Richard P. Cambria

Vascular complications associated with spontaneous aortic dissection

Three hundred twenty-five cases of spontaneous aortic dissection seen at two institutions between 1965 and 1986 were reviewed to assess the incidence, morbid sequelae, and specific management of aortic branch compromise. Noncardiac vascular complications occurred in 33% of the study group, and in these patients the overall mortality rate (51%) was significantly (p less than 0.001) higher than in patients without (29%) such complications. Although aortic rupture was the strongest correlate of mortality (90%), death specifically related to vascular occlusion was common when such occlusion occurred in the carotid, mesenteric, and renal circulation. There was a strong correlation between stroke and carotid occlusion (22/26 cases), yet specific carotid revascularization was only used during the chronic phase of the disease. Similarly, peripheral operation was ineffective in reducing the mortality rate in the setting of mesenteric (87%) and renal (50%) ischemia. Fifteen patients required either fenestration or graft replacement of the abdominal aorta for acute obstruction, rupture, or chronic aneurysm development. Thirty-eight patients (12%) demonstrated some degree of lower extremity ischemia, and one third of these required a direct approach on the abdominal aorta or iliofemoral segments to restore circulation. Selected patients with acute aortic dissection may require peripheral vascular operation in accordance with a treatment strategy that directs initial attention to the immediate life-threatening complications.

Five-year results of endovascular treatment with the Gore TAG device compared with open repair of thoracic aortic aneurysms

OBJECTIVES Report the results of a phase II multicenter, prospective trial comparing endovascular treatment of descending thoracic aneurysm (TEVAR) with the TAG device to surgical controls after 5 years of follow-up. METHODS The Gore TAG trial compared the TAG endograft patients (n = 140) with standard open surgical controls (n = 94) with enrollment from September of 1999 to May of 2001. An additional 51 patients were enrolled in 2003 after revision of the endograft. Follow-up consisted of patient visits, computed tomography (CT) scans and x-rays at 1, 6, and 12 months and yearly. Significant sac size change was defined as >or=5 mm increase or decrease from the 1 month baseline measurement. Migration was defined as >or=10 mm cranial or caudal movement of the device inside the aorta. Significance was determined as P <or= .05. RESULTS At 5 years, aneurysm-related mortality was lower for TAG patients at 2.8% compared with open controls at 11.7% (P = .008). No differences in all-cause mortality were noted, with 68% of TAG patients and 67% of open controls surviving to 5 years (P = .43). Major adverse events at 5 years were significantly reduced in the TAG group; 57.9% vs 78.7% (P = .001). Endoleaks in the TAG group decreased from 8.1% at 1 month to 4.3% at 5 years. Five TAG patients have undergone major aneurysm-related re-interventions at 5 years (3.6%), including one arch aneurysm repair for type 1 endoleak and migration, one open conversion and five endovascular procedures for endoleaks in three patients. There were fewer secondary procedures not directly related to aneurysm repair in the TAG vs the open repair group at 5 years, 15.0% vs 31.9%, (P = .01). For TAG patients, sac size at 60 months decreased in 50% and increased in 19% compared with the 1-month baseline. Comparison with the modified low-porosity device at 24 months showed sac increase in 12.9% of original vs 2.9% in modified grafts (P = .11). At 5 years, there have been no ruptures, one migration, no collapse, and 20 instances of fracture in 19 patients, all before the revision of the TAG graft. CONCLUSIONS In anatomically suitable patients, TAG treatment of thoracic aneurysms is superior to surgical repair at 5 years. Although sac enlargement is concerning, early modified device results indicate this issue may be resolved.

International controlled clinical trial of thoracic endovascular aneurysm repair with the Zenith TX2 endovascular graft: 1-year results

PURPOSE This trial evaluated the safety and effectiveness of thoracic endovascular aortic repair (TEVAR) with a contemporary endograft system compared with open surgical repair (open) of descending thoracic aortic aneurysms and large ulcers. METHODS Forty-two international trial sites enrolled 230 subjects with descending thoracic aortic aneurysms or ulcers. The study compared 160 TEVAR subjects treated with the Zenith TX2 Endovascular Graft (William Cook Europe, ApS, Bjaeverskov, Denmark) with 70 open subjects. Subjects were evaluated preprocedure, predischarge, 1, 6, and 12 months, and yearly through 5 years with medical examination, laboratory testing, chest radiographs, and computed tomography scans. Mortality rates, prespecified severe morbidity composite index, major morbidity, clinical utility, aneurysm rupture, and secondary interventions were compared. The TEVAR subjects were evaluated by a core laboratory for device performance, including change in aneurysm size, endoleak, migration, and device integrity. RESULTS The 30-day survival rate was noninferior (P < .01) for the TEVAR group compared with the open group (98.1% vs 94.3%). The severe morbidity composite index was lower for TEVAR (0.2 +/- 0.7 vs 0.7 +/- 1.2; P < .01). Cumulative major morbidity scores were significantly lower at 30 days for the TEVAR group compared with the open group (1.3 +/- 3.0 vs 2.9 +/- 3.6, P < .01). The TEVAR patients had fewer cardiovascular, pulmonary, and vascular adverse events, although neurologic events were not significantly different. Clinical utility for the TEVAR patients was superior to that of the open patients. No ruptures or conversions occurred in the first year. Reintervention rates were similar in both groups. At 12 months, aneurysm growth was identified in 7.1% (8/112), endoleak in 3.9% (4/103), migration (>10 mm) in 2.8% (3/107), and other device issues were rare. None of the patients with migration experienced endoleak, aneurysm growth, or required a secondary intervention. CONCLUSIONS Thoracic endovascular aortic repair with the TX2 is a safer and effective alternative to open surgical repair for the treatment of anatomically suitable descending thoracic aortic aneurysms and ulcers at 1 year of follow-up. Device performance issues are infrequent, but careful planning and regular follow-up with imaging remain a necessity.

Initial experience with endovascular aneurysm repair: Comparison of early results with outcome of conventional open repair

PURPOSE To determine the safety, effectiveness, and problems encountered with endovascular repair of abdominal aortic aneurysm (AAA). Initial experience with endoluminal stent grafts was examined and compared with outcome for a matched concurrent control group undergoing conventional operative repair of AAA. METHODS Over a 3-year period, 30 patients underwent attempts at endovascular repair of infrarenal AAA. Of the 28 (93%) successfully implanted endografts, 8 were tube endografts, 8 bifurcated grafts, and 12 aortouniiliac grafts combined with femorofemoral bypass. Most of the procedures were performed in the past year because the availability of bifurcated and aortoiliac endografts markedly expanded the percentage of patients with AAA who might be treated with endoluminal methods. The follow-up period ranged from 1 to 44 months, with a mean value of 11 months. RESULTS Endovascular procedures demonstrated significant advantages with respect to reduced blood loss (408 versus 1287 ml), use of an intensive care unit (0.1 versus 1.75 days), length of hospitalization (3.9 versus 10.3 days), and quicker recovery (11 versus 47 days). Although the total number of postoperative complications was identical for the two groups, the nature of the complications differed considerably. Local and vascular complications characteristic of endovascular repair could frequently be corrected at the time of the procedure and tended to be less severe than systemic or remote complications, which predominated among the open surgical repair group. On an intent-to-treat basis, 23 (77%) of the 30 AAAs were successfully managed with endoluminal repair. The seven (23%) failures were attributable to two immediate conversions caused by access problems, three persistent endoleaks, one late conversion caused by AAA expansion, and one late rupture. CONCLUSIONS Although less definitive than those for conventional operations, these early results suggest that endovascular AAA repair offers considerable benefits for appropriate patients. The results justify continued application of this method of AAA repair, particularly in the treatment of older persons at high risk.

Distal Aortic Perfusion and Cerebrospinal Fluid Drainage for Thoracoabdominal and Descending Thoracic Aortic Repair: Ten Years of Organ Protection

Objective To report the long-term results of our experience using cerebrospinal fluid drainage and distal aortic perfusion in descending thoracic and thoracoabdominal aortic repair. Summary Background Data Repair of thoracoabdominal and thoracic aortic aneurysm by the traditional clamp-and-go technique results in a massive ischemic insult to several major organ systems. Ten years ago, we began to use distal aortic perfusion and cerebrospinal fluid drainage (adjunct) to reduce end-organ ischemia. Methods Between January 1991 and February 2003, we performed 1004 thoracoabdominal or descending thoracic repairs. Adjunct was used in 741 (74%) of 1004. Multivariable data were analyzed by Cox regression. Number needed to treat was calculated as the reciprocal of the risk difference. Results Immediate neurologic deficit was 18 (2.4%) of 741 with adjunct and 18 (6.8%) of 263 without (P < 0.0009). In high-risk extent II aneurysms, the numbers were 11 (6.6%) of 167 with adjunct, and 11 (29%) of 38 without. Long-term survival was improved with adjunct (P < 0.002). The long-term survival results persisted after adjustment for age, extent II aneurysm, and preoperative renal function. Conclusion Use of adjunct over a long period of time has produced favorable results; approximately 1 neurologic deficit saved for every 20 uses of adjunct overall. In extent II aneurysms, where the effect is greatest, this increases to 1 saved per 5 uses. Adjunct is also associated with long-term survival, which is consistent with mitigation of ischemic end-organ injury. These long-term results indicate that cerebrospinal fluid drainage and distal aortic perfusion are safe and effective adjunct for reducing morbidity and mortality following thoracic and thoracoabdominal aortic repair.

Long-term Outcomes After Endovascular Abdominal Aortic Aneurysm Repair: The First Decade

Objective:The proper role of endovascular abdominal aortic aneurysm repair (EVAR) remains controversial, largely due to uncertain late results. We reviewed a 12-year experience with EVAR to document late outcomes. Methods:During the interval January 7, 1994 through December 31, 2005, 873 patients underwent EVAR utilizing 10 different stent graft devices. Primary outcomes examined included operative mortality, aneurysm rupture, aneurysm-related mortality, open surgical conversion, and late survival rates. The incidence of endoleak, migration, aneurysm enlargement, and graft patency was also determined. Finally, the need for reintervention and success of such secondary procedures were evaluated. Kaplan-Meier and multivariate methodology were used for analysis. Results:Mean patient age was 75.7 years (range, 49–99 years); 81.4% were male. Mean follow-up was 27 months; 39.3% of patients had 2 or more major comorbidities, and 19.5% would be categorized as unfit for open repair. On an intent-to-treat basis, device deployment was successful in 99.3%. Thirty-day mortality was 1.8%. By Kaplan-Meier analysis, freedom from AAA rupture was 97.6% at 5 years and 94% at 9 years. Significant risk factors for late AAA rupture included female gender (odds ratio OR, 6.9; P = 0.004) and device-related endoleak (OR, 16.06; P = 0.009). Aneurysm-related death was avoided in 96.1% of patients, with the need for any reintervention (OR, 5.7 P = 0.006), family history of aneurysmal disease (OR, 9.5; P = 0.075), and renal insufficiency (OR, 7.1; P = 0.003) among its most important predictors. 87 (10%) patients required reintervention, with 92% of such procedures being catheter-based and a success rate of 84%. Significant predictors of reintervention included use of first-generation devices (OR, 1.2; P < 0.01) and late onset endoleak (OR, 64; P < 0.001). Current generation stent grafts correlated with significantly improved outcomes. Cumulative freedom from conversion to open repair was 93.3% at 5 through 9 years, with the need for prior reintervention (OR, 16.7; P = 0.001) its most important predictor. Cumulative survival was 52% at 5 years. Conclusions:EVAR using contemporary devices is a safe, effective, and durable method to prevent AAA rupture and aneurysm-related death. Assuming suitable AAA anatomy, these data justify a broad application of EVAR across a wide spectrum of patients.

Outcomes following endovascular abdominal aortic aneurysm repair (EVAR): an anatomic and device-specific analysis.

OBJECTIVE We performed a device-specific comparison of long-term outcomes following endovascular abdominal aortic aneurysm repair (EVAR) to determine the effect(s) of device type on early and late clinical outcomes. In addition, the impact of performing EVAR both within and outside of specific instructions for use (IFU) for each device was examined. METHODS Between January 8, 1999 and December 31, 2005, 565 patients underwent EVAR utilizing one of three commercially available stent graft devices. Study outcomes included perioperative (< or =30 days) mortality, intraoperative technical complications and need for adjunctive procedures, aneurysm rupture, aneurysm-related mortality, conversion to open repair, reintervention, development and/or resolution of endoleak, device related adverse events (migration, thrombosis, or kinking), and a combined endpoint of any graft-related adverse event (GRAE). Study outcomes were correlated by aneurysm morphology that was within or outside of the recommended device IFU. chi2 and Kaplan Meier methods were used for analysis. RESULTS Grafts implanted included 177 Cook Zenith (CZ, 31%), 111 Gore Excluder (GE, 20%), and 277 Medtronic AneuRx (MA, 49%); 39.3% of grafts were placed outside of at least one IFU parameter. Mean follow-up was 30 +/- 21 months and was shorter for CZ (20 months CZ vs 35 and 31 months for GE and MA, respectively; P < .001). Overall actuarial 5-year freedom from aneurysm-related death, reintervention, and GRAE was similar among devices. CZ had a lower number of graft migration events (0 CZ vs 1 GE and 9 MA); however, there was no difference between devices on actuarial analysis. Combined GRAE was lowest for CZ (29% CZ, 35% GE, and 43% MA; P = .01). Graft placement outside of IFU was associated with similar 5-year freedom from aneurysm-related death, migration, and reintervention (P > .05), but a lower freedom from GRAE (74% outside IFU vs 86% within IFU; P = .021), likely related to a higher incidence of graft thrombosis (2.3% outside IFU vs 0.3% within IFU; P = .026). The differences in outcome for grafts placed within vs outside IFU were not device-specific. CONCLUSION EVAR performed with three commercially available devices provided similar clinically relevant outcomes at 5 years, although no graft migration occurred with a suprarenal fixation device. As anticipated, application outside of anatomically specific IFU variables had an incremental negative effect on late results, indicating that adherence to such IFU guidelines is appropriate clinical practice.

Clinical experience with epidural cooling for spinal cord protection during thoracic and thoracoabdominal aneurysm repair

PURPOSE This report summarizes our experience with epidural cooling (EC) to achieve regional spinal cord hypothermia and thereby decrease the risk of spinal cord ischemic injury during the course of descending thoracic aneurysm (TA) and thoracoabdominal aneurysm (TAA) repair. METHODS During the interval July 1993 to Dec. 1995, 70 patients underwent TA (n = 9, 13%) or TAA (n = 61) (type I, 24 [34%], type II, 11 [15%], type III, 26 [37%]) repair using the EC technique. The latter was accomplished by continuous infusion of normal saline (4 degrees C) into a T11-12 epidural catheter; an intrathecal catheter was placed at the L3-4 level for monitoring of cerebrospinal fluid temperature (CSFT) and pressure (CSFP). All operations (one exception, atriofemoral bypass) were performed with the clamp-and-sew technique, and 50% of patients had preservation of intercostal vessels at proximal or distal anastomoses (30%) or by separate inclusion button (20%). Neurologic outcome was compared with a published predictive model for the incidence of neurologic deficits after TAA repair and with a matched (Type IV excluded) consecutive, control group (n = 55) who underwent TAA repair in the period 1990 to 1993 before use of EC. RESULTS EC was successful in all patients, with a 1442 +/- 718 ml mean (range, 200 to 3500 ml) volume of infusate; CSFT was reduced to a mean of 24 degrees +/- 3 degrees C during aortic cross-clamping with maintenance of core temperature of 34 degrees +/- 0.8 +/- C. Mean CSFP increased from baseline values of 13 +/- 8 mm Hg to 31 +/- 6 mm Hg during cross-clamp. Seven patients (10%) died within 60 days of surgery, but all survived long enough for evaluation of neurologic deficits. The EC group and control group were well-matched with respect to mean age, incidence of acute presentations/aortic dissection/aneurysm rupture, TAA type distribution, and aortic cross-clamp times. Two lower extremity neurologic deficits (2.9%) were observed in the EC patients and 13 (23%) in the control group (p < 0.0001). Observed and predicted deficits in the EC patients were 2.9% and 20.0% (p = 0.001), and for the control group 23% and 17.8% (p = 0.48). In considering EC and control patients (n = 115), variables associated with postoperative neurologic deficit were prolonged (> 60 min) visceral aortic cross-clamp time (relative risk, 4.4; 95% CI, 1.2 to 16.5; p = 0.02) and lack of epidural cooling (relative risk, 9.8; 95% CI, 2 to 48; p = 0.005). CONCLUSION EC is a safe and effective technique to increase the ischemic tolerance of the spinal cord during TA or TAA repair. When used in conjunction with a clamp-and-sew technique and a strategy of selective intercostal reanastomosis, EC has significantly reduced the incidence of neurologic deficits after TAA repair.

Transperitoneal versus retroperitoneal approach for aortic reconstruction: A randomized prospective study*

A prospective, randomized study was conducted to compare the retroperitoneal versus transperitoneal approach for elective aortic reconstruction. One hundred thirteen patients (transperitoneal = 59, retroperitoneal = 54) were randomized between March 1987 and October 1988. In addition, to assess the changing course of patients undergoing aortic reconstruction similar data were gathered retrospectively on a group of 56 patients undergoing aortic reconstruction by the same surgeons performed via a transperitoneal approach in 1984 to 1985. Randomized patients were identical in age, male to female ratio, smoking history, incidence and severity of cardiopulmonary disease, indication for operation, and use of epidural anesthetics. Details of operation including operative and aortic cross-clamp times, crystalloid and transfusion requirements, degree of hypothermia on arrival at the intensive care unit, and perioperative fluid and blood requirements did not differ significantly for patients undergoing transperitoneal versus retroperitoneal reconstruction. Respiratory morbidity, as assessed by percent of patients requiring postoperative ventilation, deterioration in pulmonary function tests, and the incidence of respiratory complications, was identical in randomized patients. Other aspects of postoperative recovery including recovery of gastrointestinal function, the requirement for narcotics, metabolic parameters of operative stress, the incidence of major and minor complications, and the duration of hospital stay were similar for randomized patients undergoing transperitoneal and retroperitoneal reconstruction. When compared to retrospectively reviewed patients having aortic reconstruction, randomized patients undergoing transperitoneal and retroperitoneal operations had highly significant (p less than 0.001) reductions in postoperative ventilation, transfusion requirements, and length of hospital stay. Such trends were all independent of transperitoneal versus retroperitoneal approach.(ABSTRACT TRUNCATED AT 250 WORDS)

Comparative early and late cardiac morbidity among patients requiring different vascular surgery procedures

PURPOSE The evaluation of coronary artery disease (CAD) in patients undergoing vascular surgery can provide information with respect to perioperative and long-term risk for CAD-related events. However, the extent to which the required surgical procedure itself imparts additional risk beyond that dictated by the presence of CAD determinants remains in question. The purpose of this study was to quantify the relative contributions of specific vascular procedures and CAD markers on perioperative and long-term cardiac risk. METHODS The study cohort comprised 547 patients undergoing vascular surgery from two medical centers who underwent clinical evaluation, dipyridamole thallium testing, and either aortic (n = 321), infrainguinal (n = 177), or carotid (n = 49) vascular surgery between 1984 and 1991. Perioperative and late cardiac risk of fatal or nonfatal myocardial infarction (MI) was compared for the three procedures before and after adjustment for the influence of comorbid factors. These adjusted estimates may be regarded as the component of risk because of type of surgery. RESULTS Perioperative MI occurred in 6% of patients undergoing aortic and carotid artery surgery, and in 13% of patients undergoing infrainguinal procedures (p = 0.019). Significant (p < 0.05) predictors of MI were history of angina, fixed and reversible dipyridamole thallium defects, and ischemic ST depression during testing. Although patients undergoing infrainguinal procedures exhibited more than twice the risk for perioperative MI compared with patients undergoing aortic surgery (relative risk: 2.4[1.2 to 4.5, p = 0.008]), this value was reduced to insignificant levels (1.6[0.8 to 3.2, p = 0.189]) after adjustment for comorbid factors. There was little change in comparative risk between carotid artery and aortic procedures before (1.0[0.3 to 3.6, p = 0.95]) or after (0.6[0.2 to 2.3, p = 0.4]) covariate adjustment. The 4-year cumulative event-free survival rate was 90% +/- 2% for aortic, 74% +/- 5% for infrainguinal, and 78% +/- 7% for carotid artery procedures (p = 0.0001). Predictors of late MI included history of angina, congestive heart failure, diabetes, fixed dipyridamole thallium defects, and perioperative MI. Patients undergoing infrainguinal procedures exhibited a threefold greater risk for late events compared with patients undergoing aortic procedures (relative risk: 3.0[1.8 to 5.1, p = 0.005]), but this value was reduced to 1.3(0.8 to 2.3, p = 0.32) after adjustment. Long-term risk among patients undergoing carotid artery surgery was less dramatically altered by risk factor adjustment. CONCLUSION In current practice, among patients referred for dipyridamole testing before operation, observed differences in cardiac risk of vascular surgery procedures may be primarily attributable to readily identifiable CAD risk factors rather than to the specific type of vascular surgery. Thus the cardiac and diabetic status of patients should be given careful consideration whenever possible, regardless of surgical procedure to be performed.