A smartphone-enabled wireless and batteryless implantable blood flow sensor for remote monitoring of prosthetic heart valve function.

Aortic valve disease is one of the leading forms of complications in the cardiovascular system. The failing native aortic valve is routinely surgically replaced with a bioprosthesis. However, insufficient durability of bioprosthetic heart valves often requires reintervention. Valve degradation can be assessed by an analysis of the blood flow characteristics downstream of the valve. This is cost and labor intensive using clinical methodologies and is performed infrequently. The integration of consumer smartphones and implantable blood flow sensors into the data acquisition chain facilitates remote management of patients that is not limited by access to clinical facilities. This article describes the characteristics of an implantable magnetic blood flow sensor which was optimized for small size and low power consumption to allow for batteryless operation. The data is wirelessly transmitted to the patient's smartphone for in-depth processing. Tests using three different experimental setups confirmed that wireless and batteryless blood flow recording using a magnetic flow meter technique is feasible and that the sensor system is capable of monitoring the characteristic flow downstream of the valve.

Non-physiologic closing of bi-leaflet mechanical heart prostheses requires a new tri-leaflet valve design.

Mechanical heart valve prostheses are based on older designs without changes during the last 40 years. Today, there is an unmet need for less thrombogenic mechanical prostheses. Analysis of the relationship between flow characteristics and thromboembolic complications is possible using numerical and biomolecular flow studies that have shown that the reverse rather than the forward flow is responsible for local platelet activation and thrombosis. After peak flow, leaflets experience flow deceleration and the leaflets are still widely open when the flow becomes zero. The closure of the valve starts with the onset of reverse flow. Therefore, the valve closes extremely fast with most of the leaflet traveling angle occurring in <10 ms with excessively high reverse flow velocities. The pivoting spaces, so-called "Hot Spots" should be eliminated to prevent pathologic shear stress that result in thrombosis. A novel tri-leaflet valve combines favorable hemodynamics with the durability of mechanical heart valve. This valve closes within 60 ms, much slower than bi-leaflet valves and similar to the closing mode of a tissue valve. Micro-particle image velocimetry did not show critical regions of flow stagnation and zones of excessive shear in the pivoting region suggesting low potential for thrombogenic events that should allow to avoid long-term anticoagulation.

Automated diagnosis of heart valve degradation using novelty detection algorithms and machine learning.

The blood flow through the major vessels holds great diagnostic potential for the identification of cardiovascular complications and is therefore routinely assessed with current diagnostic modalities. Heart valves are subject to high hydrodynamic loads which render them prone to premature degradation. Failing native aortic valves are routinely replaced with bioprosthetic heart valves. This type of prosthesis is limited by a durability that is often less than the patient's life expectancy. Frequent assessment of valvular function can therefore help to ensure good long-term outcomes and to plan reinterventions. In this article, we describe how unsupervised novelty detection algorithms can be used to automate the interpretation of blood flow data to improve outcomes through early detection of adverse cardiovascular events without requiring repeated check-ups in a clinical environment. The proposed method was tested in an in-vitro flow loop which allowed simulating a failing aortic valve in a laboratory setting. Aortic regurgitation of increasing severity was deliberately introduced with tube-shaped inserts, preventing complete valve closure during diastole. Blood flow recordings from a flow meter at the location of the ascending aorta were analyzed with the algorithms introduced in this article and a diagnostic index was defined that reflects the severity of valvular degradation. The results indicate that the proposed methodology offers a high sensitivity towards pathological changes of valvular function and that it is capable of automatically identifying valvular degradation. Such methods may be a step towards computer-assisted diagnostics and telemedicine that provide the clinician with novel tools to improve patient care.

Leaflet Kinematics of Mechanical and Bioprosthetic Aortic Valve Prostheses.

The hemodynamic performance of artificial aortic valves (AVs) and the probability for structural valve deterioration can be linked to the valve kinematics. Comparability among different studies is limited because of variations in the experimental setups and physiologic boundary conditions. This study presents results of kinematic measurements of bioprosthetic and mechanical AVs that were tested in an identical experimental setting such that they can be directly compared with each other. The kinematics of AVs is typically presented in the form of the geometric orifice area and its temporal evolution. These parameters cannot capture asynchronous leaflet motion and out-of-plane leaflet velocity. In this work, each leaflet was tracked individually for a more detailed understanding of the leaflet kinematics, asynchronous leaflet motion, and leaflet tip velocities. A bioprosthetic valve, Edwards INTUITY (EINT), and two mechanical valves, Medtronic ADVANTAGE (MADV) and a Lapeyre-Triflo FURTIVA (TFUR), were tested in a compliant model of the aortic root in a physiologic flow loop. TFUR and MADV opened alike with maximum leaflet tip velocities of 0.77 and 0.66 m/s, respectively. The opening of EINT showed significantly higher local in-plane leaflet velocities of more than 2 m/s. EINT and TFUR exhibited similar early and slow closure. MADV closed significantly later with increased velocity. TFUR had a median maximum leaflet tip velocity of 0.39 m/s during valve closure and that of MADV was 0.83 m/s, whereas EINT exhibited a median maximum local in-plane leaflet velocity of 0.37 m/s. EINT experienced leaflet fluttering during systole with a flapping frequency of 36 Hz.

Time-Resolved Micro PIV in the Pivoting Area of the Triflo Mechanical Heart Valve.

The Lapeyre-Triflo FURTIVA valve aims at combining the favorable hemodynamics of bioprosthetic heart valves with the durability of mechanical heart valves (MHVs). The pivoting region of MHVs is hemodynamically of special interest as it may be a region of high shear stresses, combined with areas of flow stagnation. Here, platelets can be activated and may form a thrombus which in the most severe case can compromise leaflet mobility. In this study we set up an experiment to replicate the pulsatile flow in the aortic root and to study the flow in the pivoting region under physiological hemodynamic conditions (CO = 4.5 L/min / CO = 3.0 L/min, f = 60 BPM). It was found that the flow velocity in the pivoting region could reach values close to that of the bulk flow during systole. At the onset of diastole the three valve leaflets closed in a very synchronous manner within an average closing time of 55 ms which is much slower than what has been measured for traditional bileaflet MHVs. Hot spots for elevated viscous shear stresses were found at the flanges of the housing and the tips of the leaflet ears. Systolic VSS was maximal during mid-systole and reached levels of up to 40 Pa.