One-Year Results of the Portico Transcatheter Aortic Heart Valve Using the Next-Generation FlexNav Delivery System.

Background: The FlexNav delivery system (DS) features a hydrophilic coating, stability layer, and integrated sheath to facilitate valve deployment in vessel diameters ≥5.0 mm.

Methods: Data were pooled from 2 concurrent prospective, multicenter, premarket studies (PORTICO IDE [n = 147] and FlexNav EU CE Mark [n = 46]) to evaluate the safety and efficacy of the FlexNav DS to deliver the Portico valve in the Global FlexNav study.

Safety Profile of an Intra-Annular Self-Expanding Transcatheter Aortic Valve and Next-Generation Low-Profile Delivery System.

Objectives: The aim of this study was to characterize the safety profile of an intra-annular self-expanding valve with a next-generation low-profile delivery system (DS).

Background: Key design modifications to the FlexNav DS include the addition of a hydrophilic-coated, integrated sheath and stability layer to facilitate gradual, controlled deployment in vessels with diameter ≥5 mm.

Methods: Patients were pooled from 2 concurrent prospective, multicenter, single-arm studies (FlexNav DS arm of PORTICO IDE [Portico Re-Sheathable Transcatheter Aortic Valve System U.

Self-expanding intra-annular versus commercially available transcatheter heart valves in high and extreme risk patients with severe aortic stenosis (PORTICO IDE): a randomised, controlled, non-inferiority trial.

Background: Randomised trial data assessing the safety and efficacy of the self-expanding intra-annular Portico transcatheter aortic valve system (Abbott Structural Heart, St Paul, MN, USA) compared with any commercially available valves are needed to compare performance among designs.

Methods: In this prospective, multicentre, non-inferiority, randomised controlled trial (the Portico Re-sheathable Transcatheter Aortic Valve System US Investigational Device Exemption trial [PORTICO IDE]), high and extreme risk patients with severe symptomatic aortic stenosis were recruited from 52 medical centres experienced in performing transcatheter aortic valve replacement in the USA and Australia. Patients were eligible if they were aged 21 years or older, in New York Heart Association functional class II or higher, and had severe native aortic stenosis.

Prospective US investigational device exemption trial of a sutureless aortic bioprosthesis: One-year outcomes.

Objectives: We performed a prospective, single-arm clinical trial approved under a Food and Drug Administration Investigational Device Exemption to assess safety and efficacy of Perceval, a sutureless bovine pericardial aortic valve representing the initial US experience.

Methods: From June 2013 to January 2015, 300 patients (mean age 76.7 ± 7.

Minimally Invasive Robotically Assisted Repair of Partial Anomalous Venous Connection.

We describe a novel robotically assisted minimally invasive surgical technique for repair of partial anomalous pulmonary vein connection (PAPVC). Partial anomalous pulmonary vein connection is a rare congenital anomaly that consists in drainage of one or more pulmonary veins into the systemic venous system. Traditionally, large thoracotomy incision and sometimes establishment of cardiopulmonary bypass are needed to redirect the abnormal pulmonary vein to the left-sided reservoir.

5-year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic stenosis (PARTNER 1): a randomised controlled trial.

Background: The Placement of Aortic Transcatheter Valves (PARTNER) trial showed that mortality at 1 year, 2 years, and 3 years is much the same with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) for high-risk patients with aortic stenosis. We report here the 5-year outcomes.

Methods: We did this randomised controlled trial at 25 hospitals, in Canada (two), Germany (one), and the USA (23).

5-year outcomes of transcatheter aortic valve replacement compared with standard treatment for patients with inoperable aortic stenosis (PARTNER 1): a randomised controlled trial.

Background: Based on the early results of the Placement of Aortic Transcatheter Valves (PARTNER) trial, transcatheter aortic valve replacement (TAVR) is an accepted treatment for patients with severe aortic stenosis who are not suitable for surgery. However, little information is available about the late clinical outcomes in such patients.

Methods: We did this randomised controlled trial at 21 experienced valve centres in Canada, Germany, and the USA.

Direct percutaneous transaortic approach for treatment of aortic pseudoaneurysms.

Aortic pseudoaneurysms (APAs) can develop months or years after aortic and cardiac surgery. If not treated appropriately, APAs can lead to fatal complications and ultimately death. We describe a case of a 61-year old patient with a diagnosed large pseudoaneurysm 5 years after his aortic valve surgery, who was treated with a novel transcatheter direct transaortic approach.

Available transcatheter aortic valve replacement technology.

Transcatheter aortic valve replacement (TAVR) is an alternative and now recommended therapy for patients who meet indications for surgical valve replacement and are high or prohibitive surgical risk. Available TAVR technologies are rapidly emerging to treat this complex patient population. This review discusses the specific valve designs of the transcatheter heart valves currently used, newer generation modifications to overcome limitations of earlier valve designs, and novel imaging modalities, such as computed tomographic angiography-fluoroscopy and echocardiography-fluoroscopy fusion imaging, available for pre-procedural planning and intra-procedural guidance.

Successful first-in-man percutaneous transapical-transseptal Melody mitral valve-in-ring implantation after complicated closure of a para-annular ring leak.

Aims: Transcatheter techniques can theoretically be applied to the treatment of para-annular ring (PAR) leaks. Little is known about their potential application and resultant complications in such cases. We describe the first-in-man percutaneous transapical-transseptal Melody valve-in-ring (ViR) implantation after a complication from percutaneous PAR leak closure.

Long-term outcomes of inoperable patients with aortic stenosis randomly assigned to transcatheter aortic valve replacement or standard therapy.

Background: The long-term outcomes of transcatheter aortic valve replacement (TAVR) in inoperable patients with severe aortic stenosis remain unknown.

Methods And Results: In the Placement of Aortic Transcatheter Valves (PARTNER) study, 358 patients were randomly assigned to TAVR or standard therapy. We report the 3-year outcomes on these patients, and the pooled outcomes for all randomly assigned inoperable patients (n=449) in PARTNER, as well, including the randomized portion of the continued access study (n=91).

A revised methodology for aortic-valvar complex calcium quantification for transcatheter aortic valve implantation.

Aims: We sought to optimize a method for quantification of the calcium in the aortic-valvar complex for the prediction of significant paravalvular leak (PVL) after transcatheter aortic valve implantation (TAVI).

Methods And Results: All patients had severe symptomatic aortic stenosis and were treated with balloon-expandable TAVI (Sapien/Sapien-XT, Edwards Lifesciences LLC, Irvine, CA, USA). In order to correct for precise annular sizing, only patients with available contrast computed tomography (CT) data for measurements were included (n = 198).

Comprehensive analysis of mortality among patients undergoing TAVR: results of the PARTNER trial.

Background: Patients with severe aortic stenosis (AS) who were deemed too high risk or inoperable for conventional aortic valve replacement (AVR) in the PARTNER (Placement of Aortic Transcatheter Valves) trial were randomized to transcatheter aortic valve replacement (TAVR) versus AVR (PARTNER-A arm) or standard therapy (PARTNER-B arm).

Objectives: This study compared when and how deaths occurred after TAVR versus surgical AVR or standard therapy.

Methods: The PARTNER-A arm included 244 transfemoral (TF) and 104 transapical (TA) TAVR patients, and 351 AVR patients; the PARTNER-B arm included 179 TF-TAVR patients and 179 standard therapy patients.

Challenges and future opportunities for transcatheter aortic valve therapy.

Background: Transcatheter aortic valve replacement (TAVR) is a novel less-invasive therapy for high-risk patients with severe aortic stenosis (AS). Despite the impressive clinical growth of TAVR, there are many challenges as well as future opportunities.

Results: The heart valve team serves as the central vehicle for determining appropriate case selection.

Percutaneous complete repair of failed mitral valve prosthesis: simultaneous closure of mitral paravalvular leaks and transcatheter mitral valve implantation - single-centre experience.

Aims: Structural deterioration and paravalvular leak (PVL) are complications associated with surgically implanted prosthetic valves, historically requiring reoperation. We present our experience of complete transcatheter repair of a degenerated mitral bioprosthesis.

Methods And Results: From March 2012 to October 2012, we reviewed consecutive, high-risk surgical patients (n=5) who underwent transcatheter repair of a failed mitral bioprosthesis with severe paravalvular regurgitation (PVR).

Defining the learning curve for robotic-assisted endoscopic harvesting of the left internal mammary artery.

Objective: Robotic-assisted techniques are continuing to cement their role in coronary surgery, particularly in facilitating the endoscopic harvesting of the left internal mammary artery (LIMA), regardless of how the subsequent bypass grafting is performed. As more surgeons attempt to become trained in robotic-assisted procedures, we sought to better define the learning curve associated with robotic-assisted endoscopic LIMA harvest.

Methods: Between January 2011 and July 2012, a total of 77 patients underwent robotic-assisted minimally invasive direct coronary artery bypass surgery at our institution.

Stratification of outcomes after transcatheter aortic valve replacement according to surgical inoperability for technical versus clinical reasons.

Objectives: The goal of this study was to examine the impact of reasons for surgical inoperability on outcomes in patients undergoing transcatheter aortic valve replacement (TAVR).

Background: Patients with severe aortic stenosis may be deemed inoperable due to technical or clinical reasons. The relative impact of each designation on early and late outcomes after TAVR is unclear.

Transapical aortic valve replacement for severe aortic stenosis: results from the nonrandomized continued access cohort of the PARTNER trial.

Background: Transapical (TA) aortic valve replacement was an integral part of the Placement of Transcatheter Aortic Valves (PARTNER) trial. Enrollment during the randomized trial included 104 transapical (premarket approval TA [PMA-TA]) and 92 surgical aortic valve replacements (SAVR) within the TA cohort. On completion of the trial, enrollment continued in a nonrandomized continued access (NRCA) program.

Determinants and outcomes of acute transcatheter valve-in-valve therapy or embolization: a study of multiple valve implants in the U.S. PARTNER trial (Placement of AoRTic TraNscathetER Valve Trial Edwards SAPIEN Transcatheter Heart Valve).

Objectives: This study investigated the determinants and outcomes of acute insertion of a second transcatheter prosthetic valve (TV) within the first (TV-in-TV) or transcatheter valve embolization (TVE) after transcatheter aortic valve replacement (TAVR).

Background: TAVR failure can occur with both TV-in-TV and TVE as a consequence of TAVR malpositioning. Only case reports and limited series pertaining to these complications have been reported to date.

Aortic annular sizing for transcatheter aortic valve replacement using cross-sectional 3-dimensional transesophageal echocardiography.

Objectives: This study compared cross-sectional three-dimensional (3D) transesophageal echocardiography (TEE) to two-dimensional (2D) TEE as methods for predicting aortic regurgitation after transcatheter aortic valve replacement (TAVR).

Background: Data have shown that TAVR sizing using cross-sectional contrast computed tomography (CT) parameters is superior to 2D-TEE for the prediction of paravalvular aortic regurgitation (AR). Three-dimensional TEE can offer cross-sectional assessment of the aortic annulus but its role for TAVR sizing has been poorly elucidated.