Historically, chordae replacement has been used with high reproducibility and excellent results for repairing leaflet prolaspe but has required open-heart surgery with bypass to stop the heart while the repair is performed. The NeoChord DS1000 is a disposable device that is intended to replace damaged chordae by delivering artifical chordae tendinae or "neochords" in a beating heart using minimally invasive techniques. In patients with severe degenerative mitral valve regurgitation, early surgery is recommended for patients with no symptoms because the probability of surgical success is high. Waiting until symptoms develop is associated with harmful changes in the heart’s structure and function that may increase the potential for surgical complications. However, patients with no symptoms might be reluctant to undergo open-heart surgery with bypass. The NeoChord DS1000 may offer patients a less invasive procedure choice.
The NeoChord procedure is performed on the beating heart through a 2 to 3 inch incision between the ribs, unlike some repair procedures where the sternum is cut and the rib cage is spread open. Using echocardiographic guidance, the NeoChord DS1000 is introduced through the lowest part of the heart (apex), into the left ventricle, and between the mitral valve leaflets. The prolapsed leaflet is then grasped using the expandable jaws of the device. When the monitor confirms that the leaflet has been adequately captured, the ePTFE suture is deployed and attached to the leaflet. The suture is then pulled through the apex of the heart as the DS1000 is removed. The correct length of the suture is determined by using real time echocardiographic guidance and observing the improvement in mitral valve regurgitation in the beating heart. The suture is then secured to the apex of the heart.
The goal of mitral valve repair is to restore natural leaflet motion and to preserve a large valve opening with leaflets that fit well together. The NeoChord DS1000 is designed with these goals in mind and uses minimally invasive surgical techniques, potentially avoiding the complications associated with open- heart surgery performed on a stopped heart. The surgeon gets immediate confirmation that the regurgitation is reduced, unlike procedures where the repair is done on a stopped heart and the heart must be started again to determine if the repair was successful. The benefits of minimally invasive mitral valve surgery may include a shorter hospital stay, faster recovery and less scarring.
The NeoChord DS1000 (A) has the following features: A tip with expandable jaws to grasp the leaflet and 4 fiber-optic channels (B) each of which corresponds to an indicator light on the device monitor (C) to confirm proper leaflet capture. The needle (D) is also included in the device to deploy the suture after confirmation of leaflet capture.
Seeburger J, Leontjev S, Neumuth M, Noack T, Höbartner M, Misfeld M, Borger MA, Mohr FW. Trans-apical beating-heart implantation of neo-chordae to mitral valve leaflets: results of an acute animal study. Eur J Cardiothorac Surg. 2011 May 17. [Link]
Seeburger J, Borger MA, Tschernich H, Leontjev S, Holzhey D, Noack T, Ender J, Mohr FW. Transapical Beating Heart Mitral Valve Repair. Circulation: Cardiovascular Interventions. 2010; 3: 611-612.[Link]
Seeburger J, Winkfein M, Höebartner M, Noack T, Kiefer P, Vollroth M, Leontjev S, Mohr FW. Transapical neochord implantation. Multimedia Manual of Cardiothoracic Surgery. doi:10.1510/mmcts.2010.004606[Link]
Leipzig – Dallas International Heart 2011 - 7th International Live Case Meeting, December 1-3, 2011.Dr. Seeburger presented a paper featuring the NeoChord DS1000 entitled, “Transapical Off-Pump Mitral Valve Repair.”[Link]
Transcather Cardiovascular Therapeutics (TCT -2011), November 7-11, 2011.Dr. Richard Daly presented a paper entitled, “Off-pump, Transapical Placement of Artificial Chordae Tendinae to Correct Mitral Insufficiency: European Trial Update.”
25th Annual Meeting of the European Association for Cardio-Thoracic Surgery, October 1-5, 2011.Dr. Seeburger presented a paper entitled, “Value of Three-Dimensional Real-Time Transoesophagel Echocardiography in Guiding Transapical Beating Heart Mitral valve Repair” that featured the NeoChord DS1000.[Link]
Dallas – Leipzig International Valve 2010 Meeting, December 9-11, 2010.Dr. Michael Borger presented the DS1000 system.
Transcather Cardiovascular Therapeutics (TCT -2010), September 21-25, 2010.Dr. Seeburger presented, “Transapical Beating Heart Mitral Valve Repair With Implantation of Neo-Chordae - Initial Clinical Experience.”
24th Annual Meeting of the European Association for Cardio-Thoracic Surgery, September 11, 2010.Dr. Seeburger presented, “Transapical chordal replacement: First clinical experience.”[Link]
TACT (Transapical Artificial Chordae Tendinae) Trial
The TACT trial is a multi-center, nonrandomized, prospective evaluation of the NeoChord DS1000 device. The trial is ongoing in Europe including sites in Germany, Italy, and Lithuania. The principle investigator of the TACT trial is Dr. Friedrich Wilhelm Mohr. Initial results are encouraging and were most recently presented at the 2011 Transcatheter Cardiovascular Therapeutics Meeting by Dr. Richard Daly. The TACT trial has also been presented at major cardiac meetings.[See Publications] For more information about the TACT trial, please contact us at email@example.com.
The NeoChord DS1000 System is CE marked and approved for sale in Europe.
CAUTION: In the United States, the NeoChord device is not available for commercial use.