bluuebunny/crossref_metadata_2025_split huggingface dataset:
Effects of semaglutide on functional capacity in patients with type 2 diabetes and peripheral arterial disease: rationale and design of the STRIDE trial
Authors: Sillesen H , Debus E S , Enggaard R B B , Frenkel O , Heled Y , Mansor-Lefebvre S , Bonaca M P 
Published: October 2021

Abstract

Background/Introduction
Lower extremity peripheral arterial disease (PAD) is a severe form of atherosclerotic cardiovascular (CV) disease. The classical symptom is intermittent claudication (IC), associated with limited walking ability and poor health-related quality of life (QoL). Type 2 diabetes (T2D) is one of the leading causes of PAD; ∼30% of patients with PAD have T2D. While anti-atherosclerotic drugs and lifestyle changes are recommended, there are no effective drugs to specifically improve functional outcomes in PAD and T2D. Semaglutide is a glucagon-like peptide-1 receptor agonist (GLP-1RA) approved as an adjunct to diet and exercise for glycaemic control in patients with T2D. In the T2D SUSTAIN clinical trial programme, once-weekly (OW) subcutaneous semaglutide 0.5 and 1.0 mg was superior for glycaemic control and weight loss vs placebo and a range of approved antidiabetic drugs. In SUSTAIN 6, a dedicated CV outcomes trial, OW semaglutide resulted in a 26% reduction in three-point major adverse CV events (MACE) compared with placebo in patients with T2D at high CV risk, leading to its approval for MACE risk reduction in those with T2D and CV disease in the USA. Evidence suggests this may be partly attributable to the anti-inflammatory and anti-atherosclerotic effects of semaglutide, which may also apply to PAD.

Purpose
The STRIDE trial will demonstrate the effect of OW semaglutide 1.0 mg vs placebo on walking ability in patients with T2D and PAD with IC.

Methods
STRIDE is a 52-week, randomised, double-blind, placebo-controlled, phase 3b trial. Trial design and eligibility criteria are shown in the Figure; ∼800 patients will be randomised 1:1 to OW semaglutide 1.0 mg or placebo, both added to standard of care. The primary endpoint is change in maximum walking distance on a constant load treadmill test from baseline to week 52. Secondary confirmatory endpoints include changes in pain-free walking distance and PAD-specific, health-related patient-reported outcomes (Vascular QoL Questionnaire-6) from baseline to week 52.

Results
The trial started in October 2020 and is currently recruiting, with ∼120 sites in ∼20 countries across Asia, Europe, and North America.

Conclusion
STRIDE is the first and only dedicated PAD outcomes trial with a GLP-1RA and thus presents a unique trial design. While major adverse limb events typically occur in the later stages of PAD, STRIDE instead measures the effect of OW semaglutide on functional outcomes such as walking ability and QoL, which affect everyday living in patients with PAD and IC. STRIDE data will provide important clinical insights regarding the role of OW semaglutide in patients with T2D and PAD.

Funding Acknowledgement
Type of funding sources: Private company. Main funding source(s): Novo Nordisk A/S
Real-world experience with the cusp overlap deployment technique for procedural optimization during self-expanding transcatheter aortic valve implantation: our city best practice trial
Authors: Maier O , Binneboessel S , Klein K , Piayda K , Polzin A , Westenfeld R , Jung C , Berisha N , Zeus T , Kelm M , Veulemans V 
Published: October 2021

Abstract

Background
Aortic valve stenosis treated by transcatheter aortic valve implantation (TAVI) is a fast-growing section in interventional cardiology. Optimal implantation depth (ID) of self-expanding TAVI devices is an important condition for hemodynamic and clinical outcomes. The cusp overlap technique (COT) offers optimized fluoroscopic projections for TAVI with self-expanding devices due to improved anatomic discrimination by elongation of the left ventricular outflow tract and isolation of the non-coronary cusp (NCC) for better assessment of ID.

Purpose
This single-center observational study aims to investigate short-term clinical performance, safety, and efficiency outcomes regarding optimized ID in patients undergoing transfemoral TAVI with self-expanding prostheses and COT.

Methods
From September 2020 to December 2020, a total of 71 patients underwent TAVI with a newer-generation self-expanding device and COT. The optimal fluoroscopic projection was generated by overlapping the right (RCC) and left coronary cusps (LCC) on the multidetector computed tomography annular plane. Final ID was assessed by the arithmetic mean of distances measured from NCC and LCC to the distal prosthesis end. Outcomes were compared with a control cohort of 339 patients who underwent TAVI from January 2016 to August 2020 with a three-cusp coplanar view only during valve deployment.

Results
ID was significantly reduced in the COT cohort (4.3±1.9 vs. 5.0±2.3 mm; p=0.012) with better achievement of optimal ID (2–4 mm) (63.4% vs. 49.9%; p=0.03) and optimization of delta NCC-LCC ID symmetry (1.4±1.3 vs. 1.7±1.3 mm; p=0.026). The rate of pacemaker implantation following TAVI could be reduced (9.9% vs. 19.4%; p=0.05). Six of the seven patients receiving pacemaker in the COT cohort (85.7%) showed ID above membranous septum length. COT resulted in notably higher rates of device repositioning by recapturing (57.8% vs. 16.2%; p&lt;0.001) compared to control cohort. Though, procedure time was prolonged in the COT cohort (82.0±26.5 vs. 74.9±27.5 min; p=0.05) while radiation dose and amount of contrast medium did not differ between the cohorts. No difference was observed in hemodynamic outcomes regarding transvalvular pressure gradients and at least moderate paravalvular leak. Patients implanted with COT had a shorter length of hospital stay (7.1±6.0 vs. 10.3±6.8 days; p&lt;0.001), possibly due to a lower complication rate regarding new conduction disturbances and pacemaker implantation.

Conclusion
TAVI using the cusp overlap deployment technique is associated with an optimized implantation depth and a low rate of procedural complications. Therefore, a reduction of new pacemaker implantations and shortened length of hospital stay could be achieved.

Funding Acknowledgement
Type of funding sources: None.
Prospective evaluation of commissural alignment of balloon-expandable transcatheter heart valves utilizing pre- and post-procedure computed-tomogrpahy
Authors: Steinmetz Y , Wollak A , Vitkon Barkay I , Wolff R , Orlev A , Harari E , Ben Ami C , Shohat O , Glikson M , Dvir D 
Published: October 2021

Abstract

Background
Previous studies suggested that bioprosthetic valve commissural alignment may improve device performance and clinical outcomes in patients undergoing transcatheter aortic valve implantation (TAVI). However, no cath-lab method for correct commissural alignment of balloon-expandable valves was described to-date. Our aim is to evaluate the impact of a predefined patient specific crimped SAPIEN 3 orientation on its final implant orientation in relation to original valve commissures and overlap with coronary arteries as demonstrated by cardiac computed tomography (CT) in tricuspid aortic valve stenosis patients.

Methods and results
A prospective study of patients undergoing TAVI with SAPIEN 3 (Edwards Lifesciences), including post procedure cardiac CT. Patients were divided to 2 groups, a planned group in which the SAPIEN 3 was crimped before implantation in a pre-defined position, and a control group with conventional valve deployment. All patients underwent pre and post TAVI cardiac CT, which were evaluated by cardiac imaging experts that were blinded to the method of valve deployment. Twenty-eight patients were prospectively evaluated before and after TAVI with SAPIEN 3. All patients had elevated risk for open-heart surgery (age 77.6±7.9 years, 68% male, STS PROM 4.4%±3.4%). Fifteen patients were included in the active alignment group vs. thirteen patients in the control. Patients in the active alignment group had a trend for more correct commissural alignment (73.3% vs. 38.5%, p=0.06). There was no statistically significant difference in patient characteristics, echocardiographic measures or in anatomical CT features between the active commissural alignment and control groups.

Conclusion
This is probably the first study that shows that patient-specific initial crimped orientation of balloon-expandable TAVI may improve our ability to have correct commissural alignment of the implanted valve. Our prospective study continues to recruit patients and updated study results will be presented.

Funding Acknowledgement
Type of funding sources: None.
Machine learning identifies clinical parameters to predict mortality in patients undergoing transcatheter mitral valve repair
Authors: Zweck E , Spieker M , Horn P , Iliadis C , Metze C , Kavsur R , Tiyerili V , Nickenig G , Baldus S , Kelm M , Becher M U , Pfister R , Westenfeld R ,   Heart Failure Network Rhineland
Published: October 2021

Abstract

Background
Transcatheter Mitral Valve Repair (TMVR) with MitraClip is an important treatment option for patients with severe mitral regurgitation. The lack of appropriate, validated and specific means to risk stratify TMVR patients complicates the evaluation of prognostic benefits of TMVR in clinical trials and practice.

Purpose
We aimed to develop an optimized risk stratification model for TMVR patients using machine learning (ML).

Methods
We included a total of 1009 TMVR patients from three large university hospitals, of which one (n=317) served as an external validation cohort. The primary endpoint was all-cause 1-year mortality, which was known in 95% of patients. Model performance was assessed using receiver operating characteristics. In the derivation cohort, different ML algorithms, including random forest, logistic regression, support vectors machines, k nearest neighbors, multilayer perceptron, and extreme gradient boosting (XGBoost) were tested using 5-fold cross-validation in the derivation cohort. The final model (Transcatheter MITral Valve Repair MortALIty PredicTion SYstem; MITRALITY) was tested in the validation cohort with respect to existing clinical scores.

Results
XGBoost was selected as the final algorithm for the MITRALITY Score, using only six baseline clinical features for prediction (in order of predictive importance): blood urea nitrogen, hemoglobin, N-terminal prohormone of brain natriuretic peptide (NT-proBNP), mean arterial pressure, body mass index, and creatinine. In the external validation cohort, the MITRALITY Score's area under the curve (AUC) was 0.783, outperforming existing scores which yielded AUCs of 0.721 and 0.657 at best. 1-year mortality in the MITRALITY Score quartiles across the total cohort was 0.8%, 1.3%, 10.5%, and 54.6%, respectively. Odds of mortality in MITRALITY Score quartile 4 as compared to quartile 1 were 143.02 [34.75; 588.57]. Survival analyses showed that the differences in outcomes between the MITRALITY Score quartiles remained even over a timeframe of 3 years post intervention (log rank: p&lt;0.005). With each increase by 1% in the MITRALITY score, the respective proportional hazard ratio for 3-year survival was 1.06 [1.05, 1.07] (Cox regression, p&lt;0.05).

Conclusion
The MITRALITY Score is a novel, internally and externally validated ML-based tool for risk stratification of patients prior to TMVR. These findings may potentially allow for more precise design of future clinical trials, may enable novel treatment strategies tailored to populations of specific risk and thereby serve future daily clinical practice.

Funding Acknowledgement
Type of funding sources: None. Summary Figure
Right ventricular diastolic dysfunction and postoperative cardiac complications in patients undergoing coronary artery bypass grafting
Authors: Sumin A , Korok E V , Sergeeva T Y U 
Published: October 2021

Abstract

Background
Perioperative right ventricular (RV) dysfunction is associated with increased postoperative morbidity and mortality in patients undergoing heart surgery and large vessels. Almost all data on the importance of right ventricle function is specifically focused on its systolic dysfunction, which usually develops with severe left heart dysfunction. At the same time, the perioperative assessment of right ventricle filling during cardiac surgery has been far less studied.

Purpose
To evaluate whether the presence of preexisting RV diastolic dysfunction in patients undergoing coronary artery bypass grafting (CABG) is associated independently with higher incidents of postoperative cardiac complications. Design: one-center observational study.

Methods
The patient population consisted of those who underwent CABG in the cardiovascular surgery department from February 2017 to November 2018 (n=200, 153 males). Transthoracic echocardiography was performed on a Philips Clear Vue 550. Following RV systolic and diastolic parameters were studied: peak velocity of early (Et) and late (At) transtricuspid RV filling and their ratio. Tissue Doppler imaging was used to measure peak diastolic and systolic velocities at the tricuspid annulus (et', a't, s't), TAPSE, and RV Tei index. All patients were divided into 2 groups: with RV diastolic dysfunction (RVDD, n=92), and without RV diastolic dysfunction (control, n=108).

Results
Compared with those without RVDD, in patients with RVDD postoperative heart failure (HF, primary outcome) developed more frequently (p=0.026). The risk of developing postoperative HF was 3.39 in patients with RVDD compared with patients without RVDD (95% CI, 1.15–9.97; p=0.025). Left ventricular ejection fraction (LVEF) increase predicted a lower risk of postoperative HF with an OR = 0.95 (95% CI, 0.9–1.0; p=0.051). Female sex, cardiopulmonary bypass, increase of left ventricular mass index, and Et / At ratio also increased the risk of postoperative HF developing. But only RVDD, cardiopulmonary bypass and female sex were associated independently with development postoperative HF in the multivariate analyses.

Conclusion
Decreased preoperative RV diastolic function, cardiopulmonary bypass and female sex are independent risk factors for development postoperative HF after CABG in coronary artery disease patients. In contrast, LVEF and RV systolic dysfunction were not associated independently with this outcome. Therefore, assessment of preoperative RV diastolic function will be useful for predicting development postoperative HF following CABG. In addition, the Et / At ratio was the best echocardiographic marker associated with the postoperative HF development after CABG surgery.

Funding Acknowledgement
Type of funding sources: None.
Impact of tricuspid repair on surgical death in patients undergoing mitral valve surgery due to rheumatic disease
Authors: Viana T , Vieira De Melo R M , Da Silva D N V , Santana G P , De Paula M L N , Azevedo D F C , Figueiredo C S , Lopes J B , Damasceno L M , Soares P F , Santos J V S , Tolentino A , Passos L C S 
Published: October 2021

Abstract

Introduction
Observational studies differ on the impact of performing tricuspid repair on surgical mortality. Some studies demonstrate increased surgical mortality related to right ventricular failure and circulatory shock, while there are other studies that evidence improvement in quality of life and signs of right heart failure in the long time.

Objective
To evaluate the impact on surgical mortality of concomitant tricuspid annuloplasty in patients undergoing cardiac surgery for rheumatic mitral valve disease, who have moderate to severe tricuspid regurgitation.

Methods
This is a prospective cohort from January 1, 2017 to December 30, 2020. All patients over 18 years of age who underwent cardiac surgery to correct rheumatic mitral valve disease with moderate to significant tricuspid regurgitation were included. The primary outcome was 30-days mortality.

Results
165 patients were included, 98 (59.4%) underwent tricuspid valve annuloplasty. The mean age was 46, 5 (±12) years, the median of Euroscore II was 2,33%. The 30-days mortality was 17 (10.3%) and there was no difference between the groups submitted or not to tricuspid repair: 12 (12.2%) versus 5 (7.5%); p=0.44, respectively. In the multivariate analysis involving seven variables with a potential prediction of death in 30 days, tricuspid repair had no association with death, RR 2,4 (0,5 – 8,3); p=0.27.

Conclusion
In patients with rheumatic heart disease undergoing cardiac surgery for rheumatic mitral valve disease, perform tricuspid annuloplasty in individuals who had moderate to severe tricuspid insufficiency was not associated with increased surgical mortality.

Funding Acknowledgement
Type of funding sources: None.
Simultaneously measured interarm blood pressure difference is not associated with pulse wave velocity in a clinical dataset of at-risk hypertensive patients
Authors: Nolde J , Lugo-Gavidia L M , Kannenkeril D , Chan J , Robinson S , Jose A , Joyson A , Schlaich L , Carnagarin R , Azzam O , Kiuchi M , Schlaich M ,   Dobney Hypertension Centre
Published: October 2021

Abstract

Background/Introduction
Recent analysis of systolic inter-arm differences in blood pressure from the INTERPRESS-IPD Collaboration suggest an association with increased all-cause mortality, cardiovascular mortality and cardiovascular events, previous studies have demonstrated associations with other risk parameters.

Purpose
We aimed to reproduce these associations in a cohort of 199 treated, at-risk, hypertensive patients with pulse wave velocity (PWV) as a surrogate marker of cardiovascular (CV) damage.

Methods
Simultaneously measured Inter-arm blood pressure differences, 24 hour ambulatory BP and PWV were measured in 199 treated patients of a tertiary hospital hypertension outpatient clinic. Associations between systolic inter-arm BP difference and PWV were analyzed with uni- and multivariate regression models.

Results
Out of 199 participants, 90 showed an Inter-arm blood pressure difference of more than 5 mmHg. The Inter-arm difference was not associated with PWV. Furthermore, neither observed single blood pressure measurements nor 24 hour ambulatory blood pressure was associated with Inter-arm blood pressure differences.

Conclusion
In our clinical patient cohort we failed to observe an association between inter-arm BP differences and PWV. Mode of assessment, study design or the sample characteristics of this treated, hypertensive cohort may explain the negative results. The limited sample size of the study poses a challenge to the detection of smaller effects in our study.

Funding Acknowledgement
Type of funding sources: None.
The relationship between diastolic blood pressure and the risk of cardiovascular events in patients with atrial fibrillation whose systolic blood pressure was treated to less than 130 mmHg
Authors: Ikeda S , Iguchi M , Ogawa H , Ishigami K , Doi K , Hamatani Y , Ide Y , Fujino A , Ishii M , Masunaga N , Esato M , Wada H , Hasegawa K , Abe M , Akao M 
Published: October 2021

Abstract

Background
Hypertension is one of the major risk factors of cardiovascular events in patients with atrial fibrillation (AF). Low diastolic blood pressure (DBP) has been reported to be associated with the incidence of cardiovascular events, but current guidelines recommend an intensive blood pressure target of less than 130/80 mmHg for AF patients taking oral anticoagulants without mentioning the lower limits of DBP.

Methods
The Fushimi AF Registry is a community-based prospective survey of AF patients in a city of Japan. Follow-up data were available in 4,472 patients, and hypertensive patients who received prescription of any antihypertensive agents and whose systolic blood pressure was treated to less than 130 mmHg were available were examined (n=1,319). We divided the patients into four groups according to their DBP at baseline; G1 (DBP&lt;60 mmHg, n=349), G2 (60≤DBP&lt;70, n=434), G3 (70≤DBP&lt;80, n=386) and G4 (80≤DBP, n=150), and compared the clinical background and outcomes among groups.

Results
The proportion of female was grater in G1 group, and the patients in G1 group were older. During the median follow-up of 2,458 days, in Kaplan-Meier analysis, the incidence rates of cardiovascular events (composite of cardiac death, ischemic stroke, systemic embolism, non-fatal myocardial infarction and heart failure hospitalization during follow up) were the highest in G1 group and the lowest in G3 group (G1: 7.2% per person-year vs. G2: 4.9% vs. G3: 2.2% vs. G4: 4.4%; p&lt;0.01). Multivariate Cox proportional hazards regression analysis revealed that DBP was an independent determinant of cardiovascular events (G1 vs. G3; hazard ratio (HR): 1.96, 95% confidence intervals (CI): 1.39–2.76, G2 vs. G3; HR: 1.79, 95% CI: 1.28–2.50, G4 vs. G3; HR: 1.56, 95% CI: 0.99–2.45) (Figure 1). When we examined the association of DBP according to 10 mmHg increment, patients with excessively low DBP (&lt;50 mmHg) had significantly higher incidence of cardiovascular events than patients with DBP of 70–79 mmHg (HR: 2.80, 95% CI: 1.81–4.33), and DBP exhibited J curve association with higher incidence of cardiovascular events (Figure 2).

Conclusion
In Japanese AF patients whose systolic blood pressure was treated to less than 130 mmHg, patients with excessively low DBP had significantly higher incidence of cardiovascular events, and DBP exhibited J curve association with higher incidence of cardiovascular events.

Funding Acknowledgement
Type of funding sources: None.