Roberto Gandini

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.

Simultaneous Hybrid Revascularization by Carotid Stenting and Coronary Artery Bypass Grafting – The SHARP Study

OBJECTIVES In an attempt to reduce post-operative events we investigated a new therapeutic strategy consisting of a simultaneous hybrid revascularization by carotid artery stenting (CAS), immediately followed by an on-pump coronary artery bypass graft (CABG). BACKGROUND Preventing stroke and cardiovascular events after coronary artery revascularization in patients with elevated surgical risk is a complex and multifaceted problem. METHODS One hundred-one consecutive patients with severe carotid and coronary artery disease and a standard EuroSCORE >or=5 were included in this multicenter study. Immediately after CAS, patients underwent CABG. The primary end point was the incidence of stroke, acute myocardial infarction (AMI), or death at 30 days. Secondary outcomes were transient ischemic attacks; major local complications; bleeding and systemic complications within 30 days after treatment; and any stroke, AMI, or death occurring from the 31st day to the end of the 12-month follow-up. All clinical outcomes were assessed by an independent monitoring board. RESULTS The rate of procedural success was 98%. The 30-day cumulative incidence of disabling stroke, AMI, or death was 4%: 2 patients died (2%) in the post-operative period, and 2 patients (2%) had a stroke immediately after CAS and before CABG. Three patients died from the 31st day to the 12th month after the procedure. CONCLUSIONS Our findings indicate that in high-risk patients with coronary artery disease suitable for CABG and carotid artery disease, the hybrid revascularization by CAS immediately followed by CABG is a promising and feasible therapeutic strategy.

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.

Intraluminal recanalization of long infrainguinal chronic total occlusions using the Crosser system

Purpose: To assess the safety and efficacy of a device for vibrational angioplasty in the percutaneous intraluminal recanalization of long infrainguinal chronic total occlusions (CTO). Technique: The Crosser CTO Recanalization System is a mechanical recanalization device that uses high-frequency vibrational energy to disrupt and channel through fibrocalcific plaque without harming the vessel wall, thus assisting in the recanalization of an occluded artery. In 12 diabetic patients (7 men; median age 71 years, range 58–80) with critical limb ischemia owing to long (median length 26 cm, range 21–32) infrainguinal CTOs resistant to conventional guidewire techniques, the Crosser CTO Recanalization System was successful in intraluminally crossing the occlusion in 9 (75%) patients in <5 minutes (mean 4:03 minutes). The safety endpoint (distal lumen guidewire position with no vessel perforation or dissection) was achieved in all successful cases. Conclusion: In our preliminary experience, the Crosser CTO Recanalization Catheter decreased crossing time, was safe, and achieved a high rate of intraluminal recanalization of long infrainguinal CTOs.

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.

Randomized control study of the outback LTD reentry catheter versus manual reentry for the treatment of chronic total occlusions in the superficial femoral artery

To assess the efficacy and safety of the Outback device in patients with a chronic total occlusion (CTO) of the superficial femoral artery and evaluate its impact on fluoroscopy and procedural times.

Sixty-four-section CT cerebral perfusion evaluation in patients with carotid artery stenosis before and after stenting with a cerebral protection device

BACKGROUND AND PURPOSE: Brain tissue viability depends on cerebral blood flow (CBF) that has to be kept within a narrow range to avoid the risk of developing ischemia. The aim of the study was to evaluate by 64-section CT (VCT) the cerebral perfusion modifications in patients with severe carotid stenosis before and after undergoing carotid artery stent placement (CAS) with a cerebral protection system. MATERIALS AND METHODS: Fifteen patients with unilateral internal carotid stenosis (≥70%) underwent brain perfusional VCT (PVCT) 5 days before and 1 week after the stent-placement procedure. CBF and mean transit time (MTT) values were measured. RESULTS: Decreased CBF and increased MTT values were observed in the cerebral areas supplied by the stenotic artery as compared with the areas supplied by the contralateral patent artery (P < .001). A significant normalization of the perfusion parameters was observed after the stent-placement procedure (mean pretreatment MTT value, 5.3 ± 0.2; mean posttreatment MTT value, 4.3 ± 0.18, P < .001; mean pretreatment CBF value, 41.2 mL/s ± 2.1; mean posttreatment CBF value, 47.9 mL/s ± 2.9, P < .001). CONCLUSIONS: PVCT is a useful technique for the assessment of the hemodynamic modifications in patients with severe carotid stenosis. The quantitative evaluation of cerebral perfusion makes it a reliable tool for the follow-up of patients who undergo CAS.

Endovascular Treatment of a Giant Superior Mesenteric Artery Pseudoaneurysm Using a Nitinol Stent-Graft

A 68-year-old woman presenting with gastrointestinal bleeding (hematocrit 19.3%) and in a critical clinical condition (American Society of Anesthesiologists grade 4) from a giant superior mesenteric artery pseudoaneurysm (196.0 × 131.4 mm) underwent emergency endovascular treatment. The arterial tear supplying the pseudoaneurysm was excluded using a 5.0 mm diameter and 31 mm long monorail expanded polytetrafluoroethylene (ePTFE)-covered self-expanding nitinol stent. Within 6 days of the procedure, a gradual increase in hemoglobin levels and a prompt improvement in the clinical condition were observed. Multislice CT angiograms performed immediately, 5 days, 30 days and 3 months after the procedure confirmed the complete exclusion of the pseudoaneurysm.

Endovascular radiofrequency renal denervation in treating refractory arterial hypertension: a preliminary experience.

PurposeThis study was done to investigate the efficacy and safety of percutaneous renal denervation with the Symplicity catheter for reducing blood pressure in patients with essential hypertension resistant to medical therapy (systolic blood pressure >160 mmHg despite the use of three or more antihypertensive drugs, including a diuretic).Materials and methodsIn September 2010, five patients affected by essential hypertension resistant to medical therapy were treated. All patients were studied by computed tomography angiography (CTA) of the renal arteries before the procedure and underwent follow-up at 30 and 60 days with colour Doppler ultrasound (CDUS) with evaluation of resistive index, glomerular filtration rate (GFR), 24-h blood pressure and serum catecholamine concentration. Student’s t test was used to assess the effectiveness of the procedure in lowering blood pressure.ResultsIn treated patients, mean blood pressure at baseline was 171/100 mmHg [standard deviation (SD)±8/10]; mean GFR was 91.6 ml/min/1.73 m2 (SD±15). Blood pressure after the procedure was reduced by −18/−5 and −13/−10 mmHg at 30 and 60 days, respectively, with a mean medication reduction of 3.6. No complications occurred during the intra- or periprocedural period or during short-term follow-up.ConclusionsThe Symplicity system proved to be efficacious and without serious adverse events in reducing blood pressure and antihypertensive medication use in patients affected by essential hypertension resistant to medical therapy. Although encouraging, our data are preliminary and need to be validated by larger prospective randomised studies.RiassuntoObiettivoScopo del presente studio è stato valutare l’efficacia e la sicurezza della procedura di simpaticectomia renale percutanea a radiofrequenza mediante catetere Symplicity nel ridurre la pressione arteriosa sistemica in pazienti con ipertensione essenziale resistenti alla terapia farmacologica convenzionale (pressione sistolica>160 mmHg con 3 o più farmaci antiipertensivi, incluso diuretico).Materiali e metodiNel mese di settembre 2010, sono stati trattati 5 pazienti affetti da ipertensione arteriosa essenziale non rispondenti a terapia. È stata eseguita angio-tomografia computerizzata (TC) delle arterie renali pre-procedurale e follow-up a 30 e 60 giorni con eco-color Doppler, valutazione degli indici di resistenza, del filtrato glomerulare, monitoraggio della pressione arteriosa nelle 24 ore e misurazione della catecolaminemia. L’analisi dei dati è stata effettuata mediante il test t di Student.RisultatiI valori pressori medi basali della popolazione erano 171/100 mmHg [deviazione standard (DS)±8/10], con filtrato glomerulare medio di 91,6 ml/min/1,73 m2 (DS±15). Il decremento pressorio medio post-procedurale è stato di −18/−5 mmHg e −13/−10 mmHg a 30 e 60 giorni con riduzione media di 3,6 farmaci. Non vi sono state complicanze intra-/peri-procedurali e nel successivo follow-up a breve termine.ConclusioniIl sistema Symplicity si è dimostrato efficace nel ridurre i livelli pressori e la somministrazione dei farmaci anti-ipertensivi, in assenza di evidenti eventi avversi. Nonostante incoraggianti premesse, sarà necessario validare i preliminari dati ottenuti mediante più ampi studi prospettici randomizzati.