Publications by authors named "Fabrizio Fanelli"

98 Publications

Treating Peripheral Chronic Total Occlusions: Putting a New Device in Perspective.

Authors:
Fabrizio Fanelli

J Vasc Interv Radiol 2022 Jan;33(1):60-61

Vascular and Interventional Radiology Unit, Careggi University Hospital, Florence, Italy. Electronic address:

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http://dx.doi.org/10.1016/j.jvir.2021.09.022DOI Listing
January 2022

Portosystemic shunt is an effective treatment for complications of portal hypertension in hepatic myeloid metaplasia and improves nutritional status.

Liver Int 2021 Dec 28. Epub 2021 Dec 28.

Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.

In patients affected by myelofibrosis with hepatic myeloid metaplasia (HMM), portal hypertension (PHT) complications may develop. In this case series, we analysed the efficacy and safety of transjugular portosystemic shunt (TIPS) in the treatment of PHT-related complications and its effects on the nutritional status. Six patients were evaluated and the average follow-up period after TIPS was 33 (IQR 5) months. None of the patients developed hepatic failure, nor any recurrence of variceal bleeding was recorded. No additional paracentesis or endoscopic prophylactic treatment for PHT-related complications were required. In all subjects, the average dose of diuretics was almost halved three months after TIPS. Three patients died during the follow-up, but none for liver-related causes. All patients showed an improvement in the global nutritional status. In conclusion, TIPS represent an effective and safe treatment option for patients affected by complications of PHT secondary to HMM and drives to an improvement of the nutritional status.
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http://dx.doi.org/10.1111/liv.15148DOI Listing
December 2021

Safety and Effectiveness of Paclitaxel Drug-Coated Devices in Peripheral Artery Revascularization: Insights From VOYAGER PAD.

J Am Coll Cardiol 2021 11;78(18):1768-1778

Department of Medicine, Division of Cardiology, University of Colorado School of Medicine, Aurora, Colorado, USA; CPC Clinical Research, Aurora, Colorado, USA.

Background: Paclitaxel drug-coated devices (DCDs) were developed to improve lower extremity revascularization (LER) patency in peripheral artery disease (PAD) but have been associated with long-term mortality.

Objectives: This study assessed DCD safety and effectiveness in LER for PAD.

Methods: VOYAGER PAD (Vascular Outcomes Study of ASA [acetylsalicylic acid] Along with Rivaroxaban in Endovascular or Surgical Limb Revascularization for PAD) randomized patients with PAD who underwent LER to rivaroxaban or placebo. The primary VOYAGER PAD study efficacy and safety outcomes were composite cardiovascular and limb events and Thrombolysis In Myocardial Infarction major bleeding. For prespecified DCD analyses, primary safety and effectiveness outcomes were mortality and unplanned index limb revascularization (UILR). Major adverse limb events (MALE) were a secondary outcome. Inverse probability treatment weighting was used to account for each subject's propensity for DCD treatment. Effects of rivaroxaban were assessed with Cox proportional hazards models.

Results: Among 4,316 patients who underwent LER, 3,478 (80.6%) were treated for claudication, and 1,342 (31.1%) received DCDs. Median follow-up was 31 months, vital status was ascertained in 99.6% of patients, and there were 394 deaths. After weighting, DCDs were not associated with mortality (HR: 0.95; 95% CI: 0.83-1.09) or MALE (HR: 1.08; 95% CI: 0.90-1.30) but were associated with reduced UILR (3-year Kaplan-Meier: 21.5% vs 24.6%; HR: 0.84; 95% CI: 0.76-0.92). Irrespective of DCD use, consistent benefit of rivaroxaban for composite cardiovascular and limb events (P = 0.88) and safety of rivaroxaban with respect to bleeding (P = 0.57) were observed.

Conclusions: In >4,000 patients with PAD who underwent LER, DCDs were not associated with mortality or MALE but were associated with persistent reduction in UILR. These findings provide insight into the safety and effectiveness of DCDs in PAD. (Vascular Outcomes Study of ASA [acetylsalicylic acid] Along with Rivaroxaban in Endovascular or Surgical Limb Revascularization for PAD [VOYAGER PAD]; NCT02504216).
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http://dx.doi.org/10.1016/j.jacc.2021.08.052DOI Listing
November 2021

Effect of Rivaroxaban and Aspirin in Patients With Peripheral Artery Disease Undergoing Surgical Revascularization: Insights From the VOYAGER PAD Trial.

Circulation 2021 10 12;144(14):1104-1116. Epub 2021 Aug 12.

CPC Clinical Research, Aurora, CO (M.R.N., N.G., W.H.C., T.B., N.J., C.N.H., W.R.H., M.P.B.).

Background: Patients with peripheral artery disease requiring lower extremity revascularization (LER) are at high risk of adverse limb and cardiovascular events. The VOYAGER PAD trial (Vascular Outcomes Study of ASA [Acetylsalicylic Acid] Along With Rivaroxaban in Endovascular or Surgical Limb Revascularization for PAD) demonstrated that rivaroxaban significantly reduced this risk. The efficacy and safety of rivaroxaban has not been described in patients who underwent surgical LER.

Methods: The VOYAGER PAD trial randomized patients with peripheral artery disease after surgical and endovascular LER to rivaroxaban 2.5 mg twice daily plus aspirin or matching placebo plus aspirin and followed for a median of 28 months. The primary end point was a composite of acute limb ischemia, major vascular amputation, myocardial infarction, ischemic stroke, or cardiovascular death. The principal safety outcome was Thrombolysis in Myocardial Infarction major bleeding. International Society on Thrombosis and Haemostasis bleeding was a secondary safety outcome. All efficacy and safety outcomes were adjudicated by a blinded independent committee.

Results: Of the 6564 randomized, 2185 (33%) underwent surgical LER and 4379 (67%) endovascular. Compared with placebo, rivaroxaban reduced the primary end point consistently regardless of LER method (-interaction, 0.43). After surgical LER, the primary efficacy outcome occurred in 199 (18.4%) patients in the rivaroxaban group and 242 (22.0%) patients in the placebo group with a cumulative incidence at 3 years of 19.7% and 23.9%, respectively (hazard ratio, 0.81 [95% CI, 0.67-0.98]; =0.026). In the overall trial, Thrombolysis in Myocardial Infarction major bleeding and International Society on Thrombosis and Haemostasis major bleeding were increased with rivaroxaban. There was no heterogeneity for Thrombolysis in Myocardial Infarction major bleeding (-interaction, 0.17) or International Society on Thrombosis and Haemostasis major bleeding (-interaction, 0.73) on the basis of the LER approach. After surgical LER, the principal safety outcome occurred in 11 (1.0%) patients in the rivaroxaban group and 13 (1.2%) patients in the placebo group; 3-year cumulative incidence was 1.3% and 1.4%, respectively (hazard ratio, 0.88 [95% CI, 0.39-1.95]; =0.75) Among surgical patients, the composite of fatal bleeding or intracranial hemorrhage (=0.95) and postprocedural bleeding requiring intervention (=0.93) was not significantly increased.

Conclusions: The efficacy of rivaroxaban is associated with a benefit in patients who underwent surgical LER. Although bleeding was increased with rivaroxaban plus aspirin, the incidence was low, with no significant increase in fatal bleeding, intracranial hemorrhage, or postprocedural bleeds requiring intervention. Registration: URL: http://www.clinicaltrials.gov; Unique Identifier: NCT02504216.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.121.054835DOI Listing
October 2021

Reply to "The VOYAGER PAD Trial in Surgical Perspective: A Debate".

Eur J Vasc Endovasc Surg 2021 05 1;61(5):723-724. Epub 2021 Apr 1.

Department of Surgery, Division of Vascular Surgery, University of Colorado School of Medicine, Aurora, CO, USA.

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http://dx.doi.org/10.1016/j.ejvs.2021.02.051DOI Listing
May 2021

SFA: Do we need to Protect it?

Authors:
Fabrizio Fanelli

Cardiovasc Intervent Radiol 2021 05 11;44(5):709-710. Epub 2021 Mar 11.

Vascular and Interventional Radiology Department, "Careggi" University Hospital, Florence, Italy.

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http://dx.doi.org/10.1007/s00270-021-02807-3DOI Listing
May 2021

Prediction Model for Freedom from TLR from a Multi-study Analysis of Long-Term Results with the Zilver PTX Drug-Eluting Peripheral Stent.

Cardiovasc Intervent Radiol 2021 Feb 6;44(2):196-206. Epub 2020 Oct 6.

Department of Medicine, Ohio Health/Riverside Methodist Hospital, Columbus, OH, USA.

Purpose: Develop a prediction model to determine the impact of patient and lesion factors on freedom from target lesion revascularization (ffTLR) for patients who are candidates for Zilver PTX drug-eluting stent (DES) treatment for femoropopliteal lesions.

Methods: Patient factors, lesion characteristics, and TLR results from five global studies were utilized for model development. Factors potentially associated with TLR (sex, age, diabetes, hypertension, hypercholesterolemia, renal disease, smoking status, Rutherford classification, lesion length, reference vessel diameter (RVD), popliteal involvement, total occlusion, calcification severity, prior interventions, and number of runoff vessels) were analyzed in a Cox proportional hazards model. Probability of ffTLR was generated for three example patient profiles via combinations of patient and lesion factors. TLR was defined as reintervention performed for ≥ 50% diameter stenosis after recurrent clinical symptoms.

Results: The model used records from 2227 patients. The median follow-up time was 23.9 months (range: 0.03-60.8). The Kaplan-Meier estimates for ffTLR were 90.5% through 1 year and 75.2% through 5 years. In a multivariate analysis, sex, age, Rutherford classification, lesion length, RVD, total occlusion, and prior interventions were significant factors. The example patient profiles have predicted 1-year ffTLRs of 97.4, 92.3, and 86.0% and 5-year predicted ffTLRs of 92.8, 79.5, and 64.8%. The prediction model is available as an interactive web-based tool ( https://cooksfa.z13.web.core.windows.net ).

Conclusions: This is the first prediction model that uses an extensive dataset to determine the impact of patient and lesion factors on ffTLR through 5 years and provides an interactive web-based tool for expected patient outcomes with the Zilver PTX DES.

Clinical Trial Registrations: Zilver PTX RCT unique identifier: NCT00120406; Zilver PTX single-arm study unique identifier: NCT01094678; Zilver PTX China study unique identifier: NCT02171962; Zilver PTX US post-approval study unique identifier: NCT01901289; Zilver PTX Japan post-market surveillance study unique identifier: NCT02254837.

Levels Of Evidence: Zilver PTX RCT: Level 2, randomized controlled trial; Single-arm study: Level 4, large case series; China study: Level 4, case series; US post-approval study: Level 4, case series Japan PMS study: Level 4, large case series.
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http://dx.doi.org/10.1007/s00270-020-02648-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7806559PMC
February 2021

Direct percutaneous embolization of aneurysm sac: a safe and effective procedure to treat post-EVAR type II endoleaks.

Radiol Med 2021 Feb 13;126(2):258-263. Epub 2020 Jul 13.

Department of Emergency Radiology, "Careggi" University Hospital, Florence, Italy.

Purpose: To report safety and effectiveness of type II endoleak embolization, with percutaneous direct aneurysm sac puncture.

Materials And Methods: Fifty patients, 31 male (mean age 55 ± 5), with post-EVAR type-II endoleak underwent direct percutaneous sac puncture for embolization. Procedures were performed, under local anesthesia. Sac puncture was done using a 20G needle under rotational angiography guidance. A coaxial system (4 Fr catheter + 2.7 microcatheter) was used to navigate the sac. During the follow-up period, all patients underwent contrast-enhanced ultrasound (CEUS) at 6 and 12 months.

Results: Technical success, with complete exclusion of the aneurysm sac, was achieved in all cases. Time of procedure varied between 36 and 68 min (mean 51.36 min). Mean fluoroscopy time was 16.7 min. A posterior left access was used in 41 cases, posterior right access in 6 cases, and an anterior approach in 3. In 19 cases (38%), one or more feeding vessels were visualized and embolized. Sac embolization was done using Onyx plus micro-coils in 31 cases (62%) and Onyx alone in 19 cases (38%). Mean amount of Onyx was 6 ml. No complications, correlated with the direct percutaneous sac puncture, or to Onyx injection occurred. After 1-year follow-up, sac shrinkage occurred in 34 cases (68%), while in 16 patients (32%) sac size remained stable without evidence of sac perfusion.

Conclusion: Percutaneous direct sac embolization using Onyx in combination or not with microcoils represents a safe and valid technique to solve post-EVAR type II endoleaks.
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http://dx.doi.org/10.1007/s11547-020-01247-2DOI Listing
February 2021

CIRSE Standards of Practice on Analgesia and Sedation for Interventional Radiology in Adults.

Cardiovasc Intervent Radiol 2020 Sep 17;43(9):1251-1260. Epub 2020 Jun 17.

Department of Interventional Radiology, St George's University of London, London, UK.

This CIRSE Standards of Practice document provides best practices for the safe administration of procedural sedation and analgesia for interventional radiology procedures in adults. The document is aimed at health professionals involved in the provision of sedation and analgesia during interventional radiology procedures. The document has been developed by a writing group consisting of physicians with internationally recognised expertise in interventional radiology, and analgesia and sedation.
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http://dx.doi.org/10.1007/s00270-020-02536-zDOI Listing
September 2020

The Voyager PAD study: a game changer in medical treatment after endovascular recanalization on peripheral arterial disease?

Authors:
Fabrizio Fanelli

Cardiovasc Intervent Radiol 2020 10 20;43(10):1587-1588. Epub 2020 May 20.

Vascular and Interventional Radiology Department, "Careggi" University Hospital, Florence, Italy.

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http://dx.doi.org/10.1007/s00270-020-02524-3DOI Listing
October 2020

Rivaroxaban in Peripheral Artery Disease after Revascularization.

N Engl J Med 2020 05 28;382(21):1994-2004. Epub 2020 Mar 28.

From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.

Background: Patients with peripheral artery disease who have undergone lower-extremity revascularization are at high risk for major adverse limb and cardiovascular events. The efficacy and safety of rivaroxaban in this context are uncertain.

Methods: In a double-blind trial, patients with peripheral artery disease who had undergone revascularization were randomly assigned to receive rivaroxaban (2.5 mg twice daily) plus aspirin or placebo plus aspirin. The primary efficacy outcome was a composite of acute limb ischemia, major amputation for vascular causes, myocardial infarction, ischemic stroke, or death from cardiovascular causes. The principal safety outcome was major bleeding, defined according to the Thrombolysis in Myocardial Infarction (TIMI) classification; major bleeding as defined by the International Society on Thrombosis and Haemostasis (ISTH) was a secondary safety outcome.

Results: A total of 6564 patients underwent randomization; 3286 were assigned to the rivaroxaban group, and 3278 were assigned to the placebo group. The primary efficacy outcome occurred in 508 patients in the rivaroxaban group and in 584 in the placebo group; the Kaplan-Meier estimates of the incidence at 3 years were 17.3% and 19.9%, respectively (hazard ratio, 0.85, 95% confidence interval [CI], 0.76 to 0.96; P = 0.009). TIMI major bleeding occurred in 62 patients in the rivaroxaban group and in 44 patients in the placebo group (2.65% and 1.87%; hazard ratio, 1.43; 95% CI, 0.97 to 2.10; P = 0.07). ISTH major bleeding occurred in 140 patients in the rivaroxaban group, as compared with 100 patients in the placebo group (5.94% and 4.06%; hazard ratio, 1.42; 95% CI, 1.10 to 1.84; P = 0.007).

Conclusions: In patients with peripheral artery disease who had undergone lower-extremity revascularization, rivaroxaban at a dose of 2.5 mg twice daily plus aspirin was associated with a significantly lower incidence of the composite outcome of acute limb ischemia, major amputation for vascular causes, myocardial infarction, ischemic stroke, or death from cardiovascular causes than aspirin alone. The incidence of TIMI major bleeding did not differ significantly between the groups. The incidence of ISTH major bleeding was significantly higher with rivaroxaban and aspirin than with aspirin alone. (Funded by Bayer and Janssen Pharmaceuticals; VOYAGER PAD ClinicalTrials.gov number, NCT02504216.).
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http://dx.doi.org/10.1056/NEJMoa2000052DOI Listing
May 2020

Transjugular intrahepatic portosystemic shunt (TIPS): current indications and strategies to improve the outcomes.

Intern Emerg Med 2020 01 9;15(1):37-48. Epub 2020 Jan 9.

Department of Experimental and Clinical Medicine, University of Florence, Viale Morgagni 85, 50134, Florence, Italy.

Transjugular intrahepatic portosystemic shunt (TIPS) represents a very effective treatment of complications of portal hypertension. Established indications to TIPS in cirrhotic patients include portal hypertensive bleeding and refractory ascites. Over the years additional indications have been proposed, such as the treatment of vascular disease of the liver, hepatic hydrothorax, hepatorenal syndrome and bleeding from ectopic varices. Indications under evaluation include treatment of portal hypertension prior to major abdominal surgery and treatment of portal vein thrombosis. In spite of these advances, there are still uncertainties regarding the appropriate workup for patients to be scheduled for TIPS. Moreover, prevention and management of post-TIPS complications including hepatic encephalopathy and heart failure are still suboptimal. These issues are particularly relevant considering aging in TIPS candidates in Western countries. Correct selection of patients is mandatory to prevent complications which may eventually frustrate the good hemodynamic results and worsen the patient's quality of life or even life expectancy. The possible role of small diameter TIPS to prevent post-procedural complications is discussed.
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http://dx.doi.org/10.1007/s11739-019-02252-8DOI Listing
January 2020

Provisional Stenting Using the Zilver PTX Drug-Eluting Stent After Drug-Coated Balloon Angioplasty: Initial Experience From the Double Drug Dose "3D" Study.

J Endovasc Ther 2020 02 22;27(1):34-41. Epub 2019 Oct 22.

Department of Radiology, "Careggi" University Hospital, University of Florence, Italy.

To explore the provisional use of a drug-eluting stent (DES) after suboptimal drug-coated balloon (DCB) angioplasty in complex, calcified femoropopliteal lesions. A prospective, single-center, investigator-initiated pilot study enrolled 15 patients (mean age 71.3 years; 9 men) with symptomatic stenosis (n=6) or occlusion (n=9) of the native superficial femoral and/or proximal popliteal arteries who experienced suboptimal DCB dilation despite postdilation. Lesion characteristics were evaluated with computed tomography angiography and duplex ultrasound confirmed by intravascular ultrasound. Follow-up included clinical and imaging evaluations as well as blood tests to monitor inflammatory markers. Endpoints included systemic inflammation, acute/chronic thrombosis, aneurysm formation, and mortality. Provisional stenting was required for residual stenosis >50% in 4 cases and flow-limiting dissection in 11. Provisional spot stenting was done using the Zilver PTX DES. Clinical improvement was observed in all cases. After 24-month follow-up all patients were alive and in good clinical condition. One- and 2-year primary patency rates were 93.3% and 92.9%, respectively; secondary patency was 100%. Restenosis required reintervention in 2 cases. No local or systemic complications or toxicity were observed due to the use of a double dose of paclitaxel. No significant increase in any inflammation marker was observed in the perioperative period, and no aneurysm formation was seen over 24 months of follow-up. Combined DCB plus DES therapy seems to be safe and correlated with high primary patency following suboptimal angioplasty. Larger studies are required to confirm the safety and efficacy of this approach.
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http://dx.doi.org/10.1177/1526602819884062DOI Listing
February 2020

Genetic and environmental factors on heart rate, mean arterial pressure and carotid intima-media thickness: A longitudinal twin study.

Cardiol J 2021 6;28(3):431-438. Epub 2019 Sep 6.

Italian Twin Registry, Centre for Behavioural Sciences and Mental Health; Istituto Superiore di Sanità, Viale Regina Elena 299, 00161 Rome, Italy.

Background: Heart rate (HR), mean arterial pressure (MAP) and carotid intima-media thickness (cIMT) are moderately heritable cardiovascular traits, but the environmental effects on the longitudinal change of their heritability have never been investigated.

Methods: 368 Italian and Hungarian twins (107 monozygotic, 77 dizygotic) underwent oscillometric measurement and B-mode sonography of bilateral carotid arteries in 2009/2010 and 2014. Within- -individual/cross-study wave, cross-twin/within-study wave and cross-twin/cross-study wave correlations were estimated, and bivariate Cholesky models were fitted to decompose the total variance at each wave and covariance between study waves into additive genetic, shared and unique environmental components.

Results: For each trait, a moderate longitudinal stability was observed, with within-individual/crosswave correlations of 0.42 (95% CI: 0.33-0.51) for HR, 0.34 (95% CI: 0.24-0.43) for MAP, and 0.23 (95% CI: 0.12-0.33) for cIMT. Cross-twin/cross-wave correlations in monozygotic pairs were all significant and substantially higher than the corresponding dizygotic correlations. Genetic continuity was the main source of longitudinal stability, with across-time genetic correlations of 0.52 (95% CI: 0.29-0.71) for HR, 0.56 (95% CI: 0.31-0.81) for MAP, and 0.36 (95% CI: 0.07-0.64) for cIMT. Overlapping genetic factors explained respectively 57%, 77%, and 68% of the longitudinal covariance of the HR, MAP and cIMT traits.

Conclusions: Genetic factors have a substantial role in the longitudinal change of HR, MAP and cIMT; however, the influence of unique environmental factors remains relevant. Further studies should better elucidate whether epigenetic mechanisms have a role in influencing the stability of the investigated traits over time.
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http://dx.doi.org/10.5603/CJ.a2019.0089DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8169182PMC
September 2021

Peripheral artery disease and amputations with Sodium-Glucose co-Transporter-2 (SGLT-2) inhibitors: A meta-analysis of randomized controlled trials.

Diabetes Res Clin Pract 2019 Jul 28;153:138-144. Epub 2019 May 28.

Diabetology, Careggi Hospital and University of Florence, Italy. Electronic address:

Background: Concerns have been raised on the risk of lower limb amputations with SGLT-2 inhibitors. Aim of the present metanalysis is the assessment of the effect of SGLT-2inhibitors on peripheral artery disease and lower limb amputations in randomized controlled trials performed in patients with type 2 diabetes.

Methods: A Medline and Embase search for "Canaglifozin" OR "Dapaglifozin" OR "Empaglifozin" OR "Ertuglifozin" OR "Ipraglifozin" OR Tofoglifozin" OR "Luseoglifozin" was performed, collecting randomized clinical trials (duration > 12 weeks) up to December 1st, 2018, comparing SGLT-2i at approved dose with placebo or other active comparators different from SGLT-2 inhibitors. Furthermore, unpublished studies were searched in the www.clinicaltrials.gov register. Separate analyses were performed for individual molecules of the class. In addition, a separate analysis was performed for placebo-controlled trials. Mantel-Haenszel odds ratio with 95% Confidence Interval (MH-OR) was calculated for all outcomes defined above.

Results: A total of 27 trials fulfilling the inclusion criteria was identified. The overall incidence of peripheral artery disease was increased with SGLT-2 inhibitors (MH-OR: 1.26 [1.04, 1.52]). The increase of risk was statistically significant only with canagliflozin. MH-OR for amputation in the three cardiovascular safety trials with SGLT-2 inhibitors was 1.22 [0.59-2.52].

Conclusions: At present, there is no reason to believe that empagliflozin or dapagliflozin increase the risk of either peripheral artery disease of lower limb amputations. Canagliflozin could be associated with a specific risk, which needs to be further investigated.
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http://dx.doi.org/10.1016/j.diabres.2019.05.028DOI Listing
July 2019

Intravascular lithotripsy for calcific coronary and peripheral artery stenoses.

EuroIntervention 2019 Oct;15(8):714-721

Structural Interventional Cardiology, Careggi University Hospital, Florence, Italy.

Heavily calcified lesions may be difficult to dilate adequately with conventional balloons and stents, which causes frequent periprocedural complications and higher rates of target lesion revascularisation (TLR). High-pressure non-compliant balloon angioplasty may be of insufficient force to modify calcium and, even when successful, may be limited in its ability to modify the entire calcified lesion. Scoring and cutting balloons hold theoretical value but data to support their efficacy are lacking and, because of their high lesion crossing profile, they often fail to reach the target lesion. Rotational and orbital atherectomy target superficial calcium; however, deep calcium, which may still impact on vessel expansion and luminal gain, is not affected. Intravascular lithotripsy (IVL), based on lithotripsy for renal calculi, is a new technology which uses sonic pressure waves to disrupt calcium with minimal impact to soft tissue. Energy is delivered via a balloon catheter, analogous to contemporary balloon catheters, with transmission through diluted ionic contrast in a semi-compliant balloon inflated at low pressure with sufficient diameter to achieve contact with the vessel wall. With coronary and peripheral balloons approved in Europe, peripheral balloons approved in the USA and multiple new trials beginning, we review the indications for these recently introduced devices, summarise the clinical outcomes of the available trials and describe the design of ongoing studies.
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http://dx.doi.org/10.4244/EIJ-D-18-01056DOI Listing
October 2019

Transjugular Intrahepatic Portosystemic Shunt does not affect the efficacy and safety of direct-acting antivirals in patients with advanced cirrhosis: A real-life, case-control study.

Dig Liver Dis 2019 06 7;51(6):870-874. Epub 2019 Feb 7.

Department of Experimental and Clinical Medicine, University of Florence, Italy; Research Center Denothe, University of Florence, Italy. Electronic address:

Background: Transjugular Intrahepatic Portosystemic Shunt (TIPS) is a well-established treatment for complications of portal hypertension.

Aims: To analyze the impact of TIPS on virologic response and safety profile in patients treated with direct-acting antivirals (DAAs).

Methods: We analyzed data from HCV-positive cirrhotic patients treated with DAAs. Twenty-one patients with previous TIPS placement were compared with 42 matched subjects without TIPS. Logistic regression was used to identify predictors of hepatic function worsening and adverse events.

Results: No differences were found between the two groups in particular regarding sustained virologic response (92.5 and 97.6% in TIPS vs no-TIPS, p = 0.559). Model for End-stage Liver Disease (MELD) of both TIPS and no-TIPS groups declined from baseline to week 24 of follow-up (from 12.5 ± 3.5 to 10.8 ± 3.4 and from 11.1 ± 3.5 to 10.3 ± 3.4, p = 0.044 and 0.025). There were no differences in adverse event rates. At univariate analysis, age was associated with MELD increase from baseline to week 24 (OR 1.111, 95% CI 1.019-1.211, p = 0.017), and patients with higher baseline MELD developed serious adverse events more frequently (OR 0.815, 95% CI 0.658-1.010, p = 0.062). Patients with or without TIPS did not show differences in transplant-free survival.

Conclusion: TIPS placement does not affect virologic response and clinical outcome of patients receiving DAAs.
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http://dx.doi.org/10.1016/j.dld.2018.11.015DOI Listing
June 2019

Use of Paclitaxel-Eluting Technologies in the Femoropopliteal Segment Under Scrutiny Over Possible Link to Late All-Cause Mortality: Time to Panic or an Opportunity to Resurge?

J Endovasc Ther 2019 02;26(1):41-43

3 Department of Angiology, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany.

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http://dx.doi.org/10.1177/1526602818824682DOI Listing
February 2019

Clinical and endovascular practice in interventional radiology: a contemporary European analysis.

CVIR Endovasc 2018 28;1(1). Epub 2018 Jun 28.

2Department of Interventional Radiology, Beaumont Hospital and Royal College of Surgeons in Ireland, Dublin 9, Ireland.

Background: The purpose of this survey was to determine the current trends in endovascular practice by Interventional Radiologists (IR's) across Europe and to understand the engagement by Interventional Radiology (IR) with clinical practice. CIRSE European members were invited to participate in an online survey between July 11th, 2016 and August 8th, 2016. A 54 question survey was created to capture a comprehensive overview of IR endovascular practice and clinical engagement.

Results: Four hundred and five valid responses were received (9.9%) from a broad geographic distribution from across Europe. 76% of IR's practised in centres with more than 400 beds as 60% worked in an academic or university teaching hospital. 36% dedicated 80-100% of their time to IR and 59% dedicated at least 60% of their time to IR. 24/7 IR on-call was available in the hospitals of 73% or respondents. 78% had dedicated IR nursing staff and 67% had nursing support on-call, 55% had inpatient admission privileges and 27% had dedicated IR inpatient beds. 65% of IR's had admitting rights to day-case beds. 42% ran IR outpatient clinics and 36% performed ward rounds. 81% of respondents performed peripheral arterial disease (PAD) intervention and IR was the main provider of PAD intervention in 67% of centres. Vascular Surgery or Medicine were the main referrers (71%) to IR for PAD intervention. 37% of centres had a hybrid operating theatre and 80% of IR's had access to this.

Conclusion: IR remains a substantial player in the field of PAD Intervention. The continued evolution of outpatient clinics and clinical practice is key to retention and future expansion in the field of endovascular therapy for PAD.
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http://dx.doi.org/10.1186/s42155-018-0010-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6319508PMC
June 2018

Genetic and environmental determinants of longitudinal stability of arterial stiffness and wave reflection: a twin study.

J Hypertens 2018 12;36(12):2316-2323

Italian Twin Registry, Centre for Behavioural Sciences and Mental Health, Istituto Superiore di Sanità, Rome, Italy.

Background: We aimed at evaluating the impact of genetic and environmental factors on longitudinal changes in aortic pulse wave velocity (aPWV) and aortic augmentation index (aAIx).

Method: Three hundred and sixty-eight Italian and Hungarian adult twins (214 monozygotic, 154 dizygotic) underwent repeated evaluations of aPWV and aAIx (TensioMed Arteriograph). Within-individual/cross-wave, cross-twin/within-wave and cross-twin/cross-wave correlations were calculated; bivariate Cholesky models were fitted to calculate additive genetic (A), shared environmental (C) and unique environmental (E) components.

Results: For both aPWV and aAIx, cross-twin correlations in monozygotic pairs (r between 0.35 and 0.56) were all significant and always higher than in dizygotic pairs, both at wave 1 and at wave 2. Heritability and unshared environmental proportion of variance at each wave were substantially time-invariant for aPWV (heritability 0.51, 95% CI 0.36-0.63 at wave 1; 0.49, 95% CI 0.34-0.62 at wave 2), whereas for aAIx, we observed a diminished genetic effect (heritability 0.57, 95% CI 0.45-0.67 at wave 1; 0.37, 95% CI 0.21-0.51 at wave 2). Overlapping genetic factors explained a high proportion (0.88, 95% CI 0.61-1.00) of longitudinal covariance for aPWV, and had a relatively lower impact on aAIx (0.55, 95% CI 0.35-0.70). Genetic correlations of aPWV (r = 0.64, 95% CI 0.42-0.85) and aAIx (r = 0.70, 95% CI 0.52-0.87) between waves were lower than 1, suggesting a potential contribution of novel genetic variance on arterial stiffening.

Conclusion: Changes in aPWV and aAIx over time are largely genetically determined. Our results might stimulate further studies on genetic and epigenetic factors influencing the process of vascular ageing.
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http://dx.doi.org/10.1097/HJH.0000000000001869DOI Listing
December 2018

Updated Clinical and Radiological Classification of Lower Limb Atherosclerotic Disease.

Ann Vasc Surg 2019 Feb 13;55:272-284. Epub 2018 Aug 13.

Department of Interventional Radiology, Azienda Universitario Ospedaliera "Careggi", Florence, Italy.

Lower limb atherosclerotic disease has classically been classified as acute or chronic; however, this is an evolving process that has a wide spectrum of clinical and imaging aspects. Owing to the evolvement of endovascular and imaging techniques, we have now garnered new information regarding the pathophysiology and behavior of atherosclerotic disease, also in response to endovascular and surgical techniques. Clinical presentation can actually be classified according to the time of presentation, ranging from acute (<2 weeks) and subacute (from 2 weeks to 3 months) to chronic (over 3 months) and acute/subacute on underlying chronic disease. Imaging characteristics such as the presence of thrombus, number of collaterals, and target vessel wall features may help in defining the correct type of atherosclerotic lesion, triggering the appropriate treatment strategy. Clinical and imaging characteristics of those different stages are complex and not systematically addressed by current guidelines, that do not show any specific recommendations for imaging pathways/characteristics or treatment. This review illustrates the clinical and imaging characteristics of the different stages of lower limb atherosclerotic disease and related treatment options.
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http://dx.doi.org/10.1016/j.avsg.2018.06.011DOI Listing
February 2019

Overcoming glucose delivery by on-line hemodiafiltration: a feasible chimera for diabetics on dialysis.

J Nephrol 2019 Feb 6;32(1):151-154. Epub 2018 Jun 6.

Technical Dialysis and Clinical Application Specialist Nipro Medical Europe Italian Branch, Milan, Italy.

The increasing number of patients with diabetes undergoing renal replacement therapy has raised interest in the issue of glucose delivery with the substitution fluid-over 20 g per session. The ideal situation would be to have a glucose-containing bath to avoid glycemic disarrays and a glucose-free substitution fluid. But this seems a chimera because the substitution fluid is nothing else than an ultrapure dialysis bath. In this technical note, we present a cheap solution to realize the desired mix, using a commercially available glucose-free dialysate and adding glucose in the inlet dialysate compartment of the dialyzer by means of a common pump and a unique handmade T-tube. Our in vitro experiments showed glucose levels in the dialysate (mean ± SD, mg/dl): 99.7 ± 4.6 at baseline, 100.7 ± 7.3 at mid-session and 100.7 ± 2.1 at the end of dialysis, whereas measurements in the substitution fluid always gave a "low" output (p < 0.0001). Similar results were obtained in single 1- and 4-h in vivo experiments carried out in a non-diabetic overweight hemodialysis patient. Our simple, yet unequivocal, results lay the foundation for assembling a hemodialysis machine equipped with an infusion pump to modify the on-line substitution fluid without affecting the dialysate. This would overcome the ethical issue of delivering glucose intravenously in certain groups of patients.
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http://dx.doi.org/10.1007/s40620-018-0503-5DOI Listing
February 2019

Rationale and design for the Vascular Outcomes study of ASA along with rivaroxaban in endovascular or surgical limb revascularization for peripheral artery disease (VOYAGER PAD).

Am Heart J 2018 05 3;199:83-91. Epub 2018 Feb 3.

CPC Clinical Research, Aurora, CO; University of Colorado School of Medicine, Division of Cardiology, University of Colorado Denver, Aurora, CO. Electronic address:

Background: Patients with peripheral artery disease (PAD) undergoing a lower-extremity revascularization are at heightened risk for ischemic cardiac and limb events. Although intensification of antithrombotic therapy after revascularization has demonstrated benefit in coronary disease populations, this approach has not been well studied or shown consistent benefit in PAD. Recent trial evidence demonstrated that a treatment strategy of rivaroxaban added to background antiplatelet therapy reduced ischemic risk in patients following recent acute coronary syndromes, as well as in patients with stable atherosclerotic vascular disease. Whether these benefits extend to the population of patients with symptomatic lower-extremity PAD undergoing revascularization is the objective of the VOYAGER PAD trial.

Study Design: VOYAGER PAD is an international randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of rivaroxaban in symptomatic PAD patients undergoing a peripheral surgical and/or endovascular revascularization. Patients are randomized in a 1:1 ratio to either rivaroxaban 2.5 mg twice daily or placebo, on a background of low-dose aspirin (100 mg daily). In addition, the use of a limited course of P2Y inhibition is allowed at the discretion of the site investigator. The primary efficacy end point is a novel composite of myocardial infarction, ischemic stroke, cardiovascular death, acute limb ischemia, and major amputation of vascular etiology. The primary safety end point is major bleeding according to the Thrombolysis in Myocardial Infarction definition. Enrolment began in August 2015 and will complete randomization of at least 6,500 patients by January 2018. This event-driven trial is expected to observe outcomes over a mean patient follow-up of 30 months.

Conclusions: VOYAGER PAD is evaluating the efficacy of rivaroxaban added to background antiplatelet therapy to reduce major cardiovascular and limb ischemic vascular outcomes in the high-risk population of PAD patients undergoing peripheral revascularization.
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http://dx.doi.org/10.1016/j.ahj.2018.01.011DOI Listing
May 2018

Current Status of Distal Embolization in Femoropopliteal Endovascular Interventions.

Vasc Endovascular Surg 2018 Aug 18;52(6):440-447. Epub 2018 Apr 18.

4 Department of Interventional Radiology, Azienda Ospedaliera Universitaria "Careggi", Florence, Italy.

The application of advanced endovascular techniques in very complex femoropopliteal atherosclerotic lesions has shown to expose patients to a higher risk of distal embolization (DE). This complication can affect both the short- and long-term outcomes, leading to worsening ischemia, early minor/major amputation, and longer hospital stay. Recently, there has been an increasing body of evidence on pathophysiology and clinical-radiological management of DE that however has not been systematically addressed by guidelines. The aim of this review was to analyze the current evidence outlining definition and classification, risk assessment, prevention, and management strategies of DE in femoropopliteal endovascular interventions.
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http://dx.doi.org/10.1177/1538574418764050DOI Listing
August 2018

Aortic Dissection: Novel Surgical Hybrid Procedures.

Interv Cardiol 2017 May;12(1):56-60

Department of Interventional Radiology, University College Hospital Galway, Galway, Ireland.

The management of patients with aortic dissection is challenging and its treatment is an area of development and innovation. Conventional surgical techniques are associated with significant risks in terms of mortality and morbidity in such high-risk patients. As a result of cumulative advances in technology, classical surgical techniques have been improved and enhanced by the newer endovascular approaches, leading to novel surgical hybrid procedures. Impressive early results have been seen with frozen elephant techniques, revascularisation of the supra-aortic branches and branched/fenestrated thoracic endovascular aortic repair-alone procedures. This review describes the techniques involved in the latest hybrid procedures for aortic dissection and their outcomes.
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http://dx.doi.org/10.15420/icr.2016:16:3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5808688PMC
May 2017

Under-dilated TIPS Associate With Efficacy and Reduced Encephalopathy in a Prospective, Non-randomized Study of Patients With Cirrhosis.

Clin Gastroenterol Hepatol 2018 07 3;16(7):1153-1162.e7. Epub 2018 Mar 3.

HPB Surgery and Liver Transplantation Unit, Modena Hospital, University of Modena and Reggio Emilia, Modena, Italy.

Background & Aims: Portosystemic encephalopathy (PSE) is a major complication of trans-jugular intrahepatic porto-systemic shunt (TIPS) placement. Most devices are self-expandable polytetrafluoroethylene-covered stent grafts (PTFE-SGs) that are dilated to their nominal diameter (8 or 10 mm). We investigated whether PTFE-SGs dilated to a smaller caliber (under-dilated TIPS) reduce PSE yet maintain clinical and hemodynamic efficacy. We also studied whether under-dilated TIPS self-expand to nominal diameter over time.

Methods: We performed a prospective, non-randomized study of 42 unselected patients with cirrhosis who received under-dilated TIPS (7 and 6 mm) and 53 patients who received PTFE-SGs of 8 mm or more (controls) at referral centers in Italy. After completion of this study, dilation to 6 mm became the standard and 47 patients were included in a validation study. All patients were followed for 6 months; Doppler ultrasonography was performed 2 weeks and 3 months after TIPS placement and every 6 months thereafter. Stability of PTFE-SG diameter was evaluated by computed tomography analysis of 226 patients with cirrhosis whose stent grafts increased to 6, 7, 8, 9, or 10 mm. The primary outcomes were incidence of at least 1 episode of PSE grade 2 or higher during follow up, incidence of recurrent variceal hemorrhage or ascites, incidence of shunt dysfunction requiring TIPS recanalization, and reduction in porto-caval pressure gradient.

Results: PSE developed in a significantly lower proportion of patients with under-dilated TIPS (27%) than controls (54%) during the first year after the procedure (P = .015), but the proportions of patients with recurrent variceal hemorrhage or ascites did not differ significantly between groups. No TIPS occlusions were observed. These results were confirmed in the validation cohort. In an analysis of self-expansion of stent grafts, during a mean follow-up period of 252 days after placement, none of the PTFE-SGs self-expanded to the nominal diameter in hemodynamically relevant sites (such as portal and hepatic vein vascular walls).

Conclusions: In prospective, non-randomized study of patients with cirrhosis, we found under-dilation of PTFE-SGs during TIPS placement to be feasible, associated with lower rates of PSE, and effective.
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http://dx.doi.org/10.1016/j.cgh.2018.01.029DOI Listing
July 2018

Correction to: Clinical and endovascular practice in interventional radiology: a contemporary European analysis.

CVIR Endovasc 2018 21;1(1):17. Epub 2018 Aug 21.

2Department of Interventional Radiology, Beaumont Hospital and Royal College of Surgeons in Ireland, Dublin 9, Ireland.

[This corrects the article DOI: 10.1186/s42155-018-0010-8.].
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http://dx.doi.org/10.1186/s42155-018-0023-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6319505PMC
August 2018

Genetic influence on femoral plaque and its relationship with carotid plaque: an international twin study.

Int J Cardiovasc Imaging 2018 Apr 11;34(4):531-541. Epub 2017 Oct 11.

Centre for Behavioural Sciences and Mental Health, Istituto Superiore di Sanità, Rome, Italy.

To disentangle genetic and environmental influences on the development of femoral plaques using a population of adult twins. To evaluate the potential role of shared genetic and environmental factors in the co-occurrence of femoral and carotid plaques. The sample included 566 twins belonging to 164 monozygotic (MZ) and 119 dizygotic (DZ) twin pairs, who underwent peripheral arterial assessment by B-mode ultrasound in different centers. The variance in femoral plaques onset was due to genetic factors and the remaining 50% was explained by common (15%) and unique (35%) environmental factors. Findings on sidedness and number of femoral plaques indicated that also these traits were mainly under genetic control. No effect of common environment was found on plaques composition, and variability of this trait was explained by genetics (64%) and unique environment (36%). Covariation between the liabilities to carotid and femoral plaques was mainly attributed to shared genes (77%), with the remaining 23% explained by individual-specific environmental factors shared by the two districts. Inter-individual differences in plaque onset as well as in their number, sidedness and composition are mainly genetic in origin. The results on the cooccurrence of carotid and femoral plaque underline the genetic role in atherogenesis.
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http://dx.doi.org/10.1007/s10554-017-1256-2DOI Listing
April 2018

Effective treatment of benign biliary strictures with a removable, fully covered, self-expandable metal stent: A prospective, multicenter European study.

United European Gastroenterol J 2017 Apr 7;5(3):398-407. Epub 2016 Sep 7.

Department of Gastroenterology, Klinikum Ludwigsburg, University of Heidelberg, Germany.

Background: Temporary placement of removable, fully covered, self-expandable metal stents (fcSEMS) for treatment of benign biliary strictures (BBS) has been reported to be effective. However, the optimal extraction time point remains unclear and stent migration has been a major concern.

Objective: The objective of this study was to evaluate the efficacy and safety of this treatment modality using an fcSEMS with a special antimigration design and prolonged stent indwell time.

Methods: We performed a prospective, single-arm study at six tertiary care centers in Europe. Patients with BBS underwent endoscopic or percutaneous implantation of an fcSEMS (GORE® VIABIL® Biliary Endoprosthesis, W.L. Gore & Associates, Flagstaff, AZ, USA). The devices were scheduled to be removed nine months later, and patients were to return for follow-up for an additional 15 months.

Results: Forty-three patients were enrolled in the study. Stricture etiology was chronic pancreatitis in the majority of patients (57.5%). All fcSEMS were placed successfully, either endoscopically (76.7%) or percutaneously (23.3%). Stent migration was observed in two patients (5.2%). Primary patency of the SEMS prior to removal was 73.0%. All attempted stent removals were successful. At removal, stricture was resolved or significantly improved without need for further therapy in 78.9% of patients. Stricture recurrence during a follow-up of two years post-implant was observed in two patients.

Conclusions: Temporary placement of the fcSEMS is a feasible, safe and effective treatment for BBS. The design of the device used in this study accounts for very low migration rates and facilitates easy stent retrieval, even after it has been in place for up to 11 months.
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http://dx.doi.org/10.1177/2050640616663757DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5415213PMC
April 2017

Comparison of Image Quality and Diagnostic Performance of Cone-Beam CT during Drug-Eluting Embolic Transarterial Chemoembolization and Multidetector CT in the Detection of Hepatocellular Carcinoma.

J Vasc Interv Radiol 2017 Jul 9;28(7):978-986. Epub 2017 May 9.

Vascular and Interventional Radiology Unit, Department of Radiological, Oncological and Anatomo-pathological Sciences, Sapienza University of Rome, Rome, Italy.

Purpose: To compare image quality and diagnostic performance of cone-beam computed tomography (CT) and multidetector CT in the detection of hypervascular hepatocellular carcinoma (HCC) in patients with cirrhosis undergoing transarterial chemoembolization with drug-eluting embolic agents.

Materials And Methods: Fifty-five consecutive patients referred for chemoembolization of hypervascular HCC were prospectively enrolled. Imaging included preprocedural multidetector CT within 1 month before planned treatment, intraprocedural cone-beam CT, and 1-month follow-up multidetector CT. Analysis of image quality was performed with calculations of lesion-to-liver contrast-to-noise ratio (LLCNR) and lesion-to-liver signal-to-noise-ratio (LLSNR). One-month follow-up multidetector CT was considered the reference standard for the detection of HCC nodules.

Results: Median LLCNR values were 3.94 (95% confidence interval [CI], 3.06-5.05) for preprocedural multidetector CT and 6.90 (95% CI, 5.17-7.77) for intraprocedural cone-beam CT (P < .0001). Median LLSNR values were 11.53 (95% CI, 9.51-12.44) for preprocedural multidetector CT and 9.36 (95% CI, 8.12-10.39) for intraprocedural cone-beam CT (P < .0104). Preprocedural multidetector CT detected 115 hypervascular nodules with typical HCC behavior, and cone-beam CT detected 15 additional hypervascular nodules that were also visible on 1-month follow-up multidetector CT.

Conclusions: Cone-beam CT has a significantly higher diagnostic performance compared with preprocedural multidetector CT in the detection of HCCs and can influence management of patients with cirrhosis by identifying particularly aggressive tumors.
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http://dx.doi.org/10.1016/j.jvir.2017.03.008DOI Listing
July 2017
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