Caval-Aortic Access to Allow Transcatheter Aortic Valve Replacement in Otherwise Ineligible Patients
Key result
Transcaval access achieves 100% procedural success and tract closure for prohibitive-risk TAVR candidates.
- n=19
Why the study?
Available transcatheter aortic valves require large introducer sheaths that risk major vascular complications or preclude TAVR in patients lacking access options.
Does TAVR via caval-aortic access allow successful valve replacement in prohibitive-risk patients ineligible for standard access routes?
Key Points
- To describe the first clinical experience and evaluate the procedural safety and tract closure of caval-aortic access for transcatheter aortic valve replacement (TAVR) in patients lacking standard access options.
- Conducted a single-center retrospective review of 19 prohibitive-risk patients (79% women) undergoing TAVR via caval-aortic access between July 2013 and January 2014.
- Evaluated procedural success, tract creation from the inferior vena cava to the abdominal aorta, closure device implantation, and outcomes over 111 (range 39 to 229) days of follow-up.
- Caval-aortic access and tract closure were achieved in all 19 patients, and TAVR was successful in 17 patients, with no deaths attributable to caval-aortic access.
- Modified VARC-2 major vascular complications occurred in 6 patients, with 2 (11%) requiring percutaneous intervention, and 79% (15/19) requiring blood transfusions.
- Immediate post-procedure aorto-caval flow occurred in all patients, and 15 of 16 patients (94%) with imaging after the first week demonstrated complete closure of the tract.
Study Design
Type
Observational (n=19)
Multicenter
No
Structured PICO
Does TAVR via caval-aortic access allow successful valve replacement in prohibitive-risk patients ineligible for standard access routes?
P
Population
19 prohibitive-risk patients (79% women) with severe aortic stenosis who lacked conventional access options, followed for a mean of 111 days after undergoing TAVR via caval-aortic access.
I
Intervention
Transcatheter aortic valve replacement (TAVR) via caval-aortic access (percutaneous entry into the abdominal aorta from the femoral vein through the adjoining inferior vena cava) with subsequent tract closure using nitinol occluder devices.
O
Outcome
Procedural success (caval-aortic access, tract closure, and TAVR success) and 30-day outcomes including modified VARC-2 major vascular complications and bleeding.safety
Caval-aortic access provides a feasible, novel route for TAVR in prohibitive-risk patients lacking traditional access options, though it is associated with significant bleeding risks.
Limitations
- Small number of patients
- Single-center study
- Short-term follow-up
- Off-label use of commercial closure devices not purpose-built for this application
- Small numbers of patients
- Single center
- Short-term follow up
- Off-label use of commercial devices for access and closure
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“This is a seminal study. It challenged conventional wisdom, objecting to the idea of safe passage between the vena cava and the aorta. More important, it is the first of many non-surgical minimally-invasive tissue-crossing, or so-called transmural catheter procedures developed at NIH that can be applied to diverse fields of medicine.”
“anybody we talked to said it couldn't be done, the patients would die immediately, and that it would be heresy basically.”
MMMichael MackCardiac surgeon, The Heart Hospital Baylor
“Although I congratulate the investigators on this very innovative approach—it is ingenious, I must admit—I think that there are other less invasive alternatives when you can't do a transfemoral approach, which is a small minority of patients currently.”
Implication
Caval-aortic access enabled TAVR in most prohibitive-risk patients without access-related mortality; leaves open whether controlled studies will establish safety and broader applicability.
Abstract
OBJECTIVES: This study describes the first use of caval-aortic access and closure to enable transcatheter aortic valve replacement (TAVR) in patients who lacked other access options. Caval-aortic access refers to percutaneous entry into the abdominal aorta from the femoral vein through the adjoining inferior vena cava. BACKGROUND: TAVR is attractive in high-risk or inoperable patients with severe aortic stenosis. Available transcatheter valves require large introducer sheaths, which are a risk for major vascular complications or preclude TAVR altogether. Caval-aortic access has been successful in animals. METHODS: We performed a single-center retrospective review of procedural and 30-day outcomes of prohibitive-risk patients who underwent TAVR via caval-aortic access. RESULTS: Between July 2013 and January 2014, 19 patients underwent TAVR via caval-aortic access; 79% were women. Caval-aortic access and tract closure were successful in all 19 patients; TAVR was successful in 17 patients. Six patients experienced modified VARC-2 major vascular complications, 2 (11%) of whom required intervention. Most (79%) required blood transfusion. There were no deaths attributable to caval-aortic access. Throughout the 111 (range 39 to 229) days of follow up, there were no post-discharge complications related to tract creation or closure. All patients had persistent aorto-caval flow immediately post-procedure. Of the 16 patients who underwent repeat imaging after the first week, 15 (94%) had complete closure of the residual aorto-caval tract. CONCLUSIONS: Percutaneous transcaval venous access to the aorta allows TAVR in otherwise ineligible patients, and may offer a new access strategy for other applications requiring large transcatheter implants.
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Cite This Study
Greenbaum et al. (2014) conducted an observational in Severe symptomatic aortic stenosis (n=19). Caval-aortic access for transcatheter aortic valve replacement (TAVR) was evaluated on Procedural success of caval-aortic access and tract closure. Caval-aortic access and tract closure were successful in 100% of prohibitive-risk patients, enabling successful TAVR in 89% (17 of 19) with no access-related deaths.