Feature | Structural Heart | August 12, 2019| Ashish Pershad, M.D., and Kenith Fang, M.D., FACS

National Coverage Determination Will Make TAVR Available to More Patients at More Centers

Valve technology and collaborative process have evolved over time

Example of an aortic valve CT imaging workup for TAVR valve sizing and assessing access routes. This patient has an aneurism in the aortic arch. Image from GE Healthcare.

Example of an aortic valve CT imaging workup for TAVR valve sizing and assessing access routes. This patient has an aneurism in the aortic arch. Image from GE Healthcare.

As we usher in a new era for treating patients with aortic stenosis, we have been reflecting on the evolution of the technology used for transcatheter aortic valve replacement (TAVR) and the evolution of our collaborative process as a team over years as a center in the PARTNER 3 clinical trial. PARTNER 3, which this year showed low-risk patients fared as well or better with TAVR as they did with surgery. This led to the broader National Coverage Determination (NCD) approved in June 2019, opening Medicare payments to most patients; and changes are coming to society guidelines and U.S. Food and Drug Administration (FDA) guidance, which will bring TAVR to more patients and centers.

Through three generations of valves, multiple clinical trials, surveillance through a national registry, and nearly a decade of experience, TAVR safety has steadily improved. The replacement valve technology has evolved along with our heart team’s approach all the way from evaluation of patients to the choice of TAVR or surgery, the procedure itself and follow up. 

 

Evolution of the TAVR technology
Manufacturers rapidly modified valves and the delivery sheaths from generation 1 to 3. First, delivery catheters became smaller, and the lower profile catheter is less likely to cause vascular injury.  Valves were also redesigned to have a skirt or a wrap around them, reducing the incidence of paravalvular leak, an Achilles heel of TAVR early on.

 

Evolution of the Collaborative Process
As the valves have evolved, so has our approach as a team to placing them. As surgeons, interventional cardiologists, general cardiologists, and imagers working together at Banner — University Medicine Heart Institute, we learned that planning is 90 percent of the procedure. At the same time, we have come to fully appreciate the need for strong collaboration focused around the needs of each patient. 

Moving from ultrasound to computed tomography (CT) scans to choose valve sizes was a significant early change in our process that helped us identify and prevent major complications, such as valve embolization. A CT angiogram (CTA) allows for better delineation of coplanar deployment angles to support proper valve positioning, which reduces the incidence of para valvular leaks. A CTA also provides information needed for careful assessment of access vessel quality and size, facilitating selection of the most suitable access for TAVR and minimizing the risk of vascular complications.

Personalizing choices for each patient is another part of our team process. For a small portion of patients, surgery remains the best choice. Certain anatomy is likely to lead to complications with TAVR, including when blood vessels in the groin are too small, when coronary height is too low, or when congenital abnormalities are found in the aortic valve. Surgery is also a better option when opening the chest is required for another reason, such as a concomitant blockage, the need for mitral valve replacement in addition to the aortic valve replacement, or when work is required on the aorta. 

It takes a well-developed team pulling together in the best interest of the patient to identify an individualized approach to aortic valve replacement, considering patient history and available imaging, while pushing aside motivations related to ego, money, or even uninformed patient preferences. 

Sometimes a well-functioning team will determine if a third choice is in the patient’s best interest, and that is to do nothing when it would be futile because the patient is likely to die from another condition. 

Editor’s note: Ashish Pershad, M.D., interventional cardiologist, and Kenith Fang, M.D., a cardiothoracic surgeon, collaborate at Banner – University Medicine Heart Institute in Phoenix, one of the centers that participated in the PARTNER 3 clinical trial. 

Watch an interview with Pershad in the VIDEO: Comparison Between Watchman vs. Amulet LAA Occluders
 

 

Related TAVR Content:

CMS Finalizes Updates to Coverage Policy for Transcatheter Aortic Valve Replacement

TAVR Operator and Hospital Requirements Outlined in 2018 AATS/ACC/SCAI/STS Expert Consensus

Interventional Imagers: The Conductors of the Heart Team Orchestra

 

Length of Stay Impacts TAVR Outcomes

VIDEO: Applications in Cardiology for 3-D Printing and Computer Aided Design — Dee Dee Wang, M.D.

Hospital Consolidation May Increase Access to TAVR, New Cardiac Technologies

VIDEO: Conscious Sedation for TAVR Procedures — Mario Goessl, M.D.

Recent Advances in Transcatheter Valve Technology

VIDEO: TAVR For Asymptomatic Severe Aortic Stenosis — Philippe Genereux, M.D.

How to Perform Transcaval TAVR Access — Adam Greenbaum, M.D.

VIDEO: Outcomes Following Urgent TAVR - Results from the TVT Registry — Sammy Elmariah, M.D.

TAVR Stands Equal to Surgical Valve Replacement

VIDEO: Clinical Outcomes With the Lotus TAVR Valve — Ted Feldman, M.D.

How to Build an Integrated Heart Team — Brijeshwar Maini, M.D., Brian Bethea, M.D.

VIDEO: TAVR for Degenerated Surgical Valves — Valve-in-Valve TAVR Procedures — Sammy Elmariah, M.D.

Advances in Heart Valve Technology in 2017
 

 

 

 

Related Content

New Alliance Announced Between Transcatheter Cardiovascular Therapeutics and VEITHsymposium
News | Cath Lab | June 20, 2019
VEITHsymposium and the Cardiovascular Research Foundation (CRF) announced an alliance between Transcatheter...
Novel Index Accurately Predicts PCI Success Post-Procedure Compared to Established Measurement Metrics
News | Cath Lab | June 19, 2019
Results from a comprehensive analysis demonstrate the effectiveness of measuring a non-hyperemic pressure ratio (NHPR...
Philips Healthcare, Volcano IVUS showing an implanted stent. IVUS might offer an alternative to contrast angiography in patients with acute kidney disease (AKD).
News | Cath Lab | June 14, 2019
June 14, 2019 – A late-breaking study examined the effects of intravascular ultrasound (IVUS) guided drug-eluting ste
Videos | Cath Lab | May 20, 2019
This is a walk through of the primary structural heart hybrid cath lab at...
Mobility May Predict Elderly Heart Attack Survivors' Repeat Hospital Stays
News | Cath Lab | April 23, 2019
Determining which elderly heart attack patients take longer to stand from a seated position and walk across a room may...
FDA Releases New Guidance on Medical Devices Containing Nitinol
News | Cath Lab | April 18, 2019
April 18, 2019 — The U.S.
Angiography shows a stenotic lesion in the mid right coronary artery, undilatable by standard high-pressure balloon angioplasty (inset, arrowheads). (B) Optical coherence tomography (OCT) cross-sectional (top) and longitudinal (bottom) images acquired before IVL and coregistered to the OCT lens (arrow in A) demonstrate severe near-circumferential calcification in the area of the stenosis. (C) Angiography demonstrates improvement in the area of stenosis after IVL lithoplasty.

Figure 2: Angiography demonstrates a stenotic lesion in the mid right coronary artery, undilatable by standard high-pressure balloon angioplasty (inset, arrowheads). (B) Optical coherence tomography (OCT) cross-sectional (top) and longitudinal (bottom) images acquired before IVL and coregistered to the OCT lens (arrow in A) demonstrate severe near-circumferential calcification (double-headed arrow) in the area of the stenosis. (C) Angiography demonstrates improvement in the area of stenosis after IVL (inset; note the cavitation bubbles generated by IVL [black arrows]). (D) OCT cross-sectional (top) and longitudinal (bottom) images acquired post-IVL and coregistered to the OCT lens (white arrow in C) demonstrate multiple calcium fractures and large acute luminal gain. (E) Angiography demonstrates complete stent expansion with the semicompliant stent balloon (inset) without the need for high-pressure noncompliant balloon inflation. (F) OCT cross-sectional (top) and longitudinal (bottom) images acquired post-stenting and coregistered to the OCT lens (arrow in E) demonstrate further fracture displacement (arrow), with additional increase in the acute area gain (5.17 mm2), resulting in full stent expansion and minimal malapposition.

Feature | Cath Lab | April 15, 2019 | Dean Kereiakes, M.D., FACC, FSCAI, and Jonathan Hill, M.D., DISRUPT CAD III Co-Principal Investigators
Over the last 40 years, despite multiple advancements in percutaneous coronary interventions, calcified lesions remai
BIOTRONIK’s PK Papyrus covered coronary stent. The stent ius used in emergency coronary artery dissections to repair the vessel wall.
Technology | Cath Lab | April 15, 2019
April 15, 2019 — Biotronik began its U.S.
Overlay Init