 95% confidence interval, 1.02-1.25) predicted a poorer survival rate after PDT. A higher serum albumin level (hazard ratio, 0.16; 95% confidence interval, 0.04-0.59) predicted a lower mortality rate after PDT. CONCLUSIONS: Patients with unresectable cholangiocarcinoma without a visible mass may benefit from earlier treatment with PDT.


Subject(s)
Bile Duct Neoplasms/drug therapy , Bile Duct Neoplasms/mortality , Bile Ducts, Intrahepatic , Cholangiocarcinoma/drug therapy , Cholangiocarcinoma/mortality , Hematoporphyrin Photoradiation , Aged , Antineoplastic Agents , Cholangiopancreatography, Endoscopic Retrograde , Cholangiopancreatography, Magnetic Resonance , Female , Humans , Male , Middle Aged , Multivariate Analysis , Photosensitizing Agents/therapeutic use , Retrospective Studies , Serum Albumin/analysis , Survival Analysis
17.
Gastroenterology ; 132(4): 1226-33, 2007 Apr.
Article in English | MEDLINE | ID: mdl-17408660

ABSTRACT

BACKGROUND & AIMS: Photodynamic therapy (PDT) for high-grade dysplasia (HGD) in Barrett's esophagus is a Food and Drug Administration-approved alternative to esophagectomy. Critical information regarding overall survival of patients followed up long-term after these therapies is lacking. Our aim was to compare the long-term survival of patients treated with PDT with patients treated with esophagectomy. METHODS: We reviewed records of patients with HGD seen at our institution between 1994 and 2004. PDT was performed 48 hours following the intravenous administration of a photosensitizer using light at 630 nm. Esophagectomy was performed by either transhiatal or transthoracic approaches by experienced surgeons. We excluded all patients with evidence of cancer on biopsy specimens. Vital status and death date information was queried using an institutionally approved Internet research and location service. Statistical analysis was performed using Kaplan-Meier curves and Cox proportional hazards ratios. RESULTS: A total of 199 patients were identified. A total of 129 patients (65%) were treated with PDT and 70 (35%) with esophagectomy. Overall mortality in the PDT group was 9% (11/129) and in the surgery group was 8.5% (6/70) over a median follow-up period of 59 +/- 2.7 months for the PDT group and 61 +/- 5.8 months for the surgery group. Overall survival was similar between the 2 groups (Wilcoxon test = 0.0924; P = .76). Treatment modality was not a significant predictor of mortality on multivariate analysis. CONCLUSIONS: Overall mortality and long-term survival in patients with HGD treated with PDT appears to be comparable to that of patients treated with esophagectomy.


Subject(s)
Barrett Esophagus/therapy , Esophagectomy , Esophagoscopy/methods , Photochemotherapy/methods , Barrett Esophagus/mortality , Barrett Esophagus/pathology , Female , Follow-Up Studies , Humans , Injections, Intravenous , Male , Middle Aged , Photosensitizing Agents/administration & dosage , Proportional Hazards Models , Retrospective Studies , Severity of Illness Index , Survival Rate/trends , Time Factors , Treatment Outcome
18.
Gastrointest Endosc ; 65(3): 527-31, 2007 Mar.
Article in English | MEDLINE | ID: mdl-17321262

ABSTRACT

BACKGROUND: Endoscopic mucosal resection has been used to stage and treat early neoplasia in Barrett's esophagus. The ability to do this in the setting of portal hypertension has not been reported. OBJECTIVE: Our purpose was to describe the feasibility and efficacy of endoscopic mucosal resection in patients with portal hypertension and Barrett's esophagus. DESIGN: Retrospective case series. SETTING: Two tertiary referral centers. PATIENTS: Patients with Barrett's esophagus and high-grade dysplasia or adenocarcinoma in the setting of portal hypertension. INTERVENTION: Endoscopic mucosal resection of endoscopically visible lesions. MAIN OUTCOME MEASUREMENTS: Complete resection of neoplastic lesion, lack of variceal bleeding. RESULTS: Four patients were treated with endoscopic mucosal resection a total of 5 times. Endoscopic mucosal resection was successfully performed without significant GI bleeding. LIMITATIONS: This preliminary case series describes feasibility of the procedure. Whether this can be generalized remains to be determined, although it may be an option in poor surgical candidates. CONCLUSIONS: Endoscopic mucosal resection appears to be relatively safe in selected patients with portal hypertension and Barrett's esophagus. Further studies are needed to confirm these findings.


Subject(s)
Barrett Esophagus/surgery , Endoscopy, Gastrointestinal/methods , Hypertension, Portal/complications , Aged , Aged, 80 and over , Barrett Esophagus/complications , Barrett Esophagus/pathology , Follow-Up Studies , Humans , Hypertension, Portal/physiopathology , Intestinal Mucosa/pathology , Intestinal Mucosa/surgery , Male , Middle Aged , Retrospective Studies
19.
Gastrointest Endosc ; 65(1): 60-6, 2007 Jan.
Article in English | MEDLINE | ID: mdl-17185080

ABSTRACT

BACKGROUND: Stricture formation is the leading cause of long-term morbidity after photodynamic therapy (PDT). Risk factors for stricture formation have not been studied. OBJECTIVE: To assess risk factors for stricture formation in patients undergoing PDT for Barrett's esophagus with high-grade dysplasia (HGD). DESIGN: Retrospective cohort study. SETTING: Barrett's Unit, Mayo Clinic, Rochester, Minnesota. METHODS: Records of patients undergoing PDT for HGD were reviewed. Patients underwent PDT by using either bare cylindrical diffusing fibers (2.5-5.0 cm in length) or balloon diffusers with 5- to 7-cm windows. Univariate and multivariate logistic regression analyses were performed to assess risk factors for stricture formation. MAIN OUTCOME MEASUREMENT: Esophageal stricture formation. RESULTS: Thirty-five of 131 patients (27%) developed strictures. On multivariate analysis, statistically significant predictors of stricture formation were the following: EMR before PDT was odds ratio (OR) 2.7, 95% confidence interval (CI) 1.13-6.59; a prior history of esophageal stricture was OR 2.7, 95% CI 1.15-6.47; and the number of PDT applications was OR 2.2, 95% CI 1.22-4.12. The OR for stricture formation in patients when centering balloons were used was 0.41, 95% CI 0.11-1.46, P = .168, indicating that centering balloons did not significantly decrease the risk of stricture formation. LIMITATIONS: Retrospective single-center study; small proportion of patients treated with centering balloons. CONCLUSIONS: Risk factors for development of strictures after PDT included history of a prior esophageal stricture, performance of EMR before PDT, and more than 1 PDT application in 1 treatment session. The use of centering balloons was not associated with a statistically significant reduction in the risk of stricture formation.


Subject(s)
Barrett Esophagus/drug therapy , Dihematoporphyrin Ether/adverse effects , Esophageal Stenosis/epidemiology , Photochemotherapy/adverse effects , Photosensitizing Agents/adverse effects , Adult , Aged , Aged, 80 and over , Barrett Esophagus/pathology , Dihematoporphyrin Ether/therapeutic use , Esophageal Stenosis/chemically induced , Female , Humans , Logistic Models , Male , Middle Aged , Mucous Membrane/surgery , Multivariate Analysis , Odds Ratio , Photosensitizing Agents/therapeutic use , Retrospective Studies , Risk Factors
20.
Clin Gastroenterol Hepatol ; 4(2): 173-8, 2006 Feb.
Article in English | MEDLINE | ID: mdl-16469677

ABSTRACT

BACKGROUND & AIMS: The aim of this study was to assess the validity of frozen section analysis of endoscopic mucosal resection (EMR) specimens from Barrett's esophagus as compared with permanent sections for the detection of neoplasia. Frozen sections help to give immediate feedback for surgical procedures. It has not been determined whether EMR can be adequately interpreted by using frozen sections to aid endoscopists in completely resecting neoplastic lesions. METHODS: EMR specimens from Barrett's esophagus with high-grade dysplasia (HGD) and/or carcinoma were tested by frozen section. Pathologists evaluated EMR specimens for the depth of invasion as well as the appearance of clear margins of resection. The kappa statistic was calculated to assess the degree of agreement between the frozen section and permanent section diagnoses. RESULTS: Twenty-three consecutive patients underwent 30 EMRs with frozen section diagnosis. Frozen section revealed a carcinoma in 7 specimens (23%) and dysplasia in 20 (66%). Permanent sections found carcinoma in 8 specimens (26%), dysplasia in 19 specimens (63%), and normal or nondysplastic Barrett's esophagus in the remainder. The kappa statistic for the depth of invasion of EMR specimens was 0.93 (near perfect agreement). The kappa statistic for the margins of the EMR specimens was 0.80 (excellent agreement). CONCLUSIONS: This study indicated that frozen section analysis of esophageal EMR specimens is valid as compared with permanent section. This technique might allow rapid evaluation about the degree and depth of involvement of cancers. This allows physicians to make decisions regarding further therapy if margins are involved or decrease the use of EMR for histologically benign-appearing lesions.


Subject(s)
Barrett Esophagus/pathology , Esophagoscopy , Esophagus/pathology , Frozen Sections , Aged , Esophageal Neoplasms/pathology , Female , Humans , Male , Mucous Membrane/pathology , Neoplasm Invasiveness/pathology
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