Predictors of echocardiographic response in the Budapest-CRT upgrade trial
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Key result
CRT-D upgrade increases odds of echocardiographic response ~457% vs ICD alone in PICM.
- OR 5.57
- 95% CI 2.56-12.12
- P<0.0001
- n=360
Why the study?
Up to 30% of patients fail to respond to CRT, and while echocardiographic predictors are well described in de novo CRT, evidence in CRT upgrade populations remains limited.
Does CRT-D upgrade improve echocardiographic response in HFrEF patients with prior pacemaker/ICD, ≥20% RV pacing, and wide-paced QRS compared to ICD upgrade alone?
Key Points
- To identify clinical, device, and anatomical predictors of echocardiographic response among heart failure patients undergoing cardiac resynchronization therapy upgrade.
- In a randomized trial (NCT02270840), 360 patients with HFrEF, prior pacemaker or ICD, ≥ 20% right ventricular (RV) pacing burden, and wide-paced QRS (≥ 150 ms) were randomized to CRT-D upgrade (n = 215) or ICD upgrade (n = 145).
- Echocardiographic response, evaluated at 12 months in 275 patients with paired echocardiographic data, was defined as a ≥ 15% reduction in left ventricular end-systolic volume (LVESV).
- Independent predictors of echocardiographic response included CRT-D allocation (OR 5.57, 95% CI 2.56-12.12, p < 0.0001), greater RV pacing burden (OR 1.02 per %, 95% CI 1.00-1.04, p = 0.024), non-ischemic cardiomyopathy (OR 2.50, 95% CI 1.15-5.26, p = 0.021), and lateral LV lead position (OR 8.79, 95% CI 1.28-60.39, p = 0.027).
Study Design
Type
RCT (n=360)
Blinding
Echocardiographic datasets were analyzed offline by two independent, experienced readers blinded to clinical information, randomization, and outcomes
Randomization
3:2 ratio
Multicenter
Yes
Structured PICO
Does CRT-D upgrade improve echocardiographic response in HFrEF patients with prior pacemaker/ICD, ≥20% RV pacing, and wide-paced QRS compared to ICD upgrade alone?
P
Population
360 patients with heart failure and reduced ejection fraction, a previously implanted pacemaker or ICD, ≥20% right ventricular pacing burden, and wide-paced QRS, followed for 12 months.
I
Intervention
CRT-D upgrade
C
Comparator
ICD upgrade alone
O
Outcome
Echocardiographic response defined as ≥ 15% reduction in left ventricular end-systolic volume (LVESV) at 12 monthssurrogate
Main Result
Odds Ratio: 5.57 (95% CI 2.56–12.12)
Absolute Event Rate: 75% vs 32%
p-value: p=<0.0001
In HFrEF patients with pacing-induced cardiomyopathy, upgrading to CRT-D significantly improves echocardiographic outcomes, with greater benefits seen in those with non-ischemic etiology, higher RV pacing burden, and lateral LV lead positioning.
Limitations
- Specific inclusion and exclusion criteria may influence results and generalizability
- Limited number of subjects in different subgroups
- Underrepresentation of women limits the ability to evaluate sex as an independent predictor
- Echocardiographic response could not be evaluated when data was missing at any timepoint
- Long-axis LV lead positions were not documented, and short-axis positions were assessed by the implanting physician
- Echocardiographic response is a surrogate endpoint that does not always translate into clinical improvement
- Changes in guideline-directed medical therapy (GDMT) were not documented
- Underrepresentation of women in the trial may have limited the ability to evaluate sex as an independent predictor
- Changes in GDMT were not documented which could potentially influence results
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“The findings support performing an CRT upgrade in this patient population. HFrEF patients with a pacemaker or ICD should be strictly followed in clinical practice and in those with intermittent or permanent RV pacing, a CRT upgrade should be performed immediately without deferring the procedure to a later date (e.g., battery replacement) to avoid or reduce the risk of further adverse events such as mortality, HF hospitalization or LV remodeling.”
CLCecilia LindeCardiologist, Karolinska University Hospital, Stockholm
“The results are likely to influence clinical practice and future guidelines recommendations”
Implication
CRT-D upgrade boosts echocardiographic response in pacing-induced cardiomyopathy; extends de novo predictors to upgrades, prioritizing non-ischemic etiology and lateral lead position.
Abstract
BACKGROUND AND AIMS: Up to 30% of patients fail to respond after cardiac resynchronization therapy (CRT). While echocardiographic predictors of response are well described in de novo CRT, evidence in CRT upgrade populations remains limited. We investigated predictors of echocardiographic response in the BUDAPEST-CRT Upgrade trial cohort. METHODS: In this randomized trial, 360 patients with heart failure and reduced ejection fraction (HFrEF) with priorly implanted pacemaker or ICD, ≥ 20% right ventricular (RV) pacing burden, and wide-paced QRS (≥ 150 ms) were randomized to CRT-D upgrade (n = 215) or ICD upgrade (n = 145). Echocardiographic response was defined as ≥ 15% reduction in left ventricular end-systolic volume (LVESV) at 12 months. RESULTS: Among 275 patients with paired echocardiographic data, 161 (59%) were responders. Responders had fewer HF hospitalizations (0.6% vs. 7.0%, p = 0.003), more often received mineralocorticoid receptor antagonists (71% vs. 59%, p = 0.038), and showed a higher baseline RV pacing burden (88.9% vs. 83.4%, p = 0.025) than non-responders. Independent predictors of echocardiographic response were randomization to CRT-D (OR 5.57, 95% CI 2.56-12.12, p < 0.0001), greater RV pacing burden (OR 1.02 per %, 95% CI 1.00-1.04, p = 0.024), non-ischemic cardiomyopathy (OR 2.50, 95% CI 1.15-5.26, p = 0.021), and a lateral LV lead position (OR 8.79, 95% CI 1.28-60.39, p = 0.027). CONCLUSIONS: In patients with pacing-induced cardiomyopathy, CRT-D upgrade significantly improved echocardiographic outcomes. Non-ischemic etiology, higher RV pacing burden, and lateral LV lead positioning were associated with greater benefit. These results underscore the importance of tailored patient selection and lead placement strategies to optimize CRT-D upgrade outcomes.
Discussion
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Cite This Study
Merkel et al. (2026) conducted an RCT in Heart failure with reduced ejection fraction (HFrEF) and pacing-induced cardiomyopathy (n=360). CRT-D upgrade vs. ICD upgrade alone was evaluated on Echocardiographic response (≥ 15% reduction in left ventricular end-systolic volume at 12 months) (OR 5.57, 95% CI 2.56-12.12, p=<0.0001). Upgrading to CRT-D significantly increased the odds of echocardiographic response at 12 months compared to ICD upgrade alone in patients with pacing-induced cardiomyopathy (OR 5.57).
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