December 2024

Synopsis: The PERSEVERE trial evaluated the AMDS Hybrid Prosthesis, a novel self-expanding stent, for patients with acute DeBakey Type I (ADTI) aortic dissection and malperfusion. The device demonstrated reduced major adverse events (MAEs), no distal anastomotic new entry (DANE) tears at 30 days, and favorable postoperative aortic remodeling.

Summary: Current guidelines recommend urgent hemiarch repair for patients with acute DeBakey Type I (ADTI) aortic dissection. However, malperfusion and poor distal aortic remodeling remain significant contributors to morbidity and mortality in this population. The PERSEVERE trial investigated the AMDS Hybrid Prosthesis, a novel self-expanding stent designed for antegrade deployment into the arch and descending thoracic aorta during open repair. This study examined outcomes in patients with ADTI and malperfusion treated with the device.

The trial was a prospective, single arm, nonblinded study conducted at 26 sites. Eligible patients were between 18–80 years old with clinical or radiographic evidence of malperfusion. Exclusion criteria included life expectancy < 2 years, coronary malperfusion, circulatory shock, connective tissue disorders, and primary entry tears in the arch or distal aorta. Two co-primary endpoints were evaluated: the incidence of 30-day major adverse events (MAEs)—a composite of all-cause mortality, new disabling stroke, renal failure requiring dialysis, and myocardial infarction—and the occurrence of any distal anastomotic new entry (DANE) tears at 30 days. Results were compared to a reference cohort of similar patients from five previous studies, with predefined performance goals of 58% for MAEs and 45% for DANE. Secondary endpoints included technical success, aortic remodeling parameters, and unanticipated aortic reoperations.

A total of 93 patients were enrolled, with an average age of 59 years. Most patients were male (79%) and white (60%), and 82% presented with clinical malperfusion. Cerebral perfusion was utilized in 95% of cases (46% antegrade, 48% retrograde). Concomitant cardiac operations were common (84%), including aortic root interventions (39%), aortic valve resuspensions (37%), other valve interventions (23%), and coronary artery bypass grafting (5%).

The incidence of 30-day MAEs was 27% (reference cohort: 58%), including 10% 30-day mortality, 11% new disabling stroke, 19% new renal failure, and no myocardial infarctions. No DANE tears were observed at 30 days (reference cohort: 45%). Both co-primary endpoints met the predefined goals. Technical success was achieved in 99% of patients. Postoperative aortic remodeling demonstrated stable or decreased total aortic diameters in zones 1 (94%), 2 (89%), and 3 (81%). Corresponding reductions in false lumen diameter were observed in zones 1 (-11.6 ± 6.4 mm), 2 (-10.8 ± 5.5 mm), and 3 (-3.5 ± 6.0 mm).

In conclusion, early results from the PERSEVERE trial demonstrated significant reductions in MAEs and no incidence of DANE in patients with ADTI and malperfusion treated with the AMDS Hybrid Prosthesis. Secondary outcomes showed encouraging postoperative aortic remodeling. The device’s simple deployment technique and minimal additional circulatory arrest time make it a promising, safe, and effective option for the treatment of ADTI dissection.

The PERSEVERE trial, while demonstrating promising early results, is limited by its single-arm design, small sample size, and short term follow up. The lack of long-term data and a control group restricts the ability to draw definitive conclusions about the device's effectiveness relative to standard treatments.

Bottom Line:
The AMDS Hybrid Prosthesis demonstrates reduced major adverse events, no distal new entry tears, and favorable aortic remodeling in patients with ADTI dissection and malperfusion. This novel device offers a feasible and effective solution to improve outcomes in open aortic repair.

Synopsis: Total face restoration for severe facial disfigurement continues to pose a challenge in plastic surgery despite major advancements in face transplantation over the past decade. This is a cohort study of patients who underwent total facial restoration using autologous tissue transfer. This reconstructive strategy was associated with significant improvements in patients’ quality of life, return to work/school, facial aesthetics, and functional status, with low rates of flap necrosis.

Summary: Facial disfigurement leads to profound physical, psychological, and social challenges, with traditional reconstruction methods often failing due to mismatches in size, color, and texture. This study sought to present a refined, systematic approach to comprehensive facial reconstruction. This is a single-center long-term retrospective cohort study from the Department of Plastic Surgery at Jiao Tong University, examining 24 patients with severe facial disfigurement due to chemical and flame burns who underwent total face restoration using autologous tissue transfer from 2005-2022. The creation of the final flap was a two-stage process first requiring prefabrication by harvesting a lateral circumflex femoral vessel-based free fascial flap implanted in the subcutaneous pocket of the chest, with expansion of the overlying skin. This was followed by prelamination of the chest flap using a 3-D printed cartilage scaffold to construct the nose and lips. Finally, the complete flap was transferred to the face as a pedicled flap, supercharged locally with two additional vascular pedicles. Intraoperative indocyanine green angiography (IGA) was used to evaluate perfusion and guide openings made for the mouth, nostrils, and palpebral fissures. Primary outcomes included quality of life, satisfaction with facial aesthetics, and functional status, assessed through three validated questionnaires: the 36-Item Short Form Health Survey, the Aesthetic and Functional Status Score of Facial Soft-Tissue Deformities/Defects, and the EuroQoL Health-Related Quality of Life scale. Reconstructive outcomes and flap healing were also evaluated.

At a mean follow-up of 5 years, patients reported significant improvements in quality of life, particularly in social functioning (mean [SD]: preoperative 53.65 [34.51] to postoperative 80.73 [19.10]) and emotional stability (preoperative 56.67 [25.55] to postoperative 71.17 [18.51]). Ninety-two percent of patients returned to work. Facial aesthetic scores improved significantly (preoperative 4.96 [3.26] to postoperative 11.52 [3.49]; P<.001), as did functional status scores (preoperative 11.09 [3.51] to postoperative 15.78 [3.26]; P<.001). Patients regained basic facial functions, including eye and mouth movement, as well as compound facial expressions. By the last follow-up, 50% of patients achieved full facial sensation, compared to only 5% preoperatively. Two patients experienced partial flap necrosis; one required no further intervention, while the other underwent skin grafting.

These findings demonstrate that autologous tissue transfer using a prefabricated, prelaminated, expanded flap, combined with modern techniques like 3D printing and intraoperative IGA, is a viable and safe option for total face reconstruction, yielding acceptable functional and aesthetic outcomes.

Limitations of this study include the absence of detailed reporting on complications such as infections, revision surgeries, and donor site issues. As a single-center study, generalizability is limited, though this remains one of the largest total facial reconstruction cohorts to date. Additionally, this technique does not incorporate bone or facial musculature reconstruction. However, the authors propose that integrating bone into their method could eventually address the needs of approximately one-third of facial transplant candidates worldwide without requiring lifelong immunosuppression. Further research is necessary to refine and expand this approach.

Bottom Line: Autologous tissue transfer using a prefabricated, prelaminated, expanded flap offers a promising, viable approach for total face restoration in patients with severe facial disfigurement, providing significant functional and aesthetic improvements without the need for lifelong immunosuppression.

Synopsis: This is a national analysis of ACGME case logs submitted by general surgery chief residents to evaluate the distribution of case numbers and types by trainee sex and underrepresented in medicine (URiM) status. The study found that female and URiM residents logged fewer major cases compared to male and non-URiM residents.

Summary: The American Board of Surgery requires graduating chief residents to submit operative case logs as part of the licensing process. Traditionally, the number and complexity of cases performed during residency have been considered markers of training quality. Prior work by the U.S. Resident Operative Experience (ROPE) Consortium demonstrated disparities in operative experience by resident race and sex; however, this data reflected only 21 programs. Therefore, this study performed a national analysis of chief resident case logs submitted to the Accreditation Council for Graduate Medical Education (ACGME) to assess the distribution of case numbers and case types/complexities by trainee sex and race.

The ACGME case log database was queried for logs submitted by chief residents at ACGME-accredited general surgery programs between 2017 and 2022. Total major cases, cases by category, and cases by subcategory were analyzed based on resident sex (male/female, defined by biologic status) and underrepresented in medicine (URiM) status. URiM residents were defined as African American, Mexican-American, Native American (American Indian, Alaska Native, Native Hawaiian), and mainland Puerto Rican.

A total of 319 ACGME programs submitted case logs from 6458 chief residents, of whom 2625 (40.6%) were female and 854 (13.2%) were URiM. Among all residents, the mean number of major cases logged was 1113.45 (SD ± 160.55). Female residents logged 37.18 fewer major cases, 7.46 fewer surgeon chief cases, and 4.02 fewer teaching assistant (TA) cases compared to male residents (p < 0.001). URiM residents logged significantly fewer major cases (19.96 fewer cases, p = 0.001) but showed no significant difference in surgeon chief or TA cases compared to non-URiM residents.

When analyzed by case category, small but significant differences were observed by resident sex. Female residents logged fewer cases in abdominal, alimentary tract, endoscopy, head and neck, basic laparoscopy, complex laparoscopy, operative trauma, thoracic, and vascular categories but significantly more cases in breast surgery. No significant differences were noted in endocrine, nonoperative trauma, pediatric, plastics, skin and soft tissue, or surgical critical care categories by resident sex. When examined by race, URiM residents logged significantly fewer cases in abdominal, alimentary tract, endoscopy, basic laparoscopy, and complex laparoscopy categories (differences ranging from 5–12 cases per category). However, URiM residents logged more operative trauma cases (difference = 2), with no differences observed in other categories.

In subcategory analyses, female residents logged significantly fewer cases in access, anastomosis, repair, exposure or endarterectomy, appendix, biliary, colonoscopy, esophagus, hernia, large intestine, liver, open thoracotomy, pancreas, stomach, and upper endoscopy (differences = 0.6–8.4 cases per subcategory). They logged more axilla and mastectomy cases (differences = ~1–2 cases per subcategory). URiM residents logged fewer cases in access, anorectal, biliary, colonoscopy, hernia, large intestine, and upper endoscopy subcategories (differences = ~1–5 cases per subcategory). No significant differences were found in other subcategories for URiM residents.

There are several limitations to this study, most of which stem from the self-reported nature of case logs, which may not reflect the actual number or complexity of cases performed. Additionally, disparities may arise due to parental leave, program-level effects on operative case opportunities, and variability between program types and geographic locations.

Bottom Line: Female and URiM residents log significantly fewer major cases compared to their male and non-URiM peers, differences which are equivalent to 1–3 months of surgical training. This study highlights structural bias in surgical education that must be urgently confronted and corrected.