Practice patterns of peripheral vascular interventions for peripheral artery disease in the office-based laboratory setting versus outpatient hospital.

OBJECTIVE: Controversy exists regarding the value and limitations of different sites of service for peripheral artery disease treatment. We aimed to examine practice patterns associated with peripheral vascular interventions (PVIs) performed in the office-based laboratory (OBL) vs outpatient hospital site of service using a nationally representative database. METHODS: Using 100% Medicare fee-for-service claims data, we identified all patients undergoing PVI for claudication or chronic limb-threatening ischemia (CLTI) between January 2017 and December 2022. We evaluated the associations of patient and procedure characteristics with site of service using multivariable hierarchical logistic regression. We used multinomial regression models to estimate the relative risk ratios (RRRs) of site of service and intervention type (angioplasty, stent, or atherectomy) and intervention anatomic level (iliac, femoropopliteal, or tibial) after adjusting for baseline patient characteristics and clustering by physician. RESULTS: Of 848,526 PVI, 485,942 (57.3%) were performed in an OBL. OBL use increased significantly over time from 48.3% in 2017 to 65.5% in 2022 (P < .001). Patients treated in OBLs were more likely to be Black (adjusted odds ratio [aOR], 1.14; 95% confidence interval [CI], 1.11-1.18) or other non-White race (aOR, 1.13; 95% CI, 1.08-1.18), have fewer comorbidities, and undergo treatment for claudication vs CLTI (aOR, 1.30; 95% CI, 1.26-1.33) compared with patients treated in outpatient hospital settings. Physicians with majority practice (>50% procedures) in an OBL were more likely to practice in urban settings (aOR, 21.58; 95% CI, 9.31-50.02), specialize in radiology (aOR, 18.15; 95% CI, 8.92- 36.92), and have high-volume PVI practices (aOR, 2.15; 95% CI, 2.10-2.29). The median time from diagnosis to treatment was shorter in OBLs, particularly for patients with CLTI (29 vs 39 days; P < .001). The OBL setting was the strongest predictor of patients receiving an atherectomy alone (adjusted RRR [aRRR] 6.67; 95% CI, 6.59-6.76) or atherectomy + stent (aRRR, 10.84; 95% CI, 10.64-11.05), and these findings were consistent in subgroup analyses stratified by PVI indication. The OBL setting was also associated with higher risk of tibial interventions for both claudication (aRRR, 3.18; 95% CI, 3.11-3.25) and CLTI (aRRR, 1.89; 95% CI, 1.86-1.92). The average reimbursement (including professional and facility fees) was slightly higher for OBLs compared with the hospital ($8742/case vs $8459/case; P < .001). However, in a simulated cohort resetting the OBL's intervention type distribution to that of the hospital, OBLs were associated with a hypothetical cost savings of $221,219,803 overall and $2602 per case. CONCLUSIONS: The OBL site of service was associated with greater access to care for non-White patients and a shorter time from diagnosis to treatment, but more frequently performed high-cost interventions compared with the outpatient hospital setting. The benefit to patients from improved access to peripheral artery disease care in OBL settings must be balanced with the potential limitations of receiving differential care.

Prior authorization requirements in the office-based laboratory setting are administratively inefficient and threaten timeliness of care.

OBJECTIVE: The objective of this study was to investigate the administrative and clinical impacts of prior authorization (PA) processes in the office-based laboratory (OBL) setting. METHODS: This single-institution, retrospective analysis studied all OBL PAs pursued between January 2018 and March 2022. Case, PA, and coding information was obtained from the practice's scheduling database. RESULTS: Over the study period, 1854 OBL cases were scheduled; 8% (n = 146) required PA. Of these, 75% (n = 110) were for lower extremity arterial interventions, 19% (n = 27) were for deep venous interventions, and 6% (n = 9) were for other interventions. Of 146 PAs, 19% (n = 27) were initially denied but 74.1% (n = 7) of these were overturned on appeal. Deep venous procedures were initially denied, at 43.8% (n = 14), more often than were arterial procedures, at 11.8% (n = 13). Of 146 requested procedures, 4% (n = 6) were delayed due to pending PA determination by a mean 14.2 ± 18.3 working days. An additional 6% (n = 8) of procedures were performed in the interest of time before final determination. Of the seven terminally denied procedures, 57% (n = 4) were performed at cost to the practice based on clinical judgment. CONCLUSIONS: Using PA appeals mechanisms, while administratively onerous, resulted in the overturning of most initial denials.

Long-term outcomes and cost savings of office fulguration of papillary Ta low-grade bladder cancer.

OBJECTIVES: To assess whether office-based fulguration (OF) under local anaesthesia for small, recurrent, pathological Ta low-grade (LG) non-muscle-invasive bladder cancer (NMIBC) is an effective alternative to transurethral resection of bladder tumour (TURBT), avoiding the costs and risks of procedure, and anesthesia. PATIENTS AND METHODS: Of 521 patients with primary TaLG NMIBC, this retrospective study included 270 patients who underwent OF during follow-up for recurrent, small, papillary LG-appearing tumours at a university centre (University Health Network, University of Toronto, Canada). We assessed the cumulative incidence of cancer-specific mortality (CSM) and disease progression (to MIBC or metastases), as well as possible direct cost savings. RESULTS: In the 270 patients with recurrent TaLG NMIBC treated with OF, the mean (sd) age was 64.9 (13.3) years, 70.8% were men, and 60.3% had single tumours. The mean (sd, range) number of OF procedures per patient was 3.1 (3.2, 1-22). The median (interquartile range) follow-up was 10.1 (5.8-16.2) years. Patients also underwent a mean (sd) of 3.6 (3.0) TURBTs during follow-up in case of numerous or bulkier recurrence. In all, 44.4% of patients never received intravesical therapy. The 10-year incidence of CSM and progression were 0% and 3.1% (95% confidence interval 0.8-5.4%), respectively. Direct cost savings in Ontario were estimated at $6994.14 (Canadian dollars) per patient over the study follow-up. CONCLUSIONS: This study supports that properly selected patients with recurrent, apparent TaLG NMIBC can be safely managed with OF under local anaesthesia with occasional TURBT for larger or numerous recurrent tumours, without compromising long-term oncological outcomes. This approach could generate substantial cost-saving to healthcare systems, is patient-friendly, and could be adopted more widely.

Global International Society of University Colon and Rectal Surgeons in collaboration with European Society of Coloproctology audit on office-based and surgical treatment of haemorrhoidal disease: Study protocol.

AIM: Haemorrhoidal disease (HD) is one of the most common anal disorders in the adult population. Despite that, treatment options differ among different countries and specialists, even for the same grade of HD. The aim of this study is to evaluate the differences in patient demographics, surgeon preference for the treatment option, outcomes as well as patient satisfaction rate for the procedure using an office-based or surgical approach for the treatment of HD among International Society of University Colon and Rectal Surgeons (ISUCRS) and European Society of Coloproctology (ECSP) fellows. METHOD: A panel of the ISUCRS and ECSP members will answer questions that are included in a questionnaire about the treatment of HD. The questionnaire will be distributed electronically to ISUCRS and ECSP fellows included in our database and will remain open from 1 April 2024 to 31 May 2024. CONCLUSION: This multicentre, global prospective audit will be delivered by consultant colorectal and general surgeons as well as trainees. The data obtained will lead to a better understanding of the incidence of HD, treatment and diagnostic possibilities. This snapshot audit will be hypothesis generating and inform areas the need future prospective study.

Impact of COVID-19 on patients undergoing scheduled procedures for chronic venous disease.

OBJECTIVE: The COVID-19 pandemic has drastically altered the medical landscape. Various strategies have been employed to preserve hospital beds, personal protective equipment, and other resources to accommodate the surges of COVID-19 positive patients, hospital overcapacities, and staffing shortages. This has had a dramatic effect on vascular surgical practice. The objective of this study is to analyze the impact of the COVID-19 pandemic on surgical delays and adverse outcomes for patients with chronic venous disease scheduled to undergo elective operations. METHODS: The Vascular Surgery COVID-19 Collaborative (VASCC) was founded in March 2020 to evaluate the outcomes of patients with vascular disease whose operations were delayed. Modules were developed by vascular surgeon working groups and tested before implementation. A data analysis of outcomes of patients with chronic venous disease whose surgeries were postponed during the COVID-19 pandemic from March 2020 through February 2021 was performed for this study. RESULTS: A total of 150 patients from 12 institutions in the United States were included in the study. Indications for venous intervention were: 85.3% varicose veins, 10.7% varicose veins with venous ulceration, and 4.0% lipodermatosclerosis. One hundred two surgeries had successfully been completed at the time of data entry. The average length of the delay was 91 days, with a median of 78 days. Delays for venous ulceration procedures ranged from 38 to 208 days. No patients required an emergent intervention due to their venous disease, and no patients experienced major adverse events following their delayed surgeries. CONCLUSIONS: Interventions may be safely delayed for patients with venous disease requiring elective surgical intervention during the COVID-19 pandemic. This finding supports the American College of Surgeons' recommendations for the management of elective vascular surgical procedures. Office-based labs may be safe locations for continued treatment when resources are limited. Although the interventions can be safely postponed, the negative impact on quality of life warrants further investigation.

Office-based blue laser therapy for inferior turbinate hypertrophy: a pilot study.

PURPOSE: To investigate the subjective effect of office-based blue laser therapy for inferior turbinate hypertrophy in patients with nasal obstruction. METHODS: Patients with nasal obstruction who underwent office-based blue laser for the inferior turbinate hypertrophy between October 2022 and December 2023 were included in the study. The two outcome measures used to gauge the improvement in nasal obstruction and success of surgery were the Nasal Obstruction Symptom Evaluation (NOSE) scale and the Visual Analogue Scale (VAS). Patient's level of comfort during the procedure was also rated using a 10-point VAS scale. RESULTS: A total of 14 patients were included in this study. The mean age of the study group was 41.47 ± 18.52 and the F/M ratio was 4.67. All patients reported significant improvement in nasal breathing. The mean NOSE score decreased significantly from 13.07 ± 3.89 pre-operatively to 2.64 ± 2.43 post-operatively (p = 0.002). Similarly, the mean VAS score decreased from 7.43 ± 0.85 to 2.0 ± 1.57 (p = 0.002) following surgery. The procedure was well-tolerated by all participants and the mean total score ranged from 6 to 9 with an average of 7.59 ± 1.34. CONCLUSION: Office-based blue laser therapy for inferior turbinate hypertrophy may be an effective treatment modality for nasal obstruction from the patient's perspective. Although the procedures were tolerated well with no complications noted, these results should be cautiously interpreted until studies using objective measures are conducted.

Office-based blue laser therapy for vocal fold polyps and Reinke's edema: a case study and review of the literature.

PURPOSE: To report the efficacy of blue laser in the treatment of vocal fold polyps and Reinke's edema in an office setting. METHODS: The medical records and video-recordings of patients who underwent office-based blue laser therapy in a tertiary referral center for vocal fold polyps and/or Reinke's edema were reviewed. The primary outcome measures were the Voice Handicap Index-10 (VHI-10) score and disease regression. Acoustic and aerodynamic parameters were also analyzed. RESULTS: Thirty-five patients (21 with vocal fold polyps and 14 with Reinke's edema) were included and a total of 47 lesions were treated. Out of the 35 patients, 7 patients were lost for follow-up. The mean VHI-10 score dropped significantly after surgery by 17.41 ± 8.67 points (p < 0.001). The endoscopic examinations of 38 lesions were reviewed (17 vocal fold polyps and 21 Reinke's edema) before and up to 6 months after laser therapy. In the subgroup with vocal fold polyps (N = 17), there was complete disease regression in 13 and partial in 4. In the subgroup with Reinke's edema (N = 21), there was complete disease regression in 7 and partial disease regression in 14. For patients with vocal fold polyp, there was a significant decrease in shimmer and a significant increase in maximum phonation time postoperatively. For patients with Reinke's edema, there was a significant decrease in shimmer and noise-to-harmonic ratio following treatment. CONCLUSION: Office-based blue laser therapy is an effective treatment for vocal fold polyps and Reinke's edema leading to complete or partial disease regression. All patients had improvement in voice quality.

Feasibility and preliminary clinical tolerability of low-field MRI-guided prostate biopsy.

OBJECTIVE: We evaluate the clinical feasibility of a portable, low-field magnetic resonance imaging (MRI) system for prostate cancer (PCa) biopsy. METHODS: A retrospective analysis of men who underwent a 12-core systematic transrectal ultrasound-guided prostate biopsy (SB) and a low-field MRI guided transperineal targeted biopsy (MRI-TB). Comparison of the detection of clinically significant PCa (csPCa) (Gleason Grade [GG] ≥ 2) by SB and low field MRI-TB, stratified by Prostate Imaging Reporting & Data System (PI-RADS) score, prostate volume, and prostate serum antigen (PSA) was performed. RESULTS: A total of 39 men underwent both the MRI-TB and SB biopsy. Median (interquartile range [IQR]) age was 69.0 (61.5-73) years, body mass index (BMI) was 28.9 kg/m2 (25.3-34.3), prostate volume was 46.5 cc (32-72.7), and PSA was 9.5 ng/ml (5.5-13.2). The majority (64.4%) of patients had PI-RADS ≥ 4 lesions and 25% of lesions were anterior on pre-biopsy MRII. Cancer detection rate (CDR) was greatest when combining SB and MRI-TB (64.1%). MRI-TB detected 74.3% (29/39) cancers. Of which, 53.8% (21/39) were csPCa while SB detected 42.5% (17/39) csPCa (p = 0.21). In 32.5% (13/39) of cases, MRI-TB upstaged the final diagnosis, compared to 15% (6/39) of cases in which SB upstaged the final diagnosis (p = 0.11). CONCLUSION: Low-field MRI-TB is clinically feasible. Although future studies on the accuracy of MRI-TB system are needed, the initial CDR is comparable to those seen with fusion-based prostate biopsies. A transperineal and targeted approach may be beneficial in patients with higher BMI and anterior lesions.

A comparison of laboratory-based and office-based Framingham risk scores to predict 10-year risk of cardiovascular diseases: a population-based study.

BACKGROUND: Two versions of Framingham's 10-year risk score are defined for cardiovascular diseases, namely laboratory-based and office-based models. The former is mainly employed in high-income countries, but unfortunately, it is not cost-effective or practical to utilize it in countries with poor facilities. Therefore, the present study aims to identify the agreement and correlation between laboratory-based and office-based Framingham models. METHODS: Using laboratory-based and office-based Framingham models, this cross-sectional study used data from 8944 participants without a history of CVDs and stroke at baseline in the Fasa cohort study to predict the 10-year risk of CVDs. The laboratory-based model included age, sex, diabetes, smoking status, systolic blood pressure (SBP), treatment of hypertension, total cholesterol, and high-density lipoprotein (HDL); and the office-based model included age, sex, diabetes, smoking status, SBP, treatment of hypertension, and body mass index (BMI). The agreement between risk categories of laboratory-based and office-based Framingham models (low [< 10%], moderate [from 10 to < 20%], high [≥ 20%]) was assessed by kappa coefficients and percent agreement. Then, the correlation between the risk scores was estimated using correlation coefficients and illustrated using scatter plots. Finally, agreements, correlation coefficient, and scatter plots for laboratory-based and office-based Framingham models were analyzed by stratified Framingham risk score factors including sex, age, BMI categories, hypertension, smoking, and diabetes status. RESULTS: The two models showed substantial agreement at 89.40% with a kappa coefficient of 0.75. The agreement was substantial in all men (kappa = 0.73) and women (kappa = 0.72), people aged < 60 years (kappa = 0.73) and aged ≥ 60 years (kappa = 0.69), smokers (kappa = 0.70) and non-smokers (kappa = 0.75), people with hypertension (kappa = 0.73) and without hypertension (kappa = 0.75), diabetics (kappa = 0.71) and non-diabetics (kappa = 0.75), people with normal BMI (kappa = 0.75) and people with overweight and obesity (kappa = 0.76). There was also a very strong positive correlation (r ≥ 0.92) between laboratory-based and office-based models in terms of age, sex, BMI, hypertension, smoking status and diabetes status. CONCLUSIONS: The current study showed that there was a substantial agreement between the office-based and laboratory-based models, and there was a very strong positive correlation between the risk scores in the entire population as well across subgroups. Although differences were observed in some subgroups, these differences were small and not clinically relevant. Therefore, office-based models are suitable in low-middle-income countries (LMICs) with limited laboratory resources and facilities because they are more convenient and accessible. However, the validity of the office-based model must be assessed in longitudinal studies in LMICs.

Reprint of: Early peripheral vascular interventions for claudication are associated with higher rates of late interventions and progression to chronic limb threatening ischemia.

OBJECTIVE: Despite societal guidelines that peripheral vascular intervention (PVI) should not be the first-line therapy for intermittent claudication, a significant number of patients will undergo PVI for claudication within 6 months of diagnosis. The aim of the present study was to investigate the association of early PVI for claudication with subsequent interventions. METHODS: We evaluated 100% of Medicare fee-for-service claims to identify all beneficiaries with a new diagnosis of claudication from January 1, 2015 to December 31, 2017. The primary outcome was late intervention, defined as any femoropopliteal PVI performed >6 months after the claudication diagnosis (through June 30, 2021). Kaplan-Meier curves were used to compare the cumulative incidence of late PVI for claudication patients with early (≤6 months) PVI vs those without early PVI. A hierarchical Cox proportional hazards model was used to evaluate the patient- and physician-level characteristics associated with late PVIs. RESULTS: A total of 187,442 patients had a new diagnosis of claudication during the study period, of whom 6069 (3.2%) had undergone early PVI. After a median follow-up of 4.39 years (interquartile range, 3.62-5.17 years), 22.5% of the early PVI patients had undergone late PVI vs 3.6% of those without early PVI (P < .001). Patients treated by high use physicians of early PVI (≥2 standard deviations; physician outliers) were more likely to have received late PVI than were patients treated by standard use physician of early PVI (9.8% vs 3.9%; P < .001). Patients who had undergone early PVI (16.4% vs 7.8%) and patients treated by outlier physicians (9.7% vs 8.0%) were more likely to have developed CLTI (P < .001 for both). After adjustment, the patient factors associated with late PVI included receipt of early PVI (adjusted hazard ratio [aHR], 6.89; 95% confidence interval [CI], 6.42-7.40) and Black race (vs White; aHR, 1.19; 95% CI, 1.10-1.30). The only physician factor associated with late PVI was a majority of practice in an ambulatory surgery center or office-based laboratory, with an increasing proportion of ambulatory surgery center or office-based laboratory services associated with significantly increased rates of late PVI (quartile 4 vs quartile 1; aHR, 1.57; 95% CI, 1.41-1.75). CONCLUSIONS: Early PVI after the diagnosis of claudication was associated with higher late PVI rates compared with early nonoperative management. High use physicians of early PVI for claudication performed more late PVIs than did their peers, especially those primarily delivering care in high reimbursement settings. The appropriateness of early PVI for claudication needs critical evaluation, as do the incentives surrounding the delivery of these interventions in ambulatory intervention suites.

Early peripheral vascular interventions for claudication are associated with higher rates of late interventions and progression to chronic limb threatening ischemia.

OBJECTIVE: Despite societal guidelines that peripheral vascular intervention (PVI) should not be the first-line therapy for intermittent claudication, a significant number of patients will undergo PVI for claudication within 6 months of diagnosis. The aim of the present study was to investigate the association of early PVI for claudication with subsequent interventions. METHODS: We evaluated 100% of Medicare fee-for-service claims to identify all beneficiaries with a new diagnosis of claudication from January 1, 2015 to December 31, 2017. The primary outcome was late intervention, defined as any femoropopliteal PVI performed >6 months after the claudication diagnosis (through June 30, 2021). Kaplan-Meier curves were used to compare the cumulative incidence of late PVI for claudication patients with early (≤6 months) PVI vs those without early PVI. A hierarchical Cox proportional hazards model was used to evaluate the patient- and physician-level characteristics associated with late PVIs. RESULTS: A total of 187,442 patients had a new diagnosis of claudication during the study period, of whom 6069 (3.2%) had undergone early PVI. After a median follow-up of 4.39 years (interquartile range, 3.62-5.17 years), 22.5% of the early PVI patients had undergone late PVI vs 3.6% of those without early PVI (P < .001). Patients treated by high use physicians of early PVI (≥2 standard deviations; physician outliers) were more likely to have received late PVI than were patients treated by standard use physician of early PVI (9.8% vs 3.9%; P < .001). Patients who had undergone early PVI (16.4% vs 7.8%) and patients treated by outlier physicians (9.7% vs 8.0%) were more likely to have developed CLTI (P < .001 for both). After adjustment, the patient factors associated with late PVI included receipt of early PVI (adjusted hazard ratio [aHR], 6.89; 95% confidence interval [CI], 6.42-7.40) and Black race (vs White; aHR, 1.19; 95% CI, 1.10-1.30). The only physician factor associated with late PVI was a majority of practice in an ambulatory surgery center or office-based laboratory, with an increasing proportion of ambulatory surgery center or office-based laboratory services associated with significantly increased rates of late PVI (quartile 4 vs quartile 1; aHR, 1.57; 95% CI, 1.41-1.75). CONCLUSIONS: Early PVI after the diagnosis of claudication was associated with higher late PVI rates compared with early nonoperative management. High use physicians of early PVI for claudication performed more late PVIs than did their peers, especially those primarily delivering care in high reimbursement settings. The appropriateness of early PVI for claudication needs critical evaluation, as do the incentives surrounding the delivery of these interventions in ambulatory intervention suites.

Outcomes of elective peripheral endovascular interventions for peripheral arterial disease performed in hospital outpatient departments, ambulatory surgical centers and office-based labs.

BACKGROUND: A recent shift in the location where peripheral endovascular interventions (PVI) are performed has occurred, from traditional settings such as hospital outpatient departments (HOPD), to ambulatory surgical centers (ASC) and outpatient-based laboratories (OBL). Different settings may influence the safety and efficacy of the PVI, as well as how it is done. This study aims to compare the postprocedural outcomes and intraprocedural details between the three settings. METHODS: The Vascular Quality Initiative database was queried for all elective infrainguinal PVIs for occlusive peripheral arterial disease between January 2016 and December 2021. The primary outcomes were rates of postprocedural hospital admissions, postprocedural medical complications, and access site complications. Secondary outcomes included technical success and intraprocedural details, such as types and number of devices used, amount of contrast, and fluoroscopy time. The χ2 test, analysis of variance, and multivariate logistic regression were used to analyze the outcomes. RESULTS: A total of 66,101 PVI cases (HOPD, 57,062 [83.33%]; ASC, 4591 [6.95%]; OBL, 4448 [6.73%]) were included in the study. There were 445 cases requiring hospital admission (HOPD, 398 [0.70%]; ASC, 26 [0.57%]; OBL, 21 [0.47%]; P = .126). There were no significant differences in cardiac, pulmonary, or renal complications. Access site complications occurred in less than 1.7% of all cases and were significantly higher in OBLs when compared with ASCs (adjusted odds ratio [aOR], 3.70; 95% confidence interval [CI], 1.70-8.03; P = .001) and significantly lower in ASCs in comparison to HOPDs (aOR, 0.27; 95% CI, 0.18-0.41; P < .001). Technical success occurred in at least 92% of all cases, regardless of setting. There was a 16-fold increase in the use of atherectomy devices in an OBL vs HOPD setting (aOR, 16.79; 95% CI, 11.77-23.95; P < .001) and a five-fold increase in the use of atherectomy devices in an ASC vs HOPD setting (aOR, 5.37; 95% CI, 2.47-11.65; P < .001). There was a five-fold decrease in the use of special balloons in an OBL vs HOPD setting (aOR, 0.20; 95% CI, 0.10-0.39; P < .001) and a four-fold decrease when comparing ASCs with HOPDs (aOR, 0.25; 95% CI, 0.12-0.51; P < .001). CONCLUSIONS: Elective PVIs performed in any outpatient setting proved to be safe and technically successful. However, there are significant differences in the way PVIs are performed in each setting, such as the greater use of atherectomy devices in OBLs and greater use of special balloons in HOPDs. Long-term studies are needed to evaluate the durability and reintervention outcomes and understand factors associated with practice pattern variability across these different settings.

In-office KTP laser treatment for laryngeal pathologies: 5-years outcomes.

INTRODUCTION: In the past two decades, laser systems were introduced into the office setting for laryngeal pathologies, offering the advantages of a shorter procedure and recovery. To date, long-term data on outcomes is limited. This study aims to evaluate the efficacy and safety of the office-based potassium-titanyl-phosphate (KTP) laser procedure for laryngeal pathologies. METHODS: A retrospective cohort of in-office KTP laser procedures for two main vocal folds lesions groups: (i) benign and pre-malignant; and (ii) intraepithelial lesions in a prior invasive cancer field between 2010 and 2020. Data were collected from electronic medical records, telephone interviews, and video documentation of the procedure, including treatment completion, disease control, and whether additional interventions were required. RESULTS: A total of 81 patients underwent 153 in-office KTP laser procedures for benign (36, 44.4%), pre-malignant (15, 18.5%), and lesions in a prior malignancy field (30, 37.1%) with a mean of 1.89 ± 1.81 procedures per patient. One hundred and thirty-eight (90.2%) procedures were well tolerated and completed successfully. During the 5-years of follow-up, 63% of the patients with previous malignancy were managed exclusively in the office. In the pre-malignant group, 76% required no additional type of intervention. Patients with papilloma required significantly more procedures per patient compared with other pathologies (3.6 ± 4 vs. 1.61 ± 1, p-value = 0.02). Surgery was required only in 18.2% of the papilloma patients. Three (1.9%) patients had short-term complications, all resolved within 6 months. Failure to complete the procedure was significantly associated with active smoking (p-value < 0.001) and, in most cases (90%), was related to patient intolerance. CONCLUSION: Office-based KTP laser laryngeal procedures have shown promising results for both benign and selected cases of lesions in a prior malignancy field with a high compliance and a very low complication rate, suggesting its use as an effective and safe treatment modality for selected patients.

Endovascular experience at an academic office-based procedure center.

OBJECTIVE: The number of office-based procedure centers with the capability of performing a wide range of endovascular procedures has substantially increased over the past decade. This shift in practice settings has occurred faster in the private sector as compared to the academic environment. The purpose of our study was to evaluate the clinical outcomes of endovascular procedures performed at a dedicated academic outpatient procedural center. METHODS: We reviewed the clinical data of 400 patients who underwent 499 endovascular procedures in a university-based, academic outpatient procedure center between November 2013 and December 2016. Outcomes analyzed included procedure-related complications, limb loss, mortality, and emergency department visits or hospital admissions that occurred within 30 days following the procedure. RESULTS: The 400 patients had a mean age of 65 ± 13 years with slightly more females (51%; n = 203) as compared to males (49%; n = 197). Most patients (71%; 284) were Caucasian while 80 (20%) were African-Americans. Associated comorbidities included hypertension (86%), diabetes mellitus (51%), chronic kidney disease (42%), and obesity (mean body mass index of 29 ± 6). Based on anesthetic risk, most were ASA class 3 (81%), while ASA 1 and 2 comprised 17% and ASA 4 only 2%. Medicare beneficiaries accounted for 254 (64%) of our patients. Pre-operative studies included mainly duplex ultrasound (62%) and other noninvasive arterial studies (57%).The mean procedural time was 58 min (range, 7 to 200) with an overall technical success rate of 97%. There were no deaths. Complications developed in 10 patients following the 483 procedures (2.1%) being hospitalized with four of them transferred directly to the emergency room. The reasons for these hospitalizations included acute limb ischemia, arterial pseudoaneurysm, deep vein thrombosis, congestive heart failure, myocardial infarction, and lower extremity pain not vascular in origin. Financial reimbursement at the office-based center was higher than that seen with hospital-based procedures. CONCLUSIONS: Endovascular procedures performed in an academic office-based procedure center are safe and associated with good clinical outcomes. A small minority of patients have subsequent ER visits or hospital admissions. Academic institutions should consider adding an office-based procedure center based on today's competitive healthcare market.

Implementing harm reduction kits in an office-based addiction treatment program.

BACKGROUND: The rising rates of drug use-related complications call for a paradigm shift in the care for people who use drugs. While addiction treatment and harm reduction have historically been siloed in the US, co-location of these services in office-based addiction treatment (OBAT) settings offers a more realistic and patient-centered approach. We describe a quality improvement program on integrating harm reduction kits into an urban OBAT clinic. METHODS: After engaging appropriate stakeholders and delivering clinician and staff trainings on safer use best practices, we developed a clinical workflow for universal offering and distribution of pre-packaged kits coupled with patient-facing educational handouts. We assessed: (1) kit uptake with kit number and types distributed; and (2) implementation outcomes of feasibility, acceptability, appropriateness, and patient perceptions. RESULTS: One-month post-implementation, 28% (40/141) of completed in-person visits had at least one kit request, and a total of 121 kits were distributed. Staff and clinicians found the program to be highly feasible, acceptable, and appropriate, and patient perceptions were positive. CONCLUSIONS: Incorporating kits in OBAT settings is an important step toward increasing patient access and utilization of life-saving services. Our program uncovered a significant unmet need among our patients, suggesting that kit integration within addiction treatment can improve the standard of care for people who use drugs.

Laboratory-based and office-based Globorisk scores to predict 10-year risk of cardiovascular diseases among Iranians: results from the Fasa PERSIAN cohort.

BACKGROUND: Globorisk is a novel risk prediction model for predicting cardiovascular disease (CVD). Globorisk is a country-specific risk prediction model that determines CVD risk for all countries. This model has two versions; laboratory-based and office-based. This study aimed to determine the agreement between laboratory-based and office-based models in a large sample of the general population. METHODS: Baseline data from the Fasa cohort study was used for the current study. In total, 6810 participants ≥ 40 years without any history of cardiovascular disease or stroke were included in the study. To determine the laboratory-based risk model, factors include age, sex, current smoking status, history of diabetes, systolic blood pressure (SBP), and total cholesterol. To estimate the office-based risk model, factors were age, sex, current smoking status, SBP, and body mass index (BMI). Kappa statistics was used to distinguish the agreement between grouped scores in these two models. Additionally, correlation coefficients and scatter plots were used to determine the linear correlation between the two models. RESULTS: In this study 46.53% of the participants were men. The mean age (SD) of participants was 51.08 (7.88) years. Agreements between the two models were moderate and substantial in all women and all men, respectively. The agreement between the two CVD risk groups was 90.15% (kappa = 0.717) in all men, 92.94% (kappa = 0.571) among men aged < 60 years and 77.60% (kappa = 0.645) in men aged ≥ 60 years. The agreement between the two CVD risk groups was 86.68% (kappa = 0.572) among all women, 93.96% (kappa = 0.274) among women aged < 60 years and 62.46% (kappa = 0.422) among women aged ≥ 60 years. A very strong positive correlation (r = 0.94) was found between the two risk scores in all men, and it was similar among men aged < 60 years (r = 0.84) and men aged > 60 years (r = 0.94). Among all women, there was a very strong positive correlation (r = 0.87), and the strong positive correlation remained among < 60 years old (r = 0.76) and women > 60 years old (r = 0.76). CONCLUSION: The Globorisk office-based model which is easier to use as it does not require blood testing can determine the risk groups in this population. The Globorisk office-based model may be used for CVD risk screening in low-middle income countries where resources are limited.

Effectiveness and safety of repeated percutaneous intervention in an office-based endovascular center in maintaining hemodialysis access.

OBJECTIVES: Percutaneous dialysis access interventions are routinely used to maintain the patency of dialysis access despite the lack of data regarding their long-term effectiveness. This retrospective study was undertaken to study the effectiveness and safety of percutaneous dialysis access interventions in arm fistulas and bridge grafts in an office-based endovascular center. METHODS: Patients who had a percutaneous dialysis access intervention in their upper extremity access site, performed at a single office-based endovascular center over a nine-year period (2007-2016) were included in this study. The patients' demographic factors, patency, and complications were analyzed. Patients were entered in the study after first percutaneous dialysis access intervention. RESULTS: A total of 298 limbs in 259 patients had 913 procedures carried out over a nine-year period. There were 190 access arteriovenous fistulas and 108 arteriovenous grafts. The two most common arteriovenous fistulas were the brachiocephalic fistula (n = 74, 39%) and radio cephalic fistula (n = 69, 36%). Arteriovenous grafts were most commonly placed in the upper arm (n = 66, 61%) followed by the forearm (n = 42, 39%). The mean overall patency for all limbs was 50.86 months. Arteriovenous fistulas had a significantly longer patency than arteriovenous grafts (51.65 vs. 42.09 months; P = 0.01). In addition, patients with two or more percutaneous dialysis access intervention in their arteriovenous fistula had significantly greater patency than those with only one percutaneous dialysis access intervention (58.5 vs. 7.6 months; hazard ratio 0.41; P = 0.0008). This was not true for the arteriovenous graft group. Women represented 49% of the patient group. Their accesses had shorter patency than men (39.8 vs. 60 months; P = 0.0007). CONCLUSIONS: This data support the use of repeated percutaneous dialysis access intervention to maintain long-term patency of dialysis access sites in an office-based endovascular center. Overall, fistulas have longer patency than grafts and women have poorer outcomes as compared to men.

Feasibility and Safety of Office-Based Transnasal Balloon Dilation for Neopharyngeal and Proximal Esophageal Strictures in Patients with a History of Head and Neck Carcinoma.

The aim of this study was to assess feasibility and safety of office-based transnasal balloon dilation of neopharyngeal and proximal esophageal strictures in patients with a history of head and neck carcinoma. The secondary objective was to explore its effectiveness. This prospective case series included patients previously treated for head and neck carcinoma with neopharyngeal or proximal esophageal strictures who underwent transnasal balloon dilation under topical anesthesia. The target dilation diameter was 15 mm; if necessary dilation procedures were repeated every 2-4 weeks until this target was reached. Completion rates, adverse events, and patient experiences measured by VAS scores (0 = no complaints - 10 = unbearable complaints), dysphagia scores based on food consistency (0 = no dysphagia - 5 = unable to swallow liquids/saliva), and self-reported changes in swallowing symptoms were recorded. Follow-up was 2 months. Twenty-six procedures were performed in 12 patients, with a completion rate of 92%. One minor complication occurred, i.e. an infection of the dilation site. Tolerance of the procedure was good (median VAS = 2). The dysphagia score improved after a mean of 2.2 procedures per patient, however not significantly. Eight patients reported improvement in dysphagia, of whom 3 had recurrence of dysphagia within 1 month post-treatment. Office-based transnasal balloon dilation is a feasible and safe in-office procedure which is well-tolerated by patients. The dilations can improve dysphagia, although effects might be transient.

Dynamics of lidocaine in topical anesthesia for office-based laryngeal procedures: A pilot study.

OBJECTIVES: To study topical lidocaine for office-based laryngeal procedures recording onset, duration, and subjective experience of topical anesthesia. STUDY DESIGN: Nine healthy volunteers were anesthetized with 4 % lidocaine endoscopically. Laryngeal sensitivity prior to and during anesthesia was recorded until normal sensation returned measured by air-puff sensory testing. Subjective experience of the process was recorded. METHODS: Questionnaires regarding subjective experience were completed prior to, during, and after anesthesia. Laryngeal sensitivity via air-pulse trigger of the laryngeal adductor reflex (LAR) prior to and after 3 mL shower of 4 % lidocaine was recorded at 30 second intervals until the larynx was insensate with no LAR at 10 mmHg. Time to anesthesia was recorded and post-endoscopy questionnaire was given. Upon subjective change in sensation, sensitivity via air-pulse trigger of the LAR was recorded until baseline sensation returned. A post-anesthesia questionnaire recorded the subjective experience. RESULTS: Average time to full anesthesia was 110 s (±31.2). Subjective return of sensation was noted at 10 min (±2.5), however time to return to normal LAR was 22 min (±5.8). Based on three standard deviations, 99.7 % of the population will be anesthetized at 3.4 min, report subjective change at 18.2 min and regain full sensation at 40 min. CONCLUSIONS: Office-based laryngeal procedures should be performed at least 2 min following topical 4 % lidocaine with a window for manipulation of at least 16 min. Oral intake should be delayed for over 45 min to ensure complete return of sensation. The laryngeal shower of lidocaine is subjectively tolerated. LEVEL OF EVIDENCE: 2C Outcomes Research.

Safety of office-based flexible endoscopic procedures of the pharynx and larynx under topical anesthesia.

INTRODUCTION: Flexible endoscopic procedures (FEP) using a working channel allowed otolaryngologists to perform more procedures on the pharynx and the larynx under local anesthesia. The purpose of this work is to demonstrate the feasibility and safety of this technique by studying the adverse effects of this practice in an office-based setting. METHODS: This is a monocentric retrospective cohort study. We searched the database using the French procedural code for FEP performed in an outpatient setting between January 2005 and December 2020. Data regarding the patient's characteristics, indications, and periprocedural complications were extracted. RESULTS: In total, we included 231 patients with a total of 308 FEP: 36% biopsy, 20% hyaluronic acid injection (including 3.5% at the level of the cavum), 20% injection of other substances (in descending order: botulinum toxin, cidofovir, physiological serum, cortisone), 20% exploration for an occult tumor, 3% samples for microbiological analysis, 1% other procedures. Of the 308 FEP included in this study, 24 patients (10.3%) had complications corresponding to 7.8% of the procedures performed. During the procedures, reported complications include minor laryngeal bleeding (n = 5), vasovagal syncope (n = 5), laryngospasm (n = 1) or nausea (n = 3), dysphagia (n = 3), and voice disorders (n = 3). Post-procedural complications were hypertensive crisis (n = 1), asthma attack (n = 1), pneumonia (n = 1), laryngitis (n = 1). Using the Clavien-Dindo classification system, these complications could be defined as grade I (laryngeal bleeding, vasovagal syncope, laryngospasm, dysphagia, nausea, voice disorders, and laryngitis) and grade II (hypertensive crisis, asthma attack, pneumonia) in 9.1% and 1.2% of cases, respectively. Most of these complications were self-limiting, while asthma attacks, pneumonia, laryngitis, and voice disorders required a medical intervention. All complications were managed without sequelae. There was no serious complication grade (no grade III, IV or V). CONCLUSIONS: FEP, which is now well standardized in our institution, makes it possible to carry out a wide range of interventions with little morbidity. These results are in line with those of literature but this technique remains out of nomenclature in France. Our experience led to the development of an evidence-based standard of care that can serve as a framework for practitioners on a nationwide level, while the work to establish official guidelines by the French society of phoniatrics and laryngology is in progress.