Target Vessel Reintervention Research Articles

Endovascular devices for severely calcified peripheral lesion preparation: state of the art

Over the last few decades, endovascular revascularization techniques have revolutionized the treatment of peripheral artery disease, offering a less invasive alternative to surgery. However, the successful treatment of heavily calcified lesions is often compromised by various vascular complications, including recoils, dissections, and the need for target vessel reinterventions. This has prompted the development of several tools for lesion preparation, with the aim of achieving better procedural outcomes. This review aims to summarize the main characteristics and current evidence related to the available devices for preparing severely calcified peripheral lesions.

Frailty is Not Associated with Worse Outcomes following Lower Extremity Angiograms for Limb Ischemia in Nonagenarians

Endovascular interventions are performed routinely with minimal risk in younger populations. The safety and efficacy of endovascular interventions in nonagenarians is under examined. We sought to examine the following (1) mortality and limb salvage rates in the nonagenarian population and (2) whether frailty was associated with outcomes following lower extremity (LE) interventions for both acute limb ischemia (ALI) and chronic limb threatening ischemia (CLTI). A retrospective review of patients ≥90years who underwent a LE angiogram for ALI or CLTI over a 12-year period at a single institution was performed. Primary outcomes were 30-day and 12-month limb salvage and mortality rates. Patient demographics, 30-day complications, and 12-month target vessel reintervention (TVR) were reviewed. Frailty scores were calculated using the 11-factor modified frailty index (MFI-11). From 2009 to 2021, 76 patients (36% male) with a mean age of 93 (range: 90-102) underwent endovascular procedures for ALI (n=13) and CLTI (n=63). 30-day amputation and mortality rates were 6% and 8%, respectively. Patient demographics, preoperative functional status, and TVR rates were not different between patients who had early amputation (≤30days) and those who achieved limb salvage. Seventy-two patients (94%) had follow-up data at 30days. There was an 8% mortality rate at 30days. Of those alive at 30days, 94% of patients had successful limb salvage. Fifty-eight patients had complete follow-up data at 12months. Of the patients alive at 12-month follow-up (75%), the limb salvage rate was 98%. Patients with amputation at 30days had a significantly higher mortality rate at 12months compared to those who did not (83% vs. 19%; P<0.01). Based on MFI-11 scoring, 35% of the population was considered frail (≥0.27). Frail patients did not have significantly different 30-day outcomes (limb salvage: 94% vs. 88%; mortality 8% vs. 9%, P=0.41 and 0.94, respectively) or 12-month outcomes (limb salvage: 82% vs. 94%; mortality: 32% vs. 22%, P=0.28 and 0.39, respectively). Endovascular procedures can be done safely in nonagenarians with low mortality and amputation rates. Patients with early amputation are at significantly higher risk of death at 12months. Frailty, as measured by a validated index, was not associated with early or late outcomes. When compared to immediate amputation, nonagenarian patients and their families should be counseled as to the benefit from a minimally invasive endovascular procedure.

Effectiveness and Safety of Atherectomy versus Plain Balloon Angioplasty for Limb Salvage in Tibioperoneal Arterial Disease

PurposeTo evaluate the effectiveness and safety of atherectomy versus plain balloon angioplasty (POBA) for treatment of critical limb ischemia (CLI) due to tibioperoneal arterial disease (TPAD). Materials and MethodsPatients enrolled in the Vascular Quality Initiative registry who had CLI (Rutherford Class 4–6) and underwent atherectomy versus POBA alone for isolated TPAD were retrospectively identified. Of eligible patients, a cohort of 2,908 patients was propensity matched 1:1 by clinical and angiographic characteristics. The atherectomy group comprised 1,454 patients with 2,183 arteries treated, and the POBA group comprised 1,454 patients with 2,141 arteries treated. The primary study endpoint was major ipsilateral limb amputation. Secondary endpoints were minor ipsilateral amputations, any ipsilateral amputation, primary patency, target vessel reintervention (TVR), and wound healing at 12 months. ResultsThe median follow-up period was 507 days, the mean patient age was 69 years ± 11.7, and the mean occluded length was 6.9 cm ± 6.5. There was a trend toward higher technical success rates with atherectomy than with POBA (92.9% vs 91.0%, respectively; P = .06). The rates of major adverse events during the procedure were not significantly different. The 12-month major amputation rate was similar in the atherectomy and POBA groups (4.5% vs 4.6%, respectively; P = .92; odds ratio, 0.97; 95% CI, 0.68–1.37). There was no difference in 12-month TVR (17.9% vs 17.8%; P = .97) or primary patency (56.4% vs 54.5%; P = .64) between the atherectomy and POBA groups. ConclusionsIn a large national registry, treatment of CLI from TPAD using atherectomy versus POBA showed no significant differences in procedural adverse events, major amputations, TVR, or vessel patency at 12 months.

Body mass index and long-term outcomes in patients with chronic total occlusions undergoing retrograde endovascular revascularization of the infra-inguinal lower limb arteries.

The aim of the present study is to assess the relationship between body mass index (BMI) and long-term clinical outcomes in retrograde endovascular recanalization (ER) regarding chronic total occlusions (CTOs) of the infra-inguinal lower limb arteries. The study included patients who underwent retrograde ER of CTOs localized in superficial, popliteal or below-the-knee arteries. During follow-up, major adverse cardiac and cerebrovascular and major adverse lower limb events (MALE) were evaluated. MALE was defined as amputation, target lesion re-intervention, target vessel re-intervention and surgical treatment. The study included 405 patients at the mean age of 67.2 ± 10.4. The authors divided the overall group of patients according to BMI into < 25 (n = 156, 38.5%) and ≥ 25 kg/m2 (n = 249, 61.5%), and then into < 30 (n = 302, 75.8%) and ≥ 30 kg/m2 (n = 103, 24.2%). During the average follow-up 1,144.9 ± 664.3 days, the mortality rate was higher in the group of patients with BMI < 25 kg/m2 (10.5% vs. 5.3%, p = 0.051), and in the group of patients with BMI < 30 kg/m2 (8.7% vs. 2.9%, p = 0.048). The comparison of Kaplan-Meier curves revealed borderline differences when assessing months to death for the BMI < 25 kg/m2 (p = 0.057) and BMI < 30 kg/m2 (p = 0.056) grouping variables. Obese and overweight patients undergoing CTO ER of the lower limb arteries from retrograde access are related to lower death rates during long-term follow-up.

Procedural and Mid-Term Outcomes of Coronary Protection During Transcatheter Aortic Valve Replacement in Patients at Risk of Coronary Occlusion: Insight From a Single-Centre Retrospective Analysis

BackgroundDetailed procedural analysis and long-term data is limited for coronary protection (CP) during transcatheter aortic valve replacement (TAVR) for patients with high anatomical risk for coronary occlusion (CO). We aim to assess the procedural and mid-term outcomes of CP during TAVR. MethodsWe retrospectively analyzed patients who underwent TAVR at Henry Ford Hospital, USA from January 2015 to August 2019 and identified those considered at risk of CO and underwent pre-emptive CP with or without subsequent “chimney” stenting (i.e. coronary stenting with intentional protrusion into the aorta). Procedural features, immediate and mid-term clinical outcomes were reviewed. ResultsTwenty-five out of 1166 (2.1%) patients underwent TAVR with CP, including 10 (40%) valve-in-valve procedures. Twenty-eight coronary arteries (Left: n = 11, Right: n = 11; Left + Right: n = 3) were protected. Eleven coronaries (39.3%) were electively “chimney”-stented due to angiographic evidence of coronary impingement (63.6%), tactile resistance while withdrawing stent (27.3%) and electrocardiogram change (9.1%). Twenty-four patients (24/25, 96%) had successful TAVR without CO. Procedure-related complications included stent-balloon entrapment (n = 1), stent entrapment (n = 1) and occlusive distal stent edge dissection (n = 1). After a mean follow-up of 19.1 months, there was 1 cardiac death but no target vessel re-intervention or myocardial infarction. ConclusionsOur study found that angiographic evidence of coronary impingement (63.6%) was the most common reason for stent deployment during TAVR with CP. The mid-term clinical outcome of CP with TAVR was favorable.

Mortality and chronic obstructive pulmonary disease in patients treated with endovascular revascularization of the infra-inguinal lower limb arteries from retrograde access.

BackgroundIn this trial, our objective was to evaluate the relationship between long-term clinical outcomes in patients with peripheral arterial disease (PAD) treated with retrograde endovascular recanalization (ER) of chronic total occlusions (CTOs) regarding the infra-inguinal lower limb arteries and chronic obstructive pulmonary disease (COPD).MethodsA total of 834 consecutive subjects were enrolled in the study. The mean age was 67.8±10.6 years (62.6% males). COPD was diagnosed in 98 patients (11.7%). The infra-inguinal location included the deep, superficial and common femoral artery, popliteal artery or below the knee arteries. During follow-up, we evaluated major adverse cardiac and cerebrovascular events (MACCE) and major adverse limb events (MALE). MACCE was considered as death, stroke/transient ischemic attack, myocardial infarction, percutaneous coronary intervention or coronary artery bypass grafting operation, while MALE regarded amputation, target lesion re-intervention, target vessel re-intervention and surgical action.ResultsThe mean follow-up was 1,144.9±664.3 days and the interquartile range was 1,110.5 (504.5–1,734.7). Data were collected between 2006 and 2016. We noticed significant differences in death rates among the COPD and non-COPD groups. The cumulative number of events (deaths) was 12.2%, 17.3%, 18.4%, 22.4%, 23.5%, 23.5% and 23.5% in the COPD group and 6.1%, 7.5%, 10.5%, 11.3%, 11.4% 11.5% and 11.5% in the non-COPD group after 1, 2, 3, 4, 5, 6 and 7 years of follow-up, and was notably greater for COPD (P=0.0007).ConclusionsPatients with COPD and PAD treated with the ER and retrograde approach due to CTOs are related to higher mortality than non-COPD patients.

Long-term outcome upon treatment of calcified lesions of the lower limb using scoring angioplasty balloon (AngioSculpt\u2122)

AimsIn peripheral artery disease (PAD), endovascular treatment success of heavily calcified lesions is often compromised by a number of vascular complications, such as recoils, dissections and need for target vessel re-interventions. The increasing use of scoring balloon techniques has raised the hope for better periprocedural outcomes; however, the knowledge regarding the actual benefits of the scoring balloon technique in comparison to standard therapy is still limited. Thus, the aim of the current study was to determine the safety and effectiveness of scoring balloon angioplasty in a real-life patients’ collective with PAD.Methods and ResultsA total of 425 patients with moderate to severely calcified femoropopliteal lesions received interventional treatment between 2011 and 2018 at the single center; 230 received a treatment with a scoring balloon (AngioSculpt™), and 195 received a plain procedure without AngioSculpt™. Key questions of this analysis were: (1) whether AngioSculpt™ can be used as a safe and effective stand-alone treatment in heavily calcified lesions in a 24-month follow-up, as well as (2) whether target lesion preparation with scoring balloon bears additional benefits to standard treatment (PTA ± stent implantation). In terms of freedom from target lesion revascularization there were no significant differences between AngioSculpt™ and standard procedure (82.3% vs. 78.1%, P > 0.05). Vessel preparation with balloon angioplasty had no additional effects on survival and amputation rates in comparison to standard treatment without AngioSculpt™ (P > 0.05). The deployment of a scoring balloon did not reduce the subsequent need for additional stent implantations (32.6%, and 32.3%, P > 0.05).ConclusionLesion preparation with AngioSculpt™ scoring balloon represents a safe and effective tool in the treatment of complex femoropopliteal lesions. In this retrospective analysis, AngioSculpt™ scoring balloon angioplasty did not significantly improve vessel patency- both when used as an adjunctive in preparation for stenting and as stand-alone treatment. A prospective study is needed to further investigate the scoring balloon treatment options.Graphic abstract

Impact of Platelet Volume on the Clinical Outcomes of Patients with Acute Coronary Syndrome.

Platelets with high hemostatic activity play an important role in the pathophysiology of acute coronary syndrome (ACS), and mean platelet volume (MPV) has been proposed to be an indicator of platelet reactivity. We evaluated the predictive value of MPV and the responsive value of MPV with different antiplatelet agents in association with the clinical outcomes of ACS patients. A total of 1094 patients with ACS and 472 patients without ACS were included. Blood samples were taken at hospital admission, at routine follow-up within one year, and beyond one year. The patients were divided into a "high MPV group" (> 9.0 fl, n = 305), "medium MPV group" (7.9-9.0 fl, n = 517), and "low MPV group" (< 7.9 fl, n = 272). The average follow-up time was 2.4 years, and the endpoints were major adverse cardiovascular events (MACEs) including all-cause mortality, time to recurrent ACS, target vessel re-intervention and stroke. MPV was significantly higher in the patients with ACS than in those without ACS (8.6 ± 1.1 vs. 8.4 ± 1.0 fl, p = 0.007). MPV decreased in the following year (8.38 ± 1.02 fl, p < 0.001) and also beyond one year (8.38 ± 0.94 fl, p < 0.001) after ACS events. The changes in MPV were not significantly different between the patients receiving either clopidogrel or ticagrelor. The high MPV group had more cardiovascular risk factors and more MACEs than the low MPV group (p = 0.017). A higher MPV in patients with ACS was associated with more cardiovascular risk factors and more cardiovascular events during clinical follow-up.

On-Treatment Platelet Reactivity is a Predictor of Adverse Events in Peripheral Artery Disease Patients Undergoing Percutaneous Angioplasty

Few data are available on the association between a different entity of platelet inhibition on antiplatelet treatment and clinical outcomes in patients with peripheral artery disease (PAD). The aim of this study was to evaluate the degree of on-treatment platelet reactivity, and its association with ischaemic and haemorrhagic adverse events at follow up in PAD patients undergoing percutaneous transluminal angioplasty (PTA). In this observational, prospective, single centre study, 177 consecutive patients with PAD undergoing PTA were enrolled, and treated with dual antiplatelet therapy with aspirin and a P2Y12 inhibitor. Platelet function was assessed on blood samples obtained within 24 h from PTA by light transmission aggregometry (LTA) using arachidonic acid (AA) and adenosine diphosphate (ADP) as agonists of platelet aggregation. High on-treatment platelet reactivity (HPR) was defined by LTA ≥ 20% if induced by AA, and LTA ≥ 70% if induced by ADP. Follow up was performed to record outcomes (death, major amputation, target vessel re-intervention, acute myocardial infarction and/or myocardial revascularisation, stroke/TIA, and bleeding). HPR by AA and HPR by ADP were found in 45% and 32% of patients, respectively. During follow up (median duration 23 months) 23 deaths (13%) were recorded; 27 patients (17.5%) underwent target limb revascularisation (TLR), two (1.3%) amputation, and six (3.9%) myocardial revascularisation. Twenty-four patients (15.6%) experienced minor bleeding. On multivariable analysis, HPR by AA and HPR by ADP were independent predictors of death [HR 3.8 (1.2–11.7), p = .023 and HR 4.8 (1.6–14.5), p = .006, respectively]. The median value of LTA by ADP was significantly lower in patients with bleeding complications than in those without [26.5% (22–39.2) vs 62% (44.5–74), p < .001). LTA by ADP ≤ 41% was independently associated with bleeding HR 14.6 (2.6–24.0), p = .001] on multivariable analysis. In this study a high prevalence of on-clopidogrel and aspirin high platelet reactivity was found, which was significantly associated with the risk of death. Conversely, a low on-clopidogrel platelet reactivity was associated with a higher risk of bleeding. These results document that the entity of platelet inhibition is associated with both thrombotic and bleeding complications in PAD patients.

On-Treatment Platelet Reactivity is a Predictor of Adverse Events in Peripheral Artery Disease Patients Undergoing Percutaneous Angioplasty

Few data are available on the association between a different entity of platelet inhibition on antiplatelet treatment and clinical outcomes in patients with peripheral artery disease (PAD). The aim of this study was to evaluate the degree of on-treatment platelet reactivity, and its association with ischaemic and haemorrhagic adverse events at follow up in PAD patients undergoing percutaneous transluminal angioplasty (PTA). In this observational, prospective, single centre study, 177 consecutive patients with PAD undergoing PTA were enrolled, and treated with dual antiplatelet therapy with aspirin and a P2Y12 inhibitor. Platelet function was assessed on blood samples obtained within 24h from PTA by light transmission aggregometry (LTA) using arachidonic acid (AA) and adenosine diphosphate (ADP) as agonists of platelet aggregation. High on-treatment platelet reactivity (HPR) was defined by LTA≥20% if induced by AA, and LTA≥70% if induced by ADP. Follow up was performed to record outcomes (death, major amputation, target vessel re-intervention, acute myocardial infarction and/or myocardial revascularisation, stroke/TIA, and bleeding). HPR by AA and HPR by ADP were found in 45% and 32% of patients, respectively. During follow up (median duration 23 months) 23 deaths (13%) were recorded; 27 patients (17.5%) underwent target limb revascularisation (TLR), two (1.3%) amputation, and six (3.9%) myocardial revascularisation. Twenty-four patients (15.6%) experienced minor bleeding. On multivariable analysis, HPR by AA and HPR by ADP were independent predictors of death [HR 3.8 (1.2-11.7), p=.023 and HR 4.8 (1.6-14.5), p=.006, respectively]. The median value of LTA by ADP was significantly lower in patients with bleeding complications than in those without [26.5% (22-39.2) vs. 62% (44.5-74), p<.001). LTA by ADP ≤ 41% was independently associated with bleeding HR 14.6 (2.6-24.0), p=.001] on multivariable analysis. In this study a high prevalence of on-clopidogrel and aspirin high platelet reactivity was found, which was significantly associated with the risk of death. Conversely, a low on-clopidogrel platelet reactivity was associated with a higher risk of bleeding. These results document that the entity of platelet inhibition is associated with both thrombotic and bleeding complications in PAD patients.

Drug-eluting stents vs bioresorbable stents (scaffolds) vs drug-eluting balloons: the advantages and drawbacks of new technologies.

2016;11(3-4):124. VII. nacionalni sastanak o kardiovaskularnim intervencijama s međunarodnim sudjelovanjem VI. sastanak intervencijskih kardioloskih medicinskih sestara i tehnicara The introduction of bare-metal stents (BMS) significantly advanced the field of interventional cardiology by reducing the number of reinterventions. In order to reduce restenosis, drug-eluting stents (DES) were developed, and are further differentiated by stent platform, polymer type, and active substance. The first generation of DES, paclitaxel-eluting stents (PES) and sirolimus-eluting stents, are no longer used as the second generation of stents are superior: zotarolimus-eluting stents (ZES) and everolimuseluting stents (EES). They are biocompatible, cause less inflammatory reactions, and become covered with endothelium more quickly. Resolute zotarolimus-eluting stents (R-ZES) and EES are comparable, and are superior in relation to other DES’s. Meta-analyses of studies have proven DESs with bioresorbable polymer (biolimus and sirolimus) superior to 1st generation DESs (sirolimus) in their reduced revascularisation of target veins and reduced incidence of in-stent thrombosis in a 5-year period. However, if these stents are compared with the new generation of DESs, it becomes clear that the percentage of target vessel reintervention is comparable. DESs with resorbable polymer are comparable to R-ZES in their incidence of in-stent thrombosis and mortality rates, while they are inferior to EES. It is difficult to design a non-polymer DES due to problems in attaining a stable concentration of anti-proliferation drug necessary to prevent neointimal hyperplasia. The first studies are promising, and have shown no significant differences in the later loss of lumens, angiographic restenosis, or revascularization of target veins due to restenosis as compared to a standard DES with paclitaxel. The time necessary to release this drug is one month, and its application would reduce the length of dual antiplatelet therapy, thus completely eliminating rare indications for the application of BMS.1-3

Long-term Comparative Outcomes of Carotid Artery Stenting Following Previous Carotid Endarterectomy vs De Novo Lesions

Purpose: To report the long-term outcomes of patients who underwent carotid artery stenting (CAS) for de novo carotid stenosis vs patients treated for restenosis after carotid endarterectomy (CEA). Methods: A retrospective review was conducted of all 385 patients (mean age 68.6±9.6 years; 231 men) who underwent 435 CAS procedures at a large tertiary care center between January 1999 and December 2013. For analysis, patients were stratified based on their lesion type [de novo (dn) vs post-CEA restenosis (res)] and subclassified by symptoms status [symptomatic (Sx) or asymptomatic (Asx)], creating 4 groups: (1) CAS-dn Asx, (2) CAS-dn Sx, (3) CAS-res Asx, and (4) CAS-res Sx. For the CAS-res group, the mean elapsed time from CEA to CAS was 72.4±63.6 months. Outcomes included target vessel reintervention (TVR) and in-stent restenosis (ISR), the latter defined by a carotid duplex ultrasound velocity >275 cm/s. Results: The main indication for initial carotid angiography with possible revascularization was severe carotid stenosis (≥70%-99% on duplex) in both CAS-dn and CAS-res groups (83.6% vs 83.7%, p=0.999). There were no significant differences in the percentage of patients with postintervention residual stenosis (<30%; 100% each arm) or complications between CAS-res vs CAS-dn: in-hospital stroke (1.4% vs 1.8%, respectively), myocardial infarction (0.9% vs 0%), or death (0.9% vs 0%). Mean follow-up was 62.4±45.6 months (median 53.5, range 1–180). Average clinical/TVR follow-up was greater for the CAS-res group (71.9±48.6 months) compared with 53.3±40.5 months for the CAS-dn group (p<0.001). Across the 4 study groups, there were no differences in freedom from ISR (p=0.174) or TVR (p=0.856). Multivariate analysis found peripheral vascular disease (PVD) as the sole ISR independent predictor [hazard ratio (HR) 1.92, 95% confidence interval (CI) 1.03 to 3.62, p=0.041], while significant predictors for TVR were age <65 years at the time of the procedure (HR 2.55, 95% CI 1.05 to 6.18, p=0.039) and PVD (HR 2.46, 95% CI 1.03 to 5.87, p=0.043). Conclusion: The current study suggests that CAS is a feasible and durable therapeutic option for recurrent restenosis after CEA. Long-term outcomes were similar for patients treated for de novo lesions or post-CEA restenosis. Age and PVD appear to influence long-term CAS durability.

Minimally Invasive Direct Coronary Artery Bypass Graft Surgery or Percutaneous Coronary Intervention for Proximal Left Anterior Descending Artery Stenosis: A Meta-Analysis

We conducted a metaanalysis comparing early and midterm cardiovascular adverse events associated with minimally invasive direct coronary artery bypass graft surgery (MIDCABG) and percutaneous coronary intervention (PCI), with a focus on drug-eluting stents (DES). A systematic literature review (MEDLINE, EMBASE, Scopus, and so forth) yielded 12 studies (7randomized controlled trials; 5 observational) pooling more than 2,000 patients. A random effect, inverse variance metaanalysis was conducted, and a subgroup analysis of the PCI-DES cohort was performed. Events were compared as risk ratios using a 95% confidence interval (CI). Heterogeneity of results was evaluated by Eggers I(2) test. Results are presented as early (0 to 1 year) and midterm (2 to 5 years). Midterm mortality in the PCI and MIDCABG groups (3.6% and 2.6%, respectively) was comparable (1.24, 95% CI: 0.66 to 2.33; p= 0.5; I(2)= 0%). Risk of early restenosis was lower in the MIDCABG cohort compared with PCI (0.40, 95% CI: 0.16 to 0.99; p= 0.05; I(2)= 57%). Although the early risk of recurrence of angina was comparable, over time it was 61% (43% to 74%) lower for MIDCABG patients (p < 0.001). Midterm results on analysis of the entire cohort demonstrated an increased risk for target vessel reinterventions (3.84, 95% CI: 2.7 to 5.5; p < 0.001) in the PCI cohort. Subgroup analysis revealed that the PCI-DES cohort (4 studies; 456 patients) had a higher risk of recurrent angina (risk ratio 3.4, 95%CI: 1.9 to 6.2; p < 0.001; I(2)= 0%) and target vessel reinterventions (risk ratio 4.16, 95% CI: 2.7 to 6.6; p<0.001; I(2)= 0%) at midterm follow-up (2 to 5 years). Survival rates are comparable after either MIDCABG or PCI for proximal LAD disease. However, even the use of DES was associated with significantly higher rates of angina recurrence and the need for target vessel reintervention as compared with MIDCABG.

Fenestrated endovascular repair of complex aortic aneurysms

Fenestrated endovascular aneurysm repair (FEVAR) provides an endovascular solution for patients with large abdominal aortic aneurysms and challenging neck anatomy in addition to repair of endoleaks and pseudoaneurysms. This article reports the midterm outcomes of FEVAR from a single-tertiary referral centre in Ireland. From 2006 to 2012, nine consecutive asymptomatic patients with neck anatomy unfavourable for standard EVAR underwent endovascular repair with a customised fenestrated Zenith stent graft. An additional three patients had fenestrated grafts for repair of pseudoaneurysms (n = 2) following open AAA repair and a type I endoleak (n = 1). All patients were prospectively enrolled in a computerised database. Outcomes including mortality, morbidity, renal function, target vessel patency, endoleak and reintervention were analysed. The mean age and aneurysm size in the primary repair group were 74 years (65-84 years) and 6 cm (5-8.3 cm), respectively, and in the secondary repair group, the mean age was 66 years (61-75 years). No procedures required open conversion, and no visceral arteries were lost. On completion angiography, two patients in group 1 had a type I endoleak and one had a type III endoleak. There were no endoleaks in the secondary repair group. Follow-up ranged from 30 days to 6 years. There was one death within 30 days (8 %) and two deaths at 3 years from non-aneurysm-related causes. Six patients required secondary interventions. Three patients had a transient post-operative creatinine rise of >30 %. Our study supports FEVAR as a feasible and effective therapy in the management of patients with complex aortic aneurysms.

Angiographic evaluation of graft patency in robotic-assisted coronary artery bypass surgery: 8 year follow-up

Robotic telemanipulation systems have emerged as facilitating tools that enhance minimally invasive cardiac surgery.The purpose of this study was to evaluate graft patency by a combination of invasive and non-invasive coronary angiography methods in robotic-assisted coronary artery surgery(CABG) for optimal quality control. Between April 2004 and February 2012, patients who had robotic-assisted CABG were called to have cardiac catheterization or multislice computed tomographic angiography to evaluate graft patency. One hundred patients out of a total 250 cases were followed for graft patency for a mean period of 60.3 ± 23.8 (range 12-94) months. Mean operative time and left internal mammary artery harvest time was 165.96 ± 19.5 and 41.74 ± 5.9 (range 30-55) min. Postoperative graft patency rate was 94% and freedom from target vessel re-interventions was 98%. Robotic-assisted CABG can be accomplished with low morbidity, mortality and re-intervention rates. It is a safe procedure in selected patients and produces excellent mid-term graft patency.

Is totally endoscopic coronary artery bypass safe, feasible and effective?

A best evidence topic was written according to a structured protocol. The question addressed was whether totally endoscopic coronary artery bypass (TECAB) is safe, effective and feasible. A total of 171 papers were found, of which eight represented the best evidence. The authors, date, journal, study type, population, main outcome measures and results are tabulated. The da Vinci robotic system was utilized in seven retrospective studies and one multicentre prospective trial, comprising 724 patients undergoing TECAB. Patient-related outcomes, including the incidence of major adverse cardiac events, graft patency and survival, were investigated. From the studies evaluated, TECAB appears to be safe operation with low complication rates and excellent early- and mid-term graft patencies. The incidence of internal thoracic artery injury was documented in four studies and ranged from 0 to 10%. Re-exploration for bleeding was necessary in 1-15% of patients. Conversion to open techniques was performed in 0-24% of cases. There was no in-hospital mortality in the majority of studies, but this reached 2.1% in a large series of 228 patients. Target-vessel reintervention rates varied between 0 and 12.1% according to the institutional experience. Pre- and post-discharge graft patencies were excellent at 93-100 and 92-100%, respectively. Intraoperative variables, such as time taken for internal thoracic artery harvest, anastomosis, cross-clamp, cardiopulmonary bypass (CPB) and the overall operation were as follows: internal thoracic artery harvest time (range 5-187 min), anastomosis time (range 6-82 min), cross-clamp time (range 30-223 min), CPB time (range 41-268 min) and operative time (range 84-600 min). TECAB is a technically demanding and time-consuming procedure associated with a significant learning curve. Proctoring and structured training programmes are currently supported by European and international societies to encourage wider uptake of the procedure. In conclusion, TECAB represents a feasible alternative to conventional coronary artery bypass in selected patients. It is associated with low morbidity and excellent mid-term graft patency. Larger, prospective and multicentre trials are required to assess the long-term and patient-reported outcomes of TECAB.

Drug-Eluting Stents Compared With Bilateral Internal Thoracic Artery Grafts for Diabetic Patients

Diabetic patients with multivessel coronary artery disease who undergo coronary artery bypass grafting (CABG) or percutaneous coronary interventions (PCI) are at greater risk of late morbidity and mortality than nondiabetic patients. We questioned earlier comparisons of these two approaches that showed no differences in survival rates. This study compares drug-eluting stents (DES) and bilateral internal thoracic artery (BITA) grafting in diabetic patients with multivessel coronary artery disease. All diabetic patients who underwent left-sided arterial revascularization with BITA grafting between January 2002 and May 2006 were evaluated. Their outcomes were compared with those of diabetic patients who underwent PCI with DES (Cypher). The Cox proportional hazards model defined predictors of outcome events after forcing propensity score with patients' characteristics into the model. The outcomes of 226 BITA patients were compared with those of 271 DES patients (mean follow-up 62 months). The 5-year reintervention-free survival (Kaplan-Meier 86% versus 65%, log rank p = 0.000) and major adverse cardiovascular events-free survival (81% versus 54%, p = 0.001) were significantly better in the BITA group. Assignment to the PCI group was associated with decreased adjusted survival (hazard ratio 3.01, 95% confidence interval: 1.59 to 5.73, p = 0.000) and increased risk of target vessel reinterventions (hazard ratio 7.00, 95% confidence interval: 3.1 to 15.70). The adjusted risk of major adverse cardiovascular events increased with the number of DES-treated vessels. This is the first demonstration of significantly better long-term adjusted survival and outcomes of diabetic patients who underwent CABG with BITA grafting compared with diabetic patients who underwent PCI with DES.

Review of a 13-Year Single-Center Experience with Minimally Invasive Direct Coronary Artery Bypass as the Primary Surgical Treatment of Coronary Artery Disease

In this study, we review our experience with 1768 minimally invasive direct coronary artery bypass (MIDCAB) operations. The focus is on long-term outcome with more than 10 years of follow-up. All patients undergoing standard MIDCAB between 1996 and 2009 were included. For all 1768 patients, pre-, intra-, and postoperative data could be completed. Long-term follow-up information about health status, major adverse cardiac and cerebrovascular events (MACCE), and freedom from angina was collected annually via questionnaire or personal contact. Five-year follow-up is available for 1313 patients, and 10-year-follow-up is available for 748 patients. A multivariate Cox regression analysis was performed to determine risk factors for long-term outcome. Mean age was 63.4 ± 10.8 years, mean ejection fraction was 60.0% ± 14.2%, and perioperative mortality risk calculated by logistic EuroSCORE was 3.8 ± 6.2%. In 31 patients (1.75%) intraoperative conversion to sternotomy was necessary. Early postoperative mortality was 0.8% (15 patients); 0.4% (7 patients) had a perioperative stroke. Seven hundred twelve patients received routine postoperative angiogram, showing 95.5% early graft patency. Short-term target vessel reintervention was needed in 59 patients (3.3%) (11 percutaneous transluminal coronary angioplasty (PTCA)/stent, 48 re-operation). Kaplan-Meyer analysis revealed a 5-year survival rate of 88.3% (95% confidence interval [CI], 86.6% to 89.9%) and a 10-year-survival rate of 76.6% (95% CI, 73.5% to 78.7%). The freedom from MACCE and angina after 5 and 10 years was 85.3% (95% CI, 83.5% to 87.1%) and 70.9% (95% CI, 68.1% to 73.7%), respectively. MIDCAB is a safe operation with low postoperative mortality and morbidity. With excellent short-term and long-term results, it is a very good alternative compared to both percutaneous coronary intervention (PCI) and conventional surgery.

Primary carotid artery stenting versus carotid artery stenting for postcarotid endarterectomy stenosis

Carotid artery stenting (CAS) has been advocated as an alternative to carotid endarterectomy (CEA) in high-risk surgical patients, including stenosis after CEA. This study compared early and midterm clinical outcomes for primary CAS vs CAS for post-CEA stenosis. This study analyzed 180 high-risk surgical patients: 68 had primary CAS (group A), and 112 had CAS for post-CEA stenosis (group B). Patients were followed-up prospectively and had duplex ultrasound imaging at 1 month and every 6 months thereafter. All patients had cerebral protection devices. Kaplan-Meier life-table analysis was used to estimate rates of freedom from stroke, stroke-free survival, > or =50% in-stent stenosis, > or =80% in-stent stenosis, and target vessel reintervention (TVR). Patients had comparable demographic and clinical characteristics. Carotid stent locations were similar. Indications for CAS were transient ischemic attacks (TIA) or stroke in 50% for group A and 45% for group B. The mean follow-up was comparable, at 21 (range, 1-73) vs 25 (range, 1-78) months, respectively. The technical success rate was 100%. The perioperative stroke rates and combined stroke/death/myocardial infarction (MI) rates were 7.4% for group A vs 0.9% for group B (P = .0294). No perioperative MIs occurred in either group. One death was secondary to stroke. The combined early and late stroke rates were 10.8% for group A and 1.8% for group B (P = .0275). The stroke-free rates at 1, 2, 3, and 4 years for groups A and B were 89%, 89%, 89%, and 89%; and 98%, 98%, 98%, and 98%, respectively (P = .0105). The rates of freedom from > or =50% carotid in-stent stenosis were 94%, 83%, 83%, and 66% for group A vs 96%, 91%, 83%, and 72% for group B (P = .4705). Two patients (3%) in group A and seven patients (6.3%) in group B had > or =80% in-stent stenosis (all were asymptomatic except one). The freedom from > or =80% in-stent stenosis at 1, 2, 3, and 4 years for groups A and B were 100%, 98%, 98%, and 78% vs 99%, 96%, 92%, and 87%, respectively (P = .7005). Freedom from TVR rates at 1, 2, 3, and 4 years for groups A and B were 100%, 100%, 100%, and 100% vs 99%, 97%, 97%, and 92%, respectively (P = .261). CAS for post-CEA stenosis carried a lower risk of early postprocedural neurologic events than primary CAS, with a trend toward a higher restenosis rate during follow-up.

Feasibility, safety, and efficacy of totally endoscopic coronary artery bypass grafting: Multicenter European experience

The invention of robotic systems has begun a new era of endoscopic cardiac surgery. Reports on totally endoscopic coronary artery bypass grafting are limited, however, and data regarding feasibility, safety, and efficacy are needed to determine this technique's position in the therapeutic armamentarium. This study describes the largest multicenter experience in the literature with robotic totally endoscopic coronary artery bypass grafting specifically addressing procedural feasibility, safety, and efficacy. Between September 1998 and November 2002, a total of 228 patients with coronary artery disease were scheduled for totally endoscopic coronary artery bypass grafting with the da Vinci Surgical System (Intuitive Surgical Inc, Sunnyvale, Calif.) at five European institutions. Patients underwent totally endoscopic coronary artery bypass grafting with either an on-pump (group A, n = 117) or an off-pump approach (group B, n = 111). Patients underwent postoperative angiography or stress electrocardiography and were followed up for 6 months. Procedural feasibility was demonstrated through the completion of 164 successful totally endoscopic cases. Sixty-four patients (group C, 28%) had conversion to nonrobotic procedures. Conversion rates decreased with time. The overall procedural efficacy, as defined by angiographic patency or lack of ischemic signs on stress electrocardiography, was 97%. The incidence of major adverse cardiac events within 6 months was 5%. Both on- and off-pump totally endoscopic coronary artery bypass grafting are feasible, with a conversion rate that diminishes with increasing experience. Conversion does not adversely affect outcome and thus constitutes a safe alternative. Although target vessel reintervention may be slightly higher than that reported for open coronary artery bypass grafting, graft patency and major adverse cardiac events for both approaches are comparable to those reported in the Society of Thoracic Surgeons database, demonstrating the safety and efficacy of the totally endoscopic coronary artery bypass grafting procedure.