Live TAVR Cases Pose No Additional Risk for Patients
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Performing transcatheter aortic valve replacement (TAVR) in a live case setting compared with the standard cath lab procedure results in no additional risk or complications for patients, according to results presented May 9, 2013, at the annual meeting of the Society for Cardiovascular Angiography and Interventions (SCAI) in Orlando, FL.
Ron Waksman, MD, of Washington Hospital Center (Washington, DC), presented results from the retrospective VERITAS (Transcatheter Aortic Valve IntERvention-LIve Case TrAnsmiSsion) study of 60 patients from 6 centers in the United States, Switzerland, Germany, Canada, Italy, and the United Kingdom who underwent TAVR during live case or taped transmissions. Of these, 46 were matched with control subjects undergoing TAVR under standard non-transmitted conditions according to:
- Valve type and access strategy: Sapien (Edwards Lifesciences, Irvine, CA) transfemoral, Sapien transapical, or CoreValve (Medtronic, Minneapolis, MN) transfemoral
- STS score
- Date of procedure
- Primary operator
A third group of 18 unmatched live or taped procedures were included in the analysis as registry cases.
Procedure Length Only Difference
Overall, the rate of intraprocedural complications including paravalvular leak, aortic insufficiency, and device failure was similar among the 3 groups. In addition, Valve Academic Research Consortium (VARC) complications such as death, cardiac death, acute kidney injury, unplanned bypass, and end organ failure were similar between cases and controls (table 1).
Table 1. In-hospital Complications: Live vs. Control TAVR Casesa
|
Live |
Control |
Death |
2.2% |
4.3% |
Cardiac Death |
2.2% |
2.2% |
AKI |
4.3% |
2.2% |
Unplanned Bypass |
4.3% |
2.2% |
End Organ Failure |
2.2% |
2.2% |
aP = NS for all
Vascular complications also were similar for all bleeding types, as were additional post-procedural outcomes.
Procedural variables including the number of operators, fluoroscopy time, amount of contrast used, and length of hospital stay also were similar. In fact, the only procedural difference was procedural time, which was nearly 30 minutes longer in the live cases.
Table 2. Procedural Variables: Live vs. Control Cases
|
Live |
Control |
P Value |
No. of Operators |
3.0 ± 1.7 |
2.8 ± 1.4 |
0.538 |
Fluoroscopy Time, min |
20.9 ± 13.0 |
20.8 ± 16.1 |
0.964 |
Contrast Volume, cc |
172.6 ± 102.8 |
157.3 ± 75.4 |
0.435 |
Length of Stay, days |
10.5 ± 5.8 |
10.7 ± 6.4 |
0.919 |
Procedural Time, min |
129 ± 49.7 |
100.8 ± 42.7 |
0.007 |
Support for Educational Value of Live Cases
Live case demonstrations have been performed for more than 30 years but safety issues have persisted, particularly with regard to patient risk and benefit, Dr. Waksman said in a press briefing. Some medical societies discourage and have considered banning live transmission of cardiovascular procedures for these reasons. In 2010, several medical societies, including SCAI, published an expert consensus document stating that data were insufficient to properly assess the risk presented by live dissemination of cardiothoracic surgery and interventions.
Dr. Waksman said the new study adds to the totality of evidence and provides additional justification for allowing live cases.
“We basically think that this [study] is a strong signal to support the continuation of live cases,” Dr. Waksman said. However, he stressed that live cases should only be performed by operators with experience doing them and in the case of TAVR, with ample experience in that technique, although he did not specify how much experience might be necessary. He also added that the importance of having 1 operator focused solely on the patient during the case is paramount.
FDA Issues
When the study was initiated, TAVR was not yet approved in the United States. Now that it is, the US Food and Drug Administration (FDA) still will not allow live cases involving investigational devices to be broadcast.
“I do hope that the FDA . . . will change the policy to allow the use of investigational devices for live case demonstrations,” Dr. Waksman observed. “Because I think there is a value to them when physicians . . . can see it with their own eyes and they can talk with the patient about [not just something they heard] but something they saw.”
Also at the press briefing, Timothy Henry, MD, of the Minneapolis Heart Institute (Minneapolis, MN), said the trial is important because “we live in a time with rapidly changing technology and many of the people who are going to use those technologies didn’t learn them in their training, so there have to be mechanisms for how we adopt new technology and learn how to use it.”
In terms of who should be performing live cases, Dr. Waksman said experience has shown they are not for everyone. “You can be a terrific operator but you need to know how to . . . not be distracted when doing a live case,” he said. “Also, not everyone is a good educator. This is another tool for teaching.”
Dr. Henry added that the next step should be to try to document the specific educational advantages or disadvantages of live cases.
Study Details
The majority of matched live (71.7%) and control (76.1%) cases as well as registry cases (61.1%) involved the Sapien device. Femoral access was used in 88.6% of matched live cases, 91.3% of controls and 72.2% of registry cases.
Source:
Waksman R. Results from the VERITAS study: The impact of live case transmission on patient outcomes during transcatheter aortic valve replacement. Presented at: Society for Cardiovascular Angiography and Interventions Scientific Sessions; May 9, 2013; Orlando, FL.
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L.A. McKeown is a Senior Medical Journalist for TCTMD, the Section Editor of CV Team Forum, and Senior Medical…
Read Full BioDisclosures
- The study was sponsored by a partial grant from the US Food and Drug Administration.
- Drs. Waksman and Henry report no relevant conflicts of interest.
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