Course Of Long-term Follow-up Research Articles

The Role of Microbiome-Based Therapeutics in Clostridioides difficile Infection: Durable, Long-Term Results of RBX2660.

A recently published manuscript described findings from a phase 2 open label study of the microbiota-based live biotherapeutic product RBX2660 in patients with two or more previous recurrent Clostridioidesdifficile infection (rCDI) episodes, and described long-term safety and sustained treatment success through 24months. As previous studies have typically focused on short-term clinical outcomes, these new data provide insight into the tolerability, safety, and efficacy of RBX2660 over the long term. When microbiota-based products were first evaluated, the long-term efficacy and safety were principal concerns of the United States Food and Drug Administration. Microbiota-based live biotherapeutic products (LBPs) represent an emerging approach to the management of CDI and perhaps other gastrointestinal and medical conditions whose pathogenesis is defined by microbial dysbiosis. RBX2660 is a human-derived, broad consortium microbiota-based LBP that consists of a population of microbes obtained from healthy stool donors and may reflect the symbiotic nature of a healthy colonic microbiome. RBX2660 is rectally administered and does not require sedation or special preparation of the recipient. Potential advantages of the rectal administration of RBX2660 include the ease of administration and lack of need for any bowel preparation, which may benefit those who are frail, have swallowing issues, or cannot take bowel laxative preparations. In this multicenter prospective trial of rCDI, patients who achieved treatment success 8weeks after receiving RBX2660 continued to have a sustained clinical response over the course of long-term follow-up, with more than 90% of treatment responders remaining CDI-free at 6, 12, and 24months. Following receipt of RBX2660, the gut microbiota of those with treatment success were restored from a dysbiotic state to become more diverse and similar to RBX2660 composition. The restoration of the microbiota occurred as early as 7days after RBX2660 administration and remained stable through the 24-month analysis. No new adverse outcomes were observed during the prospective assessment, and the safety profile of RBX2660 was consistent with previous studies. Based on the clinical studies, RBX2660 will most likely benefit those with ≥ 1 rCDI episode or those who are at a high risk of subsequent rCDI, such as patients who have comorbid conditions including renal disease, heart disease, or inflammatory bowel disease, or who are immunosuppressed. The role of microbiome-based therapeutics in 47 Clostridioides difficile infection: Durable, long-term results of RBX2660 (MP4 511833 KB).

Partial second toe pulp free flaps in early childhood.

BackgroundThe introduction of the partial second toe pulp free flap has enabled superior aesthetic and functional results for fingertip reconstruction in adults. Children undergoing fingertip amputation for various reasons have limited options for reconstruction. Conventional treatment could shorten the finger, leading to poor cosmesis and function. We report 18 years of our experiences with fingertip reconstruction using partial second toe pulp free flaps in patients in early childhood.MethodsMedical charts of children who had undergone fingertip reconstruction using partial second toe pulp free flaps from 2001 to 2018 were retrospectively reviewed. The surgical procedures were identical to those for adults, except for the usage of 11-0 nylon sutures. Patients’ demographic data, vessel size, flap dimensions, length of the distal phalanx, and functional outcomes over the course of long-term follow-up were documented. The statistical analysis was performed with the Student t-test, the Mann-Whitney U test, and Pearson correlation analysis.ResultsEighteen toe pulp flaps in 17 patients (mean age, 3.0 years) were identified. All the flaps survived without any major complications. In long-term follow-up, the flap-covered distal phalanges showed growth in line with regular development. There was no donor-site morbidity, and all children adapted to daily life without any problems. In two-point discrimination tests, the fingertip sensation recovered to almost the same level as that in the contralateral finger.ConclusionsPartial second toe pulp free flaps are an excellent option for fingertip reconstruction in young children, as well as in adults.

The issue of permanent pacemaker implantation following cardiac surgery

The issue of postoperative arrhythmias requiring pacemaker therapy is widely studied in the field of cardiac surgery and it is a complex perioperative problem. The aim of this paper is to summarize the relevant international guidelines and recommendations and to present our hospital's experience. We present the current, decisive recommendations and important studies, and present patients who underwent pacemaker implantation within one month after cardiac surgery between 01. 01. 2014 and 31. 12. 2018 in our hospital and compare them with the international findings. According to the international literature, the rate of permanent pacemaker implantation after cardiac surgery ranges from about 1.5% to 5%, and this rate seems to increase later. We have detailed information and many identified predictors about the development of conduction disturbances, but the current guidelines provide only weak recommendations. In the early perioperative period (1 month), pacemaker implantation was required in 15 cases (0.55%); in the course of long-term follow-up, 6 patients were still pacemaker-dependent. Perioperative arrhythmias are frequent and serious complications after cardiac surgery, prolong patient recovery time and put financial burden on the hospitals. The rate of need for a permanent pacemaker is low in our hospital, and in the late follow-up we can find only a small part of patients with pacemaker dependency. It would be necessary to start a prospective study and to develop a standardized protocol based on the information currently available. This would be a useful and authoritative help for the postoperative care in cardiac surgery. Orv Hetil. 2020; 161(31): 1271-1280.

Long-term Outcomes of Primary Repair of the Anterior Cruciate Ligament Combined With Biologic Healing Augmentation to Treat Incomplete Tears

Background: Surgical treatment to repair partial anterior cruciate ligament (ACL) injury without reconstruction has demonstrated inconsistent clinical success. Purpose: To examine the long-term clinical outcomes of primary ACL repair combined with biologic healing augmentation in patients with symptomatic partial ACL tears. Study Design: Case series; Level of evidence, 4. Methods: 50 patients (mean age, 29.5 years) with a partial ACL tear and symptomatic knee instability were treated with primary ligament repair in conjunction with marrow stimulation and followed prospectively for a mean duration of 10.2 years (range, 5.3-14.3 years). Comparative analysis of preinjury, preoperative, and postoperative scores using patient-reported assessment instruments was performed to examine clinical outcomes. Correlation of final outcome scores with patient age, type of ACL tear, side-to-side difference in ligamentous laxity, and body mass index (BMI) was performed through use of Spearman rank analysis. Results: 44 patients were available for assessment at final follow-up. The median Tegner Activity Scale score of 7 at final follow-up was the same as the preinjury median score of 7 (P = .128). The mean Marx Activity Scale, International Knee Documentation Committee (IKDC) Subjective, and Lysholm Knee Questionnaire scores were 10.8, 90.4, and 96.2, respectively, at final follow-up. Mean final Knee injury and Osteoarthritis Outcome Score (KOOS) subset assessments of Pain, Symptoms, Activities of Daily Living, Sports, and Quality of Life were 98.6, 97.5, 99.7, 94.3, and 95.6, respectively. Secondary ACL insufficiency occurred in 27% of patients. Clinical outcome scores were similar for all scoring instruments between patients treated for an associated diagnosis of meniscal or articular cartilage injury. No significant correlations of age, BMI, ACL tear type, or laxity and final IKDC Subjective, Lysholm, or KOOS scores were found. Analysis revealed a negative correlation of patient age and Tegner score at preinjury (rs = −0.333, P = .022) and at final follow-up (rs = −0.376, P = .013). The mean side-to-side difference in ligamentous laxity of 3.4 mm at short-term follow-up in those patients who developed secondary ACL insufficiency over the duration of follow-up was significantly greater than the mean of 0.9 mm in those who did not (P = .010). Conclusion: Primary ACL repair combined with biologic healing augmentation to treat select cases of knee instability secondary to incomplete ACL rupture demonstrated good to excellent long-term outcomes in this cohort for those patients who did not experience secondary ACL insufficiency, with high rates of restoration of knee stability and return to preinjury athletic activities. The rate of secondary treatment for recurrent ACL insufficiency over the course of long-term follow-up was greater than would be expected for primary ACL reconstruction. Greater side-to-side differences in objective findings of ligamentous laxity were identified at shorter term follow-up in the patients who later went on to experience symptomatic secondary ACL insufficiency, compared with those who maintained stability long term.

Is Rectosigmoid Vaginoplasty Still Useful?

BackgroundThe ideal vaginoplasty must be successful functionally as well as have a natural appearance, and also must retain its functionality and appearance over the long term. Conventional vaginoplasty techniques have functional limitations and are associated with recurrent complications, but rectosigmoid vaginoplasty is known to have a high satisfaction rate due to its functional similarity with the vagina. We conducted the present study to assess the usability of rectosigmoid vaginoplasty over the course of long-term follow-up.MethodsFrom March 1992 to February 2014, 84 patients were treated with rectosigmoid vaginoplasty; 44 had gender identity disorder, 29 had vaginal agenesis, 8 had female pseudohermaphroditism, and 3 had gynecologic malignancies after radical pelvic surgery. This retrospective study was based on a review of the patients' records, clinical examinations, complications, and questionnaires about appearance, function, and sexual intercourse.ResultsAll patients who underwent rectosigmoid vaginoplasty were discharged within 2 weeks without surgical flap loss. The early complications were partial flap necrosis, difficulty in defecation, mucous hypersecretion, and postoperative ileus. The late complications were vaginal introitus contracture, vaginal prolapse, and difficulty in urination. The mean length and diameter of the neovagina 3.4 years after rectosigmoid vaginoplasty were 13.2 cm and 3.8 cm, respectively. On questionnaires about satisfaction, 70% of patients reported excellent satisfaction, 11% good, 12% fair, and 7% poor.ConclusionsRectosigmoid vaginoplasty is useful, safe, and well-accepted operative method with good functional and cosmetic results, such as natural lubrication and adequate vaginal length and width obtained without requiring the use of a dilator.

Treatment outcome of ion beam therapy in eight patients with head and neck cancers.

Ion beam therapy has enabled us to treat formerly untreatable malignant tumors. The aim of the present study was to investigate the long-term follow-up course of patients with head and neck cancers who received ion beam therapy. The subjects were 8 patients (3 men and 5 women aged 43-78years) with head and neck cancers who visited our department from 2006 to 2015 and received ion beam therapy. Six patients received carbon ion beam therapy, and the other two patients received proton beam therapy. The medical records of the patients were retrospectively analyzed. The primary site was the nasal and paranasal sinuses in six cases, nasopharynx in one case, and external auditory canal in one case. The histological type was olfactory neuroblastoma, malignant melanoma, and adenoid cystic carcinoma in two cases each, and chondrosarcoma and squamous cell carcinoma in one case each. The exposure dose ranged from 64 to 70.4 GyE. The average follow-up period was 42.0months. Early adverse events were generally mild, and complete therapeutic response was obtained in all cases. However, five patients developed severe late complications including craniospinal dissemination, osteoradionecrosis of the maxilla and skull base, brain necrosis, and loss of eyesight. Three patients died of distant metastasis, local recurrence and/or brain necrosis within 2years, and four patients have been surviving with distant metastasis or severe late complications. Ion beam therapy exhibits outstanding antitumor effects, but the severe late complications of the therapy must also be recognized.

Prevalence and risk factors for periprosthetic fracture in older recipients of total hip replacement: a cohort study.

BackgroundThe growing utilization of total joint replacement will increase the frequency of its complications, including periprosthetic fracture. The prevalence and risk factors of periprosthetic fracture require further study, particularly over the course of long-term follow-up. The objective of this study was to estimate the prevalence and risk factors for periprosthetic fractures occurring in recipients of total hip replacement.MethodsWe identified Medicare beneficiaries who had elective primary total hip replacement (THR) for non-fracture diagnoses between July 1995 and June 1996. We followed them using Medicare Part A claims data through 2008. We used ICD-9 codes to identify periprosthetic femoral fractures occurring from 2006–2008. We used the incidence density method to calculate the annual incidence of these fractures and Cox proportional hazards models to identify risk factors for periprosthetic fracture. We also calculated the risk of hospitalization over the subsequent year.ResultsOf 58,521 Medicare beneficiaries who had elective primary THR between July 1995 and June 1996, 32,463 (55%) survived until January 2006. Of these, 215 (0.7%) developed a periprosthetic femoral fracture between 2006 and 2008. The annual incidence of periprosthetic fracture among these individuals was 26 per 10,000 person-years. In the Cox model, a greater risk of periprosthetic fracture was associated with having had a total knee replacement (HR 1.82, 95% CI 1.30, 2.55) or a revision total hip replacement (HR1.40, 95% CI 0.95, 2.07) between the primary THR and 2006. Compared to those without fractures, THR recipients who sustained periprosthetic femoral fracture had three-fold higher risk of hospitalization in the subsequent year (89% vs. 27%, p < 0.0001).ConclusionA decade after primary THR, periprosthetic fractures occur annually in 26 per 10,000 persons and are especially frequent in those with prior total knee or revision total hip replacements.

Suicide mortality in relation to dietary intake of n-3 and n-6 polyunsaturated fatty acids and fish: equivocal findings from 3 large US cohort studies.

Intake of n-3 and n-6 polyunsaturated fatty acids (PUFAs) has been implicated in the pathogenesis of depression. We sought to estimate the association between intake of fish and n-3 and n-6 PUFAs and suicide mortality over the course of long-term follow-up. In this prospective cohort study, biennial questionnaires were administered to 42,290 men enrolled in the Health Professionals Follow-up Study (1988-2008), 72,231 women enrolled in the Nurses' Health Study (1986-2008), and 90,836 women enrolled in Nurses' Health Study II (1993-2007). Dietary fish and n-3 and n-6 PUFA intakes were assessed every 4 years using a validated food-frequency questionnaire. Suicide mortality was ascertained through blind physician review of death certificates and hospital or pathology reports. Adjusted relative risks of suicide mortality were estimated with multivariable Cox proportional hazards models and pooled across cohorts using random-effects meta-analysis. The pooled multivariable relative risks for suicide among persons in the highest quartile of intake of n-3 or n-6 PUFAs, relative to the lowest quartile, ranged from 1.08 to 1.46 for n-3 PUFAs (Ptrend = 0.11-0.52) and from 0.68 to 1.19 for n-6 PUFAs (Ptrend = 0.09-0.54). We did not find evidence that intake of n-3 PUFAs or fish lowered the risk of completed suicide.

The Utility of Serum Thyroglobulin Measurement at the Time of Remnant Ablation for Predicting Disease-Free Status in Patients with Differentiated Thyroid Cancer: A Meta-Analysis Involving 3947 Patients

Decisions regarding initial therapy and subsequent surveillance in patients with differentiated thyroid cancer (DTC) depend upon an accurate assessment of the risk of persistent or recurrent disease. The objective of this study was to examine the predictive value of a single measurement of serum thyroglobulin (Tg) just before radioiodine remnant ablation (preablation Tg) on subsequent disease-free status. Sources included MEDLINE and BIOSYS databases between January 1996 and June 2011 as well as data from the author's tertiary-care medical center. Included studies reported preablation Tg values and the outcome of initial therapy at surveillance testing or during the course of long-term follow-up. Two investigators independently extracted data and rated study quality using the Quality Assessment of Studies of Diagnostic Accuracy included in Systematic Reviews-2 (QUADAS-2) tool. Fifteen studies involving 3947 patients with DTC were included. Seventy percent of patients had preablation Tg values lower than the threshold value being examined. The negative predictive value (NPV) of a preablation Tg below threshold was 94.2 (95% confidence interval = 92.8-95.3) for an absence of biochemical or structural evidence of disease at initial surveillance or subsequent follow-up. The summary receiver operator characteristic curve based on a bivariate mixed-effects binomial regression model showed a clustering of studies using a preablation Tg below 10 ng/ml near the summary point of optimal test sensitivity and specificity. Preablation Tg testing is a readily available and inexpensive tool with a high NPV for future disease-free status. A low preablation Tg should be considered a favorable risk factor in patients with DTC. Further study is required to determine whether a low preablation Tg may be used to select patients for whom radioiodine remnant ablation can be avoided.

Does Weber’s rotation osteotomy induce degenerative joint disease at the shoulder in the long term?

Weber's internal rotation osteotomy of the humeral head is recommended for the treatment of anteroinferior shoulder instability with a large Hill-Sachs defect. The observation of severe joint degeneration in the course of long-term follow-up provided the motivation for this study. An osteotomy was performed in 42 patients from 1984 to 1990. Thirty-four patients were available for clinical and radiological follow-up after 14.5 years. Our own CT-based classification was applied to categorize the degree of osteoarthritis. A shoulder prosthesis was implanted in 9 patients (26%). Only 3 patients (9%) did not show any signs of degeneration. A statistically significant relationship was found between increased internal rotation of the humeral head and disease severity (P = .03). A lower incidence of joint degeneration (P = .02) was found for patients with generalized ligamentous laxity. We therefore recommend this osteotomy only as a salvage procedure whereby the internal rotation of the humeral head should not exceed 20 degrees .

Long-term evaluation of interferon therapy in hepatitis C virus-associated cirrhosis: does IFN prevent development of hepatocellular carcinoma?

During the course of long-term follow-up, we examined the efficacy of interferon (IFN) in the improvement of liver function and prevention of hepatocellular carcinoma (HCC) in hepatitis C virus (HCV) associated cirrhosis patients. Fifty-five cirrhotic patients, in whom HCC nodules in the liver were not detected by ultrasonography (US) or computed tomography (CT), received 3 or 6 million units of human lymphoblastoid IFN daily for two weeks and 3 times a week for 22 weeks. Complete response (CR) was defined as normalization of serum alanine aminotransferase (ALT) together with negative HCV RNA at 6 months after IFN therapy completion. Any other pattern of response was defined as non-response (NR). After IFN therapy the patients were followed up every 1-3 months for at least 1 year (average follow-up period, about 40 months) with serological tests and US or CT. In the 8 CR patients, the serum ALT levels remained normal and HCV RNA remained negative. Platelet count, white blood cell count, serum albumin and zinc turbidity test have recovered to the normal range at final follow-up. Ten of the 47 patients with NR have developed HCC, whereas no patients with CR has developed HCC during follow-up. We conclude that IFN improves the liver function and may prevent the development of HCC even in cirrhotic patients who show CR to IFN therapy.

Free fat transplantation in the face

Several operative procedures have been described for correction of soft tissue defects in the face. Free fat transplantation has been criticised many times. In a twelve-year period, we have carried out 19 free fat transfers from the gluteal fold, of a size ranging from the palm of a child's hand to the size of an adult hand. Follow-up has been possible in 12 patients with 14 such transfers. Initially, grafts tended to be too large and subsequent fat reduction was required. It is apparent that the tendency to resorption of non-vascularised fat can only be estimated to a limited extent. Ultrasound examination in the course of long-term follow-up showed structural changes within the grafts but none was particularly striking. The fat has a good consistency on palpation particularly for the cheeks and remains in situ after healing. This technique still has a role in suitable cases.

Effect of left atrial plication for the giant left atrium on left ventricular function.

Left atrial plication (LAP) following Kawazoe's method was performed on eight patients with mitral valve stenosis associated with a giant left atrium. To investigate the effect of LAP particularly on left ventricular function, the preoperative and postoperative left ventricular function in these patients were compared. The data were also compared to that of the non-left atrial plication (non-LAP) group with left atrial dimension of 60 mm or over. In the LAP group, there were significant differences between preoperative and postoperative data in the following parameters; New York Heart Association (NYHA) class, cardiothoracic ratio, mean pulmonary arterial pressure (PAP), left ventricular end-diastolic pressure (LVEDP), left atrial dimension, stroke volume index, ejection fraction and cardiac index. On the contrary, in the non-LAP group, there were significant differences between preoperative and post-operative data in the following two factors; NYHA class and PAP. The size of the left atrium in the non-LAP group remained unchanged over the course of long-term follow-up. Despite severe clinical symptoms and severely reduced cardiac function of the patients in the LAP group, cardiac function in all patients improved satisfactorily. This suggests that left atrial plication has a considerably beneficial effect on left ventricular function, and therefore, may be recommended for patients with a giant left atrium.

Intracranial aneurysm in infancy

Angiography demonstrated an aneurysm of the left anterior cerebral artery in a 4-month-old baby who was admitted for subarachnoid hemorrhage. A surgical cure with long-term follow-up course was achieved. Clinical and pathogenetic aspects are presented. The rarity of such lesions in childhood and their successful surgical treatment are discussed briefly.