A Pilot Single-Blinded, Randomized, Controlled Trial Comparing BNT162b2 vs. JNJ-78436735 Vaccine as the Third Dose After Two Doses of BNT162b2 Vaccine in Solid Organ Transplant Recipients.

Solid Organ Transplant (SOT) recipients are at significant higher risk for COVID-19 and due to immunosuppressive medication, the immunogenicity after vaccination is suboptimal. In the previous studies, booster method showed significant benefit in this population. In the current study, we compared using a mix-and-match method vs. same vaccine as a third dose in SOT recipients. This was a patient-blinded, single center, randomized controlled trial comparing BNT162b2 vs. JNJ-78436735 vaccine as the third dose after two doses of BNT162b2 vaccine. We included adult SOT recipients with functional graft who had received two doses of BNT162b2 vaccine. Participants were randomly assigned to receive either BNT162b2 or JNJ-78436735 in one-to-one ratio. Primary outcome was SARS-CoV-2 IgG positivity at 1 month after the third dose. Sixty SOT recipients, including 36 kidney, 12 liver, 2 lung, 3 heart, and 5 combined transplants, were enrolled, and 57 recipients were analyzed per protocol. There were no statistically significant differences between the two vaccine protocols for IgG positivity (83.3% vs. 85.2% for BNT162b2 and JNJ-78436735, respectively, p = 0.85, Odds Ratio 0.95, 95% Confidence Interval 0.23-4.00). Comparison of the geometric mean titer demonstrated a higher trend with BNT162b2 (p = 0.09). In this pilot randomized controlled trial comparing mix and match method vs. uniform vaccination in SOT recipients, both vaccines were safely used. Since this was a small sample sized study, there was no statistically significant difference in immunogenicity; though, the mix and match method showed relatively lower geometric mean titer, as compared to uniform vaccine. Further studies need to be conducted to determine duration of this immunogenicity. Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT05047640?term=20210641&draw=2&rank=1, identifier 20210641.

Heart Failure in Older Adults.

Heart failure (HF) is a leading cause of morbidity, hospitalization, and mortality in older adults and a growing public health problem placing a huge financial burden on the health care system. Many challenges exist in the assessment and management of HF in geriatric patients, who often have coexisting multimorbidity, polypharmacy, cognitive impairment, and frailty. These complex "geriatric domains" greatly affect physical and functional status as well as long-term clinical outcomes. Geriatric patients have been under-represented in major HF clinical trials. Nonetheless, available data suggest that guideline-based medical and device therapies improve morbidity and mortality. Nonpharmacologic strategies, such as exercise training and dietary interventions, are an active area of research. Targeted geriatric evaluation, including functional and cognitive assessment, can improve risk stratification and guide management in older patients with HF. Clinical trials that enroll older patients with multiple morbidities and HF and evaluate functional status and quality of life in addition to mortality and cardiovascular morbidity should be encouraged to guide management of this age group.

Heart failure with normal ejection fraction: current diagnostic and management strategies.

Heart failure with normal ejection fraction (HFNEF), previously known as diastolic heart failure (HF), is defined as a syndrome of HF with normal or near normal ejection fraction (≥ 50%) and evidence of abnormal left ventricular (LV) diastolic function. It represents about 50% of patients diagnosed with HF. HFNEF is not a benign disease as it carries a morbidity and mortality risk as high as that associated with HF and reduced ejection fraction (HFREF). HFNEF shares some risk factors, hemodynamic consequences and clinical presentations with HFREF, though they differ in the pathophysiology and cardiac morphology. Therapies such as ß-blockers (BBs) and angiotensin-receptor blockers (ARBs), which are beneficial in HFREF have not shown a survival benefit in HFNEF. Therapies focus on control of hypertension, control of heart rate, revascularization in case of ischemia for long term management and use of diuretics in acute decompensated HFNEF. Exercise therapy improves performance in HFNEF.