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Triple Resynchronization in Paced Heart Failure Patients - TRIP-HF
Description:
The goal of the trial was to evaluate the effect of triple-site compared with dual-site cardiac resynchronization therapy in patients with chronic congestive heart failure (CHF).
Hypothesis:
Triple-site biventricular pacing will be more effective in producing ventricular resynchronization as measured by an increase in the Z ratio.
Study Design
Study Design:
Patients Screened: 40
Patients Enrolled: 33
NYHA Class: III or IV, 92% and 8%, respectively
Mean Follow Up: 9 months
Mean Patient Age: 70 years
Female: 0
Mean Ejection Fraction: 24
Patient Populations:
• CHF (New York Heart Association functional class III or IV) despite optimal medical therapy for at least 1 month,
• Permanent atrial fibrillation with a slow ventricular rate that requires permanent pacing or planned atrioventricular node ablation, and
• LV ejection fraction ≤35%
Exclusions:
• Indication for an internal cardiac defibrillator
• Myocardial infarction, cardiac surgery, or coronary revascularization within the past 3 months
• Chronic pulmonary or thyroid disease
• Need for intravenous inotropes
• Less than 1-year life expectancy
• Inability to comply with follow-up procedures
• Age less than 18 years or pregnant
Primary Endpoints:
Global quality of ventricular resynchronization by calculating the Z ratio
Secondary Endpoints:
• Change in LV end-systolic volume
• Change in the quality of life as assessed by the Minnesota Living with Heart Failure questionnaire
• Change in exercise capacity as assessed by a 6-minute hall walk
• Change in procedure-related and overall morbidity and mortality
Drug/Procedures Used:
Patients with drug-refractory CHF were implanted with a 3-lead biventricular pacemaker (i.e., 2 leads in the left ventricle [LV] and 1 lead in the right ventricle [RV]). After 3 months of conventional biventricular pacing, 33 patients were randomized to 3-lead followed by 2-lead pacing for 3 months each versus 2-lead followed by 3-lead pacing for 3 months each.
Concomitant Medications:
At baseline, the use of angiotensin-converting enzyme inhibitors or angiotensin-receptor blockers was 96% and beta-blockers was 73%.
Principal Findings:
Two LV leads were unable to be implanted in six patients for an 85% success rate; however, four of these patients received at least 1 LV lead. There was one adverse event during implantation: an uncomplicated coronary sinus dissection. During follow-up, two patients died from end-stage HF.
There was no change in the primary outcome, the Z ratio (0.76 with 3 leads and 0.78 with 2 leads; p = 0.94).
LV ejection fraction was 35% versus 27% (p = 0.0010), LV end-systolic volume was 134 cm3 versus 157 cm3 (p = 0.019), and LV end-systolic diameter was 53.9 mm versus 57.0 mm (p = 0.024), respectively for 3 leads versus 2 leads.
The distance covered during a 6-minute walk test was 402 m versus 431 m (p = 0.058), and the quality-of-life score was 22 versus 22 (p = 0.75), respectively for 3 leads versus 2 leads.
Interpretation:
Among patients with refractory HF symptoms, the use of 3 leads (2 in the LV and 1 in the RV) failed to improve global ventricular resynchronization as assessed by the Z ratio, compared with 2 leads. The authors postulated that this may have been partly due to the fact that 30% of the patients had a QRS duration less than 150 ms and therefore started with a higher Z ratio.
This therapy also did not improve the distance covered in a 6-minute hall walk or the quality of life. Despite this, 3-lead cardiac resynchronization improved LV ejection fraction and reduced LV end-systolic volume and diameter. Since this therapy did improve some parameters of LV reverse remodeling, further studies are warranted.
References:
Leclercq C, Gadler F, Kranig W, et al. A randomized comparison of triple-site versus dual-site ventricular stimulation in patients with congestive heart failure. J Am Coll Cardiol 2008;51:1455-1462.
Keywords: Follow-Up Studies, Quality of Life, Heart Failure, Ventricular Remodeling, Pacemaker, Artificial, Cardiac Resynchronization Therapy, Atrioventricular Node
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