A multicenter prospective randomized controlled trial of cardiac resynchronization therapy guided by invasive dP/dt
Manav Sohal1,2, Shoaib Hamid3, Giovanni Perego4
1Guy's and St. Thomas' NHS Foundation Trust, London, United Kingdom.
Insights
Guiding left ventricular (LV) lead placement using acute hemodynamic response (AHR) improved cardiac resynchronization therapy (CRT) outcomes. This method demonstrated better reverse remodeling at six months compared to conventional CRT.
Area of Science:
- Cardiology
- Medical Devices
- Clinical Trials
Background:
- Cardiac resynchronization therapy (CRT) is crucial for heart failure management.
- No established periprocedural metric consistently improves CRT outcomes in multicenter settings.
Purpose of the Study:
- To evaluate if targeting left ventricular (LV) lead placement to the coronary sinus (CS) branch with the best acute hemodynamic response (AHR) improves CRT outcomes.
- To assess the correlation between AHR and reverse remodeling at 6 months post-CRT.
Main Methods:
- A multicenter randomized controlled trial comparing guided CRT with conventional CRT.
- In the guided arm, LV dP/dtmax was measured during biventricular (BIV) pacing to identify optimal CS branches for LV lead placement.
- The primary endpoint was a ≥15% reduction in LV end-systolic volume (LVESV) at 6 months.
Main Results:
- 73% of patients in the guided arm achieved ≥15% LVESV reduction versus 60% in the conventional arm (P=.02).
- Patients with AHR ≥10% showed significantly higher rates of LVESV reduction (84%) compared to those with AHR <10% (28%; P<.001).
- Guided CRT involved longer procedure and fluoroscopy times.
Conclusions:
- Invasive measurement of LV dP/dtmax during BIV pacing to determine AHR effectively predicts reverse remodeling 6 months after CRT.
- LV lead placement guided by LV dP/dtmax measurement leads to superior reverse remodeling rates.
Background:
No periprocedural metric has demonstrated improved cardiac resynchronization therapy (CRT) outcomes in a multicenter setting.
Objective:
We sought to determine if left ventricular (LV) lead placement targeted to the coronary sinus (CS) branch generating the best acute hemodynamic response (AHR) results in improved outcomes at 6 months.
Methods:
In this multicenter randomized controlled trial, patients were randomized to guided CRT or conventional CRT. Patients in the guided arm had LV dP/dtmax measured during biventricular (BIV) pacing. Target CS branches were identified and the final LV lead position was the branch with the best AHR and acceptable threshold values. The primary endpoint was the proportion of patients with a reduction in LV end-systolic volume (LVESV) of ≥15% at 6 months.
Results:
A total of 281 patients were recruited across 12 centers. Mean age was 70.8 ± 10.9 years and 54% had ischemic etiology. Seventy-three percent of patients in the guided arm demonstrated a reduction in LVESV of ≥15% at 6 months vs 60% in the conventional arm (P = .02). Patients with AHR ≥ 10% were more likely to demonstrate a reduction of ESV ≥ 15% (84% of patients with an AHR ≥10% vs 28% with an AHR <10%; P < 0.001). Procedure duration and fluoroscopy times were longer in the pressure wire-guided arm (104 ± 39 minutes vs 142 ± 39 minutes; P < .001 and 20 ±16 minutes vs 28 ± 15 minutes; P = .002).
Conclusions:
AHR determined by invasively measuring LV dP/dtmax during BIV pacing predicts reverse remodeling 6 months after CRT. Patients in whom LV dP/dtmax was used to guide LV lead placement demonstrated better rates of reverse remodeling.
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