Enrico Pampana

Long-Term Outcomes of Diabetic Patients With Critical Limb Ischemia Followed in a Tertiary Referral Diabetic Foot Clinic

OBJECTIVE We describe the long-term outcomes of 510 diabetic patients with critical limb ischemia (CLI) and an active foot ulcer or gangrene, seen at the University Hospital of Rome Tor Vergata, a tertiary care clinic. RESEARCH DESIGN AND METHODS These patients were seen between November 2002 and November 2007 (mean follow-up 20 ± 13 months [range 1–66 months]). The Texas Wound Classification was used to grade these wounds that were either class C (ischemia) and D (ischemia+infection) and grade 2–3 (deep–very deep). This comprehensive treatment protocol includes rapid and extensive initial debridement, aggressive use of peripheral percutaneous angioplasty, empirical intravenous antibiotic therapy, and strict follow-up. RESULTS The protocol was totally applied (with percutaneous angioplasty [PA+]) in 456 (89.4%) patients and partially (without percutaneous angioplasty [PA−]) in 54 (10.6%) patients. Outcomes for the whole group and PA+ and PA− patients are, respectively: healing, n = 310 (60.8%), n = 284 (62.3%), and n = 26 (48.1%); major amputation, n = 80 (15.7%), n = 67 (14.7%), and n = 13 (24.1%); death, n = 83 (16.25%), n = 68 (14.9%), and n = 15 (27.8%); and nonhealing, n = 37 (7.25%), n = 37 (8.1%), and n = 0 (0%) (χ2 <0.0009). Predicting variables at multivariate analysis were the following: for healing, ulcer dimension, infection, and ischemic heart disease; and for major amputation, ulcer dimension, number of minor amputations, and age. Additional predicting variables for PA+ patients were the following: for healing, transcutaneous oxygen tension [ΔTcPo2]; and for major amputation, basal TcPo2, basal A1C, ΔTcPo2, and percutaneous angioplasty technical failure. CONCLUSIONS Early diagnosis of CLI, aggressive treatment of infection, and extensive use of percutaneous angioplasty in ischemic affected ulcers offers improved outcome for many previously at-risk limbs. Ulcer size >5 cm2 indicates a reduced chance of healing and increased risk of major amputation. It was thought that all ulcers warrant aggressive treatment including percutaneous angioplasty and that treatment should be considered even for small ischemic ulcers.

The “Safari” Technique to Perform Difficult Subintimal Infragenicular Vessels

The purpose of this study was to describe the efficacy of planned combined subintimal arterial flossing with antegrade–retrograde intervention (SAFARI) to obtain the precise recanalization of the patent portion of a distal runoff vessel in critical limb ischemia (CLI) patients presenting long occlusions involving the popliteal trifurcation. Four patients at risk of limb loss due to long occlusions involving the leg vessel tree and not suitable for a surgical bypass were treated by the subintimal antegrade and retrograde (posterior tibial or anterior tibial artery) approach. The patent portion of the runoff vessel was previously assessed by magnetic resonance angiography (MRA) and directly punctured under Doppler ultrasound (US) guidance. A subintimal channel rendezvous was performed to allow snaring of the guidewires. Subsequently, a balloon dilatation was performed without stent deployment. All patients were successfully recanalized and had complete healing of the limb lesions. At the 12-month follow-up all patients showed clinical improvement with no major complications related to the procedure. This combined antegrade and retrograde subintimal approach is currently an excellent endovascular option in patients with long occlusions extending onto the leg vessels trifurcation and at risk of limb loss.

Male varicocele: transcatheter foam sclerotherapy with sodium tetradecyl sulfate--outcome in 244 patients.

PURPOSE To retrospectively evaluate the recurrence rate, resolution of pain, improvement of semen parameters, and achievement of pregnancy after transcatheter foam sclerotherapy (TCFS) in varicocele by using sodium tetradecyl sulfate (STS) foam. MATERIALS AND METHODS The institutional review board approved the study; informed consent was waived. A retrospective study was conducted in 244 consecutive male patients (mean age, 28.2 years; range, 17-42 years) with 280 varicoceles treated with TCFS between January 2000 and January 2004. The gonadal vein was selectively catheterized by using left antecubital transbrachial venous access; a foam of 3% STS and air was injected. Follow-up was performed with physical and Doppler ultrasonographic examinations and by using a questionnaire-based assessment of pain and pregnancy. Semen analysis was performed according to World Health Organization guidelines. Significant differences in semen parameters before and after treatment were determined by using the Wilcoxon signed rank test. RESULTS Technical success rate was 97.1% (272 varicoceles). Complete follow-up results (mean, 40.3 months +/- 19.46 [standard deviation]) in 225 varicoceles (80.4%) revealed eight (3.6%) grade II-III recurrent varicoceles and resolution of pain in 164 (96.5%) of 170 cases. Statistically significant improvement of all semen parameters was achieved in infertile patients after treatment (P < .001). Of 59 patients with pretreatment sperm alterations who desired pregnancy, 23 (39.0%) achieved pregnancy (mean follow-up, 28.6 months +/- 7.77). CONCLUSION TCFS in male varicocele with 3% STS foam was associated with a low recurrence rate, a high rate of pain resolution, and a significant improvement of pretreatment sperm parameter alterations; a substantial increase in pregnancy achievement was obtained for patients with pretreatment sperm alterations who desired pregnancy.

Emergency Endograft Placement for Recurrent Aortocaval Fistula after Conventional AAA Repair

Purpose: To report a novel case in which a stent-graft was used to emergently treat an aortocaval fistula that recurred after conventional abdominal aortic aneurysm (AAA) repair. Case Report: A 67-year-old man was treated urgently for ruptured AAA with surgical placement of a 16-mm Dacron interposition graft. During the procedure, an aortocaval fistula was repaired primarily. The patient was discharged in satisfactory condition but returned 20 days later with dyspnea, bilateral perimalleolar edema, and a bruit in the mesogastric region. The high flow fistula was again present just above the aortic bifurcation at the distal anastomosis of the existing graft. The patients condition deteriorated rapidly, so a bifurcated Vanguard stent-graft was deployed in an emergency procedure. Subsequent imaging confirmed satisfactory closure of the fistula. The patient was discharged 8 days after endograft placement, and he continues to be without signs of fistula recurrence at 2 years. Conclusions: Endograft treatment of vascular lesions in the acute setting is becoming more common as our experience with the devices grows. Endovascular repair of primary aortocaval fistulas appears to be an efficacious and minimally invasive means of dealing with these lesions in AAA patients.

Intra-arterial Thrombectomy versus Standard Intravenous Thrombolysis in Patients with Anterior Circulation Stroke Caused by Intracranial Arterial Occlusions: A Single-center Experience

BACKGROUND Severely impaired patients with persisting intracranial occlusion despite standard treatment with intravenous (IV) administration of recombinant tissue plasminogen activator (rtPA) or presenting beyond the therapeutic window for IV rtPA may be candidates for interventional neurothrombectomy (NT). The safety and efficacy of NT by the Penumbra System (PS) were compared with standard IV rtPA treatment in patients with severe acute ischemic stroke (AIS) caused by large intracranial vessel occlusion in the anterior circulation. METHODS Consecutive AIS patients underwent a predefined treatment algorithm based on arrival time, stroke severity as measured by the National Institutes of Health Stroke Scale (NIHSS) score, and site of arterial occlusion on computed tomographic angiography (CTA). NT was performed either after a standard dose of IV rtPA (bridging therapy [BT]) or as single treatment (stand-alone NT [SAT]). Rates of recanalization, symptomatic intracranial bleeding (SIB), mortality, and functional outcome in NT patients were compared with a historical cohort of IV rtPA treated patients (i.e., controls). Three-month favourable outcome was defined as a modified Rankin Scale (mRS) score ≤2. RESULTS Forty-six AIS patients were treated with NT and 51 with IV rtPA. The 2 groups did not differ with regard to demographics, onset NIHSS score (18.5±4 v 17±5; P=.06), or site of intracranial occlusion. Onset-to-treatment time in the NT and IV rtPA groups was 230 minutes (±78) and 176.5 (±44) minutes, respectively (P=.001). NT patients had significantly higher percentages of major improvement (≥8 points NIHSS score change at 24 hours; 26% v 10%; P=.03) and partial/complete recanalization (93.5% v 45%; P<.0001) compared to controls. Treatment by either SAT or BT similarly improved the chance of early recanalization and early clinical improvement. No significant differences were observed in the rate of SIB (11% v 6%), 3-month mortality (24% v 25%), or favorable outcome (40% v 35%) between NT and IV rtPA patients. CONCLUSIONS Despite significantly delayed time of intervention, NT patients had higher rates of recanalization and early major improvement, with no differences in symptomatic intracranial hemorrhages. Early NIHSS score improvement did not translate into better 3-month mortality or outcome. NT seems a safe and effective adjuvant treatment strategy for selected patients with severe AIS secondary to large intracranial vessel occlusion in the anterior circulation.

Management of Biliary Neoplastic Obstruction with Two Different Metallic Stents Implanted in One Session

The efficacy of the “one-step” technique using two different metallic stents (Wallstent and Ultraflex) and associated rate of complications was studied in 87 patients with jaundice secondary to malignant biliary obstruction, with bilirubin level less than 15 mg/dl and Bismuth type 1 or 2 strictures. The study group, composed of 40 men and 47 women with a mean age of 59.4 years (range 37–81 years), was treated with a “one-step” percutaneous transhepatic implantation of self-expanding stents. The cause of the obstruction was pancreatic carcinoma in 38 patients (44%), lymph node metastasis in 20 patients (23%), gallbladder carcinoma in 13 patients (15%), cholangiocarcinoma in 12 patients (14%) and ampullary carcinoma in four patients (5%). A significant reduction in jaundice was obtained in all but one patient, with a drop of total serum bilirubin level from a mean of 13.7 mg/dl to 4.3 mg/dl within the first 4 days. The mean postprocedural hospitalization period was 5.4 days in the Wallstent group and 6.4 days in the Ultraflex group. Mean survival rate was 7.8 months (Wallstent group) and 7.1 months (Ultraflex group). The use of both stents did not reveal any significant difference in parameters tested. The implantation of these self-expandable stents in one session, in selected patients, is clinically effective, devoid of important complications and cost-effective due to the reduction in hospitalization.

CT angiography-based collateral flow and time to reperfusion are strong predictors of outcome in endovascular treatment of patients with stroke

Background Collateral flow (CF) is an effective predictor of outcome in acute ischemic stroke (AIS) with potential to sustain the ischemic penumbra. However, the clinical prognostic value of CF in patients with AIS undergoing mechanical thrombectomy has not been clearly established. We evaluated the relationship of CF with clinical outcomes in patients with large artery anterior circulation AIS treated with mechanical thrombectomy. Methods Baseline collaterals of patients with AIS (n=135) undergoing mechanical thrombectomy were independently evaluated by CT angiography (CTA) and conventional angiography and dichotomized into poor and good CF. Multivariable analyses were performed to evaluate the predictive effect of CF on outcome and the effect of time to reperfusion on outcome based on adequacy of the collaterals. Results Evaluation of CF was consistent by both CTA and conventional angiography (p<0.0001). A higher rate of patients with good collaterals had good functional outcome at 3-month follow-up compared with those with poor collaterals (modified Rankin Scale (mRS) 0–2: 60% vs 10%, p=0.0001). Patients with poor collaterals had a significantly higher mortality rate (mRS 6: 45% vs 8%, p=0.0001). Multivariable analyses showed that CF was the strongest predictor of outcome. Time to reperfusion had a clear effect on favorable outcome (mRS ≤2) in patients with good collaterals; in patients with poor collaterals this effect was only seen when mRS ≤3 was considered an acceptable outcome. Conclusions CTA is a valid tool for assessing the ability of CF to predict clinical outcome in patients with AIS treated with mechanical thrombectomy. Limiting time to reperfusion is of definite value in patients with good collaterals and also to some extent in those with poor collaterals.

Safety of early carotid artery stenting after systemic thrombolysis: a single center experience.

Background. Patients with acute ischemic stroke due to internal carotid artery (ICA) disease are at high risk of early stroke recurrence. A combination of IV thrombolysis and early carotid artery stenting (CAS) may result in more effective secondary stroke prevention. Objective. We tested safety and durability of early CAS following IV thrombolysis in stroke patients with residual stenosis in the symptomatic ICA. Methods. Of consecutive patients treated with IV rtPA, those with residual ICA stenosis ≥70% or <70% with an ulcerated plaque underwent early CAS (>24 hours). The protocol included pre-rtPA MRI and MR angiography, and post-rtPA carotid ultrasound and CT angiography. Stroke severity was assessed by the NIH Stroke Scale (NIHSS). Three- and twelve-month stent patency was assessed by ultrasound. Twelve-month functional outcome was assessed by the modified Rankin Scale (mRS). Results. Of 145 consecutive IV rtPA-treated patients, 6 (4%) underwent early CAS. Median age was 76 (range 67–78) years, median NIHSS at stroke onset was 12 (range 9–16) and 7 (range 7-8) before CAS. Median onset-to-CAS time was 48 (range 30–94) hours. A single self-expandable stent was implanted to cover the entire lesion in all patients. The procedure was uneventful in all patients. After 12 months, all patients had stent patency, and the functional outcome was favourable (mRS ≤ 2) in all but 1 patient experiencing a recurrent stroke for new-onset atrial fibrillation. Conclusion. This small case series of a single centre suggests that early CAS may be considered a safe alternative to CEA after IV rtPA administration in selected patients at high risk of stroke recurrence.

Long term outcomes of diabetic haemodialysis patients with critical limb ischemia and foot ulcer

AIM To evaluate the outcomes of diabetic dialysis patients with critical limb ischemia and foot ulcer. METHODS The study group included 599 diabetic, 99 dialyzed (Ds) (16.5%) and 500 not dialyzed (NDs) (83%) patients with critical limb ischemia and foot ulcers identified as stage C (ischemia) or D (ischemia plus infection) of Texas Wound Classification. All patients were treated by endovascular revascularization. Outcomes were expressed as healing, major amputation, death and non healing after 12months. The mean follow-up was 15±13months. RESULTS The outcomes of the whole population were: 48.9% healing, 11.3% major amputation, 12.7% death, 27.1 non healing. At the multivariate analysis dialysis was a negative predictor of healing and a positive predictor of major amputation. Outcomes for Ds and NDs were respectively: healing (30.3 vs 52.6%), major amputation (14.4 vs 10.8%), death (21.1 vs 11%) and non-healing (34.2 vs 25.6%) (X=0.0004). Amputation occurred earlier in Ds than in NDs. According to the multivariate analysis in Ds ischemic heart disease and lower ΔTcPO2 were negative predictors for healing. Successful revascularization was a negative predictor for major amputation. HDL and carotid artery disease were predictive factors of death among NDs. Among Ds high blood pressure values were the only predictor of amputation while no variable resulted predictive of healing or death. CONCLUSIONS Our study shows that our limb salvage protocol ensures a good rate of limb salvage in Ds even if they have a higher risk of amputation and death compared to NDs.

Foot Embolization During Limb Salvage Procedures in Critical Limb Ischemia Patients Successfully Managed With Mechanical Thromboaspiration: A Technical Note.

Purpose: To illustrate the use of a mechanical thromboaspiration device originally designed for clot retrieval in acute stroke in the treatment of acute distal embolism occurring during percutaneous revascularization of the femoropopliteal and below-the-knee arterial segments. Technique: The Penumbra system was adapted for aspiration of thrombus in the distal foot arteries as a standalone device. The 2 over-the-wire, tapered lumen catheters have long working lengths (139 cm for the 4MAX to 153 cm for the 3MAX) that allow advancement below the ankle even with a retrograde contralateral approach. Once the occluded arterial segment is reached, the catheters are connected to the dedicated pump for continuous vacuum aspiration. The use of the device is illustrated in 3 diabetic patients (1 woman and 2 men; ages 88, 70, and 73 years, respectively) undergoing limb salvage procedures who experienced distal embolization that would have seriously jeopardized the foot circulation. The lumens of the occluded arteries were restored without complication. Conclusion: While further evaluation in a larger cohort of patients is needed, this initial experience using the Penumbra system in the peripheral vasculature suggests that this is a rapid, effective approach to address intraprocedural foot embolization and avoid possible grave clinical sequelae.