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In late 2010 and in 2011, the results of the first randomized controlled trial of transcatheter aortic valve implantation (TAVI) were received with much excitement. In this Review, Dr. Rodés-Cabau discusses the main characteristics of transcatheter valves and the TAVI procedure, and evaluates the acute and late outcomes associated with TAVI. The first human transcatheter aortic valve implantation (TAVI) in 2002, and several subsequent single-center series, showed the feasibility of this new approach for the treatment of patients with severe aortic stenosis who were considered to be at very high or prohibitive surgical risk. More-recent multicenter registries have confirmed the safety and efficacy of this procedure, despite a very-high-risk patient profile. Moreover, the randomized, controlled PARTNER trial has confirmed both the superiority of TAVI over medical treatment in patients not considered to be candidates for standard surgical aortic valve replacement and the noninferiority of TAVI compared with surgical aortic valve replacement in high-risk patients. The hemodynamics of transcatheter valves are usually excellent, although residual paravalvular aortic regurgitation (usually trivial or mild) is frequent. Stroke, major vascular complications, and conduction disturbances leading to permanent pacemaker implantation remain among the most-concerning periprocedural complications of TAVI. Nevertheless, promising preliminary data exist for long-term outcomes following TAVI, 'valve-in-valve' TAVI for surgical prosthesis dysfunction, and for the treatment of lower-risk patients. Improvements in transcatheter valve technology, optimization of procedural and midterm results, and confirmation of long-term durability of transcatheter valve prostheses will determine the expansion of TAVI towards the treatment of a broader spectrum of patients. Key Points Transcatheter aortic valve implantation (TAVI) represents a less-invasive strategy than surgical aortic valve replacement (SAVR) for the treatment of severe symptomatic aortic stenosis The transfemoral approach is usually the first option for TAVI; transapical, subclavian, axillary, and transaortic routes are alternative approaches TAVI is currently the treatment of choice for patients not considered to be candidates for SAVR, and a proven alternative for those considered to be at high surgical risk Transcatheter valves are associated with excellent hemodynamic results, usually with concomitant improvements in the patient's functional status and quality of life; however, minor residual aortic regurgitation occurs in many patients Periprocedural stroke, vascular and conduction disturbance complications, occurrence of moderate or severe paravalvular aortic regurgitation, relatively high midterm mortality, and valve durability beyond 3-year follow-up are unresolved issues in TAVI The 'valve-in-valve' treatment of surgical prosthesis dysfunction and the treatment of intermediate-risk patients are two of the most-important fields for the development of TAVI in the near future

The assessment and management of tricuspid valve disease have evolved substantially during the past several years. Whereas tricuspid stenosis is uncommon, tricuspid regurgitation is frequently encountered and is most often secondary in nature and caused by annular dilatation and leaflet tethering from adverse right ventricular remodelling in response to any of several disease processes. Non-invasive assessment of tricuspid regurgitation must define its cause and severity; advanced three-dimensional echocardiography, MRI, and CT are gaining in clinical application. The indications for tricuspid valve surgery to treat tricuspid regurgitation are related to the cause of the disorder, the context in which it is encountered, its severity, and its effects on right ventricular function. Most operations for tricuspid regurgitation are done at the time of left-sided heart valve surgery. The threshold for restrictive ring annuloplasty repair of secondary tricuspid regurgitation at the time of left-sided valve surgery has decreased over time with recognition of the risk of progressive tricuspid regurgitation and right heart failure in patients with moderate or lesser degrees of tricuspid regurgitation and tricuspid annular dilatation, as well as with appreciation of the high risks of reoperative surgery for severe tricuspid regurgitation late after left-sided valve surgery. However, many patients with unoperated severe tricuspid regurgitation are also deemed at very high or prohibitive surgical risk. Novel transcatheter therapies have begun to emerge for the treatment of tricuspid regurgitation in such patients. Experience with such therapies is preliminary and further studies are needed to determine their role in the management of this disorder.

Tricuspid valve disease, and particularly tricuspid regurgitation, is a highly prevalent condition with a complex pathophysiology and long-term adverse consequences. Although historically neglected, tricuspid valve disease has gained increasing recognition, with important advances in the assessment and management of this disorder over the past 2 decades. Surgical treatment remains the standard of care, but it continues to have one of the the highest death rates among all cardiac valve-related procedures, and a broad range of patients still do not receive effective therapy for tricuspid valve disease in contemporary clinical practice. Therefore, several alternative, less-invasive technologies for treating patients with severe, native tricuspid valve disease at high surgical risk have been developed in the past decade, with promising early results. This Review summarizes key findings and highlights the latest developments in the diagnosis and management framework that are transforming clinical practice in the complex field of tricuspid valve disease.Tricuspid valve disease, particularly tricuspid regurgitation, is a highly prevalent condition with complex pathophysiology and long-term adverse consequences. In this Review, Rodés-Cabau and colleagues discuss the latest insights on the natural history and clinical and imaging assessment of tricuspid valve disease, highlighting the surgical management and emerging transcatheter therapies that are transforming clinical practice for this challenging disease.

Patients with ST-segment elevation MI and multivessel coronary disease who had undergone successful culprit-lesion PCI were assigned to a strategy of either PCI of all other suitable stenoses or no further revascularization. At 3 years, the risk of cardiovascular death or new MI was lower with complete revascularization.

Accumulating clinical experience and technological improvements have provided the basis for transcatheter aortic valve implantation (TAVI) to emerge as a well-established means for treating patients with severe symptomatic aortic stenosis at high or prohibitive surgical risk. During this decade, TAVI has emerged as a valid alternative to surgical aortic valve replacement in patients at intermediate surgical risk, and several studies are currently being performed to evaluate the role of TAVI in patients at low surgical risk. Furthermore, promising, but preliminary, data are emerging on the efficacy of TAVI for treating patients with bicuspid aortic valve disease, as well as patients with pure aortic regurgitation. In this Perspectives article, we summarize the evolving indications for TAVI, and give our opinion on the future perspectives for this procedure.

Coexistence of moderate aortic stenosis (AS) in patients with heart failure (HF) with reduced ejection fraction is not uncommon. Moderate AS increases afterload, whereas pharmacologic reduction of afterload is a pillar of contemporary HF management. Unloading the left ventricle by reducing the transaortic gradient with transfemoral transcatheter aortic valve replacement (TAVR) may improve clinical outcomes in patients with moderate AS and HF with reduced ejection fraction. The TAVR UNLOAD (NCT02661451) is an international, multicenter, randomized, open-label, clinical trial comparing the efficacy and safety of TAVR with the Edwards SAPIEN 3 Transcatheter Heart Valve in addition to optimal heart failure therapy (OHFT) vs OHFT alone in patients with moderate AS (defined by a mean transaortic gradient ≥20 mm Hg and <40 mm Hg, and an aortic valve area >1.0 cm2 and ≤1.5 cm2 at rest or after dobutamine stress echocardiography) and reduced ejection fraction. A total of 600 patients will be randomized in a 1:1 fashion. Clinical follow-up is scheduled at 1, 6, and 12 months, and 2 years after randomization. The primary end point is the hierarchical occurrence of all-cause death, disabling stroke, hospitalizations related to HF, symptomatic aortic valve disease or nondisabling stroke, and the change in the Kansas City Cardiomyopathy Questionnaire at 1 year. Secondary end points capture effects on clinical outcome, biomarkers, echocardiographic parameters, and quality of life. The TAVR UNLOAD trial aims to test the hypothesis that TAVR on top of OHFT improves clinical outcomes in patients with moderate AS and HF with reduced ejection fraction.

Body composition (fat mass [FM] and skeletal muscle mass [SMM]) predicts clinical outcomes. In particular, loss of SMM (sarcopenia) is associated with frailty and mortality. There are no data on the prevalence and impact of FM and SMM in patients undergoing transcatheter aortic valve implantation (TAVI). The objective of this study is to determine body composition from pre-TAVI computed tomography (CT) and evaluate its association with clinical outcomes in patients who underwent TAVI. A total of 460 patients (mean age 81 ± 8 years, men: 51%) were included. Pre-TAVI CTs of the aorto-ilio-femoral axis were analyzed for FM and SMM cross-sectional area at the level of the third lumbar vertebrae (L3). Regression equations correlating cross-sectional area at L3 to total body FM and SMM were used to determine prevalence of sarcopenia, obesity, and sarcopenic obesity in patients (64%, 65%, and 46%, respectively). Most TAVI procedures were performed through a transfemoral approach (59%) using a balloon-expandable valve (94%). The 30-day and mid-term (median 12 months [interquartile range 6 to 27]) mortality rates were 6.1% and 29.6%, respectively. FM had no association with clinical outcomes, but sarcopenia predicted cumulative mortality (hazard ratio 1.55, 95% confidence interval 1.02 to 2.36, p = 0.04). In conclusion, body composition analysis from pre-TAVI CT is feasible. Sarcopenia, obesity, and sarcopenic obesity are prevalent in the TAVI population, with sarcopenia predictive of cumulative mortality.

The long-term cardiovascular (CV) outcomes of COVID-19 have not been fully explored. This was an international, multicenter, retrospective cohort study conducted between February and December 2020. Consecutive patients ≥18 years who underwent a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) for SARS-CoV2 were included. Patients were classified into two cohorts depending on the nasopharyngeal swab result and clinical status: confirmed COVID-19 (positive RT-PCR) and control (without suggestive symptoms and negative RT-PCR). Data were obtained from electronic records, and clinical follow-up was performed at 1-year. The primary outcome was CV death at 1-year. Secondary outcomes included arterial thrombotic events (ATE), venous thromboembolism (VTE), and serious cardiac arrhythmias. An independent clinical event committee adjudicated events. A Cox proportional hazards model adjusted for all baseline characteristics was used for comparing outcomes between groups. A prespecified landmark analysis was performed to assess events during the post-acute phase (31-365 days). A total of 4,427 patients were included: 3,578 (80.8%) in the COVID-19 and 849 (19.2%) control cohorts. At one year, there were no significant differences in the primary endpoint of CV death between the COVID-19 and control cohorts (1.4% vs. 0.8%; HRadj 1.28 [0.56-2.91]; p = 0.555), but there was a higher risk of all-cause death (17.8% vs. 4.0%; HRadj 2.82 [1.99-4.0]; p = 0.001). COVID-19 cohort had higher rates of ATE (2.5% vs. 0.8%, HRadj 2.26 [1.02-4.99]; p = 0.044), VTE (3.7% vs. 0.4%, HRadj 9.33 [2.93-29.70]; p = 0.001), and serious cardiac arrhythmias (2.5% vs. 0.6%, HRadj 3.37 [1.35-8.46]; p = 0.010). During the post-acute phase, there were no significant differences in CV death (0.6% vs. 0.7%; HRadj 0.67 [0.25-1.80]; p = 0.425), but there was a higher risk of deep vein thrombosis (0.6% vs. 0.0%; p = 0.028). Re-hospitalization rate was lower in the COVID-19 cohort compared to the control cohort (13.9% vs. 20.6%; p = 0.001). At 1-year, patients with COVID-19 experienced an increased risk of all-cause death and adverse CV events, including ATE, VTE, and serious cardiac arrhythmias, but not CV death. URL: https://www.clinicaltrials.gov. Unique identifier: NCT04359927.

In patients with heart failure, interventions to reduce elevated left atrial pressure improve symptoms and reduce the risk of hospital admission. We aimed to assess the safety and potential efficacy of therapeutic left-to-right interatrial shunting in patients with heart failure with reduced ejection fraction. We did this proof-of-principle cohort study at one centre in Canada. Patients (aged ≥18 years) with New York Heart Association (NYHA) class III chronic heart failure with reduced ejection fraction were enrolled under the Canadian special access programme. Shunt implants were done after transseptal catheterisation with transoesophageal echocardiographic guidance under general anaesthesia. Patients had clinical and echocardiography evaluations at baseline and months 1 and 3 after shunt implantation. Between Oct 10, 2013, and March 27, 2015, we enrolled ten patients. The device was successfully implanted in all patients; no device-related or procedural adverse events occurred during follow-up. Transoesophageal echocardiography at 1 month showed that all shunts were patent, with no thrombosis or migration. From baseline to 3 month follow-up, we recorded improvements in NYHA classification (from class III to class II in seven [78%] of nine patients, from class III to class I in one [11%] patient, and no change in one [11%] patient; p=0·0004); quality of life, as assessed by the Duke Activity Status Index (from a mean score of 13 [SD 6·2] to 24·8 [12·9]; p=0·016) and the Kansas City Cardiomyopathy Questionnaire (from a mean score of 44·3 [SD 9·8] to 79·1 [13·0]; p=0·0001); and 6 min walk test distance (from a mean of 244 m [SD 112] to 318 m [134]; p=0·016). Pulmonary capillary wedge pressure was reduced from a mean of 23 mm Hg (SD 5) at baseline to 17 mm Hg (8) at 3 months (p=0·035), with no changes in right atrial pressure, pulmonary arterial pressure, or pulmonary resistance. No patient was admitted to hospital for worsening heart failure. One (10%) patient was admitted to hospital with gastrointestinal bleeding at month 1; one (10%) patient died after incessant ventricular tachycardia storm, which led to terminal heart failure 2 months post-procedure. This first-in-man experience with an implanted left-to-right interatrial shunt demonstrates initial safety and early beneficial clinical and haemodynamic outcomes in patients with heart failure with reduced ejection fraction. Further large-scale randomised studies are warranted. V-Wave.

ObjectivesMitral regurgitation (MR) is a common entity in patients with aortic stenosis undergoing transcatheter aortic valve replacement (TAVR), but its influence on outcomes remains controversial. The purpose of this meta-analysis was to assess the clinical impact of and changes in significant (moderate–severe) MR in patients undergoing TAVR, overall and according to valve design (self-expandable (SEV) vs balloon-expandable (BEV)).MethodsAll national registries and randomised trials were pooled using meta-analytical guidelines to establish the impact of moderate–severe MR on mortality after TAVR. Studies reporting changes in MR after TAVR on an individual level were electronically searched and used for the analysis.ResultsEight studies including 8015 patients (SEV: 3474 patients; BEV: 4492 patients) were included in the analysis. The overall 30-day and 1-year mortality was increased in patients with significant MR (OR 1.49, 95% CI 1.16 to 1.92; HR 1.32, 95% CI 1.12 to 1.55, respectively), but a significant heterogeneity across studies was observed (p<0.05). The impact of MR on mortality was not different between SEV and BEV in meta-regression analysis for 30-day (p=0.360) and 1-year (p=0.388) mortality. Changes in MR over time were evaluated in nine studies including 1278 patients. Moderate–severe MR (SEV: 326 patients; BEV: 192 patients) improved in 50.5% of the patients at a median follow-up of 180 (30–360) days after TAVR, and the degree of improvement was greater in patients who had received a BEV (66.7% vs 40.8% in the SEV group, p=0.001).ConclusionsConcomitant moderate–severe MR was associated with increased early and late mortality following TAVR. A significant improvement in MR severity was detected in half of the patients following TAVR, and the degree of improvement was greater in those patients who had received a BEV.