Hepatic Ablation Technology: Assessment of Conflicts of Interest in Recent Literature.

INTRODUCTION: Collaboration between the health care industry and surgeons is critical in modern medicine. Conflict of interest (COI) has the risk of introducing bias into research studies. We investigated the accuracy of self-disclosed COI for studies that researched the use of microwave ablation for liver metastasis. METHODS: A literature search identified studies that investigated the use of microwave ablation for liver cancer between 2016 and 2022. We utilized the Open Payments Database to query individual authors' financial contributions from the industry. The accuracy of the disclosure statement and financial contribution for each study and author was calculated. We compared the amount of financial contribution authors received based on the accuracy of their COI statement. RESULTS: Twenty-five studies of interest were identified. The mean number of authors was 8.24. A disclosure statement was present in 52% of studies. Of those, 28% had an incongruent disclosure statement. 9/25 (36%) of studies had a conflict of interest based on financial payments provided by industry. Overall, authors received an average of $440,483.41 (SD $1,889,375.34). We did not find a difference in the financial contribution's value based on the disclosure statement's accuracy (P = .55). CONCLUSIONS: Over a quarter of studies in our review of microwave ablation literature had discrepancies in the reporting of conflicts of interest, highlighting the need for improved reporting of potential conflicts of interest to protect the integrity of clinical research. Compared to other fields of surgery, we found a lower rate of undisclosed COI, suggesting that the scope of cancer-directed surgery may be more resistant to industry influence.

What Is New with Rezum Water Vapor Thermal Therapy for LUTS/BPH?

PURPOSE OF REVIEW: Rezum® is a novel convection-based thermal therapy for benign prostatic hyperplasia (BPH) induced lower urinary tract symptoms (LUTS). This review provides an overview of its safety, efficacy, cost, and potential role in the paradigm of BPH/LUTS therapies. RECENT FINDINGS: Data regarding Rezum® stems primarily from one large randomized controlled trial of 197 patients with 4 years of follow-up. The efficacy and safety of Rezum® is further supported by 4 additional studies including 1 prospective pilot study, 1 crossover study, and 2 retrospective studies. Durable improvements in IPSS (47-60%), QoL (38-52%), Qmax (45-72%), and PVR (11-38%) were seen without causing deterioration of sexual function. Rezum® offers a cost-effective and safe approach to treating BPH/LUTS and should be considered as a possible first-line therapy for patients with moderate to severe symptoms.

Evaluating patient preferences for thermal ablation versus nonthermal, nontumescent varicose vein treatments.

OBJECTIVE: To measure patient preferences for attributes associated with thermal ablation and nonthermal, nontumescent varicose vein treatments. METHODS: Data were collected from an electronic patient preference survey taken by 70 adult participants (aged 20 years or older) at three Center for Vein Restoration clinics in New Jersey from July 19, 2019, through August 13, 2019. Survey participation was voluntary and anonymous (participation rate of 80.5% [70/87]). Patients were shown 10 consecutive screens that displayed three hypothetical treatment scenarios with different combinations of six attributes of interest and a none option. Choice-based conjoint analysis estimated the relative importance of different aspects of care, trade-offs between these aspects, and total satisfaction that respondents derived from different healthcare procedures. Market simulation analysis compared clusters of attributes mimicking thermal ablation and nonthermal, nontumescent treatments. RESULTS: Of the six attributes studied, out-of-pocket (OOP) expenditures were the most important to patients (37.2%), followed by postoperative discomfort (17.1%), risk of adverse events (16.3%), time to return to normal activity (11.0%), number of injections (10.0%), and number of visits (8.4%). Patients were willing to pay the most to avoid postoperative discomfort ($68.9) and risk of adverse events ($65.8). The market simulation analysis found that, regardless of the level of OOP spending, 60% to 80% of respondents favored attribute combinations corresponding with nonthermal, nontumescent procedures over thermal ablation, and that less than 1% of participants would forgo either treatment under no cost sharing. CONCLUSIONS: Patients are highly sensitive to OOP costs for minimally invasive varicose vein treatments. Market simulation analysis favored nonthermal, nontumescent procedures over thermal ablation.

Cost-effectiveness analysis of magnetic resonance-guided focused ultrasound ablation for palliation of refractory painful bone metastases.

OBJECTIVE: The aim of this study was to determine if magnetic resonance-guided focused ultrasound (MRgFUS) is cost-effective compared with medication, for refractory pain from bone metastases in the United States. METHODS: We constructed a Markov state transition model using TreeAge Pro software (TreeAge Software, Inc., Williamstown, MA, USA) to model costs, outcomes, and the cost-effectiveness of a treatment strategy using MRgFUS for palliative treatment of painful bone metastases compared with a Medication Only strategy (Figure 1). Model transition state probabilities, costs (in 2018 US$), and effectiveness data (quality-adjusted life-years [QALYs]) were derived from available literature, local expert opinion, and reimbursement patterns at two U.S. tertiary academic medical centers actively performing MRgFUS. Costs and QALYs, discounted at three percent per year, were accumulated each month over a 24-month time horizon. One-way and probabilistic sensitivity analyses were performed. RESULTS: In the base-case analysis, the MRgFUS treatment strategy costs an additional $11,863 over the 2-year time horizon to accumulate additional 0.22 QALYs, equal to a $54,160/QALY ICER, thus making MRgFUS the preferred strategy. One-way sensitivity analyses demonstrate that for the base-case analysis, the crossover point at which Medication Only would instead become the preferred strategy is $23,341 per treatment. Probabilistic sensitivity analyses demonstrate that 67 percent of model iterations supported the conclusion of the base case. CONCLUSIONS: Our model demonstrates that MRgFUS is cost-effective compared with Medication Only for palliation of painful bone metastases for patients with medically refractory metastatic bone pain across a range of sensitivity analyses.

Surgical robotic arm control for tissue ablation.

In the technology driven era, robot assisted surgery is gradually emerging as a revolutionized surgical procedure over traditional laparoscopic method. Despite the concerns about robotic surgery for minimally invasive surgical procedures, robotized surgical arms have been used in many hospitals. Certain surgical procedures require removal of a segment of an organ or body part like excision biopsy, linear thin layer of soft tissue, triangular mass, and tangential excision in burn management, where shaving-off at an angle of the tissue layer to be removed. For such minimally invasive procedures, we have designed a surgical arm governed by a rotary flexible joint. The surgical arm has a medical grade scalpel in its one end and the other end is connected to a D.C. servo motor. The motion of the surgical arm is controlled by the newly designed non-integer order controller. We have experimentally demonstrated the functioning of the surgical arm by ablating the tissue in-vitro. Our surgical robotic arm is cost effective, high precision and free from potential human errors.

Direct Costs Incurred Among Women Undergoing Surgical Procedures to Treat Uterine Fibroids.

BACKGROUND: Uterine fibroids (UF) affect up to 70%-80% of women by 50 years of age and represent a substantial economic burden on patients and society. Despite the high costs associated with UF, recent studies on the costs of UF-related surgical treatments remain limited. OBJECTIVE: To describe the health care resource utilization (HCRU) and all-cause costs among women diagnosed with UF who underwent UF-related surgery. METHODS: Data from the IBM MarketScan Commercial Claims and Encounters database and Medicaid Multi-State database were independently, retrospectively analyzed from January 1, 2009, to December 31, 2015. Women aged 18-64 years with ≥ 1 UF claim from January 1, 2010, to December 31, 2014, a claim for a UF-related surgery (hysterectomy, myomectomy, uterine artery embolization [UAE], or ablation) from January 1, 2010, to November 30, 2015, and continuous enrollment for ≥ 1 year presurgery and ≥ 30 days postsurgery qualified for study inclusion. A 1-year period before the date of the first UF-related surgical claim after the first UF diagnosis was used to report baseline demographic and clinical characteristics. Surgery characteristics were reported. All-cause HCRU and costs (adjusted to 2017 U.S. dollars) were described by the 14 days pre-, peri-, and 30 days postoperative periods, and independently by the inpatient or outpatient setting. RESULTS: Overall, 113,091 patients were included in this study: commercial database, n = 103,814; Medicaid database, n = 9,277. Median time from the initial UF diagnosis to first UF-related surgical procedure was 33 days for the commercial population and 47 days for the Medicaid population. Hysterectomy was the most common UF-related surgery received after UF diagnosis (commercial, 68% [n = 70,235]; Medicaid, 75% [n = 6,928]). In both populations, 97% of patients had ≥ 1 outpatient visit from 14 days presurgery to 30 days postsurgery (commercial, n = 100,402; Medicaid, n = 9,023), and the majority of all UF-related surgeries occurred in the outpatient setting (commercial, 64% [n = 66,228]; Medicaid, 66% [n = 6,090]). Mean total all-cause costs for patients with UF who underwent any UF-related surgery were $15,813 (SD $13,804) in the commercial population (n = 95,433) and $11,493 (SD $26,724) in the Medicaid population (n = 4,785). Mean total all-cause costs for UF-related surgeries for the commercial/Medicaid populations were $17,450 (SD $13,483)/$12,273 (SD $19,637) for hysterectomy, $14,216 (SD $16,382)/$11,764 (SD $15,478) for myomectomy, $17,163 (SD $13,527)/$12,543 (SD $23,777) for UAE, $8,757 (SD $9,369)/$7,622 (SD $50,750) for ablation, and $12,281 (SD $10,080)/$5,989 (SD $5,617) for myomectomy and ablation. Mean total all-cause costs for any UF-related surgery performed in the outpatient setting in the commercial and Medicaid populations were $14,396 (SD $11,466) and $6,720 (SD $10,374), respectively, whereas costs in the inpatient setting were $18,345 (SD $16,910) and $21,805 (SD $43,244), respectively. CONCLUSIONS: This retrospective analysis indicated that surgical treatment options for UF continue to represent a substantial financial burden. This underscores the need for alternative, cost-effective treatments for the management of UF. DISCLOSURES: This study was sponsored by Allergan, Dublin, Ireland. Allergan played a role in the conduct, analysis, interpretation, writing of the report, and decision to publish this study. Harrington and Ye are employees of Allergan. Stafkey-Mailey, Fuldeore, and Yue are employees of Xcenda. Ta was a contractor at Allergan at the time the study was conducted and is currently supported by a training grant from Allergan. Bonine, Shih, and Gillard are employees of Allergan and have stock, stock options, and/or restricted stock units as employees of Allergan. Banks has no disclosures to report. This study was presented as a poster at Academy of Managed Care Pharmacy Nexus 2017; October 16-19, 2017; Dallas, TX.

Prior authorization as a utilization management tool for elective superficial venous procedures results in high administrative cost and low efficacy in reducing utilization.

OBJECTIVE: Prior authorization (PA) is a process used by payers for safety and cost savings purposes, but it has received criticism for being time-consuming and costly because of administrative burden. Our study evaluated efficacy of PA applied to in-office lower extremity superficial venous procedures. METHODS: All in-office lower extremity venous procedures scheduled to be performed at our institution in 2017 were included in the study. Variables of interest were type of procedure, initial PA status (approved or denied), rationale for the decision, and final status after appeal. Cost analysis was performed using Centers for Medicare and Medicaid Services allowable rates to approximate billing and reimbursement data (proprietary) as well as calculated using industry averages. RESULTS: For 2017, of 1959 procedures scheduled, 57.9% (n = 1134) required PA. Of these, only 6.1% (n = 69) received initial PA denial, and nearly 40% of the denials (n = 27) were overturned after appeal. Of the 42 denials that were upheld, 15 resulted in cancellations; the remainder were performed by patient self-pay (n = 11) or by the provider pro bono (n = 16). Overturned denials were a result of either submission of incomplete clinical data on initial PA request or insufficient documentation of clinical necessity. When Centers for Medicare and Medicaid Services allowable rates were applied for cost analysis, the denials resulted in <$60,000 payer savings. Administrative expenses totaled >$110,000 when industry standards were applied, which far exceeds any calculated payer savings using the same methods. The 15 denials resulting in procedure cancellations (1.3% of all PAs) could be considered a net savings to the health care system but only approximated a mere $30,000. CONCLUSIONS: Our study demonstrates that PA is not a cost-effective measure for utilization management of outpatient superficial venous procedures when surgeon practices are already well aligned with insurance guidelines. For these physicians and physician groups, the administrative cost associated with the PA process exceeds the savings seen by the insurance companies.

A review of United States endovenous ablation practice trends from the Medicare Data Utilization and Payment Database.

OBJECTIVE: The growth of endovenous ablation in the United States over the last few years has raised concerns of overuse by many vascular societies and payers. Reasons for such growth are unclear (ie, increased awareness, less invasive procedure, or inappropriate overuse). The Medicare Provider Utilization and Payment database was analyzed to define metrics of current practice trends in Medicare patients by providers. METHODS: The Medicare Provider Utilization and Payment database was queried for endothermal ablation Current Procedural Terminology codes (36475, 36476, 36478, and 36479) from 2012 through 2015. These results were imported into a relational database program. Queries were designed to ascertain the practice trends of all providers, inclusive of all specialties, and the data were exported to a spreadsheet program for analysis. Analysis for ablations per patient was calculated by assessing the number of beneficiaries who underwent at least one ablation by a provider in relation to the total number of ablations performed by that provider. RESULTS: Most saphenous vein ablations were done by vascular surgeons (29%), cardiologists (21%), or general surgeons (14%). The remaining one-third was performed by 33 other provider specialties ranging from nuclear medicine specialists to ophthalmologists. Regional variation was significant with 51% of ablations being performed in the south (Florida, 15.7% and Texas, 11.4%). The Western region had the greatest percentage growth of 62% with the addition of 14,788 cases added between 2012 and 2015. Ablations per patient averaged 1.8 in the aggregate dataset. Over the 4-year period, there was a steady increase seen in the number of patients undergoing ablation, number of ablations performed, number of providers performing ablation, average amount of ablations being performed as well as the number and proportion of providers performing more than ablations per patient. The number of ablations per patient was higher than average in specialties without any formal vascular training. CONCLUSIONS: Endovenous ablation is performed by a wide variety of subspecialists with different levels of formal training for the management of chronic venous disease. This data analysis can help to establish better guidelines and governance over the use of endovenous ablation, but care should be taken to realize this is only an average and many patients will require more than two ablations for appropriate care. As our health care system shifts from a fee-for-service to a value-based system, and taxpayer-funded resources in Medicare patients become less available, it is important that practice trends be scrutinized using data-driven initiatives so that the appropriate physician treats the appropriate patient for the appropriate reasons.

Cost-Effectiveness of Current and Emerging Treatments of Varicose Veins.

OBJECTIVES: To analyze the cost-effectiveness of current technologies (conservative care [CONS], high-ligation surgery [HL/S], ultrasound-guided foam sclerotherapy [UGFS], endovenous laser ablation [EVLA], and radiofrequency ablation [RFA]) and emerging technologies (mechanochemical ablation [MOCA] and cyanoacrylate glue occlusion [CAE]) for treatment of varicose veins over 5 years. METHODS: A Markov decision model was constructed. Effectiveness was measured by re-intervention on the truncal vein, re-treatment of residual varicosities, and quality-adjusted life-years (QALYs) over 5 years. Model inputs were estimated from systematic review, the UK National Health Service unit costs, and manufacturers' list prices. Univariate and probabilistic sensitivity analyses were undertaken. RESULTS: CONS has the lowest overall cost and quality of life per person over 5 years; HL/S, EVLA, RFA, and MOCA have on average similar costs and effectiveness; and CAE has the highest overall cost but is no more effective than other therapies. The incremental cost per QALY of RFA versus CONS was £5,148/QALY. Time to return to work or normal activities was significantly longer after HL/S than after other procedures. CONCLUSIONS: At a threshold of £20,000/QALY, RFA was the treatment with highest median rank for net benefit, with MOCA second, EVLA third, HL/S fourth, CAE fifth, and CONS and UGFS sixth. Further evidence on effectiveness and health-related quality of life for MOCA and CAE is needed. At current prices, CAE is not a cost-effective option because it is costlier but has not been shown to be more effective than other options.

Amaze: a double-blind, multicentre randomised controlled trial to investigate the clinical effectiveness and cost-effectiveness of adding an ablation device-based maze procedure as an adjunct to routine cardiac surgery for patients with pre-existing atrial fibrillation.

BACKGROUND: Atrial fibrillation (AF) can be treated using a maze procedure during planned cardiac surgery, but the effect on clinical patient outcomes, and the cost-effectiveness compared with surgery alone, are uncertain. OBJECTIVES: To determine whether or not the maze procedure is safe, improves clinical and patient outcomes and is cost-effective for the NHS in patients with AF. DESIGN: Multicentre, Phase III, pragmatic, double-blind, parallel-arm randomised controlled trial. Patients were randomised on a 1 : 1 basis using random permuted blocks, stratified for surgeon and planned procedure. SETTING: Eleven acute NHS specialist cardiac surgical centres. PARTICIPANTS: Patients aged ≥ 18 years, scheduled for elective or in-house urgent cardiac surgery, with a documented history (> 3 months) of AF. INTERVENTIONS: Routine cardiac surgery with or without an adjunct maze procedure administered by an AF ablation device. MAIN OUTCOME MEASURES: The primary outcomes were return to sinus rhythm (SR) at 12 months and quality-adjusted life-years (QALYs) over 2 years after randomisation. Secondary outcomes included return to SR at 2 years, overall and stroke-free survival, drug use, quality of life (QoL), cost-effectiveness and safety. RESULTS: Between 25 February 2009 and 6 March 2014, 352 patients were randomised to the control (n = 176) or experimental (n = 176) arms. The odds ratio (OR) for return to SR at 12 months was 2.06 [95% confidence interval (CI) 1.20 to 3.54; p = 0.0091]. The mean difference (95% CI) in QALYs at 2 years between the two trial arms (maze/control) was -0.025 (95% CI 0.129 to 0.078; p = 0.6319). The OR for SR at 2 years was 3.24 (95% CI 1.76 to 5.96). The number of patients requiring anticoagulant drug use was significantly lower in the maze arm from 6 months after the procedure. There were no significant differences between the two arms in operative or overall survival, stroke-free survival, need for cardioversion or permanent pacemaker implants, New York Heart Association Functional Classification (for heart failure), EuroQol-5 Dimensions, three-level version score and Short Form questionnaire-36 items score at any time point. Sixty per cent of patients in each trial arm had a serious adverse event (p = 1.000); most events were mild, but 71 patients (42.5%) in the maze arm and 84 patients (45.5%) in the control arm had moderately severe events; 31 patients (18.6%) in the maze arm and 38 patients (20.5%) in the control arm had severe events. The mean additional cost of the maze procedure was £3533 (95% CI £1321 to £5746); the mean difference in QALYs was -0.022 (95% CI -0.1231 to 0.0791). The maze procedure was not cost-effective at £30,000 per QALY over 2 years in any analysis. In a small substudy, the active left atrial ejection fraction was smaller than that of the control patients (mean difference of -8.03, 95% CI -12.43 to -3.62), but within the predefined clinically equivalent range. LIMITATIONS: Low recruitment, early release of trial summaries and intermittent resource-use collection may have introduced bias and imprecise estimates. CONCLUSIONS: Ablation can be practised safely in routine NHS cardiac surgical settings and increases return to SR rates, but not survival or QoL up to 2 years after surgery. Lower anticoagulant drug use and recovery of left atrial function support anticoagulant drug withdrawal provided that good atrial function is confirmed. FURTHER WORK: Continued follow-up and long-term clinical effectiveness and cost-effectiveness analysis. Comparison of ablation methods. TRIAL REGISTRATION: Current Controlled Trials ISRCTN82731440. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 19. See the NIHR Journals Library website for further project information.

White Paper: Interventional MRI: Current Status and Potential for Development Considering Economic Perspectives, Part 1: General Application.

Background MRI is attractive for the guiding and monitoring of interventional procedures due to its high intrinsic soft tissue contrast and the possibility to measure physiologic parameters like flow and cardiac function. Method The current status of interventional MRI for the clinical routine was analyzed. Results The effort needed for the development of MR-safe monitoring systems and instruments initially resulted in the application of interventional MRI only for procedures that could not be performed by other means. Accordingly, biopsy of lesions in the breast, which are not detectable by other modalities, has been performed under MRI guidance for decades. Currently, biopsies of the prostate under MRI guidance are established in a similar fashion. At many sites blind biopsy has already been replaced by MR-guided biopsy or at least by the fusion of MR images with ultrasound. Cardiovascular interventions are performed at several centers for ablation as a treatment for atrial fibrillation. Conclusion Interventional MRI has been established in the clinical routine for a variety of indications. Broader application can be expected in the clinical routine in the future owing to the multiple advantages compared to other techniques. Key points · Due to the significant technical effort, MR-guided interventions are only recommended in the long term for regions in which MRI either facilitates or greatly improves the intervention.. · Breast biopsy of otherwise undetectable target lesions has long been established in the clinical routine. Prostate biopsy is currently being introduced in the clinical routine for similar reasons. Other methods such as MR-guided focused ultrasound for the treatment of uterine fibroids or tumor ablation of metastases represent alternative methods and are offered in many places.. · Endovascular MR-guided interventions offer advantages for a number of indications and have already been clinically established for the treatment of children with congenital heart defects and for atrial ablation at individual centers. Greater application can be expected in the future.. Citation format · Barkhausen J, Kahn T, Krombach GA et al. White Paper: Interventional MRI: Current Status and Potential for Development Considering Economic Perspectives, Part 1: General Application. Fortschr Röntgenstr 2017; 189: 611 - 623.

Ablative surgery for Parkinson's disease: Is there still a role for pallidotomy in the deep brain stimulation era?

Posteroventral pallidotomy has already been considered the surgical procedure of choice for Parkinson's disease patients with motor complications. Recently, however, several factors led to its replacement by deep brain stimulation. Nevertheless, pallidotomy has a well-documented efficacy and safety evidence regarding the reduction of parkinsonian motor symptoms. Yet, there may be manysituations where it may be considered as a better option than neuromodulation. Herein we review those possible conditions, giving emphasis to the costs, which we found to be the most limiting factor. Importantly, a cost comparison between deep brain stimulation and pallidotomy was also provided.

Cost-effectiveness of using recombinant human thyroid-stimulating hormone before radioiodine ablation for thyroid cancer treatment in Spanish hospitals. / Coste-efectividad de la utilización de la tirotropina recombinante humana previa a la ablación con radioyodo en el tratamiento del cáncer de tiroides en hospitales españoles.

OBJECTIVES: In thyroid cancer treatment, the thyroid-stimulating hormone (TSH) must be elevated before radioiodine ablation, either by exogenous (with recombinant human thyrotropin [rhTSH]) or endogenous stimulation by thyroid hormone withdrawal (THW). The use of rhTSH avoids hypothyroidism and favours the subsequent elimination of radioiodine, but involves the cost of the product. For this reason, a cost-effectiveness analysis was performed, taking into account all costs involved and the benefits associated with the use of this therapy. MATERIAL AND METHODS: Using a Markov modelling with two analysis arms (rhTSH and THW), stratified into high (100mCi/3700 MBq) and low (30mCi/1110 MBq) radioiodine doses, and using 17 weekly cycles, the incremental cost per quality-adjusted life-year (QALY) related to the use of rhTSH was determined. The clinical inputs included in the model were based on published studies and in a treatment survey conducted in Spain. RESULTS: Radioablation preparation with rhTSH is superior to THW, showing additional benefits (0.048 AVAC), as well as cost savings (-€614.16), with an incremental cost-effectiveness rate (ICER) of -€12,795/QALY. The univariate and multivariate sensitivity analyses showed the result to be robust. CONCLUSIONS: The use of rhTSH previous to radioablation in Spain has cost savings, as well as a series of health benefits for the patient, making it highly cost-effective.

Effects of repeated use and resterilization on structural and functional integrity of microwave ablation antennas.

OBJECTIVE To determine effects of repeated use and resterilization on structural and functional integrity of microwave ablation (MWA) antennas. SAMPLE 17 cooled-shaft MWA antennas (3 groups of 5 antennas/group and 2 control antennas). PROCEDURES 1, 2, and 3 ablations in the livers of bovine cadavers were performed at the maximum recommended settings. Antennas were cleaned and sterilized in hydrogen peroxide plasma, and the process was repeated (reprocessing cycle; n = 6). Control antennas were only sterilized (6 times). Aerobic and anaerobic bacterial cultures were performed, and antennas were microscopically assessed for damage. RESULTS 6 cycles were completed. Thirteen of 15 MWA antennas remained functional for up to 4 cycles, 10 were functional after 5 cycles, and only 7 were functional after 6 cycles. Progressive tearing of the silicone coating of the antennas was observed, with a negative effect of the number of cycles for silicone tearing. Size of the ablation zone decreased mildly over time after cycles 5 and 6; however, this was not considered clinically relevant. No significant changes in the shape of ablation zones were detected. All cultures yielded negative results, except for an isolated case, which was considered a contaminant. CONCLUSIONS AND CLINICAL RELEVANCE Structural and functional integrity of the microwave antennas remained acceptable during repeated use and reprocessing for up to 4 cycles. However, there was a decrease in functional integrity at cycles 5 and 6. We suggest that these microwave antennas be subjected to > 3 reprocessing cycles. Antennas should be carefully examined before reuse.

Healthcare Cost of Over-Diagnosis of Low-Grade Dysplasia in Barrett's Esophagus.

INTRODUCTION: Published reports have demonstrated that many Barrett's esophagus patients are over-diagnosed as low-grade dysplasia (BE-LGD). We performed an analysis of the surveillance and treatment costs associated with the over-diagnosis of BE-LGD. METHODS: As the principal cost variables, we used endoscopic and histologic procedures performed during the recommended surveillance intervals for patients with BE-LGD, the national average Medicare reimbursement for the Current Procedural Terminology codes of the procedures performed, and a spreadsheet-based tool we created to determine the overall healthcare cost associated with the over-diagnosis of BE-LGD in the US population. RESULTS: The average excess cost (range) for every patient in the US who is over-diagnosed with BE-LGD is estimated to be $5557 ($3115 to $8072). The principal contributors to the excess cost of over-diagnosis of BE-LGD in these patients are: endoscopy ($2626 to $4639), pathologist biopsy review ($275 to $2185), and esophagogastroduodenoscopy-guided endoscopic ablation ($214 to $1249). CONCLUSIONS: The healthcare cost of over-diagnosis of BE-LGD is significant. To reduce the overall healthcare cost impact of over-diagnosis of BE-LGD, strict adherence to the recommendations of the American Gastroenterological Association, American College of Gastroenterology, and American Society for Gastrointestinal Endoscopy that pathology review of all BE biopsy specimens be performed by a gastrointestinal pathologist is warranted.

Value of delayed duplex ultrasound assessment after endothermal ablation of the great saphenous vein.

OBJECTIVE: Endothermal ablation (ETA) of the great saphenous vein (GSV) is associated with a small but definite risk of endothermal heat-induced thrombosis (EHIT) extending into the common femoral vein. Follow-up duplex ultrasound imaging to detect EHIT after ETA is considered standard of care, although the exact timing of duplex ultrasound imaging to detect EHIT after ETA remains unclear. We hypothesized that an additional duplex ultrasound assessment 1 week after ETA would not identify a significant number of patients with EHIT and would significantly increase health care costs. METHODS: This was a retrospective review of consecutive ETA GSV procedures from 2007 to 2014. All patients were evaluated with duplex ultrasound imaging on postprocedure day 1, and 79% of patients underwent a second ultrasound assessment 1 week postprocedure. EHIT was considered present when proximal GSV closure progressed to level ≥4, based on a six-tier classification system. RESULTS: From January 1, 2007, until December 31, 2014, 842 patients underwent GSV ETA. Patients with EHIT were more likely to have had a prior deep venous thrombosis (DVT; P = .002) and a larger GSV (P = .006). Forty-three procedures (5.1%) were classified as having EHIT requiring anticoagulation, based on a level ≥4 proximal closure level. Of the 43 patients with EHIT, 20 (47%) were found on the initial ultrasound assessment performed 24 hours postprocedure, but 19 patients (44%) with EHIT would not have been identified with a single postoperative ultrasound scan performed 24 hours after intervention. These 19 patients had a level ≤3 closure level at the duplex ultrasound scan performed 24 hours postprocedure and progressed to EHIT on the delayed duplex ultrasound scan. Lastly, thrombotic complications in four patients (9%), representing three late DVT and one DVT/pulmonary embolism presenting to another hospital, would not have been identified regardless of the postoperative surveillance strategy. Maximum GSV diameter was the only significant predictor of progression to EHIT on multivariate analysis (P = .007). Based on 2014 United States dollars, the two-ultrasound surveillance paradigm is associated with health care charges of $31,109 per identified delayed venous thromboembolism event. CONCLUSIONS: Delayed duplex ultrasound assessment after ETA of the GSV comes with associated health care costs but does yield a significant number of patients with progression to EHIT. Better understanding of the timing, risk factors, and significance of EHIT is needed to cost-effectively care for patients after ETA for varicose veins.

[Treatment of small renal masses: Effectiveness and cost-comparison analysis]. / Le traitement des petites tumeurs du rein: efficacité et comparaison des coûts.

OBJECTIVE: The stage of discovery and treatment of kidney cancer have changed. Partial nephrectomy is the standard treatment for small renal masses (SRM). Also are recommended the thermal ablative techniques. The cost of these treatments for the establishment and society is often unclear. The purpose of this study was to calculate the cost of treatment of SRM in order to assess the profitability for a health institution that invests in innovation. MATERIALS AND METHODS: A retrospective single-center study was conducted with 124 patients treated for SMR (T1a) by open partial nephrectomy (OPN), laparoscopic partial nephrectomy (LPN) and robot-assisted partial nephrectomy (LRPN), radio frequency (RF) and cryotherapy (CT) between 2009 and 2011. We calculated the price of stay of each patient, searched the amount billed to health insurance and calculated the profitability of treatment for the establishment. RESULTS: The OPN cost on average 7884±1201€ and reported 451±1861€, the LPN cost on average 6973±3503€ and reported 2271±3370€, the cost of the LRPN was on average 9600±4595€ and resulted in a deficit of 838±3007€. The radiofrequency cost on average 2724±813€ and caused a deficit of 954±684€, cryotherapy cost on average 6702±857€ and resulted in a deficit of 4723±941€. CONCLUSION: According to current repayment terms, the LPN was the treatment of SRM that offered the best profitability.

A Cost-effectiveness Analysis of Surgery, Endothermal Ablation, Ultrasound-guided Foam Sclerotherapy and Compression Stockings for Symptomatic Varicose Veins.

OBJECTIVE: The aim was to investigate the cost-effectiveness of interventional treatment for varicose veins (VV) in the UK NHS, and to inform the national clinical guideline on VV, published by the National Institute of Health and Care Excellence. DESIGN: An economic analysis was constructed to compare the cost-effectiveness of surgery, endothermal ablation (ETA), ultrasound-guided foam sclerotherapy (UGFS), and compression stockings (CS). The analysis was based on a Markov decision model, which was developed in consultation with members of the NICE guideline development group (GDG). METHODS: The model had a 5-year time horizon, and took the perspective of the UK National Health Service. Clinical inputs were based on a network meta-analysis (NMA), informed by a systematic review of the clinical literature. Outcomes were expressed as costs and quality-adjusted life years (QALYs). RESULTS: All interventional treatments were found to be cost-effective compared with CS at a cost-effectiveness threshold of £20,000 per QALY gained. ETA was found to be the most cost-effective strategy overall, with an incremental cost-effectiveness ratio of £3,161 per QALY gained compared with UGFS. Surgery and CS were dominated by ETA. CONCLUSIONS: Interventional treatment for VV is cost-effective in the UK NHS. Specifically, based on current data, ETA is the most cost-effective treatment in people for whom it is suitable. The results of this research were used to inform recommendations within the NICE guideline on VV.

Ablative therapy for people with localised prostate cancer: a systematic review and economic evaluation.

BACKGROUND: For people with localised prostate cancer, active treatments are effective but have significant side effects. Minimally invasive treatments that destroy (or ablate) either the entire gland or the part of the prostate with cancer may be as effective and cause less side effects at an acceptable cost. Such therapies include cryotherapy, high-intensity focused ultrasound (HIFU) and brachytherapy, among others. OBJECTIVES: This study aimed to determine the relative clinical effectiveness and cost-effectiveness of ablative therapies compared with radical prostatectomy (RP), external beam radiotherapy (EBRT) and active surveillance (AS) for primary treatment of localised prostate cancer, and compared with RP for salvage treatment of localised prostate cancer which has recurred after initial treatment with EBRT. DATA SOURCES: MEDLINE (1946 to March week 3, 2013), MEDLINE In-Process & Other Non-Indexed Citations (29 March 2013), EMBASE (1974 to week 13, 2013), Bioscience Information Service (BIOSIS) (1956 to 1 April 2013), Science Citation Index (1970 to 1 April 2013), Cochrane Central Register of Controlled Trials (CENTRAL) (issue 3, 2013), Cochrane Database of Systematic Reviews (CDSR) (issue 3, 2013), Database of Abstracts of Reviews of Effects (DARE) (inception to March 2013) and Health Technology Assessment (HTA) (inception to March 2013) databases were searched. Costs were obtained from NHS sources. REVIEW METHODS: Evidence was drawn from randomised controlled trials (RCTs) and non-RCTs, and from case series for the ablative procedures only, in people with localised prostate cancer. For primary therapy, the ablative therapies were cryotherapy, HIFU, brachytherapy and other ablative therapies. The comparators were AS, RP and EBRT. For salvage therapy, the ablative therapies were cryotherapy and HIFU. The comparator was RP. Outcomes were cancer related, adverse effects (functional and procedural) and quality of life. Two reviewers extracted data and carried out quality assessment. Meta-analysis used a Bayesian indirect mixed-treatment comparison. Data were incorporated into an individual simulation Markov model to estimate cost-effectiveness. RESULTS: The searches identified 121 studies for inclusion in the review of patients undergoing primary treatment and nine studies for the review of salvage treatment. Cryotherapy [3995 patients; 14 case series, 1 RCT and 4 non-randomised comparative studies (NRCSs)], HIFU (4000 patients; 20 case series, 1 NRCS) and brachytherapy (26,129 patients; 2 RCTs, 38 NRCSs) studies provided limited data for meta-analyses. All studies were considered at high risk of bias. There was no robust evidence that mortality (4-year survival 93% for cryotherapy, 99% for HIFU, 91% for EBRT) or other cancer-specific outcomes differed between treatments. For functional and quality-of-life outcomes, the paucity of data prevented any definitive conclusions from being made, although data on incontinence rates and erectile dysfunction for all ablative procedures were generally numerically lower than for non-ablative procedures. The safety profiles were comparable with existing treatments. Studies reporting the use of focal cryotherapy suggested that incontinence rates may be better than for whole-gland treatment. Data on AS, salvage treatment and other ablative therapies were too limited. The cost-effectiveness analysis confirmed the uncertainty from the clinical review and that there is no technology which appears superior, on the basis of current evidence, in terms of average cost-effectiveness. The probabilistic sensitivity analyses suggest that a number of ablative techniques are worthy of further research. LIMITATIONS: The main limitations were the quantity and quality of the data available on cancer-related outcomes and dysfunction. CONCLUSIONS: The findings indicate that there is insufficient evidence to form any clear recommendations on the use of ablative therapies in order to influence current clinical practice. Research efforts in the use of ablative therapies in the management of prostate cancer should now be concentrated on the performance of RCTs and the generation of standardised outcomes. STUDY REGISTRATION: This study is registered as PROSPERO CRD42012002461. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

A national analysis of the complications, cost, and mortality of percutaneous lung ablation.

PURPOSE: To perform a national analysis of the safety and cost of percutaneous image-guided lung malignancy ablation. MATERIALS AND METHODS: Using the National (Nationwide) Inpatient Sample, we evaluated complications, need for further intervention, in-hospital mortality, length of hospitalization, and hospital charges for patients undergoing inpatient percutaneous image-guided lung ablation in the United States during the period 2007-2011. Additionally, an analysis of the relationship between specific patient factors, procedural complications, and mortality was performed. RESULTS: The study group consisted of 3,344 patients, including 2,072 (61.9%) patients treated for primary lung carcinomas and 1,277 (38.1%) patients treated for pulmonary metastatic disease. In-hospital mortality occurred after 43 (1.3%) ablation procedures. A Charlson comorbidity index score ≥ 4 was associated with higher mortality (odds ratio [OR], 2.84; 95% confidence interval [CI], 1.16-6.91). Pneumothorax was the most common complication (38.4%), followed by pneumonia (5.7%) and effusion (4.0%). Neither pneumothorax nor chest tube insertion was associated with higher in-hospital mortality rates (pneumothorax, OR, 1.10; 95% CI, 0.59-2.04, and chest tube insertion, OR, 1.45; 95% CI, 0.78-2.68). Surgical reintervention via thoracoscopy or thoracotomy occurred in 31 cases (0.9%). Median length of hospitalization was 1 day (interquartile range, 1-3 d), and median hospital charges were $22,320 (interquartile range, $13,705-$43,026). CONCLUSIONS: Percutaneous image-guided lung ablation of primary and metastatic disease has an acceptable safety profile, and surgical reintervention is rarely required. The most frequent complications of percutaneous lung ablation were not associated with increased in-hospital mortality.