Showing papers in "Journal of Cardiovascular Surgery in 2013"

The Zilver® PTX® Single Arm Study: 12-month results from the TASC C/D lesion subgroup

Abstract: Aim The aim of the present article was to report the 12-month results of the Zilver® PTX® Single Arm StudyTASC C/D de novo lesion subgroup. Methods The Zilver PTX Drug-Eluting Peripheral Stent is a self-expanding nitinol stent with a polymer-free paclitaxel coating. This is a prospective, single-arm, multicentre clinical study evaluating the Zilver PTX Drug-Eluting Peripheral Stent for treating patients with symptomatic lesions in the above-the-knee femoropopliteal artery. This study enrolled 787 patients (900 lesions) with Rutherford class 2 or higher treated with the Zilver PTX stent; 135 were long de novo lesions, corresponding to TASC II Class C or D. Results The 135 long lesions had a mean length of 226.1±43.6 mm. The 12-month Kaplan-Meier estimates included a 77.6% primary patency rate, an 84.7% event-free survival rate, and an 85.4% rate of freedom from target lesion revascularization (TLR). The 12-month stent fracture rate was 2.1%. Conclusion The primary patency rates in the analysis of the TASC C/D de novo lesion subgroup of the Zilver PTX Single Arm Study indicate that endovascular therapy outcomes with a paclitaxel eluting stent may equal those of bypass surgery. Endovascular treatment with DES may play an important role for treatment of patients who present with TASC C or D femoropopliteal lesions.

Covered endovascular reconstruction of aortic bifurcation (CERAB) technique: a new approach in treating extensive aortoiliac occlusive disease.

Abstract: Endovascular treatment of occlusive disease of the aortic bifurcation is challenging. We developed the Covered Endovascular Reconstruction of Aortic Bifurcation or CERAB-technique, as a new approach for extensive and/or recurrent aortoiliac occlusive disease using three covered balloon expandable stents to reconstruct the aortic bifurcation. This configuration provides the ability to deal with TransAtlantic Inter-Society Consensus (TASC II) C and D lesions, simulating a neo-bifurcation or flow divider in combination with the benefits of covered stents. The intervention can be performed percutaneously or as a hybrid procedure. Initial results are encouraging and further studies are indicated.

Iliofemoral venous stenting extending into the femoral region: initial clinical experience with the purpose-designed Zilver Vena stent.

Abstract: AIM The aim of the study was to assess the early clinical experience with the Zilver Vena stent in treating patients with iliofemoral venous obstruction at a tertiary referral hospital. METHODS Demographic, procedural, and follow-up data of 20 patients (12 women; mean age of 59 ± 17 years) treated for iliofemoral vein obstruction between January 2011 and December 2012 were retrospectively reviewed. Most patients presented with acute obstruction (N.=14; 70%), and 10 patients (50%) had an active malignancy. Patency was established venographically at procedure end, and was evaluated with Duplex ultrasound in follow-up. RESULTS Venous obstructions were attributed primarily to extrinsic compression from a malignant or other mass in the pelvis (N.=9) and May-Thurner (N.=5). Flow was re-established through the obstructed venous segment in all patients at procedure end. In follow-up, three patients experienced early stent thrombosis (<30 days); the clinical patency rate was 85% (17/20 patients). Clinical improvement was demonstrated by decreased leg swelling in the remaining 17 patients. CONCLUSION The Zilver Vena stent performed favorably in this challenging patient population; these results need to be confirmed in multicenter studies.

The diabetic foot: a review.

Abstract: Diabetic foot ulceration (DFU) is among the most frequent complications of diabetes. Neuropathy and ischaemia are the initiating factors and infection is mostly a consequence. We have shown in this review that any DFU should be considered to have vascular impairment. DFU will generally heal if the toe pressure is >55 mmHg and a transcutaneous oxygen pressure (TcPO2) <30 mmHg has been considered to predict that a diabetic ulcer may not heal. The decision to intervene is complex and made according to the symptoms and clinical findings. If both an endovascular and a bypass procedure are possible with an equal outcome to be expected, endovascular treatments should be preferred. Primary and secondary mid-term patency rates are better after bypass, but there is no difference in limb salvage. Bedridden patients with poor life expectancy and a non-revascularisable leg are indications for performing a major amputation. A deep infection is the immediate cause of amputation in 25% to 50% of diabetic patients. Patients with uncontrolled abscess, bone or joint involvement, gangrene, or necrotising fasciitis have a "foot-at risk" and need prompt surgical intervention with debridement and revascularisation. As demonstrated in this review, foot ulcer in diabetic is associated with high mortality and morbidity. Early referral, non-invasive vascular testing, imaging and intervention are crucial to improve DFU healing and to prevent amputation. Diabetics are eight to twenty-four times more likely than non-diabetics to have a lower limb amputation and it has been suggested that a large part of those amputations could be avoided by an early diagnosis and a multidisciplinary approach.

Meta-analysis of the prevalence, incidence and natural history of critical limb ischemia.

Abstract: Aim Critical limb ischemia (CLI) is a significant morbid condition among the elderly. The epidemiology and natural history of this condition are poorly defined. Methods Systematic review and meta-analysis of studies evaluating the prevalence, incidence and natural history of CLI were performed. Results Six studies reported on the prevalence of severe lower limb ischemia (ABI 65 years old of 113 and 200/100,000 population per year, respectively. Nine studies reported on the treatment strategy in 2144 legs with CLI: the pooled rate of any revascularization procedure was 70.4%, of primary amputation 8.4%, and of conservative treatment 20.3%. After conservative treatment for CLI, one-year pooled leg salvage rate was 57.4% (95%CI 45.1-69.7%, ten studies reporting on 734 legs included), survival 75.4% (95%CI 59.2-91.6%, four studies included) and amputation-free survival 51.4% (95%CI 32.7-71.2%, five studies included). Conclusion The incidence of CLI in the elderly is rather high. Series reporting on treatment strategies in these patients showed that a revascularization is attempted in 70% of cases. Conservative treatment in patients with unreconstructable CLI, high operative risk and/or refusing any revascularization procedure is associated with acceptable one year leg salvage.

Tips and tricks for a correct "endo approach".

Abstract: The world is facing an epidemic of diabetes, consequently in the next years critical limb ischemia due to diabetic artery disease will become a major issue for vascular and endovascular operators. Revascularization is a key therapy in these patients because reestablishing an adequate blood supply to the wound is essential for healing avoiding a major amputation. In this paper, we summarize our experience in endovascular treatment of diabetic critical limb ischemia, focusing of the main technical challenges in treating below-the-knee vessels. We describe the following topics: 1) targets of the revascularization therapy: "complete" versus "partial" revascularization and the concept of wound related artery. Every procedure must be tailored on technically realistic strategies and on the general patient status; 2) the antegrade femoral access using both, the X-ray and the ultrasound guided techniques; 3) the chronic total occlusions crossing strategy proposing a step-by-step approach: endoluminal, subintimal, retrograde approaches. Particular attention has been given to the different retrograde approaches: pedal-plantar loop technique, trans-collateral approaches and the different types of retrograde puncture. For each step we provide a complete description of the technical details and of the suitable devices. Eventually we in brief describe: 3) acute result optimization and 4) prevention of restenosis.

Ruptured AAA: state of the art management.

Abstract: Since its introduction more than two decades ago, endovascular aneurysm repair (EVAR) has become the primary choice for elective treatment of abdominal aortic aneurysms (AAA) in many medical centers. The (dis)advantages, including 30-day mortality and long-term survival, of both open and endovascular elective AAA repair have been studied extensively, including four randomized trials. On the contrary, the survival benefit of EVAR for ruptured AAAs is not as well established as in elective situations. In the absence of randomized trials, the best treatment modality for ruptured AAA has not been revealed. In this manuscript, we describe the design and (preliminary) results of recently completed and ongoing randomized trials. Furthermore, the trends in management and the results of the treatment of ruptured AAA in our tertiary center over a 20-year period are presented. In the last decade, a progressive increase in the proportion of patients managed by EVAR was observed. This increase was associated with an overall increase in the number of treated patients and, simultaneously, a decrease in the overall 30-day mortality (53% versus 39%) was seen when comparing the two last decades. The 30-day mortality rates were significantly lower in the patients treated with EVAR (24%) compared to open repair (52%). The survival advantage for EVAR after ruptured AAA persisted during the first 5 years after repair, but was lost after that period. The estimated 5-year survival was 44% and 39% for EVAR and open repair, respectively. These data support that endovascular repair is an effective and safe strategy as a primary treatment modality for ruptured AAA.

Open repair for juxtarenal aortic aneurysms.

Abstract: Abdominal aortic aneurysms (AAAs) are classified as juxtarenal if their proximal extent is next to the origin of the renal arteries but does not involve them. An AAA is suprarenal if it extends above at least one renal artery and ends below the celiac axis. Juxtarenal AAAs need inter-renal or suprarenal clamping, with the aortic reconstruction usually made at the infrarenal level. Aneurysms requiring suprarenal clamping, often supraceliac, and the reconstruction (direct attachment or bypass) of at least one renal artery, are often defined as suprarenal AAAs. Endovascular aortic repair (EVAR) is feasible in most of cases of infrarenal AAAs and has been shown to be as effective as open repair (OR) in reducing aneurysm-related mortality and perioperative mortality with shorter length of stay. However, the feasibility of standard EVAR with an on-label use of commercially available devices is limited in the juxtarenal aorta. In our series, approximately, 20% to 30% of patients with an AAA are considered not eligible for standard EVAR owing to their anatomy, and in the most of the cases are patients with juxtarenal AAAs. Fenestrated and branched endografts and newer "off the shelf" techniques (such as chimney, periscope, sandwich) have been recently described, all with the purpose of widening the therapeutic range of EVAR to the treatment of aneurysms with involvement of renal and visceral arteries. However, safety, efficacy, long-term results, and cost-effectiveness of these expensive techniques have still to be carefully assessed. For these reasons, the OR is currently still considered the gold standard for treatment of juxtarenal AAAs, reserving endovascular strategies mainly for high-risk patients having comorbidities or other contraindications for conventional repair. If compared to open repair of infrarenal AAAs, juxtarenal AAA OR is technically more complex and might require specific organ-protection strategies in order to minimize ischemia-reperfusion injury to kidneys and visceral organs. Because of the complexity of the surgical procedure and of the multiple clinical problems, an optimal operative strategy for the treatment of juxtarenal AAAs has not been established yet. The choice of the surgical access, clamping level, methods of organ protection and their impact on renal, respiratiry, cardiac and gastrointestinal morbidity are still debated issues.

Increased risk of late aortic events after isolated aortic valve replacement in patients with bicuspid aortic valve insufficiency versus stenosis.

Abstract: AIM Bicuspid aortic valve (BAV) is a very heterogeneous disorder and risk of aortic events in BAV may be influenced by phenotype of the disease Correlation has been proposed between aortic dilatation patterns and functional status of the BAV (ie, stenosis versus insufficiency) The aim of our study was to evaluate the risk of late aortic events after isolated aortic valve replacement (AVR) in patients with BAV stenosis versus insufficiency METHODS Review of our institutional BAV database identified 442 consecutive BAV patients (mean age 55±12 years, 76% men), who underwent isolated AVR from 1995 through 2005 A subgroup of 376 (85%) patients presented with an isolated/predominant BAV stenosis (Group I), whereas 66 (15%) patients had an isolated BAV insufficiency (Group II) Follow-up information (a total of 3864 patient-years) was 100% complete Mean follow-up period was 94±39 years Adverse aortic events were defined as the need for proximal aortic surgery or the occurrence of aortic dissection/rupture, or sudden death during follow-up RESULTS Actuarial survival rates in Group I and Group II were 86±2% vs 94±3% at 10 years, and 76±3% vs 85±6% at 15 years, respectively (P=02) Proximal aortic surgery was performed in 6 (15%) patients in Group I vs 2 (3%) patients in Group II Freedom from proximal aortic re-interventions was 95±3% in Group I vs 90±8% in Group II at 15 years after AVR (P=04) Aortic dissection/rupture occurred in 2 patients in Group II Freedom from late adverse aortic events was 93±3% in Group I vs 78±9% in Group II at 15 years postoperatively (P=002) CONCLUSION BAV patients with isolated valve insufficiency are at increased risk of late aortic events, as compared with BAV stenosis patients at 15 years after AVR

Smooth muscle cell phenotypic diversity between dissected and unaffected thoracic aortic media.

Abstract: Aim: Smooth muscle cell (SMC) phenotypic switching in the aortic media may play a critical role in the pathogenesis of thoracic aortic dissection (TAD). However, few investigations are available and most of the observations are based on histological examinations without in vitro evidence. This study, which was performed both in vivo and in vitro, was designed to investigate SMC phenotypic diversity between dissected and unaffected aortic media. Methods: Using optimized explant technique, aortic medial SMCs were obtained from patients with TAD and controls. In vivo and in vitro expression of α-smooth muscle actin (α-SMA), smooth muscle-myosin heavy chain 2 (SM-MHC-2), smooth muscle-calponin (SM-Calponin), Vimentin, osteopontin (OPN) and non-muscle myosin heavy chain B (SMemb) were evaluated by immunostaining and immunoblotting. SMC proliferation was also analyzed. Results: Although the majority of SMCs from the dissected media displayed an elongated, spindle- or triangle-like shape as control SMCs, there were some oval or flat, quadrate cells in the dissection cultures. In contrast with controls, SMCs derived from the dissected media uniformly showed the negative staining for the contractile proteins and the intense staining for the synthetic markers. Similarly, in vitro protein levels of α-SMA, SM-MHC-2, SM-Calponin and Vimentin were significantly decreased to 60.1% (P<0.05), 12.0% (P<0.01), 23.1% (P<0.01) and 32.5% (P<0.01) respectively, whereas those of OPN and SMemb were markedly elevated by5.7- and 10.3-fold respectively (P<0.01 for both). In vivo expression of the phenotypic markers showed the parallel results. Furthermore, SMCs derived from the dissected media exhibited the enhanced proliferation (P<0.05). Conclusion: We have established a simple and potent method to acquire SMCs from the dissected and unaffected aortic media. Compared to the contractile SMCs in the unaffected media, those in the dissected media manifest phenotypic switching from the contractile to the synthetic type. The primary cultures can be subsequently used as in vitro models and contribute to further elucidating the etiopathogenesis of TAD.

BRAVISSIMO: 12-Month Results from a Large Scale Prospective Trial

Abstract: The BRAVISSIMO study is a prospective, non-randomized, multi-center, multi-national, monitored trial, conducted at 12 hospitals in Belgium and 11 hospitals in Italy This manuscript reports the findings up to the 12-month follow-up time point for both the TASC A&B cohort and the TASC C&D cohort The primary endpoint of the study is primary patency at 12 months, defined as a target lesion without a hemodynamically significant stenosis on Duplex ultrasound (>50%, systolic velocity ratio no greater than 20) and without target lesion revascularization (TLR) within 12 months Between July 2009 and September 2010, 190 patients with TASC A or TASC B aortoiliac lesions and 135 patients with TASC C or TASC D aortoiliac lesions were included The demographic data were comparable for the TASC A/B cohort and the TASC C/D cohort The number of claudicants was significantly higher in the TASC A/B cohort, The TASC C/D cohort contains more CLI patients The primary patency rate for the total patient population was 931% The primary patency rates at 12 months for the TASC A, B, C and D lesions were 940%, 965%, 913% and 902% respectively No statistical significant difference was shown when comparing these groups Our findings confirm that endovascular therapy, and more specifically primary stenting, is the preferred treatment for patients with TASC A, B, C and D aortoiliac lesions We notice similar endovascular results compared to surgery, however without the invasive character of surgery

The multilayer flow modulator stent for the treatment of arterial aneurysms.

Abstract: Aim The purpose of this manuscript was to: 1) report our experience with the Multilayer Flow Modulator (MFM) for the treatment of peripheral, visceral and aortic aneurysms; 2) review the published literature regarding the outcomes of patients treated with the MFM; and 3) develop initial treatment guidelines regarding the MFM. Methods We reviewed our clinical experience with the MFM in 58 high surgical risk patients. Thirty-one peripheral (PAAs), 9 visceral (VAAs) and 18 aortic aneurysms (10 thoracoabdominal [TAAA]; 8 abdominal) were treated. In addition, the PubMed database through April 2013, along with relevant websites and scientific presentations at international meetings, were quered regarding the MFM. Seventeen articles and 3 presentations were identified. Data regarding 178 patients treated with the MFM were included for analysis including 57 PAAs, 31 VAAs and 90 complex degenerative aortic lesions. Outcomes including technical success, 30-day mortality, endoleak rate and aneurysm-related survival were studied. Results In our experience, there were 47 males and the mean age was 62 years (16-80). In patients with PAAs and VAAs, technical success with the MFM was 100%. At 30 days, there were no deaths. Initial MFM patency was 97.5% (39/40) with patency of the thrombosed MFM successfully restored. Longer-term follow-up (mean 16 ± 8 months) demonstrated progressive thrombosis and shrinkage of the aneurysm sacs and all side-branches were patent. In patients with aortic aneurysms, technical success was 100%, with no complications and no deaths at 30 days. Longer-term follow-up (8 ± 7 months) demonstrated aneurysm-related survival of 100%, all-cause survival of 83.3%, intervention-free survival of 100% and 100% patency of the side branches. The longest duration for aneurysm sac thrombosis was 18 months. A significant mean diameter reduction was observed at 6 months (17.3 mm for the transversal maximal diameter and 13.83 mm for the antero-posterior diameter) in the TAAA group. In the literature review, there was 100% technical success and a 97.7% 30-day survival rate in patients with PAAs and VAAs treated with the MFM. In follow-up (range 5-26 months), there were no aneurysm-related deaths or aneurysm ruptures and the overall survival was 95.5%. Complete aneurysm exclusion was observed in 94.3% of the patients with significant aneurysm shrinkage in 83% of the patients. Nine (10%) MFMs occluded with most occlusions resulting from pre-existing conditions. Patency of 5 occluded MFMs were restored and 4 occluded MFMs were not treated and were asymptomatic. All covered side branches were patent except in a patient with thrombophilia who also had an occluded MFM. The treatment of complex aortic degenerative lesions with MFM demonstrates a 95.5% 30-day survival with 2 aneurysm ruptures for contrindicated use (previously ruptured aneurysm; mycotic aneurysm). Over the follow-up (range 3-28 months), all-cause survival was 87.8% and aneurysm-related survival was 96.7% (1 late rupture due to a type 1 endoleak). Side branches were patent for 97.7% of the treated cases and a 13.3% endoleak rate was reported. There were no neurological, renal or respiratory complications. Complete exclusion and size stability were achieved for most of the cases. Conclusion Clinical experience with the MFM is increasing. The MFM has been used to treat many types of aneurysms including peripheral, visceral and aortic. Early results suggest that use of the MFM can help prevent aneurysm-related mortalities while maintining branch vessel patency. Additional study and investigation is needed.

Spinal cord function monitoring during endovascular treatment of thoracoabdominal aneurysms: implications for staged procedures.

Abstract: Aim Spinal cord ischemia is a well-known complication in the treatment of thoracoabdominal aneurysms (TAAA). Despite the fact that endovascular treatment of TAAA is less invasive, spinal cord ischemia rate is not reduced if compared to open repair. Methods We report the results of our experience of spinal cord function monitoring by measuring motor evoked potentials (MEP) during endovascular treatment of TAAA type II and III. Depending on the level of the MEPs the decision is made whether to stage the procedure or not. We treated ten patients according to this protocol. Results In two patients, MEPs decreased 50% or more and procedures were staged. Both experienced no neurological complications after first and second procedure. No MEPs decrease was seen during the second procedures. One of the other eight patients had a temporary right lower leg pararesis. Conclusion In conclusion we state that our first experience demonstrates the value of assessing spinal cord function during extensive endovascular TAAA repair with subsequent strategies to prevent paraplegia.

Plaque-infiltrating T lymphocytes in patients with carotid atherosclerosis: an insight into the cellular mechanisms associated to plaque destabilization.

Abstract: AIM Inflammation plays a crucial role in the progression of atherosclerotic plaques The aim of the present study was to investigate phenotypic and functional characteristics of plaque-infiltrating T lymphocytes associated with a complicated phenotype of carotid atherosclerotic lesions METHODS Atherosclerotic plaques were obtained from 17 patients undergoing carotid endarterectomy and cultured to isolate infiltrating T lymphocytes Blood samples were obtained from patients and from 20 sex- and age-matched healthy subjects The presence of lymphocytes (CD3+ cells) within atherosclerotic plaques was determined by immunohistochemistry Phenotypic characteristics and intracellular cytokine expression of plaque-infiltrating and circulating T lymphocytes were determined by flow cytometry Cytokine levels in supernatants from infiltrating T cell cultures were evaluated by enzyme-linked immunosorbent assay RESULTS A higher number of CD3+ cells was detected in complicated than in uncomplicated plaques Complicated plaques had higher percentages of tumor necrosis factor (TNF)-α- and interferon (IFN)-γ- positive cells than uncomplicated ones, especially in CD4+ subpopulation In patients the percentages of TNF-α-positive cells were higher in infiltrating than in circulating lymphocyte samples Intracellular TNF-α, IFN-γ, interleukin (IL)-4 and IL-10 expression resulted higher in circulating lymphocyte samples from patients than in those from healthy subjects Supernatants of infiltrating T cell cultures from complicated plaques showed higher levels of TNF-α and lower levels of IL-4 than those from uncomplicated plaques CONCLUSION Our data provide new information on the presence of increased percentages of pro-inflammatory T lymphocytes in complicated plaques with respect to uncomplicated ones and support the concept of the key role played by activated T cells in the progression of atherosclerotic lesions

Unique demands of the femoral anatomy and pathology and the need for unique interventions.

Abstract: With the aging of the population the incidence of peripheral artery disease (PAD) is increasing, which is histologically characterized by fibrocalcific intimal plaques as well as underlying Monckeberg's medial calcinosis as compared to coronary and carotid artery disease Superficial femoral artery (SFA) is one of the longest and most dynamically active vessels in the body undergoing torsion, compression, flexion, and extension from leg motion, and is known to be more susceptible to atherosclerosis because of low shear stress or spiral flow, best appreciated in the long segment in its lesser curvature Endovascular interventions are now considered the first-line strategy for the treatment of PAD patients presenting with claudication or critical limb ischemia, where physiologic stresses on the arterial wall, anatomic considerations, and lesion characteristics impact on their success Stent fracture and malapposition, are a common phenomenon in PAD which are attributed to severe calcification and fibrosis along with greater motion of the lower extremity, that result in the dampening of the efficacy of stenting and balloon angioplasty Better designs of self-expanding stents have resulted in either reduction in stent fracture rates or its elimination at least in the short-term follow-up studies, to date Although drug-eluting stents (DES) have reduced restenosis rates in the coronary circulation, this benefit has not been consistently observed in PAD However, recent clinical studies utilizing novel Zilver-PTX self-expanding stent (DES) have demonstrated favorable patency rate Also, in patients with critical limb ischemia, better outcomes have been reported for below-the-knee utilization of DES Nevertheless, drawbacks of stent technology remain and interests in the greater use of drug-coated balloons (DCB) for PAD have emerged Randomized controlled trials have consistently shown superiority of DCB over uncoated balloons in reducing neointimal formation in patients with SFA disease Moreover, there is a growing interest in atherectomy as an alternative treatment strategy for PAD, thus decreasing plaque burden with possibly avoidance of barotrauma The results from registries support the effectiveness of the atherectomy devices; however, prospective randomized controlled trials are needed to confirm their benefit

Carotid stenting in asymptomatic patients: how to identify patients without symptoms and at high risk for neurologic events.

Abstract: Aortic occlusive syndromes encompass a wide variety of aortic and aortoiliac conditions that present with devastating clinical sequale of hypertension coupled with visceral and lower limb ischemia Clinical presentations, natural history, etio-pathology, diagnosis, management and outcomes of each of these disorders is unique Risk factor management, endovascular intervention, and/or surgical revascularization compete and complement each other in an exciting manner to give best long-term outcomes Common causes of aortic occlusion include: 1) atherosclerotic occlusive disease, including aortoiliac occlusive diseases (AIOD); acute aortic occlusion (embolic/thrombotic/dissection; 2) mid aortic syndrome: Takayasu arteritis; congenital aortic hypoplasia; fibromuscular dysplasia; neurofibromatosis; 3) coral reef aorta

Advanced endovascular techniques for thoracic and abdominal aortic dissections.

Abstract: Endovascular treatment of aortic dissection is still in its infancy and consists usually of implantation of thoracic tubular stent-grafts to cover the proximal entry tear and redirect flow into the true lumen. Large registries comparing endovascular treatment by thoracic endovascular aortic repair (TEVAR) with open surgery for aortic dissection of the descending aorta have demonstrated a clear benefit for endovascular treatment with lower mortality and morbidity rates turning TEVAR into the standard treatment for complicated type B aortic dissection. With this momentum of success endovascular techniques continue to challenge open surgical techniques also in the aortic arch and the ascending aorta. TEVAR for aortic dissection has become more complex requiring an individualized treatment strategy as endovascular techniques have developed with the advent of new devices and increased experience of the operators. In many cases straight implantation of a thoracic tubular stent-graft is sufficient. But as rerouting of the blood flow can also change perfusion of vital side-branches the endovascular operator needs to have a large armamentarium of techniques and adjunctive procedures in order to sufficiently address the individual patient morphology. This chapter reviews a variety of endovascular techniques including access techniques, proximal sealing, the Petticoat-technique, false lumen deployment, fenestration techniques, branch vessel stenting and false lumen obstruction by various techniques.

Percutaneous endovascular aneurysm repair with the ultra-low profile Ovation Abdominal Stent-Graft System.

Abstract: AIM Aim of the study was to report our single-center experience of the ultra-low profile OvationTM Abdominal Stent-Graft System with totally percutaneous endovascular aneurysm repair (PEVAR) METHODS Between December 2010 and March 2013 we electively treated 35 patients (male: 89%, mean age: 73±7 years) with abdominal aortic aneurysm (AAA) using bilateral PEVAR with the OvationTM endograft Most (77%) cases were characterized by challenging femoral artery anatomy Patients returned for follow-up visits at 1, 3, 6 months and annually thereafter RESULTS Technical success was 971% One type Ia endoleak was identified on final angiography, which was treated with an extension cuff No groin complications were observed, including lymphocele, hematoma, pseudoaneurysm, dehiscence, or wound infection Mean follow-up was 10 months (range 1-24 months) No death was registered One type Ia endoleak was identified at the 12-month follow-up, which resolved with placement of a Palmaz balloon-expandible stent No type II, III, or IV endoleaks were identified No migration, AAA enlargement, AAA rupture, or conversion to open surgery was reported Two patients (57%) developed monolateral iliac limb occlusion at 58 and 72 days of follow-up, respectively In one case a limb kinking was observed and treated with iliac kissing stent The other limb occlusion was due to external iliac artery severe stenosis and was treated with thrombolysis and iliac artery stenting CONCLUSION PEVAR with the OvationTM endograft is feasible and safe in patients with unfavorable anatomy

Acute type A aortic dissection intimal tears by 64-slice computed tomography: a role for endovascular stent-grafting?

Abstract: Aim The goal of this study was to identify physical characteristics of primary intimal tears in patients arriving to the hospital alive with acute type A aortic dissection using 64-multislice computerized tomography (MSCT) in order to determine anatomic feasibility of endovascular stent-grafting (ESG) for future treatment. Methods Radiology database was screened for acute type A aortic dissection since the time of acquisition of the 64-slice CT scanner and cross-referenced with surgical database. Seventeen patients met inclusion criteria. Images were reviewed for number, location, and size of intimal tears and aortic dimensions. Potential obstacles for ESG were determined. Results Ascending aorta (29%) and sinotubular junction (29%) were the most frequent regions where intimal tears originated. Location of intimal tears in nearly 75% of patients was inappropriate for ESG, and 94% of patients did not have sufficient proximal or distal landing zone required for secure fixation. Only 71% of patients underwent surgical aortic dissection repair after imaging and 86% of entry tears detected on MSCT were confirmed on intraoperative documentation. Only one patient would have met all technical criteria for ESG using currently available devices. Conclusion Location of intimal tear, aortic valve insufficiency, aortic diameter>38 mm are major factors limiting use of ESG for acute type A dissection. Available stents used to treat type B aortic dissection do not address anatomic constraints present in type A aortic dissection in the majority of cases, such that development of new devices would be required.

Management of ischemic diabetic foot.

Abstract: Diabetic foot pathology represent the more disabling complication of diabetes. More the 1 million of diabetes patients undergo a lower limb amputation per year; 85% of these amputation are preceded by un ulcer that can be avoided by a prevention program. Critical limb ischemia (CLI), the only independent cause of major amputation in diabetic population, can be correctly treated when an early diagnosis is made. Both endoluminal and surgical revascularization procedures can be applied in diabetes with high rate of success when performed by skilled operator. Infection of diabetic foot, in particular in patients suffering from peripheral artery disease (PVD), may rapidly evolves in severe local or systemic infection putting the patient at high risk of major amputation or death. Together with an early diagnosis of infection and ischemia it is mandatory to apply a correct medical and surgical treatment protocol with the aim to control infection and to improve blood perfusion to the foot. In case of infection surgical procedure should be applied first while revascularization procedure will follow soonest. Antibiotic therapy should be chosen considering different local biological pattern and different type of infection. Reconstructive surgery, the last step in treatment of any diabetic foot lesion, must obtain a functional residual foot or a stump that will allow the patient to go back walking soonest with residual good walking capacity.

The association of the artificial heart-lung with deep hypothermia in open heart surgery.

Abstract: Angiogenesis is the physiologic formation of new vessels from existent vascular bed. Angiogenic branching is regulated by balance of angiogenic activators and angiogenic inhibitors. The most remarkable factor affecting angiogenesis is vascular endothelial growth factor which acts via receptor tyrosin kinase. Ongoing studies on angiogenesis also highlight therapeutic approaches for tumor metastasis and metabolic diseases.

Midterm results of the transarterial use of Onyx in the treatment of persisting type II endoleaks after EVAR.

Abstract: AIM Type II endoleaks with growing aneurysm sac >5 mm in diameter after EVAR require treatment. Different treatment options have been reported. The aim of this study was to evaluate the use of an ethylene-vinyl alcohol copolymer (Onyx) in an endovascular approach. METHODS Between January 2010 and December 2011, 10 consecutive patients with persistent type II endoleaks leading to aneurysm growth >5 mm were treated in our center by transarterial Onyx embolization by super selective cannulation of the endoleak with microcatheters. Technical success was defined as transarterial Onyx deployment directly into the aneurysm sac. Clinical success was defined as stable or shrinking axial aneurysmal diameter during follow- up using an angiographic computed tomography. RESULTS Ten patients with 13 persistent type II endoleaks leading to aneurysm sac growth of >5 mm were identified in the time period. Technical success was 92% (12/13 patients). Two patients underwent a staged procedure because several, unconnected type II endoleaks were present. In one patient a cannulation of the inflow vessel responsible for the endoleak was not possible, continued efforts led to a rupture of the hypogastric artery which was treated by covered stent implantation. In one patient an extravasation of onyx out of the aneurysm sac into the inferior vena cava during the embolization process made a transvenous goose snare maneuver necessary to retrieve the dislocated copolymer. No further complications were observed during the mean follow-up of 19.8 months (range, 3-31 months). In all patients with successful embolization the aneurysm sac remained stable or was decreased within the follow-up period. CONCLUSION Use of Onyx in the endovascular treatment of type II endoleaks after EVAR is feasible, safe when accurately deployed and efficient. Further studies are necessary to evaluate the value of the different treatment modalities (translumbar vs. transarterial).

Endovascular strategies for infrarenal aneurysms with short necks.

Abstract: The aim of this paper was to review the current options for endovascular treatment of abdominal aortic aneurysms (AAAs) with short infrarenal neck. Studies reporting endovascular treatment of AAAs with short proximal neck were reviewed. Fenestrated endovascular aneurysm repair (F-EVAR) is most frequently reported for the treatment of patients with short neck AAA, with high technical success rates (≥ 99%), low operative mortality (≤ 3.5%) and excellent mid- and long-term results in terms of target vessel patency (≥ 97%). Chimney-EVAR (Ch-EVAR) is far less reported, but also presents with high technical success rates (>97%), varying operative mortality rates (0-12.5%), and excellent short- and mid-term target vessel patency (≥ 96%). Ch-EVAR, however, seems to be associated with high postoperative stroke up to 6.3%, and increased proximal type I endoleak (5-31%). Standard EVAR performed outside manufacturers' instructions for use (IFU) is also documented in the treatment of short proximal neck AAA, but is associated with increased operative mortality and morbidity, type I endoleak, and migration, compared to standard EVAR in AAA with longer proximal neck length. F-EVAR currently represents the most validated and reliable endovascular option for the treatment of short-neck AAA. Ch-EVAR is feasible, but lacks long-term data. Its use seems only favored in acute high surgical risk patients, in elective cases complicated with unintentional renal artery coverage or in anatomies unsuitable for F-EVAR. Standard EVAR in short neck AAA is associated with poorer outcomes and should not be recommended as first choice.

Superficial femoral artery TASC D Registry: twelve-month effectiveness analysis of the Pulsar-18 SE nitinol stent in patients with critical limb ischemia.

Abstract: Aim Single center observational study analyzing the primary patency rate and freedom from target lesions revascularization rate of the Pulsar-18 nitinol stent after recanalization of long superficial femoral artery (SFA) occlusions (TASC D) in 22 patients with critical limb ischemia (CLI). Methods Between 1/2011 and 7/2011, 22 consecutive patients (9 male, 13 female) with chronic total occlusions (CTO) of the femoro-popliteal arteries presenting with CLI (17 patients with Rutherford 4 score, and 5 patients with Rutherford 5 score) were enrolled and successfully recanalized using the Pulsar-18 self-expanding (SE) nitinol stent (BIOTRONIK AG, Buelach, Switzerland). Primary patency at 12 months was defined as no binary restenosis (>50%) on Duplex ultrasound (PSVR Results Technical success, with establishing an antegrade straight line flow to the foot through a reopened SFA, was achieved in all 22 patients. Subintimal and intraluminal recanalization techniques were used. Two patients with Rutherford 5 score had a minor amputation shortly after the recanalization procedure. All other patients had a complete wound healing of their lesions during a 6 month follow-up. After 12 month follow-up the primary patency rate of the Pulsar-18 SE nitinol stent was 77% with a per protocol restenosis in 5 of 22 patients. Seventeen patients showed a walking capacity on treadmill test >300 meters (Rutherford II). Two patients with a documented restenosis were Rutherford, these patients were treated conservatively. Three patients with restenosis and a Rutherford III score were scheduled for an endovascular target lesion revascularization leading to a freedom from target lesion revascularization rate of 86%. Conclusion Endovascular intervention of long SFA occlusions using subintimal or intraluminal recanalization technique with implantation of the Pulsar-18 SE nitinol stent in CLI patients is safe and clinically effective with a primary patency rate after 12 months of 77% and a freedom from target lesion revascularization rate of 86%.

Guidelines for treatment of patients with diabetes and infected ulcers.

Abstract: Diabetic foot ulcers and their consequences do not only represent a major tragedy for the patient and his/her family, but also place a significant burden on the healthcare systems and society in general. Diabetic patients may develop foot ulcers due to neuropathy (autonomic, sensory, and motor deficits), angiopathy or both. As a result of the additional immunopathy associated with diabetes, the probability of these wounds to become infected is extremely high. Diabetic foot infections can be classified in mild, moderate and severe according to local and systemic signs. Their identification should lead to a prompt and systematic evaluation and treatment, ideally performed by a multidisciplinary team. Decisions concerning empirical initial antibiotic agent(s), desirable route of administration, duration and need of hospitalization should be based on the more likely involved pathogen(s), the severity of the infection, the ulcer chronicity and the presence of significant ischemia. Wound cultures, ideally from ulcer tissue, are strongly advisable and can help guiding and narrowing the antibiotic spectrum. Appropriate wound care and off-loading should not be neglected. When revascularization is required, the correct timing can be crucial for limb salvage. Since the recurrence of ulcer and infection is high, the implementation of appropriate preventive measures can be critical. Ultimately, the definitive goal in the treatment of diabetic foot infections is to prevent the amputation catastrophe.

Results of the Cox-Maze III/IV procedure in patients over 75 years old who present for cardiac surgery with a history of atrial fibrillation.

Abstract: Aim Elderly patients with atrial fibrillation (AF) present a special challenge. Despite the documented advantage in ablating AF, the addition of the procedure may add complexity and potentially impact patient outcome. This study explored the impact of the Cox-Maze III/IV procedure on elderly patients experiencing AF who present for cardiac surgery. Methods Forty-four patients aged ≥ 75 with concomitant surgery underwent the Cox-Maze III/IV procedure for AF. These patients were followed using our extensive longitudinally designed registry to include health related quality of life (HRQL). Late death was captured by the Social Security Index and the National Death Index. Results The mean age for this sample was 79.5 ± 3 years and mean additive euroSCORE was 9 ± 2.1 (high risk). The majority of patients with the Cox-Maze procedure underwent concomitant valve surgery (N. = 41, 93%). There was a low incidence of STS measured perioperative outcomes in this group. NSR rates at six months were 90% (26/29) and 85% (23/27) at 12 months for the ablation group. There were no embolic strokes and major bleeding events occurred in only two patients. By Kaplan-Meier analysis, two-year cumulative survival was 89.6% and there was only one operative mortality in this group (2.3%). Conclusion Addition of the Cox-Maze III/IV procedure in patients ≥ 75 years may add to the complexity of the surgical procedure, but does not increase the operative risk. Age should not be the only discriminating factor when considering the Cox-Maze III/IV procedure for patients aged ≥ 75 years who present for cardiac surgery while experiencing atrial fibrillation.

Open Surgical Repair of Thoracoabdominal Aortic Aneurysms

Abstract: Objectives: Thoracoabdominal aortic aneurysm (TAAA) surgery possesses high morbidity and mortality rates and is in the high-risk surgery category. We present the results of patients who underwent surgery for thoracoabdominal aortic aneurysm repair in a two-year period. Materials and Methods: Twelve patients underwent thoracoabdominal aortic aneurysm repair in our clinic between March 2010 and June 2012. The mean age of the patients was 50.2 ± 14.4 years. There were ten male patients. According to the modified Crawford classification, four patients underwent surgery for type 1; 2 for type 3; 3 for type 4 and 3 for type 5 thoracoabdominal aortic aneurysm. Distal femoral bypass was performed in 10 patients. Catheterization was performed for the drainage of cerebrospinal fluid. Results: Three of the patients presented with rupture and underwent emergency surgery. Two of the patients had type 1 and one had type 4 thoracoabdominal aortic aneurysm. Mortality occurred in three patients, two of which had undergone surgery due to rupture. One patient developed paraparesis in the postoperative period. Conclusions: Thoracoabdominal aortic aneurysm repair is a high-risk procedure requiring good surgical ex- perience, a multidisciplinary approach, good anesthetic management and a cautious intensive care follow up.

Total blood volume of Asian patients undergoing cardiac surgery is far from that predicted by conventional methods.

Abstract: AIM Current cardiopulmonary bypass (CPB) procedures use non-hematic fluids to prime bypass circuits, often resulting in marked hemodilution. Patients' total blood volume (TBV) is estimated prior to hemodilution. We aimed to evaluate differences between calculation of TBV by Nadler's formula, a classic reference book method, and an established formula calculated by the authors. METHODS A total of 285 patients of Asian origin received primary cardiac surgery between September 2010 and October 2011 in our institution. Patients' total blood volume was estimated by: 1) standard Nadler formula: TBV (men) =0.417H3+0.045TBM-0.030L TBM (total body mass, Kg); TBV (women) =0.414H3+0.0328 TBM-0.030L; 2) classic reference book method: patient's weight in kilograms times 7% (women) or 7.5% (men); and 3) our practical calculation: TBV=HCT2*(CPB prime volume + intravenous fluids before CPB - urine volume before CPB)/(HCT1- HCT2). RESULTS Bland-Altman plotting revealed no mean differences between Nadler formula and reference book TBV measurements (Figure 1A). Differences in means (95% limit of agreement) for reference book/Nadler formulas was 0.52 (-0.21, 1.24, N.=285). Comparing authors' results with those of reference book/Nadler, TBV yielded divergent results. TBV correlated positively to patient's height (P=0.001) and body surface area (P<0.01), and correlated positively to height after controlling for age and gender (β=87.3, SE=42.9, P=0.043). CONCLUSION Total blood volume of Asian patients calculated by the authors differs markedly from that estimated by Nadler and classic reference book formulas, which suggests that more accurate calculation of TBV is needed for Asian cardiac patients requiring CPB, especially patients with valvular disease.

Role of bioresorbable stents in the superficial femoral artery.

Abstract: Bioresorbable stents or scaffolds are a new technology in the treatment of coronary and peripheral vascular disease. Their goal is to provide adequate support to the dilated vessel segment for the time needed and to disappear through a controlled resorption process afterwards. Doing so they can offer the early advantages and avoid the late complications related to stent placement such as stent-induced restenosis, stent fracture and problems at reintervention. Although the first implantation dates from more than ten years ago, this technology is still in its infancy and experience is still being built up. Most studies till now have been performed in the coronary arteries although the superficial femoral artery is an equally appealing area of application. Bioresorbable scaffolds are made of resorbable polymers or metals with or without antiproliferative drug elution. Early experiences in coronary arteries as well as in other areas such as the superficial femoral artery (SFA) have shown the importance of the material that is used, the design of the device and the duration of the absorption process. They suggest that elution of an antiproliferative drug might be necessary to obtain clinically acceptable results. Although initial results are promising with some of the newer generation devices results of larger studies with longer follow-up are eagerly awaited to define the precise place of this new technology. This article gives an overview of the existing evidence, the available devices, the clinical studies that have been performed in different areas and the preliminary results of a large multicenter study with a bioresorbable stent in the SFA.

How to manage infected aortic endografts.

Abstract: Aortic endografts have become the preferred treatment for aneurysms of the descending thoracic aorta and the infrarenal aorta. The prevalence of endograft infections is about 0.6%, and with the growing number of patients with aortic endografts, the number of patients with endograft infections has also increased. It is important for physicians who treat aneurysmal disease with endografting to understand the pathophysiology, work-up, and treatment options available. Currently, the mainstay of treatment is prolonged antibiotic therapy, explant of all prosthetic material, and reconstruction of the vasculature with either an in situ or extra-anatomic bypass. However, there is a growing experience of less invasive treatment strategies that can be used in patients who cannot withstand an operation of this magnitude.