Prótesis AMDS in type A dissection with malperfusion: extending treatment to the arch without replacing it

This study evaluates the AMDS Hybrid Prosthesis as an adjunct to conventional open repair in acute DeBakey type I aortic dissection with malperfusion, aiming to stabilize the aortic arch, expand the true lumen, and reduce dynamic malperfusion without routine total arch replacement.

I remember a congress several years ago, where a Chinese group proudly presented their results with routine total arch replacement using the frozen elephant trunk technique in patients with type I type A aortic dissection. After the presentation, a Japanese “heavyweight” congratulated them on their results, praising their experience with devices that, at that time, still had only preliminary use, particularly in the field of aortic dissection. Nothing anticipated the criticism that followed: “However, you are exposing your patients to unnecessary surgical risk. Surgery for type A aortic dissection should focus on saving the patient’s life, and unnecessary steps such as routine aortic arch replacement should be avoided.”

That comment has stayed with me ever since, particularly after what happened last winter, when the burden of patients with aortic dissection and organ malperfusion requiring treatment during both my on-call shifts and those of my colleagues caught us by surprise.

Current trends in the management of these patients seem to be moving toward initial correction of malperfusion, with the potential price this may entail, before addressing the main entry tear in the ascending aorta through replacement with a suprasinus tubular graft, with or without extension to an aortic root repair procedure or hemiarch replacement. After all, despite what classic studies told us, correction of that first entry tear does not appear to be effective in many cases for resolving organ malperfusion, particularly M3 malperfusion according to the TEM classification, involving visceral, spinal cord, renal, and/or limb territories. Only intervention on the distal arch and descending aorta, with expansion of the true lumen, is likely to achieve that effect. However, undertaking a frozen elephant trunk approach does not seem prudent as a standardized strategy for this disease.

The PERSEVERE study fits into this context. It analyzes 1-year outcomes with the AMDS Hybrid Prosthesis in patients with acute DeBakey type I dissection complicated by malperfusion, including M2 cerebral and M3 malperfusion. This was a prospective, multicenter, single-arm study that included 93 patients across 26 centers in the United States. Its aim was to evaluate the safety and effectiveness of this device as an adjunct to conventional open repair, with particular attention to major clinical events, arch patency, reinterventions, aortic remodeling, and the development of new distal anastomotic entry tears, known as DANE.

The rationale behind the device is attractive. AMDS does not aim to replace the aortic arch, but rather to stabilize it from within. It combines a proximal component sutured into the distal anastomosis with an uncovered stent that is deployed across the arch and proximal descending aorta. The goal is to re-expand the true lumen, promote false lumen thrombosis, reduce dynamic malperfusion, and prevent the distal anastomosis itself from becoming a new entry tear.

As a result of this concept, the reported outcomes are undoubtedly striking. At 1 year, mortality was 20%, with most events concentrated within the first 30 days. Disabling stroke occurred in 12%, the need for dialysis in 20%, and myocardial infarction in 2%. No DANE was documented on postoperative computed tomographic follow-up. Freedom from unplanned aortic reintervention was 96%, and arch patency reached 100%. In addition, imaging data showed favorable signs of remodeling, with true lumen expansion and false lumen thrombosis in a high proportion of patients in zones 1 to 3.

COMMENTARY:

This study has the merit of addressing a highly relevant grey area. For years, the classic strategy in type A dissection has fluctuated between two poles: repairing only what is necessary to save the patient’s life or performing more extensive arch procedures in the hope of improving distal aortic outcomes. The first option is faster and more reproducible, but it may leave behind a problematic residual aorta. The second may be more complete, but it adds complexity, circulatory time, and neurologic risk in a patient who is already critically ill. The current alternative of treating malperfusion first by an endovascular approach remains, in many cases, an impractical option because advanced interventional vascular radiology programs are not universally available, the preferred strategy is not always clear, whether septal fenestration, branch angioplasty, PETTICOAT, or true lumen stenting, and it is not suitable for patients presenting with hemodynamic instability.

AMDS appears precisely in this intermediate space. Its promise is to extend treatment to the arch without requiring arch replacement. In other words, it offers part of the theoretical benefits of a more aggressive strategy such as frozen elephant trunk, while proposing an intervention that is more widely adoptable, both from the surgeon’s technical standpoint and in terms of surgical aggressiveness for the patient. If this balance is confirmed, it could represent a very valuable tool for patients with DeBakey I dissection and malperfusion, in whom time, distal perfusion, and technical simplicity are decisive factors.

However, these results should be read with enthusiasm, but not naivety. PERSEVERE is not a randomized trial. The comparison is made against historical controls, which inevitably introduces selection bias, time-related differences in management, and possible variation in center experience. Moreover, although 93 patients represent a relevant cohort for a disease of this complexity, this remains a small number to define accurately the impact on infrequent events, anatomic subgroups, or long-term outcomes.

It is also important to remember that 1-year follow-up in aortic disease is only the beginning of the story. Dissection is not a 12-month disease. The true value of any strategy intended to modify the course of the residual aorta will be measured at 5, 10, or 15 years. The absence of DANE and favorable remodeling are very promising signals, but they do not yet prove a definitive reduction in late aneurysmal degeneration, complex reinterventions, or aorta-related mortality.

There is also an interesting conceptual point. AMDS does not replace the aortic arch, but neither is it simply an innocuous adjunct to proximal repair. It reinforces the arch and proximal descending aorta. Its relative simplicity should not lead us to trivialize it. It requires appropriate indication, avoiding resection of pathologic aorta when a hemiarch replacement technique is required, favorable anatomy, with the entry tear not involving the aortic arch but only the root or ascending aorta, E1, experience in the treatment of acute aortic dissection, and strict tomographic follow-up. Returning to the anecdote I mentioned at the beginning, the risk lies not only in using it, but in using it too early, too late, or in patients in whom it does not solve the main problem.

Perhaps the greatest appeal of the device is precisely its pragmatism. It does not aim to turn every type A dissection into a total arch replacement. Nor does it passively accept that the distal aorta should be left abandoned after limited repair. It proposes a third way: acting on the mechanism of malperfusion and on false lumen dynamics without necessarily converting the operation into complex arch surgery. Beyond the context of malperfusion at the initial presentation of aortic dissection, it is becoming increasingly difficult to accept that the sole objective should be to close the initial entry tear and survive the immediate postoperative period. The residual aorta matters. Remodeling matters. Distal malperfusion matters. And, above all, what matters is finding solutions that improve that future without turning every emergency operation into a maximalist procedure.

REFERENCE:

Szeto WY, Fukuhara S, Fleischman F, Sultan I, Brinkman W, Arnaoutakis G, et al; PERSEVERE Investigators. One-Year Results of Novel Aortic Arch Hybrid Prosthesis for Repair of Acute DeBakey Type I Dissection With Malperfusion: PERSEVERE Study. Ann Thorac Surg. 2026 May;121(5):1069-1079. doi: 10.1016/j.athoracsur.2025.10.036.

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