Findings Published From Feasibility Study of TAVR in Low-Risk Patients
August 31, 2018—Online in Journal of the American College of Cardiology (JACC), Ron Waksman, MD, et al published findings from a prospective multicenter trial assessing the safety and feasibility of transcatheter aortic valve replacement (TAVR) with commercially available devices in low-risk patients with symptomatic severe aortic stenosis.
In JACC, the investigators concluded that TAVR is safe in low-risk patients with symptomatic severe aortic stenosis, low procedural complication rates, short hospital length of stay, zero mortality, and zero disabling stroke at 30 days. Subclinical leaflet thrombosis was observed in a minority of TAVR patients at 30 days.
The Low-Risk TAVR trial was a prospective, multicenter, unblinded, comparison to historical controls from the Society of Thoracic Surgeons (STS) database. The primary endpoint was all-cause mortality at 30 days.
As summarized in JACC, the investigators enrolled 200 low-risk patients with symptomatic severe aortic stenosis at 11 centers to undergo TAVR. The investigators compared outcomes with an inverse probability weighting adjusted control cohort of 719 patients who underwent surgical aortic valve replacement (SAVR) at the same institutions using the STS database. The investigators reported the following:
| TAVR | SAVR | |
| n = 200 | n = 719 | |
| 30-Day All-Cause Mortality | 0% | 1.7% |
| In-Hospital Stroke | 0% | 0.6% |
| Permanent Pacemaker Implantation | 5% | 4.5% |
Additionally, in the TAVR group, there were low rates of new-onset atrial fibrillation (3%) and length of stay (2.0 ± 1.1 days). One (0.5%) TAVR patient had greater-than mild paravalvular leak and 14% of patients had evidence of subclinical leaflet thrombosis at 30 days in the TAVR group, reported the investigators in JACC.
In November 2015, MedStar Heart & Vascular Institute at MedStar Washington Hospital Center in Washington, DC, announced that the FDA granted the institution the first investigational device exemption to evaluate the safety and effectiveness of TAVR in patients with severe aortic stenosis who are at low risk for surgical mortality, with Dr. Waksman of MedStar as lead investigator.
Dr. Waksman presented an interim analysis of the study at CRT 2018, the Cardiovascular Research Technologies conference held March 3–6 in Washington, DC.
advertisement
Featured Video
Evolut™ PRO System
Sponsored by Medtronic
Related Articles
An Update on Transcatheter Tricuspid Valve Therapies
A review of the current state of transcatheter tricuspid valve therapies and where they are headed next.
By Antonio Mangieri, MD; Giorgios Tzanis, MD; and Azeem Latib, MD
Aortic Valve-in-Valve Hemodynamics
Considerations for this minimally invasive approach to treating patients with failed bioprostheses.
By Danny Dvir, MD
Top 5 Articles From August 2018
Transcatheter Chordal Repair for Degenerative Mitral Regurgitation
Current and future directions of therapeutic options for patients with degenerative MR.
By Andrea Colli, MD, PhD; Alessandro Fiocco, MD; Nicola Pradegan, MD; Matteo Nadali, MD; Laura Besola, MD; Eleonora Bizzotto, MD; and Gino Gerosa, MD
An Update on Transcatheter Tricuspid Valve Therapies
A review of the current state of transcatheter tricuspid valve therapies and where they are headed next.
By Antonio Mangieri, MD; Giorgios Tzanis, MD; and Azeem Latib, MD
Transcatheter Leaflet Repair for Functional MR
What will randomized trials mean for the future of mitral intervention?
By Ted Feldman, MD, FESC, FACC, MSCAI; Paul Sorajja, MD, FACC, FSCAI; Paul Grayburn, MD, FACC, FSCAI; and Francesco Maisano, MD
Clinical Data for Stenting High-Risk Patients Requiring Short DAPT
Discussing the clinical benefits of the COBRA PzF NanoCoated Coronary Stent (NCS).
With Gilles Montalescot, MD, PhD; Axel de Labriolle, MD, PhD; and Donald Cutlip, MD
State of the Art of Transcatheter Mitral Annuloplasty: Present and Future
An appraisal of current and upcoming devices for direct and indirect transcatheter annuloplasty procedures.
By Shingo Kuwata, MD, PhD; and Francesco Maisano, MD
Top 5 from EVToday's Current Issue
Post-PTA Dissection: Clinical Impact, Identification, and Repair
Discussion on the prevalence of post-angioplasty dissections, guidelines for their identification, and the use of the Tack Endovascular System® for repair.
With Ehrin J. Armstrong, MD, MSc; Nicolas W. Shammas, MD, MS, EJD; and Christian Wissgott, MD
Roundtable Discussion: SFA Vessel Prep in the Real World
A discussion on the current role of vessel preparation, when to use it and when not to use it, device selection, and data related to cost-effectiveness and algorithm creation.
By Moderator: Marianne Brodmann, MD
Panel: Ehrin J. Armstrong, MD; Lawrence A. Garcia, MD; Gunnar Tepe, MD; Jos C. van den Berg, MD, PhD; and Thomas Zeller, MD
Use Caution in Comparing SFA Trial Data
Not all superficial femoral artery device trials are created equal—in fact, none are.
By William A. Gray, MD; and Mario Landini
Roundtable Discussion: Surveying the Landscape: SFA Drug Delivery Trial Designs and Data
Experts discuss key elements of SFA trials, whether a global algorithmic approach to treating SFA disease is possible, and the limitations of cross-trial platform comparisons.
