Incidence Of Late Adverse Events Research Articles

Moderately hypofractionated proton beam therapy for localized prostate cancer: 5-year outcomes of a phase II trial.

The usefulness of moderately hypofractionated radiotherapy for localized prostate cancer has been extensively reported, but there are limited studies on proton beam therapy (PBT) using similar hypofractionation schedules. The aim of this prospective phase II study is to confirm the safety of a shortened PBT course using 70Gy relative biological effectiveness (RBE) in 28 fractions. From May 2013 to June 2015, 102 men with localized prostate cancer were enrolled. Androgen deprivation therapy was administered according to risk classification. Toxicity was assessed using Common Terminology Criteria for Adverse Events version 4.0. Of the 100 patients ultimately evaluated, 15 were classified as low risk, 43 as intermediate risk, and 42 as high risk. The median follow-up time of the surviving patients was 96months (range: 60-119months). The 5-year cumulative incidences of grade 2 gastrointestinal/genitourinary adverse events were 1% (95% CI: 0.1-6.9) and 4% (95% CI: 1.5-10.3), respectively; no grade ≥ 3 gastrointestinal/genitourinary adverse events were observed. The current study revealed a low incidence of late adverse events in prostate cancer patients treated with moderately hypofractionated PBT of 70Gy (RBE) in 28 fractions, indicating the safety of this schedule.

Late adverse events to iodinated contrast media in patients treated with IL-2: a safety report from the Danish Renal Carcinoma Group (DaRenCa) study - 1.

A higher incidence of late adverse events (LAEs) to iodinated contrast media in interleukin-2 (IL-2)-treated patients has been reported. To assess the incidence of LAEs after administration of iodinated contrast media in patients with metastatic renal cell carcinoma (mRCC) treated with IL-2. Patients were randomized to treatment with IL-2 and interferon-α with/without bevacizumab in the Danish Renal Carcinoma Group study - 1. Patients underwent a computed tomography (CT) scan at baseline, at one month, at three months, and every third month until RECIST 1.1 defined progression. LAEs due to iodinated contrast media were systematically registered according to the Common Terminology Criteria for Adverse Events classification. In total, 89 patients were included and underwent a total of 507 contrast-enhanced CT scans. An overall incidence of 46 (9.1%) LAEs was observed in 38 of 89 (42.7%) patients; 3 LAEs at baseline (3.4% of all baseline scans), 39 (13.9%) LAEs during IL-2-based therapies, and 4 (2.9%) LAEs after termination of IL-based therapies. There was no difference in progression-free survival, overall survival, and treatment response in patients experiencing LAEs compared to patients without LAEs (P = 0.2, P = 0.5, and P = 0.6, respectively). Patients with mRCC demonstrated a higher incidence of LAEs after administration of iodinated contrast during ongoing IL-2 therapy, indicating that iodinated contrast media may cause a recall phenomenon of IL-2 toxicities in patients with mRCC. Treatment with IL-2 should not be a contraindication for contrast-enhanced scans in patients with mRCC but expertise and vigilance are required.

Long-Term Follow-up of a Randomized Controlled Trial on Accelerated Radiation Therapy Versus Standard Fractionated Radiation Therapy for Early Glottic Cancer (JCOG0701A3)

We previously reported the primary results of JCOG0701, a randomized, multicenter, phase III, non-inferiority trial comparing accelerated fractionation (Ax) to standard fractionation (SF) for early glottic cancer (GC). In the primary results, although the similar efficacy of 3-year PFS and toxicity of Ax compared with SF was observed, the non-inferiority of Ax was not confirmed statistically. To evaluate the long-term follow-up results of JCOG0701, we conducted JCOG0701A3 as an ancillary study of JCOG0701. In JCOG0701, 370 patients were randomly assigned to receive SF of 66-70 Gy (33-35 fractions) (n=184) or Ax of 60-64.8 Gy (25-27 fractions) (n=186). The data cutoff date for this analysis was in June 2020. Overall survival, progression-free survival, and late adverse events including central nervous system ischemia (CNSI) were analyzed. With median follow-up period of 7.1 years (range: 0.1-12.4), PFS of the SF and Ax arms were 76.2% and 78.2% at 5 years and 72.7% and 74.8% at 7 years (p=0.44). OS of SF and Ax arms were 92.7% and 89.6% at 5 years and 90.8% and 86.5% at 7 years (p=0.92). Among 366 patients with a protocol treatment, the cumulative incidence of late adverse events of SF and Ax arms were 11.9% and 7.4% at 8 years (HR: 0.53, 95% CI: 0.28-1.01, p=0.06). CNSI of Grade 2 or higher was observed in 4.1% for SF arms and 1.1% for Ax arm (p=0.098). After a long-term follow-up Ax showed comparable efficacy to SF and a tendency for better safety. Ax may be suitable for early GC because of its convenience in minimizing treatment time, cost, and labor.

Safety of Continuous Erector Spinae Catheters in Chest Trauma: A Retrospective Cohort Study.

The erector spinae block is an efficacious analgesic option for the management of rib fracture--related pain. Despite there being minimal published data specifically addressing the safety profile of this block, many societies have made statements regarding its safety and its use as an alternative to traditional regional anesthesia techniques in patients at risk of complications. The primary aim of this study was to characterize the safety profile of erector spinae plane block catheters by determining the incidence of early complications. The secondary aim of this study was to characterize the incidence of late adverse events, as well as the erector spinae plane block catheter failure rate. We analyzed electronic medical record data of patients who had an erector spinae plane block catheter inserted for the management of rib fractures between November 2017 and September 2020. To assess early adverse events, data collection included hypotension, hypoxemia, local anesthetic systemic toxicity, and pneumothorax thought to be associated with erector spinae plane block catheter insertion. Late complications included catheter site infection and catheter site hematoma. A total of 224 patients received 244 continuous erector spinae catheters during the study period. After insertion of the erector spinae, there were no immediate complications such as hypotension, hypoxia, local anesthetic toxicity, or pneumothorax. Of all blocks inserted, 7.7% were removed due to catheter failure (8.4 per 100 catheters; 95% confidence interval [CI], 5.1-13.9 per 100 catheters). This resulted in a failure rate of 1.9 per 1000 catheter days (95% CI, 1.1-6.7 catheter days). Late complications included 2 erythematous catheter sites and 2 small hematomas not requiring intervention. The incidence of a minor late complication was 16.7 per 1000 catheters (95% CI, 6.1-45.5 per 1000 catheters). This study supports the statements made by regional anesthesia societies regarding the safety of the erector spinae plane block. Based on the results presented in this population of trauma patients, the erector spinae plane block catheter is a low-risk analgesic technique that may be performed in the presence of abnormal coagulation status or systemic infection.

Why not de-intensification for uterine cervical cancer?

ObjectiveThe majority of uterine cervical cancer is known to be related to human papillomavirus (HPV), and HPV-related tumors are known to be radio-sensitive. In the management of HPV-related oropharyngeal cancer, de-intensification of treatment has been attempted; however, no such attempt is performed in the management of cervical cancer. The aim of this study was to identify a group of patients who can safely be treated by de-escalated treatment intensity. MethodsFrom the Asian international multi-institutional retrospective study involving 13 Japanese, one Thailand, and one Korean institutions based on 469 patients, squamous cell carcinoma (Scc), tumor reduction ratio ≥29%, tumor size before brachytherapy ≤4 cm, and total treatment time (TTT) <9 weeks were identified as factors having an influence on local control. Based on these findings, low-risk patients having these four factors were extracted, and treatment outcomes categorized in 10 Gy increment of CTVHR D90 were compared. ResultsAmong 469 patients, 162 patients (34.5%) met the criteria of low-risk group, and 63, 41, 43, and 15 patients were categorized in CTVHR D90 50–60 Gy, 60–70 Gy, 70–80 Gy, and >80 Gy, respectively. While 4-y progression-free survival ranged from 66 to 80%, 4-y local control was consistently over 90% in every dose group. Rectum and bladder D2cc and incidence of late adverse events decreased as CTVHR D90 decreased. ConclusionsThe low-risk patients achieved favorable local control with CTVHR D90 <80 Gy. A personalized treatment strategy based on tumor response could also be adopted for cervical cancer.

Ion therapy guideline (Version 2020)

Ion therapy guideline (Version 2020)

The evaluation of adding induction chemotherapy to concurrent chemoradiotherapy for locally advanced nasopharyngeal carcinoma: a meta-analysis.

We performed a meta-analysis to compare the efficacy and safety of induction chemotherapy (IC) followed by cisplatin-based concurrent chemoradiotherapy (CCRT) versus cisplatin-based CCRT for patients with locally advanced nasopharyngeal carcinoma (LA-NPC). We systematically searched PubMed, the Cochrane Library and Embase until February 29, 2020, for eligible randomized controlled trials (RCTs). The quality of the studies was assessed with the Cochrane Collaboration risk of bias tool. The following outcomes of interest were analyzed: 1) progression-free survival (PFS); 2) overall survival (OS); 3) distant metastasis-free survival (DMFS); 4) locoregional failure-free survival (LRFFS); and 5) any grade 3 or 4 treatment-related adverse events (AEs). The data were pooled with the use of hazard ratios (HRs) or odds ratios (ORs). Subgroup, heterogeneity and sensitivity analyses were performed. After screening all studies selected from the initial search, seven trials with 2233 patients met the inclusion criteria. Compared to cisplatin-based CCRT alone, there was reliable evidence that IC significantly improved PFS (HR 0.65, 95% CI 0.55-0.75, P < 0.00001), OS (HR 0.61, 95% CI 0.45-0.83, P = 0.002), DMFS (HR 0.65, 95% CI 0.53-0.79, P < 0.0001) and LRFFS (HR 0.68, 95% CI 0.53-0.88, P = 0.003) and was associated with a markedly increased risk of AEs (grade 3/4) during the IC and CCRT phases. No significant difference in the incidence of late AEs (grade 3/4) was observed between different arms. Compared to cisplatin-based CCRT alone, IC followed by cisplatin-based CCRT confers real and substantial favorable survival outcomes with controllable toxicities. Therefore, it is reasonable to define IC followed by cisplatin-based CCRT as one of the standard treatment strategies for patients with LA-NPC.

RF37 LATE OUTCOMES OF SURGICAL REPAIR OF TRUNCUS ARTERIOSUS. A 2 DECADES EXPERIENCE

Background and aim: To determine whether the right ventricle outflow tract (RVOT) type of reconstruction is correlated to different outcomes in long term results in patients who survived after surgical repair of truncus arteriosus (TA). Methods: We retrospectively reviewed the outcomes of 30 patients with TA who underwent successful surgical repair in our center between 1994–2017. We analyzed late results according to the type of RVOT repair. Results: Among 30 survivors after TA repair, 6 (20%) were affected by DiGeorge syndrome. The RVOT reconstruction was achieved by means of a conduit (Contegra or Homograft) in 53.6%. In the remaining group of patients, a direct right ventricle-pulmonary artery anastomosis ± interposition of left atrial appendage (LAA) was performed. At a median follow-up time of 12 years (range 4 months-23 years, 93% complete), 6 patients (3 affected by DiGeorge syndrome) died late. Between RVOT groups, there was no difference in terms of late mortality; however, the use of a conduit was significantly associated with a higher risk for reoperation (p 0.021; OR 8.80, 1.35–57.4, Figure 1). Conclusions: Post surgical history of patients with TA is characterized by a higher incidence of late adverse events when RVOT is reconstructed by means of a conduit. Reconstruction of the RVOT with a direct anastomosis and/or left atrial appendage interposition reduces effectively the need for reoperation in long term.

Tratamiento de alta intensidad con estatinas para pacientes estables en monoterapia con ácido acetilsalicílico a los 12 meses de un implante de stent farmacoactivo: estudio aleatorizado

Introduction and objectivesCurrent guidelines on the treatment of blood cholesterol recommend continuous maintenance of high-intensity statin treatment in drug-eluting stent (DES)-treated patients. However, high-intensity statin treatment is frequently underused in clinical practice after stabilization of DES-treated patients. Currently, the impact of continuous high-intensity statin treatment on the incidence of late adverse events in these patients is unknown. We investigated whether high-intensity statin treatment reduces late adverse events in clinically stable patients on aspirin monotherapy 12 months after DES implantation. MethodsClinically stable patients who underwent DES implantation 12 months previously and received aspirin monotherapy were randomly assigned to receive either high-intensity (40mg atorvastatin, n = 1000) or low-intensity (20mg pravastatin, n = 1000) statin treatment. The primary endpoint was adverse clinical events at 12-month follow-up (a composite of all death, myocardial infarction, revascularization, stent thrombosis, stroke, renal deterioration, intervention for peripheral artery disease, and admission for cardiac events). ResultsThe primary endpoint at 12-month follow-up occurred in 25 patients (2.5%) receiving high-intensity statin treatment and in 40 patients (4.1%) receiving low-intensity statin treatment (HR, 0.58; 95%CI, 0.36-0.92; P = .018). This difference was mainly driven by a lower rate of cardiac death (0 vs 0.4%, P = .025) and nontarget vessel myocardial infarction (0.1 vs 0.7%, P = .033) in the high-intensity statin treatment group. ConclusionsAmong clinically stable DES-treated patients on aspirin monotherapy, high-intensity statin treatment significantly reduced late adverse events compared with low-intensity statin treatment.Clinical trial registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01557075.Full English text available from: www.revespcardiol.org/en

High-intensity Statin Treatments in Clinically Stable Patients on Aspirin Monotherapy 12 Months After Drug-eluting Stent Implantation: A Randomized Study

Introduction and objectivesCurrent guidelines on the treatment of blood cholesterol recommend continuous maintenance of high-intensity statin treatment in drug-eluting stent (DES)-treated patients. However, high-intensity statin treatment is frequently underused in clinical practice after stabilization of DES-treated patients. Currently, the impact of continuous high-intensity statin treatment on the incidence of late adverse events in these patients is unknown. We investigated whether high-intensity statin treatment reduces late adverse events in clinically stable patients on aspirin monotherapy 12 months after DES implantation. MethodsClinically stable patients who underwent DES implantation 12 months previously and received aspirin monotherapy were randomly assigned to receive either high-intensity (40mg atorvastatin, n = 1000) or low-intensity (20mg pravastatin, n = 1000) statin treatment. The primary endpoint was adverse clinical events at 12-month follow-up (a composite of all death, myocardial infarction, revascularization, stent thrombosis, stroke, renal deterioration, intervention for peripheral artery disease, and admission for cardiac events). ResultsThe primary endpoint at 12-month follow-up occurred in 25 patients (2.5%) receiving high-intensity statin treatment and in 40 patients (4.1%) receiving low-intensity statin treatment (HR, 0.58; 95%CI, 0.36-0.92; P = .018). This difference was mainly driven by a lower rate of cardiac death (0 vs 0.4%, P = .025) and nontarget vessel myocardial infarction (0.1 vs 0.7%, P = .033) in the high-intensity statin treatment group. ConclusionsAmong clinically stable DES-treated patients on aspirin monotherapy, high-intensity statin treatment significantly reduced late adverse events compared with low-intensity statin treatment.Clinical trial registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01557075.

Radiation with or without Antiandrogen Therapy in Recurrent Prostate Cancer

BackgroundSalvage radiation therapy is often necessary in men who have undergone radical prostatectomy and have evidence of prostate-cancer recurrence signaled by a persistently or recurrently elevated prostate-specific antigen (PSA) level. Whether antiandrogen therapy with radiation therapy will further improve cancer control and prolong overall survival is unknown.MethodsIn a double-blind, placebo-controlled trial conducted from 1998 through 2003, we assigned 760 eligible patients who had undergone prostatectomy with a lymphadenectomy and had disease, as assessed on pathological testing, with a tumor stage of T2 (confined to the prostate but with a positive surgical margin) or T3 (with histologic extension beyond the prostatic capsule), no nodal involvement, and a detectable PSA level of 0.2 to 4.0 ng per milliliter to undergo radiation therapy and receive either antiandrogen therapy (24 months of bicalutamide at a dose of 150 mg daily) or daily placebo tablets during and after radiation therapy. The primary end point was the rate of overall survival.ResultsThe median follow-up among the surviving patients was 13 years. The actuarial rate of overall survival at 12 years was 76.3% in the bicalutamide group, as compared with 71.3% in the placebo group (hazard ratio for death, 0.77; 95% confidence interval, 0.59 to 0.99; P=0.04). The 12-year incidence of death from prostate cancer, as assessed by means of central review, was 5.8% in the bicalutamide group, as compared with 13.4% in the placebo group (P<0.001). The cumulative incidence of metastatic prostate cancer at 12 years was 14.5% in the bicalutamide group, as compared with 23.0% in the placebo group (P=0.005). The incidence of late adverse events associated with radiation therapy was similar in the two groups. Gynecomastia was recorded in 69.7% of the patients in the bicalutamide group, as compared with 10.9% of those in the placebo group (P<0.001).ConclusionsThe addition of 24 months of antiandrogen therapy with daily bicalutamide to salvage radiation therapy resulted in significantly higher rates of long-term overall survival and lower incidences of metastatic prostate cancer and death from prostate cancer than radiation therapy plus placebo. (Funded by the National Cancer Institute and AstraZeneca; RTOG 9601 ClinicalTrials.gov number, NCT00002874.)

Time-related changes in neointimal tissue coverage of a novel Sirolimus eluting stent: Serial observations with optical coherence tomography.

DES has reduced rates of restenosis compared with BMS but it has been associated with delayed healing and increase of stent thrombosis. The aim of our study was to evaluate the vascular time-related changes following implantation of a new SES coated with an amorphous silicon carbide that allows faster re-endothelisation (Orsiro-Biotronik). This prospective registry enrolled STEMI-patients with multi-vessel disease, thus candidates for a two-step procedure. PCI of the culprit lesion was performed with at least one Orsiro stent that was OCT-analysed during the second-step procedure (deferred to 30,90 and 180-days). 16 of the 95 patients with MVD underwent an OCT evaluation of the study device implanted in the culprit lesion during the second-step staged procedure and were enrolled in the present Registry. A total of 3060-struts were analysed. The percentage of uncovered struts was 19.6% at30-days, 1.3% at90-days and 1.8% at180-days (p<0.001). The percentage of cross section with ≥1 uncovered struts were 51.3% at30-days, 6.5% at90-days and 5.7% at180-days (p<0.001). The percentage of cross sections containing thrombus was 6.2% at30-days while no thrombus was detected both at90 and 180-days. Our data shows that the new Orsiro stent promotes early and persistent strut coverage with low peri-strut thrombus. This pilot OCT evaluation might suggest a low incidence of late adverse events and anticipate safe outcome after early withdrawal of dual antiplatelet therapy.

¿Está justificada la cirugía coronaria sin bomba en pacientes de bajo riesgo? Comparación de los resultados a largo plazo de la cirugía con bomba frente a sin bomba en pacientes jóvenes

ObjetiveOff-pump coronary artery bypass grafting (OPCAB) reduces postoperative morbidity in high risk surgical patients, nevertheless recent publications show in them a greater incidence of late adverse events. To assess the safety of OPCAB surgery in patients with a low surgical risk, we analyzed mid term results in young patients. MethodsIt was a retrospective and observational study. All patients younger than 65 years, submitted to coronary artery bypass grafting (CABG) during 2009 and 2010 were included. Patients were classified in On-pump and Off-pump revascularization. Long term clinical follow-up was conducted. The primary objective of the study was to analyze the composite end-point of hospital readmission due to acute coronary syndrome (ACS), new revascularization, stroke and death of cardiovascular origin. ResultsThe study included 200 patients; 105 (52.5%) On-pump and 95 (47.5%) Off-pump. Mean logistic Euroscore was 2.43% (Standard deviation 3.85%), with a mean age of 57.26 years (Standard deviation 5.96 years). Mean follow-up was 29 months (18-41 months). Off-pump patients had significantly less adverse events (4.2% Off-pump; 17.1% On-pump; P=.004), with a significant decrease in hospital readmission due to ACS (1.1% Off-pump; 7.6% On-pump; P=.037) and lesser cardiovascular death (1.1 Off-Pump; 6.7% On-Pump; P=.043).In survival analysis, OPCAB was significantly associated with a better outcome (hazard ratio 0.246; P=.011). ConclusionOPCAB is not associated with worse late outcome than On-pump CABG in patients younger than 65 years.

Covered Self-expanding Metal Stents May be Preferable to Plastic Stents in the Treatment of Chronic Pancreatitis-related Biliary Strictures

Covered self-expanding metal stents (CSEMS) are being increasingly used in the endoscopic treatment of benign biliary strictures (BBS). There is no solid evidence yet to support their routine use. To evaluate feasibility, success rate, and complications of CSEMS compared with multiple plastic stents (PS) in BBS in a systematic review. A systematic search of electronic databases (Medline, Scopus, and Embase) for studies published from 2000 to 2012 combined to hand-search of reference lists resulted 4977 articles. Out of 99 potentially relevant studies selected for full-text review, 12 CSEMS (376 patients) and 13 PS studies (570 patients) met the final inclusion criteria. A systematic review comparing the 2 methods was made using proportion meta-analysis. A tendency to successful use of CSEMS in strictures related to chronic pancreatitis (CP) was shown: clinical success of 77% and 33% [95% confidence interval (CI), 61%-94% vs. 4%-63%, P=0.06] was achieved with CSEMS and PS at 12 months follow-up, respectively. There were no differences in the success rates of other etiologies except CP or in the early complications. In CSEMS, incidence of late adverse events was lower in CP-related strictures (3% vs. 67%, 95% CI, 0%-13% vs. 17%-99%, P=0.02). The median number of endoscopic retrograde cholangiopancreatographies was lower with CSEMSs: 1.5 versus 3.9 (P=0.002). Improved clinical success with fewer endoscopic sessions and corresponding complication rate may be achieved with CSEMS treatment compared with PS in BBS secondary to CP. In other BBS etiologies, this systematic review remains inconclusive.

Late Adverse Events after Enhanced and Unenhanced MRI and CT: A Prospective Study

Prospective evaluation of frequency of late and very late adverse events in patients undergoing enhanced or unenhanced magnetic resonance imaging (MRI) or computed tomography (CT). The imaging procedure was performed according to the protocols of the department. All patients were contacted 3days after their imaging procedure for the occurrence of late adverse events (LAEs) and a month later for the occurrence of very late adverse events (VLAEs) using a structured questionnaire. A total of 1042 (71%) among 1473 patients completed both the 3-day and 1-month questionnaire. The incidence of LAEs was significantly higher in the enhanced MRI (38%) and CT (27%) groups than unenhanced MRI (20%) and CT (16%) groups. The frequency of nausea, dizziness, abdominal pain and diarrhoea was significantly higher in the enhanced MRI group than in the MRI control group, while taste sensation was reported more frequent in the enhanced CT group than in the CT control group. The incidence of VLAEs was significantly higher in the enhanced CT (21%) than unenhanced CT group (13%). The same LAEs and VLAEs were reported in all four groups. LAEs and VLAEs were reported more often in patients with allergy in both the enhanced and unenhanced groups. The incidence of LAEs and VLAEs was higher in the enhanced groups than in the unenhanced groups. The most reported adverse events in the enhanced groups were also reported in the unenhanced groups. Patients with allergy reported LAE and VLAE more often. This suggests that adverse events may not always be caused by the contrast media.

Indirect diagnosis of pancreatic exocrine insufficiency (PEI) in chronic pancreatitis (CP) by endoscopic ultrasound (EUS)-guided elastographic quantification of pancreatic fibrosis: A prospective observational study

s / Pancreatology 13 (2013) S2–S98 S75 b)When comparedwith abstainers, heavy drinker intake is a risk factor to develope CP (p1⁄40,038; O.R1⁄42,583) c) Pancreas divisum is a risk factor to develope ARP (p1⁄40,000; O.R1⁄410,533) but not CP. d) Moderate alcohol intake is not statistically significant in both ARP and CP. Conclusion: Heavy alcohol consumption and smoking inhabits are independent risks for CP. Pancreas divisum is a risk factor to develope ARP. PII-75 Abstract id: 197. Covered self-expanding metal stents (CSEMS) may offer improved clinical success compared to multiple plastic stents (PS) in strictures secondary to chronic pancreatitis: A systematic review and metaanalysis Antti Siiki , Mika Helminen , Juhani Sand , Johanna Laukkarinen . Dept. of Gastroenterology and Alimentary Tract Surgery, Tampere University Hospital, Tampere, Finland 2 Science Center, Pirkanmaa Hospital District and School of Health Sciences, University of Tampere, Tampere, Finland Introduction: CSEMS are being increasingly used in the endoscopic treatment of benign biliary strictures (BBS). Despite promising results, there is not yet solid evidence to support their routine use. Aims: To evaluate feasibility of CSEMS compared to PS in BBS in terms of clinical success and complications. Materials & methods: A systematic search of Medline, Scopus and Embase database for studies published 2000-2012 combined to handsearch of reference lists resulted 4977 articles. Out of 99 potentially relevant studies selected for full-text review, 12 CSEMS (376 patients) and 13 PS studies (570 patients) met the final inclusion criteria. A systematic review was made using proportion meta-analysis. Results: A tendency to successful use of CSEMS in strictures related to chronic pancreatitis (CP) was shown: clinical success of 77% and 33% (95% CI 61-94% vs. 4-63%, p1⁄40.06) was achieved with CSEMS and PS at 12 months follow-up, respectively. There were no differences in the success rates of other etiologies except CP or in the early complications. In CSEMS, incidence of late adverse events was lower in CP related strictures (3% vs. 67%, 95%CI 0-13% vs. 17-99%, p1⁄40.02). The median number of ERCPs was lower with CSEMSs (1.5 vs. 3.9, p1⁄40.002). Conclusion: Improved clinical success with fewer endoscopic sessions and corresponding complication rate may be achieved with CSEMS compared to PS in BBS secondary to chronic pancreatitis. PII-76 Abstract id: 182. Indirect diagnosis of pancreatic exocrine insufficiency (PEI) in chronic pancreatitis (CP) by endoscopic ultrasound (EUS)-guided elastographic quantification of pancreatic fibrosis: A prospective observational study J. Enrique Dominguez-Mu~ noz , Margarita Casti~ neira-Alvari~ no , Maria Luaces-Regueira , Jos e Lari~ no-Noia , Laura Nieto-Garcia , Julio IglesiasGarcia . University Hospital of Santiago. Foundation for Research in Digestive Diseases, Spain 2 Foundation for Research in Digestive Diseases, Spain Introduction: Diagnosis of PEI is hindered by methodological difficulties of pancreatic function tests. The probability of PEI increases as fibrosis develops. Pancreatic fibrosis in CP can be quantified by EUS-guided elastography. Aims:We aimed at evaluating if pancreatic elastography can be used to predict PEI in patients with CP. Materials & methods: Prospective observational study including patients consecutively diagnosed with CP based on EUS ( 5 criteria) and/or s-MRCP findings. PEI was diagnosed by 13C-mixed triglyceride breath test and defined as a 13C-cumulative recovery rate 5.5). Conclusion: The degree of pancreatic fibrosis as measured by EUSguided elastography allows quantifying the probability of PEI, and thus the need for oral pancreatic enzyme therapy, in patients with CP PII-77 Abstract id: 296. Morphological features of pancreatic cystic lesions in endoscopic ultrasonography (EUS) examination – A single-center experience Malgorzata Degowska, Marek Stobinski, Janusz Milewski, Grazyna

C-Reactive Protein and Cardiovascular Diseases

C-reactive protein (CRP) is a unique risk marker and plays a role in the pathogenesis of inflammation and atherosclerosis. It is synthesized and secreted mainly by hepatocytes in response to interleukin-6 (IL-6) and either IL-1 or tumor necrosis factor-alpha. The average plasma half life of CRP is 19 hours. CRP activates complement, increases phagocytic activity of neutrophils, increases respiratory burst of neutrophils, and induces expression of adhesion molecules, synthesis of tissue factor, cytokines from monocytes and platelet aggregation. CRP is involved in development of atherosclerosis and thrombosis. High sensitive-CRP (hs-CRP) is a very novel biochemical marker. It is elevated in various conditions including: inflammation both acute and chronic, acute myocardial infarction, unstable angina, peripheral vascular diseases, diabetes, renal disease, hypertension, and cardiopulmonary bypass. A positive association has been reported between CRP levels and age, smoking, body mass, total cholesterol, lipoprotein a [Lp(a)], homocysteine and fibrinogen. It has a predictive value for the development of peripheral vascular disease, restenosis following percutaneous coronary interventions with or without stent implantation, and complications following cardiopulmonary bypass. Preprocedural high levels of plasma CRP are associated with high incidence of late adverse events (composite of cardiac death, nonfatal myocardial infarction, clinical occurrence of symptoms, progression of significant coronary lesion in vessels other then treated ones) after successful coronary stenting. Baseline levels of CRP predict risk of future myocardial infarction, and stroke in apparently healthy middle-aged men and women. CRP levels predict atherosclerotic vascular disease in patients with end-stage renal disease. Increased pretransplant CRP levels are associated with higher risk of acute rejection in transplant recipients. Various strategies to reduce the adverse effects of CRP have been discussed.

Long‐term risk of clinical events from stenting side branches of coronary bifurcation lesions with drug‐eluting and bare‐metal stents: An observational meta‐analysis

To compare the long-term risks of coronary bifurcation lesions treated with side-branch stenting using drug-eluting versus bare-metal stents. Side-branch stenting is an off-label practice, but when needed, the incidence of late adverse events may differ between drug-eluting and bare-metal stents. We systematically searched PubMed, and the National Institutes of Health and Cochrane Registries for studies of coronary bifurcation stenting reporting clinical outcomes over at least 5 months. Data were extracted and cross checked independently by two investigators for inclusion in an observational meta-analysis. Clinical outcomes included major adverse clinical events (MACE), death, myocardial infarction, target vessel revascularization (TVR), and definite stent thrombosis. We used random-effects models and meta-regression in 6,825 subjects from 42 studies. Most (79%) of the heterogeneity in MACE between treatment groups was explained by differences in stent type, side-branch stenting, and length of follow-up. Compared with drug-eluting stents without side-branch stenting, drug-eluting stents with side-branch stenting had a 3% higher incidence of myocardial infarction [95% confidence interval (CI) = 0.3%, 5%, P < 0.05], but no significant increase in MACE, death, TVR, or stent thrombosis. Bare-metal stenting without side-branch stenting had 10% (95% CI = 3%, 16%, P < 0.01) higher MACE, and 10% (95% CI = 4%, 17%, P < 0.01) higher TVR, whereas bare-metal side-branch stenting had 31% (95% CI = 23%, 39%, P < 0.001) higher MACE, and 19% (95% CI = 10%, 28%, P < 0.001) higher TVR. Side-branch stenting has a much smaller impact on long-term MACE with drug-eluting stents compared with bare-metal stents. Although this study does not support routine side-branch stenting, when side-branch stenting is required, drug-eluting stents are associated with less adverse outcomes.

Midterm results of surgical intervention for congenital heart disease in adults: An Italian multicenter study

We have analyzed, in a clinical multicenter study, the effect of cardiac surgery in adults with congenital heart disease in Italy. We collected clinical data from 856 patients aged 19 years or older who underwent surgical intervention from January 1, 2000, to December 31, 2004. Patients were divided into 3 surgical groups: group 1, palliation (3.1%); group 2, repair (69.7%); and group 3, reoperation (27.4%). Preoperatively, 34.6% of patients were in New York Heart Association class I, 48.4% were in class II, 14.2% were in class III, and 2.8% were in class IV. Sinus rhythm was present in 83%. There were 1179 procedures performed in 856 patients (1.37 procedures per patient), with a hospital mortality of 3.1%. Overall mean intensive care unit stay was 2.3 days (range, 1-102 days). Major complications were reported in 247 (28.8%) patients, and postoperative arrhythmias were the most frequent. At a mean follow-up of 22 months (range, 1 month-5.5 years; completeness, 87%), late death occurred in 5 (0.5%) patients. New York Heart Association class was I in 79.3%, II in 17.6%, and III in 2.9%, and only 1 (0.11%) patient was in class IV. Overall survival estimates are 82.6%, 98.9%, and 91.8% at 5 years for groups 1, 2, and 3, respectively. Freedom from adverse events at 5 years is 91% for acyanotic patients versus 63.9% for preoperative cyanotic patients (P < .0001). Surgical intervention for congenital heart disease in adults is a safe and low-risk treatment. However, patients presenting with preoperative cyanosis show a higher incidence of late adverse events and complications.

The impact of plasma levels of C-reactive protein, lipoprotein (a) and homocysteine on the long-term prognosis after successful coronary stenting: The global evaluation of new events and restenosis after stent implantation study

ObjectivesThe objective of this study was to evaluate the association of high plasma levels of either C-reactive protein (CRP), lipoprotein (a) (Lp[a]) or total homocysteine (tHCY) with the long-term prognosis after successful coronary stenting (CS) BackgroundHigh plasma levels of either CRP, Lp(a) or tHCY may have an impact in coronary artery disease. However, long-term prospective data after coronary stenting (CS) are limited. MethodsFour-hundred and eighty-three consecutive patients with either stable or unstable coronary syndromes were followed for up to three years after successful CS. The composite of cardiac death, myocardial infarction or rehospitalization for rest unstable angina, whichever occurred first, was the prespecified primary end point. Moreover, the one-year incidence of clinical recurrence of symptoms, in-stent restenosis (ISR) and progression of atherosclerosis to a significant lesion (PTSL) were additionally evaluated. PTSL was defined as an increase by at least 25% in the luminal diameter stenosis of a known nonsignificant lesion (≤50% luminal diameter stenosis) that was located in a nonintervened vessel at restudy, resulting in an angiographically significant lesion (≥70% luminal diameter stenosis). ResultsBy the end of the follow-up, high plasma levels of either CRP or Lp(a) but not tHCY were independently associated with the primary end point. In particular, CRP ≥0.68 mg/dl (p < 0.001) or Lp(a) ≥25 mg/dl (p = 0.003) conferred a significantly increased risk. By 1 year, a CRP ≥0.68 mg/dl conferred a significantly increased risk for clinical recurrence of symptoms (p < 0.001) or PTSL (p < 0.001). None of the studied biochemical markers was related to ISR. ConclusionsHigh plasma levels of either CRP or Lp(a) but not tHCY may be associated with a higher incidence of late adverse events after successful CS. PTSL in vessels not previously intervened upon may play a significant role in the underlying pathophysiology as opposed to ISR.