BACKGROUND: In women with severe aortic stenosis, there are limited data regarding outcome differences following transcatheter (TAVR) vs surgical aortic valve replacement (SAVR). OBJECTIVES: The authors sought to examine outcomes of TAVR vs SAVR in a patient-level pooled analysis of women in the RHEIA and PARTNER 3 trials. METHODS: Patients in both trials were randomly allocated to a balloon-expandable SAPIEN 3/Ultra valve or to surgical bioprostheses. Individual patient data of female participants in the 2 trials were pooled. The primary endpoint was all-cause mortality, all stroke, or rehospitalization at 1 year. RESULTS: A total of 376 women were randomized to TAVR and 336 to SAVR. The mean age was ∼73 years, and the mean Society of Thoracic Surgeons (STS) score was 2.1%. Kaplan-Meier estimates of event rates at 1 year with TAVR vs SAVR were 8.5% vs 16.8% for the composite of all-cause mortality, all stroke, or rehospitalization (absolute difference -8.2%; 95% CI: -13.1% to -3.3%; P < 0.001), 1.1% vs 2.1% (P = 0.27) for all-cause mortality, 2.7% vs 3.9% (P = 0.35) for all stroke, and 5.4% vs 11.9% (P = 0.002) for rehospitalization. The composite endpoint of all-cause death or stroke was similar between the 2 treatment groups: 3.5% vs 5.4% (absolute difference -1.9%; 95% CI: -5.0% to 1.1%; P = 0.21). CONCLUSIONS: Among women with symptomatic severe aortic stenosis, TAVR led to a reduction in the rate of the combined endpoint of all-cause mortality, stroke, or rehospitalization at 1-year follow-up, largely due to a significant reduction in the rate of rehospitalization.
- MeSH
- aortální chlopeň * chirurgie patofyziologie diagnostické zobrazování MeSH
- aortální stenóza * mortalita chirurgie patofyziologie diagnostické zobrazování MeSH
- bioprotézy MeSH
- časové faktory MeSH
- cévní mozková příhoda mortalita etiologie terapie MeSH
- chirurgická náhrada chlopně * škodlivé účinky mortalita přístrojové vybavení MeSH
- hodnocení rizik MeSH
- lidé MeSH
- protézy - design MeSH
- randomizované kontrolované studie jako téma MeSH
- rizikové faktory MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- sexuální faktory MeSH
- srdeční chlopně umělé MeSH
- stupeň závažnosti nemoci MeSH
- transkatetrální implantace aortální chlopně * škodlivé účinky mortalita přístrojové vybavení MeSH
- výsledek terapie MeSH
- znovupřijetí pacienta MeSH
- Check Tag
- lidé MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- srovnávací studie MeSH
Reconstruction of the anatomic defect following extra-articular shoulder resection is a challenging problem, particularly in cases when function of the deltoid muscle and rotator cuff are compromised. Standard reconstruction techniques often result in either instability or rigidity. Constrained implants have been used to overcome these problems; however, they have been associated with a high rate of aseptic loosening. Recently, a novel double-constrained implant has been introduced, yielding promising functional results. Nonetheless, this implant exhibited a cosmetic defect related to protrusion of the humeral component that becomes apparent with time as result of surrounding muscle atrophy. An updated improved design of the implant has been developed to counteract this.We report the case of a 15-year-old patient who underwent an extra-articular (Malawer type V) shoulder resection due to osteosarcoma and received an innovated custom-made double-constrained implant. Moreover, we describe a new modification of the Malawer utilitarian approach to the shoulder girdle that enhances tumor visibility and allows safer dissection. The patient recovered well with satisfactory outcomes at 18 months follow-up, highlighting the potential benefits of this implant design and surgical approach.
- MeSH
- artroplastika ramenního kloubu * metody MeSH
- lidé MeSH
- mladiství MeSH
- nádory kostí * chirurgie patologie MeSH
- náhrada ramenního kloubu * MeSH
- osteosarkom * chirurgie patologie MeSH
- ověření koncepční studie MeSH
- prognóza MeSH
- protézy - design * MeSH
- ramenní kloub * chirurgie patologie MeSH
- výsledek terapie MeSH
- zákroky plastické chirurgie * metody MeSH
- Check Tag
- lidé MeSH
- mladiství MeSH
- mužské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- kazuistiky MeSH
PURPOSE: Revision total hip arthroplasty (rTHA) is an increasingly common procedure due to the growing number of primary total hip arthroplasties (THAs) performed worldwide. This study evaluates the long-term implant survival, functional outcomes, and radiographic performance of cemented femoral stem (Beznoska s.r.o., Kladno, Czechia) in rTHA. METHODS: A retrospective analysis was conducted on 183 patients who underwent rTHA with cemented stem between March 2012 and December 2023. The mean follow-up duration was 71.26(± 39.31) months. Implant survival was analyzed using Kaplan-Meier survival estimates, and failure modes were assessed. Radiographic changes were classified using the Gruen Zones system. Functional outcomes were evaluated using the Harris Hip Score (HHS). Cox proportional hazard models were applied to identify prognostic factors influencing implant survival. RESULTS: The five-year implant survival rate was 98.1%, declining to 83.9% at twelve years. The overall failure rate was 3.83%, with periprosthetic infection (4 cases) being the most common cause, followed by aseptic loosening (2 cases). Radiographic changes were observed in 24.03% of cases, predominantly in Gruen Zones 2, 6, and 1. Functional outcomes were favorable, with a mean HHS of 81.28(± 5.74), comparable to outcomes reported for uncemented revision stems. Age, stem diameter, and stem length did not significantly impact implant survival. CONCLUSION: The cemented stem demonstrated favourable long-term survival, with high implant retention rates. Functional outcomes indicated overall satisfactory performance. Radiographic evaluation revealed localized changes around the implant, predominantly in Gruen Zones 2, 6, and 1. Implant failure was relatively rare, with periprosthetic infection being the most common cause.
- MeSH
- cementování MeSH
- dospělí MeSH
- Kaplanův-Meierův odhad MeSH
- kostní cementy MeSH
- kyčelní kloub diagnostické zobrazování chirurgie MeSH
- kyčelní protézy * škodlivé účinky MeSH
- lidé středního věku MeSH
- lidé MeSH
- náhrada kyčelního kloubu * metody přístrojové vybavení škodlivé účinky MeSH
- protézy - design MeSH
- radiografie MeSH
- reoperace * MeSH
- retrospektivní studie MeSH
- selhání protézy * MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
BACKGROUND: Current therapy for in-stent restenosis (ISR) is based on drug-eluting stents (DES) or drug-eluting balloon catheters. This prospective randomized study compared the efficacy of a novel sirolimus-eluting balloon (SEB) catheter to that of a paclitaxel-eluting balloon (PEB) catheter for the treatment of bare-metal stent (BMS-ISR) or DES-ISR. METHODS: A total of 145 patients with 158 BMS or DES-ISR lesions were randomly assigned to the treatment with either SEB or PEB. The in-segment late lumen loss at 12 months, the 12-month incidence of binary ISR, and major adverse cardiac events (cardiac death, nonfatal acute myocardial infarction, or target lesion revascularization) were compared between groups. RESULTS: The noninferiority of SEB compared with PEB in the treatment of BMS/DES-ISR with respect to late lumen loss was not demonstrated (Δlate lumen loss, -0.024 mm [95% CI, -0.277 to 0.229]; for a noninferiority margin of 0.20 mm), except in the post hoc subanalysis for the BMS-ISR group (-0.203 mm [95% CI, -0.584 to 0.178]). No significant differences in the incidence of repeated binary ISR (31.6% versus 30.4%, P=0.906) or 12-month major adverse cardiac events (31% for both; P>0.999) between the SEB and PEB groups were observed. CONCLUSIONS: The noninferiority of SEB relative to PEB in the treatment of BMS/DES-ISR with respect to late lumen loss was not confirmed. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03667313.
- MeSH
- balónková koronární angioplastika * škodlivé účinky přístrojové vybavení MeSH
- biokompatibilní potahované materiály * aplikace a dávkování MeSH
- časové faktory MeSH
- kardiovaskulární látky aplikace a dávkování škodlivé účinky MeSH
- koronární angioplastika * škodlivé účinky přístrojové vybavení MeSH
- koronární restenóza * diagnostické zobrazování terapie mortalita etiologie MeSH
- lidé středního věku MeSH
- lidé MeSH
- nemoci koronárních tepen * diagnostické zobrazování terapie mortalita MeSH
- paclitaxel * aplikace a dávkování škodlivé účinky MeSH
- prospektivní studie MeSH
- protézy - design MeSH
- rizikové faktory MeSH
- senioři MeSH
- sirolimus * aplikace a dávkování škodlivé účinky MeSH
- srdeční katétry MeSH
- stenty uvolňující léky škodlivé účinky MeSH
- stenty škodlivé účinky MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- hodnocení ekvivalence MeSH
- multicentrická studie MeSH
- srovnávací studie MeSH
PURPOSE: Carotid artery stenting with single-layer stents carries a risk of periprocedural cerebral embolization compared to carotid endarterectomy. Dual-layer micromesh stents were designed for improved plaque coverage and sustained embolic protection. This analysis aimed to confirm the Roadsaver dual-layer micromesh stent safety in a real-world carotid artery stenting cohort. MATERIALS AND METHODS: ROADSAVER was a prospective, single-arm, multicenter, observational study. Patients with carotid artery stenosis, eligible for elective stenting, were enrolled at 52 sites across 13 European countries. All procedures followed standard practice. The primary outcome was the 30-day major adverse event rate, defined as the cumulative incidence of any death or stroke. All deaths, strokes, and carotid artery revascularizations were independently adjudicated. RESULTS: In total, 1965 patients were analysed (mean age 70.6 ± 8.8 years). Cerebral ischaemia symptoms were present in 49.4% of participants. Radial/ulnar access was used in 26.3% of cases and embolic protection in 63.8%. The 30-day major adverse event incidence was 2.2% (1.6% in asymptomatic and 2.8% in symptomatic patients), with any stroke at 1.9%, any death at 0.8%, and stroke-related death at 0.5%. Predictors of higher 30-day major adverse event risk, identified through multivariable modelling, included residual stenosis ≥ 30%, thromboembolic venous disease, previous myocardial infarction, age ≥ 75 years, family history of atherosclerosis, non-insulin-dependent diabetes mellitus, symptomatic carotid stenosis, and stent length. CONCLUSION: Dual-layer micromesh carotid artery stenting is safe, with a low 30-day major adverse event incidence in real-world asymptomatic and symptomatic patients, supporting the sustained embolic protection design concept. LEVEL OF EVIDENCE: Level 2, observational study (with dramatic effect).
- MeSH
- cévní mozková příhoda prevence a kontrola etiologie MeSH
- lidé středního věku MeSH
- lidé MeSH
- prospektivní studie MeSH
- protézy - design MeSH
- senioři MeSH
- stenóza arteria carotis * terapie chirurgie diagnostické zobrazování MeSH
- stenty * MeSH
- výsledek terapie 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
- pozorovací studie MeSH
- Geografické názvy
- Evropa MeSH
BACKGROUND: A multicentre European randomized control trial - European Uncomplicated Type B Aortic Repair (EU-TBAR) is being developed to compare pre-emptive thoracic endovascular aortic repair (TEVAR) with custom-made devices versus conventional optimal medical therapy. The pretrial set-up is confluent on different pillars, including evaluation of 1) European activity, trends, and governance; 2) outcome reporting; and 3) cost evaluation. This article aimed to demonstrate the observational cross-sectional survey results from participating centers and highlight the risk assessment, activity, practices, and governance of uncomplicated type B aortic dissection (uTBAD). METHODS: This observational cross-sectional European survey used a questionnaire that examined the understanding, risk assessment, local governance oversight, and clinical activity of uTBAD. The data were collected and managed using Research Electronic Data Capture (REDCap). RESULTS: Out of 43 surveyed surgeons, 37 (86%) responded within a month from 14 European countries. Most reported low annual uTBAD encounters, with autumn being the most common season for cases. Pre-emptive TEVAR was recommended by 43.2% of participants, who favored subacute intervention timing. The Gore TAG was the most used TEVAR device, and custom devices were available for 73% of respondents. Risk factors for uTBAD were ranked, with 'Rapid Aortic Enlargement' deemed most critical. A majority of centers had protocols and multidisciplinary teams, with most having readily available radiology services. Only 45.9% had transfer services to specialized centers. CONCLUSIONS: uTBAD remains a misnomer of a dynamic, ongoing disease process requiring early diagnosis and intervention. Pre-emptive TEVAR in high-risk uTBAD is becoming more common, with encouraging results prompting an expansion of indication criteria to a broader uTBAD population managed conservatively. Nevertheless, further evidence is needed through large randomized controlled trials, mainly European collaboratives, to reach a definitive conclusion on the optimum surgical management of uTBAD.
- MeSH
- aneurysma hrudní aorty * chirurgie diagnostické zobrazování ekonomika MeSH
- časové faktory MeSH
- cévní protézy trendy MeSH
- cévy - implantace protéz * škodlivé účinky přístrojové vybavení trendy ekonomika MeSH
- chirurgové * trendy MeSH
- disekce aorty * chirurgie diagnostické zobrazování ekonomika MeSH
- endovaskulární výkony * škodlivé účinky přístrojové vybavení trendy ekonomika MeSH
- hodnocení rizik MeSH
- lékařská praxe - způsoby provádění * trendy MeSH
- lidé MeSH
- protézy - design MeSH
- průřezové studie MeSH
- průzkumy zdravotní péče MeSH
- rizikové faktory MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- pozorovací studie MeSH
- Geografické názvy
- Evropa MeSH
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
