Trends in Surgical Patents Held by Surgeons From 1993 to 2018.

OBJECTIVE: This study aims to quantify the number of patent-holding surgeons and determine their specialty demographics. SUMMARY BACKGROUND DATA: The number of intellectual property filings related to surgery has exponentially increased over the past 40 years, yet surgeon inventor status among these inventions remains poorly defined. METHODS: A query of the United States Patent and Trademark Office (USPTO) Patent Full-Text and Image Database was performed over the years 1993 to 2018. Patents related to surgery were defined as surgical devices, implantables, dressings, introducers, and sterilization equipment based on Cooperative Patent Classification (CPC) code. Inventor names were cross-indexed with names of active Fellows in the American College of Surgeons (FACS) as of 2019. Surgeon inventors were identified and differences between specialty and sex were evaluated. RESULTS: A total of 275,260 patents related to surgery were issued over the study period. The number of surgical patents has increased by 462% from 4593 per year to 21,241 per year. A total of 9008 patents were held by a total of 2164 surgeons (4% of FACS). This represents 3.3% of all surgical patents with a mean of 5 patents (range 1-346) per patent-holding surgeon. Specialties with the largest number of patent holders include neurosurgery (9%) and orthopedic surgery (8%). Ninety-seven percent of patent-holding surgeons were male. CONCLUSIONS: 3.3% of patents related to surgery involve a surgeon inventor, and although the number of surgical patents has shown an exponential increase, surgeon involvement in these inventions has grown minimally. Surgical innovation training may offer an opportunity to reduce these discrepancies and increase surgeon involvement as patent holders.

A physician-led initiative to improve clinical documentation results in improved health care documentation, case mix index, and increased contribution margin.

INTRODUCTION: Clinical documentation is the key determinant of inpatient acuity of illness and payer reimbursement. Every inpatient hospitalization is placed into a diagnosis related group with a relative value based on documented procedures, conditions, comorbidities and complications. The Case Mix Index (CMI) is an average of these diagnosis related groups and directly impacts physician profiling, medical center profiling, reimbursement, and quality reporting. We hypothesize that a focused, physician-led initiative to improve clinical documentation of vascular surgery inpatients results in increased CMI and contribution margin. METHODS: A physician-led coding initiative to educate physicians on the documentation of comorbidities and conditions was initiated with concurrent chart review sessions with coding specialists for 3 months, and then as needed, after the creation of a vascular surgery documentation guide. Clinical documentation and billing for all carotid endarterectomy (CEA) and open infrainguinal procedures (OIPs) performed between January 2013 and July 2016 were stratified into precoding and postcoding initiative groups. Age, duration of stay, direct costs, actual reimbursements, contribution margin (CM), CMI, rate of complication or comorbidity, major complication or comorbidity, severity of illness, and risk of mortality assigned to each discharge were abstracted. Data were compared over time by standardizing Centers for Medicare and Medicaid Services (CMS) values for each diagnosis related group and using a CMS base rate reimbursement. RESULTS: Among 458 CEA admissions, postcoding initiative CEA patients (n = 253) had a significantly higher CMI (1.36 vs 1.25; P = .03), CM ($7859 vs $6650; P = .048), and CMS base rate reimbursement ($8955 vs $8258; P = .03) than precoding initiative CEA patients (n = 205). The proportion of admissions with a documented major complication or comorbidity and complication or comorbidity was significantly higher after the coding initiative (43% vs 27%; P < .01). Among 504 OIPs, postcoding initiative patients (n = 227) had a significantly higher CMI (2.23 vs 2.05; P < .01), actual reimbursement ($23,203 vs $19,909; P < .01), CM ($12,165 vs $8840; P < .01), and CMS base rate reimbursement ($14,649 vs $13,496; P < .01) than precoding initiative patients (n = 277). The proportion of admissions with a documented major complication or comorbidity and complication or comorbidity was significantly higher after the coding initiative (61% vs 43%; P < .01). For both CEA and OIPs, there were no differences in age, duration of stay, total direct costs, or primary insurance status between the precoding and postcoding patient groups. CONCLUSIONS: Accurate and detailed clinical documentation is required for key stakeholders to characterize the acuity of inpatient admissions and ensure appropriate reimbursement; it is also a key component of risk-adjustment methods for assessing quality of care. A physician-led documentation initiative significantly increased CMI and CM.

Outcomes of fenestrated and branched endovascular repair of complex abdominal and thoracoabdominal aortic aneurysms.

BACKGROUND: More than 80% of infrarenal aortic aneurysms are treated by endovascular repair. However, adoption of fenestrated and branched endovascular repair for complex aortic aneurysms has been limited, despite high morbidity and mortality associated with open repair. There are few published reports of consecutive outcomes, inclusive of all fenestrated and branched endovascular repairs, starting from the inception of a complex aortic aneurysm program. Therefore, we examined a single center's consecutive experience of fenestrated and branched endovascular repair of complex aortic aneurysms. METHODS: This is a single-center, prospective, observational cohort study evaluating 30-day and 1-year outcomes in all consecutive patients who underwent fenestrated and branched endovascular repair of complex aortic aneurysms (definition: requiring one or more fenestrations or branches). Data were collected prospectively through an Institutional Review Board-approved registry and a physician-sponsored investigational device exemption clinical trial (G130210). RESULTS: We performed 100 consecutive complex endovascular aortic aneurysm repairs (November 2010 to March 2016) using 58 (58%) commercially manufactured custom-made devices and 42 (42%) physician-modified devices to treat 4 (4%) common iliac, 42 (42%) juxtarenal, 18 (18%) pararenal, and 36 (36%) thoracoabdominal aneurysms (type I, n = 1; type II, n = 4; type III, n = 12; type IV, n = 18; arch, n = 1). The repairs included 309 fenestrations, branches, and scallops (average of 3.1 branch arteries/case). All patients had 30-day follow-up for 30-day event rates: three (3%) deaths; six (6%) target artery occlusions; five (5%) progressions to dialysis; eight (8%) access complications; one (1%) paraparesis; one (1%) bowel ischemia; and no instances of myocardial infarction, paralysis, or stroke. Of 10 type I or type III endoleaks, 8 resolved (7 with secondary intervention, 1 without intervention). Mean follow-up time was 563 days (interquartile range, 156-862), with three (3%) patients lost to follow-up. On 1-year Kaplan-Meier analysis, survival was 87%, freedom from type I or type III endoleak was 97%, target vessel patency was 92%, and freedom from aortic rupture was 100%. Average lengths of intensive care unit stay and inpatient stay were 1.4 days (standard deviation, 3.3) and 3.6 days (standard deviation, 3.6), respectively. CONCLUSIONS: These results show that complex aortic aneurysms can now be treated with minimally invasive fenestrated and branched endovascular repair. Endovascular technologies will likely continue to play an increasingly important role in the management of patients with complex aortic aneurysm disease.

Surgeon leadership in the coding, billing, and contractual negotiations for fenestrated endovascular aortic aneurysm repair increases medical center contribution margin and physician reimbursement.

BACKGROUND: Fenestrated endovascular aneurysm repair (FEVAR) allows endovascular treatment of thoracoabdominal and juxtarenal aneurysms previously outside the indications of use for standard devices. However, because of considerable device costs and increased procedure time, FEVAR is thought to result in financial losses for medical centers and physicians. We hypothesized that surgeon leadership in the coding, billing, and contractual negotiations for FEVAR procedures will increase medical center contribution margin (CM) and physician reimbursement. METHODS: At the UMass Memorial Center for Complex Aortic Disease, a vascular surgeon with experience in medical finances is supported to manage the billing and coding of FEVAR procedures for medical center and physician reimbursement. A comprehensive financial analysis was performed for all FEVAR procedures (2011-2015), independent of insurance status, patient presentation, or type of device used. Medical center CM (actual reimbursement minus direct costs) was determined for each index FEVAR procedure and for all related subsequent procedures, inpatient or outpatient, 3 months before and 1 year subsequent to the index FEVAR procedure. Medical center CM for outpatient clinic visits, radiology examinations, vascular laboratory studies, and cardiology and pulmonary evaluations related to FEVAR were also determined. Surgeon reimbursement for index FEVAR procedure, related adjunct procedures, and assistant surgeon reimbursement were also calculated. All financial analyses were performed and adjudicated by the UMass Department of Finance. RESULTS: The index hospitalization for 63 FEVAR procedures incurred $2,776,726 of direct costs and generated $3,027,887 in reimbursement, resulting in a positive CM of $251,160. Subsequent related hospital procedures (n = 26) generated a CM of $144,473. Outpatient clinic visits, radiologic examinations, and vascular laboratory studies generated an additional CM of $96,888. Direct cost analysis revealed that grafts accounted for the largest proportion of costs (55%), followed by supplies (12%), bed (12%), and operating room (10%). Total medical center CM for all FEVAR services was $492,521. Average surgeon reimbursements per FEVAR from 2011 to 2015 increased from $1601 to $2480 while the surgeon payment denial rate declined from 50% to 0%. Surgeon-led negotiations with the Centers for Medicare & Medicaid Services during 2015 resulted in a 27% increase in physician reimbursement for the remainder of 2015 ($2480 vs $3068/case) and a 91% increase in reimbursement from 2011 ($1601 vs $3068). Assistant surgeon reimbursement also increased ($266 vs $764). Concomitant FEVAR-related procedures generated an additional $27,347 in surgeon reimbursement. CONCLUSIONS: Physician leadership in the coding, billing, and contractual negotiations for FEVAR results in a positive medical center CM and increased physician reimbursement.

Complete regression of a symptomatic, mycotic juxtarenal abdominal aortic aneurysm after treatment with fenestrated endovascular aneurysm repair.

Mycotic abdominal aortic aneurysms are rare and present unique challenges when potential treatment options are considered. Although aortic resection with in situ grafting techniques or extra-anatomic reconstruction are the treatments of choice, endovascular aortic repair has emerged as a suitable alternative in critically ill patients. We report the successful endovascular repair of a symptomatic, mycotic juxtarenal aortic aneurysm using a physician-modified fenestrated endograft. In this patient, with >6 months of follow-up, the aneurysm has completely regressed, illustrating that in select patients with complex mycotic aneurysms, endovascular repair combined with appropriate medical management is a viable treatment strategy.

Autologous and synthetic pediatric iliofemoral reconstruction: a novel technique for pediatric iliofemoral artery reconstruction.

Pediatric lower extremity arterial catheterization-related injuries can result in significant long-term morbidity. Revascularization is challenging due to concerns for long-term patency and growth accommodation with synthetic grafts. We describe a novel technique for iliofemoral revascularization using common iliac artery transposition and bridging polytetrafluoroethylene grafts. We treated two children who underwent femoral catheterization resulting in lifestyle-limiting claudication. Both patients experienced immediate resolution of symptoms. Postoperative imaging demonstrated widely patent vasculature. ASPIRE (autologous and synthetic pediatric iliofemoral reconstruction) is a method of pediatric iliofemoral artery revascularization that allows for an autologous artery to span the hip joint, reducing graft thrombosis risk and accommodating patient growth.

Cold Therapy for Pain Control in Pediatric Appendectomy Patients: A Randomized Controlled Trial.

PURPOSE: Topical ice has been shown to reduce pain scores and opioid use in adults with midline abdominal incisions. This study was designed to evaluate the efficacy of a cold therapy system in children following laparoscopic appendectomy. METHODS: Patients 7 years and older who underwent laparoscopic appendectomy at our institution from December 2021-September 2022 were eligible. Patients were randomized to standard pain therapy (control) or standard plus cold therapy (treatment) utilizing a modified ice machine system with cool abdominal pad postoperatively. Pain scores on the first 3 postoperative days (PODs), postoperative narcotic consumption, and patient satisfaction were analyzed. RESULTS: Fifty-eight patients were randomized, 29 to each group. Average survey response rate was 74% in control and 89% in treatment patients. There was no significant difference in median pain scores or narcotic use between groups. Cold therapy contributed to subjective pain improvement in 71%, 74%, and 50% of respondents on PODs 1, 2, and 3 respectively. CONCLUSION: A majority of patients reported cold therapy to be a helpful adjunct in pain control after appendectomy, though it did not reduce postoperative pain scores or narcotic use in our cohort - likely due to this population's naturally expedient recovery and low baseline narcotic requirement. TYPE OF STUDY: Randomized Controlled Trial. LEVEL OF EVIDENCE: Level I.

Pediatric button battery ingestion: A single center experience and risk score to predict severe outcomes.

PURPOSE: The purpose of this study was to analyze the management and outcomes of primary button battery ingestions and their sequelae at a single high-volume center, and to propose a risk score to predict the likelihood of a severe outcome. METHODS: The medical record was queried for all patients under 21 years old evaluated at our institution for button battery ingestion from 2008 to 2021. A severe outcome was defined as having at least one of the following: deep/circumferential mucosal erosion, perforation, mediastinitis, vascular or airway injury/fistula, or development of esophageal stricture. From a selection of clinically relevant factors, logistic regression determined predictors of a severe outcome, which were incorporated into a risk model. RESULTS: 143 patients evaluated for button battery ingestion were analyzed. 24 (17%) had a severe outcome. The independent predictors of a severe outcome in multivariate analysis were location of battery in the esophagus on imaging (96%), battery size >/ = 2 cm (95%), and presence of any symptoms on presentation (96%), with P < 0.001 in all cases. Predicted probability of a severe outcome ranged from 88% when all three risk factors were observed, to 0.3% when none were present. CONCLUSION: We report the presentation, management, and complication profiles of a large cohort of BB ingestions treated at a single institution. A risk score to predict severe outcomes may be used by providers initially evaluating patients with button battery ingestion in order to allocate resources and expedite transfer to a center with pediatric endoscopic and surgical capabilities. LEVEL OF EVIDENCE: Level IV. TYPE OF STUDY: Clinical Research Paper.

Outcomes of laparoscopic gastrostomy in children with and without the use of a modified T-fastener technique.

BACKGROUND: Laparoscopic gastrostomy is commonly performed for durable enteral access in children. T-fasteners have been used intraoperatively to achieve a secure gastropexy, traditionally using external bolsters. We compare the safety profile of a modified paired T-fastener technique to standard laparoscopic-assisted suture gastropexy. METHODS: A retrospective matched case-control study was performed of pediatric patients who underwent laparoscopic gastrostomy at a single center from 2015 to 2021. In the paired T-fastener group, pairs of T-fasteners were passed into the stomach in a square configuration, allowing the suture pairs to be tied subcutaneously. This cohort was matched in a 1:2 fashion with age, sex, and body mass index or weight-matched controls who underwent laparoscopic gastrostomy with buried transabdominal gastropexy. RESULTS: Thirty patients underwent laparoscopic gastrostomy using the paired T-fastener technique and were matched to 60 controls. There was no significant difference in median operative time or 30-day complication rates between the groups, but the paired T-fastener technique significantly reduced the number of trocars required, and it was used for patients with thicker abdominal walls. CONCLUSION: We demonstrate the modified paired T-fastener technique as a safe, efficient means of gastropexy in pediatric laparoscopic gastrostomy. The paired T-fastener approach eliminates external bolsters, reduces additional trocars, and may be advantageous for thicker abdominal walls while maintaining a similar complication profile to standard laparoscopic gastrostomy.

Outcomes of internal biliary diversion using cholecystocolostomy for patients with severe Alagille syndrome.

Alagille syndrome (AGS) is a disorder that leads to increased serum cholesterol and bile acids, which can result in debilitating xanthomas and pruritus. External biliary drainage and transplantation are effective treatments for AGS. Internal biliary diversion with Roux-en-Y cholecystocolostomy has been described for other biliary conditions, but not AGS. Three patients with severe pruritus due to AGS underwent Roux-en-Y cholecystocolostomy for internal biliary drainage. Retrospective analysis compared preoperative and post-operative lab values and symptom scores (0, none-4, severe). Three patients underwent cholecystocolostomy. All patients had at least three diagnostic criteria for AGS. Mean preoperative pruritus score was 3.33 (range, 2-4) and mean post-operative score was 1. Mean preoperative xanthoma score was 1.33 (range, 0-4) and post-operative score was 1 at 2-month follow-up. Roux-en-Y cholecystocolostomy can be considered for AGS, which is refractory to medical management. This procedure accomplishes internal biliary diversion without significant physiologic derangements.

Functional side-to-side splenorenal shunts to treat extrahepatic portal vein thrombosis in children.

BACKGROUND: Surgical shunts are commonly used to manage complications resulting from extrahepatic portal vein thrombosis (EHPVT) in children. We describe a single-center experience utilizing a functional Side-to-Side Splenorenal Shunt (fSRS), created using either an enlarged inferior mesenteric vein (IMV) or left adrenal vein (LAV). METHODS: Pediatric patients with isolated EHPVT who were poor candidates for a Rex shunt and who underwent a fSRS procedure at our institution between 2003 and 2020 were reviewed. The pre/post shunt portosystemic gradient change, rates of early and late complications, postoperative shunt patency, and mortality were evaluated. RESULTS: Twelve EHPVT patients (mean age of 6.1 years) underwent a fSRS procedure. The mean portosystemic gradient change for the cohort was -11.7 mmHg (±4.9). There were no cases of recurrent variceal bleeding or episodes of shunt thrombosis reported after fSRS procedures. CONCLUSIONS: Surgical shunts continue to be an important adjunct in the treatment of complications related to EHPVT. The functional Side-to-Side Splenorenal Shunt is a safe alternative that is easy to perform, involves minimal dissection and requires only a single anastomosis.

Midaortic syndrome and renovascular hypertension.

Midaortic syndrome (MAS) is a rare condition characterized by stenosis of the abdominal aorta with or without the involvement of branch vessels. The majority of cases are thought to be idiopathic though MAS has been associated with a number of conditions including granulomatous vasculitis, neurofibromatosis-1 (NF-1), Alagille Syndrome, fibromuscular dysplasia (FMD), and Williams syndrome. Patients typically present with hypertension due to decreased renal perfusion. Less common presentations include renal insufficiency, heart failure, claudication, stroke, and abdominal pain. Imaging modalities help establish the diagnosis of MAS including duplex ultrasound, computed tomography angiography (CTA), magnetic resonance angiography (MRA), and angiography. Initial therapy focuses on medical management with antihypertensives prior to intervention. Invasive interventions are indicated when there is evidence of end organ damage or dysfunction such as decreased renal function, poorly growing kidneys, cerebrovascular accident, left ventricular hypertrophy or frank cardiac failure. Endovascular interventions may assist in diagnosis and may treat some lesions although reintervention rates are high. Most patients require some type of surgical intervention, and a variety of surgical options are available based on anatomic findings. Renal revascularization may be accomplished by renal artery bypass, autotransplantation, or renal artery reconstruction. Aortic lesions may be repaired using patch angioplasty or aortoaortic bypass. Mesenteric arteries do not typically require reconstruction as they are rarely symptomatic. More novel options include the use of tissue expanders to lengthen the aorta to allow for primary aortic reconstruction (TESLA) or the use of the meandering mesenteric artery as an autologous aortic bypass graft (MAGIC).

The Paired T-Fastener Technique: A Bolster-Free Gastropexy for Laparoscopic Gastrostomy Tube Placement.

Purpose: Gastropexy during laparoscopic gastrostomy tube (GT) insertion can be technically challenging. T-fasteners are an effective method of gastropexy. However, the use of external bolsters requires an additional procedure for removal and may cause skin complications due to pressure necrosis. We describe our experience utilizing T-fasteners in a novel way that eliminates external bolsters during laparoscopic GT placement. Methods: Pediatric patients requiring enteral access who underwent gastrostomy at a single institution using the paired T-fastener technique were reviewed. Gastropexy was achieved by passing pairs of T-fasteners, under laparoscopic and/or endoscopic guidance, through single stab incisions into the stomach in a square configuration, allowing the suture from one T-fastener to be tied subcutaneously to its paired suture. This eliminates the need for external bolsters. Operative time and 30-day postoperative complications, including local wound infection, granulation tissue formation, bleeding, and tube replacement, are reported. Results: Thirty patients underwent gastrostomy placement using the paired T-fastener technique. Mean age was 9.2 years (standard deviation [SD] 6.9) and mean weight 29.9 kg (SD 21.0). Mean tube length was 2.2 cm (SD 0.71). Eight patients underwent an additional procedure at the time of gastrostomy. Mean operative time was 74.4 minutes (SD 39.7). Five patients developed a local wound infection requiring antibiotics. Five developed granulation tissue. Seven patients underwent tube replacement within 30 days for dislodgment or stem upsize. Conclusion: The paired T-fastener technique is a safe and efficient method for primary button gastrostomy placement. This method eliminates the need for additional trocars or external bolsters and may be helpful in patients with thick abdominal walls.

A national analysis of pediatric falls from a building.

INTRODUCTION: Falls remain the leading cause of unintentional pediatric trauma in the United States. Identifying risk factors for pediatric building falls would influence public health policy. We hypothesized that building falls disproportionately affect low income communities. METHODS: We performed a cross-sectional analysis of the Kids' Inpatient Database for years 2006, 2009, and 2012. We identified cases (age <12 years) of falls from a building using external cause of injury codes. Patient characteristics and injuries were analyzed using ICD-9 codes. National estimates were obtained using case weighting. Multivariable logistic regression was performed to adjust for confounders. RESULTS: There were 2,294 hospitalizations nationally for pediatric falls from a building. The victims were predominately male, in early childhood, non-Hispanic White, in the lowest income quartile, resided in urban settings, and occurred during summer. The mean age was 3.76 years. Logistic regression revealed males were 33% more likely than females, and as compared to non-Hispanic White youth, Black (33%) and Asian or Pacific Islanders (65%) were more likely to experience a fall from a building. Toddlers and those in early childhood were at significantly increased odds than those younger than one year old. Children in the highest income quartile were 29% more likely to experience a building fall. CONCLUSIONS: Building falls are a common cause of injury in the U.S. for children under 12 years old. Injury prevention strategies focused on the parents of children aged 1-5 years has the potential to make a significant public health impact.