César Morís

A randomized comparison ofrepeat 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.

Late Cardiac Death in Patients Undergoing Transcatheter Aortic Valve Replacement Incidence and Predictors of Advanced Heart Failure and Sudden Cardiac Death

BACKGROUND Little evidence exists of the burden and predictors of cardiac death after transcatheter aortic valve replacement (TAVR). OBJECTIVES The purpose of this study was to assess the incidence and predictors of cardiac death from advanced heart failure (HF) and sudden cardiac death (SCD) in a large patient cohort undergoing TAVR. METHODS The study included a total of 3,726 patients who underwent TAVR using balloon (57%) or self-expandable (43%) valves. Causes of death were defined according to the Valve Academic Research Consortium-2. RESULTS At a mean follow-up of 22 ± 18 months, 155 patients had died due to advanced HF (15.2% of total deaths, 46.1% of deaths from cardiac causes) and 57 had died due to SCD (5.6% of deaths, 16.9% of cardiac deaths). Baseline comorbidities (chronic obstructive pulmonary disease, atrial fibrillation, left ventricular ejection fraction ≤40%, lower mean transaortic gradient, pulmonary artery systolic pressure >60 mm Hg; p < 0.05 for all) and 2 procedural factors (transapical approach, hazard ratio [HR]: 2.38, 95% confidence interval [CI]: 1.60 to 3.54; p < 0.001; presence of moderate or severe aortic regurgitation after TAVR, HR: 2.79, 95% CI: 1.82 to 4.27; p < 0.001) independently predicted death from advanced HF. Left ventricular ejection fraction ≤40% (HR: 1.93, 95% CI: 1.05 to 3.55; p = 0.033) and new-onset persistent left bundle-branch block following TAVR (HR: 2.26, 95% CI: 1.23 to 4.14; p = 0.009) were independently associated with an increased risk of SCD. Patients with new-onset persistent left bundle-branch block and a QRS duration >160 ms had a greater SCD risk (HR: 4.78, 95% CI: 1.56 to 14.63; p = 0.006). CONCLUSIONS Advanced HF and SCD accounted for two-thirds of cardiac deaths in patients after TAVR. Potentially modifiable or treatable factors leading to increased risk of mortality for HF and SCD were identified. Future studies should determine whether targeting these factors decreases the risk of cardiac death.

Registro de Actividad de la Sección de Hemodinámica y Cardiología Intervencionista del año 1997

Se presentan los resultados del Registro de Actividad de Hemodinamica y Cardiologia Intervencionista de la Sociedad Espanola de Cardiologia de 1999. Han participado 90 centros que representan la practica totalidad de los laboratorios de hemodinamica; 83 centros realizaron su actividad fundamentalmente en pacientes adultos y en siete la actividad fue exclusivamente pediatrica. Durante 1999 se realizaron 82.805 estudios diagnosticos, el 79% de los cuales fueron coronariografias (65.234; 1.637 por millon de habitantes) con un aumento global del 11,4% respecto a 1998. Se realizaron 23.010 procedimientos de intervencionismo coronario (590 por millon de habitantes) con un incremento del 14,2% respecto a 1998. Las cifras de exito (94%) y de complicaciones (2,2%) son similares a las de anos precedentes habiendose utilizado inhibidores de la glicoproteina IIb/IIIa en el 12,4% de los casos. El 10,2% de los procedimientos fueron realizados para tratar un infarto agudo de miocardio. El stent intracoronario continua siendo el dispositivo mas utilizado y, con 17.783 procedimientos (el 23% mas que en 1998), ha supuesto el 77,3% de todas las intervenciones coronarias realizadas. Se han implantado 22.946 unidades de stent, el 87% de forma electiva y el 21,4% sin predilatacion, con una baja tasa de complicaciones (0,85% de oclusion subaguda, 1,95% de infarto agudo de miocardio y 0,9% de mortalidad). Tanto la aterectomia rotacional (473 procedimientos) como la direccional (52 procedimientos) continuan en lento descenso con respecto a las cifras de 1998 En el intervencionismo valvular se ha registrado, respecto a 1998, un ascenso del 4% en el numero de valvuloplastias en adultos (525 frente a 505), mientras que el intervencionismo pediatrico ha aumentado un 21% (678 frente a 557 procedimientos). Para concluir, queremos destacar el alto grado de participacion de los laboratorios en el Registro, y aunque la actividad sigue en alza, sus indices son todavia inferiores a los europeos.

Anomalías congénitas de las arterias coronarias del adulto descritas en 31 años de estudios coronariográficos en el Principado de Asturias: principales características angiográficas y clínicas

Objective. The aim of this study was to determine the incidence of adult congenital anomalies of the coronary arteries over 31 years of angiographic studies, describing their angiographic and clinical characteristics. The results have been compared with the main series published. Methods. The diagnostic angiographic reports done in the Principado de Asturias from 1968 to 1999 are reviewed. In those in which a congenital anomaly was diagnosed, the clinical report and the angiography were studied. The initial course of the anomaly was defined following angiographic criteria. Results. Thirteen thousand five hundred reports were reviewed describing 75 patients with 75 anomalies (0.5%) incluiding: anomalous origin of the left circumflex coronary artery (n = 24), coronary artery fistulae (n = 21), both coronary arteries arising from the left coronary sinus (n = 15), single coronary arteries (n = 6), both coronary arteries arising from the right coronary sinus (n = 2), separated origin of anterior descending and left circumflex coronary arteries (n = 3), anterior descending artery arising from the right coronary sinus (n = 2), and others (n = 1). Angiographic studies were done because of: angina (59%), dysnea (25%), atypical chest pain (7%), syncope (3%), dizziness (3%) and palpitations (3%). The initial course was retroaortic in all the circumflex arteries, interarterial in the right coronaries, anterior in the anterior descending arteries and retroaortic, septal and combined, in the left coronaries. Conclusions. Adult congenital anomalies of the coronary arteries are not very common and are usually casual findings of diagnostic angiographic studies. Left circumflex coronary artery anomalies are the most frequently diagnosed.

Percutaneous implantation of the CoreValve self-expanding aortic valve prosthesis in patients with severe aortic stenosis: early experience in Spain.

INTRODUCTION AND OBJECTIVES The aim of the study was to describe early experience and medium-term follow-up with the CoreValve self-expanding aortic prosthesis at three Spanish hospitals. METHODS The study included patients with severe symptomatic aortic stenosis. Other inclusion criteria were: aortic valve area <1 cm(2) (<0.6 cm(2)/m(2)); aortic valve annulus diameter in the range 20-27 mm; diameter of the ascending aorta at the level of the sinotubular junction < or = 40 mm (small prosthesis) or < or = 43 mm (large prosthesis), and femoral artery diameter >6 mm. RESULTS The study included 108 patients with a mean age of 78.6 + or - 6.7 years, a mean aortic valve area of 0.63 + or - 0.2 cm(2) and a mean logistic EuroSCORE of 16% + or - 13.9% (range, 2.27%-86.4%). After valve implantation, the maximum echocardiographic transaortic valve gradient decreased from 83.8 + or - 23 to 12.6 + or - 6 mmHg. No patient presented with greater than grade-2 residual aortic regurgitation on angiography. The procedural success rate was 98.1%. No patient died during the procedure. Definitive pacemaker implantation was carried out for atrioventricular block in 38 patients (35.2%). At 30 days, all-cause mortality and the rate of the combined endpoint of death, stroke, myocardial infarction or referral for surgery were 7.4% and 8.3%, respectively. The estimated 1-year survival rate calculated using the Kaplan-Meier method was 82.3% (for a median follow-up period of 7.6 months). CONCLUSIONS Our early experience indicates that percutaneous aortic valve replacement is a safe and practical therapeutic option for patients with severe aortic stenosis who are at a high surgical risk.

Mutations in filamin C cause a new form of familial hypertrophic cardiomyopathy

Mutations in different genes encoding sarcomeric proteins are responsible for 50-60% of familial cases of hypertrophic cardiomyopathy (HCM); however, the genetic alterations causing the disease in one-third of patients are currently unknown. Here we describe a case with familial HCM of unknown cause. Whole-exome sequencing reveals a variant in the gene encoding the sarcomeric protein filamin C (p.A1539T) that segregates with the disease in this family. Sequencing of 92 HCM cases identifies seven additional variants segregating with the disease in eight families. Patients with FLNC mutations show marked sarcomeric abnormalities in cardiac muscle, and functional analysis reveals that expression of these FLNC variants resulted in the formation of large filamin C aggregates. Clinical studies indicate that FLNC-mutated patients have higher incidence of sudden cardiac death. On the basis of these findings, we conclude that mutations in the gene encoding the sarcomeric protein filamin C cause a new form of familial HMC.

Long-Term Clinical Benefit of Sirolimus-Eluting Stents in Patients With In-Stent Restenosis: Results of the RIBS-II (Restenosis Intra-stent: Balloon angioplasty vs. elective sirolimus-eluting Stenting) Study

OBJECTIVES We sought to assess the long-term effectiveness and safety of sirolimus-eluting stents (SES) in patients with in-stent restenosis (ISR). BACKGROUND Treatment of patients with ISR remains a challenge. The long-term outcome of patients with ISR treated with SES remains unknown. METHODS The RIBS-II (Restenosis Intra-stent: Balloon angioplasty vs. elective sirolimus-eluting Stenting) study was a randomized trial conducted in 150 patients with ISR (76 SES, 74 balloon angioplasty [BA]). The long-term (>1 year) clinical outcome and pre-specified subgroup analyses were pre-defined secondary study end points. RESULTS At 1 year, the event-free survival (death, myocardial infarction, target vessel revascularization [TVR]) was better in the SES group (88% vs. 69%, p < 0.005). Additional long-term (>3 years) clinical follow-up was obtained in 97% of patients (median 3.3 years). After the first year, 3 patients died (1 SES, 2 BA), 5 suffered myocardial infarction (4 SES, 1 BA), and 7 required TVR (4 SES, 3 BA). At last follow-up, definitive/probable/possible stent thrombosis was similar in both groups (2/2/1 SES vs. 1/0/3 BA, p = NS). At 4 years, the event-free survival was 76% in the SES arm and 65% in the BA arm (p = 0.019). On multivariate analysis, SES implantation was an independent predictor of event-free survival. Subgroup analyses were consistent with the main outcome measure. CONCLUSIONS In patients with ISR, SES implantation remains effective and safe at very long-term clinical follow-up.

Stenting the Stent: Initial Results and Long-Term Clinical and Angiographic Outcome of Coronary Stenting for Patients With In-Stent Restenosis

Stent restenosis constitutes a therapeutic challenge affecting an increasing number of patients. Conventional angioplasty and debulking techniques are currently used in these patients. However, the potential role of a second stent implantation in this setting (stenting the stent) remains unknown. Therefore, 65 consecutive patients (12 women, aged 62 +/- 11 years) undergoing stent implantation (42 elective and 23 unplanned) for the treatment of in-stent restenosis (diffuse [> 10 mm] in 39 [60%]) were studied. Angiographic success was obtained in all patients. Three patients developed hospital complications: 1 died from refractory heart failure and 2 suffered non-Q-wave myocardial infarctions. During follow-up (mean 17 +/- 11 months) 1 patient died (noncardiac cause) and only 9 (14%) required target vessel revascularization. Kaplan-Meier event-free survival (freedom from death, myocardial infarction, and target vessel revascularization) at 1 year was 84%. Using Cox analysis, patients with unstable symptoms, a short time to stent restenosis, nonelective stenting, and B2-C lesions tended to have poorer prognosis. After adjustment, nonelective stenting was associated (adjusted RR 2.9, 95% confidence interval [CI] 0.82 to 10.3, p = 0.09) with an adverse clinical outcome. On quantitative angiography (core lab) restenosis was found in 13 of 43 patients (30%) (75% of those eligible). Logistic regression analysis identify restenosis length (adjusted RR 1.43, 95% CI 1.04 to 2.14, p = 0.04), and time to restenosis (adjusted RR 0.67, 95% CI 0.47 to 0.94, p = 0.01) as the only independent predictors of recurrent restenosis. Thus, repeat coronary stenting is a safe and efficacious strategy for the treatment of patients with in-stent restenosis. Both elective and nonelective stenting provide excellent initial results. The long-term clinical and angiographic outcome of these patients is also favorable.

Espectro mutacional de los genes sarcoméricos MYH7, MYBPC3, TNNT2, TNNI3 y TPM1 en pacientes con miocardiopatía hipertrófica ☆

Introduccion y objetivos Las mutaciones en los genes sarcomericos son la causa mas frecuente de miocardiopatia hipertrofica. Para cada gen, la frecuencia de mutaciones varia entre los estudios, y las manifestaciones clinicas son muy heterogeneas, lo que dificulta el empleo de la informacion genetica en la practica clinica. Nuestro objetivo es determinar la frecuencia de mutaciones en los genes sarcomericos MYH7, MYBPC3, TNNT2, TNNI3 y TPM1 en una serie de pacientes con miocardiopatia hipertrofica. Metodos Se analizaron las regiones codificantes de estos cinco genes mediante secuenciacion en 120 pacientes (el 29% con antecedentes familiares), comparando el fenotipo segun el gen mutado. Resultados Se hallaron mutaciones en 32 pacientes; 10 y 20 tenian mutaciones en MYH7 (8%) y MYBPC3 (16%). Se hallaron mutaciones de TNNT2 y TPM1 en 2 y 1 pacientes, y ninguna de TNNI3. Dos pacientes tenian dos mutaciones (dobles mutantes). El 61% de las mutaciones no habian sido descritas previamente. No hallamos diferencias en la media de edad al diagnostico o el tamano de la hipertrofia entre los portadores de mutaciones en MYH7 y los de MYBPC3. Conclusiones El 26% de los pacientes tenian mutaciones en alguno de los cinco genes estudiados. Mas de la mitad de las mutaciones no habian sido descritas. El gen MYBPC3 fue el mas mutado, seguido de MYH7. No se hallaron diferencias fenotipicas entre los pacientes segun el gen mutado, lo que dificultaria el empleo de la informacion genetica para estratificar el riesgo en estos pacientes.

Prevalence and outcome of newly detected diabetes in patients who undergo percutaneous coronary intervention

AIMS The beneficial effect of specific measures in patients with newly detected diabetes during percutaneous coronary intervention (PCI) has been poorly studied. Here, we determined the prevalence of newly detected diabetes in a cohort of patients who underwent PCI and analysed their clinical outcome. METHODS AND RESULTS A prospective study included patients without previous diagnosis of diabetes that were referred for PCI between November 2005 and May 2006. Major cardiac events were registered after admission and during 12 months of follow-up, and oral glucose tolerance was tested at 15 days after hospital discharge. Six hundred and sixty-two consecutive patients were referred to our hospital for PCI. The distribution of the glycometabolic state of the entire population was (95% CI): known diabetes 28.8% (25.2-32.6), newly detected diabetes 16.2% (13.1-19.8), impaired glucose tolerance 24.5% (20.8-28.5), impaired fasting glucose 1% (0.4-2.4), and normal glucose regulation 29.5% (25.5-33.7). In a multivariable analysis, the presence of newly detected diabetes was not an independent predictor of cardiac events after 1 year of follow-up. CONCLUSION The prevalence of diabetes in patients who underwent PCI was very high (45%), 35% of which was patients with newly detected diabetes. In our series newly detected diabetes was not an independent predictor of outcome at 12 months. Nevertheless, this finding requires independent confirmation in other series to draw general conclusions on the whole spectrum of percutaneous interventions.