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Archive for the ‘Mitral Valve: Repair and Replacement’ Category

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

Posted in Cardiac and Cardiovascular Surgical Procedures, Mitral Valve: Repair and Replacement, Robotically assisted Cardiothoracic Surgery on July 22, 2022| Leave a Comment »

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

Reporter: Aviva Lev-Ari, PhD, RN

Mitral valve surgery is performed when the heart’s mitral valve needs to be repaired. Traditionally, mitral valve surgery required opening the chest and putting the patient on heart-lung bypass to keep blood circulating during surgery. Since 2016, UCSF surgeons have been performing minimally invasive mitral valve surgery without having to open the sternum and with smaller incisions. Robotically assisted mitral valve surgery adds yet another level of precision.

“Robotically assisted mitral valve surgery allows us to make even smaller incisions with greater precision,” said Tom C. Nguyen, M.D., robotic heart surgeon and chief of Cardiothoracic Surgery at UCSF. “By using the robotic arms, we have more degrees of articulation than with our natural wrists. The robot also magnifies the surgical field 10X in 3D. Ultimately, this translates into more precise surgery with faster recovery.”

During the robotically assisted surgery, the surgeon looks through a 3D camera to see the mitral valve as well as other structures inside the heart. The surgeon uses the robotic surgical system to guide the robotic arms and movements of the surgical instruments.

“Every valve looks different, and the extraordinary 3D vision that the robot camera provides, is just a real step up from all the technologies we have been using in the past,” said Tobias Deuse, M.D., cardiac and transplant surgeon and director of Minimally-invasive Cardiac Surgery. “The camera, together with the increased mobility of the instruments, allows for a very thorough evaluation of the valve and helps us make good and long-lasting repairs.”

Thanks to these innovations, mitral valve patients have fewer complications and can be discharged within three-to-four days. This patient’s symptoms included increased fatigue and palpitations. Since the surgery, he is at home and his recovery is going well.

In addition to mitral valve surgery, there are plans for additional robotically assisted cardiothoracic surgeries, including removal of intracardiac tumors and myxomas as well as for coronary revascularization.

SOURCE

https://www.universityofcalifornia.edu/news/ucsf-performs-first-robotic-cardiac-surgery-san-francisco?utm_source=fiat-lux&utm_medium=internal-email&utm_campaign=article-general&utm_content=text

Other robotic surgeries currently being performed at UCSF

encompass a wide range of specialties and procedures, including:

removing cancerous tissue from the lungs, uterus, ovaries, colon, rectum, esophagus, bladder, prostate, head and neck, liver and pancreas. Other robotic surgeries are used for
the treatment of uterine fibroids and endometriosis, female pelvic organ prolapse repairs,
hernia repairs and
bariatric surgery.

Other related articles on Mitral Valve Repair published in this Open Access Online Scientific Journal include the following:

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

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

https://pharmaceuticalintelligence.com/2022/04/20/tricvalve-transcatheter-bicaval-valves-system-interventional-cardiologists-at-cleveland-clinic-have-successfully-completed-the-first-implantation-in-north-america/

and another 64 articles

https://pharmaceuticalintelligence.com/?s=Mitral+valve

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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

Cardiac Surgery Recommendations Switch to Patient Blood Management

— Four societies outline pre- to post-op strategies to improve outcomes

by Crystal Phend, Contributing Editor, MedPage Today June 30, 2021

Reporter: Aviva Lev-Ari, PhD, RN

STS/SCA/AmSECT/SABM Update to the Clinical Practice Guidelines on Patient Blood Management

Published:June 30, 2021 DOI:https://doi.org/10.1016/j.athoracsur.2021.03.033

Switching from “blood conservation” to the broader “patient blood management” (PBM) approach is probably the biggest change, Tibi told MedPage Today.

“Basically we’re considering blood as another vital organ,” he said. “Why that is important is because now we look at a patient’s blood system as an organ that needs to be assessed and treated for the sake of that organ and not simply to decide when or when not to transfuse.”

Recommendations span the entire spectrum from preoperative assessment of bleeding risk and anemia to intraoperative perfusion and blood salvage practices to postoperative treatment with human albumin for volume replacement.

“Most hospitals around the U.S. are acutely aware of patient blood management and, to some degree or another, are implementing many of the things we are talking about,” noted Tibi, who is immediate past president of SABM. Nationwide, the amount of blood transfused in cardiac surgery has dropped 45% in the past 10 to 15 years but still ranges widely from center to center.

SOURCE

https://www.annalsthoracicsurgery.org/article/S0003-4975(21)00556-7/fulltext

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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 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

Posted in Cardiac and Cardiovascular Surgical Procedures, Implantation, Mitral Valve: Repair and Replacement, Replacement, TMVR - Transcatheter Mitral Valve Repair, tagged Left ventricular outflow tract (LVOT) obstruction (LVOTO) on July 25, 2018| Leave a Comment »

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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Mitral Valve Repair Global Leader: Edwards LifeSciences acquired Harpoon Medical for $250 in 12/2017 followed by $690 million buyout of Valtech Cardio 1/2017 and $400 million acquisition of CardiAQ Valve Technologies in 8/2016

Posted in Cardiac and Cardiovascular Surgical Procedures, Mitral Valve: Repair and Replacement on December 8, 2017| Leave a Comment »

Mitral Valve Repair Global Leader: Edwards LifeSciences acquired Harpoon Medical for $250 in 12/2017 followed by $690 million buyout of Valtech Cardio 1/2017 and $400 million acquisition of CardiAQ Valve Technologies in 8/2016

Reporter: Aviva Lev-Ari, PhD

UPDATED on 3/25

Edwards Prevails In U.S. Patent Office Review That Finds Boston Scientific Transcatheter Valve Patent Claims Invalid

WASHINGTON, March 23, 2018 — Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced that the United States Patent and Trademark Office (USPTO) decided in Edwards’ favor in an Inter Partes Review (IPR) of Boston Scientific’s U.S. transcatheter heart valve patent, number 8,992,608 (the ‘608 patent). The USPTO determined that all claims of the ‘608 patent that have been asserted against Edwards are invalid.

The ‘608 patent was asserted against Edwards in a case filed by Boston Scientific in Delaware in 2016. Subsequently, Edwards asserted three of its own foundational transcatheter heart valve patents against Boston Scientific. The Edwards patent claims are unaffected by the USPTO’s ruling and will continue to trial, which is expected later in 2018.

Acquisitions of small players marks the ENTRY of Edwards LifeSciences into the Mitral Valve Repair Market, following MAJOR success in TAVR.

Harpoon Medical (trans apical approach) in 12/2017 and
CardiAQ Valve Technologies in 8/2016
$690 million buyout of Valtech Cardio, 1/2017 – It does not include Valtech Cardio’s trans-septal mitral valve replacement program; that business is slated to be spun out on its own before the buyout’s closing, expected in early 2017, but Edwards said last year that it’s due to keep an option to buy.

Edwards buys mitral valve repair player in $250M deal – Harpoon Medical

“The unique beating-heart repair procedure for mitral valve patients complements Edwards’ comprehensive portfolio of treatments for structural heart disease, and reinforces our commitment to innovation in cardiac surgery.”

The HARPOON system is designed to facilitate echo-guided repair of mitral valve regurgitation, by stabilizing the prolapsed mitral valve leaflet to restore proper coaptation and valve function. The HARPOON device is currently investigational and not available for commercial use. It is expected to receive CE Mark approval soon.

“There are a significant number of patients currently undergoing mitral valve surgery that we believe can benefit from Harpoon’s therapy during a minimally invasive, beating-heart procedure,” said device inventor James S. Gammie, M.D., chairman of the company’s scientific advisory board and professor and chief of cardiac surgery at the University of Maryland School of Medicine. “This therapy offers the potential for earlier treatment of degenerative mitral valve disease with faster recovery and less morbidity, while also providing the opportunity for more consistent procedures and outcomes for patients.”

Edwards will discuss the HARPOON technology further at its annual Investor Conference on Dec. 7.

Edwards Lifesciences closes $690m Valtech Cardio buy

JANUARY 24, 2017 BY BRAD PERRIELLO LEAVE A COMMENT

Edwards Lifesciences (NYSE:EW) said yesterday that it closed the $690 million buyout of Valtech Cardio and most of the heart valve repair technologies it’s developing.

Valtech makes the Cardioband device, which is designed to reshape the mitral valve using specially designed anchors.

The deal, announced in November 2016, calls for $340 million in up-front cash and another $350 million in milestones over 10 years. It does not include Valtech Cardio’s trans-septal mitral valve replacement program; that business is slated to be spun out on its own before the buyout’s closing, expected in early 2017, but Edwards said last year that it’s due to keep an option to buy.

Or Yehuda, Israel-based Valtech was the target of a previous takeover attempt by HeartWare International that was spiked early this year after a proxy war. (HeartWare itself was acquired by Medtronic (NYSE:MDT) for $1.1 billion in August.) Valtech won CE Mark approval in the European Union for Cardioband in September 2015 but the device is not approved for the U.S. market.

“We look forward to the Valtech team joining Edwards. We believe their knowledge, experience and the Cardioband technology are valuable additions to Edwards,” Edwards chairman & CEO Michael Mussallem said in prepared remarks.

Edwards Lifesciences bought CardiAQ Valve Technologies and its mitral valve device for $400 million last August.

Shares in Edwards have plummeted today in mid-day trading, down 9.1% at $89.06 as of 12:45 p.m. EST.

Last month, Edwards said it closed the $690 million buyout of Valtech Cardio and most of the heart valve repair technologies it’s developing.

Valtech makes the Cardioband device, which is designed to reshape the mitral valve using specially designed anchors.

The deal, announced in November 2016, calls for $340 million in up-front cash and another $350 million in milestones over 10 years. It does not include Valtech Cardio’s trans-septal mitral valve replacement program; that business is slated to be spun out on its own before the buyout’s closing, expected in early 2017, but Edwards said last year that it’s due to keep an option to buy.

SOURCE

http://www.massdevice.com/edwards-pauses-cardiaq-valve-clinical-trial-enrollment/

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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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Less is More: Minimalist Mitral Valve Repair: Expert Opinion of Prem S. Shekar, MD, Chief, Division of Cardiac Surgery, BWH – #7, 2017 Disruptive Dozen at #WMIF17

Posted in Cardiac and Cardiovascular Surgical Procedures, Interviews with Scientific Leaders, Mitral Valve: Repair and Replacement, PCI on May 17, 2017| Leave a Comment »

Less is More: Minimalist Mitral Valve Repair: Expert Opinion of Prem S. Shekar, MD, Chief, Division of Cardiac Surgery, BWH – #7, 2017 Disruptive Dozen at #WMIF17

Reporter: Aviva Lev-Ari, PhD, RN

Article ID #235: Less is More: Minimalist Mitral Valve Repair: Expert Opinion of Prem S. Shekar, MD, Chief, Division of Cardiac Surgery, BWH – #7, 2017 Disruptive Dozen at #WMIF17. Published on 5/17/2017

WordCloud Image Produced by Adam Tubman

Highlights LIVE Day 3: World Medical Innovation Forum – CARDIOVASCULAR • MAY 1-3, 2017 BOSTON, MA • UNITED STATES

11:45 am – 12:45 pm
Boston Scientific Ballroom

Disruptive Dozen: 12 Technologies that will reinvent Cardiovascular Care

Moderator: Calum MacRae, MD, PhD

Chief of Cardiovascular Medicine, Brigham and Women’s Hospital
Associate Professor of Medicine, Harvard Medical School

Anthony Rosenzweig, MD

Chief, Cardiology Division, Massachusetts General Hospital
Professor of Medicine, Harvard Medical School

12. Aging and Heart Disease: Can we reverse the process?

11.Nanotechnologies for Cardiac Diagnosis and Treatment

10. Breaking the Code: Diagnosis and Therapeutic Potential of RNA

9. Expanding the Pool of Organs for Transplant

8. Finding Cancer therapies without Cardiotoxicity

7. Less is more: Minimalist Mitral Valve Repair

6. Understanding Why exercise works for Just about every thing

5. Power Play: The Future of Implantable Cardiac Devices

4. Adopting the Orphan of Heart Disease

3. Targeting Inflammation in cardiovascular Disease

2. Harnessing Big Data and Deep Learning for Clinical Decision Support

Quantitative Molecular Imaging for Cardiovascular Phynotypes

SOURCE

Highlights LIVE Day 3: World Medical Innovation Forum – CARDIOVASCULAR • MAY 1-3, 2017 BOSTON, MA • UNITED STATES

Excerpts from Prem S. Shekar, MD Presentation

The success achieved with TAVR

least traumatic
short recovery
quicker return to normal lifestyle

encouraged Medical devices Manufacturers to develop Mitral Valve Repair technologies to address the large unmet need for percutaneous treatment of patients with Mitral Valve disease:

Mild or Severe (4 Million in the US, alone).

Mitral Regurgitation (MR) – imperfect closure of the valve permits blood from LV to return back towards the lungs.

Causes for MR

the degenerative myxomatous disease
senile calcific degenerative disease causing enlargement of the LV, infection or Trauma.

Mitral stenosis – narrowing of the valve

Causes for Mitral Stenosis

rheumatic fever
senile calcific degeneration – obstruction to the forward flow of blood resulting in increased fluid pressure inside the lungs.

Symptoms of MR – managed by drugs or Surgery for correction (Open Heart surgery or MIS – both procedures require use of bypass machine, the heart been stopped for the duration of repair/replacement) for Valve Repair or Valve Replacement

shortness of breath
fatigue

Uncorrected Mitral Valve disease can lead to

irregular heart rhythms
increased risk for stroke
CHF
Death

Transcatheter Mitral Valve Correction

Valve replacement
use of Repair devices on the Mitral leaflets
implantation of neochords
remodeling of the mitral annulus

Comparison of TARV with Transcatheter Mitral Valve Correction

Aortic Valve vs Mitral Valve: difference in complexity and artistic nature of Mitral repair
Ability to perform a Percutaneous repair on a Mitral Valve with same degree of accuracy and reproducibility as a Percutaneous repair on an Aortic Valve — will remain a challenge.
development of advance imaging technologies will play a key role in achieveing success with Percutaneous repair on a Mitral Valve
Percutaneous repair on a Mitral Valve need to overcome the complex structure and integrated relationship with the LV.

Leading Challenges in the Development of Percutaneous repair on a Mitral Valve Technologies

Mitral is a bigger Valve than the Aortic
It is more difficult to access
It is Asymmetrical
It lacks an anatomically well-defined annulus to which to anchor the artificial valve
Its geometry changes throughout the cardiac cycle
Placement of a replacement valve bears the risk of LV outflow tract obstruction

Patient Candidate Profile forPercutaneous repair on a Mitral Valve

Patient with a failed Mitral Valve bioprosthesis – Severe Mitral Valve Disease
Failed Mitral Valve Repairs
Senile calcific degeneration
Mitral Regurgitation unmanaged by medication
Variable surgical risk related to co-morbidities

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Cardiovascular Medical Devices: Cardiac Surgery, Cardiothoracic Surgical Procedures and Percutaneous Coronary Intervention (PCI) / Coronary Angioplasty – 248 articles

Mitral Valve Repair: Who is a Patient Candidate for a Non-Ablative Fully Non-Invasive Procedure? – Last Updated on 4/8/2017

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

Lev-Ari, A. 5/19/2014. Transcatheter Mitral Valve (TMV) Procedures: Centers for Medicare & Medicaid Services (CMS) proposes to cover Transcatheter Mitral Valve Repair (TMVR)

Transcatheter Mitral Valve (TMV) Procedures: Centers for Medicare & Medicaid Services (CMS) proposes to cover transcatheter mitral valve repair (TMVR)

Lev-Ari, A. 1/26/2014. Transcatheter Valve Competition in the United States: Medtronic CoreValve infringes on Edwards Lifesciences Corp. Transcatheter Device Patents

https://pharmaceuticalintelligence.com/2014/01/26/transcatheter-valve-competition-in-the-united-states-medtronic-corevalve-infringes-on-edwards-lifesciences-corp-transcatheter-device-patents/

Lev-Ari, A. 1/26/2014. Developments on the Frontier of Transcatheter Aortic Valve Replacement (TAVR) Devices

https://pharmaceuticalintelligence.com/2014/01/26/developments-on-the-frontier-of-transcatheter-aortic-valve-replacement-tavr-devices/

Larry H. Bernstein and Aviva Lev-Ari 6/23/2013 Survivals Comparison of Coronary Artery Bypass Graft (CABG) and Percutaneous Coronary Intervention (PCI) / Coronary Angioplasty

https://pharmaceuticalintelligence.com/2013/06/23/comparison-of-cardiothoracic-bypass-and-percutaneous-interventional-catheterization-survivals/

Larry H Bernstein and Lev-Ari, A. 6/23/2013 First case in the US: Valve-in-Valve (Aortic and Mitral) Replacements with Transapical Transcatheter Implants – The Use of Transfemoral Devices.

https://pharmaceuticalintelligence.com/2013/06/23/valve-in-valve-replacements-with-transapical-transcatheter-implants/

Larry H Bernstein and Lev-Ari, A. 6/17/2013 Transcatheter Aortic Valve Replacement (TAVR): Postdilatation to Reduce Paravalvular Regurgitation During TAVR with a Balloon-expandable Valve

https://pharmaceuticalintelligence.com/2013/06/17/postdilatation-to-reduce-paravalvular-regurgitation-during-transcatheter-aortic-valve-replacement/ 

Larry H Bernstein and Lev-Ari, A. 6/17/2013 Trans-apical Transcatheter Aortic Valve Replacement in a Patient with Severe and Complex Left Main Coronary Artery Disease (LMCAD)

https://pharmaceuticalintelligence.com/2013/06/17/management-of-difficult-trans-apical-transcatheter-aortic-valve-replacement-in-a-patient-with-severe-and-complex-arterial-disease/ 

Larry H Bernstein and Lev-Ari, A. 6/18/2013 Ventricular Assist Device (VAD): A Recommended Approach to the Treatment of Intractable Cardiogenic Shock

https://pharmaceuticalintelligence.com/2013/06/18/a-recommended-approach-to-the-treatmnt-of-intractable-cardiogenic-shock/

Larry H Bernstein and Lev-Ari, A.6/20/2013 Phrenic Nerve Stimulation in Patients with Cheyne-Stokes Respiration and Congestive Heart Failure

https://pharmaceuticalintelligence.com/2013/06/20/phrenic-nerve-stimulation-in-patients-with-cheyne-stokes-respiration-and-congestive-heart-failure/

Lev-Ari, A. 2/12/2013 Clinical Trials on transcatheter aortic valve replacement (TAVR) to be conducted by American College of Cardiology and the Society of Thoracic Surgeons

https://pharmaceuticalintelligence.com/2013/02/12/american-college-of-cardiologys-and-the-society-of-thoracic-surgeons-entrance-into-clinical-trials-is-noteworthy-read-more-two-medical-societies-jump-into-clinical-trial-effort-for-tavr-tech-f/

Lev-Ari, A. 12/31/2012 Renal Sympathetic Denervation: Updates on the State of Medicine

https://pharmaceuticalintelligence.com/2012/12/31/renal-sympathetic-denervation-updates-on-the-state-of-medicine/

Lev-Ari, A. 9/2/2012 Imbalance of Autonomic Tone: The Promise of Intravascular Stimulation of Autonomics

https://pharmaceuticalintelligence.com/2012/09/02/imbalance-of-autonomic-tone-the-promise-of-intravascular-stimulation-of-autonomics/

Lev-Ari, A. 8/13/2012Coronary Artery Disease – Medical Devices Solutions: From First-In-Man Stent Implantation, via Medical Ethical Dilemmas to Drug Eluting Stentshttps://pharmaceuticalintelligence.com/2012/08/13/coronary-artery-disease-medical-devices-solutions-from-first-in-man-stent-implantation-via-medical-ethical-dilemmas-to-drug-eluting-stents/

Lev-Ari, A. 7/18/2012Percutaneous Endocardial Ablation of Scar-Related Ventricular Tachycardia

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Lev-Ari, A. 6/13/2012Treatment of Refractory Hypertension via Percutaneous Renal Denervation

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Lev-Ari, A. 6/22/2012Competition in the Ecosystem of Medical Devices in Cardiac and Vascular Repair: Heart Valves, Stents, Catheterization Tools and Kits for Open Heart and Minimally Invasive Surgery (MIS)

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Lev-Ari, A. 6/19/2012Executive Compensation and Comparator Group Definition in the Cardiac and Vascular Medical Devices Sector: A Bright Future for Edwards Lifesciences Corporation in the Transcatheter Heart Valve Replacement Market

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Lev-Ari, A. 6/22/2012Global Supplier Strategy for Market Penetration & Partnership Options (Niche Suppliers vs. National Leaders)in the Massachusetts Cardiology & Vascular Surgery Tools and Devices Market for Cardiac Operating Rooms and Angioplasty Suites

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Lev-Ari, A. 7/23/2012Heart Remodeling by Design: Implantable Synchronized Cardiac Assist Device: Abiomed’s Symphony

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Lev-Ari, A. (2006b). First-In-Man Stent Implantation Clinical Trials & Medical Ethical Dilemmas. Bouve College of Health Sciences, Northeastern University, Boston, MA 02115

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Edwards Lifesciences closes $690m a buy of Valtech Cardio and most of the heart valve repair technologies it’s developing

Posted in Cardiac and Cardiovascular Surgical Procedures, Mitral Valve: Repair and Replacement, PCI, tagged transcatheter structural heart disease technologies on January 25, 2017| Leave a Comment »

Edwards Lifesciences closes $690m a buy of Valtech Cardio and most of the heart valve repair technologies it’s developing

Reporter: Aviva Lev-Ari, PhD, RN

Valtech’s Cardioband device is designed to reshape the mitral valve using specially designed anchors, aka

transcatheter structural heart disease technologies.

Valtech won CE Mark approval in the European Union for Cardioband in September 2015 but the device is not approved for the U.S. market.

Israel-based Valtech was the target of a previous takeover attempt by HeartWare International that was spiked early this year after a proxy war. (HeartWare itself was acquired by Medtronic (NYSE:MDT) for $1.1 billion in August.)

Deal Terms:

SOURCE

http://www.massdevice.com/edwards-lifesciences-closes-690m-valtech-cardio-buy/?utm_source=newsletter-170124&utm_medium=email&utm_campaign=newsletter-170124&spMailingID=10291384&spUserID=MTU0MTAzNDg3OTA5S0&spJobID=1081981757&spReportId=MTA4MTk4MTc1NwS2

Edwards Lifesciences closes $690m Valtech Cardio buy

JANUARY 24, 2017 BY BRAD PERRIELLO

EDWARDS LIFESCIENCES COMPLETES ACQUISITION OF VALTECH CARDIO

IRVINE, Calif., Jan. 23, 2017 – Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced that it has closed its acquisition of Valtech Cardio Ltd., a privately held company based in Israel and developer of the Cardioband System for transcatheter repair of the mitral and tricuspid valves. Edwards announced in November that it had signed an agreement to acquire Valtech.

Under the terms of the merger agreement, Edwards paid $340 million in stock and cash for Valtech at closing, subject to typical adjustments. In addition, there is the potential for up to $350 million in pre-specified milestone-driven payments over the next 10 years. Edwards’ financial guidance provided at its Investor Conference in December incorporated the expected financial impact of the transaction in 2017.

“We look forward to the Valtech team joining Edwards. We believe their knowledge, experience and the Cardioband technology are valuable additions to Edwards,” said Michael A. Mussallem, Edwards’ chairman and CEO. “This therapy has the potential to be a breakthrough structural heart therapy to help many patients in desperate need, and we look forward to gaining valuable insights from its commercial use in Europe.”

The Cardioband System is not approved for sale in the United States. The mitral application of the Cardioband System has received CE Mark in Europe.

About Edwards Lifesciences

Edwards Lifesciences, based in Irvine, Calif., is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world’s leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. For more information, visit http://www.edwards.com and follow us on Twitter @EdwardsLifesci.

SOURCE

https://www.sec.gov/Archives/edgar/data/1099800/000109980017000003/ex-991pressreleasevaltechc.htm

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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

Funding, Deals & Partnerships: BIOLOGICS & MEDICAL DEVICES; BioMed e-Series; Medicine and Life Sciences Scientific Journal – http://PharmaceuticalIntelligence.com

Archive for the ‘Mitral Valve: Repair and Replacement’ Category

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

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

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

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

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

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

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

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Mitral Valve Repair Global Leader: Edwards LifeSciences acquired Harpoon Medical for $250 in 12/2017 followed by $690 million buyout of Valtech Cardio 1/2017 and $400 million acquisition of CardiAQ Valve Technologies in 8/2016

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Edwards Lifesciences closes $690m a buy of Valtech Cardio and most of the heart valve repair technologies it’s developing

Edwards Lifesciences closes $690m Valtech Cardio buy

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

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