Bilateral Implant-based Breast Reconstruction with Unilateral Radiotherapy: A Matched Cohort Study Comparing Nipple-sparing Mastectomy and Skin-sparing Mastectomy.

Background: Nipple-sparing mastectomy (NSM) preserves the natural nipple-areola complex and entire native breast skin, with the goal of better cosmetic outcomes in breast reconstruction. In bilateral TE/implant-based reconstruction requiring unilateral postmastectomy radiotherapy (PMRT), progressive radiation-induced fibrosis can lead to increasing nipple asymmetry with cosmetic dissatisfaction. Thus, PMRT may ultimately negate the intended positive cosmetic value of NSM compared with skin-sparing mastectomy (SSM). This study compares (1) surgical complications, (2) patient satisfaction, and (3) aesthetic outcomes between NSM versus SSM in bilateral implant-based reconstruction with unilateral PMRT. Methods: This retrospective matched cohort study included consecutive NSM patients with bilateral TE/implant breast reconstruction + unilateral PMRT matched 1:2 to SSM group. Patients completed PMRT and TE exchange to implants. Demographics, oncologic stage, comorbidities, and complications were collected. Patient satisfaction was evaluated by BREAST-Q. Aesthetic outcomes were assessed by blinded reviewers with a five-point Likert scale. Results: Among 58 patients who underwent bilateral TE/implant reconstruction with unilateral PMRT, 17 NSM patients were matched to 41 SSM patients by age, body mass index, and comorbidities. No significant differences existed in overall surgical complications and individual BREAST-Q questionnaire scores between cohorts. However, aesthetic outcomes scores were higher in SSM compared with NSM. Conclusions: Although NSM is generally associated with superior cosmetic outcomes compared with SSM, it has far less impact in bilateral implant-based breast reconstruction with unilateral PMRT due to the negative postradiotherapy effect on nipple symmetry.

Validation of the ACC Expert Consensus Decision Pathway for Patients With Chest Pain.

BACKGROUND: The American College of Cardiology (ACC) recently published an Expert Consensus Decision Pathway for chest pain. OBJECTIVES: The purpose of this study was to validate the ACC Pathway in a multisite U.S. METHODS: An observational cohort study of adults with possible acute coronary syndrome was conducted. Patients were accrued from 5 U.S. Emergency Departments (November 1, 2020, to July 31, 2022). ECGs and 0- and 2-hour high-sensitivity troponin (Beckman Coulter) measures were used to stratify patients according to the ACC Pathway. The primary safety outcome was 30-day all-cause death or myocardial infarction (MI). Efficacy was defined as the proportion stratified to the rule-out zone. Negative predictive value for 30-day death or MI was assessed among the whole cohort and in a subgroup of patients with coronary artery disease (CAD) (prior MI, revascularization, or ≥70% coronary stenosis). RESULTS: ACC Pathway assessments were complete in 14,395 patients, of whom 51.7% (7,437 of 14,395) were women with a median age of 56 years (Q1-Q3: 44-68 years). Known CAD was present in 23.5% (3,386 of 14,395) and 30-day death or MI occurred in 8.1% (1,168 of 14,395). The ACC Pathway had an efficacy of 48.1% (95% CI: 47.3%-49.0%). Among patients in the rule-out zone, 0.3% (22 of 6,930) had death or MI at 30 days, yielding a negative predictive value of 99.7% (95% CI: 99.5%-99.8%). In patients with known CAD, 20.0% (676 of 3,386) were classified to the rule-out zone, of whom 1.5% (10 of 676) had death or MI. CONCLUSIONS: The ACC expert consensus decision pathway was safe and efficacious. However, it may not be safe for use among patients with known CAD.

European Society of Cardiology 0/1-hour algorithm (high-sensitivity cardiac troponin T) performance across distinct age groups.

BACKGROUND: To determine if the European Society of Cardiology 0/1-hour (ESC 0/1-h) algorithm with high-sensitivity cardiac troponin T (hs-cTnT) meets the ≥99% negative predictive value (NPV) safety threshold for 30-day cardiac death or myocardial infarction (MI) in older, middle-aged and young subgroups. METHODS: We conducted a subgroup analysis of adult emergency department patients with chest pain prospectively enrolled from eight US sites (January 2017 to September 2018). Patients were stratified into rule-out, observation and rule-in zones using the hs-cTnT ESC 0/1-h algorithm and classified as older (≥65 years), middle aged (46-64 years) or young (21-45 years). Patients had 0-hour and 1-hour hs-cTnT measures (Roche Diagnostics) and a History, ECG, Age, Risk factor and Troponin (HEART) score. Fisher's exact tests compared rule-out and 30-day cardiac death or MI rates between ages. NPVs with 95% CIs were calculated for the ESC 0/1-h algorithm with and without the HEART score. RESULTS: Of 1430 participants, 26.9% (385/1430) were older, 57.4% (821/1430) middle aged and 15.7% (224/1430) young. Cardiac death or MI at 30 days occurred in 12.8% (183/1430). ESC 0/1-h algorithm ruled out 35.6% (137/385) of older, 62.1% (510/821) of middle-aged and 79.9% of (179/224) young patients (p<0.001). NPV for 30-day cardiac death or MI was 97.1% (95% CI 92.7% to 99.2%) among older patients, 98.4% (95% CI 96.9% to 99.3%) in middle-aged patients and 99.4% (95% CI 96.9% to 100%) among young patients. Adding a HEART score increased NPV to 100% (95% CI 87.7% to 100%) for older, 99.2% (95% CI 97.2% to 99.9%) for middle-aged and 99.4% (95% CI 96.6% to 100%) for young patients. CONCLUSIONS: In older and middle-aged adults, the hs-cTnT ESC 0/1-h algorithm was unable to reach a 99% NPV for 30-day cardiac death or MI unless combined with a HEART score. TRIAL REGISTRATION NUMBER: NCT02984436.

Performance of the European Society of Cardiology 0/1-hour algorithm with high-sensitivity cardiac troponin T at 90 days among patients with known coronary artery disease.

BACKGROUND: The European Society of Cardiology (ESC) 0/1-h high sensitivity troponin T (hs-cTnT) algorithm does not differentiate risk based on known coronary artery disease (CAD: prior myocardial infarction [MI], coronary revascularization, or ≥ 70% coronary stenosis). We recently evaluated its performance among patients with known CAD at 30-days, but little is known about its longer-term risk prediction. The objective of this study is to determine and compare the performance of the algorithm at 90-days among patients with and without known CAD. METHODS: We performed a pre-planned subgroup analysis of the STOP-CP cohort, which prospectively enrolled ED patients ≥21 years old with symptoms suggestive of ACS without ST-elevation on initial ECG across 8 US sites (1/25/2017-9/6/2018). Participants with 0- and 1-h hs-cTnT measures (Roche, Basel, Switzerland) were stratified into rule-out, observe, and rule-in groups using the ESC 0/1-h algorithm. Algorithm performance was tested among patients with or without known CAD, as determined by the treating provider. The primary outcome was cardiac death or MI at 90-days. Fisher's exact tests were used to compare 90-day event and rule-out rates between patients with and without known CAD. Negative predictive values (NPVs) for 90-day cardiac death or MI with exact 95% confidence intervals were calculated and compared using Fisher's exact test. RESULTS: The STOP-CP study accrued 1430 patients, of which 31.4% (449/1430) had known CAD. Cardiac death or MI at 90 days was more common in patients with known CAD than in those without [21.2% (95/449) vs. 10.0% (98/981); p < 0.001]. Using the ESC 0/1-h algorithm, 39.6% (178/449) of patients with known CAD and 66.1% (648/981) of patients without known CAD were ruled-out (p < 0.001). Among rule-out patients, 90-day cardiac death or MI occurred in 3.4% (6/178) of patients with known CAD and 1.2% (8/648) without known CAD (p = 0.09). NPV for 90-day cardiac death or MI was 96.6% (95%CI 92.8-98.8) among patients with known CAD and 98.8% (95%CI 97.6-99.5) in patients without known CAD (p = 0.09). CONCLUSION: Patients with known CAD who were ruled-out using the ESC 0/1-h hs-cTnT algorithm had a high rate of missed 90-day cardiac events, suggesting that the ESC 0/1-h hs-cTnT algorithm may not be safe for use among patients with known CAD. TRIAL REGISTRATION: High-Sensitivity Cardiac Troponin T to Optimize Chest Pain Risk Stratification (STOP-CP; ClinicalTrials.gov: NCT02984436; https://clinicaltrials.gov/ct2/show/NCT02984436).