Early real-world implant experience with a helix-fixation ventricular leadless pacemaker.

BACKGROUND: Roughly one in six patients receiving conventional transvenous pacemaker systems experience significant complications within 1 year of implant, mainly due to the transvenous lead and subcutaneous pocket. A new helix-fixation single-chamber ventricular leadless pacemaker (LP) system capable of pre-deployment exploratory electrical mapping is commercially available. Such an LP may mitigate complications while streamlining the implantation. In this study, the initial real-world implant experience of the helix-fixation LP was evaluated following its commercial release. METHODS: In patients indicated for single-chamber right ventricular pacing, helix-fixation Aveir VR LPs (Abbott, Abbott Park, IL) were implanted using the dedicated loading tool, introducer, and delivery catheter. Implant procedural characteristics, electrical parameters, and any 30-day procedure-related adverse events of consecutive implant attempts were retrospectively evaluated. RESULTS: A total of 167 patients with Class I indication for permanent pacing received implants in four North American centers (57% male, 70 years old). Pre-fixation electrical mapping of potential sites allowed repositioning to be avoided in 95.7% of patients. Median [interquartile range] LP procedure and fluoroscopy durations were 25.5 min [20.0, 35.0] and 5.7 min [4.0, 9.2], respectively. Pacing capture threshold, sensed R-wave amplitude, and impedance were 0.8 V [0.5, 1.3], 9.0 mV [6.0, 12.0], and 705 Ω [550, 910], respectively. Implantation was successful in 98.8% of patients, with 98.2% free from acute adverse events. CONCLUSIONS: The initial, real-world experience of the helix-fixation ventricular leadless pacemaker demonstrated safe and efficient implantation with minimal repositioning, viable electrical metrics, and limited acute complications.

Retrieval of Chronically Implanted Dual-chamber Leadless Pacemakers in an Ovine Model.

BACKGROUND: The clinical utilization of leadless pacemakers (LPs) as an alternative to traditional transvenous pacemakers is likely to increase with the advent of dual-chamber LP systems. Since device retrieval to allow LP upgrade or replacement will become an important capability, the first such dual-chamber, helix-fixation LP system (Aveir DR; Abbott, Abbott Park, IL) was specifically designed to allow catheter-based retrieval. In this study, the preclinical performance and safety of retrieving chronically implanted dual-chamber LPs was evaluated. METHODS: Atrial and ventricular LPs were implanted in the right atrial appendage and right ventricular apex of 9 healthy ovine subjects. After ≈2 years, the LPs were retrieved using a dedicated transvenous retrieval catheter (Aveir Retrieval Catheter; Abbott) by snaring, docking, and unscrewing from the myocardium. Comprehensive necropsy/histopathology studies were conducted to evaluate device- and procedure-related outcomes. RESULTS: At a median of 1.9 years postimplant (range, 1.8-2.6), all 18 of 18 (100%) LPs were retrieved from 9 ovine subjects without complications. The median retrieval procedure duration for both LPs, from first-catheter-in to last-catheter-out, was 13.3 minutes (range, 2.5-36.4). Postretrieval, all right atrial, and right ventricular implant sites demonstrated minimal tissue disruption, with intact fibrous tissue limited to the distal device body. No significant device-related trauma, perforation, pericardial effusion, right heart or tricuspid valve injury, or chronic pulmonary thromboembolism were observed at necropsy. CONCLUSIONS: This preclinical study demonstrated the safe and effective retrieval of chronically implanted, helix-fixation, dual-chamber LP systems, paving the way for clinical studies of LP retrieval.

Dual-chamber leadless pacing: Atrioventricular synchrony in preclinical models of normal or blocked atrioventricular conduction.

BACKGROUND: Dual-chamber leadless pacemakers (LPs) require robust communication between distinct right atrial (RA) and right ventricular (RV) LPs to achieve atrioventricular (AV) synchrony. OBJECTIVE: The purpose of this preclinical study was to evaluate a novel, continuous implant-to-implant (i2i™) communication methodology for maintaining AV-synchronous, dual-chamber DDD(R) pacing by the 2 LPs. METHODS: RA and RV LPs were implanted and paired in 7 ovine subjects (4 with induced complete heart block). AV synchrony (% AV intervals <300 ms) and i2i communication success (% successful i2i transmissions between LPs) were evaluated acutely and chronically. During acute testing, 12-lead electrocardiographic and LP diagnostic data were collected from 5-minute recordings, in 4 postures and 2 rhythms (AP-VP and AS-VP, or AP-VS and AS-VS) per subject. Chronic i2i performance was evaluated through 23 weeks postimplant (final i2i evaluation period: week 16-23). RESULTS: Acute AV synchrony and i2i communication success across multiple postures and rhythms were median [interquartile range] 100.0% [100.0%-100.0%] and 99.9% [99.9%-99.9%], respectively. AV synchrony and i2i success rates did not differ across postures (P = .59, P = .11) or rhythms (P = 1, P = .82). During the final i2i evaluation period, the overall i2i success was 98.9% [98.1%-99.0%]. CONCLUSION: Successful AV-synchronous, dual-chamber DDD(R) leadless pacing using a novel, continuous, wireless communication modality was demonstrated across variations in posture and rhythm in a preclinical model.

Wireless Communication Between Paired Leadless Pacemakers for Dual-Chamber Synchrony.

BACKGROUND: Leadless pacemakers (LPs) can mitigate conventional pacemaker complications related to the transvenous leads and subcutaneous pocket surrounding the pulse generator. Although single-chamber leadless pacing has been established, multichamber pacing requires wireless bidirectional communication across multiple LPs to maintain synchrony. This preclinical study demonstrates the chronic performance of implant-to-implant (i2i) communication that achieves synchronous, dual-chamber pacing with 2 LPs. METHODS: The i2i communication modality employs subthreshold electrical signals conducted between implanted LPs through the blood and myocardial tissue on a beat-by-beat basis. Right atrial and right ventricular LPs were implanted in 9 ovine subjects. The i2i transmission performance was evaluated 13 weeks after implant. RESULTS: Right atrial and right ventricular LPs were implanted successfully and without complication in 9 ovine subjects. A total of 8715±457 right atrial-to-right ventricular and right ventricular-to-right atrial transmissions were sent per hour, with a success rate of 99.2±0.9%. Of periods with i2i communication failure when DDD pacing was not possible, 97.3±1.8% were resolved within 6 s. CONCLUSIONS: For the first time, synchronized, dual-chamber pacing has been demonstrated in a chronic preclinical feasibility study by 2 leadless pacemakers using beat-to-beat, wireless communication, achieving a success rate of 99.2%.

Preclinical safety and electrical performance of novel atrial leadless pacemaker with dual-helix fixation.

BACKGROUND: Complications associated with transvenous pacemakers, specifically those involving the lead or subcutaneous pocket, may be avoided with leadless pacemakers (LPs). The safety and efficacy of single-chamber right ventricular LPs have been demonstrated, but their right atrium (RA) use poses new design constraints. OBJECTIVES: The purpose of this study was to evaluate the implant success, electrical performance, and safety of a novel RA LP design in benchtop and preclinical studies. METHODS: A new LP was designed with a dual-helix fixation mechanism specific to the RA anatomy. A 12-week preclinical ovine study was conducted to evaluate implant success, electrical performance, mechanical stability, and safety in vivo, with supporting benchtop measurements to quantify the mechanical forces needed for device retrieval and dislodgment. RESULTS: LPs were successfully implanted in all 10 ovine subjects with no complications. The pacing capture threshold improved significantly over time from implant to week 12 (1.1 ± 0.7 V vs 0.4 ± 0.2 V, P = .008). Sensing amplitudes and pacing impedances were stable from implant to week 12 (4.8 ± 1.8 mV vs 6.0 ± 1.9 mV, P = .160; and 393 ± 77 Ω vs 398 ± 65 Ω, P = .922, respectively). Gross pathology and microscopic histology revealed no adverse interactions and no evidence of device dislodgment or clinically significant myocardial perforation. Benchtop ex vivo porcine atrial tissue measurements revealed greater pull forces required to dislodge the LP vs transvenous active fixation lead (0.42 ± 0.18 lbf vs 0.29 ± 0.08 lbf, P = .020), and greater rotational forces required for deliberate extraction (0.28 ± 0.04 lbf vs 0.14 ± 0.07 lbf, P <.001). CONCLUSION: The novel atrial LP demonstrated successful implantation, with acceptable electrical performance, mechanical stability, and safety in a 12-week preclinical study.

Acoustic remote sensing for source localization and atmospheric tomography: Applications of the cross-correlation Green's function retrieval method.

In this work, the application of the cross-correlation Green's function retrieval method for source localization and atmospheric acoustic tomography is presented. Open field experimental measurements of an acoustic source, with an impulsive waveform, are conducted for the evaluation of an array system. Of particular interest are the source localization and sound speed estimation capabilities of the array system. The cross-correlation delay-and-sum beamformer is used to estimate source directivity and sound speed. This beamformer inherently employs the cross-correlation Green's function retrieval method between a pair of receivers. The beamforming results adequately identify the various source directions as well as the scatterers along the propagation path. Reasonable sound speed estimates are obtained at the peak frequency of the retrieved Green's functions. In the case of atmospheric acoustic tomography, the estimated sound speed from the array system can serve as an average background sound speed in a tomographic inversion algorithm. Utilizing a tomographic inversion algorithm with radial basis functions and the estimated sound speed, the reconstruction of temperature and wind velocity profiles are demonstrated.

Green's function extraction by crosscorrelation and multidimensional deconvolution for outdoor sound propagation.

In this work, the Green's function is estimated from outdoor measurements of controlled-sources. Crosscorrelation and multidimensional deconvolution have successfully been employed for Green's function retrieval. Crosscorrelation assumes a lossless medium and equipartitioned wavefield; when these assumptions are not satisfied it may result in a Green's function smeared with the source point-spread function. Multidimensional deconvolution removes the point-spread function from the retrieved Green's function. Both methods are employed to estimate the Green's function between two array stations for a single and multiple controlled-sources. The results demonstrate that the source-to-center radius has a negligible effect on the retrieved Green's function, if the source-to-center radius is larger than the distance between the two array stations.

Measurement of back-scattering patterns from single laser trapped aerosol particles in air.

We demonstrate a method for measuring elastic back-scattering patterns from single laser trapped micron-sized particles, spanning the scattering angle range of θ=167.7°-180° and φ=0°-360° in spherical coordinates. We calibrated the apparatus by capturing light-scattering patterns of 10 µm diameter borosilicate glass microspheres and comparing their scattered intensities with Lorenz-Mie theory. Back-scattering patterns are also presented from a single trapped Johnson grass spore, two attached Johnson grass spores, and a cluster of Johnson grass spores. The method has potential use in characterizing airborne aerosol particles, and may be used to provide back-scattering data for lidar applications.

Percutaneous Retrieval of Implanted Leadless Pacemakers: Feasibility at 2.5 Years Post-Implantation in an In Vivo Ovine Model.

OBJECTIVES: This in vivo ovine study describes the feasibility and safety of retrieving implanted leadless pacemakers (LPs). BACKGROUND: Although LPs have been shown to be removable soon after implantation, there are no data on the feasibility of removing chronically implanted LPs. METHODS: This study was performed in 2 phases. In the mid-term cohort, 10 chronically (5.3 months) implanted animals underwent retrieval, followed by: 1) immediate necropsy in 5; and 2) in the remaining 5, reimplantation of a new LP followed by necropsy at 6 weeks. In the long-term cohort, 8 additional sheep underwent retrieval at 2.3 ± 0.1 years followed by necropsy. Retrieval was performed using either a single or triple loop snare. All 18 LPs (100%) were successfully retrieved. The time from retrieval catheter insertion to retrieval was 2:35 ± 01:11 and 3:04 ± 01:13 minutes in the mid-term and long-term study groups, respectively. RESULTS: There were no significant differences in retrieval times using either snare. Intracardiac echocardiography was used pre- and post-retrieval to confirm the absence of pericardial effusion in all 8 sheep. On necropsy, there was no evidence of pericardial bleeding or perforation. Only minor tissue disruption and hemorrhage was noted at the implant site after retrieval. Histology demonstrated fibrous connective tissue at the contact sites of endocardium and LP can and at the helix. There was no evidence of pulmonary thromboembolism. CONCLUSIONS: We demonstrate the feasibility and safety of percutaneous, catheter-based retrieval in chronic LP implants of a maximum duration of approximately 2.5 years.

Feasibility and efficacy of percutaneously delivered leadless cardiac pacing in an in vivo ovine model.

INTRODUCTION: In this in vivo ovine study, we describe the course of pacing and sensing parameters during follow-up as well as the gross and histopathological features at the implant site of the recently described leadless cardiac pacemaker (LCP). METHODS AND RESULTS: All sheep underwent LCP implantation in the right ventricular (RV) apex. Serial pacing/sensing thresholds were assessed. In the first cohort, 11 animals were followed up for a period of 3 months, followed by necropsy. In the second cohort, 7 additional sheep were followed for a period of up to 18 months. Mean pacing and sensing thresholds in the 3-month cohort were 1.0 ± 0.5 V and 9.0 ± 3.7 mV at implant, and 0.7 ± 0.2 V and 8.1 ± 3.9 mV at 90 days, respectively. At necropsy at 3 months, all devices were securely implanted at the RV apex without extrusion of helix beyond the RV wall. Besides endocardial reactive changes in the RV apex surrounding the distal portion of the LCP, there were no other grossly visible abnormalities. In the second cohort (7 sheep), mean pacing and sensing thresholds were 1.0 ± 0.5 V and 9.9 ± 3.8 mV at implant, and 0.86 ± 0.4 V and 4.25 ± 1 mV, respectively, at 18 months of follow-up. CONCLUSION: We demonstrate that after implantation of the LCP, pacing/sensing parameters remain adequate up to 18 months in follow-up. In addition, pathological changes at the implant site and within the RV are limited in severity at 90 days, supporting the efficacy and safety of this novel approach to pacing.

In situ infrared aerosol spectroscopy for a variety of nerve agent simulants using flow-through photoacoustics.

We present newly measured results of an ongoing experimental program established to measure optical cross sections in the mid- and long-wave infrared for a variety of chemically and biologically based aerosols. For this study we consider only chemically derived aerosols, and in particular, a group of chemical compounds often used as simulants for the detection of extremely toxic organophosphorus nerve agents. These materials include: diethyl methylphosphonate (DEMP), dimethyl methylphosphonate (DMMP), diisopropyl methylphosphonate (DIMP), and diethyl phthalate (DEP). As reported in a prior study [Appl. Opt. 44, 4001 (2005)], we combine two optical techniques well suited for aerosol spectroscopy [i.e., flow-through photoacoustics and Fourier transform infrared (FTIR) emission spectroscopy], to measure in situ the absolute extinction and absorption cross sections over a variety of wavelengths spanning the IR spectral region from 3 to 13 mum. Aerosol size distribution(s), particle number density, and dosimetric measurements are recorded simultaneously in order to present optical cross sections that are aerosol mass normalized, i.e., m(2)/gram. Photoacoustic results, conducted at a series of CO(2) laser lines, compare well with measured broadband FTIR spectral extinction. Both FTIR and photoacoustic data also compare well with Mie theory calculations based on measured size distributions and previously published complex indices of refraction.

Results of the prospective multicenter trial of robotically assisted totally endoscopic coronary artery bypass grafting.

BACKGROUND: Robotic technology has been proven safe and efficacious in the performance of mitral valve repair and atrial septal defect repair. This report describes a Food and Drug Administration-sanctioned multicenter study of the safety and efficacy of the da Vinci system (Intuitive Surgical, Inc, Mountain View, CA) for totally endoscopic coronary artery bypass (TECAB) surgery. METHODS: Patients requiring left anterior descending (LAD) coronary artery revascularization were eligible. The procedure was performed with femoro-femoral cardiopulmonary bypass (CPB), endoaortic balloon occlusion, and thoracoscopy. All aspects of the procedure were performed with the robotic system, from internal mammary artery harvest to coronary anastomosis. RESULTS: Ninety-eight patients requiring single-vessel LAD revascularization were enrolled at 12 centers. Thirteen patients (13%) were excluded intraoperatively (eg, failed femoral cannulation, inadequate working space). In 85 patients (69 men, age 58 +/- 10 years) who underwent TECAB, CPB time was 117 +/- 44 minutes, cross-clamp time was 71 +/- 26 minutes, and hospital length of stay was 5.1 +/- 3.4 days. There were five (6%) conversions to open techniques. There were no deaths or strokes, one early reintervention, and one myocardial infarction (1.5%). Three-month angiography was performed in 76 patients, revealing significant anastomotic stenoses (> 50%) or occlusions in 6 patients. Overall freedom from reintervention or angiographic failure was 91%. CONCLUSIONS: Robotic TECAB was accomplished with no mortality, low morbidity, and angiographic patency and reintervention rates comparable with published data. Although the use of CPB was a limitation of the technique, this experience represents a step toward more advanced procedures, such as multivessel or off-pump TECAB.

In situ measurement of the infrared absorption and extinction of chemical and biologically derived aerosols using flow-through photoacoustics.

In an effort to establish a more reliable set of optical cross sections for a variety of chemical and biological aerosol simulants, we have developed a flow-through photoacoustic system that is capable of measuring absolute, mass-normalized extinction and absorption cross sections. By employing a flow-through design we avoid issues associated with closed aerosol photoacoustic systems and improve sensitivity. Although the results shown here were obtained for the tunable CO2 laser waveband region, i.e., 9.20-10.80 microm, application to other wavelengths is easily achievable. The aerosols considered are categorized as biological, chemical, and inorganic in origin, i.e., Bacillus atrophaeus endospores, dimethicone silicone oil (SF-96 grade 50), and kaolin clay powder (alumina and silicate), respectively. Results compare well with spectral extinction measured previously by Fourier-transform infrared spectroscopy. Comparisons with Mie theory calculations based on previously published complex indices of refraction and measured size distributions are also presented.

Measured infrared optical cross sections for a variety of chemical and biological aerosol simulants.

We conducted a series of spectral extinction measurements on a variety of aerosolized chemical and biological simulants over the spectral range 3-13 microm using conventional Fourier-transform IR (FTIR) aerosol spectroscopy. Samples consist of both aerosolized particulates and atomized liquids. Materials considered include Bacillus subtilis endospores, lyophilized ovalbumin, polyethylene glycol, dimethicone (SF-96), and three common background materials: kaolin clay (hydrated aluminum silicate), Arizona road dust (primarily SiO2), and diesel soot. Aerosol size distributions and mass density were measured simultaneously with the FTIR spectra. As a result, all optical parameters presented here are mass normalized, i.e., in square meters per gram. In an effort to establish the utility of using Mie theory to predict such parameters, we conducted a series of calculations. For materials in which the complex indices of refraction are known, e.g., silicone oil (SF-96) and kaolin, measured size distributions were convolved with Mie theory and the resultant spectral extinction calculated. Where there was good agreement between measured and calculated extinction spectra, absorption, total scattering, and backscatter were also calculated.