Performance Of Transcatheter Heart Valve Research Articles

Comparative study of mechanical and transcatheter heart valves for aortic valve replacement

Heart valve diseases required prompt treatments, including medication and replacement. As for aortic valve replacement, the transcatheter heart valve (THV) was recently introduced to substitute the conventional mechanical heart valve (MHV), as the former possess lower surgical risks. However, there lies concerns on the performance of THV, upon being compared to MHV.

Haemodynamic analysis on the performance of transcatheter heart valve

Transcatheter aortic valve replacement (TAVR) is a viable alternative to its surgical counterpart, as TAVR is a minimal invasive catheter-based procedure without the need of open-heart chest incision. Nonetheless, the effectiveness and potential complications of transcatheter heart valve (THV) necessitated further study, particularly on the concerns of stenosis and thrombosis formations.

Long term follow up of elderly patients treated with self-expanding transcatheter aortic valve implantation; a single center experience

Abstract Background and aims The information of long term clinical performance of transcatheter heart valves is limited. Our aim is to assess the clinical outcomes and rate of structural valve deterioration (SVD) in patients after self-expanding transcatheter aortic valve implantation (TAVI) at 10-year follow-up. Methods A total of 141 consecutive patients undergoing self-expanding TAVI for native aortic valve stenosis or failed aortic surgical bioprosthesis, between 2008 and 2012 at our institution were included. We considered SVD as defined for the consensus statement from the European Association of Percutaneous Cardiovascular Interventions (European Society of Cardiology/European Association for Cardio-Thoracic Surgery). SVD cumulative incidence was calculated considering death in the absence of valve damage as a competitive risk. Results At the time of TAVI mean age was 78±5 years, male 44%. Percutaneous prosthesis implanted were self-expanding in 100% of patients (size: 26 mm in 72%, 29 mm in 28%). Mortality at 1, 5, and 10-year follow-up was 14%, 32%, and 72%, respectively. There was one death due to prosthetic valve endocarditis. Of the total cohort, 11 patients had severe SVD, with a cumulative incidence at 10 years of 8,21 (95% CI 4.09- 14.14%). The rate of SVD at 4, 6, 8, and 10 years was 0%, 1.41%, 2.83%, and 8.21%, respectively (Figure 1 and 2). Of the 11 patients with severe SVD, seven died, two patients had reintervention (both had redo TAVI), and the other two patients remain in close follow-up. In survivors at 10-year follow-up (n=41) the median of mean gradient was 8 mmHg (interquartile Rank 6–13 mmHg) and in 8.4% an prosthetic valve regurgitation ≥moderate was detected. Diabetes, chronic obstructive pulmonary disease, chronic kidney disease, previous stroke and high pulmonary systolic pressure were independent predictors of global mortality. SVD was not associated with any of studied variables (Age, arterial hypertension, obesity, chronic kidney disease, atrial fibrillation, previous aortic bioprosthesis, left ventricle function <50%, prosthetic valve regurgitation, valve size and ballon postdilatation) Conclusions A low rate of SVD at 10-year follow-up was observed in this serie of elderly patients with severe aortic stenosis treated with self-expanding TAVI. This study provides insights into the long-term performance of self-expanding TAVI. Funding Acknowledgement Type of funding sources: None. Cumulative incidence of SVD and deathSVD with confidence intervals

Ten year follow-up of high-risk patients treated during the early experience with transcatheter aortic valve replacement.

The long-term clinical performance of transcatheter heart valves (THV) is unknown. This study assessed the clinical outcomes, rate of structural valve deterioration (SVD) and bioprosthetic valve failure in patients after transcatheter aortic valve replacement (TAVR) to 10-year follow-up. Consecutive patients undergoing TAVI for native aortic valve stenosis or failed aortic surgical bioprosthesis, between 2005 and 2009 at our institution were included. A total of 235 consecutive patients. At the time of TAVI mean age was 82.4 ± 7.9 years. All patients were judged to be high risk, with a STS score > 8 in 53.6%. THVs implanted were the Cribier-Edwards (20.9%), Edwards SAPIEN (77.4%) or CoreValve (1.7%). Mortality at 1, 5, and 10-year follow-up was 23.4%, 63%, and 91.6%, respectively. Of the total cohort, 15 patients had structural valve deterioration/bioprosthetic valve failure, with a cumulative incidence at 10-years of 6.5% (95% CI 3.3%, 9.6%). The rate of SVD/BVF at 4, 6, 8, and 10 years was 0.4%, 1.7%, 4.7%, and 6.5%, respectively. Nine patients had moderate SVD and six patients had severe SVD. Of the six patients with severe SVD, two patients had reintervention (one patient had redo TAVR, and the second had surgical aortic valve replacement). Survivors (n = 19) at 10-year follow-up, had a mean gradient of 14.0 ± 7.6 mmHg and aortic regurgitation ≥moderate in 5%. Quality of life measures in 10-year survivors demonstrated ADLs 6/6 in 43.8%, and ambulation without a mobility aid of 62.5%. Using early generation balloon expandable THVs in a high-risk population, there was a low rate of structural valve deterioration and valve failure at 10-year follow-up. This study provides insights into the long-term performance of transcatheter heart valves and patients self-reported derived benefits.

Evaluación multimodal de la degeneración estructural de válvulas percutáneas en el seguimiento a largo plazo

Introduction and objectivesWe assessed the long-term hemodynamic performance of transcatheter heart valve (THV) by paired transthoracic echocardiography (TTE), and the incidence, characteristics and factors associated with THV structural valve degeneration (SVD). MethodsA total of 212 patients who underwent transcatheter aortic valve replacement and had a potential follow-up >5 years with at least 1 TTE ≥ 1-year postprocedure were included. All patients had a TTE at 1 to 5 years and 36 had another one at 6 to 10 years. SVD was defined as subclinical (increase >10mmHg in mean transvalvular gradient+decrease >0.3cm2 in valve area and/or new-onset mild or moderate aortic regurgitation) and clinically relevant (increase> 20mmHg in mean transvalvular gradient+decrease> 0.6cm2 in valve area and/or new-onset moderate-to-severe aortic regurgitation). Fifteen patients had a transesophageal echocardiography at the time of SVD diagnosis, and 85 an opportunistic computed tomography examination at 1 (0.5-2) years. ResultsTransvalvular mean gradient increased and valve area decreased over time (P<.01). At 8 years of follow-up, SVD occurred in 30.2% of patients (clinically relevant: 9.3%). Transesophageal echocardiography revealed thickened and reduced-mobility leaflets in 80% and 73% of SVD cases, respectively. No baseline or procedural factors were associated with SVD. THV underexpansion (3.5%) or eccentricity (8.2%) had no impact on valve hemodynamics/SVD at follow-up. ConclusionsA gradual THV hemodynamic deterioration occurred throughout a 10-year period, leading to SVD in ∼30% of patients (clinically relevant in < 10%). Leaflet morphology/mobility were frequently impaired in SVD cases, but THV geometry did not influence valve hemodynamics or SVD.

Multimodality evaluation of transcatheter structural valve degeneration at long-term follow-up

Introduction and objectivesWe assessed the long-term hemodynamic performance of transcatheter heart valve (THV) by paired transthoracic echocardiography (TTE), and the incidence, characteristics and factors associated with THV structural valve degeneration (SVD). MethodsA total of 212 patients who underwent transcatheter aortic valve replacement and had a potential follow-up >5 years with at least 1 TTE ≥ 1-year postprocedure were included. All patients had a TTE at 1 to 5 years and 36 had another one at 6 to 10 years. SVD was defined as subclinical (increase >10mmHg in mean transvalvular gradient+decrease >0.3cm2 in valve area and/or new-onset mild or moderate aortic regurgitation) and clinically relevant (increase> 20mmHg in mean transvalvular gradient+decrease> 0.6cm2 in valve area and/or new-onset moderate-to-severe aortic regurgitation). Fifteen patients had a transesophageal echocardiography at the time of SVD diagnosis, and 85 an opportunistic computed tomography examination at 1 (0.5-2) years. ResultsTransvalvular mean gradient increased and valve area decreased over time (P<.01). At 8 years of follow-up, SVD occurred in 30.2% of patients (clinically relevant: 9.3%). Transesophageal echocardiography revealed thickened and reduced-mobility leaflets in 80% and 73% of SVD cases, respectively. No baseline or procedural factors were associated with SVD. THV underexpansion (3.5%) or eccentricity (8.2%) had no impact on valve hemodynamics/SVD at follow-up. ConclusionsA gradual THV hemodynamic deterioration occurred throughout a 10-year period, leading to SVD in ∼30% of patients (clinically relevant in < 10%). Leaflet morphology/mobility were frequently impaired in SVD cases, but THV geometry did not influence valve hemodynamics or SVD.

Long-Term Outcomes of High-Risk or Inoperable Patients Who Underwent Transcatheter Aortic Valve Implantation

Few studies have evaluated transcatheter aortic valve implantation (TAVI) beyond 5 years. We investigated long-term outcomes (≥5 years) and transcatheter heart valve (THV) performance in patients who had undergone TAVI at least 5 years previously, based on annual follow-up. We reviewed 114 consecutive patients who were of high surgical risk or inoperable and underwent TAVI for severe aortic stenosis from October 2009 to November 2013. There was no lost to follow-up, and median time to death or latest follow-up was 5.0 years (range: 0.1 to 8.5). Structural valve degeneration (SVD) was defined on transthoracic echocardiography (TTE) as follows: (1) mean pressure gradient ≥20 mm Hg with a >10 mm Hg increase from the post-TAVI baseline, and/or (2) moderate or severe transvalvular regurgitation. The mean patient age was 82.7 ± 6.4 years, and 37.7% of patients were men. Median Society of Thoracic Surgeons score was 7.6% (interquartile range 5.8 to 10.9). TTE ≥5 years was 76.1% complete (51 of 67 patients who survived ≥5 years postoperatively). The estimated cumulative survival rates at 1, 3, 5, and 7 years were 88.6%, 72.8%, 58.8%, and 45.3%, respectively. Albumin <3.5 g/dl was strongly associated with increased long-term mortality on multivariate analysis. Longitudinal TTE confirmed durable performance of THV up to 7 years in the majority of patients; however, 6 patients (5.3% of the total cohort) experienced SVD during the follow-up. In conclusion, this study demonstrated favorable long-term survival and stable THV performance after TAVI, although SVD was not rare.

Comparison of Hemodynamic Performance of Transcatheter Heart Valves with Supra-annular or Intra-annular Position for Transcatheter Aortic Valve-in-valve Implantation in Failed Bioprostheses

Comparison of Hemodynamic Performance of Transcatheter Heart Valves with Supra-annular or Intra-annular Position for Transcatheter Aortic Valve-in-valve Implantation in Failed Bioprostheses

Hydrodynamic Performance of the Medtronic CoreValve and the Edwards SAPIEN XT Transcatheter Heart Valve in Surgical Bioprostheses: An In Vitro Valve-in-Valve Model

Valve-in-valve transcatheter aortic valve replacement (TAVR) is becoming a valuable option with promising clinical results in failed bioprosthetic heart valves. Sizing recommendations are based on size compatibility rather than on broad clinical data, in vitro measurements, or biomechanical evidence. The hemodynamic performance of transcatheter heart valves within degenerated surgical heart valves is unknown. We evaluated the in vitro hydrodynamic performance of two commercially available transcatheter heart valves (Medtronic CoreValve [Medtronic, Minneapolis, MN] and Edwards SAPIEN XT [Edwards Lifesciences, Irvine, CA]) in two different bioprosthetic aortic valves (Edwards Perimount [Edwards Lifesciences] and St. Jude Trifecta [St. Jude Medical, St. Paul, MN]). Within the Edwards Perimount (23 mm) prosthesis, pressure gradients were higher for the SAPIEN XT compared with the CoreValve (11.2 ± 0.1 mm Hg versus 10.1 ± 0.1 mm Hg, p < 0.01), whereas effective orifice area (1.99 ± 0.01 cm(2) versus 1.80 ± 0.01 cm(2), p < 0.01) and total paravalvular leakage (9.0% ± 1.0% versus 5.4% ± 1.3%, p < 0.01) were increased when using the CoreValve. Similarly, measurements in the St. Jude Trifecta revealed higher transvalvular pressure gradients (13.0 ± 0.2 mm Hg versus 10.9 ± 0.3 mm Hg, p < 0.01) and lower effective orifice area for the SAPIEN XT compared with the CoreValve. However, total relative regurgitation was higher with SAPIEN XT as compared with the CoreValve in St. Jude Trifecta prostheses (11.2% ± 1.4% versus 8.3% ± 0.9%, p < 0.01). Both transcatheter heart valve prostheses performed well in the described valve-in-valve settings. Hydrodynamic results were in line with the International Organization for Standardization standards for all configurations. The observed differences indicate a necessity for preclinical valve-in-valve tests in addition to clinical long-term data about longevity.

Effect of Aortic Annulus Size and Prosthesis Oversizing on the Hemodynamics and Leaflet Bending Stress of Transcatheter Valves: An In Vitro Study

BackgroundThere are few data about the patient- and prosthesis-related factors influencing the hemodynamics of transcatheter heart valves (THVs). The objective of this in vitro study was to assess the effect of aortic annulus size and prosthesis oversizing on the valve hemodynamics and estimated leaflet bending stress of the Edwards SAPIEN balloon-expandable THV (Edwards Lifesciences, Irvine, CA). MethodsThe effective orifice area (EOA) of the 23-mm and 26-mm SAPIEN THVs were measured by Doppler echocardiography in a pulse duplicator under the following experimental conditions: (1) stroke volume of 20, 30, 50, 70, and 80 mL and (2) aortic annulus size of 19, 20, 21, and 22 mm for the 23-mm SAPIEN and 22, 23, and 24, and 25 mm for the 26-mm SAPIEN. The percentage of valve oversizing was calculated as follows: % OS = 100 × [(prosthesis nominal area − aortic annulus area)/aortic annulus area], where % OS is the percentage of oversizing. The leaflet bending stress was measured by high-speed camera imaging of the THV leaflet opening. ResultsThe 2 independent determinants of valve EOA were the aortic annulus diameter (R2 = 0.33; P < 0.001) and the stroke volume (R2 = 0.63; P < 0.001). The prosthesis size and % OS were not independently related to EOA. However, a larger % OS was independently associated with higher peak systolic leaflet bending stress (ΔR2 = 0.11; P < 0.0001). ConclusionsThe hemodynamic performance of THV is in large part determined by the aortic annulus diameter in which the valve is deployed. Oversizing (up to 20% in area) has no significant effect on valve EOA but is associated with higher leaflet bending stress, which might promote faster structural valve degeneration in the long term.