Results from the SOLVE-TAVI trial reported at TCT 2018

September 23, 2018

SAN DIEGO - September 23, 2018 - The first randomized study to compare general versus local anesthesia during transcatheter aortic valve replacement (TAVR) in patients with intermediate to high surgical risk found local anesthesia to be both safe and effective. In addition, the study found that a current generation balloon-expandable valve had similar outcomes to a current generation self-expanding one.

Findings from the SOLVE-TAVI trial were reported today at the 30th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world's premier educational meeting specializing in interventional cardiovascular medicine.

TAVR is increasingly performed in symptomatic patients with severe aortic stenosis at high to intermediate surgical risk. Based on registry data, approximately half of the procedures are performed with general anesthesia and the other half with local anesthesia with possible conscious sedation. The registry data also suggests lower mortality, lower morbidity, shorter ICU and hospital stay, and shorter procedure times with local anesthesia. However, there is a lack of adequately powered randomized trials comparing the two types of anesthesia in TAVR.

In this randomized, prospective, multicenter trial, 447 patients with severe symptomatic aortic stenosis and intermediate to high surgical risk were randomized in a 2 by 2 factorial design to either general versus local anesthesia with conscious sedation and also to the balloon-expandable Sapien 3 valve or the self-expanding CoreValve Evolut R.

The primary endpoint for the valve strategy was all-cause mortality, stroke, moderate or severe prosthetic valve regurgitation, and permanent pacemaker implantation at 30 days. The endpoint occurred in 27.2% of the Evolut R group compared to 26.1% of the Sapien 3 group (Rate difference -1.14; 90% CI: -8.15 - 5.87; Pequivalence=0.02). Examining individual components of the primary endpoint, the rate of relevant valve regurgitation and permanent pacemaker rates were similar with both devices; however, there was a rate of stroke with the balloon-expandable valve.

The primary efficacy endpoint for the anesthesia comparison was powered for equivalence and consisted of the composite of all-cause mortality, stroke, myocardial infarction, infection requiring antibiotic treatment, and acute kidney injury at 30 days. The primary endpoint occurred in 27.0% of the local anesthesia group compared to 25.5% of the general anesthesia group (Rate difference -1.52; 90% CI: -8.47 - 5.42; Pequivalence=0.02). General anesthesia was associated with a higher rate of catecholamine use but did not affect procedure times, valve-related outcome, or clinical outcomes.

"The SOLVE-TAVI trial is the first adequately powered randomized trial comparing local versus general anesthesia in patients with symptomatic aortic valve stenosis undergoing TAVR," said Holger Thiele, MD, Director of the Heart Center Leipzig - University Hospital in Leipzig, Germany. "Results indicate that local anesthesia is both safe and effective and may be a good option for those patients undergoing TAVR with an intermediate or high surgical risk."
-end-
The SOLVE-TAVI trial was funded by German Heart Research Foundation. Dr. Thiele has no conflicts of interest.

About CRF and TCT

The Cardiovascular Research Foundation (CRF) is a nonprofit research and educational organization dedicated to helping doctors improve survival and quality of life for people suffering from heart and vascular disease. For over 25 years, CRF has helped pioneer innovations in interventional cardiology and educated doctors on the latest treatments for heart disease.

Transcatheter Cardiovascular Therapeutics (TCT) is the annual scientific symposium of CRF and the world's premier educational meeting specializing in interventional cardiovascular medicine. Now in its 30th year, TCT features major medical research breakthroughs and gathers leading researchers and clinicians from around the world to present and discuss the latest evidence-based research in the field. TCT also includes interactive training where clinicians can gain vital skills to apply immediately to their practices.

For more information, visit http://www.crf.org and http://www.tctconference.com

Cardiovascular Research Foundation

Related Stroke Articles from Brightsurf:

Stroke alarm clock may streamline and accelerate time-sensitive acute stroke care
An interactive, digital alarm clock may speed emergency stroke care, starting at hospital arrival and through each step of the time-sensitive treatment process.

Stroke patients with COVID-19 have increased inflammation, stroke severity and death
Stroke patients who also have COVID-19 showed increased systemic inflammation, a more serious stroke severity and a much higher rate of death, compared to stroke patients who did not have COVID-19, according a retrospective, observational, cross-sectional study of 60 ischemic stroke patients admitted to UAB Hospital between late March and early May 2020.

'Time is vision' after a stroke
University of Rochester researchers studied stroke patients who experienced vision loss and found that the patients retained some visual abilities immediately after the stroke but these abilities diminished gradually and eventually disappeared permanently after approximately six months.

More stroke awareness, better eating habits may help reduce stroke risk for young adult African-Americans
Young African-Americans are experiencing higher rates of stroke because of health conditions such as high blood pressure, diabetes and obesity, yet their perception of their stroke risk is low.

How to help patients recover after a stroke
The existing approach to brain stimulation for rehabilitation after a stroke does not take into account the diversity of lesions and the individual characteristics of patients' brains.

Kids with headache after stroke might be at risk for another stroke
A new study has found a high incidence of headaches in pediatric stroke survivors and identified a possible association between post-stroke headache and stroke recurrence.

High stroke impact in low- and middle-income countries examined at 11th World Stroke Congress
Less wealthy countries struggle to meet greater need with far fewer resources.

Marijuana use might lead to higher risk of stroke, World Stroke Congress to be told
A five-year study of hospital statistics from the United States shows that the incidence of stroke has risen steadily among marijuana users even though the overall rate of stroke remained constant over the same period.

We need to talk about sexuality after stroke
Stroke survivors and their partners are not adequately supported to deal with changes to their relationships, self-identity, gender roles and intimacy following stroke, according to new research from the University of Sydney.

Standardized stroke protocol can ensure ELVO stroke patients are treated within 60 minutes
A new study shows that developing a standardized stroke protocol of having neurointerventional teams meet suspected emergent large vessel occlusion (ELVO) stroke patients upon their arrival at the hospital achieves a median door-to-recanalization time of less than 60 minutes.

Read More: Stroke News and Stroke Current Events
Brightsurf.com is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.