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Biomedical subjects

M D Dake

Publications and source records attributed to M D Dake.

At least 37 records · Page 2Linked to original sources

Chronically occluded inferior venae cavae: endovascular treatment.

PURPOSE: To report the results of endoluminal recanalization and stent placement in patients with chronic occlusions of the inferior vena cava (IVC). MATERIALS AND METHODS: Seventeen consecutive patients (12 male, five female patients; mean age, 40.6 years; age range, 15-77 years) with chronic IVC occlusions were treated during a 6-year period. The mean duration of symptoms was 32 months. Underlying active malignancy was the cause of occlusion in four patients. Five patients with superimposed acute thrombus underwent catheter-directed thrombolysis prior to IVC recanalization. Clinical patency was defined as absence or improvement of symptoms. Clinical follow-up was supplemented with ultrasonography, vena cavography, or both in 10 patients. RESULTS: Technical success was achieved in 15 (88%) patients. Additional thrombolytic therapy and stent placement was needed in two patients to maintain patency at 4 and 6 months after the procedure. Twelve patients had IVCs that remained patent after a mean follow-up of 19 months for a primary patency rate of 80%. The primary assisted patency rate was 87% (13 of 15). There were four deaths owing to underlying disease 6-21 months after the procedures. There were no procedure-related complications. CONCLUSION: Endoluminal recanalization and stent placement in chronically occluded IVCs has a good intermediate-term outcome and should be considered in patients who have symptoms and who often do not have adequate alternative therapy.

Adolescent↗

True-lumen collapse in aortic dissection: part II. Evaluation of treatment methods in phantoms with pulsatile flow.

PURPOSE: To discover and evaluate the effective treatment methods to prevent or relieve true-lumen collapse in models of aortic dissection. MATERIALS AND METHODS: Two phantoms were built to simulate type B aortic dissection. After true-lumen collapse was induced, experiments were conducted to evaluate the effectiveness of clinically relevant variables in relieving the collapse. Variables included entry-tear size, branch-vessel flow distribution, distal reentry communication between the true and false limbs, aortic fenestrations, and pump output. To test the effect of closing the entry tear, a stent-graft was deployed over the entry tear under physiologic conditions in a mock-flow loop. The difference in the effect of each variable on the prevention and relief of true-lumen collapse was also investigated. RESULTS: It was more difficult to relieve true-lumen collapse than it was to prevent it. Placement of a stent-graft over the entry tear was the most effective method of relieving true-lumen collapse. Less-effective procedures included opening a false-lumen outflow branch and opening the distal reentry branch. Opening the fenestration-branch loops, meant to simulate the creation of artificial fenestrations in the intimal flap, did not relieve true-lumen collapse. CONCLUSION: The definitive treatment for true-lumen collapse in aortic dissection is direct repair of the entry tear to decrease false-lumen inflow. Otherwise, increasing the false-lumen outflow and/or creating distal fenestrations between the true and false lumina distal to the level of the compromised aortic branch are less-effective alternatives.

Aortic Dissection↗

Aortic aneurysmal disease: assessment of stent-graft treatment-CT versus conventional angiography.

PURPOSE: To compare computed tomographic (CT) angiography and conventional angiography for determining the success of endoluminal stent-graft treatment of aortic aneurysms. MATERIALS AND METHODS: Forty patients underwent conventional angiography and CT angiography following treatment of aortoiliac aneurysms with endoluminal stent-grafts. Six additional sets of conventional angiographic-CT angiographic examinations were performed in five patients after placement of additional stent-grafts or coil embolization to treat perigraft leakage. Three faculty CT radiologists who were blinded to patient clinical data and outcome independently interpreted the CT angiograms, and three faculty angiographers, who were not involved in the stent-graft deployment, interpreted the conventional angiograms. Images were assessed for the presence of postdeployment complications. A reference standard was developed by experienced radiologists using all available images and clinical data. Sensitivities, specificities, and kappa values were calculated. RESULTS: Perigraft leakage was the most commonly identified complication. Twenty perigraft leaks were detected in the results of 46 examinations. Sensitivities and specificities for detecting perigraft leakage were 63% and 77% for conventional angiography and 92% and 90% for CT angiography, respectively. The kappa value was 0. 41 for conventional angiography and 0.81 for CT angiography. CONCLUSION: CT angiography is the preferred method for establishing the presence of perigraft leakage following treatment of aortoiliac aneurysms with stent-grafts.

Adult↗

Cost identification of abdominal aortic aneurysm imaging by using time and motion analyses.

PURPOSE: To compare the costs of performing helical computed tomographic (CT) angiography with three-dimensional rendering versus intraarterial digital subtraction angiography (DSA) for preoperative imaging of abdominal aortic aneurysms (AAAs). MATERIALS AND METHODS: A single observer determined the variable direct costs of performing nine intraarterial DSA and 10 CT angiographic examinations in age- and general health-matched patients with AAA by using time and motion analyses. All personnel directly involved in the cases were tracked, and the involvement times were recorded to the nearest minute. All material items used during the procedures were recorded. The cost of labor was determined from personnel reimbursement data, and the cost of materials, from vendor pricing. The variable direct costs of laboratory tests and using the ambulatory treatment unit for postprocedural monitoring, as well as all fixed direct costs, were assessed from hospital accounting records. The total costs were determined for each procedure and compared by using the Student t test and calculating the CIs. RESULTS: The mean total direct cost of intraarterial DSA (+/- SD) was $1,052 +/- 71, and that of CT angiography was $300 +/- 30, which are significantly different (P < 4.1 x 10(-11)). With 95% confidence, intraarterial DSA cost 3.2-3.7 times more than CT angiography for the assessment of AAA. CONCLUSION: Assuming equal diagnostic utility and procedure-related morbidity, institutions may have substantial cost savings whenever CT angiography can replace intraarterial DSA for imaging AAAs.

Accounting↗

Peripheral arterial obstruction: prospective study of treatment with a transluminally placed self-expanding stent-graft. International Trial Study Group.

PURPOSE: To evaluate the safety and efficacy of an endoluminal prosthesis for treatment of peripheral arterial occlusive disease (PAOD). MATERIALS AND METHODS: A self-expanding endoprosthesis with an expanded polytetrafluoroethylene tube inside a nitinol support structure was implanted in 127 patients with symptomatic PAOD in the iliac (61 limbs) and femoral arteries (80 limbs). Clinical category status, ankle-brachial index, and color duplex flow imaging results were recorded before treatment, at discharge, and at 1, 3, 6, and 12 months after treatment. Aspirin was administered throughout the study, and heparin was administered during and for 2 days after the procedure. RESULTS: Endoprosthesis deployment was technically successful in all patients. Complications occurred in 24 of 141 procedures and included three major complications. Early thrombosis (within 30 days) occurred in one iliac and three femoral arteries. Late restenosis or reocclusion was observed in five iliac and 14 femoral arteries within the 1st year. Primary patency rates in iliac arteries were 98% +/- 3% (standard error) and 91% +/- 4%, respectively, at 6 and 12 months after treatment. Primary patency rates in femoral arteries were 90% +/- 3% and 79% +/- 5%, respectively, at 6 and 12 months. Secondary patency rates were 95% and 93% for iliac and femoral arteries, respectively, at 12 months after treatment. CONCLUSION: The device used in this study can be implanted without additional risks to the patient and provided encouraging patency rates up to 1 year.

Adult↗

Endovascular treatment of hepatic venous outflow obstruction after piggyback technique liver transplantation.

BACKGROUND: The piggyback technique of orthotopic liver transplantation is an attractive alternative that preserves the recipient inferior vena cava and allows uninterrupted venous blood return during the anhepatic phase. As with other transplantation techniques, the vascular anastomoses required by the piggyback technique can develop strictures. METHODS: Review of records of 264 piggyback transplantations revealed two cases of delayed-onset hepatic venous obstruction from anastomotic strictures. Both patients also had symptoms of inferior vena cava obstruction, with azotemia and lower extremity edema. Both patients were treated percutaneously with balloon-expandable stents. RESULTS: Rapid, dramatic resolution of symptoms was achieved in both patients. Patients remain completely asymptomatic at 39 and 3 months of follow-up. CONCLUSIONS: Hepatic venous anastomotic strictures in recipients of piggyback technique transplants are a very uncommon complication. They may be easily and effectively treated by minimally invasive endovascular intervention.

Adolescent↗

Endovascular stent-graft placement for the treatment of acute aortic dissection.

BACKGROUND: The standard treatment for acute aortic dissection is either surgical or medical therapy, depending on the morphologic features of the lesion and any associated complications. Irrespective of the form of treatment, the associated mortality and morbidity are considerable. METHODS: We studied the placement of endovascular stent-grafts across the primary entry tear for the management of acute aortic dissection originating in the descending thoracic aorta. We evaluated the feasibility, safety, and effectiveness of transluminal stent-graft placement over the entry tear in 4 patients with acute type A aortic dissections (which involve the ascending aorta) and 15 patients with acute type B aortic dissections (which are confined to the descending aorta). Dissections involved aortic branches in 14 of the 19 patients (74 percent), and symptomatic compromise of multiple branch vessels was observed in 7 patients (37 percent). The stent-grafts were made of self-expanding stainless-steel covered with woven polyester or polytetrafluoroethylene material. RESULTS: Placement of endovascular stent-grafts across the primary entry tears was technically successful in all 19 patients. Complete thrombosis of the thoracic aortic false lumen was achieved in 15 patients (79 percent), and partial thrombosis was achieved in 4 (21 percent). Revascularization of ischemic branch vessels, with subsequent relief of corresponding symptoms, occurred in 76 percent of the obstructed branches. Three of the 19 patients died within 30 days, for an early mortality rate of 16 percent (95 percent confidence interval, 0 to 32 percent). There were no deaths and no instances of aneurysm or aortic rupture during the subsequent average follow-up period of 13 months. CONCLUSIONS: These initial results suggest that stent-graft coverage of the primary entry tear may be a promising new treatment for selected patients with acute aortic dissection. This technique requires further evaluation, however, to assess its therapeutic potential fully.

Acute Disease↗

Pelvic arterial embolization for control of obstetric hemorrhage: a five-year experience.

OBJECTIVE: Obstetric hemorrhage is a significant cause of maternal morbidity and death. Postpartum hemorrhage that cannot be controlled by local measures has traditionally been managed by bilateral uterine artery or hypogastric artery ligation. These techniques have a high failure rate, often resulting in hysterectomy. In contrast, endovascular embolization techniques have a success rate of >90%. An additional benefit of the latter procedure is that fertility is maintained. We report our experience at Stanford University Medical Center in which this technique was used in 6 cases within the past 5 years. STUDY DESIGN: Six women between the ages of 18 and 41 years underwent placement of arterial catheters for emergency (n = 3) or prophylactic (n = 3) control of postpartum bleeding. Specific diagnoses included cervical pregnancy (n = 1), uterine atony (n = 3), and placenta previa and accreta (n = 2). RESULTS: Control of severe or anticipated postpartum hemorrhage was obtained with transcatheter embolization in 4 patients. A fifth patient had balloon occlusion of the uterine artery performed prophylactically, but embolization was not necessary. In a sixth case, bleeding could not be controlled in time, and hysterectomy was performed. The only complication observed with this technique was postpartum fever in 1 patient, which was treated with antibiotics and resolved within 7 days. CONCLUSIONS: Uterine artery embolization is a superior first-line alternative to surgery for control of obstetric hemorrhage. Use of transcatheter occlusion balloons before embolization allows timely control of bleeding and permits complete embolization of the uterine arteries and hemostasis. Given the improved ultrasonography techniques, diagnosis of some potential high-risk conditions for postpartum hemorrhage, such as placenta previa or accreta, can be made prenatally. The patient can then be prepared with prophylactic placement of arterial catheters, and rapid occlusion of these vessels can be achieved if necessary.

Adolescent↗

Thoracic aortic aneurysm repair with an endovascular stent graft: the "first generation".

OBJECTIVE: The feasibility and efficacy trial of an endovascular stent-grafting system for the treatment of aneurysms of the descending thoracic aorta was investigated. METHODS: After Institutional Review Board approval, 103 patients (mean age 69 years) underwent stent graft repair of a descending thoracic aortic aneurysm between July 1992 and November 1997. The stent graft was fabricated using self-expanding "Z" stents covered by a woven Dacron tube graft. Follow-up, which averaged 22 months, was 100% complete. Simultaneous open abdominal aortic aneurysm repair was performed in 19 patients. RESULTS: Complete aneurysm thrombosis was achieved in 86 patients (83%). Early mortality, defined as a death during the same hospitalization or in less than 30 days, was 9 +/- 3%, and was significantly associated with preoperative cerebrovascular accident (CVA) or myocardial infarction. Major perioperative morbidity occurred in 31 patients, and included paraplegia in 3, CVA in 7, and respiratory insufficiency in 12 patients each. Actuarial survival was 81 +/- 4% at 1 year, and 73 +/- 5% at 2 years. Treatment failure (including all late, sudden, unexplained deaths) occurred in 38 patients, and only 53 +/- 10% of patients were free of treatment failure at 3.7 years. Five patients required late operative therapy for endoleaks associated with aneurysm enlargement. CONCLUSIONS: Satisfactory results were achieved using this "first-generation" homemade stent graft device. Mortality and morbidity occurred frequently, but may have been associated with the high-risk character of this patient population. Medium-term results were acceptable, but continued aortic enlargement, with the late development of endoleaks, is a significant concern. Second-generation devices with commercial development, coupled with this initial experience, should allow improved clinical results in the future. Longer term follow-up is still necessary to fully define the efficacy of this endovascular approach.

Adult↗

Percutaneous balloon fenestration and stenting for life-threatening ischemic complications in patients with acute aortic dissection.

OBJECTIVES: Acute aortic dissection frequently causes life-threatening ischemia of end-organs, historically associated with mortality exceeding 60%. Reperfusion with the use of interventional radiologic methods has evolved as a promising treatment. We report results of our initial 6 years of experience with percutaneous balloon fenestration of the intimal flap and endovascular stenting. METHODS: Forty patients (32 male and 8 female) with a median age of 53 years (range 16-86 years) underwent percutaneous treatment for peripheral ischemic complications of 10 type A and 30 type B acute aortic dissections since 1991. Twenty patients had ischemia of multiple organ systems. Thirty patients had renal, 22 had leg, 18 had mesenteric, and 1 had arm ischemia. RESULTS: Fourteen patients were treated with stenting of either the true or false lumen combined with balloon fenestration of the intimal flap, 24 with stenting alone, and 2 with fenestration alone. Successful revascularization was achieved in 93% +/- 4% (+/-70% confidence levels) of patients (37/40). Nine patients had procedure-related complications. The 30-day mortality rate was 25% +/- 7% (10/40), often related to irreversible ischemia of intra-abdominal organs that was present before the procedure. Of the remaining 30 patients, 5 have died and the remaining 25 continue to have relief of ischemic symptoms at a mean follow-up of 29 months. CONCLUSION: Percutaneous balloon fenestration of the intimal flap and endovascular stenting is an effective treatment for life-threatening ischemic complications of acute aortic dissection.

Acute Disease↗

Histopathologic evaluation of an expanded polytetrafluoroethylene-nitinol stent endoprosthesis in canine iliofemoral arteries.

PURPOSE: The authors assess a new ePTFE-nitinol stent for its long-term patency, healing, and properties of endothelialization. MATERIALS AND METHODS: Adult greyhounds (n = 18) underwent bilateral iliofemoral placement of an endoprosthesis (Hemobahn) consisting of a nitinol stent lined with an ultrathin expanded polytetrafluoroethylene (ePTFE) material. Histologic and quantitative morphometric analyses were performed on devices explanted at 2 weeks and 1, 3, 6, and 12 months. The source of endothelialization was examined in four additional devices modified by sealing either the proximal and distal ends or the entire graft with poly(tetrafluoroethylene-co-hexafluoropropylene) (FEP), a nonporous laminate to prevent potential transgraft endothelial cell migration. RESULTS: Device patency assessed with both intravascular ultrasound and histologic study showed minimal arterial stenosis, irrespective of implant duration. The neointima at less than 3 months consisted of fibrin and inflammatory infiltrate; at later time points, it was composed of mostly smooth muscle cells. Flow surfaces were more than 75% endothelialized by 3 months, which was nearly complete by 6 months. Modified endoprostheses entirely enveloped with FEP resulted in endothelialization of only the proximal and distal ends; the middle regions showed nonocclusive thrombi. Conversely, devices wrapped proximally and distally showed nearly complete endothelialization. CONCLUSIONS: This ePTFE-nitinol endoprosthesis demonstrated long-term patency at up to 1 year after implantation and showed early and nearly complete endothelialization by 6 months. The design promoted rapid endothelialization of flow surfaces, particularly in the midregion of the device possibly by transgraft migration.

Alloys↗

1999 Gary J. Becker Young Investigator Award. MR-guided transjugular portosystemic shunt placement in a swine model.

PURPOSE: To evaluate the performance of portal venous puncture with use of magnetic resonance (MR) guidance, and to place a transjugular intrahepatic portosystemic shunt (TIPS) in a swine model. MATERIALS AND METHODS: A study of 12 swine was performed to evaluate the ability of interventional MR imaging to guide portal vein puncture and TIPS placement. Six swine had catheters placed in the right hepatic vein under C-arm fluoroscopy. A nitinol guide wire was left in the vein and the animals were then moved into an open configuration MR imaging unit. A TIPS needle set was used to puncture the portal vein using MR fluoroscopy. The animals were transferred to the C-arm, and venography confirmed portal vein puncture. A follow-up study was performed in six additional swine to place a TIPS using only MR imaging guidance. MR tracking was used to advance a catheter from the right atrium into the inferior vena cava. Puncture of the portal vein was performed and a nitinol stent was placed, bridging the hepatic parenchyma. MR venogram confirmed placement. RESULTS: Successful portal vein puncture was achieved in all animals. The number of punctures required decreased from 12 in the first animal to a single puncture in the last eight swine. A stent was successfully placed across the hepatic tract in all six swine. CONCLUSIONS: Real-time MR imaging proved to be a feasible method to guide portal vein puncture and TIPS placement in pigs.

Animals↗

Descending thoracic aortic aneurysm: thoracic CT findings after endovascular stent-graft placement.

PURPOSE: To evaluate the usefulness of thoracic computed tomography (CT) after placement of an endovascular stent-graft for the treatment of descending thoracic aortic aneurysm. MATERIALS AND METHODS: From 1992 to 1996, 85 patients with thoracic aortic aneurysm underwent stent-graft placement. In 63 patients, thoracic CT scans were obtained both before and within 10 days after placement. The CT findings were retrospectively studied, and their clinical effect analyzed. In 20 of 63 patients, long-term follow-up CT findings were also evaluated. RESULTS: After stent-graft placement in the 63 patients, CT demonstrated an increase in pleural effusion in 46 (73%), periaortic changes in 21 (33%), perigraft leak in 13 (21%), atelectasis in six (10%), mural thrombus within the stent-graft in two (3%), and new aortic dissection in one (2%). The mean maximum diameter of the aneurysm was 58.8 mm before and 60.0 mm after stent-graft insertion. Sixty-two (98%) patients were successfully treated until discharge. Interventional procedures were performed to eliminate the leakage into the aneurysm sac in 10 patients with perigraft flow depicted at CT. Other complications were managed conservatively. CONCLUSION: Thoracic CT is useful in the treatment of patients after stent-graft insertion for the management of descending thoracic aortic aneurysm.

Adult↗

The stent decade: 1987 to 1997. Stanford Stent Summit faculty.

In January 1997, experts from the United States, Europe, and Japan gathered at Stanford University to review their collective experience with intracoronary and noncoronary stenting and to identify and prioritize issues requiring further clinical investigation. This report summarizes the discussions that took place during this stent summit. Knowledge of stent-tissue interaction from animal and human pathologic specimens was reviewed in the context of evolving stent designs. The relative merits of coil and slotted tubular stent designs were discussed. Stent deployment routines, including self-expansion, balloon expansion, and high-pressure delivery were debated. The potential for covered stents and coated stents was explored. Problems surrounding the routine deployment of stents were identified: small vessel disease, long lesions, bifurcation stenoses, vein graft disease, ostial disease, left main stenoses, and intrastent restenosis. The value of intravascular ultrasound, as an adjunct to stenting, was explored and debated. An algorithm for "provisional stenting" based on ultrasound criteria was developed. Noncoronary stenting of the aorta, iliacs, and carotids were discussed. Clinical applications that may lead to randomized clinical trials were identified.

Carotid Arteries↗

The "first generation" of endovascular stent-grafts for patients with aneurysms of the descending thoracic aorta.

OBJECTIVE: Our goal was to determine whether endovascular stent-grafting is feasible and effective for patients with aneurysms of the descending thoracic aorta. METHODS: Starting in July 1992, we conducted a prospective, uncontrolled clinical trial in 103 patients (mean age 69 years [range 34-89 years]) who underwent endovascular treatment of aneurysms of the descending thoracic aorta using a custom-fabricated, self-expanding stent-graft device. Follow-up was 100% complete and averaged 22 months. Sixty-two patients (60%) were judged not to be reasonable candidates for a conventional "open" surgical procedure. RESULTS: Complete thrombosis of the aneurysm was ultimately achieved in 86 (83%) patients. The early mortality rate was 9% +/- 3% (+/- 70% CL). Multivariable analysis revealed that myocardial infarction or stroke was linked with a higher likelihood of early death (P = .001). Early serious complications included paraplegia in 3% +/- 2% and stroke in 7% +/- 3%. Actuarial survival estimates at 1 year and 2 years were 81% +/- 4% and 73% +/- 5% (+/- 1 SE), respectively; being judged not to be a surgical candidate portended a higher probability of death (P = .003). According to the intent-to-treat principle, "treatment failure" (including all late sudden unexplained deaths) occurred in 38 patients; 53% +/- 10% of patients were free from treatment failure at 3.7 years. Stent-graft related complications occurred commonly and were linked with several anatomic, technical, and patient-related risk factors. CONCLUSIONS: This 5-year clinical trial involving use of a "first generation" device indicates that endovascular stent-grafting of descending thoracic aortic aneurysms is feasible with acceptable medium-term results. More refined, commercially developed devices available today offer less traumatic and more precise stent-graft deployment; these major technical advantages, coupled with important lessons we have learned over time and better patient selection, should be associated with more salutary clinical results in the future.

Adult↗

Superior vena cava syndrome after heart transplantation: percutaneous treatment of a complication of bicaval anastomoses.

OBJECTIVES: Our objectives were (1) to investigate the incidence and cause of symptomatic superior vena caval anastomotic stenosis and central venous thrombosis in patients receiving heart or heart-lung transplantation and (2) to explore percutaneous methods of thrombolysis and endoluminal intervention to treat these complications. METHODS: Review of 1016 cases revealed three cases of superior vena cava syndrome. Anatomy, surgical technique, and medical risk factors were examined. Percutaneous treatments, including urokinase thrombolysis, mechanical thrombolysis, balloon angioplasty, and stent placement, were attempted. RESULTS: All three of these patients underwent transplantation by means of the bicaval anastomotic technique. In addition, the diameters of the donor and recipient cavae were grossly mismatched in all three. Stenoses in all three patients were successfully treated percutaneously with balloon angioplasty and stent placement. Treatment of the accompanying large-volume thrombosis was problematic in these patients, and two had hemorrhagic complications of urokinase thrombolysis. A mechanical thrombolysis device was used successfully in the third patient. CONCLUSIONS: Anastomotic stricture and central venous thrombosis is an uncommon complication of the bicaval anastomotic technique of heart and heart-lung transplantation. Discrepancy between donor and recipient caval diameters appears to be the major risk factor. Endoluminal thrombolysis and stenting provides rapid and enduring relief of symptoms and precludes repeat sternotomy, cardiopulmonary bypass, and general anesthesia.

Adult↗