EVEREST II mitral-valve clip: It's a good start but still a long way to the top

Cardiologist/Sherpa Dr Ted Feldman (Evanston Hospital, IL) presented the EVEREST II data, a study comparing a percutaneous approach to standard surgical repair for mitral-valve leak. EVEREST is a fitting title for this study, as the 29 035 ft (that's 8850 m for all you metric folks) summit is the highest mountain on earth and considered one of the most challenging peaks in the history of mountain climbing. Similarly, the challenges of the timing of therapy, selection of treatment options, and reliability of quantification of mitral regurgitation are legendary.

In order to truly understand the impact of this study, we need to level the playing field a bit. First, I want to take nothing from the study and all of those who participated. Although some might not want to acknowledge it, this is one of the single most important advances in the field of mitral-valve pathology since surgical repair. However, it's so early in its development it's quite like a phase 2 trial that's still trying to find its legs. The current technique provides only a small glimpse of just how large this field of percutaneous valvular therapy will become. I want to state for the record that including transfusion in the 30-day MACE rate to make the surgical therapy appear far more "dangerous" was playing a little bit of dirty pool. I want to point out that after transfusion and the need for a ventilator for 48 hours is taken out of the MACE rate, mitral-valve surgery is still a relatively safe and far more efficacious approach to the therapy of significant mitral regurgitation when purely looking at the postprocedure volume of the regurgitant jet.

The residual mitral regurgitation is the most disappointing aspect of this small trial. With a short 30-day and one-year follow up, I fear those patients will continue to be stable for only a short while, as many patients with moderate to severe mitral regurgitation will begin to deteriorate once again with debilitating dyspnea. What exactly do we think will keep the ventricle from continuing to increase in size and ultimately fail in these patients? Are we just putting off the inevitable? For some patients at advanced age, where quality becomes far more important than quantity, this procedure will be just the thing they are looking for. The perfect patients will be those whose risk will be considered too great for surgery and their life expectancy too short to worry about long-term results.

Then, as pointed out by Dr Craig Smith (Columbia University, NY), who commented to heartwire, there is the worrisome possibility that the patient with a single percutaneous repair under his belt will be taking home some metal instead of undergoing a native valve repair in the future. Once you've gone in with a clip, fused the edges together, and started the process of scarring, you have probably wrecked any hope for a repair opportunity. On the other hand, by that time, we might as well accept it's just time for a new valve and do it.

Like a long and treacherous climb, not everyone will be able to make it to the top of the mountain. Some can't even begin the journey, and for those who do, there are dangers and advantages to every choice that is made along the way. With regard to percutaneous mitral-valve repair, the adventure is just beginning.

See also:

EVEREST II: Mitral-clip device noninferior to surgical repair or replacement 

Your comments

	EVEREST II mitral-valve clip: It's a good start but still a long way to the top
	# 1 of 5	March 18, 2010 09:11 (EDT)
	denilson	DEAR considerations perfect. the evolution of hemodynamics is important for the advancement of cardiology for treatment procedures less invasive, but we need more evidence and security to display them.
	# 2 of 5	May 26, 2010 10:12 (EDT)
	Linda RN.	I was part of the Everest 1 and 2 studies as a patient. I had my first clip placed on 3/05. Unfortunately my posterior leaflet was in 3 pieces and it made it difficult to place the clip for Dr. Feldman. I felt like a new woman when I woke up from surgery. I immediately noticed the results. And I felt great for about 2 months. I returned to Evanston for my 4 week check up only to find out that a piece of my leaflet had torn away from the clip. I went back to Evanston for several return visits and Echos and soon my regurg was as bad as when I first appeared on their doorstep. After several months Dr Feldman, with much determination, was able to convince the FDA for me to receive a second clip. In 1/06 I was in the OR again for my second heart surgery. Even with 2 clips they never were able to get the reduction of regurg they were looking for. My biggest fear was to have open heart. The complications frightened me esp at my young age of 43. I had 3 young children at home that I wanted to see grow up. In August of 06 Dr. Feldman referred me to Dr. Alexander a well known and excellent cardiac surgeon. He was able to repair my valve despite the scar tissue and the 2 previous clippings. I suffered a stroke in surgery that affected the sensory and fine motor skills on the left side of my body. I have recovered mostly from the stroke. My left leg is still numb and my coordination is not as good as before my surgery but I feel so much better physically. I still have a ASD from the clippings that never closed on it's own.  I'll be on blood thinners the rest of my life in hopes of preventing another stroke. I will never forget all the kind professional people I met at Evanston. Even though the clip did not work for me, I don't regret giving it a try. I hope you fine success in these trials as they continue.
	# 3 of 5	May 11, 2011 01:47 (EDT)
	SueLeap	I am a 63 year old woman just diagnosed with moderate mitral valve regergitation/arterial fibrillation. It was discovered while having dental surgery. My fib is about 63% of the time. Strong family history of grandmother dying from blood clot, mother with pacemaker since age 65, father open heart surgery in early 50's with multiple heart attacks. I have also been experiencing lower body numbness (waves of numbnes) for the past two years which have not yet been finitely diagnosed. I am looking for discussions of similar experiences and treatments. Thanks.
	# 4 of 5	May 11, 2011 04:17 (EDT)
	Melissa	Sue, I am completely sympathetic with your situation and your concerns, unfortunately, as stated in the yellow box above, this is not an appropriate forum for this type of exchange among patients. This venue is for the purpose of discussion of news and topics  between health care providers.  I would strongly suggest that you sit down and discuss these issues with your cardiovascular health care provider and I wish you the best. Perhaps you could seek an opinion from a local tertiary center that specializes in valvular issues. Good luck!!! Melissa
	# 5 of 5	July 21, 2012 07:30 (EDT)
	Mitral Valve Surgery	Great tips, cheers to the article author. Its understandable to me now, the effectiveness and importance is mind-boggling. Thank you once again and good luck!

You must be a member (with full membership) to post a comment.

Already a member?

Enter your login information below:

 Remember me on this computer

Forgot your username and/or password?

        Login        

Enjoy all the benefits of theheart.org

With full membership, you can check out our educational and editorial content, search the site, receive our newsletters, join discussions, download slides and much more.

Membership is free!

    Join now for full access