Pacemaker System Research Articles

Leadless Pacemakers - Implant, Explant and Long-Term Safety and Efficacy Data.

Implantable cardiac pacemakers have seen remarkable progress in the last sixty years and remained as cornerstone therapy for symptomatic bradycardia. Despite this progress the current day traditional transvenous implanted pacemaker systems are limited by the need for a surgically created pocket for the generator, indwelling leads in the vascular system and lastly passage through the tricuspid valve. A majority of the implant and explant related complications are due to the surgical pocket and indwelling leads. Leadless pacemakers represent a major leap in technology and emerged as an alternative to traditional systems promises to eliminate lead and pocket associated complications. As with any disruptive technology, some questions remain unanswered with the leadless pacing systems, specifically longevity and end of life management for the device. Despite the unknowns, as the technology progresses, it is possible that pacing leads will become extinct and pacemakers will miniaturize even further. This review summarizes the available technology, implant and explant details, and long-term safety and efficacy data for leadless pacemakers.

Generalized Attack Model for Networked Control Systems, Evaluation of Control Methods

Networked Control Systems (NCSs) have been implemented in several different industries. The integration with advanced communication networks and computing techniques allows for the enhancement of efficiency of industrial control systems. Despite all the advantages that NCSs bring to industry, they remain at risk to a spectrum of physical and cyber-attacks. In this paper, we elaborate on security vulnerabilities of NCSs, and examine how these vulnerabilities may be exploited when attacks occur. A general model of NCS designed with three different controllers, i.e., proportional-integral-derivative (PID) controllers, Model Predictive control (MPC) and Emotional Learning Controller (ELC) are studied. Then three different types of attacks are applied to evaluate the system performance. For the case study, a networked pacemaker system using the Zeeman nonlinear heart model (ZHM) as the plant combined with the above-mentioned controllers to test the system performance when under attacks. The results show that with Emotional Learning Controller (ELC), the pacemaker is able to track the ECG signal with high fidelity even under different attack scenarios.

Placement Of Cardiac PacemaKEr Trial (POCKET) - rationale and design: a randomized controlled trial.

A pacemaker system consists of one or two leads connected to a device that is implanted into a pocket formed just below the collarbone. This pocket is typically subcutaneous, that is, located just above the pectoral fascia. Even though the size of pacemakers has decreased markedly, complications due to superficial implants do occur. An alternative technique would be intramuscular placement of the pacemaker device, but there are no randomized controlled trials (RCTs) to support this approach, which is the rationale for the Placement Of Cardiac PacemaKEr Trial (POCKET). The aim is to study if intramuscular is superior to subcutaneous placement of a pacemaker pocket. In October 2016, we started to enroll 200 consecutive patients with an indication for bradycardia pacemaker implantation. Patients are randomized to random block sizes, stratified by age group (cut-off: 65 years) and sex, and then randomized to either subcutaneous or intramuscular implant. A concealed allocation procedure is employed, using sequentially numbered, sealed envelopes. Pocket site is blinded to the patient and in all subsequent care. The primary endpoint is patient overall satisfaction with the pocket location at 24 months as measured using a visual analog scale (VAS) 0-10. Secondary endpoints are: complications, patient-reported satisfaction at 1, 12, and 24 months (overall satisfaction, pain, discomfort, degree of unsightly appearance, movement problems, and sleep problems due to device). POCKET is a prospective interventional RCT designed to evaluate if intramuscular is superior to subcutaneous placement of a bradycardia pacemaker during a two-year follow-up.

Laryngeal pacing for bilateral vocal fold paralysis: Voice and respiratory aspects.

To evaluate the effects of neurostimulation with the laryngeal pacemaker (LP) system in patients with bilateral vocal fold paralysis (BVFP) in terms of voice quality and respiratory function. Feasibility study, first-in-human, single-arm, open-label, prospective, multicenter study with group-sequential design and 6-month follow-up period, as described in details in our previous publication. Nine symptomatic BVFP subjects were unilaterally implanted with the LP system at three study sites in Germany and Austria. Subjective and objective voice function, spirometric parameters other than peak expiratory/inspiratory flow (PEF/PIF), and PEF-meter self-assessment were evaluated pre- and 6 months postimplantation. In general, the LP system did not considerably change the voice quality of the implanted patients. Only the sound pressure level range improved significantly 6 months postimplantation (P = 0.018). The LP system implantation did not affect the glottal closure configuration, the duration of the closed phase, and the mucosal wave of the implanted side. The evaluated spirometric parameters were not significantly affected by laryngeal pacing, whereas PEF meter self-assessment showed a stable and significant (P = 0.028) improvement of the PEF within a week upon activation of the LP system. Neurostimulation with the LP system results in an immediate and stable PEF improvement, without negative effects on the voice quality. The PEF meter self-assessment confirmed the spirometry results of the PEF. The stimulated abduction did not affect the glottal closure during phonation. These results should be confirmed in larger and more homogenous patient cohorts. 2b Laryngoscope, 127:1838-1844, 2017.

Pacemaker and ICD oversensing induced by movements near the MRI scanner bore.

The effect of the movement near the MRI scanner bore for people with a pacemaker (PM) or an implantable cardioverter defibrillator (ICD) is experimentally evaluated and discussed. The authors performed in vitro measurements on a saline-filled human-shaped phantom (male, 170 cm height), equipped first with an MR-conditional PM (bicameral configuration, DDD programming), then with an MR-conditional ICD (biventricular configuration, detection algorithms enable but shock delivery disable). Both the devices were able to transmit in real-time the detected cardiac activity (electrograms) while moving the phantom around the MRI scanner. The phantom was also equipped with an accelerometer and a magnetic field probe to measure the angular velocity and the magnetic field variation during the experiment. Unipolar versus bipolar sensing mode and maximum sensitivity versus nominal settings were tested. The sensing functions of the PM and ICD systems began to react to motion induced electromagnetic interference starting at an angular velocity as low as 2 rad/s (|dB/dT| = 2 T/s). The motion induced EMI in PM and ICD systems was interpreted as sensed intrinsic heartbeats which resulted in inappropriate pacing inhibition and arrhythmia classification. At the maximum speed of about 6 rad/s (|dB/dT| = 3 T/s), the induced EMI affected classification of ectopic beats and two episodes of VF were inappropriately recorded. These results demonstrate that motion in and around an MR scanner can induce EMI significant enough to be misinterpreted by implanted PMs and ICDs leading to inappropriate changes in therapy. These findings highlight that PM or ICDs, including MR-conditional systems should not enter the MRI room, except in case of an examination under specified conditions.

Genetically Blocking the Zebrafish Pineal Clock Affects Circadian Behavior.

The master circadian clock in fish has been considered to reside in the pineal gland. This dogma is challenged, however, by the finding that most zebrafish tissues contain molecular clocks that are directly reset by light. To further examine the role of the pineal gland oscillator in the zebrafish circadian system, we generated a transgenic line in which the molecular clock is selectively blocked in the melatonin-producing cells of the pineal gland by a dominant-negative strategy. As a result, clock-controlled rhythms of melatonin production in the adult pineal gland were disrupted. Moreover, transcriptome analysis revealed that the circadian expression pattern of the majority of clock-controlled genes in the adult pineal gland is abolished. Importantly, circadian rhythms of behavior in zebrafish larvae were affected: rhythms of place preference under constant darkness were eliminated, and rhythms of locomotor activity under constant dark and constant dim light conditions were markedly attenuated. On the other hand, global peripheral molecular oscillators, as measured in whole larvae, were unaffected in this model. In conclusion, characterization of this novel transgenic model provides evidence that the molecular clock in the melatonin-producing cells of the pineal gland plays a key role, possibly as part of a multiple pacemaker system, in modulating circadian rhythms of behavior.

Cardiovascular magnetic resonance in patients with magnetic resonance conditional pacemaker systems at 1.5T: influence of pacemaker related artifacts on image quality including first pass perfusion, aortic and mitral valve assessment, flow measurement, short tau inversion recovery and T1-weighted imaging.

There are only limited data on the impact of device-related artifacts on image quality in cardiovascular magnetic resonance imaging (CMR) in patients with pacemakers (PM). Adenosine stress perfusion, T1-weighted imaging and flow measurement as well as valve characterization have not been evaluated previously concerning artifact burden. We aimed to assess image quality in all routinely used CMR sequences. We analyzed 2623 myocardial segments in CMR scans of 61 patients with MR conditional PM (mean age 72.1 ± 11.5years), 23 (37.7%) with right sided, 38 (62.3%) with left-sided devices. There were no relevant artifacts in patients with right-sided devices irrespective of the imaging sequence. In left-sided implants no PM-induced artifacts were found in first pass perfusion sequence, flow analysis and T1 weighted imaging. Only few patients with left-sided devices showed significant PM-artifacts in aortic (3/38, 7.9%)/mitral (n = 2/38, 5.3%) valve imaging and STIR (n = 3/35, 8.6%). In STIR only 14/805 (1.7%) segments were involved. In left-sided PM SSFP cine sequences had more artifact burden than LGE with 377/1505 (25.0%) vs. 162/1505 (10.8%) myocardial segments involved by relevant artifacts respectively (p < 0.001). Apart from cine and LGE imaging in anterior myocardial segments with left-sided implants presence of MRI conditional pacemakers does not affect CMR image quality in multimodal CMR examinations to a significant extent. Our data supports evidence that reduced image quality does not need to be a major concern in PM patients undergoing CMR.

Leadless Cardiac Pacemaker Implantation After Lead Extraction in Patients With Severe Device Infection.

Conventional pacemaker therapy is limited by short- and long-term complications, most notably device infection. Transcatheter pacing systems (TPS) may be beneficial in this kind of patients as they eliminate the need for a device pocket and leads and thus may reduce the risk of re-infection. We assessed a novel procedure in 6 patients with severe device infection who were pacemaker dependent. After lead extraction a single chamber TPS was implanted into the right ventricle. Of the 6 patients who underwent lead extraction due to severe device infection at our institution, 3 were diagnosed with a pocket infection only, whereas the other 3 showed symptoms of both pocket and lead infection. Successful lead extraction and TPS implantation was accomplished in all patients. Four patients were bridged with a temporary pacemaker between 2hours and 2days after lead extraction, whereas 2 patients had the TPS implanted during the same procedure just before traditional pacemaker system removal. All patients stayed free of infection during the follow-up period of 12 weeks. An additional positron emission tomography scan was performed in each patient and indicated no signs of an infection around the TPS. Transcather pacemaker implantation was safe and feasible in 6 patients and did not result in re-infection even if implanted before removal of the infected pacemaker system within the same procedure. Therefore, implantation of a TPS may be an option for patients with severe device infection, especially in those with blocked venous access or who are pacemaker dependent.

Safety evaluation of a leadless transcatheter pacemaker for magnetic resonance imaging use

Increased magnetic resonance imaging (MRI) adoption and demand are driving the need for device patients to have safe access to MRI. The aim of this study was to address the interactions of MRI with the Micra transcatheter pacemaker system. A strategy was developed to evaluate potential MRI risks including device heating, unintended cardiac stimulation, force, torque, vibration, and device malfunction. Assessment of MRI-induced device heating was conducted using a phantom containing gelled saline, and Monte Carlo simulations incorporating these results were conducted to simulate numerous combinations of human body models, position locations in the MRI scanner bore, and a variety of coil designs. Lastly, a patient with a Micra pacemaker who underwent a clinically indicated MRI scan is presented. Compared to traditional MRI conditional pacemakers, the overall risk with Micra was greatly reduced because of the small size of the device and the absence of a lead. The modeling results predicted that the nonperfused temperature rise of the device would be less than 0.4°C at 1.5 T and 0.5°C at 3 T and that the risk of device heating with multiple device implants was not increased as compared with a single device. The clinical case study revealed no MRI-related complications. The MRI safety assessment tests conducted for the Micra pacemaker demonstrate that patients with a single device or multiple devices can safely undergo MRI scans in both 1.5- and 3-T MRI scanners. No MRI-related complications were observed in a patient implanted with a Micra pacemaker undergoing a clinically indicated scan.

The two nerve rings of the hypostomal nervous system of Hydra vulgaris-an immunohistochemical analysis.

In Hydra vulgaris, physiological and pharmacological evidence exists for a hypostomal circumferential neuro-effector pathway that initiates ectodermal pacemaker activity at tentacular-hypostomal loci coordinating body and tentacle contractions. Here, we describe an ectodermal nerve ring that runs below and between the tentacles, and an anti-GABAB receptor antibody-labeled ring coincident with it. The location of this ring is consistent with the physiology of the hypostomal pacemaker systems of hydra. We also describe a distally located, ectodermal ring of nerve fibers that is not associated with anti-GABAB receptor antibody labeling. The neurites and cell bodies of sensory cells contribute to both rings. The location of the distal ring and its sensory cell neurites suggests an involvement in the behavior of the mouth. Between the two rings is a network of anastomosing sensory and ganglion cell bodies and their neurites. Phase contrast, darkfield, and antibody-labeled images reveal that the mouth of hydra comprises five or six epithelial folds whose endoderm extensively labels with anti-GABAB receptor antibody, suggesting that endodermal metabotrobic GABA receptors are also involved in regulating mouth behavior.

Late Outcome and Predictors of Adverse Events Related to the Implantation of a Permanent Pacemaker in Patients with Isolated Congenital Atrioventricular Block.

Isolated congenital atrioventricular block (ICAVB) is a rare, and pacemaker implantation is the only effective treatment. We sought to identify the predictive factors of adverse events related to pacemaker implantation in ICAVB. This is a cohort study of patients diagnosed with ICAVB who underwent pacemaker implantation from 1980 to 2014 in a single center. During the studied period, a total of 647 patients underwent implantation of their first permanent cardiac pacemaker before 30years of age. Of these, only 62 (9.5%) were diagnosed with ICAVB. This condition was diagnosed in utero in 15 (24.2%) cases, 5 (8.1%) in the neonatal period, 32 (51.6%) during childhood, and 10 (16.1%) during adolescence and young adulthood. The presence of autoantibodies (anti-Ro/SSA) was observed in 41% of mothers who underwent serological evaluation. Age at the time of the initial pacemaker implant was 9.8±9years. During a mean follow-up time of 15years, 1 (1.7%) death occurred due to infectious endocarditis. Complications related to pacemaker implant were reported in 24 patients (38.7%). The number of complications was significantly higher in the group with an epimyocardial implantation site (HR 6; CI 2.45-14.95). Ventricular dysfunction occurred in 6 (11.7%) patients; however, we were not able to identify any predictors of it. Our results showed a low mortality rate after permanent therapy. However, these patients exhibited high morbidity related to the pacemaker system, and the epimyocardial implant site was an independent predictor of complications. Predictors of left ventricular dysfunction were not found in the present study.

Long-term outcome of transvenous pacemaker implantation in infants: a retrospective cohort study.

Evaluation of long-term outcome of transvenous pacemaker (PM) implantation in infants. A retrospective analysis of all transvenous PM implantations in infants <10 kg between September 1997 and October 2001 was made. Indications for PM implantation, age at implantation, and determinants of long-term outcome including cardiac function, PM function, and PM (system) complications were noted. Seven patients underwent transvenous VVI(R) PM implantation. Median age at implantation was 3 days (range: 1 day to 14 months), median weight 3.5 kg (range: 2.3-8.7 kg), and median follow-up 14 years (range: 12.3-16.3 years). Pacemaker indications were congenital complete atrioventricular block (n = 4), long QT syndrome with heart block (n = 2), and post-operative complete atrioventricular block with sinus node dysfunction (n = 1). No procedural complications were noted. Today all patients are alive and symptom free with good PM and cardiac function. Two patients underwent PM generator relocation for imminent skin necrosis and skin traction. Two patients suffered from asymptomatic left subclavian vein occlusion and developed thrombosis on the PM electrode. Three patients were converted to an epicardial PM system, due to atrial perforation after upgrading procedure (n = 1), syncope with need for implantable cardioverter defibrillator implantation (n = 1), and systolic dysfunction with development of dilated cardiomyopathy, which normalized under cardiac resynchronization therapy pacing (n = 1). Two patients needed atrioventricular (AV) valve repair for severe insufficiency. Two patients underwent repositioning of dysfunctional PM leads. In five patients, transvenous leads were removed. Indications were elective lead replacement (n = 1), atrial perforation (n = 1), and switch to an epicardial system (n = 3). Transvenous PM implantation in infants (<10 kg) is associated with a high incidence of vascular occlusion, thrombosis, and severe atrioventricular valve regurgitation during long-term follow-up. We advocate an epicardial approach for PM implantation in small children.

Antibradycardia therapy : Indication and implementation

Pacemaker therapy (PMT) in grown-up congenital heart disease (GUCH) must meet the demands of ayoung, dynamic and heterogeneous group of patients. The duration of the therapy has to be planned for several decades and should be accompanied by an invasive procedure at the very least. Most of the patients enter adulthood with their pacemaker (PM) already implanted; for others the indications can be derived from the published guidelines for GUCH and PMT, but need to be adjusted to the individual situation of the patient. Depending on the underlying heart disease the decision on the use of either an epimyocardial or a transvenous PM system has to be made. Both electrodes and PM should correspond to the latest technical developments to optimally adapt to the patients' multiple requirements. In the case of PM system revisions abandoned leads should be removed and vascular stenosis or occlusions cleared to be prepared for later revisions. During any cardiac surgery epimyocardial PM systems should be checked against the patient's needs and expanded or revised accordingly. Epimyocardial resynchronization systems in particular offer more opportunities for compensating for cardiac dysfunction with greater reliability using asecond ventricular lead. The PMT is an essential part of the medical treatment for many patients with GUCH and contributes significantly to the well-being and quality of life. Against this background, acompetent and consequent follow-up regime requires experienced physicians. An integrated telemetric monitoring system for the PM has proven valuable and supports the early recognition of cardiac arrhythmia.

Intra-cardiac pacemaker infection: Surgical management and outcome

BackgroundPacemaker infections are rare, but serious complications of pacemaker therapy. The generator pocket, the pacing leads, or both may be involved. MethodsWe report 21 patients with infected pacemaker systems. All had infected pacemaker and pacemaker leads with tricuspid valve endocarditis. Pacemaker systems were completely removed in all patients. Extracorporeal circulation with beating heart was employed for the explantation of infected pacing leads, generator and removal of vegetations on tricuspid valve and repair of tricuspid valve. Then a permanent epicardial pacemaker lead was inserted. ResultsNo complications occurred in patients with localized generator pocket infections. Two patients with infected leads, who were preoperatively already in a serious clinical condition, died of septic shock in the early postoperative period. No recurrent infections were observed. ConclusionExplantation of the complete pacemaker system has proved a reliable method to eradicate infection. Complications were rare, except in patients who present lately in a critically ill condition and septic shock.

Cardiovascular Implantable Electronic Device Infections due to Propionibacterium Species.

Propionibacterium species are part of the normal skin flora and often considered contaminants when identified in cultures. However, they can cause life-threatening infections, including prosthetic cardiovascular device infections. Clinical presentation and management of cardiovascular implantable electronic device (CIED) infection due to Propionibacterium species has not been well described. Retrospective review of all cases of CIED infection due to Propionibacterium species admitted to Mayo Clinic between January 1, 1990 and December 31, 2014. Patient charts were reviewed for clinical, microbiological, and imaging data. Descriptive analysis was performed. We identified 14 patients with CIED infection due to Propionibacterium species, accounting for 2.3% of all CIED infections. Patients were predominantly male (n = 12, 86%). The median age at admission was 58.5 years (range 22-83). Twelve patients had implantable cardioverter defibrillators (ICDs) and two had permanent pacemaker systems. Twelve patients had generator pocket infection (86%). Two patients met clinical criteria for CIED-related infective endocarditis. Median time between last device manipulation and infection was 9 months (range 1-98). All patients were treated with complete device removal and antibiotic therapy. Six-month follow-up data were available for 10 patients (71%), with no relapses documented. CIED infections due to Propionibacterium species accounted for 2.3% of all device infections over a 25-year period. The most common infectious syndrome was generator pocket infection with delayed onset. There was an unanticipated predominance of ICDs in this cohort. Cure was achieved in all cases with complete device removal and antibiotic therapy.

MR feature tracking in patients with MRI-conditional pacing systems: The impact of pacing.

To develop feature tracking (FT) software to perform strain analysis on conventional (nontagged) cardiac magnetic resonance imaging (MRI) function images. With the advent of MRI-conditional pacemaker systems, effects of cardiac pacing on myocardial strain can be studied using MR. In this study the impact of pacing on left ventricular (LV) strain was investigated using MR-FT in patients with an MRI-conditional cardiac implantable electronic device (CIED). FT was performed on 32 1.5T MR studies (16 patients with an MRI-conditional CIED and 16 control patients with normal scans). Short- and long-axis steady state free precession (SSFP) cines were used for the FT analysis. Strain was assessed using CVI(42) software (Circle Cardiovascular Imaging, Alberta, Canada). In addition, the intra- and interobserver variability was determined using the intraclass correlation coefficient. Of the 16 patients with an MRI-conditional CIED, five patients were paced during the MRI exam. Despite the occasional presence of susceptibility artifacts induced by the CIED, radial, circumferential, and longitudinal strain parameters could be derived for all patients. Peak radial strain and peak circumferential strain were reduced during pacing when compared to the control group; for radial strain: 20.1 ± 4.7% vs. 33.1 ± 6.9%, P < 0.001, and for circumferential strain -7.5 ± 3.5% vs. -14.9 ± 3.2%, P < 0.05. Peak strain parameters were reproducible on an intra- and interobserver level. MR-FT is feasible in patients with an MRI-conditional CIED and can be used to quantify regional wall motion. J. MAGN. RESON. IMAGING 2016;44:964-971.

Hypersensitivity reactions to implantable cardiac pacemakers and defibrillators

Nowadays, for modern electrotherapy of cardiac arrhythmias different pacemaker systems are used. Antibradycardia pacing systems (e. g. single-chamber, two-chamber, three-chamber systems, frequency-adapted pacemaker) can be distinguished from antitachycardia pacing systems like implantable or portable cardioverter defibrillators and combined antibradycardia/antitachycardia systems. Cutaneous reactions overlying apacemaker or defibrillator are often termed "pacemaker dermatitis". In terms of the differential diagnostic workup, these cutaneous reactions can have various causes. After exclusion of infection by analyzing clinical and laboratory-chemical results, "pressure dermatitis" or the often clinically asymptomatic "reticular telangiectatic erythema" (synonym "postimplantation erythema") must be considered. Histological examination of the affected skin can contribute to the diagnosis. In case of suspected contact hypersensitivity to implant material, allergological exploration should be realized. In addition to patch testing with commercially available contact allergens, product-related material metal alloy discs are often available from the pacemaker manufacturer for epicutaneous testing. Due to the lack of additional benefit compared to standardized patch testing, aclear recommendation for such metal alloy discs cannot be given. In selected cases of suspected hypersensitivity reaction, sensitization can eventually be analyzed by the lymphocyte transformation test. Positive reactions must always be critically interpreted taking into consideration the corresponding clinical signs. Depending on the cause, cutaneous reactions are occasionally self-limiting. In many cases, however, removal of the pacemaker is inevitable.

The cumulative effects and clinical safety of repeat magnetic resonance imaging on an MRI-conditional Pacemaker system at 1 .5 Tesla

The cumulative effects and clinical safety of repeat magnetic resonance imaging on an MRI-conditional Pacemaker system at 1 .5 Tesla

Extraction of a trapped pacemaker lead in a pacemaker-dependent patient

A 47-year-old female with a dual chamber pacemaker was referred to our institution for transvenous lead removal because of suspected pocket infection.The history of this patient started in 2002 with a tricuspid valve endocarditis. Therefore, the patient had tricuspid valve repair that yielded a poor outcome.The patient received biological tricuspid valve in 2006. Due to postoperative total atrioventricular-block a DDDR device was implanted. The biological valve degenerated and thus was replaced by a mechanical one in 2014. During this valve implantation the atrial lead was removed and the ventricular lead was trapped by the mechanical valve between the native tricuspid valve annulus of the right ventricle and the outer ring of the mechanical valve. Three months after the last revision the patient developed signs of inflammation. The pocket was opened and a swab test proved positive for Staphylococcus epidermidis. After disinfection with iodine solution the pacemaker was placed under the pectoralis muscle. However, during the following 3 months the patient suffered from swelling over the pacemaker pocket and severe pain.In awareness of the previous history and the clinical symptoms we decided to implant a new pacemaker system on the left side and explant the infected system on the right side.<Learning objective: Pocket infections always require system explantation. Simultaneous explantation of an infected system and implantation of a new system within the same session is not recommended but was necessary in this case. Even complex lead extraction like this one can be successfully performed applying the appropriate tools (locking stylet, Evolution device, Cook Intravascular Inc., Leechburg, PA, USA).>

Laryngeal pacing via an implantable stimulator for the rehabilitation of subjects suffering from bilateral vocal fold paralysis: A prospective first-in-human study.

To evaluate the performance and safety of the newly developed Laryngeal Pacemaker System (LP System) for the treatment of bilateral vocal fold paralysis (BVFP). Feasibility, first-in-human, single-arm, open-label, prospective, multicenter study with a group sequential design and a 6-month follow-up period. Nine symptomatic BVFP subjects were implanted unilaterally with the LP System. Pre- and 6-month postimplantation evaluations consisted of the 6-Minute Walk Test (6MWT), the Peak Expiratory and Inspiratory Flow (PEF and PIF) evaluation, the PEF meter analysis, the 36-Item Short Form Health Survey (SF-36), the Glasgow Benefit Inventory (GBI), the 12-Item Voice Handicap Index (VHI-12), and the Fiberoptic Endoscopic Evaluation of Swallowing. The safety profile of the LP System was continuously monitored. The LP System implantation was achieved in 8/9 cases. Seven of the nine subjects completed the study. Absolute PEF and PIF values improved significantly 6 months postimplantation (P < .05). 6MWT results showed a non-statistically significant improvement (P = .09). The mental component of the SF-36 showed a significant improvement (P = .043), whereas the other SF-36 components, the GBI, and the VHI-12 results did not changed significantly. The LP System did not affect the voice and swallowing quality and maintained a reliable safety profile for the duration of the study. This feasibility study showed that the LP System has the potential to become an effective and safe treatment for BVFP subjects without compromising the patients' voice. 2b Laryngoscope, 126:1810-1816, 2016.