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

Hadassah Opens Israel’s First Heart Valve Disease Clinic

Reporter: Aviva Lev-Ari, PhD, RN



“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 Currently, these invasive procedures are often superseded by less invasive cardiac catheterizations.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.”



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The presence of any Valvular Heart Disease (VHD) did not influence the comparison of Dabigatran [Pradaxa, Boehringer Ingelheim] with Warfarin

Reporter: Aviva Lev-Ari, PhD, RN


UPDATED on 10/22/2018

Dabigatran (Pradaxa) was no better than aspirin for prevention of recurrent stroke among patients with an embolic stroke of undetermined source in the RE-SPECT ESUS trial reported at the World Stroke Congress.


Pradaxa® (dabigatran etexilate)
Clinical experience of Pradaxa® equates to over 9 million patient-years in all licensed indications worldwide. Pradaxa® has been in the market for more than ten years and is approved in over 100 countries.15
Currently approved indications for Pradaxa® are:16,17
  • Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and a risk factor for stroke
  • Primary prevention of venous thromboembolic events in patients undergoing elective total hip replacement surgery or total knee replacement surgery
  • Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and the prevention of recurrent DVT and recurrent PE in adults
Dabigatran, a direct thrombin inhibitor (DTI), was the first widely approved drug in a new generation of direct oral anticoagulants, available to target a high unmet medical need in the prevention and treatment of acute and chronic thromboembolic diseases.18,19,20





Event Rate and Outcome Risk, With vs Without Valvular Heart Disease

Outcome Valvular heart disease, event rate/y, % No valvular heart disease, event rate/y, % HR (95% CI)* P
Stroke, systemic embolic event 1.61 1.41 1.09 (0.88–1.33) 0.43
Major bleeding 4.36 2.84 1.32 (1.16–1.33) <0.001
Intracranial hemorrhage 0.51 0.41 1.20 (0.83–1.74) 0.32
All-cause mortality 4.45 3.67 1.09 (0.96–1.23) 0.18
*Adjusted using propensity scores


Comparison of Dabigatran versus Warfarin in Patients with Atrial Fibrillation and Valvular Heart Disease: The RE-LY Trial

Michael D. Ezekowitz, Rangadham Nagarakanti, Herbert Noack, Martina Brueckmann, Claire Litherland, Mark Jacobs, Andreas Clemens,Paul A. Reilly, Stuart J. Connolly, Salim Yusuf and Lars Wallentin



Results—There were 3950 patients with any VHD:

  • 3101 had mitral regurgitation,
  • 1179 tricuspid regurgitation,
  • 817 aortic regurgitations,
  • 471 aortic stenosis and
  • 193 mild mitral stenosis.

At baseline patients with any VHD had more

  • heart failure,
  • coronary disease,
  • renal impairment and
  • persistent atrial fibrillation.

Patients with any VHD had higher rates of

  • major bleeds (HR 1.32; 95% CI 1.16-1.5)

but similar

  • stroke or systemic embolism (SEE) rates (HR 1.09; 95% CI 0.88-1.33).

For D110 patients, major bleed rates were lower than warfarin (HR 0.73; 95% CI 0.56-0.95 with and HR 0.84; 95% CI 0.71-0.99 without VHD) and

For D150 similar to warfarin in patients with (HR 0.82; 95% CI 0.64-1.06) or without VHD (HR 0.98; 95% CI 0.83-1.15).

For D150 patients stroke/SEE rates were lower versus warfarin with (HR 0.59; 95% CI 0.37-0.93) and without VHD (HR 0.67; 95% CI 0.52-0.86) and similar to warfarin for D110 irrespective of presence of VHD (HR 0.97 CI 0.65-1.45 and 0.85 CI 0.70-1.10).

For intracranial bleeds and death rates for D150 and D110 were lower vs warfarin independent of presence of VHD.

Conclusions—The presence of any VHD did not influence the comparison of dabigatran with warfarin.

Clinical Trial Registration—URL: http://clinicaltrials.gov. Unique Identifier: NCT00262600.





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Clinical Trials for Transcatheter Mitral Valves Annulus Repairs and TAVR: CT Structural Software for Procedural Planning and Anatomical Assessments

Reporter: Aviva Lev-Ari, PhD, RN






What to Look for in CT Structural Heart Planning Software

An interview with Jonathan Leipsic, M.D., FSCCT, chairman of the department of radiology, St. Paul’s Hospital, Vancouver, Canada, at the Society of Cardiovascular Computed Tomography (SCCT) 2016 meeting. Leipsic is heavily involved with the procedural planning and anatomical assessments for TAVR and clinical trials for new transcatheter mitral valves and annulus repairs. 


From: Diagnostic and Interventional Cardiology <mail@sgc-ecms.com>

Reply-To: <DoNotReply@sgc-ecms.com>

Date: Monday, August 15, 2016 at 11:20 AM

To: Aviva Lev-Ari <AvivaLev-Ari@alum.berkeley.edu>

Subject: VIDEO: What to Look for in CT Structural Heart Planning Software

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Moderate Ischemic Mitral Regurgitation: Outcomes of Surgical Treatment during CABG vs CABG without Mitral Valve Repair

Curator: Aviva Lev-Ari, PhD, RN


Original Article

Michler RE et al. Two-year outcomes of surgical treatment of moderate ischemic mitral regurgitation. N Engl J Med2016 Apr 3; [e-pub]. (http://dx.doi.org/10.1056/NEJMoa1602003)

– See more at: http://www.jwatch.org/na40963/2016/04/03/repairing-moderate-mitral-regurgitation-during-cabg-update#sthash.3wfUSvPm.dpuf


April 3, 2016

Repairing Moderate Mitral Regurgitation During CABG: An Update


Harlan M. Krumholz, MD, SM reviewing Michler RE et al. N Engl J Med 2016 Apr 3.

Two-year findings do not support widespread adoption of the combined procedure.

When the Cardiothoracic Surgical Trials Network randomized 301 patients with moderate mitral regurgitation to undergo coronary artery bypass grafting (CABG) alone or CABG plus mitral valve repair, the two groups had similar postsurgical ventricular dimensions, survival, and major adverse events at 1 year. However, the combined-procedure group had a significantly lower prevalence of moderate-to-severe mitral regurgitation — but longer postsurgical hospital stays and higher incidences of postoperative supraventricular arrhythmias and serious neurologic events (NEJM JW Cardiol Jan 2015 and N Engl J Med 2014; 371:2178).

We now have the 2-year findings.

  • The postsurgical left-ventricular end-systolic volume index was again similar between the two groups.
  • Two-year mortality was slightly, but not significantly, higher with CABG alone than with the combined procedure (10.6% vs. 10.0%)
  • CABG-alone group had a significantly higher incidence of moderate-to-severe mitral regurgitation (32% vs. 11%).
  • The two groups had similar rates of hospital readmission and
  • The two groups had similar major adverse events,
  • Most quality-of-life scores were similar between the two groups.

except that

  • serious neurologic events and supra-ventricular arrhythmias were significantly more common with the combined procedure.



Michler RE et al. Two-year outcomes of surgical treatment of moderate ischemic mitral regurgitation. N Engl J Med2016 Apr 3; [e-pub]. (http://dx.doi.org/10.1056/NEJMoa1602003)




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

Articles on Heart Failure N=6


Articles on coronary artery bypass graft CABG N=36


Articles on Pharmacotherapy of Cardiovascular Diseases N=296


Articles on Mitral Valve Repair or Replacement N = 47

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FDA approves 4th-gen MitraClip for TMVR 

Updated Issue with Delivery System Deployment Process: MitraClip Clip Recalled by Abbott Vascular

Reporter: Aviva Lev-Ari, PhD, RN


UPDATED on 11/21/2019

MitraClip Cases Often Involve Risky Pulmonary HTN

Intervention should be earlier in the disease course, study suggests

by Nicole Lou, Reporter, MedPage Today/CRTonline.org

As in the case of mitral valve surgery, there is a graded association between pulmonary hypertension and increased mortality following the MitraClip procedure, a registry study showed.

Higher invasive mean pulmonary arterial pressure (mPAP) at baseline was associated with greater likelihood of death and heart failure readmission 1 year after transcatheter mitral valve repair (P<0.001):

  • No pulmonary hypertension (mPAP <25 mm Hg): 27.8%
  • Mild pulmonary hypertension (mPAP 25-34 mm Hg): 32.4%
  • Moderate pulmonary hypertension (mPAP 35-44 mm Hg): 36.0%
  • Severe pulmonary hypertension (mPAP 45 mm Hg or above): 45.2%

The overall incidence of the composite outcome was 33.6% in a U.S. registry that showed most people going into valve repair with at least mild pulmonary hypertension, according to the report by Sammy Elmariah, MD, MPH, of Massachusetts General Hospital in Boston, and colleagues, published online in JAMA Cardiology.

After multivariable adjustment, pulmonary hypertension remained significantly associated with mortality (HR 1.05 per 5-mm Hg increase in mPAP, 95% CI 1.01-1.09) and heart failure hospitalization (HR 1.04 per 5-mm Hg increase in mPAP, 95% CI 1.01-1.07) after MitraClip placement.

The findings have implications for patient management, according to Elmariah’s team.

Primary Source

JAMA Cardiology

Source Reference: Al-Bawardy R, et al “Association of pulmonary hypertension with clinical outcomes of transcatheter mitral valve repair” JAMA Cardiol 2019; DOI: 10.1001/jamacardio.2019.4428.



UPDATED on 7/17/2019

FDA approves 4th-gen MitraClip for TMVR



UPDATED on 9/20/2018

TCT: Second Chance for MitraClip in Functional Mitral Regurgitation?

COAPT takes the spotlight in San Diego

by Nicole Lou, Contributing Writer, MedPage Today

This article is a collaboration between MedPage Today® and:

 Medpage Today

SAN DIEGO — The highly-anticipated COAPT trial — examining cardiovascular outcomes in certain heart failure patients treated with the MitraClip device — will be a highlight of the upcoming Transcatheter Cardiovascular Therapeutics (TCT) conference, which turns 30 years old this year.

COAPT will be the MitraClip’s shot at redemption and features a similar patient population as the MITRA-FR trial, which showed no improvement over medical therapy alone for preventing hard outcomes in heart failure patients with secondary mitral regurgitation. MITRA-FR was recently presented at the European Society of Cardiology meeting.




Photo of MitraClip Clip Delivery System®



Device Use

The Abbott Vascular MitraClip Delivery System is intended to treat patients with degenerative mitral regurgitation (DMR) a condition involving a dysfunction of the heart’s mitral valve. The MitraClip Clip Delivery System is indicated for use in patients who have been determined to be at prohibitive risk for mitral valve surgery.

The delivery system has three parts: a delivery catheter; a steerable sleeve; and an implantable clip. The implantable clip is introduced into the left atrium of the heart through the steerable sleeve and the delivery catheter. The implantable clip is then positioned and closed between the leaflets that separate the left atrium and the left ventricle to reduce the reversed blood flow.

Reason for Recall

Abbott Vascular has received reports of cases where the Clip Delivery System could not be detached from the Clip due to a malfunction of the device. These cases resulted in open heart surgery to retrieve the delivery system. Abbott Vascular is therefore recalling the MitraClip Delivery System to provide updated instructions and training for health care providers who use the device.

The use of affected products may cause serious adverse health consequences, including serious patient injury or death. Currently there are 3,534 devices on the market, with nine reports of this malfunction. There has been 1 death.

Who May be Affected

  • Health care providers implanting the MitraClip Clip Delivery System
  • All patients undergoing a mitral regurgitation procedure using the MitraClip Clip Delivery System

What to Do

On February 4, 2016, Abbott Vascular issued a safety notice to all physicians using the device instructing them to:

  • Carefully read the revised deployment sequence instructions
  • Participate in training with an Abbott Vascular representative
  • Share the information with other pertinent staff

Contact Information:

Customers can contact Abbott Vascular Customer Support at 1-800-227-9902.

Date Recall Initiated:

February 4, 2016

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program online, by regular mail or by FAX.




Abbott Issues Voluntary Safety Notice on MitraClip® Delivery System Deployment Process

MitraClip Delivery System by Abbott: Safety Notice – Reinforcement of Proper Procedures to Operate and Deploy

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UPDATED on 3/17/2019


The Pascal transcatheter mitral valve repair system was approved for use in Europe, Edwards announced. (MassDevice) Level III echo training has been around for years but is now codified in a statement from the American College of Cardiology, the American Heart Association, and the American Society of Echocardiography.

Prospects for First-in-man Implantation of Transcatheter Mitral Valve by Direct Flow Medical

Reporter: Aviva Lev-Ari, PhD, RN

  • Market share for surgically implantable  devices 800,000 U.S. annually
  • Market share for Mitral Valve Repair an untapped 5-6M annually patient population 


From: Edward Hlozek <mind.and.associates.inc@gmail.com> on behalf of Edward Hlozek <ehlozek@valvecure.com>

Date: Thursday, March 3, 2016 at 12:55 PM

To: Aviva Lev-Ari <AvivaLev-Ari@alum.berkeley.edu>

Subject: Re: Prospects for First-in-man Implantation of Transcatheter Mitral Valve by Direct Flow Medical | Leaders in Pharmaceutical Business Intelligence

VIEW IMAGES of the Procedure

Current Products at Direct Flow Medical



Published on Jul 23, 2013

Dr. Randy Martin and Corporate Vice President of Edwards Lifesciences, Don Bobo, discuss the current state of mitral valve disease in the U.S. and the need for additional education around mitral valve repair.

The AATS 2013 Mitral Conclave convened on May 2nd and 3rd, 2013, to bring the world’s leading figures in mitral valve disease together to discuss management guidelines, imaging, pathology, minimally invasive procedures, percutaneous approaches, surgical techniques, devices, and long-term results.

The 1,000+ attendees included leaders in the field of mitral valve surgery and physicians from more than 60 countries. The Mitral Foundation is proud to have sponsored this video series, “Thought Leaders” hosted by Dr. Randy Martin.

View the complete AATS 2013 Mitral Conclave webcast at http://www.aats.org/mitral/webcast
Learn more about the Mitral Foundation, including education and training opportunities, at http://www.mitralfoundation.org

Direct Flow Medical® Transcatheter Aortic Valve System

The Direct Flow Medical system is designed to treat aortic stenosis with minimal risk of aortic regurgitation, a significant clinical complication with current transcatheter aortic heart valve replacement (TAVR) systems. By reducing the risks of TAVR, the Direct Flow Medical system is designed to improve the long-term outcomes of patients undergoing this procedure.

The system’s unique design encompasses a distinctive metal-free valve frame and flexible, low-profile delivery system, which enables limitless repositionability and repeated assessment of full hemodynamic performance before final implantation.




Direct Flow Medical Unveils Transcatheter Mitral Valve

Company hopes to achieve first-in-man implantation in fourth quarter of 2016

Direct Flow Medical, transcatheter mitral valve, preclinical case

February 18, 2016 — Direct Flow Medical Inc. announced its transcatheter mitral valve (TMV) development program at the 2nd Annual Zurich Heart Team Mitral Valve meeting by featuring the Direct Flow Medical Transcatheter Mitral Valve in a preclinical case presentation.

The Direct Flow Medical Transcatheter Mitral Valve is built upon the conformable, repositionable and retrievable Direct Flow Medical Transcatheter Aortic Valve. The aortic valve has more than 2,500 implants and excellent published clinical results including low rates of paravalvular leak, pacemaker implant and mortality. The mitral-specific valve design features low atrial profile, low ventricular projection, and unique conformable sealing and fixation rings for the complex mitral annulus.

Azeem Latib, M.D., San Raffaele Hospital, Milan, presented preclinical results demonstrating transapical implant feasibility. Latib noted, “The valve’s unique conformable ring design is ideally suited for the complex shape of the mitral annulus.” He said, “Implanting this valve was similar to implanting the Direct Flow Medical Transcatheter Aortic Valve as I had total procedural control and performed a full hemodynamic assessment prior to deployment.”

Direct Flow Medical President and CEO Dan Lemaitre said that much of the mitral valve’s preclinical testing is completed, and the company hopes to achieve a first-in-man implant objective in the fourth quarter of 2016.

For more information: www.directflowmedical.com

– See more at: http://www.dicardiology.com/content/direct-flow-medical-unveils-transcatheter-mitral-valve#sthash.WTb1EvYs.gc3onuP1.dpuf

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Boston Scientific ($BSX) has obtained an exclusive $200 million option to acquire Israel’s MValve Technologies, maker of a transcatheter mitral valve replacement (TMVR) system for mitral regurgitation

Reporters: Gerard Loiseau and Aviva Lev-Ari, PhD, RN

Boston Scientific announces $200M option to purchase Israeli transcatheter mitral valve player


By Varun Saxena

Boston Scientific’s Lotus valve is implanted in the mitral valve using MValve’s docking system–Courtesy of Boston Scientific

Boston Scientific ($BSX) announced that it has obtained an exclusive $200 million option to acquire Israel’s MValve Technologies, maker of a transcatheter mitral valve replacement (TMVR) system for mitral regurgitation. Boston Scientific also said it is providing additional financing to the company in anticipation of a first in-human clinical trial. The bigwig has been financing MValve since 2012.

The official announcement of the option came just now, though Israeli newspaper paper Globes broke the news last year. Such a transaction would add to the $1 billion-plus spent by competitors Abbott ($ABT), Medtronic ($MDT) and Edwards ($EW) in recent months, as they place their bets on different companies in the hopes of winning the battle for transcatheter mitral valve dominance. The treatment paradigm is expected to someday become several multiples of the fast-growing market for transcatheter aortic valve replacements, estimated to be $2 billion at present.

MValve is developing a docking system for TMVR that works in conjunction with Boston Scientific’s Lotus Valve (currently used for TAVR, at least in Europe). That makes Boston Scientific’s approach distinct from those of its competitors, which are acquiring companies that make the actual implants as well as the associated delivery catheters. In general, delivery systems pose fewer clinical risks than the implants that they deliver, so Boston Scientific’s strategy could prove clever, assuming its Lotus Valve proves efficacious in the mitral valve too.

“The TMVR segment represents another significant growth opportunity as we continue to build our Structural Heart portfolio,” said Kevin Ballinger, senior vice president and president of Boston Scientific’s interventional cardiology unit, in a statement. “This round of financing will support the development of the MValve technology in anticipation of a first-in-human clinical trial, and we are pleased to be continuing our collaboration.”

In fact, MValve just announced the first implantation of the Lotus TAVR using its docking system. The procedure occurred in Bonn, Germany, on a 72-year-old with mitral valve disease and a failing surgical valve. Mitral valve surgery and other transcatheter therapies were not possible due to the patient’s challenging anatomy, heavy calcification, and failed prior treatments attempts, according to an MValve release, demonstrating how transcatheter technologies enable treatment in patients who otherwise lack options.

“The MValve docking device provides a secure platform within the mitral annulus, enabling the implantation of an approved transcatheter heart valve, such as the Lotus valve, in the native mitral position,” said Dr. Maurice Buchbinder, the founder of MValve, in a statement. “This procedure in many ways mimics the ‘Valve-in-Valve’ or ‘Valve-in-Ring’ procedures currently performed in patients with degenerated previously implanted surgical prostheses.”

The procedure was conducted using a transapical (between the ribs in the chest) delivery approach. The transfemoral approach (through the arteries in the leg) is generally considered the most desirable for transcatheter devices.

Following the clinical and economic success of TAVRs, investors are supportive of bigwigs’ move to enter what promises to be an even more lucrative arena. But left ventricular assist device specialist HeartWare ($HTWR) saw its stock fall 20% when it announced the acquisition of Israel’s Valtech Cardio, which is developing transcatheter and surgical devices for mitral valve repair and replacement. Compounding matters, activist investor Engaged Capital just took a 5% stake in the company and is campaigning to block the transaction.

Still, TMVR is a must-(pay-to-)play market for cardiology generalists like Boston Scientific. So far, the bigwigs have focused on mitral valve replacement, but mitral valve repair is showing promise too, as evidenced by the recent $5 million Series A financing round for Germany’s coramaze technologies.

The only approved transcatheter devices for the mitral valve are in the repair arena, led by Abbott’s FDA-approved Mitraclip, which earns $250 million per year. Cardiac Dimension’s Carillon device and Valtech’s Cardioband have CE marks.

Expect more data from aspirants like Harpoon Medical at the upcoming Transcatheter Therapies Conference in San Francisco. Due to the surge in dealmaking for mostly unapproved devices, several early-stage companies are exiting stealth mode.

But not MValve. The company doesn’t have a website, for it doesn’t need suitors due to Boston Scientific’s financial backing and $200 million option.



Other related articles on this topic published in this Open Access Online Scientific Journal, including the following:


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