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Introduction: Trials investigating aspirin omission in patients taking oral anticoagulation (OAC) after percutaneous coronary intervention (PCI) or acute coronary syndrome (ACS) were not powered to assess rates of major bleeding or ischemic events.Methods: We performed an updated meta-analysis and network analysis of randomized trials comparing treatment with or without aspirin in patients taking OAC and a P2Y12-inhibitor after PCI or ACS. The primary outcome was TIMI major bleeding.Results: Five trials enrolling 11,542 patients allocated to antithrombotic regimens omitting (n = 5795) or including aspirin (n = 5747) were included. Aspirin omission was associated with a lower risk of TIMI major bleeding (RR = 0.56, 95% CI [0.44-0.71]; P < 0.001) but a trend towards a higher risk of MI (RR = 1.21, 95% CI [0.99-1.47]; P = 0.06), which was significantly higher when only non-vitamin K antagonist OAC (NOAC)-based trials were considered (Pinteraction = 0.02). The risk of stent thrombosis was comparable with both strategies (RR = 1.29, 95% CI [0.87-1.90]; P = 0.20), with a trend towards a higher risk of ST with aspirin omission when only NOAC-based trials were considered (Pinteraction = 0.06). Risks of stroke and death were similar with both strategies. Network meta-analysis ranked dabigatran (low dose) without aspirin as the best strategy for bleeding reduction (P-score = 0.86) and apixaban with aspirin as the best strategy for MI reduction (P-score = 0.66).Conclusions: In patients taking OAC after PCI or ACS, aspirin omission is associated with a lower risk of TIMI major bleeding, with a numerically increased risk of MI, which is statistically significant when only NOAC-based trials are considered. This supports individualization of the treatment regimen based on patient risk.

We aimed to evaluate the efficacy and safety of a low-dose imaging protocol to reduce intraprocedural radiation during transcatheter aortic valve implantation (TAVI). Observational analysis: 802 transfemoral TAVI patients receiving balloon-expandable devices ≥23 mm at a high-volume centre. After propensity score matching, a standard-dose group (SD, n = 333) treated between January 2014 and February 2016 was compared with a low-dose group (LD, n = 333) treated between August 2017 and March 2019 after departmental uptake of a low-dose imaging protocol (reduced field size, high table height, use of “fluoro save,” 3.75 frames/second acquisition, increased filtering). Primary end point was dose-area product (DAP). Secondary safety end points were VARC-2 device success and a composite of in-hospital complications. The LD protocol was associated with lower DAP (4.64 [2.93, 8.42] vs 22.73 [12.31, 34.58] Gy⋅cm2, p

Objectives The aim of this study was to compare outcomes after transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 Ultra (Ultra) and SAPIEN 3 (S3) transcatheter heart valves (T...

Introduction and hypothesis Transcatheter aortic valve implantation (TAVI) has become the standard treatment in intermediate and high-risk patients with high degree aortic stenosis (AS).(1–2) These has been also extended to low-risk and younger patients.(3–5) Besides the use of computed-tomography (CT) as diagnostic method to measure the aortic anatomy for transcatheter heart valve (THV) size decision and the radiation exposure (RE) during TAVI, younger patients are more exposed to radiation and contrast media (CM) complications due to a potentially second procedure.(6) Reducing RE and CM using only angiography aortic measurement could reduce the risk of RE and CM related complications without compromising the efficacy of the THV. We hypothesize that angiographic aortic root (AR) measure has good correlation with CT measure without compromising safety and efficacy of the THV. Methods Observational analysis: 1250 transfemoral TAVI patients with balloon or self-expandable valves were included. Aortic root CT measurement was done in all patients. AR measurement using Follow the right cup rule (7) was additionally done in 505 patients. Correlation between CT only (Group I n=745) versus CT and AR measurement (Group II n=505) was done. An inter and intraobserver validation analysis was done. Primary endpoint was VARC-2 device success. Secondary safety endpoints were composite of in-hospital and 30-days complications. Results Really good intra (0.86, p Conclusions Compared to CT, AR measurement is a good option selecting THV size. No differences regarding device success and in-hospital and 30 days follow-up complications were observed. AR measurement could replace CT in specific cases. Funding Acknowledgement Type of funding sources: None. Angiographic and CT measurementsEndpoints

As we approach 20 years of clinical experience with transcatheter aortic valve replacement (TAVR), a vast portfolio of high-quality clinical data has accumulated, confirming the safety and efficacy of TAVR across the entire spectrum of surgical risk. Although many aspects of this innovative therapy have been thoroughly studied, several challenges remain. As TAVR is expanding to include younger low-risk patients, with longer life expectancy, one major unsolved issue is represented by transcatheter heart valve (THV) durability, since robust THV durability data are currently limited to approximately 5-6 years. Additionally, steric interactions between THV components and coronary ostia may render coronary access particularly difficult, and thus personalized decisions regarding THV type and implanting techniques are of paramount importance to secure future coronary access. Since bicuspid aortic valve (BAV) stenosis may be associated with unfavorable anatomic factors, it has represented an exclusion criterion in major randomized TAVR trials. Albeit promising data are available from multicenter registries, results of specifically designed randomized trials are eagerly needed to inform use of TAVR for BAV stenosis. Although valve-in-valve (ViV) TAVR has emerged as an effective treatment option for degenerated aortic bioprostheses, ViV procedures are associated with specific risks, which mandated the development of specific techniques aimed at reducing the occurrence of periprocedural adverse events. Despite the transfemoral approach represents the access of choice for TAVR, a significant proportion of patients have significant peripheral artery disease and alternative vascular access routes have been increasingly evaluated with encouraging data regarding their safety and feasibility.Mit dem Erreichen von 20 Jahren klinischer Erfahrung im kathetergestützen Aortenklappenersatz (TAVR) hat sich eine riesige Menge klinischer Daten hoher Qualität angesammelt, die die Sicherheit und Wirksamkeit der TAVR für das ganze Spektrum chirurgischer Risiken bestätigen. Obwohl viele Aspekte dieser innovativen Therapie gründlich untersucht wurden, bleiben verschiedene Herausforderungen. Da die Indikation zur TAVR zunehmend auch auf jüngere Low-Risk-Patienten mit höherer Lebenserwartung ausgedehnt wird, stellt die Lebensdauer der Transkatheter-Herzklappen (THV) ein großes ungelöstes Problem dar, denn robuste Daten dazu sind derzeit auf etwa 5–6 Jahre begrenzt. Außerdem können sterische Wechselwirkungen zwischen THV-Komponenten und Koronarostien den Koronarzugang sehr erschweren, daher sind personalisierte Entscheidungen in Bezug auf THV-Typ und Implantationstechniken von großer Bedeutung zur Sicherung eines zukünftigen Koronarzugangs. Da eine Stenose einer bikuspiden Aortenklappe (BAV) möglicherweise mit ungünstigen anatomischen Faktoren einhergeht, gilt sie als Ausschlusskriterium in größeren randomisierten TAVR-Studien. Trotz vielversprechender Daten aus Multi-Zentrums-Registern sind dringend Ergebnisse speziell designter randomisierter Studien erforderlich zur Information über den Einsatz von TAVR bei BAV-Stenose. Auch wenn sich die Valve-in-Valve(VIV)-TAVR als wirksame Therapieoption für degenerierte Aortenbioprothesen erwiesen hat, gehen damit spezifische Risiken einher, welche die Entwicklung spezifischer Techniken erfordern, deren Ziel die Verminderung periprozeduraler Nebenwirkungen ist. Der transfemorale Zugangsweg ist zwar der Zugang der Wahl bei TAVR, doch weist ein erheblicher Teil der Patienten eine relevante periphere Arteriosklerose auf; daher werden zunehmend alternative Gefäßzugänge untersucht – mit ermutigenden Daten zur Sicherheit und Machbarkeit.

A 76 year-old man with previous mitral valve replacement (27-mm Magna Mitral Ease, Edwards Lifesciences, Irvine, California), abdominal endovascular aneurysm repair (EVAR) and iliobifemoral grafting for peripheral artery disease presented with heart failure secondary to mitral stenosis (mean

Aims To investigate the clinical outcomes associated with an antithrombotic therapy with or without clopidogrel after transcatheter aortic valve replacement (TAVR). Methods and results This is a study-level meta-analysis including all randomized trials investigating antithrombotic regimens after TAVR. The protocol was registered with PROSPERO (CRD42020191036). We searched electronic scientific databases for eligible studies. The primary outcome was all-cause death. Main secondary outcome was major bleeding. Other outcomes were life-threatening (or disabling) bleeding, myocardial infarction (MI) and stroke. Six eligible trials randomly allocated 3056 TAVR patients to aspirin or oral anticoagulation (OAC) with clopidogrel (n = 1525) versus aspirin and/or OAC without clopidogrel (n = 1531). In the overall estimates, an antithrombotic therapy with clopidogrel versus without displayed a comparable risk of all-cause death [Risk Ratio—RR = 0.83, 95% Confidence intervals—CI (0.57–1.20); P = 0.25] and major bleeding [RR = 1.33, 95% CI (0.61–2.92); P = 0.39]. However, the combination of aspirin or OAC with clopidogrel doubled the risk of major bleeding as compared to aspirin or OAC without clopidogrel [RR = 2.08, 95% CI (1.27–3.42); P = 0.015, P for interaction = 0.021]. Treatment strategies did not differ with respect to the risk of life-threatening bleeding, MI and stroke. Conclusions In patients receiving TAVR, a therapeutic strategy of aspirin or OAC with clopidogrel significantly increases the risk of major bleeding without impact on mortality and ischemic outcomes compared to aspirin or OAC without clopidogrel. The performance of different antithrombotic regimens in terms of long-term clinical outcomes and bioprosthesis valve function requires further investigation. Graphic abstract Forest plots from pairwise and network meta-analyses associated with an antithrombotic therapy with or without clopidogrel Risk ratio for all outcomes of interest calculated with the pairwise meta-analysis (left side) and for main outcomes calculated with the network meta-analysis (right side) in patients allocated to an antithrombotic therapy with clopidogrel or without. The diamonds indicate the point estimate and the left and the right ends of the lines the [95% CI]. CI: Confidence intervals; OAC; oral anticoagulation.

Background This study compares two latest-generation self-expanding transcatheter heart valves (THV), the supra-annular ACURATE neo (Boston Scientific) and the intra-annular Centera THV (Edwards Lifesciences). Methods In this single center observational cohort trial 317 patients treated with the ACURATE neo and 78 patients treated with the Centera TVH were included. The main endpoints were device success and the early safety endpoint at 30 days. Results Besides higher incidence of diabetes mellitus and higher body mass index in patients treated with the ACURATE neo THV, there were no baseline differences between the groups. Device success was similar in both groups (neo: 91.8% vs. Centera: 93.6%; P=0.598), with numerically higher rates of moderate to severe paravalvular leakage in the ACURATE neo group (4.7% vs. 1.3%; P=0.214). At 30 days all-cause mortality rates were low in both groups (0.3% vs. 0%; P=0.620) and no difference occurred in the early safety at 30 days (19.3% vs. 16.7%; P=0.599). However, all-cause stroke rates were significantly higher in patients treated with the Centera THV (6.4 vs. 1.6%; P=0.015). Conclusions The ACURATE neo and the Centera THV show low mortality rates as well as comparable, favorable hemodynamics. The finding of higher stroke rates at 30 days with the repositionable Centera SE-THV needs further assessment.

Implantation of bioprosthetic surgical valves has been a common procedure in elderly patients with severe aortic stenosis due to patients´ preferences avoiding anticoagulation therapy. However, this valve presents sometime certain deterioration degree (i.e., dysfunction due to stenosis or regurgitation) or even paravalvular leak. Transcatheter heart valve implantation is a good alternative in high-risk patients. The valve-in-valve procedure has been shown to be a safe and effective procedure. However, the presence of the fixed sewing ring of the surgical bioprosthesis can hamper appropriate expansion of the THV. For this reason, the use of cracking balloon seems to be a safe alternative to increase the effective orifice area. We present a case of a patient with a degenerated previous implanted biological valve and paravalvular leak. We used the treatment strategy of valve-in-valve with post-dilatation with high-pressure balloon, in a way to treat both, the degenerated valve and the paravalvular leak. The use of a single percutaneous procedure was enough and safe to treat both problems without further complications.