Midterm stability and hemodynamic performance of a transfemorally implantable nonmetallic, retrievable, and repositionable aortic valve in patients with severe aortic stenosis: Up to 2-year follow-up of the direct-flow medical valve: A pilot study

Klaudija Bijuklic, Thilo Tuebler, Hermann Reichenspurner, Hendrik Treede, Andreas Wandler, John H. Harreld, Reginald Low, Joachim Schofer

Research output: Contribution to journalArticle

27 Citations (Scopus)

Abstract

Background-Misplacement during percutaneous aortic valve implantation can be associated with severe complications. The direct flow medical (DFM) valve is repositionable and retrievable; however, the nonmetallic inflatable and conformable design of the valve results in less radial force, which may have an impact on stability and valve function over time. We, therefore, analyzed the midterm stability of the position, shape, and hemodynamic performance of the DFM percutaneous aortic valve. Methods and Results-Sixteen symptomatic high-risk for surgery patients with aortic stenosis and a logistic EuroSCORE >20 underwent implantation and were the subject of this analysis. Clinical, echocardiographic, and dual-source multislice computed tomography data were obtained during 2-year follow-up. The 1- and 2-year survival rates were 81% and 69%, respectively. The dual-source multislice computed tomography follow-up indicated no changes in position, diameter, and orifice area of the DFM valve over time. Echocardiography revealed a significant decrease of the mean gradient from baseline (50.1±11.3 mm Hg) to 30 days (19.6±5.7 mm Hg, P<0.001), which remained stable over 2 years. The aortic valve area increased from 0.57±0.15 cm 2 at baseline to 1.47±0.35 cm 2 at 30 days (P<0.001) and did not significantly change during 2-year follow-up. Of the patients, 73% had no aortic regurgitation (AR) and 27% had minimal AR. Conclusions-In this preliminary series, the 2-year follow-up data of patients, in whom the nonmetallic, repositionable, and retrievable DFM valve was successfully implanted, show stability of the position, shape, and hemodynamic performance, with no AR in most patients.

Original languageEnglish (US)
Pages (from-to)595-601
Number of pages7
JournalCirculation: Cardiovascular Interventions
Volume4
Issue number6
DOIs
StatePublished - Dec 2011

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Aortic Valve Stenosis
Aortic Valve
Aortic Valve Insufficiency
Hemodynamics
Multidetector Computed Tomography
Echocardiography
Survival Rate

Keywords

  • Aortic stenosis
  • Percutaneous aortic valve implantation
  • Retrievable aortic valve prosthesis

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Midterm stability and hemodynamic performance of a transfemorally implantable nonmetallic, retrievable, and repositionable aortic valve in patients with severe aortic stenosis : Up to 2-year follow-up of the direct-flow medical valve: A pilot study. / Bijuklic, Klaudija; Tuebler, Thilo; Reichenspurner, Hermann; Treede, Hendrik; Wandler, Andreas; Harreld, John H.; Low, Reginald; Schofer, Joachim.

In: Circulation: Cardiovascular Interventions, Vol. 4, No. 6, 12.2011, p. 595-601.

Research output: Contribution to journalArticle

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abstract = "Background-Misplacement during percutaneous aortic valve implantation can be associated with severe complications. The direct flow medical (DFM) valve is repositionable and retrievable; however, the nonmetallic inflatable and conformable design of the valve results in less radial force, which may have an impact on stability and valve function over time. We, therefore, analyzed the midterm stability of the position, shape, and hemodynamic performance of the DFM percutaneous aortic valve. Methods and Results-Sixteen symptomatic high-risk for surgery patients with aortic stenosis and a logistic EuroSCORE >20 underwent implantation and were the subject of this analysis. Clinical, echocardiographic, and dual-source multislice computed tomography data were obtained during 2-year follow-up. The 1- and 2-year survival rates were 81{\%} and 69{\%}, respectively. The dual-source multislice computed tomography follow-up indicated no changes in position, diameter, and orifice area of the DFM valve over time. Echocardiography revealed a significant decrease of the mean gradient from baseline (50.1±11.3 mm Hg) to 30 days (19.6±5.7 mm Hg, P<0.001), which remained stable over 2 years. The aortic valve area increased from 0.57±0.15 cm 2 at baseline to 1.47±0.35 cm 2 at 30 days (P<0.001) and did not significantly change during 2-year follow-up. Of the patients, 73{\%} had no aortic regurgitation (AR) and 27{\%} had minimal AR. Conclusions-In this preliminary series, the 2-year follow-up data of patients, in whom the nonmetallic, repositionable, and retrievable DFM valve was successfully implanted, show stability of the position, shape, and hemodynamic performance, with no AR in most patients.",
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T1 - Midterm stability and hemodynamic performance of a transfemorally implantable nonmetallic, retrievable, and repositionable aortic valve in patients with severe aortic stenosis

T2 - Up to 2-year follow-up of the direct-flow medical valve: A pilot study

AU - Bijuklic, Klaudija

AU - Tuebler, Thilo

AU - Reichenspurner, Hermann

AU - Treede, Hendrik

AU - Wandler, Andreas

AU - Harreld, John H.

AU - Low, Reginald

AU - Schofer, Joachim

PY - 2011/12

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AB - Background-Misplacement during percutaneous aortic valve implantation can be associated with severe complications. The direct flow medical (DFM) valve is repositionable and retrievable; however, the nonmetallic inflatable and conformable design of the valve results in less radial force, which may have an impact on stability and valve function over time. We, therefore, analyzed the midterm stability of the position, shape, and hemodynamic performance of the DFM percutaneous aortic valve. Methods and Results-Sixteen symptomatic high-risk for surgery patients with aortic stenosis and a logistic EuroSCORE >20 underwent implantation and were the subject of this analysis. Clinical, echocardiographic, and dual-source multislice computed tomography data were obtained during 2-year follow-up. The 1- and 2-year survival rates were 81% and 69%, respectively. The dual-source multislice computed tomography follow-up indicated no changes in position, diameter, and orifice area of the DFM valve over time. Echocardiography revealed a significant decrease of the mean gradient from baseline (50.1±11.3 mm Hg) to 30 days (19.6±5.7 mm Hg, P<0.001), which remained stable over 2 years. The aortic valve area increased from 0.57±0.15 cm 2 at baseline to 1.47±0.35 cm 2 at 30 days (P<0.001) and did not significantly change during 2-year follow-up. Of the patients, 73% had no aortic regurgitation (AR) and 27% had minimal AR. Conclusions-In this preliminary series, the 2-year follow-up data of patients, in whom the nonmetallic, repositionable, and retrievable DFM valve was successfully implanted, show stability of the position, shape, and hemodynamic performance, with no AR in most patients.

KW - Aortic stenosis

KW - Percutaneous aortic valve implantation

KW - Retrievable aortic valve prosthesis

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