ResearchPad - medical-implants https://www.researchpad.co Default RSS Feed en-us © 2020 Newgen KnowledgeWorks <![CDATA[Incidence and determinants of Implanon discontinuation: Findings from a prospective cohort study in three health zones in Kinshasa, DRC]]> https://www.researchpad.co/article/elastic_article_7634 Kinshasa is Africa's third largest city and one of the continent’s most rapidly growing urban areas. PMA2020 data showed that Kinshasa has a modern contraceptive prevalence of 26.5% among married women in 2018. In Kinshasa’s method mix, the contraceptive implant recently became the dominant method among contraceptive users married and in union. This study provides insight into patterns of implant use in a high-fertility setting by evaluating the 24-month continuation rate for Implanon NXT and identifying the characteristics associated with discontinuation.MethodologyThis community-based, prospective cohort study followed 531 Implanon users aged 18–49 years at 6, 12 and 24 months. The following information was collected: socio-demographic characteristics, Method Information Index (MII) and contraceptive history. The main outcome variable for this study was implant discontinuation. The incidence rate of discontinuation is presented as events per 1000 person/months (p-m), from the date of enrolment. The Cox proportional hazards modelling was used to measure predictors of discontinuation.ResultsA total of 9158.13 p-m were available for analysis, with an overall incidence rate of 9.06 (95% CI: 9.04–9.08) removals per 1000 p-m. Of nine possible co-variates tested, the likelihood of discontinuation was higher among women who lived in military camps, had less than three children, never used injectables or implants in the past, had experienced heavy/prolonged bleeding, and whose MII score was less than 3.ConclusionIn addition to four client characteristics that predicted discontinuation, we identified one programmatic factor: quality of counseling as measured by the Method Information Index. Community providers in similar contexts should pay more attention to clients having less than three children, new adopters, and to clients living military camps as underserved population, where clients have less access to health facilities. More targeted counselling and follow-up is needed, especially on bleeding patterns. ]]> <![CDATA[The stability of long-segment and short-segment fixation for treating severe burst fractures at the thoracolumbar junction in osteoporotic bone: A finite element analysis]]> https://www.researchpad.co/article/5c61e8dbd5eed0c48496f278

The majority of compressive vertebral fractures in osteoporotic bone occur at the level of the thoracolumbar junction. Immediate decompression is often required in order to reduce the extent of neurological damage. This study evaluated four fixation methods for decompression in patients with thoracolumbar burst fractures, and presented the most suitable method for osteoporotic patients. A finite element model of a T7–L5 spinal segment was created and subjected to an L1 corpectomy to simulate a serious burst fracture. Five models were tested: a) intact spine; 2) two segment fixation (TSF), 3) up-three segment fixation (UTSF), below-three segment fixation (BTSF), and four segment fixation (FSF). The ROM, stiffness and compression ratio of the fractured vertebra were recorded under various loading conditions. The results of this study showed that the ROM of the FSF model was the lowest, and the ROMs of UTSF and BTSF models were similar but still greater than the TSF model. Decreasing the BMD to simulate osteoporotic bone resulted in a ROM for the four instrumented models that was higher than the normal bone model. Of all models, the FSF model had the highest stiffness at T12-L2 in extension and lateral bending. Similarly, the compression ratio of the FSF model at L1 was also higher than the other instrumented models. In conclusion, FSF fixation is suggested for patients with osteoporotic thoracolumbar burst fractures. For patients with normal bone quality, both UTSF and BTSF fixation provide an acceptable stiffness in extension and lateral bending, as well as a favorable compression ratio at L1.

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<![CDATA[Mutation screening in non-syndromic hearing loss patients with cochlear implantation by massive parallel sequencing in Taiwan]]> https://www.researchpad.co/article/5c79b005d5eed0c4841e3c60

Objectives

To explore the molecular epidemiology of rare deafness genes in Taiwanese sensorineural hearing impairment (SNHI) patients with cochlear implantation (CI) by performing massive parallel sequencing (MPS) and correlating genetic factors and CI outcomes.

Methods

We enrolled 41 Taiwanese non-syndromic deafness patients with CI that lacked known mutations in common deafness genes. All probands were screened by a targeted exon amplification method that used massively parallel sequencing to screen a customized panel that included 40 relatively rare non-syndromic deafness genes.

Results

Thirteen candidate variants in nine relatively rare deafness genes (MYO15A, TMC1, MYH14, MYO3A, ACTG1, COL11A2, DSPP, GRHL2, and WFS1) were identified in 24.4% (10/41) of the non-syndromic deafness probands with CI. According to the ACMG Standards and Guidelines, five variants in MYO15A and ACTG1 were classified as likely pathogenic variants. Two of three multi-generational pedigrees exhibiting deafness were analyzed for the segregation of the disorder with the possible disease-causing variants. Patients with variants detected in most of the identified variant-bearing genes showed relatively good CI outcomes.

Conclusions

We successfully identified candidate variants in partially deaf Taiwanese probands who lacked the known mutations in common deafness genes. Comparing the progress of hearing rehabilitation in CI patients with their apparent causative variants and the expression profiles of their altered genes allowed us to speculate on how alterations in specific gene sets may influence outcomes in hearing rehabilitation after CI.

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<![CDATA[Intraoperative loading of calcium phosphate-coated implants with gentamicin prevents experimental Staphylococcus aureus infection in vivo]]> https://www.researchpad.co/article/5c5df36bd5eed0c48458127d

Orthopedic device-related infection (ODRI) is a potentially devastating complication arising from the colonization of the device with bacteria, such as Staphylococcus aureus. The aim of this study was to determine if intraoperative loading of a clinically approved calcium phosphate (CaP) coating with gentamicin can protect from ODRI in vivo. First, CaP-coated titanium aluminium niobium (TAN) discs were used to investigate the adsorption and release kinetics of gentamicin in vitro. Gentamicin loading and subsequent release from the coating were both rapid, with maximum loading occurring following one second of immersion, and >95% gentamicin released within 15 min in aqueous solution, respectively. Second, efficacy of the gentamicin-loaded CaP coating for preventing ODRI in vivo was investigated using a CaP-coated unicortical TAN screw implanted into the proximal tibia of skeletally mature female Wistar rats, following inoculation of the implant site with S. aureus. Gentamicin-loading prevented ODRI in 7/8 animals, whereas 9/9 of the non-gentamicin treated animals were infected after 7 days. In conclusion, gentamicin can be rapidly and simply loaded onto, and released from, CaP-based implant coatings, and this is an effective strategy for preventing peri-operative S. aureus-induced ODRI in vivo.

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<![CDATA[Determinants of corrosion resistance of Ti-6Al-4V alloy dental implants in an In Vitro model of peri-implant inflammation]]> https://www.researchpad.co/article/5c5ca287d5eed0c48441e57d

Background

Titanium (Ti) and its alloys possess high biocompatibility and corrosion resistance due to Ti ability to form a passive oxide film, i.e. TiO2, immediately after contact with oxygen. This passive layer is considered stable during function in the oral cavity, however, emerging information associate inflammatory peri-implantitis to vast increases in Ti corrosion products around diseased implants as compared to healthy ones. Thus, it is imperative to identify which factors in the peri-implant micro-environment may reduce Ti corrosion resistance.

Methods

The aim of this work is to simulate peri-implant inflammatory conditions in vitro to determine which factors affect corrosion susceptibility of Ti-6Al-4V dental implants. The effects of hydrogen peroxide (surrogate for reactive oxygen species, ROS, found during inflammation), albumin (a protein typical of physiological fluids), deaeration (to simulate reduced pO2 conditions during inflammation), in an acidic environment (pH 3), which is typical of inflammation condition, were investigated. Corrosion resistance of Ti-6Al-4V clinically-relevant acid etched surfaces was investigated by electrochemical techniques: Open Circuit Potential; Electrochemical Impedance Spectroscopy; and Anodic Polarization.

Results

Electrochemical tests confirmed that most aggressive conditions to the Ti-6Al-4V alloy were those typical of occluded cells, i.e. oxidizing conditions (H2O2), in the presence of protein and deaeration of the physiological medium.

Conclusions

Our results provide evidence that titanium’s corrosion resistance can be reduced by intense inflammatory conditions. This observation indicates that the micro-environment to which the implant is exposed during peri-implant inflammation is highly aggressive and may lead to TiO2 passive layer attack. Further investigation of the effect of these aggressive conditions on titanium dissolution is warranted.

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<![CDATA[Outcomes of cardiac resynchronization therapy in patients with atrial fibrillation accompanied by slow ventricular response]]> https://www.researchpad.co/article/5c424385d5eed0c4845e0487

It remains unclear as to whether cardiac resynchronization therapy (CRT) would be as effective in patients with atrial fibrillation (AF) accompanied by slow ventricular response (AF-SVR, < 60 beats/min) as in those with sinus rhythm (SR). Echocardiographic reverse remodeling was compared between AF-SVR patients (n = 17) and those with SR (n = 88) at six months and 12 months after CRT treatment. We also evaluated the changes in QRS duration; New York Heart Association (NYHA) functional class; and long-term composite clinical outcomes including cardiac death, heart transplantation, and heart failure (HF)-related hospitalization. Left ventricular pacing sites and biventricular pacing percentages were not significantly different between the AF-SVR and SR groups. However, heart rate increase after CRT was significantly greater in the AF-SVR group than in the SR group (P < 0.001). At six and 12 months postoperation, both groups showed a comparable improvement in NYHA class; QRS narrowing; and echocardiographic variables including left ventricular end-systolic volume, left ventricular ejection fraction, and left atrial volume index. Over the median follow-up duration of 1.6 (interquartile range: 0.8–2.2) years, no significant between-group differences were observed regarding the rates of long-term composite clinical events (35% versus 24%; hazard ratio: 1.71; 95% confidence interval: 0.23–12.48; P = 0.60). CRT implantation provided comparable beneficial effects for patients with AF-SVR as compared with those with SR, by correcting electrical dyssynchrony and increasing biventricular pacing rate, in terms of QRS narrowing, symptom improvement, ventricular reverse remodeling, and long-term clinical outcomes.

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<![CDATA[Engineering vasculature: Architectural effects on microcapillary-like structure self-assembly]]> https://www.researchpad.co/article/5c3e4faed5eed0c484d78005

One of the greatest obstacles to clinical translation of bone tissue engineering is the inability to effectively and efficiently vascularize scaffolds. The goal of this work was to explore systematically whether architecture, at a scale of hundreds of microns, can be used to direct the growth of microcapillary-like structures into the core of scaffolds. Biphasic bioceramic patterned architectures were produced using silicone molds of 3D printed parts. Grooves and ridges were designed to have widths of 330 μm and 660 μm, with periodicities respectively of 1240 μm and 630 μm. Groove depth was varied between 150 μm and 585 μm. Co-cultures of human dermal microvascular endothelial cells (HDMECs) and human osteoblasts (hOBs) were used to grow microcapillary-like structures on substrates. Bioceramic architecture was found to significantly affect microcapillary-like structure location and orientation. Microcapillary-like structures were found to form predominantly in grooves or between convexities. For all patterned samples, the CD31 (endothelial cell marker) signal was at least 2.5 times higher along grooves versus perpendicular to grooves. In addition, the average signal was at least two times higher within grooves than outside grooves for all samples. Grooves with a width of 330 μm and a depth of 300 μm resulted in the formation of individual, highly aligned microcapillary-like structures with lengths around 5 mm. Extensive literature has focused on the role of nano- and micro-topography (on the scale below tens of microns) on cellular response. However, the idea that architecture at a scale much larger than a cell could be used to modulate angiogenesis has not been systematically investigated. This work shows the crucial influence of architecture on microcapillary-like structure self-assembly at the scale of hundreds of microns. Elucidating the precise correspondence between architecture and microcapillary-like structure organization will ultimately allow the engineering of microvasculature by tuning local scaffold design to achieve desirable microvessel properties.

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<![CDATA[Long-term probability of intraocular pressure elevation with the intravitreal dexamethasone implant in the real-world]]> https://www.researchpad.co/article/5c390b97d5eed0c48491d656

Purpose

To evaluate the long-term cumulative probability of intraocular pressure (IOP) elevation with the intravitreal dexamethasone implant (IDI) when used to treat different indications: diabetic macular edema, uveitis, retinal vein occlusion.

Methods

705 IDI injections (429 eyes) were assessed and Kaplan-Meier graphs were generated to assess: the probability of different levels of IOP elevation (IOP≥21, ≥25 or ≥35 mmHg), IOP change ≥10 mmHg, initiation of IOP-lowering treatment, glaucoma surgery, IOP change with repeat injections and IOP elevation in eyes with glaucoma and ocular hypertension (OHT).

Results

The cumulative probability of IOP ≥21, ≥25 and ≥35 mmHg was 50%-60%, 25%-30% and 6%-7% at 12–24 months, respectively. The probability of initiating IOP-lowering medication was 31%-54% at 12–24 months. Glaucoma and OHT eyes had a higher probability of mild IOP elevation (≥21 mmHg, 65.1%, 75% and 57.8%, p = 0.01), yet a similar moderate (≥25 mmHg, 22.3%, 28% and 30.2%, p = 0.91) and severe elevation of IOP (≥35 mmHg, 3.7%, 7.1% and 4%, p = 0.71) as normal eyes. Glaucoma surgery was required in only 0.9% cases (4/429). At baseline, 8.8% of the treated eyes had glaucoma, 6.7% OHT and 16.9% were already on IOP-lowering medication.

Conclusions

In the long-term (24 months), IOP elevation is common, generally mild (30% IOP, ≥25 mmHg) and well-tolerated, resolving with topical treatment (54%) and rarely requiring surgery (0.9%).

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<![CDATA[Zn-alloy provides a novel platform for mechanically stable bioresorbable vascular stents]]> https://www.researchpad.co/article/5c3667f5d5eed0c4841a6b17

Metallic Zn alloys have recently gained interest as potential candidates for developing platforms of bioresorbable vascular stents (BVS). Previous studies revealed that Mg alloys used for BVS can degrade too early, whereas PLLA materials may fail to provide effective scaffolding properties. Here we report on results of a new bioresorbable, metallic stent made from a Zn-Ag alloy studied in a porcine animal model of thrombosis and restenosis. While the tensile strength (MPa) of Zn-3Ag was higher than that of PLLA and resembled Mg’s (WE43), fracture elongation (%) of Zn-3Ag was much greater (18-fold) than the PLLA’s or Mg alloy’s (WE43). Zn-3Ag exposed to HAoSMC culture medium for 30 days revealed degradation elements consisting of Zn, O, N, C, P, and Na at a 6 nm surface depth. Platelet adhesion rates and blood biocompatibility did not differ between Zn-3Ag, PLLA, Mg (WE43), and non-resorbable Nitinol (NiTi) stent materials. Balloon-expandable Zn-3Ag alloy BVS implanted into iliofemoral arteries of 15 juvenile domestic pigs were easily visible fluoroscopically at implantation, and their bioresorption was readily detectable via X-ray over time. Histologically, arteries with Zn-3Ag BVS were completely endothelialized, covered with neointima, and were patent at 1, 3, and 6 months follow-up with no signs of stent thrombosis. Zn-3Ag alloy appears to be a promising material platform for the fabrication of a new generation of bioresorbable vascular stents.

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<![CDATA[Cardiac implantable electronic device (CIED) infections are expensive and associated with prolonged hospitalisation: UK Retrospective Observational Study]]> https://www.researchpad.co/article/5c3667b4d5eed0c4841a612f

Background

There are limited reports outlining the financial cost of treating cardiac implantable electronic device (CIED) infection outside the United States. This study aimed to determine the average treatment cost of CIED infection in a large UK tertiary referral centre and compared costs of different treatment pathways that are recognised in the management of CIED infection (early versus delayed re-implantation).

Methods

We retrospectively analysed cost and length of stay (LOS) data for consecutive patients undergoing infected CIED extraction with cardiac resynchronization therapy (CRT-D [with defibrillator], CRT-P [with pacemaker]), implantable cardioverter-defibrillators (ICDs) and permanent pacemakers (PPMs).

Results

Between January 2013 and March 2015, complete data was available for 84 patients (18 [21.4%] CRT-D, 24 [28.6%] ICDs and 42 [50.0%] PPMs). When all cases were considered the cost of infection ranged from £5,139 (PPM) to £24,318 (CRT-D). Considering different treatment strategies; 41 (48.8%) underwent CIED extraction and re-implantation during the same admission (early re-implant strategy (ER). 43 (51.2%) underwent extraction, but were then discharged home to be re-admitted for day-case re-implantation (delayed re-implant strategy (DR)). Median LOS was significantly shorter in DR compared to ER (5.0 vs. 18.0 days, p<0.001). The total cost of CIED infection episode was similar for both treatment strategies (median £14,241.48 vs. £14,741.70 including wearable defibrillator (Lifevest) and outpatient antibiotics costs, ER vs. DR; p = 0.491).

Conclusion

CIED infections are expensive and associated with significant health-economic burden. When all device types were considered, a DR strategy is associated with reduced LOS without an increased cost penalty.

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<![CDATA[Lack of mutagenicity, genotoxicity and developmental toxicity in safety assessment tests of Lactobacillus mali APS1]]> https://www.researchpad.co/article/5c1c0aeed5eed0c484426f00

Lactobacillus (L.) mali APS1 isolated from sugary kefir grains has been proven to affect energy and glucose homeostasis. However, without proper safety assessment it cannot be recommended as probiotics for human consumption. For genotoxicity, the Ames test showed no mutagenic effect of L. mali APS1 in the presence or absence of S9 mix metabolic activation. In-vitro mammalian chromosomal aberration test showed that the number of Chinese hamster ovary cells with abnormal chromosomes was <5% after L. mali APS1 treatment. Moreover, L. mali APS1 showed no risk of genotoxicity potential compared to the control. L. mali APS1 administration did not cause significant (p>0.05) changes in body weight, the number of reticulocytes, or in the occurrence percentage of micronucleus in Imprinting Control Region (ICR) mice. Based on the absence of maternal or fetal effects at any dosage level investigated, the teratogenicity could be defined as greater than 1,670 mg/kg b.w./day for maternal general toxicity and fetal development when L. mali APS1 was orally administered by gavage to pregnant SD rats during gestation days 6 to 15.

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<![CDATA[Effect of increasing heart rate on finger photoplethysmography fitness index (PPGF) in subjects with implanted cardiac pacemakers]]> https://www.researchpad.co/article/5c084236d5eed0c484fcc339

Finger photoplethysmography (PPG) is a noninvasive method that measures blood volume changes in the finger. The PPG fitness index (PPGF) has been proposed as an index of vascular risk and vascular aging. The objectives of the study were to determine the effects of heart rate (HR) on the PPGF and to determine whether PPGF is influenced by blood pressure (BP) changes. Twenty subjects (78±8 years, 3 female) with permanent cardiac pacemakers or cardioverter defibrillators were prospectively recruited. HR was changed by pacing, in a random order from 60 to 100 bpm and in 10 bpm increments. At each paced HR, the PPGF was derived from a finger photoplethysmogram. Cardiac output (CO), stroke volume (SV) and total peripheral resistance (TPR) were derived from the finger arterial pressure waveform. Brachial blood pressure (BP) was measured by the oscillometric method. This study found that as HR was increased from 60 to 100 bpm, brachial diastolic BP, brachial mean BP and CO were significantly increased (p<0.01), whilst the PPGF and SV were significantly decreased (p<0.001). The effects of HR on the PPGF were influenced by BP, with a decreasing HR effect on the PPGF that resulted from a higher BP. In conclusion, HR was a significant confounder for PPGF and it must be taken into account in analyses of PPGF, when there are large changes or differences in the HR. The magnitude of this effect was BP dependent.

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<![CDATA[Effect of antibiotic infused calcium sulfate/hydroxyapatite (CAS/HA) insets on implant-associated osteitis in a femur fracture model in mice]]> https://www.researchpad.co/article/5c9405a1d5eed0c484538ea8

Cerament (Bonesupport Holding, Lund, Sweden) is a bioresorbable synthetic bone substitute consisting of calcium sulfate and hydroxyapatite which is successfully used as a bone graft in bone defects or in delayed and non-unions after fractures. Besides, calcium sulfate/ hydroxyapatite (CAS/HA) could have, attributed to its composition and osteoinductive properties, have great importance in the treatment of bone infections with critical size defects (CSD). Aim of the study was to evaluate the effects of antibiotic infused CAS/HA on inflammation and bone healing in an implant-associated osteitis mice model. In a standardized murine model, the left femur of 72 BALB/c mice were osteotomized, generating a CSD (2,5 mm) with stabilization through a 6-hole titanium locking plate. Osteitis has been induced through inoculation of Staphylococcus aureus (SA) into the fracture gap. To analyze the effect of CAS/HA, following groups were generated with either CAS/HA, CAS/HA with gentamycin (CAS/ HA-G) or CAS/HA with vancomycin (CAS/HA-V) insets placed into the osteotomy. Debridément and lavages were progressed on day 7 and 42 to determine the local bacterial growth and the immune reaction. Fracture healing was quantified on day 7 and 42 by x-ray and bone healing markers from blood samples. Progression of infection was assessed by estimation of colony-forming units (CFU) and immune response was analyzed by determination of Interleukin (IL)– 6 and polymorphonuclear neutrophils (PMN) in lavage samples. Osteitis induced higher IL-6 and PMN-levels in the lavage samples on day 7. Both parameters showed a reduction in all groups on day 42. CAS/HA-V revealed a significant reduction of CFU and PMNs in lavage samples on day 42. A positive effect on bone healing could only be shown in non-infected mice. Whereas, application of mere CAS/HA in infected mice did show tendencies of bone destruction and lysis, independent of impregnation with antibiotics or not. Thus, application of CAS/HA in acute implant-associated infections is not recommended. In non-infectious environments or after infect-convalescence CAS/HA could albeit serve as a suggestive tool in trauma and orthopedic surgery.

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<![CDATA[Synovium extra cellular matrices seeded with transduced mesenchymal stem cells stimulate chondrocyte maturation in vitro and cartilage healing in clinically-induced rat-knee lesions in vivo]]> https://www.researchpad.co/article/5c915faed5eed0c48420ad96

Osteoarthritis (OA) is a progressive disease associated with cartilage injury and its inherently limited repair capability. Synovium-based cellular constructs (sConstructs) are proposed as possible treatments. Equine sConstructs were produced from decellularized synovium-based extracellular matrix scaffolds (sECM) seeded with synovium-derived mesenchymal stem cells (sMSC), and engineered to express green fluorescent protein (GFP), or bone morphogenetic protein-2 (BMP-2). Survival, distribution, and chondrogenic potential of the sConstructs in vitro and in vivo were assessed. sConstructs in co-culture with chondrocytes increased chondrocyte proliferation, viability, and Col II production, greatest in BMP-2-sConstructs. Chondrocyte presence increased the production of hyaluronic acid (HA), proteoglycan (PG), and BMP-2 by the sConstructs in a positive feedback loop. sECM alone, or GFP- or BMP-2-sConstructs were implanted in synovium adjacent to clinically created full-thickness rat-knee cartilage lesions. At 5 weeks, the lesion area and implants were resected. Gross anatomy, adjacent articulate cartilage growth and subchondral bone repair were scored; and peripheral, central and cartilage lesion measurements taken. For all scores and measurements, sConstruct implants were significantly greater than controls, greatest with the BMP-2-sConstructs. Immunohistochemistry demonstrated migration of endogenous cells into the sECM, with greater cellularity in the constructs with intense positive GFP staining confirming engraftment of implanted sMSC and continued gene expression. In summary, exposing cartilage to sConstructs was chondrogenic in vitro and in vivo, and resulted in substantially increased growth in vivo. This effect was mediated, in part, by soluble ECM and cell factors and upregulation of anabolic growth proteins, such as BMP-2. This work is “proof of concept” that sConstructs surgically implanted adjacent to cartilage damage can significantly improve cartilage and subchondral bone repair, and potentially prevent the progression of OA.

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<![CDATA[Anxiety, depression and quality of life in acute high risk cardiac disease patients eligible for wearable cardioverter defibrillator: Results from the prospective multicenter CRED-registry]]> https://www.researchpad.co/article/5c900d06d5eed0c48407de48

Background

Psychological distress is common in patients with cardiovascular disease and negatively impacts outcome.

Hypothesis

Psychological distress is high in acute high risk cardiac patients eligible for a WCD, and associated with low quality of life. Distress is aggravated by WCD.

Methods

Consecutive patients eligible for a WCD were included in the prospective, multicenter “Cologne Registry of External Defibrillator” registry. Quality of life (Short Form-12), depressive symptoms (Beck-Depression Inventory II) and anxiety (State Trait Anxiety Inventory) were assessed at enrollment and 6-weeks, and associations with WCD prescription were analyzed.

Results

123 patients (mean [SD] age 59 [± 14] years, 75% male) were included, 85 (69%) of whom received a WCD. At enrollment 21% showed clinically significant depressive symptoms and 52% anxiety symptoms, respectively. At 6 weeks, depressive and anxious symptoms significantly decreased to 7% and 25%, respectively. Depressive symptoms at enrollment and changes at 6 weeks showed significant associations with health-related quality of life, whereas anxious symptoms did not. There was a trend for better improvement of depression scores in patients with WCD (mean [SD] change in score points: -4.1 [6.1] vs -1.8 [3.9]; p = 0.09), whereas change of the anxiousness score was not different (-4.6 [9.5]) vs -3.7 [9.1], p = 0.68).

Conclusion

In patients eligible for a WCD, depressive and anxiety symptoms were initially common and depressive symptoms showed a strong association with reduced health-related quality of life contributing to their clinical relevance. WCD recipients showed at least similar improvement of depression and anxiety at 6 weeks when compared to non recipients.

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