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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_3590_Библиотеки_им_академика_М_И_Перельмана
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122 2—AORTIC VALVE INTERVENTIONS
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registry data have reported a 6% rate of stroke or transient ischemic attack (TIA) at 30 days,6
which is similar to that reported in the PARTNER 2 trial (6%) but higher than in the PARTNER
3 trial (,1% stroke at 30 days).
PLANNING
Pre-TAVR CT allows assessment of carotid size, anatomy, calcification, and stenosis. A minimal
common carotid diameter of 7 mm is required, with less than 50% stenosis of the common or
internal carotid artery.
6
Cerebral magnetic resonance angiography is often performed because an occluded contralateral
carotid artery and stenotic or occluded vertebral arteries are contraindications to a transcarotid
approach. Anatomic variants, including bovine arch and prior ipsilateral carotid intervention, are
currently considered contraindications, but this may change depending on individual anatomy and
with increasing experience of the technique.
Fig. 11.9 Exposing the axillary artery.
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Fig. 11.10 Fluoroscopic image of transaxillary transcatheter valve insertion setup just before valve insertion.
TECHNIQUE
Access may be through the right or left common carotid. The left may provide superior alignment. A
pigtail catheter is inserted through the radial or femoral artery, as for a transfemoral approach. During
intervention, cerebral function should be monitored with continuous electroencephalography. A small
incision is made over the left clavicle and blunt dissection performed to expose the common carotid.
The vagus nerve is identified and retracted. Heparin is administered to maintain an ACT of 250 to
300 seconds. Vascular clamps are placed while a 6F sheath is inserted into the common carotid using
the standard Seldinger technique (Fig. 11.11). Crossing of the valve is performed using a straighttipped wire and AL1 and then exchanged for a stiff wire with ventricular curve. The delivery sheath
is then inserted over the stiff wire and advanced into the ascending aorta under fluoroscopic guidance.
The valve is then deployed using the steps described in the transfemoral chapter. After valve deployment, the delivery system is removed from the sheath. Before sheath removal, vascular clamps are
placed to minimize blood loss and the carotid incision is repaired using 6-0 Prolene sutures (Ethicon,
Somerville, NJ) (Fig. 11.12). The pigtail is used for completion angiography to demonstrate carotid
artery patency; intraoperative duplex ultrasound will allow additional assessment.
APPROACH-SPECIFIC SURGICAL PITFALLS AND COMPLICATIONS
Bleeding and stroke are the major concerns after transcarotid intervention; however, registry data
have suggested similar stroke rates to the PARTNER 2 cohort.
access site is possible, and angiography and/or duplex ultrasonography of the great vessels is
recommended after vessel repair to ensure patency.
Transcaval
ADVANTAGES, DISADVANTAGES, AND CONTRAINDICATIONS
Transcaval access for TAVR was first reported in 2013. A prospective study including 100 patients evaluated the safety and feasibility of this approach.
patients who were not candidates for transfemoral, transapical, or transaortic access. Thirty-day
6
Carotid artery stenosis at the
7
Transcaval access enabled TAVR in
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Fig. 11.11 Vascular access in the left common carotid. Here the sheath has been inserted through the skin
before entering the carotid artery to increase stability. (From Mylotte D, Sudre A, Teiger E, et al. Transcarotid
transcatheter aortic valve replacement: feasibility and safety. J Am Coll Cardiol Intv. 2016;11(5):472-480.)
Fig. 11.12 Proximal (A) and distal (B) vascular clamps are used to control access-site bleeding during
surgical closure of the left common carotid arteriotomy (C). (From Mylotte D, Sudre A, Teiger E, et al.
Transcarotid transcatheter aortic valve replacement: feasibility and safety. J Am Coll Cardiol Intv.
2016;11(5):472-480.)
mortality was 8% in a patient population with an STS score of 10%. The main advantage is that
it offers a percutaneous access option for patients who may not have other access options. Other
advantages include similar catheterization laboratory setup as used for traditional transfemoral
TAVR and the ease of recovery because this a truly percutaneous option. The main disadvantage
is the complexity of the procedure, which has a steep learning curve.
Contraindications include a porcelain abdominal aorta without a suitable calcium-free target
window remote from significant branch vessels. Procedural CT planning is key to a successful
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operation. Other contraindications include severe celiac or superior mesenteric artery obstruction
such that covered stent occlusion of the inferior mesenteric arteries would result in bowel ischemia and severe peripheral vascular disease that would prevent delivery of covered stents through
arterial access if required.
PLANNING
The abdominal aorta is assessed on TAVR CT to identify a suitable calcium-free location for
passage from the inferior vena cava (IVC) into the aorta. A detailed description of CT analysis
is outlined by Lederman et al.
8
The calcium-free window should be larger than the outer diameter of the sheath in at least one dimension. In addition to being a sufficient calcium-free window, the site chosen should be away from the bowel and with sufficient distance from the branch
vessels of the aorta and IVC to allow placement of a covered stent if needed due to bleeding.
CT analysis allows guidance of puncture location relative to the radiopaque landmarks such as
the lumbar vertebrae and iliac crests and selection of a working angle for the transcaval crossing
maneuver (Fig. 11.13).
If present, areas of aortic atheroma or chronic dissection should be avoided. However, aortic
ectasia and focal aneurysm are not contraindications.
TECHNIQUE
Venous and arterial access is obtained, ideally with a 6F sheath in the femoral artery and two
venous sheaths (one for temporary pacing). The valve is always delivered through the right
femoral vein. A marker pigtail is placed in the abdominal aorta and IVC and simultaneous contrast injection performed, often under digital subtraction angiography (DSA).
A single-loop gooseneck snare is inserted into the abdominal aorta, distal to the target puncture
site (Fig. 11.14B and C). Heparin is administered to maintain an ACT of 250 to 300 seconds. A
7F short IMA or renal curve guide catheter is placed in the femoral vein, and a braided 0.0350
microcatheter with a stiff coronary wire (e.g., Confienza Pro 12 with amputated tip, or Astato wire
Asahi Abbott, Santa Clara, CA) within a piggyback (Vascular Solutions, Minneapolis, MN)
0.0140 wire converter (Fig. 11.15) is advanced through the guide catheter (see Fig. 11.14D). The
wire is advanced through the wall of the IVC into the aorta under fluoroscopic guidance, using the
loop snare for orientation. The use of biplane fluoroscopy is advantageous. The wire is briefly
electrified to puncture through the IVC and aorta and then snared. The snare and guidewire are
advanced in tandem into the thoracic aorta. The microcatheter is then advanced over the wire into
AB C
Fig. 11.13 CT for transcaval planning. There was severe iliofemoral calcification (A), which precluded trans-
femoral access. For a transcaval approach, there must be a suitable calcium-free zone in the aorta that can
be accessed through the IVC. The vertebral bodies are used to identify the level for puncture (B and C).
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BC
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A
DEF
Fig. 11.14 Overview of transcaval access and closure. (A) Simultaneous aortic and caval angiography. (B
and C) A caval-aortic crossing system composed of a loop snare in the aorta and a guide catheter in the IVC,
viewed in orthogonal projections. (D) The Confienza wire is advanced across the IVC wall (arrow), using the
loop snare as a target. (E and F) After the TAVR has been completed, a nitinol cardiac occluder device (typically ADO 8/10 mm) is positioned across the caval-aortic access tract. (F) A completion aortogram showing
complete occlusion of the access tract by the nitinol occluder.
0.014
guidewire
with
amputated tip
Fig. 11.15 Coaxial crossing system consisting of 0.0140 guidewire within a piggyback wire converter,
within a braided microcatheter, delivered via a guide catheter.
Piggyback
0.035 wire
converter
the aorta and then used to exchange for a stiff 0.0350 wire (usually the Lunderquist, Cook Medical, Bloomington, IN). If the microcatheter will not advance, a 2.0- or 2.5-mm noncompliant
coronary balloon is advanced and inflated across the aortic wall and the microcatheter is then
reinserted.
9
Once the Lunderquist wire is positioned in the thoracic aorta, the introducer sheath (e.g.,
Edwards eSheath) is advanced through the IVC into the descending aorta over the wire. Once
Braided
microcatheter
Guide
catheter
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the sheath is in position, TAVR can be performed as described in the transfemoral chapters. The
femoral temporary pacing wire is best placed after crossing the IVC into the aorta to avoid dislodgement. After successful valve implantation and removal of the introducer sheath, protamine
is administered and the arteriovenous fistula is closed with nitinol closure devices such as the
Amplatzer Duct Occluder or Amplatzer Ventricular Septal Defect Occluder (St. Jude Medical)
(see Fig. 11.14E).
Completion aortogram of the abdominal aorta should be performed (see Fig. 11.14F). This
commonly shows a small residual fistula, which is typically fully occluded on CT at 1 year.
7
APPROACH-SPECIFIC SURGICAL PITFALLS AND COMPLICATIONS
Procedural outcomes in initial series appeared encouraging, with 30-day survival of 92%. Vascular
complications are the major risk, occurring in 13% of cases in early series.
closure device may not seal the iatrogenic fistula and a covered stent should be kept on standby if
needed for bailout. Covered stents were required in up to 20% of cases in early series but are rarely
needed in contemporary practice. Twenty-five percent of patients had a retroperitoneal hematoma
on predischarge CT scan due to an expected small amount of extravasation during closure of the
aortocaval access.
10
Late vascular complications have not been reported.
10
In some cases, the
Conclusions
Patients who require alternative access sites are more complex with a greater prevalence of comorbidities than patients who undergo transfemoral TAVR. Choice of access site is based on institutional and operator experience. The majority of patients are able to undergo successful TAVR
through one of these access sites. Preprocedural planning is key for a successful procedure.
Summary and Take-Home Points
n
Patients who require alternative access sites generally harbor a higher risk profile than
transfemoral TAVR patients.
n
Due to a lack of randomized data, there is no preferred alternative approach, and choice of
access will be dependent on the patient’s anatomy, valve type, surgeon, and institutional
experience.
n
Regardless of access type, developing and following a standardized safety checklist before
starting contributes to a safe and successful procedure.
References
1. Beurtheret S, Karam N, Resseguier N, et al. Femoral versus nonfemoral peripheral access for transcatheter
aortic valve replacement. J Am Coll Cardiol. 2019;74:2728-2739.
2. Fraccaro C, Napodano M, Tarantini G, et al. Expanding the eligibility for transcatheter aortic valve implantation the trans-subclavian retrograde approach using: the III generation CoreValve revalving system.
JACC Cardiovasc Interv. 2009;2:828-833.
3. Dahle TG, Kaneko T, McCabe JM. Outcomes following subclavian and axillary artery access for transcatheter aortic valve replacement: Society of the Thoracic Surgeons/American College of Cardiology TVT
Registry Report. JACC Cardiovasc Interv. 2019;12:662-669.
4. Modine T, Sudre A, Collet F, et al. Transcutaneous aortic valve implantation using the axillary/subclavian
access with patent left internal thoracic artery to left anterior descending artery: feasibility and early
clinical outcomes. J Thorac Cardiovasc Surg. 2012;144:1416-1420.
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5. Schäfer U, Ho Y, Frerker C, et al. Direct percutaneous access technique for transaxillary transcatheter aortic
valve implantation: "The Hamburg Sankt Georg approach." JACC Cardiovasc Interv. 2012;5:477-486.
6. Mylotte D, Sudre A, Teiger E, et al. Transcarotid transcatheter aortic valve replacement: feasibility and
safety. JACC Cardiovasc Interv. 2016;9:472-480.
7. Lederman RJ, Babaliaros VC, Rogers T, et al. The fate of transcaval access tracts: 12-month results of the
Prospective NHLBI Transcaval Transcatheter Aortic Valve Replacement Study. JACC Cardiovasc Interv.
2019;12:448-456.
8. Lederman RJ, Greenbaum AB, Rogers T, Khan JM, Fusari M, Chen MY. Anatomic suitability for
transcaval access based on computed tomography. JACC Cardiovasc Interv. 2017;10:1-10.
9. Lederman RJ, Babaliaros VC, Greenbaum AB. How to perform transcaval access and closure for transcatheter aortic valve implantation. Catheter Cardiovasc Interv. 2015;86:1242-1254.
10. Greenbaum AB, Babaliaros VC, Chen MY, et al. Transcaval access and closure for transcatheter aortic
valve replacement: a prospective investigation. J Am Coll Cardiol. 2017;69:511-521.
CHAPTER 12
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Aortic Valve-in-Valve TAVR
Elad Maor Israel M. Barbash
Transcatheter aortic valve-in-valve (VIV) is an established treatment of degenerative surgical
bioprostheses in patients at high operative risk and was approved by the US Food and Drug
Administration in 2015. The aortic VIV procedure is not currently approved to treat paraprosthetic valve regurgitation or failed/degenerated transcatheter heart valves (THVs), and it is
contraindicated in patients with infective endocarditis.
Indications
Although there are no randomized clinical trials specifically addressing this treatment and the
long-term durability of this treatment remains to be determined, the American Heart Association/
American College of Cardiologists (AHA/ACC) guidelines for the management of patients with
valvular heart disease give it a class IIa indication (level of evidence B) based on nonrandomized
data, including registries and case series.
tional Data and PARTNER II valve-in-valve registry) show that the most common indication for
the procedure was valve stenosis in 30% to 50% of patients followed by pure valve regurgitation in
20% to 30%, and combined valve failure in the remaining patients. Reported 30-day mortality is
up to 8%, stroke rate is up to 3%, and the 1-year survival rate is similar in both registries at 83%
to 88%, respectively.
2,3
1
Data from two large registries (Valve-in-Valve Interna-
AHA Recommendations
IIa B – NR For severely symptomatic patients with bioprosthetic aortic valve stenosis judged
by the heart team to be at high/prohibitive risk of reoperation and in whom
improvement in hemodynamics is anticipated, a transcatheter valve-in-valve
procedure is reasonable.
I C For patients in whom TAVR is being considered, a heart valve team, including
experts in valvular heart disease, cardiac imaging, interventional cardiology, cardiac anesthesia, and cardiac surgery, should collaborate to provide optimal patient
care.
Contraindications
n
Active endocarditis
n
Native prosthesis too small or too large for VIV transcatheter aortic valve replacement
(TAVR)
n
Patient with poor life expectancy/comorbidities that would preclude likely benefit from
VIV TAVR procedure
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Specific Considerations for Valve-in-Valve TAVR
When approaching transcatheter aortic VIV implantation, all the concepts that were described
earlier in this book hold. This includes the building blocks of structural interventions, TAVR
patient selection, and procedural planning. However, when planning an aortic VIV procedure,
two major pitfalls that are unique for this procedure must be considered. First, therapy of small
surgical valves should be approached with caution, as patient prosthesis mismatch (PPM) and
significant residual gradients remain a major challenge, with 28% of patients having a residual
aortic gradient of 20 mmHg or more. Second, when the indication for the procedure is valvular
regurgitation, every effort should be taken to rule out aortic paravalvular leak because VIV implantation is not expected to improve hemodynamics in this case.
In addition to careful patient selection and procedural planning, the VIV procedure itself has
particular operator-associated aspects that are different compared with standard TAVR. On the
one hand, the surgical heart valve provides a perfect circular annulus to allow even expansion of
the transcatheter valve. It is also a suitable anchor for fixation and can partially protect from
complications such as annular rupture or complete atrioventricular (AV) block. On the other
hand, operators must be aware of the critical importance of precise valve positioning and the risk
of coronary obstruction.
Procedural Planning
MECHANISM OF BIOPROSTHESIS FAILURE
Transcatheter aortic VIV is less likely to improve patient outcome in cases of PPM or paravalvular regurgitation. These entities are not uncommon, and every effort should be made to rule them
out early during procedural planning. Transthoracic echocardiography (TTE) is the primary
imaging modality for the assessment of bioprosthetic valves. Comprehensive imaging should
include valve prosthesis components, antegrade velocity, mean gradient, aortic valve effective
orifice area, and evaluation of any transvalvular or paravalvular regurgitation. Transesophageal
echocardiography (TEE) should be strongly considered when paravalvular leak is suspected or
when transthoracic imaging is suboptimal.
Bioprostheses are prone to structural valve degeneration, which can present as either leaflet
calcification, resulting in stenosis, or leaflet flail or tear, resulting in regurgitation. Early degeneration is associated with several risk factors, including young patient age, renal disease, and PPM
of the originally implanted valve. When valve degeneration is suspected, careful echocardiography is mandatory, and four-dimensional computed tomography (4DCT) should also be considered to understand the mechanism of valve degeneration and to confirm the need for reintervention. Although not used routinely in clinical practice, 4DCT is particularly helpful for the
detection of valve thrombosis and pannus formation.
Every effort should be made to distinguish PPM from valve degeneration. PPM is likely
when, despite a relatively small valve area and elevated gradients, leaflet morphology is normal.
When available, careful evaluation of echocardiographic studies at the time of original valve
implantation is necessary, because PPM is associated with abnormal valve hemodynamics at the
time of prosthesis implantation.
plantation should be considered when there is an increase in transvalvular gradients over time
with concomitant decrease in valve area.
5,6
Valve degeneration is likely, and transcatheter aortic VIV im-
4
TRUE INTERNAL DIAMETER OF THE SURGICAL VALVE
The next step after confirming the need for VIV implantation is to understand the true internal diameter (ID) of the aortic bioprosthesis. Valve size labeling is not standardized and
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Fig. 12.1 Schematic diagram of stented bioprosthesis. Valve labeling may refer to internal diameter, outer
diameter, or external diameter, as shown in the figure. Also, as the figure shows, valve height and aortic
protrusion might not refer to the same measurement. (© 2018 Mayo.)
varies between different manufacturers. Valve labeling may refer to ID, outer diameter, or
external diameter (Fig. 12.1). Different bioprostheses with the same label size can have dif-
ferent IDs and external sewing ring diameters. The stent labeled ID is a measurement of the
stent frame without leaflets. Leaflet type and mounting inside or outside the stent frame
influence the true ID. The exact ID of the bioprosthesis is the critical information needed
for VIV implantation and can easily be obtained from the VIV application.
is free and includes design and sizing information for multiple types of surgical valves, as well
as fluoroscopic images of all surgical valves. Examples of several commonly used surgical
valves are shown in Figs. 12.2 and 12.5.
SELECTION OF TRANSCATHETER VALVE TYPE AND SIZE
Residual stenosis (,20 mmHg) is not uncommon after aortic VIV procedures, and is reported
among 28% of patients. Larger surgical valve size, supra-annular THV type, and higher trans-
catheter implantation depth can all reduce postprocedural gradients. Therefore proper selec-
tion of transcatheter valve type and size is critical. There are two main transcatheter valve
designs: intra-annular valves, where the leaflets are built at the level of the annulus; and supra-
annular valves, where the leaflets are above the annulus. Commercially, SAPIEN 3 (Edwards
Lifesciences), Evolut R (Medtronic), and PORTICO (St. Jude Medical) are the most com-
monly available valves, with the first being an intra-annular valve, whereas the other two are
supra-annular.
7
The application
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