TCT-396: Defining The Incidence Of Late Major Cardiac Adverse Events (mace) In A Non-selected, Complex, Real-world Population: Very Long-term Outcomes (> 4 Years) Of Patients In The Desire-Late Registry

AbstractThere is limited evidence supporting the usefulness of endoscopic retrograde pancreatic drainage (ERPD) for symptomatic pancreaticojejunal anastomotic stenosis (sPJS). We examined the usefulness of ERPD for sPJS. We conducted a retrospective analysis of 10 benign sPJS patients. A forward-viewing endoscope was used in all sessions. Following items were evaluated: technical success, adverse events, and clinical outcome of ERPD. The technical success rate was 100% (10/10) in initial ERPD; 9 patients had a pancreatic stent (no-internal-flap: n = 4, internal-flap: n = 5). The median follow-up was 920 days. Four patients developed recurrence. Among them, 3 had a stent with no-internal-flap in initial ERPD, the stent migrated in 3 at recurrence, and a stent was not placed in 1 patient in initial ERPD. Four follow-up interventions were performed. No recurrence was observed in 6 patients. None of the stents migrated (no-internal-flap: n = 1, internal-flap: n = 5) and no stents were replaced due to stent failure. Stenting with no-internal-flap was associated with recurrence (p = 0.042). Mild adverse events developed in 14.3% (2/14). In conclusions, ERPD was performed safely with high technical success. Recurrence was common after stenting with no-internal-flap. Long-term stenting did not result in stent failure.Clinical trial register and their clinical registration number: Nos. 58-115 and R2-9.

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Alemtuzumab in the long-term treatment of relapsing-remitting multiple sclerosis: an update on the clinical trial evidence and data from the real world

Therapeutic Advances in Neurological Disorders ◽

10.1177/1756285617722706 ◽

2017 ◽

Vol 10 (10) ◽

pp. 343-359 ◽

Cited By ~ 58

Author(s):

Tjalf Ziemssen ◽

Katja Thomas

Keyword(s):

Multiple Sclerosis ◽

Adverse Events ◽

Mechanism Of Action ◽

Real World ◽

Continuous Treatment ◽

The Real ◽

Relapsing Remitting ◽

Remitting Multiple Sclerosis ◽

Relapsing Remitting Multiple Sclerosis

Alemtuzumab is a humanized monoclonal antibody approved for the treatment of relapsing-remitting multiple sclerosis (RRMS), given as two annual courses on five consecutive days at baseline and on three consecutive days 12 months later. Here we provide an update on the long-term efficacy and safety of alemtuzumab in RRMS, including real-world experience, and advances in our understanding of its mechanism of action. Recent data from the phase II/III extension study have demonstrated that alemtuzumab reduces relapse rates, disability worsening, and the rate of brain volume loss over the long term, with many patients achieving no evidence of disease activity. In high proportions of patients, preexisting disability remained stable or improved. Alemtuzumab is associated with a consistent safety profile over the long term, with no new safety signals emerging and the overall annual incidence of reported adverse events decreasing after the first year on treatment. Acyclovir prophylaxis reduces herpetic infections, and monitoring has been shown to mitigate the risk of autoimmune adverse events, allowing early detection and overall effective management. Data from clinical practice and ongoing observational studies are providing additional information on the real-world use of alemtuzumab. Recent evidence on the mechanism of action of alemtuzumab indicates that in addition to its previously known effects of inducing depletion and repopulation of T and B lymphocytes, it also results in a relative increase of cells with memory and regulatory phenotypes and a decrease in cells with a proinflammatory signature, and may further promote an immunoregulatory environment through an impact on other innate immune cells (e.g. dendritic cells) that play a role in MS. These effects may allow preservation of innate immunity and immunosurveillance. Together, these lines of evidence help explain the durable clinical efficacy of alemtuzumab, in the absence of continuous treatment, in patients with RRMS.

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TCT-45 Long Term Safety and Effectiveness of XIENCE V® Everolimus Eluting Coronary Stent System in Real-World Population: Three-Year Clinical Outcomes from the XIENCE V® USA Study

Journal of the American College of Cardiology ◽

10.1016/j.jacc.2012.08.054 ◽

2012 ◽

Vol 60 (17) ◽

pp. B14

Author(s):

James Hermiller ◽

Mitchell Krucoff ◽

weiying zhao ◽

Luis Gruberg ◽

William Lombardi ◽

...

Keyword(s):

Clinical Outcomes ◽

Real World ◽

Coronary Stent ◽

World Population ◽

Stent System

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EP.WE.14Prognostic significance of metabolic syndrome in patients undergoing carotid artery revascularisation: A systematic review and meta-analysis

British Journal of Surgery ◽

10.1093/bjs/znab308.001 ◽

2021 ◽

Vol 108 (Supplement_7) ◽

Author(s):

Shahab Hajibandeh ◽

Shahin Hajibandeh

Keyword(s):

Myocardial Infarction ◽

Systematic Review ◽

Adverse Events ◽

Meta Analysis ◽

Prognostic Significance ◽

Long Term Outcomes ◽

Short Term ◽

All Cause Mortality ◽

Major Adverse Events

Abstract Aims to evaluate prognostic significance of metabolic syndrome (MetS) in patients undergoing carotid artery revascularisation. Methods A systematic review and meta-analysis was performed in compliance with PRISMA standards to evaluate prognostic significance of MetS in patients undergoing carotid endarterectomy or carotid stenting. Short-term (<30 days) postoperative outcomes (all-cause mortality, stroke or transient ischaemic attack (TIA), myocardial infarction, major adverse events) and long-term outcomes (restenosis, all-cause mortality, stroke or TIA, myocardial infarction, major adverse events) were considered as outcomes of interest. Random effects modelling was applied for the analyses. Results Analysis of 3721 patients from five cohort studies showed no difference between the MetS and no MetS groups in terms of the following short-term outcomes: all-cause mortality (OR: 1.67,P=0.32), stroke or TIA (OR: 2.44,P=0.06), myocardial infarction (OR: 1.01,P=0.96), major adverse events (OR: 1.23, P = 0.66). In terms of long-term outcomes, MetS was associated with higher risk of restenosis (OR: 1.75,P=0.02), myocardial infarction (OR: 2.12,P=0.04), and major adverse events (OR: 1.30, P = 0.009) but there was no difference between the two groups in terms of all-cause mortality (OR: 1.11, P = 0.25), and stroke or TIA (OR: 1.24, P = 0.33). The quality and certainty of the available evidence were judged to be moderate. Conclusions The best available evidence suggest that although MetS may not affect the short-term postoperative morbidity and mortality outcomes in patients undergoing carotid revascularisation, it may result in higher risks of restenosis, myocardial infarction and major adverse events in the long-term. Evidence from large prospective cohort studies are required for more robust conclusions.

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Occult catheter rupture causing episodic symptoms in a patient treated with epoprostenol

Pulmonary Circulation ◽

10.1177/2045893217748054 ◽

2017 ◽

Vol 8 (1) ◽

pp. 204589321774805 ◽

Cited By ~ 1

Author(s):

Barbara L. LeVarge ◽

Anica C. Law ◽

Blanche Murphy

Keyword(s):

Pulmonary Hypertension ◽

Pulmonary Arterial Hypertension ◽

Adverse Events ◽

Arterial Hypertension ◽

Long Term Outcomes ◽

Pulmonary Arterial

Infection, thrombosis, and catheter dislodgment are well-recognized potential complications of chronic intravenous prostanoid therapy for pulmonary arterial hypertension. As long-term outcomes of pulmonary hypertension patients improve, novel adverse events are likely to arise. We describe the sudden development of unexplained hypotension and lightheadedness in a patient receiving intravenous epoprostenol for several years, ultimately determined to be due to an unusual catheter complication, not previously described in this population.

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Long-Term Outcomes of Real-World Korean Patients with Atrial-Fibrillation-Related Stroke and Severely Decreased Ejection Fraction

Journal of Clinical Neurology ◽

10.3988/jcn.2019.15.4.545 ◽

2019 ◽

Vol 15 (4) ◽

pp. 545

Author(s):

Jin-Man Jung ◽

Yong-Hyun Kim ◽

Sungwook Yu ◽

Kyungmi O ◽

Chi Kyung Kim ◽

...

Keyword(s):

Atrial Fibrillation ◽

Ejection Fraction ◽

Real World ◽

Long Term Outcomes ◽

Korean Patients

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The long-term outcomes of radiosurgery for arteriovenous malformations in pediatric and adolescent populations

Journal of Neurosurgery Pediatrics ◽

10.3171/2015.1.peds14407 ◽

2015 ◽

Vol 16 (2) ◽

pp. 222-231 ◽

Cited By ~ 29

Author(s):

Shunya Hanakita ◽

Tomoyuki Koga ◽

Masahiro Shin ◽

Hiroshi Igaki ◽

Nobuhito Saito

Keyword(s):

Adverse Events ◽

Arteriovenous Malformations ◽

Therapeutic Option ◽

Long Term Outcomes ◽

Bleeding Rate ◽

Study Institute ◽

Delayed Complications ◽

Risk Of Hemorrhage

OBJECT Although stereotactic radiosurgery (SRS) has been accepted as a therapeutic option for arteriovenous malformations (AVMs) in children and adolescents, substantial data are still lacking regarding the outcomes of SRS for AVMs in this age group, especially long-term complications. This study aimed to clarify the long-term outcomes of SRS for the treatment of AVM in pediatric patients aged ≤ 18 years. METHODS Outcomes of 116 patients who were aged 4–18 years when they underwent SRS between 1990 and 2009 at the study institute were analyzed retrospectively. RESULTS The median follow-up period after SRS was 100 months, with 6 patients followed up for more than 20 years. Actuarial obliteration rates at 3 and 5 years after SRS were 68% and 88%, respectively. Five hemorrhages occurred in 851 patient-years of follow-up. The annual bleeding rate after SRS before obliteration was calculated as 1.3%, which decreased to 0.2% after obliteration. Shorter maximum nidus diameter (p = 0.02) and higher margin dose (p = 0.03) were associated with a higher obliteration rate. Ten patients experienced adverse events after SRS. Of them, 4 patients presented with delayed complications years after SRS (range 9–20 years after SRS). CONCLUSIONS SRS can reduce the risk of hemorrhage in pediatric and adolescent AVMs, with an acceptable risk of complications in the long term. However, adverse events such as expanding hematoma and radiation necrosis that can occur after substantial follow-up should be taken into account at the time that treatment decisions are made and informed consent is obtained.

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