Clinical practice guideline for transcatheter versus surgical valve replacement in patients with severe aortic stenosis in Latin America.

In elderly (75 years or older) patients living in Latin America with severe symptomatic aortic stenosis candidates for transfemoral approach, the panel suggests the use of transcatheter aortic valve implant (TAVI) over surgical aortic valve replacement (SAVR). This is a conditional recommendation, based on moderate certainty in the evidence (⨁⨁⨁Ο).This recommendation does not apply to patients in which there is a standard of care, like TAVI for patients at very high risk for cardiac surgery or inoperable patients, or SAVR for non-elderly patients (eg, under 65 years old) at low risk for cardiac surgery. The suggested age threshold of 75 years old is based on judgement of limited available literature and should be used as a guide rather than a determinant threshold.The conditional nature of this recommendation means that the majority of patients in this situation would want a transfemoral TAVI over SAVR, but some may prefer SAVR. For clinicians, this means that they must be familiar with the evidence supporting this recommendation and help each patient to arrive at a management decision integrating a multidisciplinary team discussion (Heart Team), patient's values and preferences through shared decision-making, and available resources. Policymakers will require substantial debate and the involvement of various stakeholders to implement this recommendation.

TAVR in patients with hip fracture and severe aortic stenosis: how and when?

Comorbidities are common in elderly patients with hip fracture and are associated with an increased mortality after surgery. Internal medicine/geriatric leaded multidisciplinary hip fracture teams may play a pivotal role in the clinical management of complex patients. Treatment strategy is particular relevant in patients with severe aortic stenosis that represent more than 5% of patients with hip fracture. These patients have a high in-hospital mortality and poor 1-year survival (less than 50%). Transcatheter aortic valve replacement (TAVR) may be an option in selected patients; however, the choice to treat and, in the case, the timing of valve replacement in relation to hip surgery is highly dependent on clinical conditions before trauma. In this paper, three different scenario of TAVR timing after hip fracture are reported.

Management of patients with severe aortic stenosis in the TAVI-era: how recent recommendations are translated into clinical practice.

OBJECTIVE: Approximately 3.4% of adults aged >75 years suffer from aortic stenosis (AS). Guideline indications for aortic valve replacement (AVR) distinguish between patients with symptomatic and asymptomatic severe AS. The present analysis aims to assess contemporary practice in the treatment of severe AS across Europe and identify characteristics associated with treatment decisions, namely denial of AVR in symptomatic patients and assignment of asymptomatic patients to AVR. METHODS: Participants of the prospective, multinational IMPULSE database of patients with severe AS were grouped according to AS symptoms, and stratified into subgroups based on assignment to/denial of AVR. RESULTS: Of 1608 symptomatic patients, 23.8% did not undergo AVR and underwent medical treatment. Denial was independently associated with multiple factors, including severe frailty (p=0.024); mitral (p=0.002) or tricuspid (p=0.004) regurgitation grade III/IV, and the presence of renal impairment (p=0.017). Of 392 asymptomatic patients, 86.5% had no prespecified indication for AVR. Regardless, 36.3% were assigned to valve replacement. Those with an indexed aortic valve area (AVA; p=0.045) or left ventricular ejection fraction (LVEF; p<0.001) below the study median; or with a left ventricular end systolic diameter above the study median (p=0.007) were more likely to be assigned to AVR. CONCLUSIONS: There may be considerable discrepancies between guideline-based recommendations and clinical practice decision-making in the treatment of AS. It appears that guidelines may not fully capture the complete clinical spectrum of patients with AS. Thus, there is a need to find ways to increase their acceptance and the rate of adoption.

Transcatheter Mitral Valve Replacement After Surgical Repair or Replacement: Comprehensive Midterm Evaluation of Valve-in-Valve and Valve-in-Ring Implantation From the VIVID Registry.

BACKGROUND: Mitral valve-in-valve (ViV) and valve-in-ring (ViR) are alternatives to surgical reoperation in patients with recurrent mitral valve failure after previous surgical valve repair or replacement. Our aim was to perform a large-scale analysis examining midterm outcomes after mitral ViV and ViR. METHODS: Patients undergoing mitral ViV and ViR were enrolled in the Valve-in-Valve International Data Registry. Cases were performed between March 2006 and March 2020. Clinical endpoints are reported according to the Mitral Valve Academic Research Consortium (MVARC) definitions. Significant residual mitral stenosis (MS) was defined as mean gradient ≥10 mm Hg and significant residual mitral regurgitation (MR) as ≥ moderate. RESULTS: A total of 1079 patients (857 ViV, 222 ViR; mean age 73.5±12.5 years; 40.8% male) from 90 centers were included. Median STS-PROM score 8.6%; median clinical follow-up 492 days (interquartile range, 76-996); median echocardiographic follow-up for patients that survived 1 year was 772.5 days (interquartile range, 510-1211.75). Four-year Kaplan-Meier survival rate was 62.5% in ViV versus 49.5% for ViR (P<0.001). Mean gradient across the mitral valve postprocedure was 5.7±2.8 mm Hg (≥5 mm Hg; 61.4% of patients). Significant residual MS occurred in 8.2% of the ViV and 12.0% of the ViR patients (P=0.09). Significant residual MR was more common in ViR patients (16.6% versus 3.1%; P<0.001) and was associated with lower survival at 4 years (35.1% versus 61.6%; P=0.02). The rates of Mitral Valve Academic Research Consortium-defined device success were low for both procedures (39.4% total; 32.0% ViR versus 41.3% ViV; P=0.01), mostly related to having postprocedural mean gradient ≥5 mm Hg. Correlates for residual MS were smaller true internal diameter, younger age, and larger body mass index. The only correlate for residual MR was ViR. Significant residual MS (subhazard ratio, 4.67; 95% CI, 1.74-12.56; P=0.002) and significant residual MR (subhazard ratio, 7.88; 95% CI, 2.88-21.53; P<0.001) were both independently associated with repeat mitral valve replacement. CONCLUSIONS: Significant residual MS and/or MR were not infrequent after mitral ViV and ViR procedures and were both associated with a need for repeat valve replacement. Strategies to improve postprocedural hemodynamics in mitral ViV and ViR should be further explored.

Patient-specific in vitro testing for evaluating TAVR clinical performance-A complementary approach to current ISO standard testing.

Following in vitro tests established for surgical prosthetic heart valves, transcatheter aortic valves (TAV) are similarly tested in idealized geometries-excluding effects that may hamper TAVR performance in situ. Testing in vitro in pulse duplicator systems that incorporated patient-specific replicas would enhance the testing veracity by bringing it closer to the clinical scenario. To that end we compare TAV hemodynamic performance tested in idealized geometries according to the ISO standard (baseline performance) to that obtained by testing the TAVs following deployment in patient-specific replicas. Balloon-expandable (n = 2) and self-expandable (n = 3) TAVs were tested in an idealized geometry in mock-circulation system (following ISO 5840-3 guidelines) and compared to the measurements in a dedicated mock-circulation system adapted for the five patient-specific replicas. Patient-specific deployments resulted in a decline in performance as compared to the baseline idealized testing, as well as a variation in performance that depended on the design features of each device that was further correlated with the radial expansion and eccentricity of the deployed TAV stent (obtained with CT-scans of the deployed valves). By excluding the deployment effects in irregular geometries, the current idealized ISO testing is limited to characterize the baseline device performance. Utilizing patient-specific anatomic contours provides performance indicators under more stringent conditions likely encountered in vivo. It has the potential to enhance testing and development complementary to the ISO standard, for improved TAV safety and effectiveness.

Transcatheter aortic valve implantation versus surgical aortic valve replacement during the COVID-19 pandemic-Current practice and concerns.

COVID-19 has had a dramatic impact on the provision of healthcare. COVID-19 can manifest with cardiac and thrombotic presentations. Additionally, patients with cardiovascular comorbidities are at an increased risk of adverse outcomes related to COVID-19 infection. This in turn has led to a significant reduction in the provision of cardiac surgery with alternative management options utilized to address patients with significant disease. In terms of aortic valve disease, transcatheter aortic valve implantation (TAVI) provides advantages over surgical aortic valve replacement in with a lower burden on healthcare resources. COVID-19 also resulted in changes in management strategies and as such TAVI is now being considered in younger- and low-risk patients. However, long term data with regard to TAVI is still unknown, and the use in patient groups that have been excluded in the large pivotal studies that established TAVI as an alternative to surgery has raised specific concerns in the use of TAVI as the preferred treatment choice. With the long term ramification unknown, it is essential that decisions are made with caution.

Transcatheter aortic valve implantation during the COVID-19 pandemic: Clinical expert opinion and consensus statement for Asia.

OBJECTIVES: The impact of the COVID-19 pandemic on the treatment of patient with aortic valve stenosis is unknown and there is uncertainty on the optimal strategies in managing these patients. METHODS: This study is supported and endorsed by the Asia Pacific Society of Interventional Cardiology. Due to the inability to have face to face discussions during the pandemic, an online survey was performed by inviting key opinion leaders (cardiac surgeon/interventional cardiologist/echocardiologist) in the field of transcatheter aortic valve implantation (TAVI) in Asia to participate. The answers to a series of questions pertaining to the impact of COVID-19 on TAVI were collected and analyzed. These led subsequently to an expert consensus recommendation on the conduct of TAVI during the pandemic. RESULTS: The COVID-19 pandemic had resulted in a 25% (10-80) reduction of case volume and 53% of operators required triaging to manage their patients with severe aortic stenosis. The two most important parameters used to triage were symptoms and valve area. Periprocedural changes included the introduction of teleconsultation, preprocedure COVID-19 testing, optimization of protests, and catheterization laboratory set up. In addition, length of stay was reduced from a mean of 4.4 to 4 days. CONCLUSION: The COVID-19 pandemic has impacted on the delivery of TAVI services to patients in Asia. This expert recommendation on best practices may be a useful guide to help TAVI teams during this period until a COVID-19 vaccine becomes widely available.

Impact of Transcatheter Aortic Valve Durability on Life Expectancy in Low-Risk Patients With Severe Aortic Stenosis.

BACKGROUND: Recent clinical trial results showed that transcatheter aortic valve replacement (TAVR) is noninferior and may be superior to surgical aortic valve replacement (SAVR) for mortality, stroke, and rehospitalization. However, the impact of transcatheter valve durability remains uncertain. METHODS: Discrete event simulation was used to model hypothetical scenarios of TAVR versus SAVR durability in which TAVR failure times were varied to determine the impact of TAVR valve durability on life expectancy in a cohort of low-risk patients similar to those in recent trials. Discrete event simulation modeling was used to estimate the tradeoff between a less invasive procedure with unknown valve durability (TAVR) and that of a more invasive procedure with known durability (SAVR). Standardized differences were calculated, and a difference >0.10 was considered clinically significant. In the base-case analysis, patients with structural valve deterioration requiring reoperation were assumed to undergo a valve-in-valve TAVR procedure. A sensitivity analysis was conducted to determine the impact of TAVR valve durability on life expectancy in younger age groups (40, 50, and 60 years). RESULTS: Our cohort consisted of patients with aortic stenosis at low surgical risk with a mean age of 73.4±5.9 years. In the base-case scenario, the standardized difference in life expectancy was <0.10 between TAVR and SAVR until transcatheter valve prosthesis failure time was 70% shorter than that of surgical prostheses. At a transcatheter valve failure time <30% compared with surgical valves, SAVR was the preferred option. In younger patients, life expectancy was reduced when TAVR durability was 30%, 40%, and 50% shorter than that of surgical valves in 40-, 50-, and 60-year-old patients, respectively. CONCLUSIONS: According to our simulation models, the durability of TAVR valves must be 70% shorter than that of surgical valves to result in reduced life expectancy in patients with demographics similar to those of recent trials. However, in younger patients, this threshold for TAVR valve durability was substantially higher. These findings suggest that durability concerns should not influence the initial treatment decision concerning TAVR versus SAVR in older low-risk patients on the basis of current evidence supporting TAVR valve durability. However, in younger low-risk patients, valve durability must be weighed against other patient factors such as life expectancy.

The learning curve in transcatheter aortic valve implantation clinical studies: A systematic review.

BACKGROUND: Transcatheter aortic-valve implantation (TAVI) has become an essential alternative to surgical aortic-valve replacement in the treatment of symptomatic severe aortic stenosis, and this procedure requires technical expertise. The aim of this study was to identify prospective studies on TAVI from the past 10 years, and then to analyze the quality of information reported about the learning curve. MATERIALS AND METHODS: A systematic review of articles published between 2007 and 2017 was performed using PubMed and the EMBASE database. Prospective studies regarding TAVI were included. The quality of information reported about the learning curve was evaluated using the following criteria: mention of the learning curve, the description of a roll-in phase, the involvement of a proctor, and the number of patients suggested to maintain skills. RESULTS: A total of sixty-eight studies met the selection criteria and were suitable for analysis. The learning curve was addressed in approximately half of the articles (n = 37, 54 percent). However, the roll-in period was mentioned by only eight studies (12 percent) and with very few details. Furthermore, a proctorship was disclosed in three articles (4 percent) whereas twenty-five studies (37 percent) included authors that were proctors for manufacturers of TAVI. CONCLUSION: Many prospective studies on TAVI over the past 10 years mention learning curves as a core component of successful TAVI procedures. However, the quality of information reported about the learning curve is relatively poor, and uniform guidance on how to properly assess the learning curve is still missing.

[Update to the position paper of the Italian Society of Interventional Cardiology (SICI-GISE) on institutional and operator requirements for transcatheter aortic valve implantation (TAVI). Chapter 2: Technical nursing care in TAVI]. / Update del documento di posizione della Società Italiana di Cardiologia Interventistica (SICI-GISE) sui requisiti minimi per ospedali ed operatori che eseguono procedure di impianto transcatetere di protesi valvolare aortica (TAVI). Capitolo 2: La realtà tecnico-infermieristica nella TAVI.

Calcific degenerative aortic stenosis is the most frequent valve disease in the western population. Transcatheter aortic valve implantation procedures are significantly increasing, as they now represent the first choice in inoperable patients and have been shown to be non-inferior to cardiac surgery in patients at high and intermediate surgical risk. In this scenario, it is necessary to define and standardize the technical nursing care to guarantee patient safety and improve quality of care.The purpose of this document is to propose, on the basis on currently available literature, a model for the development of assistance based on shared objectives and clinical competence.

The short-term and long-term outcomes of transcatheter or surgical aortic valve replacement in elderly patients: A protocol for a systematic review.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) has become an essential alternate option for people suffering from aortic stenosis. However, the efficacy and safety of TAVR for elderly population (aged over 80 years) is still unclear. METHODS: We plan to perform a systematic review and meta-analysis of clinical controlled trials and propensity-match cohort studies to evaluate the short- and long-term outcomes in elderly aortic stenosis patients who undergo a transcatheter or surgical aortic valve replacement. We will search PubMed, EMBASE, and Cochrane Library using a comprehensive strategy. The related conference proceedings and reference lists of the included studies will also be checked to identify additional studies. Two reviewers will screen retrieved records, extract information, and assess the risk of bias independently. STATA software will be used to conduct data synthesis. There is no requirement of ethical approval and informed consent. RESULTS: This study will be submitted to a peer-reviewed journal for publication. CONCLUSION: This is the first systematic assessment of TAVR for elderly patients with aortic stenosis. We hope it will provide a relatively comprehensive reference for clinical practice and future relevant clinical trials. ETHICS AND DISSEMINATION: Ethics approval and patient consent are not required as this study is a systematic review and meta-analysis. PROSPERO REGISTRATION NUMBER: CRD42019140857. STUDY PROTOCOL REGISTRY: The protocol has been registered in PROSPERO, which is an International Prospective Register of Systematic Reviews. The registration number is CRD42019140857.

Appropriateness of Transcatheter Aortic Valve Replacement: Insight From the OCEAN-TAVI Registry.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is widely used; however, its appropriateness is unknown. We sought to investigate the appropriateness of TAVR. METHODS AND RESULTS: We assigned appropriateness ratings to patients undergoing TAVR for severe aortic stenosis between October 2013 and May 2017 at 14 Japanese hospitals participating in the optimized transcatheter valvular intervention-transcatheter aortic valve implantation registry according to the US appropriate use criteria for treating severe aortic stenosis. To account for the influence of uncaptured variables on appropriate use criteria ratings, we initially assigned them to a best-case scenario where they were assumed to classify a case to the most appropriate clinical scenario and then to a worst-case scenario where assumed least appropriate. Overall proportion of TAVRs classified as appropriate, maybe appropriate, or rarely appropriate was assessed. In addition, extent of hospital-level variation in rarely appropriate procedures was evaluated. Of 2036 TAVRs (median age [25th, 75th]: 85.0 years [81.0-88.0]; 70.5% female the Society of Thoracic Surgeons Predicted Risk of Mortality score: 6.2% [4.4-8.9]), in the best-case scenario, 177 (8.7%) were not successfully mapped, and 1580 (77.6%) were classified as appropriate, 180 (8.8%) as maybe appropriate, 99 (4.9%) as rarely appropriate, respectively. In the worst-case scenario, the rate of rarely appropriate increased to 6.8%. The majority of rarely appropriate TAVRs was performed in patients with moderate to severe dementia (defined as mini-mental status examination of ≤17), bicuspid aortic valve, or anticipated life expectancy <1 year. There was substantial variation in the proportion of rarely appropriate TAVR across hospitals (median rate of rarely appropriate: 4.9% [3.8-6.6] in the best-case scenario, P<0.001; 6.5% [5.6-8.6] in the worst-case scenario, P<0.001). CONCLUSIONS: In clinical practice, the proportion of rarely appropriate TAVRs ranged from 4.9% to 6.8% with substantial institutional variation. Our study elucidates common clinical scenarios deemed rarely appropriate and clarifies the potential targets of quality improvement. Registration: URL: https://www.umin.ac.jp/ctr/index.htm. Unique identifier: UMIN000020423.

Early effects of transcatheter aortic valve replacement on cardiac sympathetic nervous function assessed by 123I-metaiodobenzylguanidine scintigraphy in patients with severe aortic valve stenosis.

PURPOSE: The effects of transcatheter aortic valve replacement (TAVR) on cardiac sympathetic nervous (CSN) function have not been fully explored. This study aimed to investigate the early (within 2 weeks) effects of TAVR on CSN function in patients with severe aortic valve stenosis (AS) using 123I-metaiodobenzylguanidine (MIBG) scintigraphy. METHODS: Of 143 consecutive patients who were scheduled to undergo TAVR, 67 (18 men; median age 86 years) were evaluated in this single-centre prospective observational study. MIBG scintigraphy was performed at baseline and 3-14 days after the TAVR procedure to evaluate the heart-mediastinum ratio (H/M) and washout rate (WR). Differences between baseline and post-TAVR MIBG parameters were analysed. MIBG parameter changes were compared with echocardiographic parameters. Furthermore, factors involved in the improvement in MIBG parameters were investigated. RESULTS: All patients successfully underwent TAVR with improved echocardiographic parameters, including aortic valve area (AVA; 0.6 cm2 vs. 1.6 cm2), peak velocity (4.5 m/s vs. 2.0 m/s), mean pressure gradient (50 mmHg vs. 9 mmHg), and left ventricular ejection fraction (56% vs. 62%) (all p < 0.001). On MIBG imaging, delayed H/M significantly increased (2.57 vs. 2.68, p < 0.001), whereas WR decreased (32.2% vs. 26.8%, p < 0.001). In multivariate analysis, higher baseline WR was associated with improvement in WR (> 3%). Female sex, Clinical Frailty Scale score ≤ 5, baseline estimated glomerular filtration rate, and baseline AVA were predictors of improvement in delayed H/M (> 0.1). Baseline AVA and E/E' were independent predictors of improvement in both WR and delayed H/M. CONCLUSIONS: The CSN function was impaired in patients with AS, as assessed using MIBG scintigraphy. WR and delayed H/M improved immediately after TAVR. Improvement in CSN function may be related to echocardiographic AS severity at baseline before TAVR.

2019 Canadian Cardiovascular Society Position Statement for Transcatheter Aortic Valve Implantation.

Transcatheter aortic valve implantation (TAVI) or replacement has rapidly changed the treatment of patients with severe symptomatic aortic stenosis. It is now the standard of care for patients believed to be inoperable or at high surgical risk, and a reasonable alternative to surgical aortic valve replacement for those at intermediate surgical risk. Recent clinical trial data have shown the benefits of this technology in patients at low surgical risk as well. This update of the 2012 Canadian Cardiovascular Society TAVI position statement incorporates clinical evidence to provide a practical framework for patient selection that does not rely on surgical risk scores but rather on individual patient evaluation of risk and benefit from either TAVI or surgical aortic valve replacement. In addition, this statement features new wait time categories and treatment time goals for patients accepted for TAVI. Institutional requirements and recommendations for operator training and maintenance of competency have also been revised to reflect current standards. Procedural considerations such as decision-making for concomitant coronary intervention, antiplatelet therapy after intervention, and follow-up guidelines are also discussed. Finally, we suggest that all patients with aortic stenosis might benefit from evaluation by the heart team to determine the optimal individualized treatment decision.