Research Spotlight

Israni, R., K. A. Betts, F. Mu, J. Davis, J. Wang, D. Anzalone, G. I. Uwaifo, H. Szerlip, V. Fonseca and E. Wu (2021). “Determinants of Hyperkalemia Progression Among Patients with Mild Hyperkalemia.” Adv Ther 38(11): 5596-5608.

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INTRODUCTION: The progression of mild hyperkalemia and the predictors of progression have not been well characterized. In this study we aimed to characterize the progression of hyperkalemia and identify the risk factors for hyperkalemia progression. METHODS: Adults with mild hyperkalemia (at least one serum potassium measure > 5.0 and ≤ 5.5 mEq/L) were identified using electronic medical records from the Research Action for Health Network (2012-2018). Progression to moderate-to-severe and progression to severe hyperkalemia were defined as the first occurrences of a serum potassium measure > 5.5 and > 6.0 mEq/L, respectively. Kaplan-Meier analyses were conducted to estimate progression rates for all patients and by pre-specified patient subgroups. Hazard ratios (HR) of moderate-to-severe and severe hyperkalemia progression were estimated using Cox models. RESULTS: Of 35,369 patients with mild hyperkalemia, 16.9% and 8.7% progressed to moderate-to-severe and severe hyperkalemia, respectively. Rates of hyperkalemia progression elevated with the severity of chronic kidney disease (CKD). The highest progression rates were seen in patients with CKD stage 5 (stage 5 vs. no CKD: moderate-to-severe, 50.2% vs. 12.0%; severe, 31.3% vs. 3.9%; p < 0.001). Higher progression rates were also observed in patients with heart failure, hypertension, and type II diabetes compared with patients without those conditions (all p < 0.001). The most prominent risk factors were CKD stage 5 (HR of progression to moderate-to-severe hyperkalemia, 3.32 [95% CI 3.03-3.64]; severe, 4.08 [3.55-4.69]), CKD stage 4 (2.19 [1.97-2.43], 2.28 [1.92-2.71]), CKD stage 3 (1.57 [1.46-1.68], 1.65 [1.46-1.87]), type I diabetes (1.37 [1.18-1.61], 1.54 [1.23-1.93]), and serum potassium (1.12 [1.10-1.15], 1.13 [1.10-1.17] per 0.1 mEq/L increase) (all p values < 0.05). CONCLUSION: Hyperkalemia progression rates increased significantly with CKD stage and were also higher among patients with higher baseline potassium level, heart failure, hypertension, and diabetes.

Yeh, R. W., W. Bachinsky, R. Stoler, C. Bateman, J. A. Tremmel, J. D. Abbott, S. Dohad, W. Batchelor, P. Underwood, D. J. Allocco and A. J. Kirtane (2021). “Rationale and design of a randomized study comparing the agent drug coated balloon to plain old balloon angioplasty in patients with In-stent restenosis.” Am Heart J 241: 101-107.

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BACKGROUND: Drug-coated balloon (DCB) technology was developed as an alternative treatment for obstructive coronary artery disease (CAD) and in-stent restenosis (ISR). Management of coronary ISR is clinically challenging and frequently encountered in practice. The Agent DCB uses an inactive excipient to effectively deliver a targeted, therapeutic dose of paclitaxel to the vessel wall. STUDY DESIGN: AGENT IDE is a prospective, multicenter, randomized controlled trial to evaluate superiority of the Agent DCB to balloon angioplasty in treating patients with ISR. A total of 480 patients with ISR of a previously treated lesion length <26 mm and reference vessel diameter >2.0 mm to ≤4.0 mm will be initially randomized. Subjects presenting with recent myocardial infarction (MI), complex lesions, or thrombus in the target vessel will be excluded. An adaptive group sequential design with one formal interim analysis for sample size re-estimation will be conducted, and the sample size may be increased to a maximum of 600 subjects. The primary endpoint is the rate of 12-month target lesion failure (TLF; composite of any ischemia-driven revascularization of the target lesion (TLR), target vessel related MI, or cardiac death) and will be tested for superiority in the test arm against the control. Functional status and general health-related quality of life will be measured by changes in the EQ-5D scores. Subjects will be followed for 5 years following the index procedure. CONCLUSION: This study will prospectively evaluate the safety and efficacy of Agent DCB in patients treated for coronary ISR.

Squiers, J. J., J. M. DiMaio, J. Van Zyl, B. Lima, G. Gonzalez-Stawisnksi, A. E. Rafael, D. M. Meyer and S. A. Hall (2021). “Long-term outcomes of patients with primary graft dysfunction after cardiac transplantation.” Eur J Cardiothorac Surg 60(5): 1178-1183.

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OBJECTIVES: The International Society of Heart and Lung Transplantation (ISHLT) criteria for primary graft dysfunction (PGD) after cardiac transplantation have been shown to stratify patient outcomes up to 1 year after transplantation, but scarce data are available regarding outcomes beyond the 1st year. We sought to characterize survival of patients with PGD following cardiac transplantation beyond the 1st year. METHODS: A retrospective review of consecutive patients undergoing isolated cardiac transplantation at a single centre between 2012 and 2015 was performed. Patients were diagnosed with none, mild, moderate or severe PGD by the ISHLT criteria. Survival was ascertained from the United Network for Organ Sharing database and chart review. Kaplan-Meier curves were plotted to compare survival. The hazard ratio for mortality associated with PGD severity was estimated using Cox-proportional hazards modelling, with a pre-specified conditional survival analysis at 90 days. RESULTS: A total of 257 consecutive patients underwent cardiac transplantation during the study period, of whom 73 (28%) met ISHLT criteria for PGD: 43 (17%) mild, 12 (5%) moderate and 18 (7%) severe. Patients with moderate or severe PGD had decreased survival up to 5 years after transplantation (log-rank P < 0.001). Landmark analyses demonstrated that patients with moderate or severe PGD were at increased risk of mortality during the first 90-days after transplantation as compared to those with none or mild PGD [hazard ratio (95% confidence interval) 18.9 (7.1-50.5); P < 0.001], but this hazard did not persist beyond 90-days in survivors (P = 0.64). CONCLUSIONS: A diagnosis of moderate or severe PGD is associated with increased mortality up to 5 years after cardiac transplantation. However, patients with moderate or severe PGD who survive to post-transplantation day 90 are no longer at increased risk for mortality as compared to those with none or mild PGD.

Squiers, J. J., S. Ghamande, T. Qiu, C. Robinson, C. Bertschy, A. C. Arroliga and W. Peters (2021). “Universal preprocedural SARS-CoV-2 testing protocol within a large healthcare system.” Br J Surg 108(10): e326-e327.

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Previous reports regarding preoperative SARS-CoV-2 screening and testing protocols have focused on the efficacy of identification of asymptomatic infection among individuals scheduled for elective surgery. Limited information is available regarding the safety of care for patients who test negative and undergo the scheduled procedure. Therefore, the present study sought to assess the safety of a preprocedural protocol instituted by the authors’ healthcare system by measuring the incidence of positive SARS-CoV-2 tests during the immediate postprocedural period and evaluating for any SARS-CoV-2 transmission related to these cases. [No abstract; excerpt from article].

Wani, S., R. Yadlapati, S. Singh, T. Sawas, D. A. Katzka and S. P.-E. E. N. E. C. P. Spechler (2021). “Post-Endoscopy Esophageal Neoplasia in Barrett’s Esophagus: Consensus Statements from an International Expert Panel.” Gastroenterology Oct 13;S0016-5085(21)03620-9. [Epub ahead of print].

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Esophageal adenocarcinoma (EAC) is a lethal cancer with increasing incidence and mortality rates over the last several decades; incidence rising seven-fold in the U.S. from 1975 to 2016. As many as 40% of patients with Barrett’s-associated EACs present with advanced disease with a dismal 5-year survival rate. Several factors contribute to identification at an advanced stage, including the limited effectiveness of current screening and surveillance strategies. [No abstract; excerpt from article].