Impact of closed loop stimulation on prognostic cardiopulmonary variables in patients with chronic heart failure and
Joachim Proff1, Béla Merkely2, Roland Papp2
1Medizinische Klinik für Kardiologie, Charite Universitaetsmedizin Berlin, Campus Benjamin Franklin, Hindenburgdamm 30, 12203 Berlin, Germany.
Insights
Closed loop stimulation (CLS) may improve ventilatory efficiency in heart failure patients with chronotropic incompetence (CI) undergoing cardiac resynchronization therapy (CRT). This pilot study found CLS responders had better heart function, suggesting potential benefits for less advanced heart failure.
Area of Science:
- Cardiology
- Heart Failure Management
- Electrophysiology
Background:
- Clinical effects of rate-adaptive pacing in heart failure (HF) patients with chronotropic incompetence (CI) undergoing cardiac resynchronization therapy (CRT) are not well-defined.
- Closed loop stimulation (CLS) is an innovative rate-adaptive sensor integrated into CRT devices.
Purpose of the Study:
- To evaluate the effectiveness of CLS in CRT patients with severe CI.
- To assess the impact of CLS on key prognostic variables determined by cardiopulmonary exercise (CPX) testing.
Main Methods:
- A randomized, crossover, multicenter study (BIO|CREATE) involving 20 CRT patients with severe CI.
- Patients were randomized to DDD-40 or DDD-CLS modes for 1-month periods.
- Symptom-limited treadmill CPX tests were performed in each mode, with a ≥5% decrease in ventilatory efficiency (VE) slope defining CLS response.
Main Results:
- Seventeen patients with complete data showed a mean intra-individual VE slope change of -4.1% with CLS (P=0.23).
- Forty-seven percent of patients (8/17) were CLS responders, exhibiting a significant VE slope decrease of -16.4% (P=0.029).
- CLS responders demonstrated improved left ventricular ejection fraction and reduced LV volumes compared to non-responders.
Conclusions:
- CLS activation may enhance VE slope in CRT patients with severe CI and less advanced HF.
- Further investigation is warranted to ascertain the long-term clinical outcomes associated with CLS therapy.
Aims:
Clinical effects of rate-adaptive pacing in heart failure patients with chronotropic incompetence (CI) undergoing cardiac resynchronization therapy (CRT) remain unclear. Closed loop stimulation (CLS) is a new rate-adaptive sensor in CRT devices. We evaluated the effectiveness of CLS in CRT patients with severe CI, focusing primarily on key prognostic variables assessed by cardiopulmonary exercise (CPX) testing.
Methods And Results:
In the randomized, crossover, multicentre BIO|CREATE study, 20 CRT patients with severe CI and NYHA Class II/III (60%/40%) were randomized 1:1 to the sequence DDD-40 mode to DDD-CLS mode, or the sequence DDD-CLS mode to DDD-40 mode (1 month in each mode). Patients underwent symptom-limited treadmill-based CPX test in each mode. An improvement (decrease) of the ventilatory efficiency (VE) slope of ≥5% during CLS was regarded as positive response to CLS. Seventeen patients with full data sets had a mean intra-individual VE slope change of -1.8 ± 3.0 (-4.1%) with CLS (P = 0.23). Eight patients (47%) were CLS responders, with a -6.1 ± 2.7 (-16.4%) slope change (P = 0.029). Compared to non-responders, CLS responders had a higher left ventricular (LV) ejection fraction (46 ± 3 vs. 36 ± 9%; P = 0.0070), smaller end-diastolic LV volume (121 ± 34 vs. 181 ± 41 mL; P = 0.0085), smaller end-systolic LV volume (65 ± 23 vs. 114 ± 39 mL; P = 0.0076), and were predominantly in NYHA Class II (P = 0.0498).
Conclusion:
The data of the present pilot study are compatible with the notion that CLS activation may improve VE slope in CRT patients with severe CI and less advanced heart failure. Further research is needed to determine the long-term clinical outcomes of CLS.
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