Large diameter Advanta V12 covered stent trial for coarctation of the aorta: COARC Study

BACKGROUND: Covered stent implantation for treatment of coarctation of the aorta (CoA) is effective and can prevent aortic wall injury. Prospective studies with long-term follow-up, including imaging, are lacking. We report the acute and long-term outcomes for use of the Large Diameter Advanta V12 covered stent for treatment of native and recurrent CoA. METHODS: A prospective, multicenter, nonrandomized study was performed including 70 patients (43 male), median age 17 years, median weight 57.4 kg with CoA who underwent implantation of the Large Diameter Advanta V12 covered stent. Annual follow-up for 5 years included Doppler echocardiography to calculate diastolic velocity: systolic velocity ratio. RESULTS: CoA diameter increased from 5.6±3.6 to 14.9±3.9 mm (P<0.0001) and the pressure gradient decreased from 35.8±16.2 to 5.6±7.9 mm Hg (P<0.0001). Preimplantation diastolic velocity: systolic velocity of 0.6±0.16 dropped to 0.34±0.13 (P<0.0001) and was maintained at 5 years. Computed tomography angiograms at 12 months post implantation demonstrated the stent: transverse arch diameter to be similar, 0.91±0.09 to post procedure 0.86±0.14. Major adverse vascular events at 30 days and 12 months were 1.4% and 4.3%, respectively. Significant adverse events included three patients who required stent implantation to treat infolding. There were no mortalities. CONCLUSIONS: The Large Diameter Advanta V12 covered stent is safe and effective for the treatment of CoA with an immediate and sustained reduction of the pressure gradient over 12 months and 5 years as assessed by preimplantation and post implantation Doppler echocardiography and 12-month computed tomography angiography.

Stenting of aortic coarctation: acute, intermediate, and long-term results of a prospective multi-institutional registry--Congenital Cardiovascular Interventional Study Consortium (CCISC).

INTRODUCTION: Since the 1980s, stent implantation has evolved as an important therapeutic strategy for coarctation of the aorta. However, available data is frequently flawed by short follow-up, lack of adequate follow-up imaging, and retrospective nature of data collection. METHODS: Data was prospectively collected using a multicenter registry congenital cardiovascular interventional study consortium (CCISC). Between 2000 and 2009, 302 patients from 34 centers with a median weight of 58 kg underwent stent implantation for coarctation. Eligible patients (44%) completed intermediate follow-up (3-18 months) with integrated imaging (cath, CT, MRI), whereas 21% completed long-term follow-up (>18-60 months). Procedural success was defined as UL/LL systolic gradient of less than 20 mm Hg, lack of significant recurrent obstruction, and freedom from unplanned repeat intervention. RESULTS: Acute procedural success was 96%. Cumulative intermediate success was 86%, and cumulative long-term success was 77%. Unplanned repeat interventions were required in 4%, and aortic wall complications were seen in 1% of patients (dissection n = 1 and aneurysm n = 3). Other adverse events (n = 15) occurred mainly acutely and included technical complications such as stent malposition (n = 9). At long-term follow-up, 23% of patients continued to have systolic blood pressure above the 95th centile, 9% had an upper-to-lower limb blood pressure gradient in excess of 20 mm Hg, and 32% were taking antihypertensive medication. CONCLUSIONS: This study documented acute, intermediate, and long-term outcome data comparable or superior with other surgical or interventional series. However, even with successful initial stent therapy, patients continue to require long-term follow-up and have associated long-term morbidity, relating to aortic wall complications, systemic hypertension, recurrent obstruction as well as need for repeat intervention.

Monitoreo inalámbrico de presión arterial pulmonar en pacientes con insuficiencia cardíaca / Wireless pulmonary artery pressure monitoring in patients with congestive heart failure

Antecedentes: El monitoreo continuo y remoto de presiones intracardiacas ha sido reportado de utilidad en el manejo y prevención de hospitalización en pacientes con Insuficiencia Cardíaca (IC). Objetivos: Describir la técnica y las complicaciones en el seguimiento a mediano plazo de un sensor inalámbrico(Sensor CardioMEMS Heart Sure®) pulmonar; evaluar la exactitud de la determinación de la presión en arteriapulmonar (PAP) después de un año de implante y su correlación con la presión estimada por cateterismo cardíaco convencional (catéter de Swan-Ganz).Método: Fueron incluidos en el estudio pacientes con IC avanzada con al menos una hospitalización en el año previo al implante de este sensor. Se realizaron mediciones simultáneas con catéter de Swan-Ganz (SG) durante el implante y a los 60, 180 días y un año de seguimiento. Se empleó análisis de regresión lineal como una medida de la correlación entre los métodos. La variabilidad entre las técnicas se evaluó mediante análisis del Bland-Altman.Resultados: En este reporte fueron incluidos 27 pacientes, 24 hombres con edad promedio de 64+/-14.1 años y FE promedio de 25 por ciento, la gran mayoría en clase funcional III de la NYHA. Un paciente falleció 190 días post implante por causa extra cardíaca y otro falleció 45 días post implante por shock cardiogénico. La PAP sistólica, diastólica y media cuantificada a 60 días, 6 meses y un año post implante tuvo una correlación adecuada cuando se comparó con el cateterismo de SG preservando la calidad de la curva de presión obtenida desde el sensor. La calidad de la señal se ha mantenido hasta más de un año de seguimiento. Conclusión: Existió muy buena correlación entre las presiones obtenidas con el sensor y las mediciones del catéter de SG. Es necesario validar este sistema en un número mayor de enfermos y establecer su papel en el manejo de la IC crónica.

Background: Continuous and remote intracardiac pressure monitoring has been reported to be useful to manage patients with congestive heart failure (CHF) and to prevent rehospitalization. Aim: To describe the technical aspects and complications in the use of a wireless pulmonary artery pressure sensor (CardioMEMS Heart Sure© ) in a medium term follow up. Also, to evaluate de precision of pulmonary artery pressure (PAP) measurement one year after implantation of the device. Methods: Patients with advanced CHF with at least one hospitalization in the preceding year were included. PAP was measured through Swan Ganz catheterization at the time of device implantation and after 60 days, 6 months and one year of follow up. Linear regression was used to estimate inter method correlation and Bland-Altman analysis to estimate variability among methods Results: Twenty-seven patients (24 men) aged 64 +/-14.1 (SD) years, most of them in functional class III were included. The mean ejection fraction was 25 percent. One patient died 190 days after implant due to non cardiac causes and another 45 days post implant from cardiogenic shock. Systolic, diastolic and mean PAP was measured 60 days, 6 months and 1 year post implant. The correlation with Swan Ganz catheter measurement was adequate. The quality of the signal obtained from the PAP sensor was maintained at one year of follow up. Conclusion: A very good correlation between wireless and Swan Ganz measurements of PAP was observed. More extensive assessment of this method is needed to establish its usefulness in the management of patients with chronic CHF.

Intermediate follow-up following intravascular stenting for treatment of coarctation of the aorta.

BACKGROUND: We report a multiinstitutional study on intermediate-term outcome of intravascular stenting for treatment of coarctation of the aorta using integrated arch imaging (IAI) techniques. METHODS AND RESULTS: Medical records of 578 patients from 17 institutions were reviewed. A total of 588 procedures were performed between May 1989 and Aug 2005. About 27% (160/588) procedures were followed up by further IAI of their aorta (MRI/CT/repeat cardiac catheterization) after initial stent procedures. Abnormal imaging studies included: the presence of dissection or aneurysm formation, stent fracture, or the presence of reobstruction within the stent (instent restenosis or significant intimal build-up within the stent). Forty-one abnormal imaging studies were reported in the intermediate follow-up at median 12 months (0.5-92 months). Smaller postintervention of the aorta (CoA) diameter and an increased persistent systolic pressure gradient were associated with encountering abnormal follow-up imaging studies. Aortic wall abnormalities included dissections (n = 5) and aneurysm (n = 13). The risk of encountering aortic wall abnormalities increased with larger percent increase in CoA diameter poststent implant, increasing balloon/coarc ratio, and performing prestent angioplasty. Stent restenosis was observed in 5/6 parts encountering stent fracture and neointimal buildup (n = 16). Small CoA diameter poststent implant and increased poststent residual pressure gradient increased the likelihood of encountering instent restenosis at intermediate follow-up. CONCLUSIONS: Abnormalities were observed at intermediate follow-up following IS placement for treatment of native and recurrent coarctation of the aorta. Not exceeding a balloon:coarctation ratio of 3.5 and avoidance of prestent angioplasty decreased the likelihood of encountering an abnormal follow-up imaging study in patients undergoing intravascular stent placement for the treatment of coarctation of the aorta. We recommend IAI for all patients undergoing IS placement for treatment of CoA.

Procedural results and acute complications in stenting native and recurrent coarctation of the aorta in patients over 4 years of age: a multi-institutional study.

BACKGROUND: We report a multi-institutional experience with intravascular stenting (IS) for treatment of coarctation of the aorta. METHODS AND RESULTS: Data was collected retrospectively by review of medical records from 17 institutions. The data was broken down to prior to 2002 and after 2002 for further analysis. A total of 565 procedures were performed with a median age of 15 years (mean=18.1 years). Successful reduction in the post stent gradient (<20 mm Hg) or increase in post stent coarctation to descending aorta (DAo) ratio of >0.8 was achieved in 97.9% of procedures. There was significant improvement (P<0.01) in pre versus post stent coarctation dimensions (7.4 mm+/-3.0 mm vs. 14.3+/-3.2 mm), systolic gradient (31.6 mm Hg+/-16.0 mm Hg vs. 2.7 mm Hg+/-4.2 mm Hg) and ratio of the coarctation segment to the DAo (0.43+/-0.17 vs. 0.85+/-0.15). Acute complications were encountered in 81/565 (14.3%) procedures. There were two procedure related deaths. Aortic wall complications included: aneurysm formation (n=6), intimal tears (n=8), and dissections (n=9). The risk of aortic dissection increased significantly in patients over the age of 40 years. Technical complications included stent migration (n=28), and balloon rupture (n=13). Peripheral vascular complications included cerebral vascular accidents (CVA) (n=4), peripheral emboli (n=1), and significant access arterial injury (n=13). Older age was significantly associated with occurrence of CVAs. A significant decrease in the technical complication rate from 16.3% to 6.1% (P<0.001) was observed in procedures performed after January 2002. CONCLUSIONS: Stent placement for coarctation of aorta is an effective treatment option, though it remains a technically challenging procedure. Technical and aortic complications have decreased over the past 3 years due to, in part, improvement in balloon and stent design. Improvement in our ability to assess aortic wall compliance is essential prior to placement of ISs in older patients with coarctation of the aorta.