Learning from patient and site perspectives to develop better digital health trials: Recommendations from the Clinical Trials Transformation Initiative.

In order to harness the potential of digital health technologies to enhance the quality of clinical research, it is critical to first understand how to engage patients and research sites when planning and conducting digital health trials. To pave the way for the more effective use of digital health technologies in trials, the Clinical Trials Transformation Initiative has developed the first comprehensive, evidence-based set of recommendations for incorporating patient and site perspectives in digital health trials. While directed primarily at sponsors, these recommendations are expected to be valuable for all stakeholders including investigators.

Impact of Transcatheter Aortic Valve Replacement on Risk Profiles of Surgical Aortic Valve Replacement Patients.

Background: The advent of transcatheter aortic valve replacement (TAVR) has changed which patients undergo surgical aortic valve replacement (SAVR). We sought to understand the impact of TAVR on the characteristics of SAVR patients in the United States.

Methods: A cohort of 2959 patients who underwent isolated SAVR at 11 US hospitals that perform both TAVR and SAVR from 2013 through 2017 were grouped by the Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database version (v)2.

Feasibility of Coronary Access and Aortic Valve Reintervention in Low-Risk TAVR Patients.

Objectives: The aim of this study was to evaluate the feasibility of coronary access and aortic valve reintervention in low-risk patients undergoing transcatheter aortic valve replacement (TAVR) with a balloon-expandable transcatheter heart valve (THV).

Background: Younger, low-risk TAVR patients are more likely than older, higher risk patients to require coronary angiography, percutaneous coronary intervention, or aortic valve reintervention, but their THVs may impede coronary access and cause coronary obstruction during TAVR-in-TAVR.

Methods: The LRT (Low Risk TAVR) trial (NCT02628899) enrolled 200 subjects with symptomatic severe aortic stenosis to undergo TAVR using commercially available THVs.

Transcatheter Aortic Valve Replacement in Patients With Symptomatic Severe Aortic Stenosis and Prior External Chest Radiation.

Background/purpose: Surgical aortic valve replacement (SAVR) in patients with symptomatic severe aortic stenosis (AS) and prior chest radiation is associated with poor outcomes in comparison with patients without prior radiation. Our objective was to compare clinical outcomes of patients with and without prior chest radiation undergoing transcatheter aortic valve replacement (TAVR) for symptomatic severe AS.

Methods/materials: Between January 2003 and January 2017, 1150 patients underwent TAVR at our institution.

Role of contractile reserve as a predictor of mortality in low-flow, low-gradient severe aortic stenosis following transcatheter aortic valve replacement.

Objectives: The aim of this study was to determine the prognostic value of contractile reserve (CR) at baseline in patients with low-flow, low-gradient severe aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR).

Background: Patients with severe AS, left ventricular dysfunction, and low transaortic gradient are at high risk for mortality during surgical aortic valve replacement (SAVR). Furthermore, patients without CR have been shown to have perioperative mortality comparable to that of patients treated medically for severe AS.

The impact of in-hospital P2Y12 inhibitor switch in patients with acute coronary syndrome.

Background/purpose: Dual antiplatelet therapy (DAPT) varies after placement of drug-eluting stents (DES) in patients presenting with acute coronary syndromes (ACS). Our aim was to study patient characteristics and predictors of switching, in-hospital or at discharge, from clopidogrel (CLO) to ticagrelor (TIC) or vice versa.

Methods/materials: The study population included patients with ACS who had DES and initially received either CLO or TIC between January 2011 and December 2017.

Clinical Characteristics, Procedural Factors, and Outcomes of Percutaneous Coronary Intervention in Patients With Mechanical and Bioprosthetic Heart Valves.

There is scarcity of evidence regarding antiplatelet and anticoagulant therapy in patients with prosthetic valves undergoing percutaneous coronary intervention (PCI). Our goal was to compare clinical outcomes between patients with mechanical or bioprosthetic valves undergoing PCI. The study population comprised patients with either a bioprosthetic or mechanical heart valve in the aortic and/or mitral position undergoing PCI between January 2003 and July 2017.

Accuracy of predicted orthogonal projection angles for valve deployment during transcatheter aortic valve replacement.

Background: Multi-detector computed tomography (MDCT) predicted orthogonal projection angles have been introduced to guide valve deployment during transcatheter aortic valve replacement (TAVR). Our aim was to investigate the accuracy of MDCT prediction methods versus actual angiographic deployment angles.

Methods: Retrospective analysis of 2 currently used MDCT methods: manual multiplanar reformations (MR) and the semiautomatic optimal angle graph (OAG).

Predicted magnitude of alternate access in the contemporary transcatheter aortic valve replacement era.

Objectives: We aimed to evaluate the true extent of alternate access in a contemporary cohort of transcatheter aortic valve replacement (TAVR) patients.

Background: Appropriate access selection for TAVR impacts clinical outcomes. Despite device miniaturization, some patients remain ineligible for transfemoral arterial access.

Utility of an additive frailty tests index score for mortality risk assessment following transcatheter aortic valve replacement.

Background: The impact of frailty assessment on outcomes in patients undergoing transcatheter aortic valve replacement (TAVR) remains unclear. Our aim was to evaluate the individual effect of each frailty test and the utility of an additive frailty index score on short- and long-term survival following TAVR.

Methods: Retrospective analysis of consecutive TAVR patients for whom a complete set of frailty tests was obtained: algorithm defined grip strength and 5-m walking tests, body mass index <20 kg/m, Katz activities of daily living ≤4/6, serum albumin <3.

Antiplatelet and anticoagulation regimen in patients with mechanical valve undergoing PCI - State-of-the-art review.

A common clinical dilemma regarding treatment of patients with a mechanical valve is the need for concomitant antiplatelet therapy for a variety of reasons, referred to as triple therapy. Triple therapy is when a patient is prescribed aspirin, a P2Y12 antagonist, and an oral anticoagulant. Based on the totality of the available evidence, best practice in 2017 for patients with mechanical valves undergoing percutaneous coronary intervention (PCI) is unclear.

MynxGrip® vascular closure device versus manual compression for hemostasis of percutaneous transfemoral venous access closure: Results from a prospective multicenter randomized study.

Purpose: Evaluate the safety of MynxGrip® for common femoral vein closure.

Methods And Materials: This is a multicenter, randomized, prospective study of 208 patients who were slated to undergo diagnostic/interventional procedures via femoral venous access. Patients were randomized 1:1 to receive venous hemostasis via MynxGrip® (n = 104) or manual compression (n = 104) utilizing 5, 6, and 7 Fr sheaths.

Utility of Invasive Electrophysiology Studies in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation.

Permanent pacemaker (PPM) implantation remains common after transcatheter aortic valve implantation (TAVI). Invasive electrophysiology studies (EPSs) may reduce PPM implantation rates by identifying patients who do not require long-term pacing. At our institution, a new strategy in which patients with equivocal indications for pacing underwent EPSs to determine the need for PPM implantation was adopted.

Temporal trends in patient referral for Transcatheter aortic valve replacement and reasons for exclusion at a high-volume Center in the United States.

Background: Clinical indications for transcatheter aortic valve replacement (TAVR) and elements of the implantation procedure, including delivery system miniaturization and novel access options, have evolved over time. The reasons patients are excluded from TAVR also have changed. The impact of these changes on patient referral for and exclusion from TAVR is unknown.

Contemporary transcatheter aortic valve replacement with third-generation balloon-expandable versus self-expanding devices.

Objectives: To evaluate balloon-expandable and self-expanding third-generation transcatheter aortic valve replacement (TAVR) devices according to patient selection criteria and outcomes.

Background: Two competing third-generation TAVR technologies are currently commercially available in the US. There are no published head-to-head comparisons of the relative performance of these two devices.

Choice of Balloon-Expandable Versus Self-Expanding Transcatheter Aortic Valve Impacts Hemodynamics Differently According to Aortic Annular Size.

We sought to determine whether balloon-expandable valve (BEV) and self-expanding valve (SEV) affect valve hemodynamics differently according to native aortic annulus size. Transcatheter aortic valve replacement can achieve superior prosthetic valve hemodynamics compared with surgical aortic valve replacement, particularly in patients with small aortic annulus. One hundred ninety-three consecutive transcatheter aortic valve replacement patients were grouped into tertiles defined by computed tomography derived aortic annulus systolic perimeter.

Use of an ePTFE-covered nitinol self-expanding stent graft for the treatment off pre-closure device failure during transcatheter aortic valve replacement.

Objectives: Our aim was to describe our experience with the use of an ePTFE-covered nitinol self-expanding stent graft (GORE® VIABAHN® Endoprosthesis, Gore Medical, USA) placed in the common femoral artery for the treatment of suture-mediated pre-closure device failure following transcatheter aortic valve replacement (TAVR).

Background: Access site-related vascular complications (VC) following sheath removal related to pre-closure device failure during TAVR are common and treatment options may vary.

Methods: We performed an observational study on a series of consecutive patients who underwent TAVR between 2013 and 2015.

Impact of baseline mitral regurgitation on short- and long-term outcomes following transcatheter aortic valve replacement.

Background: The prevalence of concomitant significant mitral regurgitation (MR) in patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR) ranges from 2% to 33%. The impact of significant MR on post-TAVR outcomes remains controversial.

Methods: The data from a cohort of patients with symptomatic severe AS undergoing TAVR at out institution were retrospectively analyzed.

The impact of prior stroke on the outcome of patients with severe aortic stenosis undergoing transcatheter aortic valve replacement.

Aims: The present study aimed to evaluate the impact of prior cardiovascular events (CVE) on outcome in patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR).

Methods And Results: Patients with severe AS undergoing TAVR between May 2007 and March 2015 were included and categorized to patients with and without prior stroke, defined as embolic, hemorrhagic stroke and transit ischemic attack. Baseline, procedural characteristics, in-hospital outcomes, and 1-month and 1-year mortality were compared in accordance with the Valve Academic Research Consortium-2 consensus.

The adjunctive use of Angio-Seal in femoral vascular closure following percutaneous transcatheter aortic valve replacement.

Aims: The objective of this study was to describe and evaluate the adjunctive technique of Angio-Seal (AS) use to augment the dual Perclose ProGlide (PP) in achieving haemostasis in patients undergoing transfemoral percutaneous transcatheter aortic valve replacement (TAVR).

Methods And Results: All patients who underwent TAVR from May 2007 to January 2015 via a planned transfemoral percutaneous approach with a dual PP pre-close strategy were retrospectively analysed. This cohort was divided into two groups: dual PP versus dual PP with adjunctive AS (PP+AS) use based on the specific status of intraprocedural haemostasis.

Comparison of clinical outcomes with the utilization of monitored anesthesia care vs. general anesthesia in patients undergoing transcatheter aortic valve replacement.

Background: There is no clear consensus in regard to the optimal anesthesia utilization during transcatheter aortic valve replacement (TAVR). The aim was to compare outcomes of transfemoral (TF) TAVR under monitored anesthesia care (MAC) vs. general anesthesia (GA) and evaluate the rates and causes of intra-procedural MAC failure.

Aortic Regurgitation in Patients Undergoing Transcatheter Aortic Valve Replacement With the Self-Expanding CoreValve Versus the Balloon-Expandable SAPIEN XT Valve.

The incidence of aortic regurgitation (AR) after transcatheter aortic valve replacement (TAVR) in a self-expanding and a balloon-expandable system is controversial. This study aimed to examine the incidence and severity of post-TAVR AR with the CoreValve (CV) versus the Edwards XT Valve (XT). Baseline, procedural, and postprocedural inhospital outcomes were compared.

Impact of Functional Versus Organic Baseline Mitral Regurgitation on Short- and Long-Term Outcomes After Transcatheter Aortic Valve Replacement.

The impact of the specific etiology of mitral regurgitation (MR) on outcomes in the transcatheter aortic valve replacement (TAVR) population is unknown. This study aimed to evaluate the longitudinal changes in functional versus organic MR after TAVR in addition to their impact on survival. Consecutive patients who underwent TAVR from May 2007 to May 2015 who had baseline significant (moderate or greater) MR were included.

Body mass index association with survival in severe aortic stenosis patients undergoing transcatheter aortic valve replacement.

Background: Conflicting results have been reported regarding impact of body mass index (BMI) on outcome of transcatheter aortic valve replacement (TAVR) patients. This study evaluates the impact of BMI on 1 year mortality in patients undergoing TAVR via the transfemoral (TF) access.

Methods: Aortic stenosis (AS) patients undergoing TAVR via a TF access between May 2007 and December 2014 were categorized to 4 groups by BMI: low (<20), normal (20-24.

Prevalence and impact of pulmonary hypertension on patients with aortic stenosis who underwent transcatheter aortic valve replacement.

Limited amount of data suggest that patients with aortic stenosis and pulmonary hypertension (PH) who undergo transcatheter aortic valve replacement (TAVR) experience decrease in PH postprocedure. Inconsistent use of systolic pulmonary artery pressure cut-off values in previous studies limits our ability to draw meaningful conclusions regarding the prognostic role of PH in assessment of TAVR candidates. A total of 415 consecutive patients who underwent TAVR were included in the present study.