Outcomes After Transcatheter Aortic Valve Replacement Among Medicare Beneficiaries: The Impact of Frailty and Social Vulnerability.

Background: Transcatheter aortic valve replacement (TAVR) is an accepted alternative to surgery in many patients with severe aortic stenosis. Clinical trials have evaluated early and late outcomes in selected TAVR patients, but predictors of late mortality have been less well studied in a broadly inclusive, national patient cohort undergoing TAVR. We sought to characterize 5-year outcomes after TAVR in Medicare beneficiaries and to evaluate the incremental predictive value of demographics, comorbidities, procedural factors, frailty, and social vulnerability in determining late mortality risk.

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.

The impact of perioperative stroke and delirium on outcomes after surgical aortic valve replacement.

Objective: The effects of stroke and delirium on postdischarge cognition and patient-centered health outcomes after surgical aortic valve replacement (SAVR) are not well characterized. Here, we assess the impact of postoperative stroke and delirium on these health outcomes in SAVR patients at 90 days.

Methods: Patients (N = 383) undergoing SAVR (41% received concomitant coronary artery bypass graft) enrolled in a randomized trial of embolic protection devices underwent serial neurologic and delirium evaluations at postoperative days 1, 3, and 7 and magnetic resonance imaging at day 7.

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.

Impact of Aortic Atherosclerosis Burden on Outcomes of Surgical Aortic Valve Replacement.

Background: Epiaortic ultrasound detects and localizes ascending aortic atherosclerosis. In this analysis we investigated the association between epiaortic ultrasound-based atheroma grade during surgical aortic valve replacement (SAVR) and perioperative adverse outcomes.

Methods: SAVR patients in a randomized trial of 2 embolic protection devices underwent a protocol-defined 5-view epiaortic ultrasound read at a core laboratory.

Effect of Cerebral Embolic Protection Devices on CNS Infarction in Surgical Aortic Valve Replacement: A Randomized Clinical Trial.

Importance: Stroke is a major complication of surgical aortic valve replacement (SAVR).

Objective: To determine the efficacy and adverse effects of cerebral embolic protection devices in reducing ischemic central nervous system (CNS) injury during SAVR.

Design, Setting, And Participants: A randomized clinical trial of patients with calcific aortic stenosis undergoing SAVR at 18 North American centers between March 2015 and July 2016.

Midterm, multicenter clinical and hemodynamic results for the Trifecta aortic pericardial valve.

Objective: To evaluate the midterm hemodynamic performance and clinical outcomes of the Trifecta aortic pericardial valve.

Methods: In a multicenter, prospective, nonrandomized, follow-up study, 710 patients underwent surgical implantation of a pericardial stented aortic prosthesis (Trifecta valve; St Jude Medical, St. Paul, Minn).

Is Surgical Intervention the Optimal Therapy for the Treatment of Aortic Valve Stenosis for Patients With Intermediate Society of Thoracic Surgeons Risk Score?

Background: Patients at intermediate risk (IR) according to The Society of Thoracic Surgeons risk score are today frequently oriented toward the transfemoral aortic valve replacement (TAVR) option. Our goal was to evaluate the best treatment strategies for IR patients with severe aortic stenosis.

Methods: Of a consecutive series of 1,144 surgical aortic valve replacements (AVRs) performed in our institution between 2008 and 2014, we reviewed the early and late outcomes of two different groups: a low-risk (LR) group of 470 patients, and an IR group of 620.

Rate Control versus Rhythm Control for Atrial Fibrillation after Cardiac Surgery.

Background: Atrial fibrillation after cardiac surgery is associated with increased rates of death, complications, and hospitalizations. In patients with postoperative atrial fibrillation who are in stable condition, the best initial treatment strategy--heart-rate control or rhythm control--remains controversial.

Methods: Patients with new-onset postoperative atrial fibrillation were randomly assigned to undergo either rate control or rhythm control.

The effect of postoperative medical treatment on left ventricular mass regression after aortic valve replacement.

Objective: The study objective was to analyze factors associated with left ventricular mass regression in patients undergoing aortic valve replacement with a newer bioprosthesis, the Trifecta valve pericardial bioprosthesis (St Jude Medical Inc, St Paul, Minn).

Methods: A total of 444 patients underwent aortic valve replacement with the Trifecta bioprosthesis from 2007 to 2009 at 6 US institutions. The clinical and echocardiographic data of 200 of these patients who had left ventricular hypertrophy and follow-up studies 1 year postoperatively were reviewed and compared to analyze factors affecting left ventricular mass regression.

Suture technique does not affect hemodynamic performance of the small supra-annular Trifecta bioprosthesis.

Objective: The study objective was to evaluate whether aortic valve replacement with the Trifecta valve (St Jude Medical Inc, St Paul, Minn) using simple sutures produces better hemodynamic performance than valve replacement with noneverting pledget-reinforced sutures.

Methods: We analyzed prospectively acquired 1-year hemodynamic data of patients with small aortic annulus sizes who were enrolled in a multicenter trial of the Trifecta aortic valve bioprosthesis and underwent aortic valve replacement with a 19-mm or 21-mm bioprosthesis between August 2007 and November 2009. We compared preoperative clinical information and 1-year postoperative hemodynamic data for noneverting pledget-reinforced sutures (group 1) versus everting mattress sutures or simple sutures (group 2).

The St Jude Medical Trifecta aortic pericardial valve: results from a global, multicenter, prospective clinical study.

Background: The St Jude Medical Inc (St Paul, Minn) Trifecta valve is a novel aortic biological prosthesis that incorporates several design features, including a true supra-annular sewing cuff, a stent design that maximizes valve hemodynamics while minimizing leaflet stresses, and an ethanol-based anticalcification technology. This study establishes the safety and early clinical and hemodynamic performance of the Trifecta valve.

Methods: The Trifecta bioprosthesis was implanted in 1014 eligible patients between 2007 and 2009 at 31 centers.

Reproducibility of left atrial ablation with high-intensity focused ultrasound energy in a calf model.

Objective: Achieving transmural tissue ablation might be necessary for successful treatment of atrial fibrillation. The purpose of this study was to evaluate the reproducibility of transmural left atrial ablation using a high-intensity focused ultrasound energy system in a calf model.

Methods: Nine heparinized bovines underwent a beating-heart left atrial ablation with a single application of the high-intensity focused ultrasound device.

Off-pump epicardial high intensity focused ultrasound ablation of atrial fibrillation in patients undergoing structural heart repair.

There are a number of different devices and approaches to the management of atrial fibrillation (AF) coexisting in patients undergoing structural heart repair. Based on the widespread applicability and safety of an epicardial approach, the uniqueness of the energy source and the lesion set obtainable, we began a systematic program in 2005 utilizing high intensity focused ultrasound (HIFU). Our approach has been standardized in the operative and postoperative phases.

Epicardial ultrasonic ablation of atrial fibrillation during concomitant cardiac surgery is a valid option in patients with ischemic heart disease.

Background: Surgical therapy of atrial fibrillation concomitant to coronary bypass grafting using epicardial Ultrasound technology was assessed after a minimum 6-month follow-up.

Methods And Results: A cohort of 98 consecutive patients with a mean age of 72+/-7.58 years and a primary diagnosis of ischemic heart disease had surgery for structural disease.

Ultrasonic cardiac ablation for atrial fibrillation during concomitant cardiac surgery: long-term clinical outcomes.

Background: Therapeutic ultrasound as an alternative to the maze procedure was evaluated in this large US experience. Safety and efficacy were assessed at 6-, 12-, and 18-month visits with systematic 24-hour Holter monitoring.

Methods: From February 2005 to February 2007, 220 patients were prospectively enrolled in a single center study, and among them 129 patients with concomitant cardiac surgery and at least 6-month follow-up were reviewed.