Long-term Clinical Efficacy Research Articles

A Long-Term Follow-up, Multicenter, Comparative Study of the Radiologic, and Clinical Results Between a CaO-SiO2-P2O5-B2O3 Bioactive Glass Ceramics (BGS-7) Intervertebral Spacer and Titanium Cage in 1-Level Posterior Lumbar Interbody Fusion

This is a prospective, stratified randomized, multicenter, 4-year follow-up study. The authors aimed to evaluate the long-term clinical efficacy and safety of CaO-SiO2-P2O5-B2O3 glass ceramics (BGS-7) spacers in 1-level posterior lumbar interbody fusion (PLIF) at a 4-year follow-up. According to 1-year follow-up results, BGS-7 spacer showed similar fusion rates and clinical outcomes compared with titanium cage. A long-term follow-up study beyond 2 years is necessary to investigate the status of intervertebral bone graft volumes. Moreover, longer follow-up is mandatory to also evaluate the safety and efficacy of BGS-7 spacers, because they remain in the intervertebral space for a long time. In this prospective, randomized, multicenter, 4-year follow-up study, we evaluated 62 of the 74 patients who underwent 1-level PLIF. During 1-level PLIF, titanium cages filled with autologous local bone were inserted into the control group patients and BGS-7 spacers were inserted to the experimental group patients. Bone fusion was evaluated by plain radiography and thin-section computed tomography. Visual Analog Scale (VAS), the Oswestry Disability Index (ODI), Short Form-36 Health Survey (SF-36), and evaluation of safety were conducted after 48 months. Computed tomography scan showed a bone fusion rate of 90.6% in the BGS-7 spacer group and 93.3% in the control group, with no significant differences between groups. The BGS-7 spacer group showed a significantly larger area directly fused to the endplate than the control group (P<0.001). The BGS-7 spacer group showed a significant increase in the fused area compared with the titanium group at 1- and 4-year follow-up. The ODI, SF-36, back pain, and lower limb pain in both groups showed significant improvement after surgery, and no significant differences were observed between the groups. Both groups showed no additional adverse events. The 4-year follow-up study showed similar fusion rates and clinical outcomes in both the BGS-7 spacer and autologous bone with a titanium cage in 1-level PLIF. However, the BGS-7 spacer implants showed a larger area of fusion with the endplates than that of autologous bone with a titanium cage. Therefore, the results demonstrated that the BGS-7 spacer can be considered as a novel intervertebral spacer to achieve successful spinal fusion without safety concerns for long-term use.

Implications of early failure of isolated endovascular tibial interventions

BackgroundEndovascular tibial interventions for chronic limb-threatening ischemia are frequent, but the implications of early failure (≤30 days) of an isolated tibial intervention are still unclear. The aim of this study was to examine the patient-centered outcomes after early failure of isolated tibial artery intervention. MethodsA database of patients undergoing lower extremity endovascular interventions between 2007 and 2017 was retrospectively queried. Patients with chronic limb-threatening ischemia (Rutherford classes 4, 5, and 6) were selected, and failures within 30 days were identified. Lack of technical success at the time of the procedure was an exclusion. Intention-to-treat analysis by patient was performed. Patient-oriented outcomes of clinical efficacy (absence of recurrent symptoms, maintenance of ambulation, and absence of major amputation), amputation-free survival (survival without major amputation), and freedom from major adverse limb events (MALEs; above-ankle amputation of the index limb or major reintervention [new bypass graft, jump or interposition graft revision]) were evaluated. ResultsThere were 1779 patients (58% male; average age, 65 years; 2898 vessels) who underwent tibial intervention for chronic limb-threatening ischemia; 284 procedures (16%) were early failures. In the early failure group, 124 cases (44%) were considered immediate (<24 hours), and 160 cases (56%) failed within the first 30 days after intervention. The two modes of failure were hemodynamic failure (47%) and progression of chronic limb-threatening ischemia (53%). Bypass after early failure was successful in patients with adequate vein, target vessel of ≥3 mm, and good inframalleolar runoff. Progression of symptoms was associated with major amputation in patients with Rutherford class 5 and class 6 disease. Presentation with diabetes and end-stage renal disease were identified as independent clinical predictors for early failure. Lesion calcification, reference vessel diameter <3 mm, lesion length >300 mm, and poor inframalleolar runoff were identified as independent anatomic predictors for early failure and increased MALEs. Early failure was predictive of poor long-term clinical efficacy (11% ± 9% vs 39% ± 8% at 5 years, mean ± standard error of the mean, early vs no early failure; P = .01) and amputation-free survival (16% ± 9% vs 47% ± 9% at 5 years, mean ± standard error of the mean, early vs no early failure; P = .02). ConclusionsBoth clinical and anatomic factors can predict early failure of endovascular therapy for isolated tibial disease. Early failure significantly increases 30-day major amputation and 30-day MALEs and is associated with poor long-term patient-centered outcomes.

Northwell intracoronary brachytherapy for the treatment of recurrent drug eluting stent in-stent restenosis (NITDI study group).

The purpose of this study is to report on safety, short-term and long-term clinical efficacy following intracoronary brachytherapy (ICBT) for restenosis (ISR) in patients with drug eluting stents (DES). ICBT is an effective treatment for ISR of bare metal stents (BMS) but its utilization has waned due to the advent of DES. ISR following DES occurs at a frequency of 8% or greater. A retrospective analysis was performed on patients treated on an institutional review board (IRB) approved protocol using ICBT for DES ISR between January 2011 and October 2016. All patients were followed for 24 months for procedural complications, mortality, clinical ISR/target lesion revascularization (TLR) and stroke. A total of 290 patients were identified with a mean age of 66.6 years. All of them had high rates of typical coronary artery disease risk factors. Our primary outcome, composite of in-hospital mortality, myocardial infarction (MI), safety outcomes and procedural failure was noted in 1(0.3%) patient who had a MI. No other secondary outcome was noted in-hospital. At 1-year follow up, 12.4% patients had ISR, 1.7% patients died, and 1 (0.3%) had ischemic stroke. At 2-year, 14.7% had ISR, and total 6 (2.1%) patients had MI. ICBT demonstrates excellent technical success rates for treatment, safety, and reasonable efficacy over 2-years to be free from recurrent clinical ISR. This study represents the largest ICBT data for DES ISR to date among very complex lesion subsets, however, more prospective data will be needed to determine the optimal patient for treatment.

Efficacy and Safety of Hylan G-F 20 Versus Intra-Articular Corticosteroids in People with Knee Osteoarthritis: A Systematic Review and Network Meta-Analysis

Background:Direct injection of corticosteroids into the joint is a standard treatment for knee osteoarthritis (OA). However, the treatment is somewhat controversial with regard to the benefit of both single and repeated injections; evidence that they are beneficial comes from small studies that show only modest improvements. The aim of this study was to estimate the short- and long-term clinical efficacy and safety of hylan G-F 20 versus intra-articular corticosteroids (IACS) for the treatment of pain in knee OA using Bayesian network meta-analysis.Methods:Based on a pre-specified protocol, MEDLINE, Embase, and CENTRAL were searched from inception to June 2018 to identify randomized controlled trials. The Cochrane Collaboration’s tool for assessing risk of bias in randomized trials was used to assess the included studies. Hylan G-F 20 and IACS were compared using Bayesian network meta-analysis. Efficacy was evaluated at 1, 3, and 6 months, and at the final follow-up for safety outcomes. A pain hierarchy was used to select 1 pain outcome per study.Results:Forty-two trials were included for analysis. The network meta-analysis of pain showed that hylan G-F 20 may be equivalent to IACS in the short-term, but by 6 months the benefit relative to IACS was statistically significant, standardized mean difference (95% credible interval): –0.13 (–0.26, –0.01). There were no statistical differences in adverse events.Conclusions:Hylan G-F 20 may perform better in relieving pain at 6 months post-injection compared to IACS. Both agents were relatively well tolerated, with no clear differences in safety.

The Long-Term Clinical Efficacy of Smart Plug in the Treatment of Aqueous Tear Deficiency Dry Eye: Results of a 5-Year Study

Background: Dry eye syndrome, which affects 10% to 20% of adults, is a disorder of the tear film and is associated with symptoms of ocular discomfort. Smart Plug is a mechanical treatment in which the tear drainage system is blocked in order to aid in the preservation of natural tears on the ocular surface. Purpose: To evaluate the long-term clinical efficacy of Smart Plug in the treatment of aqueous tear deficiency dry eye. Patients and Methods: Retrospective study. Three hundred and two patients with aqueous tear deficiency dry eye were enrolled and all the patients accepted the punctual plug of Smart plug from Jan. 2011 to Jan. 2016. The clinical symptoms, Schirmer’s I test, Fluorescein staining (FL), tear break up time (TBUT), and complications were observed and analyzed. Results: Three hundred and two patients (604 eyes) were treated with Smart Plug (22 cases accepted upper and lower punctual plug, 280 cases only lower punctual plug). There were 109 males (36.1%) and 193 females (63.9%) with a mean age of 44.54 years old (Range from 25 to 83 years). Ten cases required the upper Smart Plug after lower punctual plug insertion because of no significantly improved symptoms. Smart plug was removed in 3 patients (1%) due to tearing. Six patients had mild postoperative tearing and no special treatment was required. Lacrimal canaliculitis occurred postoperatively in 8 cases (2.6%) (6 lower and 2 upper), and the affected plug was removed and treated with topical antibiotic eye drops. The BUT, SIT and FL scores of all patients were significantly improved from (2.11 ± 1.01, 4.20 ± 1.07, 6.06 ± 1.97) to (4.34 ± 1.22, 9.01 ± 1.56, 2.33 ± 1.28) respectively after at least 36 months of follow-up (All P P < 0.05). Conclusion: During a mean follow-up of 4.3 years, Smart plug is an effective method for the treatment of aqueous tear deficiency dry eye in spite of its postoperative complications such as canaliculitis and tearing.

Comparison of three digestive tract reconstruction methods for the treatment of Siewert II and III adenocarcinoma of esophagogastric junction: a prospective, randomized controlled study

BackgroundThe incidence of adenocarcinoma of esophagogastric junction (AEG) has recently risen worldwide, including in Eastern Asia. The aim of the study was to explore the short-term and long-term clinical efficacy of piggyback jejunal interposition reconstruction single-tract reconstruction (PJIRSTR), piggyback jejunal interposition reconstruction double-tract reconstruction (PJIRDTR), and total gastrectomy esophageal jejunal Roux-en-Y anastomosis (TGRY) for the treatment of Siewert II and III AEG patients.MethodsA total of 300 Siewert II and III AEG patients admitted to Shanxi Tumor Hospital from June 2015 to December 2017 were prospectively selected. Patients were randomly divided into PJIRSTR group (n = 98), PJIRDTR group (n = 103), and TGRY group (n = 99) using the random number table method.ResultsThere were no statistically significant differences in total operation time, intraoperative blood loss, time of first anal exhaust, and postoperative hospital stay among the three groups (F = 2.526, 0.457, 0.234, 0.453; P > 0.05). The reconstruction time of PJIRSTR group and PJIRDTR group was longer than that of TGRY group (P < 0.01). There were no significant differences in cases of anastomotic leakage, anastomotic bleeding, abdominal infection, incision infection, ileus, and dumping syndrome in three groups (P > 0.05). The incidence of reflux esophagitis at 3, 6, 12, and 18 months after surgery in the PJIRSTR group and the PJIRDTR group were significantly lower than TGRY group in the same period (P < 0.05). Compared with PJIRDTR group and TGRY group, PJIRSTR group had a small fluctuation range of postoperative nutrition indexes and had basically recovered to the preoperative level at 18 months. Four patients of Visick grade IV presented in TGRY group 18 months postoperatively, which was significantly higher compared with the other two groups.ConclusionCompared with PJIRDTR and TGRY, PJIRSTR can significantly reduce the incidence of postoperative reflux esophagitis and improve the long-term nutritional status of patients.Trial registrationChinese Clinical Trial Registry, ChiCTR-IIR-16007733. Registered 07 November 2015 – Retrospectively registered, http://www.chictr.org.cn/searchproj.aspx.

Duration of allergen immunotherapy for inhalant allergy.

We evaluated the time-course of clinical and immunologic changes that occur during and after cessation of sublingual and subcutaneous allergen immunotherapy for inhalant allergies. Increases in production of inhibitory cytokines, such as IL-10 and allergen-specific IgE and IgG4 antibodies are induced within weeks of starting immunotherapy for both seasonal and perennial allergens. In general, 2-4 months' immunotherapy is needed for onset of efficacy whereas maximal clinical effect is achieved within 1-2 years of treatment. Therefore, assuming optimal patient selection, good compliance and at least moderate allergen exposure, if immunotherapy is ineffective at 2 years, it is reasonable to discontinue the treatment. For long-term clinical efficacy, at least 3 years of either subcutaneous or sublingual immunotherapy is required and this results in clinical and immunologic tolerance -- persistence of clinical benefits and suppression of type 2 immunity for years after discontinuation of treatment. Both sublingual and subcutaneous immunotherapy are effective and well tolerated for respiratory allergy. Clinical and immunological changes occur at early stages of treatment. Long-term evaluations support recommendations in international guidelines that both routes of administration should be continued for a minimum of 3 years to achieve disease modification and long-term tolerance.

Ruxolitinib for Patients (Pts) with Polycythemia Vera: Responders Vs Non-Responders As Defined in the Response Trial

Introduction: The RESPONSE trial (NCT01243944) compared ruxolitinib (Rux) and best available therapy (BAT) in pts with polycythemia vera (PV) who were intolerant of or resistant to hydroxyurea (HU) according to modified European LeukemiaNET criteria. In the primary analysis, at week (Wk) 32, 60% of (pts) randomized to Rux achieved HCT control (HCT &lt;45%). The present analysis evaluated the effect of baseline characteristics on HCT response at Wk 32, and aimed to determine the long-term clinical efficacy of Rux in pts who did and did not achieve the protocol-defined HCT control (i.e., HCT control responders and non-responders at Wk 32) in RESPONSE at Wk 256. Methods: Adult pts with phlebotomy-dependent PV with splenomegaly, and resistant to or intolerant of HU were enrolled. Pts were randomized to receive Rux (at a starting dose of 10 mg BID) or single-agent BAT (1:1). HCT control was defined as lack of phlebotomy eligibility between Wks 8−32 with no more than 1 phlebotomy eligibility between randomization and Wk 8. Phlebotomy eligibility was based on protocol-defined HCT values (HCT &gt; 45% and ≥ 3 percentage points higher than baseline or &gt; 48%, whichever was lower; regardless of receipt of phlebotomy), and pts with missing data or assessments outside of protocol-defined time windows were considered non-responders. In this analysis, a logistic regression model was fitted to identify the significant baseline factors to predict HCT control response at Wk 32. Time to phlebotomy eligibility in the HCT control responders and time from the first phlebotomy eligibility to the second phlebotomy eligibility in the HCT control non-responders were plotted, and the changes in hematological parameters (HCT, WBC and platelet count), spleen volume and allele burden over time, up to Wk 256, were studied in HCT control responders and non-responders who were randomized to Rux treatment arm in RESPONSE. Results: A total of 222 pts were randomized to receive either Rux (n = 110) or BAT (n = 112). Baseline WBC (P=0.0198) and baseline JAK2 V617F allele burden (P=0.0159), were found to be predictors of the HCT response within Rux treated pt group (n = 110). In the HCT responder subgroup of the Rux arm, 23% (15/66) pts needed their first phlebotomy by Wk 256. In the HCT non-responder subgroup of the Rux arm, out of 28 patients who experienced their first phlebotomy between Wk 8 and Wk 32, 64% (18/28) of pts required subsequent phlebotomy by Wk 256, with a median duration of 28.4 Wks (12.7, NA). Pts receiving Rux demonstrated controlled hematologic parameters (HCT, WBC, and platelets) over the course of study, regardless of whether they were HCT control responders and HCT control non-responders at Wk 32. From Wk 48 to Wk 80, 97% HCT control responder pts and 84% HCT control non-responder pts of the Rux treatment arm required no phlebotomies. From Wk 80 to Wk 256, 91% and 68% of the evaluable pts in the Rux treatment arm remained phlebotomy-free for HCT control responders and non-responders, respectively. By Wk 256, spleen volume on an average was reduced from baseline by approximately 35% and 50% for HCT control responders and non-responders, respectively. In pts with available assessments, allele burden on an average was reduced approximately from 80% at baseline to 55% at Wk 256 in the HCT control responders, and approximately from 70% at baseline to 40% at Wk 256 in the HCT control non-responders. Conclusions: The results from present analysis demonstrated that the benefits of the Rux treatment were not limited to pts who achieved HCT control at Wk 32. Patients treated with Rux were able to maintain hematological parameters, spleen volume reduction, and JAK2 V617F allele burden reduction for a longer duration (up to 5 years), regardless of whether they were HCT control responders or non-responders at Wk 32. Disclosures Verstovsek: Constellation: Consultancy; Pragmatist: Consultancy; Incyte: Research Funding; Roche: Research Funding; NS Pharma: Research Funding; Celgene: Consultancy, Research Funding; Gilead: Research Funding; Promedior: Research Funding; CTI BioPharma Corp: Research Funding; Genetech: Research Funding; Blueprint Medicines Corp: Research Funding; Novartis: Consultancy, Research Funding; Sierra Oncology: Research Funding; Pharma Essentia: Research Funding; Astrazeneca: Research Funding; Ital Pharma: Research Funding; Protaganist Therapeutics: Research Funding. Kiladjian:Novartis: Honoraria, Research Funding; Celgene: Consultancy; AOP Orphan: Honoraria, Research Funding. Wroclawska:Novartis Pharma AG: Employment. Dong:Novartis: Employment. Vannucchi:Celgene: Membership on an entity's Board of Directors or advisory committees; CTI BioPharma: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Novartis: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Incyte: Membership on an entity's Board of Directors or advisory committees; Italfarmaco: Membership on an entity's Board of Directors or advisory committees.

Long-term clinical safety and efficacy of drug-coated balloon in the treatment of in-stent restenosis: A meta-analysis and systematic review.

The aim of this study was to evaluate the long-term clinical safety and efficacy of drug-coated balloon (DCB) in the treatment of in-stent restenosis (ISR). There is a long-term safety issue in peripheral arterial disease patients treated with paclitaxel-coated balloon, this has also raised concerns on DCB in coronary intervention. Nine randomized controlled trials (RCTs) and nine observational studies (OSs) were included with a total of 3,782 patients (1,827 in the DCB group, 1,955 in the drug-eluting stent [DES] group) being analyzed. The primary outcome measure-major adverse cardiovascular events (MACEs), target lesion revascularization (TLR), target vessel revascularization (TVR), myocardial infarction (MI), cardiac death (CD), stent thrombosis (ST), all-cause death (AD), and coronary angiography outcomes included late lumen loss (LLL), minimum luminal diameter (MLD), diameter stenosis (DS) were analyzed. DCB treatment significantly reduced the LLL (MD: -0.13; [CI -0.23 to -0.03], p = .01). No difference was found for MLD (MD: -0.1; [CI -0.24 to 0.04], p = .17) and DS% (RR = 0.98 [CI 0.80-1.20], p = .86). There was no significant difference in TLR, TVR, MI, CD, ST, AD, and the overall incidence of MACEs between the two groups up to 3 years follow-up. Subgroup analysis for different type of ISR and DES showed no significant difference in the incidence of endpoints, and there is no difference when considering RCTs or OSs only. The safety and efficacy of the DCB and DES in the treatment of ISR is comparable at up to 3 years follow-up.

Long-term efficacy of modified Sauvé-Kapandji procedure for treatment of degenerative arthritis of distal radioulnar joint

Objective To investigate the long-term clinical efficacy of modified Sauve-Kapandji procedure in the treatment of degenerative arthritis of distal radioulnar joint (DRUJ). Methods From June 2010 to April 2015, 16 patients with DRUJ degenerative arthritis were treated with modified Sauve-Kapandji procedure. The ulna of 1.0 to 1.5 cm length was excised at 2 to 3 cm proximal to the ulna head. The distal ulna and DRUJ were fused with the radius. The proximal ulna was suspended with a splited 1/2 extensor carpi ulnaris tendon. After operation, the long arm plaster was fixed for 3 to 4 weeks, then functional exercise was performed, and normal work was restored after bone healing. Results After the operation all the patients were follow-up for 3.3 to 7.0 years with an average of 4.2 years. Postoperative pain relieved, grip strength increased, forearm rotation had no significant effect, and no instability of ulna stump occurred. The pain was improved from 6.2 to 1.5 points by using the visual analogue scales (VAS). The grip strength of both hands was measured by Jamar gripper, and the percentage of grip strength of the affected hand to the healthy side recovered from an average of 30% to 85% after the operation. The total wrist function was assessed by Mayo score from 56 preoperatively to 87 postoperatively, and DASH score from 67 preoperatively to 28 postoperatively. Conclusion The application of modified Sauve-Kapandji procedure for treatment of DRUJ degenerative arthritis can stabilize ulnar stump, prevent wrist instability, relieve wrist-ulnar pain and improve forearm rotation. The clinical effect is satisfactory after operation. Key words: Osteoarthritis; Treatment outcome; Distal radioulnar joint; Sauve-Kapandji procedure

P184511 years of transcatheter aortic valve implantation in a single centre and outcomes for all 1004 patient cases completed

Abstract Background Long-term outcome data after TAVI is of key importance as indications have extended from high risk patients to intermediate risk alongside contemporary study of low risk patients. Purpose We report our complete 11 y experience of TAVI. Methods All patients (n=1004) treated with TAVI in our institution between Feb 2008 &amp; Nov 2018 were included. Data was collected prospectively and all death certificates were reviewed. Independent predictors of mortality were determined by multivariable cox proportional hazard modelling. Annular sizing was performed via echocardiography +/or angiography until Aug 2012 after which time cardiac CT was used. Results Patients were 53% female &amp; had mean age 81.9±6.6 y, logistic EuroScore 18.5%. 89% were NYHA &gt;2, and 26.7% had a left ventricular ejection fraction (LVEF) of &lt;50%. TAVI was performed for severe degenerative aortic valve disease (93.5%), while valve-in-valve (2.4%) bicuspid (2.1%) &amp; rheumatic (2%) made up the remainder. Self-expanding valves were implanted in 73% cases. 98% cases were performed under local anaesthesia. A percutaneous transfemoral approach was used in 92% cases. For the first 6 y 19% procedures were performed for urgent inpatients, rising to 42% over the last 5 y. The mean time to discharge was 5.5 d, overall, &amp; 60% cases were discharged within 72 h in the last 5 y. Mortality, for those at risk, was 3.2%, 12.8%, 53% &amp; 88% at 30 d, 1 y, 5 y &amp; 10 y. The median time to death was 2.6 y. Non-cardiac death accounted for 62% deaths, with sepsis being the main cause (55%). The main cause of cardiac death was heart failure (HF (53%)). Independent clinical predictors of death were increased age, atrial fibrillation, pulmonary disease &amp; LVEF &lt;50%. Use of a 2nd generation valve was associated with better survival at 5 y (p&lt;0.001). 30 d new permanent pacemaker and stroke incidence were 13.7% and 2% respectively. 30 d readmission occurred in 13% patients. Independent clinical predictors of 1 y HF (7%) readmission were NYHA Class &gt;2 and LVEF &lt;50%. Endocarditis was seen in 1.6% during a mean follow-up 2,593 patient y. Mean aortic gradients at 1 y, 5 y &amp; 10 y were 9.7mmHg, 8.4mmHg &amp; 10.53mmHg. One patient had severe trans-aortic regurgitation during the follow-up. A 2nd TAVI procedure was performed in 5 patients with clinically significant paravalvular regurgitation, all within 30 d. Figure 1. A. Survival. B. Predictors death Conclusion This comprehensive evaluation of all patients treated with this innovative technology provides reassurance regarding the long-term clinical efficacy of TAVI &amp; gives insight into the evolution of our programme with time.

Left main percutaneous coronary intervention-Radial versus femoral access: A systematic analysis.

Debate still occurs of the benefits of transradial access (TRA) versus transfemoral access (TFA), especially for complex percutaneous coronary interventions. Recent data has shown equivalent efficacy and improved safety outcomes with TRA. To systematically review and perform a meta-analysis comparing procedural characteristics and clinical outcomes of TRA versus TFA in patients who underwent percutaneous coronary intervention (PCI) for left main (LM) disease. We conducted an electronic database search of all published data for studies that compared TRA with TFA in patients undergoing PCI of LM disease. Event rates were compared using the odds ratio (OR) as a measure of effect size. Random-effects models were used to account for interstudy heterogeneity. A total of 12 observational studies including 17,258 patients (TRA n = 7,971; TFA n = 9,287) were included. Compared to TFA, TRA was associated with a significant reduction in access site bleeding (OR = 0.11; 95% confidence interval [CI] = 0.04-0.26; I2 = 0%; p < .0001), major bleeding (OR = 0.44; 95% CI = 0.27-0.69; I2 = 0%; p = .0005) or any bleeding episode (OR = 0.43; 95% CI = 0.27-0.69; I2 = 12%; p = .0004). Rates of access site or vascular complications (OR = 0.26; 95% CI = 0.17-0.40; I2 = 0%; p < .00001) and in-hospital mortality (OR = 0.49; 95% CI = 0.31-0.79: I2 = 11%; p = .004) were also lower in the TRA group. There were no significant differences in procedural outcomes between TRA and TFA except for a significant reduction in the rate of long-term target vessel revascularization (TVR) in the TRA group (OR = 0.62; 95% CI = 0.41-0.94: I2 = 0%: p = .02). We further performed a subgroup analysis for unprotected left main PCI only, which showed a significant reduction in rates of any bleeding episode, lower access site or vascular complications, and in-hospital mortality with TRA as compared to TFA. Patients undergoing PCI for LM disease via TRA have with less bleeding, reduced access site or vascular complications, reduced in-hospital mortality, comparable procedural success, and possibly better long-term clinical efficacy when compared to those undergoing the procedure via TFA.

A long-term evaluation of experimental potassium oxalate concentrations on dentin hypersensitivity reduction: A triple-blind randomized clinical trial

ObjectiveThe aim of this split-mouth, triple-blind, randomized clinical trial was to evaluate the long-term clinical efficacy of experimental potassium oxalate concentration (10%) in relieving dentin hypersensitivity (DH), after a four-session application protocol. MethodsPotassium oxalate gels with different concentrations (5 and 10%) were randomly assigned to half of the 31 patients from the sample in a split-mouth design. The desensitizers were applied following a four-session protocol, one session every 48 h. The primary outcome was the assessment of pain level with the visual analog scale (VAS, 0–10), at baseline, immediately after each desensitizing session, and also after the seventh day and along 1-,3-, 6-, 9- and 12-months follow-ups. Statistical analyses were performed using Friedman repeated measures and Wilcoxon signed rank tests (α = 0.05). ResultsFor both groups, the minimum of three sessions were required for the achievement of lower DH levels. Regardless of the concentration, the desensitizing effect was maintained all the way to the end of the 6-month follow-up. The 10%-potassium oxalate group was more effective for both 9 and 12-months follow-up periods (p < 0.001). No complications and adverse effects were observed. ConclusionsWhen a four-session protocol is applied, both concentrations of potassium oxalate (5 and 10%) proved to be effective on DH reduction for up to six months. However, the higher concentration promoted better long-term results.Clinical Significance: The DH is an increasing condition in clinical practice, which affects the patient’s life quality. This study provides primary clinical evidence, suggesting that multiple application sessions and higher concentrations of potassium oxalate may result in maintenance of the desensitizing effect for more extended periods.Trial registered under number: ClinicalTrials.gov NCT03083496.

Clinical efficacy evaluation of body acupuncture and scalp acupuncture combined with extracorporeal shock wave for scapulohumeral periarthritis

ObjectiveTo observe the short- and long-term clinical efficacy differences of body acupuncture and scalp acupuncture combined with extracorporeal shock wave and simple extracorporeal shock wave. MethodsSixty patients with scapulohumeral periarthritis were randomly divided into two groups: the treatment group and control group, 30 cases in each one. Both groups underwent basic rehabilitation training. Patients in the treatment group were treated with body acupuncture and scalp acupuncture combined with extracorporeal shock wave.Yújì (鱼际 LU10), Hégŭ (合谷LI4), Zhōngzhŭ (中渚TE3), Hòuxī (后溪SI3). There were three needles for the scalp acupuncture with the first between Shéntíng (神庭 GV 24) and Yìntáng (印堂 EX-HN3), and the other two straightly through the inner canthus and parallel to the first needle. Shock wave treatment was intensively applied in some pressure points around shoulder joint. The control group used the same shock wave therapy as the treatment group. Both groups were all treated once a day, 6 times a week. Patients were treated for one course which lasted for 4 weeks. VAS score, the Constant-Murley score and the HAMA (the Hamilton Anxiety Scale) are as therapeutic effect index. 30 days telephone investigation followed-up after the treatment course was evaluated. ResultsTotally 28 cases completed the clinical observation in the treatment group, and 29 cases in the control group. The total effective rate of the treatment group was 85.7% (24/28), which was higher than 69.0% (20/29) of the control group (P < 0.05). VAS score: There were significant statistical differences before and after the treatment in the two groups (the treatment group: 6.67 ± 1.43 vs 3.47 ± 1.35, the control group: 7.57 ± 1.31 vs 5.36 ± 1.45, both P < 0.05). There were significant statistical differences before the treatment and at the follow-up in the two groups (the treatment group: 6.67 ± 1.43 vs 2.68 ± 0.81, the control group: 7.57 ± 1.31 vs 4.56 ± 1.35, both P < 0.05). The VAS scores of the treatment group after treatment and at the follow-up were respectively lower than those of the control group (both P < 0.05). Shoulder joints activity score: There were significant statistical differences before and after the treatment in the two groups (the treatment group: 54.65 ± 1.65 vs 65.54 ± 2.19, the control group: 54.32 ± 2.31 vs 61.01 ± 0.95, both P < 0.05). There were significant statistical differences before treatment and at follow-up in the two groups (the treatment group: 54.65 ± 1.65 vs 66.18 ± 1.35, the control group: 54.32 ± 2.31 vs 62.11 ± 1.49, both P < 0.05). The shoulder activity scores of the treatment group after treatment and at follow-up were respectively higher than those of the control group (both P < 0.05). HAMA scores: There were singificant statistical differences before and after treatment in the two groups (the treatment group: 16.83 ± 1.56 vs 13.26 ± 2.36, the control group: 17.04 ± 1.84 vs 15.23 ± 3.17, both P < 0.05). There were significant statistical differences before treatment and at follow-up in the two groups (the treatment group: 16.83 ± 1.56 vs 11.01 ± 3.20, the control group: 17.04 ± 1.84 vs 13.68 ± 2.49, both P < 0.05). The HAMA scores of the treatment group after treatment and at follow-up were lower than those of the control group (both P < 0.05). ConclusionBody acupuncture and scalp acupuncture combined with extracorporeal shock wave can relieve the clinical symptoms of patients with scapulohumeral periarthritis, ease anxiety and improve daily life activities.

Non-invasive ventilation for obese patients with chronic respiratory failure: Are two pressures always better than one?

Obesity-related respiratory failure is increasingly common but remains under-diagnosed and under-treated. There are several clinical phenotypes reported, including severe obstructive sleep apnoea (OSA), isolated nocturnal hypoventilation with or without severe OSA and OSA complicating chronic obstructive pulmonary disease (COPD). The presence of hypercapnic respiratory failure is associated with poor clinical outcomes in each of these groups. While weight loss is a core aim of management, this is often unachievable, and treatment of sleep-disordered breathing with positive airway pressure (PAP) therapy is the mainstay of clinical practice. Although there are few long-term clinical efficacy trials, the lack of equipoise would prevent the utilization of an untreated control group. The current data support the use of PAP therapy to improve respiratory failure and is associated with improvements in health-related quality of life, reduced healthcare utilization and reduced mortality. Both continuous PAP (CPAP) and non-invasive ventilation (NIV) appear safe and effective in patients with obesity-related respiratory failure and OSA, with or without COPD, and the current evidence would not support a single therapy choice in all patients. There are no studies of CPAP in patients with isolated nocturnal hypoventilation, and NIV would be the current recommendation in this patient group. Whichever starting therapy is used, titration should be performed to correct sleep-disordered breathing and reverse chronic respiratory failure, with consideration of step-down of the treatment based on a clinical re-evaluation. In contrast, failure to reach physiological and clinical treatment targets should lead to the consideration of treatment escalation.

Mo1910 – Long-Term Clinical Efficacy of Ustekinumab in Refractory Crohn’s Disease: A Multi-Centre Belgian Cohort Study

Mo1910 – Long-Term Clinical Efficacy of Ustekinumab in Refractory Crohn’s Disease: A Multi-Centre Belgian Cohort Study

Long-Term Safety and Efficacy of Fecal Microbiota Transplant in Active Ulcerative Colitis.

The therapeutic role of fecal microbiota transplantation in ulcerative colitis varies across different reports. This study aims to evaluate the long-term safety and efficacy of a strategy called step-up fecal microbiota transplantation for ulcerative colitis. Two clinical trials (NCT01790061, NCT02560727) for moderate-to-severe ulcerative colitis (Mayo score range 6-12) were performed from November 2012 to July 2017. Both studies were pooled for analysis on the safety and efficacy of fecal microbiota transplantation in patients with ulcerative colitis over a 1-year follow-up. The step-up fecal microbiota transplantation strategy included step 1: single fecal microbiota transplantation; step 2: two or more fecal microbiota transplantations; and step 3: fecal microbiota transplantations followed by immunosuppressants. Long-term clinical efficacy and adverse events were assessed, and multiple factors related to fecal microbiota transplantation were evaluated. Of 134 eligible patientsin this real-word study, 81.3% (109/134) were included for analysis. The follow-up ranged from 1 to 5years. Fecal microbiota transplantation-related adverse events were observed in 17.4% (43/247) of fecal microbiota transplantation procedures including one serious adverse event (myasthenia gravis) and 56 non-serious adverse events. Multivariable logistic regression analysis showed that both the method of preparation of microbiota from stool using the automatic system and the delivery method of colonic transendoscopic enteral tubing were associated with a lower rate of fecal microbiota transplantation-related adverse events (p = 0.023, p = 0.017, respectively). In total, 74.3% (81/109) and 51.4% (56/109) of patients achieved clinical response at 1month and 3months after step-up fecal microbiota transplantation, respectively. Fecal microbiota transplantation should be a safe and promising therapy for ulcerative colitis. The improved fecal microbiota preparation and colonic transendoscopic enteral tubing might reduce the rate of adverse events in ulcerative colitis. ClinicalTrials.gov NCT01790061, NCT02560727.

Clinical efficacy of cisplatin, dexamethasone, gemcitabine and pegaspargase (DDGP) in the initial treatment of advanced stage (stage III-IV) extranodal NK/T-cell lymphoma, and its correlation with Epstein-Barr virus.

Objective: To evaluate the clinical efficacy and safety of the DDGP regimen in treating extranodal NK/T-cell lymphoma and investigate the correlation between Epstein-Barr virus (EBV)-DNA variation after treatment and the clinical efficacy of NK/T-cell lymphoma.Methods: Sixty-four patients with extranodal NK/T-cell lymphoma received DDGP regimen-based chemotherapy. Short-term and long-term clinical efficacy and adverse reactions were observed. The relationship between EBV-DNA changes before and after therapy and clinical efficacy was investigated.Results: After the DDGP regimen was used as the initial treatment, the short-term clinical efficacy included 39 complete remission (CR) (60.94%), 12 partial remission (PR) (18.75%), 2 stable disease (SD) (3.13%) and 11 progressive disease (PD) (17.18%). Objective response rate (ORR) was 79.69% and 82.82% for disease control rate (DCR). 3-year progression-free survival (PFS) was 62.00% and 3-year overall survive (OS) was 74.90%. Hemocytopenia was the predominant adverse effect. Between EBV-DNA positive group and its negative counterpart, a significant difference was noted in OS (P=0.046), but no difference in ORR, DCR or PFS was observed. In the EBV-DNA positive group, ORR, DCR, PFS and OS were higher for patients whose EBV-DNA copy number decreased within a normal range than patients remained positive (93.33% versus 61.53%, P=0.041 for ORR; 93.33% versus 61.53%, P=0.041 for DCR, P=0.003 for PFS, P=0.017 for OS). The main adverse reactions included bone marrow suppression, gastrointestinal reaction and coagulation dysfunction, which were mitigated and treated after expectant or dose-decrement treatment.Conclusion: DDGP regimen can significantly improve the clinical prognosis of NK/T-cell lymphoma patients with tolerable adverse reactions. The variation in EBV-DNA is correlated with clinical efficacy and prognosis, which provides a theoretical basis for NK/T-cell lymphoma therapy.Clinical trial: In November 2011, this clinical trial was registered on the website: www.ClinicalTrials.gov (No. NCT01501149).

Polymeric mesh and insulin-like growth factor 1 delivery enhance cell homing and graft-cartilage integration.

Cartilage injury, such as full-thickness lesions, predisposes patients to the premature development of osteoarthritis, a degenerative joint disease. While surgical management of cartilage lesions has improved, long-term clinical efficacy has stagnated, owing to the lack of hyaline cartilage regeneration and inadequate graft-host integration. This study tests the hypothesis that integration of cartilage grafts with native cartilage can be improved by enhancing the migration of chondrocytes across the graft-host interface via the release of chemotactic factor from a degradable polymeric mesh. To this end, a polylactide-co-glycolide/poly-ε-caprolactone mesh was designed to localize the delivery of insulin-like growth factor 1 (IGF-1), a well-established chondrocyte attractant. The release of IGF-1 (100ng/mg) enhanced cell migration from cartilage explants, and the mesh served as critical structural support for cell adhesion, growth, and production of a cartilaginous matrix in vitro, which resulted in increased integration strength compared with mesh-free repair. Further, this neocartilage matrix was structurally contiguous with native and grafted cartilage when tested in an osteochondral explant model in vivo. These results demonstrate that this combined approach of a cell homing factor and supportive matrix will promote cell-mediated integrative cartilage repair and improve clinical outcomes of cartilage grafts in the treatment of osteoarthritis.

Repair of complex abdominal wall hernias with a cross-linked porcine acellular matrix: cross-sectional results of a Dutch cohort study

BackgroundThe use of synthetic mesh in potentially contaminated and contaminated incisional hernias may lead to a higher morbidity and mortality. Biological meshes may provide a solution, but since these meshes are rarely used, little is known about long-term results. The aim of this cohort study was to evaluate the long-term clinical efficacy and patient satisfaction following Permacol™ in complex abdominal wall hernia repair (CAWHR) patients in a cross-sectional fashion. Materials and methodsAll patients were operated for CAWHR with Permacol™ in the Netherlands between 2009 and 2012. The design was a multicenter cross-sectional cohort study. The STROCSS statement was followed. Patients were interviewed, underwent abdominal examination, and completed quality-of-life questionnaires. ClinicalTrials.gov Identifier NCT02166112. Research Registry Identifier researchregistry4713. ResultsSeventy-seven patients were seen in the outpatient clinic. Their hernias were classified as potentially contaminated in 25 patients (32.5%) and infected in 52 patients (67.5%). The mean follow-up was 22.2 ± 12.6 months. The most frequent postoperative complication was wound infection (n = 21; 27.3%), meshes had to be removed in five patients (6.5%). By the time of their visit to the outpatient clinic, 22 patients (28.6%) had a recurrence of whom ten (13%) had undergone reoperation. Thirty-nine patients (50.6%) had bulging of the abdominal wall. Quality-of-life questionnaires revealed that patients graded their health status with a mean 6.8 (± 1.8) out of 10 points. ConclusionBulging and recurrence are frequently observed in patients treated with Permacol™ for CAWHR. Considering both recurrence and bulging as undesirable outcomes of treatment, a total of 46 patients (59.7%) had an unfavorable outcome. Infection rates were high, but comparable with similar patient cohorts. Quality-of-life questionnaires revealed that patients were satisfied with their general health, but scored significantly lower on most quality-of-life modalities of the Short Form-36 questionnaire.