Complementary evidence on the performance of coronary stents generated by a randomized controlled trial and a worldwide registry.

Background: Large-scale registries can provide valuable complementary data to randomized controlled trials (RCT) for the postmarketing evaluation of coronary stents, but their scientific relevance remains debated.

Methods: We sought to compare the evidence on the performance of a single coronary stent platform generated by the RCT for its regulatory approval and a well-conducted international registry. Patients treated with the Ultimaster coronary stent in the CENTURY II (CII-UM) trial (n = 551) were compared to patients in the real-world e-ULTIMASTER (e-UM) registry (n = 35,389).

Recent Developments and Current Status of Transcatheter Aortic Valve Replacement Practice in Latin America - the WRITTEN LATAM Study.

Background: Transcatheter aortic valve replacement (TAVR) is a worldwide adopted procedure with rapidly evolving practices. Regional and temporal variations are expected to be found.

Objective: To compare TAVR practice in Latin America with that around the world and to assess its changes in Latin America from 2015 to 2020.

Outcomes and regional differences in practice in a worldwide coronary stent registry.

Objective: The primary objective was to assess the performance of a new generation thin-strut sirolimus-eluting coronary stent with abluminal biodegradable polymer in an all comer population. The secondary objective was to detail differences in contemporary percutaneous coronary intervention (PCI) practice worldwide.

Methods: e-Ultimaster was an all-comer, prospective, global registry (NCT02188355) with independent event adjudication enrolling patients undergoing PCI with the study stent.

PRospective Observational Registry Evaluating the Safety and Effectivenessof Orsiro Stent in Chilean Patients - ROSES Registry.

Background: There is little information on the performance of the new generation of stents with bioabsorbable polymers in the Latin American population. This registry aimed to further validate the safety and efficacy of the Orsiro bioresorbable-polymer sirolimus-eluting stent (BPSES) in unselected patients undergoing percutaneous coronary intervention (PCI) in Chilean centers.

Methods: We prospectively enrolled patients undergoing PCI with BPSES in 6 Chilean centers.

Early Oxidative Stress Response in Patients with Severe Aortic Stenosis Undergoing Transcatheter and Surgical Aortic Valve Replacement: A Transatlantic Study.

Myocardial ischemia/reperfusion-related oxidative stress as a result of cardiopulmonary bypass is thought to contribute to the adverse clinical outcomes following surgical aortic valve replacement (SAVR). Although the acute response following this procedure has been well characterized, much less is known about the nature and extent of oxidative stress induced by the transcatheter aortic valve replacement (TAVR) procedure. We therefore sought to examine and directly compare the oxidative stress response in patients undergoing TAVR and SAVR.

State of Transcatheter Aortic Valve Implantation in Spain Versus Europe and Non-European Countries.

Background: Transcatheter aortic valve implantation (TAVI) is now the standard treatment for severe aortic stenosis in high-risk symptomatic patients, and its indications are expanding to lower-risk patients.

Objectives: The objective of this study was to analyze the state of TAVI in Spain vs other European and non-European countries.

Methods: Using an online questionnaire, we analyzed the routine practice of 250 TAVI centers worldwide.

Transcatheter Tricuspid Valve Implantation of NaviGate Bioprosthesis in a Preclinical Model.

Patients with isolated functional or recurrent tricuspid regurgitation are often denied surgery because they are considered to be at high risk. Transcatheter valve therapy provides a less invasive alternative for tricuspid regurgitation associated with right heart failure. We have evaluated the feasibility of transcatheter tricuspid valve implantation of the NaviGate valved stent in a long-term swine model.

Transcatheter mitral valve replacement with the NaviGate stent in a preclinical model.

Aims: The aim of this study was to test the feasibility of transcatheter mitral valve implantation of the NaviGate device in acute and chronic preclinical models.

Methods And Results: We evaluated NaviGate valved stent implantation in the mitral position in an acute swine model (n=24, ≤5 days) through three different approaches - transatrial, transapical, and transseptal - and in a chronic swine model (n=12, >10 days) through a transatrial approach. The NaviGate implantation procedures were successful in 83% of the acute model studies (n=20) and 83% of the chronic model studies (n=10).

Single trans-septal access technique for left atrial intracardiac echocardiography to guide left atrial appendage closure.

Objective: This registry aimed to describe the safety and feasibility of a single trans-septal (TS) access technique for left intracardiac echocardiography (ICE) guidance of left-atrial appendage (LAA) closure procedure.

Background: LAA closure is currently accepted as an alternative to oral anticoagulation (OAC) in patients with non-valvular atrial fibrillation (NVAF) who are at high-risk for bleeding. Currently, LAA closure procedure is typically performed under trans-esophageal echocardiogram (TEE) guidance.

Aspirin Versus Aspirin Plus Clopidogrel as Antithrombotic Treatment Following Transcatheter Aortic Valve Replacement With a Balloon-Expandable Valve: The ARTE (Aspirin Versus Aspirin + Clopidogrel Following Transcatheter Aortic Valve Implantation) Randomized Clinical Trial.

Objectives: The aim of this study was to compare aspirin plus clopidogrel with aspirin alone as antithrombotic treatment following transcatheter aortic valve replacement (TAVR) for the prevention of ischemic events, bleeding events, and death.

Background: Few data exist on the optimal antithrombotic therapy following TAVR.

Methods: This was a randomized controlled trial comparing aspirin (80 to 100 mg/day) plus clopidogrel (75 mg/day) (dual antiplatelet therapy [DAPT]) versus aspirin alone (single-antiplatelet therapy [SAPT]) in patients undergoing TAVR with a balloon-expandable valve.

Evaluation of current practices in transcatheter aortic valve implantation: The WRITTEN (WoRldwIde TAVI ExperieNce) survey.

Background: Transcatheter aortic valve implantation (TAVI) has been adopted worldwide as the standard treatment for severe aortic stenosis in symptomatic patients at prohibitive or high surgical risk, but there are still several areas where consensus and evidence are lacking. The purpose was to obtain a global view of current practice related to TAVI with the potential to identify the main areas of consensus and divergence between centers.

Methods: An online questionnaire was distributed in centers performing TAVI including a total of 59 questions concerning pre-procedural evaluation, procedural practices and post-procedural management.

Relationship of mitral valve annulus plane and circumflex-right coronary artery plane: Implications for Transcatheter Mitral Valve Implantation.

Aim: Transcatheter mitral valve implantation (TMVI) is a novel technology for patients with severe mitral valve disease but at high surgical risk. Imaging guidance during the procedure is critical for successful device deployment. Identification of the mitral annular plane (MAP) with fluoroscopy during the procedure is limited by lack of clearly defined landmarks.

Transfemoral implantation of CoreValve Evolut-R aortic prosthesis in patient with prior ball-cage mechanical mitral valve prosthesis.

Transcatheter aortic valve replacement remains challenge in patients with ball-cage-type mechanical valve in mitral position. Potential under-expansion of the percutaneous valve and interaction between the mitral ball-cage mechanical valve tilted towards the left ventricular outflow tract and the percutaneous valve adds risk during and after implantation. We report a successful implantation of the novel CoreValve Evolut-R self-expanding in a patient with severe aortic stenosis and a mitral Starr-Edwards mechanical valve implanted 28years ago.

Expanding indications for transcatheter aortic valve replacement.

Transcatheter aortic valve replacement (TAVR) has emerged as an accepted indication for non-operable patients with severe symptomatic native aortic valve stenosis (AS) and as a reasonable alternative for high-risk surgical AS patients. Nonetheless, the safety and efficacy of performing TAVR in several other potential indications are yet unclear. In the present manuscript the authors review the current evidence supporting TAVR for other potential indications than the typical high-risk/non-operable AS patients, providing updated results of the main clinical trials and registries exploring these particular indications.

Successful transfemoral aortic valve replacement in a bicuspid aortic stenotic valve: requirements for a safe implant.

Although transcatheter aortic valve replacement (TAVR) has been accepted as an attractive alternative for high-risk patients with severe symptomatic aortic stenosis (AS), patients with congenital bicuspid AS has been typically disqualified for this indication due to an implied risk of device dislocation, distortion, or device malfunctioning. Nonetheless, bicuspid AS is not uncommon and frequently missed by transthoracic echocardiography. We reported an interesting case of a high-risk patient with severe symptomatic bicuspid AS who underwent successful TAVR and discussed the anatomic requirements for a safe implant in patients with bicuspid AS considered candidates for TAVR.

Optimal Stenting in Saphenous Vein Graft Intervention.

Percutaneous interventions of (usually degenerated) saphenous vein grafts (SVG) are associated with higher risk of distal embolization and worse clinical outcomes, including target vessel revascularization, myocardial infarction, and death, as compared with percutaneous coronary intervention of native coronary arteries. Embolic protection devices have demonstrated value in reducing the risk of embolization and postprocedural enzyme elevation after SVG interventions. Frequently, however, such devices are not used or cannot be used.

The impact of balloon aortic valvuloplasty on aortic regurgitation in patients with severe aortic stenosis.

Background And Aim Of The Study: Severe aortic regurgitation (AR) is a contraindication for balloon aortic valvuloplasty (BAV). As the effects of mild and moderate AR are unknown, the study aim was to determine the effects of BAV in patients with mild and moderate AR.

Methods: A total of 263 consecutive patients with symptomatic severe aortic stenosis (AS) who underwent BAV was included in the study.

Intracoronary glycoprotein IIb/IIIa inhibitor infusion via a perfusion coronary catheter to decrease thrombus burden: results from the ClearWay™ Multicenter Registry.

Objectives: This multicenter registry aimed to assess the ClearWay™ (CW) perfusion catheter in reduction of thrombus burden and improvement of the coronary flow during percutaneous coronary intervention (PCI).

Background: The presence or development of thrombus during PCI is associated with poor prognosis.

Methods: The utility of the CW perfusion catheter was assessed in patients who presented with intracoronary thrombus and were subjected to PCI.

'Mother-in-child' thrombectomy technique: a novel and effective approach to decrease intracoronary thrombus burden in acute myocardial infarction.

Background: The presence of large thrombus burden in patients presenting with acute myocardial infarction (AMI) is common and associated with poor prognosis. This study aimed to describe the feasibility and safety of the novel 'mother-in-child' thrombectomy (MCT) technique in patients presenting with AMI and large thrombus burden undergoing percutaneous coronary intervention (PCI).

Methods: We studied 13 patients presenting with AMI who underwent PCI with persistent large intracoronary thrombus after standard thrombectomy.

Relationship between routine multi-detector cardiac computed tomographic angiography prior to reoperative cardiac surgery, length of stay, and hospital charges.

While multi-detector cardiac computed tomography angiography (MDCCTA) prior to reoperative cardiac surgery (RCS) has been associated with improved clinical outcomes, its impact on hospital charges and length of stay remains unclear. We studied 364 patients undergoing RCS at Washington Hospital Center between 2004 and 2008, including 137 clinically referred for MDCCTA. Baseline demographics, procedural data, and perioperative outcomes were recorded at the time of the procedure.

Innovative use of self-expanded polytetrafluoroethylene endoprosthesis for percutaneous endovascular interventions.

VIABAHN® endoprosthesis (Gore & Associates, Flagstaff, AZ), a nitinol self-expanding polytetrafluoroethylene (PTFE) lined stent, has demonstrated utility for percutaneous treatment of chronic occlusive disease involving the superficial femoral artery. In a case series communication we aimed to describe the feasibility of a PTFE-lined stent for percutaneous treatment of conditions other than chronic occlusive disease. We report the successful use of PTFE-endoprosthesis to percutaneously treat several vascular conditions, including arterio-venous fistula closure, reconstruction of a distal limb of an aorto-femoral endoprosthesis aneurysm, femoral artery perforation repair, and an exclusion of large saphenous vein graft aorto-coronary bypass aneurysm.