Daily Cardiology Research Analysis
Three impactful cardiology studies inform contemporary practice: (1) In obese atrial fibrillation, catheter ablation outperformed lifestyle modification plus antiarrhythmic drugs at 1 year (PRAGUE-25). (2) At 3 years, Amulet and Watchman FLX left atrial appendage closure devices showed similar ischemic outcomes, with hypothesis‑generating signals favoring Amulet in as-treated and per‑protocol analyses (SWISS-APERO). (3) Nationwide data suggest routine defibrillation testing during S‑ICD implanta
Summary
Three impactful cardiology studies inform contemporary practice: (1) In obese atrial fibrillation, catheter ablation outperformed lifestyle modification plus antiarrhythmic drugs at 1 year (PRAGUE-25). (2) At 3 years, Amulet and Watchman FLX left atrial appendage closure devices showed similar ischemic outcomes, with hypothesis‑generating signals favoring Amulet in as-treated and per‑protocol analyses (SWISS-APERO). (3) Nationwide data suggest routine defibrillation testing during S‑ICD implantation can be safely omitted in most patients (HONEST).
Research Themes
- Atrial fibrillation therapy optimization in obesity
- Long-term outcomes of left atrial appendage closure devices
- Procedure simplification and safety in device electrophysiology
Selected Articles
1. Catheter Ablation vs Lifestyle Modification With Antiarrhythmic Drugs to Treat Atrial Fibrillation: PRAGUE-25 Trial.
In obese patients with AF (BMI 30–40 kg/m²), catheter ablation was superior to lifestyle modification plus antiarrhythmic drugs for achieving freedom from AF at 1 year in a randomized multicenter trial. Although the lifestyle arm improved metabolic parameters, it did not match ablation’s rhythm-control efficacy.
Impact: This RCT addresses a rapidly growing AF subgroup—patients with obesity—providing head-to-head evidence to guide first-line rhythm strategy selection.
Clinical Implications: For obese AF patients, catheter ablation should be strongly considered as first-line rhythm control, while structured lifestyle modification remains essential for cardiometabolic risk reduction.
Key Findings
- Catheter ablation achieved superior 1-year freedom from AF versus lifestyle modification plus antiarrhythmic drugs.
- Lifestyle intervention improved metabolic health but did not match ablation’s rhythm-control efficacy.
- Randomized, multicenter design with 203 analyzed patients strengthens internal validity.
Methodological Strengths
- Randomized multicenter design with prespecified outcomes
- Direct head-to-head comparison of two clinically relevant strategies
Limitations
- Modest sample size and 1-year follow-up limit long-term generalizability
- Open-label design may introduce performance bias
Future Directions: Longer-term follow-up and trials integrating structured weight-loss programs with ablation could define combined strategies for durable rhythm control.
BACKGROUND: Obesity is an important risk factor for atrial fibrillation (AF). Nonrandomized studies have shown that weight loss and increased physical activity are associated with AF reduction. OBJECTIVES: The goal of this study was to assess whether treatment based on lifestyle modification (LFM; directed weight loss and physical exercise) in combination with antiarrhythmic drugs (AADs) is noninferior to catheter ablation (CA) in patients with AF and obesity. METHODS: In a randomized multicenter noninferiority trial, we enrolled patients with paroxysmal or persistent AF and a body mass index (BMI) of 30-40 kg/m RESULTS: A total of 212 patients were enrolled and randomized. Nine patients withdrew consent, leaving 203 patients for the final analysis; 100 patients were allocated to the CA group and 103 to the LFM+AAD group (overall age 60 ± 9 years, 31.5% female, BMI 34.9 ± 3.0 kg/m CONCLUSIONS: Despite important metabolic improvements associated with LFM, CA was superior to LFM combined with AADs in improving freedom from AF at 1 year in patients with AF and obesity.
2. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial.
In this randomized, multicenter LAAC trial (n=221), Amulet and Watchman FLX showed similar 3-year ischemic outcomes by intention-to-treat, while as-treated and per-protocol analyses suggested lower ischemic events with Amulet. Follow-up exceeded 96% in both arms.
Impact: Head-to-head randomized evidence beyond 1 year is scarce in LAAC; these 3-year data inform device selection and counseling.
Clinical Implications: Both devices are reasonable choices for high-bleeding-risk AF; device selection may consider anatomy, operator experience, and emerging signals favoring Amulet, pending confirmatory trials.
Key Findings
- Intention-to-treat: no significant difference in 3-year ischemic composite (HR 0.58; P=0.06).
- As-treated and per-protocol: significantly fewer ischemic events with Amulet (AT HR 0.53; PP HR 0.54).
- High follow-up completeness (~96–97%) enhances result reliability.
Methodological Strengths
- Randomized, multicenter design with 3-year follow-up
- Multiple analytic populations (ITT, AT, PP) to test robustness
Limitations
- Power for hard outcomes may be limited; device crossovers occurred (though minimal)
- Signals in AT/PP are hypothesis-generating and need confirmation
Future Directions: Larger, adequately powered trials and pooled analyses should confirm comparative effectiveness and evaluate device-specific complications and leak rates.
BACKGROUND: No study thus far has compared Amulet with Watchman FLX for clinical outcomes beyond 1 year after percutaneous left atrial appendage closure (LAAC). OBJECTIVES: The goal of this study was to compare Amulet and Watchman FLX in terms of 3-year clinical outcomes. METHODS: In the investigator-initiated SWISS-APERO (Comparison of Amplatzer Amulet and Watchman Device in Patients Undergoing Left Atrial Appendage Closure) trial, patients with atrial fibrillation and high bleeding risk undergoing LAAC were randomly assigned (1:1) to receive Amulet or Watchman/FLX across 8 centers. Study endpoint included the composite of cardiovascular death, stroke, transient ischemic attack, or systemic embolism at 3 years. Analyses were repeated in the as-treated (AT) and per-protocol (PP) populations. RESULTS: Of the 221 patients randomized to treatment, 220 completed LAAC and 3 patients randomized to receive the Amulet device received the Watchman FLX device. The follow-up rate at 3 years was 96.4% in the Amulet group and 97.3% in the Watchman group. The composite ischemic endpoint occurred numerically less frequently in the Amulet group compared with the Watchman group (18.2% vs 31.0%; HR: 0.58; 95% CI: 0.33-1.03; P = 0.06). In both the AT (17.0% vs 31.1%; HR: 0.53; 95% CI: 0.30-0.96; P = 0.035) and PP (16.2% vs 29.2%; HR: 0.54; 95% CI: 0.29-1.00; P = 0.049) populations, the composite ischemic endpoint was significantly lower in the Amulet group compared with the Watchman group. CONCLUSIONS: At 3 years after LAAC, there was no significant difference in the ischemic risk between the Amulet and the Watchman FLX groups. The lower occurrence of the ischemic composite endpoint observed in the Amulet group in both the AT and PP analyses is hypothesis generating and emphasizes the need for further studies. (Comparison of Amplatzer Amulet and Watchman Device in Patients Undergoing Left Atrial Appendage Closure [SWISS-APERO]; NCT03399851).
3. Defibrillation Testing During Implantation of Subcutaneous Implantable Cardioverter Defibrillators.
In a nationwide cohort of 4,924 S-ICD recipients with 5-year adjudicated outcomes, DT use declined over time. DT-related complications were rare (0.1%) but included deaths; DT failure occurred in 1.0% and was predicted by shock impedance ≥89 Ω and obesity. Findings support omitting routine DT and adopting a selective strategy.
Impact: This large, real-world analysis with robust methods challenges routine DT during S-ICD implantation and identifies practical predictors for selective testing.
Clinical Implications: Routine DT may be safely omitted for most S-ICD candidates; consider selective DT in patients with high shock impedance or obesity and in complex anatomies.
Key Findings
- DT-related complications were 0.1% (including 2 deaths); DT failure rate was 1.0% with most undergoing corrective reinterventions.
- Higher shock impedance (≥89 Ω) and obesity (BMI ≥30 kg/m²) independently predicted DT failure.
- DT utilization decreased from 85.4% to 66.9% (2012–2019), reflecting evolving practice.
Methodological Strengths
- Nationwide cohort with 5-year centrally adjudicated outcomes
- Propensity score–weighted comparisons to reduce confounding
Limitations
- Observational design subject to residual confounding
- Generalizability outside the French healthcare context may vary
Future Directions: Prospective randomized or pragmatic selective-DT trials could validate omission strategies and refine risk models using impedance and body habitus.
BACKGROUND: Defibrillation testing (DT) remains recommended during subcutaneous implantable cardioverter defibrillator (S-ICD) implantation due to limited supporting evidence. OBJECTIVES: The objective of this study was to evaluate the long-term impact of DT during S-ICD implantation. METHODS: The HONEST (coHOrte fraNcaise des dEfibrillateurs Sous cuTanés) study is a nationwide, ongoing observational study, including all S-ICD recipients in France (2012-2019). Five-year endpoints were centrally adjudicated, and propensity score-weighted analyses compared outcomes by DT status. RESULTS: Among 4,924 patients, DT was performed in 4,066 (82.6%), decreasing from 85.4% (2012-2014) to 66.9% in 2019 (P < 0.001). Nontested patients were older (51.2 vs 49.6 years; P = 0.007), had lower left ventricular ejection fraction (37.6% vs 43.3%; P < 0.001), and were more frequently implanted for primary prevention (68.0% vs 62.4%; P = 0.002) and structural heart disease (84.9% vs 76.8%; P < 0.001). DT-related complications occurred in 0.1%, including 2 deaths. Failure rate was 1.0%, with 87.8% undergoing corrective reinterventions. Independent predictors of DT failure were elevated shock impedance (≥89 Ω; OR: 4.60; 95% CI: 2.32-9.66; P < 0.001) and obesity (body mass index ≥30 kg/m CONCLUSIONS: Our findings suggest that DT can be safely omitted in the majority of S-ICD recipients, whereas selective DT may be considered in higher-risk subgroups. (S-ICD French Cohort Study (HONEST); NCT05302115).