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I dedicate this handbook, first and foremost, to my family who have tolerated and supported my passion for innovation and cardiology, to my wonderful colleagues (including many trainees over the years) without whom these procedures would not have been possible, and most of all to our patients who trust us with their health and lives. It is a privilege to look after you.
—Charanjit Rihal, MD, FACC
To my parents, Sue and Nabil, for their endless support and for teaching me the importance of hard work and perseverance.
—Claire E.
Raphael, MBBS, PhD, MA
LIST OF CONTRIBUTORS
Mohammed Al-Hijji, MD
Assistant Professor of Medicine
Interventional and Structural Cardiologist
Cardiovascular Diseases
The Heart Hospital-Hamad Medical Cooperation
Doha, Qatar
Mohamad Alkhouli, MD Professor of Medicine
Department of Cardiovascular Disease
Mayo Clinic College of Medicine
Rochester, Minnesota
Oluseun Alli, MD, MHA, FACC
Interventional Cardiologist Department of Cardiology
Novant Heart and Vascular Institute
Charlotte, North Carolina
Israel Barbash, MD
Associate Professor of Cardiology
Director Cath Lab Services
Tel Aviv University
Sheba Medical Center
Israel
Allison K. Cabalka, MD
Professor of Pediatrics
Mayo Clinic College of Medicine
Rochester, Minnesota
Alexander C. Egbe, MD, MPH, FACC
Cardiologist
Department of Cardiovascular Medicine
Mayo Clinic
Rochester, Minnesota
Mackram F. Eleid, MD
Department of Cardiovascular Medicine
Mayo Clinic School of Medicine
Rochester, Minnesota
Kashish Goel, MD
Assistant Professor of Medicine
Cardiovascular Diseases
Vanderbilt University
Nashville, Tennessee
Donald J. Hagler, MD, FSACI, FACC, FACP
Professor of Pediatrics and Medicine
Department of Cardiovascular Diseases
Division of Pediatric Cardiology
Mayo Clinic College of Medicine
Rochester, Minnesota
Abdallah El Sabbagh, MD
Assistant Professor
Department of Cardiovascular Diseases
Mayo Clinic
Jacksonville, Florida
Kevin L. Greason, MD
Department of Cardiovascular Surgery
Mayo Clinic
Rochester, Minnesota
Mayra Guerrero, MD Department of Cardiovascular Medicine
Mayo Clinic
Rochester, Minnesota
Rajiv Gulati, MD, PhD
Professor of Medicine
Department of Cardiology
Mayo Clinic
Rochester, Minnesota
David R. Holmes Jr., MD Professor of Medicine
Department of Cardiovascular Medicine
Mayo Clinic College of Medicine
Rochester, Minnesota
Timothy Andrew Joseph, MD
Department of Cardiovascular Disease
Mayo Clinic School of Medicine
Rochester, Minnesota
Joseph F. Maalouf, MD, FACC, FAHA, FASE Professor of Medicine
Director
Interventional Echocardiography
Consultant
Department of Cardiovascular Medicine
Mayo Clinic
Rochester, Minnesota
Elad Maor, MD, PhD
Associate Professor of Cardiology
Tel Aviv University
Sheba Medical Center
Israel
Rick Nishimura, MD Professor of Medicine Department of Cardiology Mayo Clinic Rochester, Minnesota
Sidakpal Panaich, MD
Assistant Professor Interventional Cardiology University of Iowa Iowa City, Iowa
Peter Pollak, MD Consultant
Department of Cardiovascular Diseases
Mayo Clinic Jacksonville, Florida
Claire E. Raphael, MBBS, PhD, MA
Assistant Professor Department of Cardiovascular Medicine
Mayo Clinic Rochester Minnesota
Gautam Reddy, MD
Division of Cardiovascular Diseases Huntsville Hospital Heart Center Huntsville, Alabama
Yogesh N.V. Reddy, MBBS, MSc
Senior Associate Consultant Department of Cardiovascular Diseases
Mayo Clinic
Rochester, Minnesota
Guy S. Reeder, MD Professor
Department of Cardiovascular Medicine
Mayo Clinic Rochester, Minnesota
Charanjit Rihal, MD, FACC Chair Professor of Medicine
Department of Medicine Division of Cardiovascular Diseases
Mayo Clinic Rochester, Minnesota
Gurpreet S. Sandhu, MD, PhD Chair
Department of Cardiovascular Medicine Division of Interventional Cardiology
Mayo Clinic Rochester, Minnesota
Yader Sandoval, MD
Division of Cardiovascular Diseases
Mayo Clinic Rochester, Minnesota
Saurabh Sanon, MD
Division of Cardiology
Florida Atlantic University and Tenet Health Boca Raton, Florida
Mohammad Sarraf, MD
Director of Structural Heat Program Division of Cardiovascular Diseases University of Alabama at Birmingham Birmingham, Alabama
Monisha Sudarshan, MD, MPH Thoracic Surgeon Department of Thoracic and Cardiovascular Surgery Cleveland Clinic Cleveland, Ohio
Nathaniel Taggart, MD
Associate Professor Pediatric Cardiology Mayo Clinic Rochester, Minnesota
Jeremy J. Thaden, MD
Assistant Professor of Medicine
Co-Chair for Clinical Practice and Quality Division of Cardiac Ultrasound Consultant
Department of Cardiovascular Medicine
Mayo Clinic Rochester, Minnesota
Thomas M. Waterbury, MD
Department of Cardiovascular Diseases
Mayo Clinic
Rochester, Minnesota
Robert Jay Widmer, MD, PhD
Department of Cardiovascular Medicine
Mayo Clinic College of Medicine
Rochester, Minnesota
PREFACE
The history of cardiac catheterization is a rich and colorful tale with numerous innovators, pioneers, and Nobel laureates making contributions. Werner Forssmann in 1929 took an x-ray image of a urinary catheter inserted from his own brachial vein into his right atrium, an innovation that led to both a Nobel Prize and the end of his cardiology career. Andre Cournand and Dickinson Richards Jr. from the Columbia Service at Bellevue Hospital built on Forssmann’s discovery and shared in the Nobel Prize, establishing the use of cardiac catheterization to measure pressure and saturation and the use of contrast media to image the cardiac chambers. Mason Sones at Cleveland Clinic inadvertently performed the first selective coronary angiogram in 1958 on a young man with severe rheumatic heart disease, recognized its potential, and eventually lead to the era of coronary revascularization. At the Mayo Clinic, Earl H. Wood used the physiologic techniques he developed to study why pilots lose consciousness at high G-forces and adapted them for invasive evaluation of congenital heart lesions and other cardiac shunts. His techniques were integral to successful cardiopulmonary bypass, allowing open heart surgery.
Mitral balloon valvuloplasty, developed by Kanji Inoue, a Japanese surgeon, circa 1982, and balloon aortic valvuloplasty, first performed by Alain Cribier in 1986, were early structural procedures that showed the promise of treating large macrostructures with novel therapies. Sigwart, working on a percutaneous treatment for left ventricular outflow tract obstruction in hypertrophic cardiomyopathy, demonstrated that the degree of obstruction could be effectively reduced by inflation of a balloon in a septal perforator in 1982. It took over 10 years and a move to the United Kingdom for him to gain ethical approval for a larger series of patients to produce small, highly targeted myocardial infarctions in the basal septum through the injection of alcohol.
Although coronary balloon angioplasty and stents were the dominant procedures in cardiac catheterization laboratories for over 20 years, the 2000s saw massive innovation and investment in structural interventional procedures and devices, spurred on by the development of transcutaneous heart valves. Henning Andersen was training as an interventional cardiologist when he developed the first transcatheter delivery device, crimping a porcine valve into a stent frame in 1990, which became the foundation for the first Sapien valve. Percutaneous Valve Technologies, the company founded by Alain Cribier, acquired the patent, and the first-in-human transcatheter aortic valve replacement (TAVR) was performed by Dr. Cribier a few years later in 2002. The approval of percutaneous mitral edge-to-edge clipping technology gave rise to a new era in treating mitral valve disease. Since then the pace of discovery, invention, and development of promising new technologies and techniques to meet unmet patient needs has only accelerated.
In this handbook, we describe the common and less common structural procedures. Although structural procedures share many commonalities with coronary interventional procedures, they are also fundamentally different in approach, training, and execution. Structural interventions require unique technical and cognitive skills of the interventional cardiologist (and, increasingly, surgeons) interested in minimally invasive cardiac procedures. We describe how structural procedures may be visualized as component “building blocks,” which can be utilized to develop new procedures and therapies. The future is bright.
SECTION 1. Building Blocks of Structural Intervention 1
1. Building Blocks of Structural Intervention: An Approach for Procedural Training 2
Claire E. Raphael Chanranjit Rihal
2. Access and Pitfalls 12
Yader Sandoval Rajiv Gulati
3. Imaging for SHD Interventions 22
Jeremy J. Thaden Joseph F. Maalouf
4. Hemodynamics for the Structural Interventionalist 43
Yogesh N.V. Reddy Rick A. Nishimura
5. Techniques of Transseptal Puncture 57
Mohamad Alkhouli David R. Holmes Jr.
SECTION 2. Aortic Valve Interventions 71
6. Balloon Aortic Valvuloplasty 72
Claire E. Raphael David R. Holmes Jr.
7. Transcatheter Aortic Valve Implantation: Work up and Indications for Intervention 81
Claire E. Raphael Abdallah El Sabbagh Charanjit Rihal
30. Pulmonary Balloon Angioplasty for Chronic Thromboembolic Pulmonary Hypertension 361
Abdallah El Sabbagh Gurpreet S. Sandhu
31. Transcatheter Biopsy for Intracardiac Masses 374
Gautam Reddy Charanjit Rihal
VIDEO CONTENTS
CHAPTER 15 Percutaneous Edge-to-Edge Mitral Valve Repair Using the MitraClip®
Video 15.1. Shows 3D TEE image (“surgeon’s view”) demonstrating flail P2 leaflet.
Video 15.2. Shows the same patient with views for measurement of the flail gap should be ideally less than 10 mm and flail length less than 15 mm.
Video 15.3. Shows the same patient with views for measurement of the flail gap should be ideally less than 10 mm and flail length less than 15 mm.
Video 15.4. Shows 2D TEE image demonstrating tenting of the atrial septum by the Brockenbrough needle during transseptal puncture. The ideal puncture site should be superior and posterior to ensure sufficient height above the mitral annulus (4-4.5 cm).
Video 15.5. Shows 3D TEE demonstrating positioning of the opened MitraClip® above the mitral valve flail segment.
Video 15.6. Shows 2D TEE image of clip deployment.
Video 15.7. Shows the clip deployed with creation of a tissue bridge, 3D TEE image.
Video 15.8. Shows moderate residual mitral regurgitation after deployment of the first clip. The mean transmitral diastolic gradient was 2 mmHg. Given the low gradient, a second MitraClip® was planned.
Video 15.9. Shows positioning of the second MitraClip® medial to the first.
Video 15.10. Shows the enlarged tissue bridge created with the second clip placement.
Video 15.11. Shows mild residual mitral regurgitation after the second clip. Mean gradient was 4 mmHg. Procedure completed.
Video 19.1. Deployment of Gore Cardioform Septal Occluder device in PFO. The right atrial disc has been deployed. The device is pulled back to the atrial septum and the left atrial disc is deployed.
Video 19.2. Atrial Septal Aneurysm. Closure of PFO with mobile atrial septal aneurysm and lipomatous atrial septum. (A) ICE image from right atrium. (B) After deployment of 30-mm Gore Cardioform device. The motion of the aneurysm has been completely eliminated. There was no residual shunting.
Video 19.3AB. Closure of secundum atrial septal defect with absent retroaortic rim. Video images corresponding to Figure 19.5.
Video 19.4. Closure of PFO in patient with orthodeoxia/platypnea. This video corresponds with Figure 19.8. (A) Mild right-to-left shunting by bubble study, patient is supine. (B) Severe right-to-left shunting in upright position. (C) Transesophageal echo showing highly mobile atrial septal aneurysm with patent foramen ovale. (D) TEE shows modest rightto-left shunting supine position. (E) ICE imaging from right atrium; femoral vein bubble study shows severe right-to-left shunting. (F) After closure with Amplatzer Septal Occluder; no residual shunting. (G) K-upright bubble study post-device deployment; no shunting.
CHAPTER 23 Pulmonary Vein Stenosis: Management and Outcomes
Video 23.1. Preintervention PVS.
Video 23.2. Postintervention PVS after stent deployment.
CHAPTER 26 Coarctation and PDA Closure
Video 26.1
Video 26.2
Video 26.3
Video 26.4
CHAPTER 27 Closure of Abnormal Coronary Communications: Coronary, Fistulae, Congenital, and Iatrogenic
Video 27.1
Video 27.2
Video 27.3
Building Blocks of Structural Intervention
Building Blocks of Structural Intervention: An Approach for Procedural Training
Claire E. Raphael Chanranjit Rihal
Structural heart disease (SHD) intervention 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 cases in 2018 in the United States alone1 (Fig. 1.1). These numbers are set to increase even further as the market expands into lower-risk patients and procedures become more refined. If TAVR is routinely performed in low risk patients, annual case volume may exceed 150,000 patients per year.2,3
Training in SHD is evolving, with novel procedures and devices introduced every year.
This handbook of SHD training is a “how-to” practical handbook structure covering clinical pearls of wisdom, pitfalls, and tips and tricks from the experts. We will use the “building-blocks” approach, which breaks down each procedure into component blocks, enabling practitioners to more easily train in new procedures and gain competency.4
Structured Procedural Training
The American College of Cardiology (ACC) framework for established cardiovascular training uses outcomes-based evaluations. Milestones are used to describe progression from early learner status through advanced learning until unsupervised practice is achieved. Minimal recommended procedural volumes in percutaneous coronary intervention (PCI) for both training and maintenance of competency were developed by the ACC due to the relationship between high procedural volumes and low complication rates.5 Although less evidence exists for a procedure volume–outcome relationship in structural intervention, selected procedures do show a similar relationship.6,7
For SHD, the number of mitral interventions, left atrial appendage procedures, and paravalvular leak closures, even in high-volume sites, are small compared with coronary intervention. However, if each procedure is considered a series of steps, many of which are common between structural cases, development of a competency-based framework and maintenance of procedural numbers during training and ongoing practice becomes achievable.
Modular Training Using the Building-Blocks Approach
In the modular approach, a structural intervention is considered the sum of a series of building blocks.4 By combining different building blocks, a complete structural procedure is assembled (Figs. 1.2–1.4). Procedural competency can therefore be taught and assessed by component blocks, which remain constant, rather than by procedures, which change over time. These building blocks also provide the foundation for new procedures.
Fig. 1.1 Transcatheter aortic valve replacement volume has expanded exponentially in the United States (TVT registry data), and similar trends are seen worldwide.
We describe 10 key SHD building blocks. When combined with the cognitive skills of structural intervention and device-specific training, use of these blocks aids training and assessment of competency in SHD intervention.
Cognitive Training in Structural Intervention
In addition to procedural training in each specific building block, parallel training in the complex decision-making essential for structural intervention is required. For structural interventions, preprocedural planning may be as long as the case itself and is equally as important. The access route, potential complications, and bailout plan in the event of a severe complication should be predetermined. This requires understanding of preprocedural anatomic imaging, particularly transthoracic echocardiogram/transesophageal echocardiogram (TTE/TEE) and computed tomography (CT).
Case review with imaging specialists before the intervention are often helpful, particularly for less common procedures and in the early stages of independent practice. This preplanning often avoids complications and ensures that backup equipment and personnel are available if required, for example, for surgical cutdown in the event of unfavorable vascular access.
Three key elements to cognitive training will develop during structural interventional training: cognizant observation (early learning phase), dynamic intraprocedural decisionmaking (advanced learner), and innovation ( Fig. 1.5 ). In addition to case-by-case examination and discussion, case-based conferences are a good way to increase exposure to complex disease and develop these decision-making skills. Self-directed learning and online education tools also allow case-based review and consultation of evidence-based practice guideline recommendations.
TAVR MitraClip
HEART TEAM APPROACH
CONGNITIVE SKILLS
Valvuloplasty
Occlusion
Snaring
Intraprocedural imaging guidance
Large-bore sheath
mgmt
DEVICE-SPECIFIC
TRAINING
Transseptal puncture
Navigation within the left atrium
Hemodynamics
Catheter skills LV apex entr y and exit
Fig. 1.2 The 10 core building blocks of structural intervention are demonstrated graphically. These are encapsulated by the cognitive skills developed during structural interventional training. Decision-making is best taken using a heart team approach. Device-specific training is coupled with the core 10 blocks to complete each procedure. (Reproduced from 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.)
Much of the equipment used in structural intervention is not custom made and was originally designed for other purposes, usually coronary intervention. Catheters and wires therefore need to be measured to ensure they will reach the target, and preplanning will ensure that an appropriatesized sheath is selected for delivery of the equipment needed. Particularly for vascular occlusion devices, the likely size of the defect will guide the choice of sheath. Although sizes on the manufacturer packaging are a guide, they are not always intuitive. For example, a 6F shuttle sheath (Cook Medical) will fit through an 8.5F Agilis sheath (St. Jude Medical), but a 7F will not.
Hemodynamics
Valvuloplasty
Large bore sheath management
Catheter skills
AORTIC VALVULOPLASTY
Hemodynamics
Device specific training
Valvuloplasty
Large bore sheath management
Catheter skills
TAVR
Fig. 1.3 The similarity between structural procedures is easily seen when they are broken down into component building blocks. Training in transcatheter aortic valve replacement (TAVR) may begin with performing aortic valvuloplasty. Examination of the component blocks demonstrates that the procedures are nearly identical, with the addition of device-specific training. (Adapted from 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.)
Hemodynamics
Device specific training
Intraprocedural imaging guidance
Navigation within the left atrium
Transseptal puncture
Large bore sheath management
Catheter skills
MITRA CLIP
Hemodynamics
Occlusion
Snaring
Intraprocedural imaging guidance
Navigation within the left atrium
Transseptal puncture
Catheter skills
MITRAL VALVE INTERVENTION
e.g., mitral paravalvural leak closure
Fig. 1.4 For more complex interventions on the mitral valve, training and maintenance of competency may be achieved by considering the component blocks. Learning procedural fluency is aided by this approach, and novel left-sided procedures may be more easily learned when a familiar schematic is followed with the addition of device-specific training. (Adapted from 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.)
Early learning phase Advanced learner Innovative proceduralist
• Cognizant observation
• Mastery of individual building blocks
• Participation in heart team decision-making
• Established procedural fluency
• Dynamic intraprocedural decision-making
• Use of building blocks to approach novel procedures
• Development and testing of experimental devices
Fig. 1.5 Development of cognitive skills for structural intervention.
We recommend the use of compatibility tables for advanced planning.8 These are included in the appendix.
Interdisciplinary Learning
Many of the structural intervention techniques were developed in conjunction with other disciplines. Training therefore requires learning from other disciplines, both within cardiology and beyond. For interventional imaging, training in TTE and TEE is required for an understanding of 3D relational anatomy, while training in transseptal puncture may be performed in parallel with electrophysiology trainees. Exposure to pediatric and congenital cardiology allows development of techniques for navigation of peripheral vessels and anomalous connections, while training with cardiothoracic and vascular colleagues allows better understanding of vessel entry and exit options and planning for the prevention and management of complications.
TAVR practice in the United States requires a comprehensive, multidisciplinary approach, and this approach holds true for many structural heart disease procedures. Detailed preoperative assessment, including estimation of patient- and procedure-specific risk, allows choice of appropriate access routes, informed discussion of risk and benefit with patients, and formulation of emergency management plans in the event of serious complications. Training in the cognitive skill set required for these decisions will have begun during core cardiology training,5 and structural trainees will become familiar with specific considerations for access routes, choice of device, and potential for complications.
Structured Training Schemes Using the Building-Blocks Approach
Training schemes may approach the building blocks in different orders, depending on available opportunities. Each block may be learned in parallel with other blocks. Vascular access (entry and exit) is a common cause of complications, and training in this usually begins
during coronary training. Familiarity with closure devices before starting structural training is desirable, but will depend on local opportunity and expertise. Many companies have models that enable practice in deployment of closure devices before using them in the catheter laboratory.
Most structural programs begin after completion of coronary intervention training, and therefore trainees will have gained skills in PCI decision-making, including choice of catheter and catheter manipulation. Training for transseptal puncture may be performed in parallel with trainees in electrophysiology. However, it is important to note that the position of the transseptal puncture is more important during structural procedures, as this will either aid or hinder catheter and device manipulation if it is too high or low, or posterior or anterior. 9
3D relational anatomy is a more complex skill that is gained with time and experience. Structural interventionalists need to learn to “think in 3D” to guide catheter and wire manipulation. Trainees benefit from cross-discipline training with imaging fellows to develop skills in interpretation of CT of both the heart and peripheral vasculature and TTE and TEE echocardiography. Although the structural interventionalist does not need to learn how to perform a TEE, he or she does need a comprehensive understanding of the images used, particularly during mitral procedures, and how these relate to what is seen on fluoroscopy.4
We describe the core building blocks here in brief. Dedicated chapters later in the book will describe specific blocks common to many structural procedures.
Familiarity with handling of wires and catheters; venous and arterial access; and placement of catheters in the left ventricle, aortic root, and right heart are essential for structural procedures and should be mastered before starting structural training. These are outside the scope of this textbook, but are well covered in dedicated texts.
Catheter skills
Large bore sheath managenent
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.
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.
Transseptal puncture
Navigation with the left atrium
Intraprocedural imaging guidance
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.
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.
Occlusion
Snaring
Valvuloplasty
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 procedural success, including acute improvement in left atrial pressure. We describe hemodynamic diagnosis and intra-procedural monitoring in Chapter 4.
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.
LV apex entry and exit
TABLE 1.1 n Empiric Recommendations for Recommended Minimal Training Numbers for Each Procedural Building Block
Catheter handling and PCI skills
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. D urko 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.
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
Access and Pitfalls CHAPTER 2
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.1 Structural heart interventions often require percutaneous vascular 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)2 and 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 dimensions and moderate-to-severe calcification, as well as experience of large-bore vascular access within the center performing the intervention.2–4 The miniaturization of newer devices has led to improved outcomes, with second-generation TAVR devices reported to have major vascular complications in ,5% of cases.5 Although alternative access techniques (other than femoral) are occasionally needed (e.g., transcaval, transcarotid, or subclavian),6–7 as discussed in Chapter 12, particularly in the setting of severe peripheral vascular disease, the transfemoral approach remains the preferred and most commonly used access for TAVR.1,8
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.
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
