Proportion of patients with critical limb ischemia who require an open surgical procedure in a center favoring endovascular treatment

Endovascular interventions have gained widespread acceptance as primary and secondary treatments for critical lower extremity ischemia (CLI), and many believe there is little need for open bypasses for CLI. Despite this, some patients presenting with CLI require traditional lower extremity bypass procedures at some point for successful limb salvage. To determine the proportion of patients requiring an open procedure, we reviewed our 1-year experience with CLI patients at a center committed to endovascular approaches whenever possible. We reviewed all patients presenting with CLI from January 1, 2007 to December 31, 2007. CLI was defined as ischemic rest pain, nonhealing ulceration, or gangrene for which a major amputation was imminently required. All patients underwent duplex and conventional angiography before intervention. Endovascular treatments were favored as primary, secondary, or tertiary treatments, if possible. If these failed or were impossible, standard lower extremity bypasses were performed. One hundred and forty-eight patients presented with primary, secondary, or tertiary CLI over this 1-year period. Of these, 63 (42%) were treated successfully with an endovascular intervention, and 69 (47%) required standard lower extremity bypass, and 16 (11%) required a combined endovascular and open procedure (i.e., hybrid procedure). Of these 148 patients, 46 (31%) were presenting with secondary, tertiary, or more CLI after failed previous (1-5) procedures. Despite the initial enthusiasm that the majority of patients presenting with CLI may be treated with endovascular procedures, there exists a significant cohort of patients that will ultimately require standard open surgical procedures.     

Validation of the Finnvasc score in infrainguinal percutaneous transluminal angioplasty for critical lower limb ischemia

The aim of the present study was to validate the Finnvasc score for prediction of immediate outcome after infrainguinal percutaneous transluminal angioplasty (PTA) for critical lower limb ischemia (CLI). Our registry included prospective data on 512 patients who underwent isolated infrainguinal PTA revascularization procedures for CLI. The Finnvasc score herein evaluated was calculated by assigning one point each to diabetes, coronary artery disease, foot gangrene, and urgent operation. Early mortality and major limb amputation rates after PTA revascularization were 2.5% and 12.3%, respectively. Seventy-two patients (14.1%) died and/or had lower limb amputation. Diabetes (p = 0.001), foot gangrene (p = 0.047), urgent operation (p < 0.0001), and preoperative renal failure (p = 0.001) were independent predictors of postoperative mortality and/or major limb amputation. Finnvasc score was predictive of major lower limb amputation (p = 0.003), mortality (p < 0.0001), and mortality and/or major amputation (p < 0.0001) after PTA. Mortality, major lower limb amputation, and combined end point rates in patients with a Finnvasc score of 3-4 were 12.8%, 25.6%, and 35.9%, respectively. The Finnvasc score is a simple risk scoring method which can be useful to estimate the risk of immediate postprocedural mortality and/or major lower limb amputation also in patients undergoing infrainguinal PTA for CLI.     

Midterm outcomes and risk stratification after endovascular therapy for patients with critical limb ischaemia due to isolated below-the-knee lesions

ObjectivesTo assess and risk stratify midterm clinical outcomes after endovascular therapy (EVT) by angioplasty only of patients with critical limb ischaemia (CLI) due to isolated below-the-knee (BTK) lesions.DesignRetrospective multicenter study.Materials and methodsBetween March 2004 and October 2010, 465 limbs (Rutherford 5 and 6: 79%) from 406 patients were studied. Overall survival, limb salvage, and re-intervention were examined out to 3 years by the Kaplan–Meier method and the log-rank test. Their independent predictors and risk stratification were analysed.ResultsPatient age was 71 ± 11 yrs, with 69% diabetics and 60% on dialysis. Mean follow-up was 18 ± 15 months. Overall survival was 76 ± 2 and 57 ± 4% at 1 and 3, years, respectively. Survival predictors were body mass index <18, non-ambulatory status and ejection fraction <45%. Two-year limb salvage rate was 80 ± 2%. Factors associated with major amputation were ulcers (Rutherford 6), diabetes mellitus, C-reactive protein>5 mg/dL, and age < 60 years. Two-year freedom from re-intervention was 66 ± 3%; age and below-the-ankle runoff number after angioplasty was negatively associated with re-intervention.ConclusionsDespite relatively high mortality and re-intervention rates, limb salvage rate was acceptable after EVT for CLI patients with isolated BTK lesions. Risk stratification allows occurrence estimation for each end point.     

Complete ulcer healing as primary endpoint in studies on critical limb ischemia? A critical reappraisal.

OBJECTIVES: Although complete ulcer healing is the mandatory primary efficacy criterion in current European guidelines for drug trials in critical limb ischemia (CLI), the appropriateness of this endpoint has been questioned for some time. We carried out a systematic review to assess the value of this endpoint in studies on reconstructive measures, considered to be the standard of care for CLI. METHODS: A computerized literature search (1985-2005) was performed to track down clinical studies on endovascular and surgical interventions by using the search terms CLI and ulcer healing and their synonyms. RESULTS: 1,914 papers on revascularization in CLI were identified. Complete ulcer healing was reported in 17 studies (0.9%). Among these, there were no randomized controlled trials, five prospective cohorts on endovascular procedures, and six retrospective cohorts for endovascular and surgical procedures, respectively. If healing rates or time to ulcer healing were available, they differed greatly between the studies without consistent correlation to types of therapy. CONCLUSIONS: In past and current literature, complete ulcer healing is not a consistently reported criterion for success of revascularization in CLI. Thus, its appropriateness for efficacy assessment of drug studies in CLI patients has to be questioned.     

Medical treatment and therapeutic angiogenesis of critical limb ischemia

The incidence of arteriosclerotic disease is increasing in Japan due to the aging of the population and the westernization of the diet. Peripheral arterial disease (PAD) presents with various clinical conditions. In particular, the management of patients with critical limb ischemia (CLI) such as pain at rest, ischemic ulcer, or gangrene in the lower extremities has been problematic and the treatment of these patients varies widely among countries. A surgical approach such as distal bypass using an autogenous saphenous vein is still the "gold standard" for the treatment of CLI. In addition, due to recent advances in endovascular technologies, catheter-based intervention has become a viable option, and percutaneous treatment is becoming more widely used. However, the surgical approach is not indicated for some patients with PAD. Recently, therapeutic neovascularization has been suggested as new strategy for patients with CLI. This strategy is mainly classified into two types of therapy, gene therapy and cell therapy, both of which aim to promote the development of collateral vessels in the ischemic lesions. In the present report, we discuss the current status of the medical treatment of CLI, including therapeutic angiogenesis.     

Limb-salvage angioplasty in vascular surgery practice

OBJECTIVE: To assess outcomes of percutaneous infrainguinal arterial angioplasty for treatment of chronic limb-threatening ischemia (CLI) in poor surgical candidates. METHODS: A retrospective clinical analysis of 67 consecutively treated patients (76 limbs) with CLI over a 33-month period was performed. Patients were considered poor surgical candidates because of absent distal target vessels (31 limbs), severe comorbid conditions (36 limbs), or lack of an autologous vein for distal bypass (9 limbs). Limb salvage was defined as preservation of a functional foot without the need for a prosthesis. Technical success was defined as the ability to percutaneously recanalize the arterial segment with less than 30% residual stenosis. Clinical success was healing of ulcers or minor amputation sites, resolving rest pain, or avoiding a major amputation. Successful technical and clinical outcomes were correlated with patient demographics, clinical presentation, and TransAtlantic Inter-Society Consensus arterial lesion characteristics by using the Fisher exact test. RESULTS: Seventy-six limbs were treated for rest pain (n = 12), gangrene (n = 22), or nonhealing ulcers (n = 42). There were 40 men and 27 women. The mean age was 70 years (range, 36-94 years). Lesions were located in tibial (n = 55), popliteal (n = 6), and superficial femoral (n = 15) arteries. Arterial recanalization and limb salvage was achieved in 64 (83.5%) limbs. Technical failure (n = 12) correlated with TransAtlantic Inter-Society Consensus D lesions ( P = .009) and the presence of occlusion ( P = .027). Clinical failure (major amputation, n = 12) correlated with the presence of gangrene ( P = .032) or the combination of diabetes, arterial occlusion, and gangrene ( P = .018). The single variables of age, sex, diabetes, and renal failure did not adversely affect outcomes. There was one mortality (myocardial infarction), and there were two major morbidities (femoral artery pseudoaneurysm and sepsis). CONCLUSIONS: Peripheral arterial angioplasty should be considered as an alternative to primary amputation in selected patients with CLI who are poor candidates for traditional surgical bypass.     

Revascularization for chronic critical lower limb ischemia in octogenarians is worthwhile

OBJECTIVE: Advanced age is considered a relative contraindication for surgical revascularization in patients with peripheral arterial occlusive disease. Our aim was to analyze the usefulness of endovascular and surgical revascularization in patients older than 80 years with chronic critical leg ischemia (CLI). Our hypothesis was that the clinical benefit of lower extremity revascularization is limited in octogenarians. METHODS: This was a prospective cohort study with a 1-year follow-up. Subjects included a consecutive series (January 1999 to June 2004) of patients presenting with CLI. Revascularization cohorts were either open surgical or endovascular with conservatively treated patients as a reference group. Prospective follow-up occurred after 30 days and 2, 6, and 12 months. The primary end point was sustained clinical success, defined as a categorical upward shift in clinical symptoms according to Rutherford, without major amputation and without the need for repeated target extremity revascularization (TER). Secondary clinical success was defined accordingly, including repeated TER. Mortality, major amputation, and TER were separately calculated end points. All results were stratified for age categories of nonoctogenarians (<80 years) and octogenarians (> or =80 years). Cumulative outcome was determined by the Kaplan-Meier method, and differences were assessed by log-rank tests. Multivariable analysis was performed by using Cox proportional regression. RESULTS: A total of 376 patients (158 women; mean age, 75.8 +/- 10.7 years) with 416 critically ischemic limbs were analyzed. Overall, 150 patients (39.9%) were older than 80 years, and 85 limbs were treated surgically (26 octogenarians; 30.6%), 207 limbs (96 octogenarians; 46.4%) were treated by endovascular means, and 124 limbs (45 octogenarians; 36.3%) were treated conservatively, including delayed revascularization procedures. Both sustained and secondary clinical success rates, as well as limb salvage rates, were higher in the revascularization cohorts as compared with conservatively treated patients, regardless of age category (P < .001, P < .001, and P = .006, respectively, by Cox proportional hazard model). Mortality was significantly higher in octogenarians (P = .006 by Cox proportional hazard model), particularly within 30 days after surgical revascularization (hazard ratio, 5.35; 95% confidence interval, 1.15-24.9). Patient age category did not affect the rate of major amputations or TER. CONCLUSIONS: Individually tailored revascularization improves the outcome of CLI in octogenarians as well as in nonoctogenarians; even so, endovascular revascularization should be preferred in octogenarians because of the higher mortality associated with surgery.     

Arterial intervention and reduction in amputation for chronic critical leg ischaemia

BACKGROUND: Untreated chronic critical leg ischaemia (CLI) usually leads to an amputation or death of a patient. Surgical and endovascular interventions may improve arterial flow. Long infrainguinal reconstruction may be the most useful method for preventing amputations. The value of different reconstruction methods was assessed by their impact on amputation incidence. METHODS: A nationwide 2-year analysis of the incidence of major amputations and reconstructions for CLI was done in Finland (population 5.1 million). Incidences were compared in hospital regions with more than 150 000 inhabitants. RESULTS: The overall amputation incidence was 216 per million inhabitants per year. The corresponding incidence of arterial reconstructions was 203 per million inhabitants per year. There were large variations in the incidence of amputations and reconstructions; 20-fold differences in infrapopliteal surgical reconstructions and 30-fold differences in endovascular procedures were found. There was a correlation between a high incidence of infrapopliteal surgical reconstructions and a low incidence of amputations. This correlation was found for below-knee amputations only. CONCLUSION: These results suggest that long surgical reconstructions improving perfusion directly to the ischaemic tissue can improve leg salvage.     

Interventional management of critical limb ischemia in renal patients

Critical limb ischemia (CLI) represents the most severe clinical manifestation of peripheral arterial disease (PAD), defined as the presence of chronic ischemic rest pain, ulcers, or gangrene attributable to objectively proven arterial occlusive disease. The occurrence of CLI in patients with kidney insufficiency portends a strikingly high rate of subsequent morbidity and mortality. Generally, the primary therapy for CLI is revascularization of the affected limb. However, patients with CLI and kidney insufficiency represent a unique and challenging patient subset, and data from surgical series suggest reduced rates of limb salvage and higher medium and long-term mortality rates for patients with kidney insufficiency compared with those with normal kidney function. In contemporary practice, endovascular techniques are fast replacing surgical bypass as the first-line revascularization strategy for CLI, based on high technical success rates and low rates of procedure-related morbidity and mortality. However, a large series on endovascular outcomes for the treatment of CLI in patients with kidney insufficiency is lacking. Based on the severely reduced long-term survival rates of patients with CLI and kidney insufficiency, future efforts should focus on early detection of PAD in patients with kidney insufficiency and institution of aggressive medical therapy to prevent progression in the global burden of atherosclerosis in this patient population.     

VEGF and VEGF Receptor Expression in Human Chronic Critical Limb Ischaemia

OBJECTIVE: This study quantified endogenous VEGF and VEGF receptor expression in limbs of patients with chronic critical limb ischaemia (CLI). METHODS: Skin and muscle biopsies were obtained from the legs of 25 patients undergoing limb amputation for CLI. Samples were obtained at the amputation level (thigh or calf) and, distally, from the foot and in the vicinity of ischaemic ulcers and gangrene. Control biopsies were obtained from patients undergoing amputation for non-arterial reasons or knee arthroplasty (n=7). VEGF protein levels in tissue lysates were measured by ELISA, and VEGF and KDR mRNA levels were determined using quantitative PCR. RESULTS: At the amputation level, VEGF protein and VEGF and KDR mRNA levels in CLI limbs were similar to those in controls. In the foot VEGF mRNA in skin (P=0.005) and VEGF protein levels in muscle (P=0.02) were elevated compared to levels in a proximal biopsy from the same limb. VEGF and KDR mRNA levels in the vicinity of gangrene/ulcers (VEGF P=0.01, KDR P=0.03) also were elevated. CONCLUSIONS: VEGF expression is not deficient in CLI. Indeed, it is elevated at distal sites in the ischaemic limb. These findings question the rationale for VEGF supplementation in CLI.     

The impact of diabetes on current revascularisation practice and clinical outcome in patients with critical lower limb ischaemia.

OBJECTIVE: To compare current revascularisation practice and outcome in diabetic and non-diabetic patients presenting with critical limb ischaemia (CLI) to a single vascular surgeon. METHODS: Data for 113 patients presenting with CLI were collected prospectively over a 3-year period. Forty-four (39%) were diabetic. Treatment was classified as percutaneous angioplasty, arterial reconstruction, primary major amputation, and conservative therapy. Main outcome measures were 30-day mortality, major amputation, survival, and amputation-free survival. RESULTS: Diabetic patients were more likely to present with gangrene, give a history of angina, be treated with nitrates and statins, and have lower cholesterol levels. No significant differences were found in the initial treatment options between diabetics and non-diabetics: angioplasty 39 vs 26%, surgical revascularisation 34 vs 33%, primary major amputation 9% vs 17%, and conservative treatment 11 vs 19% (p = ns in all). There were eight deaths (7%) within 30-days. At follow-up (1-44 months, median 14 months), rates of major amputation and death for the entire population were 23 and 8%, respectively. The 12-month cumulative survival and amputation-free survival rates were 90 and 72%, respectively. When comparing diabetic to non-diabetic patients, there were no significant differences in the 30-day mortality (6.8 vs 7.2%, p = 0.4), cumulative survival (93 vs 89% at 12 months, log-rank test: 0.00, p = 0.9), amputation-free survival (71 vs 73% at 12 months, log-rank test: 0.00, p = 0.99), and major amputation rates (22.7 vs 23.1% at 12 months, p = 0.96). Similarly, there were no differences in limb salvage rates between diabetic and non-diabetic patients undergoing revascularisation procedures (78 vs 90% at 12 months, log-rank test: 2.04, p = 0.15). CONCLUSIONS: In current practice, an aggressive multidisciplinary approach in diabetic patients presenting with CLI leads to similar limb salvage, amputation-free survival, mortality, and major amputation rates to those seen in non-diabetic patients. The presence of diabetes should not deter clinicians from attempting revascularisation by means of angioplasty or surgical reconstruction.     

Advanced leg salvage of the critically ischemic leg with major tissue loss by vascular and plastic surgeon teamwork: Long-term outcome

OBJECTIVE: To assess long-term outcome and prognostic factors for extreme surgery by vascular and plastic surgical teamwork for leg salvage in patients with critically ischemic large tissue defects. SUMMARY BACKGROUND DATA: Combined vascular reconstruction and microvascular free-flap transfer has been used to improve distal perfusion and cover large tissue defects caused by the critical limb ischemia (CLI) in few dedicated centers during the past 15 years. Comorbidities compromise the results of these demanding operations, and it is unclear how far this mode of treatment should be extended. METHODS: During 1989 to 2003, altogether 2157 vascular or endovascular revascularizations for CLI manifested as tissue lesions were performed. These included 81 revascularizations combined with microvascular free flap transfers in 79 patients (37-85 years). All the patients were candidates for major amputation. The patients were followed up at least 2 years or to death (mean follow-up, 62 months; SD, +/-34 months). RESULTS: One- and 5-year leg salvage rates were 73% and 66%, survival rates 91% and 63%, and amputation-free survival rates of 70% and 41%, respectively. Male gender and American Society of Anesthesiologists score 4 were associated with an increased risk of death, whereas the involvement of the heel mostly with calcaneal osteomyelitis and a large size of defect predicted major amputation. CONCLUSIONS: A combined vascular reconstruction and free-flap transfer offers an option for advanced limb salvage in a selected group of patients with CLI and a major tissue defect. Poor general condition, the involvement of the heel, and a large defect would indicate an amputation over extreme attempts for limb salvage.     

Local signs and symptoms in relation to final amputation level in diabetic patients: A prospective study of 187 patients with foot ulcers

Local signs and symptoms were evaluated in 187 consecutively presenting diabetic patients undergoing amputation for foot ulcers. From admission until final outcome the patients were treated by the same multidisciplinary team both as in- and outpatients. At the time of amputation, the types of lesions were superficial/deep ulcer (n 17), ulcer with deep infection, but without gangrene (n 40), and gangrene with or without infection (n 130). Healing after a minor amputation (below the ankle) occurred in 74 patients, while 88 patients healed after a major amputation (above the ankle), and 25 patients died before healing had occurred. Deep infection and presence of popliteal or pedal pulses were associated with healing after minor amputation and so were ulcers on the small toes, metatarsal head area and midfoot. Pain, progressive gangrene, intermittent claudication, and decubital and multiple ulcers were related to healing after major amputation. In a logistic regression analysis, pain, progressive gangrene and intermittent claudication remained. However, none of these factors excluded healing of a minor amputation and thus selection of amputation level in diabetic patients with foot ulcers cannot be based upon these factors exclusively.     

Gender differences in outcome after stent treatment of lesions in the femoropopliteal segment

Background and Aims: Although endovascular stent treatment is increasingly used in infrain-guinal atherosclerotic occlusive disease, outcome with focus on gender differences has not been reported in detail.Material and Methods: One hundred and twelve consecutive patients (67 [60%]) women, un-dergoing endovascular nitinol stent treatment of atherosclerotic lesions in the femoropopliteal segment were analysed concerning improvement in ankle brachial index (ABI), reinterventions, complications, amputation and survival rates up to 12 months after intervention. Risk factors for amputation and death were analyzed with logistic regression.Results: At presentation, women showed critical limb ischemia (CLI) more often than men (87% vs. 58 %; P = 0.001). After 12 months ABI had improved (from 0.40 ± 0.26 at baseline to 0.86 ± 0.22 after 12 months, P < 0.001), but 16 patients (15%) had been amputated and 27 patients (24 %) had died. After adjustment for age, diabetes mellitus and smoking, female gender was an independent risk factor for amputation (OR 9.0; 95% CI 1.1-76.5; P = 0.045).Conclusions: Stent treatment of lesions in the femoropopliteal segment had favourable effects on ABI and limb salvage. Treated women more often had CLI and ran a higher risk for amputation within 12 months than men. This might reflect failure of clinicians to adequately appreciate symptoms of atherosclerotic leg artery disease in women.     

The fate of patients with critical leg ischemia

In some highly specialized and aggressive units, 90% of patients with critical leg ischemia (CLI) will undergo some form of surgical or endovascular procedure; however, in most, the figure is nearer 50 to 60%. The primary amputation rate varies from around 10% to 40%. The mortality rate in these patients with standard therapy is around 20% at 1 year and between 40% and 70% at 5 years. Virtually all (95%) patients who present with ischemic gangrene, and 80% of those presenting with rest pain, are dead within 10 years. There appears to be a decline in overall major amputation rates associated with a corresponding increase in revascularizations. However, although technical advances may have resulted in a steadying or even decrease in amputations, comparisons of total amputations over a longer period suggest an increase, presumably attributable to an aging population. Some forward projections predict that major amputations will be doubled in the next 30 years.     

Primary and Secondary Amputation in Critical Limb Ischemia Patients: Different Aspects

The TASC II working group reports on primary amputation incidence rates vary between 12 and 50 per 100,000 per year. The primary amputation rate does not only depend on co-morbidities like diabetes and PAD, but also on local factors like the regional availability of vascular surgeons and interventional radiologists and their case load. Further-more, several studies could show that increasing revascularisation rates have drastically reduced amputation rates in the US, with a 50% decrease in amputation rates during a 10 year study period and a corresponding increase in surgical and endovas-cular revascularisation rates. An analysis of national and state US databases confirmed a drop in major amputations and open surgical revascularisations, in favour of an increase in endovascular interventions. The same study observed an increase in minor amputations during the same period. However, it remains unclear whether this trend is a consequence of the increased usage of endovascular procedures in high-risk patients who are unfit for open surgery or of earlier endovas-cular intervention in less critical lesions. This review gives an overview of the incidence, indication, amputation-level finding and outcome of major amputations performed in critical limb ischemia (CLI) patients.     

Increased preoperative c-reactive protein level as a prognostic factor for postoperative amputation after femoropopliteal bypass surgery for CLI

BACKGROUND AND AIMS: We evaluated the possible predictive role of C-reactive protein (CRP) on the immediate postoperative outcome after femoropopliteal bypass surgery for critical leg ischaemia (CLI). MATERIAL AND METHODS: 138 patients with CLI who underwent 143 femoropopliteal reconstructions. RESULTS: The immediate postoperative period secondary patency rate was 87%, leg salvage rate was 94%, and survival rate 97%. Nine patients (6.3%) had 30-day postoperative major amputation, three of them despite a patent bypass graft because of progression of foot infection. The preoperative serum concentration of CRP was the only predictor of postoperative major amputation (p = 0.004; for an increase of 10 mg/l: OR, 1.188; CI 95%, 1.059-1.332). The median preoperative serum concentration of CRP among patients who did not have major amputation was 13.0 mg/l (range, 1-185), whereas it was 47.5 mg/l (range, 5-168) among those who had amputation after bypass graft occlusion, and 115.0 mg/l (range, 34-222) among those who had amputation despite a patent bypass graft (p = 0.008). CONCLUSIONS: CRP may be a useful marker in risk stratification for postoperative amputation in patients undergoing femoropopliteal bypass surgery for CLI.     

Small Is Beautiful: Why Profundaplasty Should Not Be Forgotten

Background

Surgical profundaplasty (SP)is used mainly as an adjunct to endovascular management of peripheral vascular disease (PAD) today. Results from earlier series of profundaplasty alone have been controversial, especially regarding its hemodynamic effect. The question is: Can profundaplasty alone still be useful? Our aim was to evaluate its role in the modern management of vascular patients.

Methods

This was a retrospective outcome study. A consecutive series of 97 patients (106 legs) from January 2000 through December 2003 were included. In 55 (52%) legs, the superficial femoral artery was occluded. These patients were included in the current analysis. Of these patients 14 (25%) were female. Mean age was 71 ((11) years. Nineteen (35%) were diabetic. The indication for operation was claudication in 29 (53%), critical leg ischemia (CLI) in 26 (47%), either with rest pain in 17 (31%), or ulcer/gangrene in 9 (16%). Endarterectomy with patch angioplasty with bovine pericardium was performed in all cases. Mean follow-up was 33 ( 14 months. Mean preoperative ankle brachial index (ABI) was 0.6. Sustained clinical efficacy was defined as upward shift of 1 or greater on the Rutherford scale without repeat target limb revascularization (TLR) or amputation. Mortality, morbidity, need for TLR, or amputation were separate endpoints.

Results

Postoperatively, ABI was significantly improved (mean = 0.7), in 24 (44%) by more than 0.15. At three years, cumulative clinical success rate was 80%. Overall, patients with claudication had a better outcome than those with CLI (p = 0.04). Two (4%) major amputations and 2 (4%) minor ones were performed, all in patients with CLI. None of the 9 (16%) ulcers healed.

Conclusion

Profundaplasty is still a valuable option for patients with femoral PAD and claudication without tissue loss. It is a straightforward procedure that combines good efficacy with low complication rates. Further endovascular treatment may be facilitated. It is not useful for patients with the combination of critical ischemia and tissue loss.

     

Predicting which patients will develop chronic critical leg ischemia

Although numerically far less than claudicants, patients with critical leg ischemia (CLI) demand a disproportionately large commitment both in medical effort and economically and represent the major workload for vascular surgical units. The incidence and prevalence of CLI is approximately 500 to 1,000/million/year. The risk factors for the development of CLI are largely the same as those for the progression of local disease in IC, the most important, apart from age, being smoking and diabetes. Major amputation is more common amongst claudicants who are heavy smokers and who continue to smoke, and although stopping smoking slows down the vascular changes and reduces the likelihood of symptomatic progression, it does not reduce the risk of major amputation over the following 2 to 3 years. Diabetic PAOD patients are about 10 times more likely to come to amputation than nondiabetic PAOD patients, and the prevalence of gangrene is 20 to 30 times higher in individuals with diabetes and PAOD compared with nondiabetics with PAOD. There is some evidence that most of these effects of risk factors are additive.     

Nationales Register für die Erstlinientherapiestrategien bei Patienten mit kritischer Extremitätenischämie (CRITISCH-Register)

Purpose

The aim of this interdisciplinary registry is to identify the most advocated first line treatment approaches in patients with critical limb ischemia (CLI) in German vascular centres and to compare the clinical effectiveness.

Methods

A total of 1,200 patients suffering from CLI lasting >?2 weeks will be recruited into this registry. Inclusion criteria are the presence of an ankle-brachial index <?0.4 and/or Rutherford claudication class 4 at rest, trophic disorders and necrosis or gangrene Rutherford classes 5 and 6.. The patients are classified into four groups: group I endovascular approach alone, group II open surgery with bypass graft, group III femoral/profundal artery patch plasty with or without endovascular approach (hybrid procedure) and group IV no vascular intervention. Patients with isolated interventions at the aortoiliac segment are excluded. Primary composite endpoint of this non-inferiority study will be the occurrence of amputation or death.

Progress

Recruitment began on January 2013 from 29 participating vascular centres and will close on December 2014. The patients will be followed for at least 2 years. The first interim analysis will be performed after 250 events (death or amputation) have occurred.

Conclusion

This is the first interdisciplinary German registry assessing the effectiveness of different first line treatment strategies in patients suffering from CLI in a real-world practice model following the evolution of the devices and the techniques (http://www.clinicaltrials.gov, NCT01877252).