Research Spotlight

Davis, J., Israni, R., Mu, F., Cook, E.E., Szerlip, H., Uwaifo, G., Fonseca, V. and Betts, K.A. (2021). “Inpatient management and post-discharge outcomes of hyperkalemia.” Hosp Pract (1995) May 26;1-7. [Epub ahead of print]. 1-7.

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OBJECTIVES: Patients with hyperkalemia are commonly treated in the inpatient setting; however, real-world evidence is limited. The purpose of this study was to describe the inpatient management and post-discharge outcomes among patients with hyperkalemia. METHODS: Electronic medical record data (2012-2018) were used to analyze US adult patients with an inpatient stay with hyperkalemia (≥1 potassium value >5.0mEq/L). Patient characteristics, treatments, and monitoring six months prior to and during the inpatient stay, and hyperkalemia recurrence and inpatient readmissions post-discharge were summarized and compared among patients with mild (>5.0-5.5mEq/L), moderate (>5.5-6.0), and severe (>6.0) hyperkalemia. RESULTS: Of the 21,793 patients, 69.2% had mild, 19.0% had moderate, and 11.8% had severe hyperkalemia during inpatient care. The most common inpatient treatments were temporizing agents (mild: 28.9%; moderate: 46.0%; severe: 73.0%), diuretics (32.7%; 37.1%; 34.6%), and sodium-polystyrene sulfonate (11.7%; 27.8%; 45.3%). Almost no patients (0.1%) received a potassium binder at discharge. Most patients (86.8%) had their potassium levels return to ≤5.0mEq/L during the inpatient stay. Death during the inpatient stay occurred in 12.3% of mild, 15.5% of moderate, and 19.5% of severe hyperkalemic patients. Within 30 days of discharge, hyperkalemia recurred in 13.3%, 15.4%, and 18.4% of patients with mild, moderate, and severe hyperkalemia, respectively. Additionally, 19.7%, 21.5%, and 19.6% of patients were readmitted to inpatient care within 30 days post-discharge. CONCLUSION: Among patients with hyperkalemia in the inpatient setting, treatment and normalization of serum potassium levels were common. However, death, readmission, and hyperkalemia recurrence were also fairly common across all cohorts. Future studies examining measures to reduce inpatient death, readmission, and hyperkalemia recurrence among patients with hyperkalemia in inpatient care are warranted.

Karmpaliotis, D., Stoler, R., Walsh, S., El-Jack, S., Potluri, S., Moses, J., Oldroyd, K., Banning, A., Webster, M., Zaman, A., Wu, W., Ahmed, M., Underwood, P. and Allocco, D. (2021). “Safety and efficacy of Everolimus-Eluting bioabsorbable Polymer-Coated stent in patients with long coronary lesions: The EVOLVE 48 study.” Catheter Cardiovasc Interv May 29. [Epub ahead of print].

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OBJECTIVES: The EVOLVE 48 study evaluated the safety and effectiveness of the SYNERGY 48 mm stent for the treatment of long lesions. BACKGROUND: Clinical evidence supporting the use of very long stents during percutaneous coronary intervention (PCI) is limited. The bioabsorbable polymer SYNERGY stent has shown good long-term data in a broad population of patients undergoing PCI. METHODS: Patients with lesion length >34- ≤44 mm and reference vessel diameter (RVD) ≥2.5- ≤ 4.0 mm were enrolled in this prospective, multicenter, single-arm study. The primary endpoint was 12-month target lesion failure (TLF; composite of target lesion revascularization [TLR], target-vessel myocardial infarction [TV-MI], or cardiac death) compared to a prespecified performance goal (PG). RESULTS: A total of 100 patients with mean lesion length of 35.34 ± 7.15 mm (26 patients with lesion length > 40 mm) and mean RVD 2.72 ± 0.44 mm were enrolled. Moderate to severe calcification was present in 30% of the patients and 89% had pre-TIMI flow grade 3. The rates of technical and clinical procedural success were 100%. One-year TLF was observed in 4.1% patients compared to a prespecified PG of 19.5% (95% upper confidence bound = 9.1%; p < 0.0001). Cardiac death and TLR were each observed in one patient, and TV-MI in two patients treated with SYNERGY 48 mm stent. Between the 1-2-year timeframe, TV-MI occurred in one additional patient. None of the patients experienced a definite or probable stent thrombosis through 2 years. CONCLUSIONS: PCI of long coronary lesions with the 48 mm SYNERGY stent demonstrated good procedural and clinical outcomes through 2 years, supporting its clinical safety and efficacy.

Basu, R., Steiner, A.C. and Stevens, A.B. (2021). “Long-Term Care Market Trend and Patterns of Caregiving in the U.S.” J Aging Soc Policy May 21;1-18. [Epub ahead of print]. 1-18.

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Informal care is a major source of long-term services and supports (LTSS) for older adults in the U.S. However, the increasing gap between available family caregivers and those needing LTSS in coming years warrants better understanding of the balance between informal and formal home or community-based LTSS to meet the growing demand. The current study aimed to 1) identify patterns of informal and formal LTSS use among community-dwelling individuals, and 2) examine if the supply of formal LTSS predicts the use of informal care. These aims were investigated by linking the market supply of formal LTSS at the state-level to the Health and Retirement Survey data (N = 7,781). Results provide important empirical evidence that patterns of informal and formal LTSS use among older adults are heterogeneous and market supply of formal home and community-based services (HCBS) significantly predicts the use of informal care. Most older adults rely on informal care in combination with some formal supports, suggesting that the two systems work in tandem to meet the growing needs of LTSS. This offers important implications for states allocating resources to meet the LTSS needs of older adults and individuals with disabilities since states play key roles in U.S. long-term care policies.

Kandimalla, R., Wang, W., Yu, F., Zhou, N., Gao, F., Spillman, M., Moukova, L., Slaby, O., Salhia, B., Zhou, S., Wang, X. and Goel, A. (2021). “OCaMIR – A noninvasive, diagnostic signature for early stage ovarian cancer: a multi-cohort retrospective and prospective study.” Clin Cancer Res May 25;clincanres.0267.2021. [Epub ahead of print].

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PURPOSE: Due to the lack of effective screening approaches and early detection biomarkers, ovarian cancer (OC) has the highest mortality rates among gynecological cancers. Herein, we undertook a systematic biomarker discovery and validation approach to identify microRNA biomarkers for the early detection of OC. EXPERIMENTAL DESIGN: During the discovery phase, we performed small-RNA sequencing in stage-I high-grade serous OC (n=31), which was validated in multiple, independent datasets (TCGA, n=543; GSE65819, n=87). Subsequently, we performed multivariate logistic regression-based training in a serum dataset (GSE106817, n=640), followed by its independent validation in three datasets (GSE31568, n=85; GSE113486, n=140; Czech Republic cohort, n=192) and one prospective serum cohort (n=95). In addition, we evaluated the specificity of OCaMIR, by comparing its performance in other cancers (GSE31568 cohort, n=369). RESULTS: The OCaMIR demonstrated a robust diagnostic accuracy in the stage-I high-grade serous OC patients in the discovery cohort (area under the curve [AUC)]value=0.99), which was consistently reproducible in both stage-I (AUC=0.96) and all stage patients (AUC=0.89) in the TCGA cohort. Logistic regression-based training and validation of OCaMIR achieved AUC values of 0.89 (GSE106817), 0.85 (GSE31568), 0.86 (GSE113486), and 0.82 (Czech Republic cohort) in the retrospective serum validation cohorts, as well as prospective validation cohort (AUC=0.92). More importantly, OCaMIR demonstrated a significantly superior diagnostic performance compared to CA125 levels, even in stage-I patients, and was more cost effective: highlighting its potential role for the early detection of ovarian cancer. CONCLUSIONS: Small RNA sequencing identified a robust non-invasive miRNA signature for early stage serous ovarian cancer detection.

Lim, D.S., Smith, R.L., Zahr, F., Dhoble, A., Laham, R., Lazkani, M., Kodali, S., Kliger, C., Hermiller, J., Vora, A., Sarembock, I.J., Gray, W., Kapadia, S., Greenbaum, A., Rassi, A., Lee, D., Chhatriwalla, A., Shah, P., Rodés-Cabau, J., Ibrahim, H., Satler, L., Herrmann, H.C., Mahoney, P., Davidson, C., Petrossian, G., Guerrero, M., Koulogiannis, K., Marcoff, L. and Gillam, L. (2021). “Early outcomes from the CLASP IID trial roll-in cohort for prohibitive risk patients with degenerative mitral regurgitation.” Catheter Cardiovasc Interv May 18. [Epub ahead of print].

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OBJECTIVES: We report the 30-day outcomes from the roll-in cohort of the CLASP IID trial, representing the first procedures performed by each site. BACKGROUND: The currently enrolling CLASP IID/IIF pivotal trial is a multicenter, prospective, randomized trial assessing the safety and effectiveness of the PASCAL transcatheter valve repair system in patients with clinically significant MR. The trial allows for up to three roll-in patients per site. METHODS: Eligibility criteria were: DMR ≥3+, prohibitive surgical risk, and deemed suitable for transcatheter repair by the local heart team. Trial oversight included a central screening committee and echocardiographic core laboratory. The primary safety endpoint was a 30-day composite MAE: cardiovascular mortality, stroke, myocardial infarction (MI), new need for renal replacement therapy, severe bleeding, and non-elective mitral valve re-intervention, adjudicated by an independent clinical events committee. Thirty-day echocardiographic, functional, and quality of life outcomes were assessed. RESULTS: A total of 45 roll-in patients with mean age of 83 years and 69% in NYHA class III/IV were treated. Successful implantation was achieved in 100%. The 30-day composite MAE rate was 8.9% including one cardiovascular death (2.2%) due to severe bleeding from a hemorrhagic stroke, one MI, and no need for re-intervention. MR≤1+ was achieved in 73% and ≤2+ in 98% of patients. 89% of patients were in NYHA class I/II (p < .001) with improvements in 6MWD (30 m; p = .054) and KCCQ (17 points; p < .001). CONCLUSIONS: Early results representing sites with first experience with the PASCAL repair system showed favorable 30-day outcomes in patients with DMR≥3+ at prohibitive surgical risk.