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 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.

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.

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.

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.

Changes in atrioventricular conduction and predictors of pacemaker need after percutaneous implantation of the CoreValve®. Aortic valve prosthesis.

INTRODUCTION AND OBJECTIVES: Although changes in atrioventricular conduction frequently occur after percutaneous implantation of an aortic valve prosthesis, little is known about the mechanisms involved or how these changes progress. We investigated ECG abnormalities and predictors of pacemaker need after percutaneous implantation of the CoreValve® aortic valve prosthesis. METHODS: Between April 2008 and October 2009, 65 patients with symptomatic severe aortic stenosis received a CoreValve® prosthesis. Clinical and ECG parameters were recorded and predictors of pacemaker need due to advanced atrioventricular block were investigated. The analysis excluded three patients because they had pacemakers and a fourth who died during the procedure. RESULTS: The patients' mean age was 79 ± 7.8 years and their logistic EuroSCORE was 20 ± 14%. Implantation was successful in 98.4%. After implantation, 47.5% had left bundle branch block and 21 patients (34.4%) required a permanent pacemaker. The need for a pacemaker was associated with a greater depth of prosthesis implantation in the left ventricular outflow tract (LVOT): 13 ± 2.5 mm vs. 8.8 ± 2.8 mm (P< .001). Moreover, depth was the only predictor: odds ratio 1.9, 95% confidence interval 1.19-3.05 (P< .007). A cutpoint of 11.1 mm for the prosthesis depth in the LVOT had a sensitivity of 81% and a specificity of 84.6% for predicting the need for a pacemaker. CONCLUSIONS: After CoreValve® aortic valve prosthesis implantation, a high percentage of patients needed a permanent pacemaker for advanced atrioventricular block. The only independent predictor was the depth of the prosthesis in the LVOT, which could serve as an early indicator of pacemaker need.

Comparison of incidence and angiography patterns in definite thrombosis between drug-eluting and bare-metal stents.

Stent thrombosis is a feared complication of percutaneous coronary intervention due to its catastrophic consequences. We analysed the incidence of angiographically-confirmed thrombosis in 5011 consecutive patients treated with drug-eluting stents or bare-metal stents. Although the incidence of thrombosis was similar between the two groups (0.8%), angiographically-documented late thrombosis was a relatively unusual complication after implantation of either stent, though it was more common with drug-eluting stents than bare-metal stents (0.25 vs. 0.06%, P=.03).

Closure of perivalvular leaks using an Amplatzer occluder.

Reoperation of patients with perivalvular leaks due to heart failure or hemolysis is associated with increased morbidity and mortality. Percutaneous closure using an Amplatzer device offers a promising alternative. We describe our initial experience between 2004 and 2006, during which we used an Amplatzer device in eight patients for the percutaneous closure of perivalvular leaks (four aortic and four mitral). The patients were all symptomatic and had a high surgical risk. Device placement was successful in all patients with mitral leaks and in three with aortic leaks. There were no periprocedural complications. With four of the seven (57%) device placements, there was a significant reduction in the degree of regurgitation and, at 12-month follow-up, only these four patients showed clinical improvements. Of the other three, one required reoperation and two died of non-cardiovascular causes. Percutaneous closure of perivalvular leaks was feasible and safe and can be regarded as a treatment option in patients with a high surgical risk.

Comparison of medium-term outcomes obtained with drug-eluting stents and coronary artery bypass grafts in an unselected population of diabetic patients with multivessel coronary disease. Propensity score analysis.

INTRODUCTION AND OBJECTIVES: Since the introduction of drug-eluting stents, the optimum revascularization strategy in diabetic patients with multivessel coronary disease has remained controversial. METHODS: This study used multivariate logistic regression analysis and propensity score matching to compare results in 270 consecutive diabetic patients (2000-2004) with multivessel disease (> or =2 vessels with a >70% de novo stenosis involving the proximal left anterior descending coronary artery) who underwent either coronary artery bypass grafting (CABG; n=142) or implantation of a drug-eluting stent (DES; i.e. rapamycin or paclitaxel; n=128). The following clinical outcomes (i.e. major adverse cardiac or cerebrovascular events [MACCEs]) were assessed: death, nonfatal myocardial infarction (MI), stroke and repeat revascularization at 2 years. RESULTS: Patients who received DESs were older (67.5+/-7 years vs. 65.3+/-8 years; P=.05) and more often had a previous MI (49.2% vs. 28.2%; P< .01), but no more often had a depressed left ventricular ejection fraction < or =45% (32.4% vs. 28.1%). Coronary anatomy was more complex in surgical patients (SYNTAX score, 25.9+/-7 vs. 18.5+/-6; P< .001) and the quality of revascularization was better (i.e. anatomically complete revascularization: 52.8% vs. 28.1%; P< .01). The incidence of MACCEs was 18.7% in the CABG group and 21.8% in the DES group (adjusted odds ratio [OR] = 0.93; 95% confidence interval [CI], 0.47-1.86). The composite endpoint of death, MI or stroke occurred in 15.8% undergoing CABG and 12.9% receiving a DES (adjusted OR = 1.19; 95% CI, 0.72-1.88). There was less need for revascularization in CABG patients (4.3% vs. 12.1%; adjusted OR = 0.42; 95% CI, 0.16-1.14; P=.09). CONCLUSIONS: In an unselected population of diabetic patients with multivessel coronary disease, the principle advantage of CABG was the reduced need for revascularization. There was no difference in the rate of death, MI or stroke.

[Long-term prognosis in diabetic patients in whom revascularization is deferred following fractional flow reserve assessment]. / Pronóstico a largo plazo de diferir la intervención coronaria en diabéticos sobre la base de la reserva fraccional de flujo.

INTRODUCTION AND OBJECTIVES: The fractional flow reserve (FFR) has been shown to be a valid and useful measure in the functional assessment of coronary stenoses of intermediate severity. Our aim was to determine the usefulness of FFR assessment in diabetic patients, in whom determination of the FFR can be influenced by microvascular dysfunction. METHODS: Between 1997-2004, FFR assessment was used to evaluate 222 consecutive coronary lesions judged by an interventional cardiologist to be of intermediate severity (ie, 40%-70%). Intravenous adenosine (140 microg/kg per min) was used to achieve maximum hyperemia. The occurrence of cardiac events (ie, death, non-fatal acute myocardial infarction, and target lesion revascularization) was compared in diabetics and nondiabetics in whom FFR assessment gave a negative result and intervention was deferred. The mean follow-up period was 30+/-21 months. RESULTS: Revascularization was deferred for 144 lesions (in 136 patients) in which the FFR was >/=0.75. Of these, 42 lesions (29.2%) were in diabetics (40 patients). The proportion of patients who were female or who had hypertension, dyslipidemia or multivessel disease was greater in the diabetic group. There was no difference in indications for coronary angiography. In both groups, the most frequently investigated vessel was the left anterior descending coronary artery. The mean FFR was 0.87+/-0.06, and there was no difference between the groups. On long-term follow-up, there was no difference in the rate of death or acute myocardial infarction. Overall, 8.8% of nondiabetics and 14.3% of diabetics with a negative FFR test result required target lesion revascularization (P=.32). CONCLUSIONS: Our results indicate that deferring percutaneous coronary intervention in diabetics with a moderately severe coronary artery stenosis and an FFR >/=0.75 is safe.

Experiência inicial em Málaga(Espanha) com prótese aórtica CoreValve para tratamento de estenose aórtica sintomática grave / Malaga(Spain)early experience with the CoreValve aortic prosthesis for the treatment of severe symptomatic aortic stenosis

Introdução: A prevalência de estenose aórtica grave vem crescendo em decorrência do aumento da expectativa de vida. Alguns pacientes não se beneficiam do tratamento cirúrgico por causa das comorbidades associadas. Apresentamos os resultados de nossa experiência no tratamento percutâneo da estenose aórtica. Método: Estudo prospectivo, realizado entre abril de 2008 e fevereiro de 2009, em que 31 pacientes consecutivos com estenose aórtica grave sintomática e que apresentavam alto risco cirúrgico foram tratados com a prótese aórtica CoreValve. Todos os procedimentos foram realizados com anestesia local. Em 29 casos a via de acesso foi a artéria femoral, com introdutor 18 F, a punção femoral foi fechada com Prostar 10 F, e em 2 pacientes a artéria subclávia esquerda foi a via de acesso. Resultados: A média de idade foi de 77,8 ± 8,9anos e o EuroSCORE logístico médio foi de 17,5 ± 12,6%. O sucesso do implante foi de 100%. O gradiente de pico a pico após o implante desapareceu. Nenhum paciente apresentou insuficiência aórtica residual > grau 2 de Sellers. A mortalidade aos 30 dias foi de 3,2%. Foram necessários marca-passos definitivos em 31% dos pacientes. Depois de acompanhamento médio de 154 ± 90 dias, foram registrados 4 óbitos (1 morte súbita e 3 por causas não-cardíacas). Conclusões: O implante percutâneo da prótese aórtica CoreValve como tratamento alternativo da estenose aórtica grave em pacientes com alto risco cirúrgico é factível e seguro, com elevada taxa de êxito no procedimento e porcentual de complicações abaixo do esperado em função do risco cirúrgico estimado com o EuroSCORE.

Background: The prevalence of severe aortic stenosis is increasing with the rise in life expectancy. Some patients cannot undergo surgical treatment of aortic stenosis due to associated disorders. We present the results of our experience with the percutaneous treatment of aortic stenosis as an alternative to surgery in high-risk patients. Methods: This prospective cohort study included 31 consecutive high surgical risk patients with severe and symptomatic aortic stenosis treated with a CoreValve aortic prosthesis from April 2008 to February 2009. All the procedures were undertaken with local anesthesia. In 29 patients we used a femoral artery access, with an 18 F introducer, closing the femoral puncture with a 10 F Prostar, and in two patients the access was via the left subclavian artery. Results: The mean age of the patients was 77.8 ± 8.9 years and the mean logistic EuroSCORE was 17.5 ± 12.6%. The implant was successful in 100% of cases. The peak-to-peak gradient after the implant disappeared. No patient had residual aortic insufficiency Sellers' grade > 2. One-month mortality was 3.2%. A definitive pacemaker was required in 31% of the patients. After a mean follow-up of 154 ± 90 days there were four deaths (1 sudden death and 3 for noncardiac causes). Conclusions: Percutaneous implantation of the CoreValve aortic prosthesis as an alternative treatment for severe aortic stenosis in high surgical risk patients is feasible and safe, with a high success rate for the procedure and a percentage of complications below the expected for the surgical risk, as estimated by the EuroSCORE.

Tratamiento percutáneo de las bioprótesis aórticas disfuncionantes con la prótesis CoreValve® / Percutaneous treatment of a dysfunctional aortic bioprosthesis with the coreValveW prosthesis

El implante valvular aórtico percutáneo ha surgido recientemente como alternativa terapéutica para pacientes con estenosis aórtica severa sintomática y alto riesgo quirúrgico. Se presenta la experiencia inicial en el tratamiento de la disfunción de la bioprótesis aórtica mediante el implante percutáneo de prótesis aórtica CoreValve en 4 pacientes, tanto con estenosis como con insuficiencia aórtica, y se analiza los resultados hospitalarios y a medio plazo. El procedimiento se realizó con anestesia local y guiado por angiografía. Se implantaron con éxito en todos los casos, si bien uno precisó una segunda prótesis por posicionamiento alto de la primera. No hubo complicaciones mayores. Tras un seguimiento medio de 7±4,7 meses, todos los pacientes se encuentran asintomáticos (AU)

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 followup of 7 months (SD, 4.7), all patients remained asymptomatic (AU)

Alteraciones de la conducción auriculoventricular y predictores de la necesidad de marcapasos tras el implante percutáneo de la prótesis aórtica de CoreValve® / Changes in atrioventricular conduction and predictors of pacemaker need after percutaneous implantation of the CoreValve® aortic valve prosthesis

Introducción y objetivos. Los cambios en la conducción auriculoventricular son frecuentes tras el implante percutáneo de la prótesis aórtica, pero se desconoce qué mecanismos están implicados y su evolución. Analizamos las alteraciones electrocardiográficas y los predictores de la necesidad de marcapasos tras el implante percutáneo con la prótesis aórtica CoreValve®. Métodos. Entre abril de 2008 y octubre de 2009 se ha tratado a 65 pacientes con estenosis aórtica grave sintomática mediante la prótesis aórtica CoreValve®. Se analizaron características clínicas y electrocardiográficas y predictores de la necesidad de marcapasos por bloqueo auriculoventricular avanzado. Del análisis se excluyó a 3 pacientes por tener marcapasos y a un cuarto paciente que falleció durante el procedimiento. Resultados. La media de edad era 79 ± 7,8 años y el EuroSCORE logístico, 20% ± 14%. El éxito del implante fue del 98,4%. Tras el implante de la prótesis, el 47,5% tenía bloqueo de rama izquierda y 21 pacientes (34,4%) precisaron de marcapasos definitivo. La necesidad de marcapasos se relacionó con la mayor profundidad de la prótesis en el tracto de salida del ventrículo izquierdo (TSVI) (13 ± 2,5 frente a 8,8 ± 2,8 mm; p < 0,001) y fue el único predictor (odds ratio = 1,9; intervalo de confianza del 95%, 1,19-3,05; p < 0,007. Una profundidad de 11,1 mm de la prótesis en el TSVI presentó una sensibilidad del 81% y una especificidad del 84,6% para predecir la necesidad de marcapasos. Conclusiones. Tras el implante de la prótesis aórtica CoreValve®, un alto porcentaje de pacientes precisan de marcapasos definitivo por bloqueo auriculoventricular avanzado. El único predictor independiente es la profundidad de la prótesis en el TSVI y podría detectar precozmente la necesidad de marcapasos (AU)

Introduction and objectives. Although changes in atrioventricular conduction frequently occur after percutaneous implantation of an aortic valve prosthesis, little is known about the mechanisms involved or how these changes progress. We investigated ECG abnormalities and predictors of pacemaker need after percutaneous implantation of the CoreValve® aortic valve prosthesis. Methods. Between April 2008 and October 2009, 65 patients with symptomatic severe aortic stenosis received a CoreValve® prosthesis. Clinical and ECG parameters were recorded and predictors of pacemaker need due to advanced atrioventricular block were investigated. The analysis excluded three patients because they had pacemakers and a fourth who died during the procedure. Results. The patients’ mean age was 79±7.8 years and their logistic EuroSCORE was 20±14%. Implantation was successful in 98.4%. After implantation, 47.5% had left bundle branch block and 21 patients (34.4%) required a permanent pacemaker. The need for a pacemaker was associated with a greater depth of prosthesis implantation in the left ventricular outflow tract (LVOT): 13±2.5 mm vs. 8.8±2.8 mm (P<.001). Moreover, depth was the only predictor: odds ratio 1.9, 95% confidence interval 1.19- 3.05 (P<.007). A cutpoint of 11.1 mm for the prosthesis depth in the LVOT had a sensitivity of 81% and a specificity of 84.6% for predicting the need for a pacemaker. Conclusions. After CoreValve® aortic valve prosthesis implantation, a high percentage of patients needed a permanent pacemaker for advanced atrioventricular block. The only independent predictor was the depth of the prosthesis in the LVOT, which could serve as an early indicator of pacemaker need (AU)

Utilización de los dispositivos Amplatzer para el cierre de fugas perivalvulares / Closure of perivalvular leaks using an amplatzer occluder

La reintervención de los pacientes con fugas perivalvulares por insuficiencia cardiaca o hemolisis está asociada a una elevada morbimortalidad. La utilización percutánea de los dispositivos Amplatzer supone una alternativa atractiva. Presentamos nuestra experiencia inicial: entre 2004 y 2006 realizamos cierre percutáneo con dispositivo Amplatzer a 8 pacientes con fugas perivalvulares (4 aórticas y 4 mitrales), sintomáticos y con alto riesgo quirúrgico. La implantación del dispositivo fue posible en todas las mitrales y en 3 aórticas. No hubo complicaciones durante el procedimiento. En 4 (57%) de los 7 implantes se logró una reducción significativa del grado de regurgitación y, tras 12 meses de seguimiento, solamente estos pacientes mejoraron clínicamente. De los 3 restantes, 1 paciente precisó reintervención y 2 fallecieron por causa no cardiovascular. El tratamiento percutáneo de las fugas perivalvulares es factible y seguro y puede considerarse como una opción terapéutica en subgrupos de alto riesgo quirúrgico (AU)

Reoperation of patients with perivalvular leaks due to heart failure or hemolysis is associated with increased morbidity and mortality. Percutaneous closure using an Amplatzer device offers a promising alternative. We describe our initial experience between 2004 and 2006, during which we used an Amplatzer device in 8 patients for the percutaneous closure of perivalvular leaks (4 aortic and 4 mitral). The patients were all symptomatic and had a high surgical risk. Device placement was successful in all patients with mitral leaks and in 3 with aortic leaks. There were no periprocedural complications. With 4 of the 7 (57%) device placements, there was a significant reduction in the degree of regurgitation and, at 12-month follow-up, only these 4 patients showed clinical improvements. Of the other 3, 1 required reoperation and 2 died of non-cardiovascular causes. Percutaneous closure of perivalvular leaks was feasible and safe and can be regarded as a treatment option in patients with a high surgical risk (AU)

Comparación de los resultados clínicos a medio plazo de los stents farmacoactivos frente a la cirugía de revascularización coronaria en una población no seleccionada de pacientes diabéticos con afección multivaso. Análisis mediante propensity score / Comparison of medium-term outcomes obtained with drug-eluting stents and coronary artery bypass grafts in an unselected population of diabetic patients with multivessel coronary disease. Propensity score analysis

Introducción y objetivos. La estrategia de revascularización en el paciente diabético con enfermedad multivaso en la era actual de los stents farmacoactivos es controvertida. Métodos. Comparamos a 270 pacientes diabéticos consecutivos (2000-2004) con enfermedad multivaso (al menos 2 vasos con estenosis > 70% de novo y afección de la descendente anterior proximal) a los que se practicó cirugía de revascularización coronaria (n = 142) o se implantó stents farmacoactivos (rapamicina/paclitaxel) (n = 128) mediante análisis de regresión logística multivariable con propensity score. Analizamos los resultados clínicos (eventos cardiacos y cerebrovasculares mayores): muerte, infarto no fatal, ictus y necesidad de revascularización a 24 meses. Resultados. Los pacientes que recibieron stents farmacoactivos tuvieron mayor edad (67,5 ± 7 frente a 65,3 ± 8 años; p = 0,05) y más infarto previo (el 49,2 frente al 28,2%; p < 0,01), aunque no hubo diferencias en la presencia de disfunción ventricular significativa (≤ 45%): el 32,4 frente al 28,1%. En los pacientes quirúrgicos, la anatomía coronaria fue más compleja: score SYNTAX (25,9 ± 7 frente a 18,5 ± 6; p < 0,001) y la calidad de la revascularización fue superior (revascularización anatómica completa, el 52,8 frente al 28,1%; p < 0,01). La incidencia total del evento combinado fue del 18,7% en el grupo quirúrgico y el 21,8% en el grupo percutáneo (odds ratio [OR] ajustada = 0,93; intervalo de confianza [IC] del 95%, 0,47-1,86). El evento combinado de muerte, infarto e ictus fue del 15,8% en el grupo quirúrgico, frente al 12,9% en el grupo de stent farmacoactivo (OR ajustada = 1,19; IC del 95%, 0,72-1,88). Los pacientes quirúrgicos tuvieron menor necesidad de revascularización (el 4,3 frente al 12,1%; OR ajustada = 0,42; IC del 95%, 0,16-1,14; p = 0,09). Conclusiones. En una población no seleccionada de diabéticos multivaso, la ventaja de la cirugía de revascularización coronaria se centró en reducir las revascularizaciones. No encontramos diferencias en muerte, infarto o ictus (AU)

Introduction and Objectives. Since the introduction of drug-eluting stents, the optimum revascularization strategy in diabetic patients with multivessel coronary disease has remained controversial. Methods. This study used multivariate logistic regression analysis and propensity score matching to compare results in 270 consecutive diabetic patients (2000-2004) with multivessel disease (≥2 vessels with a >70% de novo stenosis involving the proximal left anterior descending coronary artery) who underwent either coronary artery bypass grafting (CABG; n=142) or implantation of a drug eluting stent (DES; ie, rapamycin or paclitaxel; n=128). The following clinical outcomes (ie, major adverse cardiac or cerebrovascular events [MACCEs]) were assessed: death, nonfatal myocardial infarction (MI), stroke, and repeat revascularization at 2 years. Results. Patients who received DESs were older (67.5 [7] years vs 65.3 [8] years; P=.05) and more often had a previous MI (49.2% vs 28.2%; P < .01), but no more often had a depressed left ventricular ejection fraction ≤45% (32.4% vs 28.1%). Coronary anatomy was more complex in surgical patients (SYNTAX score, 25.9 [7] vs 18.5 [6]; P < .001) and the quality of revascularization was better (ie, anatomically complete revascularization: 52.8% vs 28.1%; P < .01). The incidence of MACCEs was 18.7% in the CABG group and 21.8% in the DES group (adjusted odds ratio [OR] =0.93; 95% confidence interval [CI], 0.47-1.86). The composite endpoint of death, MI or stroke occurred in 15.8% undergoing CABG and 12.9% receiving a DES (adjusted OR =1.19; 95% CI, 0.72-1.88). There was less need for revascularization in CABG patients (4.3% vs 12.1%; adjusted OR=0.42; 95% CI, 0.16-1.14; P=.09). Conclusions. In an unselected population of diabetic patients with multivessel coronary disease, the principle advantage of CABG was the reduced need for revascularization. There was no difference in the rate of death, MI or stroke. and more often had a previous MI (49.2% vs. 28.2%; P < .01), but no more often had a depressed left ventricular ejection fraction ≤45% (32.4% vs. 28.1%). Coronary anatomy was more complex in surgical patients (SYNTAX score, 25.9±7 vs. 18.5±6; P < .001) and the quality of revascularization was better (i.e. anatomically complete revascularization: 52.8% vs. 28.1%; P < .01). The incidence of MACCEs was 18.7% in the CABG group and 21.8% in the DES group (adjusted odds ratio [OR] = 0.93; 95% confidence interval [CI], 0.47-1.86). The composite endpoint of death, MI or stroke occurred in 15.8% undergoing CABG and 12.9% receiving a DES (adjusted OR = 1.19; 95% CI, 0.72-1.88). There was less need for revascularization in CABG patients (4.3% vs. 12.1%; adjusted OR = 0.42; 95% CI, 0.16-1.14; P=.09). Conclusions. In an unselected population of diabetic patients with multivessel coronary disease, the principle advantage of CABG was the reduced need for revascularization. There was no difference in the rate of death, MI or stroke (AU)