Clinical outcomes following tricuspid transcatheter edge-to-edge repair with PASCAL: A meta-analysis.

BACKGROUND: Patients with severe tricuspid regurgitation (TR) exhibit high morbidity and mortality. Tricuspid transcatheter edge-to-edge repair (T-TEER) is a rapidly evolving strategy to address the unmet clinical need of severe TR therapies. OBJECTIVE: Organize the current body of evidence on outcomes following use of the PASCAL (Edwards Lifesciences) system for T-TEER. METHODS: For this meta-analysis, we searched the MEDLINE/PubMed, Embase, and Cochrane databases for keywords ["tricuspid"] and ["transcatheter" or "edge-to-edge"] and ["PASCAL" or "leaflet repair" or "valve repair"] from the database inception until January 11, 2023. Primary outcomes of interest were procedural success, mortality, New York Heart Association (NYHA) functional class, 6-min walking distance (6MWD), and TR severity. RESULTS: A total of 549 patients undergoing PASCAL or PASCAL Ace T-TEER were included. The mean age ranged from 71.0 to 80.3 years, with 25.0 to 63.6% females. The follow-up duration ranged from 30 days to 1 year. The success rate was 83.5% (409/490). There was improvement in symptoms based on NYHA classification (at 1- to 6-months; NYHA ≥3 RR 0.27 [95% CI 0.19-0.39]; p < 0.001) and 6MWD (at 1-month; 50.96 [95% CI 32.34-69.59]; p < 0.001) post-procedure. On imaging, there was improvement in TR severity post-procedure (at 1- to 12-months; ≥ severe TR 0.21 [95% CI 0.14-0.31]; p < 0.001), which remained significant with each study removed. CONCLUSION: PASCAL for T-TEER is associated with high procedural success rates along with improvements in NYHA functional class, TR severity, 6MWD, and patient-reported outcomes.

Association between ibrutinib treatment and hypertension.

BACKGROUND: Ibrutinib is a tyrosine kinase inhibitor most commonly associated with atrial fibrillation. However, additional cardiotoxicities have been identified, including accelerated hypertension. The incidence and risk factors of new or worsening hypertension following ibrutinib treatment are not as well known. METHODS: We conducted a retrospective study of 144 patients diagnosed with B cell malignancies treated with ibrutinib (n=93) versus conventional chemoimmunotherapy (n=51) and evaluated their effects on blood pressure at 1, 2, 3 and 6 months after treatment initiation. Descriptive statistics were used to compare baseline characteristics for each treatment group. Fisher's exact test was used to identify covariates significantly associated with the development of hypertension. Repeated measures analyses were conducted to analyse longitudinal blood pressure changes. RESULTS: Both treatments had similar prevalence of baseline hypertension at 63.4% and 66.7%, respectively. There were no differences between treatments by age, sex and baseline cardiac comorbidities. Both systolic and diastolic blood pressure significantly increased over time with ibrutinib compared with baseline, whereas conventional chemoimmunotherapy was not associated with significant changes in blood pressure. Baseline hypertensive status did not affect the degree of blood pressure change over time. A significant increase in systolic blood pressure (defined as more than 10 mm Hg) was noted for ibrutinib (36.6%) compared with conventional chemoimmunotherapy (7.9%) at 1 month after treatment initiation. Despite being hypertensive at follow-up, 61.2% of patients who were treated with ibrutinib did not receive adequate blood pressure management (increase or addition of blood pressure medications). Within the ibrutinib group, of patients who developed more than 20 mm Hg increase in systolic blood pressure, only 52.9% had hypertension management changes. CONCLUSIONS: Ibrutinib is associated with the development of hypertension and worsening of blood pressure. Cardiologists and oncologists must be aware of this cardiotoxicity to allow timely management of blood pressure elevations.