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.

Cancer case trends following the onset of the COVID-19 pandemic: A community-based observational study with extended follow-up.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic has impacted health care delivery worldwide. Cancer is a leading cause of death, and the impact of the pandemic on cancer diagnoses is an important public health concern. METHODS: This cross-sectional study retrospectively analyzed the electronic medical records of 80,138 cancer patients diagnosed between January 1, 2019, and May 31, 2021. Outcome measures included weekly number of new cancer cases and trends in weekly cancer cases, before and after the pandemic; patient demographics; and positive COVID-19 test rates. RESULTS: Beginning March 4, 2020, defined as the onset of the pandemic, weekly cancer cases declined precipitously (-110.0 cases per week [95% confidence interval, -190.2 to -29.8]) for 4 weeks, followed by a moderate recovery (+23.7 cases per week [9.1 to 38.4]) of 10 weeks duration. Thereafter, weekly cancer cases trended slowly back toward pre-COVID-19 baseline levels. Following the pandemic onset, there was a cumulative year-over-year decline in cancer cases overall of 7.3%, including a 20.2%, 14.3%, and 12.8% decline in nonmelanoma skin cancer, breast cancer, and prostate cancer, respectively. Changes in case volumes were accompanied by variations in patient characteristics, including region, age, gender, race, insurance coverage, and COVID-19 positive test rates (P < .01 for all). Among patients tested for COVID-19, 5.3% had a positive result. CONCLUSIONS: The data in this study demonstrate a substantial reduction in cancer diagnoses following the onset of COVID-19, which appear to reach expected pre-COVID norms 12 months later. The largest reduction was noted among cancers that are typically screen-detected or identified as part of a routine wellness examination.

The Nissen-Hill Hybrid Repair: Experience With the First 500.

INTRODUCTION: A new repair for gastroesophageal reflux and hiatal hernia, the Nissen-Hill hybrid repair, was developed to combine the relative strengths of its component repairs with the aim of improved durability. In several small series, it has been shown to be safe, effective, and durable for paraesophageal hernia, Barrett esophagus, and gastroesophageal reflux disease. This study represents our experience with the first 500 consecutive repairs for all indications. METHODS: Retrospective study of prospectively collected data for the first 500 consecutive Nissen-Hill hybrid repairs from March 2006 to December 2016, including all indications for surgery. Three quality of life metrics, manometry, radiographic imaging, and pH testing were administered before and at defined intervals after repair. RESULTS: Five hundred patients were included, with a median follow-up of 6.1 years. Indications for surgery were gastroesophageal reflux disease in 231 (46.2%), paraesophageal hernia in 202 (40.4%), and reoperative repair in 67 (13.4%). The mean age was 59, with body mass index of 30 and 63% female. A minimally invasive approach was used in 492 (98%). Thirty-day operative mortality was 1 (0.2%), with a 4% major complication rate and a median length of stay of 2 days. Preoperative to postoperative pH testing was available for 390 patients at a median follow-up of 7.3 months, with the median DeMeester score improving from 45.9 to 2.7. At long-term follow-up (229 responses), all median quality of life scores improved: Quality Of Life in Reflux And Dyspepsia 4 to 6.9, Gastroesophageal Reflux Disease-Health Related Quality of Life 22 to 3, and Swallowing 37.5 to 45 and proton pump inhibitor use dropped from 460 (92%) to 50 (10%). Fourteen (2.8%) underwent reoperation for failure. CONCLUSION: The combined Nissen-Hill hybrid repair is safe and effective in achieving excellent symptomatic and objective outcomes and low recurrence rates beyond 5 years.

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.

Surgery as a Component of Multimodality Care for Known Stage IIIA-N2 Non-small Cell Lung Cancer.

Locally advanced, stage IIIA-N2 Non-small cell lung cancer (NSCLC) represents a heterogeneous patient population. Considerable controversy exists as to the optimal management of these patients. Local therapy alone with a single modality, namely surgery or radiation, is associated with high recurrence rates and low overall survival. Consequently, multimodality treatment (chemotherapy, radiotherapy, with or without the utilization of surgery) has developed as a means of both local and systemic control for patients with stage IIIA-N2 NSCLC, and has led to improved overall survival. While it is clear that multimodality therapy is beneficial, the ideal composition of the treatment regimen remains a work in progress. As a result, the optimal management of patients with stage IIIA-N2 NSCLC is widely debated, as is the role for surgery in a multimodality treatment regimen. Herein, we review the current literature supporting multimodality therapy for stage IIIA-N2 NSCLC with an emphasis on the data supporting the role of surgery in resectable and potentially resectable patients.

Use of a report card to evaluate outcomes of achalasia surgery: beyond the Eckardt score.

BACKGROUND: Achalasia outcome is primarily defined using the Eckardt score with failure recognized as > 3. However, patients experience many changes after myotomy including new onset GERD, swallowing difficulties, and potential need for additional treatment. We aim to devise a comprehensive assessment tool to demonstrate the extent of patient-reported outcomes, objective changes, and need for re-interventions following myotomy. METHODS: We performed a retrospective chart review of surgically treated primary achalasia patients. We identified 185 patients without prior foregut surgery who underwent either per oral endoscopic myotomy (POEM) or Heller myotomy from 2005 to 2017. Eight outcome measures in subjective, objective, and interventional categories formulated a global postoperative assessment tool. These outcomes included Eckardt score, Dakkak Dysphagia score, GERD-HRQL score, normalization of pH scores and IRP, esophagitis, timed barium clearance at 5 min, and the most invasive re-intervention performed. RESULTS: Of 185 patients, achalasia subtypes included Type I = 42 (23%), II = 109 (59%), and III = 34 (18%). Patients underwent minimally invasive myotomy in 114 (62%), POEM in 71 (38%). Median proximal myotomy length was 4 cm (IQR 4-5) and distal 2 cm (IQR 2-2.5). Based on postoperative Eckardt score, 135/145 (93%) had successful treatment of achalasia. But, only 47/104 (45%) reported normal swallowing, and 78/108 (72%) had GERD-HRQL score ≤ 10. Objectively, IRP was normalized in 48/60 (80%), whereas timed barium clearance occurred in 51/84 (61%). No evidence of esophagitis was documented in 82/115 (71%). Postoperative normal DeMeester scores occurred in 38/76 (50%). No additional treatments were required in 110/139 (79%) of patients. CONCLUSIONS: Use of the Eckardt score alone to assess outcomes after achalasia surgery shows outstanding results. Using patient-reported outcomes, objective measurements, re-intervention rates, organized into a report card provides a more comprehensive and informative view.

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.

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.

Thirty- and 90-Day Morbidity and Mortality by Clavien-Dindo after Surgery for Antireflux and Hiatal Hernia.

BACKGROUND: The historic morbidity and mortality rates of antireflux and hiatal hernia operation are reported as 3% to 21% and 0.2% to 0.5%, respectively. These data come from either large national and population level or small institutional studies, with the former focusing on broad 30-day outcomes while lacking granular data on complications and their severity. Institutional studies tend to focus on long-term and quality-of-life outcomes. Our objective is to describe and evaluate the incidence of 30- and 90-day morbidity and mortality in a large, single-institution dataset. STUDY DESIGN: We retrospectively reviewed 2,342 cases of antireflux and hiatal hernia operation from 2003 to 2020 for intraoperative complications causing postoperative sequelae, as well as morbidity and mortality within 90 days. All complications were graded using the Clavien-Dindo (CD) grading system. The highest grade of complication was used per patient during 30- and 31- to 90-day intervals. RESULTS: Of 2,342 patients, the overall 30-day morbidity and mortality rates were 18.2% (427 of 2,342) and 0.2% (4 of 2,342), respectively. Most of the complications were CD less than 3a at 13.1% (306 of 2,342). In the 31- to 90-day postoperative period, morbidity and mortality rates decreased to 3.1% (78 of 2,338) and 0.09% (2 of 2,338). CD less than 3a complications accounted for 1.9% (42 of 2,338). CONCLUSIONS: Antireflux and hiatal hernia operations are safe with rare mortality and modest rates of morbidity. However, the majority of complications patients experience are minor (CD less than 3a) and are easily managed. A minority of patients will experience major complications (CD 3a or greater) that require additional procedures and management to secure a safe outcome. These data are helpful to inform patients of the risks of operation and guide physicians for optimal consent.

The classification of hiatal shapes and their use as a marker for complexity, operative interventions, and recurrence.

BACKGROUND: Diaphragmatic reconstruction is a vital, but challenging component of hiatal hernia and antireflux surgery. Results are optimized by minimizing axial tension along the esophagus, assessed with intra-abdominal length, and radial tension across the hiatus, which has not been standardized. We categorized hiatal openings into 4 shapes, as a surrogate for radial tension, to correlate their association with operative interventions and recurrence. METHODS: We retrospectively reviewed all primary hiatal hernias (≥3 cm) repaired at a single center between 2010 and 2020. Patients with intraoperative hiatal photos with at least 1 year of follow-up were included. The hiatal openings were classified into 4 shapes: slit, inverted teardrop, "D," and oval, and ordered in this manner of hypothesized increased complexity and tension. RESULTS: A total of 239 patients were studied, with 113 (47%) having a recurrence. Age (P < .001), proportion of paraesophageal hernias (P < .001), hernia axial length (P < .001), and hiatal width (P < .001) all increased as shape progressed from slit to inverted teardrop to "D" to oval. Mesh (P = .003) and relaxing incisions (P < .001) were more commonly employed in more advanced shapes, "D" and ovals. However, recurrence (P = .88) did not correlate with hiatal shape. CONCLUSION: Four different hiatal shapes are commonly seen during hernia repair. These shapes represent a spectrum of hernia chronicity and complexity necessitating increased use of operative measures but not correlating with recurrence. Despite failing to be a direct marker for recurrence risk, hiatal shape may serve as an intraoperative tool to inform surgeons of the potential need for additional hiatal interventions.

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 with primary surgery are lacking. We describe 30- and 90-day morbidity using the Clavien-Dindo classification. METHODS: A total of 298 patients underwent revision surgery between 2003 and 2020 and were propensity matched to primary surgeries (1:2 ratio) based on age, sex, body mass index, American Society of Anesthesiology classification, Los Angeles grade esophagitis, presence of Barrett's, and indication for surgery. Complications were graded using the Clavien-Dindo classification, with the highest grade of complication reported per patient. RESULTS: After matching, both groups had a majority of female patients, with a median age of 60 years and a median body mass index of 29.5 kg/m2. Most were healthy, with nonerosive 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] vs 20.6% [123/596], P = .373) with 1 death in each group. Minor complications (less than Clavien-Dindo 3A) were comparable. Patients undergoing revisional surgery experienced Clavien-Dindo 3B complications (4.7% [14] vs 0.8% [5], P > .001) more frequently, with esophageal obstruction requiring revision and esophageal/gastric leak being most common. Grade Clavien-Dindo 4 A/B complications were comparable in both groups. At 90 days, patients undergoing revisional surgery experienced overall complications (7.1% [21] vs 2.0% [12], P = .003), and Clavien-Dindo 3B complications (1.0% [3] vs 0, P = .037) more frequently, with intra-abdominal abscess washout being the most common Clavien-Dindo 3B complication. CONCLUSIONS: Revisional surgery results in similar total complications at 30 days, but additional complications can occur out to 90 days.

Long Term Outcomes of Magnetic Sphincter Augmentation: A comparative study to Nissen Fundoplication.

BACKGROUND: Magnetic sphincter augmentation (MSA) demonstrates improvement in GERD across multiple short-term studies. Long-term, single arm studies show durable outcomes, but there is limited comparative data to Nissen (NF). METHODS: We performed a retrospective propensity matched cohort study of patients with GERD undergoing MSA or NF between 2012 and 2018. Patients were matched on age, gender, BMI, size of hiatal hernia, length of Barrett's and motility in a 1-to-1 fashion. A total of 523 patients (177 MSA, 346 NF) underwent surgery and after matching 177 MSA and 177 NF were analyzed. RESULTS: At 1 year, GERD quality of life scores improved (22 to 5 MSA vs 24 to 5 NF, p=0.593). PPI use was 14% vs 5% (p=0.010). pH testing demonstrated improved DeMeester scores (42 to 21 vs 46 to 7, p<0.001). At 5 years, GERD quality of life scores were stable (5 to 5 vs 5 to 4, p=0.208). PPI use was 31% vs 26% (p=0.474). The incidence of endoscopic dilation was similar between MSA and NF (7% vs 10%, p=0.347). Reoperation rates were higher for MSA (10% vs 4%, p=0.022) and recurrent hiatal hernias were found in 18% vs 7% (p=0.007). Compared to NF, MSA undergoing complete dissection showed no difference in dilation (5% MSA vs 7% NF, p=0.527), reoperation (8% MSA vs 6% NF, p=0.684) or hernia recurrence (10% MSA vs 6% NF, p=0.432). CONCLUSIONS: MSA achieves similar improvements in quality of life and freedom from medical therapy compared to NF especially with complete hiatal repair.

Morbidity and mortality after antireflux and hiatal hernia surgery across a spectrum of ages.

BACKGROUND: Antireflux surgery (ARS) and hiatal hernia repair (HHR) are common surgical procedures with modest morbidity. Increasing age is a risk factor for complications; however, details regarding acute morbidity are lacking. This study aimed to describe the incidence rates and types of morbidities across the spectrum of ages. METHODS: A total of 2342 consecutive cases were retrospectively reviewed from 2003 to 2020 for 30-day complications. All complications were assessed using the Clavien-Dindo (CD) grading system. Patients were divided into 5 age groups: ≤59, 60 to 69, 70 to 79, 80 to 89, and ≥90 years. RESULTS: The numbers per age group were 1100 patients aged ≤59 years, 684 patients aged 60 to 69 years, 458 patients aged 70 to 79 years, 458 patients aged 80 to 89 years, and 6 patients aged ≥90 years. A total of 427 complications (18.2%) occurred, including 2 mortalities, each in the 60- to 69-year age group and the 70- to 79-year age group, for a mortality rate of 0.2%. The complication rate increased from 13.5% (149) in patients aged ≤59 years to 35.0% (35) in patients aged ≥80 years (P = .006), with CD grades I and II accounting for >70% of complications, except in patients aged ≥80 years (57.1%). CD grades IIIa and IIIb were higher in patients aged ≥80 years (26.5% [P = .001] and 11.8% [P = .021], respectively). CD grade IVa and IVb complications were rare overall. CONCLUSION: There is a modest rate of morbidity that increases as patients age, regardless of hernia type, elective or primary surgery, with most being minor complications (CD grade≤II). Our data should help patients, referring physicians, and surgeons counsel patients regarding the effect of increasing age in ARS and HHR.

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.

Preoperative consolidation-to-tumor ratio and SUVmax stratify the risk of recurrence in patients undergoing limited resection for lung adenocarcinoma ≤2 cm.

PURPOSE: Limited resection is an increasingly utilized option for treatment of clinical stage IA lung adenocarcinoma (ADC) ≤2 cm (T1aN0M0), yet there are no validated predictive factors for postoperative recurrence. We investigated the prognostic value of preoperative consolidation/tumor (C/T) ratio [on computed tomography (CT) scan] and maximum standardized uptake value (SUVmax) on (18)F-fluorodeoxyglucose-positron emission tomography (PET) scan. METHODS: We retrospectively reviewed 962 consecutive patients who underwent limited resection for lung cancer at Memorial Sloan-Kettering between 2000 and 2008. Patients with available CT and PET scans were included in the analysis. C/T ratio of 25 % (in accordance with the Japan Clinical Oncology Group 0201) and SUVmax of 2.2 (cohort median) were used as cutoffs. Cumulative incidence of recurrence (CIR) was assessed. RESULTS: A total of 181 patients met the study inclusion criteria. Patients with a low C/T ratio (n = 15) had a significantly lower 5-year recurrence rate compared with patients with a high C/T ratio (n = 166) (5-year CIR, 0 vs. 33 %; p = 0.015), as did patients with low SUVmax (n = 86) compared with patients with high SUVmax (n = 95; 5-year CIR, 18 vs. 40 %; p = 0.002). Furthermore, within the high C/T ratio group, SUVmax further stratified risk of recurrence [5-year CIR, 22 % (low) vs. 40 % (high); p = 0.018]. CONCLUSIONS: With the expected increase in diagnoses of small lung ADC as a result of more widespread use of CT screening, C/T ratio and SUVmax are widely available markers that can be used to stratify the risk of recurrence among cT1aN0M0 patients after limited resection.

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.

Persistent N2 After Induction Is Not a Contraindication to Surgery for Lung Cancer.

BACKGROUND: Surgical management for potentially resectable stage IIIA-N2 non-small cell lung cancer (NSCLC) is controversial. For some, persistent N2 disease after induction therapy is a contraindication to resection. We examined outcomes of a well-selected surgical cohort of postinduction IIIA-N2 NSCLC patients with persistent N2 disease. METHODS: We retrospectively reviewed all resected clinical IIIA-N2 NSCLC patients from 2001 to 2018. Thorough preoperative staging, including invasive mediastinal staging, was performed. Those with nonbulky N2 disease, appropriate restaging, and potential for a margin-negative resection were included. After resection, patients were classified as having persistent N2 disease or mediastinal downstaging (N2 to >N0/N1). Persistent N2 patients were further classified as uncertain resection (R[un]) or complete resection (R0) according to the International Association for the Study of Lung Cancer definition. Kaplan-Meier survival analysis was used. RESULTS: Fifty-four patients met inclusion criteria. After induction, 31 patients (57%) demonstrated persistent N2 disease, and 23 patients (43%) had mediastinal downstaging. Preinduction invasive mediastinal staging was performed in 98.1%. Most had clinical single-station N2 disease (75.9%). Margin-negative resections were performed in 100%. Eight patients were reclassified as R(un) due to positive highest sampled mediastinal station. The median overall survival for persistent N2 was 26 months for R(un) and 69 months for R0. Overall survival for the downstaged group was 67 months (P = .31). CONCLUSIONS: Overall survival for patients with non-R(un) or persistent N2 (true R0) was similar to those with mediastinal downstaging. Well-selected patients with persistent N2 disease experience reasonable survival after resection and should have surgery considered as part of their multimodality treatment. This study underscores the importance of classifying the extent of mediastinal involvement for persistent N2 patients, supporting the proposed International Association for the Study of Lung Cancer R(un) classification.

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.

Immune responses and immunotherapeutic interventions in malignant pleural mesothelioma.

Malignant pleural mesothelioma (MPM) is an aggressive, primary pleural malignancy with poor prognosis, hypothesized to originate from a chronic inflammatory state within the pleura. Similar to what has been observed in other solid tumors (melanoma, ovarian and colorectal cancer), clinical and pre-clinical MPM investigations have correlated anti-tumor immune responses with improved survival. As such, a better understanding of the complex MPM tumor microenvironment is imperative in strategizing successful immunotherapies. Herein, we review the immune responses vital to the development and progression of MPM, as well as assess the role of immunomodulatory therapies, highlighting recent pre-clinical and clinical immunotherapy investigations.