Percutaneous aortic valvoplasty in congenital aortic valvar stenosis

AbstractObjective: To evaluate immediate and midterm results with percutaneous aortic valvoplasty.Material and Methods: We reviewed the records of 141 patients undergoing percutaneous aortic valvopasty over a period of 13 years.Results: The patients were aged from 2 months to 40 years, with a mean of 10.9 ± 9.9 years. Of the total, 90 (63%) were male. The initial systolic peak-to-peak gradient decreased from 163 ± 52 mmHg to 32 ± 18 mmHg (p > 0.01) after valvoplasty in all 141 patients, while the proportional reduction ranged from 0 to 100%, with a mean of 72 ± 27%. The index of the size of the balloon to the diameter of the valvar orifice was 0.88 ± 0.19 in 128 patients. The follow-up ranged from 6 to 168 months, with a mean 51 ± 48 months in 70 patients. A significant difference was found in those failing after dilation when the initial evaluation was compared to the final evaluation of patients with follow-up. In those failing, the number of patients rose from 12 (17%) to 21 (30%) (p > 0.01). In contrast, in those in whom we achieved success, there was not such a great difference between the initial and final evaluation: 58 (83%) versus 49 (70%) (p > 0.1). The actuarial freedom curve of patients not needing new percutaneous aortic valvoplasty or surgery, by 182 months, was at 87% and 82% respectively.Conclusion: We have reviewed the largest series of patients in Latin-America reported thus far after undergoing percutaneous aortic valvoplasty, concentrating on mid term follow-up and limitations. New prospective and multicentric studies are needed from our region.

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288. Follow-Up Blood Cultures in Gram-Negative Bacteremia: How Do They Impact Outcomes

Open Forum Infectious Diseases ◽

10.1093/ofid/ofaa439.331 ◽

2020 ◽

Vol 7 (Supplement_1) ◽

pp. S144-S144

Author(s):

Azza Elamin ◽

Faisal Khan ◽

Ali Abunayla ◽

Rajasekhar Jagarlamudi ◽

aditee Dash

Keyword(s):

Clinical Outcomes ◽

Antibiotic Treatment ◽

Readmission Rate ◽

Blood Cultures ◽

Categorical Variables ◽

Gram Negative ◽

Number Of Patients ◽

Significant Difference ◽

The Impact

Abstract Background As opposed to Staphylococcus. aureus bacteremia, there are no guidelines to recommend repeating blood cultures in Gram-negative bacilli bacteremia (GNB). Several studies have questioned the utility of follow-up blood cultures (FUBCs) in GNB, but the impact of this practice on clinical outcomes is not fully understood. Our aim was to study the practice of obtaining FUBCs in GNB at our institution and to assess it’s impact on clinical outcomes. Methods We conducted a retrospective, single-center study of adult patients, ≥ 18 years of age admitted with GNB between January 2017 and December 2018. We aimed to compare clinical outcomes in those with and without FUBCs. Data collected included demographics, comorbidities, presumed source of bacteremia and need for intensive care unit (ICU) admission. Presence of fever, hypotension /shock and white blood cell (WBC) count on the day of FUBC was recorded. The primary objective was to compare 30-day mortality between the two groups. Secondary objectives were to compare differences in 30-day readmission rate, hospital length of stay (LOS) and duration of antibiotic treatment. Mean and standard deviation were used for continuous variables, frequency and proportion were used for categorical variables. P-value < 0.05 was defined as statistically significant. Results 482 patients were included, and of these, 321 (67%) had FUBCs. 96% of FUBCs were negative and 2.8% had persistent bacteremia. There was no significant difference in 30-day mortality between those with and without FUBCs (2.9% and 2.7% respectively), or in 30-day readmission rate (21.4% and 23.4% respectively). In patients with FUBCs compared to those without FUBCs, hospital LOS was longer (7 days vs 5 days, P < 0.001), and mean duration of antibiotic treatment was longer (14 days vs 11 days, P < 0.001). A higher number of patients with FUBCs needed ICU care compared to those without FUBCs (41.4% and 25.5% respectively, P < 0.001) Microbiology of index blood culture in those with and without FUBCs Outcomes in those with and without FUBCs FUBCs characteristics Conclusion Obtaining FUBCs in GNB had no impact on 30-day mortality or 30-day readmission rate. It was associated with longer LOS and antibiotic duration. Our findings suggest that FUBCs in GNB are low yield and may not be recommended in all patients. Prospective studies are needed to further examine the utility of this practice in GNB. Disclosures All Authors: No reported disclosures

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Comparative study between fat plug and inlay butterfly cartilage grafts for myringoplasty in adults

The Egyptian Journal of Otolaryngology ◽

10.1186/s43163-021-00076-y ◽

2021 ◽

Vol 37 (1) ◽

Author(s):

Ahmed Gamal Khafagy ◽

Mohamed El-Begermy ◽

Marwa Mohamed El-Begermy ◽

Pretty O. Afifi

Keyword(s):

Tympanic Membrane ◽

Chronic Otitis Media ◽

Fat Graft ◽

Cartilage Graft ◽

Tympanic Membrane Perforations ◽

Number Of Patients ◽

Significant Difference ◽

Hearing Outcomes ◽

Age Range

Abstract Background This study aims to compare the graft uptake rate and hearing improvement of fat graft versus inlay butterfly tragal cartilage in the repair of perforations in chronic otitis media mucosal in adults. In this retrospective study, twenty-eight patients were included with small dry anteroinferior tympanic membrane perforations (less than 1/3 of the tympanic membrane). The age range was 18 to 44 years old. Myringoplasty was done under general anesthesia for 8 patients with a fat graft (FG) and 20 patients with inlay butterfly cartilage graft (IBCG). Six months postoperatively, a follow-up evaluation was done for successful graft uptake and hearing outcomes. Results The success rate of graft uptake in the first group (fat graft) was 6/8 cases (75%) while in the second group (IBCG) was 19/20 (95%) with no statistically significant difference (P = 0.0148). Also, there was no statistical difference between the two groups as regards postoperative ABG, improvement changes in ABG, and number of patients with improved hearing. Conclusions Inlay butterfly cartilage graft is a useful graft in repairing small tympanic membrane perforations as regard graft take and hearing outcomes.

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Postoperative craniospinal radiotherapy of medulloblastoma in children and young adults

Srpski arhiv za celokupno lekarstvo ◽

10.2298/sarh0306226g ◽

2003 ◽

Vol 131 (5-6) ◽

pp. 226-231

Author(s):

Ivana Golubicic ◽

Jelena Bokun ◽

Marina Nikitovic ◽

Jasmina Mladenovic ◽

Milan Saric ◽

...

Keyword(s):

High Risk ◽

Brain Stem ◽

Wilcoxon Test ◽

Time Interval ◽

Tumor Removal ◽

Shunt Placement ◽

Craniospinal Radiotherapy ◽

Number Of Patients ◽

Significant Difference

PURPOSE The aim of this study was: 1. to evaluate treatment results of combined therapy (surgery, postoperative craniospinal radiotherapy with or without chemotherapy) and 2. to assess factors affecting prognosis (extend of tumor removal, involvement of the brain stem, extent of disease postoperative meningitis, shunt placement, age, sex and time interval from surgery to start of postoperative radiotherapy). PATIENTS AND METHODS During the period 1986-1996, 78 patients with medulloblastoma, aged 1-22 years (median 8.6 years), were treated with combined modality therapy and 72 of them were evaluable for the study end-points. Entry criteria were histologically proven diagnosis, age under 22 years, and no history of previous malignant disease. The main characteristics of the group are shown in Table 1. Twenty-nine patients (37.2%) have total, 8 (10.3%) near total and 41 (52.5%) partial removal. Seventy-two of 78 patients were treated with curative intent and received postoperative craniospinal irradiation. Radiotherapy started 13-285 days after surgery (median 36 days). Only 13 patients started radiotherapy after 60 days following surgery. Adjuvant chemotherapy was applied in 63 (80.7%) patients. The majority of them (46 73%) received chemotherapy with CCNU and Vincristine. The survival rates were calculated with the Kaplan-Meier method and the differences in survival were analyzed using the Wilcoxon test and log-rank test. RESULTS The follow-up period ranged from 1-12 years (median 3 years). Five-year overall survival (OS) was 51% and disease-free survival (DFS) 47% (Graph 1). During follow-up 32 relapses occurred. Patients having no brain stem infiltration had significantly better survival (p=0.0023) (Graph 2). Patients with positive myelographic findings had significantly poorer survival compared to dose with negative myelographic findings (p=0.0116). Significantly poorer survival was found in patients with meningitis developing in the postoperative period, with no patient living longer than two years (p=0.0134) (Graph 3). By analysis of OS and DFS in relation to presence of the malignant cells in liquor, statistically significant difference, i. e. positive CSF cytology was not obtained, which was of statistical importance for survival (p=0.8207). Neither shunt placement nor shunt type showed any impact on survival (p=0.5307 and 0.7119, respectively). Children younger than three years had significantly poorer survival compared to those older than 16 years (p=0.0473). Although there was a better survival rate in females than in males this was not statistically significant (p=0.2386).The analysis results of treatment showed that significantly better survival occurred in patients in whom total or subtotal tumor removal was possible (p=0.0022) (Graph 4). Patients who started radiotherapy within two months after surgery have better survival, but again this was not statistically significant, probably due to the small number of patients receiving delayed radiotherapy (p=0.2231)(Graph5). CONCLUSION Based on this factors standard and high risk group could be defined. Combined chemotherapy should to be investigated particularly for high risk subgroup. Future research should be done to define new therapeutic modalities (gene therapy, compounds active in tumor antiangiogenesis etc).

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Reguliuojamos skrandžio apjuosimo juostos: lyginamųjų studijų apžvalga

Lietuvos chirurgija ◽

10.15388/lietchirur.2011.1.2090 ◽

2011 ◽

Vol 9 (1-2) ◽

pp. 0-0

Author(s):

Tomas Abalikšta ◽

Gintautas Brimas ◽

Kęstutis Strupas

Keyword(s):

Weight Loss ◽

Comparative Studies ◽

University Hospital ◽

Cochrane Library ◽

Band Slippage ◽

Lap Band ◽

Number Of Patients ◽

Significant Difference ◽

Gastric Bands

Tomas Abalikšta, Gintautas Brimas, Kęstutis Strupas Vilniaus universiteto Medicinos fakultetas, M. K. Čiurlionio g. 21, LT-03101 VilniusVilniaus universiteto ligoninės Santariškių klinikų Pilvo chirurgijos centras,Santariškių g. 2, LT-08661 VilniusEl. paštas: [email protected] Darbo tikslas: Remiantis literatūros duomenimis palyginti skirtingas skrandžio apjuosimo reguliuojamas juostas, naudojamas chirurginiam nutukimo gydymui. Tyriamoji medžiaga ir metodai: Publikacijų paieška atlikta elektroninėse MEDLINE, Current Contents ir Cochrane Library duomenų bazėse. Apžvelgtos visos skrandį apjuosiančių reguliuojamų juostų lyginamųjų studijų publikacijos, paskelbtos iki 2010 m. sausio 1 d. Rezultatai: Atlikus literatūros šaltinių paiešką rasta 10 publikacijų, lyginančių skirtingas skrandį apjuosiančias reguliuojamas juostas. Išsamiai atlikta viena studija: perspektyvi, atsitiktinių imčių, jos tiriamųjų skaičius didelis ir stebėjimo laikotarpis ilgas, įvertinti visi gydymo rezultatai. Statistiškai reikšmingo skirtumo tarp SAGB ir LAP-BAND juostų šioje studijoje nerasta. Kitos lyginamosios juostų studijos turi trūkumų: keturios buvo ne atsitiktinių imčių (dvi iš jų retrospektyvios), trijose tiriamųjų imtis maža, visų stebėjimo laikas trumpas. Vienoje iš šių studijų nustatytas kūno masės kritimo skirtumas tarp grupių: LAP-BAND grupėje pradinė viršnorminė kūno masė sumažėjo 41,7 %, Heliogast – 28,3 %. Mechaninių juostų komplikacijų dažnis skyrėsi vienoje studijoje: LAP-BAND – 7 %, SAGB – 1 %. Skirtumas tarp „mažo skrandžio“ išsiplėtimo arba juostos nuslinkimo dažnio rastas trijose studijose (MiniMizer Extra – 0 % ir LAP-BAND – 10,8 %; SAGB – 2,4 % ir LAP-BAND – 27,6 %; SAGB – 2 % ir LAP-BAND – 23 %). Skirtumo tarp gretutinių ligų ir gyvenimo kokybės pokyčio, hospitalizacijos trukmės, juostos reguliavimų skaičiaus/dažnio, juostos penetracijos/migracijos į skrandį bei infekcinių komplikacijų dažnio nerasta. Išvados: Tik viena studija atlikta laikantis šiuolaikinių įrodymais pagrįstos medicinos keliamų reikalavimų, skirtumo tarp lygintų juostų nerasta. Reikalingos perspektyvios, atsitiktinių imčių ilgalaikės (>5 metų) lyginamosios studijos, vertinančios juostų konstrukcijos ar formos skirtumų įtaką gydymo efektyvumui ar komplikacijoms. Reikšminiai žodžiai: nutukimas, bariatrinė chirurgija, skrandžio apjuosimo reguliuojama juosta operacija. Adjustable gastric bands: review of comparative studies Tomas Abalikšta, Gintautas Brimas, Kęstutis Strupas Vilnius University Medical Faculty, M. K. Čiurlionio Str. 21, LT-03101 Vilnius, LithuaniaVilnius University Hospital Santariškių Klinikos Centre of Abdominal Surgery,Santariškių Str. 2, LT-08661 Vilnius, LithuaniaEl. paštas: [email protected] Objective: The objective of this review is to compare different adjustable gastric bands according to the data of comparative studies. Materials and Methods: A search of articles published in any language before January 2010 was carried out through the MEDLINE, Current Contents and Cochrane Library electronic databases. All articles about comparative studies of different adjustable gastric bands were eligible for review. All possible data were extracted from accepted studies and reviewed. Results: Ten comparative studies of different adjustable gastric bands were accepted. Only one comparative study of the bands was accomplished properly. It was a prospective randomised study type with a large number of patients and a long follow-up period with all possible results evaluated. No statistically significant difference between SAGB and LAP-BAND gastric bands was found in this study. The other band studies had shortcomings: four studies were non-randomised (two of them retrospective), a small number of patients in three studies, and a too short follow-up period in all studies. The difference in weight loss was stated in one of these studies: 41.7% of initial excess weight loss in the LAP-BAND group and 28.3% in the Heliogast group. Band leakage frequency was different in one study: LAP-BAND – 7%, SAGB – 1%. A difference between pouch dilatation or band slippage frequency was found in three studies (MiniMizer Extra – 0% and LAP-BAND – 10.8%; SAGB – 2.4% and LAP-BAND – 27.6%; SAGB – 2% and LAP-BAND – 23%). There was no difference between the resolution of comorbidities, improvement of the quality of life, hospital stay, band adjustment frequency, band migration or band infection rate. Conclusion: Only one accepted study was accomplished properly. There was no difference between compared adjustable gastric bands in this study. Prospective randomised long-term (more than 5 years) comparative studies are needed for a proper evaluation of band construction or shape influence on weight loss and complications. Keywords: obesity, bariatric surgery, adjustable gastric banding.

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SP9.1.1 The Impact of Anaesthetic Use on Healing in Sub-cutaneous Abscess Management: A Retrospective Before and After Cohort Study

British Journal of Surgery ◽

10.1093/bjs/znab361.165 ◽

2021 ◽

Vol 108 (Supplement_7) ◽

Author(s):

Hannah Elkadi ◽

Eleanor Dodd ◽

Theodore Poulton ◽

William Bolton ◽

Joshua Burke ◽

...

Keyword(s):

Wound Healing ◽

Local Anaesthetic ◽

Surrogate Endpoints ◽

Incision And Drainage ◽

Number Of Patients ◽

Significant Difference ◽

Patient Reported ◽

Before And After ◽

The Impact

Abstract Aims Despite being the most common surgical procedure, there is wide variation that exists in the management of simple subcutaneous abscesses with no national guideline describing best practice. During the COVID-19 Pandemic national guidelines promoted the use of regional or local anaesthetic (LA) instead of general anaesthesia (GA) to avoid aerosol generating intubation associated with GA. This study aimed to assess the impact of anaesthetic choice in outcomes following incision and drainage of subcutaneous abscesses. Methods Two cohorts of patients undergoing abscess incision and drainage at St. James’ University Hospital Leeds were retrospectively identified over a 14-week period before and after the introduction of the new COVID-19 anaesthetic guidelines. Wound healing surrogate endpoints were used: i) total number of follow up appointments and ii) attendance to healthcare services after 30 days from I&D. Result 133 patients were included. Significantly more procedures were performed under LA after the intervention (84.1% vs 5.7%; p < 0.0001) with a significant reduction in wound packing (68.3% vs 87.1%. p=0.00473). Follow up data found no significant difference in the average number of follow-up appointments (7.46 vs 5.11; p = 0.0731) and the number of patients who required ongoing treatment after 30 days (n = 14 vs n = 14, p = 0.921). Conclusion Drainage of simple subcutaneous abscess under 5 cm is safe under local anaesthetic with no significant difference in surrogate endpoints of wound healing observed in this patient cohort. Recurrent packing may not be required. Future work should explore patient reported measures such as pain management and the health economics of this intervention.

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Surgery of cholesteatoma: Surgical technique and cholesteatoma recurrences

Acta chirurgica iugoslavica ◽

10.2298/aci0401103a ◽

2004 ◽

Vol 51 (1) ◽

pp. 103-107

Author(s):

Nenad Arsovic ◽

Radomir Radulovic ◽

Snezana Jesic ◽

S. Krejovic-Trivic ◽

P. Stankovic ◽

...

Keyword(s):

Surgical Treatment ◽

Surgical Technique ◽

Complete Removal ◽

Initial Surgery ◽

Group I ◽

Number Of Patients ◽

Significant Difference ◽

Diffuse Form ◽

Surgical Failure

Past experience with open and closed techniques of tympanoplasty in surgery of cholesteatoma has shown that recurring illness is one of the major causes of surgical failure. The literature has reported varying trend of surgical treatment of cholesteatoma. The objective of the study was to analyze the significance of surgical technique in relation to the incidence and most frequent localization of recurrent cholesteatoma. Our study analyzed 120 patients operated on for cholesteatoma. The patients were divided into two groups, group I (45) with recurring disease and group II (75) without any recurring condition, which were followed up three years. Statistical analysis was carried out by modified t-test. The largest number of patients was re-operated in the first two years from the initial surgery (50%), In the majority of patients (50%), recurrent cholesteatoma was most commonly localized (stage I) in attic (20%) and much rarely in mesotympanum (11,9%). Stage III recurrent cholesteatoma was verified in 35% of patients, most frequently diffuse form (13,4%). The involvement of attic by all three stages of disease accounted for over 60%. The analysis of the used techniques of surgical treatment in both groups revealed significant difference. Open techniques of tympanoplasty were used in 60% of patients with no recurrence. Closed techniques were used more frequently in patients with recurring disease, i.e. in over 90% of cases. Recurrent cholesteatoma develops, in the majority of cases, during the first two years after the surgical intervention. Attic is the most common localization of cholesteatoma. More frequent utilization of open technique of tympanoplasty for surgery of cholesteatoma significantly reduces the incidence of recurring condition. The indications for CWD technique are the initial spread of cholesteatoma, possibility of complete removal of cholesteatoma and postoperative follow-up of patients.

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Clinical outcomes of arthroscopic repair of acetabular labral tears

BMJ Open Sport & Exercise Medicine ◽

10.1136/bmjsem-2017-000328 ◽

2018 ◽

Vol 4 (1) ◽

pp. e000328 ◽

Cited By ~ 4

Author(s):

Carlos César Vassalo ◽

Antônio Augusto Guimarães Barros ◽

Lincoln Paiva Costa ◽

Euler de Carvalho Guedes ◽

Marco Antônio Percope de Andrade

Keyword(s):

Clinical Outcomes ◽

Arthroscopic Repair ◽

Final Evaluation ◽

Labral Repair ◽

Harris Hip Score ◽

Senior Surgeon ◽

Labral Tears ◽

Significant Difference ◽

The Mean

PurposeTo evaluate the primary clinical outcomes of arthroscopic labral repair.MethodsAll patients who underwent arthroscopic repair of the acetabular labrum performed by a senior surgeon between October 2010 and December 2013 were invited to participate in this prospective study. Patients included were those who had a preoperative diagnosis of labral tears, a lateral centre edge greater than 25° and a labral tear believed to be suturable during the intraoperative evaluation. Patients with Tönnis grade 2 or grade 3 hip osteoarthritis and those who had undergone a previous hip surgery were excluded. All patients were evaluated using the modified Harris Hip Score (mHHS) during the final appointment before surgery, 4 months after surgery and at the final evaluation. Interviews were conducted by the senior surgeon.ResultsEighty-four patients (90 hips) underwent arthroscopic repair. The mean age was 44.2 years and the mean follow-up period was 43.0 months (minimum of 25 months and maximum of 59 months). The mean mHHS was 80.4 preoperatively, 95.0 at 4 months postoperatively and 96.6 at final evaluation. A statistically significant difference existed among these scores (p<0.001).ConclusionArthroscopic labral repair was associated with a clinically significant improvement in mHHS after short-term (4 months) and medium-term (43 months) follow-up.Level of evidenceLevel IV, therapeutic case series.

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Neuroleptic Dosing in Chronic Schizophrenia: A 10-Year Follow-up

The Canadian Journal of Psychiatry ◽

10.1177/070674379704200108 ◽

1997 ◽

Vol 42 (1) ◽

pp. 53-57 ◽

Cited By ~ 9

Author(s):

Gary J Remington ◽

Peter Prendergast ◽

Kalyna Z Bezchlibnyk-Butler

Keyword(s):

Empirical Data ◽

Chronic Schizophrenia ◽

Initial Evaluation ◽

Factors Influencing ◽

Number Of Patients ◽

Males And Females ◽

To Receive ◽

Dosing Patterns

Objective: To evaluate neuroleptic dosing patterns in individuals with schizophrenia over a 10-year interval. Method: Changes in neuroleptic dosing between 1980 and 1990 were followed in 65 patients with a diagnosis of chronic schizophrenia. Results: According to more recent dosing guidelines, doses were already high at the time of initial evaluation, yet overall they continued to increase during the next decade of treatment for both males and females. Patients were almost equally divided, however, by those who underwent an increase (n = 33) and those whose dose remained stable (n = 4) or was decreased (n = 28). Conclusion: A considerable number of patients with schizophrenia appear to receive progressively higher neuroleptic doses over the course of their illness, despite a lack of empirical data to support such an approach. Results are discussed in terms of current dosing recommendations and factors influencing dose changes.

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Cognitive Functions in Repeated Glioma Surgery

Cancers ◽

10.3390/cancers12051077 ◽

2020 ◽

Vol 12 (5) ◽

pp. 1077

Author(s):

Gabriele Capo ◽

Miran Skrap ◽

Ilaria Guarracino ◽

Miriam Isola ◽

Claudio Battistella ◽

...

Keyword(s):

Cognitive Functions ◽

Inferior Frontal Gyrus ◽

Insular Cortex ◽

Malignant Degeneration ◽

Low Grade ◽

Normal Range ◽

Glioma Surgery ◽

Number Of Patients ◽

Significant Difference

Low-grade gliomas (LGG) are slow-growing brain tumors infiltrating the central nervous system which tend to recur, often with malignant degeneration after primary treatment. Re-operations are not always recommended due to an assumed higher risk of neurological and cognitive deficits. However, this assumption is relatively ungrounded due to a lack of extensive neuropsychological testing. We retrospectively examined a series of 40 patients with recurrent glioma in eloquent areas of the left hemisphere, who all completed comprehensive pre- (T3) and post-surgical (T4) neuropsychological assessments after a second surgery (4-month follow up). The lesions were most frequent in the left insular cortex and the inferior frontal gyrus. Among this series, in 17 patients the cognitive outcomes were compared before the first surgery (T1), 4 months after the first surgery (T2), and at T3 and T4. There was no significant difference either in the number of patients scoring within the normal range between T3 and T4, or in their level of performance. Further addressing the T1–T4 evolution, there was no significant difference in the number of patients scoring within the normal range. As to their level of performance, the only significant change was in phonological fluency. This longitudinal follow-up study showed that repeated glioma surgery is possible without major damage to cognitive functions in the short-term period (4 months) after surgery.

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Efficacy of Yttrium-90 Zevalin Outside of Clinical Trials: Preliminary Results of a Retrospective Bi-Center Study

Blood ◽

10.1182/blood.v112.11.5015.5015 ◽

2008 ◽

Vol 112 (11) ◽

pp. 5015-5015

Author(s):

Francesco Cicone ◽

Francesco Scopinaro ◽

Sebastien Baechler ◽

Nicolas Ketterer ◽

Franz Buchegger ◽

...

Keyword(s):

Clinical Trials ◽

Clinical Setting ◽

Patient Population ◽

Statistical Significance ◽

University Hospital ◽

Low Grade ◽

Number Of Patients ◽

Significant Difference ◽

Routine Clinical Setting

Abstract Background and Aim: Due to limited data regarding the efficacy of Radioimmunotherapy with 90Y-Zevalin (RIT-Z) outside of controlled clinical trials, we carried out a biinstitutional, international retrospective study to assess the efficacy of RIT-Z in a routine clinical setting. The relationship between the number of previous therapies and outcomes as well as the response to the last therapy was assessed. Possible differences in outcomes for patients treated in the two different centers were also analyzed. Materials and Methods: Forty-three consecutive patients treated at the University Hospital of Lausanne (CHUV, Switzerland) and at S. Andrea University Hospital of Rome (Italy) were evaluated, none of which had been previously included in clinical trials. Only 31 patients entered the final analysis: patients lost at follow up, undergoing autologous transplantation (ASCT), or treated within the last 3 months were excluded. Efficacy of therapy was evaluated in terms of Overall Survival (OS), Progression Free Survival (PFS), and Time to Next Treatment (TTNT). Survival curves were obtained with the Kaplan- Meier method (statistical significance = p<0.05). Results: Characteristics of the patient population are listed in Table 1. Although 50% of the patients had aggressive histologies, patients treated at S. Andrea had slightly more favorable features than those treated at CHUV. Fourteen patients (45%) had received at least 4 previous treatments, and all had received Rituximab. Fourteen patients (45%) had not responded to the last therapy, while 6 (19%), all treated at S.Andrea, were considered disease-free at the time of RIT-Z, which was administered for consolidation. Median follow up time was 20 months (11.5 vs. 25 months for S.Andrea and CHUV, respectively). Median PFS and TTNT were similar. After achieving a partial response, 2 patients were referred to Rituximab maintenance after RIT-Z and remain progression-free. Median OS was still not attained. Although not statistically significant, a trend towards better outcomes for S. Andrea patients was found. In comparing patients with indolent and aggressive lymphoma, only PFS was found to be significantly different (median PFS: 10 vs. 5 months, p<0.05). In patients with <4 and ≥ 4 previous therapies, twenty month OS was 88% vs. 53.6% (p=0.02), respectively; median TTNT was 22 vs. 5 months (p=0.013), while differences in PFS did not attain statistical significance. The duration of response in non-responders to their last therapy was shorter than in responders: 20-month OS- 44% vs. 94% (p=0.0015), median PFS and TTNT- 3.5 vs. 15 months (p=0.0002) and 4 vs. 15 months (p=0.0001), respectively. Median PFS and TTNT after RIT-Z did not differ from those found after the last therapy. A significant difference in outcomes for heavily pretreated or refractory patients was found in those with low grade follicular lymphoma. Conclusions: Poorer outcomes were found in our patient population treated in a routine clinical setting compared to those enrolled in clinical trials. This may be related to greater heterogeneity of our study cohort which included more patients with unfavorable conditions (e.g. aggressive NHL, ≥4 treatment courses including rituximab in all, and ASCT in 25%). Our results suggest that the best benefit may be expected with RIT-Z either for consolidation or relatively earlier in the course of NHL treatment. Table 1. Total CHUV S. Andrea Population Analyzed (72%) Number of patients 43 23 20 31 Median Age 61 63 58,5 62 Aggressive Histology (FL grade 3 or DLBCL) 18 (41,8%) 8 (34,7%) 10 (50%) 11 (35,5%) Indolent Histology (FL grade 1 or 2) (%) 25 (58,2%) 15 (65,3%) 10 (50%) 20 (64,5%) Patients with ≥4 previous treatments 19 (44,2%) 12 (52,1%) 7 (35%) 14 (45,2%) Patients with previous ASCT 11 (25,6%) 6 (26%) 5 (25%) 8 (25%)

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