Publications by authors named "Giuliano Costa"

Background: Head-to-head comparisons of second and third generations of THVs are mostly limited to two-arm studies, and to mid-term follow-up so far. Aim of the study was to simultaneously compare clinical outcomes of transcatheter aortic valve replacement (TAVR) with four different transcatheter heart valves (THVs) at 5 years.

Methods: Patients undergoing transfemoral TAVR with four second-generation THV platforms and enrolled in the multicenter, prospective OBSERVANT II study from December 2016 to September 2018, were compared according to the THV received.

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  • Balloon-expandable valves (BEVs) and self-expanding valves (SEVs) are compared for their effects on patients with Sievers type 1 bicuspid aortic valve (BAV) stenosis undergoing transcatheter aortic valve replacement.
  • The analysis, based on a registry of 955 patients, found no significant difference in midterm major adverse events or technical success between BEVs and SEVs after adjusting for baseline differences.
  • However, BEVs had lower risks of new permanent pacemaker implantation and moderate or greater paravalvular regurgitation, but a higher risk of severe patient-prosthesis mismatch compared to SEVs.
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Background: The evidence of the long-term advantages of transcatheter aortic valve replacement (TAVR) over surgical aortic valve replacement (SAVR) for aortic stenosis (AS) remains scarce.

Methods: Patients with EuroSCORE II < 4 % who underwent TAVR or SAVR for AS from the prospective observational OBSERVANT study were included in this analysis. Ten-year survival was the primary outcome of this analysis.

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  • The study examines the characteristics and outcomes of patients with tapered raphe-type bicuspid aortic valve (BAV) when undergoing trans-catheter aortic valve replacement (TAVR), focusing on the safety and effectiveness of modern heart valves.
  • Researchers analyzed data from 897 patients, finding that those with tapered configurations showed similar success rates and safety between two sizing strategies: annular and supra-annular.
  • The results indicate that TAVR is a safe and effective procedure for these patients, regardless of the sizing method used, maintaining a high rate of clinical efficacy at mid-term follow-up.
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Background: Patients undergoing transcatheter aortic valve implantation (TAVI) for bicuspid aortic stenosis (AS) frequently present with ascending aortic (AAo) dilatation which is left untreated. The objective of this study was to study the natural progression and underlying mechanisms of AAo dilatation after TAVI for bicuspid AS.

Methods: Patients with a native bicuspid AS and a baseline AAo maximum diameter > 40 mm treated by TAVI and in whom post-TAVI computed tomography (CT) scans beyond 1 year were available were included.

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Left atrial appendage closure (LAAC) is a crucial intervention for stroke prevention in patients with non-valvular atrial fibrillation who are unsuitable for long-term anticoagulation. Amulet and Watchman are the most implanted devices worldwide for performing LAAC, and the aim of this review is to provide a comprehensive comparison focusing on their efficacy, safety, and short- and long-term outcomes. The Watchman device, the first to gain FDA approval, has been extensively studied and demonstrates significant reductions in stroke and systemic embolism rates.

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  • - The study compares the outcomes of different balloon-expandable (BE) transcatheter heart valve (THV) devices used to treat high-risk patients with severe pure native aortic valve regurgitation (NAVR), revealing suboptimal results with both device types.
  • - Out of 144 patients treated, those with the MyVal device had more frequent extra-large annuli, yet technical success rates were similar between MyVal (90%) and Sapien (81%).
  • - Overall, while BE devices might offer a treatment option for high-risk patients with NAVR, their effectiveness is limited and highlights the need for dedicated devices, as larger sizes might improve outcomes for traditionally unsuitable patients.
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  • The study investigates the effects of red blood cell (RBC) transfusion on short-term mortality in patients undergoing transapical transcatheter aortic valve implantation (TA-TAVI), where bleeding is common.
  • Out of 11,265 TAVI participants, 548 had TA-TAVI, with 209 receiving RBC transfusions, and the study found a significant association between transfusion and increased 30-day mortality.
  • The research concluded that RBC transfusion independently predicts higher short-term mortality in TA-TAVI patients, regardless of other factors like major bleeding and kidney injury.
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: To date, data regarding the characteristics and management of obstructive, stable coronary artery disease (CAD) encountered in patients undergoing transcatheter aortic valve implantation (TAVI) are sparse. The aim of the study was to analyze granular details, treatment, and outcomes of patients undergoing TAVI with obstructive, stable CAD from real-world practice. : REVASC-TAVI (Management of myocardial REVASCularization in patients undergoing Transcatheter Aortic Valve Implantation with coronary artery disease) is an investigator-initiated, multicenter registry, which collected data from patients undergoing TAVI with obstructive stable CAD found during the pre-TAVI work-up.

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  • Transcatheter aortic valve replacement (TAVR) for patients with bicuspid aortic valve (BAV) stenosis can lead to complications like paravalvular regurgitation (PVR), which is the leakage of blood around the valve.
  • A study involving 946 patients aimed to understand how often PVR occurs after TAVR, what factors predict it, and its impact on patient outcomes, finding that 44.7% experienced some level of PVR.
  • Moderate or severe PVR was linked to higher risks of major adverse events (MAEs) like death or hospitalization, highlighting the importance of careful monitoring and management in these patients.
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Paravalvular regurgitation remains a frequent finding after transcatheter aortic valve replacement and is associated with unfavorable outcomes if more-than-mild grade. In this case, a patient underwent a third transcatheter aortic valve replacement procedure for worsening symptoms due to severe paravalvular regurgitation. The case underlines the role of preprocedural planning in achieving treatment success.

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Background: Data on the likelihood of left ventricle (LV) recovery in patients with severe LV dysfunction and severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI) and its prognostic value are limited.

Aims: We aimed to assess the likelihood of LV recovery following TAVI, examine its association with midterm mortality, and identify independent predictors of LV function.

Methods: In our multicentre registry of 17 TAVI centres in Western Europe and Israel, patients were stratified by baseline LV function (ejection fraction [EF] >/≤30%) and LV response: no LV recovery, LV recovery (EF increase ≥10%), and LV normalisation (EF ≥50% post-TAVI).

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  • Dialysis is a serious but rare complication following transcatheter aortic valve replacement, and researchers analyzed the TRITAVI registry to develop a clinical score for assessing this risk.
  • They identified various preprocedural factors (like male sex, diabetes, and anemia) and procedural features (like contrast volume and need for transfusion) that contribute to the risk, resulting in two scoring systems (TRITAVIpre and TRITAVIpost) which demonstrated strong predictive power.
  • The study confirmed that the need for dialysis significantly increases mortality rates, emphasizing the importance of the developed scores in predicting dialysis risk before the procedure.
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  • This study compares the outcomes of two self-expanding transcatheter heart valve systems (ACURATE and EVOLUT) in patients undergoing valve-in-valve (ViV) procedures for degenerated surgical prostheses.
  • A total of 835 patients across 20 centers were analyzed, with key outcomes including technical success, device success, and 30-day mortality rates evaluated between the two groups.
  • Results showed that while overall procedural outcomes were similar, specific diameter measurements influenced device success differently between the two valve systems.
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  • The study assesses the effectiveness of self-expanding (SE) Evolut PRO/PRO+ versus balloon-expandable (BE) SAPIEN ULTRA valves in patients with small aortic annuli, using data from the OPERA-TAVI registry.
  • It finds that the 1-year primary effectiveness outcomes are similar for both valve types, but the SE group shows better results for 30-day device-related outcomes.
  • The SE valves have higher rates of disabling strokes and paravalvular leaks, while the BE valves exhibit more issues with prosthesis-patient mismatch and elevated residual mean gradients.
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Background: Coronary re-engagement after transcatheter aortic valve replacement (TAVR) using self-expanding transcatheter heart valves (THVs) systematically implanted using commissural alignment (CA) techniques has been poorly investigated.

Objectives: The aim of this study was to evaluate unsuccessful coronary cannulation, and its predictors, after TAVR using self-expanding devices implanted using CA techniques.

Methods: RE-ACCESS 2 (Reobtain Coronary Ostia Cannulation Beyond Transcatheter Aortic Valve Stent 2) was an investigator-driven, single-center, prospective study that enrolled consecutive TAVR patients receiving Evolut and ACURATE THVs implanted using CA techniques.

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Evidence regarding gender-related differences in response to transcatheter aortic valve implantation according to the valve type is lacking. This study aimed to evaluate the impact of gender on the treatment effect of Evolut PRO/PRO+ (PRO) or SAPIEN 3 Ultra (ULTRA) devices on clinical outcomes. The Comparative Analysis of Evolut PRO vs SAPIEN 3 Ultra Valves for Transfemoral Transcatheter Aortic Valve Implantation (OPERA-TAVI) is a multicenter, multinational registry including patients who underwent the latest-iteration PRO or ULTRA implantation.

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Article Synopsis
  • - The study compares 1-year clinical outcomes of TAVI patients using Evolut PRO/PRO+ and SAPIEN 3 Ultra devices, addressing a lack of midterm comparative analyses in current real-world practice.
  • - Using data from the OPERA-TAVI registry, 587 matched pairs of patients were analyzed, showing no significant difference in the primary endpoint (composite of death, disabling stroke, and rehospitalization), but higher rates of disabling stroke in the PRO group.
  • - Overall, while the clinical outcomes were similar between the two devices, patients receiving PRO experienced notably higher rates of disabling stroke, particularly within the first 30 days following the procedure.
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  • - The study investigates how prosthesis-patient mismatch (PPM) after transcatheter aortic valve implantation (TAVI) affects patient outcomes, particularly focusing on balloon-expandable and self-expandable valves in patients with small aortic annuli.
  • - Data was analyzed from a retrospective registry of 628 patients with severe aortic stenosis, revealing that those with severe PPM had a higher risk of all-cause mortality compared to those with less than moderate PPM, particularly after implantation of certain valve types.
  • - The findings conclude that patients with small aortic annuli and severe PPM face increased early mortality risk, while the use of supra-annular valves (SAV) appears to protect against severe PPM
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