Long-Term Results of a Standard Algorithm for Intravenous Port Implantation.
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ABSTRACT:
SUBMITTER: Wu CF
PROVIDER: S-EPMC8146737 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Background Efficacy data on drug-eluting stents (DES) versus bare-metal stents (BMS) in saphenous vein grafts are controversial. We aimed to compare DES with BMS among patients undergoing saphenous vein grafts intervention regarding long-term outcome. Methods and Results In this multinational trial, patients were randomized to paclitaxel-eluting or BMS. The primary end point was major adverse cardiac events (cardiac death, nonfatal myocardial infarction, and target-vessel revascularization at 1 year. Secondary end points included major adverse cardiac events and its individual components at 5-year follow-up. One hundred seventy-three patients were included in the trial (89 DES versus 84 BMS). One-year major adverse cardiac event rates were lower in DES compared with BMS (2.2% versus 16.0%, hazard ratio, 0.14; 95% CI, 0.03-0.64, P=0.01), which was mainly driven by a reduction of subsequent myocardial infarctions and need for target-vessel revascularization. Five-year major adverse cardiac event rates remained lower in the DES compared with the BMS arm (35.5% versus 56.1%, hazard ratio, 0.40; 95% CI, 0.23-0.68, P<0.001). A landmark-analysis from 1 to 5 years revealed a persistent benefit of DES over BMS (hazard ratio, 0.33; 95% CI, 0.13-0.74, P=0.007) in terms of target-vessel revascularization. More patients in the BMS group underwent multiple target-vessel revascularization procedures throughout the study period compared with the DES group (DES 1.1% [n=1] versus BMS 9.5% [n=8], P=0.013). Enrollment was stopped before the target sample size of 240 patients was reached. Conclusions In this randomized controlled trial with prospective long-term follow-up of up to 5 years, DES showed a better efficacy than BMS with sustained benefits over time. DES may be the preferred strategy in this patient population. Registration URL: https://www.clini?caltr?ials.gov; Unique identifier: NCT00595647.
| S-EPMC7763393 | biostudies-literature
Project description:Background and Purpose Midcarpal arthrodesis is a well-accepted treatment option for advanced carpal collapse. In this study, we retrospectively assessed survival, analyzed complications and reviewed the long-term follow-up after midcarpal fusion. Materials and Methods The computerized medical records of 572 patients who had undergone 594 four-corner fusions between 1992 and 2001 were explored. Furthermore 56 patients with 60 midcarpal fusions were randomized for clinical and radiological follow-up at a mean of 14.7 years. Results Forty midcarpal fusions (6.7%) had to be converted into complete wrist arthrodesis. The reasons were ongoing pain in spite of a well-healed midcarpal fusion (31) or nonunion (9). Sixty-three patients (11%) required revision surgery because of nonunion (22), hematoma (8), wound infection (3) or persisting pain (31). In clinical follow-up the mean Disabilities of the Arm, Shoulder, and Hand (DASH) score was 20.4. Pain at rest was infrequent, a mild increase with daily activity was complained of (mean visual analog scale [VAS] 3.3). The mean active range of wrist motion for extension and flexion, ulnar and radial deviation and supination and pronation reached 62.5%, 68.4%, 94.7%, and mean grip strength 84.9% of the unaffected side. All patients had radiographic abnormalities, with frequent evidence of osteoarthritis of the lunate fossa. Patients with preserved carpal height appeared to have less pain, better DASH scores and a better range of motion. Conclusions The midcarpal arthrodesis is a long-lasting treatment option for advanced carpal collapse and has good long-term results. Level of Evidence Level IV, Therapeutic study.
| S-EPMC3658689 | biostudies-other
Project description:BackgroundThe objective of this study is to evaluate the safety of fertility-sparing surgery (FSS) for early-stage epithelial ovarian cancer (EOC).MethodsA retrospective analysis was performed to identify patients treated for early-stage EOC and to compare the clinical outcomes of patients treated with FSS and radical surgery (RS).ResultsA total of 1031 patients were treated at two Institutions, 242 with FSS (group A) and 789 with RS (group B). Median duration of follow-up was 11.9 years. At univariate analyses, FSS was associated with decreased risk of relapse (P=0.002) and of tumour-related death (P=0.001). Multivariate analysis did not confirm the independent positive role of FSS neither on relapse-free interval (RFI) nor on cancer-specific survival (CSS). Tumour grade was associated with shorter RFI (P<0.001) and shorter CSS (P=0.001). The type of treatment did not influence CSS or RFI in any grade group. We also found a significant association between low-grade tumours and younger age.ConclusionsFertility-sparing surgery is an adequate treatment for patients with stage I EOC. The clinical outcome of patients with G3 tumours, which is confirmed to be the most important prognostic factor, is not determined by the type of treatment received.
| S-EPMC5023783 | biostudies-literature
Project description:ObjectivesTo evaluate the long-term audiometric outcomes, sound localization abilities, binaural benefits, and tinnitus assessment of subjects with cochlear implant (CI) after a diagnosis of unilateral severe-to-profound hearing loss.MethodThe study group consisted of 60 (mean age 52 years, range 19-84) subjects with profound hearing loss in one ear and normal to near-normal hearing in the other ear who underwent CI. Data analysis included pre- and postoperative Consonant-Nucleus-Consonant (CNC) Word scores, AzBio Sentence scores, pure tone thresholds, sound localization, and Iowa Tinnitus Handicap Questionnaire scores.ResultsPreoperative average duration of deafness was 3.69 years (standard deviation 4.31), with an average follow-up time of 37.9 months (range 1-87). CNC and AzBio scores significantly improved (both P < 0.001) postoperatively among the entire cohort, and there was much heterogeneity in outcomes with respect to deafness etiology subgroup analysis. Sound localization abilities tended to improve longitudinally in the entire cohort. Binaural benefits using an adaptive Hearing in Noise Test test showed a significant (P < 0.001) improvement with head shadow effect. Utilizing the Iowa Tinnitus Handicap Questionnaire, there was significant improvement in social, physical, and emotional well-being (P = 0.011), along with hearing abilities (P = 0.001).ConclusionsThis case series is the largest cohort of CI SSD subjects to date and systematically analyzes their functional outcomes. Subjects have meaningful improvement in word understanding, and sound localization tends to gradually improve over time. Binaural benefit analysis showed significant improvement with head shadow effect, which likely provides ease of listening.Level of evidence4 Laryngoscope, 130:1805-1811, 2020.
| S-EPMC8588258 | biostudies-literature
Project description:The standard of care for newly diagnosed glioblastoma is maximal safe surgical resection, followed by chemoradiation therapy. We assessed carmustine wafer implantation efficacy and safety when used in combination with standard care.Included were adult patients with (n = 354, implantation group) and without (n = 433, standard group) carmustine wafer implantation during first surgical resection followed by chemoradiation standard protocol. Multivariate and case-matched analyses (controlled propensity-matched cohort, 262 pairs of patients) were conducted.The median progression-free survival was 12.0 months (95% CI: 10.7-12.6) in the implantation group and 10.0 months (9.0-10.0) in the standard group and the median overall survival was 20.4 months (19.0-22.7) and 18.0 months (17.0-19.0), respectively. Carmustine wafer implantation was independently associated with longer progression-free survival in patients with subtotal/total surgical resection in the whole series (adjusted hazard ratio [HR], 0.76 [95% CI: 0.63-0.92], P = .005) and after propensity matching (HR, 0.74 [95% CI: 0.60-0.92], P = .008), whereas no significant difference was found for overall survival (HR, 0.95 [0.80-1.13], P = .574; HR, 1.06 [0.87-1.29], P = .561, respectively). Surgical resection at progression whether alone or combined with carmustine wafer implantation was independently associated with longer overall survival in the whole series (HR, 0.58 [0.44-0.76], P < .0001; HR, 0.54 [0.41-0.70], P < .0001, respectively) and after propensity matching (HR, 0.56 [95% CI: 0.40-0.78], P < .0001; HR, 0.46 [95% CI: 0.33-0.64], P < .0001, respectively). The higher postoperative infection rate in the implantation group did not affect survival.Carmustine wafer implantation during surgical resection followed by the standard chemoradiation protocol for newly diagnosed glioblastoma in adults resulted in a significant progression-free survival benefit.
| S-EPMC4633930 | biostudies-literature
Project description:BackgroundAn intravenous port, which differs from a central venous catheter, has an injection chamber at the end of the catheter. This structural difference causes the irrigation flow pattern to be quite different from that of the central venous catheter. Furthermore, the intraluminal volume differs due to the size of the injection chamber and implanted catheter length. Hence, the ideal recommended irrigation volume varies because of differences in intraluminal volume, however, the recommended irrigation volume is 10 ml and may be a cause for reported port malfunctions. This study investigates the best irrigation volume for an intravenous port by simulating the clinical scenario ex-vivo to access its usefulness.Materials and methodsThis study was composed of two tests. The irrigation volume test attempted to quantify the irrigation volume of an implanted port while the irrigation rate test attempted to simulate daily nursing practice in order to clarify the effect of irrigation flow. The human blood needed for the simulation was donated by volunteers and the total volume was 10 ml per test. The irrigation volume test was done by syringe pump with varying pre-set irrigation volume after the port and connected catheter were filled with volunteer blood. After irrigation with pre-set volume, the retained intraluminal solution was collected and quantified by Bradford assay in order to titrate the best irrigation volume. The irrigation rate test tried to simulate daily maintenance practice in different settings with the quantified irrigation volume as identified by the irrigation volume test. The retained intraluminal solution was collected and quantified by Bradford assay in order to confirm the efficacy of the quantified irrigation volume.ResultsIn both SVC and IVC ports, we identified the twenty times the intravascular volume as sufficient for a complete wash out of the blood component in the irrigation volume test. The minimal irrigation volume for SVC and IVC port were 10 ml and 15.6 ml respectively. In irrigation rate test, the irrigation for SVC and IVC port was 10 and 20 ml, respectively, for the sake of preparation convenience. We not only identified the importance of preparation, i.e. irrigation of the extension line but also confirmed the efficacy of the recommended irrigation volume.ConclusionThe irrigation volume should be varied according to the intraluminal volume. Maintenance should be performed after the extension line has been irrigated. The recommended port irrigation volume for SVC and IVC route were 10 and 20 ml, respectively.
| S-EPMC6091923 | biostudies-literature
Project description:UNLABELLED: While the literature suggests lateral unicondylar knee arthroplasty (UKA) improves function in the short- and medium-term, it is less clear on longer-term function. We asked (1) whether lateral UKA improved longer-term Knee Society scores and return to previous activity level); (2) whether there were any concerning longer-term radiographic findings (the Knee Society roentgenographic evaluation and scoring system); and (3) whether lateral UKA was durable as measured by survivorship to revision at 10 and 16 years. We retrospectively reviewed 39 patients with 40 lateral cemented metal-backed UKA. The patients had a mean age of 61 years at surgery. The etiologies were primary osteoarthritis in 24 knees, posttraumatic in 12 cases, and osteonecrosis in four cases. We performed clinical and radiographic evaluations at a minimum followup of 3 years (mean, 12.6 years; range, 3-23 years). Prostheses survivorship was 92% at 10 years and 84% at 16 years. Despite the limited number of indications and technical considerations, our data suggest lateral UKA is a reasonable alternative for isolated lateral femorotibial compartment disease. LEVEL OF EVIDENCE: Level IV, therapeutic study. See the Guidelines for Authors for a complete description of levels of evidence.
| S-EPMC2565025 | biostudies-other
Project description:Background:The aim of A MAastricht Contrast-Induced Nephropathy Guideline (AMACING) trial was to evaluate non-inferiority of no prophylaxis compared to guideline-recommended prophylaxis in preventing contrast induced nephropathy (CIN), and to explore the effect on long-term post-contrast adverse outcomes. The current paper presents the long-term results. Methods:AMACING is a single-centre, randomised, parallel-group, open-label, phase 3, non-inferiority trial in patients with estimated glomerular filtration rate [eGFR] 30-59?mL/min/1.73?m2 combined with risk factors, undergoing elective procedures requiring intravenous or intra-arterial iodinated contrast material. Exclusion criteria were eGFR < 30?mL/min/1.73?m2, dialysis, no referral for prophylaxis. The outcomes dialysis, mortality, and change in renal function at 1?year post-contrast were secondary outcomes of the trial. Subgroup analyses were performed based on pre-defined stratification risk factors. AMACING is registered with ClinicalTrials.gov: NCT02106234. Findings:From 28,803 referrals, 1120 at-risk patients were identified. 660 consecutive patients agreed to participate and were randomly assigned (1:1) to no prophylaxis (n?=?332) or standard prophylactic intravenous hydration (n?=?328). Dialysis and mortality data were available for all patients. At 365?days post-contrast dialysis was recorded in two no prophylaxis (2/332, 0.60%), and two prophylaxis patients (2/328, 0.61%; p?=?0.9909); mortality was recorded for 36/332 (10.84%) no prophylaxis, and 32/328 (9.76%) prophylaxis patients (p?=?0.6490). The hazard ratio was 1.118 (no prophylaxis vs prophylaxis) for one-year risk of death (95% CI: 0.695 to 1.801, p?=?0.6449). The differences in long-term changes in serum creatinine were small between groups, and gave no indication of a disadvantage for the no-prophylaxis group. Interpretation:Assuming optimal contrast administration, not giving prophylaxis to elective patients with eGFR 30-59?mL/min/1.73?m2 is safe, even in the long-term. Funding:Stichting de Weijerhorst.
| S-EPMC6537536 | biostudies-literature
Project description:To evaluate the long-term efficacy of intraocular pressure (IOP) reduction and complications of Ahmed Glaucoma Valve (AGV) implantation in patients with refractory glaucoma.Retrospective study.The study involved 302 refractory glaucoma patients who underwent AGV implantation and had a minimum follow-up of 6 months between March 1995 and December 2013.An operation was defined as successful when (1) the postoperative IOP remained between 5 and 21 mmHg and was reduced 30% compared to the baseline IOP with or without medication, (2) there was no loss of light perception or vision-threatening severe complications, and (3) no additional filtering or aqueous drainage surgery was required. Clinical records were reviewed.IOP, anti-glaucoma medications, and complications.The mean follow-up period was 62.25 months (range, 6 to 190 months). The cumulative probability of success was 89% at 6 months, 81% at 1 year, 66% at 3 years, 44% at 10 years, and 26% at 15 years. IOP was reduced from a mean of 32.2 ± 10.5 mmHg to 18.6 ± 9.1 mmHg at 1 month, 15.2 ± 7.0 mmHg at 6 months, and 14.2 ± 3.5 mmHg at 15 years. Surgical failures were significantly increased when preoperative IOP was high, and when severe complications occurred after AGV implantation (P < 0.05).AGV implantation was successful for IOP control in patients with refractive glaucoma in the long term. However, the success rate of surgery decreased over time. Preoperative high IOP and severe complications related to the operation were significant risk factors for failure.
| S-EPMC5667863 | biostudies-literature
Project description:This article deals with the long-term preclinical validation of WIMAGINE® (Wireless Implantable Multi-channel Acquisition system for Generic Interface with Neurons), a 64-channel wireless implantable recorder that measures the electrical activity at the cortical surface (electrocorticography, ECoG). The WIMAGINE® implant was designed for chronic wireless neuronal signal acquisition, to be used e.g., as an intracranial Brain-Computer Interface (BCI) for severely motor-impaired patients. Due to the size and shape of WIMAGINE®, sheep appeared to be the best animal model on which to carry out long-term in vivo validation. The devices were implanted in two sheep for a follow-up period of 10 months, including idle state cortical recordings and Somato-Sensory Evoked Potential (SSEP) sessions. ECoG and SSEP demonstrated relatively stable behavior during the 10-month observation period. Information recorded from the SensoriMotor Cortex (SMC) showed an SSEP phase reversal, indicating the cortical site of the sensorimotor activity was retained after 10 months of contact. Based on weekly recordings of raw ECoG signals, the effective bandwidth was in the range of 230 Hz for both animals and remarkably stable over time, meaning preservation of the high frequency bands valuable for decoding of the brain activity using BCIs. The power spectral density (in dB/Hz), on a log scale, was of the order of 2.2, -4.5 and -18 for the frequency bands (10-40), (40-100), and (100-200) Hz, respectively. The outcome of this preclinical work is the first long-term in vivo validation of the WIMAGINE® implant, highlighting its ability to record the brain electrical activity through the dura mater and to send wireless digitized data to the external base station. Apart from local adhesion of the dura to the skull, the neurosurgeon did not face any difficulty in the implantation of the WIMAGINE® device and post-mortem analysis of the brain revealed no side effect related to the implantation. We also report on the reliability of the system; including the implantable device, the antennas module and the external base station.
| S-EPMC6712079 | biostudies-literature