Biomedical subjects

James McKinsey

Publications and source records attributed to James McKinsey.

10 recordsLinked to original sources

PubMed2006

Trends, complications, and mortality in peripheral vascular surgery.

BACKGROUND: The recent evolution in treatments for peripheral vascular disease has dated available mortality statistics for vascular intervention. Moreover, many of our current mortality statistics are derived from single-institution studies that are often not reflective of outcomes in general practice. To provide current and generalizable data regarding mortality and trends for peripheral vascular interventions, we examined two national data sets (Nationwide Inpatient Sample, 1998-2003, and National Hospital Discharge Survey, 1979-2003) and four states (New York, California, Florida, and New Jersey, 1998-2003). METHODS: Four procedures--abdominal aortic aneurysm repair (nonruptured), lower extremity revascularization, amputation, and carotid revascularization--were selected by cross-referencing International Classification of Diseases, 9th Revision, diagnostic and procedural codes. For significance, the t test was used for continuous variables, the chi2 test was used for dichotomous variables, and the chi2 test was used for mortality trends. RESULTS: From 1998 to 2003, there was a progressive decrease in the national per capita rate of amputations: 13.2% overall and 21.2% for major amputations (P < .0001). Nationally and regionally, mortality has only slightly declined. For lower extremity revascularization, after a sharp increase during the 1980s to 100,000 open procedures, the volume remained constant for 10 years and began to decline in 1998, reaching 70,000 cases in 2003. In contrast, since 1996, endovascular interventions have increased 40%. Mortality during the 1998 to 2003 period remained virtually stable at 1.5% to 2% for endovascular procedures and 3% to 4% for open procedures. The overall volume of abdominal aortic aneurysm repair has not changed substantially for the past 6 years; however, endovascular repair is now used for nearly half the cases (46.5% regional and 43.0% national). Mortality for open repair has not changed, remaining at approximately 5%, whereas for endovascular repair, mortality has declined from 2.6% in 2000 to less than 1.5% in 2003. After the rapid increase in open carotid revascularization in the early 1990s, the total volume has declined 5% nationally from 1998 to 2003. Regional data demonstrated an overall 12% reduction in carotid revascularization volume since 1998; this reduction was due to a 16% decline in open carotid revascularization. During this same period, the use of angioplasty-stent carotid revascularization doubled. Mortality for the open procedures is 0.5% and is significantly higher (2%-3%) for endovascular carotid revascularization. Stroke rates for endovascular carotid revascularization are also higher: 2.13% vs 1.28% for open procedures (P < .0001). CONCLUSIONS: Dramatic shifts in the management of peripheral vascular disease have occurred together with an overall decline in mortality. There seems to be a significant mortality advantage for endovascular as compared with traditional surgery except for carotid endarterectomy. The increasing safety of vascular interventions should be considered when deciding which patients to treat but with the caveat that endovascular interventions are not always safer than open repair.

Amputation, Surgical↗

PubMed2006

Outcomes of endovascular treatment of ruptured abdominal aortic aneurysms.

INTRODUCTION: The successful application of endovascular techniques for the elective repair of abdominal aortic aneurysms (AAAs) has stimulated a strong interest in their possible use in dealing with a long-standing surgical challenge: the ruptured abdominal aortic aneurysm (RAAA). The use of a conventional open procedure to repair ruptured aneurysms is associated with a high operative mortality of 45% to 50%. In this study, we evaluated the current frequency of endovascular repair of RAAAs in four large states and the impact of this technique on patient outcome. METHODS: We examined discharge data sets from 2000 through 2003 from the four states of California, Florida, New Jersey, and New York, whose combined population represents almost a third of the United States population. Proportions and trends were analyzed by chi2 analysis and continuous variables by the Student's t test. RESULTS: We found that since the year 2000, endovascular repair has begun to emerge as a viable treatment option for RAAAs, accounting for the repair of 6.2% of cases in 2003. During the same period, the use of open procedures for RAAAs declined. The overall mortality rate for the 4-year period was significantly lower for endovascular vs open repair (39.3% vs. 47.7%, P = .005). Moreover, compared with open repair, endovascular repair resulted in a significantly lower rate of pulmonary, renal, and bleeding complications. Survival after endovascular repair correlated with hospital experience, as assessed by the overall volume of elective and nonelective endovascular procedures. For endovascular repairs, mortality ranged from 45.9% for small volume hospitals to 26% for large volume hospitals (P = .0011). Volume was also a determinant of mortality for open repairs, albeit to a much lesser extent (51.5% for small volume hospitals, 44.3% for large volume hospitals; P < .0001). CONCLUSION: We observed a benefit to using endovascular procedures for RAAAs in institutions with significant endovascular experience; however, the analysis of administrative data cannot rule out selection bias as an explanation of better outcomes. These data strongly endorse the need for prospective studies to clarify to what extent the improved survival in RAAA patients is to be attributed to the endovascular approach rather than the selection of low-risk patients.

Aortic Aneurysm, Abdominal↗

PubMed2006

Analysis of parameters associated with hypotension requiring vasopressor support after carotid angioplasty and stenting.

INTRODUCTION: Systemic hypotension has been observed for up to 36 hours in response to stimulation of the carotid baroreceptor by carotid angioplasty and stenting (CAS). The aim of this study was to identify risk factors and cardiac outcomes for postprocedural hypotension requiring vasopressor support after CAS. METHODS: Between 2003 and 2005, 143 patients (87 men; mean age, 75 years) with high-grade carotid artery stenosis (mean, 87.3%) were treated with CAS and prospectively entered into a vascular registry. Data were retrospectively analyzed to determine factors predictive of hypotension requiring vasopressor support after CAS. Atropine and appropriate intravenous crystalloid solution were administered during CAS. For the first 30 patients, atropine was only used for symptomatic patients but then became routine and was used for all patients with primary carotid stenosis. Hypotension (systolic blood pressure <90 mm Hg or a mean arterial blood pressure <50 mm Hg) unresponsive to conservative measures was treated with vasopressors (phenylephrine or norepinephrine). Patients were stratified into three groups based on hypotension requiring vasopressors: (1) no vasopressors, (2) vasopressors for < or = 24 hours (short duration), and (3) vasopressors for >24 hours (prolonged duration). Risk factors for hypotension requiring vasopressors were analyzed by univariate and multivariate logistic regression analysis. RESULTS: Postprocedural hypotension requiring vasopressor treatment was seen in 16 (11%) of 143 of patients, with 6 (4%) requiring vasopressor support for >24 hours. Mean duration of vasopressor administration for all patients was 17 +/- 10 hours (range, 6 to 36 hours). By univariate analysis, a history of a previous myocardial infarction (P = .02) or use of the PercuSurge occlusion balloon (P = .05) were both associated with increased incidence of short duration (</=24 hours) use of vasopressors, and female sex (P = .03) and age >80 years old (P = .02) were associated with prolonged (>24 hours) vasopressor requirement. On multivariate analysis adjusted for age and sex, a history of myocardial infarction (odds ratio [OR], 4.1; 95% confidence interval [CI], 1.0 to 16.4; P = .05) remained an independent predictor of short-duration vasopressors. On multivariate analysis, female sex (OR, 10.9; 95% CI, 1.2 to 100.4; P = .04) and age >80 years old (OR, 13.8, 95% CI, 1.5 to 127.2; P = .02) remained independent predictors of prolonged vasopressor use. The incidence of periprocedural myocardial infarctions, arrhythmias, or congestive heart failure did not differ between those patients who did not receive vasopressors (5/127) and those who received vasopressors for a short (< or = 24 hours) duration (1/10, P = NS) or prolonged (>24 hours) duration (0/6, P = NS). CONCLUSION: Prolonged hypotension requiring vasopressor support occurs in a minority of patients after CAS, with higher incidences in older women. In contrast, hypotension requiring a more limited duration of vasopressor use occurs more commonly in patients who had a prior myocardial infarction, independent of age or sex. In this cohort of patients, vasopressors required for hypotension were not associated with an increased incidence of periprocedural cardiac complications. Despite the increased incidence of prolonged hypotension in older women, this study demonstrates that CAS can be performed without an increase in cardiac morbidity in older women.

Aged↗

PubMed2005

Percutaneous endovascular treatment for chronic limb ischemia.

Percutaneous transluminal methods of revascularization for chronic limb ischemia have traditionally been used as an adjunctive or secondary mode of treatment. This study examines the outcomes of patients treated via endovascular methods as the primary form of treatment. The records of 66 patients (average age, 71.3 years; range, 53 to 92) with chronic limb ischemia treated from November 2000 to January 2002 at a single institution with endovascular methods were retrospectively reviewed. Thirty-one patients had disabling claudication, 15 had rest pain, 17 had minor tissue loss, and 3 had major tissue loss. There were 94 lesions in the 66 limbs: 45 lesions in the superficial femoral artery, 28 lesions in the popliteal artery, and 21 lesions in tibial arteries. Occlusive lesions were treated by subintimal angioplasty. Stenoses were treated by percutaneous transluminal angioplasty (PTA). The median length of the lesions was 12 cm. Forty-six stents were placed in 32 patients; 34 patients did not receive stents. The approach was contralateral in 71% (47/66) and ipsilateral in 29% (19/66) of cases. Patients were followed up with physical exam, anklebrachial index (ABI), and duplex ultrasonography. Post-intervention medical treatment included aspirin and clopidogrel. Long-term patency was correlated with age, comorbidities, risk factors, and the use of stents in addition to angioplasty. Endovascular treatment was technically successful in 65 of 66 patients (98%). Residual stenosis (<30%) was found in three cases, two in patients with PTA alone and one patient with PTA and a stent. Mean length of follow-up was 6.3 months (range, 6 weeks to 15 months). Post-intervention ABI improved from a mean of 0.65 to a mean of 1.01 (p < 30.05). The perioperative complication rate was 9% and included three cases of hematoma and one case each of thrombosis, lymphocele, and rash reaction to medications. Outcome measures included primary patency (89%), assisted primary patency (96%), and limb salvage (97%) at 6 months. Restenosis of >50% occurred in four patients and occlusion occurred in two. At 6 months, patients with one or more stents had a patency rate of 84% (27/32), whereas those without a stent had a patency rate of 94% (32/34) (p = NS). Endovascular treatment is a safe, feasible, and effective method with a high short-term patency rate and may be used as an alternative to bypass for chronic limb ischemia.

Aged↗

PubMed2005

Multimodal percutaneous intervention for critical venous occlusive disease.

Critical deep venous thrombosis and occlusion constitutes a small percentage of patients with venous disease, who exhibit severe symptomatology. This study examined the results of multimodal percutaneous therapy for the treatment of complex critical venous thrombotic and occlusive disease. Twenty-five patients presented with critical venous thromboses or occlusions (11 with debilitating unilateral lower extremity edema causing ambulatory impairment, 2 with debilitating bilateral lower extremity edema, 3 with phlegmasia cerulea dolens, 2 with venous claudication, 2 with superior vena cava (SVS) syndrome with respiratory compromise, 4 with debilitating upper extremity edema, and 1 with renal insufficiency). Therapeutic modalities including thrombolysis, mechanical thrombectomy, percutaneous venoplasty and stent placement, temporary inferior vena cava filtration, and ultrasound guidance were used in all cases in conjunction with long-term systemic anticoagulation. The venous access site was determined by the anatomic location of the lesion and included popliteal, femoral, brachial, and lesser saphenous. Patients were followed with clinical exam and duplex surveillance. Resolution of symptoms was achieved in 18 of 25 patients (72%) and partial resolution occurred in 4 of 25 (16%). Failure of treatment identified as both lack of clinical response and evidence of continued venous thrombosis occurred 3 of 25 patients (12%). Restoration of arterial pulses and limb salvage was achieved in the three patients with phlegmasia cerulea dolens and acute limb-threatening ischemia. Both patients with SVC syndrome experienced resolution of respiratory compromise and facial edema. The mean length of follow-up was 11 +/- 2.7 months. Complications included transfusion requirement (2), hematuria (2), retroperitoneal hematoma (1), and cellulitis (1). Acute critical venous thrombotic and occlusive disease is responsive to multimodal percutaneous treatment. The relief of pain and resolution of acutely life and limb-threatening conditions in this most severely symptomatic subset of patients represents the immediate goal of treatment.

Algorithms↗

PubMed2005

Comparison of results in endovascular interventions for infrainguinal lesions: claudication versus critical limb ischemia.

This study analyzed clinical success, patency, and limb salvage after endovascular repair in patients treated for chronic limb ischemia presenting with claudication versus critical limb ischemia. Between October 2001 and August 2004, 115 patients (mean age 71) underwent endovascular treatment for infrainguinal arterial disease. Techniques included subintimal angioplasty and transluminal angioplasty with or without stents. Lesions were classified according to Transatlantic InterSociety Consensus. Follow-up (mean 11 months) included physical exam, ankle-brachial index, and duplex ultrasound. Patency rates were determined using Kaplan-Meier and compared by log-rank analysis. One hundred ninety-nine lesions were treated in 121 limbs using percutaneous techniques. Comorbidities were similar except higher rates of diabetes mellitus (67% vs 41%, P < 0.001) and chronic renal insufficiency (22% vs 7%, P < 0.05) were found in critical limb ischemia patients. Primary patency for claudicants was 100 per cent, 98 per cent, and 85 per cent at 3, 6, and 12 months and 89 per cent, 80 per cent, and 72 per cent for critical limb ischemia, respectively (P = 0.06). Limb salvage was 91 per cent at 12 months for critical limb ischemia patients. Morbidity was similar between groups, and there was no perioperative mortality. Percutaneous intervention for both claudication and critical limb ischemia provides acceptable 12 month patency with limited morbidity.

Adult↗

PubMed2004

Continuity in the treatment of carotid artery disease: results of a carotid stenting program initiated by vascular surgeons.

The treatment of carotid artery stenosis currently constitutes a major component of vascular surgical practice. Carotid angioplasty and stenting (CAS), however, is mainly performed by nonvascular surgeon interventionalists with cerebral protection devices available only through investigational protocols. This study reports the initial results of a CAS program initiated and performed by vascular surgeons using commercially available cerebral protection devices. Fifty-seven patients were enrolled in the study over a 14-month period. All patients were at high risk for conventional endarterectomy (7 resentosis, 4 irradiation, and 46 medically high-risk ASA III). Mean age was 75.7 years (range, 45-93 years). High-grade stenosis of the carotid artery was present in all cases (mean stenosis, 85%; range, 80-99%). Twenty-four percent of patients were symptomatic. Cerebral protection was performed with an occlusion balloon-wire in 32 cases and with a filter-wire device in 24; no cerebral protection was used in 1 patient with restenosis after endarterectomy. Initially in the study, atropine was administered selectively for the development of bradycardia. Currently atropine is administered routinely prior to the initial balloon angioplasty of the carotid bulb. Clopidogrel (75 mg/day) was administered for 5 days prior to CAS and for 30 days after CAS. All 57 patients underwent successful dilatation of their carotid stenoses without occlusion or dissection. Ten of 32 patients in whom balloon occlusion was used for cerebral protection exhibited transient evidence of cerebral ischemia during protection balloon occlusion. These symptoms resolved completely without permanent neurological deficit in all cases. Development of bradycardia with a heart rate <50 bpm was significantly reduced by routine administration of atropine prior to the initial dilatation within the carotid bulb (p = 0.01). Mean hospital length of stay was 1.33 days (range, 1-5 days). There were two periprocedure myocardial infarctions, two postprocedure transient ischemic attacks, and one reversible ischemic neurologic deficit. There was no 30-day mortality. There have been no instances of hemodynamically significant restenosis during a mean follow-up period of 5.4 months. From these results we have concluded that CAS can be performed effectively and safely using commercially available cerebral protection devices. A program initiated and performed exclusively by vascular surgeons is effective and should be the standard model used in the endovascular treatment of carotid artery stenosis.

Aged↗

PubMed2004

Multicenter pivotal trial results of the Lifepath System for endovascular aortic aneurysm repair.

PURPOSE: This study was undertaken to assess the results of endovascular aortic aneurysm repair with the Lifepath abdominal aortic aneurysm (AAA) graft system. METHOD: In a prospective clinical trial, 23 centers used the Lifepath System balloon-expandable, modular bifurcated stent graft for elective endovascular aortic aneurysm repair. Stent grafts were sized according to computed tomographic angiography-based diameter measurements. All repairs were performed in the operating room through bilateral surgically exposed femoral arteries. Results were assessed with contrast agent-enhanced computed tomography scans and plain abdominal x-ray films at 1, 6, 12, 24, 36, and 48 months postoperatively. RESULTS: Over 52 months (mean follow-up, 11 months), 227 patients (206 men, 21 women) were enrolled. Technical implant success rate was 98.7%. There were five (2.2%) conversions to open surgery: two emergently because of aortic perforation; to treat refractory endoleak, immediate in one and at 12 months in one; and to replace a device with wireform fractures that had migrated at 12 months, resulting in a proximal endoleak. The perioperative mortality rate was 1.3%. There was one operative death during a secondary procedure to repair perforation of the aorta. There were two perioperative deaths, from postoperative myocardial infarction (n = 1) and pulmonary embolus (n = 1). There were 12 late deaths, from coronary artery disease (n = 4), cancer (n = 2), respiratory failure (n = 2), sepsis (n = 1), or unknown cause (n = 3). Median length of stay was 2 days (mean, 4 days). There have been no AAA ruptures after successful implantation of the device, no graft limb thromboses, and no limb dislocations. At the time of operation endoleak was noted in 43 (19%) patients, but by 6 months this was reduced to 8 (5.9%) patients (type I, n = 1; type II, n = 7). There were no type III or type IV endoleaks. Secondary interventions to treat endoleaks included open conversion (n = 2), placement of extension cuffs (n = 4), repeated balloon dilation (n = 3), and coil embolization (n = 6). The two remaining secondary interventions were emergent treatment of postoperative bleeding from a groin incision, and a colon resection because of postoperative colonic ischemia, for a 12-month secondary intervention rate of 7.5%. Wireform fractures were noted in the first generation Lifepath device in 37 of 79 (47%) patients. Graft migration (>10 mm) was observed in five patients (2.2%), each of whom also had two or more fractures of the proximal anchoring wireforms. Migration resulted in a proximal attachment endoleak in one patient. In response to wireform fractures, the device was modified after the initial 79 patients were enrolled. Wireform fracture has been observed in six patients since this modification (4%), and in only one patient did this involve fracture of a proximal anchoring wireform; none of these patients has had endoleak or graft migration. By 12 months, mean aneurysm diameter was noted to decrease by 9 mm (P <.0001), and mean aneurysm volume by 42 mL (P <.0001) from the preoperative visit. CONCLUSION: The Lifepath System demonstrates a low endoleak and secondary intervention rate and high sac regression rate, compared with other devices. The unique balloon-expandable design offers the advantages of precise placement and high radial force. The device appears to be highly resistant to limb thrombosis and modular component separation. Patients were protected from AAA rupture after successful device implantation, and demonstrated significant reduction in AAA diameter and volume. Fractures of the wireforms of the main body of the device have been observed. Careful long-term follow-up is necessary.

Adult↗

PubMed2004

Computer simulation as a component of catheter-based training.

INTRODUCTION: Computer simulation has been used in a variety of training programs, ranging from airline piloting to general surgery. In this study we evaluate the use of simulation to train novice and advanced interventionalists in catheter-based techniques. METHODS: Twenty-one physicians underwent evaluation in a simulator training program that involved placement of a carotid stent. Five participants were highly experienced in catheter-based techniques (>300 percutaneous cases), including carotid angioplasty and stenting (CAS); the remaining 16 participants were interventional novices (<5 percutaneous cases). The Procedicus VIST simulator, composed of real-time vascular imaging simulation software and a tactile interface coupled to angiographic catheters and guide wires, was used. After didactic instruction regarding CAS and use of the simulator, each participant performed a simulated CAS procedure. The participant's performance was supervised and evaluated by an expert interventionalist on the basis of 50 specific procedural steps with a maximal score of 100. Specific techniques of guide wire and catheter manipulation were subjectively assessed on a scale of 0 to 5 points based on ability. After evaluation of the initial simulated CAS procedure, each participant received a minimum of 2 hours of individualized training by the expert interventionalist, with the VIST simulator. Each participant then performed a second simulated CAS procedure, which was graded with the same scale. After completion, participants assessed the training program and its utility via survey questionnaire. RESULTS: The average simulated score for novice participants after the training program improved significantly from 17.8 +/- 15.6 to 69.8 +/- 9.8 (P < .01), time to complete simulation decreased from 44 +/- 10 minutes to 30 +/- 8 minutes (P < .01), and fluoroscopy time decreased from 31 +/- 7 minutes to 23 +/- 7 minutes ( P < .01). No statistically significant difference in score, total time, or fluoroscopy time was noted for experienced interventionalists. Improvement was noted in guide wire and catheter manipulation skills in novices. Analysis of survey data from experienced interventionalists indicated that the simulated clinical scenarios were realistic and that the simulator could be a valuable tool if clinical and tactile feedback were improved. Novices also thought the simulated training was a valuable experience, and desired further training time. CONCLUSIONS: An endovascular training program using the Procedicus VIST haptic simulator resulted in significant improvement in trainee facility with catheter-based techniques in a simulated clinical setting. Novice participants derived the greatest benefit from simulator training in a mentored program, whereas experienced interventionalists did not seem to derive significant benefit.

Blood Vessel Prosthesis Implantation↗

PubMedDate not supplied

Multimodal therapy for acute and chronic venous thrombotic and occlusive disease.

Critical deep venous thrombosis and occlusion constitutes a small percentage of patients with venous disease. However, these patients exhibit severe symptomatology including pain and extensive edema that may progress to limb- or life-threatening complications such as phlegmasia cerulea dolens and superior vena cava syndrome. This paper reviews the different multimodal percutaneous interventions currently available for the treatment of complex critical venous thrombotic and occlusive disease.

Acute Disease↗