Nicholas J. Gargiulo

Collected world and single center experience with endovascular treatment of ruptured abdominal aortic aneurysms

Background:Case and single center reports have documented the feasibility and suggested the effectiveness of endovascular aneurysm repair (EVAR) of ruptured abdominal aortic aneurysms (RAAAs), but the role and value of such treatment remain controversial. Objective:To clarify these we examined a collected experience with use of EVAR for RAAA treatment from 49 centers. Methods:Data were obtained by questionnaires from these centers, updated from 13 centers committed to EVAR treatment whenever possible and included treatment details from a single center and information on 1037 patients treated by EVAR and 763 patients treated by open repair (OR). Results:Overall 30-day mortality after EVAR in 1037 patients was 21.2%. Centers performing EVAR for RAAAs whenever possible did so in 28% to 79% (mean 49.1%) of their patients, had a 30-day mortality of 19.7% (range: 0%–32%) for 680 EVAR patients and 36.3% (range: 8%–53%) for 763 OR patients (P < 0.0001). Supraceliac aortic balloon control was obtained in 19.1% ± 12.0% (±SD) of 680 EVAR patients. Abdominal compartment syndrome was treated by some form of decompression in 12.2% ± 8.3% (±SD) of these EVAR patients. Conclusion:These results indicate that EVAR has a lower procedural mortality at 30 days than OR in at least some patients and that EVAR is better than OR for treating RAAA patients provided they have favorable anatomy; adequate skills, facilities, and protocols are available; and optimal strategies, techniques, and adjuncts are employed.

Intra-abdominal aortic graft infection: complete or partial graft preservation in patients at very high risk

BACKGROUND Total graft excision with in situ or extra-anatomic revascularization is considered mandatory to treat infection involving the body of aortic grafts. We present a series of nine patients with this complication and such severe comorbid medical illnesses or markedly hostile abdomens that traditional treatments were precluded. In these patients selective complete or partial graft preservation was used. METHODS Over the past 20 years we have treated nine infected infrarenal aortic prosthetic grafts with complete or partial graft preservation, because excision of the graft body was not feasible. In all nine patients infection of the main body of the aortic graft was documented at computed tomography or surgery. Essential adjuncts included percutaneous or operative drain placement into retroperitoneal abscess cavities and along the graft, with instillation of antibiotics three times daily, repeated debridement of infected groin wounds, and intravenous antibiotic therapy for at least 6 weeks. RESULTS One patient with purulent groin drainage treated with complete graft preservation died of sepsis. One patient with groin infection treated with complete graft preservation initially did well, but ultimately required total graft excision 5 months later, after clinical improvement. In four patients complete graft preservation was successful; two patients required excision of an occluded infected limb of the graft; and one patient underwent subtotal graft excision, leaving a graft remnant on the aorta, and axillopopliteal bypass. In summary, seven of nine patients survived hospitalization after complete or partial graft preservation; amputation was avoided in all but one patient; and no recurrent infection developed over mean follow-up of 7.6 years (range, 2-15 years). CONCLUSIONS Although contrary to conventional concepts, partial or complete graft preservation combined with aggressive drainage and groin wound debridement is an acceptable option for treatment of infection involving an entire aortic graft in selected patients with prohibitive risks for total graft excision. This treatment may be compatible with long-term survival and protracted absence of signs or symptoms of infection.

Does transrenal fixation of aortic endografts impair renal function

OBJECTIVES Transrenal fixation (TFX) of aortic endografts is thought to increase the risk for renal infarction and impaired renal function. We studied the late effects of TFX on renal function and perfusion. METHODS Of 189 patients with commercial aortic endografts, which we inserted between 1995 and 2002, we reviewed data for 130 patients (112 men, 18 women) with available creatinine (Cr) concentration and contrast enhanced computed tomography (CT) scans preoperatively and 1 to 97 months after the procedure. Of the 130 patients, 69 patients had TFX and 61 patients had infrarenal fixation (IFX). Both groups were physiologically comparable. Average age was 76 +/- 8 years for patients with TFX and 75 +/- 8 years for patients with IFX. Presence of renal infarct or renal artery occlusion was determined by nephrograms on serial contrast-enhanced CT scans. RESULTS Mean follow-up was 17 +/- 16 months (range, 1-54 months) for TFX and 21 +/- 21 months (range, 1-97 months) for IFX. Mean serum Cr concentration increased significantly during long-term follow-up in both groups (TFX, 1.3 +/- 0.5 mg/dL to 1.5 +/- 0.8 mg/dL, P <.01; IFX, 1.3 +/- 0.7 mg/dL to 1.4 +/- 0.8 mg/dL, P <.03). Creatinine clearance (CrCl) similarly decreased over long-term follow-up in both groups (TFX, 53.3 +/- 17.7 mL/min/1.73 m(2) to 47.9 +/- 16.2 mL/min/1.73 m(2), P <.01; IFX, 58.1 +/- 22.7 mL/min/1.73 m(2) to 53.1 +/- 23.4 mL/min/1.73 m(2), P <.02). There were no significant differences in the increase in Cr concentration (P =.19) or decrease in CrCl (P =.68) between TFX and IFX groups. Small renal infarcts were noted in four patients (5.8%) in the TFX group and one patient (1.6%) in the IFX group. No increase in Cr concentration or decrease in CrCl was noted in any patient with a renal infarct. Postoperative renal dysfunction developed in 7 of 69 patients (10.1%) in the TFX group and 7 of 61 patients (11.5%) in the IFX group. There were no statistically significant differences between groups with respect to number of patients with new renal infarcts (P =.37) or postoperative renal dysfunction (P =.81). CONCLUSION There is a slight increase in serum Cr concentration and decrease in CrCl after aortic endografting. However, there was no significant difference in these changes between patients with TFX and IFX. Although TFX may produce a higher incidence of small renal infarcts, these do not impair renal function. Thus our midterm results suggest that TFX can be performed safely, with no greater change in renal function than observed after IFX.

Incidence and characteristics of venous thromboembolic disease during pregnancy and the postnatal period: a contemporary series.

BACKGROUND To evaluate the incidence and characteristics of venous thromboembolic events (VTE) associated with pregnancy in a contemporary patient series. METHODS We performed a retrospective review of 33,311 deliveries between June 2003 and June 2008. Patients with objective documentation of a VTE during pregnancy or the 3-month postnatal period were identified from hospital discharge International Classification of Disease Codes edition 9 codes. Diagnosis of deep venous thrombosis (DVT) was largely made by a Duplex ultrasound, whereas pulmonary embolism (PE) was diagnosed by a computerized tomographic angiography (CTA). RESULTS Of 33,311 deliveries during the study period, 74 patients (0.22%) had a VTE. There were 40 incidents of DVT (0.12%) and 37 of PE (0.11%). DVT involved the iliac veins (6), the femoral or popliteal veins (16), the infrapopliteal veins (17), and the axillary vein (1). Most (57.5%) of the DVTs involved the left lower extremity. Thirty-eight (51.6%) of the VTEs occurred in the postnatal period, and of those 33 (87%) occurred within 1 week of delivery. Most of the postnatal VTEs (68%) were seen in patients who underwent a cesarean section. Among patients with VTE during pregnancy, there were 28% in the first trimester, 25% in the second, and 47% in the third. Events were distributed among maternal age groups as follows: 26% aged 13-24, 50% aged 25-34, and 24% aged 35-54. Of the 35 patients tested for a hypercoagulable disorder, 12 were found to have a positive test result. Five (6.8%) of these 74 patients had a prior history of VTE, with two having a hypercoagulable disorder. In addition, 45 of the 74 patients were on oral contraceptive therapy or received hormonal stimulation therapy before pregnancy. Patients with a VTE during pregnancy were treated with low molecular weight or unfractionated heparin. Most postnatal patients were treated with subcutaneous low molecular weight heparin and coumadin. Six inferior vena cava filters were placed in patients with bleeding complications as a result of anticoagulation. There were no deaths during the study period. CONCLUSIONS Comparing our results with historic controls (DVT: 0.04-0.14% and PE: 0.003-0.04%), the incidence of DVT in pregnancy has not changed significantly. We note, however, that the incidence of pulmonary embolus in our series is higher than previously reported. CTA has been used for the diagnosis of PE since the past decade. The increase in the rate of PE in the current series may be because of the higher sensitivity of CTA when compared with previous diagnostic modalities.

Fate of collateral vessels following subintimal angioplasty

Purpose: To evaluate the fate of collateral vessels adjacent to and within the target lesion following subintimal angioplasty (SIA). Methods: Pre and postprocedural angiograms were reviewed for 29 patients undergoing SIA of the lower extremity arteries over a 3-year period. The number of patent collateral vessels ≤5 cm proximal to the occlusion (proximal segment) and ≤5 cm distal to the occlusion (distal segment) were recorded pre and postprocedurally and compared. In addition, the number of collateral vessels that were re-opened within the recanalized segment following SIA was counted. Results: The mean number of patent collaterals in the proximal segment was 1.9 (range 0–4) preprocedurally and 1.4 (range 0–4) postprocedurally (p<0.002). The mean number of patent collaterals in the distal segment was 1.9 (range 0–4) pre-procedurally and 1.0 (range 0–4) postprocedurally (p<0.0001). Previously absent collaterals within the recanalized segment were observed in 4 (14%) of 29 patients post-SIA. The mean number of collateral vessels within all 3 segments (proximal, treated, and distal) was 3.9 collaterals preprocedurally and 2.9 collaterals postprocedurally Conclusions: Some collateral vessels are sacrificed during SIA, but the majority are preserved. In addition, SIA has the potential to open new collaterals within the occluded segment. These collaterals may play an important role should restenosis develop within the target segment.

Open aneurysm repair at an endovascular center: value of a modified retroperitoneal approach in patients at high risk with difficult aneurysms.

OBJECTIVE This study was undertaken to evaluate elective open abdominal aortic aneurysm (AAA) repair and the role of a modified retroperitoneal approach in a high-volume endovascular center. METHODS We reviewed prospectively collected data for 175 elective infrarenal open AAA repairs performed over 6 years. A transperitoneal approach was used in 118 procedures, and a modified retroperitoneal approach was used in 57 procedures. The incisional modification, which facilitated repair in patients with massive obesity, scarring, or ventral hernia, included a higher, more posterolateral location in the ninth intercostal space. Risk factors that added to the difficulty of the repair included aneurysms with a short (<1 cm) or no aortic neck in 45 patients; large, angled or flared aortic neck in 32 patients;, tortuous and calcified iliac arteries in 6 patients; morbid obesity in 10 patients; low ejection fraction (15%-30%) in 14 patients; chronic obstructive pulmonary disease, with forced expiratory volume at 1 second less than 55% in 4 patients; previous laparotomy in 18 patients; previous left-sided colectomy in 11 patients; large right iliac aneurysm in 8 patients; large ventral hernia in 8 patients; pelvic irradiation in 4 patients; failed endovascular repair in 5 patients; and previous failed open repair attempt in 2 patients. Many of these factors occurred with significantly greater frequency (P =.04-.001) in the retroperitoneal group. All factors were correlated with outcome. RESULTS Despite these risk factors, overall 30-day mortality was 3.5% (retroperitoneal group, 3.8%), and mean length of hospital stay was 9 days (retroperitoneal group, 8 days). There was no significant correlation between mortality or length of stay and any of the mentioned risk factors (P >.2). CONCLUSION In the era of endovascular aneurysm exclusion, open AAA repair is generally used to treat anatomically complex or difficult aneurysms, many of which are present in patients at high risk. Despite this combination of anatomic and systemic risk factors, the modified retroperitoneal approach facilitates treatment in difficult circumstances and enables open AAA repair to be performed with acceptable mortality and morbidity.

Iliac artery stenting in patients with poor distal runoff: influence of concomitant infrainguinal arterial reconstruction

OBJECTIVE Inadequate infrainguinal runoff is considered an important risk factor for iliac stent failure. However, the influence of concomitant infrainguinal arterial reconstruction (CIAR) on iliac stent patency is unknown. This study evaluated the influence of CIAR on outcome of iliac angioplasty and stenting (IAS) in patients with poor distal runoff. METHODS Over 5 years (1996 to 2001), 68 IAS procedures (78 stents) were performed in 62 patients with poor distal runoff (angiographic runoff score >or=5). The SVS/AAVS reporting standards were followed to define outcome variables and risk factors. Data were analyzed with both univariate analysis (Kaplan-Meier method [K-M]) and regression analysis (Cox proportional hazards model). RESULTS Indications for iliac artery stenting were disabling claudication (59%) and limb salvage (41%). Of the 68 procedures, IAS with CIAR was performed in 31 patients (46%), and IAS alone was performed in 37 patients (54%). Patients undergoing IAS with CIAR were older (P =.03) and had more extensive and multifocal iliac artery occlusive disease, with more TASC (TransAtlantic Inter-Society Consensus) type C lesions (P =.03), compared with patients undergoing IAS alone. No other significant differences in risk factors were noted. Runoff scores between patients undergoing IAS with CIAR and those undergoing IAS alone were not significantly different (median runoff scores, 6 [range, 5-8] and 7 [range, 5-9], respectively; P =.77). Primary stent patency rate at 1, 3, and 5 years was 87%, 54%, and 42%, respectively, for patients undergoing IAS with CIAR, and was 76%, 66%, and 55%, respectively, for patients undergoing IAS. Univariate analysis revealed that primary stent patency rate was not significantly different between the 2 groups (K-M, log-rank test, P =.81). Primary graft patency rate for CIAR was 81%, 52%, and 46% at 1, 3, and 5 years, respectively. Performing CIAR did not affect primary iliac stent patency (relative risk, 1.1; 95% confidence interval, 0.49-2.47; P =.81). Overall, there was a trend toward improved limb salvage in patients undergoing IAS with CIAR, compared with those undergoing IAS alone (K-M, log rank test, P =.07). CONCLUSION In patients undergoing IAS with poor distal runoff, CIAR does not improve iliac artery stent patency. Infrainguinal bypass procedures should therefore be reserved for patients who do not demonstrate clinical improvement and possibly for those with limb-threatening ischemia.

Histologic and duplex comparison of the perclose and angio-seal percutaneous closure devices

The intravascular and extravascular effects of percutaneous closure devices have not been well studied. We assessed the performance and healing characteristics in dogs of two devices approved by the US Food and Drug Administration. Nine adult male dogs were anesthesized prior to percutaneous access of both femoral arteries with a 6F sheath. All dogs were systemically heparinized to an activated clotting time (ACT) > 250 seconds. Duplex sonography was performed preoperatively to measure vessel diameter and flow velocity. In each dog, one of two devices (Perclose, Abbot Laboratories, Abbott Park, IL or Angio-Seal, St. Jude Medical, St. Paul, MN) was randomly deployed into one of the two femoral arteries. The other device was deployed on the opposite side. Duplex sonography was repeated immediately after deployment and 28 days later to measure changes in vessel diameter and flow velocity. At 28 days, angiography was performed on both femoral arteries before they were removed for histologic evaluation. The time required to excise each vessel reflected the degree of scarring. Hemostasis time for the Angio-Seal device far surpassed the Perclose device (39 ± 7 vs 0 minutes; p < .05). Vessel narrowing was observed only at 28 days after deployment of the Angio-Seal device (p < .05). Extensive extravascular scarring was observed with the Angio-Seal device, which resulted in a longer femoral artery dissection time and greater periadventitial scar thickness compared with the Perclose device (p < .05). When compared with the Perclose suture closure device, the Angio-Seal collagen plug closure device prolonged hemostasis time and produced greater vessel narrowing and periadventitial inflammation (extravascular scarring) in a canine model at 4 weeks.

Patency Rates of Femorofemoral Bypasses Associated with Endovascular Aneurysm Repair Surpass Those Performed for Occlusive Disease

PURPOSE To evaluate the patency rates of femorofemoral grafts performed in conjunction with aortomonoiliac or aortomonofemoral (AMI/F) endografts. METHODS Over the past 8 years, 110 patients (98 men; mean age 77+/-7 years, range 57-90) underwent aortoiliac aneurysm repair with an AMI/F endograft. Follow-up data in these patients were prospectively collected for a mean 2.3 years (range 1-68 months). RESULTS There were 2 early (<7 days) AMI/F endograft thromboses with secondary femorofemoral graft occlusion. In both patients, patency of all grafts was restored by thrombectomy plus stenting of the endograft. Three late (4, 5, and 10 months) AMI/F endograft thromboses led to femorofemoral graft failure; 2 were successfully treated, but the third patient refused further intervention. No femorofemoral bypass failed in the absence of AMI/F endograft thrombosis. There were no femorofemoral graft infections. Four-year life-table primary and secondary patency rates were 95% and 99%, respectively. CONCLUSIONS Femorofemoral bypasses with AMI/F endografts for aneurysmal disease are durable procedures and have better patency than femorofemoral grafts used to treat occlusive disease. Femorofemoral bypass patency rates alone are not a disadvantage of aortomonoiliac endografts.

Incidence and significance of nonaneurysmal-related computed tomography scan findings in patients undergoing endovascular aortic aneurysm repair

OBJECTIVE This study examined the frequency and nature of incidental findings seen on computed tomography (CT) scans during preoperative and postoperative follow-up in patients undergoing endovascular aortic aneurysm repair (EVAR). METHODS Between January 1, 2000, and March 1, 2006, 176 consecutive patients who underwent EVAR at our institution were retrospectively reviewed. Patients were included in the study if all preoperative and postoperative surveillance CT scans were performed at our institution. Eighty-two patients, 26 women (32%) and 56 men (68%), met this criterion. Their mean age was 76 years (range, 51-103 years). Official CT scan reports were reviewed. Findings were considered primary incidental if they were noted on preoperative CT scans and secondary incidental if they appeared on surveillance CT scans but not on the preoperative study. Primary and secondary incidental findings were considered either benign (eg, gallstones, diverticulosis) or clinically significant if they warranted further workup (eg, suspicious masses or changes suggestive of malignancy, internal or diaphragmatic hernias, and diverticulitis). The median follow-up was 29 months (range, 3-60 months). Each incidental finding was counted only once, on the first scan in which it appeared. RESULTS Of the 82 patients, 73 (89%) had at least one primary incidental finding, and 14 (19%) of these were clinically significant. Secondary incidental findings, many of which were clinically significant, continued to appear throughout the follow-up period. The most common clinically significant primary incidental finding was the presence of a lung mass (n = 4). The most common clinically significant secondary incidental findings were lung mass (n = 6), liver mass (n = 6), and pancreas mass (n = 3). There was a significant difference in the proportion of men to women in the group with clinically significant incidental findings vs the group without clinically significant incidental findings (P = .03959). Differences between the groups with respect to age or aneurysm size were not significant. CONCLUSION CT scans yielded surprisingly large numbers of both primary and secondary incidental findings, many of which were clinically significant. Primary incidental findings were more common than secondary incidental findings; however, clinically significant findings were found at a consistent rate throughout the study period.