Real-world evidence of Pressure-Enabled Drug Delivery for trans-arterial chemoembolization and radioembolization among patients with hepatocellular carcinoma and liver metastases.

OBJECTIVES: Pressure-Enabled Drug Delivery (PEDD), a method using pressure to advance catheter-delivered drug distribution, can improve treatment for hepatocellular carcinoma (HCC) and liver metastases, but real-world evidence is limited. We compared baseline patient characteristics, clinical complexity, and post-procedure healthcare resource utilization (HRUs) and clinical complications for PEDD and non-PEDD procedures. METHODS: This study used a retrospective, longitudinal, cohort design of claims data from Clarivate's Real World Data Repository, which includes 98% of US payers with over 300 million unique patients from all US states. We identified patients with a trans-arterial chemoembolization (TACE) or trans-arterial radioembolization (TARE) from 1 January 2019 to 31 December 2022. Subsamples grouped patients with HCC receiving a TARE procedure at their first embolization and patients with metastatic colorectal cancer (CRC) that received a TARE procedure. We reported descriptive comparisons of our full sample of patients with HCC and liver metastases receiving PEDD versus non-PEDD procedures. We then conducted a matching-adjusted comparison of HRUs and clinical complications for PEDD and non-PEDD patients among our subsamples (HCC receiving a TARE procedure at their first embolization and patients with metastatic CRC that received a TARE procedure). Matching was based on baseline demographic and clinical characteristics using coarsened exact matching and propensity-score matching. HRUs included inpatient, outpatient, and emergency department visits. Clinical complications included ascites, cholecystitis, fatigue, gastric ulcer, gastritis, jaundice, LFT increase, lymphopenia, portal hypertension, and post-embolization syndrome. RESULTS: PEDD procedures were used on patients with worse baseline disease burdens: baseline Charlson comorbidity index (mean of 6.5 vs. 5.8), any prior clinical complication related to underlying disease (33.7 vs. 31.0%), and prior systemic therapy (22.1% vs. 16.2%). PEDD patients had a greater number of procedural codes indicative of technical complexity for TACE (PEDD mean = 226.3; non-PEDD mean = 134.5; p value <.01) and TARE (PEDD mean = 205.56; non-PEDD mean = 94.8; p value <0.01). Matching-adjusted analyses of patients with HCC and CRC demonstrated comparable HRU and clinical complications for PEDD and non-PEDD procedures post-index. CONCLUSION: Despite higher baseline disease burden and complexity, post-procedure HRU and clinical complications for PEDD patients were similar to non-PEDD patients. The complex baseline clinical profile may reflect selection of challenging cases for PEDD use. Future studies should validate the benefits observed with PEDD embolization in larger samples with greater statistical power.

Smoking Trends Among Adults With Behavioral Health Conditions in Integrated Health Care: A Retrospective Cohort Study.

OBJECTIVE: Individuals with behavioral health conditions (BHCs) smoke at high rates and have limited success with quitting, despite impressive gains in recent decades in reducing the overall prevalence of smoking in the United States. This study examined smoking disparities among individuals with BHCs within an integrated health care delivery system with convenient access to tobacco treatments. METHODS: The sample consisted of patients in an integrated health care delivery system in 2010-a group (N=155,733) with one or more of the five most prevalent BHCs (depressive disorders, anxiety disorders, substance use disorders, bipolar and related disorders, and attention-deficit hyperactivity disorder) and a group (N=155,733) without BHCs who were matched on age, sex, and medical home facility. The odds of smoking among patients with BHCs versus without BHCs were examined over four years using logistic regression generalized estimating equation models. Tobacco cessation medication utilization among a subset of smokers in 2010 was also examined. RESULTS: Although smoking prevalence decreased from 2010 to 2013 overall, the likelihood of smoking decreased significantly more slowly among patients with BHCs compared with patients without BHCs (p<.001), most notably among patients with substance use and bipolar and related disorders. Tobacco cessation medication use was low, and smokers with BHCs were more likely than smokers without BHCs to utilize these products (6.2% versus 3.6%, p<.001). CONCLUSIONS: Smoking decreased more slowly among individuals with BHCs compared with individuals without BHCs, even within an integrated health care system, highlighting the need to prioritize smoking cessation within specialty behavioral health treatment.