bluuebunny/crossref_metadata_2025 huggingface dataset:
Design, concept and first in-vitro results of the percutaneous, pulsatile left ventricular assist device-PERKAT LV
Authors: Kretzschmar D , Schulze P.C , Ferrari M.W
Published: November 2020

Introduction

A very high morbidity and mortality is associated with cardiogenic shock due to left ventricular failure despite encouraging developments in interventional cardiology. Patients suffering from cardiogenic shock often require temporary mechanical circulatory support to stabilize organ perfusion. In addition, an increasing number of patients with complex multi-vessel diseases cannot undergo surgical myocardial revascularization as recommended by recent guidelines due to their comorbidities. Those patients could benefit from a protected PCI approach using a temporary mechanical assist device. The available LVAD systems have specific advantages and disadvantages.

Purpose

It was our aim to develop a percutaneous, pulsatile assist device that unloads the left ventricle in a physiologic way.

Methods

The PERKAT-LV (“PERkutane KATheterpumptechnologie”) device consists of a self-expanding nitinol pump chamber which is covered by foils. Those foils carry multiple outflow valves at the proximal part of the pump chamber. A flexible suction tube with a pigtail-shaped tip and inflow holes are attached to its distal part. The system is designed for 16F percutaneous implantation via the femoral artery. Pulling back the outer sheath unfolds the nitinol chamber in the descending aorta while the flexible suction tube bypasses the aortic arch and ascending aorta with its tip in the left ventricle. In the second implantation step, a standard IABP balloon is placed into the pumping chamber and is connected to an external IABP console. Balloon deflation generates a blood flow from the left ventricle into PERKAT LV. During balloon inflation, blood leaves the system through the outflow foil valves in the descending aorta. Positioning and schematic drawing of PERKAT-LV is demonstrated in Figure 1.

Results

Preliminary in-vitro studies using a prototype of the PERKAT LV device were performed. It was tested in different afterload settings (0, 40, 80 and 120 mmHg) using a standard 30 ccl IABP balloon and varying inflation/deflations rates (70, 80, 90, 100, 110 and 120/min). We detected flow rates ranging from 2.0 to 3.0 L/min depending on the afterload setting and inflation/deflation rate.

Conclusion

The novel percutaneously implantable and pulsatile working PERKAT-LV device offers left ventricular unloading and circulatory support of up to 3.0 L/min in a first feasibility study. At the moment, the system is extensively studied under in vitro conditions. First in vivo evaluation will follow in the near future.

Based on the current results, we believe that the system is a promising novel approach for percutaneous application of temporary left ventricular mechanical support.

Figure 1

Funding Acknowledgement

Type of funding source: Public grant(s) – National budget only. Main funding source(s): German Federal Ministry of Education and Research
Multidisciplinary approach and early use of percutaneous mechanical circulatory support devices in patients with cardiogenic shock
Authors: Venuti A , Gramegna M , Baldetti L , Calvo F , Pazzanese V , Sacchi S , Cappelletti M.A
Published: November 2020

Background

Despite progresses in the reperfusion strategies, the prognosis of patients with cardiogenic shock (CS) remains poor with a high in-hospital mortality rate. Percutaneous mechanical circulatory support systems (pMCS) reducing afterload, preload and myocardial oxygen demand, preventing compensatory tachycardia and increasing mean arterial pressure, lead to improve end-organ perfusion. Since CS progression to a refractory shock state is deleterious, timing of treatment represents a crucial issue in these patients.

Purpose

The aim of our study was to assess whether a multidisciplinary approach and an early use of pMCS could be safe and effective in improving CS patients' outcome.

Methods

We examined the outcome in terms of one-month survival of 62 patients (75.8% males, mean age 67.7±12.2 years) admitted between January and December 2018 to our Cardiac Intensive Care Unit (CICU) with cardiogenic shock due to acute coronary syndrome (ACS), acute heart failure (AHF) and other causes in 43.5%, 21.6%, 35.4% of cases respectively. For each patient, a Multidisciplinary Shock Team (CS-Team) including critical care specialists, interventional cardiologists and advanced heart failure specialists, was involved and the early use of pMCS was considered.

Results

Overall, 52 (83.9%) CS patients underwent pMCS implant, including intra-aortic ballon pump counterpulsation (IABP), Impella system (Impella), venous-arterial extracorporeal membrane oxygenation (VA ECMO) in 67.7%, 46.7%, 11.3% of cases respectively. Median time from the first CS-Team contact to the pMCS implantation was 32.5 (30–60) minutes. Among ACS-CS group, AHF-CS group and CS-due to other causes group, pMCS were implanted in 25 (92.5%), 12 (92.3%) and 15 (68.1%) patients respectively. Lower extremities ischemia, gastrointestinal/intracerebral and life-threatening bleeding and ischemic stroke were observed as pMCS related adverse events in 9.7%, 6.4%, 1.6%, 3.2%, 6.4% of cases respectively. At one month, 56 (90.3%) CS patients were discharged alive while 6 (9.7%) CS patients died during the CICU stay.

Conclusion

A multidisciplinary approach of CS patients, contemplating an early and extensive use of pMCS, may be effective in the reduction of in-hospital mortality rate with a low and acceptable occurrence of pMCS related adverse events.

Funding Acknowledgement

Type of funding source: None
Brain-derived neurotrophic factor is associated with coronary macrophage infiltrates in patients with acute coronary syndrome
Authors: Montone R.A , Camilli M , Russo M , Del Buono M , Gurguglione F , Meucci M.C , Rinaldi R , Iannaccone G , Canonico F , Liuzzo G , Niccoli G , Crea F
Published: November 2020

Background

Brain-derived neurotrophic factor (BDNF) is a neurotrophine that plays a key role in the regulation of both central and peripheral nervous system. Moreover, BDNF is secreted in multiple tissues and exerts systemic, autocrine, and paracrine effects in the cardiovascular system. Of importance, BDNF expression was enhanced in macrophages and smooth muscle cells in atherosclerotic coronary arteries and may be involved in thrombus formation. Thus, BDNF has been suggested as an important link between inflammation and thrombosis, potentially involved in the pathogenesis of acute coronary syndrome (ACS).

Purpose

In our study we aimed at assessing serum levels of BDNF in patients with ACS, evaluating differences according to clinical presentation [ST-segment elevation myocardial infarction (STEMI) vs. Non-ST-segment elevation ACS (NSTE-ACS)]. Moreover, we assessed the presence of optical coherence (OCT)-defined macrophage infiltrates (MØI) in the culprit vessel of ACS patients and evaluated their relationship with BDNF levels.

Methods

ACS patients were prospectively selected. Blood samples were collected at admission and serum levels of BDNF were subsequently assessed. Presence of OCT-defined MØI along the culprit vessel was assessed.

Results

166 ACS patients were enrolled [mean age 65.3±11.9 years, 125 (75.3%) male, 109 STEMI, 57 NSTE-ACS]. Serum levels of BDNF were higher among STEMI patients compared with NSTE-ACS [median (IQR) 2.48 pg/mL (1.54–3.34) vs. 2.12 pg/mL (1.34–2.47), p=0.007], while C-reactive protein levels did not differ between the two groups. OCT assessment was performed in 53 patients and MØI were detected in 27 patients. Of importance, patients with MØI in the culprit vessel had higher levels of BDNF compared with patients without MØI [median (IQR) 2.23 pg/mL (1.38–2.53) vs. 1.41 pg/mL (0.93–2.07), p=0.023], while C-reactive protein levels did not differ between the two groups. Of note, at multivariate regression analysis BDNF levels were independent predictor of MØI [OR: 2.20; 95% CI (1.02–4.74), p=0.043].

Conclusions

Serum levels of BDNF may reliable identify the presence of local macrophage inflammatory infiltrates in patients with ACS. Moreover, BDNF levels are higher in patients with STEMI compared with NSTE-ACS. Taken together, these data suggest that BDNF may represent an interesting link between local inflammatory activation and enhanced thrombosis in ACS.

BDNF serum levels

Funding Acknowledgement

Type of funding source: None
Gender differences in spontaneous coronary artery dissection: a nationwide analysis
Authors: Krittanawong C , Narasimhan B , Hassan Virk H , Yue B , Herzog E
Published: November 2020

Background

Spontaneous coronary artery dissection (SCAD) is a very rare cause of acute coronary syndromes in young otherwise healthy patients with a striking predilection for the female gender. Unfortunately, SCAD can result in significant morbidities and mortality. The pathological mechanism has not been fully clarified yet but hormonal changes might represent a sufficiently convincing explanation for some patients with SCAD. We hypothesized that gender difference in mortality in SCAD patients.

Methods

Data for this retrospective cohort study were extracted from the Nationwide Inpatient Sample for 2014 using the 9th revision of the International Classification of Diseases (ICD) 414.12 (spontaneous coronary artery dissection). Demographics, in-hospital mortality, conventional risk factors (diabetes, hypertension, hyperlipidemia, alcohol and tobacco abuse), acute critical illnesses like sepsis, septic shock, stroke, acute respiratory insufficiency, acute renal failure, and chronic conditions (anxiety, depression, malignancy and metastatic diseases) were studied. Univariate and multivariate logistic regression modeling were performed to determine predictors associated with the development of inpatient mortality in SCAD patients. All analyses were conducted using R 3.4.0 and STATA/MP 14.2. All p-values were two-sided, and statistical significance was determined at the level of p<0.05.

Result

A total of 270 SCAD patients were identified. Of those SCAD patients, no fibromuscular dysplasia (FMD) or pregnancy were identified. Patients were predominantly women (71%) and the mean age was 53 years. Overall in-hospital mortality was 5.6%, with 6.6% in male and 5.3% in female. Ethnicity, gender, stroke, acute renal failure, anxiety and depression did not predict mortality, length of stay, annual income, total hospital charge (all p>0.05). Multivariate analysis revealed no gender difference in SCAD patients and no independent predictors of mortality were identified.

Conclusions

This large nationwide study reveals that SCAD may be underdiagnosed but underutilization of work up such as FMD. SCAD is thought to be hormone related likely associated with female gender. Our results showed that no gender difference in mortality. Further large prospective studies are needed to determine gender difference in mortality and other predictors in mortality.

Funding Acknowledgement

Type of funding source: None
Prevalence and impact of ischemic risk on long-term bleeding and ischemic event for high bleeding risk patients
Authors: Shima Y , Miura K , Tada T , Tanaka H , Fuku Y , Kadota K
Published: November 2020

Background

Impact of ischemic risk (IR) on long term outcomes in patients at high bleeding risk (HBR) after everolimus-eluting stent (EES) implantation remains unclear.

Purpose

We aimed to evaluate long term bleeding and ischemic events in patient with HBR or IR after EES implantation.

Methods

The study population comprised 1219 patients treated with EES without in-hospital events between 2010 and 2011. The follow-up period was 2996±433 days. HBR was defined as Academic research consortium. IR defined as high-risk features of stent-driven recurrent ischemic events in Europe society of cardiology guidelines in 2019: prior stent thrombosis on adequate antiplatelet therapy, diffuse multivessel disease especially in diabetic patients, creatinine clearance <60 ml/min, at least three stents implanted, bifurcation two stents implanted, total stent length >60 mm, and treatment of a chronic total occlusion. Major bleeding (MB) was defined as defined as the occurrence of a Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding event. Primary ischemic events included myocardial infarction, definite stent thrombosis, and cardiac death. The Kaplan-Meier method was used for time-to-event analyses.

Results

Of the 1219 patients, 317 (26.0%) patients had no risk, 114 (9.4%) patients had only HBR, 288 (23.6%) patients had only IR, and 500 (41.0%) patients had both risks. The 81.4% of HBR patients had IR. The figure of Kaplan-Meier showed MB and CE for 7–8 years. Both risk groups had higher bleeding risk and Ischemic events (log rank p=0.0039, 0.0001).

Conclusion

HBR patients with EES had a high incidence of IR. Patients who had both HBR and IR are especially at risk for both ischemic events and bleeding compared to those who had no or only one risk.

Funding Acknowledgement

Type of funding source: None
Bedside assessment of the risk of non-compliance to medication is associated with mortality in elderly patients admitted for acute coronary syndromes
Authors: Briet C , Lacote C , Peron C , Blanchart K , Lemaitre A , Bignon M , Sabatier R , Ardouin P , Roule V , Beygui F
Published: November 2020

Background

Elderly patients are at high risk of mortality in the setting of acute coronary syndromes (ACS).

Purpose

We investigated whether compliance assessed by Compliance Evaluation Test (CET) in elderly patients admitted for acute coronary syndromes was associated with higher risk of one-year mortality.

Methods

We used the data from a prospective, open, ongoing cohort of patients ≥75 years old admitted for ACS to a tertiary center. The CET is a validated 6 item test easily performed at bedside. Non-compliance is defined by ≥ “Yes” answers.

We used a Cox model, un-adjusted and adjusted on predefined correlates of mortality (age, gender, and GRACE score) to assess the relationship between the risk of non-compliance and 1-year mortality.

Results

Two hundred fifty-five consecutive patients (age 83±5, female gender 59.6%, GRACE score 175±24) with CET assessment within 48 hours after admission and 1 year follow-up were included in the analysis. 225 (88%) were identified as compliant and 30 (12%) as non-compliant based on the CET.

Thirthy-six deaths occurred at 1 year follow-up, 24 (10.6%) and 12 (30%) in compliant and non-compliant patients respectively.

There was an almost 4-fold increase in the risk of one-year mortality in association with non-compliance (HR 4.16; 95% CI 2.03 to 8.5, p<0.0001) and adj-HR 3.93; 95% CI 1.87 to 8.3, p=0.003), independent of other covariables.

Conclusions

In elderly patients admitted for ACS, the risk of non-compliance assessed by the simple bedside test is associated with a 4-fold increase in the risk of 1-year mortality independent of other correlates of mortality. Our results support specific measures to improve compliance in such patients.

Survival based on compliance test

Funding Acknowledgement

Type of funding source: None
Prognostic value of fat attenuation index of pericoronary adipose tissue surrounding left anterior descending artery on coronary computed tomography angiography
Authors: Sugiyama T , Kanaji Y , Hoshino M , Yamaguchi M , Hada M , Misawa T , Sumino Y , Nogami K , Ueno H , Kakuta T
Published: November 2020

Background

Recent studies reported the association between elevated fat attenuation index (FAI) of pericoronary adipose tissue (PCAT) on coronary computed tomography angiography (CTA) and worse cardiac outcomes.

Purpose

We investigated the prognostic value of increased FAI-defined coronary inflammation status in patients with coronary artery disease.

Methods

Three-hundred fifty-eight patients (127 acute coronary syndromes [ACS], 231 stable coronary artery disease) with left anterior descending artery (LAD) as a culprit vessel who underwent coronary CTA were retrospectively studied. The FAI defined as the mean CT attenuation value of PCAT (−190 to −30 Hounsfield Unit [HU]) was measured at the proximal 40-mm segment of LAD. All subjects were divided into two groups according to the median value of FAI in the LAD. The association between the incidence of major adverse cardiac events (MACE) including all-cause death, myocardial infarction, heart failure, target and non-target vessel revascularization were evaluated.

Results

In a total of 358 patients, median FAI values surrounding the LAD was −71.46 (interquartile range, −77.10 to −66.34) HU. Thirty-eight patients (10.6%) experienced MACE during the follow-up period (median, 818 days). Kaplan-Meier analysis revealed that high FAI-LAD (>−71.46 HU [median]) was significantly associated with the incidence of MACE (log-rank test, chi-square = 4.183, P=0.041) (Figure).

Conclusions

In patients with coronary artery disease with culprit LAD lesions, elevated FAI of PCAT surrounding the LAD was associated with worse clinical outcomes. Assessment of FAI may have a potential for potential for non-invasive risk-stratification by coronary CTA.

Kaplan-Meier analysis for MACE

Funding Acknowledgement

Type of funding source: None
Secondary prevention in coronary artery disease: a risk-guidance may be beneficial
Authors: Huynh Q , Nghiem S , Byrnes J , Scuffham P , Marwick T.H
Published: November 2020

Background

Assessment of secondary event risk is now recommended for all coronary artery disease (CAD) patients. Many risk calculators have been developed for this purpose. However, their contribution to secondary prevention of CAD is limited because it is unknown whether high-risk patients would benefit more from intensive management. This study sought to apply a previously developed risk score of secondary event to predict readmission in CAD patients, and determine if higher-risk patients benefit more from intensive medical and interventional therapies.

Methods

This State-wide longitudinal study included 19,940 patients admitted to a hospital in 2010 with CAD as the principal diagnosis. Patients were followed up till the end of 2015. A previously developed and validated risk score (PEGASUS-TIMI54) was used to estimate risks of future adverse events and stratify all patients into either low risk (score<6) or high risk (score≥6) as previously recommended. The primary outcome was all-cause readmission. Secondary outcomes included all-cause mortality and days alive and out of hospital within five years of hospital discharge. Cox proportional hazards regression and linear regression were used for analysis.

Results

The high risk patients (n=6,573) had a significantly higher proportion of males and Indigenous people, had greater comorbidities, and were more likely to be readmitted or dead (all p<0.001) than their counterparts in the low risk group (n=13,367). Beta-blocker (hazards ratio HR=0.87 [95% CI: 0.79–0.95]), ACEi/ARB (HR=0.68 [95% CI: 0.62–0.73]) and PCI (HR=0.91 [95% CI: 0.88–0.95]) were negatively associated with readmission, and showed a negative interaction (p<0.001) with patients' predicted risks – implicating greater benefits for high-risk patients. CABG, on the contrary, was positively associated with readmission (HR=1.44 [95% CI: 1.15–1.80]) and showed a negative interaction (p<0.001) with patients' predicted risks. This finding suggests that patients receiving CABG were more likely to be readmitted than those not receiving CABG, but this trend reduced for patients with higher risks. Analysis of secondary outcomes suggest that all medical and interventional therapies reduced mortality risks, with the strongest effect size for CABG (HR=0.34 [95% CI: 0.29–0.48]). There was a negative interaction of statins, PCI and CABG with patients' predicted risks, implicating greater survival benefits for patients with higher risks.

Conclusions

CAD patients can be effectively risk-stratified. The use of this information for a risk-guided strategy may maximize benefits for high-risk patients.

Funding Acknowledgement

Type of funding source: None
Twenty-year survival of patients with atherosclerotic non-obstructive coronary plaques
Authors: Hlinomaz O , Sabbah M , Jarkovsky J , Machal J
Published: November 2020

Background

Atherosclerotic non-obstructive coronary artery disease (NObCAD) is frequently observed in patients referred for coronary angiography. No available data exist for the long-term prognosis of NObCAD patients beyond 10 years.

Purpose

We sought to compare the 15- and 20-year survival among patients presenting with chronic stable angina who had smooth coronary vessels, NobCAD, and obstructive (ObCAD), on invasive coronary angiography.

Methods

Coronary angiography of 671 consecutive patients presented with suspected CAD were retrospectively evaluated from single center registry between January and December 1998 and linked to administrative databases for outcomes evaluation. No CAD, NobCAD, and ObCAD were defined as 0%, 1% to 49%, and ≥50% luminal narrowing in epicardial coronary artery, respectively. The 15- and the 20-year survival rates were compared by Kaplan-Meier curve and multivariate Cox proportional hazards regression was used to identify significant independent predictors of mortality.

Results

Of 613 individuals (78.7% men with median age of 55.6 (51.0–65.2) years), 74 (12.1%) had normal coronary arteries, 42 (6.9%) had NobCAD, and 497 (81%) had ObCAD. The 15- and the 20-year survival rates were 89%, 66.7%, 62.4% and 79.7%, 54.7%, 42,5% in patients with normal, NobCAD, and ObCAD, respectively, (P=0.050 for no versus NobCAD; P=0.001 for no versus ObCAD at 20-year), These angiographic severity categories showed a strong gradient (P<0.001) (Figure 1). At 15-year follow-up, both ObCAD (adjusted HR=2.42, 95% CI (1.21–4.85), p=0.013) and NobCAD patients (HR=2.65, 95% CI (1.15–6.11), p=0.023) showed higher mortality compared to no CAD group. Independent predictors of mortality were, obstructive CAD (HR=2.34, 95% CI (1.407–3.916), P=0.001 for no versus NobCAD; HR=1.93, 95% CI (1.0–3.72), P=0.050, for no versus obstructive CAD), and age at addmission (HR=1.06, 95% CI (1.04–1.07), P<0.001).

Conclusion

The result of this analysis highlighted the less benign course of NobCAD that carries a mortality risk similar to patients with ObCAD at 15-and at 20-year follow-up. These findings support the need for aggressive anti-atherosclerotic drug therapy in such individuals and underscore the necessary efforts to improve the risk stratification and management of patients with non-obstructive CAD.

Funding Acknowledgement

Type of funding source: None
Circulating miR-133b and miR-21: potential non-invasive diagnostic biomarkers of coronary artery disease
Authors: Kumar D , Narang R , Sreenivas V , Rastogi V , Bhatia J , Saluja D , Srivastava K
Published: November 2020

Background

While coronary artery disease (CAD) has become a major threat worldwide, the timely biomarker-based early diagnosis of CAD remains a major unmet clinical challenge.

Purpose

We aimed towards assessing the level of circulatory microRNAs as candidates of novel biomarkers in early diagnosis of CAD.

Methods

A total of 147 subjects were recruited from Delhi and surrounding regions which includes 78 subjects with angiographically proven CAD, 15 pre-atherosclerotic normal coronary artery (NCA) subjects and 54 healthy individuals. Quantitative real-time PCR assays were performed using total RNA isolated from plasma of CAD patients and healthy individuals in order to measure the relative expression profiles of circulating miR-133b and miR-21. The severity level of the disease in each individual was assessed on the basis of number of diseased vessels involved and extent of stenosis.

Results

MiR-133b was found to be significantly downregulated (p<0.05) by 4.6 fold whereas miR-21 was significantly upregulated (p<0.05) by ∼2 fold in plasma samples of CAD patients as compared to healthy individuals. Importantly, both the miRNAs showed an association with disease severity as miR-133b was downregulated by 8.45 fold in acute coronary syndrome (ACS), 3.38 fold in Stable angina (SA) and 2.08 fold in NCA. MiR-21 was upregulated by 2.46 fold in ACS, 1.90 fold in SA and 1.12 fold in NCA. Moreover, miR-133b could significantly differentiate subjects with ST-elevation myocardial infarction (STEMI) from Non-STEMI. Both the miRNAs exhibited a noteworthy diagnostic potential as translated through an upstanding sensitivity and specificity. MiR-133b showed an area under the curve (AUC): 0.80 with 75.6% sensitivity and 76% specificity at recommended optimal cut-off point of 14.0 whereas, miR-21 showed and AUC value of 0.79 with 72.2% sensitivity and 69.4% specificity at optimal cut-off point of 5.59 as assessed by receiver operating characteristics (ROC) curve analysis.

Conclusions

The reduced expression of miR-133b and elevated expression level of miR-21 in plasma suggest their significant role in the pathophysiology as well as their implication towards the individual's susceptibility in developing CAD. Thus, we conclude that these two circulating miRNAs could be possible candidates of non-invasive biomarkers in the early prediction and diagnosis of CAD.

Funding Acknowledgement

Type of funding source: Other. Main funding source(s): Department of Science and Technology, New Delhi, India; University Grant Commission (JRF/SRF Fellowship: Ref no. 22/12/2013(ii)EU-V
Diagnostic value of myocardial perfusion CT to detect coexisting microvascular dysfunction in patients with obstructive epicardial coronary disease
Authors: Hada M , Kanaji Y , Ueno H , Nogami K , Misawa T , Sumino Y , Yamaguchi M , Sugiyama T , Yonetsu T , Kakuta T
Published: November 2020

Background

The usefulness of computed tomography myocardial perfusion (CTP) to assess hemodynamically significant coronary artery lesions has been previously reported. However, the diagnostic value of quantitative evaluation of regional absolute coronary flow by CTP to detect microvascular dysfunction remains unknown.

Purpose

The aim of study is to assess the diagnostic value of preprocedural CTP to detect coexisting microvascular dysfunction with functionally significant epicardial stenosis in patients with chronic coronary syndromes.

Methods and results

Thirty-three chronic coronary syndrome patients with de novo single functionally significant stenosis (Fractional flow reserve [FFR]<0.80) who underwent noncomplicated PCI were investigated. In CTP analysis, regional myocardial blood flow (MBF) at rest (rest-MBF) and hyperemia (hyperemic-MBF) were evaluated semi-automatically. Clinical characteristics, pressure-temperature sensor-chipped wire-based information and CTP findings were compared between groups with and without microvascular dysfunction defined by the index of microcirculatory resistance (IMR) (IMR≥25, n=17, IMR<25, n=16, respectively).

The determinants of coexistence of microvascular dysfunction and functional epicardial stenosis were determined. In invasive wire-based analysis, FFR, coronary flow reserve (CFRwire) and IMR were 0.68 (0.57–0.72), 1.61 (1.00–1.98), and 26.7 (19.3–39.4) respectively.

In CTP analysis, rest and hyperemic-MBF and CFR derived from CTP (CFRCTP; calculated as hyperemic-MBF/rest-MBF) were 2.00 (1.31–2.35) ml/min/g, 4.03 (2.11–5.44) ml/min/g, and 2.09 (1.49–2.09) respectively.

In the lesions with IMR>25, hyperemic-MBF was significantly lower than that in IMR<25 (3.42 [1.89–4.34] vs 4.50 [3.44–5.99], p=0.031), although there was no significant difference in regional rest-MBF and CFRCTP (1.75 [1.31–2.24] vs 2.05 [1.35–2.46], p=0.439, and 1.83 [1.21–2.11] vs 2.61 [1.91–2.91], p=0.101 respectively). Receiver operating characteristic curve analysis of hyperemic-MBF detecting IMR>25 showed area under the curve of 0.72 (0.54–0.90), sensitivity of 47% and specificity of 94%.

Conclusion

Quantitative assessment of absolute coronary flow by CTP may help detect coexisting microvascular dysfunction in patients with significant epicardial stenotic lesions.

Funding Acknowledgement

Type of funding source: None
Lack of statin therapy is associated with plaque instability in non-culprit non-ischemic lesions of diabetic patients – data from the COMBINE OCT-FFR study
Authors: Berta B , Roleder T , Hermanides R.S , Ijsselmuiden A.J.J , Alfonso F , Kauer F , Escaned J , De Luca G , Kennedy W , Wojakowski W , Kedhi E
Published: November 2020

Background

Effect of statin therapy on coronary plaque stabilisation and reducing adverse cardiovascular events is well known both in primary and secondary prevention. Nevertheless, there is a paucity of data presenting the impact of statins on plaque morphology as assessed by optical coherence tomography (OCT).

Purpose

The goal of this analysis was to evaluate the plaque morphology using OCT within non-culprit, non-ischaemic coronary lesions in diabetes mellitus (DM) patients with or without statin pre-treatment.

Methods

All patients of the COMBINE (FFR-OCT) trial underwent fractional flow reserve (FFR) measurement followed by OCT in FFR negative lesions. OCT recorded the presence of thin-cap fibroatheroma (TCFA), plaque rupture (PR), plaque erosion (PE) and calcified nodule (CN).

Results

From the 391 patients, 82 (21%) had no statin at baseline. OCT was performed in 463 lesions of which 96 lesions assessed in statin naive and 367 lesions in statin treated group. The median angiographic diameter stenosis was 50% and the median FFR value was 0.88 in both groups (p=0.953 and p=0.448, respectively). Myocardial infarction (MI) at presentation was 16.6% and did not differ between groups (p=0.380). Patients without statin pre-treatment were characterized by lower rate of known hypercholesterolemia (47.6% vs. 63.0%; p=0.011), male gender (52.4% vs. 65.7%; p=0.027), active smokers (8.5% vs. 22.3%; p=0.004) and previous MI (22.0% vs. 35.3%; p=0.022) as compared to patients with statin pre-treatment, respectively. The results of the qualitative OCT findings see in Table 1.

Conclusions

Non-ischemic lesions of DM patients without statin pre-treatment showed more vulnerable and instable plaque features like wider lipid arc, thinner fibrotic cap and a higher prevalence of lipid-rich plaque, TCFA and PR suggesting a stabilizing effect of statins on non-ischemic atherosclerotic lesions.

Funding Acknowledgement

Type of funding source: Private grant(s) and/or Sponsorship. Main funding source(s): The trial is founded from the Department of Cardiology Zwolle Heart-centrum with support from a non-restricted grant from St Jude Medical (now Abbott)
Residual functional SYNTAX score by quantitative flow ratio and improvement of exercise capacity after revascularization in patients with stable ischemic heart disease
Authors: Lee S.H , Choi K.H , Lee J.M , Shin D , Kim H.K , Doh J.H , Nam C.W , Shin E.S , Park T.K , Yang J.H , Song Y.B , Hahn J.Y , Choi S.H , Koo B.K , Gwon H.C
Published: November 2020

Background

In patients with stable ischemic heart disease (SIHD), the efficacy of percutaneous coronary intervention (PCI) in improving exercise capacity has been under debate and the differential effect of PCI for exercise capacity, according to functional completeness of revascularization, has not been evaluated.

Purpose

This study aimed to evaluate the association between improvement in exercise capacity and functional completeness of revascularization, determined by residual functional SYNTAX score (rFSS), which is the sum of residual SYNTAX score of the vessels with post-PCI quantitative flow ratio (QFR)≤0.80.

Methods

Among patients enrolled in the QFR multicenter registry, 110 patients who underwent prespecified routine exercise treadmill tests before and after PCI were analyzed. Patients were classified into functional complete revascularization (CR) group (rFSS=0) and functional incomplete revascularization (IR) group (rFSS≥1). Increase of exercise time after PCI was compared between the 2 groups. Improvement of exercise capacity was defined as ≥10% increase of exercise time after PCI.

Results

Functional CR was achieved in 79 patients (71.8%), otherwise classified as functional IR in 31 patients (18.2%). There were no significant differences in baseline characteristics including medication profiles. Increase of exercise time was significantly associated with increase of 3-vessel QFR (r=0.198, P=0.038) and rFSS (r=−0.312, P<0.001), but not with decrease of SYNTAX score (r=0.097, P=0.313). The rFSS showed significantly higher c-index to predict the improvement of exercise capacity after PCI than increase of 3-vessel QFR or decrease of SYNTAX score (0.722 vs. 0.627 vs. 0.492, respectively, P<0.001). Patients with functional CR, defined by rFSS, showed significantly higher increase of exercise time than those with functional IR (97.7 sec vs. 12.5 sec, P<0.001). Functional CR was an independent predictor of the improvement of exercise capacity after PCI (adjusted odds ratio 4.656, 95% CI 1.678–12.920, P=0.002).

Conclusions

Integrated anatomic and functional scoring system (rFSS) was significantly associated with improvement of exercise capacity after PCI. SIHD patients with functional CR, defined by rFSS, showed significantly higher exercise capacity after PCI than those with functional IR.

Summarizing Figure

Funding Acknowledgement

Type of funding source: Private company. Main funding source(s): SaeHan NK & D and Medis Corporation
Early aspirin discontinuation following acute coronary syndrome or percutaneous coronary intervention: a systematic review and meta-analysis of randomized controlled trials
Authors: Guedeney P , Mesnier J , Sorrentino S , Abcha F , Zeitouni M , Lattuca B , Silvain J , De Rosa S , Indolfi C , Collet J.P , Kerneis M , Montalescot G
Published: November 2020

Background

The respective ischemic and bleeding risks of early aspirin discontinuation following an acute coronary syndrome (ACS) or percutaneous coronary intervention (PCI) remains uncertain.

Objectives

To evaluate the safety and efficacy of early aspirin discontinuation in ACS or PCI patients treated with P2Y12 inhibitors with or without anticoagulants.

Methods

We performed a review of randomized controlled trials (RCTs) comparing a P2Y12 inhibitor-based single antiplatelet strategy following early aspirin discontinuation to a strategy of sustained dual antiplatelet therapy (DAPT) in ACS or PCI patients requiring or not anticoagulation for another indication. The primary safety endpoint was major bleeding while non-major bleeding and all bleeding were secondary safety endpoints. The primary efficacy endpoint was all-cause mortality while secondary efficacy endpoints included major adverse cardiovascular and cerebrovascular events (MACCE), myocardial infarction (MI), definite stent thrombosis (ST) or any stroke. We estimated risk ratios (RR) and 95% confidence intervals (CI) using random effect models. The study is registered in PROSPERO (CRD42019139576).

Results

We included 9 RCTs comprising 40,621 patients.Compared to prolonged DAPT, major bleeding (2.2% vs. 2.8%; RR 0.68; 95% CI: 0.54 to 0.87; p=0.002; I2: 63%), non-major bleeding (5.0% vs. 6.1%; RR: 0.66; 95% CI: 0.47 to 0.94; p=0.02; I2:87%) and all bleeding (7.4% vs. 9.9%; RR: 0.65; 95% CI: 0.53 to 0.79; p<0.0001; I2: 88%) were significantly reduced with early aspirin discontinuation (Figure 1), without significant difference for all-cause death (p=0.60), MACCE (p=0.60), MI (p=0.77), definite ST (p=0.63), and any stroke (p=0.59). Results were consistent in patients with or without anticoagulation, without significant interaction for any outcomes but MI (p=0.04).

Conclusions

In patients on DAPT after an ACS or a PCI, early aspirin discontinuation prevents bleeding events with no effect on the ischemic risk or mortality.

Figure 1. Central illustration

Funding Acknowledgement

Type of funding source: None
Efficacy and safety of low-dose rivaroxaban on top of aspirin in patients with polypharmacy and multimorbidity: an analysis from the COMPASS trial
Authors: Vanassche T , Verhamme P , Leong D , Bhatt D.L , Shestakovska O , Maggioni A.P , Fox K.A.A , Muehlhofer E , Connolly S , Yusuf S , Eikelboom J , Bosch J
Published: November 2020

Background

In patients with coronary or peripheral artery disease, intensified antithrombotic therapy with aspirin plus low dose rivaroxaban reduced cardiovascular outcomes compared with aspirin alone. Polypharmacy and multimorbidity are frequent in patients with vascular disease and are often perceived as barriers to more intensive pharmacotherapy by both patients and physicians.

Purpose

To report cardiovascular outcomes and the efficacy, safety, and net benefit of low dose rivaroxaban plus aspirin in patients with stable vascular disease by the number of concomitant cardiovascular drugs and by the number of comorbidities.

Methods

We reported ischemic events (cardiovascular death, stroke, or MI), major bleeding (ISTH modified criteria), and a prespecified net clinical outcome in participants from the randomised, double-blind COMPASS study by number of cardiovascular medications (0–2, 3, 4, 5–7) and by number of concomitant medical conditions. We compared rates and hazard ratios of patients treated with rivaroxaban plus aspirin vs aspirin alone by category of number of medications and concomitant conditions and tested for interaction between polypharmacy and multimorbidity and antithrombotic regimen.

Results

Although patients with polypharmacy and multimorbidity have a higher risk of cardiovascular events (Figure) those who required many cardiovascular drugs derived the largest absolute reduction in the net clinical outcome when adding rivaroxaban on top of aspirin. The relative efficacy, safety, and net clinical benefit of adding low-dose rivaroxaban to aspirin in patients with stable vascular diseases were not affected by the number of cardiovascular drugs or by the number of comorbidities. Multimorbidity, but not polypharmacy, was related with a higher risk of major bleeding.

Conclusion

Addition of low-dose rivaroxaban conveyed a benefit irrespective of the number of concomitant drugs or comorbid conditions. Multiple comorbidities and/or polypharmacy should not dissuade the addition of low-dose rivaroxaban to aspirin in otherwise eligible patients.

Figure 1

Funding Acknowledgement

Type of funding source: Private company. Main funding source(s): The COMPASS trial was funded by Bayer AG.
Efficacy of sonothrombolysis using acoustically activated perflutren nanodroplets versus perflutren microbubbles
Authors: El Kadi S , Qian L , Zeng P , Lof J , Stolze E , Xie F , Kamp O , Van Rossum A.C , Porter T.R
Published: November 2020

Background

The use of intermittent high mechanical index (HMI) ultrasound impulses in combination with intravenously administered microbubbles (MB) has been shown to dissolve arterial and microvascular thrombi. The recent development of liquid droplets with nanoscale diameter from commercially available microbubbles may optimize thrombus permeation and subsequent thrombus dissolution.

Methods

Thrombi were formed from fresh porcine arterial whole blood mixed with thrombin, and placed in a vascular system mimicking branching epicardial coronary circulation (Figure 1A) at 37 Celsius and flow rate. A diagnostic ultrasound system with a tissue mimicking phantom was placed on top of the thrombus to simulate transthoracic echocardiography. Thrombus treatment consisted of a 10-minute infusion of either diluted nanodroplets (ND) or MB (same concentration) with intermittent HMI fundamental multipulse (3 usec pulse duration; FUS) or single pulse harmonic (HUS) impulses. All treatments were randomized and compared with HMI impulses alone. Efficacy was evaluated by percentage thrombus dissolution (%TD). Transmission electron microscopy (TEM) of residual thrombi after treatment was performed to examine for droplet permeation and resultant formed microbubble size.

Results

A relatively monodisperse nanodroplets size distribution was formed from microbubble cooled compression (mean diameter was 147±54 nm). A total of 60 porcine arterial thrombi were tested, 20 in each MB and ND treated group (20 control). Overall, there was a significant difference in %TD between ND treated thrombi (combining HUS and FUS HMI treated groups) versus MB treated thrombi and control (p<0.0001 and p=0.02, respectively; ANOVA, Figure 1B). The highest %TD was seen in the FUS HMI treated ND group (mean 51±17%; Figure 1B). TEM of the DND treated group demonstrated significant expansion (diameters of 6 microns; Figure 1 C) of acoustically activated droplets embedded within the thrombi.

Conclusion

ND in combination with intermittent HMI ultrasound resulted in significantly greater thrombolysis compared to MB. In-vivo studies on nanodroplet mediated sonothrombolysis for vascular and microvascular thrombi should be performed with this modification of a commercially available microbubble.

Figure 1

Funding Acknowledgement

Type of funding source: Foundation. Main funding source(s): Theodore F. Hubbard Foundation
Multivessel versus culprit-only PCI in STEMI patients with multivessel disease: meta-analysis of randomized controlled trials
Authors: Feistritzer H , Jobs A , De Waha-Thiele S , Eitel I , Freund A , Abdel-Wahab M , Desch S , Thiele H
Published: November 2020

Background

Previous randomized controlled trials (RCTs) indicated a benefit of multivessel percutaneous coronary intervention (PCI) compared to culprit vessel-only PCI in ST-elevation myocardial infarction (STEMI) without cardiogenic shock.

Purpose

To perform a pairwise meta-analysis of RCTs, already including the recently published COMPLETE (The Complete versus Culprit-Only Revascularization Strategies to Treat Multivessel Disease after Early PCI for STEMI) trial, comparing multivessel PCI and culprit vessel-only PCI in STEMI patients without cardiogenic shock.

Methods

We searched MEDLINE, Cochrane Central Register of Controlled Trials, and Embase for randomized controlled trials (RCTs) comparing multivessel PCI with culprit vessel-only PCI in STEMI patients without cardiogenic shock and multivessel coronary artery disease. Only RCTs reporting mortality or myocardial reinfarction after at least 6 months following randomization were included. Hazard ratios (HRs) were pooled using random-effect models.

Results

Nine RCTs were included in the final analysis. In total, 523 (8.3%) of 6,314 patients suffered the combined primary endpoint of death or non-fatal reinfarction. This primary endpoint was significantly reduced with multivessel PCI compared to culprit vessel-only PCI (HR 0.63, 95% confidence interval [CI] 0.43–0.93; p=0.03). This finding was driven by a reduction of non-fatal reinfarction (HR 0.64, 95% CI 0.52–0.79; p=0.001), whereas no significant reduction of all-cause death (HR 0.77, 95% CI 0.44–1.35; p=0.28) or cardiovascular death (HR 0.64, 95% CI 0.37–1.11; p=0.09) was observed.

Conclusion

In STEMI patients without cardiogenic shock multivessel PCI reduced the risk of death or non-fatal reinfarction compared to culprit vessel-only PCI.

Funding Acknowledgement

Type of funding source: None
Long-term outcomes following percutaneous coronary intervention for patients with rheumatoid arthritis
Authors: Dawson L , Dinh D , Duffy S.J , Brennan A , Guymer E , Clark D , Oqueli E , Freeman M , Hiew C , Reid C , Ajani A.E
Published: November 2020

Background

Rheumatoid arthritis (RA) is the most common inflammatory arthritis and is associated with increased risk of cardiovascular events and mortality. Despite this, data regarding long-term outcomes following percutaneous coronary intervention (PCI) are limited.

Methods

We identified 756 patients with RA from the Melbourne Interventional Group PCI registry (2005–2018) and compared outcomes to the remaining cohort (N=38,579). Cox regression analysis was performed to assess risk of adverse cardiac events including long-term mortality (derived from linkage with the National Death Index [NDI]).

Results

Patients with RA were older (68.9±10.0 vs. 64.6±12.0 years) and more often female (40% vs. 23%), with higher rates of hypertension (70% vs 67%), previous stroke (9% vs 6%), peripheral vascular disease (9% vs 6%), obstructive sleep apnoea (10% vs 5%), chronic lung disease (22% vs 12%), prior myocardial infarction (32% vs 27%), and impaired renal function (eGFR<60 ml/min/1.73m2 in 31% vs 24%), while rates of current smoking were lower (20% vs. 25%), all p<0.05. Lesions were more frequently complex (ACC/AHA type B2/C in 61% vs 57%), required longer stents (>20mm in 39% vs 35%), and rates of no reflow were higher (5% vs 3%), all p<0.05. 30-day mortality was higher (4.4% vs. 3.3%, p=0.04) mainly owing to higher non-cardiac mortality (1.6% vs. 0.8%, p=0.01). National Death Index-linked long-term mortality was 28% vs. 19% (p<0.01) with mean follow-up 4.6 vs. 5.4 years. Risk of 30-day and long-term mortality (including by indication subgroup) are presented in the Table.

Conclusions

Patients with RA undergoing PCI have more comorbidities and longer, more complex coronary lesions. After adjustment, risk of short-term adverse outcomes are similar, while risk of long-term mortality is higher, particularly among patients with acute coronary syndromes.

Funding Acknowledgement

Type of funding source: None
Early restenosis and late catch-up phenomenon after newer biodegradable- and durable-polymer drug-eluting stent implantations
Authors: Masumoto A , Ohya M , Murai R , Miura K , Shimada T , Amano H , Kubo S , Tada T , Tanaka H , Fuku Y , Kadota K
Published: November 2020

Background

It is yet to be known whether mechanisms underlying restenosis in newer-generation durable-polymer (DP) and biodegradable-polymer (BP) drug-eluting stents (DES) are different.

Purpose

This study aims to assess the incidences and predictors of early restenosis and late catch-up phenomenon after newer-generation durable-polymer (DP) and biodegradable-polymer (BP) DES.

Methods

Between 2010 and 2017, 13858 lesions in 6350 patients were treated with DES (4393 BP-DES, 9465 DP-DES). The early-term (within 1 year) and late-term (from 1 to 2 years) follow-up angiographies were scheduled. Late catch-up phenomenon was defined as in-stent restenosis (ISR) in lesions that evaded ISR within 1 year after stent implantation. ISR was defined as angiographic restenosis of more than 50%.

Results

The mean patient age was 71 years, and 76.7% were male. Early-term angiographies were performed in 10955 lesions (79.0%). Of those without early-term ISR, late-term angiographies were performed in 7771 lesions (56.1%). The incidences of mid-term restenosis and late catch-up phenomenon were 6.6% and 3.9%, respectively.

In the multivariate regression analyses, history of diabetes, hemodialysis and previous PCI were independent predictors of both early restenosis and late catch-up phenomenon. Also, some lesion characteristics such as chronic total occlusion, right coronary artery ostial lesion, small vessel (defined as reference diameter <2.5mm), long lesion (defined as lesion length >30mm) and treatment of ISR lesion were independent predictors of both early restenosis and late catch-up phenomenon.

Bifurcation lesion and heavily calcified lesion treated with rotablator were independent risk of early restenosis. Bypass graft lesion was an independent predictor of late catch-up phenomenon.

Early restenosis was observed less frequently in DP-DES than in BP-DES (6.3% versus 7.4%, P=0.012). On the contrary, late catch-up phenomenon was observed more frequently in DP-DES than in BP-DES (4.3% versus 2.9%, P=0.026).

Conclusions

Some lesion characteristics were independent predictors of early restenosis and late catch-up phenomenon after newer-generation DES implantation. The deployment of BP-DES resulted in more early restenosis and less late catch-up phenomenon compared to that of DP-DES.

Early Restenosis and Late Catch-Up

Funding Acknowledgement

Type of funding source: None