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

Posted in Aortic Valve: TAVR, TAVI vs Open Heart Surgery, Artificial Vascular Structures, Cardiac and Cardiovascular Surgical Procedures, Cardiomyopathy, Cardiovascular and Vascular Systems, Frontiers in Cardiology and Cardiovascular Disorders, Heart Failure (HF), Mitral Valve: Repair and Replacement, Pulmonary Valve Replacement and Repair, TMVR - Transcatheter Mitral Valve Repair, Transcaval TAVR Procedure, Tricuspid Valve Repair, Valves & Tools on April 20, 2022| Leave a Comment »

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

The latest data on mitral valve infective endocarditis after TAVR
Links to the ACC.22 late-breaking clinical trials
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
Key interventional cardiology takeaways from ACC.22

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

Posted in Cardiac and Cardiovascular Surgical Procedures, Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and Pulmonary Arterial Hypertension (PAH), Frontiers in Cardiology and Cardiovascular Disorders, Heart Failure (HF), Mitral Valve: Repair and Replacement, TMVR - Transcatheter Mitral Valve Repair, Tricuspid Valve Repair, Valve-in-Valve Procedure on March 11, 2019| Leave a Comment »

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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Medical Devices Early Feasibility FDA’s Pathway – Accelerated Recruitment for Randomized Clinical Trials: Replacement and Repair of Mitral Valves

Posted in Aortic Valve: TAVR, TAVI vs Open Heart Surgery, Cardiac and Cardiovascular Surgical Procedures, Mitral Valve: Repair and Replacement, Tricuspid Valve Repair on November 13, 2017| Leave a Comment »

Medical Devices Early Feasibility FDA’s Pathway – Accelerated Recruitment for Randomized Clinical Trials: Replacement and Repair of Mitral Valves

Reporter: Aviva Lev-Ari, PhD, RN

 

VIEW VIDEO

https://www.dicardiology.com/videos/video-update-mitral-valve-repair-and-replacement-technologies/5638263949001?eid=333021707&bid=1921231

 

 

HEART VALVE TECHNOLOGY | NOVEMBER 07, 2017

Ted Feldman, M.D., MSCAI FACC FESC, director of the cardiac cath lab, Evanston Hospital, explains the current state of transcatheter mitral valve technologies in development and in trials. He is involved in some of these trials and was the principal investigator for the pivotal MitraClip trial. Watch the VIDEO “Transcatheter Mitral Valve Technology, Anatomical Challenges” with Juan Granada, M.D.. Read the articles “Advances and Future Directions for Transcatheter Valves,” and “Transcatheter Mitral Valve Replacement Devices in Development.”

  • MitraClip 
  • Cardioband

 

SOURCE

https://www.dicardiology.com/videos/video-update-mitral-valve-repair-and-replacement-technologies/5638263949001?eid=333021707&bid=1921231

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Advances and Future Directions for Transcatheter Valves Mitral and tricuspid valve repair technologies now in development

Posted in Aortic Valve: TAVR, TAVI vs Open Heart Surgery, Cardiac and Cardiovascular Surgical Procedures, Frontiers in Cardiology and Cardiovascular Disorders, Mitral Valve: Repair and Replacement, Origins of Cardiovascular Disease, Tricuspid Valve Repair, Valves & Tools on December 6, 2016| Leave a Comment »

Advances and Future Directions for Transcatheter Valves – Mitral and tricuspid valve repair technologies now in development

Reporter: Aviva Lev-Ari, PhD, RN

 

Based on

http://www.dicardiology.com/article/advances-and-future-directions-transcatheter-valves

 

Read the article “First TAVR Device Receives European Approval to Treat Intermediate Risk Patients”from August 2016.

Watch the video “The Evolution of TAVR Technology.” Interview with Juan Granada, M.D., executive director and chief scientific officer of the Cardiovascular Research Foundation’s Skirball Center for Innovation, at the Transcatheter Valve Therapies 2015 meeting.

 

Watch the video “TAVR Beats Surgery — Top News From ACC.16.” Dr. Vinod Thourani, professor of surgery, Division of Cardiothoracic Surgery, Department of Surgery, Emory University School of Medicine and a co-investigator for the PARTNER II Trial, discusses the biggest news item from ACC.16 — the Sapien 3 TAVR device performed better that surgical aortic valve replacement.

Watch the video “CoreValve Trumps Surgical Valve Replacement — TVT 2015.” Interview with Michael Reardon, M.D., professor of cardiothoracic surgery at DeBakey Heart and Vascular Center, and chairman of the patient screening committee, CoreValve U.S. pivotal trial, at the Transcatheter Valve Therapies 2015 meeting.

 

Read the article “FDA Clears Sapien XT for Valve-In-Valve Procedures.”

Read the article “FDA Expands Use of CoreValve for Aortic Valve-in-Valve Replacement.”

Transcatheter Mitral Valves are the Next Frontier

Most interventional and cardiac surgical experts say TMVR will be the next frontier in minimally invasive structural heart interventions. With the success and rapid growth of TAVR, there is an immense anticipation that TMVR will have an even greater impact in cardiology. This has translated into more than $2.5 billion being spent in the past year by vendors purchasing start-up TMVR companies, while less than 50 patients have actually been treated using these technologies, said Michael Mack, M.D., medical director, cardiovascular surgery, Baylor Health Care System and chairman of The Heart Hospital Baylor Plano Research Center.

However, the mitral valve involves much more complex anatomy than the aortic valve, so the devices, imaging for procedural planning and guidance will be much more sophisticated than what is used for TAVR. Among the challenges are: fixation of a device to the very small landing zone of the mitral annulus; avoiding the left ventricular outflow tract (LVOT); avoiding compression of the atrioventricular (AV) node; avoiding the papillary muscle and chordae tendineae; ensuring the device seals properly to avoid paravalvular regurgitation; and the device needs to be able to adapt to remodeling of the anatomy. There are more than 20 TMVR devices in development. The majority of these valves utilize a self-expanding nitinol frame that engages both sides of the native mitral valve annulus for fixation, similar to Amplatzer septal closure devices.

The companies with first-in-human TMVR implants include Tendyne, Neovasc and Edwards Lifesciences’ Fortis and Sapien XT devices. The Neovasc Tiara, Tendyne Bioprosthetic Mitral Valve and CardiAQ Valve Technologies TMVR system all have been granted FDA conditional investigational device exemption (IDE) studies.

Watch the video “Transcatheter Mitral Valve Therapies in Development.” 

Watch the video “Transcatheter Mitral Valve Repair Technologies.” An interview with Ted Feldman, M.D., FACC, MSCAI, FESC, cardiac cath lab director, Evanston Hospital, North Shore Health System, and principle investigator, Everest II MitraClip U.S. pivotal trial, at the Transcatheter Valve Therapies 2015 meeting.

 

Advancements in TAVR and TMVR Technologies at TCT 2016 

Watch the video VIDEO “Transcatheter Valve Technology Advancements at TCT 2016.” This is an interview Torsten Vahl, M.D., about advancements in transcatheter valve repair technology, including new devices for the aortic, mitral and tricuspid valves. Vahl is director of experimental and translational research and assistant professor of medicine, Columbia University Medical Center, Center for Interventional Vascular Therapy.

Watch the video “VIDEO: Transcatheter Mitral Valve Technology, Anatomical Challenges.” A discussion with Juan Granada, M.D., about transcatheter mitral valve advancements and device challenges at the Transcatheter Cardiovascular Therapeutics (TCT) 2016 annual meeting. Granada is executive director and chief scientific officer of the Cardiovascular Research Foundation’s Skirball Center for Innovation.

SOURCE

FEATURE | HEART VALVE TECHNOLOGY | NOVEMBER 12, 2015| DAVE FORNELL

Advances and Future Directions for Transcatheter Valves – Mitral and tricuspid valve repair technologies now in development

http://www.dicardiology.com/article/advances-and-future-directions-transcatheter-valves

 

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

 

Mitral Valve Repair: Who is a Patient Candidate for a Non-Ablative Fully Non-Invasive Procedure?

Justin Pearlman, MD, PhD, FACC and Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/11/04/mitral-valve-repair-who-is-a-candidate-for-a-non-ablative-fully-non-invasive-procedure/

 

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Hadassah Opens Israel’s First Heart Valve Disease Clinic

Posted in Aortic Valve: TAVR, TAVI vs Open Heart Surgery, Cardiac and Cardiovascular Surgical Procedures, Mitral Valve: Repair and Replacement, PCI, Tricuspid Valve Repair on December 6, 2016| Leave a Comment »

Hadassah Opens Israel’s First Heart Valve Disease Clinic

Reporter: Aviva Lev-Ari, PhD, RN

 

WEDNESDAY, NOV 30 2016

“Until recently, the default treatment for valve disease has been open heart surgery to replace the damaged valve or valves.”

The Hadassah Medical Organization has opened Israel’s first Heart Valve Disease Clinic, which is geared toward detecting and treating the most complicated cases of heart valve disease–a growing problem in an aging population.

Until recently, the default treatment for valve disease has been open heart surgery to replace the damaged valve or valves. Currently, these invasive procedures are often superseded by less invasive cardiac catheterizations. In any case, however, efficiently treating valve disease and minimizing life-threatening risk factors such as heart attack remains an ongoing struggle for cardiovascular specialists.

As Prof. Ronen Beeri, head of Hadassah’s Cardiovascular Research Center, explains: “A ‘cardio team’ is needed to treat a patient suffering from heart valve disease. The time from referral to our Heart Institute to receive treatment from the relevant specialist can sometimes take months. Generally, patients with complex issues cannot afford to wait that long. The multidisciplinary cardio team solution at our new Clinic will help streamline the process so that a patient will receive all the necessary echocardiograms and other exams needed to diagnose and begin treatment within a week’s time.”

SOURCE

http://www.hadassah.org/news-stories/heart-valve-disease.html

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First-in-Man Mitral Valve Repairs Device used for Tricuspid Valve Repair: Cardioband used by University Hospital Zurich Heart Team

Posted in Cardiac and Cardiovascular Surgical Procedures, Tricuspid Valve Repair on October 13, 2016| Leave a Comment »

First-in-Man Mitral Valve Repairs Device used for Tricuspid Valve Repair: Cardioband used by University Hospital Zurich Heart Team

Reporter: Aviva Lev-Ari, PhD, RN

 

UPDATED on 7/17/2018

VIEW VIDEO

https://www.dicardiology.com/videos/video-tricuspid-valve-imaging-and-interventions-developing-hand-hand-0?eid=333021707&bid=2175978

Rebecca Hahn, M.D., professor of medicine and director of interventional echocardiography, Columbia University Medical Center, New York, explains that techniques for imaging the tricuspid valve, the  advanced study of its disease etiology and the rapid development of transcatheter devices to treat tricuspid valve disease are all developing together. She spoke on these topics during sessions at both the American Society of Echocardiography (ASE) 2018 meeting and at the Transcatheter Valve Therapies (TVT) conference in June.

Related Transcatheter Tricuspid Valve Content:
Recent Advances in Transcatheter Valve Technology

VIDEO: Mitral and Tricuspid Valve Repair Technologies — interview with Azeem Latib, M.D.

VIDEO: Transcatheter Tricuspid Valve Repair and Replacement Technologies — interview with Rebecca Hahn, M.D.

Minneapolis Heart Institute Foundation Enrolls First Patient in TRILUMINATE Tricuspid Repair Trial

Positive, Sustained Improvement at One Year in SCOUT I Transcatheter Tricuspid Repair Trial

Gate Bioprosthesis Used in Canada’s First Transcatheter Valve Replacement for Tricuspid Regurgitation

SOURCE

https://www.dicardiology.com/videos/video-tricuspid-valve-imaging-and-interventions-developing-hand-hand-0?eid=333021707&bid=2175978

University Hospital Zurich Heart Team First to Perform Tricuspid Valve Repair with Cardioband

Device has traditionally been used for mitral valve repairs

Cardioband, first tricuspid valve repair, University Hospital Zurich, Francesco Maisano

October 10, 2016 — Francesco Maisano, clinic director at the University Hospital Zurich, recently led a team of cardiac surgeons and cardiologists in for the first time repairing a leaky tricuspid valve using a new catheter technology.

Maisano, who is also director of the Clinic for Cardiovascular Surgery at USZ, co-director of the University Heart Center and professor at the University of Zurich, began using the Cardioband in Switzerland for repair of the mitral valve. Now he and his team have succeeded in an application at a leaky tricuspid a 75-year-old patient. The patient is doing well.

The device has been used previously as a patient-friendly method of repairing a leaking mitral valve in the left heart. It is the minimally invasive alternative to open-heart surgery. Maisano was instrumental in the development of Cardioband, which can be gathered with the help of the leaky valve ring and contracted. For this, the band is placed using a catheter around the valve ring (annulus), and is fixed there by small screws and contracted with a wire, so that the flap closes again tightly.

The tricuspid valve separates the right atrium from the right chamber of the heart. A tricuspid regurgitation, i.e. an insufficient performance of the door, can cause serious symptoms. The backflow of blood into the ventricle and in the veins occur and can cause elevated pressure. This can result in problems in the legs and in the abdomen and liver damage. Also, atrial fibrillation may be associated with the consequences of tricuspid regurgitation. The current treatment of insufficiency of the tricuspid valve consisted of a surgical open-heart surgery using a heart-lung machine.

Maisano explained the advantages of the new Cardioband method: “Since the insufficiency of this heart valve is often created as the result of mitral valve disease, open-heart surgery is often risky surgery. The use of the Cardioband minimally invasive therapy without the use of cardiopulmonary bypass protects the patient and reduces the risk.”

For more information: www.valtechcardio.com

SOURCE

http://www.dicardiology.com/content/university-hospital-zurich-heart-team-first-perform-tricuspid-valve-repair-cardioband?eid=333021707&bid=1554809

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