Survival and predictive factors of mortality after 30 days in patients treated with percutaneous implantation of the CoreValve aortic prosthesis.

BACKGROUND: Few data exist on the clinical impact of transcatheter aortic valve implantation (TAVI) in patients with symptomatic aortic stenosis and a high surgical risk. The aim of this study was to determine the survival and the factors predicting mortality after 30 days post-TAVI with the CoreValve prosthesis (Medtronic, Minneapolis, MN). METHODS: From April 2008 to October 2010, the CoreValve prosthesis (Medtronic) was implanted in 133 consecutive high-risk surgical patients with symptomatic severe aortic stenosis. RESULTS: The mean age was 79.5 ± 6.7 years. The logistic European System for Cardiac Operative Risk Evaluation was 21.5% ± 14%. The implantation success rate was 97.7%. In-hospital mortality was 4.5%, and the combined end point of death, vascular complications, myocardial infarction, or stroke had a rate of 9%. Survival at 12 and 24 months was 84.5% and 79%, respectively, after a mean follow-up of 11.3 ± 8 months. The New York Heart Association functional class improved from 3.3 ± 0.5 to 1.18 ± 0.4 and remained stable at 1 year. A high Charlson index (hazard ratio [HR] 1.44, 95% CI 1.09-1.89, P < .01) and a worse Karnofsky score before the procedure (HR 0.95, 95% CI 0.92-0.99, P = .021) were predictors of mortality after 30 days. CONCLUSIONS: Transcatheter aortic valve implantation with the CoreValve prosthesis for patients with aortic stenosis and a high surgical risk is a safe, efficient option resulting in a medium-term clinical improvement. Survival during follow-up depends on the associated comorbidities. Early mortality beyond 30 days is predicted by preoperative comorbidity scores and the functional status of the patient.

Clinical and echocardiographic outcomes of transcatheter mitral valve repair in atrial functional mitral regurgitation.

BACKGROUND: Isolated atrial fibrillation can cause mitral regurgitation (MR) in patients with normal left ventricular systolic function and no organic disease of the mitral valve. Little information is available regarding outcomes of Mitraclip in patients with atrial functional mitral regurgitation (AFMR). We aimed to evaluate 12-month clinical and echocardiographic outcomes of transcatheter mitral valve repair (TMVR) with MitraClip in patients with AFMR compared to those with ventricular functional or degenerative/mixed MR. METHODS: Registry-based analysis of all consecutive patients who underwent TMVR and were included in the Spanish Registry of Mitraclip. Changes in MR and NYHA functional class, and a combined endpoint including all-cause mortality and hospitalizations due to heart failure were the main outcomes. RESULTS: Overall, 1074 (69.1% male, 73.3 ± 10.2 years-old) patients were analyzed in this report. 48 patients (4.5%) presented AFMR. AFMR was significantly reduced after TMVR, with a procedural success rate of 91.7%, and this reduction persisted at 12-month (p < 0.001). Patients with AFMR showed a significant functional improvement at 6- and 12-month follow-up in our series (baseline: NYHA III 70.8% IV 18.8% vs. 1-year: NYHA III 21.7% IV 0%; p < 0.001). The probability of survival free of readmission for heart failure and all-cause mortality within the first year after TMVR was 74.9%. Procedural and clinical outcomes, as well as recurrent rates of MR were similar acutely and at 1-year compared to other etiologies. CONCLUSION: TMVR in patients with AFMR showed no significant differences compared to ventricular functional or degenerative/mixed MR regarding MR reduction or clinical outcomes.

Impact of Percutaneous Coronary Revascularization of Severe Coronary Lesions on Secondary Branches.

INTRODUCTION AND OBJECTIVES: To analyze the percutaneous revascularization strategy for severe lesions in the secondary branches (SB) (diameter ≥ 2mm) of major epicardial arteries compared with conservative treatment. METHODS: This study analyzed patients with severe SB lesions who underwent percutaneous revascularization treatment compared with patients who received pharmacological treatment. The study examined the percentage of branch-related events (cardiovascular death, myocardial infarction attributable to SB, or the need for revascularization of the SB). RESULTS: We analyzed 679 SB lesions (662 patients). After a mean follow-up of 22.2±10.5 months, there were no significant differences between the 2 treatment groups regarding the percentage of death from cardiovascular causes (1.7% vs 0.4%; P=.14), nonfatal acute myocardial infarction (AMI) (1.7% vs 1.7%; P=.96), the need for SB revascularization (4.1% vs 5.4%; P=.45) or in the total percentage of events (5.1% vs 6.3%; P=.54). The variables showing an association with event occurrence on multivariate analysis were diabetes (SHR, 2.87; 95%CI, 1.37-5.47; P=.004), prior AMI (SHR, 3.54; 95%CI, 1.77-7.30; P<.0001), SB reference diameter (SHR, 0.16; 95%CI, 0.03-0.97; P=.047), and lesion length (SHR, 3.77; 95%CI, 1.03-1.13; P<.0001). These results remained the same after the propensity score analysis. CONCLUSIONS: The percentage of SB-related events during follow-up is low, with no significant differences between the 2 treatment strategies. The variables associated with event occurrence in the multivariate analysis were the presence of diabetes mellitus, prior AMI, and greater lesion length.

Clinical impact of drug-eluting stents in an unselected population of diabetic patients.

BACKGROUND: Drug-eluting stents (DES) have been shown in randomized trials to reduce clinical events in diabetic patients. Our aim was to determine whether these clinical results are applicable in an unselected population of patients with non-insulin-dependent diabetes mellitus (NIDDM) and insulin-dependent diabetes mellitus (IDDM). METHODS: We studied 440 consecutive patients (271 NIDDM and 169 IDDM) who underwent percutaneous coronary intervention, divided into 2 cohorts: Group A (1998-2000): 220 patients with bare metal stents, and Group B (2002-2004): 220 patients with drug-eluting stents. We analyzed major coronary adverse events (death, nonfatal acute myocardial infarction, and target lesion revascularization) over a mean follow-up of 18+/-15 months. RESULTS: Group B had more patients who were insulin-dependent (44.5 versus 32.3% p<0.001) or had hypertension (64.5 versus 54.1%; p=0.02), a lower left ventricular ejection fraction (53.89 versus 56.8%; p=0.04), more complex lesions (B2/C) (82.7 versus 62.3%; p<0.001), more treated lesions (1.40 versus 1.26; p<0.001), more stents implanted (1.69 versus 1.15; p<0.0001), and more patients treated with abciximab (76.8 versus 42.7%; p<0.0001). During the follow-up, Group B had fewer major adverse coronary events (11.7 versus 27.9%; p<0.001) and a reduction in target lesion revascularization (3.9 versus 17.2%; p<0.001), with no differences in death or myocardial infarction. Both groups experienced a significant reduction in events (NIDDM: 8.1 versus 26.7%; p<0.001 and IDDM: 16 versus 31.9%; p=0.016). Multivariate regression analysis showed the use of drug-eluting stents to be in direct relation with event-free survival (odds ratio [OR]: 3.37; 95% confidence interval [CI], 1.44-7.90; p=0.005). CONCLUSION: Despite the worse angiographic characteristics, the use of DES reduced clinical events, particularly target lesion revascularization.

[Long-term prognosis value of anemia in a non-selected population with heart failure]. / Significado pronóstico a largo plazo de la anemia en una población no seleccionada de pacientes con insuficiencia cardíaca.

BACKGROUND AND OBJECTIVE: Prevalence of anemia in heart failure is variable. Many studies have established a relation between anemia and prognosis in selected patients with heart failure. We have poor information anout the long-term prognosis in non- selected populations. PATIENT AND METHOD: We analyze the presence of anemia during 2 month in 100 consecutive patients in our hospital with a main diagnosis of heart failure (Cardiology or Internal Medicine departments). We defined anemia according to WHO criteria: hemoglobin level lower than 130 g/l (men) and 120 g/l (women). We studied the influence of anemia in long-term prognosis (follow-up of 25+/-18 m). RESULTS: Mean age was 71.8 (9) years. 41% of patients had anemia. Values of hemoglobin were related to age and creatinine, but not with cardiovascular risk factors. Patients who died (38%) had lower hemoglobin than patients who survived (121 [22] gr/dl vs 130 [17] gr/dl; p<0.02). Mortality in the anemia group was 52.5% vs 32.1% (p<0.04). In the Cox multivariable analisis, anemia was a predictor factor of mortality in the follow-up (RR = 1,55; CI 95%, 1.05-2.47; p<0.04) and functional class (III/IV) (RR=2.52; CI 95%, 1.56-4.07; p<0.001). CONCLUSIONS: In a non-selected population of patients with heart failure, the prevalence of anemia is high and has independiente prognostic value in long-term mortality with functional advanced class.

[Stability of NT-ProBNP in patients with systolic heart failure]. / Estabilidad de NT-proBNP en pacientes con insuficiencia cardiaca sistólica.

Natriuretic peptides are extremely useful in the diagnosis and prognosis of patients with heart failure. However, it is not clear whether their values are stable. We carried out a prospective study of 30 consecutive ambulatory patients (mean age, 62.6 [12.2] years) with stable systolic heart failure, as determined by the 6-minute walk test, who were in New York Heart Association class II or III and who had a left ventricular ejection fraction <30% (mean ejection fraction, 24.2% [6.68%]). At baseline, the mean N-terminal pro-brain natriuretic peptide (NT-proBNP) level and the mean distance walked in 6 minutes were 2237.3 pg/mL and 348.26 m, respectively. At 3-month follow-up, the corresponding values were 2096.2 pg/mL and 372.05 m, respectively. No significant difference was observed in NT-proBNP level or in distance walked in 6 minutes between baseline and 3 months (P=.8). Overall, there was a good correlation (r=0.94; P< .001) between the plasma NT-proBNP level at baseline and at 3 months in patients with stable chronic heart failure due to systolic dysfunction in New York Heart Association class II or III.

Clinical impact of acute kidney injury on short- and long-term outcomes after transcatheter aortic valve implantation with the CoreValve prosthesis.

BACKGROUND: Acute kidney injury (AKI) after cardiac surgery is associated with increased mortality, but few data exist on the occurrence and clinical impact of AKI associated with transcatheter aortic valve implantation (TAVI). The objective of this study was to determine the incidence and prognosis of AKI after percutaneous implantation of the CoreValve(®) (Medtronic, Minneapolis, MN, USA) prosthesis. METHODS: A total of 357 patients with severe aortic stenosis and 9 patients with pure native aortic regurgitation were treated with the CoreValve prosthesis. AKI was defined according to Valve Academic Research Consortium criteria as the absolute increase in serum creatinine ≥0.3mg/dl at 72h post percutaneous procedure. RESULTS: AKI was identified in 58 patients (15.8%), none of whom required renal replacement therapy. In patients with AKI, the mortality at 30 days was 13.5% compared with 1.6% of patients without AKI, [odds ratio (OR)=12.2 (95% CI 3.53-41.9); p<0.001] and total mortality after a mean of 26.2±17 months was 29.3% vs. 14.9% [OR=2.36 (95% CI 1.23-4.51), p=0.008]. In the multivariate analysis, AKI was an independent predictor of cumulative total mortality [hazard ratio=2.151, (95% CI from 1.169 to 3.957), p=0.014]. CONCLUSIONS: The deterioration of renal function in patients undergoing TAVI with the CoreValve prosthesis is a serious and frequent complication. The occurrence of AKI was associated with increased early mortality and was also a predictor of worse outcomes in follow-up.

Two-year clinical outcome from the Iberian registry patients after left atrial appendage closure.

AIMS: The aim of this study was to observe the percentage of thromboembolic and haemorrhagic events over a 2-year follow-up in patients with non-valvular atrial fibrillation (NVAF) undergoing closure of the left atrial appendage (LAA) with an occlusion device. Observed events and CHADS2 (congestive heart failure, hypertension, age, diabetes, stroke history), CHA2DS2-VASc (also adding: vascular disease and sex) and HAS-BLED (hypertension, abnormal liver/renal function, stroke history, bleeding predisposition, labile international normalised ratios, elderly, drugs/alcohol use)-predicted events were compared. METHODS: LAA closure with an occlusion device was performed in 167 NVAF patients contraindicated for oral anticoagulants and recruited from 12 hospitals between 2009 and 2013. At least two transoesophageal echocardiograms were performed in the first 6 months postimplantation. Antithrombotics included clopidogrel and aspirin. Patients were monitored for death, stroke, major and relevant bleeding and hospitalisation for concomitant conditions. Mean age was 74.68±8.58, median follow-up was 24 months, 5.38% had intraoperative complications and implantation was successful in 94.6% of subjects. Mortality during follow-up was 10.8%, mostly (9.5%) non-cardiac related. Bleeding occurred in 10.1% of subjects, 5.7% major and 4.4% minor though relevant, and 4.4% suffered stroke. Major bleeding and stroke/transient ischaemic attack events within 2 years (annual event rates, 290 patients/year) were less frequent than expected from CHADS2 (2.4% vs 9.6%), CHA2DS2-VASc (2.4% vs 8.3%) and HAS-BLED (3.1% vs 6.6%) risk scores (p<0.001, p=0.003, p=0.047, respectively). CONCLUSIONS: LAA closure with an occlusion device in patients contraindicated for oral anticoagulants is a therapeutic option associated with fewer thromboembolic and haemorrhagic events than expected from risk scores, particularly in the second year postimplantation.

[Influence of diabetes mellitus on clinical outcome after percutaneous coronary revascularization]. / Influencia de la diabetes mellitus en los resultados clínicos tras revascularización coronaria percutánea.

INTRODUCTION AND OBJECTIVES: Diabetes mellitus modifies the natural history of patients with coronary artery disease. The aim of this study was to assess the clinical outcome of diabetic patients with successful coronary angioplasty in our environment and to identify the factors predictive of complications during follow-up. METHODS: A retrospective analysis was made of a series of 198 diabetics and who underwent angioplasty from September 1996 to January 2000 in our hospital. A group of 198 nondiabetic patients who subsequently underwent the same procedure was used as the control group. Death, non-fatal myocardial infarction, unstable angina resulting in hospitalization and coronary revascularization were considered adverse events during a 1 year follow-up period. RESULTS: The overall frequency of coronary adverse events in a 1-year follow-up was higher in diabetics (37%) than in non-diabetics (24%; p = 0.03). Diabetics had a less favorable clinical and angiographic profile and more frequent incomplete revascularization (43 vs 30%). Diabetics with incomplete revascularization were older (66.5 vs 53.2 years), had previous angioplasty more often, anatomically more unfavorable lesions (70 vs 51% type B2-C), and a smaller ejection fraction (54.7 vs 59.4%). Diabetics had more complications at 1 year of follow-up (37 vs 24%; p = 0.03), mainly due to increased cardiovascular mortality in diabetics with incomplete revascularization (12 vs 2%). Multivariate analysis identified incomplete revascularization as the only correlate of clinical outcome. Diabetes per se was not predictive of complications during follow-up. CONCLUSIONS: Diabetics who undergo successful coronary revascularization have a less favorable clinical outcome than non-diabetic patients undergoing the same procedure at 1 year of follow up. Incomplete revascularization is associated with a less favorable outcome.

[Dynamic left ventricular outflow tract obstruction induced by exercise]. / Obstrucción dinámica intraventricular izquierda inducida por esfuerzo.

INTRODUCTION AND OBJECTIVES: Dynamic left intraventricular outflow tract obstruction occurs occasionally in patients without hypertrophic cardiomyopathy. We hypothesized that dynamic intraventricular obstruction might occur during effort in patients with angina or dyspnea without evident disease. The objective of this prospective study was to investigate: a) whether it appears with effort; b) its incidence, magnitude and determining factors, and c) its clinical course. PATIENTS AND METHOD: We performed baseline and stress Doppler echocardiography in 211 patients with angina, dyspnea or both with exercise. Patients with previous myocardial infarction, valvular heart disease, ventricular dysfunction or ventricular hypertrophy without hypertension were excluded. Dynamic intraventricular obstruction was defined as intracavitary flow velocity > or =2.5 m/s. RESULTS: 134 patients (59 women) were included: mean age was 58 (9) years; history of hypertension was present in 69.7%, dyslipidemia in 35.8% and diabetes in 24.6%. Dynamic intraventricular obstruction appeared in 18 patients (13.4%), with gradients ranging between 25 and 53 mmHg (mean 32.19 [6.6]). Demographic variables, cardiovascular risk factors and exercise performed were similar in group A (with obstruction) and group B (without obstruction). No patient in group A had evidence of ischemia. Five patients in this group had symptoms during exercise; the gradients were greater in these patients (42.65 [10.5] vs 28.15 [2.37] mmHg; P<.0001) than in the remaining group A patients. Left ventricular outflow tract size was found to be the only independent predictive factor in the multivariate analysis. After 369.9 (133.5) days of follow-up, no cardiac events were recorded. CONCLUSIONS: Our study suggests that some patients with angina or dyspnea without evidence of ischemia may develop dynamic left ventricular outflow tract obstruction induced by effort.

[Does abciximab improve the prognosis of diabetics after percutaneous coronary intervention?]. / 'El abciximab mejora el pronóstico de los diabéticos tras la intervención coronaria percutánea?

INTRODUCTION AND OBJECTIVES: It is known that the outcome of percutaneous coronary intervention is worse in diabetics than in non-diabetics. The aim of our study was to determine whether abciximab therapy could improve clinical outcome in an unselected diabetic population that underwent percutaneous coronary interventions. MATERIAL AND METHODS: We analyzed retrospectively 198 diabetic patients who underwent PTCA from January 1997 to January 2000. Seventy-three patients (36.7%) were treated with abciximab and the remaining 125 patients (63.3%) did not receive abciximab. The mean follow-up was 12.6 months. The events considered were death, non-fatal myocardial infarction, any revascularization procedure (including the target vessel), and hospital admission for unstable angina. RESULTS: Patients who received abciximab had more frequent previous myocardial infarction (67.1 vs. 52.8%; p = 0.04), worse left ventricular function (0.53 vs. 0.59%; p = 0.02), more frequent angiographic thrombus (67.1 vs. 36.8%; p < 0.001), more complex lesions (B2/C) (76.4 vs. 55.8%; p = 0.004), and less frequent location in left anterior descending artery (34.2 vs. 60.8%; p = 0.002). The indication for PTCA in patients who received abciximab was most often related to myocardial infarction. There were no differences between the groups in sex, age and distribution of diabetes treatment. Events were more frequent in diabetics not treated with abciximab than in those who were treated with abciximab (38 vs. 22%; p < 0.037). The patients not treated with abciximab suffered more frequently target vessel revascularization (22.7 vs. 7.2%; p < 0.007). There were no significant differences in the frequency of death or non-fatal myocardial infarction, but hospital readmissions for unstable angina were significantly more frequent in diabetics not treated with abciximab (29.1 vs. 15.9%; p = 0.045). Multivariate analysis identified abciximab as a predictor of the absence of complications during follow-up (OR: 0.45; p = 0.03). CONCLUSION: Abciximab treatment seems to reduce events in unselected diabetic patients undergoing percutaneous coronary intervention, particularly target vessel revascularization.

Impacto de la revascularización coronaria percutánea de lesiones coronarias graves en ramas secundarias / Impact of percutaneous coronary revascularization of severe coronary lesions on secondary branches

Introducción y objetivos: Comparar la estrategia de revascularización percutánea de lesiones graves en ramas coronarias secundarias (RS) (diámetro ≥ 2 mm) de arterias epicárdicas mayores frente al tratamiento conservador. Métodos: Estudio de cohortes retrospectivo en el que se compara a pacientes con lesiones graves en RS de arterias epicárdicas principales tratados con revascularización percutánea o con un tratamiento farmacológico a criterio del operador. Se analizó el porcentaje de eventos relacionados con la rama (muerte cardiovascular, infarto de miocardio atribuible a RS o necesidad de revascularización de la RS). Resultados: Se analizaron 679 lesiones en RS (662 pacientes). Tras un seguimiento medio de 22,2+/-10,5 meses, no hubo diferencias significativas entre ambos grupos de tratamiento en mortalidad de causa cardiovascular (el 1,7 frente al 0,4%; p=0,14), infarto agudo de miocardio (IAM) no fatal (el 1,7 frente al 1,7%; p=0,96) o necesidad de revascularización de la RS (el 4,1 frente al 5,4%; p=0,45) ni en el porcentaje total de eventos (el 5,1 frente al 6,3%; p=0,54). Las variables que mostraron asociación con la ocurrencia de eventos en el análisis multivariable fueron la diabetes (sHR=2,87; IC95%, 1,37-5,47; p=0,004), IAM previo (sHR=3,54; IC95%, 1,77-7,30; p < 0,0001), el diámetro de referencia de la RS (sHR=0,16; IC95%, 0,03-0,97; p=0,047) y la longitud de la lesión (sHR=3,77; IC95%, 1,03-1,13; p < 0,0001). Estos resultados se mantuvieron tras realizar análisis por puntuación de propensión. Conclusiones: En el seguimiento, el porcentaje de eventos relacionados con la RS fue bajo respecto al total de pacientes, sin diferencias significativas entre una y otra estrategia de tratamiento. Las variables que se asociaron con la ocurrencia de eventos en el análisis multivariable fueron la diabetes mellitus, el antecedente de IAM y la mayor longitud de la lesión

Introduction and objectives: To analyze the percutaneous revascularization strategy for severe lesions in the secondary branches (SB) (diameter ≥ 2mm) of major epicardial arteries compared with conservative treatment. Methods: This study analyzed patients with severe SB lesions who underwent percutaneous revascularization treatment compared with patients who received pharmacological treatment. The study examined the percentage of branch-related events (cardiovascular death, myocardial infarction attributable to SB, or the need for revascularization of the SB). Results: We analyzed 679 SB lesions (662 patients). After a mean follow-up of 22.2+/-10.5 months, there were no significant differences between the 2 treatment groups regarding the percentage of death from cardiovascular causes (1.7% vs 0.4%; P=.14), nonfatal acute myocardial infarction (AMI) (1.7% vs 1.7%; P=.96), the need for SB revascularization (4.1% vs 5.4%; P=.45) or in the total percentage of events (5.1% vs 6.3%; P=.54). The variables showing an association with event occurrence on multivariate analysis were diabetes (SHR, 2.87; 95%CI, 1.37-5.47; P=.004), prior AMI (SHR, 3.54; 95%CI, 1.77-7.30; P<.0001), SB reference diameter (SHR, 0.16; 95%CI, 0.03-0.97; P=.047), and lesion length (SHR, 3.77; 95%CI, 1.03-1.13; P<.0001). These results remained the same after the propensity score analysis. Conclusions: The percentage of SB-related events during follow-up is low, with no significant differences between the 2 treatment strategies. The variables associated with event occurrence in the multivariate analysis were the presence of diabetes mellitus, prior AMI, and greater lesion length

Prognostic value of fractional flow reserve: linking physiologic severity to clinical outcomes.

BACKGROUND: Fractional flow reserve (FFR) has become an established tool for guiding treatment, but its graded relationship to clinical outcomes as modulated by medical therapy versus revascularization remains unclear. OBJECTIVES: The study hypothesized that FFR displays a continuous relationship between its numeric value and prognosis, such that lower FFR values confer a higher risk and therefore receive larger absolute benefits from revascularization. METHODS: Meta-analysis of study- and patient-level data investigated prognosis after FFR measurement. An interaction term between FFR and revascularization status allowed for an outcomes-based threshold. RESULTS: A total of 9,173 (study-level) and 6,961 (patient-level) lesions were included with a median follow-up of 16 and 14 months, respectively. Clinical events increased as FFR decreased, and revascularization showed larger net benefit for lower baseline FFR values. Outcomes-derived FFR thresholds generally occurred around the range 0.75 to 0.80, although limited due to confounding by indication. FFR measured immediately after stenting also showed an inverse relationship with prognosis (hazard ratio: 0.86, 95% confidence interval: 0.80 to 0.93; p < 0.001). An FFR-assisted strategy led to revascularization roughly half as often as an anatomy-based strategy, but with 20% fewer adverse events and 10% better angina relief. CONCLUSIONS: FFR demonstrates a continuous and independent relationship with subsequent outcomes, modulated by medical therapy versus revascularization. Lesions with lower FFR values receive larger absolute benefits from revascularization. Measurement of FFR immediately after stenting also shows an inverse gradient of risk, likely from residual diffuse disease. An FFR-guided revascularization strategy significantly reduces events and increases freedom from angina with fewer procedures than an anatomy-based strategy.

Remote ischaemic postconditioning: does it protect against ischaemic damage in percutaneous coronary revascularisation? Randomised placebo-controlled clinical trial.

OBJECTIVE: Determine whether remote ischaemic postconditioning (RIP) protects against percutaneous coronary intervention-related myocardial infarction (PCI-MI). DESIGN: Single-centre, randomised, blinded to the researchers, clinical trial. ClinicalTrials.gov (NCT 01113008). SETTING: Tertiary hospital centre. PATIENTS: 232 patients underwent elective PCI for stable or unstable angina. INTERVENTIONS: Patients were randomised to RIP (induction of three 5-min cycles of ischaemia in the arm after the PCI) versus placebo. MAIN OUTCOME MEASURES: The primary outcome measure was the peak 24-h troponin I level. PCI-MI was defined by an elevation of troponin values >3 or >5 of the 99th percentile according to the classical or the new definition. The secondary outcome measure was hospital admission, PCI for stable angina or acute coronary syndrome and mortality after 1 year of follow-up. The use of RIP in diabetic patients was specifically studied. RESULTS: The mean age was 64.6 years, and 42% were diabetic. The peak troponin in the RIP patients was 0.476 vs 0.478 ng/mL (p=0.99). PCI-MI occurred in 36% of the RIP patients versus 30.8% in the placebo group (p=0.378). Diabetic RIP patients had more PCI-MI (new definition): OR 2.7; 95% CI 1.10 to 6.92; p=0.027. The secondary outcome measure was seen in 11.7% of the RIP patients versus 10.8% in the placebo group (p=0.907). CONCLUSIONS: RIP did not reduce the damage associated with elective PCI or cardiovascular events during the follow-up. The diabetic population who underwent RIP had more PCI-MI.

[Percutaneous coronary revascularization in patients with renal insufficiency]. / Revascularización coronaria percutánea en pacientes con insuficiencia renal crónica.

BACKGROUND AND OBJECTIVE: An ideal strategy of percutaneous coronary revascularization in patients with renal insufficiency has not been established yet. Our aim was to compare in this group the clinical results of bare metal stents and drug-eluting stents, and identify predictors. PATIENTS AND METHOD: In a group of 200 patients with renal disease, 93 received bare metal stents and 107 drug-eluting stents; for over 2 years we studied rates of a combined event: death, non fatal myocardial infarction, or target lesion revascularization. RESULTS: We did not identify differences in the combined event. With multivariate analysis, peripheral arterial disease, left ventricular ejection fraction <45% and treatment with statins were predictor factors. CONCLUSIONS: We had no evidence of the superiority of any type of stent in the revascularization in patients with chronic renal insufficiency.

[Factors influencing mobilisation of endothelial progenitor cells and angiogenic cytokines after an extensive acute myocardial infarction]. / Factores que influyen en la liberación de células endoteliales progenitoras y citocinas angiogénicas tras un infarto de miocardio extenso.

BACKGROUND AND OBJECTIVES: Following an acute myocardial infarction (AMI), bone-marrow derived endothelial progenitor cells (EPC) are mobilised into the peripheral blood. Our aim was to examine the factors influencing this spontaneous cell mobilisation. PATIENTS AND METHODS: In this study we analysed 47 patients with extensive AMI (left ventricular ejection fraction [LVEF] <50% by echocardiography during the first week post-AMI); we studied the peripheral blood EPC populations expressing CD133(+), CD34(+), KDR(+), CXCR4(+), as well as the cytokines VEGF (vascular endothelial growth factor), SDF-1 (stromal cell-derived factor 1) and TSP-1 (thrombospondin 1), measured on day 5±2.5 after AMI. RESULTS: The extension of AMI (CPK peak) correlated with the number of CD133(+) mobilised cells: (r=0.40; P=.011). Patients who did not receive perfusion during the acute phase (34%) had more CD34(+)CXCR4(+) cells with a median (interquartile ranges) of 2,401 (498-7,004) vs. 999 (100-1,600), P=.048, and strong correlations between VEGF and CD133(+)CD34(+)KDR(+) (r=.84; P<.01) and SDF-1 and CD34(+)CXCR4(+) (r=.67; P<.01), and between these 2 cytokines (r=.57; P=.01). In the reperfused patients, the correlation between VEGF and CD133(+)CD34(+)KDR(+) was lower (r=.38; P=.03) and the correlation between SDF-1 and CD34(+)CXCR4(+) and VEGF disappeared. Multivariate analysis showed that a VEGF >7pg/mL (P<.01) predicted the mobilisation of CD133(+)CD34(+)KDR(+), whereas hypertension showed a trend (P=.055). Diabetes (P=.045) predicted the number of CD34(+)CXCR4(+), with reperfusion treatment showing a trend in this subpopulation (P=.054). CONCLUSIONS: Mobilisation of progenitor cells after AMI is influenced by factors such as diabetes and the cytokine VEGF. Hypertension and reperfusion therapy during the acute phase also tend to influence the cell response.

Factors predicting and having an impact on the need for a permanent pacemaker after CoreValve prosthesis implantation using the new Accutrak delivery catheter system.

OBJECTIVES: The purpose of this study was to evaluate the need for a permanent pacemaker after transcatheter aortic valve implantation with the CoreValve prosthesis (Medtronic, Inc., Minneapolis, Minnesota) using the new Accutrak delivery system (Medtronic, Inc.). BACKGROUND: The need for a permanent pacemaker is a recognized complication after transcatheter aortic valve implantation with the CoreValve prosthesis. METHODS: Between April 23, 2008 and May 31, 2011, 195 consecutive patients with symptomatic aortic valve stenosis underwent transcatheter aortic valve implantation using the self-expanding CoreValve prosthesis. In 124 patients, the traditional delivery system was used, and in 71 patients, the Accutrak delivery system was used. RESULTS: There were no significant differences in baseline electrocardiographic characteristics between the traditional system and the Accutrak patients: PR interval: 153 ± 46 mm versus 165 ± 30 mm, p = 0.12; left bundle branch block: 22 (20.2%) versus 8 (12.7%), p = 0.21; right bundle branch block: 21 (19.3%) versus 8 (12.7%), p = 0.26. The depth of the prosthesis in the left ventricular outflow tract was greater with the traditional system than with the Accutrak system (9.6 ± 3.2 mm vs. 6.4 ± 3 mm, p < 0.001) and the need for a permanent pacemaker was higher with traditional system than with Accutrak (35.1% vs. 14.3%, p = 0.003). The predictors of the need for a pacemaker were the depth of the prosthesis in the left ventricular outflow tract (hazard ratio [HR]: 1.2, 95% confidence interval [CI]: 1.08 to 1.34, p < 0.001), pre-existing right bundle branch block (HR: 3.5, 95% CI: 1.68 to 7.29, p = 0.001), and use of the traditional system (HR: 27, 95% CI: 2.81 to 257, p = 0.004). CONCLUSIONS: The new Accutrak delivery system was associated with less deep prosthesis implantation in the left ventricular outflow tract, which could be related to the lower rate of permanent pacemaker requirement.

Percutaneous treatment of a dysfunctional aortic bioprosthesis with the CoreValve(®) prosthesis.

Recently, percutaneous aortic valve replacement has emerged as a therapeutic option for patients with severe symptomatic aortic stenosis and a high surgical risk. We report our initial experience in four patients with percutaneous implantation of a CoreValve aortic prosthesis to treat aortic bioprosthesis dysfunction involving aortic stenosis or regurgitation. In-hospital and medium-term outcomes were analyzed. The procedure was performed under local anesthesia and guided by angiography. The prosthesis was implanted successfully in all patients, although a second prosthesis was required in one case because the first was positioned too high. There were no major complications. After a mean follow-up of 7 months (SD, 4.7), all patients remained asymptomatic.