Sean P. Roddy

Long-term outcomes of secondary procedures after endovascular aneurysm repair

PURPOSE This study evaluated the outcomes of secondary procedures after endovascular aneurysm repair (EVAR). METHODS From 2002 to 2009, 1768 patients underwent EVAR for treatment of 1662 elective (94%) and 106 emergent (6%) infrarenal abdominal aortic aneurysm (AAA) with a variety of Food and Drug Administration-approved and commercially available stent grafts. Postoperative follow-up included clinical examination, pulse volume recording, duplex ultrasound imaging, and computed tomography and magnetic resonance angiography at 1, 6, and 12 months, and yearly thereafter. Patients with type I and III endoleaks, unexplained endotension, limb occlusion, stent graft migration, with and without type I endoleak, and aneurysm rupture underwent secondary interventions. Type II endoleak at >6 months without a decrease in the aneurysm sac underwent translumbar embolization. Data were prospectively collected. RESULTS EVAR was performed in 1768 patients. During a mean follow-up of 34 (SD, 30.03) months, 339 patients (19.2%) required additional secondary procedures for aneurysm-related complications, including type I (n = 51, 15.0%), type II (n = 136, 40.1%), and type III (n = 5, 1.5%) endoleaks; endotension (n = 8, 2.4%), stent graft migration proximal fixation site (n = 46, 13.6%), stent graft iliac limb thrombosis or stenosis (n = 25, 7.4%), subsequent iliac aneurysm formation (n = 39, 11.5%), or aneurysm rupture after EVAR (n = 29, 8.6%). The mean age was 74 (SD, 9.15) years. Mean AAA size was 5.7 (SD 3.24) cm. Compared with secondary procedures for AAA rupture, the nonrupture patients had a significantly lower mortality (1.6% vs 17.2%, P < .05) and a higher likelihood of being managed by endovascular means (98.8% vs 44.8%, P < .05). When nonruptured EVAR patients required urgent secondary procedures for type I endoleaks and stent graft migration or limb thrombosis, the mortality was 6.0% vs 0.5% for elective procedures (P < .05). CONCLUSIONS Our long-term EVAR experience indicates that 18% of patients require additional secondary procedures, and most of these patients can be managed by endovascular means with an acceptable overall mortality of 2.9%. Most type I and II endoleaks can be successfully treated by transluminal embolization, and most patients with delayed aneurysm rupture after EVAR can be successfully managed by endovascular or open surgical repair.

Strategies to improve spinal cord ischemia in endovascular thoracic aortic repair: Outcomes of a prospective cerebrospinal fluid drainage protocol

PURPOSE Although endovascular repair of thoracic aortic aneurysm has been shown to reduce the morbidity and mortality rates, spinal cord ischemia remains a persistent problem. We evaluated our experience with spinal cord protective measures using a standardized cerebrospinal fluid (CSF) drainage protocol in patients undergoing endovascular thoracic aortic repair. METHODS From 2004 to 2006, 121 patients underwent elective (n = 52, 43%) and emergent (n = 69, 57%) endovascular thoracic aortic stent graft placement for thoracic aortic aneurysm (TAA) (n = 94, 78%), symptomatic penetrating ulceration (n = 11, 9%), pseudoaneurysms (n = 5, 4%) and traumatic aortic transactions (n = 11, 9%). In 2005, routine use of a CSF drainage protocol was established to minimize the risks of spinal cord ischemia. The CSF was actively drained to maintain pressures <15 mm Hg and the mean arterial blood pressures were maintained at >/=90 mm Hg. Data was prospectively collected in our vascular registry for elective and emergent endovascular thoracic aortic repair and the patients were divided into 2 groups (+CSF drainage protocol, -CSF drainage protocol). A chi(2) statistical analysis was performed and significance was assumed for P < .05. RESULTS Of the 121 patients with thoracic stent graft placement, the mean age was 72 years, 62 (51%) were male, and 56 (46%) underwent preoperative placement of a CSF drain, while 65 (54%) did not. Both groups had similar comorbidities of coronary artery disease (24 [43%] vs 27 [41%]), hypertension (44 [79%] vs 50 [77%]), chronic obstructive pulmonary disease (18 [32%] vs 22 [34%]), and chronic renal insufficiency (10 [17%] vs 12 [18%]). None of the patients with CSF drainage developed spinal cord ischemia (SCI), and 5 (8%) of the patients without CSF drainage developed SCI within 24 hours of endovascular repair (P< .05). All patients with clinical symptoms of SCI had CSF drain placement and augmentation of systemic blood pressures to >/=90 mm Hg, and 60% (3 of 5 patients) demonstrated marked clinical improvement. CONCLUSION Perioperative CSF drainage with augmentation of systemic blood pressures may have a beneficial role in reducing the risk of paraplegia in patients undergoing endovascular thoracic aortic stent graft placement. However, selective CSF drainage may offer the same benefit as mandatory drainage.

The role of amputation as an outcome measure in cellular therapy for critical limb ischemia: implications for clinical trial design

BackgroundAutologous bone marrow-derived stem cells have been ascribed an important therapeutic role in No-Option Critical limb Ischemia (NO-CLI). One primary endpoint for evaluating NO-CLI therapy is major amputation (AMP), which is usually combined with mortality for AMP-free survival (AFS). Only a trial which is double blinded can eliminate physician and patient bias as to the timing and reason for AMP. We examined factors influencing AMP in a prospective double-blinded pilot RCT (2:1 therapy to control) of 48 patients treated with site of service obtained bone marrow cells (BMAC) as well as a systematic review of the literature.MethodsCells were injected intramuscularly in the CLI limbs as either BMAC or placebo (peripheral blood). Six month AMP rates were compared between the two arms. Both patient and treating team were blinded of the assignment in follow-up examinations. A search of the literature identified 9 NO-CLI trials, the control arms of which were used to determine 6 month AMP rates and the influence of tissue loss.ResultsFifteen amputations occurred during the 6 month period, 86.7% of these during the first 4 months. One amputation occurred in a Rutherford 4 patient. The difference in amputation rate between patients with rest pain (5.6%) and those with tissue loss (46.7%), irrespective of treatment group, was significant (p = 0.0029). In patients with tissue loss, treatment with BMAC demonstrated a lower amputation rate than placebo (39.1% vs. 71.4%, p = 0.1337). The Kaplan-Meier time to amputation was longer in the BMAC group than in the placebo group (p = 0.067). Projecting these results to a pivotal trial, a bootstrap simulation model showed significant difference in AFS between BMAC and placebo with a power of 95% for a sample size of 210 patients. Meta-analysis of the literature confirmed a difference in amputation rate between patients with tissue loss and rest pain.ConclusionsBMAC shows promise in improving AMP-free survival if the trends in this pilot study are validated in a larger pivotal trial. The difference in amp rate between Rutherford 4 & 5 patients suggests that these patients should be stratified in future RCTs.

Effect of renal insufficiency on outcome following infrarenal aortic surgery

BACKGROUND This study reviewed the effect of preoperative renal insufficiency on outcome following elective infrarenal aortic surgery. METHODS The charts of 210 consecutive patients undergoing aortic surgery (occlusive disease, 15%; aneurysmal disease, 78%; or combined disease, 7%) from 1990 to 1995 were categorized into three groups based on preoperative creatinine ([Cr] group 1 Cr < 1.5, n = 171; group 2 Cr 1.5 to 1.7, n = 22; and group 3 Cr > or = 1.8, n = 17) and calculated creatinine clearance ([CrCl] CrCl > 45 mL/min, n = 162 versus CrCl < 45 mL/min, n = 48). Patients with renal artery stenosis or those who required suprarenal cross clamping or emergency procedures were excluded. Differences in postoperative intensive care unit (ICU) stay, ventilator days, dialysis dependence, morbidity, and, mortality were compared. RESULTS Patients in groups 2 and 3 had an increased incidence of postoperative dialysis dependence (group 2 9%, group 3 8%) when compared with patients in group 1 (group 1: 0%, P < 0.05). Patients in the CrCl > 45 group had a lower mortality rate when compared with patients with a CrCl < 45 (CrCl > 45 0.6% versus CrCl < 45 8%, P <0.05) a lower incidence of dialysis (0% versus 7%, P <0.05), and a lower incidence of postoperative serum creatinine elevation from baseline (CrCl > 45 8% versus CrCl < 45 18%, P <0.05). There was no significant difference in morbidity, ICU stay, or ventilator days between the groups. Upon regression analysis, preoperative CrCl but not Cr was predictive of postoperative mortality (P <0.05). Serum Cr was more predictive than CrCl of impaired renal function postoperatively. CONCLUSIONS Preoperative CrCl is more accurate than Cr as a predictor of postoperative mortality. Patients with preoperative CrCl < 45 mL/minute who undergo elective aortic surgery have a significant increase in postoperative cardiac-related mortality and dialysis.

Lipectomy as a new approach to secondary procedure superficialization of direct autogenous forearm radial-cephalic arteriovenous accesses for hemodialysis

BACKGROUND The depth of veins can discourage surgeons from creating radial-cephalic arteriovenous accesses for hemodialysis in obese patients. Elevation and tunneled transposition are the two techniques that have been described to superficialize these veins and make them accessible for cannulation. Unfortunately, such manipulation of veins has potential drawbacks. We report lipectomy, a new technique that removes subcutaneous fat and does not mobilize the vein. METHODS This single-center prospective study included 49 consecutive patients (17 men, 32 women) who underwent second-stage lipectomy after creation of a radial-cephalic fistula. Mean patient age was 54 years, 36% had diabetes, and the mean body mass index was 31 +/- 5.6 kg/m(2). Subcutaneous fatty tissues were removed after two transverse skin incisions under regional anesthesia and preventive hemostasis. Cannulation was first allowed 1 month later, after clinical and color duplex ultrasound evaluation. Technical success was defined as the ability to remove the fat and to palpate the patent vein immediately under the skin at the end of the operation. Clinical success was defined as the ability to perform at least three consecutive dialysis sessions with two needles. All patients were checked systematically every 6 months by the surgeon. RESULTS Technical and clinical success rates were 96% (47 of 49) and 94% (46 of 49), respectively. Mean vein depth decreased from 8 +/- 2 to 3 +/- 1 mm according to duplex ultrasound imaging. The mean vein diameter increased from 6 +/- 1 to 8 +/- 2 mm. In one patient, vein tortuosity that was overlooked required conventional repeat tunneling. One extensive hematoma resulted in loss of the fistula. One patient died before the fistula could be used. Primary patency rates were 71% +/- 7% and 63% +/- 8% at 1 and 3 years, respectively, and secondary patency rates were 98% +/- 2% and 88% +/- 7%. Delayed complications were treated by surgery (n = 7) or by endovascular procedures (n = 10). CONCLUSION Lipectomy is a safe, effective, and durable approach to make deep arterialized forearm veins accessible for routine cannulation for hemodialysis in obese patients. It might even be hypothesized that incident obese dialysis patients will eventually have the highest proportion of radial-cephalic fistulas because they often have distal veins that have been preserved by their fat from previous attempts at cannulation for blood sampling or infusion.

A complex role for the progesterone receptor in the response to vascular injury

Clinical studies of hormone replacement therapy to prevent cardiovascular diseases have heightened interest in the cardiovascular effects of progestins. However, the role of the progesterone receptor (PR) in vascular biology has not been studied in vivo. We studied ovariectomized female PR knockout (PRKO) mice and their wild-type (WT) littermates using the mouse carotid artery injury model. Placebo-treated PRKO mice showed significantly greater vascular medial hypertrophy and vascular smooth muscle cell (VSMC) proliferation in response to vascular injury than did WT mice. Progesterone had no significant effect in the PRKO mice, but worsened the response to injury in WT mice. VSMCs cultured from PRKO mouse aortae were markedly hyperproliferative, and their growth was not affected by progesterone. In contrast to the in vivo findings, progesterone inhibited proliferation of WT-derived VSMCs. Furthermore, reintroduction of PR into PRKO-derived VSMCs using adenoviral methods restored progesterone-mediated inhibition of proliferation to these cells. This effect was reversed by the PR antagonist, RU 486. Thus, the effects of PR and progesterone differ markedly between cultured VSMCs and intact blood vessels. These data demonstrate a direct role for the PR in regulating the response to vascular injury and VSMC proliferation.

Outcomes of planned celiac artery coverage during TEVAR

OBJECTIVE Successful thoracic endovascular aneurysm repair (TEVAR) requires adequate proximal and distal fixation and seal. We report our experience of planned celiac artery coverage during endovascular repair of complex thoracic aortic aneurysms (TAA). METHODS Since 2004, 228 patients underwent TEVAR under elective (n=162, 71%) and emergent circumstances (66, 29%). Patients with inadequate distal stent grafts landing zones during TEVAR underwent detailed evaluation of the gastroduodenal arcade with communicating collaterals between the celiac and superior mesenteric artery (SMA) by computed tomography angiography and intraoperative arteriogram. If needed, in presence of a patent SMA and demonstration of collaterals to the celiac artery, the stent grafts were extended to the SMA with celiac artery coverage. Furthermore, instances when further lengthening of distal thoracic stent graft landing zone was needed to obtain an adequate seal, the SMA was partially covered with the endograft, and a balloon expandable stent was routinely deployed in proximal SMA to maintain patency. Outcome data were prospectively collected and analyzed retrospectively. RESULTS Thirty-one of 228 (14%) patients with TEVAR required celiac artery interruption; 24 (77%) had demonstrable collaterals to the SMA. Twelve (39%) of 31 patients underwent additional partial SMA coverage by stent graft, and proximal SMA stent. The majority of patients were females (n=20, 65%), the mean age was 74 years (range 55-87 years), and the mean TAA size was 6.5 cm. Postoperative complications included visceral ischemia in 2 (6%) patients, paraplegia in 2 (6%) patients, and death in 2 (6%) patients. All type 1b endoleaks (n=2, 6%) and type 2 endoleaks vial retrograde flow from the celiac artery (n=3, 10%) were successfully treated by transfemoral coil embolization. Over a mean follow-up of 15 months, there have been no other complications of mesenteric ischemia, spinal cord ischemia, SMA in-stent stenosis, or conversion to open surgical repair. CONCLUSIONS Our findings suggest that celiac artery coverage to facilitate adequate distal sealing during TEVAR with complex TAA is relatively safe in the presence of SMA-celiac collaterals. Pre-existing SMA stenosis can be successfully treated by balloon expandable stents during TEVAR, and endoleaks arising from distal stent grafts attachment site or via retrograde flow from the celiac artery can be successfully managed by transfemoral coil embolization. Although early results are encouraging, long-term efficacy of these procedures remains to be determined and vigilant follow-up is needed.

Reduction of hospital resources utilization in vascular surgery: A four-year experience

PURPOSE Managed care whether through risk or through capitated contracts results in reduction in resources, reduced length of hospital stay, and reduced utilization of hospital resources (collectively referred to as resource reductions). These resource reductions will become even more noticeable as a greater proportion of Medicare patients who need vascular operations select a managed-care senior product. We examined the results of a 4-year experience with resource management in an academic vascular surgery practice during which best practice plans were developed and implemented. METHODS We analyzed hospital cost data, which included both total hospital and intensive care unit length of stay, average units per operation for laboratory, pharmacy, and radiology services and operating room and direct hospital costs for 257 carotid endarterectomies performed over fiscal years (FY) 1994, 1995, 1996, and 1997 (6 month data) and 175 infrainguinal bypass procedures performed during the same period. RESULTS For carotid endarterectomy, length of stay decreased 66% over the 4-year period to an average of 2.07 days in FY97. Both radiology and pharmacy utilization were reduced after the first year of institution of best practice plans (56% and 32% respectively) with 4-year total reductions of 86% and 55% by FY97. The most notable changes included elimination of routine postoperative laboratory testing, use of aspirin rather than low-molecular-weight dextran, emphasis on oral rather than intravenous vasoactive drugs, and routine use of duplex scanning alone rather than angiography for diagnosis after FY94-95. The length of operating room time for carotid endarterectomy remained relatively constant from FY94 to FY97. As a result of these multiple factors, our study showed a 30% decrease in total average direct hospital costs for carotid endarterectomy from

The impact of hemodynamic status on outcomes of endovascular abdominal aortic aneurysm repair for rupture

9974 to

Upper extremity bypass grafting for limb salvage in end-stage renal failure.

7002 in this 4-year period. Infrainguinal bypass graft procedures showed a progressive decrease in total cost of 28% for patients without complications to