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Circulation. Arrhythmia and... Apr 2016Recent results from the largest multicenter randomized trial (Shockless IMPLant Evaluation [SIMPLE]) on defibrillation threshold (DFT) testing suggest that while shock... (Review)
Review
BACKGROUND
Recent results from the largest multicenter randomized trial (Shockless IMPLant Evaluation [SIMPLE]) on defibrillation threshold (DFT) testing suggest that while shock testing seems safe, it does not reduce the risk of failed shocks or prolong survival. A contemporary systematic review of DFT versus no-DFT testing at the time of implantable cardioverter-defibrillator implantation was performed to evaluate the current evidence and to assess the impact of the SIMPLE study.
METHODS AND RESULTS
Electronic searches were performed using 6 databases from their inception to March 2014. Relevant studies investigating implant DFT were identified. Data were extracted and analyzed according to predefined clinical end points. Predefined outcomes for interrogation were all-cause mortality, composite end point of implantable cardioverter-defibrillator efficacy (arrhythmic deaths and ineffective shocks), and composite safety end point (the sum of complications recorded at 30 days). Meta-analysis was performed including 13 studies and 9740 patients. No significant differences between DFT versus no-DFT cohorts were found in terms of all-cause mortality (risk ratio, 0.90; 95% confidence interval, 0.71-1.15; P=0.41), composite efficacy outcome (risk ratio, 1.24; 95% confidence interval, 0.65-3.37; P=0.51), and 30-day postimplant complications (risk ratio, 1.18; 95% confidence interval, 0.87-1.60; P=0.29). No significant difference was found in the trends observed when the results of the SIMPLE study were excluded or included.
CONCLUSIONS
This systematic review of contemporary data suggests a modest average effect of DFT, if any, in terms of mortality, shock efficacy, or safety. Therefore, DFT testing should no longer be compulsory during de novo implantation. However, DFT testing may still be clinically relevant in specific patient populations.
Topics: Arrhythmias, Cardiac; Defibrillators, Implantable; Electric Countershock; Heart Conduction System; Humans
PubMed: 27030699
DOI: 10.1161/CIRCEP.115.003357 -
Clinical Kidney Journal Oct 2018antineutrophil cytoplasmic antibody-associated vasculitis typically arises in post-reproductive years, but can occur during pregnancy. Concerns of treatment-related...
BACKGROUND
antineutrophil cytoplasmic antibody-associated vasculitis typically arises in post-reproductive years, but can occur during pregnancy. Concerns of treatment-related teratogenicity persist, while efficacy and safety of new therapies including intravenous immunoglobulin (IVIG) and rituximab are uncertain. There remains a paucity of maternal, fetal and pregnancy outcome data in these women, and therefore a lack of guidance on safe treatment for clinicians.
METHODS
We conducted a systematic review of the literature and a local, retrospective chart review of women with antibody-associated vasculitis (AAV) in pregnancy. Cochrane, Embase and PubMed databases and relevant conference abstracts were searched. Patient demographics, clinical presentation, management and outcomes (maternal, fetal and pregnancy-related) were analyzed.
RESULTS
Twenty-seven cases of AAV in pregnancy were included. Women presented were from 5 to 39 weeks' gestation, of which a majority were in the second trimester (median 20 weeks). The median gravida of women was 2 and the median parity was 1. Women were treated with steroids (89%), cyclophosphamide (CYC) (37%), other immunosuppressive agents [azathioprine (AZA), IVIG, plasma exchange (PLEX)] or no therapy (11%). High rates of serious complications, including preeclampsia (29%) and maternal death (7%), were reported; however, most pregnancies resulted in live birth (73%). Prematurity was common; 73% of live births occurred prior to 37 weeks' gestation and 40% prior to 34 weeks' gestation. The majority of infants were born in the third trimester (median 34.5 weeks). Rates of pregnancy termination were high (23%) and only one intrauterine death was reported, shortly after initiation of therapy (4%). Congenital abnormalities were rare, with one infant having a solitary, pelvic kidney (6%) after maternal treatment with steroids, CYC and PLEX. Use of PLEX, IVIG and AZA increased after 2005, whereas CYC use decreased. Remission often occurred postpartum (60%).
CONCLUSIONS
AAV in pregnancy can result in uncomplicated pregnancies; however, serious maternal risks exist. Further data on potentially pregnancy compatible therapies such as IVIG and rituximab are needed in this population.
PubMed: 30288261
DOI: 10.1093/ckj/sfy011 -
European Journal of Vascular and... Jul 2021The efficacy and cost effectiveness of atherectomy for femoropopliteal (FP) arterial diseases have not been determined yet. A systematic review and meta-analysis were... (Comparative Study)
Comparative Study Meta-Analysis
Atherectomy Combined with Balloon Angioplasty versus Balloon Angioplasty Alone for de Novo Femoropopliteal Arterial Diseases: A Systematic Review and Meta-analysis of Randomised Controlled Trials.
OBJECTIVE
The efficacy and cost effectiveness of atherectomy for femoropopliteal (FP) arterial diseases have not been determined yet. A systematic review and meta-analysis were performed to compare the efficacy and safety between atherectomy combined with balloon angioplasty (BA) and BA alone for patients with de novo FP steno-occlusive lesions.
METHODS
The Cochrane Library, Medline, and Embase were used to search for studies evaluating outcomes of atherectomy combined with BA compared with BA alone in FP arterial diseases from inception to July 2020. The methodological quality of the included studies was evaluated with the Cochrane Risk of Bias Tool. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework was used to assess the level of evidence for each outcome. The fixed effects model was chosen to combine the data when I < 50%; otherwise, the random effects model was used. Subgroup and sensitivity analyses were performed to further analyse the results.
RESULTS
Four RCTs were included. The meta-analysis showed that atherectomy combined with BA was associated with improved technical success rate (risk ratio [RR] 0.22, 95% confidence interval [CI] 0.13-0.38, p < .001; I = 0; high quality), reduced bailout stenting (RR 0.15, 95% CI 0.07-0.32, p < .001; I = 16%; high quality), and flow limiting dissection (RR 0.24, 95% CI 0.13-0.47, p < .001; I = 0; high quality). No statistically significant difference was found in target lesion revascularisation (TLR), primary patency, mortality, major adverse event (MAE), or ankle brachial index (ABI) after one year follow up.
CONCLUSION
Compared with BA alone, atherectomy combined with BA may not improve primary patency, TLR, mortality rate, or ABI, but may reduce the need for bailout stenting and the incidence of flow limiting dissection and increase the technical success rate in FP arterial diseases. More studies are warranted to further confirm the conclusion.
Topics: Aortic Dissection; Angioplasty, Balloon; Ankle Brachial Index; Atherectomy; Combined Modality Therapy; Femoral Artery; Follow-Up Studies; Humans; Peripheral Arterial Disease; Postoperative Complications; Randomized Controlled Trials as Topic; Stents; Treatment Outcome; Vascular Patency
PubMed: 34112574
DOI: 10.1016/j.ejvs.2021.02.012 -
Annals of Transplantation Dec 2021BACKGROUND Tacrolimus is an established component of immunosuppressive regimens for kidney transplant recipients (KTRs); however, data comparing long-term outcomes... (Meta-Analysis)
Meta-Analysis
Efficacy and Safety of Tacrolimus-Based Maintenance Regimens in De Novo Kidney Transplant Recipients: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials.
BACKGROUND Tacrolimus is an established component of immunosuppressive regimens for kidney transplant recipients (KTRs); however, data comparing long-term outcomes between formulations are lacking. We conducted a systematic literature review and network meta-analysis assessing tacrolimus (primarily Advagraf [once-daily] and Prograf [twice-daily])-based maintenance regimens. MATERIAL AND METHODS Embase, MEDLINE, and Cochrane databases and congress proceedings were searched to identify studies of adult de novo KTRs who received tacrolimus-based therapy in phase II/III randomized controlled trials. Outcomes were acute rejection, graft/patient survival, and incidence of new-onset diabetes mellitus after transplantation (NODAT) and cytomegalovirus (CMV) infection. Bayesian network meta-analysis was used to analyze treatment effects on graft/patient survival. RESULTS Sixty-eight publications (61 primary) were included. Of 21 publications reporting graft rejection following Advagraf or Prograf treatment in ≥1 study arm, 12-month biopsy-proven acute rejection (BPAR) ranged from 3.3% with Prograf to 55.0% with mycophenolic acid (MPA)+corticosteroids (CS); >24 month BPAR ranged from 0% to 58.7% (the latter with bleselumab-based therapy). Fourteen publications reported graft loss following Advagraf (0-9.6%) or Prograf (0-7.5%). Patient mortality ≤24 months after transplantation (14 publications) ranged from 0% to 8.1% with Advagraf or Prograf. Advagraf+MPA+CS and reference treatment, Prograf+MPA+CS, were associated with a similar risk of graft loss (odds ratio 1.19; 95% credible-interval 0.51, 3.06) and mortality (odds ratio 1.21; 95% credible-interval 0.1557, 9.03). Incidence of NODAT and CMV varied by treatment arm. CONCLUSIONS Graft loss and patient mortality rates were generally comparable between Advagraf- and Prograf-based regimens. Further prospective studies are needed to evaluate longer-term outcomes.
Topics: Adult; Bayes Theorem; Graft Rejection; Humans; Immunosuppressive Agents; Kidney Transplantation; Network Meta-Analysis; Randomized Controlled Trials as Topic; Tacrolimus
PubMed: 34963678
DOI: 10.12659/AOT.933588 -
Nephrology, Dialysis, Transplantation :... Aug 2018Pre-transplant donor-specific anti-human leukocyte antigen antibodies (DSAs) are known risk factors for acute rejection and reduced graft survival after kidney...
BACKGROUND
Pre-transplant donor-specific anti-human leukocyte antigen antibodies (DSAs) are known risk factors for acute rejection and reduced graft survival after kidney transplantation. DSAs may also develop de novo DSAs (dnDSAs) after transplantation but the clinical implications of these antibodies remain uncertain.
METHODS
We undertook a systematic review of observational studies that examined the association between dnDSAs and graft and patient outcomes (through August 2017) with the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system of reporting used to assess the quality of evidence available.
RESULTS
Thirty-six studies involving 10 535 transplant recipients were eligible. There was moderate quality evidence that transplant recipients who developed dnDSAs had increased risks of acute antibody-mediated rejection (AMR) [relative risk (RR) 9.66; 95% confidence interval (CI) 6.79-13.73, 16 studies, n = 4174]. For all other outcomes, the evidence was low to very low due to moderate-high heterogeneity and low study quality (acute cellular rejection, RR 2.92; 95% CI 2.16-3.94, 22 studies, n = 4991, low-quality evidence; chronic AMR and transplant glomerulopathy RR 6.78; 95% CI 4.31-10.66, 3 studies, n = 1617, very low-quality evidence; and graft loss RR 4.95; 95% CI 3.81-6.43, 19 studies, n = 5473, low-quality evidence). Meta-regression indicated that deceased kidney donation (R2 = 1.00, P < 0.001) and region of study conduction (R2 = 0.50, P = 0.005) modified associations between dnDSAs and outcomes.
CONCLUSIONS
dnDSAs are associated with increased risks of adverse graft and patient outcomes after kidney transplantation, but estimation uncertainty of the augmented risks exist due to limitations such as heterogeneity within the existing literature. Therapeutic interventions targeted to eliminate or prevent these antibodies evaluated in randomized controlled trials are needed to establish whether dnDSAs are causal to transplantation outcomes.
Topics: Graft Rejection; Graft Survival; HLA Antigens; Humans; Kidney; Kidney Failure, Chronic; Kidney Transplantation; Tissue Donors
PubMed: 29660004
DOI: 10.1093/ndt/gfy077 -
Parkinsonism & Related Disorders Sep 2020In Parkinson's disease (PD), impulsive-compulsive behaviors (ICBs) may develop as side-effect of dopaminergic medications. Abnormal incentive-driven decision-making,...
Incentive-driven decision-making networks in de novo and drug-treated Parkinson's disease patients with impulsive-compulsive behaviors: A systematic review of neuroimaging studies.
BACKGROUND
In Parkinson's disease (PD), impulsive-compulsive behaviors (ICBs) may develop as side-effect of dopaminergic medications. Abnormal incentive-driven decision-making, which is supported by the cognitive control and motivation interaction, may represent an ICBs signature. This systematic review explored whether structural and/or functional brain differences between PD patients with vs without ICBs encompass incentive-driven decision-making networks.
METHODS
Structural and functional neuroimaging studies comparing PD patients with and without ICBs, either de novo or medicated, were included.
RESULTS
Thirty articles were identified. No consistent evidence of structural alteration both in de novo and medicated PD patients were found. Differences in connectivity within the default mode, the salience and the central executive networks predate ICBs development and remain stable once ICBs are fully developed. Medicated PD patients with ICBs show increased metabolism and cerebral blood flow in orbitofrontal and cingulate cortices, ventral striatum, amygdala, insula, temporal and supramarginal gyri. Abnormal ventral striatum connectivity with anterior cingulate cortex and limbic structures was reported in PD patients with ICBs.
DISCUSSION
Functional brain signatures of ICBs in PD encompass areas involved in cognitive control and motivational encoding networks of the incentive-driven decision-making. Functional alterations predating ICBs may be related to abnormal synaptic plasticity in these networks.
Topics: Decision Making; Disruptive, Impulse Control, and Conduct Disorders; Executive Function; Humans; Impulsive Behavior; Motivation; Nerve Net; Neuroimaging; Parkinson Disease
PubMed: 32927414
DOI: 10.1016/j.parkreldis.2020.07.020 -
ASAIO Journal (American Society For... 2014Aortic insufficiency (AI) may occur while supported on a left ventricular assist device (LVAD). We conducted a systematic review to determine the incidence, predictors,... (Meta-Analysis)
Meta-Analysis Review
Aortic insufficiency (AI) may occur while supported on a left ventricular assist device (LVAD). We conducted a systematic review to determine the incidence, predictors, and consequences of AI during LVAD support. MEDLINE was searched for original studies presenting clinical data regarding patients who developed AI during LVAD implant. Seven observational studies (657 patients) were selected for review; 65% of patients underwent implantation with a continuous-flow device (Cf-LVAD). The incidence of AI was 25% (11-42%) (Support period: 412 ± 281 days). AI increased by 4% (1-6%) per month of support (p < 0.01). AI-positive patients were older at implant (weighted mean difference, 7.7 [4.3; 11.1]; p < 0.01). Female sex (0.002 ± 0.001; p = 0.01) and smaller body surface area (-0.003 ± 0.001 per m; p < 0.01) correlated with progressive AI. Destination therapy patients (odds ratio [OR], 5.3 [1.2, 24]; p = 0.02) and those with Cf-LVAD pumps were likely to develop AI (hazard ratio [HR], 2.2 [1.2, 3.8]; p < 0.01). A closed aortic valve was associated with AI (OR, 4.7 [1.9, 11.8]; p < 0.01). Survival was comparable in both cohorts (HR, 1.5 [0.81, 2.8]; p = 0.2). A significant number of patients develop de novo AI during LVAD support. Advanced age, longer support duration, continuous-flow pumps, and a closed aortic valve are associated with AI. Large cohort studies would improve our understanding of this condition.
Topics: Aortic Valve Insufficiency; Female; Heart-Assist Devices; Humans; Male
PubMed: 24399060
DOI: 10.1097/MAT.0000000000000042 -
CVIR Endovascular Aug 2019Angioplasty is a fundamental treatment for atherosclerotic disease and may be performed as the sole therapy in small vessel disease. However, the ideal duration of... (Review)
Review
OBJECTIVE
Angioplasty is a fundamental treatment for atherosclerotic disease and may be performed as the sole therapy in small vessel disease. However, the ideal duration of balloon inflation has not yet been identified. Our study investigated whether prolonged inflation of at least 1-min duration, when compared with brief inflation, affects residual stenosis after arterial angioplasty.
DATA SOURCES AND METHODS
Two independent reviewers conducted a systematic review of EMBASE, MEDLINE, CENTRAL, trial registries and grey literature, using pre-specified search syntax. Data abstraction and quantitative analysis was performed independently, according to pre-specified criteria. The primary outcome was residual stenosis after initial angioplasty, in addition to other pre-specific clinical and radiographic outcomes. All analyses were stratified by coronary, cerebrovascular, and peripheral territory. The study protocol is published and registered on PROSPERO (CRD42018092702).
RESULTS
Six relevant articles were identified, of which one investigated peripheral vascular angioplasty and five investigated coronary artery angioplasty, encompassing 1496 procedures. The studies were at moderate risk of bias. Minimal heterogeneity within coronary studies allowed for subgroup meta-analysis. Prolonged inflation was significantly associated with lower risk of residual stenosis post-inflation in the pooled coronary trials (RR 1.76 [95% CI 1.46-2.12], I = 0%, p < 0.001) in addition to approaching significance in the peripheral vascular trial (RR 2.40 [95% CI 0.94-6.13], p = 0.07). Prolonged inflation was associated with less risk of arterial dissection and need for adjunctive procedures such as stenting. Following adjunctive procedures, less residual stenosis was still observed in the prolonged angioplasty group in the reported coronary studies. Follow-up data did not reveal a significant difference in the presence of restenosis, however there was a long-term benefit of prolonged inflation in reducing overall severity of stenosis.
DISCUSSION
This is the first review investigating outcomes related to duration of balloon inflation. Both coronary and peripheral vascular evidence are in agreement that prolonged angioplasty balloon inflation greater than 60 s appears to be associated with improved immediate post-inflation results. However, long-term data is heterogeneous and inconsistently reported. We propose further investigation to address outstanding long-term outcomes, particularly in small vessel territories such as tibial vessels where angioplasty is often used as the only endovascular therapy.
TRIAL REGISTRATION
This protocol has been registered with the International Prospective Register of Systematic Reviews (PROSPERO: CRD42018092702 ) prior to conduct of the review.
PubMed: 32026993
DOI: 10.1186/s42155-019-0072-2 -
Neurological Research Apr 2020: There is a relative lack of literature on long-term aneurysm recurrence and de novo aneurysm formation following surgical treatment of unruptured intracranial...
: There is a relative lack of literature on long-term aneurysm recurrence and de novo aneurysm formation following surgical treatment of unruptured intracranial aneurysms. This retrospective single-center cohort study, therefore, analyzes the incidence of aneurysm recurrence, and the incidence of de novo aneurysms formation in patients with at least 10yrs of radiological follow-up. The data are put into the context of a systematic review of the literature.: Patients that underwent surgical treatment of an unruptured intracranial aneurysm at the Basel University Hospital were retrospectively identified. The rate of recurrent or de novo aneurysm formation was assessed for all patients with imaging follow-up ≥10yrs. A systematic review including studies with a mean follow-up period of ≥10yrs was then performed.: A total of 95 patients had undergone surgical treatment of an unruptured intracranial aneurysm between 1994 and 2008. Twenty-one patients (22.1%) had available imaging follow-up ≥10yrs (mean: 13.1yrs). In these patients, aneurysm recurrence and de novo aneurysm formation were equally found in 23.8% (n = 5; 1.8%/yr). There was no case of aneurysm rupture from a recurrent or a de novo aneurysm. The systematic literature review covered a combined cohort of 1778 patients over a mean follow-up period of 14.0yrs. In this cohort, the aneurysm recurrence rate was 16.4% (0.7%/yr), and the rate of de novo aneurysm formation was 6.2% (0.4%/yr).: Despite some discrepancy regarding the incidence, both cohorts show a non-negligible long-term risk of aneurysm recurrence and de novo aneurysm formation, which warrants life-long imaging follow-up. SD: standard deviation; DSA: digital subtraction angiography; CTA: computed tomography angiography; MRA: magnetic resonance angiography; MCA: middle cerebral artery; ACA: anterior cerebral artery; ACommA: anterior communicating artery; ICA: internal carotid artery; ADPKD: autosomal dominant polycystic kidney disease; MeSH: Medical Subject Headings.
Topics: Adult; Aged; Cohort Studies; Female; Follow-Up Studies; Humans; Intracranial Aneurysm; Male; Middle Aged; Postoperative Care; Recurrence; Retrospective Studies; Risk Factors; Time Factors
PubMed: 32048571
DOI: 10.1080/01616412.2020.1726587 -
PloS One 2014In Asia, up to 25% of breast cancer patients present with distant metastases at diagnosis. Given the heterogeneous survival probabilities of de novo metastatic breast... (Review)
Review
BACKGROUND
In Asia, up to 25% of breast cancer patients present with distant metastases at diagnosis. Given the heterogeneous survival probabilities of de novo metastatic breast cancer, individual outcome prediction is challenging. The aim of the study is to identify existing prognostic models for patients with de novo metastatic breast cancer and validate them in Asia.
MATERIALS AND METHODS
We performed a systematic review to identify prediction models for metastatic breast cancer. Models were validated in 642 women with de novo metastatic breast cancer registered between 2000 and 2010 in the Singapore Malaysia Hospital Based Breast Cancer Registry. Survival curves for low, intermediate and high-risk groups according to each prognostic score were compared by log-rank test and discrimination of the models was assessed by concordance statistic (C-statistic).
RESULTS
We identified 16 prediction models, seven of which were for patients with brain metastases only. Performance status, estrogen receptor status, metastatic site(s) and disease-free interval were the most common predictors. We were able to validate nine prediction models. The capacity of the models to discriminate between poor and good survivors varied from poor to fair with C-statistics ranging from 0.50 (95% CI, 0.48-0.53) to 0.63 (95% CI, 0.60-0.66).
CONCLUSION
The discriminatory performance of existing prediction models for de novo metastatic breast cancer in Asia is modest. Development of an Asian-specific prediction model is needed to improve prognostication and guide decision making.
Topics: Asian People; Breast Neoplasms; Female; Humans; Malaysia; Neoplasm Metastasis; Oligonucleotides; Prognosis; Singapore
PubMed: 24695692
DOI: 10.1371/journal.pone.0093755