bluuebunny/crossref_metadata_2025_split huggingface dataset:
Transfemoral-venous transcatheter access to left ventricle through the created communication of inter-ventricular septum with the assistance of arterio-venous circuit
Authors: Yan C , Fang W , Wan L , Li L , Li H , Du B , Hao S 
Published: November 2020

Abstract

Background
During transcatheter aortic/mitral valve replacement (TA/MVR), current available routes are limited due to unfavorable entry-angle, vessel-anatomy or mini-thoracotomy. Through created communication of inter-ventricular septum (C-IVS), transfemoral venous transcatheter access to left ventricle becomes feasible with the assistance of arterio-venous circuit.

Purpose
The study was conducted to investigate the feasibility and safety of transfemoral-venous transcatheter access to left ventricle through the created C-IVS in a swine model.

Methods
Via femoral artery, transcatheter puncture of mid-IVS was performed with the custom-made nickel-titanium needle (0.038-inch, needle-tip bent 60 degrees automatically associated with increased hardness when temperature was above 30°C) and 6F-sheath in 20 healthy Chinese mini-swine. Then femoral arterio-venous circuit was established through created C-IVS with hydrophilic guidewire in all swine, and femoral veno-venous circuit was further created through C-IVS and atrial septum in 4 swine. After pre-dilation of C-IVS, a 20F-sheath was introduced into left ventricle transvenously over the guidewire. Furthermore, transfemoral-venous TAVR was attempted with this approach in one swine. C-IVS was evaluated postoperatively and was further confirmed pathologically 2 months later.

Results
All transcatheter puncture of IVS was performed successfully in left ventricle and the thickness of mid-IVS was 7.67±0.98 mm. During the puncture, ventricular fibrillation occurred in one swine (successfully defibrillation) and only isolated ventricular premature beats/non-sustained ventricular tachycardia were observed in other swine. In all swine, femoral arterio-venous/veno-venous circuit was established via C-IVS, and the 20F-sheath was introduced into left ventricle safely through femoral vein and C-IVS. With the aid of vessel circuit, the 20F-sheath was further advanced into aorta in 16 swine (the entry-angle was 145.3±12.2 degrees) and into left atrium in 4 swine. After the procedure, there was one swine with moderate tricuspid regurgitation and 5 swine with mild residual shunt (2.6±0.7 mm). In addition, epicardial coronary arteries were normal in all swine. Two months later, residual shunt was still detected in 3 swine and the communication was confirmed pathologically. In other swine, there was no defect of IVS and mild replacement-scar was identified along C-IVS. In the swine underwent transfemoral-venous TAVR, prosthetic valve was deployed successfully with good function.

Conclusions
With the aid of vessel circuit, transfemoral-venous transcatheter access to left ventricle is feasible and safe via C-IVS, and transfemoral-venous TAVR was achieved successfully using this novel approach with favorable entry-angle.
Figure 1

Funding Acknowledgement
Type of funding source: Other. Main funding source(s): National Natural Science Foundation of China
Vascular closure devices in TAVI: MANTA versus ProGlide in a propensity-matched population
Authors: Sa Mendes G , Oliveira A , Campante Teles R , Araujo Goncalves P , Brito J , Mesquita Gabriel H , Raposo L , Goncalves M , Lopes P 
Published: November 2020

Abstract

Background
Vascular complications increase morbidity and mortality in transcatheter aortic valve implantation (TAVI). A collagen plug-based closure device - MANTA® was recently introduced as an alternative to the suture-mediated ProGlide® vascular closure device (VCD). Data regarding the efficacy and safety comparing both VCD is scarce. The present study sought to compare the effectiveness of both devices.

Methods
Single center retrospective analysis on prospectively collected data of 300 consecutive patients who underwent TAVI using MANTA® or ProGlide® since 2018. A 1:1 propensity-score matched population derived by a multivariate logistic regression model based on age, sex, body mass index, pre-procedural haemoglobin, EuroSCORE II, main access calcification and the sheath-to-artery ratio. The primary endpoint was the composite of major or life-threatening bleeding (VARC-2 definition), femoral artery stenosis/dissection, pseudoaneurysm and need for endovascular/surgical bailout intervention.

Results
The propensity score matching resulted in 129 matched pairs. The median age was 84 years old [IQR 80–87], 42% males with a median EuroSCOREII of 4.29% [IQR 3.05–6.24].
There were no differences in the primary endpoint between MANTA ® and ProGlide® cohorts (3.9% vs 7.8%, p=0.287, respectively). The rates of the primary endpoint with the MANTA® device decreased with center experience, with relatively steep learning curve effect concerning device success.
Major or life-threatening bleeding (3.1% vs 5.4%, p=0.540) and pseudoaneurysm (0.8% vs 2.3%, p=0.622) occurred less frequently in MANTA® cohort, but the differences did not reach statistical significance. Endovascular (stent or balloon) or surgical rescue intervention (9.3% vs 5.4%, p=0.341) and femoral artery stenosis/dissection (6.2% vs 3.1%, p=0.376), were also similar rates. In ProGlide® cohort, to achieve VCD success (without primary endpoint events), 15.5% needed more than 2 devices, significantly different from MANTA ® (p&lt;0,001).

Conclusions
In patients undergoing transfemoral TAVI, the MANTA® VCD showed a similar efficacy and safety compared to the ProGlide® device and it reduced significantly the need of additional VCDs for completion of hemostasis. These results were obtained despite a clear learning curve associated with MANTA.

Funding Acknowledgement
Type of funding source: None
No impact of direct implantation of a self-expanding valve on one-year clinical outcomes. Insights from the multicenter, randomized DIRECT trial
Authors: Toutouzas K , Benetos G , Drakopoulou M , Karmpalioti M , Xanthopoulou M , Stathogiannis K , Latsios G , Synetos A , Voudris V , Kosmas E , Mastrokostopoulos A , Katsimagklis G , Danenberg H , Vavuranakis M , Tousoulis D 
Published: November 2020

Abstract

Introduction
The DIRECT trial (Predilatation in Transcatheter Aortic Valve Implantation Trial) evaluated in a randomized fashion the safety and efficacy of direct (without balloon pre-dilatation) implantation of a self-expanding valve in all comers undergoing TAVI.

Purpose
To investigate the impact of direct implantation of a self-expanding valve on one-year clinical outcomes.

Methods
DIRECT trial randomized consecutive patients with severe aortic stenosis at 4 tertiary centers to undergo TAVI with the use of self-expanding prostheses with (pre-BAV) or without pre-dilatation (no-BAV). The primary endpoint was device success according to the VARC-2 criteria. Secondary endpoints included periprocedural mortality and stroke, new permanent pacemaker implantation and vascular complications.
All cause death, cardiac death, stroke and heart failure hospitalizations were recorded at one year and compared between the two groups using Kaplan-Meier plots.

Results
In total 171 patients were randomized in 4 centers. In the intention to treat analysis 86 patients were randomized to the pre-BAV group and 85 patients to the no-BAV TAVI group.
The device success according to the VARC-2 criteria was non-inferior in the no-BAV group compared to the pre-BAV group (65/85 - 76.5% for no-BAV versus 64/86 – 74.4% for pre-BAV, mean difference = 2.1%, 90% CI: −8.9 to 13). In the no-BAV group 25 (29.4%) patients underwent post balloon dilatation and in the pre-BAV group 13 patients (15.1%) (p=0.03).
At one year 4 deaths were recorded in pre-BAV group (4.7%) and 3 deaths in no-BAV group (3.5%). There was no difference in Kaplan-Meier plots between the two groups in all-cause mortality (log-rank p=0.72, figure). Similarly, there was no difference in one-year incidence of stroke (1 in pre-BAV and 2 in no-BAV group, log-rank p=0.55), cardiac death (log-rank p=0.66), non-cardiac death (log-rank p=0.98) and heart failure hospitalizations (1 in pre-BAV versus 3 in no-BAV group, log-rank p=0.31). Lastly, there was no difference in the incidence of permanent pacemaker implantation between the two groups at one year (27/67 in no-BAV group versus 20/69 in pre-BAV group, log-rank p=0.24)

Conclusions
Direct transcatheter aortic valve implantation is non-inferior to the procedure with pre-dilatation in self-expanding valve. Despite the overall low rate of events, direct procedure has no impact on clinical outcomes at one year.

Funding Acknowledgement
Type of funding source: Private company. Main funding source(s): Medtronic
Eight-years trends and outcomes in TAVI performed in a high-volume center
Authors: Tagliari A , Haager P.K , Miura M , Russo G , Pozzoli A , Gavazzoni M , Zuber M , Joerg L , Maisano F , Taramasso M 
Published: November 2020

Abstract

Introduction
Since the first transcatheter aortic valve implantation (TAVI), remarkable changes in procedure features and patients' profile have been reported, making it a widespread treatment for severe aortic stenosis in all risk-class patients.

Purpose
To evaluate TAVI contemporary trends and outcomes in the last 8 years in a high-volume TAVI center.

Methods
Data of adult patients submitted to TAVI from April 2012 to April 2019 in a high-volume center were obtained from the Swiss TAVI registry, a prospective national multi-center database. Patients were divided according to implant period in two groups: 1) TAVI performed from 2012 to 2016, and 2) TAVI performed from 2017 to 2019.

Results
Over a 8-years period, a total of 1485 procedures were performed, increasing from 95 in 2012 to 320 in 2018 (p&lt;0.001). A remarkable modification in patients' profile and procedure characteristics can be seen in Table 1. Despite higher age and surgical risk, a significant decrease in 1-year mortality (6.8% vs. 3.2%; p&lt;0.001) was observed in the last 3 years. This difference was especially notable in the subgroup of high-risk patients (STS score ≥8), who presented a decrease in 30-days (5% vs. 3.3%; p=0.001) and 1-year mortality (13.1% vs. 4.9%; p&lt;0.001). In multivariate analysis, age (OR 1.05, 95% CI: 1.0–1.1), non-femoral access (OR 2.7, 95% CI: 1.2–6.0), and STS score (OR 1.07, 95% CI: 1.0–1.1) were independent predictors of in-hospital mortality, while male gender (OR 1.8, 95% CI: 1.0–3.2), chronic obstructive pulmonary disease (OR 2.1, 95% CI: 1.1–3.9), and STS score (OR 1.07, 95% CI: 1.01–1.14) were predictors of 1-year mortality.

Conclusion
Significant changes in patients' profile and procedure characteristics were observed in the last 3 years of TAVI experience. Even performed in elderly and high-risk patients, TAVI was associated with low early and 1-year mortality. The Swiss TAVI registry offers a unique opportunity to monitor trends and outcomes in patient submitted to TAVI.

Funding Acknowledgement
Type of funding source: Public grant(s) – National budget only. Main funding source(s): APT is a Ph.D. study and her scientific research is supported by the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior - Brasil (Capes) - Finance Code 001.
Obesity paradox in 12,381 patients undergoing transfemoral transcatheter aortic valve implantation: from the CENTER-collaboration
Authors: Van Nieuwkerk A , Santos R.B , Regueiro A , Tchetche D , Barbanti M , D'Onofrio A , Ribichini F , Ten F , Tarasoutchi F , Orvin K , Pagnesi M , Ghattas A , Mehran R , Henriques J.P.S , Delewi R 
Published: November 2020

Abstract

Background
Transcatheter aortic valve implantation (TAVI) is a well-established treatment for symptomatic aortic valve stenosis. The majority of patients treated are overweight or obese. Obesity has traditionally been linked to reduced survival and worse cardiovascular outcomes. However, an “obesity paradox” has been described in some diseases, with improved survival of obese patients after invasive and surgical procedures.

Methods
The CENTER-collaboration included data from 10 registries or clinical trials of patients undergoing transfemoral TAVI from 2007 to 2018. Patients were divided in four groups according to body mass index (BMI): underweight: BMI &lt;18.5 kg/m2, normal weight: BMI 18.5 to 24.9 kg/m2, overweight: BMI 25 to 29.9 kg/m2, and obese: BMI ≥30 kg/m2. The primary endpoints of this analysis were differences in 30-day all-cause mortality and stroke after TAVI.

Results
Of the 12,381 patients analysed, 2% (n=205) were underweight, 29% (n=3552) had normal weight, 44% (n=5460) were overweight and 25% (n=3140) obese. Older patients had lower BMI (median of 84 years for underweight and 81 years for obese patients, p&lt;0.001). Cardiovascular risk factors such as hypertension, diabetes mellitus and dyslipidaemia increased progressively with increase of BMI category. As to clinical outcomes, there were no differences for stroke rates across BMI groups. In-hospital mortality was highest in patients who were underweight, namely 8.4%, compared to normal weight, overweight and obese patients (6.2%, 4.3% and 4.6% respectively, p&lt;0.001) as was 30-day mortality (9.8% compared to 6.9%, 5.3% and 5.2% respectively, p=0.001). On the other hand, extremely obese patients (BMI ≥40.0 kg/m2) also had worse prognosis, with a 30-day mortality of 7.6%.

Conclusions
In this global analysis of more than 12 000 patients undergoing transfemoral TAVI, overweight and obese patients had better in-hospital and 30-day survival than normal weight patients, confirming the obesity paradox. There was an inverted J-shaped relationship of body mass index with prognosis, with higher mortality rates for underweight and extremely obese patients.
Mortality and stroke per BMI category

Funding Acknowledgement
Type of funding source: Foundation. Main funding source(s): The Dutch Heart Foundation; Netherlands Organisation for Health Research and Development
Pre-existent 1st degree AV-Block before TAVI with Sapien 3 – is prolonged monitoring required?
Authors: De Torres Alba F , Kaleschke G , Vormbrock J , Reinecke H , Deschka H , Baumgartner H 
Published: November 2020

Abstract

Introduction
Pre-existing right bundle branch block (RBBB) is a well stablished risk factor for the development of high grade conduction abnormalities (CAs) after TAVI. The association of pre-existing 1st degree AV-Block (AVB1) with high grade CAs after TAVI has been inconsistent. A recently published Expert Consensus Document classifies patients with AVB1 in the lowest risk group, allowing for discharge at day 1 post-TAVI. We aimed to study the risk of these patients of developing delayed high grade CAs requiring pacemaker implantation (PM).

Methods
We studied the development CAs in 1447 consecutive patients treated with Sapien 3 between January 2014 and December 2019. After excluding valve-in-valve procedures (n=30) and pts with previously implanted PM (n=167) 1254 patients remained for analysis. All patients were monitored for at least 7 days, as this was our institutional policy during the study period. We analyzed if pre-existing ECG abnormalities predict early and delayed (&gt;24h) high grade CAs with a multivariable logistic regression model.

Results
Of 1254 pts, 159 (12.5%) required a permanent PM after TAVI. In 104 (65%) CAs requiring PM occurred intraprocedural or during the first 48h while in the remaining 35% developed with more delay. We analyzed the presence of previous CAs in pts still free from indication for PM after the first 48h after TAVI (n=1150) in order to identify characteristics that may predict delayed PM requirement (Table). In the multivariable model not only RBBB (OR 5.42, CI95% 2.69–10.94, p&lt;0.0001) but also AVB1 was significantly associated to delayed high grade CAs requiring PM implantation (OR 2.25, CI95% 1.24–4.08, p=0.005).

Conclusion
In this study, in pts requiring PM implantation after TAVI, the high grade CAs occurred after 48h in 35% of patients. Not only RBBB but also AVB1 was an independent predictor of delayed high grade CAs. These results question the safety of considering patients with pre-existing AVB1 as low-risk patients and suggest a more prolonged monitoring also for them.

Funding Acknowledgement
Type of funding source: None
Early and midterm outcomes after transaxillar versus transfemoral TAVI. data from the spanish TAVI registry
Authors: Jimenez-Quevedo P , Urbano Carrillo C , Vaquerizo B , Arzamendi D , Artaiz M , Perez-Moreiras I , Moreu J , Diaz J , Blanco-Mata R , Albarran A , Cruz-Gonzalez I , Baz J.A , Ruiz-Quevedo V , Nombela-Franco L , Moreno R 
Published: November 2020

Abstract

Transaxillary access (TAx) has emerged as a less invasive alternative access when transfemoral access (TF) is not possible in patients undergoing TAVI. The primary endpoint of this study was to compare total in-hospital and 30-day mortality of patients included in the Spanish TAVI registry that were treated by TAx versus TF access.

Methods
All patients included in the Spanish TAVI registry who were treated by TAx or TF access were analyzed. In-hospital and 30-days outcomes were assessed using the Valve Academic Research Consortium definitions. An analyses by propensity score matching and multilevel logistic regression was performed for comparing both groups.

Results
A total of 6603 patients were included, of whom 191 (2.9%) were treated by TAx and 6412 were treated with TF access. After the adjustment, the device success was similar between both groups (94%, TAx vs 95%, TF p=0.95) as well as the rate of vascular complications (11.9% Tax vs 11.9 TF; p=0.78), bleeding (7.7% TAx vs. 7.9% TF; p=0.62) and stroke (4.2% TAx vs. 2.0 TF; p=0.09). However, in-hospital and 30-day mortality was significantly higher in TAx access group versus TF 2.19 (1.13–4.26): p=0.02 and 2.11 (1.08–4, 13); P=0.02, respectively. Similarly, the rate of acute myocardial infarction 5.05 (1.94–13.1); p=0.001, renal complications 2.07 (1.19–3.60; p =) 0.01 and pacemaker implantation 1.56 (1.01–2.40); p=0.04 was higher in the TAx group versus TF.

Conclusions
Transaxillary access compared to transfemoral access is associated with an increase in total in-hospital and 30-day mortality, as a result TAx access should be considered only in those cases in which TF is not possible

Funding Acknowledgement
Type of funding source: None
Impact of the timing of coronary revascularization relative to the transcatheter aortic valve implantation procedure: insights from a propensity score analysis based on a nationwide analysis
Authors: Lantelme P , Bisson A , Lacour T , Herbert J , Ivanes F , Bourguignon T , Quilliet L , Angoulvant D , Harbaoui B , Bonnet M , Bernard A , Babuty D , Saint-Etienne C , Deharo P , Fauchier L 
Published: November 2020

Abstract

Background
The significance and the management of coronary artery disease (CAD) are disputed in patients treated by transcatheter aortic valve implantation (TAVI). In the presence of a significant CAD eligible for percutaneous coronary intervention (PCI), the issue of the timing of PCI relative to TAVI is unsettled. To answer this question, the present study aimed at comparing the short-term and long-term outcome in patients treated by staged PCI within a 90-day time interval before or after TAVI.

Methods
Based on the French administrative hospital-discharge database, the study collected information for all consecutive patients treated with TAVI between 2014 and 2018. Patients treated with PCI in the preceding 90 days before the TAVI procedure (pre-TAVI PCI) or subsequent 90 days after the TAVI procedure (post-TAVI PCI) were included. All-cause mortality, cardiovascular mortality, stroke, myocardial infarction and a combined cardiovascular endpoint were assessed at 30 days after the last procedure (short-term) and during the whole follow-up (long-term). Propensity score matching was used for the analysis of outcomes.

Results
8613 patients met the inclusion criteria with a vast majority of pre-TAVI PCI patients (N=8324) as opposed to post-TAVI PCI (N=229). After propensity score matching, 2 groups of 227 patients with comparable characteristics were obtained. At 30 days, no significant difference was observed for any of the outcome tested with the exception of myocardial infarction more frequent in post-TAVI PCI (OR 2.43 [1.17–5.07]). After a mean [SD] follow-up of 459 [569] days, all outcomes were identical between subgroups. The figure below illustrates the Kaplan Meier curve for all-cause mortality.

Conclusions
Our study based on a French nationwide database shows that PCI is performed pre-TAVI in a majority of cases, with no significant impact on outcome. Deferring PCI after TAVI seems safe and may provide an opportunity to make the decision on more objective parameters while the stenosis has been removed (such as FFR or IFR). In any case, the timing of PCI relative to TAVI does not seem to represent a concern and should be decided on an individual basis.
Figure 1

Funding Acknowledgement
Type of funding source: None
The adverse impact of HFpEF in patients with aortic stenosis: evaluation of the H2FPEF score for risk assessment among patients with preserved ejection fraction undergoing TAVI
Authors: Ludwig S , Pellegrini C , Gossling A , Rheude T , Waldschmidt L , Bhadra O.D , Linder M , Schirmer J , Seiffert M , Reichenspurner H , Blankenberg S , Westermann D , Conradi L , Joner M , Schofer N 
Published: November 2020

Abstract

Background
The H2FPEF score enables identification of patients with high probability of prevalent heart failure with preserved ejection fraction (HFpEF). High H2FPEF scores have proven to be associated with adverse outcome in patients with known HFpEF.

Objective
The aim of this study was to assess the prognostic impact of the H2FPEF score in patients undergoing Transcatheter Aortic Valve Implantation (TAVI) for severe aortic stenosis (AS) and preserved left ventricular ejection fraction (EF).

Methods
In this multi-centre study a total of 832 patients from two German high-volume centres, who received TAVI for severe AS and preserved EF (≥50%), were identified for calculation of the H2FPEF score. Score variables included BMI &gt;30 kg/m2, arterial hypertension, atrial fibrillation, systolic pulmonary artery pressure &gt;31 mmHg, age &gt;60 years, and invasively assessed elevated LV filling pressure. Patients were dichotomized according to low (1–5 points; n=570) and high H2FPEF scores (6–9 points; n=262). Kaplan-Meier and Cox regression analyses were applied to assess the prognostic impact of the H2FPEF score. Median follow-up time was 1.08 years.

Results
Patients presenting with high H2FPEF scores had higher prevalence of moderate to severe mitral and tricuspid regurgitation compared to those with low H2FPEF scores. Stroke volume index (SVI) (Figure 1A) and mean transvalvular gradient (Pmean) consistently decreased with increasing H2FPEF score. All-cause mortality 30 days after TAVI was significantly higher in patients with high H2FPEF scores (p&lt;0.0001). This finding was consistent both after 1 year (p&lt;0.0001) and 3 years (p&lt;0.0001) (Figure 1B). Multivariate analysis revealed a high H2FPEF score to be independently predictive for all-cause mortality (HR 1.62, 95% CI: 1.11–2.38, p=0.013). Among the single H2FPEF score parameters atrial fibrillation was the strongest independent predictor of adverse outcome.

Conclusion
An elevated H2FPEF score of ≥6 is independently predictive for mortality in patients with preserved EF undergoing TAVI for severe AS, which might be due to a higher proportion of paradoxical low flow low gradient AS in these patients. Our findings provide evidence that the H2FPEF score may help identify AS patients with preserved ejection fraction that are at higher risk for adverse outcome after TAVI.
Spline/SVI (A) and 3y-mortality KM (B)

Funding Acknowledgement
Type of funding source: None