bluuebunny/crossref_metadata_2025 huggingface dataset:
Risk stratification in unprotected left main coronary disease: do we have the tools?
Authors: Ventura Gomes R , Oliveira A , Goncalves M , Madeira S , Vale N , Brito J , Leal S , Raposo L , Araujo Goncalves P , Mesquita Gabriel H , Campante Teles R , Sousa Almeida M
Published: November 2020

Introduction

The evolution of percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) techniques made the choice of the optimal revascularization strategy of unprotected left main coronary disease (ULMD) challenging. Scoring systems are useful tools for the decision-making process and for risk stratification.

Purpose

To evaluate 1) the performance of the SYNTAX score I (SSI) and II (SSII) and Euroscore II (EII) in risk stratification and 2) the outcome predictors of patients (pts) with ULMD, according to the treatment strategy chosen (PCI or CABG).

Methods

Retrospective single centre cohort study of 440 consecutive pts (age 68±11 years; 76.6% male) with significant ULMD (defined as left main coronary artery stenosis >50%, with no patent arterial or venous bypass graft to left anterior descending artery), who were submitted to PCI (n=135) or CABG (n=307), between January 2006 and December 2018. Median follow-up (FU) was 4.0±1.8 years.

The primary outcome was a composite of cardiovascular (CV) death, non-fatal myocardial infarction (MI) and target lesion revascularization (TLR).

Results

During the FU period, there were 112 (25.5%) CV deaths, 26 (5,9%) non-fatal MI and 53 (12.0%) TLR.

Multivariate analysis of pts submitted to PCI showed that SSII and anatomical complete revascularization were independent predictors of the primary outcome (HR 1.045, CI 1.015–1.075, p=0.003 and HR 3,014, CI 1.655–5.489, p<0.0001, respectively). The 63 pts submitted to PCI, who had a SSII favoring CABG, had slightly more adverse events (42.9% vs 41.7%, p=0.889).

In the CABG cohort, only SSII was an independent predictor of the outcome by multivariate analysis (HR 1.061, CI 1.035–1.086, p<0.0001).

The ROC curve analysis for all cohort presented no discriminative capacity for SSI (AUC 0.538, CI 0.482–0.593, p=0.186) and a weak discrimination for SSII (AUC 0.659, CI 0.605–0.713, p<0.0001) and EII (AUC 0.653, CI 0.599–0.707, p<0.0001; Figure 1). The difference between SSII and EII was not statistically significant (DeLong test p=0.828). Similar results were found when analysing the CAGB group, however, in PCI cohort, SII and EII showed an acceptable discriminative capacity (AUC 0.722, CI 0.636–0.809, p<0.0001 and AUC 0.700, CI 0.610–0.791, p<0.0001, respectively).

Conclusion

In a real-world ULMD population, the most common risk scores, mainly those integrating anatomical and clinical features, presented a very modest role in the risk stratification, both in chronic and acute coronary syndromes. However, in pts with ULMD submitted to PCI, those risk scores had a more significant role in the risk stratification of these pts.

Figure 1. SSI, SSII, EII ROC curves for all cohort

Funding Acknowledgement

Type of funding source: None
Distal radial approach via anatomical snuffbox is associated with higer rate of radial spasm and greater patient discomfort
Authors: Kozinski L , Dabrowska-Kugacka A , Orzalkiewicz Z
Published: November 2020

Background/Introduction

Conventional transradial approach (c-TRA) at the wrist is considered as the default strategy for catheter-based procedures providing less serious access-related complications and better patients' comfort than transfemoral route. A novel distal transradial artery approach (d-TRA) via the anatomical snuffbox has been proposed recently as an noteworthy alternative. It is hypothesised that d-TRA may provide additional benefits without losing the efficacy of c-TRA.

Purpose

To assess consecutive patients' comfort undergoing coronary angiography or intervention by novel d-TRA in comparison with c-TRA.

Methods

In a span of 4 months, out of 465 caucasian subjects, 400 patients were included in a prospective, single-center, randomized (1:1) distAl vs traditioNal Transradial Access for coRonary procEdures Study (ANTARES). Hemodynamic instability, ST-elevation myocardial infarction, forearm artery occlusion or prior radial access failure were the exclusion criteria. An artery was punctured with anterior wall modified Seldinger technique, and standard 5F or 6F vascular sheaths were used.

Pain/discomfort when access gaining, radial spasm, early (within 24 hours) postprocedural local neuropathy (thumb numbness) were the analyzed parameters determining patients' comfort in both groups.

Results

Baseline characteristics of patients were matched.

Conclusion(s)

Coronary procedures performed in consecutive patients via novel d-TRA are associated with worse patient's comfort determined by higer rate of radial spasm and early postprocedural local neuropathy, and greater pain/discomfort when access gaining, in comparison with c-TRA.

Funding Acknowledgement

Type of funding source: None
One-year outcomes of percutaneous coronary intervention in native coronary arteries versus bypass grafts in patients with prior coronary artery bypass graft surgery
Authors: Abdelrahman A , Debski M , More R , Eichhofer J , Patel B
Published: November 2020

Background

Patients with prior coronary artery bypass graft (CABG) surgery often require percutaneous coronary intervention (PCI). Data are still limited in regards to the outcomes of native versus graft PCI after CABG.

Methods

We performed a retrospective study in a tertiary reference cardiac centre of consecutive patients who underwent PCI after CABG. The data were collected for patients who underwent either native or graft PCI from January 2008 to December 2018. Major adverse cardiac events (MACE) included death or myocardial infarction (MI) or revascularization. All outcomes were assessed at 1-year after each index procedure.

Results

A total of 445 PCI were performed in 410 patients (209 had native PCI and 201 had graft PCI). The groups of patients with native vessel PCI and graft PCI were statistically comparable regarding their baseline characteristics. In multivariable Cox regression graft PCI relative to native PCI was an independent risk factor for MACE (hazard ratio [HR] 1.818, 95% confidence interval [CI] 1.148–2.878).

Conclusion

Compared with native coronary PCI, bypass graft PCI was significantly associated with higher incidence of MACE at 1-year and this was mainly driven by MI and revascularization.

MACE outcomes

Funding Acknowledgement

Type of funding source: None
Optimal timing of delayed percutaneous coronary intervention in stable patients with ST-segment elevation myocardial infarction
Authors: Zhao Q , Xu H , Lv J , Zhao Y , Yang Y
Published: November 2020

Background

There is ongoing controversy and limited data about the optimal timing to perform delayed percutaneous coronary intervention (PCI) in stable ST-segment elevation myocardial infarction (STEMI) patients who have missed opportunities for acute reperfusion therapy and are in absence of ongoing ischemia.

Purpose

To evaluate the effects of timing of delayed PCI on short- and long-term safety outcomes in stable STEMI patients.

Methods

A cohort of 3,048 stable STEMI patients without acute reperfusion therapy who underwent delayed PCI were included in the study. Procedural timing was stratified into three groups: <3d, 3–7d, >7d. Primary outcomes were 30-day and 12-month major adverse cardiac events (MACE), a composite of death and reinfarction. Multivariate logistic and Cox regression models were performed.

Results

After multivariate adjustment, restricted cubic splines revealed a monotonic decrease in the risk of MACE with prolonged procedural timing (Figure-1). Delayed PCI on 3–7d and >7d were strongly associated with lower risks of MACE at 30 days (3–7d: Hazard ratio (HR) 0.43 [95% Confidence interval (CI) 0.18–0.99], P=0.046; >7d: HR 0.40 [95% CI 0.19–0.87], P=0.020) and 12 months (3–7d: HR 0.49 [95% CI 0.25–0.95], P=0.036; >7d: HR 0.42 [95% CI 0.22–0.77], P=0.006) compared with that on <3d. Delayed PCI on >7d also showed improvement in 12-month mortality (HR 0.45 [95% CI 0.22–0.91], P=0.026) over that on <3d, whereas procedure on 3–7d did not (HR 0.52 [95% CI 0.24–1.11], P=0.091). MI location and cardiac function had significant interactions with procedural timing for 12-month MACE (P-interaction=0.141 and 0.137). Procedural timing had more significant effects on MACE in patients with anterior MI or cardiac insufficiency.

Conclusion

Delayed PCI over a week after symptom onset had significant improvement in short- and long-term safety in stable STEMI patients especially with anterior MI or cardiac insufficiency. Decision-making on optimal timing should identify the high-risk individuals and balance between ischemic benefits and safety.

Figure 1

Funding Acknowledgement

Type of funding source: Public grant(s) – National budget only. Main funding source(s): National Twelfth Five-year Science and Technology Support Projects by Ministry of Science and Technology of China.
Impact of new generations drug-eluting stents overlap on six-month clinical outcomes in patients with acute anterior STEMI treated with primary PCI
Authors: Elakabawi K , Shah S.A , Fadlullah H , Yuan Z.Y , Guo N
Published: November 2020

Background

Stent overlap has been associated with adverse outcomes. However, data regarding the impact of new generations drug-eluting stents (DES) overlap in the context of ST-segment elevation myocardial infarction (STEMI) are limited.

Objective

To compare the 6-moth clinical outcomes of patients with and without new generations DES overlap implanted during primary PCI for anterior STEMI.

Methods

We evaluated a total of 1078 consecutive anterior STEMI patients who underwent primary PCI with deployment of new generations DES. The patients were divided according to the presence or absence of stent overlap into 2 groups; overlapping-stents group (n=388) and single-stent group (n=690). We compared the rates of cardiac mortality, major adverse cardiovascular events (MACEs; composite of death, reinfarction, ischemia-driven target vessel revascularization (TVR), definite stent thrombosis (ST), and stroke) between the 2 groups.

Results

There was a non-significant trend toward increased in-hospital mortality in the overlapping-stents group related to a significant higher rate of cardiogenic shock [9.5% versus 6.1%, respectively; P=0.037] and post-procedural suboptimal TIMI flow [26.3% versus 19.4%, respectively; P=0.009] as compared to the single-stent group. Yet, there were no significant differences between the 2 groups in the incidence of 6-month cardiac death: [18 (4.6%) and 21 (3%); P=0.173], MACEs: [35 (9%) and 49 (7.1%); P=0.259], reinfarction: [14 (3.6%) and 22 (3.2%); P=713], TVR: [17 (4.4%) and 28 (4.1%); P=0.799], and definite ST: [14 (3.6%) and 19 (2.8%); P=0.434], respectively.

Conclusion

The use of multiple overlapping new generations DES, if needed, is relatively safe and acceptable in the context of primary PCI for STEMI patients.

Funding Acknowledgement

Type of funding source: None
Long-term safety and performance of a novel conical bioresorbable vascular scaffold: insights from in-vitro and in-vivo studies
Authors: Ma Q , Du Y , Wang J.L , Wu S.J , Zhao Y.X , Zhou Y.J
Published: November 2020

Background

The phenomenon of size-mismatches between cylindrical stents and tapered vessels is not uncommon in current endovascular interventions which is associated with poor clinical outcomes.

Purpose

The aim of the present study was to evaluate the mechanical properties of the novel conic BRS and to validate its performance with the support of optical coherence tomography (OCT), quantitative coronary angiography (QCA) and histology up to 2 years in a porcine model.

Methods

We produced the conical BRS with the four-axis 3D printing system, with a computer-controlled rotational axis (the 4th axis) in addition to the 3 axes of traditional 3D printing systems.

Mechanical properties were evaluated by recoil and radial strength, cyclic fatigability testing.

Twelve swine that received 12 conic BRS were evaluated by OCT, QCA and histology post-implantation and at 12 and 24 months.

Results

The in vitro study showed no fractures after accelerated cycle testing over time (at 3.8×108 cycles).

The recoil rate of the scaffolds after plate compress test was 14.3±0.61%.

There was no significant peri-operative complications.

By OCT, 60±21 struts per BRS were recognizable by 2 years. Quantitative coronary angiography showed late luminal loss and percent diameter stenosis were 0.02±0.52 mm and 0.50±16.90% at 2-year follow-up.

Histopathological analysis demonstrated mild vessel injuries, inflammatory cell infiltration around struts at 1 and 2 years follow ups.

Conclusions

The conical BRS showed optimal performance and has the potential to improve clinical outcome.

OCT and histological images

Funding Acknowledgement

Type of funding source: None
Impact of diabetes mellitus on 2-year outcomes of Absorb BVS compared to Xience EES: a pooled analysis of the COMPARE-ABSORB and AIDA trial
Authors: Gao C , Kerkmeijer L , Tijssen R.Y.G , Kraak R , Tijssen J , Onuma Y , Chevalier B , West N , Morice M.C , De Winter R , Smits P , Wykrzykowska J.J , Van Geuns R.J
Published: November 2020

Background and purpose

Diabetes mellitus (DM) is associated with increased risk of cardiovascular events after percutaneous coronary intervention (PCI). To evaluate the impact of Absorb bioresorbable vascular scaffold (BVS) in patients with DM, we aimed to compare the 2-year outcomes of Absorb BVS versus 2nd generation drug eluting stents Xience (EES) by pooling diabetic patients treated with BVS or EES from two large, randomized controlled trial.

Methods

Patients with medically-treated DM and treated by Absorb BVS in the COMPARE-ABSORB and AIDA trial were pooled for analysis. The primary efficacy outcomes measure was target lesion failure (cardiac death, target-vessel myocardial infarction or target lesion revascularization), and the primary safety outcome measure was device thrombosis at 2-year follow-up.

Results

Out of a total 3515 enrolled subjects in the two trials, 913 were diabetics. Compared with the non-diabetic patients, those with DM were older, more often to have a history of hypercholesterolemia, chronic renal failure, stroke, hypertension, heart failure, peripheral vascular disease and previous PCI. At 2-years, target lesion failure occurred in 10.8% of BVS DM patients and 7.6% of EES DM patients (adjusted HR 1.43, 95% CI: 0.87–2.34, P=0.115). The 2-year rates of cardiac death (2.4% vs 1.6%, P=0.385), TV-MI (5% vs 1.6%, P=0.123) and TLR (7.8% vs 5.8%, P=0.416) showed not significant difference. The 2-year incidence of definite device thrombosis was 3.2% in Absorb BVS versus 0.7% in Xience EES (adjusted HR 4.77, 95% CI: 1.01–22.43, P=0.048).

Conclusion

This pooling of the diabetic patients from two large scale RCTs compared BVS versus 2nd generation DES, showed an increased rate of device thrombosis in BVS-treated patients at 2 years.

Funding Acknowledgement

Type of funding source: Private company. Main funding source(s): Abbott
The in vivo comparison of first versus second generation bioresorbable technologies early after implantation in the porcine coronary in stent restenosis model
Authors: Kachel M , Janas A , Jelonek M , Kazmierczak P , Buszman P.E , Fernandez C , Lukasik K , Milewski K , Buszman P.P
Published: November 2020

Background

Second generation bioresorbable scaffold (BRS) technologies with thinner struts were developed to overcome thrombotic and restenotic events when compared to first generation

Purpose

Herein we compare vascular response and scaffold recoil of first generation BRS (Absorb, BVS, 150 micron) with second generation (Meres 100, MRS, 100 micron) in the porcine model of coronary in stent restenosis model

Methods

In total 11 BRS and 13 MRS similar scaffolds were implanted in 12 domestic swine, with 110% overstretch under Optical coherence tomography guidance. Animals were followed up for 2, 7 and 28 days (8 scaffolds for each period). At terminal follow up comprehensive evaluation with OCT was performed and tissues harvested for pathology

Results

Arterial injury expressed as overstretch was similar among groups. There were no differences at 2 and 7 days with regards to lumen area (LA), neointimal area (NA) stent areas (SA) and %AS. At 28 days SA and NA were lower in the MRS group when compared to BRS (SA: 5,1 vs. 8,8 mm2, p=0,01; NA: 1,94 vs. 3.36 mm2; p=0,01). Arterial healing was similar at 28 days between MRS and BRS as expressed by embedded and covered struts (100 vs 100%, p=1,0), however at 7 days there were more uncovered struts in the MRS (43% vs 12%, p=0,01).

Conclusions

Second generation MRS have proven improved vascular response in porcine coronary model with regard to lesser neointimal hyperplasia. Thinner struts however caused recoil when compared to thicker ones at early follow-up point. Further BRS material and design improvements are necessary to achieve metallic stent - like properties.

Funding Acknowledgement

Type of funding source: Public grant(s) – National budget only. Main funding source(s): National Center for Research and Development
Cardiovascular outcomes of concurrent TAVR and PCI compared to TAVR alone using the U.S. national inpatient sample: 2011–2014
Authors: Byer M , Celli D , Zarrabian B , Colombo R
Published: November 2020

Introduction

The high concurrent prevalence of coronary artery disease (CAD) in patients with severe aortic stenosis (AS) inevitably forces experts to face a pressing decision whether to revascularize and replace the aortic valve at the same time. While current recommendations support combined transaortic valve replacement (TAVR) and percutaneous coronary intervention (PCI) for treatment of ostial/proximal lesions, or in unstable patients, less clear indications exist for patients not fulfilling this pattern. The population undergoing concomitant TAVR and PCI can be clinically challenging and thus it is important to further characterize prognosis and major cardiovascular outcomes in this cohort.

Purpose

To assess the likelihood of major cardiovascular events in patients undergoing TAVR with PCI during the same hospital admission compared to those with TAVR only. As well as to have a better understanding of the risks and possible benefits of a combined procedure and thus aid in clinical decision-making.

Methods

This study used the National Inpatient Sample (NIS) of patients undergoing a TAVR from 2011 to 2014. The NIS is a stratified systematic random sample of 20% hospital admissions in the United States. Internal Classification of Diseases Ninth Revision-Clinical Modification procedure codes were used to identify all patients that underwent a PCI and/or TAVR during the same admission. Patients aged greater than 50 years were included. Outcomes of interest included all-cause in-hospital mortality, new TIA/ischemic stroke, cardiogenic shock, cardiac arrest, hemopericardium, and length of stay. Multivariate logistic regression was used to adjust for patient and procedural confounders.

Results

Among the 33,652 patients who underwent TAVR between 2011 and 2014, 1,179 underwent a PCI during the same hospital admission. The adjusted odds of all-cause in-hospital mortality was 3.05 (95% CI 1.95–4.75) in those with a TAVR+PCI compared to TAVR only. The adjusted odds of cardiac arrest and cardiogenic shock was 2.50 (95% CI: 1.48–4.22) and 4.85 (95% CI 3.05–7.7), respectively. Furthermore, the odds of a new TIA/ischemic stroke during the same admission was 0.86 (95% CI 0.35–2.07) and odds of hemopericardium was 3.13 (95% CI: 0.71–13.70).

Conclusion

Concomitant PCI and TAVR during the same hospitalization was associated with higher all-cause in-hospital mortality, increased length of stay, cardiogenic shock, and cardiac arrest but does not appear to increase the likelihood of stroke/TIA. While this suggest worse outcomes in the cohort undergoing both procedures, the initial indications for these patients to receive a PCI might predispose them to these outcomes.

Funding Acknowledgement

Type of funding source: None
Safety and feasibility of a systematic transradial-access program for percutaneous coronary intervention in chronic total occlusions
Authors: Trejo Velasco B , Diego-Nieto A , Nunez J.C , Gonzalez-Ferreiro R , Herrero-Garibi J , Rodriguez-Collado J , Sanchez P.L , Cruz-Gonzalez I , Martin-Moreiras J
Published: November 2020

Aims

To evaluate the safety and feasibility of a transradial-access PCI program in CTO and its impact on angiographic and clinical results and in-hospital stay length.

Methods

Retrospective single-centre cohort-study including 237 consecutive patients undergoing CTO-PCI. From November 2018 onwards, a transradial-access program and all first-attempt CTO-PCI procedures were systematically performed via the radial artery. 47 patients included in the transradial-access CTO-PCI program were compared to a historical cohort of 190 CTO-PCI patients, employing transfemoral access mainly: n=150 (78.9%).

Results

Mean age was 66.9±11.4 and 199 (83.9%) patients were male, Table 1. Mean J-CTO score (2.5±1.1) was similar in both groups. Successful revascularization was achieved in 208 (87.8%) cases overall, without differences between both cohorts. No differences in periprocedural complications between both groups existed, but in-hospital complications were numerically lower in the transradial cohort (4.3% vs 13.7%, p=0.072). Mean hospital-stay was lower in the transradial-access group (0.89±1.4 vs 2.2±3.2 days, p<0,001). Same-day discharge was successfully accomplished in 56% of elective patients in the transradial-access program, Figure 1.

Conclusion

A transradial program for CTO-PCI is safe and effective in most CTO. Adoption of a transradial protocol for CTO-PCI allows same-day hospital discharge in over half of elective procedures and reduces in-hospital stay length.

Figure 1. Same-day discharge in both cohorts

Funding Acknowledgement

Type of funding source: None
Chromogranin B is associated with impaired coronary collateralization and heart failure in patients with stable angina and chronic total occlusion
Authors: Shen Y , Wang X.Q , Ding F.H , Yang Z.Q , Lu L , Zhang R.Y , Shen W.F
Published: November 2020

Background

Chromogranin B (CgB) is a member of granin family that can be cleaved into a number of bioactive peptides. Previous studies showed that CgB is produced in cardiomyocytes and is increased in heart failure animals and patients in proportion to disease severity. Chronic total occlusion (CTO) of coronary artery leads to sustained myocardial ischemia which predisposes to adverse cardiovascular outcomes including heart failure.

Purpose

In this study, we sought to investigate the association between CgB and coronary collateralization formation and heart failure in patients with stable angina and CTO.

Methods

A total of 720 subjects with stable angina and CTO of at least one major coronary artery were enrolled in this study. CgB was assayed using an ELISA kit and the degree of coronary collaterals supplying the distal aspect of a total occlusion from the contralateral vessel was graded according to Rentrop classification.

Results

These was a stepwise decrease in levels of CgB with increasing Rentrop grades of coronary collateralization (P=0.001). Compared with the good collateralization (Rentrop grade 2–3) group, CgB was significantly higher in subjects with poor coronary collateralization (Rentrop grade 0–1; 1222.95 [IQR 506.24–2710.24] pg/mL vs. 776.17 [IQR 276.24–2209.39] pg/mL, P<0.001). Consistent results were found across subgroups of age, sex and the presence of diagnosed diabetes. In subjects with poor collateralization, CgB was positively correlated to N-terminal–pro-brain natriuretic peptide (NT-proBNP) levels (both log-transformed; Pearson's r=0.280, P=0.005). This correlation was markedly enhanced (Pearson's r=0.501, P<0.001) in the poorly-collateralized heart failure subgroup with left-ventricular ejection fraction (LVEF) <50%. Consistently, an inverse correlation was present between log-transformed CgB and LVEF (Pearson's r=−0.528, P<0.001) in the same subgroup. After adjusting for conventional confounding factors and LVEF, CgB remained significantly associated with impaired coronary collateralization (odds ratio: 1.314 [95% CI 1.097–1.590], P=0.004). Inclusion of CgB led to a better diagnostic accuracy as confirmed by net reclassification improvement (NRI) of 17.70% (95% CI 8.08–27.32%, P<0.001) and integrated discrimination improvement (IDI) of 1.98% (95% CI 0.63–3.34%, P=0.004).

Conclusions

CgB is an independent predictor of poor coronary collateralization and is related to worse heart function in patients with stable angina and CTO.

Figure 1

Funding Acknowledgement

Type of funding source: Public grant(s) – National budget only. Main funding source(s): National Natural Science Foundation of China
Computed tomography derived predictors of permanent pacemaker implantation after transcatheter aortic valve implantation: a meta-analysis
Authors: Maier O , Zeus T , Jung C , Westenfeld R , Polzin A , Kelm M , Veulemans V
Published: November 2020

Background

Transcatheter aortic valve implantation (TAVI) is a well-established alternative to surgery for the treatment of patients with severe symptomatic aortic stenosis at high and intermediate surgical risk. Unfortunately, the occurrence of electrical conduction disturbances remains one of the most frequent complications of the procedure. While the impact of electrocardiographic and procedural predictors on PPI is well examined, there is still a lack of knowledge regarding anatomical predictors screened by multislice computed tomography (MSCT).

Purpose

We performed a meta-analysis to summarize available studies that reported the incidence of PPI after TAVI with new-generation devices and provided raw data for preprocedural MSCT.

Methods

The authors conducted a literature search in PubMed database until December 31, 2019 to identify studies that investigated preprocedural MSCT data and rate of PPI following TAVI with new-generation devices. Twelve observational studies (n=3133) met inclusion criteria for final analysis.

Results

PPI was performed in 509 patients (16.2%) after TAVI, mostly due to high degree atrioventricular (AV) block (80.8%). The rate of PPI varied widely from 7.9% to 35.8% in individual studies. Regarding secondary endpoints' analysis of relative risk (RR) and mean difference (MD) electrocardiographic PPI-predictors after TAVI appeared to be pre-existing atrial fibrillation (AF) (RR 1.21; 95% CI 1.05–1.40; p=0.008), right bundle branch block (RBBB) (RR 4.22; 95% CI 3.30–5.41; p<0.0001) and AV block grade I (RR 1.63; 95% CI 1.16–2.29; p=0.005). Patients requiring PPI had larger annulus perimeter (MD 1.66 mm; 95% CI 0.67–2.66 mm; p=0.001) and shorter membranous septum length (MD −0.86 mm; 95% CI −1.74–0.02 mm; p=0.05) assessed by preprocedural MSCT. Concerning calcium load of device landing zone, pacemaker dependent patients showed increased calcification of the non-coronary cusp (MD 39.76 mm3; 95% CI 18.60–60.93 mm3; p=0.0002), the left-coronary cusp (LCC) (MD 47.60 mm3; 95% CI 19.40–75.81 mm3; p=0.0009) and the total left ventricular outflow tract (LVOT) (MD 19.17 mm3; 95% CI 6.68–31.66 mm3; p=0.003). Lower implantation depth (MD 0.83 mm from NCC; 95% CI 0.20–1.47 mm; p=0.01) and oversizing by annulus diameter/area (MD 1.76%; 95% CI 0.68–2.84%; p=0.001) were procedural predictors of PPI following TAVI.

Conclusion

This structured meta-analysis proved PPI rate in 16.2% of patients following TAVI. Beside well-known electrocardiographic (AF, RBBB, AV block grade I) and procedural predictors (implantation depth, oversizing) this meta-analysis showed for the first time that MSCT derived anatomical values (annulus perimeter, membranous septum length) and distribution of device landing zone's calcification (NCC, LCC, LVOT) are associated with increased risk of PPI following TAVI.

Funding Acknowledgement

Type of funding source: None
Influence of prosthesis related factors on the occurrence of early leaflet thrombosis after transcatheter aortic valve implantation
Authors: Breitbart P , Pache G , Minners J , Hein M , Schroefel H , Neumann F.-J , Ruile P
Published: November 2020

Background

Early leaflet thrombosis (LT) is a well described phenomenon after transcatheter aortic valve implantation (TAVI) with an incidence between 10 and 16%. So far, data about predictors of LT are scarce.

Purpose

The purpose of the study was to investigate the influence of prosthesis related factors on the occurrence of LT.

Methods

Fusion imaging of pre- and post-procedural CTA was performed in 140 TAVI-patients (55 with LT, 85 without LT) to obtain a 3D-reconstruction of the transcatheter heart valve (THV) within the native annulus region. All patients received a balloon-expandable Sapien 3 THV. The length of the THV above and below the native annulus was measured within the fused images to assess the implantation depth. The deployed THV area was quantified on three heights (left ventricular outflow tract end, center of the stent, aortic end) to determine the average expansion of the prosthesis as percent of the nominal area. We also calculated the extent of prosthesis waist in percent of maximum area. The stent tilt was determined in relation to the annulus plane.

Results

After multivariate adjustment the extent of THV expansion (odds ratio per 10 percent [CI]: 0.660 [0.555–0.786], P<0.001) and waist (odds ratio per 10 percent [CI]: 0.725 [0.615–0.854], P<0.001) had significant, independent influence on the occurrence of LT. Neither the implantation depth nor the stent tilt showed any influence on LT manifestation (P=0.393 and 0.578).

Conclusion

Our study suggests that less than fully expanded Sapien 3 THVs are more prone to LT, whereas some degree of waist was protective. These deployment characteristics may help identify patients who qualify for intensified surveillance.

Funding Acknowledgement

Type of funding source: None
Determinants, impact, and association with heart failure therapies of heart failure readmission after transcatheter aortic valve replacement
Authors: Auffret V , Bakhti A , Leurent G , Bedossa M , Sharobeem S , Donal E , Galli E , Boulmier D , Le Breton H
Published: November 2020

Aims

To evaluate the incidence, predictors, and impact of heart failure (HF) readmission within 1-year post-transcatheter aortic valve replacement (TAVR), and assess the effects of the prescription of guidelines-recommended therapies (i.e. renin-angiotensin system inhibitors, beta-blockers, mineralocorticoid receptor antagonists) at discharge on the risk of HF readmission and death.

Methods and results

Patients included in the TAVR registry of a single expert centre from 2009 to 2017 were analysed. Competing-risk and Cox regressions were performed to identify predictors of HF readmission and death. Among 750 patients, 102 (13.6%) were readmitted for HF within 1-year post-TAVR. The 30-day incidence of HF readmission was 6.6%, 53 patients (7.1%) experienced late readmissions (>30 days post-TAVR), and 17 (2.3%) had multiple readmissions. Independent predictors of HF readmission included diabetes mellitus, chronic lung disease, previous acute HF, grade III or IV aortic regurgitation, and pulmonary hypertension both at discharge from the index hospitalisation but not guidelines-recommended therapies. Overall, HF readmission did not significantly impact all-cause mortality (HR: 1.36, 95% CI: 0.99–1.85). However, late (HR: 1.90, 95% CI: 1.30–2.78) and multiple HF readmissions (HR: 2.10, 95% CI: 1.17–3.76) were significantly associated with all-cause mortality. Prescription of RAS inhibitors at discharge was associated with a lower rate of all-cause mortality, especially among patients receiving doses of 25–<50% (HR: 0.67, 95% CI: 0.48–0.94), and 75–100% (HR: 0.61, 95% CI: 0.37–0.98) of the optimal daily dose.

Conclusion

HF readmission is common within 1-year of TAVR. Late and multiple HF readmissions associate with an increased risk of long-term all-cause mortality. Baseline comorbidities (diabetes, chronic lung disease, previous acute HF) and echocardiographic findings at discharge (grade III or IV aortic regurgitation, pulmonary hypertension) identified patients at high-risk of HF readmission. Guidelines-recommended therapies did not significantly affect the 1-year risk of HF readmission.

Funding Acknowledgement

Type of funding source: None
Impact of tapered-shaped left ventricular outflow tract on permanent pacemaker implantation after the third-generation balloon-expandable valve implantation
Authors: Ishizu K , Takiguchi H , Ito S , Taniguchi T , Kawaguchi T , Hayashi M , Isotani A , Yamaji K , Shirai S , Ando K
Published: November 2020

Background

In the era of transcatheter aortic valve implantation (TAVI) for patients with lower surgical risk, conduction disturbances requiring permanent pacemaker implantation (PPI) after TAVI remain a serious concern. The association between tapered-shaped left ventricular outflow tract (LVOT) and PPI after TAVI has not been elucidated.

Purposes

This study sought to identify predictors for PPI after TAVI with the third-generation balloon-expandable valve, with focus on LVOT morphology.

Methods

Of 272 consecutive patients treated with the third-generation balloon-expandable valve, 256 patients without previous PPI or bicuspid valve were retrospectively analyzed.

Results

PPI was implanted after TAVI in 20 (7.8%) patients. Patients requiring PPI had smaller LVOT area (356.3 mm2 vs. 399.4 mm2, p=0.011). Moreover, receiver-operating characteristic (ROC) statistics showed that LVOT area /annulus area possessed significantly higher predictive ability than LVOT area (area under the curve: 0.91 [95% confidence interval [CI]: 0.84 to 0.95] vs. 0.67 [95% CI: 0.57 to 0.77], p<0.001). Multivariable analysis revealed LVOT area /annulus area (odds ratio [OR]: 1.93 [95% CI: 1.38–2.71]; p<0.001 per % of decreasing), the difference between membranous septum length and implantation depth (ΔMSID) (OR: 6.82 [95% CI 2.39–19.48]; p<0.001 per mm of decreasing) and pre-existing complete right bundle branch block (CRBBB) (OR: 32.38 [95% CI 2.30–455.63]; p=0.002) as independent predictors of PPI. Further analysis using ROC statistics revealed LVOT area / annulus area of 88.5% and ΔMSID of 1.8 mm as the optimal cutoff points for prediction of PPI after the third-generation balloon-expandable valve implantation, with high negative predictive values of 98.1% and 99.0%, respectively. Figure shows the PPI rates stratified by the number of following predictors: LVOT area /annulus area <88.5%, ΔMSID <1.8 mm and pre-existing CRBBB. Patients with 2 or more predictors had significantly higher PPI rates than those with 1 or less predictor (67% [18 of 27 patients] vs. 1% [2 of 229 patients], p<0.001).

Conclusions

LVOT area /annulus area, ΔMSID and pre-existing CRBBB were identified as powerful independent predictors for PPI after TAVI. Higher valve implantation is important to prevent excessive PPI especially for patients with pre-procedural tapered-shaped LVOT, short membranous septum or pre-existing CRBBB.

PPI rates stratified by predictors

Funding Acknowledgement

Type of funding source: None
Anticoagulation with or without antiplatelet therapy after transcatheter aortic valve replacement, when less is more: a meta-analysis
Authors: Franchin L , Vaira M.P , Piroli F , Angelini F , Elia E , Bocchino P.P , Conrotto F , D'Ascenzo F , Giustetto C , De Ferrari G.M
Published: November 2020

Background

About 40% of patients undergoing transcatheter aortic valve replacement (TAVR) have a history of atrial fibrillation (AF) and an additional 10% develop AF after TAVR. However, there is paucity of data regarding the optimal antithrombotic regimen following TAVR in patients with a clinical indication for oral anticoagulants (OAC).

Purpose

To compare the prognostic impact of OAC plus at least one antiplatelet agent (APT) versus OAC therapy alone in patients undergoing TAVR.

Methods

We systematically searched the literature for studies evaluating the comparative efficacy and safety of OAC + APT versus OAC alone in TAVR. Random-effect meta-analysis was performed comparing clinical outcomes between the two groups. All-cause mortality and cardiovascular mortality were the efficacy outcomes. Stroke and major bleeding, defined as Bleeding Academic Research Consortium bleeding types 3 to 5, constituted the safety outcome.

Results

Overall, 398 titles and abstracts were identified through database searching. Four observational studies were selected, for a total of 1929 patients. After a median follow-up of 18.5 months (IQR 11.3–29.3), OAC + APT increased major bleeding events compared to OAC alone (OR=1.79; 95% CI 1.21–2.66; P=0.004) with no difference in stroke (OR 01.02; 95% CI 0.52–2.01; P=0.95), all-cause mortality (OR=1.07; 95% CI 0.78–1.47; P=0.66) and cardiovascular mortality (OR=1.08; 95% CI 0.79–1.47; P=0.62).

Conclusion

A combination strategy of OAC + APT provides increased risk of bleeding compared to OAC therapy alone in patients undergoing TAVR with similar outcomes in terms of stroke, all-cause mortality and cardiovascular mortality; therefore, when feasible, it should be advised not to add APT on top of OAC therapy in patients without other clinical indications for APT treatment.

Funding Acknowledgement

Type of funding source: None
Impact of transcatheter aortic valve replacement on anemia: new approach to Heyde's syndrome
Authors: Lopez-Pais J , Lopez Otero D , Izquierdo Coronel B , Antunez Muinos P.J , Cia Mendioroz X , Perez-Poza M , Garcia Touchard A , Otero Garcia O , Alvarez Rodriguez L , Juskova M , Sanmartin Pena J.C , Cid Alvarez A.B , Trillo Nouche R , Gonzalez Juanatey J.R , Oteo Dominguez J.F
Published: November 2020

Background

There is an association between aortic stenosis and anaemia known as Heyde's syndrome. It is caused by an acquired von Willebrand (VW) deficiency related to turbulent flow. Patients with significant paravalvular leak (SPL) remain with VW deficit. The aim of this work is to assess impact on prognosis and anaemia of SPL.

Methods

Observational analytic study developed at two university hospitals, including all consecutive patients who underwent TAVI during a 10-year period (2009 to 2018). A logistic regression model was created to determine independent predictors of anaemia at 3 months. Time to event outcomes were analysed with Cox regression. Median follow-up was 21.3±21.9 months.

Results

5.3% of 788 patients had SPL, with no differences on their basal characteristics compared to the rest of the cohort. SPL was an independent predictor of anaemia 3 months after TAVI (Odds Ratio: 8.31, Confidence Interval 95% [CI]: 2.06–33.50).

SPL had negative impact on mortality: Hazard Ratio (HR): 1.85, CI 1.2–2.9; but not on cardiovascular mortality (CV): HR 1.13, CI 0.4–3.1. Patients who had anaemia three months after TAVI had an increased mortality. (HR 2.17, CI 1.5–3.3)

Conclusion

SPL after TAVI increases mortality with no impact on CV mortality. SPL is independent predictor of anaemia 3 months after TAVI, a condition that doubles the mortality. The impact of SPL on mortality could be explained by the increase in anaemia that SPL causes. More aggressive approach to SPL could have a benefit on prognosis.

Figure 1

Funding Acknowledgement

Type of funding source: None
Stroke after transcatheter aortic valve implantation: new insights into risk prediction
Authors: Maier O , Bosbach G , Hellhammer K , Afzal S , Piayda K , Zeus T , Jung C , Westenfeld R , Polzin A , Kelm M , Veulemans V
Published: November 2020

Background

Stroke is still a feared complication following transcatheter aortic valve implantation (TAVI), associated with increased mortality and severe impact on patients' daily living. Despite technological development and knowledge improvement, cerebrovascular events (CVE) are still not predictable so far and simple risk scores are lacking.

Purpose

This study aimed to evaluate different preprocedural factors that may favour stroke after TAVI, especially regarding severity of aortic calcification.

Methods

From May 2011 to January 2018 a total of 1365 patients underwent TAVI with a balloon-expandable (n=442, 32.4%) or self-expandable (n=923, 67.6%) device at our institution. All patients underwent multi-slice computed tomography (MSCT) before TAVI. To obtain the significant factors for stroke risk prediction we performed multivariate regression analysis and selected the optimal cut-off values according to the maximum Youden index for dichotomization of the risk score items. Finally, we used receiver operating characteristics (ROC) analysis and areas under the ROC curves (AUC) to validate our risk score in comparison to other existing models.

Results

60 of 1365 patients (4.4%) had new neurological impairment after TAVI during hospital stay (mean 11.2±6.7 days). We performed propensity score matching (1:10) to balance baseline characteristics between patients with and without stroke following TAVI, resulting in 56 patients with in-hospital stroke and 521 patients without. Preprocedural factors associated with stroke turned out to be history of prior stroke (OR 1.94; 95% CI 0.85–4.43; p=0.114), aortic valve area ≥0.545 cm2 (OR 3.11; 95% CI 1.16–8.34; p=0.024), atrioventricular angle ≥48.5° (OR 2.32; 95% CI 1.20–4.49; p=0.013), RCC Agatston Score ≥447.2 AU (OR 1.8; 95% CI 0.94–3.44; p=0.077), LVOT Agatston Score ≥262.4 AU (OR 2.01; 95% CI 1.08–3.75; p=0.028) and ascending thoracic aorta Agatston Score ≥116.4 AU (OR 2.21; 95% CI 1.17–4.17; p=0.015). ROC analysis showed that our risk model had an AUC of 0.73 (95% CI 0.66–0.80; p<0.001), a sensitivity of 70.6%, a specificity of 69.0%, a positive predictive value of 19.5% and a high negative predictive value of 95.7%. Our risk model appeared to be the best for stroke prediction after TAVI compared to other risk scores used in literature before like EuroSCORE II (AUC 0.50; 95% CI 0.43–0.58; p=0.950) or CHA2DS2-VASc Score (AUC 0.62; 95% CI 0.55–0.70; p=0.004).

Conclusion

Especially aortic root calcium volume assessed by MSCT predicts CVE after TAVI and could be integrated into a six items risk model for preprocedural prediction of stroke after TAVI. This model could guide us in identifying those patients who are most likely to benefit from transcatheter cerebral embolic protection devices.

Funding Acknowledgement

Type of funding source: None
Save your brain – does the sentinel cerebral protection device work?
Authors: Dona C , Kammerlander A , Koschutnik M , Nitsche C , Dannenberg V , Winter M.P , Siller-Matula J , Andreas M , Goliasch G , Hengstenberg C , Mascherbauer J
Published: November 2020

Background

Transcatheter aortic valve implantation (TAVI) is increasingly used for the treatment of severe symptomatic aortic stenosis (AS), also in low-risk patients. Periprocedural embolic stroke is rare, but potentially associated with considerable morbidity and mortality. Thus, there is great interest in preventing any cerebral embolic event. At present, only one cerebral embolic protection systems (CPS) is commercially available and little is known about its efficacy in preventing stroke during TAVI. The Sentinel CPS is a FDA-approved system consisting of two inter-connected filters that are placed in the brachiocephalic trunk and the left carotid artery via the right radial artery.

Material and methods

Consecutive patients undergoing TAVI between 11/2018 and 11/2019 were enrolled. Consecutive patients treated by one operator received the Sentinel device, if anatomically possible. Periprocedural stroke rate, as defined by VARC2-criteria, and mortality up to 7 days after procedure was assessed. Descriptive statistics was performed to identify baseline variables associated with elevated risk of stroke and Cox-regression analysis was used to investigate its influence on outcome.

Results

268 patients (47.4% female, 81±7 years) were included. In 74 patients (27.6%), a Sentinel CPS was used, in 63 (23.5%) it was positioned correctly in the brachiocephalic trunk and left carotid artery. Only these patients were considered Sentinel-protected. Patients with and without Sentinel presented with similar baseline characteristics with regard to age (no CPS vs CPS; 80.3 vs 81.5 years; p=0.233), sex (female 47.3% vs 47.7%; p=0.967), previous stroke (6.9% vs 3.2%; p=0.373), peripheral artery disease (9.8% vs 4.8%; p=0.305), coronary artery disease (63.1% vs 57.1%; p=0.370), and kidney function (GFR 52 vs 56 ml/min/m2; p=0.283). The EuroScore II (6% vs 6%; p=0.937), periprocedural predilation (48.3% vs 47.6; p=0.925), postdilation (29.3% vs 31.7%; p=0.707) and procedure time (59min vs 66min; p=0.152) were not different. In total, 15 strokes (5.6%) occurred, of which 9 (3.3%) were disabling strokes as defined by the VARC2-criteria. In Sentinel-protected patients undergoing TAVI, no periprocedural stroke was observed (no CPS 7.3% vs 0.0%; p=0.026).

Conclusion

Our results suggest that Sentinel CPS significantly reduces periprocedural stroke rates in patients undergoing TAVI compared to patients without CPS. However, the study population is small and randomized trials are still needed.

Funding Acknowledgement

Type of funding source: None
Predictors of haemodynamic performance in patients with aortic stenosis and small annulus undergoing TAVI with self-expandable valves
Authors: Chiarito M , Regazzoli D , Cannata F , Pagnesi M , Pagnotta P.A , Stefanini G.G , Barbanti M , De Marco F , Adamo M , Van Mieghem N.M , Kim W.K , Maisano F , Colombo A , Reimers B , Latib A
Published: November 2020

Background

Small aortic annular size is one of the most important predictor of poor hemodynamic and clinical outcomes in patients treated for aortic stenosis. Post-hoc analyses of pivotal trials showed that transcatheter aortic valve intervention (TAVI) offer better outcomes then surgery in patients with small aortic annulus, especially with self-expandable valves (SEV). However, data about SEVs comparison in this population are limited.

Purpose

Our aim is to assess how valve design and oversizing, with anatomical and echographic features, impact on the hemodynamic performance of SEVs in TAVI patients with small aortic annulus.

Methods

The TAVI SMALL registry enrolled 859 patients with small aortic annulus (CT-scan annular perimeter≤72 mm or area ≤400 mm2) treated for aortic stenosis with currently available SEVs (Evolut R=397; Evolut PRO =84; Acurate Neo=140; Acurate TA= 61; Portico=177) at 9 European centers between 2011 and 2018. We performed multivariable backward logistic regression analyses to identify predictors of high postprocedural mean gradient, moderate-to-severe PPM, and moderate-to-severe para-valvular leak (PVL).

Results

After adjustment for LVEF, we identified annular perimeter and percentage of oversizing as independent predictors of lower post-procedural mean gradient.

Implantation of intra-annular rather than supra-annular bioprosthesis was the only independent predictor of moderate-to-severe PPM.

Predictors of moderate-to-severe PVL are reported in the Table.

Conclusions

Among patients with aortic stenosis and small aortic annulus treated with transcatheter SEVs, use of supra-annular bioproshtesis and oversizing were associated with improved valve performance.

Funding Acknowledgement

Type of funding source: None