One-Year Results of a Low-Profile Endograft in Acute, Complicated Type B Aortic Dissection.

BACKGROUND: The safety and effectiveness of the RelayPro endograft (Terumo Aortic) was assessed for the treatment of acute, complicated type B aortic dissection (TBAD). METHODS: A prospective pivotal trial analyzed a primary end point of all-cause mortality at 30 days. Secondary end points included technical success, major adverse events (disabling stroke, renal failure, and paraplegia/paralysis), endoleaks, patency, rupture, device integrity, false lumen perfusion, reinterventions, aortic expansion, and migration evaluated to 5 years. RESULTS: The study involved 22 United States centers and enrolled 56 patients (mean age, 59.5 ± 11.4 years) from 2017 to 2021; of whom, 73.2% were men and 53.6% were African American. TBAD was complicated by malperfusion of the kidneys (51.8%), lower extremities (35.7%), and viscera (33.9%), and rupture (10.7%). Dissection extended proximally to zones 1/2 (14.3%) and zone 3 (78.6%) and distally to the iliac arteries (67.3%). Most procedures were percutaneous (85.5%). Technical success was 100%. Median hospitalization was 7 days (interquartile range, 5-12 days). All-cause mortality at 30 days was 1.8% (1 of 56; upper 95% CI, 8.2%; P < .0001). Seven major adverse events occurred in 6 patients (10.7%), consisting of paraplegia (n = 3), paraparesis (n = 2), disabling stroke (n = 1), and renal failure (n = 1). All paraplegia/paraparesis resolved with lumbar drainage. Kaplan-Meier analysis estimated a freedom from major adverse events of 89.1% at each interval from 30 days to 3 years. There was 1 endoleak (Type Ia), 2 retrograde dissections, and aortic diameter growth occurred in 2. There has been no rupture, fistula, component separation, patency loss, stenosis, kinking, twisting, bird beak, loss of device integrity, or fracture. CONCLUSIONS: RelayPro is safe and effective in acute, complicated TBAD. Follow-up is ongoing to evaluate longer-term outcomes and durability.

Tightrope Technique for facilitating complex endovascular aortic repair in patients with severely angulated neck.

An 84-year-old presented with a large, symptomatic juxtarenal abdominal aortic aneurysm. Owing to severe angulation of the infrarenal neck, advancement of the distal bifurcated component caused dramatic lateral movement of the proximal physician-modified endovascular graft (PMEG) fenestrated device. This procedure risked aneurysm sac perforation and possible PMEG device displacement. To avoid this complication, the distal aspect of the PMEG device was tethered in place using endoscopic forceps to provide countertraction, similar to pulling a tightrope. This technique allowed for the uneventful placement of the distal bifurcated component without complication. This technique can overcome device placement challenges within an angulated aorta caused by large aneurysms.

Extracellular Matrix Patches for Endarterectomy Repair.

Patch repair is the preferred method for arteriotomy closure following femoral or carotid endarterectomy. Choosing among available patch options remains a clinical challenge, as current evidence suggests roughly comparable outcomes between autologous grafts and synthetic and biologic materials. Biologic patches have potential advantages over other materials, including reduced risk for infection, mitigation of an excessive foreign body response, and the potential to remodel into healthy, vascularized tissue. Here we review the use of decellularized extracellular matrix (ECM) for cardiovascular applications, particularly endarterectomy repair, and the capacity of these materials to remodel into native, site-appropriate tissues. Also presented are data from two post-market observational studies of patients undergoing iliofemoral and carotid endarterectomy patch repair as well as one histologic case report in a challenging iliofemoral endarterectomy repair, all with the use of small intestine submucosa (SIS)-ECM. In alignment with previously reported studies, high patency was maintained, and adverse event rates were comparable to previously reported rates of patch angioplasty. Histologic analysis from one case identified constructive remodeling of the SIS-ECM, consistent with the histologic characteristics of the endarterectomized vessel. These clinical and histologic results align with the biologic potential described in the academic ECM literature. To our knowledge, this is the first histologic demonstration of SIS-ECM remodeling into site-appropriate vascular tissues following endarterectomy. Together, these findings support the safety and efficacy of SIS-ECM for patch repair of femoral and carotid arteriotomy.

Intralobar Pulmonary Sequestration With Aneurysmal Feeding Vessel: Use of Hybrid Surgical Management.

We describe the endovascular exclusion and surgical resection of an intralobar pulmonary sequestration supplied by an aneurysmal feeding vessel from the aorta. Pulmonary sequestration is a rare congenital anomaly, and the presence of an aneurysmal feeding vessel is even rarer. The possibility of life-threatening hemorrhage resulting from failure to control these aberrant vessels has led many to pursue preoperative embolization. The anatomy in the patient described here was not deemed suitable for embolization, and we thus elected to pursue a novel approach. This case also demonstrates the diagnostic utility of magnetic resonance imaging for delineating the vasculature of pulmonary sequestrations when contrast-enhanced computed tomography is contraindicated.

Repair of superior mesenteric artery bypass pseudoaneurysm with physician-modified fenestrated aortic endograft.

Aneurysmal degeneration and pseudoaneurysm formation of visceral vein bypass grafts are rare conditions that may be associated with rupture requiring reintervention. This case represents the first report of an enlarging, complex aorta to superior mesenteric artery vein bypass pseudoaneurysm repaired using a physician-modified fenestrated aortic graft with suprarenal fixation.

Pulsed high-intensity-focused US and tissue plasminogen activator (TPA) versus TPA alone for thrombolysis of occluded bypass graft in swine.

PURPOSE: Prosthetic arteriovenous or arterial-arterial bypass grafts can thrombose and be resistant to revascularization. A thrombosed bypass graft model was created to evaluate the potential therapeutic enhancement and safety profile of pulsed high-intensity-focused ultrasound (pHIFU) on pharmaceutical thrombolysis. MATERIALS AND METHODS: In swine, a right carotid-carotid expanded polytetrafluoroethylene bypass graft was surgically constructed, containing a 40% stenosis at its distal end to induce graft thrombosis. The revascularization procedure was performed 7 days after surgery. After model development and dose response experiments (n = 11), two cohorts were studied: pHIFU with tissue plasminogen activator (TPA; n = 4) and sham pHIFU with TPA (n = 3). The experiments were identical in both groups except no energy was delivered in the sham pHIFU group. Serial angiograms were obtained in all cases. The area of graft opacified by contrast medium on angiograms was quantified with digital image processing software. A blinded reviewer calculated the change in the graft area opacified by contrast medium and expressed it as a percentage, representing percentage of thrombolysis. RESULTS: Combining pHIFU with 0.5 mg of TPA resulted in a 52% ± 4% increase in thrombolysis on angiograms obtained at 30 minutes, compared with a 9% ± 14% increase with sham pHIFU and 0.5 mg TPA (P = .003). Histopathologic examination demonstrated no differences between the groups. CONCLUSIONS: Thrombolysis of occluded bypass grafts was significantly increased when combining pHIFU and TPA versus sham pHIFU and TPA. These results suggest that application of pHIFU may augment thrombolysis with a reduced time and dose.

Complicated postpartum type B aortic dissection and endovascular repair.

BACKGROUND: Fifty percent of aortic dissections in women younger than 40 years occur in association with pregnancy. Of these, half of type B dissections occur in the postpartum period. CASE: A 30-year-old woman was status post spontaneous vaginal delivery at 30 weeks of gestation for fetal death, complicated by an eclamptic seizure. On postpartum day 4, she suffered an acute, complicated type B aortic dissection treated with endovascular stent graft placement. CONCLUSION: Endovascular repair may be an attractive option for the treatment of complicated type B aortic dissections in pregnancy and the peripartum period, with reduced maternal and fetal mortality. This may allow the fetus to remain in situ and avoid the risks of surgery and possible cardiopulmonary bypass, with little radiation risk to the fetus.

Real-world experience with type I endoleaks after endovascular repair of the thoracic aorta.

Endoleaks are a frequent complication of thoracic endovascular aortic repair (TEVAR) and will likely increase in incidence with application of the technique to more complicated aortic anatomy and a wider range of thoracic aortic pathologies. Management generally consists of aggressive repair of Type I endoleaks; however, the natural history of Type I endoleaks after TEVAR remains largely unknown. The purpose of this study was to examine the incidence and characteristics of Type I endoleaks and to evaluate clinical outcomes of patients with Type I endoleaks after TEVAR. A single-center retrospective review was performed on all patients who underwent TEVAR over a 4-year period. Type I endoleaks were detected in 21 per cent (27 of 129) of patients on post-deployment aortography or CT angiography. During a mean follow-up of 750.63 +/- 483 days, 59 per cent (16 of 27) closed spontaneously; 30 per cent (eight of 27) required secondary endovascular intervention; and 11 per cent (three of 27) have persisted with no increase in maximum aortic diameter. No patients have died or required open surgical conversion as a result of their Type I endoleak. Although accurate predictors of spontaneous resolution of Type I endoleaks have yet to be definitively characterized, our initial results suggest that it may be safe to observe small Type I endoleaks given that a large percentage resolve spontaneously and no endoleak-related deaths have occurred.

Endovascular repair of the thoracic aorta.

The use of endovascular stent grafts for treatment of the descending thoracic aorta is reviewed. Currently, 3 devices have been approved by the US Food and Drug Administration for the treatment of descending thoracic aneurysms, and multiple studies are ongoing to investigate the efficacy of endovascular treatment in such pathologies as traumatic aortic injury and Stanford type B dissection. Outcomes are highly dependent on good case planning and patient selection and will likely continue to improve as newer-generation devices and delivery systems are designed and made available.

Endovascular repair of the thoracic aorta in the post-FDA approval era.

OBJECTIVE: Endovascular repair of thoracic aortic disease is rapidly progressing as an alternative to open surgical therapy. In March of 2005, the Gore TAG thoracic endoprosthesis (W. L. Gore & Associates, Inc, Flagstaff, Ariz) received Food and Drug Administration (FDA) approval for the treatment of descending thoracic aortic aneurysms. Subsequently, off-label use of the technology expanded to include additional thoracic aortic diseases. The purpose of this study was to examine whether the outcomes with this device changed after the inclusion and exclusion criteria of FDA-controlled trials no longer governed patient selection. METHODS: A retrospective analysis was performed on all patients who underwent endovascular repair of the thoracic aorta with the Gore TAG device at our institution between March 23, 2005, and September 8, 2006. RESULTS: Fifty consecutive patients with a broad range of aortic pathologic conditions were included in the study. The results in this group compared with those of the phase II trial included the following: length of stay, 7.5 versus 7.6 days (P = .97); intensive care unit stay, 3.7 versus 2.6 days (P = .61); 30-day mortality, 2.0% versus 1.5% (P = .68); spinal cord injury, 2% versus 3% (P = .89); stroke, 4% versus 4% (P = .67); early endoleaks, 26% versus 4% (P < .01); and late endoleaks, 18% versus 7% (P = .08). At 1 year, overall survival was 92% compared with 82% in the phase II trial. CONCLUSIONS: In the post-FDA approval era, endovascular stent-graft therapy is frequently applied to patients with more challenging thoracic aortic anatomy and a wide range of pathologic conditions. Our results in this group are similar to outcomes reported for patients with descending thoracic aortic aneurysm exclusively.

Cutaneous metastases in patients with rectal cancer: a report of six cases.

Cutaneous metastases from rectal cancer are rare manifestations of disseminated disease and uniformly represent dismal survival. A retrospective review of six patients with rectal cancer metastatic to the dermis was performed. The diagnosis of rectal cancer was made concurrently with the diagnosis of the dermal metastases in all six patients. A 100 per cent histopathologic concordance existed between the tissue of the dermal metastases and primary rectal tumor. The progression of systemic metastatic disease was the cause of death in 83.3 per cent of patients (5/6). No patient survived more than 7 months from the time of diagnosis. Recognition of suspicious skin lesions as possible harbingers of undiagnosed visceral malignancy is important in managing patients both with and without a history of previous cancer.

Does preoperative ejection fraction predict operative mortality with left ventricular restoration?

BACKGROUND: Ischemic cardiomyopathy and aneurysmal disease have been treated surgically with coronary artery bypass grafting in the past. The Dor technique for left ventricular restoration has demonstrated improved outcomes in patients with ischemic, akinetic ventricles. Our hypothesis was that even marked reduction in preoperative cardiac function (ejection fraction < .25) would not correlate with worse outcomes since the ventricle would be reshaped to improve function. METHODS: A retrospective analysis was performed on all patients who had undergone ventricular restoration with the Dor procedure from January 1996 through September 2005. Patients with a preoperative ejection fraction (EF) < .25 and those with a EF > or = .25 were compared. All Society of Thoracic Surgeons database characteristics, mortality, length of stay (LOS), and need for intraaortic balloon pump (IABP) were analyzed. RESULTS: The study included 89 patients (69 men, 20 women), 28 of whom had preoperative EFs < .25 (mean, .183 +/- .035; range, .08 to .25) and 61 had an EF > or = .25 (mean, .334 +/- .074; mean, .25 to .45). Overall operative mortality was 3.4% (3/89), with no statistically significant difference between the two groups (3.6% versus 3.3%). LOS was 7.4 +/- 3.6 days versus 8.9 +/- 15.6 days (p = NS), and need for IABP was 39.2% versus 8.1% (p < 0.05). Overall 5-year survival was 82%. Five-year survival in the EF < .25 cohort was 69.6% versus 88.3% in the EF > or = .25 cohort (p = 0.066). CONCLUSIONS: Ventricular restoration with the Dor technique is a safe procedure. Marked reduction in ejection fraction is not a contraindication to left ventricular restoration; however, increased usage of IABP should be anticipated.