Understanding Factors Associated with Paid Malpractice Claims in Plastic Surgery.

BACKGROUND: Few studies have investigated malpractice broadly in the field of plastic surgery. The purpose of this analysis was to characterize plastic surgery malpractice cases and examine factors influencing malpractice case outcomes, thereby identifying areas of patient safety concern. METHODS: The Candello database, which catalogs approximately 30% of all paid and unpaid malpractice claims in the United States, was used to obtain cases involving plastic surgery closed between 2009 and 2018. A total of 2674 cases were identified. A multivariable regression model was developed to analyze factors associated with a malpractice case closing with indemnity payment. RESULTS: A total of 716 claims (26.8%) resulted in an indemnity payment. The clinical severity was determined to be high in 229 cases (8.6%). Emotional trauma [ n = 558 (20.9%)] was the most frequently cited injury category. Major differences between procedure groups were not observed, with consistent severity of injury across categories. Poor surgical technique, problems with communication among providers, inadequate informed consent, and deficient documentation were significant factors predictive of malpractice cases closing with payment. Issues with technical performance resulting in a known complication and patient factors were protective against paid claims. CONCLUSIONS: The financial and clinical severity of malpractice claims in plastic surgery were relatively low overall. Multiple factors were found to be associated with a case closing with an indemnity payment. These data highlight the importance of the informed consent process and managing expectations in the clinical care of surgical patients.

Preoperative ß-lactam antibiotic prophylaxis is superior to bacteriostatic alternatives in immediate expander-based breast reconstruction.

BACKGROUND: Staged implant-based breast reconstruction is the most common reconstructive modality following mastectomy. Postoperative implant infections can have a significant impact on adjuvant oncologic care and reconstructive outcome. Here, we investigate the impact of ß-lactam antibiotics (i.e., bactericidal) compared to alternative antibiotic agents on postoperative outcomes for implant-based breast reconstruction. METHODS: A retrospective analysis of patients who underwent immediate sub-pectoral tissue expander placement with an inferior acellular dermal matrix (ADM) sling at a single institution between May 2008 and July 2018 was performed. Patient demographics, comorbidities, and complication rates were retrieved. The impact of antibiotic regimen on postoperative outcomes, including infection rate and reconstructive failure, was investigated. RESULTS: A total of 320 patients with a mean age and BMI of 48.2 years and 25.0 kg/m2 , respectively, who underwent 542 immediate breast reconstructions were included in the study. The use of a ß-lactam antibiotic was protective against postoperative infection (odds ratio [OR] = 0.467, p = .046), infection requiring operative management (OR = 0.313, p = .022), and reconstructive failure (OR = 0.365, p = .028). Extended, that is, post-discharge, prophylaxis was not associated with any clinical benefit. CONCLUSION: The use of ß-lactam antibiotics for pre-/peri-operative prophylaxis is superior to alternative antibiotics with a bacteriostatic mechanism of action regarding rates of postoperative infection and reconstructive failure following immediate tissue expander-based breast reconstruction. Extended, that is, post-discharge, prophylaxis does not appear to be indicated, regardless of the antibiotic chosen.

A Matched-Pair Analysis of Prepectoral with Subpectoral Breast Reconstruction: Is There a Difference in Postoperative Complication Rate?

BACKGROUND: The development of acellular dermal matrices has revolutionized implant-based breast reconstruction. The most recent development has been the introduction of prepectoral breast reconstruction. However, concerns have been expressed related to the quality of soft-tissue coverage and infectious complications. Thus, the authors felt it prudent to perform a matched-pair analysis of clinical outcomes following prepectoral and subpectoral tissue expander placement. METHODS: A retrospective study of patients who underwent immediate breast reconstruction by means of prepectoral (group 1) and dual-plane subpectoral (group 2) tissue expander placement was performed. Patients in each group were matched for age, body mass index, history of radiotherapy, and type of acellular dermal matrix. Of note, patients in group 1 received perioperative antibiotic prophylaxis for less than 24 hours, whereas patients in group 2 received antibiotic prophylaxis for at least 1 week. RESULTS: A total of 80 patients (138 breast reconstructions) were included in the study (group 1, n = 40; group 2, n = 40). No difference in total postoperative complication rate (p = 0.356) and mastectomy skin necrosis rate (p = 1.0) was noted. Observed differences in major complications (p = 0.06), major infection (p = 0.09), and loss of reconstruction (p = 0.09) were not found to be significant. CONCLUSION: Immediate prepectoral tissue expander insertion with anterior acellular dermal matrix coverage and less than 24 hours of antibiotic prophylaxis is safe and compares favorably to subpectoral tissue expander placement with an inferior acellular dermal matrix sling and a prolonged course of antibiotics. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Identifying risk factors for postoperative major complications in staged implant-based breast reconstruction with AlloDerm.

Acellular dermal matrices (ADM) have reportedly been associated with postoperative complications following breast reconstruction. The purpose of this study was to identify risk factors predictive of major postoperative complications after staged implant-based breast reconstruction with ADM. A retrospective study of all patients who underwent implant-based breast reconstruction with AlloDerm between 2013 and 2017 was conducted. Demographic information, procedural data, and postoperative complications were retrieved. The main objective was to analyze patient and procedural factors associated with the occurrence of major complications, including postoperative readmission and loss of reconstruction. A total of 166 patients (288 breasts) were included. Major complications were noted in 19.9%. The overall rate of infection and mastectomy skin necrosis was 16.9% and 6.6%, respectively. Readmission occurred in 16.3% and loss of reconstruction occurred in 8.4% of patients. Risk factors for major complications included body mass index (BMI) >27.0 kg/m2 (OR 2.46; p = 0.041), higher tissue expander volume (p = 0.049), history of chemotherapy (OR 2.20; p = 0.047) and radiotherapy (OR 2.22; p = 0.040). Loss of reconstruction was associated with a BMI >27.0 kg/m2 (OR 4.00; p = 0.012), tobacco use (OR 6.64, p = 0.006), and higher tissue expander volume (p = 0.035). Similarly, readmission was associated with higher tissue expander volume (p = 0.042). In conclusion, a variety of factors were identified to be associated with major complications, including higher BMI, increased tissue expander volume, as well as history of chemotherapy and radiation. This information is valuable for pre-operative counseling and for future comparative studies between different ADM types.

Thirty-day unplanned postoperative inpatient and emergency department visits following thoracotomy.

BACKGROUND: Unplanned visits to the emergency department (ED) and inpatient setting are expensive and associated with poor outcomes in thoracic surgery. We assessed 30-d postoperative ED visits and inpatient readmissions following thoracotomy, a high morbidity procedure. MATERIALS AND METHODS: We retrospectively analyzed inpatient and ED administrative data from California, Florida, and New York, 2010-2011. "Return to care" was defined as readmission to inpatient facility or ED within 30 d of discharge. Factors associated with return to care were analyzed via multivariable logistic regressions with a fixed effect for hospital variability. RESULTS: Of 30,154 thoracotomies, 6.3% were admitted to the ED and 10.2% to the inpatient setting within 30 d of discharge. Increased risk of inpatient readmission was associated with Medicare (odds ratio [OR] 1.30; P < 0.001) and Medicaid (OR 1.31; P < 0.0001) insurance status compared to private insurance and black race (OR 1.18; P = 0.02) compared to white race. Lung cancer diagnosis (OR 0.83; P < 0.001) and higher median income (OR 0.89; P = 0.04) were associated with decreased risk of inpatient readmission. Postoperative ED visits were associated with Medicare (OR 1.24; P < 0.001) and Medicaid insurance status (OR 1.59; P < 0.001) compared to private insurance and Hispanic race (OR 1.19; P = 0.04) compared to white race. CONCLUSIONS: Following thoracotomy, postoperative ED visits and inpatient readmissions are common. Patients with public insurance were at high risk for readmission, while patients with underlying lung cancer diagnosis had a lower readmission risk. Emphasizing postoperative management in at-risk populations could improve health outcomes and reduce unplanned returns to care.

Outcomes after Phalloplasty: Do Transgender Patients and Multiple Urethral Procedures Carry a Higher Rate of Complication?

BACKGROUND: Phalloplasty is associated with improved quality-of-life in those with penile defects, and in female-to-male transgender (transmale) patients seeking gender-confirming surgery. However, aggregate complication and outcome data are sparse. This study compares phalloplasty outcomes between transmale and cismale patients and between those with primary versus staged urethroplasty. METHODS: A comprehensive literature search of PubMed, MEDLINE, and Google Scholar databases was conducted for studies relating to phalloplasty. Data on techniques, complications, outcomes, and patient demographics were collected. Analysis using the random-effects model with subgroup analyses was performed. RESULTS: A total of 50 studies (1351 patients) were included: 19 studies (869 patients) for transmale patients and 31 studies (482 patients) for cismale patients. The urethral complication rate in the transmale group was 39.4 percent (95 percent CI, 30.6 to 48.9 percent; p = 0.028) compared to 24.8 percent (95 percent CI, 16.5 to 35.4 percent; p < 0.001) in the cismale group. The overall flap complication rates for transmale and cismale patients were 10.8 percent (95 percent CI, 7.0 to 16.2 percent; p < 0.001) and 8.1 percent (95 percent CI, 5.5 to 11.7 percent; p < 0.001), respectively. Twenty-three studies (723 patients) used primary urethroplasty and 13 studies (210 patients) performed staged urethroplasty procedures. Flap complication rates of primary and staged urethroplasty were 8.6 percent (95 percent CI, 5.3 to 13.8 percent; p < 0.001) and 16.7 percent (95 percent CI, 10.7 to 24.9 percent; p < 0.001), respectively. Primary urethroplasty had superior outcomes of voiding while standing, sexual function, and patient satisfaction compared with staged urethroplasty. CONCLUSIONS: Cismale patients undergoing phalloplasty had lower urethral and flap complication rates compared with transmale patients. Staged urethroplasty had more flap complications, and worse outcomes and patient satisfaction compared with primary urethroplasty.

Emergency Department Visits Following Elective Total Hip and Knee Replacement Surgery: Identifying Gaps in Continuity of Care.

BACKGROUND: Major joint replacement surgical procedures are common, elective procedures with a care episode that includes both inpatient readmissions and postoperative emergency department (ED) visits. Inpatient readmissions are well studied; however, to our knowledge, little is known about ED visits following these procedures. We sought to characterize 30-day ED visits following a major joint replacement surgical procedure. METHODS: We used administrative records from California, Florida, and New York, from 2010 through 2012, to identify adults undergoing total knee and hip arthroplasty. Factors associated with increased risk of an ED visit were estimated using hierarchical regression models controlling for patient variables with a fixed hospital effect. The main outcome was an ED visit within 30 days of discharge. RESULTS: Among the 152,783 patients who underwent major joint replacement, 5,229 (3.42%) returned to the inpatient setting and 8,883 (5.81%) presented to the ED for care within 30 days. Among ED visits, 17.94% had a primary diagnosis of pain and 25.75% had both a primary and/or a secondary diagnosis of pain. Patients presenting to the ED for subsequent care had more comorbidities and were more frequently non-white with public insurance relative to those not returning to the ED (p < 0.001). There was a significantly increased risk (p < 0.05) of isolated ED visits with regard to type of insurance when patients with Medicaid (odds ratio [OR], 2.28 [95% confidence interval (CI), 2.04 to 2.55]) and those with Medicare (OR, 1.38 [95% CI, 1.29 to 1.47]) were compared with patients with private insurance and with regard to race when black patients (OR, 1.38 [95% CI, 1.25 to 1.53]) and Hispanic patients (OR, 1.12 [95% CI, 1.03 to 1.22]) were compared with white patients. These increases in risk were stronger for isolated ED visits for patients with a pain diagnosis. CONCLUSIONS: ED visits following an elective major joint replacement surgical procedure were numerous and most commonly for pain-related diagnoses. Medicaid patients had almost double the risk of an ED or pain-related ED visit following a surgical procedure. The future of U.S. health-care insurance coverage expansions are uncertain; however, there are ongoing attempts to improve quality across the continuum of care. It is therefore essential to ensure that all patients, particularly vulnerable populations, receive appropriate postoperative care, including pain management. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Effect of Medicare's Nonpayment Policy on Surgical Site Infections Following Orthopedic Procedures.

OBJECTIVE Orthopedic procedures are an important focus in efforts to reduce surgical site infections (SSIs). In 2008, the Centers for Medicare and Medicaid (CMS) stopped reimbursements for additional charges associated with serious hospital-acquired conditions, including SSI following certain orthopedic procedures. We aimed to evaluate the CMS policy's effect on rates of targeted orthopedic SSIs among the Medicare population. DESIGN We examined SSI rates following orthopedic procedures among the Medicare population before and after policy implementation compared to a similarly aged control group. Using the Nationwide Inpatient Sample database for 2000-2013, we estimated rate ratios (RRs) of orthopedic SSIs among Medicare and non-Medicare patients using a difference-in-differences approach. RESULTS Following policy implementation, SSIs significantly decreased among both the Medicare and non-Medicare populations (RR, 0.7; 95% confidence interval [CI], 0.6-0.8) and RR, 0.8l; 95% CI, 0.7-0.9), respectively. However, the estimated decrease among the Medicare population was not significantly greater than the decrease among the control population (RR, 0.9; 95% CI, 0.8-1.1). CONCLUSIONS While SSI rates decreased significantly following the implementation of the CMS nonpayment policy, this trend was not associated with policy intervention but rather larger secular trends that likely contributed to decreasing SSI rates over time. Infect Control Hosp Epidemiol 2017;38:817-822.

Penile Replantation: A Retrospective Analysis of Outcomes and Complications.

Purpose Penile replantation is an uncommonly performed procedure, which can alleviate physical and psychosocial sequelae of penile amputation. This study critically appraises the current literature on penile replantation. Methods A comprehensive literature search of the Medline, PubMed, and Google Scholar databases was conducted with multiple search terms related to penile replantation. Data on outcomes, complications, and patient satisfaction were collected. Results A total of 74 articles met inclusion criteria. One hundred and six patients underwent penile replantation, but outcome, complication, and satisfaction data were not standardized across all patients. Penile amputation most often resulted from self-mutilation or trauma. The majority were complete amputations (74.8%). Full sensation was maintained in 68.4% of patients. Most reported adequate urinary function (97.4%) and normal erection (77.5%). Skin necrosis (54.8%) and venous congestion (20.2%) were the most common complications. Urethral stricture (11.0%) and fistula (6.6%) were common urethral complications. Most (91.6%) patients reported overall satisfaction although there was a lack of patient-reported outcomes. Multivariate analysis suggested that complete amputation (ß = 3.15, 95% CI 0.41-5.89, p = 0.024), anastomosis of the superficial dorsal artery (ß = 9.88, 95% CI 0.74-19.02, p = 0.034), and increasing number of nerves coapted (ß = 1.75, 95% CI 0.11-3.38, p = 0.036) were associated with favorable sexual, urinary, and sensation outcomes. Increasing number of vessels anastomosed (ß = -3.74, 95% CI -7.15 to -0.32, p = 0.032) was associated with unfavorable outcomes. Conclusion Although penile replantation is associated with complications, it has a high rate of satisfaction and efficacy. Coaptation of multiple nerves and anastomosis of the superficial dorsal artery should be completed.

Analyzing treatment aggressiveness and identifying high-risk patients in diabetic foot ulcer return to care.

Rates of diabetes and its associated comorbidities have been increasing in the United States, with diabetic foot ulcer treatment representing a large cost to the patient and healthcare system. These ulcers often result in multiple hospital admissions. This study examined readmissions following inpatient care for a diabetic foot ulcer and identified modifiable factors associated with all-cause 30-day readmissions to the inpatient or emergency department (ED) setting. We hypothesized that patients undergoing aggressive treatment would have lower 30-day readmission rates. We identified patient discharge records containing International Classification of Disease ninth revision codes for both diabetes mellitus and distal foot ulcer in the State Inpatient and Emergency Department databases from the Agency for Healthcare Research and Quality, Healthcare Cost and Utilization Project in Florida and New York, 2011-2012. All-cause 30-day return to care visits (ED or inpatient) were analyzed. Patient demographics and treatment characteristics were evaluated using univariate and multivariable regression models. The cohort included 25,911 discharges, having a mean age of 63 and an average of 3.8 comorbidities. The overall rate of return to care was 30%, and 21% of subjects underwent a toe or midfoot amputation during their index stay. The most common diagnosis codes upon readmission were diabetes mellitus (19%) and infection (13%). Patients with a toe or midfoot amputation procedure were less likely to be readmitted within 30 days (odds ratio: 0.78; 95% confidence interval: 0.73, 0.84). Presence of comorbidities, black and Hispanic ethnicities, and Medicare and Medicaid payer status were also associated with higher odds of readmission following initial hospitalization (p < 0.05). The study suggests that there are many factors that affect readmission rates for diabetic foot ulcer patients. Understanding patients at high-risk for readmission can improve counseling and treatment strategies for this fragile patient population.

Effects of A Novel Decision Aid for Breast Reconstruction: A Randomized Prospective Trial.

INTRODUCTION: The choice to undergo mastectomy and breast reconstruction is a highly personal decision with profound psychosocial effects, and ultimately, the decision between implant- and autologous tissue-based reconstruction should be made based on a combination of factual information and the patient's personal values and preferences. Unfortunately, patients undergoing breast reconstruction surgery may experience decision regret. Decision aids promote patient involvement in decision making by not only providing standard information about options, but also emphasizing comparative risks, benefits, and alternatives, and most importantly by providing clarification exercises regarding personal values to guide patients toward an individualized decision. METHODS: We developed a novel decision aid to provide decision support and structured guidance for prosthetic, autologous, and combined prosthetic-autologous breast reconstruction surgery. New breast reconstruction patients of one surgeon at our institution were randomized by week to either receive the decision aid or standard preconsultation material. Immediately preceding their new patient consultation clinic visit, patients were asked to complete the validated Decisional Conflict Scale and the BREAST-Q Preoperative survey. After 3 to 5 months following breast mound reconstruction, patients were asked to complete the Decision Regret Scale, BREAST-Q Postoperative survey, and the Hospital Anxiety and Depression Scale. RESULTS: Patients who received the decision aid demonstrated a trend toward decreased preoperative decisional conflict (mean of 13.3 ± 5.5, compared to 26.2 ± 4.2; n = 8 per group, P = 0.069), with similar preoperative BREAST-Q scores. Most patients desired to know "everything" regarding their reconstruction surgery (75%), and to be "very involved" in the decisions in their care (81%), with remaining patients wanting to know "as much as I need to be prepared" and to be "somewhat involved." Postoperatively, patients who received the decision aid demonstrated significantly less decision regret (P < 0.001), although there was no significant difference in anxiety, depression, or quality of life-related outcomes as measured by the BREAST-Q. CONCLUSIONS: The use of decision aids in breast reconstruction surgery may help decrease decisional conflict and regret through promoting improved information sharing and shared decision making, which are highly important in this particular setting, patient population, and in our move toward greater patient-centered care.

Therapeutic strategies to improve drug delivery across the blood-brain barrier.

Resection of brain tumors is followed by chemotherapy and radiation to ablate remaining malignant cell populations. Targeting these populations stands to reduce tumor recurrence and offer the promise of more complete therapy. Thus, improving access to the tumor, while leaving normal brain tissue unscathed, is a critical pursuit. A central challenge in this endeavor lies in the limited delivery of therapeutics to the tumor itself. The blood-brain barrier (BBB) is responsible for much of this difficulty but also provides an essential separation from systemic circulation. Due to the BBB's physical and chemical constraints, many current therapies, from cytotoxic drugs to antibody-based proteins, cannot gain access to the tumor. This review describes the characteristics of the BBB and associated changes wrought by the presence of a tumor. Current strategies for enhancing the delivery of therapies across the BBB to the tumor will be discussed, with a distinction made between strategies that seek to disrupt the BBB and those that aim to circumvent it.

In vivo validation of a system for haptic feedback of tool vibrations in robotic surgery.

BACKGROUND: Robotic minimally invasive surgery (RMIS) lacks the haptic (kinesthetic and tactile) cues that surgeons are accustomed to receiving in open and laparoscopic surgery. We previously introduced a method for adding tactile and audio feedback of tool vibrations to RMIS systems, creating sensations similar to what one feels and hears when using a laparoscopic tool. Our prior work showed that surgeons performing box-trainer tasks significantly preferred having this feedback and believed that it helped them concentrate on the task, but we did not know how well our approach would work in a clinically relevant setting. This study constituted the first in vivo test of our system. METHODS: Accelerometers that measure tool vibrations were mounted to the patient-side manipulators of a da Vinci S surgical system. The measured vibrations were recorded and presented to the surgeon through vibrotactile and audio channels while two transperitoneal nephrectomies and two mid-ureteral dissections with uretero-ureterostomy were completed on a porcine model. We examined 30 minutes of resulting video to identify and tag manipulation events, aiming to determine whether our system can measure significant and meaningful tool vibrations during in vivo procedures. RESULTS: A total of 1,404 manipulation events were identified. Analysis of each event's accelerations indicated that 82 % of these events resulted in significant vibrations. The magnitude of the accelerations measured for different manipulation events varied widely, with hard contact causing the largest cues. CONCLUSIONS: This study demonstrates the feasibility of providing tool vibration feedback during in vivo RMIS. Significant tool vibrations were reliably measured for the majority of events during standard urological procedures on a porcine model, while real-time, naturalistic tactile and audio tool vibration feedback was provided to the surgeon. The feedback system's modules were easily implemented outside the sterile field of the da Vinci S and did not interfere with the surgical procedure.