bluuebunny/crossref_metadata_2025_split huggingface dataset:
Japanese multicenter registry evaluating the antegrade dissection reentry with cardiac computed tomography for chronic coronary total occlusion
Authors: Habara M , Tsuchikane E , Shimizu K , Kawasaki T 
Published: November 2020

Abstract

Objective
This study was performed to evaluate the efficacy of cardiac computed tomography (CT) for antegrade dissection re-entry (ADR) technique in chronic total occlusion (CTO) percutaneous coronary intervention (PCI).

Background
Although PCI of CTO is a rapidly evolving field, procedure success rate remains suboptimal. Recently, ADR with Stingray device for CTO-PCI has also evolved to one of the pillar technique of the hybrid algorithm. Although the success rate of the device could be improved, it also remains not always high especially as first crossing strategy.

Methods
Forty eight patients with total occlusion suitable for revascularization evaluated by baseline coronary angiography and cardiac CT were enrolled in this study from April 2017 to April 2019 from 30 enrolled centers. The primary observation was procedural success. Furthermore, all puncture point with Stingray were analyzed by cardiac CT. In each point, 1) plaques on the isolated myocardial side at distal puncture site (+1 point), 2) any plaques excluded above definition at distal puncture site (+2 points), 3) calcification on both 1 and 2 at distal puncture site (+1 point) were analyzed and calculated the score (Score 0–3) (Figure 1).

Results
Overall procedure success rate was 95.8% (46/48) and antegrade success rate was 91.3% (42/46). Sixteen cases were succeeded with single guidewire escalation and 32 cases were attempted ADR with Stingray system. Within them, 25 cases were succeeded and 7 cases were observed puncture failure. And 3cases were succeeded with IVUS guide and 2 cases were with retrograde appTechnical success rate with stingray was 78.1% (25/32). Cardiac CT was analyzed 60 puncture sites in 32 cases which were attempted ADR with stingray system (1.88 sites/case). CT score at ADR success point was significantly smaller compare to that at ADR failure point (0.68±1.09 vs 1.77±1.09, p&lt;0.0001).

Conclusions
Pre procedure Cardiac CT and CT score might be useful for ADR technique in CTO PCI not only for case selection but also for puncture site selection.
Figure 1

Funding Acknowledgement
Type of funding source: None
Invasive- versus computed tomography-angiography for the evaluation of coronary artery disease among elderly patients undergoing transcatheter aortic valve implantation
Authors: Berkovitch A , Finkelstein A , Barbash I.M , Fefer P , Maor E , Banai S , Brodov Y , Goitein O , Aviram G , Halkin A , Guetta V , Steinvil A , Segev A 
Published: November 2020

Abstract

Background
Coronary artery disease (CAD) is common among elderly patients with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI). Current guidelines recommend that percutaneous coronary intervention (PCI) of &gt;70% proximal coronary lesions prior to TAVI. The aim of the current study was to evaluate two approaches to CAD diagnosis pre-TAVI.

Methods
We investigated 2,027 patients undergoing TAVI for severe aortic stenosis at two large centers with different pre-procedural CAD assessment: pre-TAVI computed tomography angiography (CTA) with selective invasive angiography according to CTA results (N=831) or mandatory invasive angiography (IA) (N=1,196). Peri-procedural complications were documented according to the VARC-2 criteria. Mortality rates were prospectively documented.

Results
Mean age of the study population was 86±4, of whom 55% were female. Patients in the IA group had significantly higher rates of pre-TAVI PCI compared to the CTA group (32% vs. 17%, p&lt;0.001). Following TAVI, peri-procedural myocardial infarction (MI) rates were significantly lower among the IA group (0.1% vs. 1.5%, p=0.001). However, multivariate binary logistic regression analysis adjusted for age, gender and cardiovascular risk factors failed to show association between centers strategy and peri-procedural MI. Periprocedural bleeding rates were similar between the groups (3.5% vs. 2.9%, p=0.477). Thirty day, and 1-year mortality crude rates were similar between the groups (2.5% vs. 3.4%, p=0.25, and 10.2% vs. 12.0%, p=0.19). Multivariate cox regression adjusted for age, gender and cardiovascular risk factors did not find association between CAD clearance strategy and outcome.

Conclusions
In elderly patients, CTA driven approach for CAD evaluation pre-TAVI is a valid strategy with similar outcome as compared to invasive approach. CTA strategy significantly reduces invasive procedures rates without compromising patient's outcome.

Funding Acknowledgement
Type of funding source: None
Transcatheter aortic valve implantation with the LOTUS Edge system: early European experience
Authors: Armario X , Rosseel L , Banning A , Khogali S.S , Blackman D.J , Abdel-Wahab M.S , Tchetche D , Hildick-Smith D , Van Mieghem N.M , Spence M.S , Frerker C , Nickenig G , Pilgrim T , Sondergaard L , Mylotte D 
Published: November 2020

Abstract

Aims
To evaluate the clinical outcomes of transcatheter aortic valve implantation (TAVI) with the recently commercialised LOTUS EdgeTM system.

Methods and results
We performed a multicentre, single-arm, retrospective registry to generate early information on patients undergoing TAVI with the LOTUS EdgeTM system following its commercial release in July 2019. Novel features of this second-generation device include increased flexibility of the delivery catheter, enhanced visualisation of the locking mechanism and the depth guard technology to reduce left ventricular outflow tract interaction and, potentially, reduce the risk of permanent pacemaker (PPM) implantation. All endpoints were defined according to the VARC-2 definitions and were reported by the treating site.
A total of 286 consecutive patients from 18 participating centres were included. The mean age and STS score were 81.2±6.9 years and 5.2±5.4%, respectively. Most procedures were performed under local anaesthesia (97.2%) via transfemoral access (98.6%).
Successful vascular access, valve delivery and deployment and system retrieval were achieved in 97.6% of cases. 30-day rates of all-cause mortality (2.1%, N=6) and stroke (3.5%, N=10) were acceptable. Disabling, life-threatening or major bleeding occurred in 3.8% and major vascular complications in 2.1%. The incidence of new PPM implantation was 27.1% among all patients and 32.2% among pacemaker-naive patients. After TAVI, the mean transvalvular pressure gradient was 11.9±5.6 mmHg and the mean aortic valve area was 1.9±0.9 cm2. The rate of moderate paravalvular leak was 2.1% with no cases of severe paravalvular leak.

Conclusions
Early experience with the LOTUS EdgeTM system demonstrated acceptable 30-day clinical outcomes with impressively low rates of paravalvular leak. The requirement for new PPM remained high in this early experience. Further study is required to understand if improving operator experience with the device can reduce PPM rates.

Funding Acknowledgement
Type of funding source: None
New onset left bundle branch block after transcatheter aortic valve implantation and the effect on long-term survival – a UK wide experience
Authors: Arri S.S , Myat A , Malik I , Curzen N , Baumbach A , Gunning M , Henderson R , Ludman P , Banning A , Blackman D , Densem C , Stables R , Byrne J , Hildick-Smith D , Redwood S.R 
Published: November 2020

Abstract

Introduction
New onset left bundle branch block (LBBB) is the most common conduction disturbance associated with transcatheter aortic valve implantation (TAVI). It has been shown to adversely affect cardiac function and increase re-hospitalisation, although its impact on mortality remains contentious.

Methods
We conducted an observational cohort analysis of all TAVI procedures performed by 13 heart teams in the United Kingdom from inception of their structural programmes until 31st July 2013. The primary outcome was 1-year all-cause mortality. Secondary outcomes included left ventricular ejection fraction (LVEF) at 30 days and need for a post-TAVI permanent pacemaker (PPM).

Results
1785 patients were eligible for inclusion to the study. The primary analysis cohort was composed of 1409 patients with complete electrocardiographic (ECG) data pre- and post-TAVI. Pre-existing LBBB was present in 200 (14.2%) patients. New LBBB occurred in 323 (22.9%) patients post TAVI, which resolved in 99 (7%) patients prior to discharge. A balloon-expandable device was implanted in 968 (69%) patients, whilst 421 (30%) patients received a self-expandable valve. New LBBB was observed in 120 (12.4%) and 192 (45.6%) patients receiving a balloon- or self-expandable prosthesis respectively.
Overall 1-year all-cause mortality post TAVI was 18.7%. New onset LBBB was not associated with an increase in 1-year all-cause mortality (p=0.416). Factors that were associated with mortality included an increasing logistic EuroScore (p=0.05), history of previous balloon aortic valvuloplasty (p=0.001), renal impairment (p=0.003), previous myocardial infarction with pre-existing LBBB (p=0.028) and atrial fibrillation (p=0.039). Lower baseline peak and mean AV gradients were also associated with greater mortality at 1 year (p=0.001), likely reflecting underlying left ventricular dysfunction.
In the majority of patients, LVEF remained unchanged following TAVI. Interestingly, the presence or absence of new onset LBBB did not affect LVEF improvement at 30 days. 10% of patients required a PPM post TAVI. Predictors of PPM included new LBBB (OR 2.6, p&lt;0.001), pre-TAVI left ventricular systolic impairment (OR 1.2, p=0.037), a self-expandable device (p&lt;0.001), and pre-existing RBBB (OR 4.0, p&lt;0.001).

Conclusions
These findings suggest that new onset LBBB post TAVI does not increase mortality at 1 year or adversely affect LVEF at 30 days.

Funding Acknowledgement
Type of funding source: None
Correlation of platelet inhibition and cerebral thromboembolic events, as expressed with number of high-intensity transient signals,during Transcatheter Aortic valve Implantation
Authors: Katsianos E , Vavuranakis M , Kalantzis C.K , Voudris V.V , Kosmas E.K , Iakovou I.I , Kalogeras K.K , Siasos G.S , Bei E.B , Katsarou O , Aznaouridis K , Toutouzas K.T , Moldovan C.M , Tousoulis D.T , Vavuranakis E.V 
Published: November 2020

Abstract

Background
It has been shown that high Residual Platelet Reactivity (RPR) may contribute to platelet aggregation which propagates thrombosis on implanted materials. Therefore, we evaluated whether high RPR may predispose to an increased number of cerebrovascular emboli during Transcatheter Aortic valve Implantation (TAVI).

Methods
Consecutive patients who underwent transfemoral TAVI with a self-expandable valve were prospectively studied. A loading dose of P2Y12 inhibitor 24 hours preprocedurally was given. Additionally, aspirin was started one week prior to procedure in all patients. Platelet inhibition was assessed with P2Y12 reaction units (PRU) (Verify Now assay) as well as percentage of inhibition 30 minutes prior to procedure initiation. The number of High intensity transient signals (HITS) was assessed with Rimed Digi-Lite™ transcranial Doppler, setting a threshold for detection of HITS at 3dB, continuously, on both middle cerebral arteries during the whole procedure. Two observers reviewed offline the number of HITS.

Results
In total, 84 patients underwent TAVI (53 males, mean age=81.9yrs old ±8,98). Mean baseline PRU and percentage of platelet inhibition was 258,24±43,03 (156–376) and 48,51%±40.05 (0–100%) respectively. In the treated patients the mean absolute total number of HITS and the number of HITS per minute recorded, was 566,63±272,32, (136–1432) and 6.7/min±3.3 (2.09–13.24) respectively. Significant positive correlation was found between baseline PRU levels and number of total HITS (r=0.261, p=0.017), (Figure 1). Multivariate regression analysis revealed that PRU was independent prognostic factor of total HITS (β=0.708, p=0.06),
In order to clarify the predictive role of platelet inhibition in the total number of recorded HITS a ROC analysis was performed, obtaining an area under the curve of 0.646 (95% CI 0.518 to 0.773, p=0.047). PRU-levels≥169 were shown to predict number of HITS at the upper quartile with 76% sensitivity and 65% specificity.

Conclusion
High RPR after dual antiplatelet loading with a P2Y12 inhibitor and aspirin, resulted in larger burden of embolic HITS during TAVI procedure. A cut off point of 169 PRU units with 76% sensitivity and 65% specificity predicted detection of HITS at the higher quartile.
PRU-HITS Correlation

Funding Acknowledgement
Type of funding source: None
Temporal trends in utilization of transcatheter aortic valve implantation and patient characteristics – a nationwide cohort study
Authors: Strange J.E , Sindet-Pedersen C , Gislason G , Torp-Pedersen C , Fosboel E.L , Butt J.H , Koeber L , Olesen J.B 
Published: November 2020

Abstract

Introduction
In recent years, there has been a surge in the utilization of transcatheter aortic valve implantation (TAVI) for the treatment of severe symptomatic aortic stenosis. Randomized controlled trials have compared TAVI to surgical aortic valve replacement (SAVR) in patients at high-, intermediate-, and low perioperative risk. As TAVI continues to be utilized in patients with lower risk profiles, it is important to investigate the temporal trends in “real-world” patients undergoing TAVI.

Purpose
To investigate temporal trends in the utilization of TAVI and examine changes in patient characteristics of patients undergoing first-time TAVI.

Methods
Using complete Danish nationwide registries, we included all patients undergoing first-time TAVI between 2008 and 2017. To compare patient characteristics, the study population was stratified according to calendar year in the following groups: 2008–2009, 2010–2011, 2012–2013, 2014–2015, and 2016–2017.

Results
We identified 3,534 patients undergoing first-time TAVI. In 2008–2009, 180 patients underwent first-time TAVI compared with 1,417 patients in 2016–2017, resulting in a 687% increase in TAVI procedures performed. During the study period, the median age remained stable (2008–2009: Median age 82 year [25th–75th percentile: 78–85] vs. 2016–2017: Median age 81 years [25th–75th percentile: 76–85]; P-value: 0.06). The proportion of men undergoing first-time TAVI increased over the years (2008–2009: 49.4% vs 2016–2017: 54.9%; P-value for trend: &lt;0.05), also the proportion with diabetes increased (2008–2009: 12.2% vs. 2016–2017: 19.3%; P-value for trend: &lt;0.05). The proportion of patients with a history of stroke decreased over the years (2008–2009: 13.9% vs. 2016–2017: 12.1%; P-value for trend: &lt;0.05). The same trend was seen in patients with a history of myocardial infarction (2008–2009: 24.4% vs. 2016–2017: 11.9%; P-value for trend: &lt;0.05), ischaemic heart disease (2008–2009: 71.7% vs. 2016–2017: 29.4%; P-value for trend: &lt;0.05), and heart failure (2008–2009: 45.6% vs. 2016–2017: 29.4%; P-value for trend: &lt;0.05).

Conclusions
In this nationwide study, there was a marked increase in the utilization of TAVI in the years 2008–2017. Patients undergoing first-time TAVI had a decreasing comorbidity burden, while the age of the patients at first-time TAVI remained stable.

Funding Acknowledgement
Type of funding source: None
Prognostic value of change in nutritional status after transcatheter aortic valve replacement
Authors: Lopez Otero D , Gonzalez Ferreiro R , Lopez Pais J , Alvarez Rodriguez L , Antunez Muinos P , Cid Menendez A , Otero Garcia O , Perez Poza M , Antonio Cacho C.U , Cid Alvarez B , Sanmartin Pena X.C , Trillo Nouche R , Cruz-Gonzalez I , Gonzalez Juanatey J.R 
Published: November 2020

Abstract

Introduction and purpose
Risk of malnutrition is a frequent condition among patients undergoing transcatheter aortic valve replacement (TAVR). Nutritional status assessed by nutritional risk index (NRI) is independently associated with an increased risk of death during long-term follow-up in these patients. The aim of the study is to determine the prognostic impact of the variation in nutritional risk after TAVR.

Methods
TAVR patients were included in an observational and prospective study between 2008–2019. Baseline and 3-months post-TAVR NRI were calculated as 1.519 x albumin (g/L) + 41.7 x (real weight [kg]/ideal weight [kg]). According to this parameter, the risk of malnutrition was severe (NRI&lt;83.5), moderate (83.5≥NRI&lt;97.5) and mild (97.5≥NRI&lt;100). We analyzed the change in nutritional status after TAVR and the association between nutritional status variation and the clinical outcomes: all-cause mortality, heart failure hospitalization and the composite of all-cause death and/or heart failure hospitalization at 3 years follow-up using the Cox proportional hazards model.

Results
433 patients were included. 68.4% of patients with baseline nutritional risk had no nutritional risk after TAVR. The prevalence of risk of malnutrition was reduced to 25.2% after TAVR. During the follow-up (2.7±2.0 years), 157 (36.3%) patients died and 172 patients (39.7%) had heart failure hospitalization. Patients who remained at nutritional risk after TAVR had a higher risk of mortality (HR: 2.10 [95% CI: 1.30 to 3.39], p=0.002), heart failure hospitalization (HR: 1.97 [95% CI: 1.26 to 3.06], p=0.000) and the composite outcome (HR: 2.0 [95% CI: 1.37 to 2.91], p&lt;0.001).

Conclusions
Risk of malnutrition was a frequent condition among TAVR patients, but most patients improved their nutritional status after the procedure. The change in nutritional status is associated with prognosis: post-TAVR nutritional risk improvement is associated with reduced heart failure hospitalization, and the change to non-nutritional risk after TAVR halved the risk of mortality and heart failure hospitalization during long-term follow-up. Persistent nutritional risk after TAVR was related to poor prognosis. Further studies are needed to identify whether at nutritional risk would benefit from nutritional intervention during processes of care of TAVR programs.
Change in NRI and prognostic value

Funding Acknowledgement
Type of funding source: None
Silent cerebral embolisation during TAVI: evolution, predictors and neurocognitive effects
Authors: De Carlo M , Liga R , Migaleddu G.M , Scatturin M , Spaccarotella C , Fiorina C , Orlandi G , De Caro F , Rossi M.L , Chieffo A , Indolfi C , Reimers B , Cosottini M , Petronio A.S 
Published: November 2020

Abstract

Background
Most patients undergoing transcatheter aortic valve implantation (TAVI) develop silent cerebral ischemic lesions (SCIL) detectable at magnetic resonance imaging (MRI). The natural history and clinical relevance of SCIL are not well established. We aimed to assess the characteristics, predictors, evolution, and neurocognitive effects of SCIL.

Methods
Cerebral MRI was performed within 7 days before TAVI to assess baseline status and age-related white matter changes (ARWMC) score. MRI was repeated postoperatively to assess the occurrence, location, number and dimensions of SCIL. Patients developing SCIL underwent a third MRI at 3–5 months follow-up. A neurocognitive evaluation was performed before TAVI, at discharge and at 3-month follow-up.

Results
Of the 117 patients enrolled, 96 underwent a postprocedural MRI; SCIL were observed in 76% of patients, distributed in all vascular territories, with a median number of 2 lesions, median diameter 4.5 mm, and median total volume 140 mm3. Independent predictors of SCIL occurrence were a higher baseline ARWMC score and the use of self-expanding or mechanically-expanded bioprostheses. Among 47 patients who underwent follow-up MRI, only 26.7% of postprocedural SCIL evolved into a gliotic scar. SCIL occurrence was associated with a more pronounced transient neurocognitive decline early after TAVI and with a lower recovery at follow-up.

Conclusions
SCIL occur in the vast majority of patients undergoing TAVR and are predicted by a more diffuse white matter damage at baseline and by the use of non-balloon-expandable prostheses. Although most SCIL disappear within months, their occurrence has a limited but significant impact on neurocognitive function.
Figure 1

Funding Acknowledgement
Type of funding source: Private company. Main funding source(s): unrestricted grants from Edwards Lifesciences SA, Nyon, Switzerland, and from Medtronic Italia SpA, Milan, Italy
Indirect evaluation of device-endothelialization with cardiac-CT after transcatheter closure of atrial septal defect: how long should antiplatelet therapy last postoperatively?
Authors: Yan C , Li L , Pan X , Li S , Li H , Wan L , Wang L , Fang W 
Published: November 2020

Abstract

Background
After transcatheter closure of atrial septal defect (ASD), it is still unclear about the in-vivo process of device-endothelialization in humans, which determines the duration of antiplatelet therapy. Based on contrast-uptake within device, cardiac-CT might have the potential to assess device-endothelialization indirectly.

Purpose
The study was conducted to investigate the status of device-endothelialization with cardiac-CT after transcatheter closure of ASD.

Methods
After more than 6 months of transcatheter ASD closure, cardiac-CT was performed in 119 patients (48M/71F; age: 46.7±14.4 years). According to contrast-uptake within device, complete or incomplete device-endothelialization was determined. In the latter, it was further divided into partial-endothelialization (with filling-defect) and no-endothelialization (without filling-defect). Multivariate logistic regression was used to determine the risk factors of incomplete device-endothelialization. In addition, device-endothelialization was analyzed grossly and histopathologically in 7 patients.

Results
During the implantation-period of 2.57±2.59 years, incomplete device-endothelialization was identified in 43.7% of patients (partial-endothelialization in 36 patients and no-endothelialization in 16 patients). Complete device-endothelialization occurred in 14.3% of patients during 0.5–1 year and 73.8% after one year. After 6-month antiplatelet therapy, migraine restarted in 15 patients with incomplete device-endothelialization and 3 patients with complete device-endothelialization. After one-year antiplatelet therapy, migraine was still detected in 4 of 15 patients with incomplete device-endothelialization. There was a significant association between high in-vivo device-thickness and incomplete device-endothelialization (P&lt;0.001) after adjusted for confounding factors. Pathological findings from 7 patients corresponded well with cardiac-CT.

Conclusions
Cardiac-CT had the potential to evaluate the status of device-endothelialization after transcatheter closure of ASD and there was a good clinico-pathological correlation. Incomplete device-endothelialization was common postoperatively in humans and was associated with device-oversizing. Further research is required to determine the appropriate duration of antiplatelet therapy after device implantation.
Figure 1

Funding Acknowledgement
Type of funding source: Other. Main funding source(s): National Natural Science Foundation of China