-
[show abstract]
[hide abstract]
ABSTRACT: Most patients with critical limb ischemia (CLI) have multilevel infrainguinal peripheral arterial disease (M-PAD). One-third of CLI patients will have isolated tibial disease (ITD). The treatments for multilevel disease or ITD differ depending on whether open or endovascular procedures are used, but we questioned whether outcomes from these procedures differ. We evaluated outcomes of CLI patients after open and/or endovascular revascularization for CLI and assessed the impact of disease distribution.
Four hundred forty-six CLI patients (Rutherford 4-6) who underwent revascularization from 2001 to 2005 were evaluated arteriographically and followed after revascularization with noninvasive testing. Based on arteriographic data, all patients with ITD (occlusions in one or more tibial arteries) were compared with patients with occlusive femoropopliteal disease with or without concomitant tibial occlusions (M-PAD). Patients with disease solely above the inguinal ligament were excluded. Clinical data (survival, amputation-free survival, primary patency, secondary patency, limb salvage, maintenance of ambulation, and maintenance of living status) were acquired from a prospective vascular database, allowing the comparison of revascularization outcomes according to disease distribution.
In this study, 36% of patients had ITD and 64% presented with M-PAD. The severity of ischemia at presentation was rest pain (28.5%), ulceration (42.3%), and gangrene (29.1%). In this study, 92% presented exclusively with infrainguinal disease, and 8% presented with both suprainguinal and infrainguinal disease. Risk factors included diabetes mellitus (61.2%), smoking (61.0%), coronary artery disease (57.9%), hypertension (84.3%), hyperlipidemia (40.4%), obesity (15.5%), and chronic obstructive pulmonary disease (19.3%). In comparing the ITD and M-PAD groups, there was no difference in primary patency at 2 years. All other outcomes were statistically different out to 3 years including survival (50.4% vs. 62.6%; p=0.0026, hazard ratio [HR] 0.669); amputation-free survival (35.1% vs. 50.2%; p=0.0062; HR 0.595); limb salvage (65.2% vs. 74.4%; p=0.0062; HR 0.595); maintenance of ambulation (68.9% vs. 76.9%; p=0.0352; HR 0.644); maintenance of living status (79.0% vs. 84.8%; p=0.0403; HR 0.599); and secondary patency (66.8% vs. 74.8%; p=0.0309; HR 0.665). Multivariate analyses reveal that ITD is not an independent predictor of outcome after controlling for confounding factors, of which tissue loss and end-stage renal disease correlate most consistently with poor clinical outcomes.
After revascularization for CLI, ITD carries a worse prognosis (amputation-free survival, limb salvage, survival, maintenance of ambulation, and independent living status) compared with patients with M-PAD, despite the "greater" disease burden in M-PAD patients. ITD patients are more likely to have confounding factors such as diabetes mellitus, renal disease, and worse ischemia at presentation than those with M-PAD. The recognition of ITD may be helpful in identifying high-risk patients but is not an independent risk factor for poor outcomes.
Annals of Vascular Surgery 04/2010; 24(3):349-59. · 1.03 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: The indications for open abdominal aortic aneurysm (AAA) repair have changed with the development of endovascular techniques. The purpose of this study is to clarify the indications and outcomes for open repair since endovascular aneurysm repair (EVAR) and to compare contemporary AAA repair with the pre-EVAR era. Patients undergoing open AAA repair were identified; the demographics, outcomes, and indications for open repair were reviewed. Outcomes were compared based on indication for open repair in the EVAR era and between the pre-EVAR and EVAR eras. Open indications in the EVAR era included: age younger than 65 years with minimal comorbidities (AGE, n = 24 [9.8%]), unfavorable anatomy (ANAT, n = 146 [59.3%]), aortoiliac occlusive disease (AIOD, n = 38 [15.4%]), and miscellaneous (OTHER, n = 38 [15.4%]). Mortality (30-day and 5-year) was affected by indication: AGE = 0 and 0 per cent, ANAT = 4.1 and 49.7 per cent, AIOD = 13.5 and 32.3 per cent, and OTHER = 5.3 and 41.8 per cent. Age, sex, race, coronary artery disease, and peripheral artery disease were similar between the pre-EVAR and EVAR eras. EVAR-era patients had more diabetes mellitus, hypertension, and hyperlipidemia and longer operative time. Mortality was not different, but complication rates were lower in the pre-EVAR era (23.7 vs 43.5%, P = 0.025). Patients undergoing open AAA repair in the EVAR era have more comorbidities, longer operative times, and more complications. Outcomes for EVAR-era patients are affected by the indication for open repair. A preference for open repair in younger patients with minimal comorbidities is justified.
The American surgeon 09/2009; 75(8):665-9; discussion 669-70. · 1.28 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: Successful outcome after lower extremity revascularization is usually measured by physician-oriented terms such as graft patency and amputation-free survival. It has been increasingly appreciated that these criteria do not necessarily translate into success from the prospective of the patient. The purpose of this study, therefore, is to retrospectively examine success after lower extremity revascularization for tissue loss using patient-oriented measures and to include patients who underwent both open surgical bypass and endovascular therapy.
Between 1998 and 2005, 677 patients (316 endovascular and 361 open surgery) underwent revascularization for ischemic tissue loss. The method of revascularization (endovascular or open surgery) was left to the discretion of the surgeon. Revascularization was considered to be clinically successful if each of the following occurred: reconstruction patency until wound healing, limb salvage for 1 year, maintenance of ambulation for 1 year, and survival for 6 months. The influence of 20 intrinsic patient factors, including type of revascularization (open vs endo) was examined using the chi(2) test. Significant factors in bivariate analysis were included in a logistic regression model to determine independent predictors and probability of failure.
Overall clinical success was achieved in 277 (40.9%) patients. Success for open surgical and endovascular cohorts was 44.3% and 37.0%, respectively (P = .06). Type of intervention was not a significant factor in either bivariate or logistic regression analysis. Independent predictors of failure (odds ratio [OR]; 95% confidence interval [CI]) regardless of treatment type included impaired ambulatory status at the time of presentation (OR 3.24; CI 2.14, 4.90), diabetes (OR 1.62; CI 1.14, 2.32), endstage renal disease (ESRD) (OR 1.55; CI 1.07, 2.23), presence of gangrene (OR 2.0; CI 1.42, 2.82), and prior vascular intervention (OR 1.46; CI 1.02, 2.10). Paradoxically, hyperlipidemia (OR 0.70; CI 0.50, 0.98) was a predictor for success. Probability of failure was 35.4% (OR 1.0) if no independent predictors were present and increased with the addition of each adverse predictor. For instance, diabetic patients with impaired ambulatory status and gangrene had an 85.2% (OR 10.5) probability of failure. In the worst case scenario, a diabetic patient with ESRD, impaired ambulatory status, gangrene, and a prior vascular intervention was considered, probability of failure was a dismal 92.8% (OR 23.7).
Clinical success after lower extremity revascularization for ischemic tissue loss is determined by intrinsic patient factors and not by method of revascularization. These data reiterate that future investigation efforts should be focused less on the method of revascularization and more on identification of patient cohorts at risk for failure regardless of treatment.
Journal of vascular surgery: official publication, the Society for Vascular Surgery [and] International Society for Cardiovascular Surgery, North American Chapter 08/2009; 50(3):534-41; discussion 541. · 3.52 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: Vascular surgical education for general surgery residents is concerning as endovascular interventions increase and vascular surgery expands. The purpose of this study was to examine the effects these factors have on vascular surgery case numbers for general surgery residents and statewide surgeons and to report on former general surgery residents' perceptions of vascular surgery in training and practice.
Case numbers for all general surgery residents graduating from the Greenville Hospital System from 1991 to 2007 and for the vascular surgery fellows graduating from 2003 to 2007 were obtained. A database identified case numbers and physician specialty for vascular procedures from 1997 through 2006. A survey gained perspectives of graduated general surgery residents on the vascular experience during residency and practice and on postresidency vascular caseload.
There was significant decline in resident participation in open abdominal aortic aneurysm (22.4 versus 7.7), carotid endarterectomy (37.2 versus 31.1), aortobifemoral bypass (18.6 versus 5.5), and lower extremity bypass (42.8 versus 19.1). Numbers for dialysis access creation (49.0 versus 57.1) were maintained. Statewide, comparing 1997 with 2006, the percentages of procedures performed by vascular surgeons were: abdominal aortic aneurysm (29.3% versus 49%; p < 0.001), carotid endarterectomy (28.9% versus 45.5%; p < 0.001), and dialysis access (4.6% versus 12.3%; p=0.020). The survey of general surgery graduates revealed lower extremity bypass, carotid endarterectomy, abdominal aortic aneurysm, and dialysis access are important in training. Dialysis access was the most common operation performed by the general surgery graduates.
There is a trend toward vascular surgeons and vascular residents performing most open vascular cases. Currently practicing surgeons believe there is value to vascular exposure for general surgeons in training, and vascular surgery should remain in general surgery training.
Journal of the American College of Surgeons 05/2009; 208(5):692-7, quiz 697.e1; discussion reply 697-9. · 4.55 Impact Factor
-
Spence M Taylor,
David L Cull, Corey A Kalbaugh,
Herman F Senter,
Eugene M Langan,
Christopher G Carsten,
John W York,
Bruce A Snyder,
Bruce H Gray,
Mark P Androes,
Dawn W Blackhurst
[show abstract]
[hide abstract]
ABSTRACT: Outcomes after lower extremity revascularization are usually reported according to the level of peripheral arterial disease (PAD, aortoiliac or infrainguinal) or the method of treatment (open or endovascular surgery). Outcomes stratified by indication, ie, claudication or critical limb ischemia (rest pain and tissue loss), have not been well studied. The purpose of this study was to compare postoperative outcomes according to the preoperative indications.
Outcomes of 2,240 consecutive limb revascularizations in 1,732 patients from January 1998 through December 2005 were stratified and examined according to preoperative indication: claudication (n=999 limbs), ischemic rest pain (n=464 limbs), or tissue loss (n=777 limbs). End points measured included primary and secondary interventional or operative patency, limb salvage, survival, amputation-free survival, maintenance of ambulation, maintenance of independence, and resolution of presenting symptoms.
The proportion of medical comorbidities and the severity of disease increased significantly by cohort from claudication to rest pain to tissue loss. With a mean followup of 1,089 days (range 0 to 3,689 days), overall outcomes performance declined consistently according to indication for all end points measured at 5 years (claudication, rest pain, tissue loss, p value): secondary reconstruction patency (93%, 80%, 66%, respectively; p < 0.001), limb salvage (99%, 81%, 68%, respectively; p < 0.001), survival (78%, 46%, 30%, respectively; p < 0.001), amputation-free survival (78%, 42%, 25%, respectively; p < 0.001), maintenance of ambulation (96%, 78%, 68%, respectively; p < 0.001), maintenance of independence (98%, 85%, 75%, respectively; p < 0.001), and resolution of presenting symptoms (79%, 61%, 42%, respectively; p < 0.001).
There is a declining spectrum of outcomes performance from claudication to rest pain to tissue loss. These findings question the accuracy of all previously published data for critical limb ischemia, for which rest pain and tissue loss are usually blended and reported as a single outcomes value.
Journal of the American College of Surgeons 05/2009; 208(5):770-8; discussion 778-80. · 4.55 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: The StarClose (Abbott Vascular, Redwood City, CA) arterial closure device utilizes an extraluminal nitinol clip to establish hemostasis. The purpose of this study was to determine the safety and efficacy of StarClose from a prospective peripheral arterial disease (PAD) registry. Over an 18-month time interval, 500 StarClose devices were used in 378 consecutive patients with symptomatic PAD after diagnostic and/or therapeutic endovascular cases. Patient demographics along with objective criteria including duplex ultrasound images, common femoral artery flow velocities, and ankle-brachial indexes (ABIs) were analyzed before and after StarClose placement. All outpatients received prophylactic antibiotic (one dose), periprocedural heparin (without protamine reversal), and antiplatelet therapy. Aspirin and clopidogrel (Plavix) was used for all patients undergoing therapeutic intervention. There were 378 patients who underwent procedures for aortoiliac or infrainguinal PAD, 99 of which were bilateral. Of the 500 arteriotomy closures, 296 were therapeutic interventions with sheath sizes of 6-8 F in the common femoral artery. The diagnostic studies (n = 204 arteriotomies) were performed with a 5F sheath. The technical success in achieving hemostasis was 97.2%; only 14 devices had a deployment problem requiring prolonged manual compression. Median length of stay was 157 min for patients done on an outpatient basis. Eleven of 260 (4.2%) on duplex follow-up had a doubling of the peak systolic velocity, only one of which was symptomatic. Late follow-up showed 42 of 360 (11.7%) with a drop in ABI >0.10. Nine major complications (2.0%) were identified in follow-up. The StarClose closure device has a low major complication rate and is safe and efficacious in patients with PAD, although stenosis at the arteriotomy site may occur. The device has achieved rapid hemostasis without need for anticoagulant reversal and requires significantly less time to ambulation than manual compression.
Annals of Vascular Surgery 09/2008; 23(3):341-4. · 1.03 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: In the last decade, the Dialysis Outcome Quality Initiative (DOQI) Guidelines have enhanced the longevity of patients with end-stage renal disease (ESRD) on hemodialysis. Consequently, surgeons are increasingly challenged to provide vascular access for patients in whom options for access in the upper extremity have been expended. This situation is even more problematic in the morbidly obese patient on hemodialysis. Our group previously reported a high rate of infection and need for secondary interventions in obese patients with prosthetic femorofemoral accesses. We now report a series of patients who underwent placement of a prosthetic axilloaxillary loop access. This study presents our technique and evaluates our results, particularly as they relate to the obese patient.
From January 1998 to May 2006, 34 prosthetic axilloaxillary loop accesses were placed in 32 patients with ESRD. Eleven patients (12 accesses) were obese, as defined by a body mass index >/=30 kg/m(2). Median follow-up was 16 months. Kaplan-Meier analysis was used to determine primary and secondary patency as well as patient survival for the entire cohort and for the obese and nonobese patient cohorts. Survival curves were compared using the log-rank test for equality over strata.
The secondary patency rate was 59% at 1 year (median, 18 months). The 1-year patient survival was 69%. Infection occurred in 15% patients. Comparison of the obese vs nonobese cohorts demonstrated no statistically significant difference in 1-year primary patency (36% vs 10%, P = .17) or secondary patency (71% vs 65%, P = .34). There were no infections in the obese cohort.
These data show that the prosthetic axilloaxillary loop access has acceptable outcomes and should be considered the tertiary vascular access procedure of choice in the obese patient on hemodialysis.
Journal of vascular surgery: official publication, the Society for Vascular Surgery [and] International Society for Cardiovascular Surgery, North American Chapter 08/2008; 48(2):389-93. · 3.52 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: Current treatment of complex aortoiliac occlusive disease (AIOD) includes the aortobifemoral bypass or the femoral-femoral bypass. However, because of bilateral groin exposure and associated risks, there is a significant morbidity associated with these procedures. In appropriate patients with unilateral AIOD, the iliofemoral bypass graft (IFBPG) via a lower abdominal retroperitoneal incision can be an acceptable alternative. The purpose of this study is to review the safety and efficacy as well as long-term outcomes of IFBPG in patients with unilateral AIOD. From July 1997 through June 2006, 40 patients (64.3 +/- 11.2-years-old, range 41-89-years-old, 57.5% critical limb ischemia, 70% male, 95% smokers) with unilateral AIOD were treated with IFBPG. Perioperative complications and symptom resolution were measured and Kaplan-Meier life table analysis was used to analyze outcomes of primary and secondary patency, survival, limb salvage, contralateral intervention, and maintenance of ambulation and independent living status. The perioperative complication rate was 12.5 per cent (n = 5) including one patient who developed atrial-fibrillation and one who developed acute renal failure. Both patients experienced resolution of these symptoms before discharge. Other complications included one limb thrombosis and two wound infections. There were no perioperative deaths. Secondary patency was 97.5 per cent and 93.3 per cent at 1 and 5 years. Limb salvage in patients with critical limb ischemia (CLI) was 85.1 per cent and 79.1 per cent at 1 and 5 years. Limb amputation occurred due to infection (n = 2), or failed IFBPG (n = 2). Thirty-one patients (77.5%) experienced symptom resolution including 15 (88.2%) of the patients treated for claudication. Two patients (5%) required contralateral iliac intervention. Patient survival was 97.5 per cent and 64.5 per cent at 1 and 5 years. Greater than 90 per cent of patients maintained their functional independence at 5 years. IFBPG achieved excellent technical and functional outcomes, particularly in patients treated for vasculogenic claudication. This procedure is relatively safe and efficacious in a population of patients with complex unilateral AIOD and can be an acceptable alternative to the aortobifemoral bypass or fem-fem procedure.
The American surgeon 07/2008; 74(6):555-9; discussion 559-60. · 1.28 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: Functional success after below-knee amputation (BKA) has been poorly studied. The purpose of this study was to establish a consistent definition of "successful outcome" after BKA and to identify clinical variables influencing that definition. Three hundred nine consecutive patients undergoing BKA were evaluated postoperatively using the following definition for "successful outcome": 1) wound healing of the BKA without need for revision to a higher level; 2) maintenance of ambulation with a prosthesis for at least 1 year or until death; and 3) survival for at least 6 months. Independent clinical predictors influencing outcome were determined using bivariate and multivariable logistic regression analyses. For the cohort, median survival and maintenance of ambulation were 44 months and 60 months, respectively. Although 86.4 per cent of patients healed without the need for revision to a higher level, 63.4 per cent maintained ambulation with a prosthesis for 1 year and 86.1 per cent survived for 6 months, successful outcome as defined by attaining all three components of the definitions occurred in only 51.1 per cent (n = 158) of patients. Of 19 clinical variables examined, six were identified in bivariate analysis as significantly associated with outcome. However, only three were found to be independent predictors of outcome using logistic regression modeling. The presence of coronary artery disease [odds ratio (OR), 0.465; 95% CI, 0.289-0.747], cerebrovascular disease (OR, 0.389; 95% CI, 0.154-0.980), and impaired ambulatory ability before BKA (OR, 0.310; 95% CI, 0.154-0.623) were each associated with a decreased odds for successful outcome. Patients who presented with impaired ambulatory ability in combination with another independent predictor had only a 20 per cent to 23 per cent probability of successful outcome and patients who presented with all three had a 10.4 per cent probability of success. In contrast, patients who had none of the independent predictors at presentation had a 67.5 per cent probability of successful outcome after BKA. A standardized definition of success after BKA capable of predicting outcomes is feasible and can be a useful tool to determine rehabilitation potential. When judged by our definition, patients without predictors of failure possess a high potential for rehabilitation, whereas patients with multiple predictors rarely rehabilitate, should probably receive palliative above-knee amputation, and forgo the expense of futile prosthetic training.
The American surgeon 07/2008; 74(7):607-12; discussion 612-3. · 1.28 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: The long-term survival of patients on hemodialysis is often limited by the exhaustion of vascular access sites. A fundamental principle of vascular access surgery is that the arteriovenous (AV) access be placed as far distally in the arm as possible. This principle enhances the secondary patency of the AV grafts by preserving the proximal veins for AV graft revision and provides venous outflow for a new AV access to be placed more proximally in the extremity. The standard straight and looped AV graft configurations violate this principle by bypassing long segments of vein in the extremity that could be used for AV graft revision or new AV graft placement. We have developed a novel AV graft configuration that preserves venous outflow and enhances the longevity of each AV access site. The purpose of this review is to describe the reverse J AV graft technique and to report our outcomes with the procedure. Between February 2004 and April 2007, 26 AV grafts were placed using the reverse J configuration. Eighteen (69%) AV grafts were placed in the upper arm, 7 (27%) were placed in the forearm, and 1 (4%) was placed in the thigh. Median follow-up was 320 days. The secondary AV graft patency was 90 per cent at 6 months, 84 per cent at 12 months, and 84 per cent at 18 months. Five AV grafts were subsequently revised to a loop configuration. Overall patient survival was 85 per cent at 6 months, 68 per cent at 12 months, and 62 per cent at 18 months. Compared with the standard straight and looped AV graft configurations, the reverse J AV graft configuration preserves the length of venous outflow in the extremity for AV graft revision or new AV graft placement. Therefore, the reverse J configuration enhances the secondary patency of AV graft patency and AV access site longevity.
The American surgeon 07/2008; 74(7):620-4; discussion 624-5. · 1.28 Impact Factor
-
Spence M Taylor, Corey A Kalbaugh,
Matthew G Healy,
Anna L Cass,
Bruce H Gray,
Eugene M Langan,
David L Cull,
Christopher G Carsten,
John W York,
Bruce A Snyder,
Jerry R Youkey
[show abstract]
[hide abstract]
ABSTRACT: The purpose of this study was to reconsider current recommended treatment guidelines for vasculogenic claudication by examining the contemporary results of surgical intervention.
We performed a retrospective review of 1,000 consecutive limbs in 669 patients treated for medically refractory vasculogenic claudication and prospectively followed. Outcomes measured included procedural complication rates, reconstruction patency, limb salvage, maintenance of ambulatory status, maintenance of independent living status, survival, symptom resolution, and symptom recurrence.
Of the 1,000 limbs treated, endovascular therapy was used in 64.3% and open surgery in 35.7% of patients; aortoiliac occlusive disease was treated in 70.1% and infrainguinal disease in 29.9% of patients. The overall 30-day periprocedural complication rate was 7.5%, with no notable difference in complication rates when comparing types of treatment or levels of disease. Overall reconstruction primary patency rates were 87.7% and 70.8%; secondary patencies were 97.8% and 93.9%; limb salvage, 100% and 98.8%; and survivals, 95.4% and 76.9%, at 1 and 5 years, respectively. More than 96% of patients maintained independence and ambulatory ability at 5 years. Overall symptom resolution occurred in 78.8%, and symptom recurrence occurred in 18.1% of limbs treated, with slightly higher resolution and recurrence noted in patients treated with endovascular therapy.
Contemporary treatment of vasculogenic claudication is safe, effective, and predominantly endovascular. These data support a more liberal use of revascularization for patients with claudication and suggest that current nonoperative treatment guidelines may be based more on surgical dogma than on achievable outcomes.
Journal of the American College of Surgeons 06/2008; 206(5):1053-62; discussion 1062-4. · 4.55 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: Up to 50% of AV fistulas fail to mature, primarily because of problems with fistula cannulation. Fistula elevation procedure (FEP) is a simple superficialization procedure where the fistula is surgically exposed, mobilized, and elevated into a more superficial position for the purpose of facilitating AV fistula cannulation. The purpose of this study is to review use of FEP as an adjunct to fistula maturation.
Two hundred ninety-five FEPs were performed between February 1999 and December 2005. FEP was performed if the fistula was considered too deep to cannulate or if nurses were unable to cannulate the fistula. Kaplan-Meier life-table analysis was used to determine patency and for a subanalysis by location of FEP performed (172 brachial-cephalic, 70 brachial-basilic, 46 radial-cephalic, 7 superficial femoral vein). Survival curves were compared using log-rank test.
Functional primary patency rates for patients undergoing an adjunctive FEP were 73% at 6 months, 60% at 1 year, and 46% at 2 years. Secondary functional patency rates were 81% at 6 months, 71% at 1 year, and 59% at 2 years. There was no statistical significance in any outcomes based on anatomic site of elevation.
AV fistulas that might otherwise have been abandoned because of excessive depth or tortuosity can be successfully salvaged by an adjunctive FEP and achieve satisfactory longterm functional patency. FEP is a valuable adjunct to AV fistula creation, which will enhance fistula maturation rates.
Journal of the American College of Surgeons 06/2008; 206(5):1076-81; discussion 1081-2. · 4.55 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: It is generally accepted that failed infrainguinal bypass with prosthetic material significantly compromises arterial run off, which may limit future revascularization. It is well known that the negative consequences of early vein graft thrombosis are limited, but the effect of failed peripheral angioplasty on the distal vasculature is poorly studied. The purpose of this study was to determine whether early failure after superficial femoral artery intervention influences subsequent revascularization options.
Between July 1, 1998, and June 30, 2006, 276 patients underwent endovascular intervention of the superficial femoral artery. A prospective analysis of angiograms done before the intervention and after early failure (<or=200 days) was performed in a blinded fashion by three attending vascular surgeons to determine the optimal distal bypass site if an operation were to be performed. Inter-rater reliability of the angiogram scores was assessed using the Fleiss generalized kappa for multiple raters. Potential distal anastomotic sites were classified as above knee popliteal, below knee popliteal, tibial, or no adequate site. A consensus classification was determined for each patient (2 of 3 raters).
Of the 276 patients who underwent endovascular intervention of the superficial femoral artery, early failure was noted in 24 limbs in 23 patients. Angiographic records were available for 21 limbs in 20 patients (60% men; mean age, 65.3 +/- 11.3 years), of which 60% had critical limb ischemia, 40% had claudication, and 65% had diabetes. The distal bypass site was altered in six limbs (28.6%); four from popliteal to tibial and two from above knee to below knee popliteal. Inter-rater reliability was 0.54 (moderate/good). The procedures performed on these early failures were percutaneous transluminal angioplasty +/- stent (n = 14), infrainguinal bypass (n = 5), and no treatment (n = 1). Only 0.4% (1 of 276) of patients required major limb amputation due to early failure of a superficial femoral artery intervention.
Early failure after isolated endovascular intervention of the superficial femoral artery is infrequent and alters the distal target in 30% of early-failure patients if open bypass is planned. Salvage with repeat angioplasty, if necessary, can be accomplished in most patients, and the need for limb amputation is exceedingly rare. The early failure results in this study support a more liberal application of endovascular intervention to the superficial femoral artery in patients with lower extremity ischemia, especially claudication. The repercussions of late endovascular failure as well as the effects of disease progression need further study.
Journal of Vascular Surgery 03/2008; 47(3):562-5. · 3.21 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: It has long been evident that lifetime follow-up after endovascular aneurysm repair (EVAR) is necessary to identify late complications. The purpose of this study is to test the hypothesis that late follow-up rates for EVAR in routine practice are inferior to those reported from protocol-driven clinical trials, consequently contributing to avoidable events associated with poor long-term outcome.
From February 1999 to December 2005, 302 EVARs were performed and eligible for follow-up. Of these, 47 were performed as part of an industry-sponsored clinical trial (study patients). Responsibility for follow-up was assigned to a research nurse for study patients and to office clerical staff for nonstudy patients. Follow-up compliance was classified as either frequent (<1 missed scheduled appointment) or incomplete (>2 missed scheduled appointments). Overall survival and complication rates were analyzed.
Of the 302 patients, 203 (67.2%) had frequent follow-up and 99 (32.8%) had incomplete follow-up. The mean follow-up was significantly better in the frequent follow-up group (34.7 +/- 22 months) vs the incomplete follow-up group (18.8 +/- 18.6 months, P < .001). The 5-year survival (63.9% frequent vs 64.0% incomplete), the 5-year reintervention rate (22.3% frequent vs 10.8% incomplete), and incidence of known endoleak (14.8% frequent vs 9.1% incomplete) were statistically similar in the two groups. The incidence of major adverse events, defined as events requiring urgent surgical intervention, was significantly increased in the incomplete follow-up group (6.1% vs 0.5%; P = .006), with nearly half of these patients dying perioperatively. There was no difference in measured outcomes for study patients compared with nonstudy patients. However, mean follow-up was significantly longer for study patients vs nonstudy patients (44.8 +/- 23.7 months vs 26.8 +/- 20.9 months; P < .001).
Follow-up surveillance after EVAR is less intense in practice environments outside of clinical trials. Patients with incomplete follow-up have higher fatal complication rates than patients with frequent follow-up. These data expose a potential under-appreciated limitation of EVAR, questioning whether the findings in clinical trials defining the efficacy of EVAR can be routinely extrapolated to ordinary practice.
Journal of Vascular Surgery 09/2007; 46(3):434-40; discussion 440-1. · 3.21 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: Studies evaluating the outcome of surgical revascularization (SR) for critical limb ischemia in patients who have end-stage renal disease (ESRD) have differed widely in their findings and conclusions. Differences in definitions of success are largely responsible for the varying outcomes. We developed a method of outcomes assessment that incorporates four all-inclusive endpoints to define success. These include primary graft patency to the point of wound healing, postoperative survival of at least 6 months, limb salvage of at least 1 year, and maintenance of ambulatory status of at least 6 months. The purpose of this study was to use this novel method of defining success to determine the outcome of SR in patients with ESRD. From 1998 to 2004, 40 patients (52 limbs) with ESRD and tissue loss underwent SR for limb salvage. Secondary graft patency and limb salvage rates at 36 months were 54.7 per cent and 53 per cent, respectively. When considering each of the four components used to define success separately, success encouragingly ranged between 60 per cent (patent graft until wound healing) and 87.5 per cent (survival for 6 months). However, if all parameters were combined, clinical success was achieved in only 40 per cent (16/40) of patients. Coronary artery disease was the only factor found to significantly reduce success (P = 0.04). In conclusion, using this multiparameter definition of success, which combines four rather modest outcome milestones, favorable outcome occurred in the minority of cases. This study challenges our current method of analyzing success and questions our therapeutic approach to patients with critical limb ischemia and ESRD.
The American surgeon 07/2007; 73(6):598-605; discussion 605. · 1.28 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: Although acute appendicitis is the most frequent cause of the acute abdomen in the United States, its accurate diagnosis in reproductive-age women remains difficult. Problems in making the diagnosis are evidenced by negative appendectomy rates in this group of 20 per cent to 45 per cent. Abdominal CT scanning has been used in diagnosing acute appendicitis, but its reliability and usefulness remains controversial. There is concern that the use of CT scanning to make this diagnosis leads to increased and unwarranted healthcare charges and costs. The purpose of our study is to determine if abdominal CT scanning is an effective test in making the diagnosis of acute appendicitis in reproductive-age women (age, 16-49 years) with right lower quadrant abdominal pain and to determine if its use is cost-effective. From January 2003 to December 2006, 439 patients were identified from our academic surgical database and confirmed by chart review as undergoing an appendectomy with a pre- or postoperative diagnosis of acute appendicitis. Data, including age, presence and results of preoperative abdominal CT scans, operative findings, and pathology reports were reviewed. Comparison of patients receiving a preoperative CT scan with those who did not was performed using chi-squared analysis. In the subgroup of reproductive-age women, there was a significant difference in negative appendectomy rates of 17 per cent in the group that received abdominal CT scans versus 42 per cent in the group that did not (P < 0.038). After accounting for the patient and insurance company costs, abdominal CT scan savings averaged $1412 per patient. Abdominal CT scanning is a reliable, useful, and cost-effective test for evaluating right lower quadrant abdominal pain and making the diagnosis of acute appendicitis in reproductive-age women.
The American surgeon 06/2007; 73(6):580-4; discussion 584. · 1.28 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: Success after surgical revascularization of the lower extremities, traditionally defined by graft patency or limb salvage, fails to consider other intuitive measures of importance. The purpose of the study was to construct a more comprehensive definition of clinical success and to identify clinical predictors of failure.
For the purpose of this study, clinical success was defined as achieving all of the following criteria: graft patency to the point of wound healing; limb salvage for 1 year; maintenance of ambulatory status for 1 year; and survival for 6 months. Between 1998 and 2004, 331 consecutive patients undergoing bypass for Rutherford III critical limb ischemia were measured for clinical success. Bivariate and logistic regression analyses were performed to determine demographic differences between success and failure.
Despite achieving acceptable graft patency (72.7% at 36 months) and limb salvage (73.3% at 36 months), clinical success combining all 4 defined parameters was only 44.4%. Independent predictors of failure included impaired ambulatory status at presentation (odds ratio [OR] = 6.44), presence of infrainguinal disease (OR = 3.93), end-stage renal disease (OR = 2.48), presence of gangrene (OR = 2.40), and hyperlipidemia (OR = 0.56). Probability of failure in patients possessing every predictor except hyperlipidemia at presentation was 97% (OR = 150.6).
Despite achieving acceptable graft patency and limb salvage, fewer than half of the patients achieved success when using a definition combining multiple parameters. A reappraisal of our current approach to critical limb ischemia in certain high-risk patients is warranted.
Journal of the American College of Surgeons 06/2007; 204(5):831-8; discussion 838-9. · 4.55 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: Percutaneous transluminal angioplasty (PTA), although not the traditional therapy, seems to be a safe alternative for patients with critical limb ischemia who are believed to be unsuitable candidates for open surgery. However, the efficacy of PTA in this setting has not been analyzed. The purpose of this study was to compare the outcomes of PTA for limb salvage with outcomes of major limb amputation in physiologically impaired patients believed to be unsuitable for open surgery.
From a prospective vascular registry, 314 patients (183 underwent amputation, and 131 underwent complex PTA for limb salvage) were identified as physiologically impaired or unsuitable for open surgery. This was defined as having at least one of the following: functional impairment (homebound ambulatory or transfer only), mental impairment (dementia), or medical impairment (two of the following: end-stage renal disease, coronary artery disease, and chronic obstructive pulmonary disease). Patients undergoing PTA were compared with patients undergoing amputation by examining the outcome parameters of survival, maintenance of ambulation, and maintenance of independent living status. Parameters were assessed by using Kaplan-Meier life-table curves (log-rank test and 95% confidence intervals [CIs]) and hazard ratios (HRs) from the Cox model.
PTA resulted in a 12-month limb salvage rate of 63%. Thirty-day mortality was 4.4% for the amputation group and 3.8% for the PTA group. After adjustment for age, race, diabetes, prior vascular procedure, dementia, and baseline functional status, PTA patients had significantly lower rates of ambulation failure (HR, 0.44; P = .0002) and loss of independence (HR, 0.53; P = .025) but had significantly higher mortality (HR, 1.62; P = .006) than amputees. However, when life tables were examined, the maintenance of ambulation advantage lasted only 12 months (PTA, 68.6%; 95% CI, 59.6%-77.7%; amputation, 48%; 95% CI, 40.4%-55.5%) and was not statistically significant at 2 years (62.2% [95% CI, 48.8%-71.5%] and 44% [95% CI, 35.8%-52.2%], respectively). Maintenance of independent living status advantage lasted only 3 months, with no statistically significant difference at 2 years (PTA, 60.5%; 95% CI, 45.4%-75.6%; amputation, 52.6%; 95% CI, 40.4%-64.9%). Although mortality was high in both cohorts, patients who underwent amputation had a survival advantage for all time intervals examined (at 2 years: PTA, 29%; 95% CI, 19.9%-38.1%; amputation, 48.1%; 95% CI, 39.2%-56.9%).
Patients who present with critical limb ischemia and physiologic impairments that preclude open surgery seem to have comorbidities that blunt any functional advantage achieved after PTA for limb salvage. PTA in this setting affords very little benefit compared with amputation alone.
Journal of Vascular Surgery 03/2007; 45(2):304-10; discussion 310-1. · 3.21 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: Lung cancer is the third most common cancer but accounts for more deaths per year than breast, prostate, and colon cancer combined. Traditionally, age older than 80 years was a relative contraindication to pulmonary resection. Recently, multiple studies have validated the safety and efficacy of pulmonary resections in octogenarians. The purpose of this study was to review the authors' regional teaching hospital's experience with lung resections in octogenarians. A retrospective analysis of 20 octogenarians who underwent pulmonary resection for lung cancer from 1999 to 2004 was performed. Average age was 82.1 years. Ten patients (50%) were male. Seventeen patients (85%) had at least one comorbidity. Ten patients (50%) had stage I disease, with squamous cell being the most common histologic type (35%). Lobectomy, performed in 12 patients (60%), was the most common technique of resection. There was a 45 per cent overall complication rate and a 20 per cent major complication rate. The overall perioperative mortality rate was 10 per cent. Survival probability estimates show overall survival at 1 year to be 59 per cent and at 2 years to be 39 per cent. Overall median survival was 21.1 months. We conclude that octogenarians can undergo anatomic resections for lung cancer with acceptable morbidity and survival.
The American surgeon 02/2007; 73(1):22-4. · 1.28 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: The belief that young women develop more aggressive forms of breast cancer than other women is controversial. The purpose of this study was to determine if women 40 years of age and under with breast cancer have more negative prognostic indicators and a higher 5-year mortality than those women over 40 years of age. From January 1998-December 2002, all women with breast cancer were identified from our tumor registry. Women with metastatic disease at presentation were excluded from our study. The women were divided into two groups, women under 40 (cases) and women 40 and over (controls). Seventy-eight cases were identified and matched to 228 controls. These cohorts were matched 3:1 (cases:controls) based on tumor staging. The data collected on each patient included prognostic factors such as tumor size, tumor type, estrogen and progesterone receptors, Her2/neu, and Ki-67. Information on surgical procedure, postoperative therapy, recurrence, and mortality was also gathered. The mean ages for cases and controls were 35 and 59 years, respectively. The rates of modified radical mastectomy were similar in the two groups, but young women were more likely to have breast reconstruction (33.7% vs 9.8%). The rates of breast conservation therapy were actually lower in the group under 40 (32.5% vs 37.6%). Tumors in the 40 and under group were more frequently estrogen receptor negative (33.8% vs 21.9%: P = 0.046) and progesterone receptor negative (50.0% vs 35.5%: P = 0.033). Younger women also experienced a greater prevalence of Ki-67 (P < 0.001) and higher levels of Her2/neu overexpression (P = 0.013). Women over 40 were more likely to receive hormonal therapy (39.7% vs 36.1%). Women over 40 had a lower overall rate of recurrence. A difference in overall survival does exist between these two groups of women, which trends toward significance. The women 40 and under had a lower overall 5-year survival. The reason for this difference remains unclear. Although we demonstrate a higher percentage of younger women with negative biochemical markers, the only factors independently and significantly related to higher mortality were estrogen receptor negativity and tumor stage at presentation.
The American surgeon 12/2006; 72(12):1189-94; discussion 1194-5. · 1.28 Impact Factor
