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.

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 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.

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.

[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.

Thrombotic Versus Bleeding Risk After Transcatheter Aortic Valve Replacement: JACC Review Topic of the Week.

A large amount of evidence supports the widespread use of transcatheter aortic valve replacement (TAVR) among patients who are at low to intermediate risk for surgery. However, several controversies exist about the optimal antithrombotic regimen to use in these patients. On the one hand, concerns about ischemic stroke, subclinical leaflet thrombosis, valve thrombosis, and long-term durability suggest the need for a stronger antithrombotic regimen to ensure a better patient and valve outcome. On the other hand, the high bleeding risk of this population and the current lack of strong evidence in favor of a more aggressive antithrombotic strategy require caution. This review analyzes the rationale of antithrombotic therapy in TAVR illustrating the present scenario and future perspectives.

The Use of Intraoperative Three-Dimensional Echocardiography to Evaluate Origin of Bioprosthetic Aortic Valve Regurgitant Jets.

Degradation of bioprosthetic aortic valves can eventually lead to both paravalvular and intravalvular regurgitation. However, differentiating between the two may be difficult in the case of multiple lesions in close proximity or highly eccentric jets. Whereas such exact distinction may be of little procedural significance in open cardiac surgery, it is of crucial importance when approaching such lesions in the catheterization laboratory or hybrid operating room. Interventions on one lesion often have a significant effect on the other. For example, guidewires may damage new bioprosthetic valve leaflets and dislodge vascular plugs. Even more concerning is the possibility of undergoing a lengthy and risky procedure on a lesion that does not truly exist. Fortunately, the use of three-dimensional Doppler echocardiography can expand our vision beyond the single imaging plane of a standard two-dimensional examination, allowing extensive manipulation of cutting planes and a wider field of view. Regurgitant jets can thus be tracked in a way that may be otherwise impossible, better quantifying their true origins. Here the authors present a unique case of misdiagnosis after surgical aortic valve degradation, where the use of intraoperative three-dimensional echocardiography significantly altered the preoperative plan and reduced operative time.

Development and Application of a System Based on Artificial Intelligence for Transcatheter Aortic Prosthesis Selection.

INTRODUCTION: The interest in Expert systems has increased in the medical area. Some of them are employed even for diagnosis. With the variability of transcatheter prostheses, the most appropriate choice can be complex. This scenario reveals an enabling environment for the use of an Expert system. The goal of the study was to develop an Expert system based on artificial intelligence for supporting the transcatheter aortic prosthesis selection. METHODS: The system was developed on Expert SINTA. The rules were created according to anatomical parameters indicated by the manufacturing company. Annular aortic diameter, aortic area, aortic perimeter, ascending aorta diameter and Valsalva sinus diameter were considered. After performing system accuracy tests, it was applied in a retrospective cohort of 22 patients with submitted to the CoreValve prosthesis implantation. Then, the system indications were compared to the real heart team decisions. RESULTS: For 10 (45.4%) of the 22 patients there was no concordance between the Expert system and the heart team. In all cases with discordance, the software was right in the indication. Then, the patients were stratified in two groups (same indication vs. divergent indication). The baseline characteristics did not show any significant difference. Mortality, stroke, acute myocardial infarction, atrial fibrillation, atrioventricular block, aortic regurgitation and prosthesis leak did not present differences. Therefore, the maximum aortic gradient in the post-procedure period was higher in the Divergent Indication group (23.9 mmHg vs. 11.9 mmHg, P=0.03), and the mean aortic gradient showed a similar trend. CONCLUSION: The utilization of the Expert system was accurate, showing good potential in the support of medical decision. Patients with divergent indication presented high post-procedure aortic gradients and, even without clinical repercussion, these parameters, when elevated, can lead to early prosthesis dysfunction and the necessity of reoperation.

Development and application of a system based on artificial intelligence for transcatheter aortic prosthesis selection

Abstract Introduction: The interest in Expert systems has increased in the medical area. Some of them are employed even for diagnosis. With the variability of transcatheter prostheses, the most appropriate choice can be complex. This scenario reveals an enabling environment for the use of an Expert system. The goal of the study was to develop an Expert system based on artificial intelligence for supporting the transcatheter aortic prosthesis selection. Methods: The system was developed on Expert SINTA. The rules were created according to anatomical parameters indicated by the manufacturing company. Annular aortic diameter, aortic area, aortic perimeter, ascending aorta diameter and Valsalva sinus diameter were considered. After performing system accuracy tests, it was applied in a retrospective cohort of 22 patients with submitted to the CoreValve prosthesis implantation. Then, the system indications were compared to the real heart team decisions. Results: For 10 (45.4%) of the 22 patients there was no concordance between the Expert system and the heart team. In all cases with discordance, the software was right in the indication. Then, the patients were stratified in two groups (same indication vs. divergent indication). The baseline characteristics did not show any significant difference. Mortality, stroke, acute myocardial infarction, atrial fibrillation, atrioventricular block, aortic regurgitation and prosthesis leak did not present differences. Therefore, the maximum aortic gradient in the post-procedure period was higher in the Divergent Indication group (23.9 mmHg vs. 11.9 mmHg, P=0.03), and the mean aortic gradient showed a similar trend. Conclusion: The utilization of the Expert system was accurate, showing good potential in the support of medical decision. Patients with divergent indication presented high post-procedure aortic gradients and, even without clinical repercussion, these parameters, when elevated, can lead to early prosthesis dysfunction and the necessity of reoperation.