Conflicts of Interest in Clinical Practice: Cleveland Clinic Policy and Experience.

The Cleveland Clinic Innovation Management and Conflict of Interest ("IM&COI") Program implemented a policy on Conflicts of Interest in Clinical Practice in 2013. The policy requires review of financial interests greater than $20,000 in a year, or more than 5% equity in a company, when the clinician is prescribing or using products of the company with which they have a relationship. The IM&COI Committee developed definitions for low, medium and high levels of annual compensation and risk and uses a "Matrix" to guide disclosure based on these factors.

Exhaled Breath Volatile Organic Compounds in Pregnancy: A Pilot Study.

Objective:  This study aimed to assess the volatile organic compounds (VOC)s in breath samples collected noninvasively from pregnant women during pregnancy and postpartum and compare it with nonpregnant controls.

Study Design:  This pilot study included 50 subjects: 10 pregnant patients in their first trimester, 10 in second trimester, 10 in third trimester, 10 in the first postpartum week, and 10 nonpregnant subjects as a control. We collected exhaled breath from subjects who reported to be healthy and free of any respiratory symptoms.

Characteristic disease defects in circulating endothelial cells isolated from patients with pulmonary arterial hypertension.

Pulmonary arterial hypertension (PAH) is a progressive disease characterized by elevated pulmonary arterial pressures that can lead to right heart failure and death. No cure exists for this disease, but therapeutic advancements have extended its median survival from 2 to 7 years. Mechanistic research in PAH has been limited by factors including that a) animal models do not fully recapitulate the disease or provide insights into its pathogenesis, and b) cellular material from PAH patients is primarily obtained from donor lungs during autopsy or transplantation, which reflect end-stage disease.

Volatile organic compounds in exhaled breath of newborns: a pilot study.

Objective: To assess volatile organic compounds (VOCs) in breath samples collected non-invasively from preterm and full-term infants.

Methods: This was a pilot study included preterm and full-term infants who were not intubated or suspected or diagnosed with metabolic or gastrointestinal disorders. The samples were analyzed for VOCs using a selected-ion flow-tube mass spectrometer.

Exhaled Breath Analysis Using Selected Ion Flow Tube Mass Spectrometry and Disease Severity in Heart Failure.

Exhaled breath volatile organic compounds (VOCs) are elevated in heart failure (HF). The ability of VOCs to predict long term cardiovascular mortality and morbidity has not been independently verified. In 55 patients admitted with acute decompensated heart failure (ADHF), we measured exhaled breath acetone and pentane levels upon admission and after 48 h of diuresis.

Impact of Esophageal Pressure Measurement on Pulmonary Hypertension Diagnosis in Patients With Obesity.

Background: Elevated intrathoracic pressure could affect pulmonary vascular pressure measurements and influence pulmonary hypertension (PH) diagnosis and classification. Esophageal pressure (P) measurement adjusts for the increase in intrathoracic pressure, better reflecting the pulmonary hemodynamics in patients with obesity.

Research Question: In individuals with obesity, what is the impact of adjusting pulmonary hemodynamic determinations for P on PH diagnosis and classification? Can P be estimated by positional or respiratory hemodynamic changes?

Study Design And Methods: In this prospective cohort study, we included patients with obesity who underwent right heart catheterization and demonstrated elevated pulmonary artery wedge pressure (PAWP; ≥ 12 mm Hg).

Predictors of survival in portopulmonary hypertension: a 20-year experience.

Background And Objectives: Portopulmonary hypertension (PoPH) is a rare complication of portal hypertension associated with poor survival. Scarce data is available on predictors of survival in PoPH with conflicting results. We sought to characterize the outcomes and variables associated with survival in a large cohort of patients with PoPH in an American population of patients.

Surge capacity and capability of intensive care units across a large healthcare system: An operational blueprint for regional integration.

Objective: Many hospitals were unprepared for the surge of patients associated with the spread of coronavirus disease 2019 (COVID-19) pandemic. We describe the processes to develop and implement a surge plan framework for resource allocation, staffing, and standardized management in response to the COVID-19 pandemic across a large integrated regional healthcare system.

Setting: A large academic medical center in the Cleveland metropolitan area, with a network of 10 regional hospitals throughout Northeastern Ohio with a daily capacity of more than 500 intensive care unit (ICU) beds.

Cutaneous iontophoresis of vasoactive medications in patients with scleroderma-associated pulmonary arterial hypertension.

Background: It remains unknown whether the cutaneous microvascular responses are different between patients with scleroderma-associated pulmonary arterial hypertension (SSc-PAH) and SSc without pulmonary hypertension (PH).

Methods: We included 59 patients with SSc between March 2013 and September 2019. We divided patients into 4 groups: (a) no PH by right heart catheterization (RHC) (n = 8), (b) no PH by noninvasive screening tests (n = 16), (c) treatment naïve PAH (n = 16), and (d) PAH under treatment (n = 19).

The breath print represents a novel biomarker of malnutrition in pulmonary arterial hypertension: A proof of concept study.

Background: The breath print is a quantitative measurement of molecules in exhaled breath and represents a new frontier for biomarker identification. It is unknown whether this state-of-the-art, noninvasive method can detect malnutrition. We hypothesize that individuals with malnutrition will present with a distinguishable breath print.

Diagnosis of Clostridioides difficile infection by analysis of volatile organic compounds in breath, plasma, and stool: A cross-sectional proof-of-concept study.

Clostridioides difficile infection (CDI) is an important infectious cause of antibiotic-associated diarrhea, with significant morbidity and mortality. Current diagnostic algorithms are based on identifying toxin by enzyme immunoassay (EIA) and toxin gene by real-time polymerase chain reaction (PCR) in patients with diarrhea. EIA's sensitivity is poor, and PCR, although highly sensitive and specific, cannot differentiate infection from colonization.

Optimal Tricuspid Regurgitation Velocity to Screen for Pulmonary Hypertension in Tertiary Referral Centers.

Background: A mean pulmonary artery pressure >20 mm Hg now defines pulmonary hypertension. We hypothesize that echocardiographic thresholds must be adjusted.

Research Question: Should tricuspid regurgitation velocity thresholds to screen for pulmonary hypertension be revised, given the new hemodynamic definition?

Study Design And Methods: This multicenter retrospective study included 1,608 patients who underwent both echocardiography and right heart catherization within 4 weeks.

Causes and Circumstances of Death in Portopulmonary Hypertension.

Unlabelled: The causes and circumstances surrounding death are poorly studied in patients with portopulmonary hypertension (PoPH). We sought to determine the specific reasons for dying and characteristics surrounding this process in patients with PoPH.

Methods: All deaths of patients with PoPH followed in the Cleveland Clinic Pulmonary Vascular Program were prospectively reviewed by the pulmonary hypertension team between 1996 and 2020.

Abnormal levels of apolipoprotein A-I in chronic thromboembolic pulmonary hypertension.

Recent studies have shown low high-density lipoprotein cholesterol (HDL-C) and dysregulated lipid metabolism in chronic thromboembolic pulmonary hypertension (CTEPH). Apolipoprotein A-I (ApoA-I) is the major protein component of HDL-C and mediates most of its functions. We hypothesize that ApoA-1 and its oxidative state might be more sensitive biomarkers in CTEPH.

Is pulmonary vascular resistance index better than pulmonary vascular resistance in predicting outcomes in pulmonary arterial hypertension?

Background: In contrast to pulmonary vascular resistance (PVR), PVR index (PVRI) accounts for variations in body habitus. We tested the association of PVRI compared to PVR with clinical outcomes in lean and obese (BMI ≥30 kg/m) patients with pulmonary arterial hypertension (PAH).

Methods: This retrospective study included adult patients with PAH who underwent right heart catheterization at Cleveland Clinic between February 1992 and November 2019.

Disease-specific platelet signaling defects in idiopathic pulmonary arterial hypertension.

Idiopathic pulmonary arterial hypertension (IPAH) is a rapidly progressive disease with several treatment options. Long-term mortality remains high with great heterogeneity in treatment response. Even though most of the pathology of IPAH is observed in the lung, there is systemic involvement.

Strategic Planning for the Chest Clinician.

Having a strategic plan is important to reach organizational goals. Equally important is knowing how to develop and execute that plan. Also, such plans evolve and are executed in the context of the organization's culture, which is another critical success element.

Informing Healthcare Decisions with Observational Research Assessing Causal Effect. An Official American Thoracic Society Research Statement.

Decisions in medicine are made on the basis of knowledge and reasoning, often in shared conversations with patients and families in consideration of clinical practice guideline recommendations, individual preferences, and individual goals. Observational studies can provide valuable knowledge to inform guidelines, decisions, and policy. The American Thoracic Society (ATS) created a multidisciplinary committee to develop a research statement to clarify the role of observational studies-alongside randomized controlled trials (RCTs)-in informing clinical decisions in pulmonary, critical care, and sleep medicine.

An Algorithm for Classifying Patients Most Likely to Develop Severe Coronavirus Disease 2019 Illness.

Objectives: To develop an algorithm that predicts an individualized risk of severe coronavirus disease 2019 illness (i.e., ICU admission or death) upon testing positive for coronavirus disease 2019.

Creating an Organizational Culture for the Chest Physician: Creating an Organizational Culture for the Chest Physician.

Culture is a key driver of organizational performance and underpins strategy. As previously discussed, if the strategy is the plants and the garden plan for a garden, the culture is the soil. Without a healthy culture, nothing will grow, irrespective of how well planned the garden or how beautiful the individual flowers.