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8 1—BUILDING BLOCKS OF STRUCTURAL INTERVENTION
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Large-caliber vascular access is usually required for structural procedures. Techniques for
vessel entry and exit, including use of specialized closure devices, are covered in Chapter 2.
Imaging of the peripheral anatomy will enable troubleshooting beforehand, for example, in the
situation of heavily calcified femoral arteries. This may guide choice of closure device or need
for a surgical cutdown either at the start of the case or at the end if closure devices cannot
achieve hemostasis.
Transseptal
puncture
SHD patients may have challenging atrial septa; previous atrial septal interventions; and the
atrial septum may be patched, oversewn, and/or fibrotic. In these cases, puncture may require
electrocautery or wire puncture.
9
In contrast to electrophysiology, the location of the transseptal puncture will depend on the procedure performed, and the precise choice of location will
aid in procedural success. We describe techniques for SHD transseptal puncture in detail in
Chapter 5.
After transseptal puncture, left-sided procedures are performed using preformed or steerable
catheters within the left atrium. Detailed understanding of relational anatomy within the heart is
particularly essential to avoid trauma within the left atrium due to the thin-walled left atrial appendage, pulmonary veins, and atrial roof. Detailed anatomic understanding and close communication with procedural imagers are required. We cover intraprocedural imaging and approach
to left atrial navigation in Chapter 3.
Navigation
with the left
atrium
Intraprocedural
imaging guidance
1—BUILDING BLOCKS OF STRUCTURAL INTERVENTION 9
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We detail adjunctive imaging for structural intervention in Chapter 3. In particular, during
the procedure, the structural interventionalist must develop a 3D map of relational cardiac
anatomy, allowing catheter and wire movements to be guided by the complementary imaging
provided by fluoroscopy and intraprocedural TEE or intracardiac echocardiography.
Occlusion
Vascular occlusion is performed for abnormal communications, fistulae, and pseudoaneurysms. The telescoping catheter technique may be usefully employed to cross complex
lesions, both in the coronary arteries and in many structural interventions. This technique
may be used to deliver vascular plugs, occluding coils, septal and ductal occlusion devices,
and others.
The telescoping system is created using a 125-cm, 5F multipurpose catheter placed in a 6F
guide (usually multipurpose) catheter with an exchange-length, stiff-angled hydrophilic wire used
to cross the lesion. This provides multiple degrees of freedom and allows lesions to be crossed and
then catheters safely advanced. In Chapters 13 and 17 we describe the use of this technique in
paravalvular leak closure.
An arteriovenous or transapical rail may be required for delivery of valves, plugs, devices, or
coils. A continuous rail—either venous-arterial, venous-apical, or venous-venous—gives great
support and allows large devices to be delivered. A snare is used to create the rail. Snares may also
be used to retrieve foreign objects within the cardiovascular system. The use of snares to create a
rail is detailed in Chapter 17.
Snaring
Valvuloplasty
10 1—BUILDING BLOCKS OF STRUCTURAL INTERVENTION
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Valvuloplasty may be performed in the aortic, mitral, or pulmonary position, either as an
initial step before percutaneous valve replacement or as a standalone treatment. We describe the
technique, sizing, and procedural considerations in Chapters 6 (aortic valvuloplasty) and 14
(mitral valvuloplasty).
Hemodynamics
Invasive hemodynamics allows determination of severity of valvular heart disease.
Intraprocedural hemodynamic monitoring additionally allows invasive measurement of pro-
cedural success, including acute improvement in left atrial pressure. We describe hemodynamic
diagnosis and intra-procedural monitoring in Chapter 4.
LV apex entry
and exit
Although this is less commonly performed, left ventricular entry is essential in selected cases.
The left ventricular apex may be accessed using small sheaths by direct puncture under fluoroscopic guidance. This access route may be required for medial mitral paravalvular leaks and mitral
and aortic interventions. Preprocedural planning, procedural technique, and closure are described
in Chapter 17.
For this training paradigm, we provide empiric recommendations for numbers for each
procedural building block in Table 1.1. These recommendations require further study and
external validation. While SHD training has historically been ad hoc as part of interventional training or after completion of training, the expansion of the SHD field is now
sufficient for the development of dedicated SHD fellowship programs. Ideally training in
each building block should be performed over a concentrated training time. At our center,
for example, a 1-year dedicated fellowship following PCI training has been established.
We have used the building-blocks training approach since the late 2000s, and have over
20 graduates of our structural interventional program currently practicing structural
intervention.
1—BUILDING BLOCKS OF STRUCTURAL INTERVENTION 11
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TABLE 1.1 n Empiric Recommendations for
Recommended Minimal Training Numbers for Each
Procedural Building Block
Catheter handling and PCI skills 250
Large bore sheath management 50
Transseptal puncture 50
Occlusion 30
Navigating within the left atrium 50
LV apex entry and closure 10
Hemodynamic assessment 50
Snaring 20
Valvuloplasty 30
Intraprocedural imaging guidance 50
Summary
SHD intervention is an innovative, exciting, and rapidly evolving field. Standardized techniques
form building blocks, which may be put together to form a complex structural intervention.
References
1. Grover FL, Vemulapalli S, Carroll JD, et al. 2016 Annual Report of the Society of Thoracic Surgeons/
American College of Cardiology Transcatheter Valve Therapy Registry. Circ Cardiovasc Interv. 2017;10(10).
2. Durko AP, Osnabrugge RL, Van Mieghem NM, et al. Annual number of candidates for transcatheter
aortic valve implantation per country: Current estimates and future projections. Eur Heart J. 2018;39(28):
2635-2642.
3. De Sciscio P, Brubert J, De Sciscio M, Serrani M, Stasiak J, Moggridge GD. Quantifying the shift toward
transcatheter aortic valve replacement in low-risk patients. Circ Cardiovasc Qual Outcomes. 2017;10:e003287.
4. Raphael CE, Alkhouli M, Maor E, et al. Building blocks of structural intervention: A novel modular
paradigm for procedural training. Circ Cardiovasc Interv. 2017;10.
5. Halperin JL, Williams ES, Fuster V, et al. ACC 2015 Core Cardiovascular Training Statement (COCATS
4) (Revision of COCATS 3). J Am Coll Cardiol. 2015;65:1721-1723.
6. Singh V, Badheka AO, Patel NJ, et al. Influence of hospital volume on outcomes of percutaneous atrial
septal defect and patent foramen ovale closure: A 10-years US perspective. Catheter Cardiovasc Interv.
2015;85:1073-1081.
7. Sorajja P, Cabalka AK, Hagler DJ, Rihal CS. The learning curve in percutaneous repair of paravalvular
prosthetic regurgitation. JACC Cardiovasc Interv. 2014;7:521-529.
8. Eleid MF, Cabalka AK, Malouf JF, Sanon S, Hagler DJ, Rihal CS. Techniques and outcomes for the
treatment of paravalvular leak. Circ Cardiovasc Interv. 2015;8:e001945.
9. Alkhouli M, Rihal CS, Holmes DR. Transseptal techniques for emerging structural heart interventions.
JACC Cardiovasc Interv. 2016;9:2465-2480.
e1
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Abstract: Structural heart disease (SHD) is the fastest-growing area in cardiology and cardiac
surgery. The number of transcatheter procedures has increased from approximately 5000 procedures in 2012 to over 60,000 in 2018 in the United States alone and will increase even further as
the market expands to include lower-risk patients. Training in SHD is similarly evolving, with
new procedures and devices designed for percutaneous access. This handbook of SHD training
is a “how to” practical handbook using the building-blocks approach to break down each procedure into component blocks, enabling practitioners to more easily train and gain competency in
structural interventions.
Keywords: structural intervention, building blocks, training, structured training
CHAPTER 2
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Access and Pitfalls
Yader Sandoval Rajiv Gulati
Introduction
Procedural and clinical outcomes for patients referred to the cardiac catheterization laboratory,
including those undergoing percutaneous structural heart interventions, depend on obtaining safe
and adequate vascular access.
access with large-bore sheaths—for example, femoral venous access for transcatheter mitral valve
repair (e.g., MitraClip, Abbott Vascular, 24F) or femoral arterial access for transcatheter aortic
valve replacement (TAVR, 14–18F). Although transvenous access with large-bore sheaths is required for several structural heart interventions, major vascular complications are infrequent
compared with arterial procedures. Therefore, although many of the techniques described herein
can be applied across any vascular access, given the morbidity and mortality related to vascular
complications involving arterial procedures, this chapter will focus on arterial access.
In the early TAVR experience, vascular complications were frequent (17% of all cases)
associated with morbidity, prolonged hospitalizations, and an increased risk of death. Rates of
access complication have fallen markedly, likely due to meticulous attention to location, needle
cannulation and visualization of entry site, evolution in sheath technology, experience with largebore closure techniques, and improved patient selection. However, the impact of complications
when they do occur remains significant.
Most vascular complications are iliofemoral, with the major predictors being small-vessel di-
mensions and moderate-to-severe calcification, as well as experience of large-bore vascular access
within the center performing the intervention.
to improved outcomes, with second-generation TAVR devices reported to have major vascular
complications in ,5% of cases.
occasionally needed (e.g., transcaval, transcarotid, or subclavian),
particularly in the setting of severe peripheral vascular disease, the transfemoral approach remains
the preferred and most commonly used access for TAVR.
To minimize the occurrence and/or impact of vascular complications, we emphasize the need
for the following:
1) Prevention: procedural planning, adequate site selection, and safe vascular access using
contemporary techniques
2) Preparation: if complications should occur, techniques have been described to improve
response
3) Management: equipment available to manage complications and technical familiarity by
procedural staff to manage such complications.
1
Structural heart interventions often require percutaneous vascular
2
and
2–4
The miniaturization of newer devices has led
5
Although alternative access techniques (other than femoral) are
6–7
as discussed in Chapter 12,
1,8
Preprocedural Planning
For patients undergoing evaluation for TAVR, preprocedural multidetector computed tomography (MDCT) is an essential tool that provides unique insights about vascular anatomy and
12
2—ACCESS AND PITFALLS 13
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Renal
Infrarenal
External iliacAorto bi-iliac
Fig. 2.1 Reconstructed multidetector computed tomographic images of the abdominal aorta and its
pelvic branches demonstrating tortuosity and extensive calcific atherosclerosis. (Holmes DR Jr,
Mack MJ, Kaul S, et al. 2012 ACCF/AATS/SCAI/STS expert consensus document on transcatheter aortic
valve replacement. J Am Coll Cardiol. 2012;59:1200–1254).
Bifurcation
Common iliac
information about the most appropriate vascular access based on several key access-site features
that should be assessed, including (1) minimal lumen diameter along the course of the intended
vascular access site, (2) vascular tortuosity, (3) vascular calcification, and (4) sheath/femoral artery
ratio, as well as potential issues involving the entire aorta, such as severe elongation and kinking,
dissection, and/or large thrombus (Fig. 2.1).
To maximize procedural success, these findings should preferably be reviewed and discussed
by the multidisciplinary heart team or, at a minimum, be reviewed in advance with one of
the operators involved in the procedure.
screening imaging modality, if such is not possible or contraindicated, other imaging modalities
to consider include conventional angiography or digital subtraction angiography (considered
during pre-TAVR coronary angiography), magnetic resonance angiography, or intravascular
ultrasound.
11
Transfemoral Access and Closure Technique
Most operators favor the use of bilateral femoral arterial access for TAVR procedures. Radial
access can be considered as an alternative access route for the pigtail catheter. For femoral access,
we endorse the routine use of ultrasound-guided access, which has been shown to reduce the
number of attempts, time to access, risk of venipuncture, and vascular complications.
9,10
10
Although MDCT is the preferred preprocedural
12
14 1—BUILDING BLOCKS OF STRUCTURAL INTERVENTION
Hemostat FluoroscopyMark*
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TABLE 2.1 n TAVR Devices, Access Sheaths, and Minimal Luminal Requirements According to
Manufacturers
Device
S3 20 14F expandable sheath 5.0 n/a
Evolut 23, 26, 29 InLine sheathless 14F or
Evolut R Pro 23, 26, 29 InLine sheathless 16F or
Lotus 23 Lotus Introducer small 6 n/a
From Kaluski E, Khan SU, Sattur S, et al. Arteriotomy site complication during transcatheter aortic valve replace-
ment: Ipsilateral wire protection and bailout. Cardiovasc Revasc Med. 2018;19:724-730.
Valve Size
(mm) Sheath Required
23, 26 14F expandable sheath 5.5 n/a
29 16F expandable sheath 6 n/a
18F sheath
34 InLine sheathless 16F or
20F sheath
20F sheath
25, 27 Lotus Introducer large 6.5 n/a
Minimal Vessel
Diameter (mm)
5 6 mm/18F
6 6.7 mm/20F
6 6.7 mm/20F
Valve External
Capsule Diameter
Techniques describing contemporary femoral arterial access, which are useful for any vascular
access, especially those intended for large-bore sheaths, have been published and described here.
Minimal vessel sizes required for the different TAVR sheaths are described in Table 2.1.
1
First, the lower edge of the femoral head should be identified using a hemostat or a radi-
opaque marker (Fig. 2.2). Marking this site with a sterile marker can be useful to avoid losing the
relationship with the femoral head—something that can occur when ultrasound scanning is
performed. Second, subcutaneous local anesthetic is injected with or without ultrasound guidance. Third, ultrasound scanning is performed. Visualization is often best at a depth of 4 to 5 cm,
a depth at which both the femoral artery and vein can be visualized together, with gain modified
as desired until optimal visualization is obtained.
It is often useful to scan both proximally and distally to understand well where the common
femoral artery is located and where the bifurcation into the superficial and deep (profunda)
A B
Fig. 2.2 Identify the lower edge of the femoral head using fluoroscopy. (A and B) Use a hemostat to
identify the lower edge of femoral head. (C) Consider marking the lower edge with a sterile marker (arrow) to
avoid losing the relationship to femoral head when performing ultrasound scanning.
C
2—ACCESS AND PITFALLS 15
Maintain straight probe position CFA Bifurcation
1 cm
2 cm
3 cm
A
BC
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ABC
Fig. 2.3 Ultrasound scanning. (A) Initiate ultrasound (straight position, no tilting) scanning at a previously
identified site (Figure 2.2) using fluoroscopic guidance, and aim to identify common femoral artery (B, asterisk)
and bifurcation (C, two asterisks).
femoral arteries occurs (Fig. 2.3), as well as identifying potential sources influencing access, such
as significant vascular calcification.
Fourth, vessel access is obtained using either a standard 18-gauge or 21-gauge micropuncture
needle (see further discussion). Needle guides are available to facilitate the angulation required
for proper access. If such guides are not available or needed, careful triangulation is required
between (1) the ultrasound probe/beam, (2) the intended vessel for access, and (3) the needle
entry site (Figs. 2.4–2.6), with needle entry recommended approximately 1 to 3 cm below the
SFA
0
1 cm
PFA
2 cm
Fig. 2.4 Ultrasound guidance technique. (A) Real-time ultrasound guidance facilitates femoral arterial access and
reduces vascular complications. The attached needle guide fixes the needle’s angle of entry to intersect the vessel
at the imaging plane 1.5 cm, 2.5 cm, or 3.5 cm below the skin, depending on the guide chosen. The vessel bifurcation is kept inferior to the probe at the time of insertion. (B) The right femoral artery bifurcation is imaged in the
axial plane, identifying the separation of the profunda femoral artery (PFA) and superficial femoral artery (SFA). Compression is used to differentiate arteries from the femoral vein (FV). (C) The probe is moved superiorly until the common femoral artery (CFA) is visualized. During needle advancement, the anterior wall of the vessel is kept under the
central target line (green circles), which indicates the path of the needle. (Modified from Seto AH, Abu-Fadel MS,
Sparling JM, et al. Real-time ultrasound guidance facilitates femoral arterial access and reduces vascular complications: JACC Cardiovasc Interv. 2010;3[7]:751–758, Copyright © 2010 American College of Cardiology Foundation.)
3 cm
FV
CFA
FV
16 1—BUILDING BLOCKS OF STRUCTURAL INTERVENTION
CD
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SFA
PFA
A
Fig. 2.5 Axial ultrasound of common femoral artery. (A) The right common femoral bifurcation is imaged
in the axial plane, demonstrating the profunda femoral artery and superficial femoral artery. Compression is
used to differentiate arteries from the femoral vein. (B) The probe is moved or angled superiorly to the common femoral artery (CFA). During needle advancement, the anterior wall of the vessel is indented by the
needle tip. (C) The guide wire insertion point (arrow) can be imaged in the axial plane after cannulation
to confirm that the insertion is above the CFA bifurcation. (D) Longitudinal view shows the guide wire entry
(arrow) is superior to the CFA bifurcation (arrowhead). (Kern MJ, Set AH, Forsberg M. The Interventional
Cardiac Catheterization Handbook. 2017. Figure 2.5).
FV
CFA
B
ultrasound probe.1 Fifth, before inserting a sheath, after successful advancement of the wire (we
recommend fluoroscopic-guided wire advancement when using micropuncture to prevent the
inadvertent wiring of branches), we suggest that the needle entry site be confirmed and deemed
satisfactory using fluoroscopy (Fig. 2.7); if such is not satisfactory, then the needle can be pulled
out (for which reason the micropuncture needle is favored, given the smaller caliber hole and e)
and access reattempted.
Finally, once successful access is obtained, a short 6F sheath can be advanced in each femoral
access site and femoral angiography (Fig. 2.8) (routinely performed, unless issues with renal
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