BACKGROUND: The subcutaneous implantable cardioverter-defibrillator (S-ICD) was developed to overcome the risk of lead-related complications associated with the transvenous implantable cardioverter-defibrillator (TV-ICD). In contrast to the TV-ICD, the S-ICD is a completely extrathoracic device. Subsequently, complications differ between these 2 implantable cardioverter-defibrillators, which might impact patient perceptions of the therapies. This prespecified secondary analysis of the PRAETORIAN trial evaluates differences in quality of life. METHODS: The PRAETORIAN trial (A Prospective, Randomized Comparison of Subcutaneous and Transvenous Implantable Cardioverter Defibrillator Therapy) randomized patients with an implantable cardioverter-defibrillator indication, without the need for pacing to S-ICD or TV-ICD therapy. Two questionnaires were collected at baseline, discharge, 12 months, and 30 months. The Duke Activity Status Index measures cardiac-specific physical functioning, and the 36-Item Short Form Health Survey measures physical and mental well-being, with the subscales bodily pain and mental health being of interest in this analysis. Mann-Whitney U tests were used to compare study arms, and a mixed model was used to describe the questionnaire outcomes over time. RESULTS: Patients were randomized to S-ICD (n=426) and TV-ICD (n=423). In the S-ICD group, 20% were women versus 19% in the TV-ICD group. The median age was 63 (interquartile range, 54-69) years in the S-ICD group versus 64 (interquartile range, 56-69) years in the TV-ICD group. There were no significant differences in the Duke Activity Status Index and 36-Item Short Form Health Survey subscales for bodily pain and mental health between the groups at any time point. Patients with a shock in the last 90 days had significantly lower scores for social functioning (P=0.008) and role limitations due to emotional problems (P=0.001) than patients without a shock, but this effect did not differ between treatment arms. CONCLUSIONS: In a large randomized cohort of patients with an S-ICD or TV-ICD, no difference in overall quality of life was observed. However, implantable cardioverter-defibrillator shocks resulted in a reduction in quality of life, regardless of the device type or appropriateness. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01296022.
- MeSH
- časové faktory MeSH
- defibrilátory implantabilní * MeSH
- duševní zdraví * MeSH
- elektrická defibrilace * přístrojové vybavení škodlivé účinky MeSH
- funkční status MeSH
- kvalita života * MeSH
- lidé středního věku MeSH
- lidé MeSH
- náhlá srdeční smrt prevence a kontrola MeSH
- prospektivní studie MeSH
- protézy - design MeSH
- průzkumy a dotazníky MeSH
- rizikové faktory MeSH
- senioři MeSH
- srdeční arytmie terapie diagnóza patofyziologie MeSH
- výsledek terapie MeSH
- zdravotní stav MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
BACKGROUND: Biodegradable (BD) stents made from polydioxanone have been used only in human airways. These stents combine the advantages of classical tracheal stents, and fewer side effects are expected due to their biocompatibility and their time-limited presence in airways. However, new clinical consequences have arisen. Here, the authors share their experiences with BD stents for tracheal indications, focusing on their safety and efficacy. METHODS: This was a retrospective review of a collected database of adult patients who underwent implantation of biodegradable tracheal stents between September 2013 and December 2022 at the Department of Respiratory Medicine of the 1st Faculty of Medicine in Prague and Thomayer University Hospital. The indications included functionally significant nonmalignant tracheal stenosis and tracheomalacia. Self-expandable, biodegradable, polydioxanone tracheal stents manufactured by ELLA-CS Ltd. (Hradec Kralove, Czech Republic) were implanted during rigid bronchoscopy under general anaesthesia. All patients were followed up in the department and were provided with the necessary care. The main efficacy and safety parameters and relationships were analysed using descriptive statistics and Fisher ́s exact, Wilcoxon and Kruskal‒Wallis tests. RESULTS: A total of 65 stents were implanted in 47 adult patients. During the first two months after implantation, when adequate function was expected, the stent was found to be effective in 26 out of 39 patients who completed this period (66.7%). The clinical effectiveness reached 89.7%, as early restenoses were mostly mild and necessitated treatment in only 4 patients. The frequencies of significant mucostasis, migration and granulation tissue growth were 2.6%, 7.5% and 23.1%, respectively, during this period. Thirty-four participants completed the half-year follow-up period after the first or second stent insertion, and some were followed up beyond this period. Poor control of symptoms, the development of restenosis and the need for interventions were characteristic of this period as the stents degraded. Twenty-two patients who experienced remodelling or stabilization of the tracheal lumen achieved a stent-free state. Seven patients underwent subsequent surgical treatment. CONCLUSIONS: BD stents are safe and provide adequate tracheal support until they begin to degrade. The use of BD stents necessitates close monitoring of patients and accurate treatment of possible restenosis. TRIAL REGISTRATION: Based on project NT14146 - Biodegradable stents in the management of the large airways (2013-2015, MZ0/NT), registered on May 1, 2013, in the Research and Development and Innovation Information System of the Czech Republic and at ClinicalTrials.gov (reg. no. NCT02620319, December 2, 2015).
- MeSH
- bronchoskopie * MeSH
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladý dospělý MeSH
- polydioxanon MeSH
- protézy - design MeSH
- retrospektivní studie MeSH
- senioři MeSH
- stenóza průdušnice * chirurgie MeSH
- stenty * MeSH
- trachea chirurgie MeSH
- tracheomalacie chirurgie MeSH
- vstřebatelné implantáty * MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladý dospělý MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- Geografické názvy
- Česká republika MeSH
BACKGROUND: Total knee arthroplasty (TKA) with all-polyethylene tibial (APT) components has shown comparable survivorship and clinical outcomes to that with metal-backed tibial (MBT). Although MBT is more frequently implanted, APT equivalents are considered a low-cost variant for elderly patients. A biomechanical analysis was assumed to be suitable to compare the response of the periprosthetic tibia after implantation of TKA NexGen APT and MBT equivalent. METHODS: A standardised load model was used representing the highest load achieved during level walking. The geometry and material models were created using computed tomography data. In the analysis, a material model was created that represents a patient with osteopenia. RESULTS: The equivalent strain distribution in the models of cancellous bone with an APT component showed values above 1000 με in the area below the medial tibial section, with MBT component were primarily localised in the stem tip area. For APT variants, the microstrain values in more than 80% of the volume were in the range from 300 to 1500 με, MBT only in less than 64% of the volume. CONCLUSION: The effect of APT implantation on the periprosthetic tibia was shown as equal or even superior to that of MBT despite maximum strain values occurring in different locations. On the basis of the strain distribution, the state of the bone tissue was analysed to determine whether bone tissue remodelling or remodelling would occur. Following clinical validation, outcomes could eventually modify the implant selection criteria and lead to more frequent implantation of APT components.
BACKGROUND: Mid-term results (clinical and radiographic) of ultra-short anatomical cementless stem total hip arthroplasty (THA) in patients with osteonecrosis of the femoral head (ONFH) has not often been presented. The aim of this study is to evaluate THA using the Proxima stem in patients with ONFH in the mid-term. METHODS: The study consists of 73 patients (97 THAs) with a Proxima stem implanted between 2006 and 2015. The mean age of patients was 47.4 years, with a mean follow-up 105.2 months. The clinical results include preoperative and postoperative Harris Hip Scores (HHSs). Radiological follow-up reports on stem migration, bony trabecular development and radiolucent lines. The complications and revisions were registered. Kaplan-Meier survival analysis was performed to determine the implant survival. RESULTS: The average HHS improved significantly from 40.3 preoperatively to 98.0 at the final evaluation (p ˂ 0.0001). Stem migration (subsidence and "varisation") was observed in 11 hips (in 9 of them up to 6th postoperative month without any further progression, in 2 with progressive migration and radiological loosening). Bony trabecular development was detected in modified Gruen zones (1,2,4,6,7 for Proxima stem): in zone 1 (0%), 2 (67.0%), 4 (64.9%), 6 (64.9%), 7 (0%). Radiolucent lines were observed in 1 cup and 6 stems (2 were loose, 4 with fibrous stable fixation). Complications were found in 5 hips (5.1%): squeezing hip once, repeated dislocation in 1, 1 early deep infection, and 2 loose stems. 2 hips (2.1%) were revised (dislocation, infection). The implant survival was 98.9% and 97.9% clinically and radiologically, respectively. CONCLUSIONS: Observations in the mid-term show that the clinical and radiological results of the Proxima stem in patients with ONFH are promising. The stem design preserves the proximal femoral bone stock. The bony trabecular appearance confirms physiological proximal femoral load transmission.
- MeSH
- hlavice femuru chirurgie MeSH
- kyčelní protézy * MeSH
- lidé středního věku MeSH
- lidé MeSH
- náhrada kyčelního kloubu * škodlivé účinky metody MeSH
- následné studie MeSH
- nekróza hlavice femuru * diagnostické zobrazování chirurgie MeSH
- protézy - design MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
AIMS: Transcatheter aortic valve replacement (TAVR) has become the standard of care for selected patients with severe aortic stenosis. Multidetector computed tomography (MDCT) and transoesophageal 2D/3D (two-dimensional/three-dimensional) echocardiography (ECHO) are used for aortic annulus (AA) sizing. The aim of this study was to compare the accuracy of AA sizing by ECHO versus MDCT for Edwards Sapien balloon expandable valve in a single center. METHODS AND RESULTS: Data from 145 consecutive patients with TAVR (Sapien XT or Sapien S3) were analyzed retrospectively. A total of 139 (96%) patients had favorable outcomes after TAVR (at most mild aortic regurgitation and only one valve implanted). The 3D ECHO AA area and area-derived diameter were smaller than the corresponding MDCT parameters (464 ± 99 vs. 479 ± 88 mm2 , p < .001, and 24.2 ± 2.7 vs. 25.0 ± 5.5 mm, p = .002, respectively). The 2D ECHO annulus measurement was smaller than both the MDCT and 3D ECHO area-derived diameters (22.6 ± 2.9 vs. 25.0 ± 5.5 mm, p = .013, and 22.6 ± 2.9 vs. 24.2 ± 2.7 mm, p < .001, respectively) but larger than the minor axis diameter of the AA derived from MDCT and 3D ECHO by multiplanar reconstruction (p < .001). The 3D ECHO circumference-derived diameter was also smaller than the MDCT circumference-derived diameter (24.3 ± 2.5 vs. 25.0 ± 2.3, p = .007). The sphericity index by 3D ECHO was smaller than that by MDCT (1.2 ± .1 vs. 1.3 ± .1, p < .001). In up to 1/3 of the patients, 3D ECHO measurements would have predicted different (generally smaller) valve size than was the valve size implanted with favorable result. The concordance of the implanted valve size with the recommended size based on preprocedural MDCT and 3D ECHO AA area was 79.4% versus 61% (p = .001), and for the area-derived diameter, the concordance was 80.1% versus 61.7% (p = .001). 2D ECHO diameter concordance was similar to MDCT (78.7%). CONCLUSIONS: 3D ECHO AA measurements are smaller than MDCT measurements. If 3D ECHO-based parameters alone are used to size the Edwards Sapien balloon expandable valve, then the selected valve size would have been smaller than the valve size implanted with favorable result in 1/3 of the patients. MDCT preprocedural TAVR assessment should be the preferred method over 3D ECHO in routine clinical practice to determine Edwards Sapien valve size.
- MeSH
- aortální chlopeň diagnostické zobrazování chirurgie MeSH
- aortální stenóza * diagnostické zobrazování chirurgie etiologie MeSH
- echokardiografie transezofageální metody MeSH
- echokardiografie metody MeSH
- lidé MeSH
- multidetektorová počítačová tomografie metody MeSH
- protézy - design MeSH
- retrospektivní studie MeSH
- srdeční chlopně umělé * MeSH
- transkatetrální implantace aortální chlopně * metody MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
PURPOSE: This study aims to compare total knee replacement (TKA) with NexGen All-Poly (APT) and NexGen Metal-Backed (MBT) in terms of implant survivorship, reasons leading to implant failure and functional results of defined age categories. METHODS: A single-centre, retrospective evaluation of 812 patients who underwent knee replacement with NexGen CR between 2005 and 2021, comparing a modern congruent APT component to a modular MBT equivalent component using a similar surgical technique at a notable mean follow-up duration. Implant survival, functional outcomes using the Knee Society Score and range of motion were evaluated and compared in different age categories. RESULTS: Of the 812 NexGen CR TKAs performed at our institution, 410 (50.4%) used APT components and 402 (49.6%) MBT components. The survival rate of NexGen APT was 97.1% and that of NexGen MBT was 93.2% (p = 0.36). Removal of the implant occurred overall in 15 cases, for MBT in ten cases, and for APT in four cases. The FS was proved to be significantly higher when APT components were implanted in younger patients than for MBT (p = 0.005). A similar range of motion between the components was recorded (p = 0.1926). CONCLUSION: Under defined conditions, we measured the clinical results of implants from a single manufacturer implanted in a single department using a similar surgical technique. Considering the limitations, we suggest that all-polyethylene tibial components are equal or even superior to metal-backed ones across the examined age categories.
- MeSH
- kovy MeSH
- lidé MeSH
- polyethylen MeSH
- protézy - design MeSH
- protézy kolene * MeSH
- retrospektivní studie MeSH
- totální endoprotéza kolene * škodlivé účinky MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
OBJECTIVES: To evaluate systematically the influence of sex of dental professionals on their capability for visual color matching. MATERIALS AND METHODS: The protocol was registered on PROSPERO (CRD42020205393). PICOS question was develop based on the population, intervention, comparison, outcomes, and study design (PICOS). Eligibility criteria included cross section studies, randomized clinical trials and cohort studies that compared the effect of sex on the visual color matching process. Five electronic databases (Pubmed, Cochrane, EMBASE, Medline, and SCOPUS) and additional literature were screened independently by two researchers in July 2020. Clinical studies evaluating visual color matching skills of dental professionals were included. Studies that did not compare the difference between sexes were excluded. Duplicate articles were removed, titles and abstracts were screened, and studies were selected according to the inclusion criteria. Data were collected and reported in accordance with PRISMA guidelines. Risk of bias was assessed using Joanna Briggs Institute Critical Appraisal Tools. RESULTS: A total of 1192 articles were screened from which 132 full text articles were analyzed and 37 finally included in the systematic review. Most of the studies evaluated the color matching abilities of dental students in vitro with shade tabs or extracted teeth. Out of the 37 articles included, 25 reported no significant difference in shade matching abilities between the sexes. Of the 12 studies that found a significant difference, 11 reported that females had better scores in shade matching exercises. For all studies a low risk of bias was revealed for most of the domains. CONCLUSIONS: While the non-homogeneity of the settings and methods in the included studies make it impossible to construct aggregate statistic, this systematic review suggests that the sex is unlikely to be a critical factor influencing color matching abilities. CLINICAL SIGNIFICANCE: This study suggest that sex of dental professionals does not play a critical factor in matching satisfactory color of future dental restoration with surrounding teeth.
- MeSH
- barva MeSH
- barvení protéz * MeSH
- lidé MeSH
- vnímání barev MeSH
- zubní protéza - design MeSH
- zuby * MeSH
- Check Tag
- lidé MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- přehledy MeSH
- systematický přehled MeSH
PURPOSE OF THE STUDY Our study aimed to assess the mid-term outcomes and complications with the ICON hip resurfacing system and to carry out a detailed analysis of pitfalls and risks associated with pairing the bearing surfaces of metal-on-metal hip implants. MATERIAL AND METHODS A total of 52 hip joints were assessed in 43 patients who received the ICON hip resurfacing system at our department between 2009 and 2013. The cohort included 34 men and 9 women. Their age at the time of primary surgery ranged from 34 to 67 years, with the mean age of 51.8 years. The mean follow-up was 7.6 years. The evaluation focused on the position and osseointegration of both components, bone remodelling around the implant, and signs of potential aseptic loosening. The functional status of the hip was assessed by Harris Hip Score. RESULTS The primary stability of both components was always good, there were no femoral neck fractures reported in our cohort. All the acetabular components were stable, showing appropriate osseointegration, with no radiolucent zones or signs of osteolysis around them. There was not a single case of the femoral component stem being in a biomechanically disadvantageous varus position. In zone I and III according to Beaulé, cancellous bone osteolysis developed in two patients. The narrowing of the femoral neck below the end of the femoral component, compared to postoperative X-rays, achieved the mean value of 1.3% according to Grammatopolouse. The HHS increased from 64 to 95.5 points. An excellent outcome was observed in 48 joints, whereas the outcome of the remaining 4 joints was very good. The mean survival rate of the resurfacing hip implant calculated using the Kaplan-Meier analysis achieved 100%. The cobalt and chromium levels in the blood of patients did not exceed the reference physiological value. DISCUSSION The resurfacing system enables to preserve the bone tissue of the metaphysis and a part of the femoral head. The reduced mechanical endurance of the peripheral part of femoral components smaller in size caused by implant malposition resulted in fatal consequences in the ASR system. Greater range of motion conditioned by the design of the resurfacing system led to a mechanical wear, with a significant increase in the concentration of metal particles in the effective joint space. The elevated levels of cobalt and chromium ions in some patients induced delayed-type hypersensitivity with subsequent development of aseptic lymphocyte-dominated vasculitis associated lesions presented as peri-acetabular changes (pseudotumors to osteolysis) with subsequent failure of implant fixation. We have not observed this complication in the ICON system as yet. In patients suffering from hip pain after the resurfacing hip arthroplasty and simultaneous high chromium and cobalt blood levels, pelvic CT/MRI is indicated with reduction of artefacts around the metal material. Surgical treatment of soft tissue affections, bone defects and reimplantation using conventional or revisioncementless components is a possible treatment option. CONCLUSIONS The ideal patient indicated for hip resurfacing is a physically active man under 60 years of age (with a femoral head size of 54-60 mm), with primary or secondary osteoarthritis, no joint deformity, with a good quality bone tissue in the femoral neck and head region. As for the functional performance, the resurfacing system allows the patients a large range of motion with very good joint stability immediately after surgery. Despite that, the metal-on-metal tribological pairing must be approached with caution. The risk of developing lesions associated with ALVAL is unpredictable. In our cohort of patients with ICON hip resurfacing system, mostly excellent outcomes with minimum complications were reported provided the indication criteria and the correct surgical procedure had been complied with. Key words: hip resurfacing system, metal articulating surfaces, adverse reaction to metal particles, aseptic lymphocytedominated vasculitis associated lesions, pseudotumor.
- MeSH
- chrom MeSH
- dospělí MeSH
- kobalt MeSH
- kovy MeSH
- kyčelní kloub diagnostické zobrazování chirurgie MeSH
- kyčelní protézy * škodlivé účinky MeSH
- lidé středního věku MeSH
- lidé MeSH
- náhrada kyčelního kloubu * metody MeSH
- osteolýza * etiologie chirurgie MeSH
- protézy - design MeSH
- reoperace MeSH
- selhání protézy MeSH
- senioři MeSH
- vaskulitida * komplikace chirurgie MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- anglický abstrakt MeSH
- časopisecké články MeSH
