scholarly journals Clinical outcome after bioprosthetic aortic root replacement: A Meta-Analysis and Microsimulation model

Author(s):  
Bardia Arabkhani ◽  
Jonathan Etnel ◽  
Michiel Vriesendorp ◽  
Richard van Valen ◽  
Emmanuel Lansac ◽  
...  

Background and aim of the study This study aims to provide an overview of clinical outcome after bioprosthetic aortic root replacement and lifetime event-risk estimates of mortality and valve-related events, and the potential effect of type of prosthesis used. Methods A systematic literature search was conducted between January 2000 and August 2019. Inclusion criteria: aortic root replacement in adults. Data were pooled by inverse-variance weighting and entered a microsimulation model to calculate lifetime event-risk and (event-free) life expectancy. Results Of 2.106 publications, 31 were included (N = 5.227 patients, 74% stentless valves). Mean age was 65.4 years (74% male). Pooled early mortality was 5.5% (95% CI: 4.3-7.2%). During follow-up (mean 4.1 years, total 22.706 patient-years), late mortality was 4.8%/patient-year and reoperation 0.9%/patient-year. Linearized-occurrence-rates for thromboembolism, endocarditis, and hemorrhagic events:1.2; 0.9 and 0.5 %/patient-year; no significant difference between stented and stentless prosthesis. Translating into a 60-year-old patient, an estimated life expectancy of 14 years (general population: 22 years) and lifetime risks of thromboembolism, endocarditis and reintervention of 21%, 13%, and 8%, respectively is expected. Conclusions The study shows impaired survival and a notable lifetime risk of valve-related events after bioprosthetic aortic root replacement. The risk of thromboembolism is prominent, especially during earlier follow-up, suggesting higher risk of thromboembolism early after operation. Type of prosthesis, stented or stentless, is not associated with higher valve-related events. Moreover, this study could be used as a benchmark to compare outcome with other aortic root replacement procedures.

Author(s):  
Bardia Arabkhani

Background and aim of the study This study aims to provide an overview of clinical outcome after bioprosthetic aortic root replacement and lifetime event-risk estimates of mortality and valve-related events, and the potential effect of type of prosthesis used. Methods A systematic literature search was conducted between January 2000 and August 2019. Inclusion criteria: aortic root replacement in adults. Data were pooled by inverse-variance weighting and entered a microsimulation model to calculate lifetime event-risk and (event-free) life expectancy. Results Of 2,106 publications, 31 were included (N = 5,227 patients, 74% stentless valves). Mean age was 65.4 years (74% male). Pooled early mortality was 5.5% (95% CI: 4.3-7.2%). During follow-up (mean 4.1 years, total 22.706 patient-years), late mortality was 4.8%/patient-year and reoperation 0.9%/patient-year. Linearized-occurrence-rates for thromboembolism, endocarditis, and hemorrhagic events:1.2; 0.9 and 0.5 %/patient-year; no significant difference between stented and stentless prosthesis. Translating into a 60-year-old patient, an estimated life expectancy of 14 years (general population: 22 years) and lifetime risks of thromboembolism, endocarditis and reintervention of 21%, 13%, and 8%, respectively is expected. Conclusions The study shows impaired survival and a notable lifetime risk of valve-related events after bioprosthetic aortic root replacement. The risk of thromboembolism is prominent, especially during earlier follow-up, suggesting higher risk of thromboembolism early after operation. Type of prosthesis, stented or stentless, is not associated with higher valve-related events. Moreover, this study could be used as a benchmark to compare outcome with other aortic root replacement procedures.


2019 ◽  
Vol 11 (5) ◽  
pp. 489-496 ◽  
Author(s):  
Xiaoxi Zhang ◽  
Qiao Zuo ◽  
Haishuang Tang ◽  
Gaici Xue ◽  
Pengfei Yang ◽  
...  

PurposeTo compare the safety and efficiency of stent assisted coiling (SAC) with non-SAC for the management of ruptured intracranial aneurysms.MethodsA meta-analysis that compared SAC with coiling alone and balloon assisted coiling was conducted by database searching. The primary outcomes of this study were immediate occlusion and progressive thrombosis rate, overall perioperative complication rate, and angiographic recurrence. Secondary outcomes included mortality at discharge, hemorrhagic and ischemic complications, and favorable clinical outcome at discharge and at follow-up.ResultsEight retrospective cohort studies with 1408 ruptured intracranial aneurysms (SAC=499; non-SAC=909) were included. The SAC group tended to show a lower immediate complete occlusion rate than the non-SAC group (54.3% vs 64.2%; RR 0.90; 95% CI 0.83 to 0.99; I2=17.4%) and achieved a significantly higher progressive complete rate at follow-up (73.4% vs 61.0%; RR 1.30; 95% CI 1.16 to 1.46; I2=40.5%) and a lower recurrence rate (4.8% vs 16.6%; RR 0.28; 95% CI 0.16 to 0.50; I2=0.0%). With respect to safety concerns, overall perioperative complications in the SAC group were significantly higher (20.2% vs 13.1%; RR 1.70; 95% CI 1.36 to 2.11; I2=0.0%). However, no significant difference was found for mortality rate at discharge (6.3% vs 6.2%; RR 1.29; 95% CI 0.86 to 1.94; I2=0.0%), or favorable clinical outcome rate at discharge (73.4% vs 74.2%; RR 0.95; 95% CI 0.88 to 1.02; I2=12.1%) and at follow-up (85.6% vs 87.9%; RR 0.98; 95% CI 0.93 to 1.02; I2=0.0%; P=0.338).ConclusionsSAC has a lower recurrence rate than non-SAC. Nevertheless, further validation by well designed prospective studies is warranted for determining whether stents improve angiographic outcome without an increased complication rate or unfavorable clinical outcome.


2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Guoqiang Ma ◽  
Chaoan Wu ◽  
Miaoting Shao

AbstractSeveral authors have suggested that implants can be placed simultaneously with onlay bone grafts without affecting outcomes. Therefore, the purpose of this study was to answer the following clinical questions: (1) What are the outcomes of implants placed simultaneously with autogenous onlay bone grafts? And (2) is there a difference in outcomes between simultaneous vs delayed placement of implants with autogenous onlay bone grafts? Databases of PubMed, Embase, and Google Scholar were searched up to 15 November 2020. Data on implant survival was extracted from all the included studies (single arm and comparative) to calculate point estimates with 95% confidence intervals (CI) and pooled using the DerSimonian–Laird meta-analysis model. We also compared implant survival rates between the simultaneous and delayed placement of implants with data from comparative studies. Nineteen studies were included. Five of them compared simultaneous and delayed placement of implants. Dividing the studies based on follow-up duration, the pooled survival of implant placed simultaneously with onlay grafts after <2.5 years of follow-up was 93.1% (95% CI 82.6 to 97.4%) and after 2.5–5 years was 86% (95% CI 78.6 to 91.1%). Implant survival was found to be 85.8% (95% CI 79.6 to 90.3%) with iliac crest grafts and 95.7% (95% CI 83.9 to 93.0%) with intra-oral grafts. Our results indicated no statistically significant difference in implant survival between simultaneous and delayed placement (OR 0.43, 95% 0.07, 2.49, I2=59.04%). Data on implant success and bone loss were limited. Data indicates that implants placed simultaneously with autogenous onlay grafts have a survival rate of 93.1% and 86% after a follow-up of <2.5 years and 2.5–5years respectively. A limited number of studies indicate no significant difference in implant survival between the simultaneous and delayed placement of implants with onlay bone grafts. There is a need for randomized controlled trials comparing simultaneous and delayed implant placement to provide robust evidence.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Xiaoran Yu ◽  
Ruogu Xu ◽  
Zhengchuan Zhang ◽  
Yang Yang ◽  
Feilong Deng

AbstractExtra-short implants, of which clinical outcomes remain controversial, are becoming a potential option rather than long implants with bone augmentation in atrophic partially or totally edentulous jaws. The aim of this study was to compare the clinical outcomes and complications between extra-short implants (≤ 6 mm) and longer implants (≥ 8 mm), with and without bone augmentation procedures. Electronic (via PubMed, Web of Science, EMBASE, Cochrane Library) and manual searches were performed for articles published prior to November 2020. Only randomized controlled trials (RCTs) comparing extra-short implants and longer implants in the same study reporting survival rate with an observation period at least 1 year were selected. Data extraction and methodological quality (AMSTAR-2) was assessed by 2 authors independently. A quantitative meta-analysis was performed to compare the survival rate, marginal bone loss (MBL), biological and prosthesis complication rate. Risk of bias was assessed with the Cochrane risk of bias tool 2 and the quality of evidence was determined with the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. 21 RCTs were included, among which two were prior registered and 14 adhered to the CONSORT statement. No significant difference was found in the survival rate between extra-short and longer implant at 1- and 3-years follow-up (RR: 1.002, CI 0.981 to 1.024, P = 0.856 at 1 year; RR: 0.996, CI 0.968 to 1.025, P  = 0.772 at 3 years, moderate quality), while longer implants had significantly higher survival rate than extra-short implants (RR: 0.970, CI 0.944 to 0.997, P < 0.05) at 5 years. Interestingly, no significant difference was observed when bone augmentations were performed at 5 years (RR: 0.977, CI 0.945 to 1.010, P = 0.171 for reconstructed bone; RR: 0.955, CI 0.912 to 0.999, P < 0.05 for native bone). Both the MBL (from implant placement) (WMD: − 0.22, CI − 0.277 to − 0.164, P < 0.01, low quality) and biological complications rate (RR: 0.321, CI 0.243 to 0.422, P < 0.01, moderate quality) preferred extra-short implants. However, there was no significant difference in terms of MBL (from prosthesis restoration) (WMD: 0.016, CI − 0.036 to 0.068, P = 0.555, moderate quality) or prosthesis complications rate (RR: 1.308, CI 0.893 to 1.915, P = 0.168, moderate quality). The placement of extra-short implants could be an acceptable alternative to longer implants in atrophic posterior arch. Further high-quality RCTs with a long follow-up period are required to corroborate the present outcomes.Registration number The review protocol was registered with PROSPERO (CRD42020155342).


Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Leah B Kosyakovsky ◽  
Federico Angriman ◽  
Emma Katz ◽  
Neill Adhikari ◽  
Lucas C Godoy ◽  
...  

Introduction: Sepsis results in dysregulated inflammation, coagulation, and metabolism, which may contribute to increased cardiovascular disease (CVD) risk. We conducted a systematic review and meta-analysis to determine the association between sepsis and subsequent long-term CVD events. Methods: MEDLINE, Embase, and the Cochrane Controlled Trials Register and Database of Systematic Reviews were searched from inception to May 2020 to identify observational studies of adult sepsis survivors (defined by diagnostic codes or consensus definitions) measuring long-term CV outcomes. The primary outcome was a composite of myocardial infarction, CV death, and stroke. Random-effects models estimated the pooled cumulative incidence and adjusted hazard ratios of CV events relative to hospital or population controls. Odds ratios were included as risk ratios assuming <10% incidence in non-septic controls, and risk ratios were taken as hazard ratios (HR) assuming no censoring. Outcomes were analyzed at maximum follow-up (primary analysis) and stratified by time (<1 year, 1-2 years, and >2 years) since sepsis. Results: Of 11,235 abstracts screened, 25 studies (22 cohort studies, 2 case-crossover studies, and 1 case-control) involving 1,949,793 sepsis survivors were included. The pooled cumulative incidence of CVD events was 9% (95% CI; 5-14%). Sepsis was associated with an increased risk (HR 1.59, 95% CI 1.37-1.86) of CVD events at maximum follow-up ( Figure ); between-study heterogeneity was substantial (I 2 =97.3%). There was no significant difference when comparing studies using population and hospital controls. Significantly elevated risk was observed up to 5 years following sepsis. Conclusions: Sepsis survivors experience an approximately 50% increased risk of CVD events, which may persist for years following the index episode. These results highlight a potential unmet need for early cardiac risk stratification and optimization in sepsis survivors.


2018 ◽  
Vol 55 (3) ◽  
pp. 296-305 ◽  
Author(s):  
Martin Andrés CORONEL ◽  
Wanderley Marques BERNARDO ◽  
Diogo Turiani Hourneaux de MOURA ◽  
Eduardo Turiani Hourneaux de MOURA ◽  
Igor Braga RIBEIRO ◽  
...  

ABSTRACT BACKGROUND: Endoscopic antireflux treatments for gastroesophageal reflux disease (GERD) are still evolving, and most of the published studies address symptom relief in the short-term. Objective - We aimed to perform a systematic review and meta-analysis focused on evaluating the efficacy of the different endoscopic procedures. METHODS: Search was restricted to randomized controlled trials (RCTs) on MedLine, Cochrane, SciELO, and EMBASE for patients with chronic GERD (>6 months), over 18 years old and available follow up of at least 3 months. The main outcome was to evaluate the efficacy of the different endoscopic treatments compared to sham, pharmacological or surgical treatment. Efficacy was measured by different subjective and objective outcomes. RESULTS: We analyzed data from 16 RCT, totaling 1085 patients. The efficacy of endoscopic treatments compared to sham and proton pump inhibitors (PPIs) treatment showed a significant difference up to 6 months in favor of endoscopy with no heterogeneity (P<0.00001) (I2: 0%). The subgroup analysis showed a statistically significant difference up to 6 months in favor of endoscopy: endoscopy vs PPI (P<0.00001) (I2: 39%). Endoscopy vs sham (P<0.00001) (I2: 0%). Most subjective and objective outcomes were statistically significant in favor of endoscopy up to 6 and 12 months follow up. CONCLUSION: This systematic review and meta-analysis shows a good short-term efficacy in favor of endoscopic procedures when comparing them to a sham and pharmacological or surgical treatment. Data on long-term follow up is lacking and this should be explored in future studies.


2019 ◽  
Vol 28 (12) ◽  
pp. 1841-1851 ◽  
Author(s):  
Amer Harky ◽  
Ahmed Al-Adhami ◽  
Jeffrey S.K. Chan ◽  
Chris H.M. Wong ◽  
Mohamad Bashir

2021 ◽  
Author(s):  
Kanthika Wasinpongwanich ◽  
Tanawin Nopsopon ◽  
Krit Pongpirul

Purpose Surgical treatment is mandatory in some patients with lumbar spine diseases. To obtain spine fusion, many operative techniques were developed with different fusion rates and clinical results. This study aimed to collect randomized controlled trial (RCT) data to compare fusion rate, clinical outcomes, complications among Transforaminal Lumbar Interbody Fusion (TLIF), and other techniques for lumbar spine diseases. Methods A systematic literature search of PubMed, Embase, Scopus, Web of Science, and CENTRAL databases was searched for studies up to 13 February 2020. The meta-analysis was done using a random-effects model. Pooled risk ratio (RR) or mean difference (MD) with a 95% confidence interval of fusion rate, clinical outcomes, and complication in TLIF and other techniques for lumbar diseases. Results The literature search identified 3,682 potential studies, 15 RCTs (915 patients) were met our inclusion criteria and were included in the meta-analysis. Compared to other techniques, TLIF had slightly lower fusion rate (RR=0.84 [95% CI 0.72, 0.97], p=0.02, I2=0.0%) at 1-year follow-up while there was no difference on fusion rate at 2-year follow up (RR=1.06 [95% CI 0.96, 1.18], p=0.27, I2=69.0%). The estimated risk ratio of total adverse events (RR=0.90 [95% CI 0.59, 1.38], p=0.63, I2=0.0%) and revision rate (RR=0.78 [95%CI 0.34, 1.79], p=0.56, I2=39.0%) showed no difference. TLIF had approximately half an hour more operative time than other techniques (MD=31.88 [95% CI 5.33, 58.44], p=0.02, I2=92.0%). There was no significant difference between TLIF and other techniques in terms of the blood loss, and clinical outcomes. Conclusions Besides fusion rate at 1-year follow-up and operative time, our study demonstrated similar outcomes of TLIF with other techniques for lumbar diseases in regard to fusion rate, clinical outcomes, and complications.


2021 ◽  
Vol 12 ◽  
Author(s):  
Mohit Agrawal ◽  
Kanwaljeet Garg ◽  
Raghu Samala ◽  
Roopa Rajan ◽  
Vikas Naik ◽  
...  

Background: Magnetic resonance guided focused ultrasound (MRgFUS) is a relatively novel technique to treat essential tremor (ET). The objective of this review was to analyze the efficacy and the safety profile of MRgFUS for ET.Methods: A systematic literature review was done. The post procedure changes in the Clinical Rating Scale for Tremor (CRST) score, hand score, disability and quality of life scores were analyzed.Results: We found 29 studies evaluating 617 patients. DTI based targeting was utilized in six cohorts. A significant difference was observed in the pooled standard mean difference between the pre and postoperative total CRST score (p-value &lt; 0.001 and 0.0002), hand score (p-value 0.03 and 0.02); and the disability at 12 months (p-value 0.01). Head pain and dizziness were the most in procedure complications. The immediate pooled proportion of ataxia was 50%, while it was 20% for sensory complications, which, respectively, declined to 31 and 13% on long term follow up. A significant reduction (p = 0.03) in immediate ataxia related complications was seen with DTI targeting.Conclusion: MRgFUS for ET seems to be an effective procedure for relieving unilateral tremor. Use of DTI based targeting revealed a significant reduction in post procedure ataxia related complications as compared to traditional targeting techniques. Analysis of other complications further revealed a decreasing trend on follow up.


PLoS ONE ◽  
2021 ◽  
Vol 16 (11) ◽  
pp. e0258752
Author(s):  
Azza Alketbi ◽  
Salah Basit ◽  
Nouran Hamza ◽  
Lori M. Walton ◽  
Ibrahim M. Moustafa

Background Fatigue is considered one of the most common symptoms of multiple sclerosis (MS) and lacks a current standardized treatment. Therefore, the aim of this study was to examine the feasibility and effectiveness of a cognition-targeted exercise versus symptom-targeted exercise for MS fatigue. Methods In this Pilot, parallel-group, randomized controlled trial, sixty participants with multiple sclerosis, were randomly assigned to either a Cognition-Targeted Exercise (CTE) (N = 30, mean age 41) or a Symptom-Targeted Exercise (STE) (N = 30, mean age 42). The participants in the experimental group received eight, 50-minute sessions of weekly Cognitive Behavior Therapy (CBT) in addition to a CTE Program; whereas, participants in the control group received eight, 50-minute sessions of weekly CBT in addition to the standardized physiotherapy program (STE Program). Feasibility was assessed through recruitment rate, participant retention, adherence and safety, in addition to clinical outcome measures, including: (1) Modified Fatigue Impact Scale (MFIS), (2) Work and Social Adjustment Scale (WSAS), (3) Hospital Anxiety and Depression Scale (HADS), and Perceived Stress Scale (PSS). All outcome measures were assessed at baseline (pretreatment), following completion of the eight visit intervention protocol, and at 3-months follow-up. Results The recruitment rate was 60% and 93% of participants completed the entire study. The recruited participants complied with 98% of the required visits. No adverse events were recorded. A Generalized Estimation Equation Model revealed a significant difference over time as an interaction term during the post and follow up visit for all clinical outcome measures (p < .001). Conclusion The addition of CTE to CBT exhibited positive and more lasting influence on MS fatigue outcomes compared to Symptom-Targeted Exercise (STE). Feasibility and efficacy data from this pilot study provide support for a full-scale RCT of CTE as an integral component of Multiple Sclerosis fatigue management.


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