Is Early Cochlear Implant Device Activation Safe for All on-the-Ear and off-the-Ear Sound Processors?

2019 ◽  
Vol 24 (6) ◽  
pp. 279-284 ◽  
Author(s):  
Merve Ozbal Batuk ◽  
Mehmet Yarali ◽  
Betul Cicek Cinar ◽  
Aysun Parlak Kocabay ◽  
Munir Demir Bajin ◽  
...  
Keyword(s):  
Side Effects ◽  
Statistical Significance ◽  
Surgical Techniques ◽  
Control Group ◽  
Electrode Impedance ◽  
Early Activation ◽  
Significant Difference ◽  
Initial Activation ◽  
The Impact

Background: Cochlear implantation (CI) is an effective treatment option for patients with severe-to-profound hearing loss. When CI first started, it was recommended to wait until at least 4 weeks after the CI surgery for the initial activation because of possible complications. Advances in the surgical techniques and experiences in fitting have made initial activation possible within 24 h. Objectives: To compare the complaints and complications after early activation between behind-the-ear (BTE) and off-the-ear (OTE) sound processors and to show the impact of early activation on the electrode impedance values. Method: CI surgeries performed between March 2013 and July 2018 were retrospectively analyzed from the database. In total, 294 CI users were included in the present study. The impedance measurements were analyzed postoperatively at the initial activation prior to the stimulation, and 4 weeks after the initial activation in the first-month follow-up visit. A customized questionnaire was administered in the first-month follow-up fitting session to caregivers and/or patients who were using CI at least for 6 months. Medical records were also reviewed to identify any postoperative complications. Results: In the early activation group, impedance values were significantly lower than in the control group (p < 0.05) at first fitting. At the first-month follow-up, no significant difference was found between the groups (p > 0.05). The most common side effects were reported to be edema (6.1%) and pain (5.7%) in the early activation group. In patients with OTE sound processors, the rate of side effects such as skin infection, wound swelling, skin hyperemia, and pain was higher than in patients with BTE sound processors; however, a statistical significance was only observed in wound swelling (p = 0.005). Selecting the appropriate magnet was defined as a problem for the OTE sound processors during the initial activation. Conclusion: This study revealed that early activation of CI was clinically safe and feasible in patients with BTE sound processors. When using OTE sound processors, the audiologists should be careful during the activation period and inform patients of possible side effects. The first fitting should be delayed for 4 weeks after CI for OTE sound processors. This current study is the first to report this finding with 5 years of experience in a large cohort.

scholarly journals Impact of a nutrition consultation on the rate of high output stoma-related readmission: an ambispective cohort study

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Manuela Moreno Santamaría ◽  
José Javier Arenas Villafranca ◽  
Jimena Abilés ◽  
Francisco Rivas Ruiz ◽  
Pilar Utrilla Navarro ◽  
...  
Keyword(s):  
Cohort Study ◽  
Nutritional Status ◽  
Statistical Significance ◽  
Intestinal Resection ◽  
Control Group ◽  
Stoma Creation ◽  
Significant Difference ◽  
The Impact ◽  
High Output

AbstractThe aims of this study were to assess the impact of a follow-up nutrition consultation for ostomy patients on the rate of high output stoma (HOS)-related readmissions, as well as on the detection of poor nutritional status and their management, and to determine the associated economic impact. A single-centre ambispective cohort study was conducted in which all adult patients undergoing intestinal resection and stoma creation were recruited. Two nutrition consultations were established for early follow-up after hospital discharge and patients were prospectively included. Additionally, a retrospective search was carried out to include a control group. In both groups, a 12-month follow-up was conducted to record readmissions associated with high output stoma. A multivariate logistic regression was performed. Statistical significance level was established at p < 0.05. 170 patients were recruited, 85 patients in each cohort. Demographic data and clinical characteristics were recorded. A significant difference was observed in HOS-related readmissions, with readmission rates of 28.6% vs 10.3% in the retrospective and prospective cohort, respectively. At the first follow-up consultation, 50.5% of patients presented some degree of protein-calorie malnutrition. A statistically significant improvement in nutritional status was observed in the second evaluation. The intervention carried out resulted in a total saving of €24,175. Early follow-up of patients after discharge resulted in a significant reduction in the rate of HOS-related readmissions and allowed to identify a high percentage of patients with malnutrition. The cost analysis showed the process to be a cost-effective improvement.

Long-Term Follow-Up of Early Cochlear Implant Device Activation

2021 ◽  
pp. 1-11
Author(s):  
Stefanie Bruschke ◽  
Uwe Baumann ◽  
Timo Stöver
Keyword(s):  
Speech Recognition ◽  
Side Effects ◽  
Cochlear Implant ◽  
Surgical Techniques ◽  
Control Group ◽  
First Year ◽  
Safe Procedure ◽  
Sound Processor

Background: The cochlear implant (CI) is a standard procedure for the treatment of patients with severe to profound hearing loss. In the past, a standard healing period of 3–6 weeks occurred after CI surgery before the sound processor was initially activated. Advancements of surgical techniques and instruments allow an earlier initial activation of the processor within 14 days after surgery. Objective: Evaluation of the early CI device activation after CI surgery within 14 days, comparison to the first activation after 4–6 weeks, and assessment of the feasibility and safety of the early fitting over a 12 month observation period were the objectives of this study. Method: In a prospective study, 127 patients scheduled for CI surgery were divided into early fitting group (EF, n = 67) and control group (CG, n = 60). Individual questionnaires were used to evaluate medical and technical outcomes of the EF. Medical side effects, speech recognition, and follow-up effort were compared with the CG within the first year after CI surgery. Results: The early fitting was feasible in 97% of the EF patients. In the EF, the processor was activated 25 days earlier than in the CG. No major complications were observed in either group. At the follow-up appointments, side effects such as pain and balance problems occurred with comparable frequency in both groups. At initial fitting, the EF showed a significantly higher incidence of medical minor complications (p < 0.05). When developing speech recognition within the first year of CI use, no difference was observed. Furthermore, the follow-up effort within the first year after CI surgery was comparable in both groups. Conclusions: Early fitting of the sound processor is a feasible and safe procedure with comparable follow-up effort. Although more early minor complications were observed in the EF, there were no long-term wound healing problems caused by the early fitting. Regular inspection of the magnet strength is recommended as part of the CI follow-up since postoperative wound swelling must be expected. The early fitting procedure enabled a clear reduction in the waiting time between CI surgery and initial sound processor activation.

scholarly journals Impact of failed ab-interno trabeculectomy (trabectome) on subsequent XEN45 gel stent implantation in pseudophakic eyes

2021 ◽  
Author(s):  
D. Kiessling ◽  
C. Rennings ◽  
M. Hild ◽  
A. Lappas ◽  
T. S. Dietlein ◽  
...  
Keyword(s):  
Stent Implantation ◽  
Open Angle Glaucoma ◽  
Control Group ◽  
Repeat Surgery ◽  
Medication Score ◽  
Significant Difference ◽  
Ab Interno Trabeculectomy ◽  
The Impact ◽  
Ab Interno

Abstract Purpose To determine the impact of failed ab-interno trabeculectomy on the postoperative outcome of subsequent XEN45 gel stent (Allergan, CA, USA) implantation in pseudophakic eyes. Methods In this retrospective single-center study, we included 60 pseudophakic eyes from 60 participants who underwent XEN45 gel stent implantation. Thirty eyes each underwent primary stent implantation (control group) or had previously undergone a failed ab-interno trabeculectomy (trabectome group). The groups were matched at a 1:1 ratio based on the following criteria: preoperative and maximum Intraocular pressure (IOP), preoperative medication score, cup/disk-ratio, follow-up time, best-corrected visual acuity at baseline, age, and the proportion of patients classified as primary open angle glaucoma or exfoliation glaucoma. We defined a successful surgery by the following three scores: an IOP reduction > 20% and IOP at the longest follow-up < 21 mmHg (Score A) or < 18 mmHg (Score B) or IOP ≤ 15 mmHg and an IOP reduction ≥ 40% (Score C). One open conjunctival revision was allowed in all scores, and a repeat surgery was considered a failure. Results Following an average follow-up period of 22 ± 12 months, we observed a mean IOP reduction of 38%, from 23.5 ± 5.2–14.5 ± 5.0 mmHg. Comparative analyses between the groups did not reveal a significant difference in the postoperative IOP, postoperative medication score, side effects, revision rate, repeat surgery rate, or success rate. Conclusions Trabectome is a viable first-line procedure for medically uncontrolled glaucoma before filtering ab-interno microstent surgery is considered.

A Randomised Controlled Trail of Plasma Exchange in Rapidly Progressive Renal Failure of Myeloma.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 4899-4899
Author(s):  
William F. Clark ◽  
A. Keith Stewart ◽  
Gail A. Rock ◽  
Marion Sternbach ◽  
David M. Sutton ◽  
...  
Keyword(s):  
Serum Creatinine ◽  
Sample Size ◽  
Plasma Exchange ◽  
Kidney Failure ◽  
Statistical Significance ◽  
Control Group ◽  
Significant Difference ◽  
The Mean ◽  
Baseline Characteristics

Abstract In myeloma, plasma exchange (PE) has been suggested to prevent rapidly progressive kidney failure by reducing exposure to nephrotoxic light chains. We carried out a randomized controlled multi-centre trial comparing PE or no PE in 104 patients of whom 101 met the inclusion, exclusion criteria and 4 were lost to follow-up. We compared baseline characteristics as well as renal outcomes and performed a futility analysis to determine the sample size necessary for potential statistical significance for the changes noted. Thirty-nine patients were randomized to the control group and 58 to the PE group with a 6-month follow-up. The baseline characteristics of these 2 groups were similar including serum creatinine, dialysis dependence, age, gender, serum calcium, serum albumin, 24 -hour urine for protein levels and Durie-Salmon myeloma staging. Thirteen (33.3%) of the control group and 19 (33.3%) of the PE group died within 6 months of follow up. Ten patients (31%) in the control and 10 patients (21%) in the PE arm were dialysis dependent at 6 months. Seven patients (47%) came off dialysis in the control and 13 patients (59%) in the PE arm with the mean number of dialysis days from 0–6 months being 45.7±67.6 in the control versus 29.2±56.1 in the PE arm at 6 months. The mean serum creatinine in the control group was 314.6±256.1 μmol/L versus 215.4±215.3 μmol/L in the PE group and the composite end point of death, dialysis or serum creatinine >254 μmol/L occurred in 12 (30.8%) in the control and 11 (19.3%) in the PE arm. The futility analysis to indicate the per group sample size necessary to achieve statistical significance at 6 months for the difference we observed was infinite for cumulative mortality, 805 for dialysis dependence, 2418 for coming off dialysis, 321 for number of dialysis days, 132 for creatinine difference of 100 μmol/L and for the composite outcome of death, dialysis or creatinine>354 μmol/L, 737. We did not observe a statistically significant difference in mortality or renal morbidity for PE versus no PE in patients with myeloma and rapidly progressive kidney failure.

scholarly journals THE IMPACT OF SPORT GAMES EXERCISE PROGRAMS ON THE DEVELOPMENT OF SPECIFIC MOTOR ABILITIES IN ADOLESCENTS WITH INTELLECTUAL IMPAIRMENT

2020 ◽  
pp. 249
Author(s):  
Aleksandar Pejčić ◽  
Miodrag Kocić
Keyword(s):  
Motor Skills ◽  
Statistical Significance ◽  
Exercise Program ◽  
Experimental Program ◽  
Control Group ◽  
Mental Impairment ◽  
Motor Abilities ◽  
Significant Difference ◽  
And Control ◽  
The Impact

The aim of this study was to determine the effects of a sports games experimental program on improving specific motor abilities in adolescents with mental impairment. The study was conducted on a sample of 60 adolescents diagnosed with mild mental impairment, divided into two groups (experimental group EG, and control group CG) with an equal number of participants. The special program of sports games lasted for 12 weeks, with a weekly frequency of four times and a duration of 30 minutes per training. The participants of both groups were tested with the same variables within the specific motor skills for the sport of football and basketball. After a twelve-week experimental program of sports games, there were statistically significant improvements in the EG in the variables: SMFS, SMDR, SMCP with a statistical significance of r=0.000. The results of the ANOVA and MANOVA analyses indicated that after the application of the specific sports games program there was a statistically significant difference in the benefits for the EG compared to the CG, in the parameters of specific motor abilities with a statistical significance r=0.000 and the size of the impact. Based on these research results, it can be concluded that a specific exercise program conducted within twelve-week training of specifically dosed sports activities has significantly contributed the development of specific motor skills for football and basketball.

The Impact ofClostridium difficileInfection on Future Outcomes of Solid Organ Transplant Recipients

2018 ◽  
Vol 39 (5) ◽  
pp. 563-570 ◽  
Author(s):  
Ruihong Luo ◽  
Janice M. Weinberg ◽  
Tamar F. Barlam
Keyword(s):  
Organ Transplant ◽  
Solid Organ Transplant ◽  
Control Group ◽  
Solid Organ ◽  
Increased Risk ◽  
Significant Difference ◽  
First Occurrence ◽  
Future Outcomes ◽  
The Impact

OBJECTIVEClostridium difficileinfection (CDI) is common in solid organ transplant (SOT) recipients, but few studies have examined long-term outcomes. We studied the impact of CDI after SOT on mortality and transplant organ complication-related hospitalizations (TOH).METHODSSOT recipients ≥18 years of age with at least 1 year of posttransplant data were analyzed using the MarketScan database for 2007–2014. Patients who died within one year of transplant were followed until death. Patients were grouped as early CDI (ie, first occurrence ≤90 days posttransplant), late CDI (ie, first occurrence >90 days posttransplant) and controls (ie, no CDI occurrence during follow-up). The risk of mortality or TOH after CDI was evaluated using Cox and logistic regressions, respectively.RESULTSOverall, 96 patients had early CDI, 97 patients had late CDI, and 5,913 patients were used as controls. The risk for death was significantly higher in the early CDI group than the control group (hazard ratio [HR],1.92; 95% confidence interval [CI], 1.12–3.29;P=.018); there was no significant difference between the late CDI group and the control group (HR, 0.86; 95% CI, 0.38–1.94;P=.717). Both the early CDI group (odds ratio [OR], 2.19; 95% CI, 1.45–3.31;P<.001) and the late CDI group (OR, 4.36; 95% CI, 2.84–6.71;P<.001) had higher risk for TOH than the control group. For those patients who survived >90 days posttransplant, both the early CDI group (n=89) and the late CDI group (n=97) had increased risk for death or TOH during follow-up than the control group (n=5,734).CONCLUSIONThough our study could not prove causality, both early and late CDI occurrence in SOT recipients were associated with worse future outcomes than for SOT recipients without CDI.Infect Control Hosp Epidemiol2018;39:563–570

scholarly journals Early Outcomes in Anterior Cruciate Ligament Reconstruction: Full Tibial tunnel technique compared to all-inside technique

2019 ◽  
Vol 69 (12) ◽  
pp. 3753-3755
Author(s):  
Octav Marius Russu ◽  
Emilian Ciorcila ◽  
Andrei Marian Feier ◽  
Radu Fleaca ◽  
Sandor Gyorgy Zuh ◽  
...  
Keyword(s):  
Postoperative Pain ◽  
Acl Reconstruction ◽  
Cruciate Ligament ◽  
Statistical Significance ◽  
Tibial Tunnel ◽  
Surgical Techniques ◽  
Assessment Tools ◽  
Significant Difference ◽  
Tunnel Technique

The all-inside technique for ACL reconstruction uses the semitendinous muscle tendon as a graft, and postoperative pain is slightly reduced. Through the full tibial tunnel technique, better anatomical graft placement is obtained with promising results, yet there are only few scientific articles comparing the two techniques. The main objective is evaluation of results after ACL reconstruction by comparing the clinical results of the two surgical techniques. A prospective study was conducted that included 63 eligible patients according to pre-established criteria. The technique used was randomly indicated to each patient. Demographics and clinical examination results were collected and subsequently stored. The assessment tools used were the International Knee Documentation Committee (IKDC), Knee injury and Osteoarthritis Outcome Score (KOOS) and the Visual Analogue Scale (VAS) with a 6-month follow-up period. The statistical analysis was performed for preoperative follow-up scores, at 3 and 6 months. All patients were operated by the same surgical team under spinal anesthesia with nerve block and tourniquet applied.In regards to IKDC and KOOS scores, the difference between the two interventions was not statistically significant (p = .579 and p = .710). Postoperative pain was slightly reduced in patients in the all-inside\ group but without any statistical significance compared to full-tibial tunnel technique(p = .259). There were no graft ruptures or late postoperative complications. Regarding IKDC, KOOS and VAS evaluating tools, there is no statistically significant difference between the two evaluated methods for ACL reconstruction, all-inside and full tibial tunnel at 3 months and 6 months after surgery.

scholarly journals Prospective Evaluation of Aspergillus fumigatus-Specific IgG in Patients With Cystic Fibrosis

2021 ◽  
Vol 10 ◽  
Author(s):  
Patience Eschenhagen ◽  
Claudia Grehn ◽  
Carsten Schwarz
Keyword(s):  
Cystic Fibrosis ◽  
Aspergillus Fumigatus ◽  
Sensitivity And Specificity ◽  
Statistical Significance ◽  
Allergic Bronchopulmonary Aspergillosis ◽  
Control Group ◽  
Opportunistic Fungi ◽  
Significant Difference ◽  
Specific Igg

BackgroundIn Cystic Fibrosis (CF), the airways are often colonized by opportunistic fungi. The most frequently detected mold is Aspergillus fumigatus (Af). Af diseases are associated with significant morbidity and mortality. The most common clinical picture caused by Af is allergic bronchopulmonary aspergillosis (ABPA), triggered by an immunological reaction against Af. Af bronchitis and invasive aspergillosis rarely occur in CF as a result of spore colonization and germination. Since pulmonary mycoses and exacerbations by other pathogens overlap in clinical, radiological, and immunological characteristics, diagnosis still remains a challenge. The search for reliable, widely available biomarkers for Af diseases is therefore still an important task today.ObjectivesAf-specific IgG m3 is broadly available. Sensitivity and specificity data are contradictory and differ depending on the study population. In our prospective study on pulmonary Af diseases in CF, we determined specific IgG m3 in order to test its suitability as a biomarker for acute Af diseases and as a follow-up parameter.MethodsIn this prospective single center study, 109 patients with CF were screened from 2016 to 2019 for Af-associated diseases. According to diagnostic criteria, they were divided into four groups (control, bronchitis, ABPA, pneumonia). The groups were compared with respect to the level of Af-specific IgG (ImmunoCAP Gm3). We performed a receiver operating characteristic (ROC) curve analysis to determine cut-off, sensitivity and specificity. Twenty-one patients could be enrolled for a follow-up examination.ResultsOf the 109 patients, 36 were classified as acute Af-disease (Af bronchitis, ABPA, Af pneumonia). Of these, 21 patients completed follow up-screening. The median Af-specific Gm3 was higher in the acute Af-disease groups. There was a significant difference in Af-specific IgG m3 compared to the control group without acute Af-disease. Overall, there was a large interindividual distribution of Gm3. A cut-off value of 78.05 mg/L for Gm3 was calculated to discriminate controls and patients with ABPA/pneumonia with a specificity of 75% and a sensitivity of 74.6%. The follow up examination of 21 patients showed a decrease of Gm3 in most patients without statistical significance due to the small number of follow up patients.ConclusionAf specific IgG may be a useful biomarker for acute ABPA and Af pneumonia, but not for Af bronchitis in CF. However, due to the large interindividual variability of Gm3, it should only be interpreted alongside other biomarkers. Therefore, due to its broad availability, it could be suitable as a biomarker for ABPA and Af pneumonia in CF, if the results can be supported by a larger multicenter cohort.

scholarly journals Long term (five-year) survival following radical surgical treatment plus adjuvant chemotherapy (FAM) in advanced gastric cancer: a controlled study

2000 ◽  
Vol 55 (4) ◽  
pp. 129-136 ◽  
Author(s):  
Cláudio Bresciani ◽  
Joaquim Gama-Rodrigues ◽  
Victor Strassmann ◽  
Dan L. Waitzberg ◽  
Mitsunori Matsuda ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Surgical Treatment ◽  
Survival Rate ◽  
Tnm Classification ◽  
Controlled Study ◽  
Hematological Toxicity ◽  
Control Group ◽  
Significant Difference ◽  
The Impact

Several drugs and their associations are being used for adjuvant or complementary chemotherapy with the aim of improving results of gastric cancer treatment. The objective of this study was to verify the impact of these drugs on nutrition and on survival rate after radical treatment of 53 patients with gastric cancer in stage III of the TNM classification. A control group including 28 patients who had only undergone radical resection was compared to a group of 25 patients who underwent the same operative technique followed by adjuvant polychemotherapy with FAM (5-fluorouracil, Adriamycin, and mitomycin C). In this latter group, chemotherapy toxicity in relation to hepatic, renal, cardiologic, neurological, hematologic, gastrointestinal, and dermatological functions was also studied. There was no significant difference on admission between both groups in relation to gender, race, macroscopic tumoral type of tumor according to the Borrmann classification, location of the tumor in the stomach, length of the gastric resection, or response to cutaneous tests on delayed sensitivity. Chemotherapy was started on average, 2.3 months following surgical treatment. Clinical and laboratory follow-up of all patients continued for 5 years. The following conclusions were reached: 1) The nutritional status and incidence of gastrointestinal manifestation were similar in both groups; 2) There was no occurrence of cardiac, renal, neurological, or hepatic toxicity or death due to the chemotherapeutic method per se; 3) Dermatological alterations and hematological toxicity occurred exclusively in patients who underwent polychemotherapy; 4) There was no significant difference between the rate and site of tumoral recurrence, the disease-free interval, or the survival rate of both study groups; 5) Therefore, we concluded, after a 5-year follow-up, chemotherapy with the FAM regimen did not increase the survival rate.

Gait Analysis 1 Year after Primary TKA: No Difference between Gap Balancing and Measured Resection Technique

2019 ◽  
Author(s):  
Hermes H. Miozzari ◽  
Stéphane Armand ◽  
Katia Turcot ◽  
Anne Lübbeke ◽  
Alice Bonnefoy-Mazure
Keyword(s):  
Short Form ◽  
Surgical Techniques ◽  
Patient Reported Outcome Measures ◽  
Control Group ◽  
Global Satisfaction ◽  
Press Fit ◽  
Gait Parameters ◽  
Significant Difference ◽  
Patient Reported

AbstractMechanical alignment in total knee arthroplasty (TKA) can be achieved using dependent bone cuts. The hypothesis is that patients have a better balanced TKA, as a result. The aim of this study was to determine if this technique is superior to an independent bone cut technique in terms of gait parameters, patient-reported outcome measures (PROMs), and satisfaction assessed before surgery and at 1-year follow-up. A total of 58 patients were evaluated before and 1 year following TKA, using the Press Fit Condylar (PFC) Sigma posterior stabilizer (PS) design; 39 (70 ± 8 years; 27 women) with independent bone cuts and 19 (71 ± 7 years; 12 women) with dependent bone cuts using the Specialist TRAM. Gait was evaluated with a three-dimensional motion analysis system for spatiotemporal and kinematics parameters. Pain and functional levels were assessed using the Western Ontario and McMaster Universities arthritis index (WOMAC); general health was assessed by the short form (SF)-12. Global satisfaction, as well as patient satisfaction, related to pain and functional levels were assessed using a five-point Likert's scale. No significant difference was found between both groups in terms of age, body mass index, pain, and functional levels at baseline. At 1-year follow-up, despite an overall improvement in gait, WOMAC, SF-12 physical score and pain, none of the patients showed gait parameters comparable to a healthy control group. No surgical technique effect was observed on gait, clinical outcomes, and satisfaction level. While observing an overall improvement at 1-year follow-up, we did not find any significant difference between the two surgical techniques in terms of gait parameters, patients' outcomes, and satisfaction.

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