bluuebunny/crossref_metadata_2025_split huggingface dataset:
91Transcatheter valve-in-valve versus redo surgical aortic valve replacement for the management of failed biological prosthesis: early and late outcomes
Authors: Tam D , Dharma C , Wijeysundera H C , Austin P , Ouzounian M , Rocha R V , Fremes S E 
Published: October 2019

Abstract

Background
While the gold standard for the management of failed previous biological prosthesis was redo surgical aortic valve replacement (SAVR), valve-in-valve (ViV) transcatheter AVR (TAVR) has emerged as a less invasive option. Published studies comparing the two techniques have been small and limited to early outcomes. Herein, we compare early mortality, morbidity and late mortality between ViV TAVR and redo SAVR.

Methods
Clinical and administrative databases for Canada's most populous province, Ontario (>13 million patients), were linked to identify patients undergoing ViV and redo SAVR for a failed biological prosthesis. Baseline characteristics were compared and 1:1 propensity score matching (PSM) was performed to account for baseline differences. Standardized mean differences (SMD) were used to assess adequacy of PSM, whereby a SMD<0.10 indicated a good match. Early outcomes were compared in the matched groups using McNemar's test. In accordance to government privacy legislation, outcomes with <6 events, were presented as absolute risk difference (ARD) between ViV and Redo SAVR to prevent patient re-identification. Late mortality was compared between the matched groups using Kaplan-Meier survival curves and a Cox-proportional hazard model.

Results
Records of 558 patients undergoing intervention for a failed biological prosthesis between March 2008 to September 2017 in 11 Ontario institutions were reviewed (ViV = 214, redo SAVR = 344). Patients who underwent ViV were older (78.2±8.2 vs 69.1±11.4, p<0.001, SMD=0.92) and had more hypertension, diabetes, ischemic heart disease, atrial fibrillation, congestive heart failure compared to redo SAVR before PSM (SMD>0.20). Propensity matching on 24 variables yielded similar groups for comparison (n=133 pairs). Ages were similar between ViV and Redo SAVR (76.0±6.2 vs 76.0±8.7, SMD=0.003) along with all other comorbidities (SMD<0.1). 30-day mortality was significantly lower with ViV compared to Redo SAVR (ARD: −7.4%, 95% confidence interval (95% CI): −12.4%, −2.3%). The rate of permanent pacemaker implantation (ARD: −8.1%, 95% CI: −14.2%, −2.1%), blood transfusions (ARD: −62.2%, 95% CI: −75.2%, −49.1%) and length of stay (LOS) (mean difference: −7.8 days, 95% CI: −11.0, −4.6 days) were also lower with ViV. All-cause mortality at 5 years was similar between ViV and redo SAVR (Figure, p=0.19).
Figure 1

Conclusion
ViV TAVR was associated with lower early mortality, risk of permanent pacemaker implantation, any blood transfusion, and hospital LOS compared to redo SAVR in the largest PSM study to date. While there was no difference in late mortality at 5 years, additional studies with more subjects and longer follow-up are necessary. ViV TAVR may be the preferred approach for the treatment of failed biological prosthesis.
93The high burden of rehospitalisations following transcatheter aortic valve implantation
Authors: Aagaard D T , Fosbol E L , De Backer O , Borgersen E , Gislason G , Torp-Pedersen C T , Sondergaard L , Kober L , Butt J 
Published: October 2019

Abstract

Background
Transcatheter aortic valve implantation (TAVI) is a treatment option for severe symptomatic aortic stenosis in patients at increased surgical risk. Rehospitalisations following surgical aortic valve replacement are a strain on patients and society. However, data on the extent of the burden and cause of hospitalisations following TAVI are sparse.

Purpose
To examine rehospitalisations and factors associated with rehospitalisations in a one-year period following TAVI.

Methods
In this Danish nationwide observational cohort study, we identified all patients who underwent TAVI from January 2008 through June 2016 and were discharged alive by Danish nationwide health- and administrative registries. Subsequent rehospitalisations, defined as a hospital admission for at least one overnight stay, were classified as either cardiovascular or non-cardiovascular according to the discharge diagnosis codes. Factors associated with any rehospitalisation were identified using Cox regression.

Results
In total, 2,390 patients undergoing TAVI were included. The median age was 81 years (25th-75thpercentile 77–85 years of age) and men comprised 52% of the study population. Of all patients undergoing TAVI, 24% were hospitalised during the first 30 days after the procedure, while 54% were hospitalised during the first year. Among patients surviving the first year after the procedure, 25% were admitted to a hospital once, 14% were admitted twice, 8% were admitted three times, and 10% were admitted at least four times. Of all hospitalisations, 34% were due to a cardiovascular cause and 10% died during the one-year follow-up. Factors associated with any hospitalisation were chronic kidney disease (HR 1.72 [95% CI, 1.48–2.00]), peripheral vascular disease (HR 1.36 [95% CI, 1.16–1.59]), atrial fibrillation (HR 1.28 [95% CI 1.14–1.43]), ischemic heart disease (hazard ratio [HR] 1.23 [95% confidence interval [95% CI], 1.09–1.38]), and chronic obstructive pulmonary disease (HR 1.16 [95% CI, 1.02–1.33] (Figure).
Forrest plot

Conclusions
In a nationwide, all-comers cohort of patients undergoing TAVI, 57% of patients were hospitalised at least once during the first-year post-procedure and approximately one-third of all hospitalisations was due to a cardiovascular cause. Focus on patient selection and prevention of readmissions after TAVI is warranted.
121Clinical impact of residual SYNTAX score after physiology guided state-of-art PCI in 3VD: insight from the SYNTAX II trial
Authors: Kogame N , Modolo R , Chichareon P , Komiyama H , Taggart D , Escaned J , Banning A , Farooq V , Onuma Y , Serruys P W 
Published: October 2019

Abstract

Background
The clinical implication of residual SYNTAX score in patients treated with state-of- art PCI including hybrid iFR-FFR for three vessel disease is undetermined.

Purpose
The purpose of this study was to investigate the clinical impact of residual SYNTAX Score (rSS) after hybrid iFR-FFR guided state-of-art PCI in patients with three vessel disease (3VD).

Methods
The SYNTAX-II study was a multicentre, single arm study that investigated the impact of the state-of-art PCI strategy on clinical outcomes in 454 patients with de novo 3VD, without left main disease. All the patients treated with the state-of-art PCI in the SYNTAX II trial were retrospectively screened and analysed for rSS. The rSS was defined as the SYNTAX Score (SS) recalculated after PCI. The state-of-art PCI strategy included: heart team decision-making utilizing the SYNTAX score II, hybrid iFR-FFR decision-making strategy, intravascular ultrasound guided stent implantation, contemporary chronic total occlusion revascularization techniques and guideline-directed medical therapy. The primary endpoint of this substudy was major adverse cardiac and cerebrovascular events (MACCE – a composite of all-cause death, any stroke, myocardial infarction, or revascularization) at 2 years. Patients with rSS were stratified according to angiographically complete revascularization (rSS of 0) and previously proposed rSS cut-off value of 8 (>0 to 8, and >8).

Results
A total of 454 patients were screened and rSS were analysable in 441 patients (97.1%). Before PCI, anatomical SS was 20.3±6.4 which was after PCI reduced to 3.9±4.5 (rSS). Only 67 patients (15.2%) had rSS >8 (mean 12.3±4.1). Two-year MACCE occurred in 58 patients (13.2%). Patients with MACCE had similar rSS to those without MACCE (2.0 (IQR: 0.0 to 6.0) vs. 2.0 (IQR: 0.0 to 5.0), p=0.313). Kaplan-Meier analysis showed similar 2- year incidence of MACCE with rSS stratifications (rSS of 0 (n=140): 15.0%, >0 to 8 (n=234): 12.0%, >8 (n=67): 13.4%, log-rank p for overall = 0.703).

Conclusion
After hybrid iFR-FFR guided state-of-art PCI in 3VD, residual SYNTAX Score was very low, suggesting that complete or reasonable incomplete revascularization was achieved in majority of cases. Previously proposed rSS cut-off value of 8 was not associated with a worse clinical outcome.

Acknowledgement/Funding
European Cardiovascular Research Institute (ECRI) with unrestricted research grants from Volcano and Boston Scientific
122Mechanism and impact of lesion morphology on the late lumen loss of drug-eluting resorbable magnesium scaffolds: a serial optical coherence tomography study
Authors: Ueki Y , Raber L , Otsuka T , Losdat S , Windecker S , Garcia-Garcia H , Byrne R , Landmesser U , Koolen J , Waksman R , Haude M , Joner M 
Published: October 2019

Abstract

Introduction
Resorbable Magnesium Scaffolds have demonstrated favourable clinical results with acceptable late lumen loss (LLL). However, the pathomechanisms influencing LLL of resorbable sirolimus-eluting metallic scaffold (Magmaris) have not been analyzed.

Purpose
Using serial optical coherence tomography (OCT), we investigated potential factors, i.e. the contribution of recoil versus neointimal hyperplasia (NIH).

Methods
Patients who were enrolled into BIOSOLVE-II, and underwent serial angiography and OCT (baseline and follow-up: 6-month and/or 1-year) were analyzed. Patients were divided into 2 groups based on angiographic in-scaffold LLL <0.5mm or ≥0.5mm. Endpoints were late absolute recoil and NIH area as assessed by OCT.

Results
A total of 70 patients (LLL <0.5mm: n=41, LLL ≥0.5mm: n=29) were serially analyzed. Patient and lesion characteristics were comparable and there was no significant difference in mean and minimal scaffold area between groups at baseline. Late absolute recoil was significantly smaller among patients with LLL <0.5mm (0.53±0.68 mm2) compared with those with LLL ≥0.5mm (1.48±1.20 mm2, P<0.001) (Figure). A small difference in NIH area at follow-up was observed (LLL <0.5mm: 1.47±0.33 mm2 vs. LLL ≥0.5mm: 1.68±0.34 mm2, P=0.013). In a matched-frame analysis (baseline and follow-up), late absolute recoil varied according to the underlying plaque type (lipid: 0.63±1.23 mm2, calcified: 0.81±1.44 mm2, and fibrous: 1.20±1.52 mm2, P<0.001), while there was no difference with regards to NIH area (P=0.132).

Conclusion
The main driver of late lumen loss of sirolimus-eluting absorbable metal scaffold was late scaffold recoil, while the contribution of NIH was modest. The degree of late scaffold recoil depended on the underlying plaque type and was highest among fibrotic lesions. Future studies will address the impact of procedural factors such as adequate lesion preparation and post-dilatation.

Acknowledgement/Funding
Biotronik
126Clinical outcomes at two years of the Absorb BRS vs. the Xience metallic DES in patients presenting with ACS vs. stable coronary disease - AIDA trial substudy
Authors: Tijssen R Y G , Van Der Schaaf R J , Vink M A , Kraak R P , Hofma S H , Arkenbout E K , Weevers A P J D , Kerkmeijer L S , Onuma Y , Serruys P W J C , Piek J J , Tijssen J G P , Henriques J P , De Winter R J , Wykrzykowska J J 
Published: October 2019

Abstract

AIMS Patients with acute coronary syndrome (ACS) might represent a specific subgroup, in which bioresorbable scaffold implantation in percutaneous coronary intervention, might lead to better outcomes when compared to conventional treatment. ACS patients (STE-ACS patients in particular) are generally younger, and most often have lesions with softer plaques, a lower plaque burden and less extensive coronary artery disease. In this pre-specified subgroup analysis of the AIDA trial, we evaluated the clinical outcomes of Absorb BVS versus Xience EES treated patients presenting with or without ACS.

Methods and results
This analysis includes the 2-year outcomes of all 1845 patients randomized in the AIDA trial subdivided by clinical presentation, a pre-specified subgroup analysis. We compared patients presenting with ACS with those presenting without ACS (ACS versus no-ACS patients). Patients presenting with ACS were further sub-categorized according to the presence or absence of ST-segment elevation at presentation (STE-ACS versus NSTE-ACS patients). Baseline status by clinical presentation was known in all patients, and 842 (45.6%) patients presented with ACS, 456 (25.2%) with STE-ACS and 377 (20.4%) with NSTE-ACS.The rate of the 2-year primary endpoint of target vessel failure (TVF) was similar after treatment with Absorb BVS or Xience EES in ACS patients (10.2% versus 9.0% respectively; p=0.49) and in no-ACS patients (11.7% versus 10.7% respectively; p=0.67) Definite or probable device thrombosis occurred more frequently with Absorb BVS compared to Xience EES in ACS patients (4.3% versus 1.7% respectively, p=0.03) as well as in no-ACS patients (2.4% versus 0.2% respectively; p=0.002). There were no statistically significant interactions between clinical presentation and randomized device modality for TVF (p=0.80) and for the endpoint of definite or probable device thrombosis (p=0.17).

Conclusions
In ACS patients within AIDA, we found no difference in rates of target vessel failure between the Absorb BVS and Xience EES groups. Rates of definite or definite/probable device thrombosis were higher in the Absorb BVS group throughout all clinical presentations. No significant interaction between ACS and no-ACS patients and the occurrence of TVF

Acknowledgement/Funding
The AIDA trial was financially supported by an unrestricted research grant from Abbott Vascular.
131Left atrial phasic function in heart failure with preserved ejection fraction: cardiac magnetic resonance myocardial feature tracking, invasive hemodynamics and outcome
Authors: Schoenbauer R , Kammerlander A A , Duca F , Aschauer S , Binder C , Zotter-Tufaro C , Nitsche C , Fiedler L , Roithinger F X , Loewe C , Hengstenberg C , Bonderman D , Mascherbauer J 
Published: October 2019

Abstract

Background
Global left atrial (LA) size and function have been shown to be associated with adverse events in heart failure with preserved ejection fraction (HFpEF). The machanism of coupling from left heart failure to pulmonary circulation is still controversially discussed.

Purpose
To study the prognostic most relevant determinant of LA size and function and its backward and forward interplay.

Methods
188 HFpEF patients were prospectively enrolled and underwent baseline clinical assessment, cardiac magnetic resonance imaging (CMR) and invasive hemodynamic assessment. Coronary artery disease was ruled out by coronary angiography. 92 patients were in atrial fibrillation (AF), 96 in sinus rhythm. LA size and function were assessed by CMR including LA strain imaging by myocardial feature tracking (Figure 1A & B).

Results
Patients in AF had more pronounced dilatation of all phasic LA volumes and reduction of all phasic LA functions when compared to sinus rhythm (each p<0.001 respectively).
After 31 (9–57) months 66 patients reached the combined endpoint defined as combination from hospitalization due to heart failure and cardiovascular death. In AF no atrial functional or volume parameter was correlated to outcome. In contrast in sinus rhythm several phasic LA volume and functional parameters were associated with outcome. After multivariate cox regression analysis only reduced total LA ejection fraction and conduit strain rate were still predictive for worse outcome (p=0.031 and <0.001 respectively). After adjustment for known risk factors in HFpEF like age, six minute walking distance (6MWD), systolic pulmonary artery pressure (sPAP) and right ventricular ejection fraction as derived by CMR only impaired LA conduit strain rate remained predicitve for cardiovascular events (p=0.001). In contrast to LA booster pump function LA conduit function parameters were significantly correlated to reduced 6MWD (Figure 1C) and coupled backwards to pulmonary vasculature via correlation to sPAP and pulmonary vascular resistance (PVR) but without coupling to CMR derived elevated LV extracellular volume and left ventricular end diastolic pressure.

Conclusion
Total LA ejection fraction plays a key role in the prognosis of HFpEF. This effect seems to be mainly related to its LA conduit function but not to LA booster pump function. LA conduit function correlates to impaired 6MWD, sPAP and PVR.
132Imaging criteria for the diagnosis of heart failure with midrange and preserved LVEF in the real life
Authors: Logeart D , Paven E , Damy T , Isnard R , Salvat M , Eicher J C , Roubille F , Tribouilloy C , Bauer F , Piccard F , Trochu J N 
Published: October 2019

Abstract

Background
According to last ESC guidelines, the diagnosis of heart failure with midrange and preserved left ventricular ejection fraction (HFmrEF-HF and HFpEF) requires at least one of the following imaging criteria: LV hypertrophy with LVMI >115g/m2 in men and 95g/m2 in women, left atria dilation with LAVI >34ml/m2, TDI e' wave average <9cm/s and E/e' average ≥13.

Purpose
We analyzed the prevalence of these imaging criteria in real life patients who are labeled HFmrEF or HFpEF by using a multicenter survey on HF.

Methods
Our survey (NCT01956539) was carried out in 32 hospitals between 2015 and 2018 and included 2735 HF patients who gave their consent during consultation or hospitalization. The diagnosis of HF was left to the discretion of investigators. Besides clinical and biological data, echocardiographic data (<1 month before or <3 months after inclusion) was collected in an electronic database. No echographic variable except the LVEF was mandatory to be included.

Results
Among the 523 and 765 HF patients who were labeled respectively as HFmrEF-HF and HFpEF, the 4 echographic variables required for the diagnosis of HFmrEF or HFpEF were obtained in 512 patients. The median age was 74y [IQR 62–82], HF was de novo in 28%, AF in 34%, median NTproBNP was 1563 pg/mL [IQR 500–4372]. At least one of the 4 diagnostic criteria was present in all patients but 2, and patients had 2, 3 or 4 criteria in 43%, 37% and 1% of cases. The table shows only little differences between HFmrEF and HFpEF or de novo HF regarding the rate of each diagnostic criteria. There was no difference regarding the date of inclusion, i.e. before or after the last ESC guidelines.
Table 1 All HF patients De novo HF HFpEF HFmrEF mrEF or pEF (n=143) (n=293) (n=219) LVMI >115g/m2 (men) or 95g/m2 (women) 69.6% 64.3% 68.6% 70.2% LAVI >34ml/m2 74.2% 73.3% 80.4% 68.9% e' average <9cm/s 64.1% 55.3% 55.9% 76.1% E/e' average ≥13 35.4% 38.6% 37.3% 32.8%

Conclusion
The diagnosis of HFpEF or mrEF may be difficult and requires comprehensive echocardiography including all diagnostic variables because each single diagnostic criteria are present in only 33 to 80% cases.
247Safety and efficacy of high-sensitivity cardiac troponin for risk stratification in patients with suspected acute coronary syndrome
Authors: Bularga A , Anand A , Strachan F E , Lee K K , Stewart S , Ferry A V , Chapman A R , Marshall L , Shah A S V , Newby D E , Mills N L 
Published: October 2019

Abstract

Background
Guidelines acknowledge the emerging role of high-sensitivity cardiac troponin (hs-cTn) assays for the risk stratification and rapid rule-out of myocardial infarction, but multiple approaches have been described. We previously demonstrated the utility of a single hs-cTnI concentration <5 ng/L at presentation to risk stratify patients with suspected acute coronary syndrome (ACS).

Purpose
To assess the safety and efficacy of a hs-cTnI concentration <5 ng/L at presentation in consecutive patients included in the High-STEACS (High-SensitivityTroponin in the Evaluation of patients with Acute Coronary Syndrome) randomised controlled trial.

Methods
The High-STEACS trial was a stepped wedge cluster randomised controlled trial in ten hospitals across Scotland that included 48,282 patients in whom high-sensitivity cardiac troponin was requested by the attending clinician for evaluation of suspected ACS. Patients with ST-segment elevation myocardial infarction (STEMI) were excluded. We evaluated the negative predictive value (NPV) and sensitivity of a presentation hs-cTnI <5 ng/L for a composite outcome of type 1 myocardial infarction, or subsequent type 1 myocardial infarction or cardiac death at 30 days. To assess safety, we report the one-year risk of type 1 myocardial infarction or cardiac death. To assess efficacy, we report the proportion of patients with cardiac troponin <5 ng/L at presentation.

Results
We included 47,101 consecutive patients in the analysis (mean 61±17 years old, 47% female). Of these patients, 27,500 (58%) had a cardiac troponin <5 ng/L at presentation. Overall, 4,313/47,101 (9%) patients had a composite outcome at 30 days, but the event rate was only 0.4% in those with troponin <5 ng/L (98/27,500). The NPV for the composite outcome in those <5 ng/L was 99.7% (95% confidence intervals [CI] 99.6–99.7) and the sensitivity was 98.0% (95% CI 97.6–98.4). In those without evidence of myocardial injury at presentation (hs-cTnI <99thcentile), type 1 myocardial infarction or cardiac death at one year occurred in 197 (0.7%) patients with cardiac troponin <5 ng/L, compared to 647 (5.5%) of those ≥5 ng/L. The NPV was unchanged across all age groups, although efficacy fell as fewer older patients had hs-cTnI concentrations below the risk stratification threshold (see Figure).

Conclusion
A hs-cTnI concentration <5 ng/L at presentation identifies the majority of patients with suspected ACS as low-risk of early or late cardiac events. Although the proportion identified as low risk is reduced in older populations, the safety of this risk stratification approach is maintained across patients of all ages.

Acknowledgement/Funding
British Heart Foundation