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Archive for the ‘TMVR – Transcatheter Mitral Valve Repair’ 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

https://pharmaceuticalintelligence.com/2022/07/22/cardiothoracic-surgeons-at-uc-san-francisco-performed-the-first-robotically-assisted-mitral-valve-prolapse-surgery-in-san-francisco/

 

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.

Image Source:

https://www.cardiovascularbusiness.com/topics/structural-heart-disease/interventional-cardiologists-complete-first-heart-procedure-its?utm_source=newsletter&utm_medium=cvb_news

Related Structural Heart Disease Content:

The latest data on mitral valve infective endocarditis after TAVR

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

Older LAAO patients, especially women, face a higher risk of complications

RELATED ARTICLES ON TAVR, STRUCTURAL HEART DISEASE, CATH LAB

SOURCE

https://www.cardiovascularbusiness.com/topics/structural-heart-disease/interventional-cardiologists-complete-first-heart-procedure-its?utm_source=newsletter&utm_medium=cvb_news

Other related articles published in this Open Access Online Scientific Journal include the following:

https://pharmaceuticalintelligence.com/?s=Valve

The LINK, above will take the e-Reader to:

  • 247 articles on HUMAN HEART VALVE-RELATED REPAIR Procedures

 

Our book on Cardiac Repair Procedures

 

https://www.amazon.com/dp/B07MKHDBHF

 

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Mitralign and Corvia, Tewksbury, Mass – Investment and Acquisition by Edwards Lifesciences

 

Reporter: Aviva Lev-Ari, PhD, RN

 

Edwards LifesciencesEdwards Lifesciences (NYSE:EW) said today that it made a pair of strategic bets on the structural heart space, paying $35 million for the right to acquire Corvia Medical and paying an unspecified amount for some of mitral valve repair device maker Mitralign‘s assets.

Tewksbury, Mass.-based Corvia is developing an interatrial shunt to treat heart failure by creating a small opening between the left and right atria to lower blood pressure in the left atrium and lungs. The device has CE Mark approval in the European Union and a pivotal U.S trial aimed at winning a nod from the FDA is under way, Edwards said.

“We are extremely pleased to have the support of the global leader in patient-focused innovations for structural heart disease as we continue to advance this novel treatment for heart failure,” Corvia president & CEO George Fazio said in prepared remarks. “We are proud of our accomplishments to date and look forward to completing the pivotal study with the support of our global clinical investigators.”

The Irvine, Calif.-based company also said it bought “certain” Mitralign assets, including intellectual property and associated clinical and regulatory experience. Mitralign, also based in Tewksbury, is developing an annuloplasty system for treating functional mitral and tricuspid regurgitation.

Edwards said the transactions are not expected to affect its financial outlook for 2019.

SOURCE

https://www.massdevice.com/edwards-lifesciences-gets-in-on-corvia-mitralign/?spMailingID=1958&puid=370787

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Left ventricular outflow tract (LVOT) obstruction (LVOTO): The Role of CT in TAVR and in TMVR

Reporter: Aviva Lev-Ari, PhD, RN

 

Left ventricular outflow tract obstruction (LVOTO) is a recognised feature of this condition which arises when blood leaving the outflow tract is impeded by systolic anterior motion of the mitral valve. LVOT obstruction was defined as a resting LVOT gradient of ≥30 mm Hg, with severe obstruction defined as ≥50 mm Hg (15).

Left ventricular outflow tract (LVOT) obstruction can occur at the valvular, subvalvular, or supravalvular level. In general, there is an obstruction to forward flow which increases afterload, and if untreated, can result in hypertrophy, dilatation, and eventual failure of the left ventricle. In the United States, most cases of LVOT obstruction are congenital in individuals younger than 50 years of age.

Jonathon Leipsic, M.D., FSCCT, professor of radiology and cardiology at the University of British Columbia, Vancouver, Canada, and an expert in transcatheter valve imaging. He spoke about his experiences with TAVR and TMVR trials and devices planning at the the Society of Cardiovascular Computed Tomography (SCCT) 2018 meeting.

Watch the VIDEO “What to Look for in CT Structural Heart Planning Software.”

Issues of Concern

Common Causes of Left Ventricular Outflow Tract Obstruction

Subaortic Stenosis (SAS)

Subaortic stenosis is narrowing at the level of the aortic valve. It may be due to a discrete ridge or fibrous ring encircling the LVOT. This fibrous membrane may extend onto the aortic valve cusps and make contact with the ventricular side of the anterior mitral leaflet. The obstruction may be focal or more diffuse, resulting in a tunnel leading out of the left ventricle. The discrete form is most common. Complex subaortic stenosis can also be seen which leads to abnormal adherence to the anterior leaflet of the mitral valve to the septum and the presence of endocardial tissue in the LVOT. These type of obstructions are commonly seen in patients with ventral septal defects (VSDs).

Clinical Significance

Left ventricular outflow tract obstructions involve stenotic lesions starting in the anatomic left ventricular outflow tract and stretching to the descending portion of the aortic arch.

Obstruction can be valvar, subvalvar, or supravalvar. Obstructions to forward flow can present alone or in concert. All of these lesions result in increased afterload on the left ventricle and if severe, result in hypertrophy and eventual dilatation and failure of the left ventricle. These lesions are usually congenital in the vast majority of individuals younger than 50 years. All patients with left ventricular outflow tract obstruction at a high risk for developing infective endocarditis and prophylaxis should be instituted.

Bicuspid Aortic Valve (BAV)

Bicuspid aortic valve is one of the most common congenital cardiovascular malformations, present in about 1% to 2% of the population and more common in males. BAV can be inherited, and family clusters have been documented. In those cases, inheritance patterns are usually autosomal dominant with variable penetrance. A mutation in the NOTCH1 gene has also been described.

BAVs arise from abnormal vasculogenesis and cusp formation, resulting in the formation of 1 smaller cusp and one larger cusp. More commonly, the right and left coronary cusps are fused. BAV is usually progressive, and most valves function normally until later in life. The abnormal valve formation leads to increased leaflet stress, more turbulent flow and restricted motion which leads to accelerated valve changes including scarring, calcification, aortic stenosis, and regurgitation. BAV is associated with dilation of the ascending aorta and increased risk of aortic dissection.

Clinical Features

The most common complication of BAV is aortic stenosis.

SOURCE

Left Ventricular Outflow Tract Obstruction

Viliane Vilcant; Ofek Hai.

https://www.ncbi.nlm.nih.gov/books/NBK470446/

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Minnesota surgeons use MitraClip for the first time to do a heart valve repair without open heart surgery

Reporter: Aviva Lev-Ari, PhD, RN

UPDATED on 7/26/2022

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

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2022/07/22/cardiothoracic-surgeons-at-uc-san-francisco-performed-the-first-robotically-assisted-mitral-valve-prolapse-surgery-in-san-francisco/

 

See on Scoop.itCardiovascular and vascular imaging

This woman became the first patient in Minnesota to receive a MitraClip for a mitral heart valve repair.

See on medcitynews.com

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