Search

Despite remarkable improvements in the past two decades, the annual cardiovascular mortality rate has remained higher for women than for men. Pregnant women represent an underinvestigated population in clinical research, and the mechanisms of long-term cardiovascular complications in women with obstetric complications remain to be elucidated. Regarding advanced heart failure during pregnancy, interventional approaches are effective but still underutilised. Percutaneous mechanical circulatory support is a valuable option for peripartum cardiogenic shock, although its use during pregnancy is still limited. Survival rates have improved in recent years, but further emphasis on the importance of early recognition and initiation of heart failure treatment in this patient group is warranted. The aims of this review are to summarise the current literature on the implementation of mechanical circulatory support in cardiogenic shock during pregnancy and delivery and to understand the role of percutaneous ventricular assist devices in the management of such conditions., Competing Interests: Disclosure: AC has received speaker and consultant fees from Abiomed, Biosensor, Boston Scientific, Medtronic, Menarini and Shock Wave Medical. All other authors have no conflicts of interest to declare., (Copyright © The Author(s), 2023. Published by Radcliffe Group Ltd.)

Objectives: The authors sought to evaluate the incidence, predictors, and outcomes of new permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR) with contemporary self-expanding valves (SEV)., Background: Need for PPI is frequent post-TAVR, but conflicting data exist on new-generation SEV and on the prognostic impact of PPI., Methods: This study included 3,211 patients enrolled in the multicenter NEOPRO (A Multicenter Comparison of Acurate NEO Versus Evolut PRO Transcatheter Heart Valves) and NEOPRO-2 (A Multicenter Comparison of ACURATE NEO2 Versus Evolut PRO/PRO+ Transcatheter Heart Valves 2) registries (January 2012 to December 2021) who underwent transfemoral TAVR with SEV. Implanted transcatheter heart valves (THV) were Acurate neo (n = 1,090), Acurate neo2 (n = 665), Evolut PRO (n = 1,312), and Evolut PRO+ (n = 144). Incidence and predictors of new PPI and 1-year outcomes were evaluated., Results: New PPI was needed in 362 patients (11.3%) within 30 days after TAVR (8.8%, 7.7%, 15.2%, and 10.4%, respectively, after Acurate neo, Acurate neo2, Evolut PRO, and Evolut PRO+). Independent predictors of new PPI were Society of Thoracic Surgeons Predicted Risk of Mortality score, baseline right bundle branch block and depth of THV implantation, both in patients treated with Acurate neo/neo2 and in those treated with Evolut PRO/PRO+. Predischarge reduction in ejection fraction (EF) was more frequent in patients requiring PPI (P = 0.014). New PPI was associated with higher 1-year mortality (16.9% vs 10.8%; adjusted HR: 1.66; 95% CI: 1.13-2.43; P = 0.010), particularly in patients with baseline EF <40% (P for interaction = 0.049)., Conclusions: New PPI was frequently needed after TAVR with SEV (11.3%) and was associated with higher 1-year mortality, particularly in patients with EF <40%. Baseline right bundle branch block and depth of THV implantation independently predicted the need of PPI., Competing Interests: Funding Support and Author Disclosures Dr Pagnesi has received personal fees from Abbott, AstraZeneca, Boehringer Ingelheim, and Vifor Pharma. Dr Kim is a proctor for Boston Scientific and Abbott Vascular; and has received personal fees from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic and Meril outside the submitted work. Dr Barbanti has served as a consultant for Edwards Lifesciences. Dr De Marco has served as a proctor for Boston Scientific and Kardia. Dr Adamo has received speaker fees from Abbott Vascular and Medtronic. Dr Estévez-Loureiro has served as a consultant for Abbott Vascular and Boston Scientific; and is a proctor for Lifetech Scientific. Dr Conradi has served as an advisory board member for Abbott, Medtronic, JenaValve, and Neovasc; and has received personal fees from Edwards Lifesciences, Boston Scientific, and MicroInterventions. Dr Toggweiler is a proctor for Abbott Vascular, Boston Scientific, Medtronic, and Biosensors/NVT; and is a consultant for Boston Scientific, Medtronic, Biosensors/NVT, Medira, Shockwave, Teleflex, AtHeart, VeoSource, and Equity in Hi-D Imaging. Dr Mylotte is a proctor for Medtronic and Microport. Dr Veulemans has received lecture fees and travel support from Medtronic, Edwards Lifesciences, and Boston Scientific. Dr Søndergaard has received consultant fees and/or institutional research grants from Abbott Vascular, Boston Scientific, Edwards Lifesciences, Medtronic and SMT. Dr Wolf is a proctor for Medtronic, Boston Scientific, and Edwards Lifesciences. Dr Pilgrim has received institutional research grants from Boston Scientific, Edwards Lifesciences, and Biotronik; and has received personal fees from Boston Scientific, Biotronik, Abbott, Medtronic, and HighLifeSAS outside the submitted work. Dr Montorfano serves as a proctor for Edwards Lifesciences, Abbott Vascular, and Kardia. Dr Hildick-Smith has served as an adviser or proctor for Edwards Lifesciences, Boston Scientific, and Medtronic. Dr Taramasso is a consultant for Boston Scientific, Abbott Vascular, 4Tech, and CoreMedic; and has received speaker fees from Edwards Lifesciences. Dr Sinning is a proctor for Medtronic and Boston Scientific; has received speaker honoraria from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic; and has received research grants from Boston Scientific, Edwards Lifesciences, and Medtronic outside the submitted work. Dr Van Mieghem has received research grant support from Abbott Vascular, Boston Scientific, Edwards Lifesciences, Medtronic, PulseCath BV, and Daiichi Sankyo; and has received advisory fees from Abbott Vascular, Boston Scientific, Ancora, Medtronic, PulseCath BV, and Daiichi Sankyo. Dr Khogali is a proctor for Medtronic and Boston Scientific. Dr Wood has received grant support from Boston Scientific; and is a consultant for Medtronic. Dr MacCarthy is a proctor for Edwards Lifesciences. Dr Hamm has served on advisory boards for Medtronic. Dr Schäfer is a proctor for Boston Scientific and Medtronic; and has received lecture fees and travel support from both companies. Dr Zeus is a proctor for Medtronic; and has received speaker fees and financial scientific support from Medtronic and Edwards Lifesciences. Dr Naber has received lecture fees from Boston Scientific, Medtronic, and Abbott Vascular; and has served on advisory boards for Boston Scientific and Abbott Vascular. Dr Windecker has received institutional research and educational grants from Abbott Vascular, Amgen, AstraZeneca, Bristol Myers Squibb, Bayer, Biotronik, Boston Scientific, Cardinal Health, CardioValve, CSL Behring, Daiichi Sankyo, Edwards Lifesciences, Guerbet, InfraRedx, Johnson & Johnson, Medicure, Medtronic, Novartis, Polares, OrPha Suisse, Pfizer, Regeneron, Sanofi, Sinomed, Terumo, and V-Wave. Dr Siqueira is a proctor for Medtronic and Edwards Lifesciences. Dr Sedaghat has received travel grants and support from Medtronic. Dr Metra has received personal fees from Amgen, Vifor Pharma, AstraZeneca, Abbott Vascular, Bayer, Servier, Edwards Therapeutics, Actelion, LivaNova, and Windtree Therapeutics. Dr Latib has served on advisory boards or as a consultant for Medtronic, Boston Scientific, Philips, Edwards Lifesciences. and Abbott Vascular. Dr Mangieri has received an institutional research grant from Boston Scientific; has served on a medical advisory board for Boston Scientific; and has received speaker honoraria from Concept Medical and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Prospective data about transcatheter aortic valve implantation (TAVI) in bicuspid aortic valve (BAV) patients are limited., Aims: We aimed to evaluate the clinical impact of the Evolut PRO and R (34 mm) self-expanding prostheses in BAV patients and explore the impact of different computed tomography (CT) sizing algorithms in a prospective registry., Methods: A total of 149 bicuspid patients were treated in 14 countries. The primary endpoint was the intended valve performance at 30 days. Secondary endpoints were 30-day and 1-year mortality, severe patient-prosthesis mismatch (PPM) and the ellipticity index at 30 days. All study endpoints were adjudicated according to Valve Academic Research Consortium 3 criteria., Results: The mean Society of Thoracic Surgeons score was 2.6% (1.7-4.2). Type I L-R BAV was observed in 72.5% of the patients. Evolut valve sizes 29 and 34 mm were utilised in 49.0% and 36.9% of the cases, respectively. The 30-day cardiac death rate was 2.6%; the 1-year cardiac death rate was 11.0%. Valve performance at 30 days was observed in 142/149 (95.3%) patients. The mean aortic valve area post-TAVI was 2.1 (1.8-2.6) cm 2 , and the mean aortic gradient was 7.2 (5.4-9.5) mmHg. No patient had more than moderate aortic regurgitation at 30 days. PPM was observed in 13/143 (9.1%) surviving patients and was severe in 2 patients (1.6%). Valve function was maintained at 1 year. The mean ellipticity index remained 1.3 (interquartile range 1.2-1.4). Overall, 30-day and 1-year clinical and echocardiography outcomes were similar between the two sizing strategies., Conclusions: BIVOLUTX demonstrated a favourable bioprosthetic valve performance and good clinical outcomes after TAVI with the Evolut platform in patients with bicuspid aortic stenosis. No impact from the sizing methodology could be identified.

Background: In recent years, transcatheter aortic valve replacement (TAVR) techniques and technology have continuously improved. Data regarding the impact of these advancements on outcomes in large real-world settings are still limited. The aim of this study was to investigate temporal trends and assess contemporary outcomes after TAVR with Evolut PRO/PRO+ supra-annular self-expanding valves., Methods: This study included patients enrolled in the multicenter NEOPRO (A Multicenter Comparison of Acurate NEO Versus Evolut PRO Transcatheter Heart Valves) and NEOPRO-2 (A Multicenter Comparison of ACURATE NEO2 Versus Evolut PRO/PRO+ Transcatheter Heart Valves 2) registries who underwent transfemoral TAVR with Evolut PRO/PRO+. Procedural dates (August 2017 through November 2021) were stratified in quartiles (Q) and used to investigate temporal trends in TAVR outcomes. Predischarge, 30-day Valve Academic Research Consortium-3 defined, and 1-year outcomes were evaluated., Results: In total, 1616 patients from 28 centers were included. Over time, patients had lower Society of Thoracic Surgeon-Predicted Risk of Mortality score (Q1-4, 4.1% [2.8-6.3%], 3.7% [2.6-5.3%], 3.3% [2.4-4.9%], 2.9% [2.2-4.3%]; P <0.001) and more moderate or heavy valve calcification (Q1-4, 80%, 80%, 82%, 88%; P =0.038). Overall Valve Academic Research Consortium-3 technical success was 94.1%, with 30-day and 1-year all-cause mortality of 2.4% and 10%, respectively. Throughout the study period, procedures were associated with higher rates of 30-day device success (Q1-4, 81.2%, 82.2%, 82.0%, 88.0%; Cochran-Armitage P =0.023) and early safety (Q1-4, 66.8%, 67.5%, 74.0%, 77.6%; Cochran-Armitage P <0.001), with fewer permanent pacemaker implantations (Q1-4: 15.3%, 20.0%, 12.1%, 11.6%; Cochran-Armitage P =0.023) and residual mild or greater paravalvular leaks (Q1-4, 50.4%, 42.1%, 36.5%, 35.8%; Cochran-Armitage P <0.001)., Conclusions: TAVR with Evolut PRO/PRO+ self-expanding valve is safe and effective. Despite the treatment of heavier calcified anatomies, procedural outcomes are improving over time with less need for pacemaker implantation and less significant paravalvular leaks.

Background: Transcatheter aortic valve implant (TAVI) is gaining momentum in the treatment of severe, symptomatic aortic valve stenosis, and its indication is expanding to lower surgical risk individuals, who are generally younger and have a long life expectancy. Therefore, transcatheter bioprostheses durability appears of critical importance. Aim of the present study is to evaluate mid-term outcomes of TAVI in a high-volume single center cohort., Methods: We analyzed all consecutive patients (n = 408) who underwent transfemoral TAVI at a single, high-volume center, between 2007 and 2014. Study objectives were all-cause death and bioprosthetic valve failure (BVF) at long term follow-up. Structural valve deterioration (SVD), BVF and valve-related death were defined according to current international standards. Follow-up was performed by in person visit and transthoracic echocardiography, which was obtained only in a minority of patients, or phone call as per patient preference., Results: At a median follow-up of 1821 days, overall mortality was 64.5%, with cardiovascular disease accounting for roughly half of total deaths. Valve-related deaths occurred in 10 patients. Seventeen patients were diagnosed with BVF, and 15 required repeat intervention. Moderate and severe SVD were observed in 10 and 7 patients, respectively. In the subgroup of patients with echocardiographic mid-term follow-up (n = 76), no significant increase of transprosthetic gradients nor increase of significant regurgitation was detected., Conclusion: In the present unselected, all-comers cohort, TAVI bioprostheses appeared to have excellent durability at long-term follow-up., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Objective: To compare early clinical outcomes after transcatheter aortic valve implantation (TAVI) with three consecutive generations of self-expanding valves (SEVs)., Methods: Clinical endpoints of consecutive patients who underwent TAVI with CoreValve, Evolut R or Evolut PRO were included in a prospective database., Results: TAVI was performed with CoreValve (n = 116), Evolut R (n = 160) or Evolut PRO (n = 92). Evolut R and Evolut PRO showed a tendency towards lower permanent pacemaker implantation (PPI) rates compared to CoreValve (CoreValve 27% vs Evolut R 16% vs Evolut PRO 18%, p = 0.091). By multivariable regression analysis CoreValve had a significantly higher risk for PPI (odds ratio (OR) 2.79, 95% confidence interval (CI) 1.31-5.94, p = 0.008) compared to Evolut R, while Evolut R and PRO were similar. Severe paravalvular leakage (PVL) occurred only with CoreValve, but no significant difference was observed in moderate PVL (10% vs 8% vs 6%, p = 0.49). CoreValve had a tendency towards a higher risk for more-than-mild PVL as compared with the Evolut platform (R + PRO) (OR 2.46, 95% CI 0.98-6.16, p = 0.055). No significant differences in all-cause mortality (7% vs 4% vs 1%, p = 0.10), stroke (6% vs 3% vs 2%, p = 0.21) or major vascular complications (10% vs 12% vs 4%, p = 0.14) were observed., Conclusions: TAVI with self-expanding valves was safe, and device iterations may result in a lower need for PPI. More-than-mild PVL seemed to occur less often with repositionable technology., (© 2021. The Author(s).)

Background: We compared the prognostic value of the ADDED Index with visually estimated diameter (DS) of residual coronary stenosis (RS) in STEMI patients after successful PCI of the culprit lesion. Even though associated with a positive outcome, the functional assessment of non-culprit stenosis remains largely underused, especially in STEMI patients. The Angiography-DeriveD hEmoDynamic index (ADDED index) showed high accuracy to predict FFR and it might be used to better guide the diagnostic and therapeutic work-up of such patients., Methods: We retrospectively included 596 patients grouped on the basis of either the ADDED Index (ADDED Negative (<2.23, n = 153) vs ADDED Positive (≥2.23, n = 129)) or the DS of the RS (RS Negative (<50%, n = 177) vs RS Positive (≥50%, n = 105)). Patients without any RS served as control (n = 314). Primary endpoints were: 1) major adverse cardiac events (MACE), composite of all-cause death, myocardial infarction (MI), clinically driven revascularizations (CDR); 2) non-culprit vessel oriented clinical events (VOCE), composite of all-cause death, non-culprit vessel related MI and CDR., Results: At 24 months the rate of both MACE and VOCE was significantly higher in both the ADDED Positive and RS Positive groups. However, differently from patients in whom complete revascularization was deferred on the basis of the angiography (RS Negative), no additional risk was found for patients in the ADDED Negative group., Conclusions: In STEMI patients with MVD deferring treatment of RS on the basis of the ADDED index, rather than the visually estimated DS, is associated with a favorable clinical outcome., Competing Interests: Declaration of competing interest On behalf of all authors, the corresponding author states that there is no conflict of interest., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Introduction: We aimed to compare conduction dynamics and need for permanent pacemaker implantation (PPI) after CoreValve, Evolut R and PRO (transcatheter aortic valve replacement (TAVR))., Methods: Patients were stratified based on conduction at baseline; Cohort A had normal conduction, Cohort B had conduction abnormalities including atrioventricular (AV)-block, fascicular block or complete bundle branch block. Three different dynamic QRS-patterns were defined: stable QRS-duration, transient QRS-prolongation and persistent QRS-prolongation. We performed multivariable regression analysis to estimate the effect of the three separate transcatheter heart valves (THV's) on need for PPI at 30 days., Results: TAVR was performed with CoreValve (N = 113), Evolut R (N = 157) or Evolut PRO (N = 92). Conduction dynamics were similar between the different THVs. Overall, Evolut R and PRO showed a tendency towards less PPI compared to CoreValve (17% vs. 19% vs. 27%, P = 0.08), which was driven by a lower PPI rate in Cohort A (6% vs. 11% vs. 25%, P = 0.002). Need for PPI was restricted to patients with persistent QRS-prolongation in Cohort A (26/106) but did not correlate with conduction dynamics in Cohort B. In multivariable logistic regression analysis the use of Evolut R (OR 0.38, 95% CI 0.19-0.78, P = 0.008) and PRO (OR 0.41, 95% CI 0.19-0.91, P-value = 0.028) were independently associated with less need for PPI., Conclusion: The newer generations Evolut R and PRO were associated with less PPI compared to CoreValve. Acquired persistent conduction abnormalities predicted PPI after TAVR only in patients with normal conduction at baseline. Our findings may help identify eligible patients for early discharge after Evolut R/PRO TAVR., Competing Interests: Declaration of competing interest HK:no conflicts of interest to declare. LVG:no conflicts of interest to declare. MVW:no conflicts of interest to declare. JO:no conflicts of interest to declare. FZ:no conflicts of interest to declare. ZR:no conflicts of interest to declare. NEF:no conflicts of interest to declare. AM:no conflicts of interest to declare. IK:no conflicts of interest to declare. JD:no conflicts of interest to declare. PDJ:is proctor for Boston Scientific. NVMhas received research grants from Medtronic, Boston scientific, Edwards Lifesciences, Abbott, PulseCath. He is advisor to PulseCath, Ancora, Boston Scientific, Medtronic., (Copyright © 2021 The Author(s). Published by Elsevier Inc. All rights reserved.)

Aims: A greater number of patients with bicuspid aortic valves (BAV) may be identified and treated as indications for transcatheter aortic valve implantation (TAVI) are expected to expand to younger patients. We evaluated the contemporary frequency and management of symptomatic patients with stenotic BAV in a multicenter European registry., Methods: Between November 2017 and February 2018, all consecutive patients admitted for symptomatic aortic stenosis across six high-volume European hospitals were prospectively enrolled in the BiTri registry., Results: Of the 832 patients, 17% (n = 138) had a BAV. The most frequent BAV phenotypes were type 1 (left--right coronary cusps fusion 64%) and type 1 (right-noncoronary cusps fusion 17%). Type 0 and type 2 accounted for 12 and 2%, respectively. When compared with tricuspid patients (n = 694), BAV patients were younger, with lower surgical risk. The transthoracic echocardiography (TTE) identified BAV in 64% of patients. Multisliced computed tomography (MSCT) additionally completed the diagnosis in 20% of patients. Surgical inspection finally identified the remaining undiagnosed 16% of BAV. A combination of TTE and MSCT was the most common diagnosis method for BAV. Surgical aortic valve replacement (SAVR) was the predominant therapeutic option for BAV (70%) whilst TAVI was performed in 26%., Conclusion: BAV is frequently observed in symptomatic patients with aortic stenosis. These patients are younger, have a lower risk profile and are predominantly treated with SAVR as compared with tricuspid patients. However, TAVI is performed in almost one-third of BAV patients in contemporary European practice. TTE combined with MSCT identified 84% of BAV., (Copyright © 2020 Italian Federation of Cardiology - I.F.C. All rights reserved.)

Background: Timely myocardial reperfusion by primary percutaneous coronary intervention (pPCI) prevents the development of left ventricular (LV) dysfunction after myocardial infarction (MI). We aimed to investigate whether bare-metal stents (BMS) and drug eluting stents (DES) differently affect the recovery of LV function in patients with ST-elevation MI (STEMI)., Methods: Overall 103anterior STEMI patients were retrospectively analyzed. All patients had single vessel disease with culprit lesion at the left anterior descending coronary artery. Patients were categorized in DES group (N.=67) and BMS group (N.=36). Changes in LV contractility were assessed by trans-thoracic echocardiogram as Left Ventricular Wall Motion Score Index (LVWMSI). Follow-up visits were performed between 6 and 12 months after hospital discharge., Results: Compared to baseline, LV ejection fraction (EF) remained unchanged between the two groups at the follow-up; LVWMSI significantly improved in patients treated with DES (1.95±0.25 vs. 1.78±0.38, P<0.05), whereas did not change in those treated with BMS (2.09±0.21 vs. 1.98±0.33, P: not significant). At follow-up the LVWMSI was significantly higher in patients with DES than with BMS (P=0.048). LV end-systolic and end-diastolic volumes (LVESV, LVEDV) significantly increased in patients receiving a BMS, whereas it did not change in those receiving a DES (P<0.05). Multivariate analysis adjusted for age, gender, type of stent (DES or BMS), and type of revascularization (primary PCI or rescue PCI or thrombolysis + PCI) showed that DES implantation was an independent predictor of LVWMSI improvement (OR: 3.8 [1.143-12.969] P=0.03)., Conclusions: DES implantation is associated with a favorable impact on LV remodeling and regional contractility.

Objectives: To compare the outcomes of transfemoral ACURATE neo (NEO) and Sapien 3 (S3) patients in terms of device success and clinical safety outcomes using a propensity score analysis., Background: Differences in clinical outcomes between the latest-generation balloon-expandable S3 and self-expanding NEO in a "real-world transfemoral TAVI population" are still unclear., Methods: We compared up to 6 months clinical outcomes using a propensity score analysis (inverse probability of treatment weighting [IPTW]) to account for differences in baseline characteristics., Results: A total of 345 patients underwent transfemoral transcatheter aortic valve implantation (TAVI) with either NEO or S3 at two centers in the Netherlands. Composite device success and early safety endpoints were comparable between NEO and S3 (Device success: IPTW-adjusted OR: 0.35 [95% CI: 0.12-1.18], and early safety: IPTW-adjusted OR: 0.51 [95% CI: 0.19-1.38]). Six-months mortality was 5.3 versus 3.6%, stroke was 2.8 versus 3.3%, and pacemaker rate was 6.1 versus 8.6%, respectively with p = NS. Mean aortic gradient was lower in the NEO group (5.72 ± 2.47 vs. 9.05 ± 3.48; p = <.001), with a comparable rate of moderate or severe paravalvular leak (0 versus 2.1%; p = NS)., Conclusions: Device success and clinical safety outcomes were comparable for both valves. Up to 6-months follow-up clinical outcomes and mortality rate remained excellent. Mean aortic gradient was lower after ACURATE neo implantation., (© 2020 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Aims: The aim of this study was to investigate the total amount, size and heterogeneity of debris captured among different transcatheter valve types and while repositioning., Methods and Results: A total of 328 patients who underwent transcatheter aortic valve implantation (TAVI) with the SENTINEL cerebral embolic protection (CEP) at our centre were eligible. Histopathological and semiquantitative analysis of captured debris was performed and data were entered into our prospective database. TAVI was performed with either the Evolut R/PRO (N=123), SAPIEN 3 (N=113) or Lotus valve (N=92). Capture of debris occurred in 98% of patients. Lotus TAVI resulted in more frequent foreign body material (62% vs 40% vs 47%, p=0.006), endothelium (49% vs 30% vs 16%, p<0.0005), calcified material (33% vs 12% vs 24%, p=0.001) and myocardial tissue (19% vs 11% vs 2%, p<0.0005) compared to SAPIEN 3 or Evolut R/PRO. Native (functional) bicuspid valves (OR 2.91, 95% CI: 1.20-7.03, p=0.02) and Lotus (OR 2.44, 95% CI: 1.14-5.24, p=0.02) were associated with the highest risk for dislodging particles ≥1,000 um. Valve repositioning was independently associated with larger amounts of debris (OR 2.96, 95% CI: 1.42-6.16, p=0.004)., Conclusions: All THV platforms had similar amounts of captured debris. THV repositioning seemed to be associated with a higher risk for dislodging greater amounts of debris to the brain.

Objectives: This study sought to test the superiority in terms of efficacy and safety of a dedicated plug-based vascular closure device (VCD) during transcatheter aortic valve replacement (TAVR) over a suture-based VCD., Background: Vascular complications after TAVR are relevant and often associated with VCD failure., Methods: The MASH (MANTA vs. Suture-based vascular closure after transcatHeter aortic valve replacement) trial is an international, 2-center pilot randomized controlled trial comparing the MANTA VCD (Teleflex, Wayne, Pennsylvania) versus 2 ProGlides (Abbott Vascular, Abbott Park, Illinois). The primary composite endpoint consisted of access site-related major or minor vascular complications at 30-days' follow-up. Secondary endpoints included clinically relevant access site bleeding, time to hemostasis, and modified VCD failure (defined as failure to achieve hemostasis within 5 min or requiring additional endovascular maneuvers such as endovascular stenting, surgical techniques, or additional closure devices). Adverse events were adjudicated by an independent clinical events committee according to the VARC-2 definitions., Results: A total of 210 TAVR patients were included between October 2018 and January 2020. Median age was 81 years, 54% were male, and the median STS score was 2.7%. There was no significant difference in the primary endpoint of access site-related vascular complications between MANTA and ProGlide (10% vs. 4%; p = 0.16). Clinically significant access site bleedings were similar with both closure techniques (9% vs. 6%; p = 0.57). Modified VCD failure occurred less frequently in MANTA versus ProGlide (20% vs. 40%; p < 0.01). Suture-based closure required more often additional closure devices, whereas MANTA numerically needed more covered stents and surgical bailouts., Conclusions: Plug-based large-bore arteriotomy closure was not superior to suture-based closure. Plug-based closure required fewer, but a different kind of bailout maneuvers., Competing Interests: Author Disclosures Dr. Tchétché has been a consultant for Edwards Lifesciences, Medtronic, Boston Scientific, and 4Tech. Dr. Daemen has received institutional research support from Abbott Vascular, Boston Scientific, Medtronic, Pie Medical, and PulseCath BV; and has received consultancy and speaker fees from Boston Scientific, ReCor, Pie Medical, Medtronic, and PulseCath BV. Dr. Dumonteil has received consultancy and proctoring fees from Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr. Van Mieghem has received research grants and advisory fees from Abbott Vascular, Boston Scientific, Edwards Lifesciences, Essential Medical/Teleflex, Medtronic, and PulseCath BV. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: The optimal antithrombotic therapy after transcatheter aortic valve implantation (TAVI) is unsettled. Short and longer-term thromboembolic and bleeding risk post TAVI remain high. Non-vitamin K oral anticoagulant drugs (NOAC) may be attractive after TAVI but the implications of prolonged NOAC in this setting require further research. The aim of this study was to assess the HAS-BLED bleeding risk in a contemporary TAVI population and explore its correlation with the effective bleeding complications with or without (N)OAC., Methods: This study included 986 consecutive successful TAVI patients from 2 tertiary care facilities. Statistical analysis consisted of Cox regression. Bleedings were classified according to VARC-2 criteria., Results: Mean age was 80.5 years, mean STS was 4.7 and 54% were males. A total of 483 patients (49.2%) had AF and 42.1% were on (N)OAC. The median HAS-BLED score was 2, 42.6% had a HAS-BLED≥3. Overall 216 patients (21.9%) experienced at least 1 bleeding, 166 (16.9%) occurred early after TAVI. HAS-BLED≥3 was an independent predictor of overall and pre-discharge bleeding (respectively HR 1.347 CI 1.029-1.763, P=0.03: HR 1.403 CI 1.032-1.905, P=0.05). The incidence of bleeding was similar in patient on (N)OAC vs. patients not on (N)OAC, both in the low and high HAS-BLED cohorts (P=0.93, P=0.42 respectively). Cardiovascular mortality was significantly higher in the high HAS-BLED cohort (37.5% vs. 24%, P=0.04) and HAS-BLED≥3 was an independent predictor of late mortality (HR 1.452 CI 1.028-2.053, P=0.03)., Conclusions: In our series, contemporary TAVI patients had an elevated HAS-BLED score. The HAS-BLED score correlated with early bleedings and mortality after TAVI. Use of (N)OAC was not associated with more bleedings after TAVI.

Safety and feasibility of transfemoral Acurate neo implantation without systematic predilatation are not fully investigated. Our aim was to evaluate the use and impact of pre-implantation balloon aortic valvuloplasty (pre-BAV) before transcatheter aortic valve implantation (TAVI) with Acurate neo. The NEOPRO Registry retrospectively included 1,263 patients who underwent transfemoral TAVI with Acurate neo at 18 centers between January 2012 and March 2018. Information on pre-BAV was available for 1,262 patients (99.9%). Primary end points were pre-discharge moderate-to-severe paravalvular aortic regurgitation (PAR II+), 30-day new permanent pacemaker implantation, and 30-day all-cause mortality or stroke. A total of 1,262 patients who underwent TAVI with (n = 1,051) or without predilatation (n = 211) were included. A reduction in the pre-BAV rate was observed during the study period (from 95.7% in the first date quintile to 78.4% in the last date quintile). Patients who underwent pre-BAV had higher degrees of aortic valve (AV) and left ventricular outflow tract (LVOT) calcification. Primary endpoints were similar between pre-BAV and no pre-BAV groups (PAR II+ 5.5% vs 3.4%, p = 0.214; 30-day permanent pacemaker implantation 9.0% vs 8.0%, p = 0.660; 30-day death or stroke 4.9% vs 4.4%, p = 0.743). The need for postdilatation and other procedural outcomes were comparable between groups. Predilatation did not have a significant impact on primary endpoints across AV and LVOT calcification subgroups (subgroup analyses) and was not independently associated with primary endpoints (multivariate analyses). In conclusion, transfemoral Acurate neo implantation without predilatation appears to be feasible and safe, especially in patients with milder degrees of AV and LVOT calcification., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to evaluate and compare the outcomes of transcatheter self-expandable prostheses in patients with small annuli., Background: Transcatheter aortic heart valves appear to have better performance than surgical valves in terms of prosthesis-patient mismatch, especially in patients with aortic stenosis with small aortic annuli., Methods: TAVI-SMALL (International Multicenter Registry to Evaluate the Performance of Self-Expandable Valves in Small Aortic Annuli) is a retrospective registry of patients with severe aortic stenosis and small annuli (annular perimeter <72 mm or area <400 mm 2 on computed tomography) treated with transcatheter self-expandable valves (n = 859; Evolut R, n = 397; Evolut PRO, n = 84; ACURATE, n = 201; Portico, n = 177). Primary endpoints were post-procedural mean aortic gradient, indexed effective orifice area, and rate of severe prosthesis-patient mismatch., Results: Pre-discharge gradients were consistently low in every group, with a slight benefit with the Evolut R (8.1 mm Hg; 95% confidence interval [CI]: 7.7 to 8.5 mm Hg) and Evolut PRO (6.9 mm Hg; 95% CI: 6.3 to 7.6 mm Hg) compared with the ACURATE (9.6 mm Hg; 95% CI: 8.9 to 10.2 mm Hg) and Portico (8.9 mm Hg; 95% CI: 8.2 to 9.6 mm Hg) groups (p < 0.001). Mean indexed effective orifice area was 1.04 cm 2 /m 2 (95% CI: 1.01 to 1.08 cm 2 /m 2 ) with a trend toward lower values with the Portico. No significant differences were reported in terms of severe prosthesis-patient mismatch (overall rate 9.4%; p = 0.134), permanent pacemaker implantation (15.6%), and periprocedural and 1-year adverse events. Pre-discharge more than mild paravalvular leaks were significantly more common with the Portico (19.2%) and less common with the Evolut PRO (3.6%) compared with the Evolut R (11.8%) and ACURATE (9%) groups., Conclusions: Transcatheter self-expandable valves showed optimal clinical and echocardiographic results in patients with small aortic annuli, although supra-annular functioning transcatheter heart valves seemed to slightly outperform intra-annular functioning ones. The role of transcatheter aortic valve replacement with self-expandable valves for the treatment of aortic stenosis in patients with small annuli needs to be confirmed in larger trials., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to compare transcatheter aortic valve replacement (TAVR) with the Acurate neo (NEO) and Evolut PRO (PRO) devices., Background: The NEO and PRO bioprostheses are 2 next-generation self-expanding devices developed for TAVR., Methods: The NEOPRO (A Multicenter Comparison of Acurate NEO Versus Evolut PRO Transcatheter Heart Valves) registry retrospectively included patients who underwent transfemoral TAVR with either NEO or PRO valves at 24 centers between January 2012 and March 2018. One-to-one propensity score matching resulted in 251 pairs. Pre-discharge and 30-day Valve Academic Research Consortium (VARC)-2 defined outcomes were evaluated. Binary logistic regression was performed to adjust the treatment effect for propensity score quintiles., Results: A total of 1,551 patients (n = 1,263 NEO; n = 288 PRO) were included. The mean age was 82 years, and the mean Society of Thoracic Surgeons score was 5.1%. After propensity score matching (n = 502), VARC-2 device success (90.6% vs. 91.6%; p = 0.751) and pre-discharge moderate to severe (II+) paravalvular aortic regurgitation (7.3% vs. 5.7%; p = 0.584) were comparable between the NEO and PRO groups. Furthermore, there were no significant differences in any 30-day clinical outcome between matched NEO and PRO pairs, including all-cause mortality (3.2% vs. 1.2%; p = 0.221), stroke (2.4% vs. 2.8%; p = 1.000), new permanent pacemaker implantation (11.0% vs. 12.8%; p = 0.565), and VARC-2 early safety endpoint (10.6% vs. 10.4%; p = 1.000). Logistic regression on the unmatched cohort confirmed a similar risk of VARC-2 device success, paravalvular aortic regurgitation II+, and 30-day clinical outcomes after NEO and PRO implantation., Conclusions: In this multicenter registry, transfemoral TAVR with the NEO and PRO bioprostheses was associated with high device success, acceptable rates of paravalvular aortic regurgitation II+, and good 30-day clinical outcomes. After adjusting for potential confounders, short-term outcomes were similar between the devices., (Copyright © 2019. Published by Elsevier Inc.)

Introduction: Flavonoids are nutrients usually included in human diet with several significant biological activities. Nobiletin is a flavonoid that, besides having anti-inflammatory and anti-tumoral activity, seems to exert protective effects on cardiovascular system. Several studies investigated nobiletin as a natural drug to antagonize the atherosclerotic disease. On the contrary, literature about its potential role in modulating the main acute complication of atherosclerosis, thrombosis, is still scanty. Several studies have indicated that Tissue Factor (TF) plays a pivotal role in the pathophysiology of cardiovascular thrombotic events by triggering the formation of intracoronary thrombi. Oxidized-LDL have an important role in promoting athero-thrombotic events. This study investigates whether nobiletin might exert protective cardiovascular effects by preventing the oxidized-LDL mediated expression of TF in human endothelial cells in vitro. Moreover, we have studied whether the nobiletin effects might be modulated by the inhibition of the NF-κB pathway., Methods and Results: In HUVEC, ox-LDL induced TF-mRNA transcription as demonstrated by real time PCR and expression of functionally active TF as demonstrated by Western-blot, FACS analysis and pro-coagulant activity assay. Nobiletin prevented these ox-LDL-mediated effects by exerting antioxidant effects, finally leading to inhibition of the transcription factor NF-κB., Conclusions: These data suggest that nobiletin might be a potential antithrombotic agent of dietary origin. This flavonoid, through its antioxidant proprieties, might potentially exert an antithrombotic activity by inhibiting TF expression/activity in a cell population never investigated before in this context and that is normally represented in vessel wall such as endothelial cells., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Pregnancy-Associated Plasma Protein-A (PAPP-A) is a zinc-binding metalloproteinase protein produced by placental syncytio-trophoblasts and secreted into the maternal circulation where its concentration progressively increases until term. In recent years, PAPP-A has been studied for its potential involvement in cardiovascular (CV) disease. However, all those studies did not provide a clear view to identify the pathophysiological links between PAPP-A plasma levels and the occurrence of CV events. In this review, starting from a complete description of PAPP-A structure and biology, we present an updated overview of experimental as well as clinical evidence on the role of this metalloproteinase in CV disease. Finally, we discuss possible therapeutic approaches to antagonize its potential detrimental CV effects., (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.)

Pregnancy-associated plasma protein-A (PAPP-A) is a metalloproteinase with a controversial role in pathophysiology of cardiovascular disease. It seems involved in progression of atherosclerosis and is widely represented in atherosclerotic plaque. PAPP-A plasma levels are elevated in patients with acute coronary syndromes (ACS), thus it has been suggested that it might be a prognostic marker for developing major cardiovascular events. However, the pathophysiological link(s) between PAPP-A and ACS are still unknown. Several studies have indicated that tissue factor (TF) plays a pivotal role in the pathophysiology of ACS by triggering the formation of intracoronary thrombi following endothelial injury. This study investigates whether PAPP-A, at concentrations measurable in ACS patients, might induce TF expression in human endothelial cells in culture (HUVEC). In HUVEC, PAPP-A induced TF-mRNA transcription as demonstrated by real time PCR and expression of functionally active TF as demonstrated by FACS analysis and pro-coagulant activity assay. PAPP-A induced TF expression through the activation of Akt/NF-κB axis, as demonstrated by luciferase assay and by suppression of TF-mRNA transcription as well as of TF expression/activity by Akt and NF-κB inhibitors. These data indicate that PAPP-A promotes TF expression in human endothelial cells and support the hypothesis that this proteinase, besides being involved in progression of atherosclerosis, does not represent an independent risk factor for adverse cardiovascular events, but it rather might play an "active" role in the pathophysiology of ACS as an effector molecule able to induce a pro-thrombotic phenotype in endothelial cells.

Adipocytes are cells able to produce and secrete several active substances (adipokines) with direct effects on vascular cells. Apelin, one of the most recently identified adipokines has been studied in cardiovascular system physiology in regard to vessel vasodilation and myocardial contraction, but it has not yet completely characterised for its pathophysiological role in cardiovascular disease and especially in acute coronary syndromes (ACS). Several studies have indicated that tissue factor (TF) plays a pivotal role in the pathophysiology of ACS by triggering the formation of intracoronary thrombi following endothelial injury. This study investigates the effects of apelin 12 and apelin 13 on TF in human umbilical endothelial cells (HUVECs) and monocytes. Cells were stimulated with increasing concentrations of apelin 12 or apelin 13 and then processed to evaluate TF-mRNA levels by real-time PCR as well as TF expression/activity by FACS analysis and pro-coagulant activity. Finally, a potential molecular pathway involved in modulating this phenomenon was investigated. We demonstrate that apelin 13 but not apelin 12 induces transcription of mRNA for TF. In addition, we show that this adipokine promotes surface expression of TF that is functionally active. Apelin 13 effects on TF appear modulated by the activation of the G-protein-transcription factor nuclear factor (NF)-κB axis since G-protein inhibitors suppressed NF-κB mediated TF expression. Data of the present study, although in vitro, indicate that apelin-13, induces a procoagulant phenotype in HUVECs and monocytes by promoting TF expression. These observations support the hypothesis that this adipokine might play a relevant role as an active partaker in athero-thrombotic disease.

High-mobility group box 1 (HMGB-1) is a nuclear protein physiologically involved in the maintaining of DNA structure in the nucleus. When tissue damage occurs, necrotic cells as well as inflammatory cells, once activated, release this protein in circulating blood, where it seems to exert a direct proinflammatory action. Thus, HMGB-1 might be involved in the pathophysiology of several diseases, including cardiovascular disease. However, the experimental evidence has not yet clarified its cardiovascular role which is still debated. Specifically, it is still not completely resolved whether HMGB-1 plays a protective or detrimental role on cardiovascular function. In this review, we consider the role of HMGB-1 in pathological conditions and comment on the role of this protein in the cardiovascular disease.

We describe the case of a woman with acute coronary syndrome who was treated by percutaneous coronary intervention (PCI) and stenting of the proximal right coronary artery, which shared its short origin with the left anterior descending artery. A multi-slice computed tomography study of the patient's coronary tree, performed after percutaneous treatment, played a fundamental role in obtaining a clearer view of the coronary anatomy, as well as of stent positioning in this particular anatomy, eliminating any doubt about the PCI result.

Introduction: Adipocytes are nowadays recognized as cells able to produce and secrete a large variety of active substances with direct effects on vascular cells, known as adipokines. Visfatin is a recently identified adipokine not yet completely characterized for its pathophysiological role in cardiovascular disease. Increased levels of visfatin are measurable in the plasma of patients with coronary artery disease and specifically in those with acute coronary syndromes (ACS). Several studies have indicated that Tissue Factor (TF) plays a pivotal role in the pathophysiology of ACS by triggering the formation of intracoronary thrombi following endothelial injury. This study investigates the effects of visfatin on TF in human coronary endothelial cells (HCAECs)., Methods: HCAECs were stimulated with visfatin in a concentration range usually measurable in plasma of patients with ACS and than processed to evaluate TF-mRNA levels as well as TF expression/activity. Finally, the role of NF-κB pathway was investigated., Results: We demonstrate that visfatin induces transcription of mRNA for TF by Real Time PCR. In addition, we show that this adipokine promotes surface expression of TF that is functionally active since we measured increased procoagulant activity. Visfatin effects on TF appear modulated by the activation of the transcription factor, NF-κB, since NF-κB inhibitors suppressed TF expression. Finally, we show that the nicotinamide phopsphoribosyltransferase enzymatic activity of visfatin seems to play a pivotal role in modulating the NF-κB driven regulation of TF., Discussion: Data of the present study, although in vitro, indicate that visfatin, at doses measurable in ACS patient plasma, induces a procoagulant phenotype in human coronary endothelial cells by promoting TF expression. These observations support the hypothesis that this adipokine might play a relevant role as an active partaker in athero-thrombotic disease., (Copyright © 2012 Elsevier Ltd. All rights reserved.)

Inflammation plays a role at all stages of atherosclerosis. Neopterin, a pteridine mainly synthesized by activated macrophages, is a marker of inflammation, immune system activation and an active participant in cardiovascular disease. Measurement of neopterin levels may help follow the evolution of specific inflammatory conditions (e.g. viral infection, renal transplant rejection, systemic inflammatory diseases, nephritic syndrome and autoimmune diseases). Serum levels of neopterin are elevated also in patients with coronary artery disease (CAD) and peripheral artery disease (PAD). Moreover, plasma levels of this molecule might predict adverse cardiovascular events in patients with CAD, acute coronary syndromes or severe PAD. In addition, neopterin levels are related to the development of heart failure. We provide an updated overview on neopterin and, its links with CAD, left ventricular dysfunction, and PAD. We also describe its potential role in cardiac regenerative strategies with using bone marrow cells.

Obesity, the most common nutritional disorder in Western countries, is usually associated to cardiovascular diseases. However, the precise molecular pathways underlying this close association remain poorly understood. Nowadays, the adipose tissue is considered as an endocrine organ able to produce substances called adipo(cyto)kines that have different effects on lipid metabolism, closely involved in metabolic syndrome, and cardiovascular risk. The increased cardiovascular risk can be related also to peculiar dysfunction in the endocrine activity of adipose tissue observed in obesity responsible of vascular impairment (including endothelial dysfunction), prothrombotic tendency, and low-grade chronic inflammation. The present review aims at providing an up-dated overview on the adipocyte-derived molecules potentially involved in cardiovascular pathophysiology.

Blood coagulation is a complex biological mechanism aimed to avoid bleeding in which a highly regulated and coordinated interplay of specific proteins and cellular components respond quickly to a vascular injury. However, when this mechanisms occurs in the coronary circulation, it has not a "protective" effect, but rather, it plays a pivotal role in determining acute coronary syndromes. Coagulation recognizes Tissue Factor (TF), the main physiological initiator of the extrinsic coagulation pathway, as its starter.Since TF:VIIa complex is the critical point of the blood coagulation cascade, it is a pharmacological attractive issue for the development of agents with anti thrombotic properties that can exert their activity by inhibiting complex formation and/or its catalytic activity. In fact, it is intuitive that an antithrombotic agent able to inhibit this initial step of the coagulation pathway has several theoretical, extremely important, advantages if compared with drugs active downstream the coagulation pathway, such as FXa or thrombin. The present report gives a brief overview of TF pathophysiology, highlighting the most recent advances in the field of inhibitors of the complex TF/VIIa potentially useful in cardiovascular disease.