Background: Clinical implications of online 3-dimensional optical frequency domain imaging (3D-OFDI)-guided stenting for bifurcation lesions have not been investigated in the randomized controlled trials. The purpose of this study was to determine whether online 3D-OFDI-guided stenting is superior to angiography-guided percutaneous coronary intervention (PCI) in terms of incomplete stent apposition at the bifurcation segment. Methods: The OPTIMUM trial (Online 3-Dimensional Optical Frequency Domain Imaging to Optimize Bifurcation Stenting Using UltiMaster Stent) was a randomized, multicenter clinical trial. Eligible patients had an angiographically significant stenosis in the bifurcation lesion treated with a provisional single stent strategy using the Ultimaster sirolimus eluting stent. Patients were randomly allocated to either online 3D-OFDI-guided or angiography-guided PCI. Patients randomized to 3D-OFDI guidance underwent online 3D-OFDI assessment after rewiring into the jailed side branch after stenting and proximal optimization technique, while in the angiography guidance arm, rewiring was performed using conventional fluoroscopic/angiographic guidance. The primary end point of this trial was the postprocedural average percentage of malapposed struts per lesion assessed by OFDI in the confluence zone of the main and side branches. Results: Between June 8, 2017 and September 26, 2018, 110 patients with 111 bifurcation lesions were randomized at 4 Japanese centers. Of these, 56 patients with 57 lesions were treated with 3D-OFDI-guided PCI, whereas 54 patients with 54 lesions were treated with angiography-guided PCI. In the 3D-OFDI guidance arm, the feasibility of online 3D-OFDI was 98.2%. The average percentage of incomplete stent apposition per lesion at bifurcation was lower in the 3D-OFDI guidance arm than that in the angiography guidance arm (19.5±15.8% versus 27.5±14.2%, P =0.008). The superiority of the 3D-OFDI guidance arm was also confirmed in the strut level analysis (odds ratio: 0.54 [95% CI, 0.36–0.81]; P =0.003). Conclusions: Online 3D-OFDI-guided bifurcation PCI was superior to angiography-guided bifurcation PCI in terms of acute incomplete stent apposition at bifurcation. Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02972489.

BACKGROUND: The SPYRAL HTN-ON MED (Global Clinical Study of Renal Denervation With the Symplicity Spyral Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension in the Absence of Antihypertensive Medications)trial showed significant office and nighttime systolic blood pressure (BP) reductions in patients with hypertension following renal denervation (RDN) compared with sham-control patients, despite similar 24-hour BP reductions. We compared antihypertensive medication and BP changes among prespecified subpopulations. METHODS: The multicenter, randomized, sham-controlled, blinded SPYRAL HTN-ON MED trial (n=337) evaluated BP changes after RDN compared with a sham procedure in patients with hypertension prescribed 1 to 3 antihypertensive drugs. Most patients (n=187; 54%) were enrolled outside the United States, while 156 (46%) US patients were enrolled, including 60 (18%) Black Americans. RESULTS: Changes in detected antihypertensive drugs were similar between RDN and sham group patients in the outside US cohort, while drug increases were significantly more common in the US sham group compared with the RDN group. Patients from outside the United States showed significant reductions in office and 24-hour mean systolic BP at 6 months compared with the sham group, whereas BP changes were similar between RDN and sham in the US cohort. Within the US patient cohort, Black Americans in the sham control group had significant increases in medication burden from baseline through 6 months ( P =0.003) but not in the RDN group ( P =0.44). CONCLUSIONS: Patients enrolled outside the United States had minimal antihypertensive medication changes between treatment groups and had significant office and 24-hour BP reductions compared with the sham group. Increased antihypertensive drug burden in the US sham cohort, especially among Black Americans, may have diluted the treatment effect in the combined trial population. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02439775.

Background: This paper looks to validate the risk score from the Heart Failure Association of the European Society of Cardiology and the International Cardio-Oncology Society (HFA-ICOS) for predicting potential cardiotoxicity from anticancer therapy for patients positive for human epidermal growth factor receptor 2. Methods: A total of 507 patients with at least five years since index diagnosis of breast cancer were retrospectively divided according to the HFA-ICOS risk proforma. According to level of risk, these groups were assessed for rates of cardiotoxicity via mixed-effect Bayesian logistic regression model. Results: A follow-up of five years observed cardiotoxicity of 3.3% (n = 3) in the low-risk, 3.3% (n = 10) in the medium-risk, 4.4% (n = 6) in the high-risk, and 38% (n = 6) in the very-high-risk groups respectively. For cardiac events related to treatment, the risk was significantly higher for the very-high-risk category of HFA-ICOS compared to other categories (Beta = 3.1, 95% CrI: 1.5, 4.8). For overall cardiotoxicity related to treatment, the area under the curve was 0.643 (CI 95%: 0.51, 0.76), with 26.1% (95% CI: 8%, 44%) sensitivity and 97.9% (95% CI: 96%, 99%) specificity. Conclusions: The HFA-ICOS risk score has moderate power in predicting cancer therapy–related cardiotoxicity in HER2-positive breast cancer patients.

Although coronary computed tomographic angiography (CTA) is widely used for anatomical evaluation, its advanced analyses, including plaque characterization, computed tomography-derived fractional flow reserve (CT-FFR), and radiomics signature extraction, hold promise for improved prediction of major adverse cardiovascular events (MACE). The aim of this meta-analysis was to assess the added prognostic value of advanced coronary CTA-based analyses in predicting MACE. A systematic search of PubMed, Embase, and CENTRAL identified studies reporting coronary CTA-based advanced analyses predicting MACE. The pooled HR of advanced coronary CTA-based analyses for the prediction of MACE was the primary outcome measure. The secondary endpoint included the mean difference in C index (ΔC index) between advanced coronary CTA-based predictive models and conventional models. MACE were defined according to study-level definitions. The protocol was registered in the International Prospective Register of Systematic Reviews (CRD42024606545). Of 75 studies, 52 were included in the primary analysis of HRs (n = 58,123) and 32 in the secondary analysis of ΔC index. The median follow-up time was 36 months (Q1-Q3: 24-57 months). Most advanced coronary CTA-based analyses, including CT-FFR, high-risk plaque, fat attenuation index, total plaque volume or low-attenuation plaque volume, and radiomics-derived scores, demonstrated a significant and consistent association with MACE, observed across both pooled unadjusted and adjusted HRs. In particular, CT-FFR (HR: 6.14 [95% CI: 3.75-10.05]; P < 0.01) and high-risk plaque (HR: 4.05 [95% CI: 3.16-5.18]; P < 0.01) showed the strongest associations with MACE despite a moderate to severe between-studies heterogeneity for most of the pooled analyses. Advanced coronary CTA-based analyses show consistent association to the occurrence of MACE, suggesting their potential for refining cardiovascular risk stratification on top of conventional clinical risk assessment. Given the heterogeneity of advanced imaging analyses by coronary CTA and their varying pathophysiological targets, future comparative studies are needed to evaluate their implementation in different clinical scenarios.

Heart failure (HF) is a multi-faceted, complex clinical syndrome characterized by significant morbidity, high mortality rate, reduced quality of life, and rapidly increasing healthcare costs. A larger proportion of these costs comprise both ambulatory and emergency department visits, as well as hospital admissions. Despite the methods used by telehealth (TH) to improve self-care and quality of life, patient outcomes remain poor. HF management is associated with numerous challenges, such as conflicting evidence from clinical trials, heterogeneity of TH devices, variability in patient inclusion and exclusion criteria, and discrepancies between healthcare systems. A growing body of evidence suggests there is an unmet need for increased individualization of in-hospital management, continuous remote monitoring of patients pre and post-hospital admission, and continuation of treatment post-discharge in order to reduce re-hospitalizations and improve long-term outcomes. This review summarizes the current state-of-the-art for HF and associated novel technologies and advancements in the most frequently used types of TH (implantable sensors), categorizing devices in their preclinical and clinical stage, bench-to-bedside implementation challenges, and future perspectives on remote HF management to improve long-term outcomes of HF patients. The Review also highlights recent advancements in non-invasive remote monitoring technologies demonstrated by a few pilot observational prospective cohort studies.

BACKGROUND: Uncontrolled hypertension is common in patients with chronic kidney disease (CKD), putting these patients at high risk for adverse cardiovascular events. Radiofrequency renal denervation (RDN) lowers blood pressure (BP) in patients with hypertension. The Global SYMPLICITY Registry DEFINE enrolled over 3500 patients with uncontrolled hypertension worldwide, including patients with moderate-to-severe CKD. METHODS: Patients were categorized by their baseline estimated glomerular filtration rate (estimated glomerular filtration rate [eGFR], mL/min per 1.73 m ² ): eGFR ≥60 (no-CKD, n=2539), eGFR ≥45 to <60 (stage 3a, n=496), eGFR ≥30 to <45 (stage 3b, n=256). BP changes from baseline through 3 years were compared between groups. One-year data for 74 CKD stage 4 patients were also assessed. Safety events and eGFR were reported at all time points. RESULTS: Average baseline office systolic BP was similar across the 3 comparator groups (range: 162.8±26.4–164.7±24.8 mm Hg). At 3 years, office systolic BP reductions from baseline were −17.2±28.1 mm Hg, −12.1±30.3 mm Hg, and −13.0±27.3 mm Hg in the no-CKD, CKD 3a, and CKD 3b groups, respectively (all P <0.0001). A mild decline in eGFR through 1 year occurred in the no-CKD group but not in any CKD group. Three-year mortality was 4.3%, 7.0%, and 15.2% in no-CKD, CKD 3a, and CKD 3b groups, respectively. Adverse renal events were rare (<1.0%) across all 3 groups. Antihypertensive medication burden remained high in the no-CKD and CKD 3a groups but declined over 3 years in the CKD 3b group ( P =0.007). CONCLUSIONS: In patients with uncontrolled hypertension and moderate-to-severe CKD, radiofrequency RDN results in clinically meaningful and durable BP reduction without renal or vascular safety concerns. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01534299.