A Dual-Chamber Leadless Pacemaker.

BACKGROUND: Single-chamber ventricular leadless pacemakers do not support atrial pacing or consistent atrioventricular synchrony. A dual-chamber leadless pacemaker system consisting of two devices implanted percutaneously, one in the right atrium and one in the right ventricle, would make leadless pacemaker therapy a treatment option for a wider range of indications. METHODS: We conducted a prospective, multicenter, single-group study to evaluate the safety and performance of a dual-chamber leadless pacemaker system. Patients with a conventional indication for dual-chamber pacing were eligible for participation. The primary safety end point was freedom from complications (i.e., device- or procedure-related serious adverse events) at 90 days. The first primary performance end point was a combination of adequate atrial capture threshold and sensing amplitude at 3 months. The second primary performance end point was at least 70% atrioventricular synchrony at 3 months while the patient was sitting. RESULTS: Among the 300 patients enrolled, 190 (63.3%) had sinus-node dysfunction and 100 (33.3%) had atrioventricular block as the primary pacing indication. The implantation procedure was successful (i.e., two functioning leadless pacemakers were implanted and had established implant-to-implant communication) in 295 patients (98.3%). A total of 35 device- or procedure-related serious adverse events occurred in 29 patients. The primary safety end point was met in 271 patients (90.3%; 95% confidence interval [CI], 87.0 to 93.7), which exceeded the performance goal of 78% (P<0.001). The first primary performance end point was met in 90.2% of the patients (95% CI, 86.8 to 93.6), which exceeded the performance goal of 82.5% (P<0.001). The mean (±SD) atrial capture threshold was 0.82±0.70 V, and the mean P-wave amplitude was 3.58±1.88 mV. Of the 21 patients (7%) with a P-wave amplitude of less than 1.0 mV, none required device revision for inadequate sensing. At least 70% atrioventricular synchrony was achieved in 97.3% of the patients (95% CI, 95.4 to 99.3), which exceeded the performance goal of 83% (P<0.001). CONCLUSIONS: The dual-chamber leadless pacemaker system met the primary safety end point and provided atrial pacing and reliable atrioventricular synchrony for 3 months after implantation. (Funded by Abbott Medical; Aveir DR i2i ClinicalTrials.gov number, NCT05252702.).

Retrieval of Long-Term Implanted Leadless Pacemakers: A Single-Center Experience.

OBJECTIVES: The authors report their single-center experience with the retrieval and replacement of long-term implanted leadless cardiac pacemakers (LPs) and the factors contributing to success. BACKGROUND: LPs are a clinically effective and safe alternative to standard transvenous pacemakers for single-chamber ventricular pacing. However, the feasibility of retrieving and replacing long-term implanted LPs is not well known. METHODS: A total of 34 patients with implanted Nanostim LPs (mean implantation duration 1,570 ± 479 days) subsequently underwent retrieval. On the basis of fluoroscopic imaging, the cohort was divided into 2 groups: those with remarkable swinging movement (SM) of the LP docking button (n = 25) and those without SM (n = 9). RESULTS: The overall LP retrieval success rate was 85% (n = 29). New leadless devices were implanted in 27 patients immediately after LP retrieval. No procedure-related adverse events occurred. The rate of successful LP retrieval was significantly higher in the SM group (25 of 25 [100%]) than in the no-SM group (4 of 9 [44%]) (p < 0.001), and fluoroscopy time during the retrieval procedure was shorter in the SM group (12.7 ± 8.6 min) than in the no-SM group (45.6 ± 19 min) (p < 0.001). CONCLUSIONS: This study demonstrated the feasibility and safety of retrieval of long-term implanted LPs after a mean duration of 4 years. Retrieval was most successful in patients whose docking buttons exhibited significant SM.

Hip and thigh anatomy of the clouded leopard (Neofelis nebulosa) with comparisons to the domestic cat (Felis catus).

The clouded leopard (N. nebulosa) is an endangered felid native to Southeast Asia. It is considered to be the largest and most acrobatic of the arboreal cats. To date, published studies have focused on cranial morphology, particularly osteology and dentition. This study describes the hip and thigh morphology of N. nebulosa and compares it to the domestic cat (F. catus). A number of statistically significant differences were observed between N. nebulosa and F. catus that were primarily associated with muscle attachment surface areas rather than differences in overall morphology. F. catus had proportionally larger attachment areas for Mm. gluteus profundus, tensor fasciae latae, and biceps femoris, while N. nebulosa had larger attachment areas for Mm. gluteus medius, rectus femoris, and semitendinosus. By comparison, surface area analysis of nonfelid species (C. latrans and V. vulpes) showed more differences when compared to felids demonstrating that this analytical technique is useful for differentiating closely-related species from more distant ones. These results suggest that muscle map area analysis may be useful for comparing phylogenetic relationships between and within groups of different species and may also suggest variations in locomotor habits.

Comparative analysis of paw pad structure in the clouded leopard (Neofelis nebulosa) and domestic cat (Felis catus).

The Clouded leopard (Neofelis nebulosa) is a medium-sized highly arboreal cat. This study compares the structure of the digital, metacarpal and metatarsal pads of the manus and pes in N. nebulosa to that of the domestic cat (Felis catus). Covered by a stratified squamous cornified epithelium, the pads have a supple deposit of subepidermal fat that is partitioned by collagen fibers and extensively anchored to the muscle tendon sheaths. In both animals, a pes metatarsal pad suspensory ligament originates from the Mm. flexores digitorum profundi tendon and forms 3-4 small branches that project through the dermal fat layer and attach to the pad epidermis. In the cat manus, four tendons of equal size extend from the M. flexor digitorum superficialis (FDS) to form the manica flexoria in digits 2-4 from which extends a metacarpal pad suspensory ligament (MPSL) on digits 2 and 5 that extends into the tela subcutanea and epidermis. On digits 3 and 4 MPSL extends directly from the FDS tendon itself. In contrast, manus FDS tendons 1 and 5 in N. nebulosa were thin and either project directly to the tela subcutanea (tendon 1) or connect with the manica flexoria forming a metacarpal pad suspensory ligament (tendon 5). Tendons 2-4 connect with the manica flexoria from which MPSL project into the tela subcutanea and epidermis. In both species, the suspensory ligaments may serve to contract the pad to conform to the under lying substrate, thus enhancing the animal's ability to grip branches while climbing.