Publications by authors named "Brambilla N"

This case series highlights the successful application of robotic-assisted percutaneous coronary intervention using the R-One+ system in two acute coronary syndrome patients with significant coronary lesions. The procedures demonstrated the technology's safety, performance, and benefits such as minimal contrast use, reduced operator radiation exposure, and optimal procedural times.

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Purpose: Novel combinations are required to overcome resistance to immune checkpoint inhibitors (ICIs) in proficient mismatch repair (pMMR) or microsatellite stable (MSS) metastatic colorectal cancer (mCRC). We aimed to determine whether vorbipiprant, a prostaglandin EP4 receptor antagonist, can convert immune-resistant mCRC into a tumor responsive to anti-PD-1 inhibition.

Patients And Methods: This phase 1b/2a prospective, open-label, single-arm trial followed a 3 + 3 dose escalation and dose optimization design.

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Article Synopsis
  • 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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  • This study explores how the curvature and angulation of the aortic landing zone (LZ) can influence the depth of transcatheter aortic valve implantation (TAVI) using different types of devices: balloon-expanding (BE) and self-expanding (SE) valves.* -
  • Researchers found that SE devices exhibited greater LZ curvature and angulation characteristics compared to BE devices, affecting how deep the valves were implanted in patients.* -
  • The study concluded that greater LZ curvature (specifically at angles above 17.8°) was a reliable predictor of deeper implantation for SE devices, suggesting that device selection and anatomical factors need to be carefully considered during TAVI procedures.*
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Background: Mitral transcatheter edge-to-edge repair (M-TEER) is a guideline-recommended treatment option for patients with severe symptomatic mitral regurgitation (MR). Outcomes with the PASCAL system in a post-market setting have not been established.

Objectives: The authors report 30-day and 1-year outcomes from the MiCLASP (Transcatheter Repair of Mitral Regurgitation with Edwards PASCAL Transcatheter Valve Repair System) European post-market clinical follow-up study.

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Article Synopsis
  • The study focused on the Myval™ transcatheter heart valve (THV) for treating severe aortic stenosis, assessing its performance and outcomes over a year in 100 patients who underwent implantation.
  • Results showed a 100% technical success rate, with minor complications and a low mortality rate at 1- and 2-year follow-ups, indicating the device's safety and efficacy.
  • The authors suggest that further randomized trials are needed to fully understand the Myval THV's potential in clinical settings.
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The COVID-19 pandemic and the need for additional safe, effective, and affordable vaccines gave new impetus into development of vaccine genetic platforms. Here we report the findings from the phase 1, first-in-human, dose-escalation study of COVID-eVax, a DNA vaccine encoding the receptor binding domain (RBD) of the SARS-CoV-2 spike protein. Sixty-eight healthy adults received two doses of 0.

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Background: The impact of nodular calcifications in left ventricular outlow tract (LVOT) and aortic annulus on the procedural outcome of transcatheter aortic valve implantation (TAVI) with new-generation devices is yet to be elucidated. Similarly, computational simulations may provide a novel insight into the biomechanical features of TAVI devices and their interaction with nodular calcifications.

Methods: This retrospective single-center study included 232 patients submitted to TAVI with Evolut-R (53.

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Article Synopsis
  • Severe prosthesis-patient mismatch (PPM) is linked to negative outcomes after transcatheter aortic valve replacement (TAVR), and this study investigates its effects in patients undergoing a second TAVR (TAV-in-TAVR).
  • The study analyzed data from 155 patients across 28 centers, finding that 6.5% experienced severe PPM and 14.2% moderate PPM, with higher rates in specific TAVR types.
  • Results showed that severe PPM correlated with increased one-year all-cause mortality and worsened symptoms, although many patients saw improvement after receiving a new valve to treat the mismatch.
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Objectives: To evaluate the prognostic impact of baseline tricuspid annular plane systolic excursion/pulmonary artery systolic pressure (TAPSE/PASP) ratio, as an expression of the right ventricle-pulmonary artery (RV-PA) coupling, in patients with mitral regurgitation (MR) treated with the MitraClip.

Background: Impaired RV to PA coupling is considered a marker of RV dysfunction.

Methods: From February 2016 to February 2020, a total of 165 patients were evaluated and stratified in two groups according to a prespecified value of TAPSE/PASP ratio ≤ 0.

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Transcatheter aortic valve implantation (TAVI) has become an established alternative to surgery in patients with calcific aortic stenosis. Broad implementation of devices and increased experience have led operators to explore the feasibility of TAVI in off-label indication such as pure native aortic valve regurgitation. Given the technical issues related to the absence of leaflet calcification and aortic root or ascending aorta dilation, this procedure is typically performed in patients in whom surgical risk is deemed prohibitive.

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Background: TAVR is a safe alternative to surgical aortic valve replacement (SAVR); however, sex-related differences are still debated. This research aimed to examine gender differences in a real-world transcatheter aortic valve replacement (TAVR) cohort.

Methods: All-comer aortic stenosis (AS) patients undergoing TAVR with a Medtronic valve across 19 Italian sites were prospectively included in the Italian Clinical Service Project (NCT01007474) between 2007 and 2019.

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Computational simulations of Transcatheter Aortic Valve Implantation (TAVI) have reached a high level of complexity and accuracy for the prediction of possible implantation scenarios during the decision-making process. However, when focusing on the prosthetic device, currently different devices are available on the market which not only have different geometries, but also different material properties. The present work focuses on the calibration of Nitinol constitutive parameters of four self-expandable devices starting from experimental radial force tests on the prosthetic samples.

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Background: Transcatheter aortic valve replacement (TAVR) has determined a paradigm shift in the treatment of patients with severe aortic stenosis. However, the durability of bioprostheses is still a matter of concern, and little is known about the management of degenerated TAV. We sought to evaluate the outcomes of patients with a degenerated TAV treated by means of a second TAVR.

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Aims: The aim of this proof-of-concept study was to investigate safety and efficacy of a CT-scan based patient-specific algorithm to maximize coronary clearance and secondarily to achieve anatomically correct commissural alignment with the Acurate Neo device.

Method And Results: A total of 45 consecutive patients undergoing TAVR with the Acurate Neo THV were prospectively enrolled in the study. Mean age was 81.

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Purpose: To compare in-hospital outcome of Evolut-R 34 mm vs. smaller Evolut-R devices and to identify predictors of paravalvular leak (PVL) and deep implantation specific for Evolut-R 34 mm.

Methods: This single-center retrospective study included 359 consecutive patients undergoing transcatheter aortic valve replacement (TAVR) with Evolut-R 34 mm (N = 84,23.

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We compute the color-singlet and color-octet nonrelativistic QCD (NRQCD) long-distance matrix elements for inclusive production of P-wave quarkonia in the framework of potential NRQCD. In this way, the color-octet NRQCD long-distance matrix element can be determined without relying on measured cross section data, which has not been possible so far. We obtain inclusive cross sections of χ_{cJ} and χ_{bJ} at the LHC, which are in good agreement with data.

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The new iteration of the Portico transcatheter heart valve delivery system, the FlexNav, has been designed to enhance procedural safety and accuracy of the platform. Major technological advancements were the significant reduction of the insertion profile, allowing a transfemoral access down to 5.0 mm vessels, and the addition of a stability layer, improving deployment accuracy and thus potentially reducing implantation depth and permanent pacemaker implantation rate.

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Objectives: To compare device success and paravalvular leak rates of 3 new-generation transcatheter aortic valve replacement devices in patients with bicuspid aortic valve stenosis and to test their biomechanical performance in a computer-based simulation model of aortic root with increasing ellipticity.

Methods: This retrospective multicentre study included 56 bicuspid aortic valve patients undergoing transcatheter aortic valve replacement with new-generation devices: Lotus/Lotus Edge (N = 15; 27%), Evolut-R (N = 20; 36%) and ACURATE neo (N = 21; 37%). Three virtual simulation models of aortic root with increasing index of eccentricity (0-0.

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Objective: This study sought to investigate the procedural and mid-term outcomes of transcatheter aortic valve implantation for failed surgical bioprostheses (TAVI-ViV) with Portico device.

Background: Limited evidence coming from early experience on Portico system does not allow to fully assess safety and efficacy of this device in this ViV patients.

Methods: From January 2016 up to June 2019, 56 consecutive patients undergoing TAVI-ViV with Portico were prospectively included in our institutional TAVI database.

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Objectives: To investigate paravalvular leak (PVL) and devices success rates according to aortic angle (AA) in patients undergoing transcatheter aortic valve implantation (TAVI) with three new-generation self-expanding devices.

Background: The impact of aortic angle (AA) on TAVI device success and PVL rates is controversial.

Methods: This retrospective study included 392 patients submitted to TAVI for severe aortic stenosis with Portico, Evolut-R and Acurate-NEO, and available AA measurements at computed tomography (CT) angiography.

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Aims: In the last decade, transcatheter aortic valve (TAV) replacement determined a paradigm shift in the treatment of patients with severe symptomatic aortic stenosis. Data on long-term TAV performance are still limited. We sought to evaluate the clinical and haemodynamic outcomes of the CoreValve self-expandable valve up to 8-year follow-up (FU).

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Objective: CR4056 is a selective imidazoline-2 (I2) receptor ligand with potent analgesic activity in animal pain models. This proof-of-concept study tested CR4056 efficacy and safety in patients with knee osteoarthritis (OA) and different phenotypes.

Design: This is a multicenter, randomized, double-blind, placebo-controlled trial.

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