Total aortic arch repair involves the placement of branched and fenestrated stent grafts to reperfuse the aortic arch and each of its supra‐aortic branches.
A team of cardiac surgeons, endovascular specialists and anesthesiologists at Penn Medicine recently completed a percutaneous 3-branch endovascular total arch repair for aortic aneurysm, an exceptionally complex achievement previously performed at only a handful of institutions in the world. The team comprised Drs. Darren Schneider, Nimesh Desai, Kathleen Marulanda, Kendall Lawrence, and Jared Feinman,. The procedure was conducted using a custom device from Dr. Schneider's ongoing IDE clinical trial (ClinicalTrials.gov Identifier NCT02323581) of endovascular repair for aortic arch and throacoabdominal aortic aneurysms, and represents a component of the thriving program of clinical practice and research in endovascular surgery at Penn Medicine.
"To our knowledge, this procedure was one of the first 10 to 15 entirely percutaneous endovascular aortic arch repairs done worldwide," Dr. Desai said, citing the team effort as a testament to strong collaboration among the departments and divisions of cardiac surgery and vascular surgery, anesthesia, neurology, OR nursing and radiology techs, inpatient and outpatient nurse practitioners, and the ICU staff.
Aortic Arch Repair Concerns and Considerations
Open surgery represents the current standard of care for aortic arch repair, and is supported by long-term data. A substantial subset of patients are at prohibitive risk for open aortic surgery, however, and are thus candidates for investigational endovascular aortic arch repair. While endovascular therapies have an established place in thoracic aortic repair, no endovascular approach or procedure has been FDA approved to date for aortic arch repair. This state of affairs owes much to the distinct challenges manifest in aortic arch repair, including the absence of uniform anatomy from patient to patient, the curvature and posterior position of the distal arch, the presence of the supra‐aortic branches (i.e., the innominate, left carotid, and left subclavian arteries), and the concomitant neurological and technical risks inherent to all cardiac surgeries.
The need for safety in arch repair is acute. Both open surgical repair and TEVAR are associated with a litany of complications, including endoleaks, neurological deficits, branch vessel occlusion, device failure, iatrogenic dissection, and vascular access complications. Whether the unique physiology of the arch contributes to these risks is among the objectives of continuing investigation at this time.
Total Aortic Arch Repair
Drs. Darren Scheneider and Nimesh Desai performing percutaneous total aortic arch repair at Penn Medicine.
Although there are no validated devices in aortic arch repair, a number of device investigations are are under way at PennMedicine and other centers of surgical excellence worldwide. Given anatomical heterogeneity, the selection of the appropriate approach for each patient is left to clinical judgment. Approaches to the aortic arch and its vessels vary, but those that include reconstruction and reperfusion of the aortic arch and each of its supra‐aortic branches are regarded as "total" procedures.
Common elements in aortic arch repair include careful selection of patients on the basis of underlying pathology and patency of the AA and supra-aortic trunks; the application of individualized stents incorporating one-to-three branches and fenestrations to accommodate affected supra-aortic vessels; percutaneous device access and manipulation via the right proximal brachial and femoral arteries; continuous intraoperative imaging; continuous perfusion to avoid cerebral ischemia and embolization; as well as perfusion to the heart and distal organs.
While the future for endovascular aortic repair will involve continuing studies to address both efficacy and safety, Dr. Desai is confident that the procedure represents a major step forward in the treatment of complex aortic patients—a fitting footnote to the region's first successful percutaneous total aortic arch repair.
About IDE Studies at Penn Medicine
In the United States, many fenestrated and branched endovascular stent graft studies are conducted as physician-sponsored IDE investigations. A status granted by the FDA, IDE clinical evaluations allow physicians to provide treatments using as-yet unapproved investigational devices and collect safety and effectiveness data. At this time, only about a dozen medical centers in the US have the FDA authorization and experience to conduct to conduct treatment studies of TAAAs and aortic arch aneurysms using endovascular stent grafts. Importantly, IDE studies include independent oversight and monitoring intended to ensure patient safety.
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