Publications by authors named "Gry Dahle"

34 Publications

2-Year Outcomes of Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation.

J Am Coll Cardiol 2021 11;78(19):1847-1859

West Virginia University Heart and Vascular Institute, Morgantown, West Virginia, USA.

Background: Transcatheter mitral valve replacement (TMVR) is feasible for selected patients with severe mitral regurgitation (MR) who are poor candidates for valve surgery. Intermediate-term to long-term TMVR outcomes have not been reported.

Objectives: This study sought to evaluate the safety and effectiveness through 2-year follow-up of TMVR in high-surgical-risk patients with severe MR.

Methods: The first 100 patients enrolled in the Expanded Clinical Study of the Tendyne Mitral Valve System, an open-label, nonrandomized, prospective study of transapical TMVR, were followed for 2 years.

Results: The patients (aged 74.7 ± 8.0 years, 69.0% male) had symptomatic (66.0% New York Heart Association [NYHA] functional class III or IV) grade 3+ or 4+ MR that was secondary or mixed in 89 (89.0%). Prostheses were successfully implanted in 97 (97.0%) patients. At 2 years, all-cause mortality was 39.0%; 17 (43.6%) of 39 deaths occurred during the first 90 days. Heart failure hospitalization (HFH) fell from 1.30 events per year preprocedure to 0.51 per year in the 2 years post-TMVR (P < 0.0001). At 2 years, 93.2% of surviving patients had no MR. No patient had >1+ MR. The improvement in symptoms at 1 year (88.5% NYHA functional class I or II) was sustained to 2 years (81.6% NYHA functional class I or II). Among survivors, the left ventricular ejection fraction was 45.6 ± 9.4% at baseline and 39.8 ± 9.5% at 2 years (P = 0.0012). Estimated right ventricular systolic pressure decreased from 47.6 ± 8.6 mm Hg to 32.5 ± 10.4 mm Hg (P < 0.005).

Conclusions: In this study, the impact of TMVR on severity of MR, reduction in HFH rate, and improvement in symptoms was sustained through 2 years. All-cause mortality and the need for HFH was highest in the first 3 months postprocedure. (Expanded Clinical Study of the Tendyne Mitral Valve System; NCT02321514).
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http://dx.doi.org/10.1016/j.jacc.2021.08.060DOI Listing
November 2021

Fifty Years After the Introduction of Vein Grafts for CABG: New Evidence for a No-Touch Harvesting Approach.

Circulation 2021 10 4;144(14):1130-1132. Epub 2021 Oct 4.

Klinik für Herz-,Thorax- und Gefässchirurgie, Deutsches Herzzentrum Berlin, Germany (J.K.).

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http://dx.doi.org/10.1161/CIRCULATIONAHA.121.056610DOI Listing
October 2021

Risk scores for prediction of 30-day mortality after transcatheter aortic valve implantation: Results from a two-center study in Norway.

Health Sci Rep 2021 Jun 6;4(2):e283. Epub 2021 May 6.

Department of Cardiology University Hospital of North Norway Tromsø Norway.

Objectives: Transcatheter aortic valve implantation (TAVI)-specific risk scores have been developed based on large registry studies. Our aim was to evaluate how both surgical and novel TAVI risk scores performed in predicting all cause 30-day mortality. In addition, we wanted to explore the validity of our own previously developed model in a separate and more recent cohort.

Methods: The derivation cohort included patients not eligible for open surgery treated with TAVI at the University Hospital of North Norway (UNN) and Oslo University Hospital (OUS) from February 2010 through June 2013. From this cohort, a logistic prediction model (UNN/OUS) for all cause 30-day mortality was developed. The validation cohort consisted of patients not included in the derivation cohort and treated with TAVI at UNN between June 2010 and April 2017. EuroSCORE, Logistic EuroSCORE, EurosSCORE 2, STS score, German AV score, OBSERVANT score, IRRMA score, and FRANCE-2 score were calculated for both cohorts. The discriminative accuracy of each score, including our model, was evaluated by receiver operating characteristic (ROC) analysis and compared using DeLong test where < .05 was considered statistically significant.

Results: The derivation cohort consisted of 218 and the validation cohort of 241 patients. Our model showed statistically significant better accuracy than all other scores in the derivation cohort. In the validation cohort, the FRANCE-2 had a significantly higher predictive accuracy compared to all scores except the IRRMA and STS score. Our model showed similar results.

Conclusion: Existing risk scores have shown limited accuracy in predicting early mortality after TAVI. Our results indicate that TAVI-specific risk scores might be useful when evaluating patients for TAVI.
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http://dx.doi.org/10.1002/hsr2.283DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8102057PMC
June 2021

Computed Tomography-Derived 3D Modeling to Guide Sizing and Planning of Transcatheter Mitral Valve Interventions.

JACC Cardiovasc Imaging 2021 08 17;14(8):1644-1658. Epub 2021 Mar 17.

Department of Interventional Cardiology, Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands. Electronic address:

A plethora of catheter-based strategies have been developed to treat mitral valve disease. Evolving 3-dimensional (3D) multidetector computed tomography (MDCT) technology can accurately reconstruct the mitral valve by means of 3-dimensional computational modeling (3DCM) to allow virtual implantation of catheter-based devices. 3D printing complements computational modeling and offers implanting physician teams the opportunity to evaluate devices in life-size replicas of patient-specific cardiac anatomy. MDCT-derived 3D computational and 3D-printed modeling provides unprecedented insights to facilitate hands-on procedural planning, device training, and retrospective procedural evaluation. This overview summarizes current concepts and provides insight into the application of MDCT-derived 3DCM and 3D printing for the planning of transcatheter mitral valve replacement and closure of paravalvular leaks. Additionally, future directions in the development of 3DCM will be discussed.
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http://dx.doi.org/10.1016/j.jcmg.2020.12.034DOI Listing
August 2021

Current Devices in TMVI and Their Limitations: Focus on Tendyne.

Authors:
Gry Dahle

Front Cardiovasc Med 2020 23;7:592909. Epub 2020 Dec 23.

Oslo University Hospital, Oslo, Norway.

Mitral valve regurgitation (MR) has a high incidence in the western world, and mortality is high for untreated severe MR. Catheter based repair was introduced with MitraClip in 2003, and some additional devices later came into the market. To expand the transcatheter treatment options for mitral valve disease, the first transcatheter mitral valve implantation (TMVI) was performed by Søndergaard et al. 2012, only 10 years after the first transcatheter aortic valve implantation (TAVI), however, the development has been much slower for the TMVI than for TAVI. From 2012, studies were started for several devices to prove feasibility and safety. However, there were big challenges in valve design; delivery systems and anchoring in addition to anatomical issues (avoid LVOT obstruction and paravalvular leak, big size of annulus). The main valves in studies were CardiaQ (later bought by Edwards Lifesciences, Irvine, United States), Tiara (Neovasc Inc., Richmond, Canada), Twelve (later Intrepid, Medtronic, MN, United States) and Tendyne™ (Abbott, MN, United States). I will focus on the Tendyne™ valve that is the only CE approved transcatheter mitral valve implant. It is available in a large number of sizes and is repositionable and retrievable. The results for the 100 first patients included in the early feasibility study (EFS) at 1 and 2 years are promising. Initially feasible for MR, but further investigations show promising results also for implant in mitral annular calcification.
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http://dx.doi.org/10.3389/fcvm.2020.592909DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7793646PMC
December 2020

Improved right ventricular function following transapical transcatheter mitral valve implantation for severe mitral regurgitation.

Int J Cardiol Heart Vasc 2021 Feb 16;32:100687. Epub 2020 Dec 16.

Department of Cardiology, St Vincent's Hospital, Sydney, Australia.

Background: Transapical transcatheter mitral valve implantation (TMVI) may be a therapeutic option for patients with severe mitral regurgitation (MR) excluded from cardiac surgery due to excessive risk. Exclusion criteria frequently include pulmonary hypertension and right ventricular (RV) dysfunction. The effect of TMVI on RV function has not previously been well-characterized. The aim of this study was to examine the procedural and 3-month impact of TMVI on RV hemodynamics and function.

Methods: This was a multi-center, retrospective, observational cohort study of patients with >3+MR undergoing TMVI. Pre- and post-TMVI hemodynamics were assessed with right heart catheterization. RV function was assessed at baseline, pre-discharge and at 3-months by echocardiography.

Results: Forty-six patients (age 72±9 years; 34 men) with ≥3+MR underwent TMVI over a 5-year period. Successful device implantation was achieved in all patients with abolition of MR (p < 0.001) and reduction in left-ventricular end-diastolic volume (p = 0.001). RV stroke work index (RVSWI) increased intra-operatively (7 ± 4 g/m/beat/m vs 11 ± 5 g/m/beat/m; p < 0.001). At 3-months there were reductions in severity of tricuspid regurgitation (TR) (p < 0.001) and pulmonary artery systolic pressure (PASP) (49 ± 16 mmHg vs 36 ± 12 mmHg; p < 0.001), and improvements in RV fractional area change (28 ± 7% vs 34 ± 9%, p<0.001), tricuspid annular plane systolic excursion (TAPSE) (1.0 ± 0.3 vs 1.5 ± 0.5cm, p = 0.03), and RV free wall longitudinal strain (-14.2±5.0 vs -17.6±7.3, p = 0.05).

Conclusions: Transapical TMVI results in significant improvement of RV function that is sustained to 3-months as evidenced by improvements in RVSWI and RV fractional area change, as well as reductions in PASP and TR severity.
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http://dx.doi.org/10.1016/j.ijcha.2020.100687DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7749427PMC
February 2021

Essential information on surgical heart valve characteristics for optimal valve prosthesis selection: Expert consensus document from the European Association for Cardio-Thoracic Surgery (EACTS)-The Society of Thoracic Surgeons (STS)-American Association for Thoracic Surgery (AATS) Valve Labelling Task Force.

J Thorac Cardiovasc Surg 2021 02 15;161(2):545-558. Epub 2020 Oct 15.

Heart Surgery Division, European Hospital, Rome, Italy. Electronic address:

Comprehensive information on the characteristics of surgical heart valves (SHVs) is essential for optimal valve selection. Such information is also important in assessing SHV function after valve replacement. Despite the existing regulatory framework for SHV sizing and labelling, this information is challenging to obtain in a uniform manner for various SHVs. To ensure that clinicians are adequately informed, the European Association for Cardio-Thoracic Surgery (EACTS), The Society of Thoracic Surgeons (STS) and American Association for Thoracic Surgery (AATS) set up a Task Force comprised of cardiac surgeons, cardiologists, engineers, regulatory bodies, representatives of the International Organization for Standardization and major valve manufacturers. Previously, the EACTS-STS-AATS Valve Labelling Task Force identified the most important problems around SHV sizing and labelling. This Expert Consensus Document formulates recommendations for providing SHV physical dimensions, intended implant position and hemodynamic performance in a transparent, uniform manner. Furthermore, the Task Force advocates for the introduction and use of a standardized chart to assess the probability of prosthesis-patient mismatch and calls valve manufacturers to provide essential information required for SHV choice on standardized Valve Charts, uniformly for all SHV models.
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http://dx.doi.org/10.1016/j.jtcvs.2020.10.001DOI Listing
February 2021

Essential Information on Surgical Heart Valve Characteristics for Optimal Valve Prosthesis Selection: Expert Consensus Document From the European Association for Cardio-Thoracic Surgery (EACTS)-The Society of Thoracic Surgeons (STS)-American Association for Thoracic Surgery (AATS) Valve Labelling Task Force.

Ann Thorac Surg 2021 01 6;111(1):314-326. Epub 2020 Oct 6.

Heart Surgery Division, European Hospital, Rome, Italy. Electronic address:

Comprehensive information on the characteristics of surgical heart valves (SHVs) is essential for optimal valve selection. Such information is also important in assessing SHV function after valve replacement. Despite the existing regulatory framework for SHV sizing and labelling, this information is challenging to obtain in a uniform manner for various SHVs. To ensure that clinicians are adequately informed, the European Association for Cardio-Thoracic Surgery (EACTS), The Society of Thoracic Surgeons (STS) and American Association for Thoracic Surgery (AATS) set up a Task Force comprised of cardiac surgeons, cardiologists, engineers, regulatory bodies, representatives of the International Organization for Standardization and major valve manufacturers. Previously, the EACTS-STS-AATS Valve Labelling Task Force identified the most important problems around SHV sizing and labelling. This Expert Consensus Document formulates recommendations for providing SHV physical dimensions, intended implant position and hemodynamic performance in a transparent, uniform manner. Furthermore, the Task Force advocates for the introduction and use of a standardized chart to assess the probability of prosthesis-patient mismatch and calls valve manufacturers to provide essential information required for SHV choice on standardized Valve Charts, uniformly for all SHV models.
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http://dx.doi.org/10.1016/j.athoracsur.2020.05.060DOI Listing
January 2021

Essential information on surgical heart valve characteristics for optimal valve prosthesis selection: expert consensus document from the European Association for Cardio-Thoracic Surgery (EACTS)-The Society of Thoracic Surgeons (STS)-American Association for Thoracic Surgery (AATS) Valve Labelling Task Force.

Eur J Cardiothorac Surg 2021 01;59(1):54-64

Heart Surgery Division, European Hospital, Rome, Italy.

Comprehensive information on the characteristics of surgical heart valves (SHVs) is essential for optimal valve selection. Such information is also important in assessing SHV function after valve replacement. Despite the existing regulatory framework for SHV sizing and labelling, this information is challenging to obtain in a uniform manner for various SHVs. To ensure that clinicians are adequately informed, the European Association for Cardio-Thoracic Surgery (EACTS), The Society of Thoracic Surgeons (STS) and American Association for Thoracic Surgery (AATS) set up a Task Force comprised of cardiac surgeons, cardiologists, engineers, regulatory bodies, representatives of the International Organization for Standardization and major valve manufacturers. Previously, the EACTS-STS-AATS Valve Labelling Task Force identified the most important problems around SHV sizing and labelling. This Expert Consensus Document formulates recommendations for providing SHV physical dimensions, intended implant position and haemodynamic performance in a transparent, uniform manner. Furthermore, the Task Force advocates for the introduction and use of a standardized chart to assess the probability of prosthesis-patient mismatch and calls valve manufacturers to provide essential information required for SHV choice on standardized Valve Charts, uniformly for all SHV models.
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http://dx.doi.org/10.1093/ejcts/ezaa263DOI Listing
January 2021

Three-dimensional versus two-dimensional transthoracic echocardiography for left ventricular outflow tract measurements in severe aortic stenosis. A cross-sectional study using computer tomography and Haegar sizers as reference.

Scand Cardiovasc J 2020 Aug 15;54(4):220-226. Epub 2020 May 15.

Department of Cardiology, Vestfold Hospital trust, Tonsberg, Norway.

In grading of aortic stenosis, two-dimensional transthoracic echocardiography (2D TTE) routinely results in underestimation of the left ventricular outflow tract (LVOT) area, and hence the aortic valve area (AVA). We investigated whether three-dimensional (3D) TTE measurements of the LVOT would be more accurate. We evaluated the feasibility, agreement and inter-observer variability of 3D TTE LVOT measurements with computed tomography (CT) and Haegar sizers as reference. Sixty-one patients with severe aortic stenosis were examined with 2D and 3D TTE. 41 had CT and 13 also had perioperative Haegar sizing. Pearson's correlation and Bland-Altman plots were used to compare methods. Inter-observer variability was tested for 2D and 3D TTE. Trial registration: Current research information system in Norway (CRISTIN). Id: 555249. Feasibility was 67% with 3D TTE and 100% with 2D TTE and CT. Mean LVOT area for 2D, 3D, CT and Haegar sizers were 3.7 ± 0.6 cm2, 4.0 ± 0.9 cm2, 5.2 ± 0.8 cm2 and 4.4 ± 1.0 cm2 respectively. Bias and limits of agreements for 2D TTE was 1.5 ± 1.3 cm2, compared with CT and 0.4 ± 1.5 cm2 with Haegar sizers. Corresponding results for 3D TTE were 1.2 ± 1.6 cm2 and 0.2 ± 1.8 cm2. Intraclass correlation coefficients for LVOT area were 0.62 for 3D and 0.86 for 2D. 2D TTE showed better feasibility and inter-observer variability in measurements of LVOT than 3D TTE. Both echocardiographic methods underestimated LVOT area compared to CT and Haegar sizers. These observations suggest that 2D TTE is still preferable to 3D TTE in the assessment of aortic stenosis.
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http://dx.doi.org/10.1080/14017431.2020.1761559DOI Listing
August 2020

Predictors of early mortality after transcatheter aortic valve implantation.

Open Heart 2019;6(1):e000936. Epub 2019 Apr 23.

Department of Cardiology, University Hospital of North Norway, Tromsø, Norway.

Objectives: To investigate whether preoperative echocardiographic evaluation of ventricular function, especially right ventricular systolic and diastolic parameters including speckle-tracking analysis, could aid in the prediction of 30-day mortality after transcatheter aortic valve implantation (TAVI) in patients with aortic stenosis.

Methods: This is a prospective observational cohort study including 227 patients accepted for TAVI at the University Hospital of North Norway and Oslo University Hospital from February 2010 through June 2013. All patients underwent preoperative transthoracic echocardiography with retrospective speckle-tracking analysis. Primary endpoint was all-cause 30-day mortality.

Results: All-cause 30-day mortality was 8.7 % (n = 19). Independent predictors of 30-day mortality were systolic pulmonary arterial pressure (SPAP) > 60 mm Hg (HR: 7.7, 95% CI: 1.90 to 31.3), heart failure (HR: 2.9, 95% CI: 1.1 to 7.78), transapical access (HR: 3.8, 95% CI: 1.3 to 11.2), peripheral artery disease (HR: 6.0, 95% CI: 2.0 to 18.0) and body mass index (HR: 0.73, 95% CI: 0.61 to 0.87). C-statistic for the model generated was 0.91 (95% CI: 0.85 to 0.98). Besides elevated SPAP, no other echocardiographic measurements were found to be an independent predictor of early mortality.

Conclusion: Except for elevated systolic pulmonary artery pressure, our data suggests that clinical rather than echocardiographic parameters are useful predictors of 30-day mortality after TAVI.
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http://dx.doi.org/10.1136/openhrt-2018-000936DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6519416PMC
February 2021

Characteristics of surgical prosthetic heart valves and problems around labeling: A document from the European Association for Cardio-Thoracic Surgery (EACTS)-The Society of Thoracic Surgeons (STS)-American Association for Thoracic Surgery (AATS) Valve Labelling Task Force.

J Thorac Cardiovasc Surg 2019 10 10;158(4):1041-1054. Epub 2019 May 10.

Department of Cardiac Surgery, European Hospital, Rome, Italy. Electronic address:

Intraoperative surgical prosthetic heart valve (SHV) choice is a key determinant of successful surgery and positive postoperative outcomes. Currently, many controversies exist around the sizing and labeling of SHVs rendering the comparison of different valves difficult. To explore solutions, an expert Valve Labelling Task Force was jointly initiated by the European Association for Cardio-Thoracic Surgery (EACTS), The Society of Thoracic Surgeons (STS) and the American Association for Thoracic Surgery (AATS). The EACTS-STS-AATS Valve Labelling Task Force, comprising cardiac surgeons, cardiologists, engineers, regulators and representatives from the International Organization for Standardization (ISO), and major valve manufacturers, held its first in-person meeting in February 2018 in Paris, France. This article was derived from the meeting's discussions. The Task Force identified the following areas for improvement and clarification: reporting of physical dimensions and characteristics of SHVs determining and labeling of SHV size, in vivo and in vitro testing, and reporting of SHV hemodynamic performance and thrombogenicity. Furthermore, a thorough understanding of the regulatory background and the role of the applicable ISO standards, together with close cooperation between all stakeholders (including regulatory and standard- setting bodies), is necessary to improve the current situation. Cardiac surgeons should be provided with appropriate information to allow for optimal SHV choice. This first article from the EACTS-STS-AATS Valve Labelling Task Force summarizes the background of SHV sizing and labeling and identifies the most important elements where further standardization is necessary.
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http://dx.doi.org/10.1016/j.jtcvs.2019.04.001DOI Listing
October 2019

Characteristics of Surgical Prosthetic Heart Valves and Problems Around Labelling: A Document From the European Association for Cardio-Thoracic Surgery (EACTS)-The Society of Thoracic Surgeons (STS)-American Association for Thoracic Surgery (AATS) Valve Labelling Task Force.

Ann Thorac Surg 2019 07 10;108(1):292-303. Epub 2019 May 10.

Department of Cardiac Surgery, European Hospital, Rome, Italy. Electronic address:

Intraoperative surgical prosthetic heart valve (SHV) choice is a key determinant of successful surgery and positive postoperative outcomes. Currently, many controversies exist around the sizing and labelling of SHVs rendering the comparison of different valves difficult. To explore solutions, an expert Valve Labelling Task Force was jointly initiated by the European Association for Cardio-Thoracic Surgery (EACTS), The Society of Thoracic Surgeons (STS) and the American Association for Thoracic Surgery (AATS). The EACTS-STS-AATS Valve Labelling Task Force, comprising cardiac surgeons, cardiologists, engineers, regulators and representatives from the International Organization for Standardization (ISO) and major valve manufacturers, held its first in-person meeting in February 2018 in Paris, France. This article was derived from the meeting's discussions. The Task Force identified the following areas for improvement and clarification: reporting of physical dimensions and characteristics of SHVs determining and labelling of SHV size, in vivo and in vitro testing and reporting of SHV hemodynamic performance and thrombogenicity. Furthermore, a thorough understanding of the regulatory background and the role of the applicable ISO standards, together with close cooperation between all stakeholders (including regulatory and standard-setting bodies), is necessary to improve the current situation. Cardiac surgeons should be provided with appropriate information to allow for optimal SHV choice. This first article from the EACTS-STS-AATS Valve Labelling Task Force summarizes the background of SHV sizing and labelling and identifies the most important elements where further standardization is necessary.
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http://dx.doi.org/10.1016/j.athoracsur.2019.03.020DOI Listing
July 2019

Characteristics of surgical prosthetic heart valves and problems around labelling: a document from the European Association for Cardio-Thoracic Surgery (EACTS)-The Society of Thoracic Surgeons (STS)-American Association for Thoracic Surgery (AATS) Valve Labelling Task Force.

Eur J Cardiothorac Surg 2019 06;55(6):1025-1036

Department of Cardiac Surgery, European Hospital, Rome, Italy.

Intraoperative surgical prosthetic heart valve (SHV) choice is a key determinant of successful surgery and positive postoperative outcomes. Currently, many controversies exist around the sizing and labelling of SHVs rendering the comparison of different valves difficult. To explore solutions, an expert Valve Labelling Task Force was jointly initiated by the European Association for Cardio-Thoracic Surgery (EACTS), The Society of Thoracic Surgeons (STS) and the American Association for Thoracic Surgery (AATS). The EACTS-STS-AATS Valve Labelling Task Force, comprising cardiac surgeons, cardiologists, engineers, regulators and representatives from the International Organization for Standardization (ISO) and major valve manufacturers, held its first in-person meeting in February 2018 in Paris, France. This article was derived from the meeting's discussions. The Task Force identified the following areas for improvement and clarification: reporting of physical dimensions and characteristics of SHVs determining and labelling of SHV size, in vivo and in vitro testing and reporting of SHV haemodynamic performance and thrombogenicity. Furthermore, a thorough understanding of the regulatory background and the role of the applicable ISO standards, together with close cooperation between all stakeholders (including regulatory and standard-setting bodies), is necessary to improve the current situation. Cardiac surgeons should be provided with appropriate information to allow for optimal SHV choice. This first article from the EACTS-STS-AATS Valve Labelling Task Force summarizes the background of SHV sizing and labelling and identifies the most important elements where further standardization is necessary.
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http://dx.doi.org/10.1093/ejcts/ezz034DOI Listing
June 2019

Initial Feasibility Study of a New Transcatheter Mitral Prosthesis: The First 100 Patients.

J Am Coll Cardiol 2019 03;73(11):1250-1260

St. Vincent's Hospital, Sydney, Australia.

Background: Transcatheter mitral valve replacement (TMVR) is a rapidly evolving therapy. Follow-up of TMVR patients remains limited in duration and number treated.

Objectives: The purpose of this study was to examine outcomes with expanded follow-up for the first 100 patients who underwent TMVR with the prosthesis.

Methods: The Global Feasibility Study enrolled symptomatic patients with either primary or secondary mitral regurgitation (MR) who were at high or prohibitive surgical risk. The present investigation examines the first 100 patients treated in this study. Clinical outcomes through last clinical follow-up were adjudicated independently.

Results: In the cohort (mean age 75.4 ± 8.1 years; 69% men), there was a high prevalence of severe heart failure symptoms (66%), left ventricular dysfunction (mean ejection fraction 46.4 ± 9.6%), and morbidities (Society of Thoracic Surgeons Predicted Risk of Mortality, 7.8 ± 5.7%). There were no intraprocedural deaths, 1 instance of major apical bleeding, and no acute conversion to surgery or need for cardiopulmonary bypass. Technical success was 96%. The 30-day rates of mortality and stroke were 6% and 2%, respectively. The 1-year survival free of all-cause mortality was 72.4% (95% confidence interval: 62.1% to 80.4%), with 84.6% of deaths due to cardiac causes. Among survivors at 1 year, 88.5% were New York Heart Association function class I/II, and improvements in 6-min walk distance (p < 0.0001) and quality-of-life measurements occurred (p = 0.011). In 73.4% of survivors, the Kansas City Cardiomyopathy Questionnaire score improved by ≥10 points.

Conclusions: In this study of TMVR, which is the largest experience to date, the prosthesis was highly effective in relieving MR and improving symptoms, with an acceptable safety profile. Further study to optimize the impact on long-term survival is needed.
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http://dx.doi.org/10.1016/j.jacc.2018.12.066DOI Listing
March 2019

Single-centre first experience with transapical transcatheter mitral valve replacement with an apical tether: factors influencing screening outcomes.

Interact Cardiovasc Thorac Surg 2019 05;28(5):695-703

Department of Cardiothoracic Surgery, Oslo University, Oslo, Norway.

Objectives: Transcatheter mitral valve replacement has recently been introduced as an alternative treatment option for severe mitral regurgitation. We present our single-centre first experience with screening and implantation outcomes.

Methods: Twenty-five patients with mitral regurgitation grades 3 and 4 were screened based on study inclusion/exclusion criteria, echocardiography and computed tomography imaging. All patients were evaluated by the centre's Heart Team, followed by the Tendyne's internal screening process. Patients who failed the screening criteria were considered for alternative treatments.

Results: Of the 25 patients screened for transcatheter mitral valve replacement, 14 patients failed screening and 11 patients passed. The patients who failed screening were more often older, were women and were smaller in stature than those who passed screening. The main reason for patients to fail screening changed during the study from large annular dimensions to a small predicted neo-left ventricular outflow tract. Eight of the 11 patients who passed screening were treated using the Tendyne device, and 3 patients required alternate treatments due to urgency including 1 MitraClip procedure and 2 surgical repairs. Of the 14 patients who failed the screening, 5 patients had open surgery (4 patients received mitral valve repair and 1 mitral valve replacement). All 8 patients who underwent the Tendyne procedure were successfully treated without mortality during the observation time.

Conclusions: Transcatheter mitral valve replacement is an effective and safe treatment for well-selected patients with symptomatic mitral regurgitation. For patients who fail the screening process, the MitraClip procedure or open surgical valve repair are feasible.
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http://dx.doi.org/10.1093/icvts/ivy343DOI Listing
May 2019

Standardized Definition of Structural Valve Degeneration for Surgical and Transcatheter Bioprosthetic Aortic Valves.

Circulation 2018 01;137(4):388-399

Royal Brompton Hospital, London, United Kingdom (N.E.M.).

Bioprostheses are prone to structural valve degeneration, resulting in limited long-term durability. A significant challenge when comparing the durability of different types of bioprostheses is the lack of a standardized terminology for the definition of a degenerated valve. This issue becomes especially important when we try to compare the degeneration rate of surgically inserted and transcatheter bioprosthetic valves. This document, by the VIVID (Valve-in-Valve International Data), proposes practical and standardized definitions of valve degeneration and provides recommendations for the timing of clinical and imaging follow-up assessments accordingly. Its goal is to improve the quality of research and clinical care for patients with deteriorated bioprostheses by providing objective and strict criteria that can be utilized in future clinical trials. We hope that the adoption of these criteria by both the cardiological and surgical communities will lead to improved comparability and interpretation of durability analyses.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.117.030729DOI Listing
January 2018

Reduced inflammatory response by transcatheter, as compared to surgical aortic valve replacement.

Scand Cardiovasc J 2018 Feb 12;52(1):43-50. Epub 2017 Dec 12.

a The Intervention Centre , Oslo University Hospital , Oslo , Norway.

Objectives: The inflammatory response to on-pump cardiac surgery is well known. Systemic inflammatory response syndrome after transcatheter valve implantation (TAVI) has been reported. The objective of this study was to study the inflammatory response during TAVI, and compare with the response during surgical aortic valve replacement.

Methods: Eighteen patients undergoing transcatheter implantation, either by a transfemoral (n = 9) or transaortal (n = 9) approach were compared with eighteen patients admitted for surgical replacement. Blood samples per- and postoperatively were analysed for C3bc, terminal complement complex, myeloperoxidase, macrophage inflammatory protein-1β, monocyte chemo-attractant peptide-1, eotaxin, IL-6 and troponin-T. All markers were measured at defined time points and the areas under the curve were compared.

Results: Activation of complement, granulocytes, monocytes and eosinophils were significantly lower in the transcatheter group as compared to the surgical group (<0.01). There was no difference in generation of troponin T and IL-6. A small difference in complement activation was observed between the transfemoral and transaortal placement of TAVI. There was no significant difference in clinical outcomes between the TAVI and surgical groups.

Discussion: Activation and release of inflammatory markers was significantly less during with TAVI as compared to SAVR, particularly for markers associated with extracorporeal circulation. TAVI and SAVR generated the same degree of IL-6 and troponin T, indicating that the burden on the myocardial tissue was the same. Clinical Trials: Gov ID: NCT03074838 Unique protocol ID: 2012/7919.
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http://dx.doi.org/10.1080/14017431.2017.1416157DOI Listing
February 2018

EVALUATION OF OCCUPATIONAL RADIATION DOSE IN TRANSCATHETER AORTIC VALVE IMPLANTATION.

Radiat Prot Dosimetry 2018 Apr;179(1):9-17

Department of Diagnostic Physics, Oslo University Hospital, Oslo, Norway.

Occupational doses during fluoroscopy in interventional procedures vary largely (Kim et al. (Occupational radiation doses to operators performing cardiac catheterization procedures. Health Phys. 2008;94:211-227)). In transcatheter aortic valve implantation, the operators' positions and use of radiation shielding are particularly related to the entry choice on the patient's heart. This study evaluates how occupational doses depend on operator positioning during transfemoral and transaortal access. Occupational dosimetric readings were collected with electronic dosemeters on two cardiothoracic surgeons and one cardiologist during 31 procedures. The findings were significantly higher body doses and eye lens doses to the surgeons during transaortal access compared to transfemoral access. The median equivalent eye lens dose per procedure received by the cardiologists was 0.05-0.06 mSv; hence, the cardiologists should wear protective eye wear to prevent reaching the proposed annual dose limit of 20 mSv to the eye lens. Surgeons ought to use protective eye wear as well, and should only perform a restricted number of transcatheter aortic valve implantations with transaortal access annually.
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http://dx.doi.org/10.1093/rpd/ncx184DOI Listing
April 2018

Single centre experience with transapical transcatheter mitral valve implantation.

Interact Cardiovasc Thorac Surg 2017 08;25(2):177-184

Department of Cardiothoracic and Thoracic surgery, Oslo University Hospital, Oslo, Norway.

Objectives: A transcatheter heart valve technique can be used in failed mitral valve repairs with annuloplasty rings, deterioriated bioprostheses and in mitral annular calcification, all serving as 'docking stations' for balloon-expandable valves. Specially designed transcatheter mitral valve platforms are used in ongoing studies for native mitral valve regurgitation. We present our single centre experience with transcatheter mitral valve implantation-transapical approach procedures in eleven patients.

Methods: Eleven patients were treated between 2011 and 2016. They had severe mitral regurgitation due to either failed repair annuloplasty rings (N = 6), failed bioprostheses (N = 2) or in the native valve (N = 3), all at high risk for open mitral valve surgery. Three different types of transcatheter valves were used: (1) the SAPIEN XT/SAPIEN 3, (2) the Lotus valve and (3) a Tendyne transcatheter mitral valve. Computed tomography reconstruction, echocardiography, 3D printing and bench tests were done in the preoperative evaluation and procedural planning. Transapical approach access was performed via a left minithoracotomy.

Results: Implantation success was 100% with no left ventricular outflow tract obstruction. Good haemodynamics and improved New York Heart Association class were demonstrated in all patients. One patient died before 30 days due to sepsis. One patient had a valve thrombosis when switching from Coumadin to new oral anticoagulant and had a second valve implanted into the first one as a 'valve-in-valve' procedure.

Conclusions: The transapical approach is a safe and straight forward procedure for accessing the mitral valve. 'Transcatheter aortic valve implantation' prostheses may be used in redo surgery due to an already sufficient 'docking station'. These specially designed new prostheses may be beneficial for addressing mitral valve regurgitation, but are still under evaluation. Anticoagulation is mandatory.
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http://dx.doi.org/10.1093/icvts/ivx038DOI Listing
August 2017

Transcatheter Mitral Valve Replacement for Patients With Symptomatic Mitral Regurgitation: A Global Feasibility Trial.

J Am Coll Cardiol 2017 Jan 28;69(4):381-391. Epub 2016 Dec 28.

Center for Valve and Structural Heart Disease and Cardiothoracic Surgery Service, Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis, Minnesota.

Background: Symptomatic mitral regurgitation (MR) is associated with high morbidity and mortality that can be ameliorated by surgical valve repair or replacement. Despite this, many patients with MR do not undergo surgery. Transcatheter mitral valve replacement (TMVR) may be an option for selected patients with severe MR.

Objectives: This study aimed to examine the effectiveness and safety of TMVR in a cohort of patients with native valve MR who were at high risk for cardiac surgery.

Methods: Patients underwent transcatheter, transapical delivery of a self-expanding mitral valve prosthesis and were examined in a prospective registry for short-term and 30-day outcomes.

Results: Thirty patients (age 75.6 ± 9.2 years; 25 men) with grade 3 or 4 MR underwent TMVR. The MR etiology was secondary (n = 23), primary (n = 3), or mixed pathology (n = 4). The Society of Thoracic Surgeons Predicted Risk of Mortality was 7.3 ± 5.7%. Successful device implantation was achieved in 28 patients (93.3%). There were no acute deaths, strokes, or myocardial infarctions. One patient died 13 days after TMVR from hospital-acquired pneumonia. Prosthetic leaflet thrombosis was detected in 1 patient at follow-up and resolved after increased oral anticoagulation with warfarin. At 30 days, transthoracic echocardiography showed mild (1+) central MR in 1 patient, and no residual MR in the remaining 26 patients with valves in situ. The left ventricular end-diastolic volume index decreased (90.1 ± 28.2 ml/m at baseline vs. 72.1 ± 19.3 ml/m at follow-up; p = 0.0012), as did the left ventricular end-systolic volume index (48.4 ± 19.7 ml/m vs. 43.1 ± 16.2 ml/m; p = 0.18). Seventy-five percent of the patients reported mild or no symptoms at follow-up (New York Heart Association functional class I or II). Successful device implantation free of cardiovascular mortality, stroke, and device malfunction at 30 days was 86.6%.

Conclusions: TMVR is an effective and safe therapy for selected patients with symptomatic native MR. Further evaluation of TMVR using prostheses specifically designed for the mitral valve is warranted. This intervention may help address an unmet need in patients at high risk for surgery. (Early Feasibility Study of the Tendyne Mitral Valve System [Global Feasibility Study]; NCT02321514).
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http://dx.doi.org/10.1016/j.jacc.2016.10.068DOI Listing
January 2017

Edwards SAPIEN XT in Native Stenotic Mitral Valve, Open Technique on Cardiopulmonary Bypass: An Option, But Safe?

Innovations (Phila) 2016 Jul-Aug;11(4):288-90

From the Department of Thoracic and Cardiovascular Surgery, Rikshospitalet, Oslo University Hospital, Oslo, Norway.

A 73-year-old woman underwent open mitral valve replacement with the transcatheter Edwards SAPIEN XT valve (Edwards Lifesciences, Corp, Irvine, CA USA) on cardiopulmonary bypass in a native, stenotic mitral valve. Because of left ventricular outflow tract obstruction, the patient died 25 days after implantation. There are previous reports of transcatheter valve implantation in native mitral valve with procedural success. However, in one case report, the patient died 10 days postoperatively.
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http://dx.doi.org/10.1097/IMI.0000000000000272DOI Listing
May 2017

Long-term outcomes after transcatheter aortic valve implantation: the impact of intraoperative tissue Doppler echocardiography.

Interact Cardiovasc Thorac Surg 2016 09 30;23(3):403-9. Epub 2016 May 30.

The Intervention Centre, Rikshospitalet, Oslo University Hospital, Oslo, Norway

Objectives: Transcatheter aortic valve implantation improves survival in patients with severe aortic stenosis who are ineligible for surgical valve replacement; however, not all patients benefit from the procedure. We endeavoured to identify these patients using intraoperative echocardiography and hypothesized that intraoperative left ventricular function in response to the acute afterload reduction during the procedure was related to long-term outcomes.

Methods: We prospectively included 64 patients who were scheduled for transcatheter aortic valve implantation and divided them into responders and non-responders based on their left ventricular intraoperative responses to the acute afterload reduction after valve deployment. Responders were defined by increases of ≥20% in left ventricular longitudinal peak systolic velocities determined by tissue Doppler echocardiography. All patients were assessed for the following outcomes at 12 months: cardiac mortality, adverse cardiac events, quality of life, New York Heart Association class, N-terminal pro-brain natriuretic peptide (NT-proBNP) and echocardiography.

Results: Thirty-five patients (55%) were classified as responders and 29 patients (45%) as non-responders. Compared with responders, non-responders had higher risks of death (28 vs 9%, respectively, P = 0.04) and cardiac events (66 vs 26%, respectively, P < 0.01) during the 12-month follow-up. Significant long-term improvements in quality of life, NT-proBNP and left ventricular function were observed only in the responders. Preoperative risk stratification, intraoperative handling, aortic gradient and valve area were similar between groups.

Conclusions: Intraoperative assessment of left ventricular function by tissue Doppler echocardiography predicted long-term outcomes after transcatheter aortic valve implantation. Our results suggest that a preoperative test of myocardial contractile reserve might improve risk stratification and patient selection prior to the procedure.
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http://dx.doi.org/10.1093/icvts/ivw159DOI Listing
September 2016

Intraoperative improvement in left ventricular peak systolic velocity predicts better short-term outcome after transcatheter aortic valve implantation.

Interact Cardiovasc Thorac Surg 2016 Jan 13;22(1):5-12. Epub 2015 Oct 13.

The Intervention Centre, Rikshospitalet, Oslo University Hospital, Oslo, Norway

Objectives: Left ventricular function is expected to improve after transcatheter aortic valve implantation due to the acute reduction in afterload, but does not occur in all patients. We hypothesized that the immediate intraoperative response in systolic left ventricular longitudinal motion during the procedure could be a predictor of short-term outcome.

Methods: Sixty-four patients treated with transcatheter aortic valve implantation for severe aortic stenosis were included. Transoesophageal 4- and 2-chamber echocardiograms were obtained immediately prior to and ∼15 min after valve implantation. Patients were defined as responders if their average left ventricular longitudinal peak systolic velocity increased by ≥20% from the preimplantation value and was related to the 3-month outcome.

Results: Thirty-five patients were classified as responders, with an increase in the intraoperative longitudinal peak systolic velocity from an average of 2.2 ± 0.8 to 3.1 ± 1.1 cm/s (P < 0.001); the velocity was unchanged in the remaining 29 patients, who averaged 2.4 ± 1.1 cm/s. There were significantly fewer adverse cardiac events in the responder group at the 3-month follow-up (20 vs 45%, P = 0.03) and the New York Heart Association class was significantly better in the responders compared with non-responders. Responders had a significant reduction in N-terminal probrain natriuretic peptide levels [243 (113-361) vs 163 (64-273), P = 0.004] at the 3-month follow-up, whereas non-responders did not [469 (130-858) vs 289 (157-921), P = 0.48].

Conclusions: An immediate improvement in the longitudinal peak systolic velocity during the transcatheter aortic valve implantation procedure predicted a better short-term outcome and may be useful in identifying patients who are at risk of a less favourable outcome after transcatheter aortic valve implantation.
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http://dx.doi.org/10.1093/icvts/ivv277DOI Listing
January 2016

Transcatheter aortic valve implantation and intraoperative left ventricular function: a myocardial tissue Doppler imaging study.

J Cardiothorac Vasc Anesth 2015 Feb;29(1):115-20

The Intervention Centre, Rikshospitalet, Oslo University Hospital, Oslo, Norway.

Objective: Transcatheter aortic valve implantation in patients turned down for surgical aortic valve replacement is a high-risk procedure. Severe aortic stenosis is associated with impaired left ventricular longitudinal motion, and myocardial peak systolic velocity is a measure of left ventricular function in these patients. The present study aimed to quantify the acute changes in left ventricular function during the procedure by using myocardial tissue Doppler imaging and transthoracic cardiac output measurements.

Design: Prospective observational study.

Setting: Tertiary care university hospital.

Participants: 40 patients with severe aortic stenosis scheduled for transcatheter aortic valve implantation.

Interventions: Transesophageal 4-chamber and 2-chamber echocardiograms were performed immediately before and ~15 minutes after valve implantation. Longitudinal myocardial peak systolic velocity was obtained by tissue Doppler imaging from 8 basal segments and averaged. Cardiac output was measured by the lithium dilution method, and systemic vascular resistance index and stroke volume were calculated.

Measurements And Main Results: Longitudinal myocardial peak systolic velocity improved immediately after valve implantation, from -2.3±0.8 to -3.0±1.1 cm/sec (p<0.001); this represented an average increase of 31%±33%. Cardiac output increased from 3.2±0.8 L/min to 3.6±0.9 L/min (15%±33%; p = 0.04). This was due to increased heart rate (59±9 beats/min to 72±12 beats/min; p<0.001) and not to an improved stroke volume. Systemic vascular resistance index was reduced from 2,937±984 dynes*sec/cm(5)/m(2) to 2,436±730 dynes*sec/cm(5)/m(2) (p = 0.003).

Conclusion: Intraoperative echocardiography tissue Doppler imaging detected immediate improvement in left ventricular long-axis motion after transcatheter aortic valve implantation. The method provided detailed information not obtainable by routine hemodynamic monitoring.
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http://dx.doi.org/10.1053/j.jvca.2014.10.016DOI Listing
February 2015

Concomitant transatrial valve-in-valve in pulmonal and tricuspid position.

Catheter Cardiovasc Interv 2015 Nov 3;86(5):897-902. Epub 2015 Feb 3.

Department of Cardiothoracic Surgery, Guys and St. Thomas' Hospital, London, United Kingdom.

Transcatheter valve implantation in the pulmonary valve has been established as a valuable treatment option for patients with conduit failure in the right ventricular outflow tract, most often with the use of the Melody valve. Transcatheter valve-in-valve (VIV) implantation in the tricuspid position is restricted to single case reports, most often with the implantation of the Edwards SAPIEN valve. A 67 years old male with carcionoid syndrome and previously implanted bioprosthesis in the pulmonary and tricuspid valve now presented with worsening symptoms due to degeneration of both bioprostheses. The risk of new open surgery was deemed to high. We report of the first transatrial double VIV implantation using the balloon expandable Edwards SAPIEN XT in pulmonary and tricuspid position.
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http://dx.doi.org/10.1002/ccd.25843DOI Listing
November 2015

Direct aorta ascending approach in transcatheter aortic valve implantation.

Innovations (Phila) 2014 Jan-Feb;9(1):1-9

From the Department of Cardiothoracic Surgery, Oslo University Hospital, Oslo, Norway.

Objective: Direct aorta ascending approach [transaortic approach (TAo)] is a new access way for transcatheter aortic valve implantation (TAVI) to be used in patients with peripheral vascular disease and as an alternative to transapical approach.

Methods: Both the Edwards SAPIEN and CoreValve systems were used. Depending on the position of the ascending aorta, the relation to the sternum, the brachiocephalic vein, vein grafts, and left and right internal mammary artery grafts from previous heart surgery, either right minithoracotomy or left ministernotomy was selected. Computed tomographic scan with reconstruction was applied for this decision making. A hybrid operating room was used with echocardiographic and fluoroscopy guidance.

Results: We have done 30 procedures via the aorta ascendens. The mean age of the patients was 80 years, and 18 were men. The mean Logistic EuroSCORE of 33 reflects the comorbidities. More than half of the patients had coronary vessel disease and had undergone coronary artery bypass graft; 20% had abdominal aortic aneurysm. The mean ejection fraction was 41%, and the patients were in New York Heart Association class III to IV. The mean gradient was 50 mm Hg, and the mean valve area was 0.7 cm. The mean valve size was 28 mm. The use of Edwards SAPIEN versus CoreValve was 50%/50%, and thoracotomy versus sternotomy was 9 versus 21. All procedures were done successfully, but one patient had a periprocedural valve-in-valve implantation. Twenty-two patients were extubated in the operation room. The patients stayed in the intensive care unit for one night. Six patients were reoperated on. One patient had a postoperative balloon aortic valvuloplasty. The overall survival was 81% (follow up, 1-18 months).

Conclusions: Access design is an important issue in TAVI. When central approach is needed, TAVI-TAo is safe. For patients with low ejection fraction, the TAVI-TAo is preferred to the TAVI-transapical. The cannulation technique of the aorta is well known for cardiothoracic surgeons, and the method is feasible both for the Medtronic CoreValve and the Edwards SAPIEN valve, either via right minithoracotomy or ministernotomy to obtain the best coaxial alignment. It seems easier to position the bigger valves more precisely via this central approach.
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http://dx.doi.org/10.1097/IMI.0000000000000046DOI Listing
November 2014

Transapical valve-in-valve-in-ring for stenotic mitral valve repair.

Innovations (Phila) 2013 Sep-Oct;8(5):376-80

From the *Department of Cardiothoracic Surgery, Oslo University Hospital, Oslo, Norway; and †Kardiologisk Klinikk, Rigshospitalet, Copenhagen, Denmark.

A 53-year-old woman, previously treated with irradiation and chemotherapy for Hodgkin lymphoma, was referred for redo valve surgery. She had had a pacemaker implantation and undergone coronary bypass surgery, mitral valve repair with a Carpentier-Edwards 28-mm Physio-annuloplasty ring, as well as a mechanical tricuspid valve replacement and a transfemoral CoreValve 26-mm implantation. She had cardiac cachexia, pleura effusion, and a failed mitral valve repair with stenosis. She was judged inoperable for open surgery but suitable for a transapical valve-in-valve implantation on partial femorofemoral bypass. A 26-mm Edwards SAPIEN XT aortic valve inversely mounted on the Ascendra + delivery catheter was balloon expanded into the Physio ring. During expansion, the introducer sheath remained too deep into the left ventricle and rotated the SAPIEN valve upward to the left atrium, creating the onset of a new mitral regurgitation and retaining the stenosis. Another Edwards SAPIEN XT 26-mm valve was then positioned into the first valve in a "valve-in-valve-in-ring" tandem configuration. Both valves were supported by the Physio ring. The stenosis and the regurgitation were thereafter eliminated.
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http://dx.doi.org/10.1097/IMI.0b013e3182a6940bDOI Listing
September 2014

Transcatheter valve-in-ring implantation after failure of surgical mitral repair.

Eur J Cardiothorac Surg 2013 Jul 25;44(1):e8-15. Epub 2013 Mar 25.

Assistance Publique-Hôpitaux de Paris, Bichat-Claude Bernard Hospital, Paris, France.

Objectives: Redo surgery after failed mitral valve repair may be high risk, or contraindicated in patients with comorbidities. Because of this high risk, other interventional possibilities like transcatheter valve implantation might be of benefit. We report our experience with transcatheter mitral valve-in-ring implantation (TVIR) in high-risk patients after failure of surgical ring annuloplasty.

Methods: From January 2010 to February 2012, following a multidisciplinary discussion, 17 high-risk patients underwent TVIR using Edwards SAPIEN XT prostheses, via either a transvenous transseptal (n = 8), or a transapical approach (n = 9).

Results: Patients were aged 70 ± 16 years, in New York Association classes III/IV. Their mean logistic EuroSCORE was 36 ± 17% and mean Society of Thoracic Surgeons risk score 13 ± 9%. The mean time interval between surgery and repair failure was 7 ± 3 years. Annuloplasty rings were semi-rigid in 14 cases, flexible in 2, and rigid in 1. Manufacturers ring diameters were 26 mm in 4 patients, 27 mm in 1, 28 mm in 9, 30 mm, 31 mm and 34 mm in 1. The predominant failure mode was regurgitation in 12 cases and stenosis in 5. SAPIEN XT diameters were 26 mm in 15 patients, 23 mm and 29 mm in 1. Procedural success rate was 88% (15/17). Emergency surgery was needed in 1 patient due to acute dislodgement of the ring. The degree of mitral regurgitation was reduced to none or mild in all but 2 patients; final mean gradient was 7 ± 3 mmHg. Thirty-day survival was 82% (14/17 patients). At last follow-up (13 ± 5 months), survival rate was 71% (12/17).

Conclusions: These preliminary results suggest that TVIR is feasible, with low operative risk, and may provide short-term clinical and haemodynamic improvement in selected high-risk patients with failure of mitral ring annuloplasty.
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http://dx.doi.org/10.1093/ejcts/ezt155DOI Listing
July 2013
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