bluuebunny/crossref_metadata_2025 huggingface dataset:
Impact of diabetes mellitus on the early phase arterial healing after drug-eluting stent implantation: a multicenter coronary angioscopic study
Authors: Ishihara T , Sotomi Y , Tsujimura T , Okuno S , Iida O , Kobayashi T , Hamanaka Y , Omatsu T , Higuchi Y , Mano T
Published: November 2020

Background

Diabetes mellitus (DM) is a strong risk factor for major cardiac and cerebrovascular events. In particular, coronary artery disease with DM is often complicated with complex lesions. Drug-eluting stents (DES) are mainly used for these lesions, and dual-antiplatelet therapy (DAPT) has been used to prevent stent thrombosis. Early arterial healing after DES implantation may enable short DAPT strategy. However, the impact of DM on the arterial healing in the early phase has not been elucidated to date.

Purpose

We evaluated the arterial healing in the early phase after DES implantation using coronary angioscopy (CAS) and compared the findings between DM and non-DM patients.

Methods

This study was a multicenter retrospective observational study. We analyzed CAS findings of 337 lesions from 270 patients which were evaluated 3 to 5 months after DES implantation. Patients were divided into two groups: DM (149 lesions in 118 patients) versus non-DM groups (188 lesions in 152 patients). We assessed neointimal coverage (NIC) grades (maximum, minimum and dominant), thrombus adhesion and maximum yellow color of plaque underneath the stent. NIC was graded as follows: grade 0, stent struts were not covered; grade 1, stent struts were covered by thin layer; grade 2, stent struts were buried under neointima. Yellow color was graded as follows: grade 0, white; grade 1, light yellow; grade 2, yellow; grade 3, intensive yellow.

Results

Minimum NIC coverage grade was lower in DM group than in non-DM group (P=0.002, Figure), while maximum and dominant NIC coverage grades were similar between them (P=0.94 and P=0.59, respectively). Thrombus adhesion (44.3% versus 38.8%, P=0.32) and maximum yellow color grade (P=0.78) were also similar between DM and non-DM groups. Even after the adjustment by the confounding factors such as follow-up duration and primary disease of acute coronary syndrome, DM was an independent factor predicting grade 0 of minimum NIC (odds ratio [OR] 1.83 [95% confidence interval 1.11–3.03], P=0.019).

Conclusion

DM patients showed less covered struts than non-DM patients 3 to 5 months after DES implantation, suggesting that the recent ultra-short DAPT strategy might not be easily applicable to DM patients.

Minimum neointimal coverage grade

Funding Acknowledgement

Type of funding source: None
Percutaneous vs. surgical revascularization for patients with unprotected left main stenosis: a meta-analysis of 5 years follow-up RCTs
Authors: De Filippo O , D'Ascenzo F , Elia E , Doronzo M.P , Montefusco A , Pennone M , Angelini F , Franchin L , Bruno F , Salizzoni S , Gaudino M , Rinaldi M , De Ferrari G.M
Published: November 2020

Introduction

5-year survival of patients with ULM (Unprotected Left Main) stenosis according to the choice of revascularization (percutaneous vs. surgical) remains to be defined.

Methods and results

Randomized Controlled Trials (RTCs) comparing Percutaneous Coronary Intervention (PCI) vs. Coronary Artery Bypass Graft (CABG) with a follow-up of at least 5 years were included. All-cause death was the primary endpoint. MACCE (a composite endpoint of all-cause mortality, myocardial infarction [MI], stroke and repeat revascularization) along with its single components and cardiovascular (CV) death were the secondary ones. Analyses were stratified according to use of first vs. last generation coronary stents. Subgroup comparisons were performed according to Syntax Score (below or above 33) and to age (using cutoffs of each trial's subgroup analysis). 4 RCTs with 4394 patients were identified: 2197 were treated with CABG, 657 with first generation and 1540 with last generation stents. At 5 years rates of all-cause death did not differ (OR 0.93: 0.71–1.21), as those of CV death and stroke. CABG reduced rates of MACCE (OR 0.69: 0.60–0.79), mainly driven by MI (OR 0.48: 0.36–0.65) and revascularization (OR 0.53: 0.45–0.64). Benefit of CABG for MACCE was consistent, although with different extent, across values of Syntax Score (OR 0.76: 0.59–0.97 for values <32 and OR 0.63: 0.47–0.84 for values ≥33) while was not evident for “younger” patients (OR 0.83: 0.65–1.07 vs. OR 0.65: 0.51–0.84 for “older” patients, all CI 95%).

Conclusion

For patients with ULM disease, PCI and CABG yielded same survival benefit at 5 years. CABG reduced risk of MI, revascularization and MACCE especially in older patients and in those with diffuse coronary disease.

Funding Acknowledgement

Type of funding source: None
Comparison of coronary bifurcation lesions stenting techniques- a network meta-analysis
Authors: Barrett O , Hadad L , Abramowitz Y , Cafri C , Rosenstein G , Merkin M , Zahger D , Koifman E
Published: November 2020

Background

Coronary bifurcations lesions (CBL) are account for 15–20% of all percutaneous coronary interventions (PCI) and constitute a major challenge for interventionists in terms of procedural success rate and long-term cardiac events. Based on data from multiple randomized trials and registries, current guidelines advocate the use of provisional side branch (SB) stenting strategy for the majority of CBL's. However, for true or complex CBL's (long side branches lesions, difficult side branches access or high risk of side branches compromise), which account for up to 25% of CBL's, this strategy may by unsafe and ineffective due to a potential risk of intraprocedural or long-term occlusion of a significant side branch and a two-stenting technique may be needed in order to achieve optimal results. Up to date, the optimal two- stenting technic for CBL remains in debate. Accordingly, our aim was to compare different stenting techniques in coronary bifurcation lesions.

Methods

We performed a MEDLINE search for randomized controlled trials (RCT) and observational studies comparing stenting techniques in CBL's with reported clinical outcomes. Mixed treatment comparison model generation was performed to directly and indirectly compare culotte, T and protrusion (TAP), crush and provisional techniques

Results

A total of 13 RCT and 12 observational studies were identified including 6806 patients, among whom 1,201 were treated with cullotte, 2,731 with crush, 797 with TAP and 2077 with provisional stenting. The Bayesian hierarchical random-effects model demonstrated a significant reduction in target lesion revascularization (TLR) rate with crush techniques compared with provisional technique (OR 0.64 95% CI 0.42–0.97) along with a trend for reduction in major adverse cardiovascular (MACE) events (OR 0.75, 95% CI 0.55–1.02). TAP and culotte techniques did not show similar results. Equality of other endpoints, including mortality, myocardial infarction and re-stenosis was found between all CBL's techniques (Figure 1).

Discussion

Our findings suggest improved outcomes with crush technique compared to other double stenting techniques in terms of TLR with a trend towards MACE reduction. Further research is required to determine the optimal stenting technique for coronary bifurcations lesions along with the utility of imaging and physiology in this complex subset.

Figure 1. Comparison of double stentin techniques

Funding Acknowledgement

Type of funding source: None
Late survival benefit of percutaneous coronary intervention compared with medical therapy in patients with coronary chronic total occlusion: a 10-year follow-up study
Authors: Park T.K , Choi S.H , Lee J.M , Yang J.H , Song Y.B , Hahn J.Y , Gwon H.C , Lee S.H
Published: November 2020

Background

As an initial treatment strategy, percutaneous coronary intervention (PCI) for coronary chronic total occlusion (CTO) did not show mid-term survival benefits compared with optimal medical therapy (OMT).

Purpose

To compare 10-year clinical outcomes between OMT and PCI in CTO patients.

Methods

Between March 2003 and February 2012, 2,024 patients with CTO were enrolled in a single center registry and followed for about 10 years. We excluded CTO patients who underwent coronary artery bypass grafting, and classified patients into the OMT group (n=664) or PCI group (n=883) according to initial treatment strategy. Propensity-score matching was performed to minimize potential selection bias. The primary outcome was cardiac death.

Results

In the PCI group, 699 patients (79.2%) underwent successful revascularization. Clinical and angiographic characteristics revealed more comorbidities and more complex lesions in the OMT group than in the PCI group. At 10 years, the PCI group had lower risks of cardiac death (10.4% versus 22.3%; HR 0.43; 95% CI 0.32 to 0.57; p<0.001) than the OMT group. After the propensity-score matching analyses, the PCI group had lower risks of cardiac death (13.6% versus 20.8%; HR 0.62; 95% CI 0.44 to 0.88; p=0.007), acute myocardial infarction (6.3% versus 11.2%; HR 0.55; 95% CI 0.34 to 0.91; p=0.02), any revascularization (23.9% versus 32.2%; HR 0.67; 95% CI 0.51 to 0.88; p=0.004) than the OMT group. The beneficial effects of CTO PCI were consistent across various subgroups (all p-values for interaction: non-significant).

Conclusions

As an initial treatment strategy, PCI reduced late cardiac death compared with OMT in CTO patients.

Cardiac death in matched population

Funding Acknowledgement

Type of funding source: None
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

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

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<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

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

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<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<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<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

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 <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<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<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

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 (>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<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

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

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

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 >30 kg/m2, arterial hypertension, atrial fibrillation, systolic pulmonary artery pressure >31 mmHg, age >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<0.0001). This finding was consistent both after 1 year (p<0.0001) and 3 years (p<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
Geometrical predictors of small virtual neoLVOT size in functional mitral regurgitation
Authors: Reid A , Anastasius M , Ben Zekry S , Turaga M , Webb J , Boone R , Moss R , Cheung A , Ye J , Leipsic J , Blanke P
Published: November 2020

Background

LVOT obstruction is a potentially lethal complication of transcatheter mitral valve replacement (TMVR). An anticipated neoLVOT area of <2cm2 is presumed to imply prohibitive risk. Measurement of the anticipated neoLVOT can be time consuming and requires specialist software to facilitate virtual valve implantation.

Purpose

To determine simple geometrical predictors of prohibitive neoLVOT size.

Methods

165 consecutive, non-calcific FMR patients referred to a transcatheter heart valve program were analysed. Segmentation of the mitral annulus and left heart geometry was performed using CT. Suitability for a default D-shaped TMVR was determined by proprietary annular inclusion criteria. Systolic neoLVOT area was determined via virtual valve implantation of the default TMVR.

Results

Sufficient image data for annular and neoLVOT suitability assessment was available in 152 patients. 105 patients (69%) were suitable for TMVR based on annular measurements. Of these, neoLVOT area was >2cm2 in 88 (84%). Overall, compared to patients not suitable for TMVR (n=64), those suitable had larger ventricles with lower LVEF, and larger annuli (table 1). Using binomial logistic regression involving the variables within table 1, LVESD was the sole statistically significant variable to predict neoLVOT area of <2cm2 (p=0.02). LVESD <48mm had 82% sensitivity and 94% specificity for the presence of prohibitive neoLVOT (figure 1).

Conclusion

Smaller LVESD is a strong predictor of small neoLVOT, and hence LVOT obstruction post default D-shaped TMVR implantation. This simple measure may therefore be used to streamline patient selection for advanced pre-procedural imaging analysis.

Predicting NeoLVOT size <2 cm2

Funding Acknowledgement

Type of funding source: None
A matter of proportions: a novel framework to classify functional tricuspid regurgitation
Authors: Fortuni F , Dietz M.F , Prihadi E.A , De Ferrari G.M , Bax J.J , Delgado V , Ajmone Marsan N
Published: November 2020

Background

Current approaches for the assessment of tricuspid regurgitation (TR) severity do not correct for right ventricular (RV) size. Similarly to what recently proposed for the left heart, we hypothesized that TR severity can be proportional or disproportional to RV dilation.

Purpose

To characterize the clinical features and the prognosis of patients with disproportionate vs proportionate functional TR (FTR).

Methods

A total of 345 patients (mean age: 70±12 years; 40% male) with significant (≥ moderate) FTR, preserved left ventricular systolic function and who did not undergo tricuspid valvular repair during follow-up were included. Proportional and disproportional FTR were defined according to the ratio between TR severity (vena contracta [VC] width) and RV size (tricuspid annulus [TA] diameter). A prognostic relevant cut-off for VC/TA was identified with spline curve analysis. The primary end-point was all-cause mortality and the event rates were compared between patients with proportionate and disproportionate FTR.

Results

The cut-off for disproportionate FTR associated with an increase in all-cause mortality was identified at 0.24 (Figure 1: left panel). According to this cut-off, 172 (50%) patients showed disproportionate FTR, while the remaining had proportionate FTR. Patients with disproportionate FTR were more frequently symptomatic, had smaller RV basal diameter, higher TR severity, greater left atrial volume, higher prevalence of mitral regurgitation, and higher pulmonary artery pressures compared to those with proportionate FTR. During a median follow-up of 61 (interquartile range, 28–101) months, 135 (39%) patients died. The cumulative 5-year survival rate was significantly worse in patients with disproportionate FTR (57% vs 74%, P=0.001; Figure 1: right panel) and on multivariable Cox regression analysis disproportionate FTR was independently associated with poor outcome (HR 1.56; 95% CI 1.06–2.29; P=0.023) together with age, coronary artery disease, renal impairment, reduced RV systolic function, and increased pulmonary artery pressures. Importantly, this novel framework outperformed the TR grading system recommended by current guidelines, which in this population was not able to effectively stratify the prognosis (HR for severe FTR vs moderate FTR 1.09; 95% CI 0.72–1.64; P=0.694).

Conclusions

In patients with significant FTR, characterization of TR severity in relation to RV size significantly improves risk-stratification since disproportionate FTR if left untreated is associated with worse prognosis compared with proportionate FTR.

Figure 1

Funding Acknowledgement

Type of funding source: None
Impact of caval vein implantation on severity of tricuspid regurgitation, renal and hepatic function in patients with severe secondary tricuspid regurgitation
Authors: Mattig I , Hewing B , Knebel F , Stangl V , Laule M , Stangl K , Dreger H
Published: November 2020

Background

Severe tricuspid regurgitation (TR) is an important determinant for functional capacity and survival. It frequently occurs in patients with advanced heart failure resulting in progressive venous congestion with cardiorenal and cardiohepatic syndrome. The prospective, randomized TRICAVAL study reported the effect of inferior caval vein implantation of an Edwards Sapien XT valve (CAVI) in comparison to optimal medical therapy (OMT) in patients with severe TR. The study did not detect a superior functional outcome after CAVI, but a significant improvement in quality of life. Due to safety concerns, the study was stopped prematurely after 4 periprocedural complications.

Purpose

We hypothesised that CAVI reduces reflux into the inferior vena cava and leads to an increase in systolic right atrial pressure, which may result in an improvement of TR severity. The present subanalysis of the TRICAVAL study evaluates the impact of inferior caval vein implantation on TR severity, right heart parameters and renal and hepatic function.

Methods

Twenty-eight patients with severe TR were randomized in either CAVI group (n=14) with caval vein implantation of an Edwards Sapien XT valve or OMT group (n=14). Medical history, clinical examination, laboratory testing and echocardiographic measurements were analysed in patients with completed FUP (OMT [n = 10], CAVI [n = 8]). Follow-up examinations were performed at baseline and three months after enrolment.

Results

After three months, the CAVI group exhibited a significant reduction of systolic hepatic vein reflux volume (5.0 [1.3–11.0] ml vs. 14.0 [10.3–18.0] ml, p<0.05) and hepatic vein diameter (10.8 [10.0–12.0] mm vs. 14.0 [11.5–15.0] mm, p<0.05) in comparison to OMT. Compared to baseline, CAVI improved body weight (80.7 [69.0–87.7] kg versus 75.5 [63.8–84.6] kg, p<0.05) and abdominal circumference (101.5±13.8 cm versus 96.3±15.4 cm, p≤0.01) paralleled by a trend to lower doses of diuretics. However, over the FUP period, there were no significant changes regarding TR severity, right heart function and morphology as well as renal and hepatic function within both groups, nor in the comparison between CAVI and OMT.

Conclusion

As a proof of our concept, CAVI resulted in a decrease in systolic hepatic vein reflux, hepatic vein diameter and clinical signs of venous congestion. However, TR severity, right heart function and morphology as well as renal and hepatic function remained stable.

Funding Acknowledgement

Type of funding source: Private company. Main funding source(s): Edwards Lifesciences, Incorporated (Irvine, CA)
Association between long non coding RNA levels and hypertension mediated organ damage
Authors: Marketou M , Kontaraki J , Patrianakos A , Maragkoudakis S , Plevritaki A , Lempidakis D , Theodosaki O , Plataki M , Papadaki S , Vardas P , Parthenakis F
Published: November 2020

Purpose

Long non coding RNAs (lncRNAs) are emerging as important components of regulatory networks underlying cardiovascular development and pathophysiology. They exhibit distinctive roles in modulating tissue-specific epigenomic states that are critical for the transcriptional and epigenetic reprogramming that may underpin cardiovascular disease pathogenesis. We investigated the association between gene expression levels of the lncRNAs CARMEN and FENDRR in peripheral blood mononuclear cells (PBMCs) and asymptomatic hypertension mediated organ damage.

Methods

We included 56 patients with essential hypertension (38 women, mean age 77±8 years). Twenty nine normotensive individuals (14 women, mean age 76±10 years) were also included as controls. PBMCs were isolated and lncRNAs' expression levels were determined by quantitative real-time reverse transcription polymerase chain reaction. Hypertension mediated organ damage (MOD), namely carotid wall thickening, left ventricular hypertrophy, and albuminuria were assessed in all patients.

Results

Hypertensive patients showed significantly higher CARMEN (19.95±5.9 versus 5.69±2.82, p<0.001) and FENDRR (37.7±11.8 versus 10.21±8.02, p<0.001) expression levels compared with controls. Increased CARMEN expression levels in PBMCs showed a significant relationship with the number of organs involved (r=0.49, p=0.001). No significant relationship was revealed for FENDRR levels.

Conclusions

Our data reveal that in essential hypertension, increased CARMEN expression levels in PBMCs could be a marker of subclinical MOD. Further studies are needed to assess their role as potential biomarkers or future therapeutic targets in those patients.

Funding Acknowledgement

Type of funding source: None
Exaggerated blood pressure response at mild exertional intensity is associated with lower exercise capacity and worsening of cardiac structural and functional profile
Authors: Woznicka A.K , Kabaj M , Kosowski W , Zachwyc J , Pehcerczyk R , Przewlocka-Kosmala M , Jankowska E.A , Ponikowski P , Kosmala W
Published: November 2020

Even with normal blood pressure (BP) measured at rest, some individuals may experience excessive BP elevation with exercise, termed as an “exaggerated BP response to exercise” (ExBPR). The most common definition of ExBPR is SBP ≥210 mm Hg in men and ≥190 mm Hg in women at peak exercise intensity (ExBPR-PI). However, evidence exists that increase in SBP ≥150 mm Hg at an early stage of exercise stress test (i.e. at mild exercise intensity, ExBPR-MI) can effectively identify hypertension not diagnosed by conventional methods. No studies exploring the pathophysiological significance of ExBPR-MI have been undertaken to date.

Aim

To investigate the association of ExBPR-MI with exercise capacity and cardiac morpho-functional characteristics.

Methods

A group of 109 subjects (mean age 52±13 yrs) with and without a pre-established diagnosis of hypertension, having clinical indications for an exercise stress test, with seated clinic BP <140/90 mm Hg, underwent resting echocardiographic imagining and cardiopulmonary exercise testing using a ramped Bruce protocol.

Results

Based on the BP response at 3 minutes of exercise, the population was divided into two subsets: ExBPR-MI+ and ExBPR-MI− (SBP ≥ and <150 mmHg, respectively). The ExBPR-MI+ group was characterized by lower peak oxygen uptake, higher LV mass and left atrial size, and more impaired LV diastolic function (lower E/A and e', and higher E/e'). When the study cohort was stratified using peak BP response, significant differences indicating an adverse impact of ExBPR-PI were demonstrated only for LV diastolic parameters but not for peak VO2 and cardiac morphology indices (Table 1).

Conclusions

ExBPR-MI predisposes to reduced exercise capacity and detrimental alterations in cardiac morphology and function. As mild exercise intensity is more frequently present during routine daily activities than peak exercise intensity, ExBPR-MI may be a more important pathophysiological contributor to target organ damage than peak BP response, and may represent a potential new target for preventive and therapeutic measures.

Table 1

Funding Acknowledgement

Type of funding source: Public grant(s) – National budget only. Main funding source(s): National Science Centre Poland
Is insulin resistance play a role in left atrium dysfunction in young hypertensive patients?
Authors: Khomova I.A , Bazdyreva E.A , Khramkova A.I , Ezhova N.E , Shavarova E , Kobalava Z.D
Published: November 2020

Insulin resistance with normoglycemia could lead to subclinical inflammation, left atrium enlargement and ventricular systolic and diastolic dysfunction. The aim of our study was to analyzed associations between markers of insulin resistance and parameters of left atrium function in young hypertensive patients.

Methods

965 young people were screened, among which 64 (6.6%) had high normal blood pressure and 57 (5.9%) had arterial hypertension. 121 patients with uncomplicated arterial hypertension grade 1–2 were included to the study (81% male, mean age 25.6 (7.3) years, 22 (18%) had obesity, 51 (42%) were smokers). All patients undergone clinical and laboratory evaluation, 24-h blood pressure monitoring, echocardiography. LA function were evaluated by 2D-speckle tracking echocardiography with left atrial reservoir strain (LASr), left atrial booster strain (LASb), left atrial conduit strain (LACs). Insulin level, serum glucose, was measured by using overnight fasting blood sampling between 7 am and 9 am. Insulin resistance was evaluated by HOMA-IR.

Results

Mean office systolic BP was 132 [122; 138]; diastolic BP – 70 [63; 76]. LAVI was 23 [19; 27] ml/m2. Mean insulin was 8.1 [5.4; 12.3] mIU/l, HOMA-IR – 1.9 [1.2; 2.8]. Correlations between LASr and body mass, waist circumference, insulin level, uric acid, HOMA-IR, E/e', LASb and insulin, HOMA-IR, uric acid, LASc and body mass, waist circumference, insulin level were revealed (p<0.05). Independent association LASc with BMI (B −0.22, p=0.02), LASb with insulin level (B −0.37, p=0.02), LASr with insulin (B −0.37, p=0.02) and with left ventricular (LV) global longitudinal strain (B −0.32, p=0.046) were confirmed in multiple stepwise regression model. Associations between endomyocardial LASb and insulin, HOMA-IR, endomyocardial LASr and body mass, waist circumference, insulin, uric acid, HOMA-IR, E/e', LASra and insulin and HOMA-IR, LASre with body mass, waist circumference, insulin, uric acid, HOMA-IR (p<0.05) were found during correlation analysis. Multiple stepwise regression showed independent associations endomyocardial LASb with HOMA-IR (B −0.44, p=0.005), endomyocardial LASr with HOMA-IR (B −0.46, p=0.003) and with LV global longitudinal strain (B −0.31, p=0.04), LASra with HOMA-IR (B −0.46, p=0.008), LASre with body mass (B −0.48, p=0.036) and with insulin (B −0.38, p=0.001).

Conclusion

Left atrium reservoir function is load dependent and influenced by LV function. For subclinical left atrium remodeling assessment booster function should be analized along with reservoir function. In young hypertensive patients insulin level were independently associated with left atrial dysfunction.

Funding Acknowledgement

Type of funding source: Public Institution(s). Main funding source(s): Project 5-100