One-year real-world outcomes for patients undergoing transcatheter mitral valve repair: the Gulf MTEER registry (GULF Mitral Transcatheter Edge to Edge Repair).

BACKGROUND: Severe mitral regurgitation (MR) with left ventricular dysfunction portends worse outcomes. Over the course of the last two decades, transcatheter repair of the mitral valve offered an alternative therapeutic modality for those deemed inoperable or high risk. Landmark studies such as the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation and Multicentre Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary Mitral Regurgitation trials have shown conflicting results with respect to all-cause death and heart failure rehospitalisations. The Gulf Mitral Transcatheter Edge to Edge Repair registry (Gulf MTEER registry) is a regional registry that captured outcomes in those undergoing transcatheter repair of the mitral valve. The objectives of this study were to describe the baseline characteristics of patients undergoing transcatheter mitral valve repair in the Gulf region and estimate the cardiovascular effects of the mitral transcatheter therapies in routine practice. METHODS: The Gulf MTEER registry is an observational, multicentre, retrospective registry that enrolled all patients undergoing transcatheter repair of the mitral valve from four of the Gulf countries (Saudi Arabia, Kuwait, Bahrain, Oman) between 1 January 2017 and 31 December 2019. Baseline characteristics, echocardiographic parameters and immediate procedural success were reported. The primary outcome was a composite of death and rehospitalisations at 1 year. The secondary outcomes were the individual components of the composite endpoint; that is, death and rehospitalisations at 1 year as well as residual or recurrent MR or worsening New York Heart Association class and a need for repeat repair. RESULTS: A total of 176 patients were enrolled. Men constituted 56.3% of the total. At 1 year the primary outcome occurred in 21.1% (95% CI 15.6, 27.9). The secondary outcomes of death occurred in 5.4% (CI 2.9, 10.0) and rehospitalisations occurred in 16.9% (CI 11.9, 23.3). Univariate analysis revealed that the odds of having death or re-hospitalisation was two times higher if the effective regurgitant orifice (ERO) >40 mm2 irrespective of the therapy. CONCLUSIONS: The Gulf MTEER registry is the first registry in the Gulf region defining the patient population receiving MTEER therapies and evaluating 1-year outcomes. This is a low risk cohort with a high rate of immediate procedural success and low rate of all-cause death and rehospitalisations at 1 year. The odds of an event was two times higher if the ERO ≥40 mm2 with only a signal to higher odds for low left ventricular ejection fraction and larger end systolic dimension.

One-Year Outcomes for Patients Undergoing Transcatheter Aortic Valve Replacement: The Gulf TAVR Registry.

BACKGROUND: The use of transcatheter aortic valve replacement (TAVR) is steadily increasing with TAVR procedures offered to patients across the entire spectrum of surgical risks. The Gulf TAVR registry captures the demographics of patients undergoing TAVR in the Gulf region, comorbidities that drive outcomes, procedural success, complications, and one-year outcomes of death or rehospitalization. METHODS: This is a retrospective cohort study for adult patients aged at least 18 years undergoing TAVR at eight centers in the Gulf region. The primary outcome was a composite of death or re-hospitalization at one-year. Secondary outcomes included the individual components of the composite, stroke, and myocardial infarction (MI). We used multivariable Cox regression to determine factors associated with the composite endpoint. RESULTS: A total of 795 patients (56% male) were included in the final analysis with a mean age of 74.6 (standard deviation (SD) 8.9) years, Society of Thoracic Surgeons Score (STS) Score 4.9 (4.2), ejection fraction of 53% (12.7%). Transfemoral approach was employed in over 95% (762/795). The primary outcomes rate was 12.8% (95% confidence interval [CI]: 10.6-15.4); secondary endpoints were death 5.4% (95% CI 4.0-7.2); stroke 0.8% (95% CI 0.3, 1.7), MI 0.8% (95% CI 0.4-1.9), rehospitalization: 9.3% (95% CI 7.5-11.5) of whom 71.6% were related to cardiovascular causes. 77% of the cardiovascular admissions were attributable to heart failure or the need for pacemaker implantation. Stage IV or V chronic kidney disease was significantly associated with the primary composite endpoint (Hazard Ratio: 2.49, [95% CI: 1.31, 4.73], p = 0.005). Although not significant, paravalvular leak and severe left ventricular dysfunction showed a 2-fold and 3-fold increased risk for the composite endpoint, respectively. CONCLUSIONS: The Gulf TAVR registry is the first of its kind in the region. It profiles an elderly population with a high procedural success rate and a low rate of complications. One-year outcomes were primarily driven by repeat hospitalization for heart failure and pacemaker implantation indicating a need to optimize heart failure management and improve algorithms for the detection of conduction abnormalities.

Agreement in reporting between trial publications and current clinical trial registry in high impact journals: A methodological review.

OBJECTIVES: The primary objective of this systematic survey was to examine the percentage of studies in which there was agreement in the reporting of the primary outcome between the currently updated version of the clinical trial registry and the published paper. We also investigated the factors associated with agreement in reporting of the primary outcome. METHODS: We searched PubMed for all randomized control trials (RCT)s published in 2012-2015 in the top five general medicine journals (based on the 2014 impact factor). Two hundred abstracts (50 from each year) were randomly selected for data extraction. Agreement in reporting of 11 key study conduct items (e.g., sample size) and study characteristics (e.g., funding, number of sites) were extracted by two independent reviewers. ANALYSIS: Descriptive analyses were conducted to determine the proportion of studies on which there was agreement in reporting of key study conduct items. Generalized estimating equations were used to explore factors associated with agreement in reporting of the primary outcome. RESULTS: Of the 200 included studies, 87% had agreement in reporting of the primary outcome. After adjusting for other covariates, having greater than 50 sites was associated with an increased likelihood of agreement in reporting of the primary outcome (odds ratio=7.1, 95% confidence interval=1.39, 36.27, p=0.018). CONCLUSIONS: We identified substantive disagreement in reporting between publications and current clinical trial registry, which were associated with several study characteristics. Further measures are needed to improve reporting given the potential threats to the quality and integrity of scientific research.

Improvement in the quality of abstracts in major clinical journals since CONSORT extension for abstracts: a systematic review.

BACKGROUND: We sought to determine if the publication of the Consolidated Standards of Reporting Trials (CONSORT)(1) extension for abstracts in 2008 had led to an improvement in reporting abstracts of randomized controlled trials (RCTs).(2) METHODS: We searched PubMed for RCTs published in 2007 and 2012 in top-tier general medicine journals. A random selection of 100 trial abstracts was obtained for each year. Data were extracted in duplicate on the adherence to the CONSORT extension for abstracts. The primary outcome was the mean number of items reported and the secondary outcome was the odds of reporting each item. We also estimated incidence rate ratios (IRRs).(3) RESULTS: Significantly more checklist items were reported in 2012 than in 2007: adjusted mean difference was 2.91 (95% confidence interval [CI](4) 2.35, 3.41; p<0.001). In 2012 there were significant improvements in reporting the study as randomized in the title, describing the trial design, the participants, and objectives and blinding. In the Results section, trial status and numbers analyzed were also reported better. The IRRs were significantly higher for 2012 (IRR 1.32; 95% CI 1.25, 1.39; p<0.001) and in multisite studies compared to single site studies (IRR 1.08; 95% CI 1.03, 1.15; p=0.006). CONCLUSIONS: There was a significant improvement in the reporting of abstracts of RCTs in 2012 compared to 2007. However, there is still room for improvement as some items remain under-reported.