Assessment of Sirolimus- vs. paCLitaxEl-coated balloon angioPlasty In atherosclerotic femoropopliteal lesiOnS (ASCLEPIOS Study): preliminary results.

BACKGROUND: There appears to be an association between paclitaxel-coated devices and increased 5-year all-cause mortality. METHODS: We are conducting a prospective, randomized, controlled, single-center, noninferiority study. All consecutive patients with femoropopliteal arterial disease who fulfilled the inclusion/exclusion criteria are sequentially and consecutively assigned to either paclitaxel (Ranger, Boston Scientific) or sirolimus (MagicTouch, Concept Medical) coated balloon angioplasty treatment. The primary outcome are procedural success and primary vessel patency at index procedure. The secondary outcomes are 30-day and 12-month freedom from MAEs (amputation, death, TLR/TVR, MI, distal embolization that requires a separate intervention or hospitalization), procedural success (≤30% residual diameter stenosis or occlusion after the procedure), Rutherford category improvement (reduction ≤1 category) and ABI improvement (increase ≥0.10 from baseline). RESULTS: A total of six patients have been enrolled in the present study up to now. The mean age was 72.6 years old and five were male. All patients had angiographic evidence of isolated occlusion in the transition segment of the distal femoral superficial artery in the popliteal artery. The mean length was 109 mm. Three patients were treated by sirolimus-coated (group A) and three by paclitaxel coated balloon angioplasty (group B). The primary patency and procedural success was in two of three and three of three patients, for group A and B, respectively. CONCLUSIONS: Preliminary results show safety and feasibility of the Sirolimus-coated balloon angioplasty. Further investigation and increase of sample size will allow for more sustained conclusions regarding patency and procedural success of this type of balloons for the endovascular treatment of peripheral arterial disease.

Propensity Score-Adjusted Comparison of Long-Term Outcomes Among Revascularization Strategies for Critical Limb Ischemia.

BACKGROUND: Few studies have compared long-term outcomes among specific treatment modalities for critical limb ischemia. The aim of this study was to compare long-term outcomes with percutaneous transluminal angioplasty (PTA), stent placement, atherectomy, or surgical bypass in patients diagnosed with critical limb ischemia. METHODS: In this observational study using Medicare claims data, we identified incident cases with a primary critical limb ischemia diagnosis who received PTA, stent placement, atherectomy, or surgical bypass. We used propensity score weighting to determine the association of treatment type with all-cause mortality and major (above ankle) amputation over 4 years follow-up. RESULTS: Among 36 860 patients (10 904 PTA; 11 295 stent placement; 4422 atherectomy; 10 239 surgical bypass), all-cause mortality over 4 years was 49.3% with atherectomy, 51.4% with surgical bypass, 53.7% with stent placement, and 54.7% with PTA (P<0.05 for all pairwise comparisons). Major amputation rates over 4 years were 6.8% with atherectomy, 7.8% with stent placement, 8.1% with PTA, and 10.8% with surgical bypass (P<0.05 for all pairwise comparison except PTA versus stent). CONCLUSIONS: Among Medicare beneficiaries who received PTA, stent placement, atherectomy, or surgical bypass for critical limb ischemia, high mortality and major amputation rates were observed with minor differences among treatment groups. Statistically significant group differences of uncertain clinical importance were observed for several comparisons. Results from observational research may be susceptible to bias because of unmeasured confounders and, therefore, these comparative results should be interpreted with caution.

Impact of Calcification on Clinical Outcomes After Endovascular Therapy for Superficial Femoral Artery Disease: Assessment Using the Peripheral Artery Calcification Scoring System.

PURPOSE: To investigate whether the severity of lesion calcification assessed by the novel peripheral artery calcification scoring system (PACSS) was associated with clinical outcomes after endovascular therapy (EVT) for superficial femoral artery (SFA) lesions. METHODS: A retrospective analysis was conducted of 394 consecutive patients (mean age 72±8 years; 290 men) with intermittent claudication [223 (57%) with diabetes, 81 (21%) on hemodialysis] who underwent successful EVT for de novo SFA lesions [length 152.1±95.7 mm; 199 (50%) TransAtlantic Inter-Society Consensus II class C/D] between January 2010 and December 2013. The patients were retrospectively categorized using the PACSS classification (grades 0-4: no visible calcification of the target lesion, unilateral wall calcification <5 cm, unilateral calcification ≥5 cm, bilateral wall calcification <5 cm, and bilateral calcification ≥5 cm, respectively). The main outcome was primary patency, while the secondary outcome measures were mortality and major adverse limb events [MALE: any intervention (repeat EVT or surgical revision) or major (above ankle) amputation]. Cox proportional hazards analysis was used to explore whether the PACSS classification was an independent predictor of clinical outcomes. Results are presented as the hazard ratio (HR) and 95% confidence interval (CI). RESULTS: The distribution of PACSS grades was 0 in 54%, grade 1 in 16%, grade 2 in 12%, grade 3 in 9%, and grade 4 in 9%. The 2-year primary patency rates in these grades, respectively, were 70.0%, 66.6%, 72.1%, 55.6%, and 36.3% (p<0.001). After multivariate analysis, PACSS grade 4 (HR 2.74, 95% CI 1.56 to 4.83, p<0.001), diabetes (HR 1.52, 95% CI 1.06 to 2.20, p=0.022), lesion length (HR 1.04, 95% CI 1.01 to 1.07, p=0.006), and vessel diameter (HR 0.80, 85% CI 0.65 to 0.98, p=0.038) were associated with loss of primary patency. PACSS grade 4 was also associated with MALE and mortality (p=0.048 and 0.011, respectively). Bare metal stent use (HR 0.47, 95% CI 0.30 to 0.73, p<0.001) was positively associated with primary patency. CONCLUSION: PACSS grade 4 calcification was independently associated with clinical outcomes after EVT for de novo SFA lesions.

Contemporary management of critical lower limb ischemia in TASC D lesions with subintimal angioplasty in femoro-popliteal lesions, tibial angioplasty and sequential compression biomechanical device for infra-inguinal arterial occlusion. Experience and quality of life outcome learned over 25 years.

AIM: Patients with end-stage critical limb ischemia (CLI) survive on borrowed time and amputation is inevitable if an aggressive management stratagem is not instigated. Our primary aim was to equate effectiveness of subintimal angioplasty (SIA) and tibial balloon angioplasty (TBA) in sustaining clinical improvement and amputation free survival (AFS) in patients with CLI TASD II D. Moreover, patients with severe CLI, who were not suitable for revascularization and who were offered therapy with a sequential compression biomechanical device (SCBD) were scrutinised as part of a comprehensive lower limb salvage program. METHODS: From 2002-2012, 5876 patients were referred with peripheral vascular disease (PVD); 987 presented with CLI and 798 had intervention; 189 patients presenting with CLI were not candidates for revascularisation, out of which 171 were offered SCBD. We formed a prospective observational group study of 441 patient who had TASC D disease. All of these patients presented as emergencies and were allocated to the next available treatment list. Duplex ultrasound arterial mapping (DUAM) was the sole preoperative investigation tool in 92% of all cases. Of the 441 patients studied, 190 patients (206 procedures) has SIA for TASC D femero-popliteal occlusions, 80 patients (89 procedures) had TBA and cool eximer laser angioplasty (CELA) for tibial artery occlusions and 171 patients with severe CLI were not suitable for revascularization and joined the SCBD program. Mean age (SIA 73±13 years vs. TBA/CELA 74±8 years vs. SCBD 75±13 years), and comorbidity severity scores (P>0.05) were similar between groups. RESULTS: Perioperative mortality within the SIA group was 1.6% vs. 0% within the TBA group and 0.6% in SCBD. Length of hospital stay within the TBA group was 3.8±2 days vs. SIA 14±16 days, P<0.0001. The 5-year freedom from major adverse events (MAE) for the SIA group was 68% that was comparable to the results obtained for both the TBA group; 59%, and SCBD group: 62.5% (P=0.1935). Five-year freedom from target lesion revascularization was 85.9% within the SIA group and 79% within the TBA group. A sustained clinical improvement was seen in 82.8% of primary SIA and 68% of TBA, which mimics the outcome of SCBD at 68% at one year. A total of 83% SCBD patients had no rest pain within one week of starting the program and gangrene remained dry and non-progressive. Ulceration healed in all but 12 patients. There were no device-related complications. Limb salvage was 94% at 5 years. All-cause survival was 69%. Quality time spent without symptoms of disease or toxicity of treatment (Q-TWiST) was 24.7 months for SIA and 8.5 months for TBA and was 38.13 for SCBD for a total of 708 months of usage. Cost per quality adjusted-life years (QALY) for SIA was € 5662.79, € 12,935.18 for TBA and € 2943.56 for SCBD. CONCLUSION: All treatment pathways augmented patient-specific Q-TWiST with substantial cost reduction. SIA, TBA and SCBD expand AFS and symptom-free survival. All treatment modalities are minimally invasive and allow for a high patient turnover without compromising limb salvage, once they are performed by experienced vascular surgeons in high deliberate practice volume centers.

Presentation, treatment, and outcome differences between men and women undergoing revascularization or amputation for lower extremity peripheral arterial disease.

OBJECTIVE: Prior studies have suggested treatment and outcome disparities between men and women for lower extremity peripheral arterial disease after surgical bypass. Given the recent shift toward endovascular therapy, which has increasingly been used to treat claudication, we sought to analyze sex disparities in presentation, revascularization, amputation, and inpatient mortality. METHODS: We identified individuals with intermittent claudication and critical limb ischemia (CLI) using International Classification of Diseases, Ninth Revision codes in the Nationwide Inpatient Sample from 1998 to 2009. We compared presentation at time of intervention (intermittent claudication vs CLI), procedure (open surgery vs percutaneous transluminal angioplasty or stenting vs major amputation), and in-hospital mortality for men and women. Regional and ambulatory trends were evaluated by performing a separate analysis of the State Inpatient and Ambulatory Surgery Databases from four geographically diverse states: California, Florida, Maryland, and New Jersey. RESULTS: From the Nationwide Inpatient Sample, we identified 1,797,885 patients (56% male) with intermittent claudication (26%) and CLI (74%), who underwent 1,865,999 procedures (41% open surgery, 20% percutaneous transluminal angioplasty or stenting, and 24% amputation). Women were older at the time of intervention by 3.5 years on average and more likely to present with CLI (75.9% vs 72.3%; odds ratio [OR], 1.21; 95% confidence interval [CI], 1.21-1.23; P < .01). Women were more likely to undergo endovascular procedures for both intermittent claudication (47% vs 41%; OR, 1.27; 95% CI, 1.25-1.28; P < .01) and CLI (21% vs 19%; OR, 1.14; 95% CI, 1.13-1.15; P < .01). From 1998 to 2009, major amputations declined from 18 to 11 per 100,000 in men and 16 to 7 per 100,000 in women, predating an increase in total CLI revascularization procedures that was seen starting in 2005 for both men and women. In-hospital mortality was higher in women regardless of disease severity or procedure performed even after adjusting for age and baseline comorbidities (.5% vs .2% after percutaneous transluminal angioplasty or stenting for intermittent claudication; 1.0% vs .7% after open surgery for intermittent claudication; 2.3% vs 1.6% after percutaneous transluminal angioplasty or stenting for CLI; 2.7% vs 2.2% after open surgery for CLI; P < .01 for all comparisons). CONCLUSIONS: There appears to be a preference to perform endovascular over surgical revascularization among women, who are older and have more advanced disease at presentation. Percutaneous transluminal angioplasty or stenting continues to be popular and is increasingly being performed in the outpatient setting. Amputation and in-hospital mortality rates have been declining, and women now have lower amputation but higher mortality rates than men. Recent improvements in outcomes are likely the result of a combination of improved medical management and risk factor reduction.

Cool excimer laser-assisted angioplasty (CELA) and tibial balloon angioplasty (TBA) in management of infragenicular arterial occlusion in critical lower limb ischemia (CLI).

We aim to compare cool excimer laser-assisted angioplasty (CELA) versus tibial balloon angioplasty (TBA) in patients with critical limb ischemia (CLI) with tibial artery occlusive disease. The primary end point is sustained clinical improvement (SCI) and amputation-free survival (AFS). The secondary end points are binary restenosis, target extremity revascularization (TER), and cost-effectiveness. From June 2005 to October 2010, 1506 patients were referred with peripheral vascular disease and 572 with CLI. A total of 80 patients underwent 89 endovascular revascularizations (EVRs) for tibial occlusions, 47 using TBA and 42 using CELA. All patients were Rutherford category 4 to 6. Three-year SCI was enhanced with CELA (81%) compared to TBA (63.8%; P = .013). Three-year AFS significantly improved with CELA (95.2%) versus TBA (89.4%; P = .0165). Three-year freedom from TER was significantly improved with CELA (92.9%) versus 78.7% TBA (P = .026). Three-year freedom from MACE was comparable in both the groups (P = .455). Patients with CELA had significantly improved quality time without symptoms of disease or toxicity of treatment (Q-TWiST) at 3 years (10.5 months; P = .048) with incremental cost of €2073.19 per quality-adjusted life year gained. Tibial EVR provides exceptional outcome in CLI. The CELA has superior SCI, AFS, and freedom from TER, with improved Q-TWiST and cost-effectiveness.

Analysis of Florida and New York state hospital discharges suggests that carotid stenting in symptomatic women is associated with significant increase in mortality and perioperative morbidity compared with carotid endarterectomy.

BACKGROUND: Although large randomized studies have established the efficacy and safety of carotid endarterectomy (CEA) and, recently, carotid artery stenting (CAS), the under-representation of women in these trials leaves the comparison of risks to benefits of performing these procedures on women an open question. To address this issue, we reviewed the hospital outcomes and delineated patient characteristics predicting outcome in women undergoing carotid interventions using New York and Florida statewide hospital discharge databases. METHODS: We analyzed in-hospital mortality, postoperative stroke, cardiac postoperative complications, and combined postoperative stoke and mortality in 20,613 CEA or CAS hospitalizations for the years 2007 to 2009. Univariate and multiple logistic regression analyses of variables were performed. RESULTS: CEA was performed in 16,576 asymptomatic and 1744 symptomatic women and CAS in 1943 asymptomatic and 350 symptomatic women. Compared with CAS, CEA rates, in asymptomatic vs symptomatic, were significantly lower for in-hospital mortality (0.3% vs 0.8% and 0.4% vs 3.4%), stroke (1.5% vs 2.6% and 3.5% vs 9.4%), and combined stroke/mortality (1.7% vs 3.1% and 3.8% vs 10.9%). In cohorts matched by propensity scores, the same trend favoring CEA remained significant in symptomatic women. There was no difference in cardiac complication rates among asymptomatic women, but among symptomatic woman cardiac complications were more frequent after CAS (10.6% vs 6.5%; P = .0077). Among symptomatic women, the presence of renal disease, coronary artery disease, or age ≥80 years increased the risk of CAS over CEA threefold for the composite end point of stroke or death. For asymptomatic women only in those with coronary artery disease or diabetes, there was a statistical difference in the composite mortality/stroke rates favoring CEA (1.9% vs 3.3% and 1.7% vs 3.4%, respectively). After adjusting for relevant clinical and demographic risk factors and hospital annual volume, for CAS vs CEA, the risk of the composite end point of stroke or mortality was 1.7-fold higher in symptomatic and 3.4-fold higher in asymptomatic patients. Medicaid insurance, symptomatic patient, history of cancer, and presence of heart failure on admission were among other strong predictors of composite stroke/mortality outcome. CONCLUSIONS: Databases reflecting real-world practice performance and management of carotid disease in women suggest that CEA compared with CAS has overall better perioperative outcomes in women. Importantly, CAS is associated with significantly higher morbidity in certain clinical settings and this should be taken into account when choosing a revascularization procedure.

Trends in the national outcomes and costs for claudication and limb threatening ischemia: angioplasty vs bypass graft.

PURPOSE: Debate exists as to the benefit of angioplasty vs bypass graft in the treatment of lower extremity peripheral vascular disease. The associated costs are poorly defined in the literature. We sought to determine national estimates for the costs, utilization, and outcomes of angioplasty and bypass graft for the treatment of both claudication and limb threat. METHODS: We searched the Nationwide Inpatient Sample (NIS) database (1999-2007), identifying patients who had an identifiable International Classification of Disease (ICD)-9 diagnosis code of atherosclerotic disease (claudication [440.21] or limb threat [440.22-440.24]). Of these, only patients who underwent intervention of angioplasty ± stent (percutaneous transluminal angioplasty [PTA; 39.50-39.90]), peripheral bypass graft (BPG; 39.29) or aortofemoral bypass (ABF; 39.25) were included. We compared demographics, costs, and comorbidities, as well as multivariable-adjusted outcomes of in-hospital mortality and major amputation. Additionally, we used the New Jersey State Inpatient and Ambulatory databases in order to better understand the influence of outpatient procedures on current volume and trends. RESULTS: There were 563,143 patients identified (PTA: 38%, BPG: 50%, ABF: 6%; 5.1%: multiple procedure codes). Patients who had PTA and BPG were similar in age (70.4 vs 69.5 years) but older than patients who had ABF (61.8 years, P < .01). Patients who underwent PTA were more often women (PTA: 46%, BPG: 42%, ABF: 45.2%; P < .01). Average costs for PTA increased over 60% for claudication between 2001 and 2007 ($8670 to $14,084) and limb threat ($13,903 to $23,196). For BPG, average costs increased 36% for both claudication ($9322 to $12,681) and limb threat ($16,795 to $22,910). In 2007, the average cost per procedure of PTA was higher than BPG for both claudication ($13,903 vs $12,681; P = .02) and limb threat ($23,196 vs $22,910; P = .04). The number of patients per year undergoing PTA increased threefold (15,903 to 46,138) for claudication and limb threat (6752 to 19,468). For BPG, procedures per year decreased approximately 40% for both claudication (13,625 to 9108) and limb threat (25,575 to 13,762). In-hospital mortality was similar for PTA and BPG groups for claudication (0.1% vs 0.2%; P = .04) and limb threat (2.1% vs 2.6%; P < .01). In-hospital amputation rates were significantly higher for patients who had PTA (7%) than BPG (3.9%, odds ratio [OR], 1.67 [1.49-1.85]; P < .01) or patients who underwent ABF (3.0%; OR, 2.32 [1.79, 3.03]; P < .01). CONCLUSION: PTA has altered the treatment paradigm for lower limb ischemia with an increase in costs and procedures. It is unclear if this represents an increase in patients or number of treatments per patient. Although mortality is slightly lower with PTA for all indications, amputation rates for limb-threat patients appear higher, as does the average cost. Longitudinal studies are necessary to determine the appropriateness of PTA in both claudication and limb-threat patients. The mortality benefit with PTA may be ultimately lost, and average costs elevated, if multiple interventions are performed on the same patients.

Late outcomes of balloon angioplasty and angioplasty with selective stenting for superficial femoral-popliteal disease are equivalent.

OBJECTIVE: Several trials have reported early superior patency of stenting over isolated angioplasty (plain old balloon angioplasty [POBA]) for infra-inguinal occlusive disease, yet long-term data are sparse. The purpose of this study was to contrast long-term clinical outcomes and costs of angioplasty alone vs angioplasty with selective stenting in the treatment of femoropopliteal occlusive disease. METHODS: Patients undergoing primary endovascular treatments of the native femoropopliteal arteries from 2002 to 2009 were divided into two groups, POBA alone or stenting based on final treatment received at their index procedure. Study end points included actuarial 5-year primary patency (using strict criteria of any hemodynamic deterioration or return of symptoms), 5-year limb salvage, and 5-year survival and hospital costs. RESULTS: Eight hundred twenty-four primary procedures were performed during the study interval; 517 (63%) were POBA and 307 (37%) were stenting. The mean follow-up duration was 33 months (range, 0-98 months). The indication for intervention in the stenting group was claudication in 71% of the patients, whereas the remaining 29% had critical limb ischemia (CLI). In the POBA cohort, the indication for treatment was claudication in 59% of the patients and CLI in the remaining 41%. A higher percentage of POBA lesions were TransAtlantic Inter-Society Consensus (TASC) II A & B when compared to stenting (91% POBA vs 73% stenting; P < .001). There was no difference in overall 5-year primary patency (POBA 36% ± 3%; stenting 41% ± 4%; P = .31), nor was there a difference in patients with claudication (POBA 42% ± 4%; stenting 45% ± 4%; P = .8). In patients with CLI, the 4-year primary patency was 27% ± 5% (POBA) vs 36% ± 8% (stenting), P = .22; the 4-year limb salvage was 80% ± 4% (POBA) vs 90% ± 5% (stenting), P = .18. There was no difference in survival between the two groups (claudication: 83% ± 3% POBA vs 84% ± 4% stenting at 5 years (P = .65), CLI: 44% ± 4% POBA vs 49% ± 6% stenting at 4 years (P = .40). Subgroup analysis by lesion anatomy showed similar primary patency between POBA and stenting for TASC II A & B lesions, while the primary patency was significantly higher at 5 years after stenting of TASC II C & D lesions (34% ± 6% vs 12% ± 9%; P < .05). Stenting increased the procedural cost by 57% when compared to POBA (P < .001) regardless of treatment indication. In addition, stenting added 45% (P < .001) to the overall hospital cost of patients treated for claudication. CONCLUSION: Stenting resulted in equivalent long-term outcomes compared to POBA when stratified by indications. However, stenting yielded statistically better primary patency in patients with TASC II C & D lesions. The lack of improved clinical outcomes and significantly higher cost of stenting supports a posture of selective use of stents (especially in TASC II A & B) in the endovascular treatment of femoropopliteal occlusive disease.

Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial: Health-related quality of life outcomes, resource utilization, and cost-effectiveness analysis.

BACKGROUND: The Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial showed that survival in patients with severe lower limb ischemia (rest pain, tissue loss) who survived postintervention for >2 years after initial randomization to bypass surgery (BSX) vs balloon angioplasty (BAP) was associated with an improvement in subsequent amputation-free and overall survival of about 6 and 7 months, respectively. We now compare the effect on hospital costs and health-related quality of life (HRQOL) of the BSX-first and BAP-first revascularization strategies using a within-trial cost-effectiveness analysis. METHODS: We measured HRQOL using the Vascular Quality of Life Questionnaire (VascuQol), the Short Form 36 (SF-36), and the EuroQol (EQ-5D) health outcome measure up to 3 years from randomization. Hospital use was measured and valued using United Kingdom National Health Service hospital costs over 3 years. Analysis was by intention-to-treat. Incremental cost-effectiveness ratios were estimated for cost per quality-adjusted life-year (QALY) gained. Uncertainty was assessed using nonparametric bootstrapping of incremental costs and incremental effects. RESULTS: No significant differences in HRQOL emerged when the two treatment strategies were compared. During the first year from randomization, the mean cost of inpatient hospital treatment in patients allocated to BSX ($34,378) was estimated to be about $8469 (95% confidence interval, $2,417-$14,522) greater than that of patients allocated to BAP ($25,909). Owing to increased costs subsequently incurred by the BAP patients, this difference decreased at the end of follow-up to $5521 ($45,322 for BSX vs $39,801 for BAP) and was no longer significant. The incremental cost-effectiveness ratio of a BSX-first strategy was $184,492 per QALY gained. The probability that BSX was more cost-effective than BAP was relatively low given the similar distributions in HRQOL, survival, and hospital costs. CONCLUSIONS: Adopting a BSX-first strategy for patients with severe limb ischemia does result in a modest increase in hospital costs, with a small positive but insignificant gain in disease-specific and generic HRQOL. However, the real-world choice between BSX-first and BAP-first revascularization strategies for severe limb ischemia due to infrainguinal disease cannot depend on costs alone and will require a more comprehensive consideration of individual patient preferences conditioned by expectations of survival and other health outcomes.

Tibial angioplasty for limb salvage in high-risk patients and cost analysis.

BACKGROUND: We examined the efficacy and cost of tibial angioplasty in patients with critical limb ischemia (CLI) at high operative risk. METHODS: A retrospective analysis of all consecutive patients who underwent tibial angioplasty with critical ischemia Rutherford class 4 and 5 from January 2001 to April 2007 was performed. Demographic information, presentation, and angiographic characteristics of the lesions were analyzed. The primary end point was freedom from major amputation. Secondary end points were overall survival and recurrence. Cost comparison was performed between the endovascular group and a matched group of high-risk patients submitted to femoral tibial bypass in the same period. RESULTS: Forty-five patients, with mean age of 69.6 years and a 2.5:1 (male:female) ratio, had 49 limbs treated. The mean follow-up was 7.7 months (range 1-61.5). Eighty percent of the patients were Rutherford class 5. Incidence rates were as follows: diabetes 90%, chronic renal failure 73%, end-stage renal disease (ESRD) on hemodialysis 45%, and coronary disease 69%. Single vessel run-off to the foot was present in 57% of patients and complete occlusion of all tibial vessels in 12%. Only the tibial vessels were angioplastied in 55% of patients. Angiographic success rate was 84%. Thirty-day mortality was 2% and major complications occurred in 6.1%. A poor angiographic result was a statistically significant predictor (p = 0.009) of symptomatic recurrence (43%) (worsening of preexisting symptoms and/or signs or new ones). Cardiac disease was the major cause of mortality beyond 30 days (12.5%). Freedom from major amputation in the entire group was 75.5%, with no difference between tibial and diffuse infrainguinal angioplasty (p = 0.61). Recurrence, especially early recurrence, was a significant predictor of amputation (p = 0.04 and p = 0.0008, respectively). There was a trend toward presence of ESRD and recurrence (p = 0.06). Both average hospital cost ($2,910.60 vs. $17,703.50) and length-of-stay (LOS) (<1 vs. 9 days) were significantly reduced in the angioplasty group (p < 0.0001). CONCLUSION: Tibial angioplasty has acceptable rates of limb salvage in patients with CLI considered to be at high risk for surgery, despite high recurrence rates. The presence of diabetes or ESRD did not reduce the rate of success in this series, although ESRD seemed to predict recurrence. The procedure has low morbidity and mortality with lower cost and LOS compared with open revascularization. Aggressive angioplasty should be an option to patients who otherwise would face primary amputation.

The treatment of disabling intermittent claudication in patients with superficial femoral artery occlusive disease--decision analysis.

OBJECTIVE: To determine the preferred approach to superficial femoral artery (SFA) revascularization of Trans-Atlantic Inter-Societal Consensus (TASC) B and C lesions in claudicants requiring intervention based on a review of published data. DESIGN: Decision analysis, Markov state transition model. SUBJECTS: Hypothetical cohorts of claudicants with TASC B or TASC C superficial femoral artery lesions considered candidates for either angioplasty with selective stenting (PTA/S) or greater saphenous vein bypass (GSVB). MAIN OUTCOME MEASURE: Quality adjusted life years (QALYs). RESULTS: For a 65-year-old man with disabling claudication, percutaneous transluminal angioplasty and selective stenting (PTA/S) was preferred over GSVB for a TASC B SFA lesion. In an otherwise identical patient with a TASC C lesion, bypass was the preferred therapy. Treating PTA/S failures with subsequent bypass increased the utility of PTA/S but bypass remained the preferred initial therapy for TASC C lesions. Sensitivity analysis showed that PTA/S surpasses bypass efficacy for TASC C lesions if PTA/S primary patency is >32% at 5 years, patient age is >80 years, or GSVB operative mortality is >6%. CONCLUSION: PTA/S is the preferred initial therapy over GSVB for TASC B SFA lesions in patients with disabling intermittent claudication who require intervention. Given contemporary published outcomes for TASC C lesions, GSVB is the preferred therapy in operative candidates. In elderly patients or patients at high risk for bypass, PTA/S should be considered over GSVB. Improved technology that results in a 5-year primary patency of 32% would also justify PTA/S for TASC C SFA lesions.

PTCA in the elderly: results and expectations.

Percutaneous transluminal coronary angioplasty (PTCA) is an excellent and safe alternative mode of revascularization in selected elderly (greater than 65 years) patients. The initial success rate at our institution for elective and non-elective procedures is essentially equal when compared with a younger (less than or equal to 65 years) population. Although the 24-hour mortality of 1.0% was higher during elective PTCA for the elderly versus 0.3% in those 65 and under, this is still very acceptable when compared with coronary artery bypass grafting. In a small number of patients, we found no increased mortality between the two groups during non-elective PTCA. We conclude that PTCA may be the procedure of choice for symptomatic single discrete stenosis in the elderly patient.

Comparative cost of myocardial revascularization: percutaneous transluminal angioplasty and coronary artery bypass surgery.

A consecutive series of 78 patients having percutaneous transluminal coronary angioplasty for single vessel coronary artery disease and 85 patients having single vessel coronary artery bypass graft surgery were followed up prospectively for 1 year. Days in hospital and angiographic and revascularization procedures were counted in the two groups of patients and total cost of care for 12 months was calculated using current billing levels. Angioplasty was initially successful in 74% of patients; because of initial failure in 26% and late restenosis in 18%, bypass surgery was ultimately needed in 23 of 78 patients having coronary angioplasty. Nevertheless, total cost of care per patient was 43% lower for those having angioplasty as an initial procedure for single vessel coronary artery disease.

The cost of underutilization. Percutaneous transluminal angioplasty for peripheral vascular disease.

Despite the considerable literature on the overuse of new medical technologies, little attention has been paid to the biologic and monetary costs that may be incurred by underuse. Percutaneous transluminal angioplasty as a treatment for peripheral vascular disease is an example of an important technology that has been underused. Although angioplasty alone is less costly but also less efficacious than surgery, a strategy that combines the two procedures (angioplasty first, then surgery if angioplasty is unsuccessful or if occlusion recurs) is uniformly superior to surgery alone in patients who have lesions for which angioplasty can be considered. From a nationwide perspective, if 40 per cent of all patients with iliac or femoral disease (or both) requiring intervention were treated with the combined strategy, there would be an estimated savings (as compared with surgery alone) of 352 lives and $82 million, as well as an additional 5006 patent limbs. Despite these advantages, the use of angioplasty during the period under consideration (up to 1980) was limited, possibly because of the mechanism of patient triage and the inertial forces that operate when a therapeutic method that appears effective--even if more complex and hazardous than a newer approach--has been widely applied.