Behavior of tip-steerable needles in ex vivo and in vivo tissue.

Robotic needle steering is a promising technique to improve the effectiveness of needle-based clinical procedures, such as biopsies and ablation, by computer-controlled, curved insertions of needles within solid organs. In this paper, we explore the capabilities, challenges, and clinical relevance of asymmetric-tip needle steering through experiments in ex vivo and in vivo tissue. We evaluate the repeatability of needle insertion in inhomogeneous biological tissue and compare ex vivo and in vivo needle curvature and insertion forces. Steerable needles curved more in kidney than in liver and prostate, likely due to differences in tissue properties. Pre-bent needles produced higher insertion forces in liver and more curvature in vivo than ex vivo. When compared to straight stainless steel needles, steerable needles did not cause a measurable increase in tissue damage and did not exert more force during insertion. The minimum radius of curvature achieved by prebent needles was 5.23 cm in ex vivo tissue, and 10.4 cm in in vivo tissue. The curvatures achieved by bevel tip needles were negligible for in vivo tissue. The minimum radius of curvature for bevel tip needles in ex vivo tissue was 16.4 cm; however, about half of the bevel tip needles had negligible curvatures. We also demonstrate a potential clinical application of needle steering by targeting and ablating overlapping regions of cadaveric canine liver.

Impact of dynamic computed tomographic angiography on endograft sizing for endovascular aneurysm repair.

PURPOSE: To quantify dynamic changes in aortoiliac dimensions using dynamic electrocardiographically (ECG)-gated computed tomographic angiography (CTA) and to investigate any potential impact on preoperative endograft sizing in relation to observer variability. METHODS: Dynamic ECG-gated CTA was performed in 18 patients with abdominal aortic aneurysms. Postprocessing resulted in 11 datasets per patient: 1 static CTA and 10 dynamic CTA series. Vessel diameter, length, and angulation were measured for all phases of the cardiac cycle. The differences between diastolic and systolic aneurysm dimensions were analyzed for significance using paired t tests. To assess intraobserver variability, 20 randomly selected datasets were analyzed twice. Intraobserver repeatability coefficients (RC) were calculated using Bland-Altman analysis. RESULTS: Mean aortic diameter at the proximal neck was 21.4+/-3.0 mm at diastole and 23.2+/-2.9 mm at systole, a mean increase of 1.8+/-0.4 mm (8.5%, p<0.01). The RC for the aortic diameter at the level of the proximal aneurysm neck was 1.9 mm (8.9%). At the distal sealing zones, the mean increase in diameter was 1.7+/-0.3 mm (14.1%, p<0.01) for the right and 1.8+/-0.5 mm (14.2%, p<0.01) for the left common iliac artery (CIA). At both distal sealing zones, the mean increase in CIA diameter exceeded the RC (10.0% for the right CIA and 12.6% for the left CIA). CONCLUSION: The observed changes in aneurysm dimension during the cardiac cycle are small and in the range of intraobserver variability, so dynamic changes in proximal aneurysm neck diameter and aneurysm length likely have little impact on preoperative endograft selection. However, changes in diameter at the distal sealing zones may be relevant to sizing, so distal oversizing of up to 20% should be considered to prevent distal type I endoleak.

In-vivo imaging of changes in abdominal aortic aneurysm thrombus volume during the cardiac cycle.

PURPOSE: To evaluate in-vivo thrombus compressibility in abdominal aortic aneurysms (AAAs) to hopefully shed light on the biomechanical importance of intraluminal thrombus. METHODS: Dynamic electrocardiographically-gated computed tomographic angiography was performed in 17 AAA patients (15 men; mean age 73 years, range 69-76): 11 scheduled for surgical repair and 6 under routine surveillance. The volumes of intraluminal thrombus, the lumen, and the total aneurysm were quantified for each phase of the cardiac cycle. Thrombus compressibility was defined as the percent change in thrombus volume between diastole and peak systole. Continuous data are presented as medians and interquartile ranges (IQR). RESULTS: A substantial interpatient variability was observed in thrombus compressibility, ranging from 0.4% to 43.6% (0.2 to 13.5 mL, respectively). Both thrombus and lumen volumes varied substantially during the cardiac cycle. As lumen volume increased (5.2%, IQR 2.8%-8.8%), thrombus volume decreased (3.0%, IQR 1.0%-4.6%). Total aneurysm volume remained relatively constant (1.3%, IQR 0.4-1.9%). Changes in lumen volume were inversely correlated with changes in thrombus volume (r = -0.73; p = 0.001). CONCLUSION: In-vivo thrombus compressibility varied from patient to patient, and this variation was irrespective of aneurysm size, pulse pressure, and thrombus volume. This suggests that thrombus might act as a biomechanical buffer in some, while it has virtually no effect in others. Whether differences in thrombus compressibility alter the risk of rupture will be the focus of future research.

Phase 3, randomized, double-blind study of plasma-derived human thrombin versus bovine thrombin in achieving hemostasis in patients undergoing surgery.

OBJECTIVE: To compare the effectiveness of plasma-derived human thrombin and bovine thrombin for achieving hemostasis during surgery. METHODS: Adults (N = 305) with > or = 1 mild or moderate bleeding site not manageable by conventional modalities during elective cardiovascular, neurologic, or general surgical procedures at multiple study centers were randomized to human (n = 153) or bovine (n = 152) thrombin, applied topically with an absorbable gelatin sponge. Bleeding was assessed 3, 6, and 10 min post-application. Other evaluations included laboratory assessments, vital signs, blood loss, blood transfusions, time in specialty-care units, procedure duration, and length of hospital stay. Blood samples for antibody assessment were collected at baseline and postoperative week 5. RESULTS: The proportion of patients achieving hemostasis within 10 min (primary outcome) was equivalent for human and bovine thrombin (97.4 vs. 97.4%, respectively; ratio, 1.00; 95% CI, 0.96-1.05). The proportions of patients achieving hemostasis at 6 min (94.8 vs. 92.8%) and 3 min (73.2 vs. 72.4%) were also equivalent. No clinically meaningful differences were noted for other variables. The products had similar adverse event profiles. More patients (12.7%) who received bovine thrombin demonstrated seroconversion for > or = 1 of the 4 antibodies assayed than patients who received human thrombin (3.3%). No patients in the human thrombin group developed seroconversion for anti-human thrombin or anti-human factor V/Va antibodies. Limitations of this study include the lack of a placebo-control group, the potential for inter-surgeon variability, and the fact that antibody assessment was not evaluable in all patients. CONCLUSIONS: Plasma-derived human thrombin and bovine thrombin were equivalent in achieving hemostasis within 10, 6, and 3 min and had comparable safety profiles. None of the patients receiving human thrombin developed seroconversion for antibodies to any of the human antigens.

Prototypical metal/polymer hybrid cerebral aneurysm clip: in vitro testing for closing force, slippage, and computed tomography artifact. Laboratory investigation.

OBJECT: The aim of this study was to explore the possibility that a hybrid aneurysm clip with polymeric jaws bonded to a metal spring could provide mechanical properties comparable to those of an all-metal clip as well as diminished artifacts on computed tomography (CT) scanning. METHODS: Three clips were created, and Clips I and 2 were tested for mechanical properties. Clip 1 consisted of an Elgiloy spring (a cobalt-chromium-nickel alloy) bonded to carbon fiber limbs; Clip 2 consisted of an Elgiloy spring with polymethylmethacrylate (PMMA) jaws; and Clip 3 consisted of PMMA limbs identical to those in Clip 2 but bonded to a titanium spring. Custom testing equipment was set up to measure the aneurysm clip clamping forces and slippage. Clips 2 and 3 were visualized in vivo using a 64-slice CT unit, and the slices were reformatted into 3D images. RESULTS: According to the testing apparatus, Clip 2 had a similar closing force but less slippage than three similar commercial aneurysm clips. The artifact from the cobalt alloy spring on CT scanning largely offset the advantage of the nonmetal PMMA limbs, which created no artifact. The hybrid titanium/PMMA clip (Clip 3) created very little artifact on CT and allowed visualization of the phantom through the limbs. CONCLUSIONS: It is feasible to build a potentially biocompatible hybrid cerebral aneurysm clip with mechanical properties that closely resemble those of conventional metallic clips. Further testing should be directed toward establishing the reliability and biocompatibility of such a clip and optimizing the contour and surface treatments of the polymer

Pulse doppler and M-mode to assess viability of cardiac allografts using heterotopic femoral heart transplantation in rats.

Noninvasive assessment of heterotopic heart transplants using Doppler echocardiography was first described in two patients by Allen at Stanford in 1981. Since then, numerous experiments studying heterotopic heart transplantation in humans and large animals have confirmed its utility by employing either an intra-abdominal or cervical model. In rats, however, prior research investigating intra-abdominal heterotopic hearts has showed echocardiography to be ineffective. We have recently developed a new technique for heterotopic femoral heart transplantation in rats, which employs the novel use of trans-femoral echocardiography. Therefore, our goal was to re-examine the efficacy of echocardiography for detection of graft rejection.

A new modified technique for heterotopic femoral heart transplantation in rats.

BACKGROUND: Abbott developed the first experimental accessory heart transplant rat model in 1964. This intra-abdominal model required a labor-intensive aortic anastomosis. In 1971, Heron modified the operation by using sutureless cervical vessel anastomoses. Rao and Lisitza developed a femoral heart accessory transplant model in 1985. Our goal was to improve this femoral model for the study of cardiac transplantation between both syngeneic and allogeneic rats. METHODS: ACI and Lewis rats weighing 150 to 350 g were used as donors and recipients (n = 12). The left common carotid and left pulmonary arteries were anastomosed to the femoral artery and vein in an end-to-end fashion, respectively. Improved modifications included the use of hemostatic vessel clips, heparinization of both donor and recipient, a ventricular prolene stay-suture for secure graft placement, and transfemoral echocardiography (TFE). Total operative time averaged 61 +/- 12 minutes. RESULTS: Femoral accessory transplanted hearts (FATHs) allowed easier pulse palpation and access for TFE versus previously described cervical and intra-abdominal models. This modification allows precise detection of acute graft rejection (AGR) and is defined as absent ventricular contraction in the presence of anastomostic patency. CONCLUSIONS: Our new modified technique for heterotopic femoral heart transplantation in rats is a relatively easily learned and reproduced procedure that allows superior allograft access for palpation and improved echocardiographic assessment. Femoral heterotopic heart transplantation remains an effective model for allograft transplantation study.

Elastic and rupture properties of porcine aortic tissue measured using inflation testing.

A new inflation test device was developed to study the mechanical properties of aortic tissue. The device was used to measure failure (rupture) strength and to determine the nonlinear, anisotropic elastic properties of porcine thoracic aorta. The tester was designed to stretch initially flat, circular tissue specimens to rupture under uniform biaxial loading. Water was chosen as the pressurizing fluid. Mechanical stretch and radius of curvature during inflation were measured optically in two orthogonal directions, and the Cauchy stress components were calculated from the deformation and the applied pressure. All porcine samples that ruptured successfully did so via a tear in the circumferential direction. Thus, the failure strength was taken to be the stress in the axial direction immediately prior to rupture. The mean failure strength was 1.75 MPa and mean axial stretch at failure was 1.52. These values agree well with published data for other arterial tissues. The nonlinearly elastic deformation behavior was modeled using a hyperelastic constitutive law of the type proposed by Holzapfel et al. [Holzapfel GA, Gasser TC, Ogden RW. J Elasticity 2000;61:1-48]. The results showed that the dominant directions of anisotropy in the porcine aortas were approximately 45 degrees to the axial and circumferential directions, and that the isotropic contribution to the constitutive model was insignificant.

Elemental composition, morphology and mechanical properties of calcified deposits obtained from abdominal aortic aneurysms.

Calcified deposits exist in almost all abdominal aortic aneurysms (AAAs). The significant difference in stiffness between these hard deposits and the compliant arterial wall may result in local stress concentrations and increase the risk of aneurysm rupture. Calcium deposits may also complicate AAA repair by hindering the attachment of a graft or stent-graft to the arterial wall or cause vessel wall injury at the site of balloon dilation or vascular clamp placement. Knowledge of the composition and properties of calcified deposits helps in understanding the risks associated with their presence. This work presents results of elemental composition, microscopic morphology, and mechanical property measurements of human calcified deposits obtained from within AAAs. The elemental analyses indicate the deposits are composed primarily of calcium phosphate with other assorted constituents. Microscopy investigations show a variety of microstructures within the deposits. The mechanical property measurements indicate an average elastic modulus in the range of cortical bone and an average hardness similar to nickel and iron.

North American multicenter experience with the On-X prosthetic heart valve.

BACKGROUND AND AIM OF THE STUDY: This ongoing, longitudinal, multi-center, North American study was designed to evaluate the safety and effectiveness of the On-X valve. METHODS: The On-X valve was implanted in isolated aortic (AVR) and mitral (MVR) valve replacement patients at nine North American centers. Follow up was 98.6% complete. Anticoagulation compliance was evaluated by collection of international normalized ratio (INR) results in all patients throughout their postoperative follow up. Adverse events were recorded according to the AATS/STS guidance criteria. Hematologic studies were conducted postoperatively to evaluate hemodynamics and hemolysis. RESULTS: In total, 142 AVR and 142 MVR implants were performed; the mean follow up was 4.5 years; total follow up was 1,273 patient-years (pt-yr). At implant, the mean patient age was 59.2 years (range: 28 to 85 years); 71.8% of patients who underwent AVR and 33.1% who underwent MVR were males. Preoperatively, 89.4% of AVR patients and 56.3% of MVR patients were in sinus rhythm. The cardiac disease etiology was primarily stenotic, calcific degeneration in AVR and rheumatic or degenerative regurgitation in MVR. Hemolysis represented by postoperative elevation of serum lactate dehydrogenase was very low (median 217 IU after AVR and 251 IU after MVR at one year (82% AVR and 98% MVR of upper normal). Late adverse event rates were low, most notably thromboembolism (0.9%/pt-yr after AVR; 1.6%/pt-yr after MVR) and thrombosis. Kaplan-Meier event-free rates at five years were correspondingly high. Anticoagulation compliance analysis showed only about 40% of INR readings to be within target ranges postoperatively; thus, the control range achieved was much greater than the desired target, as might generally be expected for clinic-controlled INR. CONCLUSION: The On-X valve performed well in this study, confirming the original design intent of minimal hemolysis and low adverse event rates.

Automated methodology for determination of stress distribution in human abdominal aortic aneurysm.

Knowledge of impending abdominal aortic aneurysm (AAA) rupture can help in surgical planning. Typically, aneurysm diameter is used as the indicator of rupture, but recent studies have hypothesized that pressure-induced biomechanical stress may be a better predictor Verification of this hypothesis on a large study population with ruptured and unruptured AAA is vital if stress is to be reliably used as a clinical prognosticator for AAA rupture risk. We have developed an automated algorithm to calculate the peak stress in patient-specific AAA models. The algorithm contains a mesh refinement module, finite element analysis module, and a postprocessing visualization module. Several aspects of the methodology used are an improvement over past reported approaches. The entire analysis may be run from a single command and is completed in less than 1 h with the peak wall stress recorded for statistical analysis. We have used our algorithm for stress analysis of numerous ruptured and unruptured AAA models and report some of our results here. By current estimates, peak stress in the aortic wall appears to be a better predictor of rupture than AAA diameter. Further use of our algorithm is ongoing on larger study populations to convincingly verify these findings.

Adjunctive transmyocardial revascularization: five-year follow-up of a prospective, randomized trial.

BACKGROUND: In a prospective, randomized trial involving 263 patients who would be incompletely revascularized by coronary artery bypass grafting (CABG) alone, CABG plus transmyocardial revascularization (CABG/TMR) provided an early mortality benefit with similar angina relief compared with CABG alone at 1 year. We evaluated the long-term outcome of patients randomized to CABG/TMR or CABG alone. METHODS: Thirteen centers that enrolled 83% (218/263) of the patients in the original trial participated in this longitudinal study. Between 1996 and 1998, these centers randomized 218 patients who would be incompletely revascularized by CABG alone because of diffusely diseased target vessels to either holmium:yttrium-aluminum-garnet (holmium:YAG) CABG/TMR (n = 110) or CABG alone (n = 108). Baseline demographics and operative characteristics were similar between groups. Follow-up (mean 5.0 +/- 1.7 years) included survival and blinded angina class assessment. RESULTS: At this 5-year follow-up both groups experienced significant angina improvement from baseline, however, the CABG/TMR group had a lower mean angina score (0.4 +/- 0.7 vs 0.7 +/- 1.1, p = 0.05), a significantly lower proportion of patients with severe angina (class III/IV: 0% [0/68] vs 10% [6/60], p = 0.009), and a trend towards greater number of angina-free patients (78% [53/68] vs 63% [38/60], p = 0.08), compared with CABG alone patients. Kaplan-Meier survival at 6 years was similar between CABG/TMR and CABG alone patients (76% vs 80%, p = 0.90). CONCLUSIONS: Five-year follow-up of prospectively randomized patients who would be incompletely revascularized because of diffuse coronary artery disease indicates that the addition of TMR to conventional CABG provides superior angina relief compared to CABG alone.

Prediction of rupture risk in abdominal aortic aneurysm during observation: wall stress versus diameter.

OBJECTIVES: We previously showed that peak abdominal aortic aneurysm (AAA) wall stress calculated for aneurysms in vivo is higher at rupture than at elective repair. The purpose of this study was to analyze rupture risk over time in patients under observation. METHODS: Computed tomography (CT) scans were analyzed for patients with AAA when observation was planned for at least 6 months. AAA wall stress distribution was computationally determined in vivo with CT data, three-dimensional computer modeling, finite element analysis (nonlinear hyperelastic model depicting aneurysm wall behavior), and blood pressure during observation. RESULTS: Analysis included 103 patients and 159 CT scans (mean follow-up, 14 +/- 2 months per CT). Forty-two patients were observed with no intervention for at least 1 year (mean follow-up, 28 +/- 3 months). Elective repair was performed within 1 year in 39 patients, and emergent repair was performed in 22 patients (mean, 6 +/- 1 month after CT) for rupture (n = 14) or acute severe pain. Significant differences were found for initial diameter (observation, 4.9 +/-.1 cm; elective repair, 5.9 +/-.1 cm; emergent repair, 6.1 +/-.2 cm; P <.0001) and initial peak wall stress (38 +/- 1 N/cm(2), 42 +/- 2 n/cm(2), 58 +/- 4 N/cm(2), respectively; P <.0001), but peak wall stress appeared to better differentiate patients who later required emergent repair (elective vs emergent repair: diameter, 3% difference, P =.5; stress, 38% difference, P <.0001). Receiver operating characteristic (ROC) curves for predicting rupture were better for peak wall stress (sensitivity, 94%; specificity,81%; accuracy, 85% [with 44 N/cm(2) threshold]) than for diameter (81%, 70%, 73%, respectively [with optimal 5.5 cm threshold). With proportional hazards analysis, peak wall stress (relative risk, 25x) and gender (relative risk, 3x) were the only significant independent predictors of rupture. CONCLUSIONS: For AAAs under observation, peak AAA wall stress seems superior to diameter in differentiating patients who will experience catastrophic outcome. Elevated wall stress associated with rupture is not simply an acute event near the time of rupture.

In vivo analysis of mechanical wall stress and abdominal aortic aneurysm rupture risk.

OBJECTIVE: The purpose of this study was to calculate abdominal aortic aneurysm (AAA) wall stresses in vivo for ruptured, symptomatic, and electively repaired AAAs with three-dimensional computer modeling techniques, computed tomographic scan data, and blood pressure and to compare wall stress with current clinical indices related to rupture risk. METHODS: CT scans were analyzed for 48 patients with AAAs: 18 AAAs that ruptured (n = 10) or were urgently repaired for symptoms (n = 8) and 30 AAAs large enough to merit elective repair within 12 weeks of the CT scan. Three-dimensional computer models of AAAs were reconstructed from CT scan data. The stress distribution on the AAA as a result of geometry and blood pressure was computationally determined with finite element analysis with a hyperelastic nonlinear model that depicted the mechanical behavior of the AAA wall. RESULTS: Peak wall stress (maximal stress on the AAA surface) was significantly different between groups (ruptured, 47.7 +/- 6 N/cm(2); emergent symptomatic, 47.5 +/- 4 N/cm(2); elective repair, 36.9 +/- 2 N/cm(2); P =.03), with no significant difference in blood pressure (P =.2) or AAA diameter (P =.1). Because of trends toward differences in diameter, comparison was made only with diameter-matched subjects. Even with identical mean diameters, ruptured/symptomatic AAAs had a significantly higher peak wall stress (46.8 +/- 4.5 N/cm(2) versus 38.1 +/- 1.3 N/cm(2); P =.05). Maximal wall stress predicted risk of rupture better than the LaPlace equation (20.7 +/- 5.7 N/cm(2) versus 18.8 +/- 2.9 N/cm(2); P =.2) or other proposed indices of rupture risk. The smallest ruptured AAA was 4.8 cm, but this aneurysm had a stress equivalent to the average electively repaired 6.3-cm AAA. CONCLUSION: Peak wall stresses calculated in vivo for AAAs near the time of rupture were significantly higher than peak stresses for electively repaired AAAs, even when matched for maximal diameter. Calculation of wall stress with computer modeling of three-dimensional AAA geometry appears to assess rupture risk more accurately than AAA diameter or other previously proposed clinical indices. Stress analysis is practical and feasible and may become an important clinical tool for evaluation of AAA rupture risk.