Cost-effectiveness analysis of dyevert™ Power XT in patients with chronic kidney disease undergoing percutaneous coronary intervention procedures in Spain.

OBJECTIVE: To assess the efficiency of Dyevert™ Power XT compared to the standard clinical practice when used for percutaneous coronary interventions (PCI). METHODS: A Markov model was developed to estimate, over 3-month cycles and a lifetime time horizon, the cumulative costs and health outcomes (life years gained [LYG] and quality-adjusted life years [QALY]) in a hypothetical cohort of 1,000 patients with chronic kidney disease (CKD) 3b-4 and an average age of 72 years. The incidence of contrast-induced acute kidney injury for these patients is 18.89% in routine practice and 7.78% with Dyevert. QALYs were estimated by applying utilities by health state. Transitions between states and utilities were obtained from the literature. Overall all-cause and state-specific mortality were considered. The total cost (€2,022) estimated with the National Health System perspective included cost of the procedure and of CKD management. The parameters were validated by a panel of experts. A discount rate (3% per year) was applied to costs and outcomes. RESULTS: The use of Dyevert yielded more health benefits (34.60 LYG and 5.69 QALYs) compared to the current standard practice (33.11 LYG and 5.38 QALYs). Lifetime cost accumulated at the end of the simulation resulted €30,211/patient with Dyevert and €33,895/patient with current standard clinical practice. CONCLUSIONS: The use of Dyevert™ Power XT resulted dominant option, due to its higher effectiveness and lower cost as compared to standard clinical practice and, therefore, a preferred option in patients with CKD stages 3b-4 undergoing PCI in Spain.

TIOMAX: A Spanish Multicenter Registry of the real-world use of the TItanium OptiMAX® biostent: TIOMAX: Registro Español Multicéntrico Del Biostent De Titanio OptiMAX® En La Vida Real.

OBJECTIVES: To compare the safety and efficacy of the new cobalt-chromium bioactive stent Titan Optimax® (Hexacath, France) with its predecessor, Titan-2® . BACKGROUND: The TIOMAX registry includes 784 patients who underwent percutaneous coronary intervention with these stents in 21 Spanish hospitals. METHODS: Analysis of all patients in the registry without exclusion criteria, candidates for revascularization (March-2013/July-2014). Initially 273 patients received Titan-2® , and the next 511 received the Optimax® after its launch. RESULTS: Mean age was 65.8 ± 13.0 (78.1% men); 49.2% were STEACS patients (n = 322), 29.8% NSTEACS, and 27.3% had stable angina or silent ischemia. Most STEACS patients (76.4% of n = 322) were treated <24 hr after developing symptoms. All-cause death (D), cardiac death (CD), acute myocardial infarction (AMI), and stent thrombosis (ST) at 1 month were 1.1, 0.8, 0.1, and 0.5%, respectively, with no significant differences between groups. At 1 year, the death rate was 5.5% for Titan-2 vs. 4.1% for Optimax® , CD was 1.8% for both groups, ST 1.1 vs. 0.6%, new AMI 3.3 vs. 2.5% and target lesion revascularization (TLR) 3.7 vs. 2.9%. The primary endpoint of the composite event (CE) of D/AMI/TLR/ST occurred in 10.3% vs. 7.6% (p = 0.211). Patients with STEACS (N = 322: Titan-2/Optimax: 103/209) had better outcomes for secondary events, device-oriented failure CD/AMI/TLR (7.8% vs. 5.0%; p = 0.330), and non-fatal CE of AMI/ST/TLR (7.8% vs. 2.7%, p = 0.039). CONCLUSIONS: The Titan Optimax retains the efficacy and safety of Titan 2. It appears to perform better in the subgroup of STEACS patients, by reducing the non-fatal CE of AMI/ST/TLR.

Anatomical classification of left atrial appendages in specimens applicable to CT imaging techniques for implantation of amplatzer cardiac plug.

BACKGROUND: Certain anatomical characteristics of the left atrial appendage (LAA) are associated with complexity in the implantation of occluder devices. OBJECTIVE: The aim was to define characteristics measurable by three-dimensional imaging that would predict complexities both in the implantation procedure and the selection of the appropriate device size. METHODS: An anatomical study was performed of 50 postmortem hearts, of which 15 had a history of atrial fibrillation, and of 30 consecutive patients undergoing LAA occlusion with the Amplatzer cardiac plug (ACP). The specimens were classified according to variables that can be visualized using computerized tomography (CT). The CT scans of 30 consecutive patients were classified according to the level of the LAA ostium, the left lateral ridge (LLR), the LAA limbus and distance from LAA to the mitral annulus before undergoing LAA occlusion, and the results were correlated. RESULTS: Three types of LAA orifice were defined: type I, with a usually higher, anterior LAA ostium, a short, flattened and wide LLR and almost nonexistent limbus; type II, presenting a long, pointed and narrow LLR, and a longer, more defined limbus; type III, with a lower LAA ostium, close to the left atrium floor and the mitral annulus, a marked separation from the left pulmonary vein orifices and a limbus of intermediate length. CONCLUSION: LAA with lower ostia are more difficult to occlude. Types II and III have very prominent LLRs with longer limbi, which may increase the difficulty of inserting the guide and making measurements for selection of the right ACP size.

Prognostic Role of TAPSE to PASP Ratio in Patients Undergoing MitraClip Procedure.

BACKGROUND: Transcatheter mitral valve repair (TMVR) is an effective therapy for high-risk patients with severe mitral regurgitation (MR) but heart failure (HF) readmissions and death remain substantial on mid-term follow-up. Recently, right ventricular (RV) to pulmonary arterial (PA) coupling has emerged as a relevant prognostic predictor in HF. In this study, we aimed to assess the prognostic value of tricuspid annular plane systolic excursion (TAPSE) to PA systolic pressure (PASP) ratio as a non-invasive measure of RV-to-PA coupling in patients undergoing TMVR with MitraClip (Abbott, CA, USA). METHODS: Multicentre registry including 228 consecutive patients that underwent successful TMVR with MitraClip. The sample was divided in two groups according to TAPSE/PASP median value: 0.35. The primary combined endpoint encompassed HF readmissions and all-cause mortality. RESULTS: Mean age was 72.5 ± 11.5 years and 154 (67.5%) patients were male. HF readmissions and all-cause mortality were more frequent in patients with TAPSE/PASP ≤ 0.35: Log-Rank 8.844, p = 0.003. On Cox regression, TAPSE/PASP emerged as a prognostic predictor of the primary combined endpoint, together with STS-Score. TAPSE/PASP was a better prognostic predictor than either TAPSE or PASP separately. CONCLUSIONS: TAPSE/PASP ratio appears as a novel prognostic predictor in patients undergoing MitraClip implantation that might improve risk stratification and candidate selection.

[Ankle-brachial index in patients with chest pain and suspected acute coronary syndrome]. / Determinación del índice tobillo-brazo en pacientes con dolor torácico agudo de posible origen coronario.

BACKGROUND AND OBJECTIVE: Acute chest pain (ACP) is a non-specific symptom that may be the expression of coronary artery disease (CAD). Atherosclerosis is usually present in more than one vascular territory. Ankle-brachial index (ABI) is a useful tool for the diagnosis of peripheral arterial disease (PAD). Our aim was to evaluate the value of ABI in patients with ACP when CAD is suspected. PATIENTS AND METHODS: We performed a cross-sectional study of 94 patients, mean age: 57.4 (12.2), admitted consecutively due to ACP with suspicion of CAD. ABI and presence of CAD were determined. RESULTS: CAD was present in 22 patients (23.4%) and absent in 72 (76.6%). Asymptomatic PAD (ABI < or = 0.9) was present in 6 patients (27.2%) of CAD group and in 7 patients (9.7%) of the non-CAD group. Significant difference was found in ABI based on the presence or not of CAD [0.95 (0.23) vs 1.17 (0.15), p<0.001]. The diagnostic value of ABI for CAD detection was evaluated: area under the ROC curve was 0.8 (IC 95%: 0.70-0.87) and optimal cut-off point was 0.8 (sensitivity=22.7% and specificity=98.6%). In the multivariate analysis, ABI was the best independent predictor of CAD (p<0.001). CONCLUSION: ABI is a simple, cheap and efficient method, which complements other conventional diagnostic methods in the recognition of patients with ACP due to CAD.

Transcatheter Mitral Repair for Functional Mitral Regurgitation According to Left Ventricular Function: A Real-Life Propensity-Score Matched Study.

BACKGROUND: Transcatheter mitral valve repair (TMVR) could improve survival in functional mitral regurgitation (FMR), but it is necessary to consider the influence of left ventricular ejection fraction (LVEF). Therefore, we compare the outcomes after TMVR with Mitraclip® between two groups according to LVEF. METHODS: In an observational registry study, we compared the outcomes in patients with FMR who underwent TMVR with and without LVEF <30%. The primary endpoint was the combined one-year all-cause mortality and unplanned hospital readmissions due to HF. The secondary end-points were New York Heart Association (NYHA) functional class and mitral regurgitation (MR) severity. Propensity-score matching was used to create two groups with the same baseline characteristics, except for baseline LVEF. RESULTS: Among 535 FMR eligible patients, 144 patients with LVEF <30% (group 1) and 144 with LVEF >30% (group 2) had similar propensity scores and were included in the analyses. The primary study endpoint was significantlly higher in group 1 (33.3% vs. 9.4%, p = 0.002). There was a maintained improvement in secondary endpoints without significant differences among groups. CONCLUSION: FMR patients with LVEF <30% treated with MitraClip® had higher mortality and readmissions than patients with LVEF ≥30% treated with the same device. However, both groups improved the NYHA functional class and MR severity.

Long-term Event Reduction After Left Atrial Appendage Closure. Results of the Iberian Registry II.

INTRODUCTION AND OBJECTIVES: Many patients with nonvalvular atrial fibrillation are still left without protection due to a contraindication for anticoagulants. This study aimed to establish the occurrence of stroke and major bleeding events in patients with nonvalvular atrial fibrillation and left atrial appendage closure with long-term follow-up and to explore the factors associated with higher long-term mortality. METHODS: Analysis of a multicenter single cohort prospectively recruited from 2009 to 2015. Thromboembolic and bleeding events were compared with those expected from CHA2DS2-VASc and HAS-BLED scores. Multivariate analysis examined variables associated with mortality during follow-up. RESULTS: A total of 598 patients (1093 patient-years) with a contraindication for anticoagulants were recruited (median 75.4 years). The success rate of left atrial appendage closure device implantation was 95.8%. Thirty patients (5%) experienced periprocedural complications. The rate of events (per 100 patient-years) during follow-up (mean 22.9 months; median 16.1 months) was as follows: death 7.0%; ischemic stroke 1.6% (vs 8.5% expected according to CHA2DS2-VASc; P < .001); intracranial hemorrhage 0.8%; gastrointestinal bleeding 3.2%; severe bleeding 3.9% (vs 6.3% expected by HAS-BLED, P = .002). These results were improved in the subgroup of 176 patients with follow-up > 24 months (mean follow-up 46.6 months, 683 patient-years) for severe bleeding 2.6% (vs 6.3% expected by HAS-BLED, P < .033). The factors significantly associated with higher mortality were age (HR, 1.1), intracranial hemorrhage (HR, 6.8), and stroke during follow-up (HR, 2.7). CONCLUSIONS: Left atrial appendage closure significantly reduced the incidence of stroke and bleeding events and the benefit was maintained. Intracranial hemorrhage, age and stroke were associated with higher mortality.

Sirolimus-eluting stents versus bare-metal stents in patients with in-stent restenosis: results of a pooled analysis of two randomized studies.

BACKGROUND: Treatment of patients with in-stent restenosis (ISR) remains a challenge. We sought to compare results of sirolimus-eluting stents (SES) with those of bare-metal stents (BMS) in patients with ISR. METHODS: The results obtained in the stent arm of two randomized studies were analyzed. The RIBS I study (450 patients with ISR) allocated 224 patients to BMS; the RIBS II study (150 patients with ISR) allocated 76 patients to SES. Complete 1-year follow-up was obtained in all 300 patients treated with stents. RESULTS: Although inclusion/exclusion criteria were identical in the two studies, when compared with patients in the BMS group, patients in the SES arm had more adverse baseline characteristics, more diffuse lesions, and smaller vessels. However, late angiographic findings including in-segment recurrent restenosis rate (11 vs. 38%, P < 0.001), minimal lumen diameter (2.52 vs. 1.63 mm, P < 0.001), and late loss (0.13 vs. 1.04 mm, P < 0.001) were significantly better after SES. The 1-year event-free survival was also significantly improved in the SES group (88 vs. 78%, P < 0.05), as the result of a lower requirement for repeated revascularizations (10.5 vs. 19.6%, P < 0.05). Prespecified subgroup analyses were consistent with the main outcome measures. After adjusting for (a) imbalances in baseline characteristics (restenosis OR 0.11 [95% confidence interval (CI) 0.03-0.36]; adverse events hazard ratios (HR) 0.33 [95% CI 0.13-0.84]) and (b) the propensity score (restenosis OR 0.08 [95% CI 0.03-0.28]; adverse events HR 0.24 [95% CI 0.09-0.66]), results of the SES group were superior to those obtained in the BMS group. CONCLUSIONS: When compared with BMS, SES improved the long-term clinical and angiographic outcome of patients with ISR.

Abciximab offers greater benefits to insulin-dependent diabetic patients undergoing coronary stent implantation.

INTRODUCTION AND OBJECTIVES: Abciximab use does not exceed 25% in most of the studies on diabetic patients undergoing stent implantation. The aim of this study was to evaluate whether abciximab could be more beneficial in different subgroups such as insulin-dependent (ID) patients and whether its use could provide additional benefits to those afforded by drug-eluting stents in these patients. PATIENTS AND METHODS: A total of 373 consecutive diabetics [223 non-insulin-dependent (NID) and 150 ID patients] who had undergone stent implantation were examined with a follow-up of 25.6+/-16.2 months. Abciximab was used in 21.7%. RESULTS: The abciximab-treated group had a lower rate of revascularization (26.8% vs. 15.8%. P=.02). The results by subgroups were as follows: NID nonabciximab, 23.5%; NID abciximab, 19% (P=NS); ID nonabciximab, 32.7%; ID abciximab, 12.2% (P=.05). In multivariate analysis, the restenosis predictors were insulin dependency (OR, 2.7), abciximab use (OR, 0.18), stent diameter (OR, 0.18). CONCLUSIONS: Abciximab use in diabetics with stent implantation has a favorable effect by reducing the need for new revascularization. This benefit is more evident in ID patients; the negative prognosis effect of being insulin-dependent is eliminated, and the percentage of events in this population over a long follow-up period is equal to those in NID patients.

Long-term results (three to five years) of the Restenosis Intrastent: Balloon angioplasty versus elective Stenting (RIBS) randomized study.

OBJECTIVES: We sought to analyze the very late outcomes of patients treated for in-stent restenosis (ISR) according to treatment allocation and 10 prespecified variables. BACKGROUND: Long-term results (>2 years) of patients with ISR undergoing repeat coronary interventions are not well established. METHODS: The Restenosis Intrastent: Balloon angioplasty versus elective Stenting (RIBS) randomized study compared these two strategies in 450 patients with ISR. A detailed systematic protocol was used for late clinical follow-up. RESULTS: At one-year follow-up (100% of patients), the event-free survival was similar in the two groups (77% stent implantation [ST] arm, 71% balloon angioplasty [BA] arm, log-rank p = 0.19). Additional long-term clinical follow-up (median 4.3 years, range 3 to 5 years) was obtained in 98.6% of patients. During this time 22 additional patients died (9 ST arm, 13 BA arm), 7 suffered a myocardial infarction (3 ST arm, 4 BA arm), 23 required coronary surgery (11 ST arm, 12 BA arm), and 9 underwent repeat coronary interventions (4 ST arm, 5 BA arm) (nonexclusive events). At four years the event-free survival was 69% in the ST arm and 64% in the BA arm (log-rank p = 0.21). Among the 10 prespecified variables, vessel size > or = 3 mm had a major influence on the clinical outcome at four years, with better results in the ST group (hazard ratio 0.51, 95% confidence interval 0.3 to 0.89, p = 0.016). CONCLUSIONS: Patients with ISR undergoing repeat interventions have a significant event rate at late follow-up. Continued medical surveillance should be continued after one year. Patients with large vessels have a better outcome after repeat stenting.

Value of the American College of Cardiology/American Heart Association angiographic classification of coronary lesion morphology in patients with in-stent restenosis. Insights from the Restenosis Intra-stent Balloon angioplasty versus elective Stenting (RIBS) randomized trial.

BACKGROUND: The implications of the American College of Cardiology/American Heart Association (ACC/AHA) lesion classification in patients with in-stent restenosis (ISR) are unknown. METHODS: Four hundred fifty patients included in the RIBS randomized study were analyzed. A centralized core laboratory assessed ISR classifications including ACC/AHA, the classification of Mehran et al (Circulation 1999;100:1872-8), diffuse/focal, and a new quantitative ISR index (lesion length/stent length). Logistic regression models were constructed for prespecified outcome measures including (1) unsatisfactory acute results and (2) recurrent restenosis rate. RESULTS: Complex (B2/C) lesions (78%) more frequently obtained unsatisfactory acute results (20% vs 8%, P = .007), smaller minimal lumen diameter after the procedure (2.45 +/- 0.5 vs 2.73 +/- 0.5 mm, P = .001) and at follow-up (1.48 +/- 0.8 vs 1.94 +/- 0.8 mm, P = .0001), and had a higher restenosis rate (43 vs 24%, P = .001) than simple (A/B1) lesions. On logistic regression analysis, all classification schemes were useful to predict unsatisfactory initial results (area under the curve: 0.63, 0.61, 0.59, and 0.62) and recurrent restenosis (area under the curve: 0.60, 0.64, 0.61, and 0.63). The predictive ability of these schemes persisted despite adjustment for potential confounders. Although the ACC/AHA classification was a better predictor of acute results, the classification of Mehran was superior to predict restenosis. CONCLUSIONS: The ACC/AHA classification provides a useful tool to determine acute procedural results and the long-term angiographic outcome of patients with ISR.

[Structural features of the sinus of valsalva and the proximal portion of the coronary arteries: their relevance to retrograde aortocoronary dissection]. / Características estructurales de los senos de Valsalva y porción proximal de las arterias coronarias. Su relevancia durante la disección retrógrada aortocoronaria.

INTRODUCTION AND OBJECTIVES: Retrograde aortocoronary dissection is an unusual complication of coronary angioplasty. Our study provides new structural details of the aortic sinuses and the proximal portions of the coronary arteries, which enable better understanding of several clinical features associated with this complication. METHODS: We studied eight aortic sinus specimens from patients with structural ischemic heart disease using dissection, histologic analysis, and scanning electron microscopy, and compared findings with those in eight control specimens. RESULTS: We observed the following features: a) in 10 specimens (71%), the left coronary artery diameter was greater than the right; b) the angle that the ascending aorta made with the left coronary artery was acute, whereas that with the right coronary artery was closer to a right angle, thereby possibly providing a better approach for catheterization; c) in contrast to those of the right coronary artery, the periostial wall and sinotubular junction of the left coronary artery were formed by more smooth muscle cells and by a dense matrix of collagen type-I fibers, and d) the aortic sinuses and coronary arteries in structural ischemic heart disease specimens displayed structural alterations that affected the aortic tunica media and the collagen distribution at the sinotubular junction. CONCLUSIONS: The morphological and structural differences observed between right and left sides suggest that the left aortic sinus is more resistant to traction and is, therefore, less prone to iatrogenic dissection. Structural ischemic heart disease is a risk factor that increases the likelihood of aortocoronary dissection.

Percutaneous balloon mitral valvuloplasty and closure of the left atrial appendage: Synergy of two procedures in one percutaneous intervention.

Mitral stenosis (MS) is frequently associated with the development of atrial fibrillation (AF) as a consequence of hemodynamic and inflammatory changes in the left atrium. Both conditions predispose to thrombus formation, with frequent involvement of the left atrial appendage (LAA), and consequent increase in the incidence of systemic thromboembolic events. Percutaneous mitral valvuloplasty (PMV) reduces the risk of thromboembolism in patients with significant mitral stenosis. Percutaneous LAA closure is also associated with a reduction in thromboembolic risk in patients with AF, but there are no data regarding the use of this technique in patients with significant mitral valve disease. We report the case of a 57-year-old-woman with significant MS and permanent AF, in New York Heart Association functional class II, who despite adequate oral anticoagulation with acenocoumarol, presented several clinical episodes of systemic thromboembolism in the last four years. It was decided to perform a combined percutaneous procedure, including both PMV and percutaneous LAA closure with the Amplatzer Cardiac Plug device. No significant acute complications occurred and the patient was discharged on indefinite treatment with acenocoumarol associated with aspirin 100 mg/d for three months. After a one-year follow-up, there have been no new embolic episodes or other complications.

Comparison of the Efficacy of Everolimus-Eluting Stents Versus Drug-Eluting Balloons in Patients With In-Stent Restenosis (from the RIBS IV and V Randomized Clinical Trials).

Treatment of patients with in-stent restenosis (ISR) remains a challenge. This study sought to compare the efficacy of everolimus-eluting stents (EESs) and drug-eluting balloons (DEBs) with paclitaxel in patients with ISR. A pooled analysis of the Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloon vs Everolimus-Eluting Stent (RIBS IV) and Restenosis Intra-Stent of Bare-Metal Stents: Drug-Eluting Balloon vs Everolimus-Eluting Stent (RIBS V) randomized trials was performed using patient-level data. In both trials, EESs were compared with DEBs in patients with ISR (RIBS V included 189 patients with bare-metal ISR; RIBS IV included 309 patients with drug-eluting ISR). Inclusion and exclusion criteria were identical in both trials. A total of 249 patients were allocated to EES and 249 to DEB. Clinical follow-up at 1 year was obtained in all (100%) patients and late angiography (median 249 days) in 91% of eligible patients. Compared with patients treated with DEBs, patients treated with EESs obtained better short-term results (postprocedural minimal lumen diameter 2.28 ± 0.5 vs 2.12 ± 0.4 mm, p <0.0001). At follow-up, patients treated with EESs had larger in-segment minimal lumen diameter (primary end point 2.16 ± 0.7 vs 1.88 ± 0.6 mm, p <0.0001; absolute mean difference 0.28 mm; 95% confidence interval [CI] 0.16 to 0.40) and net lumen gain (1.33 ± 0.6 vs 1.00 ± 0.7 mm, p <0.0001) and had lower %diameter stenosis (19 ± 21% vs 28 ± 22%, p <0.0001) and binary restenosis rate (8.7% vs 15.7%, p = 0.02). Consistent results were observed in the in-lesion analysis. No interactions were found between the underlying stent type and treatment effects. At 1-year clinical follow-up, the composite of cardiac death, myocardial infarction, and target vessel revascularization was significantly reduced in the EES arm (8.8% vs 14.5%, p = 0.03; hazard ratio 0.59, 95% CI 0.31 to 0.94) mainly driven by a lower need for target vessel revascularization (6% vs 12.4%, p = 0.01, hazard ratio 0.46, 95% CI 0.25 to 0.86). This pooled analysis of the RIBS IV and RIBS V randomized trials demonstrates the superiority of EES over DEB in the treatment of patients with ISR.

A randomized comparison of repeat stenting with balloon angioplasty in patients with in-stent restenosis.

OBJECTIVES: This randomized trial compared repeat stenting with balloon angioplasty (BA) in patients with in-stent restenosis (ISR). BACKGROUND: Stent restenosis constitutes a therapeutic challenge. Repeat coronary interventions are currently used in this setting, but the recurrence risk remains high. METHODS: We randomly assigned 450 patients with ISR to elective stent implantation (224 patients) or conventional BA (226 patients). Primary end point was recurrent restenosis rate at six months. Secondary end points included minimal lumen diameter (MLD), prespecified subgroup analyses, and a composite of major adverse events. RESULTS: Procedural success was similar in both groups, but in-hospital complications were more frequent in the balloon group. After the procedure MLD was larger in the stent group (2.77 +/- 0.4 vs. 2.25 +/- 0.5 mm, p < 0.001). At follow-up, MLD was larger after stenting when the in-lesion site was considered (1.69 +/- 0.8 vs. 1.54 +/- 0.7 mm, p = 0.046). However, the binary restenosis rate (38% stent group, 39% balloon group) was similar with the two strategies. One-year event-free survival (follow-up 100%) was also similar in both groups (77% stent vs. 71% balloon, p = 0.19). Nevertheless, in the prespecified subgroup of patients with large vessels (> or =3 mm) the restenosis rate (27% vs. 49%, p = 0.007) and the event-free survival (84% vs. 62%, p = 0.002) were better after repeat stenting. CONCLUSIONS: In patients with ISR, repeat coronary stenting provided better initial angiographic results but failed to improve restenosis rate and clinical outcome when compared with BA. However, in patients with large vessels coronary stenting improved the long-term clinical and angiographic outcome.

[Silent left ventricular pseudoaneurysm and rupture to a second pseudoaneurysm]. / Seudoaneurisma ventricular izquierdo silente con rotura a segunda bolsa seudoaneurismática.

Left ventricular pseudoaneurysm is usually associated with myocardial infarction and ventricular wall rupture, although it can also be associated with other pathological conditions. Rupture causes shock, and death if not repaired urgently. We report the very rare case of a man with coronary lesions that resulted in a silent myocardial infarction with rupture of the myocardial wall and the subsequent development of a large, posterolateral, left ventricular pseudoaneurysm. This was followed by rupture of the primary pseudoaneurysm and the consequent creation of a second pseudoaneurysm, which finally resulted in shock and death.

Clinical and angiographic follow-up in patients with Cypher or Taxus stents in populations with high percentage of trial-excluded lesions.

BACKGROUND: Drug-eluting stents (DESs) are being used in real life in patients with complex lesions usually excluded from the published trials. It is reasonable to think that the results could be worse, and the performance may be different between DES when these complex lesions are included. METHODS AND MATERIAL: To investigate this issue, we studied our first 82 patients with DES (54 patients with Cypher (C) and 28 patients with Taxus (T) (129 lesions, with 1.57 lesions per patient). Seventy-one complex lesions were treated with C stent, 41 with T stent, and 17 with no DES. It was a high-risk population, as reflected by 64% unstable angina and 40% diabetes mellitus. Of the 112 DES complex lesions treated, 38% would have been excluded from the Sirius and Taxus IV trials. RESULTS: The main data on intra-segment angiographic measures showed a late luminal loss lower for the C stent than for the T stent (0.17+/-0.45 and 0.44+/-0.6, P=.02, respectively). The restenosis and target lesion revascularization percentages were also lower for the C stent (8.4% vs. 24.4%, P=.07 and 5.6% vs. 17.1%, P<.05, respectively). In the complex lesions without restenosis, 28% would have been excluded from the trials, while in complex lesions with restenosis, there were 53% (P=.05) (with a homogeneous percentage between the C and T groups). The predictor variables of restenosis in the 112 DES-treated complex lesions were length (P=.03, IC=0.97-1.6) and the pre-reference diameter (P=.06). CONCLUSIONS: In our experience, the C stent is superior to the T stent when treating populations with a high percentage of complex lesions excluded from the trials.

Immediate and Long-Term Results of Drug-Eluting Stents in Mammary Artery Grafts.

UNLABELLED: Percutaneous intervention of a coronary graft is the treatment of choice when the graft fails. The objective is to report the long-term results of drug-eluting stents (DES) in mammary artery grafts (MAG). Patients who had been treated with DES for MAG in 27 centers were selected. The baseline and procedural clinical data were included prospectively, and the follow-up was performed with the patients, families, and medical records. Two hundred and sixty-eight patients were included: age 65.5 ± 10.1 years, diabetes 47.8%, ejection fraction 55.5 ± 14.9%. INDICATION: stable angina 28.4%, unstable angina 38.1%, non-ST-elevation myocardial infarction 21.6%, ST-elevation myocardial infarction 5.3%, and heart failure 6.7%; 1.19 ± 0.59 stents/patient were implanted measuring 18.8 ± 8.8 mm in length and 2.68 ± 0.35 mm in diameter. Rapamycin was used in 78 cases (29.1%), paclitaxel in 77 (28.7%), everolimus in 70 (26.1%), zotarolimus in 34 (12.7%), and biolimus in 9 (3.4%). All cases were successful except for 1 in which the patient died 30 minutes after the procedure. There were no other inhospital events. After a follow-up of 41 months (Q25: 23.7 to Q75: 57.8), 24 patients (9%) died of heart-related causes and 20 (7.5%) of noncardiac causes. Repeat revascularization was necessary in 31 cases, and in 1 additional patient, there was total occlusion, which was not treated. These 32 patients represented 11.9% of the total. In conclusion, the implantation of DES in MAG shows very high procedural success and also low long-term event rates.

[Pulsating thoracic mass as a main symptom of gigantic pseudoaneurysm of the ascending aorta]. / Masa pulsátil torácica como síntoma principal de seudoaneurisma gigante de aorta ascendente.

The pseudoaneurysms of the ascending aorta are very infrequent but their diagnosis is important because of the associated high mortality. They usually appear in patients who have undergone aortic-related surgery, but the time that passes until they appear can be very prolonged and suspicious signs and symptoms can be quite anodyne. We present two cases of pseudoaneurysms of ascending aorta in two patients who underwent cardiovascular operations several months before, which were of such a considerable size that the first and practically the only symptoms were the sudden appearance of a pulsating thoracic mass because of pseudoaneurysm compression at this site.

[Rupture and intracoronary entrapment of an angioplasty guidewire with the X-Sizer thromboatherectomy catheter during rescue angioplasty]. / Rotura y atrapamiento intracoronario de una guía de angioplastia con el extractor de trombos X-Sizer en una angioplastia de rescate.

The X-Sizer thromboatherectomy catheter represents an important advance for thrombectomy in thrombus-containing lesions, especially in patients who require primary and rescue angioplasty. Although it is safe, some complications have been reported as its use becomes more widespread. To our knowledge, the intracoronary breakage and retention of the angioplasty guidewire has not been reported. We describe a case of this rare complication and analyze the causes, prevention and treatment alternatives.