Prognostic role of CA-125 in patients undergoing transcatheter aortic valve replacement: A systematic review and meta-analysis.

Transcatheter aortic valve replacement (TAVR) has become a widely used therapy for patients with severe aortic stenosis. Carbohydrate antigen 125 (CA-125) is a promising biomarker in some cardiovascular diseases. This systematic review aims to assess the prognostic role of CA-125 in patients undergoing TAVR. We searched electronic databases from inception to March 2023 to include cohort studies evaluating the association between preprocedural CA-125 levels and mortality or heart failure (HF) readmission at 12 months in patients undergoing TAVR. We pooled crude (cHR) and adjusted hazard ratios (aHR) with their 95% confidence interval (CI) using a random-effects model. The risk of bias was evaluated using the QUIPS tool. The certainty of the evidence was assessed using the GRADE approach. We included five cohort studies involving 1594 patients. Higher levels of CA-125 were significantly associated with an increased risk of mortality or HF readmission using crude (cHR 2.79, 95% CI 1.45-5.36, I2 = 72%) and adjusted (aHR 3.27, 95% CI 2.07-5.18, I2 = 0%, high certainty) effect estimates compared with lower levels. Similarly, there was also associated with increased mortality using crude (cHR 2.68, 95% CI 1.99-3.60, I2 = 0%) and adjusted (aHR 2.17, 95% CI 1.54-3.07, I2 = 0%, high certainty) effect estimates. The risk of bias varied between low to moderate across studies. Our meta-analysis suggests that CA-125 has incremental prognostic value in patients undergoing TAVR. Further studies are needed to determine the clinical utility of CA-125 in guiding treatment decisions in this population.

The added value of hypertonic saline solution to furosemide monotherapy in patients with acute decompensated heart failure: A meta-analysis and trial sequential analysis.

We assessed the effects of hypertonic saline solution (HSS) plus furosemide versus furosemide alone in patients with acute decompensated heart failure (ADHF). We searched four electronic databases for randomized controlled trials (RCTs) until June 30, 2022. The quality of evidence (QoE) was assessed using the GRADE approach. All meta-analyses were performed using a random-effects model. A trial sequential analysis (TSA) was also conducted for intermediate and biomarker outcomes. Ten RCTs involving 3013 patients were included. HSS plus furosemide significantly reduced the length of hospital stay (mean difference [MD]: -3.60 days; 95% confidence interval [CI]: -4.56 to -2.64; QoE: moderate), weight (MD: -2.34 kg; 95% CI: -3.15 to -1.53; QoE: moderate), serum creatinine (MD: -0.41 mg/dL; 95% CI: -0.49 to -0.33; QoE: low), and type-B natriuretic peptide (MD: -124.26 pg/mL; 95% CI: -207.97 to -40.54; QoE: low) compared to furosemide alone. HSS plus furosemide significantly increased urine output (MD: 528.57 mL/24 h; 95% CI: 431.90 to 625.23; QoE: moderate), serum Na+ (MD: 6.80 mmol/L; 95% CI: 4.92 to 8.69; QoE: low), and urine Na+ (MD: 54.85 mmol/24 h; 95% CI: 46.31 to 63.38; QoE: moderate) compared to furosemide alone. TSA confirmed the benefit of HSS plus furosemide. Due to the heterogeneity in mortality and heart failure readmission, meta-analysis was not performed. Our study shows that HSS plus furosemide, compared to furosemide alone, improved surrogated outcomes in ADHF patients with low or intermediate QoE. Adequately powered RCTs are still needed to assess the benefit on heart failure readmission and mortality.

Temporal Trends and Factors Associated With the Inclusion of Patient-Reported Outcomes in Heart Failure Randomized Controlled Trials: A Systematic Review.

Background Patient-reported outcomes (PROs) are important measures of treatment response in heart failure. We assessed temporal trends in and factors associated with inclusion of PROs in heart failure randomized controlled trials (RCTs). Methods and Results We searched MEDLINE, Embase, and CINAHL for studies published between January 2000 and July 2020 in journals with an impact factor ≥10. We assessed temporal trends using the Jonckheere-Terpstra test and conducted multivariable logistic regression to explore trial characteristics associated with PRO inclusion. We assessed the quality of PRO reporting using the Consolidated Standards of Reporting Trials (CONSORT) PRO extension. Of 417 RCTs included, PROs were reported in 226 (54.2%; 95% CI, 49.3%-59.1%), with increased reporting between 2000 and 2020 (P<0.001). The odds of PRO inclusion were greater in RCTs that were published in recent years (adjusted odds ratio [aOR] per year, 1.08; 95% CI, 1.04-1.12; P<0.001), multicenter (aOR, 1.89; 95% CI, 1.03-3.46; P=0.040), medium-sized (aOR, 2.35; 95% CI, 1.26-4.40; P=0.008), coordinated in Central and South America (aOR, 5.93; 95% CI, 1.14-30.97; P=0.035), and tested health service (aOR, 3.12; 95% CI, 1.49-6.55; P=0.003), device/surgical (aOR, 6.66; 95% CI, 3.15-14.05; P<0.001), or exercise (aOR, 4.66; 95% CI, 1.81-12.00; P=0.001) interventions. RCTs reported a median of 4 (interquartile interval , 3-6) of a possible of 11 CONSORT PRO items. Conclusions Just over half of all heart failure RCTs published in high impact factor journals between 2000 and 2020 included PROs, with increased inclusion of PROs over time. Trials that were large, tested pharmaceutical interventions, and coordinated in North America / Europe had lower adjusted odds of reporting PROs relative to other trials. The quality of PRO reporting was modest.