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Transcatheter aortic valve replacement (TAVR) is an effective and safe therapy for severe aortic stenosis. Rapid or fast pacing is required for implantation, which can be performed via a pre-existing cardiac implantable electric device (CIED). However, safety data on CIEDs for pacing in TAVR are missing. The aim of this study was to elucidate procedural safety and feasibility of internal pacing with a CIED in TAVR. Patients undergoing TAVR with a CIED were included in this analysis. Baseline characteristics, procedural details, and complications according to Valve Academic Research Consortium 3 (VARC-3) criteria after TAVR were compared between both groups. A total of 486 patients were included. Pacing was performed using a CIED in 150 patients and a transient pacemaker in 336 patients. No differences in technical success according to VARC-3 criteria or procedure duration occurred between the groups. The usage of transient pacers for pacing was associated with a significantly higher bleeding rate (bleeding type ≥2 according to VARC-3-criteria; 2.0% vs 13.1%; P < 0.01). Furthermore, impairment of the CIED appeared in 2.3% of patients after TAVR only in the group in which pacing was performed by a transient pacer, leading to surgical revision of the CIED in 1.3% of all patients when transient pacemakers were used. Internal pacing using a CIED is safe and feasible without differences of procedural time and technical success and might reduce bleeding rates. Furthermore, pacing using a CIED circumvents the risk of lead dislocation. Our data provide an urgent call for the use of a CIED for pacing during a TAVR procedure in general. [Display omitted] [ABSTRACT FROM AUTHOR]

Introduction: Cochlear implantation has become the standard of care for the treatment of moderate-to-profound bilateral sensorineural hearing loss. However, current technologies, all of which rely on an external sound processor, have intrinsic limitations that prevent certain activities and diagnostics, thus hampering full integration into a patient's lifestyle. The Envoy Medical (White Bear Lake, MN, USA) Acclaim® fully implanted cochlear implant is a new device currently undergoing testing that has been designed to alleviate many of the current constraints by housing all components within the patient, thus allowing for near-constant use in many environments that are not conducive to a traditional cochlear implant. Methods: As part of an Early Feasibility Study, three adult implant candidates were implanted with the Acclaim® cochlear implant. Surgical video and photography were taken, and initial observations were recorded. Implantation with the Acclaim® device is largely similar to a traditional cochlear implant, with modifications to allow room for the implanted sensor as well as the implantation of a battery in the subcutaneous tissues of the chest. Results: This study demonstrates a step-by-step overview of implanting the Acclaim® and discusses initial insight and experiences with the first three implantations with this new device. Conclusions: All three surgeries proceeded without complication, and at activation, all three patients were hearing through their devices. Surgery is more technically challenging compared to a standard cochlear implant, but the skills needed can all be mastered by a dedicated otologic surgeon. [ABSTRACT FROM AUTHOR]

Intravenous treprostinil administration by an implantable pump is an attractive option for pulmonary arterial hypertension (PAH) treatment and is the subject of recent publications. Short-term studies are promising, but there is still a lack of long-term prospective data. We analyzed the treprostinil flow rate administered by the Lenus Pro® implantable pump in 2 patients suffering from PAH during follow-up times of respectively 4.2 and 3 years. The flow rate delivered by the pumps in these 2 patients exceeded the manufacturer admitted margin of error within 2 years and continued to increase to reach, respectively, 158 and 120% of the expected flow rate at the end of the follow up. In one case, the implantable pump had to be removed for this reason. The ex-vivo flow rate of the withdrawn pump determined in the laboratory reached 173% of the predicted value. This correlated with the in-vivo measurement, which suggests a continuous flow increase even after pump removal and without treprostinil use. Spontaneous flow increase from such an implantable pump is a potentially major pitfall, which needs to be identified and actively managed by the responsible clinicians.

This article describes the surgical orthodontic treatment of maxillary hypoplasia in a patient with cleft lip and palate using maxillary distraction osteogenesis with internal maxillary distractors. Maxillary advancement was performed to correct the retrusive maxillary facial profile and Class III malocclusion. Rotational movement of the distraction segment was made to correct the upper dental midline. Although maxillary advancement was insufficient because of unexpected breakage of the intraoral distractor after completion of the distraction, skeletal traction with a face mask compensated for the shortage. Successful esthetic improvement and posttreatment occlusal stability were achieved with no discernible relapse after 2 years of retention. [ABSTRACT FROM AUTHOR]

The implanted system for treprostinil has been described in previous publications. There is no information published about how to handle this system around lung or heart-lung transplantation. We present the experience from the DelIVery for Pulmonary Arterial Hypertension study. Seven subjects from five pulmonary arterial hypertension centers were included in this retrospective chart review. All subjects were participating in the previously described DelIVery for pulmonary arterial hypertension study. Seven subjects with implanted pumps have been listed for lung or heart-lung transplant. Six subjects underwent lung or heart-lung transplantation and one remains on the transplant list. Three different methods of patient management for transplant were used. In three subjects, the implanted system was filled with saline prior to transplantation and treprostinil was infused via an external system. Three subjects had their drug-filled implanted pump and catheter system explanted at the time of transplant. One patient had the drug-filled implanted system removed prior to being listed for transplantation. Four subjects were hospitalized while waiting for transplantation. In conclusion, the implanted system for treprostinil is an important advance in the care of pulmonary arterial hypertension subjects. The experience described here provides three effective strategies for managing the implanted system around lung or heart-lung transplantation. The optimal strategy will depend on patient characteristics and lung transplant program preferences and wait list times., (© The Author(s) 2021.)

Background: The DelIVery for Pulmonary Arterial Hypertension clinical trial was a multi-center, prospective, single arm, Investigational Device Exemption study utilizing a fully implantable, programmable intravascular delivery system consisting of a pump and a catheter for intravenous treprostinil. The study met its primary endpoint and demonstrated that the intravascular delivery system significantly reduced catheter related complications at 22,000 subject-days of follow-up compared with a predefined objective performance criterion. Here we summarize the results obtained during a 6.4-year follow-up period., Methods: Throughout study follow-up, participants had clinic visits and medication refills at least every 12 weeks (dependent on the subjects' dose). All adverse events and intravascular delivery system complications were evaluated and recorded., Results: Sixty pulmonary arterial hypertension subjects were followed post device implantation for approximately 282 patient-years (range 87 days to 6.4 years). Of the 60 subjects, 14 died (1 related to intravascular delivery system pump failure), 2 withdrew after lung transplants, and 2 withdrew due to pump pocket infection. No catheter-related bloodstream infections, catheter thrombosis or occlusions, or catheter kinks occurred through 282 patient-years. Two participants had adverse events of abdominal pain, rash, due to subcutaneous treprostinil "leaks" after one catheter puncture and one catheter laceration during pump refill and replacement, respectively. Eight pump failure events occurred: seven pump motor stalls and one early replacement (faulty battery)., Conclusion: Delivery of treprostinil with an intravascular delivery system is a safe alternative to an external delivery system, while providing enhanced life experiences. To preserve the risk-benefit ratio, treatment at specialized pulmonary arterial hypertension centers is recommended until training is disseminated at other sites., (© The Author(s) 2019.)