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BACKGROUND: To compare clinical and economic outcomes after sternotomy for cardiac surgery with skin closure through 2-octyl cyanoacrylate plus polymer mesh tape (2OPMT) versus conventional absorbable sutures plus waterproof wound dressings (CSWWD). METHODS: Retrospective study using the Premier Healthcare Database. Patients undergoing a cardiac surgery requiring sternotomy with 2OPMT or CSWWD were included. Primary outcome was 60-day cumulative incidence of diagnosis for wound complications (infection, dehiscence). Secondary outcomes were index admission hospital length of stay (LOS), total hospital-borne costs, discharge status, and 60-day cumulative incidences of inpatient readmission and reoperation. After propensity score matching, outcomes were compared between the 2OPMT and CSWWD groups using bivariate multilevel mixed-effects generalized linear models. RESULTS: Overall, 7,901 2OPMT patients and 10,775 CSWWD patients were eligible for study. After propensity score matching on 68 variables, each group comprised 5,338 patients (total study N = 10,676). The 2OPMT and CSWWD groups did not differ significantly in terms of the 60-day cumulative incidences of wound complication (3.47% vs 3.47%, p = 0.996), inpatient readmission (12.6% vs. 13.6%, p = 0.354), and reoperation (10.3% vs 10.1%, p = 0.808), as well as discharge to home versus non-home setting (77.2% vs. 75.1%), p = 0.254. However, the 2OPMT group had significantly lower LOS (9.2 days vs 10.6 days, p < 0.001) and total hospital-borne costs ($50,174 vs $60,526, p < 0.001). CONCLUSIONS: This large observational study provides evidence that sternotomy skin closure with 2OPMT is associated with nearly identical 60-day cumulative incidence of wound complication as compared with CSWWD, while exhibiting a significant association with lower LOS and total hospital-borne costs. Trial registration Not applicable.
Assuntos
Procedimentos Cirúrgicos Cardíacos , Esternotomia , Bandagens , Cianoacrilatos , Humanos , Polímeros , Estudos Retrospectivos , Telas Cirúrgicas , Infecção da Ferida Cirúrgica , SuturasRESUMO
Importance: Immune checkpoint inhibitors (ICIs) have revolutionized melanoma treatment and are now standard of care. Although sex is associated with immune function and immune-related diseases, the interaction between sex and ICIs is understudied. Objective: To examine whether cancer immunotherapy effectiveness varies between female and male patients with advanced melanoma treated with either nivolumab plus ipilimumab combination therapy or anti-programmed cell death protein 1 (PD-1) therapy (namely, pembrolizumab or nivolumab). Design, Setting, and Participants: The study population consisted of 1369 older adults (aged ≥65 years) with a record of melanoma diagnosis from January 1, 1991, to December 31, 2015, in the Surveillance, Epidemiology, and End Results-Medicare linked database. Patients with a diagnosis of stage III or stage IV melanoma and a claims record showing nivolumab plus ipilimumab combination therapy or anti-PD-1 therapy (ie, pembrolizumab or nivolumab) as their last type of ICI prescribed were included in the analyses. Patients were followed up through December 31, 2017, for the overall survival analysis. Statistical analysis was performed from September 19, 2019, to February 20, 2021. Exposures: Sex, last prescribed ICI, and prior use of ipilimumab. Main Outcomes and Measures: The primary outcome was overall survival, defined as time from the index date until death from any cause, with patients censored at the end of the study (December 31, 2017). Cox proportional hazards regression modeling was used to examine the association of sex with ICI outcomes while adjusting for prior use of ipilimumab, age at ICI initiation, Charlson Comorbidity Index, cancer stage at the time of diagnosis, and autoimmune disease diagnosis. Results: Among the 1369 patients in the study (982 men [71.7%]; median age, 75 years [IQR, 69-82 years]), the outcome of nivolumab plus ipilimumab combination therapy depended on sex (Wald χ2 = 9.48; P = .009 for interaction). The mortality hazard ratio (HR) for women with prior ipilimumab use receiving combination therapy was 2.06 times (95% CI, 1.28-3.32; P = .003) higher than their male counterparts. No significant difference was observed between women and men receiving anti-PD-1 therapy with (HR, 0.97 [95% CI, 0.68-1.38]; P = .85) or without prior ipilimumab use (HR, 0.85 [95% CI, 0.67-1.07]; P = .16). For women with prior ipilimumab use, combination therapy was associated with 2.82 times higher mortality hazards than anti-PD-1 therapy (95% CI, 1.73-4.60). No statistically significant difference was seen in mortality risk between anti-PD-1 therapy and combination therapy for men. Conclusions and Relevance: This cohort study suggests that female patients with advanced melanoma may not benefit as much from combination ICIs as male patients would. Tumor mutation burden or estrogen level may serve as an important biomarker associated with ICI response in metastatic melanoma.
Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Inibidores de Checkpoint Imunológico/uso terapêutico , Ipilimumab/uso terapêutico , Melanoma/tratamento farmacológico , Nivolumabe/uso terapêutico , Neoplasias Cutâneas/tratamento farmacológico , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Feminino , Humanos , Masculino , Melanoma/patologia , Fatores Sexuais , Neoplasias Cutâneas/patologia , Análise de Sobrevida , Estados UnidosRESUMO
PURPOSE: Open colorectal surgery is associated with a high rate of postoperative wound complications. This is a single-arm study of real-world outcomes of triclosan-coated barbed suture (Ethicon's STRATAFIXTM Symmetric PDSTM Plus Knotless Tissue Control Device [SSPP]) used in open colorectal surgery. METHODS: Retrospective cohort study using the Premier Healthcare Database. The study included patients who underwent an inpatient open colorectal surgery with wound closure using SSPP (size 0 or 1 to increase the likelihood the suture was used in fascia) between October 2015-September 2019 (N=593). Wound complications, hospital length of stay, total hospital costs (2019 US$), and all-cause readmissions post-discharge were measured. Post-hoc multivariable analyses compared wound complications between non-elective admissions and elective. RESULTS: The overall incidence of wound complications within 30-days post-procedure was 7.1%, with the majority of those being surgical site infections (SSI) (6.0%). Mean operation time was 190 (standard deviation [SD]=64.4) mins, postoperative length of stay was 8.1 (SD=11.9) days, 30-day readmission rate was 11.8%, and total hospital costs were $31,693 (SD=$40,076). As compared with published literature on the rate of SSI in colorectal surgery, the 30-day rate of SSI in the present study (6.0%) fell within the range of 5.4% to 18.2% for open colorectal surgery and from 4.3% to 21.5% for combined open and minimally invasive procedures. Multivariable-adjusted incidence proportions of wound complications were slightly lower for non-elective admissions and did not differ significantly from those of elective admissions. CONCLUSION: The rate of wound complications observed in the present study falls within the range of rates previously reported in the literature, suggesting a safe and effective role for SSPP in open colorectal surgery. In post hoc analyses, the adjusted rate of wound complications was similar between non-elective and elective admissions. Head-to-head studies are required to determine comparative advantages or disadvantages for SSPP versus other sutures.
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Importance: Colorectal cancer (CRC) is the second leading cause of cancer-related mortality in the United States. The prognosis for patients with CRC varies widely, but new prognostic biomarkers provide the opportunity to implement a more individualized approach to treatment selection. Objective: To assess the cost-effectiveness of 3 therapeutic strategies, namely, endoscopic therapy (ET), laparoscopic colectomy (LC), and open colectomy (OC), for patients with T1 CRC with biomarker profiles that prognosticate varying levels of tumor progression in the US payer perspective. Design, Setting, and Participants: In this economic evaluation study, a Markov model was developed for the cost-effectiveness analysis. Risks of all-cause mortality and recurrent cancer after ET, LC, or OC were estimated with a 35-year time horizon. Quality of life was based on EuroQoL 5 Dimensions scores reported in the published literature. Hospital and treatment costs reflected Medicare reimbursement rates. Deterministic and probabilistic sensitivity analyses were performed. Data from patients with T1 CRC and 6 biomarker profiles that included adenomatous polyposis coli (APC), TP53 and/or KRAS, or BRAFV600E were used as inputs for the model. Data analyses were conducted from February 27, 2019, to May 13, 2019. Exposures: Endoscopic therapy, LC, and OC. Main Outcomes and Measures: The primary outcomes were unadjusted life-years, quality-adjusted life-years (QALYs), and the incremental cost-effectiveness ratio (ICER) between competing treatment strategies. Results: Endoscopic therapy had the highest QALYs and the lowest cost and was the dominant treatment strategy for T1 CRC with the following biomarker profiles: BRAFV600E, APC(1)/KRAS/TP53, APC(2) or APC(2)/KRAS or APC(2)/TP53, or APC(1) or APC(1)/KRAS or APC(1)/TP53. The QALYs gained ranged from 16.97 to 17.22, with costs between $68â¯902.75 and $77â¯784.53 in these subgroups. For the 2 more aggressive biomarker profiles with worse prognoses (APC(2)/KRAS/TP53 and APCwt [wild type]), LC was the most effective strategy (with 16.45 and 16.61 QALYs gained, respectively) but was not cost-effective. Laparoscopic colectomy cost $65â¯234.87 for APC(2)/KRAS/TP53 and $71â¯250.56 for APCwt, resulting in ICERs of $113â¯290 per QALY and $178â¯765 per QALY, respectively. Conclusions and Relevance: This modeling analysis found that ET was the most effective strategy for patients with T1 CRC with less aggressive biomarker profiles. For patients with more aggressive profiles, LC was more effective but was costly, rendering ET the cost-effective option. This study highlights the potential utility of prognostic biomarkers in T1 CRC treatment selection.