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Yesterday, Professor William Abraham (Ohio State University, Columbus, OH, USA) presented results from two different studies investigating ways that devices can be used to address unmet needs and improve the management of heart failure.
In-heart left atrial pressure monitoring: Promising early findings with the V-LAP™ system in patients with chronic heart failure
Prior studies using implantable haemodynamic monitors have demonstrated that pressure-guided heart failure treatment results in a reduction in the risk of heart failure hospitalisation and improved quality of life.
Prof. Abraham describes how these findings have been extended: “Rather than monitoring pulmonary artery pressure, it is preferable to measure left atrial pressure—an increase of left atrial pressure is the most specific and earliest sign of impending heart failure exacerbation. To this end, the V-LAP™ left atrium monitoring system was developed using the very latest next-generation implantable haemodynamic monitoring technology. The device is wireless, has no battery or moving parts to replace, and provides very accurate measurements.”
The VLAP™ sensor is implanted using a transseptal approach, under angiographic and echocardiographic guidance. Once implanted, the sensor directly measures absolute pressures in the left atrium, compensates for pressure drift, transmits wirelessly daily haemodynamic feedback and detects common comorbidities, such as mitral regurgitation and atrial fibrillation. Yesterday, Prof. Abraham presented early findings from the VECTOR-HF trial, which represents the first-in-man experience, testing its feasibility, safety and preliminary effectiveness (LBT21).
“Results so far with the V-LAP™ sensor appear to demonstrate the clinical utility of heart failure management guided by left atrial pressure monitoring.”
He continues, “In the patients studied to date, we have already seen predominant patterns of left atrial pressure changes. Some patients appear to have low day-today variability in left atrial pressures and are easily managed—these patients appear to do very well, and the risk of hospitalisation is low. In other patients, V-LAP™ detects higher day-to-day variability and greater effort is needed to reduce left atrial pressure, but once lowered, these patients can also avoid hospital admissions. The cases presented at Heart Failure 2019 clearly support the conduct of a pivotal trial to further explore the utility of left atrial pressure monitoring and to determine how far it can lead us in the optimisation and individualisation of heart failure management.”
Relationship between baseline biomarkers and outcomes after transcatheter mitral valve repair: An update from COAPT
Last year, the benefits of transcatheter mitral-valve repair were clearly demonstrated in patients with heart failure and moderate-to-severe or severe secondary mitral regurgitation who remained symptomatic despite the use of maximal doses of guideline-directed medical therapy.1 In the COAPT trial, the MitraClip™ procedure reduced rates of hospitalisation for heart failure and all-cause mortality compared with medical therapy alone over 2 years.1
Delving further into these findings, Prof. Abraham presented a Clinical Trial Update yesterday investigating the effect of baseline levels of the biomarkers on the outcomes of patients enrolled in COAPT (LBT20). “Brain natriuretic peptide (BNP) and NTproBNP are well-established prognostic predictors in patients with heart failure,” says Prof. Abraham, “and we wanted to determine if biomarkers at baseline predicted outcomes after the MitraClip procedure.”
Of the 614 patients enrolled in COAPT, BNP or NTproBNP levels were measured at baseline in 417 and 155 patients, respectively. There were no significant differences in mean baseline values of BNP and NTproBNP between the device group and the control group. However, there was a significantly higher 2-year rate of heart failure hospitalisation in patients from both groups who had baseline BNP or NTproBNP levels that were higher vs lower than the median. Of note, the prognosis of patients was improved by transcatheter mitral valve repair regardless of baseline levels of BNP or NTproBNP, although, the absolute benefit was greatest in higher-risk patients with biomarker levels above the median compared with below the median.
“While the relationship between baseline biomarkers and clinical outcomes has been established in numerous drug trials in heart failure, this is one of the first device trials to demonstrate a similar finding, particularly in patients with moderate-to-severe or severe secondary mitral regurgitation.”
Regarding next steps, Prof. Abraham says, “Now we have looked at the predictive value of baseline biomarker levels, we plan to investigate whether changes in BNP levels in response to reduced mitral regurgitation following the MitraClip™ procedure are also predictive of, or associated with, improved clinical outcomes. These further analyses may help determine which patients best respond to transcatheter mitral valve repair.”
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