Fabien Maldonado - Academia.edu (original) (raw)

Papers by Fabien Maldonado

Clinical transplantation, Jun 24, 2023

Journal of bronchology & interventional pulmonology, Aug 15, 2022

Social Science Research Network, 2018

Journal of bronchology & interventional pulmonology, Jul 16, 2020

Background: Major airway bleeding is the most feared complication of transbronchial cryobiopsy (T... more Background: Major airway bleeding is the most feared complication of transbronchial cryobiopsy (TBC). Radial endobronchial ultrasound (REBUS) has been used to assess the peripheral lung, primarily to identify pulmonary nodules, and also peripheral blood vessels. Using REBUS-guided TBC to avoid peripheral vasculature might reduce bleeding risk. This prospective randomized double-blind pilot trial was designed to investigate the feasibility of study procedures and inform the power calculation and clinical significance of a future large randomized trial. Methods: Consecutive TBCs were randomized to be performed with or without REBUS guidance in the same patient. A nonblinded operator obtained each biopsy while a blinded second operator managed the bleeding after each biopsy and determined when hemostasis had been obtained. Feasibility of study procedures and the ability to recruit patients were of primary interest. Time to hemostasis after each biopsy was also examined. Results: Forty TBCs were performed in 10 patients (4 biopsies per patient) over an enrollment period of 6 months. The time to control bleeding between biopsies was not statistically different between intervention and control arms [−14.3 (−120.1 to 92.0) s, P=0.7878]. Mean bleeding time was 139.4±59.895 seconds (REBUS 132.25± 89.305 s, non-REBUS 146.55±82.043 s). A trend towards the decreased grade of bleeding and less need for additional interventions was observed with REBUS use, but this difference did not reach statistical significance in this pilot investigation. Conclusion: Our findings suggest that REBUS-guided TBC is feasible. We did not observe any statistically significant difference in time to hemostasis or bleeding grade in this pilot study.

$Research paper thumbnail of Tunneled Indwelling Pleural Catheters for Refractory Pleural Effusions after Solid Organ Transplant. A Case-Control Study$

Annals of the American Thoracic Society, Aug 1, 2016

Rationale: The use of tunneled indwelling pleural catheters for management of refractory pleural ... more Rationale: The use of tunneled indwelling pleural catheters for management of refractory pleural effusions continues to increase. Pleural space infections are among the most common and serious complication of the procedure. The risk may be higher in patients receiving immunosuppressive medications. Objectives: The aim of this study was to assess the risk of infections complicating placement of a tunneled indwelling pleural catheter in patients who have received a solid organ transplant. Methods: Electronic medical records were retrospectively reviewed to identify patients with prior solid organ transplant who subsequently underwent placement of a tunneled intrapleural catheter. We selected a matched sample of comparison patients without solid organ transplant who underwent the same procedure during the study period. Detailed chart abstraction was performed to compare baseline clinical information with procedure outcomes in both groups. Measurements and Main Results: Nineteen study patients underwent kidney, liver, lung, or heart transplant. Another 55 patients were included in the nontransplant comparison group. Transplant patients were taking a mean of 2.4 (range, 1-4) immunosuppressive medications. In transplant patients, the intrapleural catheter remained in place for a median of 95 days (interquartile range, 58-256 d). Two of the 19 transplant patients (16.9% 90-day Kaplan-Meier estimate) and 4 of the 55 control patients (11.0% weighted 90-day Kaplan-Meier estimate) developed a major infectious complication (not significant). There were no deaths attributed to intrapleural catheter placement in either group. Conclusions: In a series of 19 patients with solid organ transplantation taking daily immunosuppressive medications who underwent placement of a tunneled intrapleural catheter, we report an 11% rate of major infectious complications over the lifetime of the catheter in the transplant group with no significant difference in 90-day estimated risk of complication between transplant and nontransplant comparison group.

Chest, Mar 1, 2020

BACKGROUND Thoracentesis can be accomplished by active aspiration or drainage with gravity. We in... more BACKGROUND Thoracentesis can be accomplished by active aspiration or drainage with gravity. We investigated whether gravity drainage could protect against negative-pressure related complications, such as chest discomfort, re-expansion pulmonary edema or pneumothorax, compared to active aspiration. METHODS This prospective, multicenter single blinded randomized controlled trial allocated patients with large free-flowing effusions estimated ≥ 500 mL 1:1 to active aspiration or gravity drainage. Patients rated chest discomfort on 100 mm visual analog scales before, during, and after drainage. Thoracentesis was halted at complete evacuation or for persistent chest discomfort, intractable cough, or other complication. The primary outcome was overall procedural chest discomfort scored five minutes post-procedure. Secondary outcomes included measures of discomfort and breathlessness through 48 hours post-procedure. RESULTS One hundred forty-two patients were randomized with 140 in the final analysis. Groups did not differ for the primary outcome (mean VAS score difference 5.3 mm, 95% CI -2.4 to 13.0, p = 0.17). Secondary outcomes of discomfort and dyspnea did not differ between groups. Comparable volumes were drained in both groups but procedure duration was significantly longer in the gravity arm (mean difference 7.4 minutes, 95% CI 10.2 to 4.6, p<0.001). There were no serious complications. CONCLUSIONS Thoracentesis via active aspiration and gravity drainage both appear safe and result in comparable levels of procedural comfort and dyspnea improvement. Active aspiration requires less total procedural time.

Journal of bronchology & interventional pulmonology, Mar 17, 2021

Background: Navigational bronchoscopy is commonly used to sample lung nodules, with a better safe... more Background: Navigational bronchoscopy is commonly used to sample lung nodules, with a better safety profile but lower diagnostic yield than computerized tomography-guided transthoracic needle biopsy. The addition of digital tomosynthesis to electromagnetic navigation, using intraprocedural images obtained from a C-arm fluoroscope to identify target lesion location and update navigational guidance, may improve diagnostic yield. Methods: Consecutive bronchoscopies using tomosynthesis-assisted fluoroscopic electromagnetic navigational bronchoscopy (F-ENB) at a single institution over a 1-year period were included. The primary outcome was diagnostic yield. A bronchoscopy was defined as diagnostic if pathologic examination revealed malignancy or specific histological findings indicative of lesional sampling with confirmatory 6-month follow-up for benign lesions. Results: A total of 324 patients with 363 nodules underwent F-ENB between April 25, 2018 and April 29, 2019. The average nodule size was 1.9±1.1 cm, 65% of the nodules were located in the peripheral third of the lung. A bronchus sign was present in 24% of cases. Of the 363 nodules, 299 (82.4%) had lesional findings. At 6-month follow-up, among these 299 nodules, 6 were found to be false negatives and 12 nodules were lost to follow-up. Considering all nodules lost to follow-up as false negatives, the 6-month diagnostic yield was 77.4%. Pneumothorax complicated 8 (2.5%) of cases. There was 1 episode of respiratory failure. Conclusion: This retrospective study suggests the diagnostic yield of F-ENB may exceed that of traditional ENB. Future prospective and comparative studies are needed to confirm these promising data.

The European respiratory journal, Jul 8, 2019

Surgical lung biopsy (SLB) in diffuse parenchymal lung disease (DPLD) has been associated with si... more Surgical lung biopsy (SLB) in diffuse parenchymal lung disease (DPLD) has been associated with significant in-hospital mortality (16% for non-elective patients, 1.7% for elective patients, overall 6.4%) [1, 2]. Overall 30-day mortality from SLB is reported at 1.5-4.5% from case series and 2.4% from a large European database [3]. Transbronchial cryobiopsy (TBC) has been proposed as a safer alternative to SLB for diagnosis of DPLD [4]. Existing studies on TBC report immediate procedural complications, but data on mortality at 30 and 90 days is sparse [2]. This is a report of 30-and 90-day mortality after TBC at a large volume interventional pulmonary practice in the USA examined in relation to indices of baseline disease severity. Individual case elements that led to practice changes are described. These descriptions elucidate clinical features potentially portending an increased risk of poor outcome.

Journal of Thoracic Disease, Feb 1, 2019

The Lancet Respiratory Medicine, May 1, 2019

Background: In patients with non-expandable lung, pleural fluid removal can result in excessively... more Background: In patients with non-expandable lung, pleural fluid removal can result in excessively negative pleural pressure, associated with chest discomfort, pneumothorax, and reexpansion pulmonary edema. Monitoring pleural pressure during thoracentesis may reduce discomfort and protect against complications. Methods: In this prospective randomized single-blind trial, subjects with large pleural effusions at two academic medical centers were randomly assigned (1:1 ratio) to symptom-guided ("control") versus symptom-plus-manometry-guided ("manometry") thoracentesis. All had free-flowing effusions meeting pre-specified criteria suggesting volume of at least 500 milliliters. Subjects, who were blinded to assignment, rated chest discomfort on visual analog scales before, during, and after drainage. Pleural pressure was measured at regular intervals in the manometry group. Drainage was discontinued before complete evacuation for persistent chest discomfort, incessant cough, complication, rapidly falling pleural pressure, or end-expiratory pleural pressure lower than-20 cm H2O (latter two only in the manometry group). We performed a modified intention-to-treat analysis. The primary outcome was overall procedural chest discomfort through 5 minutes post-procedure. This trial was registered at clinicaltrials.gov, NCT02677883. Findings: Between March 4, 2016 and September 8, 2017, 191 patients were screened. One hundred twenty-eight eligible subjects were randomized with four excluded from the final analysis of 62 subjects per group due to manometer malfunction (n=2), inability to access effusion due to pleural tumor burden (n=1), and inability to remain seated (n=1). There was no difference in the primary outcome of overall procedural chest discomfort between groups (mean difference 2.4, 95% CI-5.7-10.5; p = 0.78). Six asymptomatic pneumothoraces ex-vacuo occurred in the control group; no serious complications occurred in either group. Interpretation: Measurement of pleural pressure during large-volume thoracentesis does not alter procedure-related chest discomfort. This is the first study to directly assess the impact of pleural manometry on important patient-centered clinical outcomes during thoracentesis, and does not support its routine use. Funding: Centurion Medical Products PANEL: RESEARCH IN CONTEXT Evidence before this study Chest discomfort, reexpansion pulmonary edema, and pneumothorax ex-vacuo complicating thoracentesis have been associated with development of excessively negative pleural pressure in the setting of nonexpandable lung. Routine pleural manometry during aspiration has been advocated as potentially protective against these complications, but prospective comparative studies are lacking. Added value of this study This is the first prospective, randomized trial of routine pleural manometry during therapeutic thoracentesis for important clinical and patient-centered outcomes. Manometry did not reduce chest discomfort and there were no serious complications in either group. Implications of all the available evidence This randomized trial provides the most methodologically-rigorous evidence to date that routine manometry does not provide clinical or patient-centered benefit during therapeutic thoracentesis, supporting prior prospective case series and retrospective studies which have concluded the same.

Otolaryngology-Head and Neck Surgery, Aug 23, 2013

Subglottic stenosis is a fibrotic narrowing of the airway at the level of the cricoid cartilage, ... more Subglottic stenosis is a fibrotic narrowing of the airway at the level of the cricoid cartilage, which results in dyspnea, stridor, and airway obstruction. Proposed etiologies include intubation trauma, autoimmune/inflammatory disorders, infectious processes, and congenital narrowing. 1 Roughly 5% of cases are considered idiopathic. 2 Idiopathic subglottic stenosis (ISS) develops almost exclusively in females in their third to sixth decades. 3 Several authors have suggested a possible hormonal cause due to the preponderance of female patients noted in their respective series. 3,4 A combination of both medical and surgical management is employed at Mayo to maintain airway patency. Extraesophageal reflux has been implicated as a contributing factor in ISS. A landmark study by Koufman et al. identified a relationship between laryngotracheal stenosis (LTS) and laryngopharyngeal reflux (LPR). 5 Obesity is known to be associated with an increased incidence of estrogen related tumors. 6 Obesity increases total body estrogen by the process termed 'peripheral aromatization'. Clinically, patients with obesity appear to present more frequently with ISS then non-obese patients. The relationship between BMI and ISS has not been previously addressed in the current literature.

Chest, 2019

Respirology, 2019

Background and objective: The diagnostic yield of electromagnetic navigation bronchoscopy (ENB) i... more Background and objective: The diagnostic yield of electromagnetic navigation bronchoscopy (ENB) is inferior to that of computed tomography (CT)-guided needle biopsy for pulmonary nodules. One explanation for this is divergence between the nodule location on the preprocedure CT scan and its actual location during the procedure. Fluoroscopic ENB (F-ENB) consists of digital tomosynthesis using a conventional C-arm to re-register the target lesion based on near real-time imaging. We performed a retrospective review of ENB cases at our institution before and after introduction of F-ENB to assess diagnostic yield. Methods: All consecutive ENB procedures performed at our institution from

Respirology Case Reports, 2019

Persistent pulmonary opacities associated with respiratory symptoms that progress despite medical... more Persistent pulmonary opacities associated with respiratory symptoms that progress despite medical treatment present a diagnostic dilemma for pulmonologists. We describe the case of a 37‐year‐old woman presenting with progressive fatigue, shortness of breath, and weight loss over six months with a progressively worsening right basilar infiltrate on chest imaging in spite of antibacterial therapy. Transbronchial cryobiopsy was used to establish the diagnosis after a bronchoscopy with traditional forceps biopsies was non‐diagnostic. This case demonstrates the value of cryobiopsy as a second‐line strategy for pulmonary infiltrates when aetiology remains unclear after less invasive testing.

ABSTRACTAIMSTo evaluate computer-derived (CALIPER) CT variables against FVC change as potential d... more ABSTRACTAIMSTo evaluate computer-derived (CALIPER) CT variables against FVC change as potential drug trials endpoints in IPF.METHODS71 Royal Brompton Hospital (discovery cohort) and 23 Mayo Clinic Rochester and 24 St Antonius Hospital Nieuwegein IPF patients (validation cohort) were analysed. Patients had two CTs performed 5-30 months apart, concurrent FVC measurements and were not exposed to antifibrotics (to avoid confounding of mortality relationships from antifibrotic use). Cox regression analyses (adjusted for patient age and gender) evaluated outcome for annualized FVC and CALIPER vessel-related structures (VRS) change and examined the added prognostic value of thresholded VRS changes beyond standard FVC change thresholds.RESULTSChange in VRS was a stronger outcome predictor than FVC decline when examined as continuous variables, in discovery and validation cohorts. When FVC decline (≥10%) and VRS thresholds were examined together, the majority of VRS change thresholds indepen...

American journal of respiratory and critical care medicine, Jun 1, 2018