Percutaneous MitraClip Device or Surgical Mitral Valve Repair in Patients With Primary Mitral Regurgitation Who Are Candidates for Surgery: Design and Rationale of the REPAIR MR Trial.

Background The current standard of care for the treatment of patients with primary mitral regurgitation (MR) is surgical mitral valve repair. Transcatheter edge-to-edge repair with the MitraClip device provides a less invasive treatment option for patients with both primary and secondary MR. Worldwide, >150 000 patients have been treated with the MitraClip device. However, in the United States, MitraClip is approved for use only in primary patients with MR who are at high or prohibitive risk for mitral valve surgery. The REPAIR MR (Percutaneous MitraClip Device or Surgical Mitral Valve Repair in Patients With Primary Mitral Regurgitation Who Are Candidates for Surgery) trial is designed to compare early and late outcomes associated with transcatheter edge-to-edge repair with the MitraClip and surgical repair of primary MR in older or moderate surgical risk patients. Methods and Results The REPAIR MR trial is a prospective, randomized, parallel-controlled, open-label multicenter, noninferiority trial for the treatment of severe primary MR (verified by an independent echocardiographic core laboratory). Patients with severe MR and indications for surgery because of symptoms (New York Heart Association class II-IV), or without symptoms with left ventricular ejection fraction ≤60%, pulmonary artery systolic pressure >50 mm Hg, or left ventricular end-systolic diameter ≥40 mm are eligible for the trial provided they meet the moderate surgical risk criteria as follows: (1) ≥75 years of age, or (2) if <75 years of age, then the subject has a Society of Thoracic Surgeons Predicted Risk Of Mortality score of ≥2% for mitral repair (or Society of Thoracic Surgeons replacement score of ≥4%), or the presence of a comorbidity that may introduce a surgery-specific risk. The local surgeon must determine that the mitral valve can be surgically repaired. Additionally, an independent eligibility committee will confirm that the MR can be reduced to mild or less with both the MitraClip and surgical mitral valve repair with a high degree of certainty. A total of 500 eligible subjects will be randomized in a 1:1 ratio to receive the MitraClip device or to undergo surgical mitral valve repair (control group). There are 2 co-primary end points for the trial, both of which will be evaluated at 2 years. Each subject will be followed for 10 years after enrollment. The study has received approval from both the Food and Drug Administration and the Centers for Medicare and Medicaid Services, and enrolled its first subject in July 2020. Conclusions The REPAIR MR trial will determine the safety and effectiveness of transcatheter edge-to-edge repair with the MitraClip in patients with primary MR who are at moderate surgical risk and are candidates for surgical MV repair. The trial will generate contemporary comparative clinical evidence for the MitraClip device and surgical MV repair. Registration https://clinicaltrials.gov/ct2/show/NCT04198870; NCT04198870.

Bioprosthetic Aortic Valve Hemodynamics: Definitions, Outcomes, and Evidence Gaps: JACC State-of-the-Art Review.

A virtual workshop was organized by the Heart Valve Collaboratory to identify areas of expert consensus, areas of disagreement, and evidence gaps related to bioprosthetic aortic valve hemodynamics. Impaired functional performance of bioprosthetic aortic valve replacement is associated with adverse patient outcomes; however, this assessment is complicated by the lack of standardization for labelling, definitions, and measurement techniques, both after surgical and transcatheter valve replacement. Echocardiography remains the standard assessment methodology because of its ease of performance, widespread availability, ability to do serial measurements over time, and correlation with outcomes. Management of a high gradient after replacement requires integration of the patient's clinical status, physical examination, and multimodality imaging in addition to shared patient decisions regarding treatment options. Future priorities that are underway include efforts to standardize prosthesis sizing and labelling for both surgical and transcatheter valves as well as trials to characterize the consequences of adverse hemodynamics.

Association of Radial Artery Graft vs Saphenous Vein Graft With Long-term Cardiovascular Outcomes Among Patients Undergoing Coronary Artery Bypass Grafting: A Systematic Review and Meta-analysis.

Importance: Observational studies have suggested that the use of radial artery grafts for coronary artery bypass grafting may improve clinical outcomes compared with the use of saphenous vein grafts, but this has not been confirmed in randomized trials. Objective: To compare clinical outcomes between patients receiving radial artery vs saphenous vein grafts for coronary artery bypass grafting after long-term follow-up. Design, Setting, and Participants: Patient-level pooled analysis comparing radial artery vs saphenous vein graft in adult patients undergoing isolated coronary artery bypass grafting from 5 countries (Australia, Italy, Serbia, South Korea, and the United Kingdom), with enrollment from 1997 to 2009 and follow-up completed in 2019. Interventions: Patients were randomized to undergo either radial artery (n = 534) or saphenous vein (n = 502) grafts for coronary artery bypass grafting. Main Outcomes and Measures: The primary outcome was a composite of death, myocardial infarction, or repeat revascularization and the secondary outcome was a composite of death or myocardial infarction. Results: A total of 1036 patients were randomized (mean age, 66.6 years in the radial artery group vs 67.1 years in the saphenous vein group; 376 [70.4%] men in the radial artery group vs 351 [69.9%] in the saphenous vein group); 942 (90.9%) of the originally randomized patients completed 10 years of follow-up (510 in the radial artery group). At a median (interquartile range) follow-up of 10 (10-11) years, the use of the radial artery, compared with the saphenous vein, in coronary artery bypass grafting was associated with a statistically significant reduction in the incidence of the composite outcome of death, myocardial infarction, or repeat revascularization (220 vs 237 total events; 41 vs 47 events per 1000 patient-years; hazard ratio, 0.73 [95% CI, 0.61-0.88]; P < .001) and of the composite of death or myocardial infarction (188 vs 193 total events; 35 vs 38 events per 1000 patient-years; hazard ratio, 0.77 [95% CI, 0.63-0.94]; P = .01). Conclusions and Relevance: In this individual participant data meta-analysis with a median follow-up of 10 years, among patients undergoing coronary artery bypass grafting, the use of the radial artery compared with the saphenous vein was associated with a lower risk of a composite of cardiovascular outcomes.

Impact of the COVID-19 pandemic: a perspective from industry.

The global COVID-19 pandemic has led to unprecedented change throughout society.1 As the articles in this supplement outline, all segments of the broader cardiovascular community have been forced to adapt, to change models of care delivery, and to evolve and innovate in order to deliver optimal management for cardiovascular patients. The medtech/device industry has not been exempt from such change and has been forced to navigate direct and indirect COVID-associated disruption, with effects felt from supply chain logistics to the entire product lifecycle, from the running of clinical trials to new device approvals and managing training, proctoring and congresses in an increasingly-online world. This sea-change in circumstances itself has enforced the industry, in effect, to disrupt its own processes, models and activities. Whilst some of these changes may be temporary, many will endure for some time and some will doubtless become permanent; one thing is for sure: the healthcare ecosystem, including the medical device industry, will never look quite the same again. Although the pandemic has brought a short- to medium-term medical crisis to many countries, its role as a powerful disruptor cannot be underestimated, and may indeed prove to be a force for long-term good, given the accelerated innovation and rapid adaptation that it has cultivated.

Angiographic Outcome of Coronary Artery Bypass Grafts: The Radial Artery Database International Alliance.

BACKGROUND: We used a large patient-level data set including 6 angiographic randomized controlled trials (RCTs) on coronary artery bypass conduits to explore incidence and determinants of coronary graft failure. METHODS: Patient-level angiographic data of 6 RCTs comparing long-term outcomes of the radial artery and other conduits were joined. Primary outcome was graft occlusion at maximum follow-up. The analysis was divided as (1) left anterior descending coronary (LAD) distribution and (2) non-LAD distribution (circumflex and right coronary artery). Mixed-model multivariable Cox regression including all baseline characteristics with stratification by individual trials was used to identify predictors of graft occlusion. RESULTS: Included were 1091 patients and 2281 grafts, consisting of 921 left internal mammary arteries, 74 right internal mammary arteries, 710 radial arteries, and 576 saphenous veins. All left internal mammary arteries were used on the LAD, the other conduits were used on the non-LAD distribution. Mean angiographic follow up was 65 ± 29 months. Occlusion rates were 2.3% for the left internal mammary arteries, 13.5% for the left internal mammary arteries, 9.4% for the right internal mammary arteries, and 17.5% for the saphenous veins. At multivariable analysis, type of conduit used, age, female sex, left ventricular ejection fraction of less than 0.50, and use of the Y graft were significantly associated with graft occlusion in the non-LAD distribution. CONCLUSIONS: Our analyses showed that failure of the left internal mammary arteries-to-LAD bypass is a very uncommon event. For the non-LAD distribution, the nonuse of radial artery, age, female sex, left ventricular ejection fraction of less than 0.50, and use of the Y graft configuration were significantly associated with midterm graft failure.

The RADial artery International ALliance (RADIAL) extended follow-up study: rationale and study protocol.

It is generally accepted that radial artery (RA) grafts have better mid-term patency rate compared to saphenous vein grafts. However, the clinical correlates of the improved patency rate are still debated. Observational studies have suggested increased survival and event-free survival for patients who receive an RA rather than a saphenous vein, but they are open to bias and confounders. The only evidence based on randomized data is a pooled meta-analysis of 6 randomized controlled trial comparing the RA and the saphenous vein published by the RADial artery International Alliance (RADIAL). In the RADIAL database, improved freedom from follow-up cardiac events (death, myocardial infarction and repeat revascularization) was found at 5-year follow-up in the RA arm. The most important limitation of the RADIAL analysis is that most of the included trials had an angiographic follow-up in the first 5 years and it is unclear whether the rate of repeat revascularization (the main driver of the composite outcome) was clinically indicated due to per-protocol angiographies. Here, we present the protocol for the long-term analysis of the RADIAL database. By extending the follow-up beyond the 5th postoperative year (all trials except 1 did not have angiographic follow-up beyond 5 years), we aim to provide data on the role of RA in coronary artery bypass surgery with respect to long-term outcomes.

Outcomes Following Transcatheter Aortic Valve Replacement for Degenerative Stentless Versus Stented Bioprostheses.

OBJECTIVES: A large comprehensive analysis of transcatheter aortic valve replacement (TAVR) was performed for failed stentless bioprostheses. BACKGROUND: Valve-in-valve (ViV) transcatheter aortic replacement (TAVR) is an alternative to redo surgery for patients with a failing aortic bioprosthesis. METHODS: Unadjusted outcome data were collected from the VIVID (Valve-in-Valve International Data) registry between 2007 and 2016 from a total of 1,598 aortic ViV procedures (291 stentless, 1,307 stented bioprostheses). RESULTS: Bioprosthetic failure was secondary to aortic regurgitation in 56% of stentless and 20% stented devices (p < 0.001). ViV-TAVR access was transfemoral in 71.1% stentless and 74.2% stented ViV-TAVR. Self-expanding devices were more frequently used in stentless ViV-TAVR (56.0% vs. 39.9%; p = 0.05), but there was no difference between balloon-expanding and self-expanding TAVR devices for stented ViV-TAVR (48.6% vs. 45.1%). The degree of oversizing for all mechanisms of bioprosthesis failure was 9 ± 10% for stentless ViV-TAVR vs. 6 ± 9% for stented ViV-TAVR (and 8 ± 10% for stentless ViV-TAVR vs. 3 ± 9% for stented ViV-TAVR in patients with predominant aortic regurgitation; both p < 0.001). Initial device malposition (10.3% vs. 6.2%; p = 0.014), second transcatheter device (7.9% vs. 3.4%), coronary obstruction (6.0% vs. 1.5%), and paravalvular leak occurred more frequently in stentless ViV-TAVR (all p < 0.001). Hospital stay duration (median 7 days) was no different, and 30-day (6.6% vs. 4.4%; p = 0.12) and 1-year mortality year (15.8% vs. 12.6%; p = 0.15) were numerically higher, but not statistically different, after stentless ViV-TAVR. CONCLUSIONS: Stentless ViV-TAVR is associated with greater periprocedural complications (initial device malposition, second transcatheter device, coronary obstruction, paravalvular leak), but no difference in 30-day and 1-year outcome.

Effect of Calcium-Channel Blocker Therapy on Radial Artery Grafts After Coronary Bypass Surgery.

BACKGROUND: Few studies have evaluated the effect of chronic calcium-channel blocker therapy (CCB) on the angiographic and clinical outcome of radial artery (RA) grafts used for coronary bypass surgery. OBJECTIVES: The purpose of this study was to evaluate if CCB influences midterm clinical and angiographic outcomes of RA grafts. METHODS: Patient-level data of 6 angiographic randomized trials evaluating RA graft status at midterm follow-up were joined in this observational analysis. Cox regression and propensity score methods were used to evaluate the effect of CCB on the incidence of a composite of major adverse cardiac events (MACE) (death, myocardial infarction, and repeat revascularization) and graft occlusion. RESULTS: The study population included 732 patients (502 on CCB). The median clinical follow-up was 60 months. The cumulative incidence of MACE at 36, 72, and 108 months was 3.7% vs. 9.3%, 13.4% vs. 17.6%, and 16.8% vs. 20.5% in the CCB and no CCB groups, respectively (log-rank p = 0.003). Protocol-driven angiographic follow-up was available in 243 patients in the CCB group and 200 in the no CCB group. The median angiographic follow-up was 55 months. The cumulative incidence of RA occlusion at 36, 72, and 108 months was 0.9% vs. 8.6%, 9.6% vs. 21.4%, and 14.3% vs. 38.9% in the CCB and no CCB groups, respectively (log-rank p < 0.001). After controlling for known confounding, CCB therapy was found to be consistently associated with a significantly lower risk of MACE (multivariate Cox hazard ratio: 0.52; 95% confidence interval: 0.31 to 0.89; p = 0.02) and RA graft occlusion (multivariate Cox hazard ratio: 0.20; 95% confidence interval: 0.08 to 0.49; p < 0.001). CONCLUSIONS: In patients with RA grafts CCB is associated with significantly better midterm clinical and angiographic RA outcomes.

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

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.

Cardiac rehabilitation to improve health-related quality of life following trans-catheter aortic valve implantation: a randomised controlled feasibility study: RECOVER-TAVI Pilot, ORCA 4, For the Optimal Restoration of Cardiac Activity Group.

OBJECTIVES: Transcatheter aortic valve implantation (TAVI) is often undertaken in the oldest frailest cohort of patients undergoing cardiac interventions. We plan to investigate the potential benefit of cardiac rehabilitation (CR) in this vulnerable population. DESIGN: We undertook a pilot randomised trial of CR following TAVI to inform the feasibility and design of a future randomised clinical trial (RCT). PARTICIPANTS: We screened patients undergoing TAVI at a single institution between June 2016 and February 2017. INTERVENTIONS: Participants were randomised post-TAVI to standard of care (control group) or standard of care plus exercise-based CR (intervention group). OUTCOMES: We assessed recruitment and attrition rates, uptake of CR, and explored changes in 6-min walk test, Nottingham Activities of Daily Living, Fried and Edmonton Frailty scores and Hospital Anxiety and Depression Score, from baseline (30 days post TAVI) to 3 and 6 months post randomisation. We also undertook a parallel study to assess the use of the Kansas City Cardiomyopathy Questionnaire (KCCQ) in the post-TAVI population. RESULTS: Of 82 patients screened, 52 met the inclusion criteria and 27 were recruited (3 patients/month). In the intervention group, 10/13 (77%) completed the prescribed course of 6 sessions of CR (mean number of sessions attended 7.5, SD 4.25) over 6 weeks. At 6 months, all participants were retained for follow-up. There was apparent improvement in outcome scores at 3 and 6 months in control and CR groups. There were no recorded adverse events associated with the intervention of CR. The KCCQ was well accepted in 38 post-TAVI patients: mean summary score 72.6 (SD 22.6). CONCLUSIONS: We have demonstrated the feasibility of recruiting post-TAVI patients into a randomised trial of CR. We will use the findings of this pilot trial to design a fully powered multicentre RCT to inform the provision of CR and support guideline development to optimise health-related quality of life outcomes in this vulnerable population. Retrospectively registered 3rd October 2016 clinicaltrials.gov NCT02921880. TRIAL REGISTRATION: Clinicaltrials.Gov identifier NCT02921880.

Transcatheter Aortic Valve Replacement to Treat Liver Decompensation.

•Critical aortic stenosis can cause severe biventricular disease.•Painless jaundice can present secondary to severe biventricular failure.•TAVR treats high-risk critical aortic stenosis.•TAVR can reverse clinical and biochemical congestive hepatopathy.•High-risk TAVR can be performed using circulatory support.

Radial-Artery or Saphenous-Vein Grafts in Coronary-Artery Bypass Surgery.

BACKGROUND: The use of radial-artery grafts for coronary-artery bypass grafting (CABG) may result in better postoperative outcomes than the use of saphenous-vein grafts. However, randomized, controlled trials comparing radial-artery grafts and saphenous-vein grafts have been individually underpowered to detect differences in clinical outcomes. We performed a patient-level combined analysis of randomized, controlled trials to compare radial-artery grafts and saphenous-vein grafts for CABG. METHODS: Six trials were identified. The primary outcome was a composite of death, myocardial infarction, or repeat revascularization. The secondary outcome was graft patency on follow-up angiography. Mixed-effects Cox regression models were used to estimate the treatment effect on the outcomes. RESULTS: A total of 1036 patients were included in the analysis (534 patients with radial-artery grafts and 502 patients with saphenous-vein grafts). After a mean (±SD) follow-up time of 60±30 months, the incidence of adverse cardiac events was significantly lower in association with radial-artery grafts than with saphenous-vein grafts (hazard ratio, 0.67; 95% confidence interval [CI], 0.49 to 0.90; P=0.01). At follow-up angiography (mean follow-up, 50±30 months), the use of radial-artery grafts was also associated with a significantly lower risk of occlusion (hazard ratio, 0.44; 95% CI, 0.28 to 0.70; P<0.001). As compared with the use of saphenous-vein grafts, the use of radial-artery grafts was associated with a nominally lower incidence of myocardial infarction (hazard ratio, 0.72; 95% CI, 0.53 to 0.99; P=0.04) and a lower incidence of repeat revascularization (hazard ratio, 0.50; 95% CI, 0.40 to 0.63; P<0.001) but not a lower incidence of death from any cause (hazard ratio, 0.90; 95% CI, 0.59 to 1.41; P=0.68). CONCLUSIONS: As compared with the use of saphenous-vein grafts, the use of radial-artery grafts for CABG resulted in a lower rate of adverse cardiac events and a higher rate of patency at 5 years of follow-up. (Funded by Weill Cornell Medicine and others.).

'Porcelain aorta': a proposed definition and classification of ascending aortic calcification.

Introduction: 'Porcelain aorta' is listed in the second consensus document of the Valve Academic Research Consortium as a risk factor in aortic valve replacement. However, the extent of circumferential involvement is poorly defined with great variability in reported incidence. We present a simple, reproducible classification to describe the extent of aortic calcification and thus appropriately define 'porcelain aorta', aiding clinical decision-making and registry data collection. Methods: 175 consecutive CT aortograms were reviewed. The aorta was divided into three sections, and each section divided into quadrants. These were individually scored using a 5-point scale (0-no calcification, 5-complete contiguous calcification).Results for each quadrant were summated for each segment to provide an indication of the distribution of calcification. Results: Only one patient (0.6%) had a 'true' porcelain aorta, defined as contiguous calcification across all quadrants at any aortic level. Intraobserver and interobserver variation was excellent for the ascending aorta (K=0.85-0.88 and 0.81-0.96, respectively) while the interobserver variation in the transverse arch was good at 0.75. Conclusions: Our data suggest the incidence of 'true' porcelain aorta may be significantly lower than reported in the literature. The predominance of calcification within the anterior wall of the proximal ascending aorta and the superior wall of the transverse arch may be clinically important. Application of this quick, simple and reproducible grading system, with no requirement for advanced software, may provide a tool to support accurate assessment of focal aortic calcification and its relationship to subsequent procedural risk.

Impact of Pre-Existing Prosthesis-Patient Mismatch on Survival Following Aortic Valve-in-Valve Procedures.

OBJECTIVES: The aim of this study was to determine whether the association of small label size of the surgical valve with increased mortality after transcatheter valve-in-valve (ViV) implantation is, at least in part, related to pre-existing prosthesis-patient mismatch (PPM) (i.e., a bioprosthesis that is too small in relation to body size). BACKGROUND: Transcatheter ViV implantation is an alternative for the treatment of patients with degenerated bioprostheses. Small label size of the surgical valve has been associated with increased mortality after ViV implantation. METHODS: Data from 1,168 patients included in the VIVID (Valve-in-Valve International Data) registry were analyzed. Pre-existing PPM of the surgical valve was determined using a reference value of effective orifice area for each given model and size of implanted prosthetic valve indexed for body surface area. Severe PPM was defined according to the criteria proposed by the Valve Academic Research Consortium 2: indexed effective orifice area <0.65 cm2/m2 if body mass index is <30 kg/m2 and <0.6 cm2/m2 if BMI is ≥30 kg/m2. The primary study endpoint was 1-year mortality. RESULTS: Among the 1,168 patients included in the registry, 89 (7.6%) had pre-existing severe PPM. Patients with severe PPM had higher 30-day (10.3%, p = 0.01) and 1-year (unadjusted: 28.6%, p < 0.001; adjusted: 19.3%, p = 0.03) mortality rates compared with patients with no severe PPM (4.3%, 11.9%, and 10.9%, respectively). After adjusting for surgical valve label size, Society of Thoracic Surgeons score, renal failure, diabetes, and stentless surgical valves, presence of pre-existing severe PPM was associated with increased risk for 1-year mortality (odds ratio: 1.88; 95% confidence interval: 1.07 to 3.28; p = 0.03). Patients with severe PPM also more frequently harbored high post-procedural gradients (mean gradient ≥20 mm Hg). CONCLUSIONS: Pre-existing PPM of the failed surgical valve is strongly and independently associated with increased risk for mortality following ViV implantation.

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

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.

Standardized definition of structural valve degeneration for surgical and transcatheter bioprosthetic aortic valves

ABSTRACT: 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.

Novel United Kingdom prognostic model for 30-day mortality following transcatheter aortic valve implantation.

OBJECTIVE: Existing clinical prediction models (CPM) for short-term mortality after transcatheter aortic valve implantation (TAVI) have limited applicability in the UK due to moderate predictive performance and inconsistent recording practices across registries. The aim of this study was to derive a UK-TAVI CPM to predict 30-day mortality risk for benchmarking purposes. METHODS: A two-step modelling strategy was undertaken: first, data from the UK-TAVI Registry between 2009 and 2014 were used to develop a multivariable logistic regression CPM using backwards stepwise regression. Second, model-updating techniques were applied using the 2013-2014 data, thereby leveraging new approaches to include frailty and to ensure the model was reflective of contemporary practice. Internal validation was performed by bootstrapping to estimate in-sample optimism-corrected performance. RESULTS: Between 2009 and 2014, up to 6339 patients were included across 34 centres in the UK-TAVI Registry (mean age, 81.3; 2927 female (46.2%)). The observed 30-day mortality rate was 5.14%. The final UK-TAVI CPM included 15 risk factors, which included two variables associated with frailty. After correction for in-sample optimism, the model was well calibrated, with a calibration intercept of 0.02 (95% CI -0.17 to 0.20) and calibration slope of 0.79 (95% CI 0.55 to 1.03). The area under the receiver operating characteristic curve, after adjustment for in-sample optimism, was 0.66. CONCLUSION: The UK-TAVI CPM demonstrated strong calibration and moderate discrimination in UK-TAVI patients. This model shows potential for benchmarking, but even the inclusion of frailty did not overcome the need for more wide-ranging data and other outcomes might usefully be explored.

Anatomy of the Tricuspid Valve, Pathophysiology of Functional Tricuspid Regurgitation, and Implications for Percutaneous Therapies.

The tricuspid valve is a complex dynamic apparatus made up of many different closely linked structures: the annulus, the three leaflets, the chordae, the papillary muscles and the right ventricle. Other nearby structures, such as the coronary sinus ostium, the conduction system, the membranous septum, and the right coronary artery must be taken into account when dealing with the tricuspid. Annulus dilation and leaflet tethering due to right ventricular remodeling are the 2 major mechanisms responsible for most tricuspid regurgitation cases. Precise knowledge of tricuspid anatomy and function, as well as careful preoperative planning, is fundamental for successful transcatheter tricuspid procedures.