Volume associated dynamic geometry and spatial orientation of the inferior vena cava.

BACKGROUND: The geometry and dynamics of the vena cava are poorly understood and current knowledge is largely based on qualitative data. The purpose of this study is to quantitate the dimensional changes that occur in the infrarenal inferior vena cava (IVC), in response to changes in intravascular volume. METHODS: IVC dimensions were measured at 1 cm and 5 cm below the renal veins, on serial contrasted computed tomographic (CT) scans, in 30 severely injured trauma patients during hypovolemic (admission) and fluid resuscitated (follow-up) states. Changes in volume of the infrarenal segment were calculated and correlated with changes in IVC diameter and orientation. The orientation of the infrarenal caval segment was quantified as the angulation of the major axis from the horizontal. A representation of the IVC diameter, as would be seen on standard anterior-posterior venographic imaging, was determined by projecting the CT image of the major axis onto a coronal plane. CT representations of venographic diameters were compared with measurements of the true major axis to assess accuracy of venograms for caval sizing and filter selection. RESULTS: All patients had evidence of a collapsed IVC (<15 mm minor axis dimension) on admission. Mean time between admission and follow-up CT was 49.5 (range: 1-202) days. The volume of the infrarenal segment increased more than twofold with resuscitation, increasing from 6.9 +/- 2.2 (range: 3.1-12.4) mL on admission, to 15.7 +/- 5.0 (range: 9.2-28.5) mL on follow-up (P < .01). At both 1 and 5 cm below the renal veins, the IVC expanded anisotropically such that the minor axis expanded up to five times its initial size accommodating 84% of the increased volume of the segment, while only small diameter changes were observed in the major axis accounting for less than 5% of the volume increase (P < .001). Further, the IVC was left-anterior-oblique in all patients, with the major axis 26 degrees off the horizontal on average. This orientation did not change significantly with volume resuscitation (P > 0.5). The obliquity of the IVC resulted in significant underestimation of caval size of up to 6.8 mm, when using the venographic representation for sizing instead of the true major axis (P < 0.001). CONCLUSIONS: In response to changes in intravascular volume, the IVC undergoes profound anisotropic dimensional changes, with greater displacement seen in the minor axis. In addition, the IVC is oriented left-anterior oblique and caval orientation is not altered by changes in volume status. IVC obliquity may result in underestimation of caval size by anterior-posterior venogram.

Radiosurgical Ablation of the Renal Nerve in a Porcine Model: A Minimally Invasive Therapeutic Approach to Treat Refractory Hypertension.

BACKGROUND: Hypertension is strongly associated with cardiovascular diseases such as heart failure, stroke, kidney disease, and has been correlated with an increased risk for heart attack. Current treatment regimens for hypertension are highly inadequate, with reports indicating that only 50.1% of the clinical population with the disease has their blood pressure under control. OBJECTIVE: To study the feasibility of using minimally invasive radiosurgery to ablate the renal nerves as a novel treatment for refractory hypertension, and to assess the safety and efficacy of such an approach. METHODS: A Hanford porcine (miniswine) model (N = 6) was used to investigate the feasibility of using the CyberHeart radiosurgical platform (CyberHeart Inc., Mountain View, CA, USA) to create safe renal nerve ablations. Norepinephrine (NE) levels were measured pre and post treatment. Additionally, renal nerve and arterial histology were studied to examine effect. RESULTS: Plasma norepinephrine levels showed a decrease over the six-month time point. Urea, nitrogen, and creatinine levels showed no changes post procedure. Histology documented no significant arterial injury in targeted areas. Renal nerves documented histologic change consistent with nerve ablation. CONCLUSION: CyberHeart radiosurgery of the renal nerve is feasible and resulted in norepinephrine reduction and renal nerve injury consistent with radiosurgical targeted ablation.

Cost-Effectiveness of Cardiac Radiosurgery for Atrial Fibrillation: Implications for Reducing Health Care Morbidity, Utilization, and Costs.

In the United States (U.S.), atrial fibrillation (AF) is the second-most common cardiovascular condition after hypertension, affecting four million Americans each year. Individuals with AF are three times more likely to be hospitalized over the span of a year when compared to medically matched control groups. The considerably large clinical population of individuals with AF mandates that the cost-effectiveness and efficacy of current treatment regimens for AF have egregious implications for health care spending and public health. Unfortunately, catheter ablation for AF treatment has been shown to make only modest gains in quality-adjusted life years, has yet to demonstrate cost-utility advantages over conventional therapies for AF, and has a reported rate of recurrence for AF that is notably high. Thus, there is a major unmet clinical need for a therapeutic option to treat AF that produces more consistent and efficacious results that are cost-effective. Cardiac radiosurgery as a therapy for AF has the potential to be remarkably cost-effective and produce robust patient outcomes. CyberHeart Inc. has developed the world's first-ever cardiac radiosurgery (CRS) system designed to ablate the heart non-invasively. Procedures that ablate the heart utilizing the Cyberheart CRS system are anticipated to allow higher efficacy and more consistent results than current techniques such as catheter ablation. The aim of this study is to present the current healthcare utilization and expenditures in AF treatment, report the cost-effectiveness of catheter ablation for AF, and project the potential cost-effectiveness of cardiac radiosurgery for the treatment of AF.

Endovascular edge-to-edge mitral valve repair: short-term results in a porcine model.

BACKGROUND: The edge-to-edge technique is an accepted method for the surgical repair of a regurgitant mitral valve. This study reports the initial use of an endovascular technology that enables a double-orifice edge-to-edge mitral valve repair without cardiopulmonary bypass in an animal model. METHODS AND RESULTS: Adult pigs (n=14) were anesthetized, and left thoracotomy was performed for epicardial echo imaging. Using femoral vein access, a steerable guide catheter was placed transseptally into the left atrium. An implantable clip designed to grasp and approximate the middle scallops of the anterior and posterior mitral leaflets was introduced through the guide catheter. The clip was opened in the left atrium, advanced through the mitral orifice, and retracted to grasp the leaflet edges. When a functional double-orifice valve was confirmed by echo, the clip was closed to coapt the leaflets and detached from the delivery catheter. Before final clip detachment, echo demonstrated a double orifice in all 14 animals. In 2 studies, the clip released from the anterior mitral leaflet. Retrospective analysis of echo images indicated an incomplete grasp of the anterior leaflet. Immediate postmortem examination revealed that the clip successfully approximated the middle scallops of the anterior and posterior leaflets in all 12 double-orifice studies. CONCLUSIONS: This study demonstrates for the first time that an endovascular system can be successfully used to perform the edge-to-edge repair technique in a nondiseased porcine model. This technique is potentially applicable as a percutaneous catheterization laboratory procedure for the treatment of mitral regurgitation in humans.

Morphologic changes and outcome following endovascular abdominal aortic aneurysm repair as a function of aneurysm size.

HYPOTHESIS: Small infrarenal abdominal aortic aneurysms have a more favorable clinical and morphologic outcome compared with medium and large abdominal aortic aneurysms following endovascular aneurysm repair(EVAR). DESIGN: A prospective clinical series of 206 patients undergoing elective EVAR between 1996 and 2001. SETTING: A tertiary care academic health center. PATIENTS: Patients were grouped according to aneurysm size: small (<50 mm), medium (50-60 mm), and large (>60 mm). INTERVENTIONS: Primary EVAR and secondary procedures to secure fixation of the stent graft and surgical conversions. MAIN OUTCOME MEASURES: Aneurysm diameter, endoleaks, and long-term morphologic changes were analyzed postoperatively with 3-dimensional reconstructions of computed tomographic angiograms. RESULTS: Groups were similar in age, comorbidities, and follow-up (mean +/- SD, 32.1 +/- 11.8 months). There were 30 small aneurysms, 92 medium aneurysms, and 84 large aneurysms, with a mean size of 45.1 +/- 3.7 mm, 53.8 +/- 3.1 mm, and 66.1 +/- 6.8 mm, respectively (P<.01). There was no significant difference in proximal neck or iliac artery diameter among the 3 groups. The proximal aortic neck length (28.1 +/- 11.6 mm [small]; 23.9 +/- 11.3 mm [medium]; and 22.1 +/- 11.6 mm [large]; P<.05) was significantly shorter in large aneurysms. Furthermore, there was a significant increase (6% [small]; 15% [medium]; and 21% [large]; P<.05) in angulated necks in large aneurysms. Following treatment, aneurysm diameter remained stable in most patients (83% [small]; 82% [medium]; and 83% [large]), with a mean decrease of 2.0 +/- 6.5 mm, 2.1 +/- 6.1 mm, and 3.7 +/- 7.7 mm in each group, respectively (P =.45). There was no difference in the incidence of endoleaks, aneurysm contraction, or aneurysm expansion based on preoperative aneurysm diameter. Secondary procedures were performed in 5 (20%) of 25, 9 (5.2%) of 170, and 5 (36%) of 11 aneurysms that contracted, remained stable, or expanded, respectively, following EVAR (P<.05). CONCLUSIONS: There is a 15% increase in neck angulation and a 27% decrease in neck length in large compared with small infrarenal abdominal aortic aneurysms, with no difference in outcome. Aneurysms that are stable following EVAR have a significantly lower incidence of requiring secondary procedures.

CaRESS: carotid revascularization using endarterectomy or stenting systems.

The primary objective of the CaRESS Phase I trial is to determine the sample size needed to reliably test the hypothesis that carotid stenting systems with distal embolic protection (CAS) is equivalent to carotid endarterectomy (CEA) in the treatment of symptomatic and asymptomatic carotid artery disease in a broad-risk population. A total of 397 patients were treated at 14 clinical centers. The primary endpoint results of combined all-cause mortality and stroke at 30-days and 1-year are presented. The CaRESS Phase I study was able to closely resemble clinical practice and results suggest equivalence between treatment groups.

Endovascular Techniques and Peripheral Vascular Surgery.

Endovascular is an increasingly popular term that describes the use of catheter-based instruments to diagnose and treat vascular disease. Implicit in this terminology is its association with techniques that are less invasive to the patient than traditional surgical techniques. Endovascular techniques began in 1963 with the advent of the Fogarty arterial embolectomy catheter for removal of clotted blood from the peripheral arterial circulation. Shortly thereafter, radiologist Charles Dotter introduced the concept of arterial dilatation which was popularised a decade later by cardiologist Andreas Gruntzig with the use of a non-dispensible plastic balloon catheter. During the next two decades, endovascular techniques proliferated in the growing fields of interventional cardiology and interventional radiology, yet were embraced more slowly by the surgical community.

New Devices and Techniques for Thrombectomy of Arteries and Grafts.

An arterial embolus is an obstructive segment of material which travels along the bloodstream until lodging in an artery which is too small in diameter to permit its passage. The embolus will halt flow of oxygenating blood to all tissue beyond the point of obstruction. Blood distal to the obstruction will stagnate and thrombose - or clot in place, effectively propagating the obstructive material along the artery. Arterial embolism poses a threat to both life and limb and prior to the mid-1960s was difficult for surgeons to treat because there was no simple and effective means to remove the embolus and associated distal thrombus.

A porcine model for endolaparoscopic abdominal aortic repair and endoscopic training.

OBJECTIVES: The goals of this laboratory model were to evaluate the performance of the surgical team and endolaparoscopic techniques in the porcine model of infrarenal abdominal aortic repair. METHODS: Twenty-four pigs underwent full endolaparoscopic aorto-aortic graft implantation with voice-activated computerized robotics. The first group of 10 pigs (acute) was sacrificed while under anesthesia at 0.5 hours (5 animals) and 2 hours (5 animals). The second group of 14 pigs (survival) were recovered from anesthesia and maintained for 7 hours (5 pigs) and 7 days (9 pigs) prior to sacrifice. Survival animals were observed for evidence of hind limb dysfunction. All grafts were visually inspected at autopsy. RESULTS: All animals survived the operation. All grafts were successfully implanted, and all were patent with intact anastomoses at autopsy. Mean aortic clamp time for each group was as follows: acute, 92.9 +/- 28.04 minutes; survival, 59.6 +/- 13.8 minutes; P=0.0008. Total operative time for each group was as follows: acute, 179 +/- 39.6 minutes; survival, 164.6 +/- 48 minutes; P=0.44 ns. Estimated blood loss for each group was as follows: acute, 214 -/+ 437.8 mL; survival 169.2 +/- 271 mL; P=0.76 ns. from respiratory arrest; 1 animal suffered motor sensory dysfunction of the hind limbs (spinal cord ischemia); significant bleeding occurred in 6 of 24 pigs; 8 of the 9 seven-day survivors required minimal pain medication and had normal hind limb function. CONCLUSIONS: The reduction in aortic clamp time, total operative time, and blood loss as the study progressed indicate the feasibility of this surgical protocol and the maturation of the learning process, which is paramount in prevention of 2 main sources of morbidity: bleeding and spinal cord ischemia. The reduction in aortic clamp time between the acute and survival groups was dramatic and statistically significant. An intensive formal training program combining dry and live surgical laboratories is deemed essential for the development of endoscopic skill sets necessary for this challenging procedure.

Crux vena cava filter.

Inferior vena cava filters are widely accepted for pulmonary embolic prophylaxis in high-risk patients with contraindications to anticoagulation. While long-term complications have been associated with permanent filters, retrievable filters are now available and have resulted in the rapid expansion of this technology. Nonetheless, complications are still reported with optional filters. Furthermore, device tilting and thrombus load may prevent retrieval in up to 30% of patients, thereby eliminating the benefits of this technology. The Crux vena cava filter is a novel, self-centering, low-profile filter that is designed for ease of delivery, retrievability and improved efficacy while limiting fatigue-related device complications. This device has been proven safe and user-friendly in an ovine model and has recently been implanted in human subjects.

Evaluation of the Crux IVC Filter in an animal model.

PURPOSE: To determine the safety and performance of a new inferior vena cava (IVC) filter in an ovine model and evaluate the retrievability at 5 weeks. METHODS: The Crux Vena Cava Filter (VCF) is composed of 2 nitinol spiral supports with a polymeric filter suspended between them. Retrieval tails on each end facilitate retrieval. Twelve filters were placed in the infrarenal IVCs of 12 sheep. The vessels were imaged pre and post deployment to assess acute device performance. At 5 weeks, the vessels were re-imaged to evaluate continued device performance and vessel integrity. Nine of 12 filters were retrieved, and the animals were returned to their housing. The other 3 animals were sacrificed, and the filters and vessels were processed for gross and histological examination. At 9 weeks, 4 weeks after filter retrieval, vessel integrity of the remaining 9 animals was again assessed under fluoroscopy. The animals were sacrificed, and the IVCs were explanted for study. RESULTS: All 12 filters were implanted without complications at the intended deployment site and remained fixed over the implantation period. At 5 weeks, the filters intended for recovery were successfully retrieved, with a mean capture time of 9.6+/-13.7 minutes. There were no complications during the 4-week follow-up after filter retrieval. Post-retrieval imaging at 5 and 9 weeks showed no visible signs of vessel wall damage. Histological study of 3 explanted vessels and filters revealed slight neointima encapsulation of the filter elements and minimal incorporation. Gross examination of the post-retrieval vessel walls after the 4-week healing period showed minimal superficial vessel damage; histology showed minimal residual signs of hemorrhage, with little to no inflammatory reaction. CONCLUSION: The Crux VCF was deployed and safely retrieved without incident at 5 weeks in an animal model. There was no significant damage seen to the IVCs 1 month after filter retrieval.

"Over-the-wire" inversion saphenectomy: a simple, minimally invasive vein harvesting technique for arterial bypass.

PURPOSE: To examine the feasibility and clinical outcome of a novel, minimally invasive technique for harvesting the great saphenous vein (GSV) for use in peripheral arterial bypass surgery. METHODS: Between May 2001 through March 2003, 27 patients (15 men; mean age 71+/-10 years) underwent extremity bypass procedures for limb salvage (88%) or disabling claudication (12%) using the inversion technique to harvest the GSV. The veins were turned "inside out" using a unique catheter and guidewire system. With the endothelial surface exposed, valve leaflets were excised, and adherent thrombus was washed away. Veins were inverted again to turn the endothelial surface back inside the lumen for use as a bypass conduit. RESULTS: Inversion vein harvesting and arterial bypass were completed in 24 (89%) of 27 patients; 2 patients were treated with synthetic grafts because of small GSVs. Another patient was found after vein harvesting to have inadequate arterial outflow despite a good quality conduit. The average vein length was 45+/-10 cm; a mean 4+/-1 incisions were made, including those for arterial exposure. Incisions made to divide vein tributaries averaged 2 cm in length. Duration of vein harvesting was 25 minutes (range 5-80). Wound complications were minor (2 hematomas, 2 cases of erythema, 2 seromas). Of 6 grafts that occluded after 30 days, 5 involved small-diameter vein grafts (< 3.5 mm). At a mean 12 months, primary and assisted primary graft patency rates were 88% (14/16) and 94% (15/ 16), respectively, for grafts with minimum diameters > or = 4 mm versus 38% (3/8) primary patency for veins < 4 mm (n = 8, p < 0.001). The limb salvage rate was 92% (22/24). CONCLUSIONS: Over-the-wire inversion saphenectomy is a simple and reliable minimally invasive technique for arterial bypass. Incisions are small and cosmetically superior to those of the traditional long incision method. One-year follow-up suggests that grafts harvested by inversion technique have excellent durability when the minimum vein diameter is > or = 4 mm, as determined by preoperative vein mapping.

Endograft technology: highlights of the past 10 years.

The past decade has seen the evolution of an exciting technology that has changed forever the treatment of aortic aneurysmal disease. From rather crude homemade stent-grafts constructed in the surgical suite to elegant commercially manufactured devices in a variety of configurations and sizes, the aortic endograft has experienced a meteoric rise in popularity to become a beneficial, minimally invasive therapy that can obviate the risk of rupture and death. There are now 3 approved endovascular devices on the market for infrarenal abdominal aortic aneurysm repair, and it is likely that additional and improved devices will become available in the future. This review revisits the developmental history of the aortic endograft, noting the ongoing refinements that have arisen from our experiences with the growing population of stent-graft patients. Although research continues to search for solutions to the problems of endoleak and migration, long-term results even with the earlier second and third-generation devices are better than has been achieved with open surgical repair.