But what if there was a protocol that could target patients with an LVAD specifically to the goal of myocardial repair, followed by a pump exploration, one with a particularly aggressive drug regimen to encourage reverse remodeling? Many more patients may receive a bridge pump for recovery than intent and eventually have their devices removed, suggest researchers, who published their experience with such a strategy on Oct. 26 traffic.
Approximately half of 40 adult patients who received HeartMate II axial pumps (Thoratec, now Abbott) at six major LVAD centers participating in the prospective study of stage D heart failure remission (RESTAGE-HF) could get theirs Explant pumps afterwards according to the protocol.
Their survival rate without transplantation or other LVAD implantation was about 90% 1 year after explantation and 77% 3 years after.
The cardiac recovery rate after LVAD explantation exceeds previously reported levels, and such recoveries were achieved in all participating centers, “a key component for their wider application,” the group writes. “This suggests that the explant rate after LVAD could be much higher if this strategy were more widespread and supports the promotion and systematic assessment of recovery after LVAD implantation.”
The results build on a recently published experience in which 18 patients with LVADs explanted using a similar protocol achieved cardiopulmonary stress test results comparable to those of 97 healthy controls.
One of the key elements of the current protocol was optimizing the LVAD speed, or the speed of continuous flow, for the greatest possible ventricular relief. a drug regimen to intensify the reverse remodeling process; close echocardiographic follow-up, the scans obtained at reduced pump speeds to capture native contractile function; and functional test as required.
The drug regimen initiated with uptitration once the patient has been implanted and weaned from inotropes is so aggressive that it is usually not tolerated in a patient on HF without mechanical circulatory support, observed lead author Emma Birks, PhD, MBBS, University from Kentucky, Lexington, for theheart.org | Medscape Kardiologie.
Initially, the ventricular discharge on the LVAD itself rests the heart and prepares for recovery. It is therefore important that the pump is set at a speed that optimizes this process, Birks explained. The other crucial element is the intensive use of conventional HF drugs, which patients no longer tolerate at standard dosages. “They lowered their blood pressure and affected their kidneys,” she said.
But as soon as the pump is on, “suddenly you’re better, the kidneys are better. So not only can you use the drugs, we use them in large doses. ”
The regimen, which is started and titrated as soon as the newly implanted patient has discontinued inotropes, contains carvedilol, digoxin, spironolactone, an ACE inhibitor (lisinopril). and an angiotensin receptor blocker (losartan).
They continue in patients even after myocardial repair and explantation. “It’s the same protocol that we started them with,” said Birks. “The idea is that the patient tolerated it well, so we restart it after the explant and they tolerate it.”
The protocol is an “optimized” version of a protocol used in a promising previous Harefield (UK) National Health Service Trust experience with patients implanted with the first HeartMate LVAD model. Some elements, such as B. routine exercise testing has been deleted to make the protocol more attractive for use in any LVAD center.
“That was very important because it seemed a bit complicated from the start. So we simplified it a bit and tried to make it reproducible in many locations so that it could be more widely distributed. ”That seemed to be paying off across all six locations, she said. “That they all had explants was encouraging.”
The centers enrolled 40 patients with non-ischemic cardiomyopathy – 38 in NYHA Class 4 and two in Class 3B – who were found to have failed with standard optimal medication. Almost all of them were on inotropic support. Two-thirds were male and their median age was 35 years. All were intended for LVAD either as target therapy or as a bridge to transplant.
Four patients dropped out prematurely because of “medical complications unrelated to study procedures,” so 36 patients followed the protocol.
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In total, LVADs were removed from 19 patients, or approximately 53% of those who followed the protocol; 15 were followed up an average of 2.3 years after explantation.
A multivariate search identified few, if any, base predictors of successful explant, Birks said. “No matter how big the heart is” before activating the log, if it “shows early signs of reverse remodeling and is shrinking, it seems like a good sign that you can restore it.”
That can mean, “You could examine these patients early on how far they can be pushed into recovery.”
One possible impact of the experience: LVAD therapy according to the protocol in selected patients with less severe HR who are on a bad path but have not yet reached the point observed in the current cohort could give them a better chance of having myocardium Restoration.
“There is probably not enough evidence that we should have an earlier implant. Although we would like to do that, these devices still have complications, ”said Birks. But current experience “somehow pushes us in that direction to try to recover more patients in the future.”
RESTAGE-HF was supported by Thoratec, now Abbott Medical, from whom Birks has announced that it has received an institutional grant. Information for the other authors is included in the report.
traffic. Published online October 26, 2020. Summary
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