bluuebunny/crossref_metadata_2025 huggingface dataset:
P2682Long-term effects of enhanced external counterpulsation treatment on symptom burden, usage of nitrates, physical capacity and health-related quality of life in patients with refractory angina pectoris
Authors: Wu E , Desta L , Brostrom A , Martensson J
Published: October 2019

Background

Patients with refractory angina pectoris (RAP) suffer from debilitating symptoms with considerable limitation of functional capacity and impaired health-related quality of life (HRQoL) despite optimized medical therapy. Recurrent angina symptoms are strongly associated with psychological distress and cardiac anxiety (i.e., a subtype of anxiety related to cardiac sensations). Enhanced external counterpulsation (EECP) is an alternative non-invasive treatment for these patients. An EECP course includes 35 1-hour sessions over 7 weeks. No previous study has explored long-term EECP effects on cardiac anxiety in patients with RAP.

Objective

To evaluate the effects of EECP treatment in patients with RAP regarding usage of nitrates, physical capacity, cardiac anxiety and HRQoL.

Methods

A quasi experimental design with long-term follow-up (6 months) involving 50 patients (men=37, 47–91 years) who had finished one course of EECP. Assessment of average use of nitrates, six-minute walk test, functional class with Canadian Cardiovascular Society (CCS) classification and questionnaires for cardiac anxiety and HRQoL were collected pre and post treatment. In addition, the questionnaires were collected 6 months after completion of EECP.

Results

Patients used significantly less nitrates (p<0.001) compared to at the start of treatment. They enhanced the walking distance on average by 46 m after EECP (p<0.001) and CCS class also improved (p<0.001). All subscales except for one in cardiac anxiety were significantly reduced (p<0.05). All dimensions in HRQoL improved significantly (p<0.01). The positive effects in both cardiac anxiety and HRQoL were maintained 6 months after the treatment.

Conclusions

Patients with RAP received beneficial effects from EECP. Reduced symptom burden and improved physical capacity enable engagement in physical activities. Furthermore, less cardiac anxiety and improved HRQoL may enhance life satisfaction for these patients. EECP treatment should be considered to a greater extent to improve the life situation for these patients.
P2690Safety and effectiveness of thin-strut DES for bifurcated coronary lesions not involving left main: a RAIN (veRy thin stents for patients with left mAIn or bifurcatioN in real life) sub-analysis
Authors: Angelini F , De Filippo O , D'Ascenzo F , Cerrato E , Omede' P , Escaned J , Sheiban I , Cortese B , Trabattoni D , Helft G , Mattesini A , Lusher T F , Biole' C , Giustetto C , Rinaldi M
Published: October 2019

Background

Thinner stent struts of new DES (drug eluting stent) are associated with shorter time of reendothelialization, a reduction of shear stress and inflammation of coronary walls. Despite this great innovations their clinical safety and efficacy in challenging scenarios as non left main bifurcation coronary lesions has not been tested.

Methods

RAIN is a multicenter registry enrolling patients treated on bifurcated coronary lesions and left main with thin-strut DES. Baseline characteristics and procedural data were recorded. Target lesion revascularization (TLR) was the primary endpoint, whereas major adverse clinical events (MACE; composite of all-cause death, myocardial infarction (MI), target vessel revascularization (TVR), TLR and stent thrombosis (ST)) along with its single components were the secondary endpoints. A multivariate analysis to identify predictors of TLR and sub-analysis according to stenting strategy (provisional vs 2-stent technique), use of final kissing balloon (FKB) and IVUS/OCT optimization were performed.

Results

Data from 1803 patients (59% ACS, 61% stable CAD) treated on bifurcations were retrospectively evaluated. Follow up was available for 1685 (94%) patients for a median of 12 months (IQR 7–18). TLR occurred globally in 2.5% of cases (2.2% in provisional stenting, 3.5% in 2-stent technique). The rate of MACE was 9.4%, whereas all-cause death and MI, occurred in 4.1% and 3.2% of cases respectively. TVR and definite ST incidence were 3.7% and 1.1%. At multivariate analysis, chronic kidney disease (CKD) negatively influenced the main endpoint (HR 1.95, 95% CI 1.06–3.6, p=0.03), whereas post-dilatation (HR 0.56, 95% CI 0.3–0.93, p=0.04) and provisional stenting resulted being protective factors. FKB reduced TLR occurrence at FU only in 2-stent technique (p=0.03), whereas intracoronary imaging (performed in 29% of patients) were uninfluential.

Conclusion

Very thin-strut DES represents a highly effective solution in bifurcation lesions. The risk of TLR is reduced by post-dilatation and provisional stenting. FKB is recommended in 2-stent technique, whereas further studies are required to address the impact of intracoronary imaging in this setting.
P2696Clinical characteristics of late catch-up phenomenon after implantation of 2nd generation drug eluting stent
Authors: Saigusa T , Miura T , Taki M , Kobayashi M , Kanai M , Okuma Y , Yanagisawa T , Hashizume N , Otagiri K , Shoin K , Kato T , Ebisawa S , Motoki H , Kuwahara K
Published: October 2019

Introduction

Late catch-up phenomenon (LCU) of 1st generation drug eluting stent (DES) has been increasing yearly despite the rate of restenosis in 1 year has reduced compared with bare metal stent (BMS). 2nd generation DES was more improved than 1st generation DES and suggested more benefits about clinical outcome.

Purpose

To investigate the incidence and predictor of LCU after implantation of 2nd generation DES and to evaluate the association between LCU phenomenon and adverse events.

Methods

Between August 2012 and July 2013, a total of 1665 consecutive patients (1956 lesions with elective/urgent PCI) were enrolled in SHINANO 5 years Registry (a prospective observational multicenter cohort study) from 13 institutions in Nagano, Japan. 711 patients that were treated with 2nd generation DES and 576 patients with BMS were selected. Exclusion criterias were cases of 1st DES, only POBA, only aspiration and chronic total occulusion.

Results

There were significant difference about patients background between BMS and 2nd generation DES groups. Those groups were matched with propensity score. After matching, 822 patients (BMS group 411 patients, 2nd generation group 411 patients) were analyzed. The rates of 2nd DES and BMS restenosis 5 years after initial PCI were 9.2% and 8.5% (p=0.572), those of LCU were 2.6% and 5.6% (p=0.043) by 1 year landmark analysis. Cox proportional hazards analysis revealed that the DES in-stent restenosis (ISR) lesion and higher HbA1c were independent predictors for LCU from 1year to 5year (HR 5.304, p=0.009, HR 1.254, p=0.015), but 2nd generation DES was not. Kaplan Meier curve showed no association between LCU phenomenon and all cause death (p=0.446). Cox regression analysis showed LCU was not independent predictor for all cause death (p=0.414).

Conclusions

Implantation to DES-ISR lesion with 2nd generation DES was associated with higher LCU. Despite of more complex lesions with 2nd generation DES, there were no differences of LCU incidence between 2nd generation DES and BMS.

Acknowledgement/Funding

None
P2697Percutaneous coronary intervention with 2nd generation drug eluting stent versus coronary artery bypass grafting in patients with unprotected left main disease: clinical outcome from a referral center
Authors: Scudiero F , Migliorini A , Stefano P L , Marcucci R , Pennesi M , Carrabba N , Muraca I , Vitale R , Marchionni N , Valenti R
Published: October 2019

Background

Percutaneous coronary intervention (PCI) of unprotected left main coronary artery disease is currently recommended as an alternative to coronary artery bypass grafting (CABG) in patients with low and intermediate SYNTAX score.

Purpose

We sought to compare clinical outcomes of unprotected left main coronary artery disease by PCI or CABG in a “real world” population referred to high volume center.

Methods

All consecutive patients with unprotected left main coronary artery disease treated by PCI with second-generation drug-eluting stent were compared to those treated by CABG. The primary endpoint was the composite of death, non-fatal myocardial infarction (MI) or stroke at 2 years follow-up.

Results

A total of 558 patients were included. The mean age was 71±9 years, diabetes was present in 29%, and 56% of the patients presented with acute coronary syndrome. The distal left main coronary artery was involved in 84.6% of the lesions, the rate of Syntax score >32 was 50%. At 2 years, the primary end-point occurred in 10% of the patients in the PCI group and in 9.6% in the CABG group (p=0.862). The rates of death, non-fatal MI or stroke at 2 years were comparable; conversely the rate of ischemia driven revascularization at 2 years was higher in PCI group than CABG (5.5% and 1.5% p=0.010, respectively in PCI and CABG group).

Kaplan-Meier curves of MACCE

Conclusions

In a “real world” population with unprotected left main coronary artery disease, PCI with second generation stent, as compared to CABG, showed similar rates of the composite end point of death, non-fatal MI or stroke at 2 years, irrespective of coronary anatomy complexity.
P2736Hemodynamic and clinical impact in adult patients with anomalous aortic origin of the coronary artery evaluated with quantitative flow reserve
Authors: Adjedj J , Hyafil F , Aminfar F , Farnoud A , Rubimbura V , Fournier S , Ferrag W , Wijns W , Muller O , Aubry P
Published: October 2019

Background

Anomalous origin of the right coronary artery (ARCA) represents the most frequent form of abnormal coronary origin and may potentially increase the risk for sudden cardiac death. Evaluation of ARCA in adult patients referred for invasive coronary angiograms (ICA) is difficult, and clinical impact is unknown. Quantitative flow reserve (QFR) is an available method able to virtually calculate fractional flow reserve using 3-dimensional quantitative coronary angiography (3D-QCA) based on ICA.

Objectives

To evaluate the feasibility of QFR analysis in patients with ARCA and its clinical impact.

Methods

Using the registry of proximal anomalous connections of coronary arteries (ANOCOR registry), a multicentric observational registry including 472 adult patients with ANOCOR between 2010 and 2013, we retrospectively performed QFR analysis from ICA and evaluated the rate of death, myocardial infarction, unplanned revascularization and hospitalization in cardiology at 5 years.

Results

Among 128 patients with ARCA, 41 (32%) could have QFR analysis with median clinical follow-up of 8.3 years. The mean QFR value was 0.90±0.10, and 3D-QCA analysis showed preserved lumen area despite the elliptical shape of the proximal part of the ARCA which in the worst cases appeared on ICA as a significant narrowing. The event rate was 14.6% (n=6), including three deaths (one due to cancer, one due to stroke, and one cause remains unknown), two unplanned revascularizations, and one hospitalization for heart failure at 5 years. No myocardial infarction was reported.

Conclusions

QFR analysis of ARCA is feasible and non-significant QFR values are associated with good clinical outcome at 5 years. QFR of ARCA could be the evaluation of choice to help in clinical decision-making during ICA, when applicable.
P2737Changes of the amount of myocardial fibrosis after cardiac surgery in adult congenital heart disease patients: a cardiovascular magnetic resonance T1 mapping study
Authors: Tangcharoen T , Thirawut V , Prasertkulchai W , Yamwong S
Published: October 2019

Background

Myocardial fibrosis is not uncommon in patients with adult congenital heart disease (ACHD). Whether myocardial fibrosis can be resolved after cardiac surgery is questionable.

Purpose

We aimed to investigate the change of myocardial fibrosis after cardiac surgery in ACHD patients using T1 mapping CMR technique. The amount of myocardial fibrosis and cardiac function including myocardial strain were compared between non-ACHD and surgically-corrected ACHD patients.

Methods

All patients underwent cardiovascular magnetic resonance (CMR) on a 1.5T system before and after cardiac surgery. The protocol was approved by the local ethnic review board, and informed consent was obtained from each participant. Pre- and post-contrast T1 mapping were performed in the mid-cavity short-axis level with a 5(3)3 MOLLI scheme and ECG-gated acquisition. Myocardial fibrosis was expressed by the percentage of ECV. Ventricular and clinical parameters including 6-minute walk distance (6MWD), ejection fraction and myocardial strain were also analyzed. Mean ± standard deviation (SD) was reported. Paired t-test and independent sample t-test were used.

Results

Total 13 ACHD patients underwent CMR before and after surgery (34±16 years old, 9 female, 5 cyanotic, 5 underwent second operation). Median duration between CMR scanning and surgery was 308 days. Despite of increased 6 minutes-walk distance after surgery, the myocardial ECV did not significantly change (table 1). Compared with non-ACHD patients, the ECV in ACHD patients after surgery remained significantly higher (figure 1) although ventricular function including myocardial strain was not significantly different in both group (p=0.15 and 0.78 for ventricular function and strain rate respectively).

Table 1. Comparison of clinical and imaging parameter before and after surgery in ACHD patients Before surgery After surgery p LVEDVi (ml/m2) 77.5±29.1 70.8±10.4 0.34 LVEF (%) 61.0±8.3 61.8±7.5 0.72 RVEDVi (ml/m2) 122.2±74.4 80.6±26.4 0.02 RVEF (%) 60.4±13.6 56.9±10.8 0.14 6 minutes walk distance (meter) 287.3±93.0 350.4±61.6 0.05 ECV (%) 27.2±5.7 26.2±4.3 0.59

Figure 1

Conclusions

The amount of myocardial fibrosis, as expressed by percentage of the ECV, remained unchanged after surgery despite of clinical improvement. Compared with non-ACHD patients, the amount of fibrosis was significantly higher in ACHD patients after surgery.
P2744Age distribution of valvular heart disease in China: from a national multicenter prospective cohort study
Authors: Zhang B , Zhang H T , Xu H Y , Wu Y J
Published: October 2019

Background

Valvular heart disease (VHD) has been caught in two important cross-currents in recent decades: aging demography and the rise of multimodality imaging and transcatheter valve therapy. In this setting, we aim to identify the distribution, characteristics, and management of Chinese VHD patients according to age.

Methods

China Valvular Heart Disease Cohort Study (China-VHD) was conducted from March to September 2019 in 46 centers over China. It included prospectively 12331 adults with native moderate or severe VHD, of which we described the distribution, management, and in-hospital events according to age (18–44, 45–54, 55–64, 65–74, ≥75). Multivariate Logistic regression was employed to investigate the impact of age on in-hospital events composed of in-hospital mortality, acute heart failure, and stoke.

Results

In Chinese VHD population, overall percentage peaked in 55–64 year olds. The frequency of multivalvular heart disease (MVHD) saw an increasing trend with age (p for trend <0.001). Of single valvular heart disease, mitral regurgitation (MR) was the most frequent left-sided VHD followed by aortic regurgitation (AR), aortic stenosis (AS), and mitral stenosis (MS). AS frequency significantly grew with age (p for trend = 0.02) while AR peaked in 18–44 year olds and fluctuated at a lower level in the older population. In contrast, mitral valve disease (MS, MR, and mixed mitral valve disease) was most frequent in 45–54 year olds and dropped with age (p for trend all <0.001). Noteworthily, all aortic valve disease was notably frequent in men whereas mitral valve disease and MVHD more common in women. Similar to developed countries, degenerative etiology rose steeply while rheumatic and congenital origin fell with age. Regarding management, surgical valve replacement rate was similar in age groups lower than 75 years old with increasing frequency of concomitant CABG. No matter aortic or mitral, the percentage of bio-prosthesis rocketed after 65 years (aortic: 74.7%, mitral: 70.6%). In multivariate logistic regression, covariables included age, sex, BMI, hypertension, diabetes, coronary heart disease, aortic disease, cardiomyopathy, COPD, NYHA class and valvular intervention. Compared to patients younger than 45, in-hospital events significantly higher in patients over 75 only (OR: 1.69 [95% CI: 1.07–2.66], p<0.02). Moreover, women showed a lower risk of in-hospital events (OR: 0.78 [95% CI: 0.63–0.96], p<0.01).

Age distribution of VHD

Conclusion

Age plays a crucial role in valvular heart disease, best illustrated in AS. Unlike the western world, AR and MR are more frequent than AS but show a slightly decreasing trend with age. As expected, degenerative etiology is becoming more prevalent whereas rheumatism decreases. Age over 75 and male are associated with growing in-hospital events. Degenerative VHD thus present an important public-health burden.

Acknowledgement/Funding

Innovation project of Chinese academy of medical science
P2746Survival of people with valvular heart disease in the community (OxValve-Survive)
Authors: Taylor C , Ordonez-Mena J M , Roalfe A K , Wilson J , Myerson S , Prendergast B , Hobbs F D R
Published: October 2019

Background

Valvular heart disease (VHD) occurs commonly in older patients (>65 years) but the majority is mild disease, which is of uncertain importance. Understanding the impact of VHD on mortality in this older group of patients would help determine its relevance and aid the appropriate use of healthcare resources. OxValve is a cohort study in Oxfordshire screening people aged 65 and over for VHD. Over 4,009 participants were recruited between August 2009 and May 2016 and screened using echocardiography to establish the presence and severity of VHD.

AIMS To report survival in the OxValve cohort, and to investigate whether people with VHD are at increased risk of death.

Methods

The OxValve cohort was linked to Office for National Statistics mortality data to obtain date and cause of death. Cox regression was used to investigate the association of any VHD, VHD of significant severity, and VHD subtypes with all-cause and cause-specific mortality, adjusting for potential confounders including age, sex, socioeconomic status, smoking, and comorbidities.

Results

Linked mortality data was available for 3,511 OxValve participants up to September 2018 (median 5.85 years follow-up). VHD was present in 2,645 (75.3%) participants and of these 288 (8.2%) had significant VHD. In total, 311 (8.9%) participants had died. Cancer was the commonest cause of death (n=135), followed by cardiovascular disease (n=75) and respiratory disease (n=35). After adjustment for age and other covariates, mild to moderate VHD was not associated with increased all-cause mortality (HR 1.16, 95% CI: 0.89 to 1.50). However, VHD of significant severity (moderate or severe disease) was associated with a nearly two-fold higher risk of death overall (HR 1.92, 95% CI: 1:38 to 2.67) including increased CVD mortality (HR 2.25, 95% CI: 1.21 to 4.18).

DISCUSSION Mild to moderate VHD was very common, but was not associated with increased mortality. Significant VHD was however associated with a two-fold reduction in survival. Further research is required to understand the natural history of VHD, how to identify those with progressive disease and when to intervene.

Acknowledgement/Funding

NIHR Biomedical Research Centre, Oxford
P2749PCSK9 and HS-CRP are predictors of the progression of aortic stenosis in patients with stable coronary artery
Authors: Acena A , Franco-Pelaez J A , Pello Lazaro A M , Gonzalez Parra E , Gonzalez Lorenzo O , Martinez Milla J , Hernandez I , Martin Mariscal M L , Lopez Castillo M , Kallmeyer A , Lorenzo O , Albert L , Gonzalez Casasus M L , Egido J , Tunon J
Published: October 2019

Objective

There has been a great interest in knowing the factors associated with progression of aortic stenosis to try to slow down this evolution.

Methods

We studied 283 patients with chronic ischemic heart disease recording a broad number of clinical, therapeutic and analytical variables including inflammation and mineral metabolism biomarkers. We analyzed if any of these factors is a determinant of progression to aortic stenosis, defined as an increase in maximum flow speed across the aortic valve of at least 0.5 m/s.

Results

20 patients (7%) progressed to aortic stenosis in 72.4 months of follow-up. Among the patients who developed aortic stenosis, a greater age, greater percentage of peripheral arterial disease (PAD), lower treatment with beta-blockers, estimated Glomerular Filtration Rate (eGFR), total cholesterol, LDL, High-sensitivity C-reactive protein (HS-CRP), high-sensitivity troponin, N-terminal pro b-type natriuretic peptide and galectin 3 were found.

The results of the multivariate analysis showed that plasma levels of Proprotein convertase subtilisin/kexin type 9 (PCSK9) [OR: 0.668 per every increase in 100.000 μg/ml CI (0.457–0.977); p=0.038], HS-CRP [OR: 1.034 per every increase in 1 mg/dl CI (1.005–1.063); p=0.022], dyslipidemia [OR: 4.622 CI (1.285–16.618); p=0.019], PAD [OR: 9.453 CI (1.703–52.452); p=0.010], and eGFR [OR: 0.962 CI (0.939–0.986); p=0.002], remained a parameter with the ability to independently predict the progression of aortic stenosis

Conclusions

In patients with chronic ischemic heart disease, low PCSK9 and high HS-CRP plasmatic levels, low eFGR, PAD and dyslipidemia were independent predictors of progression of aortic stenosis. More studies are needed to investigate the relationships between the progression of aortic stenosis PCSK9 and inflammation.
P2762Recurrent infective endocarditis versus first-time infective endocarditis after heart valve surgery
Authors: Havers-Borgersen E , Butt J H , Oestergaard L , Bundgaard H , Smerup M , Bruun N E , Gislason G H , Torp-Pedersen C , Koeber L , Fosboel E
Published: October 2019

Introduction

Infective endocarditis (IE) may require heart valve surgery. However, it is well-known that heart valve surgery itself and previous IE predispose to IE.

Purpose

To access the risk of recurrent IE compared with first-time IE following heart valve surgery.

Methods

Using Danish nationwide registries, patients undergoing left-sided heart valve surgery (i.e. valve replacement or repair) in the course of a first-time IE hospitalization (1996–2017) were identified and matched with patients undergoing left-sided heart valve surgery due to another cause than IE in a 1:1 ratio. Patients were stratified according to type of surgical valve intervention and affected valve. The comparative risk of IE was assessed by cumulative incidence curves and multivariable Cox regression analyses.

Results

The study population comprised 975 patients with a first-time admission for left-sided IE requiring heart valve surgery (median age, 64.3 years [interquartile range 55.7–72.1], 77.6% men) matched with 975 controls undergoing left-sided heart valve surgery due to other causes than IE. The risk of recurrent IE was significantly higher than the risk of first-time IE following heart valve surgery (5.5% and 3.1% by 10 years, hazard ratio (HR) 1.72, 95% confidence interval (CI) 1.07–2.78) (Figure 1). The risk of IE recurrence was not significantly different in patients with IE undergoing valve replacement versus valve repair (5.6% and 5.4% respectively, HR 1.76, 95% CI 0.79–3.05). Likewise, the risk of IE recurrence was not significantly different for mitral versus aortic valve patients (3.5% and 6.3%, respectively, HR 0.73, 95% CI 0.36–1.48). Yet, the risk of IE recurrence was significantly higher among IE patients with biological versus mechanical prostheses (6.4% and 4.6%, respectively, HR 2.20, 95% CI 1.13–4.31).

Figure 1: Cumulative incidences

Conclusion

Following left-sided heart valve surgery, the associated risk of recurrent IE was significantly higher than the risk of first-time IE.

Acknowledgement/Funding

None
P2772The rule-out criteria for chronic thromboembolic pulmonary hypertension can identify patients without haemodynamic abnormalities and functional limitation 3 and 12 months after acute PE
Authors: Barco S , Mavromanoli A , Klok F A , Konstantinides S V
Published: October 2019

Background

Up to one-third of patients report persisting hemodynamic abnormalities and functional limitation over long-term follow-up after acute pulmonary embolism (PE).

Purpose

We tested whether a validated algorithm designed to rule-out chronic thromboembolic pulmonary hypertension (CTEPH) after acute PE can be used for identifying patients at lower risk of presenting with persisting symptoms and echocardiographic abnormalities.

Methods

The multicentre Follow-up of Acute Pulmonary Embolism (FOCUS) cohort study prospectively enrolled 1,100 consecutive patients diagnosed with acute symptomatic PE; two-year follow-up is ongoing. We focused on the scheduled visits for 3- and 12-month follow-up. The rule-out criteria are based on: the absence of ECG signs of right ventricular dysfunction and normal NT-proBNP/BNP values. Echocardiographic abnormalities were defined according to the presence of abnormal parameters indicating an intermediate/high probability of pulmonary hypertension as recommended by the 2015 ESC/ERS Society Guidelines on Pulmonary Hypertension. The presence of functional limitation was defined based on a World Health Organization classification grade ≥3, a Borg dyspnoea index ≥4, or a 6-minute walking distance <300 m.

Results

We included 323 patients (mean age 61 years, 58% men), of whom 255 have meanwhile completed a one-year follow-up. At 3- and 12-month follow-up, 194 (60%) and 155 (61%) of patients exhibited no abnormal echocardiographic findings or natriuretic peptide levels. The percentage of patients with echocardiographic abnormalities was 20.4% and 18.0%, respectively. The negative predictive value of the score for ruling out the combination of functional limitation and intermediate/high probability of pulmonary hypertension as recommended by the 2015 ESC/ERS Guidelines on Pulmonary Hypertension was 0.96 (95% CI 0.92–0.98) at 3 and 0.97 (0.92–0.99) at 12 months. The corresponding positive predictive values were 0.10 (0.06–0.17) and 0.09 (0.05–0.17), respectively.

Conclusions

The CTEPH rule-out criteria are capable of excluding functional limitation and evidence of (chronic) pulmonary hypertension 3 and 12 months after the diagnosis of acute PE.

Acknowledgement/Funding

The sponsor (University Medical Center of the Johannes Gutenberg University, Mainz) has obtained grants from Bayer Vital GmbH and Bayer Pharma AG
P2796Biodegradable polymer everolimus-eluting stents versus durable polymer everolimus-eluting stents in diabetic patients: a 3-year propensity-matched study
Authors: Matsuda H , Kagase A , Tokuda T , Ochiumi Y , Takeya M , Sato K , Murata A , Suzuki Y , Ito T
Published: October 2019

Background and introduction

Diabetic patients are at high risk of adverse cardiovascular events after percutaneous coronary intervention (PCI) even with durable polymer drug-eluting stents. A biodegradable polymer everolimus-eluting stents (BP-EES) might improve clinical outcomes in patients with diabetes mellitus.

Purpose

This study aimed to compare the mid-term clinical outcomes between BP-EES and durable polymer everolimus-eluting stents (DP-EES) in diabetic patients.

Methods

We investigated consecutive 383 patients treated with BP-EES or DP-EES at our Heart Center between January and December 2016. Among these patients, 155 (40.5%) patients had diabetes mellitus. The primary endpoint was 3-year cumulative incidence of target lesion failure (TLF) defined as target vessel-related myocardial infarction (MI) and clinical-driven target lesion revascularization (TLR). Moreover, the incidence of definite stent thrombosis (ST) was also evaluated.

Results

After propensity score matching, 148 patients were divided into 2 groups (BP-EES; N=74, DP-EES; N=74). The 3-year cumulative incidences of TLF were significantly lower in BP-EES group than in DP-EES group (BP-EES vs. DP-EES; 1.4% vs. 11.4%, p=0.01). The incidence of cardiac death, target vessel-related MI, and definite ST were none in the both group.

Figure 1

Conclusions

In diabetic patients, the incidence of TLR within 3 years was significantly lower in BP-EES than in DP-EES. In PCI for diabetic patients, BP-EES might improve clinical outcomes compared to DP-EES.
P2798Final 5-year outcomes of the TRIAS High Risk of Restenosis; a multi-centre, randomized trial comparing endothelial progenitor cell capturing stent with drug-eluting stents
Authors: Kerkmeijer L S M , Woudstra P , Klomp M , Kalkman D N , Varma C , Koolen J J , Teiger E , Florian B , Verouden N J , Tijssen J G , Beijk M A , De Winter R J
Published: October 2019

Background

One of the major long-term disadvantages of percutaneous coronary intervention (PCI) remains in-stent restenosis and need for repeat revascularisation. The polymer-regulated delivery of cytotoxic or cytostatic drugs, on drug-eluting stents (DES), impede the natural healing response of the damaged vessel wall. In animals, endothelial progenitor cells (EPCs) beneficially influence the repair of the coronary vessel wall after damage by stent placement. It is hypothesized that after immobilisation the EPCs differentiate into a functional endothelial layer and that this layer will prevent neointimal proliferation and thrombus formation. Anti-CD34+ antibodies are able to capture the EPCs. The Genous stent consist of a bare-metal stent with anti-CD34+ antibody coating.

Purpose

Demonstrating long-term performance of Genous EPC capturing stent (ECS) relative to DES regarding target lesion failure (TLF); the composite of cardiac death, myocardial infarction (MI) and any target lesion revascularisation (TLR) within 5 years.

Methods

We undertook an international, clinical trial in 26 centres planning to randomise 1300 patients with stable coronary artery disease and with a high risk of restenosis between treatment with either ECS or DES. After a routine review with 50% of the patients enrolled, early cessation of the trial was recommended by the data and safety monitoring board when TLF in the ECS population was substantially higher and treatment of new patients with an ECS would be unreasonable. The trial was terminated for safety reasons.

Results

A total of 622 were randomly assigned to receive either Genous ECS (304 patients, 367 lesions) or DES (318 patients, 388 lesions). Five year follow-up data was obtained in 95.5% of patients. TLF occurred in 29.1% of the ECS-treated patients and in 16.0% of the DES-treated patients (p<0.001) (Figure 1). This difference was driven by higher rates of TLR (22.9% vs. 10.7%, p<0.001), but not by cardiac death (6.5% vs. 4.5%, p=0.268), or MI (5.8% vs. 3.6%, p=0.175). Definite or probable stent thrombosis was seen in 8 ECS-treated patients (2.7%) and in 3 DES-treated patients (1%), p=0.11.

Figure 1. KM curves of TLF at 5year fu.

Conclusion

The Genous ECS is not sufficiently strong to compete with DES in terms of restenosis prevention in patients/lesions with a high risk of restenosis. If the addition of a EPCs capturing layer on a DES, like the COMBO stent, provides a lower risk of restenosis compared to DES will be tested in the ongoing SORT-OUT X trial.

Acknowledgement/Funding

OrbusNeich
P2804Initial experience with the novel BioMime Morph 40–60 mm long sirolimus-eluting tapered stent in long coronary lesions
Authors: Premawardhana A , Choudhury A , Sekar B , Hussain H
Published: October 2019

Aims

Aims: Long lesions treated with overlapping stents has been reported to be associated with healing problems and/or adverse events. The novel BioMime Morph is a 40, 50 and 60 mm long sirolimus-eluting cobalt chromium stent (65 μm strut thickness, biodegradable polymer) with a tapered design (0.5 mm taper from proximal to distal end) and is available in the following proximal and distal diameters (2.75–2.2 5mm, 3–2.5 mm and 3.5–3 mm). It can be a novel alternative for treatment of long coronary lesions, overcoming the limitations of overlapping stents.

Methods and results

Methods: Data was evaluated from our centre's prospective BioMime Morph database from August 2016 - January 2019. Primary endpoint was device oriented composite endpoint (DOCE: cardiac death, TV-MI, TLR and TVR). Secondary endpoints were technical (successful Morph implantation) and procedural success (successful procedure with Morph without in-hospital MACE).

Results

103 patients had BioMime Morph stents implanted, with mean follow up of 411 (±214) days and a mean age of 66 (±11) years. Co-morbidities included hypertension (58%), hypercholesterolemia (38%), diabetes mellitus (28%), PVD (2%), CVD (5%), CKD (12%), previous MI (17%), smoking (40%) and positive family history (20%). There was history of previous PCI in 18% and CABG in 4%. Indication for PCI was predominantly ACS (78% including 13% STEMI), 15% were CTOs. 80% of the procedures were performed via radial access using 5–6F sheath in 73%. Vessels treated included LAD (43%), Cx (12%) and RCA (45%). Pre-dilatation was performed in 96% including use of non-complaint balloons in 51%, scoring balloons in 12% and rotablation in 4%. Post-dilatation was performed in 99%. Buddy wire was used in 41% while a guideliner used in 13%. Technical success (secondary endpoint) was achieved in 100 whilst procedural success was achieved in 96% (4 cases of contrast induced nephropathy). Cumulative DOCE (primary endpoint) was % (cardiac death 1%, TV-MI 1%, definitive ST 0%, possible ST 1%, TLR 2% and TVR 2%). OCT follow up at 1 month, 3 month and 6 months in 2 patients showed endothelialisation even at 1 month.

Conclusions

Our initial experience of the use of the novel BioMime Morph tapered DES for treatment of long coronary lesions exhibit promising results in short to medium follow-up. Elution of the drug in 1 month along with biodegradable polymer and ultra thin struts potentially helps early healing and raises the possibility of short DAPT even in these complex long lesions. BioMime Morph stents can potentially be an alternative to overlapping conventional stents for treating long coronary lesions.
P2805Initial pathological responses of third-generation everolimus-eluting stents implantation: comparison with second-generation everolimus-eluting stents
Authors: Migita S , Simodai-Yamada S , Asakura K , Mukaiyama T , Okumura Y , Hao H
Published: October 2019

Background

Third-generation drug-eluting stent (3rd DES) is commonly used now in percutaneous coronary intervention, and it has not only thinner struts, easier delivery than second-generation drug-eluting stent (2nd DES), but also abluminal biodegradable polymer. Clinical superiority of 3rd DES has been demonstrated compared to 1st and 2nd DESs. However, pathological response after 3rd DES implantation remains unclear.

Purpose

Pathological study of coronary artery after 3rd DES implantation have not been reported as far as we have referred to the previous studies. This study aimed to examine the initial tissue response after 3rd DES and 2nd DES implantation within one year.

Methods

Using specimens obtained by autopsy, we compared the histology between 3rd DES (n=3, 8 histological sections) and 2nd DES (n=6, 41 histological sections) lesions within 1 year after stent implantation to evaluate early tissue reaction. Stent segments were fixed with 10% buffered formalin and embedded in plastic, followed by hematoxylin–eosin, Masson's trichrome and elastica van Gieson. Ratio of covered stent struts by neointima was calculated. The thickness of neointima and the area of fibrin deposition were morphometrically evaluated. The degree of inflammation around struts was examined semi-quantitatively (score 0–3).

Results

The ratio of covered struts and thickness of neointima of 3rd DES were 0.84±0.04 and 68.2±10.3μm, while those of 2nd DES were 0.69±0.05 and 30.4±4.8μm respectively. The inflammation score was similar between two groups (1.00±0.14 vs. 1.02±0.16). The area of fibrin deposition around the struts was larger in 3rd DES compared with 2nd DES (1276.6±490.3μm2 vs. 658.0±173.4μm2). These results suggest that the 3rd DES may obtain prompt as well as rich covering of struts in the initial term after DES implantation. Although the biological feature of the polymers in 3rd and 2nd DESs is different, the inflammatory responses after both 3rd and 2nd DESs implantation were similar, at least within one year after deployment. The degree of inflammation was mild, less than approximately 50 inflammatory cells (score 1) around the struts.

Conclusions

Our pathological analysis showed advanced healing process in 3rd DES compared with 2nd DES lesions in the viewpoint of strut coverage by neointima. Observation of long-term pathological response may be required to evaluate the superiority of bioabsorbable polymer in 3rd DES.
P2816Antithrombotic strategy for patients with anticoagulation indication undergoing percutaneous coronary intervention: meta-analysis of randomised controlled trials
Authors: Liao Y W , Wang T K M
Published: October 2019

Background

A significant proportion of patients having acute coronary syndrome and/or undergoing percutaneous coronary intervention (PCI) have indications for long-term anticoagulation such as atrial fibrillation. Their optimal antithrombotic strategy despite recent randomised trials. We meta-analysed outcomes comparing dual versus triple, and non-vitamin K oral anticoagulants (NOAC) versus vitamin K oral anticoagulants (VKA) antithrombotic regimens.

Methods

MEDLINE, Embase and Cochrane databases were searched for original randomised trials with relevant search terms. Two authors evaluated these studies for inclusion and extracted data pooling bleeding and cardiovascular events.

Results

The search yielded 308 articles, with 19 full-texts reviewed and 4 randomised trials totalling 6,029 patients included. Dual antithrombotic strategies were associated with significant reductions in TIMI major and minor bleeding (odds ratios 0.55, 95% confidence interval 0.36–0.83), and other bleeding endpoints including all, major, minor and intracranial bleeding (odds ratios 0.45–0.62, all P<0.05), compared with triple antithrombotic strategies in four trials, with no differences in mortality, myocardial infarction, stroke, stent thrombosis or composite cardiovascular events (odds ratio 0.79–1.13, all P>0.05). NOAC regimens were associated with significant reductions in TIMI major and minor bleeding odds ratio 0.49 (0.37–0.65), as well as major, minor and intracranial bleeding (odds ratios 0.29–0.52, all P<0.05), but again no differences in mortality or all cardiovascular endpoints (odds ratios 0.98–1.49, all P>0.05).

Conclusion

Antithrombotic strategies involving dual instead of triple agents, and NOAC instead of VKA had significantly less bleeding without increasing mortality and cardiovascular events, and are therefore preferred options in patients undergoing PCI who also require long-term anticoagulation.
P2829Arrhythmia burden during long-term follow-up in a large cohort of patients surviving out-of-hospital cardiac arrest
Authors: Caro Codon J , Rodriguez Sotelo L , Rey Blas J R , Gonzalez Fernandez O , Rosillo Rodriguez S O , Armada Romero E , Iniesta Manjavacas A , Ruiz Cantador J , Casas Sanchez B , Fernandez De Bobadilla J , Marco Clement I , Martin Polo L , Merino Argos C , Lopez-Sendon J L , Lopez-De-Sa E
Published: October 2019

Background

Data regarding incidence of ventricular (VA) and atrial arrhythmias (AA) in survivors after out-of-hospital cardiac arrest (OHCA) are scarce.

Purpose

To assess incidence of VA and AA in OHCA patients during long-term follow-up and to identify relevant predictive factors during the index hospital admission.

Methods

All consecutive patients admitted to the Acute Cardiac Care Unit after OHCA from August 2007 to January 2019 and surviving until hospital discharge were included. Cox proportional hazard models and logistic regression analysis were used to investigate clinical variables related to the incidence of VA and AA.

Results

The final analysis included 201 patients. Mean age was 57.6±14.2 years and 168 (83.6%) were male. The majority of patients experienced witnessed arrests related to shockable rhythms (176, 87.6%). Thirty-six patients (17.9%) died after a median follow-up of 40.3 months (18.9–69.1), but only 4 presented another cardiac arrest. Eighteen patients (9.0%) suffered new VA and 37 (18.4%) developed atrial fibrillation/atrial flutter. History of coronary heart disease [HR 3.59 (1.37–9.42), p=0.010] and non-acute coronary syndrome-related arrhythmia [HR 5.17 (1.18–22.60), p=0.029] were independent predictors of VA during follow-up. The optimal predictive model for atrial arrhythmias included age at the time of OHCA, LVEF at hospital discharge and non-acute coronary syndrome-related arrhythmias (p<0.001).

Table 1 Variable Without VA With VA p value Age, mean ± DS, years 57.4±14.2 60.8±14.7 0.336 Male sex, n (%) 150 (83.3) 15 (83.3) 1.000 Coronary heart disease, n (%) 36 (20.0) 11 (61.1) <0.001 Cardiomyopathy, n (%) 27 (15.0) 8 (44.4) 0.006 Shockable rhythm, n (%) 157 (87.2) 16 (88.9) 1.000 ACS-related arrhythmia (Primary VF), n (%) 83 (46.1) 2 (11.1) 0.004 LVEF at hospital discharge (%) 47.5±13.9 38.3±16.5 0.010 Death during follow-up 32 (17.8) 3 (16.7) 0.603 Cardiac arrest during follow-up 2 (1.1) 2 (11.1) 0.042 CV hospital admission during follow-up 39 (21.7) 14 (77.8) <0.001 Atrial arrhythmias during follow-up 28 (15.6) 9 (50.0) <0.001

Figure 1

Conclusions

Despite low incidence of recurrent cardiac arrest, OHCA survivors face a high incidence of VA and AA. Several clinical characteristics during index hospital admission may be useful to identify patients at high risk.
P2831Safety of atrial fibrillation catheter ablation in the elderly
Authors: Karim N , Marinelli A , Cantor E , Boyalla V , Malaczynska-Rajpold K , Ahmed O , Khan H , Haldar S , Jones D , Hussein W , Markides V , Wong T , Jarman J
Published: October 2019

Background

Catheter ablation for drug refractory, symptomatic atrial fibrillation (AF), is becoming increasingly common and can be beneficial in alleviating symptoms. However, in the elderly, there are concerns about the risks an invasive procedure poses, with limited published data available in those aged over 80 years.

Purpose

To determine the complication risk of AF catheter ablation in the elderly

Methods

Complications were identified from patient records in 3156 consecutive patients who underwent radiofrequency catheter ablation for AF, at a tertiary cardiology centre between 2013–2017. All cases were performed under general anesthesia.

Results

In this cohort of 3156 patients (mean age= 62.9±11.0 years, female = 29.9%), 90 (2.85%) (mean age= 66±10.0 years, female = 49.5%) complications were identified. In patients aged ≥80 years, complications occurred in 5 out of 99 patients (5.05%) (mean age= 82.6±1.2, female=100%), compared to 85 out of 3057 patients (2.78%) in those aged <80 years (mean age= 65±10.3, female = 49.4%). The difference was not significant p=0.18. Complications in the elderly all occurred acutely, and included groin haematoma (2.02%), pneumonia (2.02%) and pericardial effusion (1.01%).

Conclusion

Catheter ablation for AF in patients ≥80 years of age, is not associated with a significant increase in complication risk, compared to those who are younger.
P2834Diagnostic yield of holter recording after atrial fibrillation ablation - detection of asymptomatic recurrences during a one-year follow-up period
Authors: Van Vugt S P G , Volleberg R H J A , Westra S W , Thannhauser J , Evertz R , Hemels M E W , Beukema R J , De Asmundis C , Chierchia G B , Brouwer M A
Published: October 2019

Background

Strategies to detect recurrences after atrial fibrillation (AF) catheter ablation vary widely. Whereas a symptom-based approach may overestimate procedural success due to asymptomatic recurrences, continuous invasive monitoring with implantable devices may be refused by patients and is not routinely recommended. In trial settings, Holter monitoring is recommended at one year after ablation, though more frequent and intensive follow-up is encouraged for more accurate detection of arrhythmia recurrences.

Purpose

To study the diagnostic yield of Holter monitoring in the detection of asymptomatic recurrent arrhythmias after cryoballoon catheter ablation for AF.

Methods

Prospective registry on AF patients who underwent cryoballoon ablation with subsequent follow-up in our centre. Follow-up comprised routine (i.e. at 3, 6, and 12 months) and symptom-driven electrocardiographic (ECG) registrations after a three-month blanking period. In addition, patients were scheduled for six-day Holter monitoring shortly after the blanking period, at six months and at the end of the one-year follow-up period. For the current analysis, we studied the Holter recordings of the patients without previously detected arrhythmia recurrence and determined the proportion of asymptomatic recurrences at each respective monitoring period.

Results

We studied 364 patients with a median age of 60 years (IQR 54–66) and a median CHA2DS2-VASc score of 1 (IQR 1–2). One-year recurrences were documented in 119 (32.7%) patients, of which 90 were initially detected on Holter recording and 39 on ECG registrations (Table). A total of 34 patients did not report symptoms during the documentation of recurrent arrhythmia and comprised 28.6% (34/119) of all recurrences and 37.8% (34/90) of the Holter-detected recurrences. At the three-month Holter registration, 33.3% of the patients with recurrences did not report symptoms, which was 29.4% and 62.5% at the six- and twelve-month registrations, respectively (Figure).

Timing and detection of recurrences Time after ablation 3 months 3–6 months 6 months 6–12 months 12 months Patients with Holter-detected recurrences 57/119 (47.9%) 17/119 (14.3%) 16/119 (13.4%) Patients with ECG-documented recurrences 18/119 (15.1%) 11/119 (9.2%)

Proportions of asymptomatic recurrences

Conclusions

In this cohort of AF patients with serial six-day Holter monitoring after cryoballoon ablation, up to one-third of the patients had asymptomatic recurrences. Whereas Holter monitoring shortly after the blanking period detected nearly half of all one-year recurrences, the proportion of asymptomatic detected recurrences was higher in recordings at one year and seems therefore important in the detection of asymptomatic recurrences after catheter ablation.