CHD Interventions Featured Articles of July 2015

1. Medium-term CT evaluation of stent geometry, integrity, and valve function of the Edwards SAPIEN transcatheter heart valve in the pulmonary position.

Muller B, Ghawi H, Heitschmidt MG, Fogg L, Hibbeln J, Hijazi ZM, Kenny D.

Catheter Cardiovasc Interv. 2015 Jul 8. doi: 10.1002/ccd.26074. [Epub ahead of print]

PMID: 26152363

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Select item 26244967

bouddjemlineMehul Patel photoComment from Pr. Younes Boudjemline (Paris) and co-editor Dr. Mehul Patel (Grand Rapids MI), editors of congenital heart disease interventions Journal Watch: In the ongoing quest to study predictors of percutaneous pulmonary valve function, Muller et al from the Rush Center for Congenital and Structural Heart Disease serially studied 20 patients with Edward SAPIEN valve implanted in the pulmonary position. These patients were enrolled in the COMPASSION (Congenital Multi- center trial of Pulmonic vAlve regurgitation Studying the SAPIEN InterventIONal THV) feasibility trial and all valve measurements done using MDCT geometric data.  Multislice computed tomography (MSCT) is gaining interest in this field because it is superior to CMR in demonstrating detailed 3 dimensional RVOT anatomy with or without any kind of percutaneous or surgical valve. CMR usually cause image distortion secondary to radiofrequency shielding used for metal stents. Prosthesis eccentricity indices, circularity ratios, and expansion ratios (ER) were calculated.

Eccentricity index (EI) was measured using two perpendicular diameters of the prosthetic valve: the minimum external diameter and the maximum external diameter, and then the eccentricity index was calculated as (1 – minimum external diameter/maximum external diameter). A circular deployment was defined as an eccentricity index < 0.1.

Circularity ratio (CR) was calculated as the minimum valve diameter divided by the maximum valve diameter.

Expansion ratio (ER) was calculated by dividing the measured external area on MDCT by known valve areas (4.15 cm2 for the 23 mm valve and 5.31 cm2 for the 26 mm valve) with under expansion defined as ER < 90%.

Although SAPIEN valve symmetry is relatively robust with no stent fractures unlike that noted in Melody valve, under-expansion and lower measured valve area by geometrical CT scan THV measurements were strongly associated with the need for reintervention.  It is not possible to extend these findings to Melody valve because manufacturing process and valve origin is different. SAPIEN valve is made of 3 thick pericardium leaflets of equal size in contrast to the thin natural leaflets of bovine jugular vein as in Melody valve that have been shown to work in various configurations and diameters. The RVOT and its neighboring anatomy is also very important. Fig 1 panel B. shows an unexpanded bare metal stent that could have an impact on reintervention and valve function.

Take Home points:

  1. No stent fractures reported with SAPIEN valve in the COMPASSION trial.
  2. MDCT is useful in predicting future SAPIEN valve function in the pulmonary position.
  3. It was expansion ratio and not eccentricity index or circularity ratio that predicted reintervention. Perhaps a single MDCT immediately after implantation and not multiple may be useful due to the predictive valve as illustrated in this excellent study.
  4. It is important to optimize the SAPIEN valve shape at the time of implantation using multiple especially caudal angulated views.

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Suggested reading:

1. Geometrical and stress analysis of factors associated with stent fracture after melody percutaneous pulmonary valve implantation. Cosentino D, Quail MA, Pennati G, Capelli C, Bonhoeffer P, Díaz-Zuccarini V, Taylor AM, Schievano S. Circ Cardiovasc Interv. 2014 Aug;7(4):510-7. doi: 10.1161/CIRCINTERVENTIONS.113.000631. Epub 2014 Aug 5. PMID: 25097201

2.Evaluation of multislice computed tomography early after transcatheter aortic valve implantation with the Edwards SAPIEN bioprosthesis. Caudron J, Fares J, Hauville C, Cribier A, Dacher JN, Tron C, Bauer F, Litzler PY, Bessou JP, Eltchaninoff H. Am J Cardiol. 2011 Sep 15;108(6):873-81. doi: 10.1016/j.amjcard.2011.05.014. Epub 2011 Jul 7. PMID: 21741025


2. Transcoronary infusion of cardiac progenitor cells in hypoplastic left heart syndrome: Three-year follow-up of the Transcoronary Infusion of Cardiac Progenitor Cells in Patients With Single-Ventricle Physiology (TICAP) trial.

Tarui S, Ishigami S, Ousaka D, Kasahara S, Ohtsuki S, Sano S, Oh H.

J Thorac Cardiovasc Surg. 2015 Jul 8. pii: S0022-5223(15)01201-5. doi: 10.1016/j.jtcvs.2015.06.076. [Epub ahead of print]

PMID: 26232942

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Select item 26139057

Comment from Pr. Younes Boudjemline (Paris) and co-editor Dr. Mehul Patel (Grand Rapids MI), editors of congenital heart disease interventions Journal Watch: Professor Sano and his group studied the midterm safety and clinical outcomes of intra- coronary infusion of cardiosphere-derived cells (CDCs) after staged palliation in 14 patients with hypoplastic left heart syndrome (HLHS) who were undergoing 2- or 3-stage surgical palliations. Intracoronary CDC infusion was given 1 month after cardiac surgery in 7 patients and the remaining 7 patients allocated to a control group received standard care alone. The primary end point was to assess procedural feasibility and safety; the secondary end point was to evaluate cardiac function and heart failure status through 36-month follow-up.

There were no complications, including tumor formation, were reported within 36 months after CDC infusion. The study group showed significantly greater improvement in right ventricular ejection fraction (RVEF), reduced brain natriuretic peptide levels, lower incidence of unplanned catheter interventions and higher weight-for-age z score at 36 months relative to controls. As independent predictors of treatment responsiveness, absolute changes in RVEF at 36 months were negatively correlated with age, weight-for-age z score, and RVEF at CDC infusion.

Take home points:

  1. CDC infusion for HLHS is safe till 36 months after intracoronary infusion.
  2. CDC infusion resulted in significantly greater improvement in right ventricular ejection fraction (RVEF), reduced brain natriuretic peptide levels, lower incidence of unplanned catheter interventions and higher weight-for-age z score at 36 months relative to controls.
  3. Interestingly there was reduced right ventricular stiffness and improved diastology as well, which may need further investigation.
  4. This therapeutic strategy may enhance somatic growth and reduce incidence of heart failure.
  5. It remains to be seen if such results may be reproduced in a geographically diverse patient population before it could be generalized.

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Suggested reading:

1. Intracoronary autologous cardiac progenitor cell transfer in patients with hypoplastic left heart syndrome: the TICAP prospective phase 1 controlled trial. Ishigami S, Ohtsuki S, Tarui S, Ousaka D, Eitoku T, Kondo M, Okuyama M, Kobayashi J, Baba K, Arai S, Kawabata T, Yoshizumi K, Tateishi A, Kuroko Y, Iwasaki T, Sato S, Kasahara S, Sano S, Oh H. Circ Res. 2015 Feb 13;116(4):653-64. doi: 10.1161/CIRCRESAHA.116.304671. Epub 2014 Nov 17.

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3. Next generation covered stents made from nanocomposite materials: A complete assessment of uniformity, integrity and biomechanical properties.

Farhatnia Y, Pang JH, Darbyshire A, Dee R, Tan A, Seifalian AM.

Nanomedicine. 2015 Jul 31. pii: S1549-9634(15)00145-8. doi: 10.1016/j.nano.2015.07.002. [Epub ahead of print]

PMID: 26238080

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Select item 26234922

Comment from Pr. Younes Boudjemline (Paris) and co-editor Dr. Mehul Patel (Grand Rapids MI), editors of congenital heart disease interventions Journal Watch: The pursuit to find an ideal covered stent with a low profile design, improved compliance, radial strength, small diameter, increased flexibility with non-thrombogenic properties continues. Farhatnia et al studied a newer material to manufacture and modify covered stents using biocompatible and haemocompatible nanocomposite polymer, polyhedral oligomeric silsesquioxane poly(carbonate-urea) urethane (POSS-PCU). The incorporation of POSS nanoparticles  creates an inherent surface nanotopography of the material. 
 This was devised using a novel combination of ultrasonic spray atomisation system and dip- coating process to produce small calibre covered stents with metal struts fully embedded within the membrane, which also yields greater coating uniformity. Stent-polymer bonding was enhanced via silanisation and coating of reactive pre-polymer. Platelet studies supported the non-thrombogenicity of POSS-PCU. Biomechanical performances including fatigue test, peel test, acute bonding strength, diametrical compliance, bending strength, radial strength and recoil were evaluated and optimized.

Take home points:

  1. Patented POSS-PCU material could be the next generation ideal material to manufacture covered stents and this needs to be investigated in preclinical trials.
  1. A general trend whereby a thicker 
membrane confers a larger radial strength, at the expense of 
compliance was noted. However, a 20 μm-covered stent exhibited the ideal 
balance between radial strength and compliance.

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