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- Ten-year survival after postmastectomy chest-wall irradiation in breast cancer - The SUPREMO Trial
Authors: Kunkler IH, Russell NS, Anderson N, et al. Journal: New England Journal of Medicine, November 6, 2025 Trial: SUPREMO randomized phase 3 Key takeaways In intermediate-risk post-mastectomy patients (pT1–2N1; pT3N0; or pT2N0 with grade 3 and/or lymphovascular invasion), chest-wall RT did not improve 10-year overall survival vs no RT (81.4% vs 81.9%; HR 1.04, 95% CI 0.82–1.30). RT halved chest-wall recurrences (HR 0.45, 95% CI 0.20–0.99) but the absolute reduction was <2% over 10 years (1.1% vs 2.5%). No differences in disease-free or distant metastasis–free survival (10-yr DFS 76.2% vs 75.5%; DMFS 78.2% vs 79.2%). In a triple-negative subgroup, overall survival was worse with RT (HR 1.91, 95% CI 1.06–3.46). Background Whether to irradiate the chest wall after mastectomy for intermediate-risk disease (pT1–2N1; pT3N0; or pT2N0 with grade 3 and/or lymphovascular invasion) is controversial in the modern systemic therapy era. Objective Test whether omitting chest-wall RT compromises overall survival at 10 years in intermediate-risk patients treated with contemporary multimodality therapy. Methods Design/setting: International, randomized, phase 3 trial; chest-wall RT (40–50 Gy) versus no chest-wall RT. Primary endpoint: overall survival (OS). Secondary: chest-wall/locoregional recurrence, DFS, DMFS, safety. Median follow-up 9.6 years. Population: 1607 randomized; ITT: 808 RT, 799 no RT; intermediate-risk post-mastectomy; high uptake of chemotherapy (~85%) and endocrine therapy (~79%); trastuzumab ~20%. Results Overall survival (primary): 10-yr OS 81.4% (RT) vs 81.9% (no RT); HR 1.04 (P=0.80). Chest-wall recurrence: 1.1% vs 2.5%; HR 0.45 (95% CI 0.20–0.99). Absolute benefit <2%. Locoregional recurrence: 2.7% vs 4.5%; HR 0.61 (95% CI 0.36–1.03). Distant metastasis–free survival: 78.2% vs 79.2%; HR 1.06 (95% CI 0.86–1.31). Disease-free survival: 76.2% vs 75.5%; HR 0.97 (95% CI 0.79–1.18). Subgroups: No OS interaction by nodal status or age; triple-negative patients had worse OS with RT (HR 1.91, 95% CI 1.06–3.46). Safety: Overall toxicities were low; pulmonary events were uncommon but numerically higher with RT (e.g., grade ≥2 lung events 13 vs 5). Cardiac deaths ≤1% in both groups. Conclusion In intermediate-risk patients after mastectomy receiving modern systemic therapy, routine chest-wall RT did not improve 10-year OS, while offering a small absolute reduction in chest-wall recurrences. Strengths & limitations Strengths: Large, international RCT with long follow-up and high systemic-therapy adherence; robust RT quality assurance. Limitations: Initiated nearly two decades ago; evolving axillary and neoadjuvant practices; event rates lower than anticipated, limiting power for small effects. Clinical relevance For pT1–2N1 or selected pN0 with high-risk features after mastectomy, these data support considering omission of chest-wall RT when regional nodal RT is not otherwise indicated, given no OS/DMFS benefit and very low baseline chest-wall failure. Be cautious in triple-negative disease: the signal for worse OS with RT warrants multidisciplinary discussion and alignment with emerging de-escalation trials. When nodal irradiation is needed, modern planning can treat nodes while avoiding the chest wall/reconstruction, aligning with reconstructive goals and minimizing late effects. Commentary SUPREMO reflects today’s reality: excellent systemic therapy drives very low chest-wall recurrence, shrinking the marginal value of routine chest-wall RT in intermediate-risk patients. The absolute gain (<2%) in local control is unlikely to translate into survival, and late-effect avoidance (cardiac, pulmonary, reconstructive outcomes) is a compelling reason to individualize and, in many cases, omit chest-wall RT.
- Effectiveness of Liposomal Bupivacaine Transversus Abdominis Plane Block in DIEP Flap Breast Reconstruction: A Randomized Controlled Trial
Park RH et al. Plastic and Reconstructive Surgery 2024 Oct 1;154(4S):52S-59S . PMID: 38315156 Key takeaways Liposomal + plain bupivacaine TAP block did not lower opioid use vs plain bupivacaine alone after DIEP reconstruction (60.2 vs 66.9 MME; P = 0.47). Pain scores improved modestly (VAS 3.6 vs 4.3; P = 0.004 ). Length of stay (2.2 vs 2.1 days) and refill rates (17 % vs 22 %) were unchanged. No differences in 30-day complications or flap failures. Background Enhanced-Recovery protocols for autologous breast reconstruction already curb narcotic needs. Whether adding the longer-acting liposomal bupivacaine to TAP blocks yields extra benefit remains uncertain. Objective To determine if liposomal bupivacaine in TAP blocks reduces postoperative opioid consumption after DIEP-flap breast reconstruction. Methods Design: Single-center, single-blinded RCT (Level II). Setting: University of Virginia, March 2021–December 2022. Participants: 117 women undergoing unilateral or bilateral DIEP flaps; 59 control (plain bupivacaine + epinephrine), 58 experimental (liposomal + plain bupivacaine + epinephrine). Inclusion/Exclusion: ≥18 y; no active opioid use or allergy; ERAS pathway adherence. Intervention: Surgeon-delivered intra-operative TAP block (80 mL control mix vs 100 mL liposomal mix). Primary endpoint: Total postoperative opioid use in morphine-milligram equivalents (MME) during hospitalization. Secondary endpoints: VAS pain scores (PACU through 48 h), length of stay, opioid refills, 30-day complications. Stats: α = 0.05; t-test or Mann–Whitney U; power calculation ≥50 per arm. Results Opioids: Mean total MME 60.2 (liposomal) vs 66.9 (control); Δ –6.7 MME; NS (P = 0.47). Pain: Overall mean VAS 3.6 vs 4.3 (–0.7 points); significant (P = 0.004). Significant only in 24–48 h window (3.4 vs 4.1; P = 0.02). Length of stay: 2.2 ± 0.6 vs 2.1 ± 0.4 days; P = 0.55. Opioid refills: 17 % vs 22 %; P = 0.52. Complications: No significant group differences in wound issues, thrombotic events, or flap loss (all P > 0.3). Conclusion Adding liposomal bupivacaine to TAP blocks improved subjective pain but did not reduce opioids, LOS, or complications versus plain bupivacaine within a standardized ERAS pathway. Strengths & limitations Randomized, blinded design within a uniform ERAS protocol. Powered sample size with contemporary opioid-sparing regimen. Single institution; potential type II error for opioid endpoint. Pain scores not site-specific; postoperative outpatient opioid use unmeasured. Future directions Cost-effectiveness studies and exploration of alternative long-acting local anesthetics or catheter-based blocks are warranted. Clinical relevance For microsurgeons following ERAS, routine liposomal bupivacaine in TAP blocks may not justify extra cost —plain bupivacaine suffices for opioid minimization, though expect slightly higher early pain scores.
- CHALLENGE Trial: Structured Exercise after Adjuvant Chemotherapy for Colon Cancer
Study Snapshot Paper Info New England Journal of Medicine, July 2025 , PMID: 40450658 Background Despite curative surgery and modern adjuvant chemotherapy, 20 – 40 % of stage III or high-risk II colon-cancer survivors recur. Observational data link higher post-treatment physical activity with superior outcomes, but randomized evidence has been lacking. Methods Study design & scale: Multicenter (55 international sites), phase-3, open-label RCT; 889 patients randomized 1:1 (2009-2024). Population: Adults with completely resected stage III or high-risk II colon cancer, 2-6 mo after finishing FOLFOX or CAPOX; ECOG 0–1; <150 min wk⁻¹ baseline exercise. Intervention: Three-year, behavior-supported aerobic program targeting ≥ 10 MET-h wk⁻¹ above baseline A MET (Metabolic Equivalent of Task) is the energy you use at rest. Moderate-intensity activities such as brisk walking are about 3–5 METs; vigorous activities like jogging are 6–8 METs. Goal of 150–180 minutes of brisk walking per week (∼30 min on most days) in addition to one’s usual activity . Control: Health-education materials alone. Outcomes & follow-up: Primary: Disease-free survival (DFS). Key secondaries: Overall survival (OS), SF-36 physical-functioning domain, predicted VO₂, 6-min walk, safety; median follow-up 7.9 y. Results 5-year DFS: 80.3 % (exercise) vs 73.9 % (control). 8-year OS: 90.3 % (exercise) vs 83.2 % (control). Quality of life: SF-36 physical-functioning improved ~6–7 points in the exercise arm vs 1–3 points in controls at every 6-mo interval through 3 y. Functional fitness: Sustained mean gain of 5–7 MET-h wk⁻¹ plus parallel VO₂ and 6-min-walk improvements. Safety: Grade ≥3 AEs 15.4 % (exercise) vs 9.1 %; musculoskeletal events 18.5 % vs 11.5 % (10 % exercise-related). Conclusion A rigorously supported, moderate-volume aerobic exercise program initiated soon after adjuvant chemotherapy meaningfully improves long-term disease-free and overall survival while enhancing functional quality of life , with tolerable risk. These data provide level-1 evidence to integrate structured exercise into routine survivorship care for colon-cancer patients. Clinical Relevance Level I evidence shows that a modest, structured aerobic program improves survival. Plastic surgeons should investigate prescribe exercise in other reconstructive pathways to enhance outcomes.
- Nonoperative Management of Mismatch repair deficient Tumors
New England Journal of Medicine, April 2025 Key take aways: PD-1–based immunotherapy is especially effective against mismatch repair–deficient tumors due to their high mutational burden, which increases neoantigen expression and immune system recognition. Background Mismatch repair–deficient (dMMR) tumors, including certain colorectal, gynecologic, and genitourinary cancers, are highly responsive to PD-1 blockade. Prior studies in rectal cancer showed that neoadjuvant immunotherapy could eliminate the need for surgery. This trial evaluated whether that strategy could extend to all early-stage, resectable dMMR solid tumors. Study Design A phase 2 trial enrolled 124 patients with stage I–III dMMR solid tumors. Patients received dostarlimab (500 mg IV every 3 weeks for 6 months). Response was assessed with imaging, endoscopy, and circulating tumor DNA (ctDNA). Patients achieving a clinical complete response (cCR) could opt for nonoperative management. Cohort 1 : Locally advanced dMMR rectal cancer (n=50) Cohort 2 : dMMR nonrectal solid tumors (n=67), including colon, gastric, urothelial, and gynecologic malignancies Results Clinical Complete Response (cCR): Cohort 1 : 100% (49/49) achieved cCR; 37 maintained it at 12 months Cohort 2 : 65% (35/54) achieved cCR; 33 chose nonoperative management Overall: 82/103 (80%) patients avoided surgery without compromise to resectability Recurrence-Free Survival at 2 Years: Overall: 92% Rectal cancer cohort: 96% Nonrectal cohort: 85% No patients lost the opportunity for curative resection due to treatment delay Adverse Events: Mostly grade 1–2 and reversible (fatigue, rash, pruritus) Grade ≥3 in <5% of patients Clinical Relevance This study supports neoadjuvant PD-1 blockade as a viable, organ-preserving strategy for early-stage dMMR tumors. Patients with rectal cancer uniformly avoided surgery, with promising extension to select nonrectal tumors. Importantly, oncologic safety was maintained even with deferred surgery. Considerations for Practice Nonoperative management may now be considered in dMMR tumor patients showing robust response to neoadjuvant PD-1 blockade.
- A Comparison of Treatment With Skin Graft or Secondary Healing for Nasal Wound Defects After Tumor Excision
PRS Global Open, March 2025 Key take aways: Secondary healing of small (<3x3 cm) wounds on the tip or ala yields superior cosmetic outcomes compared to FTSG, although time to heal is slightly longer Background The treatment strategies for small nasal wound defects post-tumor excision often involve complex decisions regarding cosmetic outcomes and healing duration. Objective This study's primary aim was to evaluate the short- and long-term healing outcomes and cosmetic results of using FTSG versus secondary healing in patients with nasal defects post-tumor excision. Methods RCT at Linköping University Hospital Inclusion: 18+ yo Wound measuring 3x3 cm or smaller on the tip or alae Max depth: intact perichondrium (i.e. graftable) Participants randomized to FTSG or secondary healing Both groups were dressed with PolyMem (hydrophilic polyurethane foam) dressings Primary outcomes included hand scar quality as assessed by Patient and Observer Scar Assessment Scale (POSAS) : POSAS performed in short term (1 and 4 weeks) and long term (6 mo) Results A total of 30 patients were enrolled, and after exclusions for re-excision or withdrawal, 26 were analyzed. Median age of participants was 74.5 years, 50% were male. Healing times presented as median (IQR) were 35.0 days in the secondary healing group (SH) versus 28.0 days in the skin graft group (FTSG), with no statistically significant difference (P = 0.47). At the 6-month follow-up, the SH group demonstrated superior scores in observer-assessed key parameters: vascularity (P = 0.003), pigmentation (P = 0.007), thickness (P = 0.002), and relief (P = 0.01). Overall, patient-reported outcomes showed significant satisfaction in the SH group regarding scar aesthetics Conclusion While the healing duration was slightly longer for secondary healing, the long-term cosmetic results indicated that this approach may provide superior long-term outcomes compared to skin grafting. Strengths and Limitations Strengths include the randomized controlled design and the comprehensive follow-up using validated scar assessment tools. Limitations include: Small sample size Long-term follow up limited to 6mo Average age was 75 yr; do results apply to younger population? Future Directions Studies need to evaluate if these results are generalizable to younger patients Consider hybrid approaches (i.e. Integra then FTSG) Clinical Relevance The findings suggest a less invasive (and presumably less costly) approach may yield better cosmetic outcomes in elderly patients with small (3x3 cm), superficial ablative wounds of the tip or alae
- Prophylactic antibiotic-loaded cement, absorbable and non-absorbable, for implant-based breast reconstruction
Authors: Nguyen A, Leach GA, Ahmed S, Clark RC, Sorice SC, Nazerali RS, Hassanein AH, Reid CM. Affiliation: University of California San Diego; Indiana University; Stanford University. Journal: Aesthetic Surgery Journal, accepted 2025 PMID: pending Key takeaways In 295 tissue expander reconstructions, infections occurred in 7 breasts (2.4%); only 1 (0.3%) occurred after 6 weeks. Infection rates were similar between PMMA plates (4.3%) and calcium sulfate (CS) beads/discs (1.5%); difference not significant. CS was associated with lower wound dehiscence (0% vs 3.2%), less mastectomy flap necrosis (4.0% vs 13.9%), and fewer returns to the OR (4.7% vs 17.7%). No postoperative oral antibiotics were given; low infection rates suggest local delivery may safely replace routine oral prophylaxis. Background Periprosthetic infection after implant-based reconstruction is common and may lead to explantation. Local antibiotic delivery (via PMMA or CS) can extend pocket antibiotic exposure beyond the early postoperative period without systemic side effects. Objective Evaluate the efficacy and safety of prophylactic antibiotic-loaded cement—non-absorbable PMMA vs absorbable CS—in reducing infections in two-stage tissue expander reconstruction. Methods Design/setting/level of evidence: Multi-institutional retrospective cohort; Level III. Time frame & surgeons: Consecutive cases November 2021–February 2025 by two surgeons at two institutions. Population: 189 patients, 295 breasts (two-stage tissue expander reconstructions). PMMA in 93 breasts (31.5%); CS in 202 (68.5%). Intervention/comparators: PMMA plates loaded with vancomycin + tobramycin (non-absorbable). CS beads/discs loaded with vancomycin + gentamicin (absorbable). Co-interventions: No postoperative oral antibiotic prophylaxis. Endpoints (90-day): Hematoma, infection (antibiotics ± operation), wound dehiscence, mastectomy flap necrosis, return to the operating room, implant loss. Statistical approach: Group comparisons and multivariable regression (odds ratios) assessing association of cement type with outcomes. Results Any infection: 7/295 breasts (2.4%); 6 within 6 weeks (2.0%), 1 after 6 weeks (0.3%); mean onset 37 ± 18 days. By cement type: PMMA 4/93 (4.3%) vs CS 3/202 (1.5%), P = 0.21. Organisms cultured: Staphylococcus aureus (including penicillin-resistant), Staphylococcus lugdunensis, and Klebsiella oxytoca. Device loss: 4 explants (1.4%): 2 necrosis, 1 hematoma, 1 infection. Comparative safety signals (CS vs PMMA): Wound dehiscence: 0.0% vs 3.2%, P = 0.03. Mastectomy flap necrosis: 4.0% vs 13.9%, P = 0.004; adjusted OR for PMMA 3.43 (P = 0.047). Return to the operating room: 4.7% vs 17.7%, P = 0.01; adjusted OR for PMMA 4.5 (P = 0.01). Hematoma and implant loss: no significant differences. Context: Pre-intervention institutional infection rates were 6.1% and 16.7%; with local antibiotics and no postoperative orals, pooled rate was 2.4%. Conclusion Local antibiotic cement (PMMA or CS) during tissue expander reconstruction produced low infection and device-loss rates without oral antibiotics; CS showed fewer wound problems and fewer returns to the operating room than PMMA, with similar infection prevention. Strengths & limitations Strengths: Multi-institutional cohort; clinically relevant endpoints; organism-level detail; regression adjusting for confounders. Limitations: No contemporaneous control without local antibiotics; potential selection and technique confounding; underpowered for small differences; later adoption of staging may bias comparisons toward CS. Critiques and questions Causation vs association: The lower necrosis and return-to-OR rates with CS may reflect learning curve or patient population rather than an intrinsic material effect. A prospective, surgeon-balanced design is needed. Antibiotic choices and kinetics: The study mixes vancomycin + tobramycin (PMMA) with vancomycin + gentamicin (CS). Differences in aminoglycoside choice, elution, and geometry could alter coverage (e.g., S. lugdunensis, gram-negatives). Pocket-specific pharmacokinetics would clarify. Generalizability & next steps: Without a no-cement control, the absolute benefit over modern pocket prep plus perioperative IV antibiotics is uncertain. A multicenter randomized trial comparing standard care vs PMMA vs CS—with standardized flap-staging, drain policy, and an infectious-disease–guided no-oral-antibiotic pathway—would be practice-changing. Safety signals to monitor: CS re sorption course and PMMA removal burden (comfort, contour) were not systematically measured; future work should include patient-reported chest wall discomfort and imaging artifacts.
- Breast Cancer Hormone Therapy Modulates Breast Implant Capsular Contracture
Chawla M, et al. Plast Reconstr Surg Glob Open , 2025. PMID: 40765683 Key takeaways Tamoxifen use at the time of implant placement was associated with lower capsular contracture odds (OR 0.40, P = 0.006). Radiation increased capsular contracture odds (OR 3.05, P = 0.002). Surgical complications (hematoma and infection) increased odds (OR 2.66, P = 0.04). Smooth implants showed lower odds than textured (OR 0.32, P < 0.001). No significant impact of subpectoral placement or use of ADM on capsular contracture formation. Background Capsular contracture affects ~8%–15% of implant-based reconstructions and often necessitates revision. Estrogen signaling has been implicated in capsule formation; with higher amounts of estrogen increasing the presence of myofibroblasts and collagen surrounding implants. Tamoxifen may have antifibrotic effects resulting in reduced rates of capsular contracture. Objective Assess whether concurrent breast cancer hormone therapy—specifically tamoxifen—modulates capsular contracture risk after implant-based reconstruction. Methods Design/setting/LOE: Single-center retrospective case–control of patients undergoing capsulectomy/capsulotomy (Feb 2013–Dec 2021). Sample: 914 charts screened; 331 met criteria; mean age at implant 47.4 years. Inclusion: Revision after two-stage implant reconstruction (tissue expander → implant). Key exclusions: non–breast cancer, tissue-expander capsulectomy, unverifiable tamoxifen schedule. Tamoxifen exposure was defined as being on active therapy at the time of implant placement. Variables: Demographics; implant plane/texture; ADM; radiation, chemotherapy, aromatase inhibitors; postoperative complications. Outcome = capsular contracture at explant (Baker 3–4 noted). Statistics: Univariate ORs (chi-square); multivariable stepwise logistic regression; ROC performance. α=0.05. Results Cohort: 331 patients; 236 no contracture (71.3%); 95 high-grade contracture (28.7%). Subpectoral 74.9%; smooth implants 55.3%. Primary findings (univariate): Tamoxifen at implantation: OR 0.40 (95% CI 0.12–0.74), P = 0.006. Smooth vs textured surface: OR 0.32 (0.18–0.59), P < 0.001. Radiation: OR 3.05 (1.54–6.02), P = 0.002. CKD: OR 10.33 (1.14–93.66), P = 0.025 Surgical complications: OR 2.66 (1.07–6.61), P = 0.04. Multivariable (final model): Lower odds with tamoxifen and smooth implants; higher with radiation and longer implant age; ROC AUC 0.7686. Conclusion Among breast cancer patients receiving implant reconstruction, concurrent tamoxifen exposure at implantation correlated with reduced capsular contracture risk; radiation, complications and CKD significantly increased risk. Strengths & limitations Multivariable modeling with discrimination assessment (AUC 0.77). Retrospective single-center design; outcome grading variability (poor interobserver reliability). Confounding by implant era/texture possible and did not account for operative techniques (antibiotic washes, placement or ADM use). Clinical relevance For implant-based reconstruction in ER+ patients, discuss potential tamoxifen-associated protection against contracture at the time of implantation and counsel on radiation-related risk; optimize techniques to minimize postoperative complications.
- 5-year clinical outcome of the ESTOIH trial comparing the short-bite versus large-bite technique for elective midline abdominal closure
Authors : Fortelny RH, Baumann P, Hofmann A, Riedl S, Kewer JL, Hoelderle J, Shamiyeh A, Klugsberger B, Maier TD, Schumacher G, Köckerling F, Wöste G, Pession U, Albertsmeier M. Affiliation : Multicenter European group, sponsored by Aesculap AG Journal : Hernia, Aug 2025 PMID : 40879826 Key takeaways Five-year incisional hernia (IH) was 9% with short-bite vs 14% with large-bite; difference not significant (OR 1.60; p=0.155). IH increased from 1→3→5 years in both groups, consistently favoring the short-bite arm. Both cohorts used a P4HB monofilament (Monomax) suture Short-stitch cohort used 2-0 P4HB Long-stitch cohort used #1 P4HB Most 5-year IHs were epigastric; ~36% (15/42) underwent repair. Background Incisional hernia is the most common long-term complication after midline laparotomy, with an estimated incidence averaging ~10–20%. Objective Compare 5-year IH after elective midline closure using standardized P4HB suture with short-bite vs large-bite techniques. Methods Design/setting/LOE: Prospective, multicenter, parallel, double-blind RCT (Germany/Austria). Level I. Enrollment/analysis: 425 randomized (2014–2019). 5-year ITT n=362 (short-bite 175; large-bite 187). PP n=216 (108/108). Eligibility (core): Adults ASA I–III; primary midline laparotomy ≥15 cm; protocol later dropped BMI ≥ 30 exclusion and allowed benign pancreatic disease. Interventions (how the stitches differed): Large-bite (“long-stitch”): ~10 mm from fascial edge and between bites; #1 P4HB looped Target 4:1 SL:WL (Stitch length to wound length ratio) Short-bite (“small-stitch”): 5–8 mm from edge, ~5 mm apart; 2-0 P4HB single stranded suture Target SL:WL ≥ 5:1 Blinding: Patients and outcome assessors blinded; surgeons not blinded. Primary endpoint: IH at 1, 3, and 5 years (exam plus ultrasound/CT/MRI; EHS criteria). Secondary endpoints: 30-day complications (prior reports); EQ-5D-5L at baseline, 30 days, 1, 3, and 5 years. Stats/power: Planned n=468 to detect 50% relative IH reduction at 1 year; recruitment stopped after 424 randomized, reducing power for long-term differences. Results Primary outcome (5 years): ITT IH 9.14% (16/175) short-bite vs 13.90% (26/187) large-bite; OR 1.60 (95% CI 0.82–3.10), p=0.155. Trajectory: Persistent separation of curves with significant cumulative increase overall from 1→3→5 years (ITT 4.83%→9.02%→16.03%). Hernia characteristics: Mostly epigastric (52%); sizes <4 cm in 48%; repairs in 15/42 (36%). Quality of life: Early advantages for short-bite (pain/self-care at 30 days–1 year; anxiety at 3 years) but no group differences at 5 years. Conclusion In primary laparotomy closures, the short-bite technique kept 5-year IH numerically lower than large-bite, but differences were not statistically significant; absolute IH remained comparatively low in both groups. Strengths & limitations Multicenter, double-blind RCT with imaging-confirmed IH and 5-year follow-up. Same suture material across arms isolates stitch geometry. Underpowered at 5 years due to early stop/attrition; technique adherence managed via SL:WL targets and training. Clinical relevance Reconstructive surgeons should understand this approach to primary laparotomy closure , but recognize that hernia repair outcome may not translate.
- Incidence, morbidity, and mortality of pulmonary complications in free flap reconstruction: limitations of predictive models
Authors: Abdul-Rahman N-H, Harris M, Bottegal M, Sridharan S, Spector M, Snyderman C. Affiliation: University of Pittsburgh School of Medicine; Department of Otolaryngology. Journal: Otolaryngology–Head and Neck Surgery, Sept. 2025. PMID: 40407209 Key takeaways Clinically significant postoperative pulmonary complications (PPCs) occurred in 27% of head and neck microvascular free flap (MVFF) patients. Independent predictors of PPCs: advanced tumor stage (OR 1.29), longer surgery duration (OR 1.08 per hour), and postoperative hematoma (OR 2.98). PPCs markedly worsened survival: HR 3.94 for mortality; 1-year survival 75.6% with PPCs vs 89.4% without . This study built and internally validated a head and neck free flap–specific risk calculator (nomogram; AUC 0.65), outperforming generic tools ARISCAT (general preop lung‑risk score): AUC 0.51 Gupta (NSQIP pneumonia/respiratory failure): AUC 0.45 Background Postoperative pulmonary complications are frequent after major oncologic head and neck surgery but definitions and prediction tools have been inconsistent for this population. Objective Quantify PPC incidence, identify risk factors and survival impact after MVFF, evaluate ARISCAT and Gupta models, and propose an MVFF-specific nomogram. Methods Design/setting: Retrospective review at a tertiary academic center. Level of evidence: III. Cohort: 638 MVFF reconstructions (August 2019–May 2024). Exclusions: Prior head and neck radiation therapy (RT) patients were excluded. Exposure variables: Pre-, intra-, and postoperative factors (e.g., tumor stage, operative time, estimated blood loss, hematoma, transfusion). Outcome: PPCs within 30 days; graded with Modified Clavien-Dindo scale (grades 2–5 = clinically significant). Grade 1 (mild): Hypoxia or atelectasis only; no treatment required. Grade 2 (moderate): Bronchospasm; pleural effusion not needing invasive intervention; or atelectasis needing intervention/with effusion or hypoxia. Grade 3 (severe): Pneumonia, lung abscess, or significant atelectasis needing invasive intervention and/or with respiratory failure or pneumonia. Grade 4 (life-threatening): ARDS, respiratory failure, or cardiopulmonary collapse. Grade 5: Death from a PPC. Statistics: Univariate and multivariable logistic regression for PPCs; survival analysis (Cox) for mortality; model performance by AUC; creation of a nomogram with Youden-index cutoff. Results Incidence: Grades 2–5 PPCs occurred in 27% of patients. Univariate signals: Longer surgery (mean 10.06 ± 2.67 h; P = .006), estimated blood loss ≥200 mL ( P = .006), stage III/IV ( P = .013), hematoma ( P < .001), postoperative transfusion ( P = .037). Multivariable predictors of grades 2–5 PPCs: Tumor stage: OR 1.29 (95% CI 1.06–1.57; P = .012) Surgery duration: OR 1.08 (95% CI 1.01–1.17; P = .031) Hematoma: OR 2.98 (95% CI 1.50–5.94; P = .002) Tumor location: No association with PPC risk on univariate testing (e.g., oral cavity vs laryngeal/hypopharyngeal; cutaneous vs aerodigestive). Resource use and adverse outcomes: ICU transfer 17.7% with PPCs vs 3.6% without ( P < .001); length of stay 12.4 days overall (range 2–87). Mortality: In-hospital 1.4% (n=9) —all with grade 5 PPCs. One-year mortality 13.48% overall; deaths at 1 year 24.1% with PPCs vs 9.6% without ( P < .001). PPC independently predicted death ( HR 3.94 , 95% CI 1.69–9.22; P = .002). Modeling: MVFF-specific model AUC 0.65 ; ARISCAT ~ 0.51 ; Gupta ~ 0.45 . Nomogram high-risk cutoff ≥27% predicted probability. Conclusion Clinically significant PPCs are common after MVFF for head and neck cancer and are strongly associated with ICU use, longer hospitalization, and higher short- and long-term mortality; general PPC prediction scores underperform, supporting a tailored, head and neck–specific risk model. Strengths and limitations Strengths Clinically meaningful PPC definition (grades 2–5) tied to treatment and outcomes. Large, contemporary MVFF cohort with linkage to ICU use, length of stay, and 1‑year mortality. Head‑and‑neck–specific risk calculator demonstrates superiority over generic tools (ARISCAT, Gupta). Predictors are actionable (tumor stage, operative duration, postoperative hematoma). Limitations Single‑center, retrospective design limits external validity. Prior head and neck RT patients were excluded, narrowing generalizability to a high‑risk population. Model performance is modest (AUC ~0.65) with likely high specificity and lower sensitivity; thresholding may miss at‑risk patients. Mixed timing of predictors: inclusion of postoperative hematoma limits preoperative triage utility. Coarse covariate granularity: airway strategy (planned tracheostomy vs early extubation), bony vs soft‑tissue reconstruction, extent of neck dissection, and ERAS compliance not fully explored. Outcome adjudication details (e.g., pneumonia criteria, inter‑rater reliability) not described in depth. Clinical relevance Make pulmonary prevention a core reconstructive objective. Standardize airway plans (planned tracheostomy vs early extubation), pulmonary hygiene, early mobilization, and incentive spirometry alongside flap checks. Shorten and stage operations thoughtfully. Use two‑team approaches, efficient sequencing, and avoid unnecessary delays to reduce operative time. Prioritize meticulous hemostasis and early detection of bleeding. Given hematoma’s association with PPCs and mortality, reinforce OR and PACU protocols for recognition and intervention. Use risk tools judiciously. The study’s nomogram can guide level of care (e.g., step‑down vs ICU) and counseling, but do not rely on ARISCAT/Gupta; combine the nomogram with clinical judgment, especially for advanced stage tumors and very long cases. Triage resources. Consider closer postoperative monitoring and dedicated respiratory therapy for patients with advanced tumor stage, prolonged operative duration, or intraoperative events.
- Clinical outcomes of oncologic hernia repair using poly-4-hydroxybutyrate (P4HB) mesh
Authors: Levy J, Wagner BD, Shammas RL, Boe LA, Ariyan CE, Brady MS, Allen RJ Jr, Matros E, Mehrara BJ, Nelson JA. Affiliation: Memorial Sloan Kettering Cancer Center Journal: Hernia, Sept. 2025 PMID: 40960565 Key takeaways In 102 oncologic patients, hernia recurrence was 8.8% (9/102) at median 26.1 months; 0/49 in clean vs 9/53 (17.0%) in contaminated wounds. Retrorectus mesh placement and bilateral external oblique release were associated with lower recurrence (HRs ≈0.05 and ≈0.16) on univariable competing-risk analysis. Surgical-site complications occurred in 24% ; most common were seroma 8.8% and superficial dehiscence 7.8% . Background Oncologic patients have elevated wound and infection risks after ventral/incisional hernia repair. P4HB, a slowly resorbable mesh, may balance strength and biocompatibility in high-risk fields. Objective Evaluate hernia recurrence and surgical-site complications after incisional hernia repair with P4HB mesh in oncologic patients and identify surgical techniques linked to improved outcomes. Methods Design/setting/LOE: Retrospective single-center cohort, 2018–2023; Level III evidence. Population: Adults with prior intra-abdominal/pelvic malignancy and incisional hernia undergoing hernia repair with P4HB mesh. N = 102 . Inclusion/exclusion: Included oncologic laparotomy history + P4HB mesh repair. Excluded synthetic/biologic mesh, primary suture, bridging, prophylactic mesh at index cancer surgery. Techniques: Mesh placed retrorectus (Rives–Stoppa), underlay, or onlay ; component separation recorded (external oblique release or transversus abdominis release). Wound classification: CDC wound classes I–IV recorded; outcomes also compared as clean (Class I) vs contaminated (Classes II–IV). Ventral Hernia Working Group (VHWG) or European Hernia Society (EHS) hernia grades were not reported . Primary endpoints: Hernia recurrence and surgical-site complications (hematoma, infection/cellulitis, superficial dehiscence, abscess). Follow-up/assessment: Median 26.1 months (IQR 15.1–40.1); recurrence assessed by CT (88%) or exam (12%); competing-risk analysis with death as competing event. Statistics: Wilcoxon, χ²/Fisher; Fine–Gray competing-risk regression (univariable only; multivariable modeling not performed due to few recurrence events ); α = 0.05. Results Cohort characteristics: Median age 63; BMI 26; ASA III 76%; 52% contaminated fields (CDC classes: I 48%, II 43%, III 8%, IV 1%); 68% retrorectus placement; 71% bilateral external oblique release ; frequent concomitant oncologic procedures. Recurrence: 8.8% overall; 0% in clean (Class I) vs 17.0% in contaminated (Classes II–IV); P = 0.003 . Complications: Any 24% ; seroma 8.8% , superficial dehiscence 7.8% , hematoma 6.9%, infection/cellulitis/abscess 6.9%; similar across wound classes. Technique associations (competing-risk models): Retrorectus vs onlay: HR 0.05 (95% CI 0.01–0.34; P = 0.010). Bilateral external oblique release: HR 0.16 (95% CI 0.04–0.65; P = 0.010). Conclusion In oncologic incisional hernia repair, P4HB mesh yielded low recurrence and acceptable complication rates; retrorectus placement and bilateral external oblique release were associated with fewer recurrences. Strengths & limitations Strengths: Focused oncologic cohort; high rate of imaging-based recurrence assessment, though timing not standardized; technique-level analysis. Limitations: Retrospective single-center design; no multivariable adjustment (few recurrence events) → risk of residual confounding (e.g., contamination, case complexity influencing technique choice). Hernia grading (VHWG/EHS), defect size/loss-of-domain, and detailed oncologic variables (prior radiation, chemotherapy timing), smoking/diabetes were not reported or adjusted. Imaging follow-up timing was not standardized. Generalizability may be limited (high-volume cancer center, average BMI 26 ). Clinical relevance P4HB is a reasonable mesh option in contaminated or high-risk settings, balancing strength with long-term resorption. Critiques and notes Selection bias/confounding by indication: Technique choice (retrorectus plane, bilateral external oblique release) likely varied by wound cleanliness and defect complexity; without multivariable adjustment, the reported associations may reflect case selection rather than true technique effect. Missing anatomic/oncologic context: Key predictors (defect size, loss of domain, prior mesh explant/infection, radiation history, VHWG/EHS grade) are not reported, limiting risk adjustment and external validity. Follow-up adequacy: Given P4HB resorption over ~12–18 months, a median 26-month follow-up is reasonable, yet late recurrences beyond 24–36 months remain plausible. Outcome scope: Important endpoints—reoperation, mesh explantation, chronic pain, and patient-reported outcomes (function/quality of life)—are missing, constraining clinical interpretation. Comparative effectiveness: The absence of a comparator cohort (permanent synthetic or biologic mesh) or propensity-matched controls limits interpretation of the 17% recurrence observed in contaminated fields.
- Suzetrigine for acute postoperative pain — FDA Approves novel non-opioid medication
Authors: Bertoch T; D’Aunno D; McCoun J; Solanki D; Taber L; Urban J; Oswald J; Swisher MW; Tian S; Miao X; Correll DJ; Negulescu P; Bozic C; Weiner SG Affiliation: Multicenter US Trial (sponsored by Vertex Pharmaceuticals) Journal: Anesthesiology, March 2025 PMID: 40117446 Key takeaways JOURNAVX (suzetrigine) was FDA approved on January 30, 2025 , with the official indication: treatment of moderate to severe acute pain in adults. First‑in‑class oral, selective NaV1.8 inhibitor ( non-opioid ) studied for moderate‑to‑severe acute pain after abdominoplasty and bunionectomy. Primary endpoint (vs placebo) was met in both trials (SPID48 superiority). SPID48 = summed pain intensity difference over 48 h : time‑weighted area under the curve of pain‑score reduction from baseline; higher values = more total relief. Overall 48‑h analgesia comparable to hydrocodone/acetaminophen (HB/APAP). Lower nausea/vomiting than HB/APAP ; adverse events mostly mild–moderate. Background Opioids remain common for moderate–severe postoperative pain despite tolerability and dependency concerns. Targeting peripheral sodium channel NaV1.8 offers analgesia without central opioid liabilities. Objective Evaluate whether suzetrigine provides superior 0–48 h pain relief (SPID48) versus placebo and compare outcomes to HB/APAP; assess onset of meaningful relief. Methods Design: Two randomized, double‑blind, placebo‑ and active‑controlled phase 3 trials (NAVIGATE‑1 bunionectomy; NAVIGATE‑2 abdominoplasty). Treatment window 48 h. Population: Adults (18–80) with moderate–severe pain (NPRS ≥4) post‑procedure. Randomization 2:2:1 to suzetrigine : HB/APAP : placebo. Intervention & comparators: • Suzetrigine: 100 mg loading, then 50 mg q12h (oral). • Active control: hydrocodone/acetaminophen 5/325 mg q6h. • Rescue: ibuprofen 400 mg q6h PRN. • Double‑dummy blinding. Endpoints: • Primary: SPID48 vs placebo. • Key secondary: SPID48 vs HB/APAP; time to ≥2‑point NPRS reduction vs placebo. • Safety and adverse events. Results Primary endpoint (SPID48): Suzetrigine was superior to placebo in both trials on the SPID48 measure (greater time‑weighted pain relief over 0–48 h). Versus HB/APAP: No superiority on SPID48; overall analgesia at 48 h was similar . Onset: Faster time to clinically meaningful pain relief vs placebo. Safety: AEs mostly mild–moderate; lower nausea/vomiting than HB/APAP . Common AEs ≥4% included nausea, constipation, headache, dizziness, hypotension, and vomiting. Serious AEs were uncommon and balanced. Mechanism of action Suzetrigine selectively inhibits NaV1.8, a voltage‑gated sodium channel expressed on peripheral sensory nociceptors. NaV1.8 drives nociceptor excitability and action‑potential firing in inflammatory tissue; selective peripheral blockade reduces pain transmission while sparing central nervous system sodium channels (e.g., NaV1.1/1.6), aiming to avoid respiratory depression, euphoria, and addiction liability associated with opioids . Unlike nonselective sodium‑channel blockers, NaV1.8 selectivity is designed to preserve motor function and minimize CNS effects. Contraindications CYP3A / grapefruit: Contraindicated with strong CYP3A inhibitors . Avoid grapefruit (CYP3A inhibition ↑ exposure). Oral contraceptives: May reduce efficacy ; use nonhormonal backup during therapy and for 28 days after . Hepatically cleared; avoid in severe hepatic impairment , reduce dose in moderate impairment Dosing Loading: 100 mg PO once (two 50‑mg tablets). Maintenance: 50 mg PO q12h for up to 48 h (3–4 maintenance doses). Typical course: 5–6 total tablets depending on whether a final 48‑h dose is given. Pricing $15.50 per 50‑mg tablet. 6‑tablet course (includes 48‑h dose): $93.00. Safety profile Common AEs: nausea, headache, dizziness, constipation, vomiting; generally mild–moderate. Serious AEs: rare and balanced across arms in trials. GI tolerability: less nausea/vomiting than HB/APAP . CNS/respiratory: No signal of opioid‑type respiratory depression in the controlled 48‑h setting. Clinical relevance Consider suzetrigine (JOURNAVX) as a nonopioid anchor in multimodal protocols in patients prone to opioid‑related nausea/constipation or opioid addiction. Use the simple 100 mg load → 50 mg q12h regimen for a 48‑h course. Current evidence addresses acute postoperative pain up to 48 h; data for chronic pain or longer courses are limited.
- Effectiveness of the lymphatic microsurgical preventive healing approach for avoiding breast cancer–related arm lymphedema
Authors : Yono S, Hannoudi A, Chamseddine H, Rama S, Bensenhaver JM, Yoho D, Tepper D, Evangelista MS, Nathanson SD, Atisha DM. Affiliation : Division of Plastic and Reconstructive Surgery, Henry Ford Health, Detroit, MI. Journal : The Breast, July 2025 PMID : 40682911 Key takeaways In 187 ALND patients (121 LyMPHA; 66 ALND-only), LyMPHA reduced BCRL risk by ~47% (HR 0.53; 95% CI 0.28–0.98; P = 0.043). Kaplan–Meier curves showed significantly lower cumulative BCRL incidence with LyMPHA (P = 0.003). Patient-reported functional impairment was lower with LyMPHA (median 4.7% vs 11.6%; P = 0.045). Drain duration was shorter with LyMPHA (median 13 vs 15 days; P = 0.042) with no increase in complications. Background Breast cancer–related lymphedema (BCRL) impairs function, increases infection risk, and burdens patients and health systems. Preventive strategies at the time of axillary lymph node dissection (ALND) are a priority. Objective Evaluate whether immediate lymphatic reconstruction using LyMPHA at the time of ALND reduces BCRL and improves patient-reported outcomes compared with ALND alone. Methods Design and setting: Single-center retrospective cohort, 2016–2022. Level of evidence: III (retrospective comparative cohort). Participants: 187 consecutive breast cancer patients undergoing ALND; 121 received LyMPHA and 66 underwent ALND only. Mean age 56.4 ± 13.6 years. Inclusion/exclusion: Patients undergoing ALND with or without LyMPHA. Control arm also included cases where LyMPHA was attempted but not feasible (no suitable lymphatic/venous targets or intraoperative instability). Intervention: LyMPHA (immediate lymphatic reconstruction) performed after ALND, anastomosing identified arm-draining lymphatics to venous outflow. Intussusception of lymphatic(s) into into a venule, typically a side branch of thoracodorsal. Technique: U-stitch to intussuscept 1–3 lymphatics into the same venule using 8-0/9-0 nylon. Patency confirmation intraoperatively with indocyanine green (ICG) or fluorescein dye transit. Comparator: ALND alone without lymphatic reconstruction. Primary endpoint: Time to development of BCRL up to 4 years. BCRL defined as symptomatic arm lymphedema (visible swelling, tightness, heaviness/fullness, pain, impaired limb function) documented at follow-up 12–48 months post-op; counted positive only if symptoms persisted ≥12 months after ALND and required complete decongestive therapy (consensus definition). Secondary endpoints: Patient-reported outcomes including functional impairment, drain duration, and postoperative complications. Statistical approach: Kaplan–Meier analysis with log-rank test; multivariable Cox proportional hazards model adjusting for age, BMI, smoking, and adjuvant therapies. Results Primary outcome (BCRL): LyMPHA associated with lower cumulative BCRL incidence over time (log-rank P = 0.003). Adjusted effect: HR 0.53 (95% CI 0.28–0.98; P = 0.043) favoring LyMPHA. Patient-reported function: Median percent functional impairment 4.7% (LyMPHA) vs 11.6% (ALND-only); P = 0.045. Perioperative course: Drain duration median 13 vs 15 days (LyMPHA vs control); P = 0.042. Safety: Overall complication rates similar between groups (details per manuscript tables); no signal of harm with LyMPHA. Conclusion Immediate lymphatic reconstruction (LyMPHA) at ALND reduces the risk of BCRL and improves patient-reported function without increasing complications. Strengths Contemporary comparative cohort focused specifically on ALND patients. Time-to-event (KM/Cox) methods quantify prevention beyond incidence. Inclusion of patient-centered outcomes (functional impairment). Limitations Retrospective, nonrandomized design introduces potential selection bias and residual confounding. Single-center experience may limit generalizability; technique and surveillance protocols vary across institutions. Definition of BCRL not based on objective measurements. Clinical relevance For patients undergoing ALND, offering immediate lymphatic reconstruction is reasonable as it may reduce rates of BRCL by as much as half and does not increase complications. Combine ILR with structured postoperative surveillance and early conservative therapy to maximize prevention. Critiques/Questions What precise diagnostic thresholds and surveillance cadence defined incident BCRL, and were evaluators blinded to ILR status? How did regional nodal irradiation (fields, dose, timing) modify BCRL risk within each arm? What proportion of ALND cases lacked suitable lymphatic or venous targets for ILR, and how were these managed? How many anastomoses were performed on average? Did the number of bypasses correlate with outcomes? What occurred if intraoperative patency could not be demonstrated after anastomosis? What was the added operative time (and resource utilization) for LyMPHA?












