Tympanostomy Tube Innovation: Advances in Device Material, Design, and Office-Based Technology.

OBJECTIVES: With tympanostomy tube insertion remaining the most common procedure performed in children to date, growing interests in minimizing both procedural costs and anesthetic exposure in the pediatric population have inspired innovation with respect to tympanostomy tubes. As such, we aim to discuss the current state of tympanostomy tube innovation including insertion devices, tube material, and design. METHODS: Computerized literature review. RESULTS: (1) Numerous single-use devices consisting of a myringotomy knife and preloaded tympanostomy tube offer potential advantages of decreasing or eliminating operating room time and may be performed under moderate instead of a general anesthetic. (2) Innovation with respect to tympanostomy tube material and design may offer enhanced ototopical drug delivery, decreased rates of tube occlusion, and/or the ability to dissolve "on-command" with application of a novel ototopical material. (3) These technologies currently remain in various phases of preclinical and clinical testing. CONCLUSIONS: While clinical testing for a number of new technologies is preliminary and ongoing, tympanostomy tube-related innovations hold exciting promise to supplement or potentially replace the present-day armamentarium of tympanostomy tube design and insertion moving forward.

Eligibility Rates for Ambulatory EVAR.

BACKGROUND: The current results of endovascular repair of abdominal aortic aneurysms (EVAR) and the wide use of percutaneous closure systems suggest that ambulatory treatment is feasible in selected patients. The objective of this study was to evaluate the rate of eligibility to ambulatory EVAR (EVAR-Ambu) and its potential medicoeconomic impact. METHODS: Between January 2014 and December 2016, 245 patients were operated of an abdominal aortic aneurysm (AAA) in our center. The 128 patients whose anatomy was unfavorable with EVAR, which were operated in urgency or who were classified as American society of anesthesiologists 4, were excluded from the study. The 117 remaining files were reexamined to evaluate the eligibility for EVAR-Ambu retrospectively. The patients were considered as eligible if they presented all the following criteria: (1) normal surgical risk, (2) logistic feasibility of an ambulatory procedure (home <1 hr away from the hospital, available relatives), and (3) anatomical criteria of percutaneous feasibility according to angio-computed tomography. The surgical risk was evaluated according to the French High Health Authority (HAS) and the Society for Vascular Surgery (SVS) score. The balance between costs and revenue was evaluated for each patient according to the length of stay. RESULTS: Among the 117 patients, 43 (37%) and 57 (49%) were eligible for EVAR-Ambu by percutaneous route according to whether the surgical risk was assessed according to the HAS or the SVS criteria. If a conventional surgical approach was considered as compatible with EVAR-Ambu, 12 (10%) and 13 (11%) additional patients were eligible according to whether the surgical risk was assessed according to the HAS or the SVS criteria, respectively. In terms of medicoeconomic evaluation, the cost of the initial intervention depended was mainly on the cost of the stent graft and the operating room services. The cost spent of 1 night conventional hospitalization (CH) after EVAR was 603€ per day versus 490€ in the Day Surgery Unit (DSU). In comparison, the revenue for the institution was identical for DSU and a 1-night CH. According to our estimates, the balance between revenue and expenditures amounted to +122€ per patient for EVAR-Ambu versus +10€ or +119€ per patient hospitalized 1 or 2 nights, respectively. CONCLUSIONS: EVAR-Ambu is possible in a substantial proportion of patients treated for infrarenal AAA. Its medicoeconomic interest is real for the health system although it appears low at the individual level. The safety of this approach in clinical practice must be confirmed by a prospective study in selected patients.

Implementation of drug-eluting stents for the treatment of femoropopliteal disease provides significant cost-to-system savings in a single-state outpatient simulation.

OBJECTIVES: Initial data on drug-eluting stents (DES) shows that they may increase the durability of endovascular treatment of superficial femoral artery disease compared with traditional bare-metal stents (BMS). Observed decreased target lesion revascularization (TLR) rates have potential for cost savings despite an increased initial cost. The purpose of this study was to run a simulation model of progressive transition from BMS to DES over 5 years evaluating the overall cost impact of that transition. METHODS: Florida State Ambulatory Databases were searched for all patients undergoing superficial femoral artery stenting in 2013 using Current Procedural Terminology codes 37226 and 37227. A simulation model was developed to estimate the impact of a progressive transition from BMS to DES over a 5-year horizon in this patient population. Cost estimates were determined from available cost charge ratio data. For the 5-year model, 2013 served as the initial year with each subsequent year based on the expected number of interventions per year. Up to one TLR per patient was assumed for the model. The 5-year TLR rates for DES and other parameter estimates were based on pooled data from the literature. Institutional data were used to estimate that up to 48% of superficial femoral artery lesions would fit the instructions for use for the Zilver PTX (Cook Medical, Bloomington, Ind), which is currently the only DES approved by the U.S. Food and Drug Administration for peripheral interventions. The net budget impact was expressed as the difference in total costs (primary stenting and reinterventions) for a scenario where BMS is progressively replaced by Zilver PTX compared with a scenario of BMS only. Multiple sensitivity analyses were performed on the base scenario. RESULTS: We identified 4107 peripheral interventions in the first year that fit our study. The overall cost for these procedures in Florida database was $51,362,142.00. In the base case scenario, DES was introduced slowly into the population at a rate of 8% per year up to 48% at the end of the model. This strategy resulted in an overall cost savings of $1,688,953.72 compared with the model with BMS alone. Sensitivity analyses including slower adoption of DES up to only 24% at 5 years, a 20% increase in TLR rates per year for the DES, and a 10% reduction in TLR rates per year for BMS still resulted in a net savings. As long as the additional cost of a DES compared with BMS is less than $677, the DES model remains less expensive. CONCLUSIONS: The adoption of DES in lieu of traditional BMS can lead to significant cost savings in a single state model over a short time horizon.

Home monitoring after ambulatory implanted primary cardiac implantable electronic devices: The home ambulance pilot study.

BACKGROUND: The Home Monitoring (HM) system of cardiac implantable electronic devices (CIEDs) permits early detection of arrhythmias or device system failures. The aim of this pilot study was to examine how the safety and efficacy of the HM system in patients after ambulatory implanted primary CIEDs compare to patients with a standard procedure and hospitalization. HYPOTHESIS: We hypothesized that HM and their modifications would be a useful extension of the present concepts for ambulatory implanted CIEDs. METHODS: This retrospective analysis evaluates telemetric data obtained from 364 patients in an ambulatory single center over 6 years. Patients were assigned to an active group (n = 217), consisting of those who were discharged early on the day of implantation of the primary CIED, or to a control group (n = 147), consisting of those discharged and followed up with the HM system according to usual medical practices. RESULTS: The mean duration of hospitalization was 73.2% shorter in the active group than in the control group, corresponding to 20.5 ± 13 fewer hours (95% confidence interval [CI]: 6.3-29.5; P < 0.01) spent in the hospital (7.5 ± 1.5 vs 28 ± 4.5 h). This shorter mean hospital stay was attributable to a 78.8% shorter postoperative period in the active group. The proportion of patients with treatment-related adverse events was 11% (n = 23) in the active group and 17% (n = 25) in the control group (95% CI: 5.5-8.3; P = 0.061). This 6% absolute risk reduction (95% CI: 3.3-9.1; P = 0.789) confirmed the noninferiority of the ambulatory implanted CIED when compared with standard management of these patients. CONCLUSIONS: Early discharge with the HM system after ambulatory CIED implantation was safe and not inferior to the classic medical procedure. Thus, together with lower costs, HM and its modifications would be a useful extension of the present concepts for ambulatory implanted CIEDs.

Haemorrhoidal artery ligation versus rubber band ligation for the management of symptomatic second-degree and third-degree haemorrhoids (HubBLe): a multicentre, open-label, randomised controlled trial.

BACKGROUND: Optimum surgical intervention for low-grade haemorrhoids is unknown. Haemorrhoidal artery ligation (HAL) has been proposed as an efficacious, safe therapy while rubber band ligation (RBL) is a commonly used outpatient treatment. We compared recurrence after HAL versus RBL in patients with grade II-III haemorrhoids. METHODS: This multicentre, open-label, parallel group, randomised controlled trial included patients from 17 acute UK NHS trusts. We screened patients aged 18 years or older presenting with grade II-III haemorrhoids. We excluded patients who had previously received any haemorrhoid surgery, more than one injection treatment for haemorrhoids, or more than one RBL procedure within 3 years before recruitment. Eligible patients were randomly assigned (in a 1:1 ratio) to either RBL or HAL with Doppler. Randomisation was computer-generated and stratified by centre with blocks of random sizes. Allocation concealment was achieved using a web-based system. The study was open-label with no masking of participants, clinicians, or research staff. The primary outcome was recurrence at 1 year, derived from the patient's self-reported assessment in combination with resource use from their general practitioner and hospital records. Recurrence was analysed in patients who had undergone one of the interventions and been followed up for at least 1 year. This study is registered with the ISRCTN registry, ISRCTN41394716. FINDINGS: From Sept 9, 2012, to May 6, 2014, of 969 patients screened, 185 were randomly assigned to the HAL group and 187 to the RBL group. Of these participants, 337 had primary outcome data (176 in the RBL group and 161 in the HAL group). At 1 year post-procedure, 87 (49%) of 176 patients in the RBL group and 48 (30%) of 161 patients in the HAL group had haemorrhoid recurrence (adjusted odds ratio [aOR] 2·23, 95% CI 1·42-3·51; p=0·0005). The main reason for this difference was the number of extra procedures required to achieve improvement (57 [32%] participants in the RBL group and 23 [14%] participants in the HAL group had a subsequent procedure for haemorrhoids). The mean pain 1 day after procedure was 3·4 (SD 2·8) in the RBL group and 4·6 (2·8) in the HAL group (difference -1·2, 95% CI -1·8 to -0·5; p=0·0002); at day 7 the scores were 1·6 (2·3) in the RBL group and 3·1 (2·4) in the HAL group (difference -1·5, -2·0 to -1·0; p<0·0001). Pain scores did not differ between groups at 21 days and 6 weeks. 15 individuals reported serious adverse events requiring hospital admission. One patient in the RBL group had a pre-existing rectal tumour. Of the remaining 14 serious adverse events, 12 (7%) were among participants treated with HAL and two (1%) were in those treated with RBL. Six patients had pain (one treated with RBL, five treated with HAL), three had bleeding not requiring transfusion (one treated with RBL, two treated with HAL), two in the HAL group had urinary retention, two in the HAL group had vasovagal upset, and one in the HAL group had possible sepsis (treated with antibiotics). INTERPRETATION: Although recurrence after HAL was lower than a single RBL, HAL was more painful than RBL. The difference in recurrence was due to the need for repeat bandings in the RBL group. Patients (and health commissioners) might prefer such a course of RBL to the more invasive HAL. FUNDING: NIHR Health Technology Assessment programme.

Feasibility and Acceptability of Office-Based Polypectomy With a 16F Mini-Resectoscope: A Multicenter Clinical Study.

STUDY OBJECTIVE: To investigate the feasibility and acceptability of office hysteroscopic polypectomy using a novel continuous-flow operative 16F mini-resectoscope. DESIGN: Multicenter prospective case series (Canadian Task Force classification III). SETTING: "SS Antonio e Biagio" Hospital, Alessandria, and University "Federico II" of Naples. PATIENTS: One hundred eighty-two patients with endometrial polyps. INTERVENTIONS: Hysteroscopic polypectomy performed with 16F mini-resectoscope in an office setting, without analgesia and/or anesthesia. MEASUREMENTS AND MAIN RESULTS: Polypectomy was successfully performed in 175 patients in a single surgical step (96.15%), with only 1 patient (.54%) requiring a second office surgical step to complete the surgery. Seven patients (3.84%) were excluded from the analysis of operative parameters because of severe pelvic pain during the office procedure, which required a second inpatient surgical step. No major complications were recorded. CONCLUSION: Our findings demonstrate that removal of endometrial polyps using the 16F mini-resectoscope in an office setting is a feasible and safe surgical option. Outpatient see-and-treat polypectomy is an acceptable and effective alternative to inpatient resectoscopic polypectomy.

Intrauterine Morcellator Devices: The Icon of Hysteroscopic Future or Merely a Marketing Image? A Systematic Review Regarding Safety, Efficacy, Advantages, and Contraindications.

The aim of this study was to analyze all available evidence regarding the use of intrauterine morcellator (IUM), for treatment of the most prevalent intrauterine benign lesions, compared to both traditional resectoscopy and conventional outpatient operative hysteroscopy in terms of safety, efficacy, contraindications, perioperative complications, operating time, and estimated learning curve. We reported data regarding a total of 1185 patients. Concerning polypectomy and myomectomy procedures, IUM systems demonstrated a better outcome in terms of operative time and fluid deficit compared to standard surgical procedures. Complication rates in the inpatient setting were as follows: 0.02% for IUM using Truclear 8.0 (Smith & Nephew Endoscopy, Andover, Massachusetts) and 0.4% for resectoscopic hysteroscopy. No complications were described using Versapoint devices. Office polipectomy reported a total complication rate of 10.1% using Versapoint device (Ethicon Women's Health and Urology, Somerville, New Jersey) and 1.6% using Truclear 5.0 (Smith & Nephew Endoscopy). The reported recurrence rate after polypectomy was 9.8% using Versapoint device and 2.6% using Truclear 8.0. Finally, the reported intraoperative and postoperative complication rate of IUM related to removal of placental remnants using Truclear 8.0 and MyoSure (Hologic, Marlborough, Massachusetts) was 12.3%. The available evidence allows us to consider IUM devices as a safe, effective, and cost-effective tool for the removal of intrauterine lesions such as polyps, myomas (type 0 and type 1), and placental remnants. Evidence regarding Truclear 5.0 suggests that it may represent the best choice for office hysteroscopy. Further studies are needed to confirm the available evidence and to validate the long-term safety of IUM in procedures for which current data are not exhaustive (placental remnants removal).

Looking outside to meet internal challenges: the benefits of outsourcing.

Providing resourceful solutions to common facility management challenges can require many steps, including internal and external research, evaluating potential options, and implementing new protocols. The outpatient surgical services administrator at the Surgical Center of York and the Endoscopy Center of Memorial Hospital, York, Pennsylvania, addressed the challenge of managing and meeting surgeons' expectations and requests for better equipment and increased patient volume for ophthalmology procedures while maintaining a strict budget. Outsourcing of surgical equipment was identified as a viable option to meet these needs.

Ambulatory phlebectomy in the office.

Ambulatory phlebectomy is a minor, office-based surgical procedure designed to remove varicose veins. It is a perfect complement to endovenous thermal ablation of the saphenous vein. With this combination, patients can expect all varicose veins to vanish following a 1-hour procedure that employs only local anesthesia in the comfort of a physician's office. Advantages of office-based surgery are ease of scheduling for doctors and patients, less paperwork, elimination of travel time, and cost containment for the health care system. Furthermore, a procedure that is performed by the same staff daily is more streamlined and safe.

Tubal anastomosis by robotic compared with outpatient minilaparotomy.

OBJECTIVE: To compare tubal anastomosis by robotic system compared with outpatient minilaparotomy. METHODS: In this retrospective case-control study, women were identified by current procedural terminology code for tubal anastomosis. We included all cases of tubal anastomosis for reversal of a prior tubal ligation by either outpatient minilaparotomy or robotic system technique. Cases performed by laparoscopy without aid of the robot were excluded. Comparisons were based on Fisher's exact, chi(2), and Wilcoxon rank sum tests. RESULTS: There were 26 cases of tubal anastomosis performed with the robot and 41 cases performed by outpatient minilaparotomy. The two groups were comparable in age, body mass index, and parity. Anesthesia time for the robotic technique (median with interquartile range) was 283 (267-290) minutes compared with 205 (170-230) minutes with outpatient minilaparotomy (P<.001). Surgical times for the robot and minilaparotomy were 229 (205-252) minutes and 181 (154-202) minutes respectively (P=.001). Hospitalization times, pregnancy, and ectopic pregnancy rates were not significantly different. The robotic technique was more costly. The median difference in costs of the procedures was $1,446 (95% confidence interval $1,112-1,812) (P<.001). The time to return to work was significantly shorter in the robotic system group by approximately 1 week (P=.013). CONCLUSION: Robotic surgery for tubal anastomosis was successfully accomplished without conversion to laparotomy. The robotic technique for tubal anastomosis required significantly prolonged surgical and anesthesia times over outpatient minilaparotomy (P

Office hysteroscopy: a valuable but under-utilized technique.

PURPOSE OF REVIEW: The purpose of this review is to remind gynecologists of the indications for office hysteroscopy as well as to provide an update on equipment, techniques, and reimbursements. RECENT FINDINGS: Office hysteroscopy is a technique that has been available for over three decades. Whereas nearly 100% of urologists utilize office cystoscopy to evaluate bladder pathology, it is estimated that less than 20% of gynecologists utilize office hysteroscopy to evaluate intrauterine pathology. Although no one knows for sure, I speculate that the reasons for its under-utilization include a perceived lack of patients who would benefit from the procedure, expensive capital equipment with poor reimbursement, and a lack of expertise in performing the procedure. SUMMARY: As a result of not routinely using office hysteroscopy, many women who could greatly benefit from the use of the office hysteroscope are being denied a technique that is likely to keep them from more invasive and less useful procedures, such as diagnostic hysteroscopy and dilatation and curettage performed in the operating room under general anesthesia. This paper addresses these misconceptions in an effort to encourage more gynecologists to employ this technology.

A comparison of endotracheal intubation and use of the laryngeal mask airway for ambulatory oral surgery patients.

PURPOSE: This study compared current experience with the laryngeal mask airway (LMA) to previous experience with endotracheal intubation for ambulatory patients receiving general anesthesia. PATIENTS AND METHODS: A retrospective comparison of 157 patients (50 endotracheal intubation [ET] and 107 LMA cases) was conducted. The subjects were American Association of Anesthesiologist (ASA) Class I and II patients who underwent outpatient general anesthesia for dentoalveolar surgery. Procedure time, recovery time, and cost of techniques were compared. RESULTS: The patients undergoing a variety of outpatient dentoalveolar surgical procedures under general anesthesia in the LMA group had a shorter procedure time than the ET group (40 vs 44 minutes) and had a significantly shorter recovery time (54 vs 67 minutes). In addition, compared with the cost of delivering care with ET, the LMA provided slightly lower cost per case ($20 to $30 per case compared with $35 to $80 per case), depending on the anesthetic technique used. Comparing the 2 techniques for removal of 4 impacted third molars (25 patients ET and 68 patients LMA) revealed a similar procedure time of 39 minutes for both groups, but a shorter recovery time for the LMA group (54 vs 68 minutes). CONCLUSIONS: Use of the LMA has advantages over endotracheal intubation for outpatients receiving general anesthesia for dentoalveolar surgery.

Office microlaparoscopy under local anesthesia.

Office laparoscopy under local anesthesia is especially suited to meet the current pressures of quality versus cost in an era of managed care. It is likely that this technique will soon become a major part of the practicing gynecologist's diagnostic operative armamentarium. Advantages of office microlaparoscopy under local anesthesia are realized by the practitioner, the patient, and the managed care provider. Office microlaparoscopy under local anesthesia is a safe, effective, and less costly tool for the evaluation of patients with many different indications. To date, the procedure has been primarily used for patients with infertility, chronic pelvic pain, and tubal ligation. The ease of scheduling, reduced costs, and rapid recovery suggest that it may be the preferred initial procedure for these patients.

[Electrosurgical loop procedures in ambulatory gynecology]. / Elektrokirurgiske slyngeprocedurer i den ambulante gynaekologi.

The article gives a survey of the new electrosurgical excision procedures that are gaining widespread use in office gynaecology in the nineties. A special emphasis is put on the easy learning procedures, relatively low cost of equipment and the results, which seem to match the results of cold-knife- and laser-conization. The advantages and pitfalls of the see-and-treat principle are discussed and the indications, other than cervical intraepithelial neoplasia, are mentioned.

Establishment and cost analysis of an office surgical suite.

The objective of this study was to show that minor operative procedures done in a nonhospital setting can be provided more efficiently than those done in hospital and are agreeable to both patient and surgeon. A description of the facility, equipment required and types of procedures that can be performed provides a guide for other surgeons who may wish to establish an office surgical suite. The senior author's experience from 1993 to 1995 is described. Costs were compared on a procedure basis from financial data obtained from the practice and from a local 400-bed community hospital. Experience shows that patients are receptive to undergoing minor procedures outside the traditional hospital setting. An office surgical suite allows the surgeon greater flexibility in work scheduling, thereby improving productivity. The cost per case appears to be less in the office than in the hospital for the particular costs identified. The current method of funding minor surgical procedures provides an incentive to the surgeon to perform these procedures in hospital, because the individual practitioner is not responsible for any operating expenses. Thus, if costs are to be reduced and quality maintained, funding mechanisms must be reformed to allow less costly service to evolve.

Twenty-two years of office and outpatient laparoscopy: current techniques and why I chose them.

Since 1972 I have introduced the following technical modifications in outpatient laparoscopy under local anesthesia to improve safety, economy, and patient acceptability: avoiding the insufflating needle and sharp trocar in favor of open abdominal entry, using the Hasson cannula; introducing room air for insufflation instead of nitrous oxide or carbon dioxide; using the Hulka clip in place of tubal coagulation; making a single-incision, open surgical entry through the central umbilical fossa in obese patients; and completing fascial penetration with a blunt hemostat or Kelly clamp to minimize the risk of bowel or vessel injury.