Dr. Chenier and the surgical team. Source: Mission’s LinkedIn.
Asheville – A team led by Dr. Michael Chenier, an interventional cardiologist with Asheville Cardiology Associates—Mission Health, performed the first commercial TriClip procedure in North Carolina. The FDA approved the TriClip system on April 2, “and our center was the first to attend the FDA-required training in a session in Austin, Texas, prior to implants,” said Chenier.
TriClip was approved as a breakthrough therapy, which means its path to commercialization was expedited because enough data was collected to demonstrate it was more beneficial than available options. The device could not complete an ordinary clinical trial process due to logistical and ethical constraints on the treatment of a control group. As a breakthrough therapy, the procedure is tightly supervised by the FDA. Candidates for the procedure are therefore advised to seek care only from high-volume centers with comprehensive cardiac teams, like Mission. It also means that Medicare won’t make a decision about coverage until later this year.
Five years ago, Chenier and Dr. Joshua Leitner, also with Mission, successfully performed the first MitraClip procedures in Western North Carolina. The MitraClip is just like the TriClip, except it is implanted in the left side of the heart. Interestingly, or astonishingly, the patent application for MitraClip was submitted by none other than celebrity doctor Mehmet Oz. Oz also helped create the company, Evalve, that brought TriClip to market and was later acquired by Abbott.
Both clips treat faulty valves connecting the heart’s upper and lower chambers. When the valves don’t close all the way, blood flows backward. It is estimated that about 80% of the world’s population suffers from some form of tricuspid regurgitation. Most suffer no pain or discomfort, but some experience symptoms of heart failure, like a racing or pounding heart, a throbbing jugular vein, swelling of the extremities or belly, shortness of breath upon exertion, and fatigue. Left untreated, tricuspid regurgitation can, in fact, lead to heart failure as well as arrhythmia or liver or kidney impairment.
Tricuspid regurgitation is often treatable medically, with loop diuretics commonly used. Before TriClip, patients who did not respond to medication would have the option of undergoing minimally-invasive surgery. This means surgeons would cut holes in the chest and insert their tools between the ribs. In some cases, though, open heart surgery was the only option.
The procedure was something like plastic surgery, patching openings by sewing rings made of fabric or biological tissue in place, or cutting leaflets into more functional shapes and sizes. In more serious cases, the valve would be replaced by either a mechanical model or one transplanted from a pig, cow, or human. What’s more, the Society of Thoracic Surgeons reviewed 6,507 cases of patients undergoing traditional tricuspid valve surgery and found 7.3% had died as a result of the procedure and 32.0% had experienced major complications, like requiring dialysis.
By way of contrast, TriClip is a transcatheter operation, meaning the doctors send the tools up through the femoral vein and into the heart. The heart pumps blood throughout the procedure, so the patient doesn’t have to be hooked up to a heart-lung machine. Consequently, a lot of people deemed too sick to withstand open heart surgery may now be treated. Thanks to technological progress in miniaturizing tools and making possible real-time imaging inside the body, transcatheter procedures are giving more and more patients better care with less trauma. People undergoing TriClip surgery can expect to go home the same day.
Like MitraClip before it, TriClip collapses what looks like a tiny mesh hat for delivery to the heart. Using what looks like a fishing rod with reels, the physician moves the hat into position, opens it, and uses it to staple two of the three tricuspid leaflets together, appreciably reducing opportunities for backwash.
The TriClip has the same general design as the MitraClip, which has treated over 200,000 patients. In fact, the MitraClip has had great results treating tricuspid regurgitation in at least 10,000 people as an off-label use. According to Abbott, TriClip fills a technology gap with special design elements for the tricuspid valve’s “complex anatomy.” These include a shorter clip tip and an extra steering knob.
The TRILUMINATE clinical trial recruited patients with severe tricuspid regurgitation who were at-risk for open heart surgery. One group underwent TriClip surgery, and the other was treated medically. Thirty days later and through a full year, 90% of TriClip patients had their tricuspid regurgitation downgraded to moderate or better. Also, at the time of the 30-day checkup, 98% of TriClip patients reported no adverse events and “significant” improvement in their quality of life.
