Technical and early outcomes using ultrasound-guided reentry for chronic total occlusions.

BACKGROUND: Subintimal angioplasty is a common treatment for chronic total occlusions (CTOs) in the iliac and infrainguinal arteries. Although technical success has been described using intravascular ultrasound-guided reentry devices (IVUS-RED), outcomes are still not well defined. This report describes the technical aspects and longitudinal follow-up after intravascular ultrasound-guided reentry of iliac and infrainguinal CTOs. METHODS: A retrospective review was performed of 20 patients with lower extremity CTO treated with IVUS-RED from 2011 to 2013. A matched cohort of patients who underwent lower extremity interventions without the use of IVUS-RED was also identified. Procedural success, patency estimates, ankle-brachial indices (ABIs), complications, and limb salvage were analyzed. RESULTS: Twenty patients (mean age, 69 ± 13 years), including 11 men and 9 women, underwent attempted IVUS-RED-guided recanalization. Median follow-up was 4.3 months (range, 0.4-24). Eleven patients presented with critical limb ischemia (CLI), and 9 presented with claudication. Technical success was achieved in 18 (90%) patients. Ten common iliac arteries, 3 external iliac arteries, and 5 superficial femoral arteries (SFA) were treated. No intraoperative complications resulted from device use. After procedure, ABIs significantly increased (0.5-0.9; P < 0.01) in the 13 patients with follow-up. Primary patency for the entire cohort was 62% at 12 months. No patient treated for claudication required reintervention, whereas 3 (27%) of those treated for CLI required repeat interventions. During follow-up, 2 patients died unrelated to the procedure, 1 patient required an amputation, and 1 patient eventually required open revascularization. When the IVUS-RED group was compared with a cohort matched on Trans-Atlantic Inter-Society Consensus and age, no difference was found in runoff scores and patency between the 2 groups during follow-up (P > 0.05). CONCLUSIONS: Recanalization of CTO using IVUS-RED is safe and effective. Use of IVUS-RED does not adversely impact outcomes in conjunction with other endovascular techniques. Early follow-up demonstrates acceptable patency, especially in patients with claudication, and freedom from reintervention.

Endovascular debranching of the aortic arch during thoracic endograft repair.

BACKGROUND: Treatment of complex thoracic aortic pathology increasingly requires coverage of one or more aortic arch vessels. Endovascular debranching with a chimney technique can reduce or eliminate the need for surgical bypass. In this study, we evaluate our initial experience with planned endovascular debranching of the aortic arch. METHODS: During a 13-month period, nine patients were treated with endovascular debranching during thoracic endograft placement. Balloon expandable (n = 7) or self-expanding stents (n = 2) were deployed (innominate, n = 2; left common carotid, n = 2; left subclavian, n = 5) along with either TAG (W. L. Gore, Flagstaff, Ariz; n = 8) or Talent (Medtronic, Minneapolis, Minn; n = 1) endografts. Four patients required six surgical bypasses to additional arch vessels (right to left common carotid artery, n = 2; left common carotid to subclavian artery, n = 4). RESULTS: Indications for thoracic endograft placement were aortic transection (n = 4), aortic aneurysm (n = 2), aortotracheal fistula (n = 1), contained aortic aneurysm rupture (n = 1), and acute aortic dissection (n = 1). Endografts were deployed into zones 0 (n = 2), 1 (n = 2), and 2 (n = 5). Technical success of endovascular debranching was attained in eight of nine patients, with maintenance of branch perfusion and absence of endoleak. Perioperative morbidity included one myocardial infarction and one stroke that resulted in the patient's death. During subsequent follow-up (range, 2-25 months), there were no instances of endoleak secondary to chimney stents. All debranched vessels maintained primary patency. CONCLUSION: Endovascular debranching permits planned extension of the thoracic endograft over arch vessels while further minimizing the need for open reconstruction. Short-term results indicate technical feasibility of this approach. Long-term outcomes remain undefined.

Paradigm shifts in the treatment of abdominal aortic aneurysm: trends in 721 patients between 1996 and 2008.

OBJECTIVE: This study evaluated longitudinal trends in abdominal aortic aneurysm (AAA) management after later-generation endografts became available. METHODS: We retrospectively analyzed non-suprarenal AAA repairs between January 1, 1996, and December 31, 2008, performed at a single institution. Patients were stratified by endovascular AAA repair (EVAR) or open repair and the presence or absence of rupture. Thirty-day mortality rates were compared with the Fisher exact test. RESULTS: During a 13-year period, 721 patients underwent AAA repair, comprising 410 (56.9%) with EVAR and 311 (43.1%) with open repair. A bimodal distribution of EVAR usage was observed, with initial escalation in the 1990s to 70%. A nadir of EVAR occurred in the early 2000s (40%), correlating with more conservative EVAR use after the limitations of first-generation endografts were understood. Between 2005 and 2008, average EVAR use increased to 84%. The overall 30-day mortality rate for the entire cohort, including ruptured AAA, was 3.8%: 2.0% (8 of 410) for EVAR and 6.1% (19 of 311) for open repair (P < .05). Ruptured AAA had a mortality rate of 0% (0 of 8) for EVAR vs 31% (9 of 29) for open (P = .16). Non-ruptured AAA mortality was 2.0% (8 of 402) for EVAR vs 3.6% (10 of 282) for open (P = .23). EVAR and open repair both had reductions in mortality in the latter half of the series, combining to provide a significant decrease in overall mortality to 1.8% for patients treated from 2003 to 2008 compared with 4.9% for 1996 to 2002 (P < .05). Open AAA repair became more complex during the study period. The average rate for juxtarenal open AAA repair was 17.7% (range, 6.5%-34.6%) between 1996 and 2002 compared with 55.6% (range, 29.6%-100%) between 2003 and 2008 (P < .05). CONCLUSIONS: AAA treatment has undergone a profound and sustained paradigm shift, now averaging 84% of repairs performed with EVAR between 2005 and 2008. Overall mortality from AAA repair, including ruptures, was reduced 64% (from 4.9% to 1.8%) during the 13-year study period. Although EVAR and open repair both had improved mortality in the latter half of the series, the primary driver in reduced mortality for AAA repair has been the shift to EVAR.

Reimbursement of long-term postplacement costs after endovascular abdominal aortic aneurysm repair.

OBJECTIVE: Postplacement cost of surveillance and secondary procedures over 5 years increases the global cost of endovascular aortic aneurysm repair (EVAR) by nearly 50%. This study identified and assessed the reimbursement received for long-term postplacement costs after EVAR. METHODS: Between December 1995 and June 2007, 360 patients underwent EVAR at a single institution. The reimbursement collected from charges of postplacement surveillance and secondary procedures related to the aneurysmal disease was evaluated and compared against the actual costs. All amounts were converted to year 2007 dollars. To minimize costs associated with the early learning curve, the initial 50 EVAR patients between December 1995 and 1998 were excluded. Patients with <1 year follow-up were also excluded. Data are expressed as mean +/- standard error. RESULTS: The mean follow up after EVAR for 152 patients was 38.8 +/- 1.8 months. Medicare, capitated insurance, and commercial insurance provided coverage for 85 (56.0%), 49 (32.2%), and 18 (11.8%) patients, respectively. The cumulative 5-year postplacement reimbursement received per patient was $9792 meeting 81.4% of the cumulative cost of $12,027 for a net loss of $2235 per patient. Although 123 (80.9%) patients without secondary procedures generated a 5-year cumulative gain of $1830 per patient, 29 (19.1%) patients with secondary procedures averaged a 5-year cumulative loss of $9378 per patient. The average reimbursement rate over the 5-year period was 35.8% +/- 0.6%, with the lowest reimbursement rate seen in patients with Medicare at 31.6% +/- 0.7%. CONCLUSION: Current reimbursement is not sufficient to meet the costs associated with long-term surveillance and needed secondary procedures after EVAR. Inadequate reimbursement of costs associated with secondary procedures was the primary driver for the net institutional loss. Reimbursement for outpatient radiological procedures generated a modest surplus.

Long-term postplacement cost comparison of AneuRx and Zenith endografts.

Long-term postplacement costs increase the global cost of endovascular aneurysm repair (EVAR) by 44%. Secondary procedures and endoleaks significantly increase long-term expense. This study evaluates device-specific long-term postplacement costs using two different endografts. AneuRx and Zenith endografts were used to treat 250 patients with abdominal aortic aneurysms between December 1998 and June 2006 at a single institution. A relative value unit-based hospital cost accounting system was used to calculate both direct and indirect hospital departmental costs. Institutional overhead expenses, costs of professional services, and outpatient visits were also included in cost determinations. All costs were valued in 2006 dollars. To examine long-term costs, patients with <1 year follow-up were excluded. The initial 50 EVAR patients between December 1995 and 1998 were also excluded, to limit the effect of the learning curve on postplacement cost. The cumulative 5-year postplacement costs per patient were $12,465 (AneuRx) and $10,606 (Zenith, p = 0.22). Mean durations of follow-up were 38.5 +/- 5.2 months (AneuRx) and 32.8 +/- 3.8 months (Zenith, p = 0.12). For both devices, the largest cost components were secondary procedures (59.5% AneuRx vs. 56.4% Zenith) and radiologic studies (29.2% AneuRx vs. 34.9% Zenith). Freedom from secondary procedures (80% vs. 51%, p < 0.05) and endoleaks (83% vs. 58%, p = 0.05) was higher in patients treated with Zenith vs. AneuRx endografts, respectively. There was a reduction in secondary procedures and endoleaks in patients treated with Zenith compared to AneuRx. The corresponding 15% reduction in cost, however, was not statistically significant. Additional device-related cost reductions may be possible through improvements in device and technique and alterations in surveillance imaging.

A technique for increased accuracy in the placement of the "giant" Palmaz stent for treatment of type IA endoleak after endovascular abdominal aneurysm repair.

We report a deployment technique that eliminates "watermelon seeding" of the "giant" Palmaz stent in the treatment of type IA endoleak after endovascular abdominal aneurysm repair. A 5010 Palmaz stent (Cordis Corp, Miami Lakes, Fla) is asymmetrically hand-crimped on an appropriately sized valvuloplasty balloon that assures that the proximal (cranial) aspect will deploy first. A long 16 to 20F sheath is placed distal to the target area. Once the balloon and stent assembly is in position, the sheath is partially retracted to allow only the proximal (cranial) half of the balloon to expand, flaring the unsheathed proximal stent. The expanded proximal balloon prevents cranial stent migration. The sheath prevents distal (caudal) stent migration. Full retraction of the sheath allows the distal balloon and stent to expand, completing the stent deployment.

Endovascular repair of a ruptured internal iliac arterial aneurysm with a novel application of the aorto-uni-iliac converter device.

Internal iliac artery aneurysms are rarely discovered by examination and may consequently present with rupture in a patient without an established diagnosis. Ruptured internal iliac aneurysms harbor a high risk of morbidity and mortality. Although open repair is possible, endovascular repair may be an option in some patients. We present a case of a ruptured internal iliac artery aneurysm with an adjoining ipsilateral common iliac artery aneurysm repaired with a novel use of an aorto-uni-iliac device.

Long-term postplacement cost after endovascular aneurysm repair.

BACKGROUND: Previous studies have demonstrated that the initial hospital cost associated with endovascular aneurysm repair (EVAR) is approximately $20,000. However, the cost of long-term surveillance and secondary procedures is poorly characterized. METHODS: Between December 1998 and June 2006, 259 patients underwent EVAR for infrarenal aneurysms at a single institution. Follow-up costs were calculated using a relative value unit based hospital cost accounting system, which incorporates departmental direct and indirect costs. Institutional overhead costs were included using a conversion factor. Costs for professional services were determined by a cost-to-charge ratio, and outpatient visits were calculated with a time-based formula. Year 2006 costs were applied to prior years. To minimize costs associated with the early learning curve, the initial 50 EVAR patients between December 1995 and 1998 were excluded. Patients with <1 year follow-up were also excluded. Data are expressed as mean +/- standard error. RESULTS: The mean follow-up after EVAR for 136 patients was 34.7 +/- 1.8 months. The cumulative 5-year postplacement cost per patient was $11,351. The 27 patients (19.9%) who required secondary procedures had a 5-year cumulative cost of $31,696 compared with $3668 for 109 patients without secondary procedures (8.6-fold increase, P < .05). The 5-year cost for patients with endoleak was $26,739 compared with $5706 for those without endoleak (4.7-fold increase, P < .05). Overall, major cost components were 57.4% for secondary procedures and 32.5% for radiologic studies. CONCLUSIONS: During a 5-year period, the postplacement cost of EVAR increases the global cost by 44%. The subgroups of patients with endoleaks and those requiring secondary procedures generate a disproportionate share of postplacement costs. Efforts at minimizing cost should emphasize technical and device modifications aimed at reducing endoleaks and the need for secondary procedures.

The thoracic endograft: a minimally invasive treatment option for aortic diseases.

BACKGROUND: Thoracic endografts provide a less invasive surgical option for treatment of descending aortic pathology. We present our early thoracic endograft experience with endovascular management of aneurysms, penetrating aortic ulcers, and traumatic injuries. METHODS: Fifteen consecutive patients scheduled for endograft placement at a single institution were evaluated on an intent-to-treat basis. Retrospective record review was used to determine patient demographics, surgical indications, operative, and follow-up care. RESULTS: Fourteen of 15 patients (93.3%) had successful endograft implantation. Thirty-day survival was 100%, with a 0% rate of spinal cord ischemia. Morbidity included access complications in two patients (13.3%) and a myocardial infarction in one patient (6.7%). CONCLUSIONS: Descending thoracic aortic pathology can be treated with low morbidity and mortality using endografts, even in high-risk patients. Continued post-placement surveillance is necessary.