The V-LAP System for Remote Left Atrial Pressure Monitoring of Patients With Heart Failure

Perl, Leor; Meerkin, David; D’Amario, Domenico; Avraham, Binyamin Ben; Gal, Tuvia Ben; Weitsman, Tatyana; Hasin, Tal; İnce, Hüseyin; Feickert, Sebastian; D’Ancona, Giuseppe; Schäefer, Ulrich; Sievert, Horst; Leyva, Francisco; Whinnett, Zachary I.; Mario, Carlo Di; Jonas, Michael; Glikson, Michael; Habib, Manhal; Caspi, Oren; Koren, Oran; Abraham, William T.; Kornowski, Ran; Crea, Filippo

doi:10.1016/j.cardfail.2021.12.019

Cited by 27 publications

(22 citation statements)

References 46 publications

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“…LAP trends have been remotely monitored over time to guide the optimization of therapy ( Figure 1 ). The preliminary results concerning the usability and technical performance of the device have been already discussed elsewhere ( 12 ). The present manuscript aims to report the largest and longest single-center experience with this device in HF patients with a wide spectrum of HF presentations ( Tables 1 , 2 ).…”

Section: Methodsmentioning

confidence: 99%

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A 3-Year Single Center Experience With Left Atrial Pressure Remote Monitoring: The Long and Winding Road

Restivo

D’Amario

Paglianiti

et al. 2022

Front. Cardiovasc. Med.

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BackgroundDespite continuous advancement in the field, heart failure (HF) remains the leading cause of hospitalization among the elderly and the overall first cause of hospital readmission in developed countries. Implantable hemodynamic monitoring is being tested to anticipate the clinical exacerbation onset, potentially preventing an emergent acute decompensation. To date, only pulmonary artery pressure (PAP) sensor received the approval to be implanted in symptomatic heart failure patients with reduced ejection fraction. However, PAP's indirect estimation of left ventricular filling pressure can be inaccurate in some contexts.MethodsThe VECTOR-HF study (NCT03775161) is examining the safety, usability and performance of the V-LAP system, a latest-generation device capable of continuously monitoring left atrial pressure (LAP). In our center, five advanced HF patients have been enrolled. After confirmation of the transmitted data reliability, LAP trends and waveforms have guided therapy optimization. The aim of this work is to share clinical insights from our center preliminary experience with V-LAP application.ResultsOver a median follow-up time of 18 months, LAP–based therapy optimization managed to reduce intracardiac pressure over time and no hospital readmission occurred. This result was paralleled by an improvement in both functional capacity (6MWT distance 352.5 ± 86.2 meters at baseline to 441.2 ± 125.2 meters at last follow-up) and quality of life indicators (KCCQ overall score 63.82 ± 16.36 vs. 81.92 ± 9.63; clinical score 68.47 ± 19.48 vs. 83.70 ± 15.58).ConclusionPreliminary evidence from V-LAP application at our institution support a promising efficacy. However, further study is needed to confirm the technical reliability of the device and to exploit the clinical benefit of left-sided hemodynamic remote monitoring.

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Section: Methodsmentioning

confidence: 99%

“…The introduction of a novel class of implantable sensors, able to measure left atrial pressure (LAP), may overcome these limitations ( 11 ). In our center, 5 patients were implanted with this sensor as a part of a multicenter trial ( 12 ).…”

Section: Introductionmentioning

confidence: 99%

A 3-Year Single Center Experience With Left Atrial Pressure Remote Monitoring: The Long and Winding Road

Restivo

D’Amario

Paglianiti

et al. 2022

Front. Cardiovasc. Med.

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“…The V-LAP System (Vectorious Medical Technologies, Tel Aviv, Israel), is a wireless remote monitoring system that measures LAP directly ( 2 , 15 ). The system includes a sensory implant ( Figure 1B ) placed at the interatrial septum and an external unit (reader, Figure 1C ).…”

Section: Left Atrial Pressure Sensorsmentioning

confidence: 99%

“…This is a prospective, multicenter, single-arm, and open-label, first-in-human clinical study that aims to assess the safety, performance, and usability of the device in patients with NYHA class III HF. So far, 24 patients have received the device implants, which are transmitting accurate pressure measurements of LAP with no device-related complications or sensor failure events ( 2 ).…”

Section: Left Atrial Pressure Sensorsmentioning

confidence: 99%

Novel approaches for left atrial pressure relief: Device-based monitoring and management in heart failure

Miyagi

Kuroda

Karimov

et al. 2022

Front. Cardiovasc. Med.

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The importance of the left atrium (LA) has been emphasized in recent years as the features of heart failure (HF), especially with regard to variability in patient and pathology phenotypes, continue to be uncovered. Of note, among the population with HF with preserved ejection fraction (HFpEF), pressure or size of the LA have become a target for advanced monitoring and a therapeutic approach. In the case of diastolic dysfunction or pulmonary hypertension, which are often observed in patients with HFpEF, a conventional approach with clinical symptoms and physical signs of decompensation turned out to have a poor correlation with LA pressure. Therefore, to optimize HF treatment for these populations, several devices that are applied directly to the LA have been developed. First, two LA pressure (LAP) sensors (Heart POD and V-LAP Device) were developed and may enable patient self-management remotely with LAP-guided and physician-directed style. Second, there are device-based approaches that aim to decompress the LA directly. These include: (1) interatrial shunt devices; (2) left ventricular assist devices with LA cannulation; and (3) the left atrial assist device. While these novel device-based therapies are not yet commercially available, there is expected to be a rise in the proposition and adoption of a wider range of choices for monitoring or treating LA using device-based options, based on LA dimensional reduction and optimization of the clinically significant pressure relief. Further development and evaluation are necessary to establish a more favorable management strategy for HF.

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“…Currently, in the digital era, the digital world and the medical world continuously intertwine. With the emergence of digital telemedicine capabilities, including arrhythmia monitoring and continuous intra-cardiac measurements [ 79 , 80 , 81 ], the prospect of remote, digital cardio-oncology programs becoming dominant seems compelling and inevitable. These advanced programs possess the advantage of increased participation, while preserving safety for fragile patients by keeping them out of hospital, thereby saving manpower due to increased efficiency.…”

Section: Future Directionmentioning

confidence: 99%

Cardio-Oncology Rehabilitation—Present and Future Perspectives

Elad

Habib

Caspi

2022

Life

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Recent advances in cancer therapy have led to increased survival rates for cancer patients, but also allowed cardiovascular complications to become increasingly evident, with more than 40% of cancer deaths now being attributed to cardiovascular diseases. Cardiotoxicity is the most concerning cardiovascular complication, one caused mainly due to anti-cancer drugs. Among the harmful mechanisms of these drugs are DNA damage, endothelial dysfunction, and oxidative stress. Cancer patients can suffer reduced cardiorespiratory fitness as a secondary effect of anti-cancer therapies, tumor burden, and deconditioning. In the general population, regular exercise can reduce the risk of cardiovascular morbidity, mortality, and cancer. Exercise-induced modifications of gene expression result in improvements of cardiovascular parameters and an increased general fitness, influencing telomere shortening, oxidative stress, vascular function, and DNA repair mechanisms. In cancer patients, exercise training is generally safe and well-tolerated; it is associated with a 10–15% improvement in cardiorespiratory fitness and can potentially counteract the adverse effects of anti-cancer therapy. It is well known that exercise programs can benefit patients with heart disease and cancer, but little research has been conducted with cardio-oncology patients. To date, there are a limited number of effective protective treatments for preventing or reversing cardiotoxicity caused by cancer therapy. Cardiac rehabilitation has the potential to mitigate cardiotoxicity based on the benefits already proven in populations suffering from either cancer or heart diseases. Additionally, the fact that cardiotoxic harm mechanisms coincide with similar mechanisms positively affected by cardiac rehabilitation makes cardiac rehabilitation an even more plausible option for cardio-oncology patients. Due to unstable functional capacity and fluctuating immunocompetence, these patients require specially tailored exercise programs designed collaboratively by cardiologists and oncologists. As the digital era is here, with the digital world and the medical world continuously intertwining, a remote, home-based cardio-oncology rehabilitation program may be a solution for this population.

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The V-LAP System for Remote Left Atrial Pressure Monitoring of Patients With Heart Failure

Cited by 27 publications

References 46 publications

A 3-Year Single Center Experience With Left Atrial Pressure Remote Monitoring: The Long and Winding Road

A 3-Year Single Center Experience With Left Atrial Pressure Remote Monitoring: The Long and Winding Road

Novel approaches for left atrial pressure relief: Device-based monitoring and management in heart failure

Cardio-Oncology Rehabilitation—Present and Future Perspectives

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