Appraising failure of surgical and percutaneous revascularization: long term outcomes from an observational registry.

AIM: Many randomized trials have compared coronary artery bypass graft (CABG) and percutaneous coronary intervention (PCI) in terms of efficacy, but data comparing outcomes of patients in which these two techniques have failed are lacking. METHODS: We included patients undergoing PCI at our center between July 2002 and December 2004. Subjects were distinguished in 2 groups: those with at least one occluded or stenotic saphenous vein graft (CABG failure), and those with at least one stent with angiographically documented restenosis (PCI failure). The primary endpoint was the long-term rate of major adverse clinical events. RESULTS: Two hundred and thirthy four patients were included, with a medium follow up of 61±13 months; 134 were assigned to the CABG failure group, and 104 to the PCI failure group, sharing high rates of baseline risk factors. At long term rates of death were higher in post CABG group (22.1% vs. 9.9%; P=0.015, RR 2.24 C.I. 95% 1.14-4.40) while death rates in patients with diagnosis of diabetes mellitus (24.0% vs. 23.5%; P=0.969, RR 1.020 C.I. 95% 0.38-2.74) were not different CONCLUSION: PCI can be safely offered to both these kinds of patients: as recently demonstrated post CABG outcomes seem to be more favorable in patients with diabetes mellitus.

Incidence and very long- term outcomes of stent thrombosis after bare-metal or drug-eluting stent implantation: a retrospective analysis.

AIM: Stent thrombosis is a major safety issue after percutaneous coronary intervention (PCI) with stent implantation and it is associated with major early and mid-term complications. However, its long-term impact has been incompletely described. We thus aimed to appraise incidence, predictors and very long-term outlook of stent thrombosis after bare metal stent (BMS) or drug-eluting stent (DES) implantation. METHODS: We identified all patients undergoing PCI with BMS or DES at our center between July 2002 and June 2004. For the purpose of this study, we employed a composite definition of stent thrombosis including any Academic Research Consortium stent thromboses (definite, probable, or possible). We adjudicated the following clinical events: death, myocardial infarction (stent thrombosis related), repeated revascularization, and the composite of these events (i.e., major adverse cardiac events, MACE). RESULTS: A total of 1112 patients were included, 854 (76.8%) treated with BMS and 258 (23.2%) treated with DES. At a median follow-up of 61.2 (11.03) months the incidence of stent thrombosis was 20 (1.8%), with 14 (1.3%) definite, 4 (0.4%) probable, and 2 (0.1%) possible according to the American Research Consortium statement. Patients developing stent thrombosis were more likely to have more complex angiographic features at baseline (including angiographically evident thrombus, 4 [20%] vs. 73 [6.6%], P=0.02) and a saphenous vein graft as target vessel (2 [10%] vs. 28 [2.5%], P=0.04). Conversely, being treated with a BMS or a DES did not confer any significant decrease or increase in the risk of stent thrombosis, as 7 [35%] of those with stent thrombosis had received at least a DES vs. 251 [22.9%] of those without stent thrombosis, P=0.28). Early clinical outcomes (at 30 days) distinguishing those with stent thrombosis versus those without were as follows: death in four (20%) vs. 2 (0.2%, P<0.001), myocardial infarction in 1 (5%) vs. 7 (0.6%, P=0.02), revascularization in 5 (25%) vs. 43 (3.9%, P<0.001), and MACE in 8 (40%) vs. 53 (4.8%, P<0.001). After more than 60 months of clinical follow-up, outcomes were as follows: death in 7 (35%) vs. 147 (13.5%, P=0.057), myocardial infarction in 6 (30%) vs. 40 (3.6%, P<0.001), revascularization in 15 (75%) vs. 317 (29%, P<0.001), and MACE in 19 (95%) vs. 453 (41.5%, P<0.001). CONCLUSION: This long-term registry shows that stent thrombosis remains a major safety issue after PCI with stent implantation, with a significant prognostic impact. However, in the present work the risk of stent thrombosis was similar with either DES or BMS, suggesting thus that DES are not associated with any increase in long-term thrombotic risk in comparison to BMS.

Very long-term outcome of peripheral arterial disease in patients undergoing percutaneous coronary revascularization: a retrospective analysis.

AIM: Peripheral arterial disease (PAD) in patients undergoing percutaneous coronary intervention (PCI) with stent implantation is a well known risk factor leading to an increased rates of stroke, cardiovascular death and myocardial infarction. Anyway there are few data on very-long term outcome (more than 1 year follow up) of PAD after stent implantation. We thus aimed to evaluate the influence of PAD on very long-term outcome of our PCI-population. METHODS: We retrospectively identified all patients undergoing PCI with stent implantation at our center between July 2002 and June 2004, and thus eligible for at least 4 years of follow-up. For the purpose of this study, we considered a diagnosis of PAD based on clinical evaluation and/or angiographic documentation. We adjudicated the following clinical events: death, myocardial infarction, repeat revascularization, and their composite (i.e. major adverse cardiac events, MACE). RESULTS; A total of 1008 patients were included, 109 with PAD and 899 Without PAD. Those with had more often diabetes (35% vs. 25%, P=0.002), hypertension (83% vs. 68%, P=0.001) and unfavorable basal clinical condition at the start of this study: past-Percutaneous Coronary Intervention (PCI) (30% vs. 22%, P=0.005), past-Coronary Artery Bypass Graft (CABG) (24% vs. 14%, P=0.001), ejection fraction (EF) <35% (14% vs. 7%, P=0.02) and chronic renal failure (CRF) (15% vs. 6%, P=0.002). In addiction patient with PAD were more likely to have chronic total occlusion (CTO) (36% vs. 25%, p=0.02) and unprotected left main (16% vs. 8%,P=0.01). Clinical outcome at the time of follow-up (4,42 ± 1,66 years) was as follow: Revascularization (53% vs. 37%, P=0.002), Cardiac death (21% vs. 13%, P=0.04), MACE (69% vs. 49%, p<.001). Independent predictors of MACE according to our survival analysis were: PAD (HR 1.31; 95% CI 1.01-1.69), Age >75 (HR 1.23; 95% CI 1-1.51), Chronic heart failure (HR1.72; 95% CI 1.19-2.5), Unprotected left main (HR 1.48; 95% CI 1.12-1.96). CONCLUSION: This long-term registry shows that PAD remains an important clinical condition that negatively influences the outcome of patients undergoing PCI with stent implantation in a very long-term follow-up period.

Short and long term outcome of percutaneous coronary intervention with drug eluting stent and bare metal stent in patients with chronic kidney disease.

AIM: Coronary artery disease represents the most important cause of mortality and morbidity in chronic kidney disease (CKD). Despite continuous improvements in percutaneous coronary intervention (PCI), CKD is still associated with more adverse events after PCI. We performed a retrospective study to compare bare metal stents (BMS) versus drug eluting stents (DES) in CKD. METHODS: We included consecutively all patients undergoing PCI at our Centre from July 2002 to December 2005 with CKD, defined as creatinine clearance <60 mL/min. Patients who received only DES were compared to those who received only BMS. The primary end-point was the long-term rate of major adverse cardiac events (MACE, i.e. the composite of death, myocardial infarction and repeat revascularization). RESULTS: We included a total of 219 patients with CKD out of a total of 2354 patients, with 164 receiving BMS and 55 DES. After a mean follow up of 48 months, the MACE rate was significantly higher in BMS group (71% versus 38%, P<0.001). A similarly increased risk with BMS was found for death (45% versus 17%, P<0.001), whereas the rates for repeat coronary revascularization, myocardial infarction and stent thrombosis were not significantly different. Multivariable analysis showed that BMS vs.. DES implantation was not statistically significant associated with MACE, death, myocardial infarction, rePTCA or stent thrombosis. CONCLUSION: Compared with BMS, use of DES in patients with CKD is safe and effective in reducing adverse outcomes. However, differences found between groups in clinical end-point could be ascribed to selection bias and confounding factors.

Percutaneous drug-eluting stent implantation in diabetic patients: short and long term outcomes from an observational study.

AIM: The introduction of drug-eluting stents (DES) has markedly improved mid-term results of percutaneous coronary intervention (PCI) in diabetics. However, it is unclear whether the risk-benefit balance of DES in diabetics is maintained also at long-term and in insulin-requiring patients. We thus aimed to appraise long-term outcomes of diabetic patients treated with PCI with DES, stratifying according to insulin therapy. METHODS: We retrospectively collected baseline, procedural and outcome data from all patients undergoing PCI with DES from July 2002 to June 2004 at our center. We distinguished three groups: insulin-requiring diabetics, non-insulin-requiring diabetics and patients without diabetes. The primary end-point was the long-term rate of major adverse cardiac events (MACE, i.e. the composite of death, myocardial infarction, or target vessel revascularization). We also considered stent thrombosis according to the Academic Research Consortium Definition. RESULTS: We included a total of 1266 patients, with 3% of insulin-requiring diabetes, 22% with non-insulin-requiring diabetes, and 75% without diabetes. There were significant differences across groups in prevalence of male gender (respectively, 32.4%, 74.6% and 81%, P<0.001), and DES usage (54.1%, 34%, and 30.4%, P=0.007). Thirty-day MACE occurred with similar frequency in the three groups (8.1%, 7.3% and 6.3%, P=0.78), with death in 3%, 2%, and 1.4% (P=0.71) and myocardial infarction in 5.4%, 1.8% and 0.8% (P=0.02). After a median follow-up period of 58 months, MACE occurred in 59.5% of patients with insulin-requiring diabetes, in 50.6% of non-insulin-requiring diabetics and in 38.9% of non-diabetics (P<0.001). Death occurred in 24.3%, 17.5% and 8.5%, (P<0.001), myocardial infarction in 10.8%, 6.6%, and 5.1% (P=0.25), repeat revascularization in 46%, 31.6%, and 30% (P=0.11), and definite stent thrombosis in 0%, 1.1%, and 1.3% (P=0.78). CONCLUSION: Our study confirms the high risk profile of diabetic patients, especially when ischemic disease it is known. In this setting, diabetic and comorbidities fix the price not only in term of need of further revascularization, but mainly in survival decrease. It can be concluded that not only revascularization but also ­ and especially ­ comorbidities treatment plays a determinant role reducing follow-up events. Further research on additional pharmacologic treatments or hybrid revascularization strategies may mitigate the burden of morbidity and mortality.

Impact of multivessel coronary disease on long-term outcome after percutaneous recanalization of coronary chronic total occlusions.

AIM: Percutaneous coronary intervention (PCI) of chronic total occlusions (CTO) is common even with concomitant multivessel disease. We aimed to investigate the impact of multivessel disease on long-term outcome after PCI for CTO. METHODS: We collected baseline, procedural and follow-up data on patients undergoing successful PCI with stenting for CTO. We divided our population into three groups: patients with 1 vessel disease (1VD), those with 2-vessel disease (2VD) and subjects with 3-vessel disease (3VD). The primary end-point was the occurrence of major adverse cardiac events (MACE), i.e. death, myocardial infarction or target vessel revascularization. RESULTS: A total of 111 patients were included: 24 (21%) in group 1VD, 28 (25%) in group 2VD, and 59 (53%) in group 3VD. Clinical follow-up was available in 109 (98%) of them after a median of 27 months (range 6-68), yielding MACE rates of 1 (4%) in group 1VD, 5 (18%) in group 2VD, and 17 (29%) in group 3VD, respectively (P=0.03). No statistically significant difference was found comparing the 3 groups for the individual rates of death, myocardial infarction or target vessel revascularization (all P>0.05). No case of definite or probable stent thrombosis was adjudicated, despite use of DES in 99 (89%) patients. CONCLUSION: Patients with diffuse coronary disease undergoing PCI for a CTO fare a significantly worse prognosis. Nonetheless, despite liberal use of DES, stent thrombosis is rare in this setting, without differences according to the initial severity of disease, thus supporting the long-term safety of DES, even if used in this "off-label" context.

Short and long-term outcomes of percutaneous revascularization in patients with prior coronary artery bypass graft.

AIM: Patients with prior coronary artery bypass grafting (CABG) represent a sizable portion of those undergoing percutaneous coronary intervention (PCI): in many instances, it is unclear whether performing PCI on the bypass graft or in the native coronary vessels can offer the best risk-benefit balance. METHODS: We included patients with prior CABG undergoing PCI at our center between July 2002 and June 2004 and we distinguished them in three groups. Those in whom PCI was performed on stenotic saphenous vein graft (SVG group), those in whom PCI was performed on native vessels despite the presence of potentially treatable SVG disease (optional native group), and those in whom PCI had to be performed mandatorily in the native vessels because of chronic SVG occlusions or disease in non-bypassed segments (mandatory native group). The primary end-point was long-term rate of major adverse clinical events (MACE, i.e. death, myocardial infarction, or target vessel revascularization). RESULTS: We identified 109 patients: 28 were in the SVG group, 25 in the optional native group, and 56 in the mandatory native group. Early major adverse cardiac events (MACE) occurred with similar frequency in the three groups (respectively, 9.1%, 0% and 5.7%, P=0.35). After more than three years of follow-up, MACE occurred in 39.3% vs. 28 and 39.4% (P=0.59), death occurred in 27.2 vs. 24.0% vs. 13.5% (P=0.30), and TVR in 27.3% vs. 8.0% vs. 28.8% (P=0.14). CONCLUSION: In selected patients, PCI of native coronary vessels despite the presence of apparently treatable SVG lesions can be envisioned.

Repeat adverse events long after percutaneous coronary revascularization in diabetics.

AIM: Diabetics with coronary artery disease face a high risk of adverse events following coronary revascularization. However, recurrence rates of after the first revascularization have never been appraised. The aim of this study was to evaluate recurrent events in diabetics undergoing percutaneous coronary intervention (PCI) in the current era. METHODS: Authors collected baseline and outcome data of consecutive type-2 diabetics treated with PCI (July 2002-December 2005) . End-points of interest were the long-term rates of major adverse cardiac events (MACE: cardiac death, myocardial infarction [MI], percutaneous target vessel revascularization [TVR-PCI], or coronary artery bypass grafting [CABG]), non-TVR PCI, and stent thrombosis. RESULTS: A total of 429 diabetics were included, 191 (44%) insulin-dependent, with drug-eluting stents implanted in 232 (54%). After a median of 38 months, events were as follows: MACE in 167 (38.9%) subjects, cardiac death in 38 (8.8%), MI in 42 (9.8%), TVR-PCI in 130 (30.3%), CABG in 11 (2.6%), non-TVR-PCI in 52 (12.1%), and definite stent thrombosis in 9 (2.1%). Among the 129 patients undergoing TVR-PCI as first event, as many as 28 (21.7%) underwent a second TVR-PCI, 7 (5.4%) underwent a third TVR-PCI, and a further 2 (1.5%) underwent a fourth TVR-PCI, whereas CABG was performed in 2 (1.5%) and non-TVR-PCI in 4 (3.1%). CONCLUSIONS: This work, originally reporting on the risk of recurrent repeat revascularization events among diabetics treated with PCI, showed that adverse events occur frequently in these patients, but can be managed in most cases safely and successfully by means of repeat PCI only.

Analysis of recurrent revascularization events following percutaneous coronary intervention of diabetic patients.

AIM: Greater incidence of recurrent events following percutaneous coronary intervention (PCI) has been described among patients with diabetes mellitus (DM). A clear actual picture of these events can hitherto be considered as lacking. Aim of this study was to describe frequency and peculiarity of recurrent cardiovascular events following PCI in a group of high risk DM patients and to compare the impact of repeat PCI and/or surgical revascularizations on the need of further coronary interventions in a long-term follow-up. METHODS: 254 consecutive DM patients undergoing PCI for known coronary artery disease (CAD) were followed by outpatient visits for 39+/-9 months. The registered endpoints were target vessel PCI (TVR PCI), target vessel surgical revascularizations (TVR CABG), non target vessel percutaneous revascularization interventions (NON TVR PCI), and no repeat revascularizations. RESULTS: 74 (35%) of the DM patients undergoing an index PCI required further revascularization and 10 (17%) patients needed more than one repeat TVR procedure. Second TVR revascularisation procedures occurred similarly following first PCI (15%) or surgical revascularisation (17%) driven by coronary lesions located in epicardial vessels treated during the index PCI. Patients undergoing TVR surgical revascularisation disclosed a higher probability of incurring in a second PCI driven by coronary lesions located in epicardial vessels not previously treated (P=0.003) compared to those approached by PCI. CONCLUSIONS: The present study reports on a seemingly superior coronary protection of PCI compared to surgical revascularization in preventing disease progression upon the native coronary arteries. These results need confirmation in larger population samples.

Emergency endovascular treatment of a ruptured internal iliac artery aneurysm long after abdominal aortic aneurysm surgical repair.

The purpose of this report is to describe the endovascular exclusion of an internal iliac artery (IIA) aneurysm in emergency setting, long after abdominal aortic aneurysm surgical repair. An 85-year-old male presented with a contained rupture of a huge IIA aneurysm, ten years after aortoiliac bifurcated grafting. Because of poor clinical conditions an emergency endovascular treatment was planned. A stent-graft was positioned from the proximal right branch of the bifurcated surgical prosthesis to the distal external iliac artery, covering the hypogastric aneurysm neck. One month after the procedure, CT scan demonstrated the complete exclusion of the aneurysm. Endovascular treatment of IIA aneurysms is an excellent option to reduce perioperative morbidity and mortality in high risk patients, particularly in an emergency setting.

Percutaneous aortic valve replacement in two cases at high surgical risk: procedural details and implications for patient selection.

The morbidity and mortality burden of heart valve disease is increasing in the developing world, especially among the elderly. Whereas surgery remains the standard of care in fit patients with degenerative aortic stenosis, percutaneous aortic valve replacement could become an effective alternative to surgery in selected higher risk patients. The authors report on two women with aortic stenosis, both at high surgical risk (an 81-year-old female with coronary artery and cerebro-vascular disease, and a 70-year-old female with end-stage cirrhosis), in whom percutaneous valve replacement was effectively performed by means of transfemoral access and retrograde CoreValve Re-valving System implantation. Two major post-procedural complications occurred, both effectively managed, in the second patient: a third degree atrio-ventricular block (requiring permanent pace-maker implantation) and bleeding from the right femoral artery access (requiring implantation of two covered stents and blood transfusion). Despite the increased baseline risk, both patients were discharged asymptomatic, the first twelve days and the other three weeks after admission. In the authors' experience percutaneous aortic valve replacement can be performed with reasonable safety in patient with severe aortic stenosis at high surgical risk.

Temporal trends in baseline characteristics and peri-procedural complications of percutaneous drug-eluting stent implantation for unprotected left main disease: a single high-volume center experience.

AIM: Percutaneous drug-eluting stent (DES) implantation is commonly used in patients with unprotected left main (ULM) disease. As this procedure has been performed routinely in Turin Center since 2002, this article aimed to summarize a five year-experience in DES implantation in the ULM. METHODS: Baseline, procedural and in-hospital outcome data of all patients with ULM undergoing percutaneous coronary intervention (PCI) with DES between July 2002 and October 2006 at Turin Center have been collected. Patients were randomized into four groups: A (patients treated between July 2002 and December 2003), B (treated in 2004), C (treated in 2005) and D (treated in 2006). The baseline surgical risk features was to be compared with the European System for Cardiac Operative Risk Evaluation, disease location in the ULM, and in-hospital major adverse cerebro-cardiovascular events (MACCE), defined as death, myocardial infarction, repeat percutaneous revascularization, coronary artery bypass grafting, stroke, or stent thrombosis. RESULTS: Out of a total of 4 432 coronary interventional procedures 198 patients treated with DES in the ULM were identified. There was a significant increase in the number of patients treated (P=0.00095), but no difference in EuroSCORE across groups (P=0.14). Conversely, there was a significant temporal trend in the incidence of bifurcational ULM being treated with DES (P=0.03). Intriguingly, despite this increase in adverse lesion characteristics, no significant increase was found in the rate of in-hospital MACCE (P=0.93). CONCLUSION: In this single-center study, the number of patients being treated with DES for ULM disease has risen across the years, although keeping a similar surgical risk profile. Distal ULM involvement is no longer considered an absolute contraindication to PCI, as testified by the increasing frequency of such lesion among patients undergoing DES implantation at this Institution, with remarkably low rates of adverse events.

Variations of neck structures after supracricoid partial laryngectomy: a multislice computed tomography evaluation.

BACKGROUND: Surgery of laryngeal cancer used to profoundly alter the anatomy of the cervical region. Accurate anatomo-embryologic studies and repeated surgical trials allowed recognition of the cricoarytenoid complex as the smallest anatomofunctional unit able to maintain all the laryngeal functions. OBJECTIVES: The aim of this study was to determine whether significant variations of neck anatomical parameters exist after partial laryngectomy, and to analyze whether some of these parameters are associated with a positive functional outcome. METHODS: Out of 48 patients treated with a surgical technique according to Mayer-Piquet (cricohyoidoepiglottopexy, CHEP) over a 6-year period, 18 patients were enrolled in the study. Patients were all males with a mean age of 60 years. Cervical structures and their relationships were measured by computed tomography, and the measurements before and after surgery were compared. RESULTS: Our data showed that hyoid bone is modified, both in morphology and position during CHEP. More specifically the relation of the hyoid bone to other neck structures (identified by the alpha-angle) is modified. The neolarynx and trachea undergo a caudocranial shift. All diameters of the cricoid cartilage remain unchanged after surgery. The position of the epiglottis after CHEP, in particular its relation with the arytenoid cartilage, is closely related to swallowing function outcome and recovery time. CONCLUSIONS: Our study showed that these structures, and more specifically the relations among them, undergo significant variations after CHEP. Our results identify some parameters, i.e. the alpha-angle, width of the hyoid bone and position of the epiglottis, that may predispose to a positive functional outcome after surgery.

Evolving standard in the treatment of coronary artery disease. Drug-eluting stents.

Coronary stent implantation is the predominant method of percutaneous coronary interventions (PCI). This is to be attributed to the ease of use beside the better short and long term clinical outcome as compared to balloon angioplasty. Nevertheless, improvements in operator skill and stent technology together with better use of adjunctive pharmacological therapy have contributed to the improvement in clinical outcome. However, the main limitation of coronary stenting is still represented by in-stent restenosis (ISR) with an estimated rate of 17-32%. Thus, compared to coronary bypass surgery, the major adverse cardiac events following stent implantation are still higher and mainly represented by the need for re-intervention. The advent of drug eluting stents (DES) has led the experts to predict that with DES there will be little or no difference between PCI and coronary bypass surgery in terms of long-term outcome leading to a further expansion of indications. The clinical trial programs of the 2 available DES for clinical use (sirolimus-eluting stent, SES - Cypher and paclitaxol-eluting stent - Taxus) have been able to demonstrate the safety and clinical efficacy of both. Nevertheless, off-label use in patients on high risk for restenosis confirmed these data. At least for SES as was demonstrated by 2 "real world" registries. Thus, the introduction of DES represents a remarkable evolution for new standards in coronary artery disease treatment and offers hope to those patients considered to be "high risk" such as diabetics, patients with ISR, diffuse disease in whom surgery was previously the only therapeutic option. This paper will discuss the main results of the clinical trial programs of the DES (mentioned above) available for clinical use in the present time and analyze technical and procedural aspects which could affect long term outcome.