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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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216 3—MITRAL VALVE INTERVENTIONS
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the stent frame in the left ventricle, as they tend to migrate or embolize to the left atrium. Flaring
helps decrease such risk. Commonly used amounts of additional contrast are 2 mL to the 23-mm
SAPIEN 3 valve, 3 mL for the 26 mm, and 4 mL for the 29-mm SAPIEN 3 valve.
Once orientation is verified, the SAPIEN 3 valve is introduced into the eSheath and then
the inferior vena cava, with the tip of the delivery system at the right atrium. The eSheath may
need to be retracted to expose the SAPIEN 3 for alignment. This is necessary because the
working length from the venous side is shorter than when performing this step in the thoracic
aorta for TAVR procedures. Valve alignment over the balloon delivery system is performed as
is done for TAVR in the anteroposterior (AP) projection with cranial angulation if needed to
remove the parallax to visualize the stent frame in the long axis. Then, the delivery system may
be rotated counterclockwise 90 to 180 degrees over its own axis to have the Edwards logo facing the operator or facing down (Fig. 18.8). This facilitates flexing the Edwards system toward
the mitral valve in the opposite direction, as is done for TAVR. The system is then advanced
slowly across the interatrial septum and the mitral valve. If the system cannot be advanced
across the mitral valve because the pusher cannot cross the interatrial septum, the pusher can
be unlocked and the balloon delivery system advanced across the mitral valve independent of
the pusher (i.e., telescoping).
Once the system is across the mitral valve, the flex tube/pusher is unlocked and pulled back
until it meets the most distal of the three radio-opaque markers in the delivery system
(Fig. 18.9A). Pulling more than that may result in the flex tube pulled back to the right atrium,
which would not be helpful and may decrease operator’s ability to push and advance the system
during deployment. The fluoroscopy C-arm is then positioned in the predetermined deployment angle. If the landing zone of the ventricular edge of the stent has been predetermined by
CT analysis (i.e., by finding a piece of calcium or other radio-opaque marker), the ventricular
edge of the stent is placed at such a landing zone (see Fig. 18.9A). In general, 80% of the frame
in the ventricle and 20% in the left atrium is a good position that provides a margin of safety
should the device migrate a few millimeters toward the left atrium. However, in patients at high
AB
Fig. 18.8 Position of the Edwards delivery system during valve alignment and delivery. (A) Valve alignment
over the balloon delivery system is performed as is done for TAVR with the Edwards logo facing up (yellow ar-
row). (B) Then the delivery system may be rotated counterclockwise 90 to 180 degrees over its own axis to
have the Edwards logo facing the operator or facing down (yellow arrow) to facilitate flexing the Edwards system
toward the mitral valve.
18—MITRAL VALVE-IN-MAC 217
AB
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Fig. 18.9 Valve positioning and deployment. (A) Once the system is across the mitral valve, the flex tube/
pusher is unlocked and pulled back until it meets the most distal of the three radio-opaque markers in the
delivery system (white arrow). (B) A piece of calcium in the inferoposterior aspect of the mitral annulus was
identified as the transcatheter heart valves (THV) landing zone by cardiac computed tomography (CT) analysis
(yellow arrow). (C) A SAPIEN 3 valve successfully deployed at the landing zone (arrow).
risk of LVOT obstruction, a more atrial position (i.e., 60% ventricular and 40% atrial) may be
desired to help reduce this risk. The valve is then deployed slowly under rapid pacing (140 to
160 beats per minute [bpm]) while holding ventilation (see Fig. 18.9B). A slow deployment
facilitates adjustment of the position if needed.
Once deployed, the balloon is deflated and pulled back into the left atrium. The performance of
the mitral prosthesis is evaluated by TEE, and the LVOT gradient can be immediately evaluated
by simultaneous left ventricle and aortic pressures ongoing throughout the procedure.
Procedural Steps
Figs. 18.10 through 18.17 show the steps necessary when completing this procedure.
Clinical Outcomes and Complications
In the initial experience of the TMVR in the MAC Global Registry, 30-day mortality was 25%.11
Slightly lower mortality has been found in subsequent series.
The most important complication of ViMAC procedures is LVOT obstruction. It occurred
in 11% of the patients in TMVR in MAC Global Registry and was the strongest independent
predictor of 30-day and 1-year mortality.
11
Percutaneous alcohol septal ablation has been used as
a bailout strategy to reduce the LVOT gradient when severe LVOT obstruction with hemodynamic compromise occurs after transseptal TMVR.
16,17
tion is preferred, as this is key to improving outcomes. Operators can identify patients at high risk
of LVOT obstruction by evaluating the neo-LVOT area on cardiac CT analysis. The threshold
LVOT area at which obstruction occurs is not well understood at this time. One study found that
a neo-LVOT area of 189 mm
cardiac catheterization.
2
or smaller on cardiac CT was associated with LVOT gradients by
18
Patients with neo-LVOT areas of 189 mm2 or smaller may benefit from
an LVOT obstruction risk-reduction strategy.
9,10
However, prevention of LVOT obstruc-
218 3—MITRAL VALVE INTERVENTIONS
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Fig. 18.10 Transseptal puncture is performed under
transesophageal echocardiography (TEE) guidance.
Fig. 18.11 An Inoue wire is placed in the left atrium
and used to advance an Inoue dilator across the intraatrial septum.
Fig. 18.12 A 9F Dexterity steerable introducer is then
inserted into the left atrium and used to advance a
pigtail catheter across the mitral valve and into the left
ventricular apex.
18—MITRAL VALVE-IN-MAC 219
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Fig. 18.13 A small preshaped stiff wire (e.g., Safari wire)
is then positioned in the left ventricular apex. This is
used to advance a 12-mm balloon across the intraatrial
septum. This is inflated for 30 seconds and then “flossed”
across the atrial septum and across the mitral valve to ensure a smooth path for the transcatheter valve and delivery
system.
Fig. 18.14 The delivery catheter is advanced over
the Safari wire. In order for the delivery catheter and
valve to cross the atrial septostomy, counterclockwise
rotation with no or minimal catheter flexion may be required. Once across, the valve is positioned using the
pre-determined valve deployment angle using CT, which
is usually a right anterior oblique orthogonal fluoroscopic
view, as well as transesophageal echocardiography
(TEE) guidance. The ventricular edge of the THV stent
frame is placed in landing zone as previously described
in this chapter.
Fig. 18.15 The SAPIEN valve is placed in the landing zone,
approximately 80% ventricular and 20% atrial in relation to
mitral annulus. Valve expansion should be completed
steadily over a 5- to 8-second period under direct fluoroscopy until minor valve stent flaring is achieved on the ventricular side; this may require 2 to 4 ml of additional volume beyond
full deployment, depending on the prosthesis size.
220 3—MITRAL VALVE INTERVENTIONS
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Fig. 18.16 After valve deployment, evaluation with transesophageal echocardiography (TEE) is performed
to assess valve position, ensure prosthesis stability, and assess for prosthetic and paraprosthetic regurgitation. The left ventricular outflow tract size and gradient can also be measured. TEE also provides an assessment
of overall systolic function and rules out pericardial effusion.
One option to reduce LVOT obstruction risk is to surgically remove the anterior leaflet during
open transatrial TMVR.
option. Percutaneous laceration of the anterior leaflet is another alternative,
15
However, not all patients are good candidates for such an invasive
19
but the procedure
is challenging and may not always be effective. Preemptive alcohol septal ablation performed 3 to
4 weeks before the procedure has been successfully used to reduce the risk of LVOT obstruction
in patients with adequate anatomy by increasing the neo-LVOT space as a result of basal septal
thinning (Fig. 18.17).
reproducible results that facilitate safe transseptal TMVR in selected cases.
9
Although this option is not free of risk, it has been found to provide
21
An important caveat is that patients require two separate procedures: one for alcohol ablation
and the second one for TMVR weeks later. Not all patients are stable enough to wait this period.
In addition, not all patients have favorable anatomy.
Summary and Take-Home Points
n
TMVR mitral ViMAC with the compassionate use of balloon-expandable aortic THVs is
emerging as an alternative for patients at high surgical risk.
n
The transatrial delivery access route offers the opportunity of removing the anterior mitral
leaflet to reduce LVOT obstruction risk and placing sutures to prevent embolization. However, not all patients are candidates for such an invasive approach.
n
The transseptal delivery access is the least invasive option but may be associated with sig-
nificant LVOT obstruction.
n
Cardiac CT analysis helps identify patients at risk of developing TMVR-induced LVOT
obstruction. Risk reduction strategies such as alcohol ablation or percutaneous laceration of
the anterior mitral leaflet may facilitate successful transseptal ViMAC in those patients.
n
The data are limited, and ViMAC remains an off-label procedure at this time.
18—MITRAL VALVE-IN-MAC 221
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A
C
Fig. 18.17 Neo-LVOT area before and after alcohol septal ablation. (A) Baseline measurement of the left
ventricular outflow (LVOT) tract area in short-axis (white circle) view using 3Mensio Structural Heart Mitral
Workflow version 8.1. (B) Measurement of the remaining LVOT area in short-axis view after placement of a
virtual transcatheter heart valve (pink). The remaining space in the LVOT is the neo-LVOT (white). (C) Measure-
ment of the LVOT area 4 weeks after alcohol septal ablation (white circle). (D) Neo-LVOT area using the same
size virtual valve (pink) 4 weeks after alcohol septal ablation (white).
B
D
References
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mortality: the Framingham Heart Study. Circulation. 2003;107:1492-1496.
2. Casarotto D, Bortolotti U, Thiene G, Gallucci V, Cevese PG. [Rupture of the posterior wall of the left
ventricule after replacement of the mitral valve: a description of 8 cases (author’s transl)]. G Ital Cardiol.
1977;7:387-394.
3. Carrel TWP, Reineke S, Simon R, Eberle B, Windecker S. Worldwide first surgical implantation of a
trnascatheter valves stent in mitral position. Cardiovasc Med. 2012;15:202-205.
4. Hasan R, Mahadevan VS, Schneider H, Clarke B. First in human transapical implantation of an inverted
transcatheter aortic valve prosthesis to treat native mitral valve stenosis. Circulation. 2013;128:e74-e76.
5. Guerrero M, Greenbaum A, O’Neill W. First in human percutaneous implantation of a balloon expandable
transcatheter heart valve in a severely stenosed native mitral valve. Catheter Cardiovasc Interv.
2014;83:E287-E291.
6. Lim ZY, Boix R, Prendergast B, et al. First reported case of transcatheter mitral valve implantation in
mitral annular calcification with a fully repositionable and self-expanding valve. Circ Cardiovasc Interv.
2015;8:e003031. DOI: 10.1161/CIRCINTERVENTIONS.115.003031
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7. Mellert F, Sinning JM, Werner N, et al. First-in-man transapical mitral valve replacement using the
Direct Flow Medical(R) aortic valve prosthesis. Eur Heart J. 2015;36:2119.
8. Sorajja P, Gossl M, Bae R, et al. Severe mitral annular calcification: first experience with transcatheter
therapy using a dedicated mitral prosthesis. JACC Cardiovasc Interv. 2017;10:1178-1179.
9. Guerrero EA. 30-day outcomes of transcatheter mitral valve replacement in patient with severe mitral
valve disease secondary to mitral annular calcification of failed annuloplasty rings. Data presented as late
breaking clinical trial at Transcatheter Cardiovascular Therapeutics Scientific Symposium, 2017. https://
wwwtctmdcom/slide/30-day-outcomes-transcatheter-mv-replacement-patients-severe-mitral-valve-diseasesecondary.
10. Guerrero M. 30-day outcomes of transcatheter mitral valve replacement in native mitral valve disease
with severe mitral annular calcification in the United States: data from the STS/ACC TVT Registry.
Data presented at EuroPCR 2018. https://wwwtctmdcom/slide/30-day-outcomes-transcatheter-mitral-
valve-replacement-native-mitral-valve-disease-severe.
11. Guerrero M, Urena M, Himbert D, et al. 1-year outcomes of transcatheter mitral valve replacement in
patients with severe mitral annular calcification. J Am Coll Cardiol. 2018;71:1841-1853.
12. Narang A, Guerrero M, Feldman T, Pursnani A. Computed tomography assessment for transcatheter
mitral valve interventions. J Cardiovasc Surg. 2016;57:360-371.
13. Blanke P, Naoum C, Dvir D, et al. Predicting LVOT obstruction in transcatheter mitral valve implantation:
concept of the neo-LVOT. JACC Cardiovasc Imaging. 2017;10:482-485.
14. Wang DD, Eng M, Greenbaum A, et al. Predicting LVOT obstruction after TMVR. JACC Cardiovasc
Imaging. 2016;9:1349-1352.
15. Russell HM, Guerrero ME, Salinger MH, et al. Open atrial transcatheter mitral valve replacement in
patients with mitral annular calcification. J Am Coll Cardiol. 2018;72:1437-1448.
16. Guerrero M, Wang DD, O’Neill W. Percutaneous alcohol septal ablation to acutely reduce left ventricular outflow tract obstruction induced by transcatheter mitral valve replacement. Catheter Cardiovasc
Interv 2016;88(6):E191-E197.
17. Guerrero M, Wang DD, Himbert D, et al. Short-term results of alcohol septal ablation as a bail-out
strategy to treat severe left ventricular outflow tract obstruction after transcatheter mitral valve replacement
in patients with severe mitral annular calcification. Catheter Cardiovasc Interv 2017;90(7):1220-1226.
18. Wang DD, Eng MH, Greenbaum AB, et al. Validating a prediction modeling tool for left ventricular
outflow tract (LVOT) obstruction after transcatheter mitral valve replacement (TMVR). Catheter Cardiovasc
Interv. 2018 Aug 1;92(2):379-387.
19. Babaliaros VC, Greenbaum AB, Khan JM, et al. Intentional percutaneous laceration of the anterior mitral
leaflet to prevent outflow obstruction during transcatheter mitral valve replacement: first-in-human
experience. JACC Cardiovasc Interv. 2017;10:798-809.
20. Guerrero M, Wang D, Pursnani A, et al. A cardiac computed tomography–based score to categorize
mitral annular calcification severity and predict valve embolization: insights from the TMVR in MAC
Global Registry. JACC Cardiovasc Imaging 2020 May 13. pii: S1936-878X(20)30308-30309.
21. Wang DD, Guerrero M, Eng MH, et al. Alcohol septal ablation to prevent left ventricular outflow tract
obstruction during transcatheter mitral valve replacement: dirst-in-man study. JACC Cardiovasc Interv
2019 Jul 8;12(13):1268-1279.
SECTION 4
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Atrial Septal Interventions
223
CHAPTER 19
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Atrial Septal Defect, Patent Foramen
Ovale, and Atrial Septostomy
Guy S. Reeder Allison K. Cabalka
Atrial Septal Defect
Indications
Device closure of an atrial septal defect (ASD) is indicated for patients with secundum defects less than
38 mm in diameter, who have evidence of right ventricular volume overload, and do not have associated
cardiac abnormalities that would otherwise be better suited to a surgical approach (Fig. 19.1). Coexistent conditions that might prompt consideration of surgical repair include severe atrioventricular valve
insufficiency or anomalous pulmonary venous drainage. Patients with severe pulmonary hypertension
(pulmonary artery [PA] systolic pressure more than two-thirds systemic) or patients with significant left
ventricular diastolic dysfunction may need special investigations before closure is performed. Meticulous
hemodynamic catheterization with determination of Qp:Qs ratio and pulmonary arteriolar resistance
is necessary in the patient with significant pulmonary hypertension. In patients with suspected severe
left ventricular diastolic dysfunction, it may be prudent to measure the left atrial or pulmonary capillary
wedge pressure with temporary balloon occlusion of the ASD, avoiding closure in those with a substantial rise in left heart filling pressures. The advice of a congenital heart disease specialist or pulmonary
hypertension specialist may be desirable.
AHA GUIDELINES
ASD should be diagnosed by imaging techniques, with demonstration of
shunting across the defect and evidence of right ventricular volume overload
and any associated anomalies
Closure of an ASD either percutaneously or surgically is indicated for right atrial and
right ventricular enlargement with or without symptoms. (Level of Evidence: B)
Closure of an ASD, either percutaneously or surgically, is reasonable in the
presence of 1) paradoxical embolism (Level of Evidence: C) or 2) documented
orthodeoxia-platypnea (Level of Evidence: B)
Closure of an ASD, either percutaneously or surgically, may be considered in the
presence of net left-to-right shunting, PA pressure less than two-thirds systemic
levels, pulmonary vascular resistance (PVR) less than two-thirds systemic vascular resistance, or when responsive to either pulmonary vasodilator therapy or test
occlusion of the defect (patients should be treated in conjunction with providers
who have expertise in the management of pulmonary hypertensive syndromes)
(Level of Evidence: C)
Patients with severe irreversible pulmonary arterial hypertension (PAH) and no
evidence of a left-to-right shunt should not undergo ASD closure (Level of
Evidence: B)
224
I C
I B
IIa B/C
IIb C
III B
19—ATRIAL SEPTAL DEFECT, PATENT FORAMEN OVALE, AND ATRIAL SEPTOSTOMY 225
Legend:
ASD = atr
APV = anomalous pulmonary veins, PAH = pulmonar y arterial hypertension
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ASD identified
RV enlarged
No
Defect ≤ 5 mm
No hx stroke/TIA
No therapy
ial septal defect, RV = right ventricle, VHD = valvular heart disease,
Fig. 19.1 Approach to atrial septal defect in the adult.
Surgical
consultation
No Ye s
Ye s
Secundum defect
Size 5–38 mm
Sufficient ASD rims
No associated VHD or APV
No significant PA H
Consider device closure
DEVICES
Currently approved devices include the Amplatzer Septal Occluder (ASO), the Amplatzer Cribriform Occluder (Abbott Laboratories, Abbott Park, IL), and the Gore Cardioform devices (W. L.
Gore and Associates, Flagstaff, AZ) (Fig. 19.2, Table 19.1). The ASO is a self-centering device and
sized by the waist between the right and left atrial discs. It is suitable for defects up to 38 mm in
diameter. The Amplatzer Cribriform device is designed for covering multiple or fenestrated defects
in the atrial septum. It is not a self-centering device and is sized by the external diameter of the
equal-sized left and right atrial discs. The Gore Cardioform device is also noncentering and sized
by the external diameter. Because of a lack of a self-centering mechanism, the Cardioform device,
available up to 30 mm in diameter, can only be used for closing ASDs up to about half this size, or
17 to 18 mm. Recently, the Gore Cardioform ASD Occluder has been approved by the Food and
Drug Administration (FDA) for ASDs sized 8 to 35 mm in diameter. This device is self-centering
and similar in construction to the Gore Septal Occluder.
PREPROCEDURAL IMAGING
Transesophageal echocardiography (TEE) is most commonly employed to define the size, shape,
and tissue rims of the ASD in the adult patient. A rim dimension of 5 mm or greater is ideal. A
search for multiple or fenestrated defects is important. Examination of the pulmonary veins and
determination of right ventricular systolic pressure, atrioventricular valve regurgitation, and left
ventricular (LV) diastolic function are also important, the latter especially in adult patients with
heart failure. Right ventricular enlargement is a hallmark of right ventricular volume overload and
should be present if the ASD is hemodynamically significant. Catheterization and hemodynamic
measurements are usually not required, unless there is significant pulmonary hypertension or
evidence of LV diastolic dysfunction.
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