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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 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 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 )

Over the past decade, transcatheter mitral valve replacement (TMVR) technologies have evolved with the objective of improving outcomes for patients with severe mitral regurgitation (MR) deemed unsuitable for conventional mitral valve surgery. Although the safety and efficacy of transcatheter edge-to-edge mitral valve repair (TEER) is well-established, there is a sense amongst innovators that a major advantage of TMVR may be to offer a more complete solution for the correction of MR in patients whose complex anatomy means that the likelihood of achieving grade 0 or 1 MR with TEER is low. However, abrupt correction of MR in a poorly prepared left ventricle poses a number of unique haemodynamic challenges, particularly when sudden elimination of regurgitant flow causes a relative increase in left ventricular (LV) afterload. Rapid reduction in LV cavity size following MR elimination may itself result in relative LV outflow tract obstruction (LVOTO), irrespective of the intrinsic risk of LVOTO associated with TMVR. Nevertheless, TMVR on a beating heart affords the opportunity to study real-time invasive cardiac indices in high-risk patients with acute reversal of severe MR.

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.

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 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.

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.

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 P< .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.

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/m2 vs 11 ± 5 g/m/beat/m2; 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

Objectives. 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. Design. 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. Results. 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. Conclusions. 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.

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.

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.

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/m2 at baseline vs. 72.1 ± 19.3 ml/m2 at follow-up; p = 0.0012), as did the left ventricular end-systolic volume index (48.4 ± 19.7 ml/m2 vs. 43.1 ± 16.2 ml/m2; 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)

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.

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.

ObjectivesTo 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.MethodsThis 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.ResultsAll-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.ConclusionExcept for elevated systolic pulmonary artery pressure, our data suggests that clinical rather than echocardiographic parameters are useful predictors of 30-day mortality after TAVI.

Transcatheter mitral valve replacement (TMVR) is a rapidly evolving therapy. Follow-up of TMVR patients remains limited in duration and number treated.The purpose of this study was to examine outcomes with expanded follow-up for the first 100 patients who underwent TMVR with the prosthesis.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.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.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.

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.

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.

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.

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. © 2015 Wiley Periodicals, Inc.

This is the pre-print version of an article published by Taylor & Francis in Scandinavian Cardiovascular Journal on 12 December 2017, available online: http://www.tandfonline.com/10.1080/14017431.2017.1416157. 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 (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.

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.

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.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.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.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/mTMVR 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).

Transcatheter aortic valve implantation (TAVI) offers a new treatment option for patients with severe symptomatic aortic valve stenosis, classified as "inoperable". The purpose of the study was to reveal the association between ascertained hospital costs with the actual patient Diagnosis-Related Group (DRG).We examined 50 consecutive patients who underwent either transapical TAVI, (TAVI-TA) or transfemoral TAVI (TAVI-TF) with the Edwards SAPIEN valve and CoreValve(®) between September 2009 and August 2011.Fourty-nine patients had successful valve deployment. Seven patients died within 30 days of the operation. The mean length of hospital stay for TAVI-TA was 199 hours (range 77-362), and the mean costs for TAVI-TA were 55,690 US$. For TAVI-TF the mean length of hospital stay was 170 hours (range 49-276) and the mean costs were 52,087 US$.There was no significant difference between TAVI-TA and TAVI-TF patient characteristics. There was a significant discrepancy between actual hospital costs and the current Norwegian DRG reimbursement for the TAVI procedure. This discrepancy can be partly explained by excessive costs related to the introduction of a new program with new technology. Costly innovations should be considered in price-setting of reimbursement for novel technology.

A 71-year-old woman with severe congestive heart failure and failed mitral valve repair was referred for surgery. Because of her low ejection fraction, a valve-in-ring procedure was suggested. There was a great difference in the given size for the 34-mm Carpentier-Edwards-Physio-Ring and the biggest available transcatheter valve of 29 mm from Edwards. Therefore, we did a “bench test.” We expanded a 29-mm Edwards SAPIEN-XT aortic valve in a 34-mm Carpentier-Edwards-Physio-Ring. It fitted well and turned out circular with good coaptation of the leaflets. Thereafter, a successful transapical mitral valve-in-ring implantation on cardiopulmonary bypass was performed, and additional leads for cardiac resynchronization was placed.

ALCAPA, anomalous origin of the left coronary artery from the pulmonary artery is a rare congenital disease. We have from 1990 to 2003 operated on seven patients in our clinic. The objective of this study was to describe our experience of treating the condition and to remind other doctors of it as a possible diagnosis.The patients were identified by a retrospective review of our clinical records.Symptoms and signs varied from discomfort and pathologic heart murmur to ventricular fibrillation. All patients were operated on by use of cardiopulmonal bypass. Two died postoperatively within one week, two were reoperated later on because of pulmonary artery stenosis.ALCAPA should be suspected if a young patient with no previous history of heart failure presents with dyspnoe, chest pain or dysrhythmia. ALCAPA must be excluded by coronary angiography in younger patients with mitral insufficiency and no other morphological findings. Patients diagnosed early and operated on have a good prognosis.

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

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.

A 53-year-old woman, previously treated with irradiation and chemotherapy for Hodgkin lymphoma, was referred for redovalve 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.

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.

In this case, a patient with severe and extensive functional MR was treated with two MitraClips® with dramatic improvement in the MR severity and functional status. The two MitraClips® were placed some distance from each other because of the wide and extensive nature of the regurgitation, creating a three-orifice mitral valve.

As part of an evaluation of the lung cancer surgery at Akershus University hospital we wanted to describe the lung cancer surgery programme, assess 30-day mortality and review complications.We retrospectively examined medical records of all patients undergoing potentially curative surgery for non-small-cell lung cancer.The 99 patients operated on were aged 37-83 years (mean 63 years). 31% were women. 30-day mortality was 5% in total; 4% for lobectomy and 8% for pneumonectomy. No complication was recorded in 68% of the cases.Age and gender distribution in the sample was in line with the experience of others. The results were in accordance with international recommendations, for example from the British Thoracic Society: 30-day mortality not in excess of 4% for lobectomy and 8% for pneumonectomy.