Publications by authors named "David Pakeliani"

11 Publications

  • Page 1 of 1

Simultaneous Hybrid Treatment of Multilevel Peripheral Arterial Disease in Patients with Chronic Limb-Threatening Ischemia.

J Clin Med 2021 Jun 28;10(13). Epub 2021 Jun 28.

Department of Surgical, Oncological and Oral Sciences, University of Palermo, 90127 Palermo, Italy.

Background: Hybrid treatments (HT) aim to reduce conventional open surgery invasiveness and address multilevel peripheral arterial disease (PAD). Herein, the simultaneous HT treatment in patients with chronic limb-threatening ischemia (CLTI) is reported.

Methods: Retrospective analysis, for the period from May 2012 to April 2018, of patients presenting multilevel PAD with CLTI addressed with simultaneous HT. The outcomes of these interventions were measured the following metrics: early technical successes (within 30 days following treatment) and late technical successes (30 days or more following treatment) and included mortality, morbidity symptoms recurrence, and amputation. Survival and patencies were estimated. The median follow-up was 43.77 months.

Results: In the 45 included patients, the HT consisted of femoral bifurcation patch angioplasty followed by an endovascular treatment in 38 patients (84.4%) and endovascular treatment followed by a surgical bypass in 7 patients (15.6%). Technical success was 100% without perioperative mortality. Eight (17.8%) patients presented early complications without major amputations. During the follow-up, seven (15.6%) deaths occurred and six patients (13.3%) experienced symptoms recurrence, with five of those patients requiring major amputation. An estimated survival time of 5 years, primary patency, and secondary patency was 84.4%, 79.2%, and 83.3% respectively.

Conclusions: Hybrid treatments are effective in addressing patients presenting with multilevel PAD and CLTI. The common femoral artery involvement influences strategy selection. Larger studies with longer-term outcomes are required to validate the hybrid approach, indications, and results.
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http://dx.doi.org/10.3390/jcm10132865DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8268200PMC
June 2021

The use of the Amplatzer Vascular Plug in the prevention of endoleaks during abdominal endovascular aneurysm repair: A systematic literature review on current applications.

Vascular 2021 Jun 14:17085381211025152. Epub 2021 Jun 14.

Department of Medical and Surgical Sciences, 9325University of Catanzaro, Catanzaro, Italy.

Objectives: The Amplatzer Vascular Plug (AVP) is a vascular occlusion device designed to provide optimal embolization in several fields of the endovascular surgery. A full literature review was conducted to analyze AVPs in comparison with coils for the prevention of endoleaks during endovascular abdominal aortic aneurysm repair.

Methods: A systematic review was designed under PRISMA statement guidelines for systematic reviews and meta-analyses. The results were updated with a subsequent electronic search using Medline and Scopus databases up to December 2019.

Results: Eighteen articles making this comparison were found. In 79.7% of the cases, the target vessel was the internal iliac artery; in 1.6%, the common iliac artery; and in 16.7%, the inferior mesenteric artery. Risk of complications (buttock claudication, groin hematoma, endoleaks, and erectile dysfunction) after AVP was low. A cost comparison revealed that the mean cost for coils was around US$2262, while the average cost for the AVP was US$310.

Conclusions: The AVP is an effective and safe device for occluding peripheral vessels, proved to have lower complications rates. Compared with coil embolization, the AVP technique is potentially associated with lower procedural costs.
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http://dx.doi.org/10.1177/17085381211025152DOI Listing
June 2021

Efficacy and one-year outcomes of Luminor® paclitaxel-coated drug-eluting balloon in the treatment of popliteal artery atherosclerosis lesions.

Ann Vasc Surg 2021 May 2. Epub 2021 May 2.

Department of Surgical Oncological and Oral Sciences, University of Palermo, Palermo, Italy; Vascular Surgery Unit, AOUP "P. Giaccone", Palermo, Italy.

Purpose: Reporting outcomes with a new generation paclitaxel eluting balloon (Luminor®; iVascular, Vascular, S.L.U., Barcelona, Spain) in the popliteal district. Endovascular treatment of popliteal artery atherosclerotic disease is still debated without definitive evidences.

Methods: From January to June 2019, patients' data presenting popliteal artery atherosclerotic diseases and treated with the Luminor® (iVascular) drug eluting balloon (DEB) were prospectively collected. Critical limb ischemia (CLI) or severe claudication associated with popliteal artery stenosis >50% were the inclusion criteria. Measured outcomes were technical success, early and late results; including mortality, morbidity, symptoms recurrence, amputation, ankle-brachial index (ABI), survival, primary patency, secondary patency, freedom from restenosis. Median follow-up was 22.43 ± 4 (mean:21.58; IQR:20-24) months.

Results: Of the 33 included patients, 28 (85%) were diagnosed with CLI, with a mean preoperative run-off score of 5.39 (r:0-10; SD:3) and a chronic popliteal occlusion in 21 (64%). Technical success was achieved in all cases. Perioperative mortality was observed in 1 (3%) patient and perioperative complications in 2 (6%). During the follow-up were reported 2 symptoms recurrence; a significant ABI increase (0.57; IQR:0.41-0.47 vs. 0.69; IQR:0.50-0.67; P < 0.01); 1 (3%) major and 2 (6%) minor amputations. Estimated 24 months survival, primary patency, secondary patency, and freedom from restenosis were 97%, 96.9%, 100%, and 93.8% respectively.

Conclusions: In this prospective study, the use of the Luminor® (iVascular) was safe and effective in addressing atherosclerotic popliteal artery lesions. Larger studies with longer term-outcomes are required to assess the durability of this device in the popliteal artery.
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http://dx.doi.org/10.1016/j.avsg.2021.04.015DOI Listing
May 2021

Endovascular Treatment of Spontaneous and Isolated Infrarenal Acute Aortic Syndrome with Unibody Aortic Stent-Grafts.

World J Surg 2020 Dec 3;44(12):4267-4274. Epub 2020 Sep 3.

Department of Surgical, Oncological and Oral Sciences (Di.Chir.On.S.), University of Palermo, Via L. Giuffrè, 5, 90100, Palermo, Italy.

Introduction: Spontaneous acute aortic syndrome (IAAS) is rarely localized in the infrarenal aorta. The endovascular approach is preferred over conventional open surgery with fewer complications. However, dedicated endovascular devices for IAAS treatment are unavailable. The aim was to report a large single-center experience using unibody stent-grafts to address IAAS.

Methods: From April 2016 to March 2019, a retrospective analysis of patients presenting spontaneous and isolated IAAS was performed. Patients addressed with the unibody stent-graft (AFX endovascular AAA system; Endologix Inc., Irvine, CA) were included in the study. Indications to IAAS treatment were persistent symptoms and/or dilated abdominal aorta (>3 cm). The measured outcomes were technical success; early outcomes (<30 days) including mortality, morbidity, symptoms recurrence, and endoleak occurrence; and late outcomes (>30 days) including mortality, symptoms recurrence, endoleak occurrence, stent-graft patency, and survival. Median follow-up was 23.77 ± 10 months.

Results: Twenty-one patients with IAAS were included. Indications to treatment were symptoms in 14 (67%) patients and dilated abdominal aorta in 7 (33%). Technical success was achieved in all cases. No perioperative mortality and 1 (4.8%) early femoral access complication was encountered. During the follow-up were registered 1 (4.8%) aortic unrelated death and 1 (4.8%) stent-graft limb stenosis. The 36 months estimated survival and freedom from reintervention were 92% (CI: 37-43; SE: 1.7) and 94% (CI: 37-44; SE: 1.7), respectively.

Conclusions: The endovascular treatment of IAAS with unibody stent-graft (AFX endovascular AAA system; Endologix Inc.) is safe and effective with promising mid-term outcomes. The use of unibody stent-grafts expands the endovascular indication, despite the usual anatomic IAAS features. Larger studies with longer follow-up are required to validate the outcomes of the reported technique.
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http://dx.doi.org/10.1007/s00268-020-05754-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7599153PMC
December 2020

Endovascular Treatment of Spontaneous Internal Carotid Artery Dissection with Proximal Embolic Protection Device.

Ann Vasc Surg 2020 Jul 2;66:667.e9-667.e14. Epub 2020 Jan 2.

University of Palermo, Department of Surgical, Oncological and Oral Sciences (Di.Chir.On.S.), Palermo, Italy; Vascular Surgery Unit, Palermo, Italy.

Background: The aim of this study was to report the feasibility and outcomes with the endovascular treatment of spontaneous internal carotid artery dissections (ICADs) using a proximal embolic protection device (EPD).

Methods: This is a retrospective analysis of patients treated for spontaneous symptomatic ICAD using a proximal EPD from January 2017 to December 2018. Indication for treatment was the presence of neurologic symptoms. Early outcomes measured included technical success, perioperative mortality, and major cardiovascular or cerebrovascular complications. Late outcomes were recurrent neurologic symptoms, patency, and reinterventions.

Results: A total of 4 male patients with ICAD were included. A preoperative cerebral computed tomography positive for cerebral ischemic events was reported in all cases. In 3 patients, the neurologic symptoms consisted of a transient ischemic attack; the remaining patient presented an amaurosis fugax and aphasia. In 2 patients, ICAD was associated with a carotid significant stenosis. In all patients, the reported approach was feasible with no complications and complete anatomic dissection resolution. At a mean follow-up of 18 months, all stents are patent and no restenosis recurrence or complications were registered.

Conclusions: The use of proximal EPDs allowed the treatment of ICAD under flow arrest, minimizing the risk of stroke during the endovascular maneuvers. Larger series are required to validate this treatment strategy.
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http://dx.doi.org/10.1016/j.avsg.2019.12.019DOI Listing
July 2020

Improved technique for sheath supported contralateral limb gate cannulation in endovascular abdominal aortic aneurysm repair.

Vasa 2020 Jan 24;49(1):39-42. Epub 2019 Sep 24.

University of Palermo, Department of Surgical, Oncological and Oral Sciences, Vascular Surgery Unit, Palermo, Italy.

To present a technique of sheath supported contralateral limb gate (CLG) cannulation of modular bifurcated stent-graft in endovascular abdominal aortic repair. After totally percutaneous bilateral femoral access, the 9F introducer sheath is exchanged to a 30 cm 12 fr introducer sheath over a stiff wire contralateral to the intended main stent-graft insertion side and advanced into the aorta below the lowest renal artery. Parallel to the stiff wire within the sheath an additional standard J-tip guidewire with a 5 fr Pigtail angiographic catheter is advanced to the level of the renal arteries. After main body deployment, the 12 fr introducer sheath and J-tip wire with pigtail catheter are retracted until the CLG opening level, maintaining the stiff "buddy" wire in position to support the 12 fr sheath, maintaining its distal opening close to the contralateral gate opening to achieve easy cannulation. Retrospective analysis of video archive from July 2016 to February 2018 evidenced 55 recorded EVAR cases. All CLG cannulations were obtained with Standard J-tip or Terumo Glidewire wires and with Pig-Tail or Berenstein catheters. Technical success was 100 %. Mean fluoroscopy time to accomplish CLG cannulation was 37.6 33 (range 1-105) seconds. The aortic carrefour angulation on coronal axis strongly correlates with cannulation time p = <.001, with longer cannulation time for higher carrefour angulations on coronal axis (Pearson correlation coefficient 0.47). The use of 12 fr sheath with parallel wire introduction technique, appears to be a safe and reliable tool to facilitate CLG cannulation during EVAR procedures.
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http://dx.doi.org/10.1024/0301-1526/a000820DOI Listing
January 2020

Patient-Specific Rehearsal Feasibility Before Endovascular Repair of Ruptured Abdominal Aortic Aneurysm.

J Endovasc Ther 2019 12 3;26(6):871-878. Epub 2019 Sep 3.

Vascular Surgery Unit, Department of Surgical, Oncological and Oral Sciences, University of Palermo, Italy.

To evaluate the feasibility of a patient-specific rehearsal (PsR) before emergency endovascular aneurysm repairs (eEVAR) and its influence on the operation. From February 2016 to October 2016, 10 consecutive patients (mean age 75±7.4 years; 9 men) presenting with a ruptured abdominal aortic aneurysm (rAAA) suitable for standard EVAR were enrolled in the study. A 3-dimensional (3D) model of the abdominal aorta was generated on a virtual reality simulator based on the patient's computed tomography (CT) images. Following the patient-specific simulation setup, PsR was conducted during patient admission or in parallel with the preoperative eEVAR workup. Measured outcomes were PsR feasibility only in the first 4 patients and impact on operative performance thereafter (changes in device selection, the planning process, clinical outcomes, perioperative mortality, and complication rates). Technical metrics and timing of system setup, rehearsal, interval from patient arrival to the actual procedure, and eEVAR were recorded. Mean time for 3D model creation was 21.3±7.8 minutes (range 13-37); there was a significant positive relationship between aortic neck diameter and segmentation time (p=0.003). The overall mean time for simulator setup and PsR was 54±14 minutes (range 37-80); PsR alone was completed in a mean 31±40 minutes (95% confidence interval -60 to -2.2). The actual eEVAR procedure duration was 69±16 minutes (range 45-90). No delay in the actual eEVAR procedure was registered owing to the PsR pathway. In 6 patients, preprocedure rehearsal induced changes in operative strategy, including device selection, main body introduction side, and/or deployment configuration. In 4 cases, rehearsal was performed twice to achieve optimal performance. PsR before eEVAR was feasible in all cases and caused no time delays in the actual eEVAR procedure. PsR optimized eEVAR planning by identifying optimal strategy for stent-graft component selection and deployment.
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http://dx.doi.org/10.1177/1526602819873133DOI Listing
December 2019

Endovascular treatment of aortic arch aneurysm with a single-branched double-stage stent graft.

J Thorac Cardiovasc Surg 2017 11 11;154(5):e75-e77. Epub 2017 Jul 11.

Division of Cardiac Surgery, Department of Cardiac, Vascular and Thoracic Sciences, University of Padova, Padova, Italy.

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http://dx.doi.org/10.1016/j.jtcvs.2017.06.030DOI Listing
November 2017

Endovascular treatment of large and wide aortic neck: case report and literature review.

Gen Thorac Cardiovasc Surg 2017 Apr 10;65(4):219-224. Epub 2016 Feb 10.

Vascular Surgery Unit, University of Palermo, AOUP "P. Giaccone", Via L. Giuffrè, 5, 90100, Palermo, Italy.

Large (24-34 mm) and wide (≥35 mm) aortic necks are a contraindication to endovascular aneurysm repair (EVAR). A 63-year-old man, unfit for conventional surgery, presented a 79 mm abdominal aortic aneurysm with 36.5 mm aortic neck and a 62 mm right common iliac artery aneurysm. He was treated endovascularly with standard commercially available stent-graft using the so-called 'funnel technique'; by placing a thoracic stent-graft inside a bifurcated device to achieve proximal sealing. The completion angiography and the 6 months follow-up with computed tomography showed no stent-graft migration, limb occlusion or endoleak. The literature review reported 179 cases of large aortic neck managed with EVAR, all cases treated with standard devices. Conversely a wide aortic neck was reported in 9; in 2 cases were employed custom-made devices and in 7 standard stent-graft. The use of EVAR with commercially available stent-grafts is feasible and it represents an option especially in non-elective setting.
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http://dx.doi.org/10.1007/s11748-016-0627-2DOI Listing
April 2017

Extra-anatomic iliac to superior mesenteric artery bypass after bridge endovascular treatment for chronic mesenteric ischemia. A case report.

Ann Ital Chir 2015 Jul 3;86(ePub). Epub 2015 Jul 3.

Unlabelled: A 60 year old patient presenting chronic mesenteric Ischemia (CMI) was managed with superior mesenteric artery (SMA) stenting as bridge therapy to conventional open surgery. At 5 months follow-up, the SMA stent occluded. During this bridge period the patient gained his general condition and the body mass index (BMI) increased from 18 to 22. The patient was managed subsequently with iliac-SMA bypass in C-loop configuration. At 6 months follow-up the bypass is patent, the patient has no CMI symptoms and his BMI is 25. The endovascular approach did not preclude a subsequent conventional open surgery and it can be safely employed as bridge therapy. An improved patient clinical condition, also during a limited bridge period, can improve the conventional open surgery outcomes.

Key Words: Body Mass Index(BMI), Mesenteric artery, Mesenteric ischemia.
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July 2015

Spontaneous symptomatic common carotid artery pseudoaneurysm: case report and literature review.

Ann Vasc Surg 2015 May 11;29(4):837.e9-12. Epub 2015 Feb 11.

Vascular Surgery Unit, University Hospital 'P. Giaccone', Palermo, Italy.

Spontaneous common carotid artery pseudoaneurysm (CCAP) is rare but potentially lethal disease. A 78-year-old man presented with pain in correspondence of right neck side and slight right eye ptosis. No previous surgery, trauma, or venous catheterizations in the neck region were reported. The computed tomographic angiography (CTA) showed a 4-cm saccular CCAP. The patient was managed emergently with surgical CCAP excision. At 6-month follow-up, the patient is neck pain-free with complete ptosis regression, and the CTA shows no pathologic findings. The literature review reported 7 cases of pseudoaneurysm of carotid district. All these cases were managed by surgical approach, and in 1 case, an endovascular embolization procedure was associated before. The CTA was used in all cases but angiography in only one. In these cases, the surgical repair with pseudoaneurysm evacuation is still the treatment of choice.
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http://dx.doi.org/10.1016/j.avsg.2015.01.001DOI Listing
May 2015
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