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Sultan S.,National University of Ireland | Kavanagh E.P.,Galway Clinic | Stefanov F.,Mayo Institute of Technology, Galway | Sultan M.,National University of Ireland | And 5 more authors.
Journal of Vascular Surgery | Year: 2017

Objective Reported are initial 12-month outcomes of patients with chronic symptomatic aortic dissection managed by the Streamliner Multilayer Flow Modulator (SMFM; Cardiatis, Isnes, Belgium). Primary end points were freedom from rupture- and aortic-related death, and reduction in false lumen index. Secondary end points were patency of great vessels and visceral branches, and freedom of stroke, paraplegia, and renal failure. Methods Out of 876 SMFM implanted globally, we have knowledge of 542. To date, 312 patients are maintained in the global registry, of which 38 patients were identified as having an aortic dissection (12.2%). Indications included 35 Stanford type B dissections, two Stanford type A and B dissections, and one mycotic Stanford type B dissection. Results There were no reported ruptures or aortic-related deaths. All cause survival was 85.3% Twelve-month freedom from neurologic events was 100%, and there were no incidences of end-organ ischemia, paraplegia or renal insult. Morphologic analysis exhibited dissection remodeling by a reduction in longitudinal length of the dissected aorta, and false lumen volume. A statistically significant reduction in false lumen index (P =.016) at 12 months, and a borderline significant increase in true lumen volume (P =.053) confirmed dissection remodeling. Conclusions The SMFM is an option in management of complex pan-aortic dissection. Results highlight SMFM implantation leads to dissection stabilization with no further aneurysm progression, and no retrograde type A dissection. Thoracic endovascular aneurysm repair by SMFM ensued in freedom from aortic rupture, neurologic stroke, paraplegia and renal failure. Further analysis of the global registry data will inform long-term outcomes. © 2017 Society for Vascular Surgery

Sultan S.,Galway University Hospital | Hynes N.,Galway Clinic | Hamada N.,Galway University Hospital | Tawfick W.,Galway University Hospital
Vascular and Endovascular Surgery | Year: 2012

Patients with end-stage renal disease should have arteriovenous fistula (AVF) formation 3 to 6 months prior to commencing hemodialysis (HD). However, this is not always possible with strained health care resources. We aim to compare autologous proximal AVF (PAVF) with distal AVF (DAVF) in patients already on HD. Primary end point is 4-year functional primary. Secondary end point is freedom from major adverse clinical events (MACEs). From January 2003 to June 2009, out of 495 AVF formations, 179 (36%) patients were already on HD. These patients had 200 AVF formations (49 DAVF vs 151 PAVF) in arms in which no previous fistula had been formed. No synthetic graft was used. Four-year primary functional patency significantly improved with PAVF (68.9% ± SD 8.8%) compared to DAVF (7.3% ± SD 4.9%; P <.0001). Five-year freedom from MACE was 85% with PAVF compared to 40% with DAVF (P <.005). Proximal AVF bestows long-term functional access with fewer complications compared to DAVF for patients already on HD. © 2012 The Author(s).

Sultan S.,Galway University Hospital | Tawfick W.,Galway University Hospital | Hynes N.,Galway Clinic
Journal of Vascular Surgery | Year: 2013

Objective: The aim of this study was to evaluate duplex ultrasound arterial mapping (DUAM) as the sole imaging modality when planning for bypass surgery (BS) and endovascular revascularization (EvR) in patients with critical limb ischemia for TransAtlantic Inter-Society Consensus (TASC) II C/D infrainguinal lesions. Methods: This was a retrospective review evaluating the accuracy of DUAM as the sole imaging tool in determining patient suitability for BS vs EvR. Primary outcomes were the sensitivity and specificity of DUAM compared with intraoperative digital subtraction angiography. Secondary outcomes were procedural, hemodynamic, and clinical outcomes, amputation-free survival, and freedom from major adverse clinical events. Results: From 2002 to 2012, a total of 4783 patients with peripheral arterial disease were referred, of whom 622 critical limb ischemia patients underwent revascularization for TASC C and D lesions (EvR: n = 423; BS: n = 199). Seventy-four percent of EvR and 82% of BS were performed for TASC D (P =.218). The DUAM showed sensitivity of 97% and specificity of 98% in identifying lesions requiring intervention. Of the 520 procedures performed with DUAM alone, there was no difference regarding the number of procedures performed for occlusive or de novo lesions (EvR: 65% and 71%; BS: 87% and 78%; P =.056). Immediate clinical improvement to the Rutherford category ≤3 was 96% for EvR and 97% for BS (P =.78). Hemodynamic success was 79% for EvR and 77% for BS (P =.72). Six-year freedom from binary restenosis was 71.6% for EvR and 67.4% for BS (P =.724). Six-year freedom from target lesion revascularization was 81.1% for EvR and 70.3% for BS (P =.3571). Six-year sustained clinical improvement was 79.5% for EvR and 66.7% for BS (P = .294). Six-year amputation-free survival was 77.2% for EvR and 74.6% for BS (P =.837). There was a significant difference in risk of major adverse clinical events between EvR and BS (51% vs 70%; P =.034). Only 16.4% of patients required magnetic resonance angiography, which tended to overestimate lesions with 84% agreement with intraoperative findings. Six-year binary restenosis was 71% for DUAM procedures compared with 55% for magnetic resonance angiography procedures (P =.001), which was solely based on the prospective modality. Conclusions: The DUAM epitomizes a minimally invasive, economically proficient modality for road mapping procedural outcome in BS and EvR. It allows for high patient turnover with procedural and clinical success without compromising hemodynamic outcome. The DUAM is superior to other available modalities as the sole preoperative imaging tool in a successful limb salvage program.

Aim. Patients with thoracoabdominal aortic aneurysm (TAAA) have been classically managed by open surgical repair since 1955 but despite advances in surgical technique and the introduction of less invasive endovascular techniques, morbidity and mortality rates remain high. We report outcome using a novel uni-modular multi-layer stent technology. Methods. Out of 172 cases implanted worldwide we present the first 26 cases, in 7 countries, that were fully analyzed through the MFM registry. All were Crawford Thoraco-abdominal aortic aneurysms (11 type II, 9 type III, and 6 type IV); 75% were male; median age was 73years (57-91); 79.7% were ASA IV E; 62% were reintervention after previous TEVAR; mean aneurysm diameter was 67 mm and mean length was 167 mm. Primary endpoints are freedom from rupture and aneurysm-related death, aneurysm sac and lumen volume modulation, patency of visceral branches, and freedom from stroke and paraplegia. Secondary endpoints were technical success and all-cause mortality. Finite element analyses was performed on aortic sac pressure, shear stress, wall displacement and blood flow velocities. Results. All stents were deployed to their intended target. No aneurysm-related death occurred within 6 months. No peri-operative visceral or renal insult occurred. There were no cerebrovascular accidents, paraplegia or loss of visceral branches patency during follow-up. At 6 months, mean sac volume shrunk by 8% with lumen volume reduction of 14%. Average thrombus volume increased but thrombus to lumen ratio decreased by 23%. Finite element analysis post-MFM documented dampening of wall displacement by 80%. Wall pressure fell to 200 Pa with immediate depressurization of the aortic sac and dissipation of the maximum pressure zone. There was 55% immediate reduction in wall stress. MFM carries no risk of critical shuttering or loss of native side branches. With physiological modulation of the aneurysm, volume sac reduction was documented in 65% of cases. Conclusion. MFM offers immense promise for resolution of complex TAAA. A Global MFM Registry is required and long-term follow-up is mandatory.

Sultan S.,National University of Ireland | Tawfick W.,National University of Ireland | Hynes N.,Galway Clinic
Vascular and Endovascular Surgery | Year: 2013

We aim to compare cool excimer laser-assisted angioplasty (CELA) versus tibial balloon angioplasty (TBA) in patients with critical limb ischemia (CLI) with tibial artery occlusive disease. The primary end point is sustained clinical improvement (SCI) and amputation-free survival (AFS). The secondary end points are binary restenosis, target extremity revascularization (TER), and cost-effectiveness. From June 2005 to October 2010, 1506 patients were referred with peripheral vascular disease and 572 with CLI. A total of 80 patients underwent 89 endovascular revascularizations (EVRs) for tibial occlusions, 47 using TBA and 42 using CELA. All patients were Rutherford category 4 to 6. Three-year SCI was enhanced with CELA (81%) compared to TBA (63.8%; P =.013). Three-year AFS significantly improved with CELA (95.2%) versus TBA (89.4%; P =.0165). Three-year freedom from TER was significantly improved with CELA (92.9%) versus 78.7% TBA (P =.026). Three-year freedom from MACE was comparable in both the groups (P =.455). Patients with CELA had significantly improved quality time without symptoms of disease or toxicity of treatment (Q-TWiST) at 3 years (10.5 months; P =.048) with incremental cost of €2073.19 per quality-adjusted life year gained. Tibial EVR provides exceptional outcome in CLI. The CELA has superior SCI, AFS, and freedom from TER, with improved Q-TWiST and cost-effectiveness. © The Author(s) 2013.

Sultan S.,National University of Ireland | Hynes N.,Galway Clinic
Journal of Endovascular Therapy | Year: 2013

Purpose: To report 1-year results from the first subgroup of patients treated with the Multilayer Flow Modulator (MFM) stent for aortic aneurysm and dissection. Methods: Up to December 2012, 243 patients have been treated worldwide for aortic aneurysm and dissection with the Cardiatis MFM under the established indications for use. This retrospective review encompasses the first 55 of these patients (41 men; mean age 64.5±18 years), who were treated on a compassionate basis in 11 countries. There were 31 thoracoabdominal aortic aneurysms (8 Crawford type I, 3 type II, 9 type III, and 11 type IV), 7 arch aneurysms, 3 infrarenal abdominal aortic aneurysms, 8 suprarenal aortic aneurysms, and 6 type B dissections. Mean aneurysm diameter was 6.04±1.66 cm, and the mean length was 11.58±7.62 cm. The primary endpoint at 1 year was a composite of rupture and aneurysm-related death. The secondary endpoints were all-cause mortality, visceral branch occlusion, adverse events (i.e., stroke and paraplegia), and reintervention. Results: Technical success was 98.2%; there was no paraplegia or perioperative visceral or renal insult. The mean number of side branches covered was 3.7±1.3 per case (range 0-6); 108 stents were deployed (range 1-5). At 1 year, aneurysm-related survival was 93.7%, all-cause survival was 84.8%, intervention-free survival was 92.4%, and all of the 202 side branches were patent. There were no stent fractures. At 6 months, the mean rate of sac volume increase was 0.36% per month, resulting in a mean volume increase of 2.14%. At 12 months, the rate of increase had slowed to 0.28% per month, resulting in a total average increase in sac volume of 3.26%. The ratio of thrombus to total volume stayed almost constant over the 12 months at 0.48, while the ratio of flow to total volume fell from 0.21 to 0.12 at 12 months. Conclusion: MFM implantation instigates a process of aortic remodeling involving initial thrombus deposition, which slowed between 6 and 12 months. Increasing sac size did not herald rupture, and the MFM was not associated with loss of native side branches. With physiological modulation of the aneurysm, the MFM offers promise for resolution of complex thoracoabdominal pathology with off-the-shelf availability, but this disruptive technology requires further development and technical refinement. Long-term follow-up of the registry patients is mandatory before establishing a randomized controlled study. © 2013 by the International Society of Endovascular Specialists.

Alazzam M.,Galway Clinic | Gillespie A.,SheYeld University Teaching Hospitals | Hewitt M.,Cork Maternity University Hospital
Archives of Gynecology and Obstetrics | Year: 2011

Objectives To review the published literature concerning robotic surgery and its applications in the management of cervical carcinoma. Methods We electronically searched the MEDLINE from January 1990 until June 2010. We cross-examined article references to identify relevant articles not detected by the electronic search. Results The majority of the reported literature consisted of case series, case reports or retrospective comparisons. Twenty-one articles were included in this review covering the diVerent surgical applications: (5) radical trachelectomy, (12) radical hysterectomy, (3) pelvic exenteration and one parametrectomy. Conclusion Robotic surgery enabled more gynaecological oncologists to perform more complex procedures safely while maintaining the minimal access approach. © Springer-Verlag 2010.

Sultan S.,National University of Ireland | Hynes N.,Galway Clinic
Expert Review of Medical Devices | Year: 2015

Thoracoabdominal aortic repair is a high-risk procedure in most experienced centers, not only because of anatomical complexity but also due to the fragility of the patients in whom these aneurysms occur. Such repairs are complex, time-consuming and impose a systemic injury upon the patients, regardless of whether the repair is performed by open surgery or via a fenestrated/branched technique. The substantive risks associated with such repairs include death, dialysis and paralysis. The multilayer flow modulator (MFM) is a disruptive technology which promises a minimally invasive reproducible treatment option, with clinical results demonstrating physiological modulation of the aortic sac with abolition of spinal injury. The mode of action of MFM forces us to completely rethink aneurysm pathogenesis and, consequently, it has been met with much cynicism. We aim to uncloak some of the mystery surrounding the MFM, clarify its mode of action and explore the truth behind its clinical effectiveness. © 2015 Informa UK, Ltd.

Sultan S.,University Hospital Galway | Hynes N.,Galway Clinic | Sultan M.,University Hospital Galway
Journal of Endovascular Therapy | Year: 2014

Purpose: To scrutinize registry data on thoracoabdominal repairs performed using the Multilayer Flow Modulator (MFM) outside the indications for use (IFU) and analyze the adverse outcomes. Methods: Of 380 patients from Europe registered in the MFM Global Registry after treatment for thoracoabdominal aortic aneurysm (TAAA) or dissection, 38 (10%) patients (30 men; median age 71 years, range 30-91) treated on a compassionate basis outside the IFU were analyzed. Thirteen patients had chronic Stanford type B dissection with aneurysmal dilatation >6 cm. There were 6 mycotic and 4 saccular aneurysms in addition to 15 primary TAAAs. The mean aneurysm diameter was 7.1 cm. Ten patients presented with rupture, and 23 patients had previous open or thoracic endovascular aortic repair (TEVAR). Results: Although no death, paraplegia, stroke, or renovisceral compromise was documented during the initial hospital stay, technical success was zero. There were 31 (81.6%) cases in which there was failure to land the device in normal aorta. Other violations of the IFU included 12 with inadequate stent overlap and 11 cases involving a small MFM being deployed inside a larger one. Five of the 9 cases in which an undersized device was used resulted in a type I endoleak (failure mode I). During a mean follow-up of 10.0±6.9 months, all-cause mortality was 89.5% (34/38), of which 27 (71.1%) were aneurysm-related deaths. Overall survival, freedom from aneurysm-related death, and rupture-free survival estimates were 17.5%, 25.0%, 31.5%, respectively, at 18 months. There were 8 visceral branch complications; in all, 14 secondary endovascular interventions were required in 11 patients for endoleak (failure modes I and II) or stent foreshortening. No false lumen was completely thrombosed in the dissecting aneurysms. All aneurysms showed a mean sac growth rate of 0.12±0.16 cm/month. Factors having a significance influence on risk of aneurysm-related death included maximum aneurysm diameter (p=0.025, HR 1.37, 95% CI 1.04 to1.82), previous TEVAR (p=0.03, HR 2.44, 95% CI 1.10 to 2.08), and inadequate overlap between MFM devices (p<0.002, HR 4.02, 95% CI 1.70 to 9.49). Conclusion: There are clinical scenarios in which the MFM does not perform well. The MFM is not a solution for patients living on borrowed time and should not be used indiscriminately in patients in whom other modalities of aortic repair are not feasible. Its use must adhere to the IFU, and robust clinical data are required before constructing a randomized controlled trial. © 2014 by the International Society of Endovascular Specialists.

Sultan S.,National University of Ireland | Hynes N.,Galway Clinic | Elsafty N.,National University of Ireland | Tawfick W.,National University of Ireland
Vascular and Endovascular Surgery | Year: 2013

We aim to review an 8-year experience of median arcuate ligament syndrome (MALS) with chronic gastrointestinal ischemia (CGI) and evaluate clinical outcomes of arcuate ligament decompression, celiac sympathectomy, and selective revascularization. Between December 2002 and March 2012, of 25 patients referred with symptoms of CGI, 11 patients (10 women and 1 man) had clinical signs of abdominal angina and radiological evidence of MALS. Mean age was 50 ± 20.4 years. Median symptom duration was 34 months. All patients had median arcuate decompression and celiac sympathectomy. In all, 8 did not require revascularization, 2 had retrograde celiac and/or superior mesenteric artery (SMA) stenting, and 1 had SMA bypass. There was no mortality. The 30-day morbidity was 9%. Mean follow-up was 60 months. Eight patients noted complete relief of abdominal pain, and 1 reported some improvement. The MALS is not solely a vascular compression syndrome. The neurological component requires careful celiac plexus sympathectomy in addition to arcuate ligament decompression. © 2013 The Author(s).

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