Project description:BackgroundThe feasibility and outcomes of concomitant atrioventricular node ablation (AVNA) and leadless pacemaker implant are not well studied. We report outcomes in patients undergoing Micra implant with concomitant AVNA.MethodsPatients undergoing AVNA at the time of Micra implant from the Micra Transcatheter Pacing (IDE) Study, Continued Access (CA) study, and Post-Approval Registry (PAR) were included in the analysis and compared to Micra patients without AVNA. Baseline characteristics, acute and follow-up outcomes, and electrical performance were compared between patients with and without AVNA during the follow-up period.ResultsA total of 192 patients (mean age 77.4 ± 8.9 years, 72% female) underwent AVNA at the time of Micra implant and were followed for 20.4 ± 15.6 months. AVNA patients were older, more frequently female, and tended to have more co-morbid conditions compared with non-AVNA patients (N = 2616). Implant was successful in 191 of 192 patients (99.5%). The mean pacing threshold at implant was 0.58 ± 0.35 V and remained stable during follow-up. Major complications within 30 days occurred more frequently in AVNA patients than non-AVNA patients (7.3% vs. 2.0%, p < .001). The risk of major complications through 36-months was higher in AVNA patients (hazard ratio: 3.81, 95% confidence interval: 2.33-6.23, p < .001). Intermittent loss of capture occurred in three AVNA patients (1.6%), all were within 30 days of implant and required system revision. There were no device macrodislodgements or unexpected device malfunctions.ConclusionConcomitant AVN ablation and leadless pacemaker implant is feasible. Pacing thresholds are stable over time. However, patient comorbidities and the risk of major complications are higher in patients undergoing AVNA.
Project description:BackgroundThe concept of 'patient experience' has become central to how to improve healthcare. Remote communication with patients is today a frequent practice in healthcare services, showing similar outcomes to standard outpatient care while enabling cost reduction in both formal and informal care. The purpose of this study was to analyse the experiences of people with telemonitoring pacemakers.MethodsPatients were randomly allocated to either the telemonitoring or hospital monitoring follow-ups. Using the 'Generic Short Patient Experiences Questionnaire' (GS-PEQ), as well as an ad-hoc survey from the 'telehealth patient satisfaction survey' and 'costs survey', patients' experiences were measured six months after the pacemaker implant in a cohort of 50 consecutive patients. The mean age was 74.8 (± 11.75) years and 26 (52%) patients were male of which 1 was lost in follow-up. Finally, 24 patients were followed up with standard hospital monitoring, while 25 used the telemonitoring system. Differences in baseline characteristics between groups were not found.ResultsFindings showed overall positive and similar experiences in patients living with telemonitoring and hospital monitoring pacemakers. Significant differences were found in GS-PEQ concerning how telemonitoring patients received less information about their diagnosis/afflictions (p = 0.046). We did not find significant differences in other items such as 'confidence in the clinicians' professional skills', 'treatment perception adapted to their situation', 'involvement in decisions regarding the treatment', 'perception of hospital organisation', 'waiting before admission', 'satisfaction of help and treatment received', 'benefit received', and 'incorrect treatment'.ConclusionsThe remote communication of pacemakers was met with positive levels of patients' experiences similarly to patients in the hospital monitoring follow-up. However, telemonitoring patients received less information. Thus, improving the quality and timing of information is required in telemonitoring patients in the planning and organisation of future remote communication healthcare services for people living with a pacemaker implant.
Project description:Bimatoprost implant (Durysta™), developed by Allergan, is a sustained-release drug delivery system containing bimatoprost, a prostaglandin analogue with ocular hypotensive activity. The implant, administered intracamerally, involves the use of a biodegradable, solid polymer drug delivery system for slow, sustained drug release, designed to lower intraocular pressure (IOP) over a 4- to 6-months period. In March 2020, bimatoprost implant received its first approval, in the USA, for use to reduce IOP in patients with open angle glaucoma (OAG) or ocular hypertension (OHT). Allergan's clinical development programme for bimatoprost implant is ongoing. This article summarizes the milestones in the development of bimatoprost implant leading to this first approval for use in the reduction of IOP in patients with OAG or OHT.
Project description:Twelve patients with thoracic syndrome were operated during a 15 month period. Eleven patients had features of neurogenic thoracic outlet syndrome, while one presented with arterial ischemia due to distal embolism. The diagnosis was based on the characteristic history and positive stress tests. Cervical rib was present in 7 patients. Abnormal nerve conduction studies were present in 7 out of 8 cases. Supraclavicular first rib resection was done in all patients in view of the severity of symptoms. If present, the cervical rib was also excised. There was no major operative complication. Eleven out of twelve patients reported relief of symptoms. Thoracic outlet syndrome is not an uncommon disorder and often goes undiagnosed. Resection of first rib via the supraclavicular approach gives good results in majority of the patients who have incapacitating symptoms.
Project description:PurposeTo assess the feasibility, safety, and clinical outcomes of an endoscopic-assisted transaxillary approach of first rib resection for thoracic outlet syndrome (TOS) and to compare the differences in demographic and clinical data between satisfactory and unsatisfactory outcomes using this approach.MethodsWe retrospectively identified patients who underwent endoscopic-assisted first rib partial resection. A transaxillary approach for the first rib resection and neurovascular decompression were undertaken under magnified visualization. Endoscopic classification of neurovascular bundle (NVB) patterns and interscalene distance (ISD) between anterior and middle scalene muscles were evaluated intraoperatively. We assessed the Roos and DASH scores.ResultsWe reviewed 131 cases of TOS (48 women and 83 men; mean age 26.2 years; range 12 to 57). Roos classification revealed 80.2% excellent or good results. DASH scores improved significantly from 40.7 ± 20.0 to 15.7 ± 19.6 (P < .001). The complication rate was low (5.3%), with 4 pneumothorax and 3 other complications. Intraoperative NVB classification revealed 30 cases of parallel type, in which the artery and nerve travel in parallel; 69 oblique types, and 30 vertical types, in which the nerve was completely behind the middle scalene muscle or abnormal band. The ISD was narrower (5.4 ± 3.6 mm) than in previous cadaveric studies. The ISD in the parallel patterns was wider than that in the vertical patterns. In the satisfactory group, we found a significantly larger number of men, younger patients, athletes, and patients with a lower preoperative DASH score.ConclusionsAn endoscopic-assisted transaxillary approach for first rib resection in TOS provides an excellent magnified visualization, safely allowing sufficient decompression of the neurovascular bundle and satisfactory surgical outcomes. Younger male athletes with TOS may be better candidates for this procedure.Level of evidenceIV, therapeutic case series.
Project description:Objectives: The treatment for neurogenic thoracic outlet syndrome (NTOS) conventionally involves first-rib resection (FRR) surgery, which is quite challenging to perform, especially for novices, and is often associated with postoperative complications. Herein, we report a new segmental resection approach through piezo surgery that involves using a bone cutter, which can uniquely provide a soft tissue protective effect. Methods: This retrospective study involved the examination of 26 NTOS patients who underwent piezo surgery and another group of 30 patients who underwent FRR using the conventional technique. In the patient group that underwent piezo surgery, the rib was first resected into two pieces using a piezoelectric device and subsequently removed. In the patient group that underwent conventional surgery, the first rib was removed as one piece using a rib cutter and rongeurs. Results: The piezo surgery group had significantly shorter operative time (96.85 ± 14.66 vs. 143.33 ± 25.64 min, P < 0.001) and FRR duration (8.73 ± 2.11 vs. 22.23 ± 6.27 min, P < 0.001) than the conventional group. The posterior stump length of the residual rib was shorter in the piezo surgery group than in the conventional group (0.54 ± 0.19 vs. 0.65 ± 0.15 cm, P < 0.05). There were no significant differences in postoperative complications and scores of the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, the Cervical Brachial Symptom Questionnaire (CBSQ), and the visual analog scale (VAS). Even the TOS index (NTOS Index = [DASH + (0.83 × CBSQ) + (10 × VAS)]/3) and patient self-assessments of both the groups showed no significant differences. Univariate analyses indicated that the type of treatment affected operative time. Conclusion: Our results suggest that piezo surgery is safe, effective, and simple for segmental FRR in NTOS patients. Piezo surgery provides a more thorough FRR without damaging adjacent soft tissues in a relatively short duration and achieves similar functional recovery as conventional techniques. Therefore, piezo surgery can be a promising alternative for FRR during the surgical treatment of NTOS.
Project description:IntroductionLeadless pacemakers may provide a safe and attractive pacing option to patients with cardiac implantable electronic device (CIED) infection. We describe the characteristics and outcomes of patients with a recent CIED infection undergoing Micra implant attempt.Methods and resultsPatients with prior CIED infection and device explant with Micra implant within 30 days, were identified from the Micra post approval registry. Procedure characteristics and outcomes were summarized. A total of 105 patients with prior CIED infection underwent Micra implant attempt ≤30 days from prior system explant (84 [80%] pacemakers and 13 [12%] ICD/CRT-D). All system components were explanted in 93% of patients and explant occurred a median of 6 days before Micra implant, with 37% occurring on the day of Micra implant. Micra was successfully implanted in 99% patients, mean follow-up duration was 8.5 ± 7.1 months (range 0-28.5). The majority of patients (91%) received IV antibiotics preimplant, while 42% of patients received IV antibiotics postprocedure. The median length of hospitalization following Micra implant was 2 days (IQR, 1-7). During follow-up, two patients died from sepsis and four patients required system upgrade, of which two patients received Micra to provide temporary pacing support. There were no Micra devices explanted due to infection.ConclusionImplantation of the Micra transcatheter pacemaker is safe and feasible in patients with a recent CIED infection. No recurrent infections that required Micra device removal were seen. Leadless pacemakers appear to be a safe pacing alternative for patients with CIED infection who undergo extraction.
Project description:Thoracic outlet syndrome (TOS) is a complex disorder with signs and symptoms resulting from compression of the brachial plexus and subclavian vessels. Although transaxillary first-rib resection is a well-established surgical treatment for patients with symptomatic TOS, this approach sometimes does not allow adequate exposure of the insertion point of the middle scalene muscle to the posterior part of the first rib and neurovascular bundle. The objective of this Technical Note is to describe an endoscopic-assisted transaxillary approach for first-rib resection and neurolysis. An endoscopic-assisted transaxillary approach for first-rib resection in TOS can provide excellent magnified visualization and safely allow sufficient decompression of the neurovascular bundle.
Project description:Rib bone growth in red deer stags - Abstract: In 'The Bone and Joint Decade' interest is focused on genetic factors causing bone disorders. Osteoporosis, attacking 10% of the population worldwide, is the most common metabolic bone disease, which is mimiced by several ovarectomised or genetically modified 'cascadeur' animal species, but none of them is able to remedy its pathologically porous bone tissue. Regeneration in skeletal elements is the curiosity of our newly investigated osteoporosis animal model, red deer (Cervus elaphus). The cyclic physiological osteoporosis in red deer stag is a consequence of the annual antler cycle. This phenomenon raises the possibility to explore new genes involved in regulating bone mineral density (BMD) and recovery of bone resorption on the basis of comparative genomics between deer and human. Here we compared the gene expression activities of osteoporotic and regenerating flying rib bone samples versus late autumn dwell control in red deer by heterologous microarray hybridization. Identified genes were tested on human femoral bone tissue from postmenopausal osteoporotic and non-osteoporotic patients. Expression data were evaluated by Principal Components Analysis and Discriminant Analysis. Keywords: Gene Expression experiment