Daily Cardiology Research Analysis
Three impactful cardiology studies emerged today: a multinational NEJM RCT shows acute normovolemic hemodilution does not reduce transfusions in cardiac surgery; an individual participant-level pooled analysis supports finerenone for HFmrEF/HFpEF, lowering cardiovascular death or HF hospitalization; and a hierarchical Bayesian meta-analysis in Heart finds cerebral embolic protection devices during TAVI do not meaningfully reduce stroke.
Summary
Three impactful cardiology studies emerged today: a multinational NEJM RCT shows acute normovolemic hemodilution does not reduce transfusions in cardiac surgery; an individual participant-level pooled analysis supports finerenone for HFmrEF/HFpEF, lowering cardiovascular death or HF hospitalization; and a hierarchical Bayesian meta-analysis in Heart finds cerebral embolic protection devices during TAVI do not meaningfully reduce stroke.
Research Themes
- Transfusion strategies and blood conservation in cardiac surgery
- Cardiorenal-metabolic modulation for HFmrEF/HFpEF
- Periprocedural stroke prevention during TAVI
Selected Articles
1. A Randomized Trial of Acute Normovolemic Hemodilution in Cardiac Surgery.
In a 32-center randomized trial (n=2010), acute normovolemic hemodilution did not reduce the proportion of patients receiving allogeneic red-cell transfusion during hospitalization after cardiac surgery (27.3% vs 29.2%; RR 0.93, P=0.34). Mortality and safety outcomes were similar between groups.
Impact: This high-quality multicenter RCT provides definitive evidence that ANH does not meaningfully reduce transfusion exposure in modern cardiac surgery, informing perioperative blood management policies.
Clinical Implications: Routine ANH to reduce transfusion in cardiac surgery is not supported; programs should prioritize proven strategies (restrictive thresholds, antifibrinolytics, cell salvage) and tailor ANH to specific indications rather than broad use.
Key Findings
- ANH did not lower allogeneic red-cell transfusion incidence vs usual care (27.3% vs 29.2%; RR 0.93; P=0.34).
- 30-day or in-hospital mortality was similar (1.4% vs 1.6%).
- Surgery for postoperative bleeding was numerically higher with ANH (3.8% vs 2.6%).
Methodological Strengths
- Multinational, multicenter randomized controlled design with adequate sample size (n=2010).
- Prespecified outcomes and clinically relevant primary endpoint; trial registered.
Limitations
- Single-blind design; potential performance bias.
- No detailed transfusion protocol harmonization across centers; practice variability may dilute effects.
Future Directions: Identify subgroups or procedural contexts where ANH may confer benefit (e.g., complex redo surgery, high bleeding risk) and evaluate multimodal blood management bundles in pragmatic trials.
2. Efficacy and Safety of Finerenone in Heart Failure With Preserved Ejection Fraction: A FINE-HEART Analysis.
Across 3 trials with participant-level data (n=7,008 HFmrEF/HFpEF; median follow-up 2.5 years), finerenone reduced cardiovascular death or heart failure hospitalization versus placebo (HR 0.87; 95% CI 0.78–0.96; P=0.008), with consistent effects across studies, supporting use in cardio-renal-metabolic risk settings.
Impact: This prespecified IPD pooled analysis extends finerenone benefits to HFmrEF/HFpEF, a population with limited disease-modifying therapies, integrating evidence across large outcome trials.
Clinical Implications: Consider finerenone for HFmrEF/HFpEF patients with cardio-renal-metabolic risk, alongside guideline-directed therapy, to reduce CV death/HF hospitalization. Monitor potassium and renal function due to MRA class effects.
Key Findings
- Finerenone reduced the composite of cardiovascular death or HF hospitalization (HR 0.87; P=0.008).
- Effects were consistent across FIDELIO-DKD, FIGARO-DKD, and FINEARTS-HF trials.
- Population included older adults (mean 71 years) with substantial female representation (44%).
Methodological Strengths
- Prespecified individual participant-level pooled analysis across three phase III outcome trials.
- Time-to-event modeling stratified by trial; large effective sample and follow-up.
Limitations
- Pooled analysis inherits trial selection criteria; not a new randomized comparison within HFpEF alone.
- Potential heterogeneity in background therapies and populations across contributing trials.
Future Directions: Dedicated RCTs in HFpEF/HFmrEF to confirm morbidity/mortality benefits, evaluate synergy with SGLT2 inhibitors/ARNI, and refine patient selection (e.g., CKD/T2D phenotypes).
3. When absence of evidence equates to evidence of absence: the case of routine use of cerebral embolic protection devices in transcatheter aortic valve implantation.
In a hierarchical Bayesian meta-analysis of eight RCTs (n=11,590), cerebral embolic protection during transfemoral TAVI did not achieve a clinically meaningful reduction in all stroke (ARD −0.17%; NNT 588; posterior probability of benefit <1%) or disabling stroke, arguing against routine CEP use.
Impact: Synthesizing all randomized evidence with Bayesian methods provides near-conclusive evidence that current CEP devices lack clinically relevant benefit, guiding resource allocation and device use policies.
Clinical Implications: Routine CEP use during TAVI should be reconsidered; focus on stroke risk mitigation via procedural optimization, antithrombotic strategies, and patient selection rather than device-based protection.
Key Findings
- Across 8 RCTs (n=11,590), all-stroke RR median 0.94 (95% CrI 0.72–1.25) with ARD −0.17% (NNT 588).
- Disabling stroke showed ARD −0.36% (NNT 278), with <1% posterior probability of clinically relevant benefit.
- Results robust to hierarchical Bayesian modeling and updated evidence base.
Methodological Strengths
- Hierarchical Bayesian meta-analysis with absolute risk translations (ARD/NNT) and clinically defined relevance threshold.
- Exclusive inclusion of RCTs; updated systematic search and registration (PROSPERO).
Limitations
- Device heterogeneity and learning-curve effects across trials.
- Event rates relatively low, limiting precision for rare disabling stroke subtypes.
Future Directions: Evaluate targeted use in very-high-risk anatomies or novel protection concepts; alternatively, shift research focus to procedural stroke mechanisms and pharmacologic prevention.