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

Abstract

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.

Background

It is estimated that 1,762,450 individuals of all ages were diagnosed with cancer in 2019 in the United States (Siegel et al., 2019). Of those, 228,150 have a lung or thoracic cancer (Siegel et al., 2019). Percutaneous transthoracic needle biopsy (PTNB) is a standard procedure used to diagnose suspicious lung lesions. A PTNB provides tissue needed for a pathologic diagnosis prior to the initiation of cancer treatment. Biopsy specimens can also identify molecular markers utilized in targeted therapies, either as part of established clinical treatment regimens or for novel cancer therapies under investigation (Olson et al., 2011).

Risks of PTNB include pneumothorax, bleeding, and infection. Pneumothorax is the most common complication occurring in approximately 11–32% of patients who have lung biopsies and effectively managed by well-established clinical protocols (Anzidei et al., 2015; Benamore et al., 2006; Covey et al., 2004; Heerink et al., 2017; Maybody et al., 2019). Bleeding following PTNB presents as hemoptysis, the expectoration of blood that has originated from either the lungs or the bronchial tubes, or as development of a hemothorax (Bidwell & Pachner, 2005).

The incidence of significant bleeding following PTNB is 0%−1.6%,(Atwell et al., 2010; Atwell et al., 2015; Chi et al., 2017; Choi et al., 2012; Hwang et al., 2018; Kim et al., 2018; Potretzke et al., 2016; Song et al., 2013; Yeow et al., 2004) with a death rate of 0.01–0.08% (Atwell et al., 2010; Atwell et al., 2015; Tomiyama et al., 2006). If the volume of hemoptysis is self-limiting, the clinical sequela is most often inconsequential. However, life-threatening hemoptysis can result in death if clinical rescue efforts fail to stabilize the patient (Atwell et al., 2010; Robson et al., 2021). Effective interventions to improve patient outcomes after a PTNB related pneumothorax have been well described in the literature. However, there are few interventions related to the management of hemoptysis in the Interventional Radiology setting (Davidson & Shojaee, 2020; Kathuria et al., 2020; Larici et al., 2014).

In December 2016, a process improvement team at a National Cancer Institute (NCI) designated cancer center in a major metropolitan area convened to develop a critical event checklist for hemoptysis using the Plan-Do-Study-Act (PDSA) methodology (Taylor et al., 2014). The critical checklist is implemented when the volume of blood impacts a patient’s hemodynamic stability, particularly the oxygen saturation. After implementation of the checklist, the team conducted a retrospective chart review of PTNB-associated hemoptysis events to describe incidence, patient characteristics, and adoption of the critical events checklist. The purpose of this report was to describe the hemoptysis events, the implementation of a critical events checklist, and the adoption of this practice change.

Methods

PTNB procedures

PTNBs were performed in Interventional Radiology using image guidance. The interventional radiologist scheduled the procedure with computed tomography (CT), CT-fluoroscopy, or fluoroscopic guidance based on lesion characteristics. Biopsy procedures were performed with nurse administered moderate sedation, monitored anesthesia care, or general anesthesia based on the patient’s clinical history. PTNB procedures were performed in the morning to allow for at least two hours of post-biopsy observation for complications. Nurses or Certified Registered Nurse Anesthetists monitored patients’ vital signs, pulse oximetry and end-tidal carbon dioxide every five minutes during the procedure. After the procedure, a baseline anterior chest-x-ray was obtained to evaluate for a post-procedure pneumothorax. The x-ray was repeated at least one additional time at two hours after PTNB completion. If a significant pneumothorax was present and/or the patient was symptomatic, a chest tube was placed. Otherwise, additional x-rays were ordered to monitor the pneumothorax until stable (no longer enlarging). If the patient did not have a pneumothorax or if the patient had a stable pneumothorax, the patient was discharged the same day.

Development of Critical Events Hemoptysis Checklist

The process improvement team consisted of members of the Departments of Nursing, Anesthesiology, and Radiology. The PDSA methodology consists of four phases: (1) plan for the change, (2) implement a test of the change, (3) evaluate the outcomes of the testing phase, and (4) modify the plan based on evaluation.(Institute for Healthcare Improvement, 2020) The first step (Plan phase) consisted of a literature review to determine clinical interventions for hemoptysis-associated with improved outcomes (Bidwell & Pachner, 2005; Corey & Hla, 1987; Ittrich et al., 2017; Knott-Craig et al., 1993; Rali et al., 2016). The checklist was then circulated among clinical members for feedback and revision prior to implementation in March 2017. The team educated the staff on the initial checklist focusing on the most important immediate intervention of placing the patient in the lateral decubitus (LD) position with the affected (biopsied) side down (Do phase) (Choi et al., 2012; Digumarthy et al., 2016). The purpose of this positioning is to prevent blood from moving into the airways and unaffected lung (Radchenko et al., 2017). Although all patients with hemoptysis do not require LD positioning, it is an important step when the volume of blood impacts patients ability to ventilate. This position is maintained until cessation of bleeding is confirmed. The anesthesia team members also developed a list of critical intubation equipment necessary in a response. A hemoptysis kit was created to ensure that the responding anesthesiologist had the appropriate intubation equipment. Clinical leaders deployed hemoptysis kits to the procedural areas. After implementation, subsequent hemoptysis events were evaluated (Study phase). Initially, there appeared to be an improvement in outcomes including a decrease in length of stay following life-threatening hemoptysis events (internal quality metrics). It was at this time that a formal IRB-approved retrospective chart review of hemoptysis events was planned.

In August 2018, a severe hemoptysis event occurred. In review of the event, the process improvement team noted a need to take further steps to minimize the time from event identification to expert intervention. To facilitate this change, the team was expanded to include representatives from the Rapid Response Team, Thoracic Surgery, and Interventional Pulmonology (Act phase). The team implemented a process to immediately notify a thoracic surgeon and/or an interventional pulmonologist allowing for timely therapeutic bronchoscopy to treat bleeding through the secured airway. The Rapid Response Team authorized the creation of a specific hemoptysis paging group to allow for immediate response of a multidisciplinary team (Table 1, Paging Group). To ensure availability of bronchoscopy, Radiology administration secured a dedicated therapeutic bronchoscope and cart for supplies (Table 2, List of Supplies). Additionally, the clinical nurse specialist on the team educated the interventional radiology nurses in bronchoscope set-up for thoracic surgeon or interventional pulmonologist use. Since that time, the team has modified the critical event checklist over 10 times as resources have been allocated to improve the response. The most recent update was in September 2019. To further enhance learning, the team developed a successful multidisciplinary hemoptysis simulation program to practice hemoptysis events and critical checklist use in these low frequency events. The current checklist is presented in Figure 1.

Table 1.

Rapid Response Hemoptysis Paging team

The interventional radiologist signals for an “RRT IR Hemoptysis” page to be sent to the following first responders:

• Rapid response team

• Anesthesiology emergency coverage

• Interventional Pulmonology fellow and attendings (all)

• Thoracic surgery on-call physician assistant (to identify an available thoracic surgeon)

Table 2.

Hemoptysis cart supply list, listed by drawer

Drawer	Item	Drawer	Item
Bronchoscopy		Endotracheal tubes
	Fiber optic bronchoscope swivel adapter		Endotracheal tube. 8.0
	Normal saline, 500 mL bottle		Endotracheal tube. 8.5
	Olympus pigtail adapter		Endotracheal tube. 9
	Olympus single use biopsy valve X 2	Suction tubing and cleaning
	Olympus suction valve		Suction tubing
	K dissectors (“Peanuts”)		Suction canister
	Silicone spray. Ruscbit®		Biohazard labels
	Slip tip syringes. 10 mL		Enzymatic detergent solution
	Allegiance specimen container	Catheters
Airway/suction			Endobronchial tube kit. 37E
	Suction catheter with straight connector		Fogarty catheter with balloon, 5F
	Yankauer		Endobronchial tube kit. 35F
	Hemostat		Endobronchial blocker set (9 F/78 cm)
Clinical supplies		Side box
	Gauze, unsterile 4X4 gauze		Endotracheal tube uniblocker. 9.0 ID
	Luer lock syringe. 10 mL		Fogarty catheter with balloon. 14 F × 80 cm
	Aline kit

Figure 1. Hemoptysis Checklist.

Use of the hemoptysis checklist resulted in adoption of recommended practice.

Positioning patient in the lateral decubitus position is a feasible intervention.

The findings suggest benefit in preparing for and simulating hemoptysis events.

Retrospective Chart Review

The methodology for the IRB-approved (MSK 18–503) retrospective chart review is described elsewhere (Robson et al., 2021). That study summarized the incidence and severity of hemoptysis events, as well as correlations of demographic, patient, and procedure related characteristics with severe events (Robson et al., 2021). The sample included hemoptysis events following PTNB during the ten-year period between October 1, 2008 and September 30, 2018. The reported incidence of hemoptysis was 231 events in 229 patients out of 14,655 PTNB performed during the ten-year period (Robson et al., 2021). Briefly, the sample included 139 (60.7%) individuals with a smoking history, 35 (15.3%) with chronic obstructive pulmonary disease, and 162 (70.7%) with a solid tumor malignancy (Robson et al., 2021). Eighty-one (35.4%) individuals used acetylsalicylic acid (ASA) prior to the biopsy. Of those with information available, 52 (69.3%) held ASA at least 5 days, 10 (13.3%) held ASA 2–4 days, and 13 (17.3%) held the ASA one day or less. (Robson et al., 2021). Fifty (21.8%) of individuals used a non-ASA antithrombotic prior to the PTNB, with 47 (95.9%) participants holding the medication per published guidelines (Davidson et al., 2019; Robson et al., 2021).

This manuscript is a report of the secondary analysis of that sample for the purpose of describing the hemoptysis events in detail and the adoption of the critical events checklist as a standard practice during hemoptysis events.

Analysis

Summaries of the characteristics of the hemoptysis procedures and outcomes were generated using frequency distributions and median/interquartile ranges (IQR). Rates of proper LD positioning were compared pre- and post-checklist using the likelihood Chi-Square statistic. An odds ratio with the corresponding 95% confidence interval was generated to inform the amount of change in rates. A type I error rate of .05 (P < . 05) was used for statistical significance.

Results

A total of 231 hemoptysis events occurred in 229 people (2 with repeat biopsies). Descriptive summaries of those events are presented in Table 3. Blood loss was reported in 42 cases (18%) when it was considered clinically significant. The median amount of blood expectorated was 100 mL (IQR 20.0–300.0). A rapid response team was called in 24 events (10.4%) and anesthesia providers performed endotracheal intubations on 13 patients (5.6%). During the procedure, 4 (1.7%) patients suffered a cardiac arrest, two were successfully resuscitated. A total of 37 (16.0%) patients were admitted to the hospital, 26 of those (11.3%) were admitted for reasons related to the hemoptysis event. For those admitted, the median length of stay was 1 day (IQR 1–4).

Table 3.

Procedure and patient outcome factors

Moderate Sedation Medications	N	All Median (IQR)
Fentanyl dose for procedure (mcg)	207	100 (75–125)
Midazolam dose for procedure (mg)	217	2.0 (2.0–3.0)
		N (%)
Loss of pulse intraprocedure	231	4 (1.7%)
Evidence patient was placed in lateral decubitus position after hemoptysis started	227	82 (36.1%)
Disposition	231
Discharged same day		182 (78.8%)
Returned to inpatient unit		9 (3.9%)
Admitted		37 (16.0%)
Died day of procedure		3 (1.3%)
Stated reason for admission	37
Monitoring after hemoptysis		16 (43.2%)
Critical condition after cardiac arrest		2 (5.4%)
Critical condition after no cardiac arrest		3 (8.1%)
Respiratory distress		3 (8.1%)
Pneumothorax and hemoptysis		2 (5.4%)
Pneumothorax		8 (21.6%)
Hemothorax		1 (2.7%)
Monitoring after lung biopsy (high risk, no care partner)		1 (2.7%)
Other clinical reason, unrelated to biopsy		1 (2.7%)
		Median (IQR)
Recorded blood loss (mL)*	41	100 (20–300)
Length of stay related to hemoptysis (days)	27	1 (1–4)
		N (%)
Patient death related to procedure	231	4 (1.7%)
Rapid response team called	231	24 (10.4%)
Endotracheal tube placed for hemoptysis	231	13 (5.6%)

^*Reported blood loss was only reported when it was considered clinically significant.

Prior to the implementation of the critical events checklist, nurses positioned 40 of the 162 (24.7%) patients who experienced hemoptysis in the LD position. After implementation of the critical events checklist, that rate of proper patient positioning improved to 64.6% (absolute improvement of 39.9% likelihood ratio x²_(df=1)=5.57. 95% CI = 2.9 – 10.4, p < .001).

Discussion

This study is the first to examine implementation of a critical event checklist for hemoptysis events following PTNB in Interventional Radiology. No known studies have evaluated checklist compliance through a retrospective chart review evaluating documentation of key nursing interventions. Results demonstrate integration of the critical events checklist into practice with an increased number of patients being placed in the LD position following implementation.

This study found that nurses were statistically significantly more likely to position the patient in the LD position after checklist implementation than before implementation. The high rate of compliance with the hemoptysis checklist is likely a product of clinician motivation to optimize outcomes when faced with a potentially life-threatening event. Multiple methodologies have been employed to evaluate the effectiveness of checklists with most evaluations conducted in the simulation environment (Bajaj et al., 2016; Branzetti et al., 2017; De Bie et al., 2017; Geis et al., 2018; Lautz et al., 2018; Musits et al., 2019). One study evaluated checklist use in real-time and found increased adherence to critical steps (Zaidi et al., 2020). In the simulation environment, participants are observed for compliance with critical steps with and without checklist use. Study groups who were provided with a checklist to guide clinical actions most often perform specified essential steps at a higher rate than those without the checklists (Branzetti et al., 2017; De Bie et al., 2017; Lautz et al., 2018; Musits et al., 2019). The value of checklists in improving outcomes cannot be assumed since some authors have reported no difference in outcomes with checklist use (Janz et al., 2018; Menegueti et al., 2019).

There are several identified limitations to this study. The efficacy of this hemoptysis checklist on improving patient outcomes cannot be evaluated due to the most recent revision to the checklist occurring less than one year ago. At that time a dedicated hemoptysis RRT paging group was created and both Thoracic Surgery and Interventional Pulmonology were immediately involved in life-threatening events. Another limitation is that this is a retrospective chart review with the possibility of missing, inaccurate, or incomplete data, evidenced by the fact that earlier cases lacked standard documentation templates. Multiple reviews of the dataset were undertaken to mitigate this threat. There is a historical threat to internal validity since the practice of performing PTNB and the hemoptysis protocol have evolved over time. Finally, it is possible that the differences in LD positioning could be attributed to the fact that fewer patients required LD positioning prior to checklist implementation or LD positioning was performed and not documented.

There are two identified areas for future research. The first is to evaluate the change in patient outcomes before and after critical events checklist implementation. The second is better understand the adherence recommended checklist practices and sustainability of checklist use in practice.

Conclusion

Hemoptysis following PTNB is a complication that is most often self-limiting. However, the potential for hemoptysis to result in significant morbidity and mortality exists. Interventional Radiology patients stand to benefit from preparation for this emergency through timely response and improved outcomes. The adoption of the key intervention of positioning the patient into the LD position demonstrates promise for the acceptability of incorporating the checklist into practice. Additional research is needed to better understand the causes of hemoptysis and the impact of clinical interventions on patient outcomes.