VECTOR-HF II: Preliminary insights on physician-directed patient self-management in HF
M Del Trigo, I J Amat Santos, O Abdul-Jawad Altisent, R Kornowski, A A Shaul, L Perl, G Moravsky, J Nunez, D Schewel, H Manhal, O Caspi, M Bergmann, O Koren, S Anker, W T AbrahamAbstract
Background
Implantable hemodynamic monitoring has demonstrated a reduction in hospitalizations related to heart failure (HF). Implementing a self-management approach may offer a more tailored and timely treatment, encouraging improved adherence to medications, with minimal dependence on frequent caregiver intervention. Consequently, this approach may lead to better disease control and a reduced risk of HF exacerbations.
Methods
The V-LAP Left Atrium Monitoring systEm for Patients With Chronic sysTOlic & Diastolic Congestive heart Failure II (VECTOR-HF II) pilot study is a prospective, international, multicenter, single-arm clinical trial to assess the safety and performance of the V-LAP system and the Patient Self-Management (PSM) approach in NYHA functional class II and III HF patients, irrespective of left ventricular ejection fraction. Under physician directed PSM, physicians define thresholds that trigger self-adjustment of diuretic dosages when 5-day average LAP values deviate from the target range (initially set between 5-13mmHg). When average LAP is lower or higher than the predetermined self-adjustment thresholds, the physician is notified. Primary endpoints include the ability to perform LAP measurements and transmit data to the Health Care Provider (HCP) Interface and the Patient Guidance Application, as well as safety outcomes.
Results
This is an initial analysis of 26 out of 45 patients enrolled to date in the study, with a mean follow-up duration of 512 days (16.80 months, range 0-29 months). The mean age is 68.42 ± 7.63, with 4 female patients (15.4%), and mean body mass index is 27.03 ± 4.49 kg/m2. As for hemodynamic data, mean left ventricular ejection fraction is 39.79 ± 15.18%, mean systolic pulmonary artery pressure is 34.68 ± 13.34 mmHg, and mean PCWP is 13.72 ± 6.72 mmHg. To date, there was a 100% freedom from failure of the V-LAP system to obtain LAP measurements from the sensor and transmit the data to the HCP Interface and the Patient Guidance Application. At 3 months, freedom from study related MACNE events was 100%. Compliance of 96.40% has been observed in patients treated by the PSM approach defined as ≥ 5 days of successful LAP measurements per week. LAP distribution over 13,304 patient days showed 49.30% below 13 mmHg, 20.41% in the 13–16.5 mmHg range, 23.20% in the 16.5–25 mmHg range and 7.09% above 25 mmHg, indicating effective pressure management and possibly reduced risk of HF exacerbation (Figure 1). HF hospitalizations decreased from 0.57 events per patient-year before implantation to 0.20 after implantation, a 65% reduction.
Conclusions
This pilot study has thus far been successfully conducted to verify the usability and performance of the V-LAP System, using a physician directed patient self-management approach. It suggests that physician-directed PSM using the V-LAP system is feasible, safe, and has the potential to minimize physician intervention in chronic HF management.LAP Distribution Over TimeFor image description, please refer to the figure legend and surrounding text.