Archive for the ‘Transcaval TAVR Procedure’ Category

TricValve Transcatheter Bicaval Valves System – Interventional cardiologists at Cleveland Clinic have successfully completed the first implantation in North America

Reporter: Aviva Lev-Ari, PhD, RN

UPDATED on 7/22/2022

Cardiothoracic surgeons at UC San Francisco performed the first robotically assisted mitral valve prolapse surgery in San Francisco.

Reporter: Aviva Lev-Ari, PhD, RN



The Patient for this historic procedure:

An 82-year-old man presenting with severe symptomatic tricuspid regurgitation (TR) and right heart failure (RHF).

Expert Opinion: The Voice of Dr. Justin D. Pearlman, MD, PhD, FACC

The TricValve addresses the problem of severe ìncompetance of the tricuspid valve with a relatively simple procedure.

Instead of the challenge of replacing the defective valve, a catheter procedùre places valves at the two venous intake locations, the superior and ìnferior vena cava. A valve at the superior vena cava entrance to the right atrium occurs occasionally in nature, but is usually absent or fenestrated, covering the medial end if the crista supraventricularis.

A similar termed valve is occasionally found in nature on the inferior vena cava. These supernumerary valves can arrest back flow of pressure and volume from the right atrium to the upper and lower venous systems, and alleviate in particular congestion of the liver.

Normally the right atrial pressure is low, in which case this would offer no significant advantage for reproductive success natural selection to offset potential interference with blood flow into the right atrium that might promote thrombosis [Folia Morphology Morphology 66(4):303-6, MRuso].

However, in a setting of right heart failure, such as occurs from pulmonary hypertension, the tricuspid valve often becomes incompetent, and placement of the pair of vena cava valves can alleviate upstream consequences, albeit at the cost of risk of thrombosis and future impediment to other future procedures such as ablation of supraventricular arrhythmia.

The vena cava valves placed by catheter at the Cleveland Clinic helped an 80 year old man alleviate his pressing issue of hepatic congestion. Unlike a replacement tricuspid valve this procedure does not alleviate high pressures dilatìng the right atrium. Instead, it can worsen that problem.

The CLASP II TR trial is investigating the Edwards PASCAL transcatheter repair system [CLASP II TR, Edwards Lifesciences Corp, NIH NCT 0497145]

Survival data for surgìcal tricuspid valve replacements reported 37+-10 percent ten year survival, with average all cause survival of just 8.5 years [Z HIscan, Euro J CT Surgery 32(2) Aug 2007]. None-the‐less,  comparison of patients with vs without intervention for incompetance of the trìcuspid valve favored mechanical intervention [G Dreyfus Ann Thorac Surg 49:706-11,1990, D Adams, JACC 65:1931-8, 2015]. Time will tell which interventìon will prevail, and when these catheter alternatives to open chest surgery should be deployed.

The first implantation in North America: TricValve Transcatheter Bicaval Valves System

The structural heart procedure occurred in February 2022.

Rishi Puri, MD, PhD, an interventional cardiologist with Cleveland Clinic, and Samir Kapadia, MD, chair of cardiovascular medicine at Cleveland Clinic, performed the procedure. Puri has years of experience with the TricValve system, participating in a thorough analysis of its safety and effectiveness in 2021.

The TricValve system features two biological valves designed to be implanted via femoral vein access into the patient’s superior vena cava and inferior vena cava. This allows a therapy without impacting the patient’s native tricuspid valve. It is available in multiple sizes, allowing cardiologists to choose the best option for each individual patient.

Cleveland Clinic’s statement detailing the successful procedure notes that patients with severe TR and RHF have typically had limited treatment options. Tricuspid valve surgery is associated with significant risks, for instance, and prescribing diuretics is problematic when the patient also presents with kidney problems.

“TricValve can potentially provide an effective and low-risk solution for many patients who currently have no treatment options,” Puri said, adding that the workflow is quite similar to transcatheter aortic valve replacement.

The TricValve Transcatheter Bicaval Valves System was developed by P+F Products + Features GmbH, a healthcare technology company based out of Vienna, Austria. The solution was granted the FDA’s Breakthrough Device designation in December 2020, but it has still not gained full FDA approval.

This procedure was completed under a compassionate-use clearance from the FDA.

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VIDEO: TAVR durability outperforms surgical valves

How the continued rise of TAVR has impacted SAVR outcomes

VIDEO: Pascal effective in transcatheter repair of tricuspid valve regurgitation

VIDEO: MitraClip vs. surgical mitral valve replacement

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Breakthrough Procedure in Aortic Valve Repair: VIDEO: How to Perform a Transcaval TAVR Procedure

Reporter: Aviva Lev-Ari, PhD, RN

UPDATED on 7/21/2022

VIDEO: TAVR’s long-term impact on patient care

Dave Fornell | June 23, 2022 | TAVR

We spoke with Azeem Latib, MD, section head and director of interventional cardiology and director of structural heart interventions for Montefiore Health System. Latib also served as a program director for the 2022 Transcatheter Valve Therapeutics (TVT) Structural Heart Summit.

In our chat, he summarized the key advances in transcatheter aortic valve replacements (TAVR) therapy and explained a key TAVR trend that came out of TVT for “lifetime patient management.”

It was clear at the meeting that the standard-of-care thinking on TAVR replacements has shifted from just getting a valve implanted and managing immediate complications to looking decades down the road and considering next steps with that same patient. TAVR now makes up about 70% or more of the procedure volume for aortic valve replacements. Latib said the focus of many sessions at TVT was on the longer-term management of valve patients since it is clear TAVR is becoming the standard of care. If a patient gets surgical or TAVR valve today, they will likely need a replacement in 10-20 years. More times than not, Latib explained, this replacement will come in the form of another TAVR valve deployed inside the first valve.

Latib said several sessions discussed what strategy is best, with many experts favoring surgical valve replacement first and two TAVR procedures later in life to eliminate the need for open heart surgery when the patient is much older and more frail. However, many experts admitted this might not be the strategy that gets adopted as a practical standard of care because most patients want the less invasive option versus surgery. 

“I think all the companies have realized that they need to move their technologies in that direction,” Latib explained. “The bar has been set really high and so we are going to see a lot of new technologies or iterations of technology.”

The Edwards Lifesciences Sapien X4, the forth generation of the Sapien valve, is about to start the ALLIANCE pivotal trial. It is designed specifically for lower-risk patients with a lower frame height for better coronary access and it is the first balloon-expandable valve that allows the operator to turn the valve to align the commissures, which also will aid further coronary access. The valve is also designed to reduce the need to use oversized valves to ensure a good fit in the anatomy

“What this means is when you do the next valve you are not going to have issues with coronary access and having a more physiologically aligned valve on the commissures made help the valve last longer,” Latib said. 

He said the Abbott Portico and Boston Scientific Acurate Neo2 TAVR systems are also undergoing revisions to make them more user friendly and compatible with the shifting needs of TAVR.

More resources:

VIDEO: What is needed to build a structural heart program — Interview with Charles Davidson, MD

VIDEO: TAVR durability outperforms surgical valves — Interview with Michael Reardon, MD

How the continued rise of TAVR has impacted SAVR outcomes

Is TAVR a sensible choice for patients with moderate, symptomatic aortic stenosis? Medtronic aims to find out

Left bundle branch block after TAVR hurts outcomes, even when no permanent pacemaker is required

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Tiberio Frisoli, M.D., interventional structural cardiologist, senior staff physician, Henry Ford Hospital, explains how his center performs transcaval transcatheter aortic valve replacement (TAVR) access for patients who have suboptimal abdominal aortic and femoral vascular anatomy. Transcaval access was pioneered at Henry Ford Hospital and involves using femoral vein access and then using a surgical radio frequency cutter to bore a hole from the interior venacava into the aorta to allow the TAVR delivery catheter to path through. 

This procedure was developed to enable more patients to receive TAVR via the preferred femoral access route. Some patients are not candidates for femoral artery access because of calcified lesions and heart atherosclerotic plaque, which narrows the vessel lumen, and makes it difficult to thread catheters through. The transcaval access technique can bypass the restricted arteries or heavy calcified plaques to still enable a minimally invasive procedure without the need for surgery. 

This video was produced in partnership from Henry Ford Hospital.

Related Transcaval TAVR Content:

VIDEO: Transcaval Access in TAVR Procedures — Interview with Adam Greenbaum, M.D.

How to Perform Transcaval TAVR Access

VIDEO: Walk Through of the Henry Ford Hospital Structural Heart Cath Lab

Study Deems Transcaval Valve Replacement Pioneered at Henry Ford Hospital Successful

First Transcaval Aortic Valve Replacement Performed in Europe

Additional articles and videos on Henry Ford Hospital 

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