Hemoptysis associated with percutaneous transthoracic needle biopsy: Development of critical events checklist and procedure outcomes.

BACKGROUND: A percutaneous transthoracic needle biopsy (PTNB) is performed to obtain tissue for a pathologic diagnosis. A PTNB is necessary prior to the initiation of many cancer treatments. There is a risk of hemoptysis, the expectoration of blood, with the possibility for adverse, life-threatening outcomes. A critical event checklist is a cognitive aid used in an emergency to ensure critical steps are followed. To date, there are no known checklists published for management of PTNB-related, life-threatening hemoptysis. The purpose of this report is to describe the development and implementation of a critical event checklist and the adoption of the checklist into hemoptysis management. METHODS: In March 2017, a process improvement team convened to evaluate the hemoptysis response using the Plan-Do-Study-Act (PDSA) methodology. The checklist was evaluated and updated through September 2019. The team educated Interventional Radiology (IR) clinicians on the new checklist and conducted simulations on its use. A retrospective chart review was performed on hemoptysis events between the ten-year period of October 1, 2008 and September 30, 2018 to evaluate the adoption of the checklist into practice. RESULTS: There were 231 hemoptysis events occurring in 229 patients (2 with repeat biopsies). Prior to implementing the protocol and checklist, there were 166 (71.9%) hemoptysis events. After implementation there were 65 (28.1%) events. The median amount of documented blood expectorated with hemoptysis was 100 mL (IQR 20.0-300.0). Twenty-six patients were admitted after PTNB for reasons related to the hemoptysis event (11.3%). During the procedure, four (1.7%) patients with hemoptysis suffered a cardiac arrest. Prior to implementation of the protocol and critical events checklist, nurses positioned patients in the lateral decubitus (LD) position in 40 out of 162 (24.7%) cases. After implementation of the critical events checklist, nurses positioned patients in the LD position 42 out of 65 cases (64.6%) (OR=5.57(95% CI 2.99-10.367), p<0.001). DISCUSSION: Interventional Radiology nurses successfully adopted the checklist into management of hemoptysis events. The reported incidence of hemoptysis suggests a need for IR teams to prepare for and simulate hemoptysis events. Future research is needed to evaluate the change in patient outcomes before and after critical events checklist implementation.

A Pilot Study of Preoperative Single-Dose Ipilimumab and/or Cryoablation in Women with Early-Stage Breast Cancer with Comprehensive Immune Profiling.

PURPOSE: To assess the safety and tolerability of preoperative cryoablation-mediated tumor antigen presentation and/or ipilimumab-mediated immune modulation in women with operable breast cancer. EXPERIMENTAL DESIGN: In this pilot study, 19 women with breast cancer for whom mastectomy was planned were treated with preoperative tumor cryoablation (n = 7), single-dose ipilimumab at 10 mg/kg (n = 6), or both (n = 6). The primary outcome for this pilot study was safety/tolerability as defined as freedom from delays in pre-planned, curative-intent mastectomy. Exploratory studies of immune activation were performed on peripheral blood and tumor. RESULTS: Preoperative cryoablation and/or ipilimumab were safe and tolerable, with no delays in pre-planned surgery. Grade III toxicity was seen in 1 of 19 (unrelated rash after ipilimumab). Combination therapy was associated with sustained peripheral elevations in: Th1-type cytokines, activated (ICOS+) and proliferating (Ki67+) CD4+ and CD8+ T cells, and posttreatment proliferative T-effector cells relative to T-regulatory cells within tumor. CONCLUSIONS: Preoperative cryoablation and single-dose ipilimumab are safe alone or in combination with no surgical delays incurred. Potentially favorable intratumoral and systemic immunologic effects were observed with the combination, suggesting the possibility for induced and synergistic antitumor immunity with this strategy. Clin Cancer Res; 22(23); 5729-37. ©2016 AACR.