Contemporary pacemakers (PMs) are powered by primary batteries with a limited energy-storing capacity. PM replacements because of battery depletion are common and unpleasant and bear the risk of complications. Batteryless PMs that harvest energy inside the body may overcome these limitations. The goal of this study was to develop a batteryless PM powered by a solar module that converts transcutaneous light into electrical energy. Ex vivo measurements were performed with solar modules placed under pig skin flaps exposed to different irradiation scenarios (direct sunlight, shade outdoors, and indoors). Subsequently, 2 sunlight-powered PMs featuring a 4.6-cm(2) solar module were implanted in vivo in a pig. One prototype, equipped with an energy buffer, was run in darkness for several weeks to simulate a worst-case scenario. Ex vivo, median output power of the solar module was 1963 μW/cm(2) (interquartile range [IQR] 1940-2107 μW/cm(2)) under direct sunlight exposure outdoors, 206 μW/cm(2) (IQR 194-233 μW/cm(2)) in shade outdoors, and 4 μW/cm(2) (IQR 3.6-4.3 μW/cm(2)) indoors (current PMs use approximately 10-20 μW). Median skin flap thickness was 4.8 mm. In vivo, prolonged SOO pacing was performed even with short irradiation periods. Our PM was able to pace continuously at a rate of 125 bpm (3.7 V at 0.6 ms) for 1½ months in darkness. Tomorrow's PMs might be batteryless and powered by sunlight. Because of the good skin penetrance of infrared light, a significant amount of energy can be harvested by a subcutaneous solar module even indoors. The use of an energy buffer allows periods of darkness to be overcome.
7 February 2017 in IEEE Transactions on Biomedical Circuits and Systems
A new pseudo asynchronous level crossing analogue-to-digital converter (ADC) architecture targeted for low-power, implantable, long-term biomedical sensing applications is presented. In contrast to most of the existing asynchronous level crossing ADC designs, the proposed design has no digital-to-analogue converter (DAC) and no continuous time comparators. Instead, the proposed architecture uses an analogue memory cell and dynamic comparators. The architecture retains the signal activity dependent sampling operation by generating events only when the input signal is changing. The architecture offers the advantages of smaller chip area, energy saving and fewer analogue system components. Beside lower energy consumption the use of dynamic comparators results in a more robust performance in noise conditions. Moreover, dynamic comparators make interfacing the asynchronous level crossing system to synchronous processing blocks simpler. The proposed ADC was implemented in 0.35 μm complementary metal-oxide-semiconductor (CMOS) technology, the hardware occupies a chip area of 0.0372 mm 2 and operates from a supply voltage of 1.8 V to 2.4 V. The ADC's power consumption is as low as 0.6 μW with signal bandwidth from 0.05 Hz to 1 kHz and achieves an equivalent number of bits (ENOB) of up to 8 bits.
Today's cardiac pacemakers are powered by batteries with limited energy capacity. As the battery's lifetime ends, the pacemaker needs to be replaced. This surgical re-intervention is costly and bears the risk of complications. Thus, a pacemaker without primary batteries is desirable. The goal of this study was to test whether transcutaneous solar light could power a pacemaker. We used a three-step approach to investigate the feasibility of sunlight-powered cardiac pacing. First, the harvestable power was estimated. Theoretically, a subcutaneously implanted 1 cm2 solar module may harvest ∼2500 µW from sunlight (3 mm implantation depth). Secondly, ex vivo measurements were performed with solar cells placed under pig skin flaps exposed to a solar simulator and real sunlight. Ex vivo measurements under real sunlight resulted in a median output power of 4941 µW/cm2 [interquartile range (IQR) 3767–5598 µW/cm2, median skin flap thickness 3.0 mm (IQR 2.7–3.3 mm)]. The output power strongly depended on implantation depth (ρSpearman = −0.86, P < 0.001). Finally, a batteryless single-chamber pacemaker powered by a 3.24 cm2 solar module was implanted in vivo in a pig to measure output power and to pace. In vivo measurements showed a median output power of >3500 µW/cm2 (skin flap thickness 2.8–3.84 mm). Successful batteryless VVI pacing using a subcutaneously implanted solar module was performed. Based on our results, we estimate that a few minutes of direct sunlight (irradiating an implanted solar module) allow powering a pacemaker for 24 h using a suitable energy storage. Thus, powering a pacemaker by sunlight is feasible and may be an alternative energy supply for tomorrow's pacemakers.
Aims: The left atrial posterior wall is a potential ablation target in patients with recurrent atrial fibrillation despite durable pulmonary vein isolation or in patients with roof-dependent atrial tachycardia (AT). Pulsed-field ablation (PFA) offers efficient and safe posterior wall ablation (PWA), but available data are scarce. Methods and results: Consecutive patients undergoing PWA using PFA were included. Posterior wall ablation was performed using a pentaspline PFA catheter and verified by 3D-electroanatomical mapping. Follow-up was performed using 7-day Holter ECGs 3, 6, and 12 months after ablation. Recurrence of any atrial arrhythmia lasting more than 30 s was defined as failure. Lesion durability was assessed during redo procedures. Posterior wall ablation was performed in 215 patients (70% males, median age 70 [IQR 61–75] years, 67% redo procedures) and was successful in all patients (100%) by applying a median of 36 (IQR 32–44) PFA lesions. Severe adverse events were cardiac tamponade and vascular access complication in one patient each (0.9%). Median follow-up was 7.3 (IQR 5.0–11.8) months. One-year arrhythmia-free outcome in Kaplan–Meier analysis was 53%. A redo procedure was performed in 26 patients (12%) after a median of 6.9 (IQR 2.4–11) months and showed durable PWA in 22 patients (85%) with only minor lesion regression. Among four patients with posterior wall reconnection, three (75%) presented with roof-dependent AT. Conclusion: Posterior wall ablation with this pentaspline PFA catheter can be safely and efficiently performed with a high durability observed during redo procedures. The added value of durable PWA for the treatment of atrial fibrillation remains to be evaluated.
Leadless pacemakers (PMs) capable of atrioventricular (AV) synchronous pacing have recently been introduced. Initial feasibility studies were promising but limited to just a few minutes of AV synchronous pacing. Real-world, long-term data on AV synchrony and programming adjustments affecting AV synchrony in outpatients are lacking. The purpose of this study was to investigate AV synchrony and influences of PM programming adjustments in outpatients with leadless VDD PMs. All patients who received a leadless VDD PM (Micra™ AV, Medtronic) between July 2020 and May 2021 at our center were included in this observational study. AV synchrony was assessed repeatedly postoperatively and during follow-up using Holter electrocardiographic (ECG) recordings. AV synchrony was defined as a QRS complex preceded by a p wave within 300 ms. The impact of programming changes during follow-up on AV synchrony was studied. A total of 816 hours of Holter ECG from 20 outpatients were analyzed. During predominantly paced episodes (≥80% ventricular pacing), median AV synchrony was 91% [interquartile range (IQR) 34%-100%] when patients had sinus rates 50-80/min. Median AV synchrony was lower when patients had sinus rates >80/min [33% (29%-46%); P <.001]. During a stepwise optimization protocol, AV synchrony could be improved (P <.038). Multivariate analysis showed that a shorter maximum A3 window end (P <.001), lower A3 threshold (P = .046), and minimum A4 threshold (P <.001) improved AV synchrony. Successful VDD pacing in the outpatient setting during higher sinus rates is more difficult to achieve than can be presumed based on initial feasibility studies. The devices often require multiple reprogramming to maximize AV sequential pacing.
14 November 2017 in IEEE Transactions on Biomedical Engineering
Objective: Cardiac pacemakers require regular medical follow-ups to ensure proper functioning. However, device replacements due to battery depletion are common and account for ~25% of all implantation procedures. Furthermore, conventional pacemakers require pacemaker leads which are prone to fractures, dislocations or isolation defects. The ensuing surgical -interventions increase risks for the patients and costs that need to be avoided. Methods: In this study, we present a method to harvest energy from endocardial heart motions. We developed a novel generator, which converts the heart's mechanical into electrical energy by electromagnetic induction. A mathematical model has been introduced to identify design parameters strongly related to the energy conversion efficiency of heart motions and fit the geometrical constraints for a miniaturized transcatheter deployable device. The implemented final design was tested on the bench and in-vivo. Results: The mathematical model proved an accurate method to estimate the harvested energy. For three previously recorded heart motions, the model predicted a mean output power of 14.5, 41.9 and 16.9 μW. During an animal experiment, the implanted device harvested a mean output power of 0.78 μW and 1.7 μW at a heart rate of 84 and 160 bpm, respectively. Conclusion: Harvesting kinetic energy from endocardial motions seems feasible. Implanted at an energetically favorable location, such systems might become a welcome alternative to extend the lifetime of cardiac implantable electronic device. Significance: The presented endocardial energy harvesting concept has the potential to turn pacemakers into battery- and leadless systems and thereby eliminate two major drawbacks of contemporary systems.