The Impact of Ineffective Esophageal Motility on Patients Undergoing Magnetic Sphincter Augmentation.

OBJECTIVE: To evaluate and characterize outcomes of MSA in patients with IEM. SUMMARY BACKGROUND DATA: MSA improves patients with gastroesophageal reflux and normal motility. However, many patients have IEM, which could impact the outcomes of MSA and discourage use. METHODS: An international, multi-institutional case control study of IEM patients undergoing MSA matched to normal patients was performed. Primary outcomes were new onset dysphagia and need for postoperative interventions. RESULTS: A total of 105 IEM patients underwent MSA with matching controls. At 1 year after MSA: GERD-Health Related Quality of Life was similar; DeMeester scores in IEM patients improved to 15.7 and 8.5 in controls ( P = 0.021); and normalization of the DeMeester score for IEM = 61.7% and controls = 73.1% ( P = 0.079).In IEM patients, 10/12 (83%) with preop dysphagia had resolution; 11/66 (17%) had new onset dysphagia and 55/66 (83%) never had dysphagia. Comparatively, in non-IEM patients, 22/24 (92%) had dysphagia resolve; 2/24 (8%) had persistent dysphagia; 7/69 (10%) had new onset dysphagia, and 62/69 (90%) never had dysphagia.Overall, 19 (18%) IEM patients were dilated after MSA, whereas 12 (11%) non-IEM patients underwent dilation ( P = 0.151). Nine (9%) patients in both groups had their device explanted. CONCLUSIONS: Patients with IEM undergoing MSA demonstrate improved quality of life and reduction in acid exposure. Key differences in IEM patients include lower rates of objective GERD resolution, lower resolution of existing dysphagia, higher rates of new onset dysphagia and need for dilation. GERD patients with IEM should be counselled about these possibilities.

Utilization of palliative care resource remains low, consuming potentially avoidable hospital admissions in stage IV non-small cell lung cancer: a community-based retrospective review.

PURPOSE: Early referral of patients with stage IV non-small cell lung cancer (NSCLC) to outpatient palliative care has been shown to increase survival and reduce unnecessary healthcare resource utilization. We aimed to determine outpatient palliative care referral rate and subsequent resource utilization in patients with stage IV NSCLC in a multistate, community-based hospital network and identify rates and reasons for admissions within a local healthcare system of Washington State. METHODS: A retrospective chart review of a multistate hospital network and a local healthcare system. Patients were identified using ICD billing codes. In the multistate network, 2844 patients diagnosed with stage IV NSCLC between January 1, 2013, and March 1, 2018, were reviewed. In the state healthcare system, 283 patients between August 2014 and June 2017 were reviewed. RESULTS: Referral for outpatient palliative care was low: 8% (217/2844) in the multistate network and 11% (32/283) in the local healthcare system. Early outpatient palliative care (6%, 10/156) was associated with a lower proportion of patients admitted into the intensive care unit in the last 30 days of life compared to no outpatient palliative care (15%, 399/2627; p = 0.003). Outpatient palliative care referral was associated with improved overall survival in Kaplan Meier survival analysis. Within the local system, 51% (104/204) of admissions could have been managed in outpatient setting, and of the patients admitted in the last 30 days of life, 59% (87/147) experienced in-hospital deaths. CONCLUSION: We identified underutilization of outpatient palliative care services within stage IV NSCLC patients. Many patients with NSCLC experience hospitalization the last month of life and in-hospital death.

Ineffective esophageal motility is not a contraindication to total fundoplication.

INTRODUCTION: Ineffective esophageal motility (IEM) is a physiologic diagnosis and is a component of the Chicago Classification. It has a strong association with gastroesophageal reflux and may be found during work-up for anti-reflux surgery. IEM implies a higher risk of post-op dysphagia if a total fundoplication is done. We hypothesized that IEM is not predictive of dysphagia following fundoplication and that it is safe to perform total fundoplication in appropriately selected patients. METHODS: Retrospective chart review of patients who underwent total fundoplication between September 2012 and December 2018 in a single foregut surgery center and who had IEM on preoperative manometry. We excluded patients who had partial fundoplication, previous foregut surgery, other causes of dysphagia or an esophageal lengthening procedure. Dysphagia was assessed using standardized Dakkak score ≤ 40 and GERD-HRQL question 7 ≥ 3. RESULTS: Two hundred patients were diagnosed with IEM and 31 met the inclusion criteria. Median follow-up: 706 days (IQR 278-1348 days). No preoperative factors, including subjective dysphagia, transit on barium swallow, or individual components of manometry showed statistical correlation with postoperative dysphagia. Of 9 patients with preoperative dysphagia, 2 (22%) had persistent postoperative dysphagia and 7 had resolution. Of 22 patients without preoperative dysphagia, 3 (14%) developed postoperative dysphagia; for a combined rate of 16%. No patient needed re-intervention beyond early recovery or required reoperation for dysphagia during the follow-up period. CONCLUSION: In appropriately selected patients, when total fundoplication is performed in the presence of preoperative IEM, the rate of long-term postoperative dysphagia is similar to the reported rate of dysphagia without IEM. With appropriate patient selection, total fundoplication may be performed in patients with IEM without a disproportionate increase in postoperative dysphagia. The presence of preoperative IEM should not be rigidly applied as a contraindication to a total fundoplication.

Cumulative radiation dose incurred during the management of complex pleural space infection.

BACKGROUND: Complex pleural space infections are commonly managed with antibiotics, pleural drainage, intrapleural fibrinolytic therapy, and surgery. These strategies often utilize radiographic imaging during management, however little data is available on cumulative radiation exposure received during inpatient management. We aimed to identify the type and quantity of radiographic studies along with the resultant radiation exposure during the management of complex pleural space infections. METHODS: Retrospective review of community network healthcare system from January 2015 to July 2018. Patients were identified through billing databases as receiving intrapleural fibrinolytic therapy and/or surgical intervention. Patient demographics, clinical outcomes, and inpatient radiographic imaging was collected to calculate cumulative effective dose. RESULTS: A total of 566 patients were identified with 7275 total radiographic studies performed and a median cumulative effective dose of 16.9 (IQR 9.9-26.3) mSv. Multivariable linear regression analysis revealed computed tomography use was associated with increased cumulative dose, whereas increased age was associated with lower cumulative dose. Over 74% of patients received more than 10 mSv, with 7.4% receiving more than 40 mSv. CONCLUSIONS: The number of radiographic studies and overall cumulative effective dose in patients hospitalized for complex pleural space infection was high with the median cumulative effective dose > 5 times normal yearly exposure. Ionizing radiation and modern radiology techniques have revolutionized medical care, but are likely not without risk. Additional study is warranted to identify the frequency and imaging type needed during complex pleural space infection management, attempting to keep ionizing radiation exposure as low as reasonably possible.

Tunneled pleural catheter use for pleural palliation does not increase infection rate in patients with treatment-related immunosuppression.

PURPOSE: Concerns for infections resulting from antineoplastic therapy-associated immunosuppression may deter referral for symptom palliation with a tunneled pleural catheter (TPC) in patients with malignant/para-malignant pleural effusions (MPE/PMPE). While rates of TPC-related infections range from 1 to 21%, those in patients receiving antineoplastic therapy with correlation to immune status has not been established. We aimed to assess TPC-related infection rates in patients on antineoplastic therapy, determine relation to immune system competency, and assess impact on the patient. METHODS: Patients with a MPE/PMPE undergoing TPC management associated with antineoplastic therapy, from 2008 to 2016, were reviewed and categorized into those with an immunocompromised versus immunocompetent immune status. RESULTS: Of the 150 patients, a TPC-related infection developed in 13 (9%): pleural space in 11 (7%) and superficial in 2 (1%). Ninety-three percent (139/150) were identified to be immunocompromised during their antineoplastic therapy. No difference in TPC-related infections was seen in patients with an immunocompromised (9%, 12/139) versus immunocompetent status (9%, 1/11); p = 0.614. The presence of a catheter-related infection did not negatively impact overall survival over a median follow-up of 144 days (interquartile range 41-341); p = 0.740. CONCLUSIONS: These results suggest that antineoplastic therapy may not significantly increase the overall risk of TPC-related infections, as the rate remains low and comparable to rates in patients not undergoing antineoplastic therapy. Regardless of immune status, the presence of a catheter-related infection did not negatively impact overall survival. These results should reassure clinicians that the need to initiate antineoplastic therapy should not delay definitive pleural palliation with a TPC.

Feasibility, safety, and short-term efficacy of the laparoscopic Nissen-Hill hybrid repair.

BACKGROUND: A novel antireflux procedure combining laparoscopic Nissen fundoplication and Hill repair components was tested in 50 patients with paraesophageal hernia (PEH) and/or Barrett's esophagus (BE) because these two groups have been found to have a high rate of recurrence with conventional repairs. METHODS: Patients with symptomatic PEH and/or non-dysplastic BE underwent repair. Quality of life (QOL) metrics, manometry, EGD, and pH testing were administered pre- and postoperatively. RESULTS: Fifty patients underwent repair. There was no mortality and four major complications. At 13-month follow-up, there was one (2%) clinical recurrence, and two (4%) asymptomatic fundus herniations. Mean DeMeester scores improved from 57.2 to 7.7 (p < 0.0001). Control of preoperative symptoms was achieved in 90% with 6% resumption of antisecretory medication. All QOL metrics improved significantly. CONCLUSIONS: The hybrid Nissen-Hill repair for patients with PEH and BE appears safe and clinically effective at short-term follow-up. It is hoped that the combined structural components may reduce the rate of recurrence compared to existing repairs.

Assessment and reduction of diaphragmatic tension during hiatal hernia repair.

BACKGROUND: During hiatal hernia repair there are two vectors of tension: axial and radial. An optimal repair minimizes the tension along these vectors. Radial tension is not easily recognized. There are no simple maneuvers like measuring length that facilitate assessment of radial tension. The aims of this project were to: (1) establish a simple intraoperative method to evaluate baseline tension of the diaphragmatic hiatal muscle closure; and, (2) assess if tension is reduced by relaxing maneuvers and if so, to what degree. METHODS: Diaphragmatic characteristics and tension were assessed during hiatal hernia repair with a tension gage. We compared tension measured after hiatal dissection and after relaxing maneuvers were performed. RESULTS: Sixty-four patients (29 M:35F) underwent laparoscopic hiatal hernia repair. Baseline hiatal width was 2.84 cm and tension 13.6 dag. There was a positive correlation between hiatal width and tension (r = 0.55) but the strength of association was low (r (2) = 0.31). Four different hiatal shapes (slit, teardrop, "D", and oval) were identified and appear to influence tension and the need for relaxing incision. Tension was reduced by 35.8 % after a left pleurotomy (12 patients); by 46.2 % after a right crural relaxing incision (15 patients); and by 56.1 % if both maneuvers were performed (6 patients). CONCLUSIONS: Tension on the diaphragmatic hiatus can be measured with a novel device. There was a limited correlation with width of the hiatal opening. Relaxing maneuvers such as a left pleurotomy or a right crural relaxing incision reduced tension. Longer term follow-up will determine whether outcomes are improved by quantifying and reducing radial tension.

Understanding Washington State's Low Uptake of Lung Cancer Screening in Two Steps: A Geospatial Analysis of Patient Travel Time and Health Care Availability of Imaging Sites.

BACKGROUND: Early detection of lung cancer reduces cancer mortality; yet uptake for lung cancer screening (LCS) has been limited in Washington State. Geographic disparities contribute to low uptake, but do not wholly explain gaps in access for underserved populations. Other factors, such as an adequate workforce to meet population demand and the capacity of accredited screening facility sites, must also be considered. RESEARCH QUESTION: What proportion of the eligible population for LCS has access to LCS facilities in Washington State? STUDY DESIGN AND METHODS: We used the enhanced two-step floating catchment area (E2SFCA) model to evaluate how geographic accessibility in addition to availability of LCS imaging centers contribute to disparities. We used available data on radiologic technologist volume at each American College of Radiology (ACR)-accredited screening facility site to estimate the capacity of each site to meet potential population demand. Spearman rank correlation coefficients of the spatial access ratios were compared with the 2010 Rural-Urban Commuting Area codes and area deprivation index quintiles to identify characteristics of populations at risk for lung cancer with greater and lesser levels of access. RESULTS: A total of 549 radiologic technologists were identified across the 95 ACR-accredited screening facilities. We observed that 95% of the eligible population had proximate geographic access to any ACR facility. However, when we incorporated the E2SFCA method, we found significant variation of access for eligible populations. The inclusion of the availability measure attenuated access for most of the eligible population. Furthermore, we observed that rural areas were substantially correlated, and areas with greater socioeconomic disadvantage were modestly correlated, with lower access. INTERPRETATION: Rural and socioeconomically disadvantaged areas face significant disparities. The E2SFCA models demonstrated that capacity is an important component and how geographic access and availability jointly contribute to disparities in access to LCS.

The effect of pleural drainage on pulse oximetry in a post-operative thoracic surgery population.

BACKGROUND: Pleural effusions in post-operative thoracic surgery patients are common. Effusions can result in prolonged hospitalizations or readmissions, with prior studies suggesting mixed effects of pleural drainage on hypoxia. We aimed to define the impact of pleural drainage on pulse oximetry (SpO2) in post-thoracic surgery patients. METHODS: A retrospective study of post-operative thoracic surgery patients undergoing pleural drainage was performed. SpO2 and supplemental oxygen (FiO2) values were recorded at pre- and post-procedure. The primary outcome was difference in pre-procedural and post-procedural SpO2. RESULTS: We identified 95 patients with a mean age of 65 (SD - 13.8) years undergoing 122 pleural drainage procedures. Mean drainage volume was 619 (SD-423) mL and the majority of procedures (88.5 %) included a drainage of <1000 mL. SpO2 was associated with an increase from 94.0 % (SD-2.6) to 97.3 % (SD-2.0) at 24-h (p < 0.0001). FiO2 was associated with a decrease from 0.31 (SD-0.15) to 0.29 (SD-0.12) at 24-h (p = 0.0081). SpO2/FiO2 was associated with an increase from 344.5 (SD-99.0) to 371.9 (SD-94.7) at 24-h post-procedure (p < 0.0001). CONCLUSIONS: Pleural drainage within post-operative thoracic surgery patients offers statistically significant improvements in oxygen saturation by peripheral pulse oximetry and oxygen supplementation; however the clinical significance of these changes remains unclear. Pleural drainage itself may be requested for numerous reasons, including diagnostic (fevers, leukocytosis, etc.) or therapeutic (worsening dyspnea) evaluation. However, pleural drainage may offer minimal clinical impact on pulse oximetry in post-operative thoracic surgery patients.

Access to Lung Cancer Screening Among American Indian and Alaska Native Adults: A Qualitative Study.

BACKGROUND: Lung cancer is the leading cause of cancer mortality among American Indian and Alaska Native populations. American Indian and Alaska Native people use commercial tobacco products at higher rates compared with all other races and ethnicities. Moreover, they show lower adherence to cancer screening guidelines. RESEARCH QUESTION: How do American Indian and Alaska Native adults perceive and use lung cancer screening? STUDY DESIGN AND METHODS: We conducted a study in which we recorded and transcribed data from three focus groups consisting of American Indian and Alaska Native adults. Participants were recruited through convenience sampling at a national health conference. Transcripts were analyzed by inductive coding. RESULTS: Participants (n = 58) of 28 tribes included tribal Elders, tribal leaders, and non-Native volunteers who worked with tribal communities. Limited community awareness of lung cancer screening, barriers to lung cancer screening at health care facilities, and health information-seeking behaviors emerged as key themes in discussions. Screening knowledge was limited except among people with direct experiences of lung cancer. Cancer risk factors such as multigenerational smoking were considered important priorities to address in communities. Limited educational and diagnostic resources are significant barriers to lung cancer screening uptake in addition to limited discussions with health care providers about cancer risk. INTERPRETATION: Limited access to and awareness of lung cancer screening must be addressed. American Indian and Alaska Native adults use several health information sources unique to tribal communities, and these should be leveraged in designing screening programs. Equitable partnerships between clinicians and tribes are essential in improving knowledge and use of lung cancer screening.

Safety and Outcomes of Outpatient Pleural Drainage in Symptomatic Postoperative Cardiac Surgery Patients.

BACKGROUND: Symptomatic pleural effusions and anticoagulant/antiplatelet medication use in postoperative cardiac surgery are common. Guidelines and recommendations are currently mixed regarding medication management related to invasive procedure performance. We aimed to describe the outcomes of postoperative cardiac surgery patients referred for outpatient, symptomatic pleural effusion management. METHODS: A retrospective study of post-cardiac surgery patients undergoing outpatient thoracentesis from 2016 to 2021 was performed. Demographics, operative details, pleural disease characteristics, outcomes, and complications were collected. Odds ratios with confidence intervals were estimated and adjusted by multivariate logistic regression to investigate the association with multiple thoracenteses. RESULTS: A total of 110 patients underwent 332 thoracenteses. The median age was 68 years and most common operation was coronary artery bypass. Anticoagulation or antiplatelet use was identified in 97%. Thirteen complications were identified, with all major complications (n=3) related to bleeding. The amount of fluid present at the time of initial thoracentesis (>1500 milliliters) was associated with increased odds ratio of subsequent multiple thoracentesis (Unadjusted odds ratio, 6.75 (CI - 1.43 to 31.9). No other variables had a significant association with the need for multiple procedures. CONCLUSION: Within a postoperative cardiac surgery population presenting with symptomatic pleural disease, we observed that thoracentesis performed on antiplatelet and/or anticoagulant medication is relatively safe. We also identified that many patients can be managed as outpatients and that most pleural effusions remain self-limited. The presence of larger amounts of pleural fluid at initial thoracentesis may be associated with increased odds for additional drainage.

Laparoscopic Revisional Antireflux and Hiatal Hernia Surgery Results in a Higher Rate of Complications and Severity at 90-days Than Primary Surgery.

OBJECTIVE: Data on graded complications and their frequency after laparoscopic revisional antireflux and hiatal hernia surgery compared to primary surgery are lacking. We describe 30- and 90-day morbidity using the Clavien-Dindo (CD) classification. METHODS: 298 patients underwent revision surgery between 2003-2020 and were propensity matched to primary surgeries [1:2 ratio] based on age, sex, BMI, ASA classification, LA grade esophagitis, presence of Barrett's, and indication for surgery. Complications were graded using the CD classification, with the highest grade of complication reported per patient. RESULTS: After matching, both groups were majority females, with a median age of 60 and a median BMI of 29.5. Most were healthy, with non-erosive esophagitis and modest levels of Barrett's esophagus. A laparoscopic Nissen fundoplication was most common; however, a partial fundoplication was more common in revisions. Mesh, relaxing incisions and Collis were more common in revisional surgery. At 30-days, total complications were similar [23.5%, (70/298) versus 20.6% (123/596), p=0.373] with 1 death in each group. Minor complications (0.001) more frequently, with esophageal obstruction requiring revision and esophageal/gastric leak being most common. Grade CD4A/B complications were comparable in both groups. At 90-days, revision patients experienced overall complications [7.1% (21) vs 2.0% (12), p=0.003], and CD3B complications [1.0% (3) vs 0 , p=0.037] more frequently, with intra-abdominal abscess washout being the most common CD3B complication. CONCLUSION: Revisional surgery results in similar total complications at 30 days but additional complications can occur out to 90 days.

Complicated Pleural Infection is Associated With Prolonged Recovery and Reduced Functional Ability.

BACKGROUND: Management of complicated pleural infections (CPIs) had historically been surgical; however, following the publication of the second multicenter intrapleural sepsis trial (MIST-2), combination tissue plasminogen (tPA) and dornase (DNase) offers a less invasive and effective treatment. Our aim was to assess the quality of life (QOL) and functional ability of patients' recovery from a CPI managed with either intrapleural fibrinolytic therapy (IPFT) or surgery. METHODS: We identified 565 patients managed for a CPI between January 1, 2013 and March 31, 2018. There were 460 patients eligible for contact, attempted through 2 phone calls and one mailer. Two questionnaires were administered: the Short Form 36-Item Health Survey (SF-36) and a functional ability questionnaire. RESULTS: Contact was made in 35% (159/460) of patients, and 57% (90/159) completed the survey. Patients had lower QOL scores compared to average US citizens; those managed with surgery had higher scores in physical functioning (surgery: 80, IPFT: 70, P=0.040) but lower pain scores (surgery: 58, IPFT: 68, P=0.045). Of 52 patients who returned to work, 48% (25) reported an impact on their work effectiveness during recovery, similarly between management strategies (IPFT: 50%, 13/26 vs. surgery: 46%, 12/26; P=0.781). CONCLUSION: Patients with a CPI had a lower QOL compared with average US citizens. Surgically managed patients reported improved physical functioning but worse pain compared with patients managed with IPFT. Patients returned to work within 4 weeks of discharge, and nearly half reported their ability to work effectively was impacted by their recovery. With further research into recovery timelines, patients may be appropriately counselled for expectations.

Muscle mass cross-sectional area is associated with survival outcomes in malignant pleural disease related to lung cancer.

INTRODUCTION: Malignant pleural effusions are common in advanced malignancy and associated with overall poor survival. The presence of sarcopenia (decreased muscle mass) is associated with poor outcomes in numerous disease states, however, its relationship to malignant pleural disease has not been defined. We sought to understand if there was an association between decreased survival and decreased muscle mass in patients with malignant pleural effusion. METHODS: Patients with malignant pleural disease undergoing indwelling tunneled pleural catheter placement were retrospectively reviewed. Computed tomography was reviewed and cross-sectional area of pectoralis and paraspinous muscle areas were calculated. Overall survival and associations with muscle mass were calculated. RESULTS: A total of 309 patients were available for analysis, with a median age of 67 years and the majority female (58%). The median survival was 129 days from initial pleural drainage to death. Regression analysis and Kaplan-Meier survival analysis did not reveal an association with survival and muscle mass for the entire population. However, Kaplan-Meier survival analysis of the lung cancer subgroup revealed the presence of decreased muscle mass and decreased survival time. CONCLUSION: The presence of decreased muscle mass within a lung cancer population that has malignant pleural effusions are associated with decreased survival. However, the presence of decreased muscle mass within a heterogenous population of malignant pleural disease was not associated with decreased overall survival time. Further study of the role that sarcopenia may play in malignant pleural disease is warranted.

Effect of Intrapleural Fibrinolytic Therapy vs Surgery for Complicated Pleural Infections: A Randomized Clinical Trial.

Importance: There is a paucity of high-quality prospective randomized clinical trials comparing intrapleural fibrinolytic therapy (IPFT) with surgical decortication in patients with complicated pleural infections. Objective: To assess the feasibility, safety, and efficacy of an algorithm comparing tissue plasminogen activator plus deoxyribonuclease therapy with surgical decortication in patients with complicated pleural infections. Design, Setting, and Participants: This parallel pilot randomized clinical trial was performed at a single urban community-based center from March 1, 2019, to December 31, 2021, with follow-up for 90 days. Seventy-four individuals were screened and 48 were excluded. Twenty-six patients 18 years or older with clinical pleural infection and positive findings of pleural fluid analysis were included. Of these, 20 patients underwent randomized selection (10 in each group), and 6 were observed. Interventions: Intrapleural tissue plasminogen activator plus deoxyribonuclease therapy vs surgical decortication. Main Outcomes and Measures: Primary outcomes were the percentage of patients enrolled to study completion and multidisciplinary adherence. Secondary outcomes included the number of patients with and the reason for inadequate screening, screening to enrollment failures, time to accrual of 20 patients or the number accrued at 1 year, and clinical data. Results: Twenty-six patients were enrolled, 10 were randomized to each group, and 6 were observed. There was 100% enrollment to study completion in each treatment group, no protocol deviations, 2 minor protocol amendments, and no screening to enrollment failures. It took 32 months to enroll 26 patients. The 20 randomized patients had a median age of 57 (IQR, 46-65) years, were predominantly men (15 [75%]), and had a median RAPID (Renal, Age, Purulence, Infection Source, and Dietary Factors) score of 2 (IQR, 1-3). Treatment failure occurred in 1 patient and 2 crossover treatments occurred, all of which were in the IPFT group. Intraprocedure and postprocedure complications were similar between the groups. There were no reoperations or in-hospital deaths. Median duration of chest tube use was comparable in the IPFT (5 [IQR, 4-8] days) and surgery (4 [IQR, 3-5] days) groups (P = .21). Median hospital stay tended to be longer in the IPFT (11 [IQR, 4-18] days) vs surgery (5 [IQR, 4-6] days) groups, although the difference as not significantly different (P = .08). There were no 30-day readmissions or 30- or 90-day deaths. Conclusions and Relevance: In this pilot randomized clinical trial, the study algorithm was feasible, safe, and efficacious. This provides evidence to move forward with a multicenter randomized clinical trial. Trial Registration: ClinicalTrials.gov Identifier: NCT03873766.

Comparing Initial Surgery versus Fibrinolytics for Pleural Space Infections: A Retrospective Multicenter Cohort Study.

Rationale: When drainage of complicated pleural space infections alone fails, there exists two strategies in surgery and dual agent-intrapleural fibrinolytic therapy; however, studies comparing these two management strategies are limited. Objectives: To determine the outcomes of surgery versus fibrinolytic therapy as the primary management for complicated pleural space infections (CPSI). Methods: A retrospective review of adults with a CPSI managed with surgery or fibrinolytics between 1/2015 and 3/2018 within a multicenter, multistate hospital system was performed. Fibrinolytics was defined as any dose of dual-agent fibrinolytic therapy and standard fibrinolytics as 5-6 doses twice daily. Treatment failure was defined as persistent infection with a pleural collection requiring intervention. Crossover was defined by any fibrinolytics after surgery or surgery after fibrinolytics. Logistic regression with inverse probability of treatment weighting (IPTW) were employed to account for selection bias effect of management strategies in treatment failure and crossover. Results: We identified 566 patients. Surgery was the initial strategy in 55% (311/566). The surgery group had less additional treatments (surgery: 10% [32/311] versus fibrinolytics: 39% [100/255], P < 0.001), treatment failures (surgery: 7% [22/311] versus fibrinolytics: 29% [74/255], P < 0.001), and crossovers (surgery: 6% [20/311] versus fibrinolytics: 19% [49/255], P < 0.001). Logistic regression analysis with IPTW demonstrated a lower odds of treatment failure with surgery compared with any fibrinolytics (odds ratio [OR], 0.20; 95% confidence interval [CI], 0.10-0.30; P < 0.001); and compared with standard fibrinolytics (OR, 0.20; 95% CI, 0.11-0.35; P < 0.001). Conclusions: Although there is a lack of consensus as to the optimal management strategy for patients with a CPSI, in surgical candidates, operative management may offer more benefits and could be considered early in the management course. However, our study is retrospective and nonrandomized; thus, prospective trials are needed to explore this further.

Bleeding Risk With Combination Intrapleural Fibrinolytic and Enzyme Therapy in Pleural Infection: An International, Multicenter, Retrospective Cohort Study.

BACKGROUND: Combination intrapleural fibrinolytic and enzyme therapy (IET) has been established as a therapeutic option in pleural infection. Despite demonstrated efficacy, studies specifically designed and adequately powered to address complications are sparse. The safety profile, the effects of concurrent therapeutic anticoagulation, and the nature and extent of nonbleeding complications remain poorly defined. RESEARCH QUESTION: What is the bleeding complication risk associated with IET use in pleural infection? STUDY DESIGN AND METHODS: This was a multicenter, retrospective observational study conducted in 24 centers across the United States and the United Kingdom. Protocolized data collection for 1,851 patients treated with at least one dose of combination IET for pleural infection between January 2012 and May 2019 was undertaken. The primary outcome was the overall incidence of pleural bleeding defined using pre hoc criteria. RESULTS: Overall, pleural bleeding occurred in 76 of 1,833 patients (4.1%; 95% CI, 3.0%-5.0%). Using a half-dose regimen (tissue plasminogen activator, 5 mg) did not change this risk significantly (6/172 [3.5%]; P = .68). Therapeutic anticoagulation alongside IET was associated with increased bleeding rates (19/197 [9.6%]) compared with temporarily withholding anticoagulation before administration of IET (3/118 [2.6%]; P = .017). As well as systemic anticoagulation, increasing RAPID score, elevated serum urea, and platelets of < 100 × 109/L were associated with a significant increase in bleeding risk. However, only RAPID score and use of systemic anticoagulation were independently predictive. Apart from pain, non-bleeding complications were rare. INTERPRETATION: IET use in pleural infection confers a low overall bleeding risk. Increased rates of pleural bleeding are associated with concurrent use of anticoagulation but can be mitigated by withholding anticoagulation before IET. Concomitant administration of IET and therapeutic anticoagulation should be avoided. Parameters related to higher IET-related bleeding have been identified that may lead to altered risk thresholds for treatment.

Retained Granulation Cuff as a Complication of Indwelling Pleural Catheter Removal.

Recurrent pleural effusions can be managed with indwelling tunneled pleural catheters (IPC), with some patients undergoing IPC removal after appropriate palliation has occurred. Little data exists regarding complications related to IPC removal. We report on retained granulation cuffs after successful IPC removal. We identified 122 IPC removals of which 6 (4.9%) were complicated by retained granulation cuff. No additional procedures or need for retrieval were identified over a median follow-up time of 423.5 (IQR-204-1489) days. Clinicians should be aware of this potential complication, but that retained granulation cuffs appear to offer no sequelae and aggressive interventions for retrieval/removal are likely not warranted.

The Use of Intrapleural Thrombolytic or Fibrinolytic Therapy, or Both, via Indwelling Tunneled Pleural Catheters With or Without Concurrent Anticoagulation Use.

BACKGROUND: Indwelling tunneled pleural catheters (IPCs) are used regularly for recurrent pleural effusion management. Catheter obstruction is not uncommon, often requiring intrapleural medications instillation (ie, alteplase) to restore flow. The safety profile of intrapleural medications has been reported previously; however, most studies exclude anticoagulated patients. RESEARCH QUESTION: What is the safety profile of intrapleural alteplase, dornase alfa, or both when used in patients with IPCs, including in those who may be undergoing active anticoagulation? STUDY DESIGN AND METHODS: Retrospective review of patients with previously placed IPCs from January 2009 through February 2020 undergoing intrapleural alteplase therapy. Basic demographics, laboratory studies, anticoagulation medication use, and complications were collected. Descriptive statistics were used to report demographics and outcomes. Univariate Firth's logistic regression analyses were used to identify factors associated with complications, followed by multivariate regression analyses. RESULTS: A total of 94 patients underwent IPC placement and intrapleural instillation. The median age of patients was 66.1 years (interquartile range, 57.6-74.9 years). Intrapleural medications were administered 71 times in 30 anticoagulated patients and 172 times in 64 patients who were not anticoagulated. A total of 20 complications were identified in 18 patients, with one patient experiencing more than one complication. Five bleeding complications occurred with no significant increased risk with anticoagulation use (in 2 anticoagulated patients and 3 patients who were not anticoagulated; P = .092). Multivariate Firth's logistic regression demonstrated that alteplase dose (P = .04) and anticoagulation use (P = .05) were associated with any complication, but were not associated with bleeding complications. INTERPRETATION: We report a relatively low incidence of complications and, in particular, bleeding complications in patients receiving intrapleural alteplase for nondraining IPCs. Bleeding episodes occurred in five of 94 patients (5.3%) with no apparent increased risk of bleeding complication, regardless of whether receiving anticoagulation. Additional study is warranted to identify risk factors for complications, in particular bleeding complications, in this patient population.