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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.

The Society for Cardiovascular Angiography and Interventions (SCAI) Think Tank is a collaborative venture that brings together interventional cardiologists, administrative partners, and select members of the cardiovascular industry community annually for high-level field-wide discussions. The 2021 Think Tank was organized into four parallel sessions reflective of the field of interventional cardiology: (a) coronary intervention, (b) endovascular medicine, (c) structural heart disease, and (d) congenital heart disease. Each session was moderated by a senior content expert and co-moderated by a member of SCAI's Emerging Leader Mentorship program. This document presents the proceedings to the wider cardiovascular community in order to enhance participation in this discussion, create additional dialog from a broader base, and thereby aid SCAI, the industry community and external stakeholders in developing specific action items to move these areas forward.

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 or saphenous vein grafts for coronary artery bypass grafting at long-term follow-up.Design, Setting, and Participants. Patient-level pooled analysis comparing radial artery and saphenous vein grafts in adult patients undergoing isolated coronary artery bypass grafting from five countries (Australia, Italy, Serbia, South Korea, and United Kingdom; enrollment years: 1997 to 2009, follow-up completed in 2019).Intervention. Patients were randomized to receive either radial artery or saphenous vein 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. 1036 patients (534 radial artery group) were randomized (mean age 66.6 vs 67.1 years, males 70.4% vs 69.9% in the radial artery and the saphenous vein groups, respectively); 942 (90.9%) of the originally randomized patients completed 10 years of follow-up (510 radial artery group). At a median follow-up of 10 years (interquartile range 10-11), the use of the radial artery was associated with a statistically significant reduction in the incidence of the composite outcome of death, myocardial infarction or repeat revascularization (220 vs 237 events; 41 vs 47 events per 1000 patient-years; hazard ratio[HR] 0.73, 95%confidence interval[CI] 0.61-0.88, pConclusions 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 saphenous vein grafts was associated with a lower risk of a composite of cardiovascular outcomes.

Highlights • 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., Graphical 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.

Background: Conventional mitral valve (MV) operations allow direct anatomic assessment and repair on an arrested heart, but require cardiopulmonary bypass, aortic cross-clamping, sternotomy...

Objectives The study sought to determine the risk factors for post-transcatheter aortic valve replacement (TAVR) dialysis and to determine the impact of pre-TAVR or post-TAVR dialysis on mortality. Background TAVR is now established as an alternative treatment to surgical aortic valve replacement. Data examining the impact of dialysis on outcomes after TAVR are lacking. Methods The UK TAVI (Transcatheter Aortic Valve Implantation) Registry was established to report outcomes on all TAVR procedures performed within the United Kingdom (2007 to 2014). Data were collected prospectively on 6,464 patients with a median follow-up of 625 days. Results The proportion of patients on dialysis before TAVR has remained constant at 1.8%. After TAVR, the proportion of patients newly needing dialysis after TAVR has fallen from 6.1% (2007 to 2008) to 2.3% (2013 to 2014). The risk of new dialysis requirement after TAVR was independently associated with lower baseline renal function, year of procedure, impaired left ventricular function, diabetes, use of an Edwards valve, a nontransfemoral approach, need for open surgery, and moderate-to-severe aortic regurgitation after the procedure. Requirement for new dialysis after TAVR was associated with higher mortality at 30 days (hazard ratio: 6.44; 95% confidence interval: 4.87 to 8.53) and at 4 years (hazard ratio: 3.54; 95% confidence interval: 2.99 to 4.19; p Conclusions The proportion of patients needing dialysis after TAVR has decreased over time. Post-TAVR dialysis is associated with increased mortality. Factors identified with dialysis requirement after TAVR require further investigation.

Background\ud Aortic stenosis (AS) poses a perioperative management dilemma to physicians looking after patients who require non-cardiac surgery. The objective of this review is to investigate mortality and adverse cardiovascular events in patients with and without AS who underwent non-cardiac surgery.\ud \ud Methods\ud We searched MEDLINE and EMBASE for studies that evaluated mortality and adverse cardiovascular events in patients with and without AS who underwent non-cardiac surgery. Pooled risk ratios for mortality and adverse outcomes (myocardial infarction, stroke, heart failure, death) were calculated using the dichotomous analysis method and subgroup analysis was performed considering the effect of severity of AS and symptoms.\ud \ud Results\ud We identified 9 relevant studies with 29,327 participants. Among studies of severe AS, there was no significant difference in mortality (RR: 1.49, 95%CI:0.85–2.61; P = 0.16) associated with non-cardiac surgery, but there was a significant increase in the composite adverse outcome (RR: 2.30, 95%CI:1.33–3.97; P = 0.003). When the analysis involved any other degree of AS, eight studies were included and the pooled results showed a significant increase in composite adverse outcome (RR: 1.64, 95%CI:1.23–2.19; P < 0.001) and myocardial infarction (RR: 1.90, 95%CI:1.54–2.34; P < 0.001). When patients with asymptomatic AS were considered, the pooled results of four studies suggested an increased risk of composite adverse outcomes (RR: 1.59, 95%CI:1.19–2.12; P = 0.002) but not mortality, myocardial infarction, heart failure or stroke.\ud \ud Conclusions\ud Patients with AS undergoing non-cardiac surgery have not been shown to be at increased risk of mortality, but have significantly higher rates of adverse cardiovascular events compared to patients without AS.

Background The direct aortic (DA) approach allows for transcatheter aortic valve implantation (TAVI) in patients with difficult peripheral vascular anatomy. The CoreValve ADVANCE Direct Aortic (ADVANCE DA) study was performed to assess the outcomes of DA TAVI with the CoreValve System (Medtronic, Minneapolis, MN) in routine practice. Methods Patients were selected for the DA approach by local cardiac surgical teams, and TAVI was performed with patients under general anesthesia. Safety events were adjudicated according to the Valve Academic Research Consortium-2 definitions by an independent clinical events committee. All imaging data, including that from multislice computed tomography and follow-up echocardiography, were analyzed by an independent core laboratory. Results From September 2012 to February 2014, 100 patients were enrolled (52.0% male, age 81.9 ± 5.9 years, The Society of Thoracic Surgeons Score 5.9 ± 3.2%) at 9 centers in Europe. Peripheral vascular disease was present in 51.0% of patients, and 38.0% had diabetes. Of the 100 patients enrolled, 92 underwent TAVI. At 30 days after TAVI, 98.1% were free of moderate or severe paravalvular leak. At 1 year, 16 patients had died (Kaplan-Meier rate 17.9%), 1 (1.1%) patient had had a stroke, classified as nondisabling, and 15 (17.0%) patients had received a permanent pacemaker. Most patients experienced improved quality of life as measured by the Kansas City Cardiomyopathy Questionnaire overall summary score (mean change from baseline to 1 year, 39.6 ± 26.3; p Conclusions The DA approach provides a feasible alternative for patients with challenging anatomic features that may otherwise preclude use of the TAVI procedure.

Graphical abstract, Highlights • Primary mitral regurgitation (MR) is commonly due to mitral valve (MV) prolapse. • Off-pump minimally invasive MV repair is an alternative to conventional MV surgery. • This case describes MV repair using the Harpoon TSD-5 device. • The technique facilitates image-guided minimally invasive repair. • Early data suggest the Harpoon procedure is safe and durable and reduces morbidity.

The society for cardiovascular angiography and interventions (SCAI) think tank is a collaborative venture that brings together interventional cardiologists, administrative partners, and select members of the cardiovascular industry community for high-level field-wide discussions. The 2020 think tank was organized into four parallel sessions reflective of the field of interventional cardiology: (a) coronary intervention, (b) endovascular medicine, (c) structural heart disease, and (d) congenital heart disease (CHD). Each session was moderated by a senior content expert and co-moderated by a member of SCAI's emerging leader mentorship program. This document presents the proceedings to the wider cardiovascular community in order to enhance participation in this discussion, create additional dialogue from a broader base, and thereby aid SCAI and the industry community in developing specific action items to move these areas forward.

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. (C) 2019 by the American College of Cardiology Foundation.

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.

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.

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.

Objectives The authors present the UK and Irish real-world learning curve experience of the Evolut R transcatheter heart valve. Background The Evolut R is a self-expanding, repositionable, and fully recapturable second-generation transcatheter heart valve with several novel design features to improve outcomes and reduce complications. Methods Clinical, procedural, and 30-day outcome data were prospectively collected for the first 264 patients to receive the Evolut R valve in the United Kingdom and Ireland. Results A total of 264 consecutive Evolut R implantations were performed across 9 centers. The mean age was 81.1 ± 7.8 years, and the mean logistic European System for Cardiac Operative Risk Evaluation score was 19.9 ± 13.7%. Procedural indications included aortic stenosis (72.0%), mixed aortic valve disease (17.4%), and failing aortic valve bioprostheses (10.6%). Conscious sedation was used in 39.8% of patients and transfemoral access in 93.6%. The procedural success rate was 91.3%, and paravalvular leak immediately after implantation was mild or less in 92.3%. Major complications were rare: cardiac tamponade in 0.4%, conversion to sternotomy in 0.8%, annular rupture in 0.0%, coronary occlusion in 0.8%, major vascular in 5.3%, acute kidney injury in 6.1%, new permanent pacemaker implantation in 14.7%, and procedure-related death in 0.0%. At 30-day follow-up, survival was 97.7%, paravalvular leak was mild or less in 92.3%, and the stroke rate was 3.8%. Conclusions This registry represents the largest published real-world experience of the Evolut R valve. The procedural success rate was high and safety was excellent, comparable with previous studies of the Evolut R valve and other second-generation devices. The low rate of complications represents an improvement on first-generation devices.

AIMS Our aim was to assess one-year outcomes of patients enrolled in the pilot European Sentinel Registry of Transcatheter Aortic Valve Implantation (TAVI). METHODS AND RESULTS One-year outcomes of 4,571 patients (81.4±7.2 years, 2,291 [50.1%] male) receiving TAVI with the SAPIEN XT (57.3%) or CoreValve prosthesis at 137 European centres were analysed using Kaplan-Meier and Cox proportional hazards regression techniques. At one year, 3,341 patients were alive, 821 had died, and 409 were lost to follow-up. Of 2,125 patients who underwent functional assessment, 1,916 (90%) were in New York Heart Association (NYHA) Class I/II at one year, with functional improvement from baseline noted in 1,682 patients (88%). One-year survival based on 4,564 patients was estimated at 79.1%. Independent baseline predictors of mortality were increasing age and logistic EuroSCORE, the presence of NYHA III/IV, chronic obstructive pulmonary disease, and atrial fibrillation. Female gender was associated with a 4% survival benefit at one year. Vascular access routes other than transfemoral were associated with poorer survival. Procedural failure and major periprocedural complications had an adverse impact on survival. CONCLUSIONS Contemporary European experience attests to the effectiveness of routine TAVI in unselected elderly patients.

Posttraumatic tricuspid valve regurgitation (TR) is a rare entity and is almost always associated with blunt chest trauma. It is usually identified by transthoracic echocardiography after the manifestation of clinical symptoms of heart failure. Treatment varies from long-term medical therapy and observation to surgical correction with tricuspid valve replacement or repair. We describe the case of a 26-year-old man who was involved in a major road traffic accident and was referred for surgical repair a year later because of severe posttraumatic TR. The tricuspid valve was successfully reconstructed with a CardioCel patch, Gore-Tex neochordae, and a tricuspid ring. The patient recovered well.

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.

The long-term benefits of multiple arterial revascularization (MAR) in coronary artery bypass grafting remain uncertain. The aim of this study was to investigate the clinical outcome, graft patency, and need for subsequent target revascularization of radial artery (RA) versus saphenous vein graft in patients undergoing MAR in both patient- and graft-specific analyses.Between 2001 and 2016, we followed 1654 patients over a median of 7.4 years in a prospective, longitudinal study. Major adverse cardiac and cerebrovascular events, graft patency, and need for revascularization were assessed through clinical manifestation, coronary angiography, or coronary computed tomography and analyzed with propensity score-adjusted Cox regression, general estimating equation, and competing risk models.Bilateral internal thoracic artery (BITA) grafting was performed in 910 patients (55.0%), and 744 patients (45.0%) received a left internal thoracic artery graft together with at least 1 RA graft. Patients receiving BITA, of whom 187 received an additional RA, showed improved survival (hazard ratio, 0.57; 95% confidence interval [CI], 0.38-0.86; P = .009), major adverse cardiac and cerebrovascular event-free survival (hazard ratio, 0.33; 95% CI, 0.23-0.46; P .001), and lower need for repeat revascularization (subhzhard ratio, 0.59; 95% CI, 0.39-0.90; P = .015). In a subgroup of 512 patients, comparing 419 RA with 487 saphenous vein grafts, RA grafting showed a lower risk for graft occlusion (odds ratio, 0.59; 95% CI, 0.47-0.73; P .001) and target revascularization (subhazard ratio, 0.58; 95% CI, 0.43-0.78; P .001).MAR with BITA and RA grafting revealed to be the recommended strategy in coronary artery bypass grafting to achieve long-term beneficial results. The use of saphenous vein graft showed less favorable outcomes regarding patency and the need for target-vessel revascularization.

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; PCONCLUSIONS: 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.).

OBJECTIVES The first transcatheter aortic valve implantation (TAVI) in England and Wales was performed in 2007. This study presents the subsequent national activity and outcomes for both TAVI and aortic valve replacement (AVR). METHODS Data for all AVR and TAVI procedures between January 2006 and December 2012 in England and Wales were included. The number of procedures, patient characteristics, in-hospital and 30-day mortality, postoperative length of stay (PLOS) and survival were analysed separately for: isolated AVR; AVR + coronary artery bypass graft (CABG) surgery; AVR + other surgery and TAVI. RESULTS The number of TAVIs increased from 66 in 2007 (0.8% of all implants) to 1186 in 2012 (10.9% of all implants). AVR activity also increased over the study period. TAVI patients were older and had a higher mean logistic EuroSCORE than all AVR groups. The 30-day mortality rates were 2.1% for isolated AVR, 3.9% for AVR + CABG, 7.7% for AVR + other surgery and 6.2% for TAVI. In-hospital mortality has significantly improved for all groups. The 5-year survival rates were 82.6% for isolated AVR, 81.7% for AVR + CABG, 74.5% for AVR + other surgery and 46.1% for TAVI. The median PLOS after TAVI was similar to that of isolated AVR but shorter than that of the other AVR groups. CONCLUSIONS Since the introduction of TAVI, there has been an increase in both TAVI and AVR activity. TAVIs now represent over 10% of all aortic valve implants. There are distinct differences between procedural groups with respect to patient risk factors. Outcomes for all procedural groups have improved, but long-term TAVI results are required before its role in the treatment of aortic stenosis can be fully defined.

Knowledge regarding gender-specific results of percutaneous edge-to-edge mitral valve repair is scarce. The aim of this study was to investigate gender differences in outcomes in a cohort of patients treated with MitraClip implantation. A multicenter registry of 173 patients treated with MitraClip prostheses from 2009 to 2012 at 3 experienced centers was performed. One hundred nine patients (63%) were men. Men were younger (mean age 73 ± 10 vs 79 ± 9 years, p = 0.001) and had a higher prevalence of previous coronary bypass graft surgery (34% vs 13%, p = 0.002), previous myocardial infarction (46% vs 20%, p = 0.001), and diabetes mellitus (26% vs 11%, p = 0.020). There were no differences regarding New York Heart Association (NYHA) functional class before the intervention (NYHA class III or IV in 95% of men vs 97% of women, p = 0.472) or the cause of mitral regurgitation (MR) (functional in 58% of men vs 48% of women, p = 0.233). Men exhibited significantly larger ventricles (mean indexed left ventricular end-systolic diameter 2.4 ± 0.8 vs 2.0 ± 1.6 cm/m2, p = 0.002, and mean indexed left ventricular end-diastolic volume 92.7 ± 46.1 vs 59.9 ± 24.6 ml/m2, p

Objectives The U.K. Transcatheter Aortic Valve Implantation Registry reported 30-day and 1-year mortality rates of 7.1% and 21.4%, respectively, for patients who underwent transcatheter aortic valve replacement (TAVR) in the United Kingdom between 2007 and 2009. The study aim was to report long-term outcomes in this same cohort of patients. Background There are few data on outcomes beyond 3 years after TAVR in any notable number of patients. Methods Data from all TAVR procedures performed in the United Kingdom between January 2007 and December 2009 were prospectively collected. All-cause mortality status was reported in March 2014. Mortality tracking was achieved in 97.7% patients. Results The minimal time from replacement to census was 4.1 years, and the maximal time was 7.0 years. The 3- and 5-year survival rates were 61.2% and 45.5%, respectively. Independent predictors of 3-year mortality were renal dysfunction (hazard ratio [HR]: 1.65), atrial fibrillation (HR: 1.36), logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) ≥18.5 (HR: 1.33), respiratory dysfunction (HR: 1.28), and ventricular dysfunction (left ventricular ejection fraction Conclusions In the large U.K. Transcatheter Aortic Valve Implantation Registry, long-term outcomes after TAVR are favorable with 3- and 5-year survival rates of 61.2% and 45.5%, respectively. Long-term survival after TAVR is largely determined by intrinsic patient factors. Other than stroke, procedural variables, including paravalvular aortic leak, did not appear to be independent predictors of long-term survival.

The most likely mechanisms of neurologic injury after transcatheter aortic valve implantation (TAVI) and aortic valve replacement (AVR) are cerebral embolization and hypoperfusion. We set out to determine potential mechanisms of neurologic injury after TAVI compared with AVR.One hundred twenty-seven consecutive high-risk patients with severe aortic stenosis (AS) who underwent TAVI (n = 85) or AVR (n = 42) were studied. Transcranial Doppler ultrasound (TCD), cerebral oximetry, diffusion-weighted magnetic resonance imaging (DW-MRI) (before, 6 days, and 3 months after procedure), and neurocognitive assessment before and at 3 months were performed.Neurologic injury was not significantly different between TAVI and AVR at 1 (1.1% vs 2.2%, p = 0.25) and 3 months (4.7% vs 2.2%, p = 1). At 3 months, overall cognitive score was higher in AVR compared with TAVI when adjusted for baseline score; the estimated difference between groups was 0.63 (95% confidence interval 0.87% to 1.17%; p = 0.02). Cerebral embolic load was 212 (123 to 344) during AVR and 134 (76 to 244) during TAVI (p = 0.07). Cerebral oxygen desaturation during AVR (7.56 ± 2.16) was higher compared with TAVI (5.93 ± 2.47) (p0.01). Ischemic lesions measured by DW-MRI occurred in 76% of TAVI and 71% of AVR patients at 6 days (p = 0.69) and 63% and 39% at 3 months (p = 0.11). No significant association was found between cerebral emboli, cerebral oxygen desaturation, brain ischemic lesions, and general cognitive score.At 3 months follow-up, overall cognitive score was higher in AVR compared with TAVI, adjusted for baseline score. However, there was no difference in cerebral embolic load, ischemic lesions, and oxygen desaturation.

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.

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.

Conventional mitral valve (MV) operations allow direct anatomic assessment and repair on an arrested heart, but require cardiopulmonary bypass, aortic cross-clamping, sternotomy or thoracotomy, and cardioplegic cardiac arrest, and are associated with significant perioperative disability, and risks of morbidity and mortality.This study evaluated safety and performance of a transesophageal echocardiographic-guided device designed to implant artificial expanded polytetrafluoroethylene (ePTFE) cords on mitral leaflets in the beating heart.In a prospective multicenter study, 30 consecutive patients with severe degenerative mitral regurgitation (MR) were treated with a mitral valve repair system (MVRS) via small left thoracotomy. The primary (30-day) endpoint was successful implantation of cords with MR reduction to moderate or less.The primary endpoint was met in 27 of 30 patients (90%). Three patients required conversion to open mitral surgery. There were no deaths, strokes, or permanent pacemaker implantations. At 1 month, MR was mild or less in 89% (24 of 27) and was moderate in 11% (3 of 27). At 6 months, MR was mild or less in 85 % (22 of 26), moderate in 8% (2 of 26), and severe in 8% (2 of 26). Favorable cardiac remodeling at 6 months included decreases in end-diastolic (161 ± 36 ml to 122 ± 30 ml; p0.001) and left atrial volumes (106 ± 36 ml to 69 ± 24 ml; p0.001). The anterior-posterior mitral annular dimension decreased from 34.7 ± 5.8 mm to 28.2 ± 5.1 mm; p0.001 as did the mitral annular area (10.0 ± 2.7 cmMVRS ePTFE cordal implantation can reduce the invasiveness and morbidity of conventional MV surgery. The device's safety profile is promising and prospective trials comparing the outcomes of the MVRS to conventional MV repair surgery are warranted. (CE Mark Study for the Harpoon Medical Device [TRACER]; NCT02768870).

Aims: To critically review the available transcatheter aortic valve implantation techniques and their results, as well as propose recommendations for their use and development. Methods and results: A committee of experts including European Association of Cardio-Thoracic Surgery and European Society of Cardiology representatives met to reach a consensus based on the analysis of the available data obtained with transcatheter aortic valve implantation and their own experience. The evidence suggests that this technique is feasible and provides haemodynamic and clinical improvement for up to 2 years in patients with severe symptomatic aortic stenosis at high risk or with contraindications for surgery. Questions remain mainly concerning safety and tong-term durability, which have to be assessed. Surgeons and cardiologists working as a team should select candidates, perform the procedure, and assess the results. Today, the use of this technique should be restricted to high-risk patients or those with contraindications for surgery. However, this may be extended to lower risk patients if the initial promise holds to be true after careful evaluation. Conclusion: Transcatheter aortic valve implantation is a promising technique, which may offer an alternative to conventional surgery for high-risk patients with aortic stenosis. Today, careful evaluation is needed to avoid the risk of uncontrolled diffusion. (C) 2008 The European Society of Cardiology, European Association for Cardio-Thoracic Surgery, and Europa Edition. All rights reserved.

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).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.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 cmAmong 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).Pre-existing PPM of the failed surgical valve is strongly and independently associated with increased risk for mortality following ViV implantation.

This study sought to determine the risk factors for post-transcatheter aortic valve replacement (TAVR) dialysis and to determine the impact of pre-TAVR or post-TAVR dialysis on mortality.TAVR is now established as an alternative treatment to surgical aortic valve replacement. Data examining the impact of dialysis on outcomes after TAVR are lacking.The UK TAVI (Transcatheter Aortic Valve Implantation) Registry was established to report outcomes on all TAVR procedures performed within the United Kingdom (2007 to 2014). Data were collected prospectively on 6,464 patients with a median follow-up of 625 days.The proportion of patients on dialysis before TAVR has remained constant at 1.8%. After TAVR, the proportion of patients newly needing dialysis after TAVR has fallen from 6.1% (2007 to 2008) to 2.3% (2013 to 2014). The risk of new dialysis requirement after TAVR was independently associated with lower baseline renal function, year of procedure, impaired left ventricular function, diabetes, use of an Edwards valve, a nontransfemoral approach, need for open surgery, and moderate-to-severe aortic regurgitation after the procedure. Requirement for new dialysis after TAVR was associated with higher mortality at 30 days (hazard ratio: 6.44; 95% confidence interval: 4.87 to 8.53) and at 4 years (hazard ratio: 3.54; 95% confidence interval: 2.99 to 4.19; p 0.001 for all) compared with patients without dialysis requirement.The proportion of patients needing dialysis after TAVR has decreased over time. Post-TAVR dialysis is associated with increased mortality. Factors identified with dialysis requirement after TAVR require further investigation.

Background The use of transcatheter mitral valve repair (TMVR) has gained widespread acceptance in Europe, but data on immediate success, safety, and long-term echocardiographic follow-up in real-world patients are still limited. Objectives The aim of this multinational registry is to present a real-world overview of TMVR use in Europe. Methods The Transcatheter Valve Treatment Sentinel Pilot Registry is a prospective, independent, consecutive collection of individual patient data. Results A total of 628 patients (mean age 74.2 ± 9.7 years, 63.1% men) underwent TMVR between January 2011 and December 2012 in 25 centers in 8 European countries. The prevalent pathogenesis was functional mitral regurgitation (FMR) (n = 452 [72.0%]). The majority of patients (85.5%) were highly symptomatic (New York Heart Association functional class III or higher), with a high logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) (20.4 ± 16.7%). Acute procedural success was high (95.4%) and similar in FMR and degenerative mitral regurgitation (p = 0.662). One clip was implanted in 61.4% of patients. In-hospital mortality was low (2.9%), without significant differences between groups. The estimated 1-year mortality was 15.3%, which was similar for FMR and degenerative mitral regurgitation. The estimated 1-year rate of rehospitalization because of heart failure was 22.8%, significantly higher in the FMR group (25.8% vs. 12.0%, p[log-rank] = 0.009). Paired echocardiographic data from the 1-year follow-up, available for 368 consecutive patients in 15 centers, showed a persistent reduction in the degree of mitral regurgitation at 1 year (6.0% of patients with severe mitral regurgitation). Conclusions This independent, contemporary registry shows that TMVR is associated with high immediate success, low complication rates, and sustained 1-year reduction of the severity of mitral regurgitation and improvement of clinical symptoms.

Objective Current guidelines recommend that most patients aged ≥65 years should undergo mitral valve replacement (MVR) using a biological prosthesis. The objectives of this study were to assess whether these guidelines are being followed in UK practice, and to investigate whether the guidelines are appropriate based on in-hospital mortality and mid-term survival. Methods Data from the National Institute for Cardiovascular Outcomes Research Adult Cardiac Surgery Audit database from all National Health Service (NHS) hospitals and some private hospitals performing adult cardiac surgery in the UK between April 2001 and March 2011 were analysed. The overall cohort included 3862 patients aged ≥65 years who underwent first-time MVR. Propensity score matching and regression adjustment were used to compare outcomes between prosthesis groups. Results The mean age was 73.0 years (SD 4.9) with 50% of patients having surgery with a mechanical prosthesis. This proportion decreased over the study period and with increasing patient age with marked variation between hospitals. In the propensity-matched cohort, in-hospital mortality in the biological group was 6.9%, and in the mechanical group it was 5.9% giving an unadjusted OR of 1.17 (95% CI 0.84 to 1.63). There was no significant difference in mid-term survival between the matched groups with an unadjusted HR for biological prosthesis of 1.08 (95% CI 0.93 to 1.24). Similar results were found when using regression adjustment on unmatched data. Conclusions Current guidelines concerning age and mitral valve prosthesis choice are not being followed for patients aged ≥65 years. With regards to in-hospital and mid-term mortality, this study demonstrates that there is no difference between prosthesis types.

Objectives This study aimed to assess the clinical and echocardiographic results of MitraClip implantation in noncentral degenerative mitral regurgitation (dMR) compared with central dMR. Background It is unknown whether the use of MitraClip therapy in noncentral dMR is as safe and effective as in central dMR. Methods We analyzed a multicenter registry of 173 patients treated with the MitraClip and compared results of central and noncentral dMR. Results Seventy-nine patients (age 79.2 ± 8.0 years, 58.2% men) had dMR. Forty-nine patients (62%) had central dMR, with the remainder classified as noncentral dMR (n = 30, 38%). Patients with noncentral dMR had a wider pre-procedural vena contracta (8.5 ± 2.0 mm vs. 6.9 ± 2.2 mm, p = 0.039) and higher systolic pulmonary pressure (57.9 ± 18.0 vs. 47.3 ± 13.0 mm Hg, p = 0.019). Procedural success was the same in both groups (95.5% central vs. 96.7% noncentral, p = 0.866). Post-procedural MR and New York Heart Association (NYHA) functional class at 1 month (MR ≤2, 96.0% vs. 96.6%, p = 0.866, and NYHA functional class ≤II, 81.6% vs. 90.0%, p = 0.335) and 6 months (95.2% central vs. 91.7% noncentral, p = 0.679; and NYHA functional class >II, 21.1% vs. 0%, p = 0.128) did not differ between groups. There were also no differences in serious post-procedural adverse events: partial clip detachment (central n = 1 [2.0%] vs. noncentral n = 1 [3.3%], p = 1.000), death (5.4% central vs. 13.0% noncentral, p = 0.298), or heart failure admission (10.8% central vs. 8.7% noncentral, p = 0.791). Conclusions In experienced centers, MitraClip treatment can be performed safely and effectively in both central and noncentral dMR.

During the past 2 decades, the dynamic nature of valvular heart disease has become a recognized phenomenon. Changes in loading conditions, heart rate, and ventricular contractility that occur with exercise can alter the physiological effects of valvular disease.1,2 Disparity between resting evaluation of valve dysfunction and patient symptoms is not uncommon. Stress echocardiography (SE) has emerged as a modality able to provide new diagnostic information by identifying dynamic changes in the severity of valve stenosis on exertion responsible for symptoms and evaluate the severity of valve disease in altered flow states.3 This review seeks to review critically the existing evidence base, identify new emerging prognostic markers, evaluate their role in clinical practice, and identify future directions for research. The clinical scenarios where SE aids diagnosis and has prognostic value include the evaluation of asymptomatic severe aortic stenosis (AS), low-flow (LF), low-gradient (LG) AS, and moderate AS with symptoms (Table). View this table: Table. Clinical Use of Stress Echocardiography in Stenotic Valvular Heart Disease The prognosis of patients with symptomatic, severe AS is dismal.4 The prognosis for those who are asymptomatic is more favorable with a

Objectives The authors sought to examine the adoption of transcatheter aortic valve replacement (TAVR) in Western Europe and investigate factors that may influence the heterogeneous use of this therapy. Background Since its commercialization in 2007, the number of TAVR procedures has grown exponentially. Methods The adoption of TAVR was investigated in 11 European countries: Germany, France, Italy, United Kingdom, Spain, the Netherlands, Switzerland, Belgium, Portugal, Denmark, and Ireland. Data were collected from 2 sources: 1) lead physicians submitted nation-specific registry data; and 2) an implantation-based TAVR market tracker. Economic indexes such as healthcare expenditure per capita, sources of healthcare funding, and reimbursement strategies were correlated to TAVR use. Furthermore, we assessed the extent to which TAVR has penetrated its potential patient population. Results Between 2007 and 2011, 34,317 patients underwent TAVR. Considerable variation in TAVR use existed across nations. In 2011, the number of TAVR implants per million individuals ranged from 6.1 in Portugal to 88.7 in Germany (33 ± 25). The annual number of TAVR implants performed per center across nations also varied widely (range 10 to 89). The weighted average TAVR penetration rate was low: 17.9%. Significant correlation was found between TAVR use and healthcare spending per capita (r = 0.80; p = 0.005). TAVR-specific reimbursement systems were associated with higher TAVR use than restricted systems (698 ± 232 vs. 213 ± 112 implants/million individuals ≥75 years; p = 0.002). Conclusions The authors' findings indicate that TAVR is underutilized in high and prohibitive surgical risk patients with severe aortic stenosis. National economic indexes and reimbursement strategies are closely linked with TAVR use and help explain the inequitable adoption of this therapy.

Background\ud The performance of emerging transcatheter aortic valve implantation (TAVI) clinical prediction models (CPMs) in national TAVI cohorts distinct from those where they have been derived is unknown. This study aimed to investigate the performance of the German Aortic Valve, FRANCE-2, OBSERVANT and American College of Cardiology (ACC) TAVI CPMs compared with the performance of historic cardiac CPMs such as the EuroSCORE and STS-PROM, in a large national TAVI registry.\ud \ud Methods\ud The calibration and discrimination of each CPM were analyzed in 6676 patients from the UK TAVI registry, as a whole cohort and across several subgroups. Strata included gender, diabetes status, access route, and valve type. Furthermore, the amount of agreement in risk classification between each of the considered CPMs was analyzed at an individual patient level.\ud \ud Results\ud The observed 30-day mortality rate was 5.4%. In the whole cohort, the majority of CPMs over-estimated the risk of 30-day mortality, although the mean ACC score (5.2%) approximately matched the observed mortality rate. The areas under ROC curve were between 0.57 for OBSERVANT and 0.64 for ACC. Risk classification agreement was low across all models, with Fleiss's kappa values between 0.17 and 0.50.\ud \ud Conclusions\ud Although the FRANCE-2 and ACC models outperformed all other CPMs, the performance of current TAVI-CPMs was low when applied to an independent cohort of TAVI patients. Hence, TAVI specific CPMs need to be derived outside populations previously used for model derivation, either by adapting existing CPMs or developing new risk scores in large national registries.

The tricuspid valve was virtually ignored for a long time in the past. However, significant tricuspid regurgitation (TR) often accompanies left-side heart valve pathology and does not always reverse with its correction. If left untreated, TR can progress and result in progressive right ventricular failure. Current guideline recommendations still hold minor differences. Nevertheless, there is a consensus to operate on patients with severe TR undergoing left-sided valve surgery (class I) or those with mild to moderate TR with a dilated annulus (≥40 or ≥21 mm 2 , Class IIa). However, in case of the primary TR, surgical options is limited by a relatively high risk of mortality and morbidity. For these patients, new percutaneous approaches are becoming available but no long-term data are still available. In this review, we provide a comprehensive overview of the epidemiological and pathophysiological aspects of TR, and the current and future directions of therapy.

Importance Postmarket evidence generation for medical devices is important yet limited for prosthetic aortic valve devices in the United Kingdom. Objective To identify prosthetic aortic valve models that display unexpected patterns of mortality or reintervention using routinely collected national registry data and record linkage. Design, Setting, and Participants This observational study used data from all National Health Service and private hospitals in England and Wales that submit data to the National Adult Cardiac Surgery Audit (NACSA). All patients undergoing first-time elective and urgent aortic valve replacement surgery (with or without coronary artery bypass grafting) with a biological (n = 15 series) or mechanical (n = 10 series) prosthetic valve from 5 primary suppliers, and satisfying prespecified data quality criteria (n = 43 782 biological; n = 11 084 mechanical) between 1998 and 2013 were included. Valves were classified into series of related models. Outcome tracking was performed using multifaceted record linkage. The median follow-up was 4.1 years (maximum, 15.3 years). Cox proportional hazards regression with random effects (frailty models) were used to model valve effects on the outcomes, with and without adjustment for preoperative and intraoperative covariates. Main Outcomes and Measures Time to all-cause mortality or aortic valve reintervention (surgical or transcatheter). There were 13 104 deaths and 723 reinterventions during follow-up. Results Of 79 345 isolated aortic valve replacement procedures with or without coronary artery bypass grafting, 54 866 were analyzed. Biological valve implantation rates increased from 59% in 1998 and 1999 to 86% in 2012 and 2013. Two series of valves associated with significantly increased hazard of death or reintervention were identified (first series: frailty, 1.18; 95% prediction interval [PI], 1.06-1.32 and second series: frailty, 1.19; 95% PI, 1.09-1.31). These results were robust to covariate adjustment and sensitivity analyses. There were 3 prosthetic valves with a significant reduction in hazard (valve 1: frailty, 0.88; 95% PI, 0.80-0.96; valve 2: frailty, 0.88; 95% PI, 0.80-0.96; and valve 3: frailty, 0.88; 95% PI, 0.78-0.98). Conclusions and Relevance Meaningful evidence from the analysis of routinely collected registry data can inform postmarket surveillance of medical devices. Although the findings are associated with a number of caveats, 2 specific biological aortic valve series identified in this study may warrant further investigation.

Background: Tricuspid valve (TV) repair at the time of left-sided valve surgery is indicated in patients with either severe functional tricuspid regurgitation (TR) or mild-to-moderate TR with coexistent tricuspid annular dilation or right heart failure. We assessed the benefits of a concomitant TV repair strategy during left-sided surgical valve interventions, focusing on mortality and echocardiographic TR-related outcomes.Methods: A meta-analysis was performed of studies reporting outcomes of patients who underwent left-sided (mitral and/or aortic) valve surgery with or without concomitant TV repair. Primary endpoints were all-cause and cardiac-related mortality; secondary endpoints were the presence of more-than-moderate TR, TR progression, and TR severity grade. All endpoints were evaluated at the longest available follow-up.Results: Fifteen studies were included for a total of 2840 patients. TV repair at the time of left-sided valve surgery was associated with a significantly lower risk of cardiac-related mortality (odds ratio [OR] 0.38; 95% confidence interval [CI]: 0.25-0.58; p < 0.001), with a trend towards a lower risk of all-cause mortality (OR 0.57; 95% CI: 0.32-1.05; p = 0.07) at a mean weighted follow-up of 6 years. The presence of more-than-moderate TR (OR 0.19; 95% CI: 0.12-0.30; p < 0.001), TR progression (OR 0.03; 95% CI: 0.01-0.05; p < 0.001), and TR grade (standardized mean difference -1.11; 95% CI: -1.57 to -0.65; p < 0.001) were significantly lower in the TV repair group at a mean weighted follow-up of 4.7 years.Conclusions: A concomitant TV repair strategy during left-sided valve surgery is associated with a reduction in cardiac-related mortality and improved echocardiographic TR outcomes at follow-up. (C) 2017 Elsevier B.V. All rights reserved.

This editorial refers to ‘Transcatheter aortic valve implantation vs. surgical aortic valve replacement for treatment of severe aortic stenosis: a meta-analysis of randomized trials’, by G.C. Siontis et al. doi: 10.1093/eurheartj/ehw225. When transcatheter aortic valve implantation (TAVI) was first introduced, it was tested in clinical trials as a strategy against the gold standard treatment for symptomatic severe aortic stenosis, namely surgical aortic valve replacement (SAVR).1,2 Two first-generation valves (the Edwards Sapien Valve and Medtronic CoreValve) were studied in high surgical risk patients. In Cohort A of the PARTNER Trial, that TAVI should be non-inferior to surgery was seen as a major achievement for a first-generation valve.1 That TAVI might have superior outcomes to surgery, as suggested in the US PIVOTAL CoreValve Trial High Risk Cohort, was a surprise to many.2 Most commentators questioned ‘How did TAVI get so good?’ The US Pivotal Trial was the first TAVI trial to mandate rigorous computed tomography (CT) angiography pre-case planning, and changed practice as a result. It was carried out in the highest performing North American centres, with surgeons and interventionists of impeccable pedigree, and experienced proctors supervised many of the implants. Whilst it was clear that second-generation valves would be even better, the question remained if other trials would have similar findings. In this issue of the journal, Siontis and colleagues present a meta-analysis of four trials comparing TAVI with SAVR, comprising >3000 patients.3 They have included two trials, the NOTION Trial (the only completed TAVI vs. SAVR trial outside of North America), and the first TAVI Trial in a slightly less high risk patient population, PARTNER 2A in which patients were randomized to receive either the second-generation SAPIEN …

Osteogenesis imperfecta (OI) type I is a hereditary disorder of connective tissue (HDCT) characterized by blue or gray sclerae, variable short stature, dentinogenesis imperfecta, hearing loss, and recurrent fractures from infancy. We present four examples of OI type I complicated by valvular heart disease and associated with tissue fragility. The diagnosis of a type I collagen disorder was confirmed by abnormal COL1A1 or COL1A2 gene sequencing. One patient was investigated with electrophoresis of collagens from cultured skin fibroblasts, showing structurally abnormal collagen type I, skin biopsy showed unusual histology and abnormal collagen fibril ultra-structure at electron microscopy. The combined clinical, surgical, histological, ultra-structural, and molecular genetic data suggest the type I collagen defect as contributory to cardiac valvular disease. The degree of tissue fragility experienced at cardiac surgery in these individuals, also reported in a small number of similar case reports, suggests that patients with OI type I need careful pre-operative assessment and consideration of the risks and benefits of cardiac surgery. © 2013 Wiley Periodicals, Inc.

Cardiac lipomatous hypertrophy is an unusual disorder that typically affects the interatrial septum. We report a case in which large subpericardial deposits of fat were initially mistaken for a pericardial effusion and the subsequent clinical picture resembled tamponade. The patient improved following a pericardiectomy.