Heart failure & cardiomyopathiesRandomised controlled trial
Direct His/LBB Pacing as an Alternative to Biventricular Pacing in Patients With HFrEF and a Typical Left Bundle Branch Block (LBBB)
- randomized
- 1:2 randomization
- noninferiority
Authors' conclusion
In heart failure patients with LBBB, CSP-CRT was noninferior to BiV-CRT in reducing LVESV and both treatment modalities provided similar and excellent improvements in LVEF, QRS duration, heart failure symptoms, and functional capacity.
Study context
- Population
- Patients with symptomatic heart failure, left ventricular ejection fraction (LVEF) ≤35%, and LBBB (Strauss criteria)Two patients withdrew their consent before implant
- Participants
- 150 patients
- Comparison
- CSP-CRT noninferior to BIV-CRT
- Primary endpoint
- Relative change in left ventricular end-systolic volume (LVESV)
- Follow-up
- 6-month follow-up
Primary result
As reported in the abstract
Between-group differences
0.9%
95% CI −6.0% to 7.8%
P < 0.01 for noninferiority
By group
Further findings
| Outcome | Values |
|---|---|
| LVEF increase | CSP-CRT 14% (SD 8%) · BiV-CRT 14% (SD 9%) |
| QRS duration, 6-min walking distance, Minnesota Living with Heart Failure score, NYHA functional class, N-terminal pro-B-type natriuretic peptide | CSP-CRT QRS duration shortening −31 ± 22 ms · 6-min walking distance increase 37 ± 53 m · Minnesota Living with Heart Failure score reduction −16 ± 18 · NYHA functional class improvement −0.6 ± 0.6 · N-terminal pro-B-type natriuretic peptide reductions −72 ± 152 pmol/l · BiV-CRT QRS duration shortening −31 ± 21 ms · 6-min walking distance increase 24 ± 48 m · Minnesota Living with Heart Failure score reduction −13 ± 15 · NYHA functional class improvement −0.6 ± 0.7 · N-terminal pro-B-type natriuretic peptide reductions −110 ± 116 pmol/l |
LVEF increase
- P = NS
QRS duration, 6-min walking distance, Minnesota Living with Heart Failure score, NYHA functional class, N-terminal pro-B-type natriuretic peptide
- similar between groups
Crossover at implantation
- crossed over from the CSP-CRT group to the BiV-CRT group
- 15 patients (15 %)
- crossed over from BiV-CRT to the CSP-CRT group
- 1 patient
- treated with CSP-CRT (26 His-CRT, 59 patients LBB-CRT)
- 85 patients (57 %)
- treated with BiV-CRT
- 63 patients (43 %)
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Summarised from the published abstract; every number is checked against it