Disruptive endovascular technology with multilayer flow modulator stents as a therapeutic option in the management of thoracoabdominal aortic aneurysms. Early results from the global independent MFM registry
Sultan S.,Galway University Hospital |
Hynes N.,Galway Clinic
Italian Journal of Vascular and Endovascular Surgery | Year: 2012
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 |
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.
Ten-year technical and clinical outcomes in TransAtlantic Inter-Society Consensus II infrainguinal C/D lesions using duplex ultrasound arterial mapping as the sole imaging modality for critical lower limb ischemia
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.
Nason G.J.,Beaumont Hospital |
O'Kelly F.,Materials Misericordiae University Hospital |
Bouchier-Hayes D.,Galway Clinic |
Quinlan D.M.,St Vincents University Hospital |
Manecksha R.P.,St Jamess Hospital
Irish Journal of Medical Science | Year: 2015
Background: Social media is the interaction among people in which they create, share or exchange information and ideas in virtual communities and web-based networks. This year, the Irish Society of Urology (ISU) expanded its involvement in social media with a preregistered Twitter hashtag (#ISU14) for the annual meeting. Aim: The aim of this study was to highlight the use of Twitter at an annual national meeting held in 2014. Methods: The Symplur healthcare analytics website was used to prospectively examine traffic related to the 2014 ISU Annual Meeting. This feature was used to generate statistics for the number of impressions, unique tweets (excluding retweets) and distinct contributors who used the indexing hashtag #ISU14. Individual tweets were assessed using the conference hashtag on the Twitter website. Results: The total number of attendees at the conference was 119, and 99 individuals participated in Twitter using the conference hashtag (#ISU14). 31 % of attendees participated in tweeting at the conference. Over the course of the conference, a total of 798 unique tweets were generated, creating over 665,000 impressions in cyberspace. 590 (73.9 %) tweets were generated from attendees at the conference, while 26.1 % of tweets were from virtual followers. 702 (87.9 %) tweets were from urologists and 439 (55 %) tweets were of scientific nature. Tweet activity peaked during the guest lectures on both days. Conclusion: Twitter use at the ISU has been shown to facilitate interaction between delegates and allows users to follow as well as participate from afar. © 2015, Royal Academy of Medicine in Ireland.
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.