Root canal re-treatment with gutta percha - which techniques influence success?

OBJECTIVE: A systematic review and meta-analysis of the literature was carried out assessing the success rate of root canal retreatment using gutta percha. DATA SOURCES: Four of the largest databases were used to identify existing literature with no date or language restrictions. PubMed, Cochrane, ScienceDirect, Scopus and other additional sources were searched. Grey literature was also reviewed. STUDY SELECTION: Two authors, with Master's degrees in endodontics and with extensive university teaching experience, were selected to screen the databases to identify suitable studies. In case the authors were not able to agree during the study selection process, a third investigator was consulted. Specific inclusion and exclusion criteria were outlined and adhered to in the study selection. Two randomised controlled trials, seven single arm prospective studies and one single arm ambispective study published before the 10th of December 2022 were included. These studies evaluated the success of root canal re-treatment, obturated with gutta percha with at least a 1-year follow-up. Nine of the studies were published between 1998 and 2022. Seven studies were conducted in Europe, one in North America and one in Asia. DATA EXTRACTION AND SYNTHESIS: Standard Cochrane methods to assess interval validity were used. Risk of bias in individual studies was assessed using The Newcastle-Ottawa quality assessment scale (NOS) for single-arm studies, and the Cochrane risk of bias tool (RoB2) was used for randomised controlled trials. Outcome measures were standardised as either success or failure of root canal retreatment. Success was classified into 2 different criteria: Strict criteria = absence of clinical signs and symptoms and radiographically normal periodontal ligament space; and Loose criteria = absence of clinical signs and symptoms and absence or reduction of apical radiolucency in the control radiograph. Statistical analysis was undertaken using R software and the Freeman-Turkey transformation was performed. Results were visualised using forest plots. Heterogeneity between studies was measured using the Cochrane Q test and I2 values. RESULTS: Whilst following strict criteria, the success rate of non-surgical root canal retreatment obturated with gutta percha was 71% for 1-3 years follow-up (95% CI, 0.66-0.77) and 77% for 4-5 years follow-up (95% CI, 0.67-0.86). Heterogeneity was moderate (I2 = 61.4) and low (I2 = 0.0), respectively. Factors reducing the success rate of root canal re-retreatment under the strict criteria were older patients, mandibular teeth, molar teeth, the presence of a peri-apical radiolucency, teeth with a previous radiolucency, large peri-apical radiolucency's, higher initial periapical index scores and multiple visit-retreatments. Following the loose criteria, the success rate of non-surgical root canal re-treatment obturated with gutta percha was 87% for 1-3 years follow-up (95% CI, 0.79-0.93) with significant heterogeneity across the studies (I2 = 88.5%). Factors influencing the success rate under the loose criteria were large periapical lesions >5 mm and higher initial periapical index (PAI) scores. CONCLUSIONS: Non-surgical root canal retreatment results in favourable outcomes. However, there are several factors which can result in a lower success rate: the presence and size of a periapical radiolucency, a higher initial PAI score, multiple-visit retreatments, and the size and position of the tooth.

Effects of resection volume on postoperative micturition symptoms and retreatment after transurethral resection of the prostate.

PURPOSE: Despite advances in technology, such as advent of laser enucleation and minimally invasive surgical therapies, transurethral resection of the prostate (TURP) remains the most widely performed surgical technique for benign prostatic hyperplasia (BPH). We evaluated resection volume (RV)-derived parameters and analyzed the effect of RV on post-TURP outcomes. METHODS: This observational study used data from patients who underwent TURP at two institutions between January 2011 and December 2021 Data from patients with previous BPH surgical treatment, incomplete data, and underlying disease affecting voiding function were excluded. The collected data included age, prostate-specific antigen, transrectal ultrasound (TRUS)- and uroflowmetry-derived parameters, RV, perioperative laboratory values, perioperative International Prostatic Symptom Score (IPSS), follow-up period, retreatment requirements and interval between the first TURP and retreatment. RESULTS: In 268 patients without prior BPH medication, there were no differences in prostate volume (PV), transitional zone volume (TZV), or RV according to IPSS. A total of 60 patients started retreatment, including medical or surgical treatment, within the follow-up period. There was a significant difference in RV/PV between the groups without and with retreatment respectively (0.56 and 0.37; p = 0.008). However, preoperative TRUS- and uroflowmetry-derived parameters did not differ between the two groups. Multiple linear regression analysis showed that RV (p = 0.003) and RV/TZV (p = 0.006) were significantly associated with differences in perioperative IPSS. In the multivariate logistic regression analysis, only RV/PV was correlated with retreatment (p = 0.010). CONCLUSION: Maximal TURP leads to improved postoperative outcomes and reduced retreatment rate, it may gradually become a requirement rather than an option.

Clinical and ultrasonographic evaluation of the window of opportunity for retreatment with rituximab in rheumatoid arthritis patients from a multicentre real-life study.

OBJECTIVES: To determine a potential window of opportunity for retreatment with rituximab in patients with rheumatoid arthritis (RA) from a multicentre longitudinal real-life study based on tight monitoring with ultrasonography (US). METHODS: Thirty RA patients treated with rituximab were included. US parameters were collected at each time (8 visits) of the 18-month follow-up, notably the global score of power Doppler (PD) activity. Clinical relapse was defined as a DAS28 ESR of >3.2 after 6 months in responders while US relapse was defined as an increase of ≥20% of the global score of PD activity. The decision of retreatment was based exclusively on clinical findings. RESULTS: A total of 29 patients were analysed (mean (SD) age: 57.2 (12.2) years; female gender: 66%). The mean (SD) PD score decreased from 8.8 (5.2) at baseline to 4.9 (4.3) at 6 months (p <0.0001). A clinical response was observed at Month 4 or Month 6 for 93% of patients. A total of 19 patients had a first clinical relapse (with or without US relapse) after Month 6 (18 of them were retreated with rituximab). Among 10 patients without clinical relapse, 3 had US relapse (only one was retreated) and 7 had no US relapse (but 4 were retreated). CONCLUSIONS: This study highlights a great heterogeneity in terms of sequence of clinical relapse, US relapse and retreatment in RA patients receiving rituximab. Therefore, US monitoring does not seem to be relevant to determine the best time for retreatment with rituximab.

Reoperation for prolapse recurrence after sacrospinous mesh hysteropexy: characteristics of women choosing retreatment.

INTRODUCTION AND HYPOTHESIS: Factors that contribute to reoperation and surgical approaches for the management of recurrent uterovaginal prolapse after vaginal mesh hysteropexy (mesh hysteropexy) are unknown. We aimed to describe surgical management of pelvic organ prolapse recurrence after vaginal mesh hysteropexy, and patient characteristics in those who chose reoperation. METHODS: This is a descriptive analysis of women who experienced treatment failure within 5 years of mesh hysteropexy in a multi-site randomized trial. The composite definition of treatment failure included retreatment (pessary or reoperation), prolapse beyond the hymen, or bothersome prolapse symptoms. Characteristics of those pursuing and not pursuing repeat prolapse surgery, measures of prolapse, and symptom severity are described. RESULTS: Over 5-year follow up, 31/91 (34%) of the hysteropexy group met treatment failure criteria. All seven women who pursued reoperation reported bothersome prolapse symptoms; six were anatomic failures. Most seeking reoperation were early treatment failures; six (86%) by the 12-month visit and all by the 18-month visit. Compared to those electing expectant management, those pursuing reoperation had more apical prolapse, POP-Q point C median (IQR) -5.5 (-6.0, -4.0) cm versus +1.0 (-1.0, 3.0) cm respectively. Hysterectomy was performed in 6/7 reoperations (three vaginal, three endoscopic), with apical suspension in 5/6 hysterectomies. One participant with posterior compartment prolapse underwent transvaginal enterocele plication, uterosacral ligament suspension with posterior colpoperineorrhaphy. At a mean surgical follow-up of 34.3 (15.8) months, all women remained without anatomic or symptomatic failure. CONCLUSIONS: When recurrent prolapse after mesh hysteropexy occurred, most women did not choose reoperation. Those who pursued surgery experienced more significant apical prolapse and were universally symptomatic. CLINICAL TRIAL IDENTIFICATION NUMBER: NCT01802281.

International urogynecological consultation chapter 4.1: definition of outcomes for pelvic organ prolapse surgery.

INTRODUCTION AND HYPOTHESIS: This manuscript of Chapter 4 of the International Urogynecological Consultation (IUC) on Pelvic Organ Prolapse (POP) reviews the literature and makes recommendations on the definition of success in the surgical treatment of pelvic organ prolapse. METHODS: An international group containing seven urogynecologists performed an exhaustive search of the literature using two PubMed searches and using PICO methodology. The first search was from 01/01/2012-06/12/2022. A second search from inception to 7/24/2022 was done to access older references. Publications were eliminated if not relevant to the clinical definition of surgical success for the treatment of POP. All abstracts were reviewed for inclusion and any disagreements were adjudicated by majority consensus of the writing group. The resulting list of articles were used to inform a comprehensive review and creation of the definition of success in the surgical treatment of POP. OUTCOMES: The original search yielded 12,161 references of which 45 were used by the writing group. Ultimately, 68 references are included in the manuscript. For research purposes, surgical success should be primarily defined by the absence of bothersome patient bulge symptoms or retreatment for POP and a time frame of at least 12 months follow-up should be used. Secondary outcomes, including anatomic measures of POP and related pelvic floor symptoms, should not contribute to a definition of success or failure. For clinical practice, surgical success should primarily be defined as the absence of bothersome patient bulge symptoms. Surgeons may consider using PASS (patient acceptable symptom state) or patient goal attainment assessments, and patients should be followed for a minimum of at least one encounter at 6-12 weeks post-operatively. For surgeries involving mesh longer-term follow-up is recommended.

Extracorporeal shock wave lithotripsy (ESWL) versus percutaneous nephrolithotomy (PCNL) or retrograde intrarenal surgery (RIRS) for kidney stones.

BACKGROUND: Nephrolithiasis is a common urological disease worldwide. Extracorporeal shock wave lithotripsy (ESWL) has been used for the treatment of renal stones since the 1980s, while retrograde intrarenal surgery (RIRS) and percutaneous nephrolithotomy (PCNL) are newer, more invasive treatment modalities that may have higher stone-free rates. The complications of RIRS and PCNL have decreased owing to improvement in surgical techniques and instruments. We re-evaluated the best evidence on this topic in an update of a Cochrane Review first published in 2014. OBJECTIVES: To assess the effects of extracorporeal shock wave lithotripsy compared with percutaneous nephrolithotomy or retrograde intrarenal surgery for treating kidney stones. SEARCH METHODS: We performed a comprehensive search in CENTRAL, MEDLINE, Embase, and ClinicalTrials.gov with no restrictions on language or publication status. The latest search date was 6 December 2022. SELECTION CRITERIA: We included randomized controlled trials (RCTs) and quasi-RCTs that compared ESWL with PCNL or RIRS for kidney stone treatment. DATA COLLECTION AND ANALYSIS: Two review authors independently classified studies, extracted data, and assessed risk of bias. Our primary outcomes were treatment success rate at three months (defined as residual fragments smaller than 4 mm, or as defined by the study authors), quality of life (QoL), and complications. Our secondary outcomes were retreatment rate, auxiliary procedures rate, and duration of hospital stay. We performed statistical analyses using a random-effects model and independently rated the certainty of evidence using the GRADE approach. MAIN RESULTS: We included 31 trials involving 3361 participants (3060 participants completed follow-up). Four trials were only available as an abstract. Overall mean age was 46.6 years and overall mean stone size was 13.4 mm. Most participants (93.8%) had kidney stones measuring 20 mm or less, and 68.9% had lower pole stones. ESWL versus PCNL ESWL may have a lower three-month treatment success rate than PCNL (risk ratio [RR] 0.67, 95% confidence interval [CI] 0.57 to 0.79; I2 = 87%; 12 studies, 1303 participants; low-certainty evidence). This corresponds to 304 fewer participants per 1000 (397 fewer to 194 fewer) reporting treatment success with ESWL. ESWL may have little or no effect on QoL after treatment compared with PCNL (1 study, 78 participants; low-certainty evidence). ESWL probably leads to fewer complications than PCNL (RR 0.62, 95% CI 0.47 to 0.82; I2 = 18%; 13 studies, 1385 participants; moderate-certainty evidence). This corresponds to 82 fewer participants per 1000 (115 fewer to 39 fewer) having complications after ESWL. ESWL versus RIRS ESWL may have a lower three-month treatment success rate than RIRS (RR 0.85, 95% CI 0.78 to 0.93; I2 = 63%; 13 studies, 1349 participants; low-certainty evidence). This corresponds to 127 fewer participants per 1000 (186 fewer to 59 fewer) reporting treatment success with ESWL. We are very uncertain about QoL after treatment; the evidence is based on three studies (214 participants) that we were unable to pool. We are very uncertain about the difference in complication rates between ESWL and RIRS (RR 0.93, 95% CI 0.63 to 1.36; I2 = 32%; 13 studies, 1305 participants; very low-certainty evidence). This corresponds to nine fewer participants per 1000 (49 fewer to 48 more) having complications after ESWL. AUTHORS' CONCLUSIONS: ESWL compared with PCNL may have lower three-month success rates, may have a similar effect on QoL, and probably leads to fewer complications. ESWL compared with RIRS may have lower three-month success rates, but the evidence on QoL outcomes and complication rates is very uncertain. These findings should provide valuable information to aid shared decision-making between clinicians and people with kidney stones who are undecided about these three options.

Factors that affect the outcomes of root canal treatment and retreatment-A reframing of the principles.

This paper undertakes a broad and comprehensive synthesis of relevant clinical, biological, biomechanical, technical and healthcare services data to understand the factors affecting outcomes of periapical healing after root canal (re)treatment. The medical and dental evidence-based era (1980-present) is contextualized with the earlier evidence drive in endodontics (1911-1940) triggered by the focal infection era. The current evidence-based approach has a sharper focus on evidence quality and derivation of practice guidelines. Contrary views question whether guideline-driven, or expertise-development-driven endeavours would best serve outcome improvement in society. The endodontic discipline functions in a broad healthcare framework and sustains industrial, economic and trend pressures that may be deemed to influence outcomes. The nature of root canal treatment and the challenges in determining the factors that affect its outcomes is discussed. The factors potentially affecting periapical healing after root canal treatment are classified into pre-operative, intra-operative and postoperative groups. These categories subsume multiple elements with interactive influences, creating a complex picture, further confounded by some apparently surprising, counter-intuitive and contradictory findings. The technical versus biological conundrum in root canal treatment continues to cause cognitive dissonance. However, due reflection and cross-discipline-synthesis resolve the apparent data conflicts into a very simple, consistent and plausible picture of how root canal treatment works and the key factors that affect periapical healing. Root canal retreatment is considered mainly in the context of its differences from primary treatment as the majority of factors influencing outcomes are common to both. The exceptional difference is that retreatments have a proportionately reduced probability of healing by virtue of compromised apical root canal ramification access or modified host/infection interactions. Root canal (re)treatment outcomes are dominantly influenced by the nature of prior dynamic host/infection interaction (pre-operative patient factors) and how the direction of this dynamic is influenced by two factors: (1) the active efficacy of the operators' root canal treatment protocol to sustain a microbial ecological shift (intra-operative treatment factors) and dampen periapical inflammation; and (2) the passive ability of the functional tooth (and its restoration margin) to maintain its integrity to resist infection reversal (postoperative restorative factors).

Treatment outcome of surgical and non-surgical endodontic retreatment of teeth with apical periodontitis.

AIMS: To evaluate and compare the treatment outcome of root filled teeth with apical periodontitis treated either non-surgically or by endodontic microsurgery, and to assess the influence of an intra-radicular post, clinical and demographic factors. METHODOLOGY: Clinical and radiological data from 1157 patients with apical periodontitis in previously root filled teeth treated by postgraduate students at the Department of Endodontics, University of Oslo, between September 2010 and January 2020 with recall data at least 11 months from completion were studied. Surgical cases were scored using the Rud/Molven criteria and grouped into success, uncertain or failure at control. Non-surgical cases were scored with the periapical index (PAI) and similarly grouped into success, uncertain or failure at control. Chi-square analyses were used for comparison of subgroups of teeth treated and logistic regression analyses for assessment of the influence of clinical variables. RESULTS: Non-surgical retreatment was performed on 351 teeth and 107 teeth were treated with endodontic microsurgery, with overall success rates of 65.5% and 77.6%, respectively. The difference was statistically significant. Teeth with an intra-radicular post treated non-surgically (n = 30) were successful in 73.3% of cases, whereas teeth with intra-radicular post treated with endodontic microsurgery (n = 30) had a lower, 66.7% success rate. The distribution of tooth groups (anterior, premolar and molar) differed significantly between surgical and non-surgical cases, with maxillary anterior and premolar teeth more often treated surgically. Non-surgical retreatment cases were significantly influenced by patients' age (older patients had poorer outcome) and pre-operative PAI score (negatively correlated with outcome). Surgical cases were not significantly influenced by the factors studied here. CONCLUSIONS: The tooth type differed significantly for teeth treated by surgical versus non-surgical methods. Microsurgical treatment with apicectomy and retrograde filling showed significantly better treatment results than non-surgical retreatment of teeth with apical periodontitis, whereas treatment outcome in teeth with posts after non-surgical treatment tended to be better than after surgical treatment. Outcome of non-surgical retreatment was negatively influenced by older age and higher pre-operative PAI score.

The effect of periapical lesion size on the success rate of different endodontic treatments: a systematic review and meta-analysis.

INTRODUCTION: This systematic review evaluated the effect of periapical lesion (PL) size on the success rate of different endodontic treatments, including root canal treatment (RCT), non-surgical retreatment (NSR), and apical surgery (AS). METHODS: Cohorts and randomized controlled trials investigating the outcomes of endodontic treatment of permanent teeth with PL and its size were identified electronically through Web of Science, MEDLINE, Scopus, and Embase databases. Two reviewers independently conducted the study selection, data extraction, and critical appraisal process. The quality of the included studies was evaluated using the Newcastle-Ottawa Scale and the 11-item Critical Appraisal Skills Program checklist for randomized controlled trials. The success rates of the endodontic treatments (small lesions and large lesions) were estimated using the rate ratios (RRs) with an associated 95% confidence interval (CI). RESULTS: Out of 44 included studies, 42 were cohort, and 2 were randomized controlled trials. Thirty-two studies had poor quality. For the meta-analysis, five studies in RCT, 4 in NSR, and 3 in AS were considered. The RR of the endodontic treatment success in PLs was 1.04 in RCT (95% CI, 0.99-1.07), 1.11 in NSR (95% CI, 0.99-1.24), and 1.06 in AS (95% CI, 0.97-1.16). Only sub-group analysis of long-term follow-up of RCT showed a significantly higher success rate in small lesions than in large lesions. CONCLUSIONS: Considering the quality of studies and variation in outcomes and size classification, our meta-analysis demonstrated that the PL size had no significant effect on the success rate of different endodontic treatments.

Repeated Aneurysm Intervention.

Over the past 25 years the endovascular treatment of cerebral aneurysms has gained preference in some countries over the traditional surgical procedures. The review part of the article clearly demonstrates that the clinical results of both modalities are similar and the difference is seen only in technical effectivity. Surgical techniques fail far less frequently than the endovascular ones. Incompletely occluded or growing aneurysms after the endovascular approach expose the patient to the risk of rebleeding with all possible consequences. Markedly repeated procedures are much more common for endovascularly treated aneurysms, again with all the risks.In the authors institution over the past 20 years, a total of 2032 aneurysms were treated. In 1263 endovascularly managed aneurysms the regrowth or inclomplete initial occlusion necessitated 159 repeated propcedures (12.6%). In surgical group the total of 27 aneurysms needed retreatment (3.5%). The difference is statistically significant. In nine patients in endovascular group the rebleeding was the reason for repeated procedures. No rebleeding was seen in the surgical group.This fact, also shown in the review part of the article, is important in patients counseling. Given the similar clinical results of both modalities the patient should be advised on the necessity of repeated follow-ups and of possible technical failure and eventual repeated procedure which is more likely if endovascular procedure is chosen.

Epidemiological evaluation of the outcomes of initial root canal therapy in permanent teeth of a publicly insured paediatric population.

BACKGROUND: Previously published epidemiological outcome studies of nonsurgical root canal therapy (NSRCT) in the United States utilize data only from a single, private dental insurer for adult populations. AIM: This study aimed to investigate the outcomes of initial NSRCT, performed on permanent teeth, in a publicly insured paediatric population. DESIGN: New York State Medicaid administrative claims were used to follow 77 741 endodontic procedures in 51 545 patients aged 6-18, from the time of initial NSRCT until the occurrence of an untoward event (retreatment, apicoectomy, and extraction). The initial treatment and untoward events were identified by Current Dental Terminology codes. The Kaplan-Meier survival estimates were calculated at 1, 3, and 5 years. Hazard ratios for time to permanent restoration and restoration type were calculated using the Cox proportional hazards model. RESULTS: The median follow-up time was 44 months [range: 12-158 months]. Procedural, NSRCT, survival was 98% at 1 year, 93% at 3 years, and 88% at 5 years. Extraction was the most common untoward event. Teeth permanently restored with cuspal coverage had the most favorable treatment outcomes. CONCLUSIONS: Overall, 89% of teeth were retained and remained functional over a minimum follow-up time of 5 years. These results elucidate the expected outcomes of NSRCT in permanent teeth for paediatric patients with public-payer dental benefits.

Novel developments in chronic myeloid leukaemia.

PURPOSE OF REVIEW: Despite unprecedented challenges during the preceding year, there have been a wide range of significant advances in the field of chronic myeloid leukaemia. In this review article we highlight papers reporting on some of the most important developments over the last year, both with regards to the clinical management of patients with chronic myeloid leukaemia, as well as studies that help to increase our understanding of the pathophysiology of the disease. We have performed a PubMed search to identify important papers and abstracts listed over the last year and have included additional papers published prior to this, where relevant, to provide context. RECENT FINDINGS: We comment on novel biomarkers for treatment free remission as well as recent results from second generation Tyrosine Kinase Inhibitor (TKI) discontinuation studies. We discuss new techniques that are being used to assess TKI resistance as well as reviewing novel and emerging approaches to the management of resistant patients, including the use of combination therapies. SUMMARY: This review highlights some of the most important research to have been reported over the last year in the field of chronic myeloid leukaemia, encompassing emerging diagnostic techniques, biomarkers and novel therapeutic options.

Anlotinib combined with PD-1 blockade for the treatment of lung cancer: a real-world retrospective study in China.

BACKGROUND: This study evaluated the efficacy and safety of anlotinib combined with programmed cell death protein 1 (PD-1) blockade for the treatment of small-cell lung cancer (SCLC) and non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS: SCLC (n = 28) and NSCLC (n = 177) patients who received treatment at Hunan Cancer Hospital between June 1, 2019, and July 1, 2020, were retrospectively analyzed. Progression-free survival (PFS) and treatment responses were compared among patients who received combination therapy of anlotinib plus PD-1 inhibitor, or monotherapy of either chemotherapy or PD-1 inhibitor. Independent prognostic factors were identified by Cox regression analysis. RESULTS: Patients with relapsed SCLC who received anlotinib plus PD-1 inhibitor as a ≥ second-line therapy (n = 14) had a significantly longer PFS than those who received PD-1 inhibitor alone (n = 14, 5.0 vs. 3.0 months; P = 0.005). For patients with previously untreated wild-type NSCLC, the combination therapy in the first-line setting (n = 6) provided a marginally longer PFS than mono-chemotherapy (n = 6, 8.0 vs. 3.0 months; P = 0.075). For patients with relapsed NSCLC, the combination therapy in the ≥ second-line setting (n = 62) resulted in significantly higher objective response rate (19.3 vs. 5.0 vs. 2.4%; P = 0.013) and longer PFS (8.0 vs. 2.0 vs. 2.0 months; P <0.001) as compared to monotherapy of either chemotherapy (n = 41) or PD-1 inhibitor (n = 62). Anlotinib and PD-1 blockade combination therapy was an independent predictive factor of longer PFS (P <0.001). CONCLUSION: The combination of anlotinib and PD-1 inhibitor has promising efficacy and manageable toxicity as a second- or later-line treatment of relapsed NSCLC and possibly for relapsed SCLC.

Natural History of Post-Treatment Kidney Stone Fragments: A Systematic Review and Meta-Analysis.

PURPOSE: We assessed the literature around post-treatment asymptomatic residual stone fragments and performed a meta-analysis. The main outcomes were intervention rate and disease progression. MATERIALS AND METHODS: We searched Ovid®, MEDLINE®, Embase™, the Cochrane Library and ClinicalTrials.gov using search terms: "asymptomatic", "nephrolithiasis", "ESWL", "PCNL", "URS" and "intervention." Inclusion criteria were all studies with residual renal fragments following treatment (shock wave lithotripsy, ureteroscopy or percutaneous nephrolithotomy). Analysis was performed using 'metafor' in R and bias determined using Newcastle-Ottawa scale. RESULTS: From 273 articles, 18 papers (2,096 patients) had details of intervention rate for residual fragments. Aggregate intervention rates for ≤4 mm fragments rose from 19% (20 months) to 22% (50 months), while >4 mm fragments rose from 22% to 47%. Aggregate disease progression rates for ≤4 mm rose from 25% to 47% and >4 mm rose from 26% to 88%. However, there was substantial difference in definition of "disease progression." Meta-analysis comparing >4 mm against ≤4 mm fragments: intervention rate for >4 mm (vs ≤4 mm): OR=1.50 (95% CI 0.70-2.30), p <0.001, I2=67.6%, tau2=0.48, Cochran's Q=11.4 (p=0.02) and Egger's regression: z=3.11, p=0.002. Disease progression rate for >4 mm: OR=0.06 (95% CI -0.98-1.10), p=0.91, I2=53.0%, tau2=0.57, Cochran's Q=7.11 (p=0.07) and Egger's regression: z=-0.75, p=0.45. Bias analysis demonstrated a moderate risk. CONCLUSIONS: Larger post-treatment residual fragments are significantly more likely to require further intervention especially in the long term. Smaller fragments, although less likely to require further intervention, still carry that risk. Notably, there is no significant difference in disease progression between fragment sizes. Patients with residual fragments should be appropriately counselled and informed decision-making regarding further management should be done.

Impact of subcutaneous immunoglobulin on quality of life in patients with chronic inflammatory demyelinating polyneuropathy previously treated with intravenous immunoglobulin.

INTRODUCTION/AIMS: Intravenous immunoglobulin (IVIg) is a common therapy for patients with chronic inflammatory demyelinating polyneuropathy (CIDP). IVIg may cause systemic adverse events (AEs); therefore, infusion of subcutaneous immunoglobulin (SCIg) may be preferred by some patients. In this study we document the experiences of patients transitioning from IVIg to SCIg. METHODS: Transitioning subjects with CIDP were followed in a 6-month prospective, open-label study. The primary endpoint was percentage of subjects who withdrew for any reason (including significant AEs). The secondary endpoint was symptom progression or relapse requiring a change in management. Quality of life (QOL) and treatment satisfaction were assessed using the Short Form 36-item Health Survey (SF-36), Treatment Satisfaction Questionnaire for Medication (TSQM), and Chronic Acquired Polyneuropathy Patient-Reported Index (CAP-PRI). Efficacy was assessed using the Inflammatory Rasch-built Overall Disability Scale, hand-held dynamometry, limb motor strength testing (LMST), and timed 25-ft walk (T25-FW). RESULTS: Fifteen CIDP subjects transitioned from IVIg to SCIg. Of these, three (20%) met the primary endpoint and one (7%) met the secondary endpoint. The SF-36 showed a statistically significant improvement for the domain of role limitations-physical after 24 weeks (P = .03), with no significant differences observed in other domains. TSQM and CAP-PRI showed significant differences in favor of SCIg (P = .003 and .02, respectively). No significant differences were observed in efficacy after 24 weeks, except for LMST, which favored SCIg (P = .003). Eight of the 12 study completers (67%) continued with SCIg. DISCUSSION: Transition to SCIg was associated with maintained efficacy and improved QOL.

Value of early second session shock wave lithotripsy in treatment of upper ureteric stones compared to laser ureteroscopy.

PURPOSE: The safety and efficacy of early second session shock wave lithotripsy (SWL) compared with laser ureteroscopy (URS) for the treatment of upper ureteric stones were evaluated. METHODS: From January to October 2019, 108 patients with upper ureteric stones (< 1.5 cm and ≤ 1000 Hounsfield unit (HU)) were randomized into SWL and laser URS groups. The second SWL session was performed within 48-72 h of the first session. Using plain abdominal X-ray and ultrasonography, patients were evaluated 48-72 h after the first SWL session and one week after the second and third SWL sessions or one week after URS. The procedure was considered a success when no additional procedures were needed to clear the stone. To determine the stone-free rate (SFR), noncontrast computed tomography of the urinary tract was performed three months postoperatively. RESULTS: In the SWL group, the success rates were 92.6% and 94.4% after the second and third sessions. The SFR was 96.2% in the laser URS group. The success rates were not significantly different between the second and third SWL sessions versus the laser URS (p = 0.418 and 0.660, respectively). Operative and fluoroscopy times were significantly longer in the SWL group (p = 0.001), and JJ stent insertions were needed after laser URS. CONCLUSION: Ultraslow full-power SWL treatment of patients with upper ureteric stones (< 1.5 cm and ≤ 1000 HU) with an early second session is safe and effective compared to laser URS. Patients who do not respond to early second SWL session should be shifted to another treatment modality.

One-year outcomes from a phase 3 randomized trial of ravulizumab in adults with paroxysmal nocturnal hemoglobinuria who received prior eculizumab.

Ravulizumab every 8 weeks showed non-inferiority to eculizumab every 2 weeks in a 26-week, phase 3, randomized controlled trial in adults with paroxysmal nocturnal hemoglobinuria (PNH) who were clinically stable on eculizumab (NCT03056040). We report results from the first 26 weeks of the extension period in which patients continued ravulizumab (n = 96) or switched from eculizumab to ravulizumab (n = 95). At week 52, mean (SD) lactate dehydrogenase levels increased 8.8% (29%) with ravulizumab-ravulizumab and 5.8% (27%) with eculizumab-ravulizumab from primary evaluation period baseline. During the extension period, four patients (ravulizumab-ravulizumab, n = 3; eculizumab-ravulizumab, n = 1) experienced breakthrough hemolysis, but none associated with serum free C5 ≥ 0.5 µg/mL. Mean Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scores remained stable through week 52. During the extension period, proportions of patients avoiding transfusion remained stable (ravulizumab-ravulizumab, 86.5%; eculizumab-ravulizumab, 83.2%); 81.2% and 81.1%, respectively, had stabilized hemoglobin. All patients maintained serum free C5 levels < 0.5 µg/mL. Adverse events were generally similar between groups, and rates were lower in the extension period. Adults with PNH on stable eculizumab therapy who received ravulizumab over 52 weeks experienced durable efficacy, with consistent efficacy in patients who received eculizumab during the primary evaluation period and then switched to ravulizumab. Ravulizumab was well tolerated.

Postoperative Management of Salivary Gland Tumors.

OPINION STATEMENT: Salivary gland tumors represent a heterogeneous group of neoplasms characterized by varied histologies and disease outcomes. Initial treatment for the primary and gross nodal disease is usually surgery. Management of the clinically node-negative neck depends upon the risk of lymph nodal involvement. This is usually determined by the AJCC "T" stage and histology. Both surgery and radiation may be utilized to address the lymph nodes at risk. This is especially important for minor salivary gland tumors. Radiation plays an important role in the adjuvant management of salivary gland tumors by reducing the risk of locoregional recurrence. Certain histologies like adenoid cystic carcinoma have a predilection for neurotropic spread to the skull base. Radiation is particularly important in controlling disease at the skull base. The role of concurrent chemotherapy in the adjuvant treatment of salivary gland tumors is not established and remains an area of active research. Certain histologies like salivary duct carcinoma exhibit readily identifiable molecular targets amenable to targeted therapy. Finally, advanced testing of these tumors using next-generation sequencing can also potentially identify molecular targets amenable to therapy. While useful in the management of metastatic disease, the role of these therapies in the adjuvant setting remains unknown.

Quality Indicators in Vascular Surgery: Toward a National Consensus on 20 Quality Indicators in Belgium.

BACKGROUND: The aim of the present study is to develop relevant quality indicators (QI) to monitor and improve quality of care in vascular surgery. METHODS: The Delphi method was used to incorporate expert opinion to reach consensus on a set of QI. A national expert panel consisting of 52 vascular surgeons was installed on a voluntary basis and endorsed by the Belgian Society of Vascular Surgery and the Flemish Hospital Network KU Leuven. A task force team consisting of 12 surgeons was created to serve as a delegation of the expert panel to discuss and filter the obtained data from the different Delphi rounds. RESULTS: A total of 3 Delphi rounds were needed to reach consensus on a set of 20 QI. Each QI had a content validity index (using a 7-point Likert scale), a feasibility index, and a target level. Twelve outcome indicators and 8 process indicators on several vascular topics were selected: overall for all vascular treatments (n = 1), arterial occlusive disease in general (n = 3), arterial occlusive disease of the lower limbs (n = 4), arterial occlusive disease of the carotid arteries (n = 5), arterial aneurysm disease in general (n = 2), arterial aneurysm disease with endovascular treatment (n = 1), and venous disease (n = 4). CONCLUSIONS: This resulted in the successful identification of 20 validated and relevant vascular QI, focusing on arterial occlusive disease, arterial aneurysm disease, and venous disease. The next step in this project will be the performance of an implementation study.

Adjuvant addition of capecitabine to early-stage triple-negative breast cancer patients receiving standard chemotherapy: a meta-analysis.

PURPOSE: Triple-negative breast cancer (TNBC) pertains to a breast cancer subtype that has the highest metastatic and recurrence rates. The effectiveness of capecitabine as adjuvant chemotherapy for TNBC has remained unclear. This study conducted a meta-analysis of the efficacy of capecitabine as adjuvant chemotherapy for early-stage TNBC treated with taxane-/anthracycline-based chemotherapy. METHODS: We identified relevant research reports in online databases until May 2019. We finally included seven randomized clinical trials to perform this meta-analysis. Altogether, the seven trials enrolled 3151 early-stage TNBC patients, with 1552 receiving standard (neo)adjuvant chemotherapy regimens and 1599 receiving addition of capecitabine in the adjuvant settings besides standard regimens. RESULTS: A meta-analysis of the seven trials revealed a significant increase in disease-free survival (DFS) with the addition of capecitabine (Hazard ratio (HR) = 0.77, 95% CI 0.66-0.90). This improvement in DFS was significant both in trials conducted in America-Europe and in Asia. In trials involving six to eight cycles of capecitabine addition, we observed a significant improvement in DFS. Furthermore, in the meta-analysis of six trials, we detected a significant increase in overall survival (OS) favoring capecitabine (HR = 0.69, 95% CI 0.56-0.85). CONCLUSIONS: Adjuvant addition of capecitabine to early-stage TNBC patients receiving standard chemotherapy showed significant DFS and OS improvement. Future studies involving the selection of patients that may have the highest survival benefit from adding capecitabine are warranted.