Publications by authors named "Whisenant B"
Each reviewed trial of transcatheter tricuspid valve intervention demonstrated clinically meaningful improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ)-defined quality of life and favorable right ventricular remodeling. KCCQ correlates with tricuspid regurgitation (TR) reduction, heart failure hospitalization, and mortality. Change in KCCQ is therefore meaningful both as a measure of quality of life and as a surrogate endpoint of the impact of TV interventions.
View Article and Find Full Text PDFTranscatheter Edge-to-Edge Repair in Patients With Complex Tricuspid Valve Anatomy.
JACC Cardiovasc Interv
December 2024
Article Synopsis
- Untreated severe tricuspid regurgitation (TR) is linked to poor health outcomes, making effective treatment essential.
- The study evaluated the 1-year results of transcatheter edge-to-edge repair (TEER) using the TriClip system in patients with complex tricuspid valve issues, finding significant improvements in patient survival and quality of life.
- Results showed that 81% of patients experienced a reduction in TR to moderate or less after one year, with no major adverse effects noted in the first 30 days post-procedure.
Article Synopsis
- The study focuses on the impact of tricuspid regurgitation (TR) on heart remodeling, comparing outcomes in patients treated with the TriClip device versus those receiving standard medical therapy in a randomized controlled trial.
- Researchers utilized advanced imaging techniques, including cardiac magnetic resonance and 4D-CT, to assess heart changes at baseline, 30 days, and one year follow-ups.
- Results showed that the TriClip significantly reduced TR volume by 70% at 30 days, leading to notable reductions in right ventricular size and area, with these improvements maintained after one year, unlike the control group.
Article Synopsis
- * A successful case is presented involving the use of right internal jugular vein access for the PASCAL mitral valve repair system.
- * This approach offers a safer alternative for patients who cannot undergo traditional surgical procedures due to their high-risk status.
Article Synopsis
- Severe tricuspid regurgitation (TR) significantly impacts patients' health status, affecting their symptoms, physical and social functions, and overall quality of life, but may improve with a procedure called transcatheter tricuspid valve replacement (TTVR).
- The TRISCEND II trial studied 400 patients with severe TR, comparing outcomes of those receiving TTVR combined with optimal medical therapy (OMT) to those receiving OMT alone, using established health status questionnaires.
- Results showed that patients receiving TTVR+OMT experienced significantly greater improvements in health status at every follow-up, with notable differences in scores indicating enhanced quality of life compared to those who only received
Article Synopsis
- A clinical trial was conducted with 400 patients suffering from severe tricuspid regurgitation, comparing outcomes between those who received transcatheter tricuspid-valve replacement alongside medical therapy and those who received medical therapy alone.
- The primary outcome measured included death rates, hospitalizations due to heart failure, and improvements in quality of life and functional capacity, showing a significant advantage for the valve-replacement group.
- After one year, the valve-replacement group demonstrated better overall health outcomes, although there was a higher incidence of severe bleeding compared to the control group.
Article Synopsis
- - The TRILUMINATE Pivotal trial assessed the effects of tricuspid transcatheter edge-to-edge repair (T-TEER) on reducing tricuspid regurgitation (TR), a significant heart condition linked to increased health risks.
- - Involving 572 patients, mostly elderly women with prior heart conditions, the trial found that T-TEER effectively improved quality of life, with nearly half of those treated experiencing significant improvements in heart health assessments.
- - Results showed that while the treatment and control groups had similar rates of survival and heart-related surgeries, those who underwent T-TEER had notably better outcomes in TR severity and overall quality of life.
Article Synopsis
- Historically, women with aortic stenosis have been underdiagnosed and faced worse outcomes compared to men, leading to the need for better treatment recognition and participation in clinical trials.
- The SMART trial aimed to compare the clinical and hemodynamic outcomes of women with small aortic annuli receiving either self-expanding valves (SEVs) or balloon-expandable valves (BEVs) during transcatheter aortic valve replacement.
- In a study of 621 women, no significant differences were observed in the main clinical outcomes between the SEV and BEV groups after 12 months, but SEVs showed a lower rate of bioprosthetic valve dysfunction.
Article Synopsis
- The TRILUMINATE Pivotal trial investigated the impact of tricuspid regurgitation (TR) on end-organ function and the effectiveness of transcatheter edge-to-edge repair (TEER) compared to medical therapy alone in patients with severe TR.
- The study included 572 patients who were split into TEER and control groups, examining how changes in end-organ function correlate with hospitalizations for heart failure (HF) and mortality over 12 months.
- Results showed that while TEER did not significantly differ from medical therapy alone in overall end-organ function improvements, successful TEER did lead to enhanced function in specific patient subgroups, indicating potential benefits in targeted treatment.
Background: Transcatheter edge-to-edge repair (TEER) improved outcomes in patients with heart failure (HF) and severe secondary mitral regurgitation (SMR) compared with guideline-directed medical therapy (GDMT) alone regardless of the severity of baseline left ventricular ejection fraction (LVEF). The study aimed to evaluate the effect of early changes in LVEF after TEER and GDMT alone in patients with HF and severe SMR.
Methods: Within the COAPT trial, we evaluated outcomes according to changes in LVEF from baseline to 30 days.
Article Synopsis
- * Results indicate high procedural success (96.6%) and relatively low mortality rates, with 1-year all-cause mortality being 13.4%. Improvements in patient functional class and quality of life were also observed post-procedure.
- * Over the study period, there was a notable increase in the number of MViV procedures, coupled with reduced procedure times and hospital stays, highlighting advancements in the technique and
Article Synopsis
- The trial tested the ShortCut device, aimed at improving safety and effectiveness before TAVI in patients at risk for coronary artery obstruction.
- In a study with 60 patients, 100% successfully underwent leaflet splitting with minimal procedure time and high safety rates; 98.3% were free from major adverse events like stroke or mortality at discharge.
- The results suggest that using ShortCut for modifying failed bioprosthetic aortic valves is safe and leads to positive outcomes for patients facing coronary obstruction during TAVI.
Article Synopsis
- Surgical mitral valve repairs may not hold up over time, leading to potential repeat surgeries; transcatheter mitral valve-in-ring (MViR) offers a new option for high-risk patients.
- A study analyzed outcomes of MViR involving 820 patients, with most in poor heart function classes and significant mitral regurgitation; initial results showed a 30-day mortality rate of 8.3% and a 1-year rate of 22.4%.
- At one year, MViR patients experienced improvements in heart function and reduced mitral regurgitation, but there were concerns about elevated pressure gradients and a 9.1% reintervention rate, affirming MViR as a viable
Background: Patients with severe aortic stenosis and a small aortic annulus are at risk for impaired valvular hemodynamic performance and associated adverse cardiovascular clinical outcomes after transcatheter aortic-valve replacement (TAVR).
Methods: We randomly assigned patients with symptomatic severe aortic stenosis and an aortic-valve annulus area of 430 mm or less in a 1:1 ratio to undergo TAVR with either a self-expanding supraannular valve or a balloon-expandable valve. The coprimary end points, each assessed through 12 months, were a composite of death, disabling stroke, or rehospitalization for heart failure (tested for noninferiority) and a composite end point measuring bioprosthetic-valve dysfunction (tested for superiority).
Article Synopsis
- Frailty linked to worse outcomes post-transcatheter aortic valve replacement (TAVR) and is often underpinned by sarcopenia, which includes muscle mass, strength, and performance, though their impact on TAVR outcomes hasn't been fully studied.
- In a study of 445 patients with severe aortic stenosis, significant percentages were found to have slow gait (56%), weak grip (59%), and low muscle mass (42%); only slower gait speed showed a clear link to increased mortality after TAVR.
- The research indicates that while overall body fat measurements and sarcopenia criteria influence mortality risk, lower visceral fat and slow gait speed are main factors affecting post-TAVR death rates.
Objective: Although regurgitant mitral valves can be repaired through surgical or transcatheter approaches, contemporary comparative outcomes are limited with the impact of residual and recurrent mitral regurgitation (MR) on clinical outcomes being poorly defined. We hypothesized that moderate (2+) or greater residual or recurrent (RR) MR-regardless of type of repair-predicts worse clinical outcomes.
Methods: Our institutional experience of 660 consecutive patients undergoing mitral valve repair (2015-2021) consisting of 393 surgical mitral valve repair (SMVr) and 267 transcatheter edge-to-edge mitral valve repair (TEER) was studied.
Article Synopsis
- The study investigates the effects of mitral valve-in-valve (ViV) procedures on patient outcomes, particularly focusing on device position and asymmetry.
- Researchers analyzed data from 222 patients in the VIVID Registry and found that residual mitral valve stenosis was common, affecting 50% of participants, whereas left ventricular outflow tract (LVOT) obstruction was rare, occurring in 3.2% of cases.
- Key findings included that greater asymmetry of the transcatheter heart valve was linked to higher rates of residual stenosis, while deeper atrial implantation seemed to reduce the likelihood of LVOT obstruction.
One-Year Outcomes From the CLASP IID Randomized Trial for Degenerative Mitral Regurgitation.
JACC Cardiovasc Interv
October 2023
Background: The CLASP IID (Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical) trial is the first randomized controlled trial comparing the PASCAL system and the MitraClip system in prohibitive risk patients with significant symptomatic degenerative mitral regurgitation (DMR).
Objectives: The study sought to report primary and secondary endpoints and 1-year outcomes for the full cohort of the CLASP IID trial.
Methods: Prohibitive-risk patients with 3+/4+ DMR were randomized 2:1 (PASCAL:MitraClip).
Background: Favorable 6-month outcomes from the CLASP IID Registry (Edwards PASCAL transcatheter valve repair system pivotal clinical trial) demonstrated that mitral valve transcatheter edge-to-edge repair with the PASCAL transcatheter valve repair system is safe and beneficial for treating prohibitive surgical risk degenerative mitral regurgitation (DMR) patients with complex mitral valve anatomy.
Objectives: The authors sought to assess 1-year safety, echocardiographic and clinical outcomes from the CLASP IID Registry.
Methods: Patients with 3+ or 4+ DMR who were at prohibitive surgical risk, had complex mitral valve anatomy based on the MitraClip Instructions for Use, and deemed suitable for treatment with the PASCAL system were enrolled prospectively.
Article Synopsis
- Atrial fibrillation (AF) is prevalent in patients receiving transcatheter aortic valve replacement (TAVR), increasing their risk of bleeding and stroke.
- The WATCH-TAVR trial assessed the safety and effectiveness of simultaneous TAVR and left atrial appendage occlusion (LAAO) with the WATCHMAN device in patients with AF, comparing it to TAVR plus standard medical therapy.
- Results showed that patients undergoing TAVR + LAAO had significantly different rates of antiplatelet and anticoagulant use at two years, highlighting the potential benefits of combining these procedures.
Article Synopsis
- The MITRAL trial is a prospective study that assesses the safety and effectiveness of using transcatheter heart valves to replace failed surgical mitral valves in patients with severe mitral annular calcification.
- The study followed 91 high-risk patients over five years, focusing on three treatment types: mitral valve-in-valve (MViV), valve-in-ring (MViR), and valve-in-mitral annular calcification (ViMAC).
- Results showed that MViV patients had the lowest mortality rate (21.4%) and significant improvements in heart failure symptoms, while MViR and ViMAC groups had higher mortality rates (65.5% and 67.9%, respectively) despite stable heart function
Background: Real-world applicability of the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) randomized controlled trial (RCT) has been debated because of careful patient selection and the contrasting results of the MITRA-FR (Multicentre Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients with Severe Secondary Mitral Regurgitation) RCT.
Objectives: The COAPT-PAS (COAPT Post-Approval Study) was initiated to assess the safety and effectiveness of the MitraClip in patients with secondary mitral regurgitation (SMR).
Methods: COAPT-PAS is a prospective, single-arm, observational study of 5,000 consecutive patients with SMR treated with the MitraClip at 406 U.