Treatment Of Severe Aortic Stenosis Research Articles

CRT-700.08 The Impact of Beta Blockers on Transcatheter Aortic Valve Replacement Outcomes

Trans-catheter Aortic Valve Replacement (TAVR) is a novel procedure that has revolutionized the treatment for severe aortic stenosis (AS). There is limited data on the pre-operative beta-blocker (BB) impact on TAVR outcomes. A Retrospective analysis of 373 patients with severe AS who underwent TAVR

Impact of renin-angiotensin system inhibitors on clinical outcomes and ventricular remodelling after transcatheter aortic valve implantation: rationale and design of the RASTAVI randomised multicentre study

IntroductionTranscatheter aortic valve implantation (TAVI) as a treatment in severe aortic stenosis (AS) is an excellent alternative to conventional surgical replacement. However, long-term outcomes are not benign. Renin-angiotensin system (RAS)...

Functionality and Outcome in Older Patients with Severe Aortic Stenosis (FOOPAS): an interdisciplinary study concept for a prospective trial.

BackgroundFrailty is a geriatric syndrome that can influence mortality and functional recovery after treatment of severe aortic stenosis (AS). The integration of standardized geriatric assessment (GA) in clinical practice is limited by a lack of consensus on how to measure it.ObjectivesThis study aims to compare the incremental predictive value of different frailty scales to predict the outcomes following surgical aortic valve replacement, transcatheter aortic valve implantation, and conservative treatment of severe AS.MethodsA prospective cohort of 300 older adults with severe AS will be assembled after standard clinical examinations and a comprehensive GA, including 18 different tests and values. Primary outcome parameters are overall mortality, cardiovascular mortality, quality of life, and functionality. Secondary parameters are overall complications, cardiovascular complications, and costs.ResultsExpected results will contribute to the growing body of evidence on frailty based on parameters that influence clinical and functional outcome in elderly patients independent of the method of treatment. The pre-procedural assessment is expected to be valuable in discriminating new post-procedural complications from simple exacerbations of pre-existing conditions. Therefore, a new frailty test which is simple and feasible for application in a clinical routine by most medical professionals, may help in identifying patients for whom further GA should be considered. Finally, such a frailty score could support heart teams to find the right treatment for patients suffering from AS.ConclusionComparison of different frailty scales has not only the goal of finding a predictive value of mortality but also to bring in a meaningful improvement for each individual patient and to avoid disability or fatal outcomes.

Recent developments and controversies in transcatheter aortic valve implantation.

Interventional cardiology has been revolutionised by transcatheter aortic valve implantation (TAVI), which has become established as the benchmark treatment for severe aortic stenosis in patients at high risk for surgical aortic valve replacement (AVR). Increased procedural familiarity and progression in device technology has enabled improvements to be made in complication rates, which have led to a commensurate expansion in the use of TAVI; it is now a viable alternative to AVR in patients at intermediate surgical risk, and has been used in cohorts such as those with bicuspid aortic valves or pure, severe aortic regurgitation. Given the rapid expansion in the use of TAVI, including cohorts of younger patients with fewer co-morbidities, attention must be paid to further reducing remaining complications, such as cardiac tamponade or stroke. To this end, novel techniques and devices have been devised and trialled, with varying levels of success. Furthermore, significant work has gone into refining the technique with exploration of alternative imaging modalities, as well as alternative access routes to provide greater options for patients with challenging vascular anatomy. Whilst significant progress has been made with TAVI, areas of uncertainty remain such as the management of concomitant coronary artery disease and the optimum post-procedure antiplatelet regimen. As such, research in this field continues apace, and is likely to continue as use of TAVI becomes more widespread. This review provides a summary of the existing evidence, as well as an overview of recent developments and contentious issues in the field of TAVI.

Impact of previous cardiac surgery with sternotomy on clinical outcomes and quality of life after transcatheter aortic valve implantation for severe aortic stenosis.

Transcatheter aortic valve implantation (TAVI) has evolved as an effective treatment in patients with symptomatic severe aortic stenosis (AS) and increased operative risk. Data on the influence of previous sternotomy on the risk of TAVI are limited. We sought to investigate the effect of previous cardiac surgery with sternotomy on clinical outcomes and quality of life (QoL) after TAVI. The study included 148 consecutive patients with symptomatic severe AS, who underwent TAVI. Baseline charac-teristics, procedural and long-term clinical outcomes, and QoL assessment with the EQ-5D-3L questionnaire were compared between patients with and without previous sternotomy. Patients with previous sternotomy (23.0% of the population) were younger and more often male, had higher rate of previous myocardial infarction (MI; 26 [22.8%] vs. 22 [64.7%], p = 0.001), and lower median left ventricular ejection frac-tion (60.0% [50.0-65.0] vs. 50.0% [42.0-60.0], p = 0.004). Periprocedural risk measured with the Logistic Euroscore and the Society of Thoracic Surgeons scale was comparable in both groups. There were no differences in 30-day and 12-month all-cause mortality between the groups with and without sternotomy (10 [8.8%] vs. 2 [5.9%], p = 0.7; odds ratio [OR] adjusted for age/sex/previous MI, 0.56, 95% confidence interval [CI] 0.10-3.29; for 12-month mortality adjusted OR 0.19, 95% CI 0.04-0.99). At the longest available follow-up, mortality was higher in patients without sternotomy (30 [26.3%] vs. 3 [8.8%], p = 0.03; adjusted OR 0.10, 95% CI 0.02-0.42). Similar rates of other complications after TAVI were noted. No differences in the EQ-5D-3L questionnaire at baseline and 12-month follow-up were confirmed. TAVI seems to be a safe and effective technique for the treatment of severe AS in patients with previous cardiac surgery.

Antihypertensive Treatment in Severe Aortic Stenosis.

Previously, antihypertensive treatment in severe aortic stenosis was considered a relative contraindication. However, recent studies have shown that antihypertensive treatment may be safe and even beneficial in terms of reducing the progression of left ventricular pressure overload and even retarding the progression of valvular aortic stenosis. To date, no randomized clinical trials have been performed and no definite treatment guideline exist for the proper antihypertensive regimens. Antihypertensive treatment with β-blockers has generally been avoided in patients with severe aortic stenosis (AS) due to the concerns for inducing left ventricular dysfunction and hemodynamic compromise in the presence of severe outflow tract obstruction. Although it remains unclear whether antihypertensive treatment with a β-blocker is associated with increased risk of cardiovascular events in patients with AS, recent studies have shown that the use of β-blockers may be safe and may even be beneficial. Renin-angiotensin system (RAS) are upregulated in AS and have been shown to be involved in valve calcification and progression in both experimental models and in human trials. As such, theoretically, RAS inhibition would have benefit in retarding the progression of valvular stenosis as well as have benefit in left ventricle remodeling. Recent clinical studies are indeed showing that use of RAS inhibition may be beneficial in patients with AS. Future clinical trials to establish the ideal target blood pressure and antihypertensive regimens in severe AS is essential.

Surgical treatment of elderly patients with severe aortic stenosis in the modern era - review.

Surgical treatment of severe aortic stenosis offers good early and long-term results, even in elderly patients. Despite the implementation of percutaneous methods for the very high-risk group, surgical valve replacement remains the gold standard. The advanced age of patients should not be the only indicator limiting the possibility of surgery. In this review we present the most important information on the results of aortic stenosis surgical treatment in the groups of older patients. New methods such as percutaneous and minimally invasive methods of surgery are also discussed. Additionally, the presented information is referred to current guidelines for the treatment of severe aortic stenosis.

Transcatheter Aortic Valve Implantation in Small Anatomy: Patient Selection and Technical Challenges.

Transcatheter aortic valve implantation (TAVI) has become a standard treatment for severe aortic stenosis. Although this technique has reached relative maturity, further optimisation of patient selection and device implantation is essential to improve prognosis. Smaller body size is a predictor of a challenging TAVI procedure due to specific anatomical difficulty and adverse events including annulus rupture, acute coronary obstruction and vascular complications. A newer generation, lower profile TAVI system is useful for patients with smaller anatomy. Moreover, TAVI is superior to surgical aortic valve replacement in patients with a narrowing annulus because this treatement has a low incidence of prosthesis-patient mismatch.

Preprocedural Right Ventricular Systolic Pressure Is a Predictor of Mortality in Patients Undergoing Transcatheter Aortic Valve Implantation

Introduction: Transcatheter aortic valve implantation (TAVI) is the gold standard treatment for severe aortic stenosis (AS) in high-risk patients, and non-inferior to surgical aortic valve replacement in intermediate-risk patients. There are numerous established predictors of periprocedural mortality in the international literature but few have been described based on Australian patients. The primary objective of this study was to identify demographic, clinical, and biochemical predictors of mortality in patients who underwent TAVI in an Australian cohort.

Association of postprocedural aortic regurgitation with mitral regurgitation worsened after transcatheter aortic valve replacement.

There is a paucity of investigation which demonstrates a predictor of mitral regurgitation (MR) worsened after aortic valve replacement (TAVR). The aim of this study was to identify the predictor of worsened MR after transcatheter TAVR. We retrospectively studied a total of 209 patients with mild or less MR at baseline who underwent TAVR for the treatment of severe aortic stenosis with the balloon-expandable device. We found the presence of MR worsened after TAVR in 6% (12 patients) of all patients. Moderate or more postprocedural aortic regurgitation (AR) (odds ratio, 8.104; 95% confidence interval, 1.78-36.87; P=.007) was identified as a predictor of MR worsening after TAVR. In-hospital outcomes indicated that patients within whom MR worsened suffered congestive heart failure more than those with unchanged or improved MR after TAVR (P<.05). Significant postprocedural AR was associated with MR worsened from mild or less to moderate or more after TAVR. Worsened MR might affect in-hospital congestive heart failure.

Transcatheter aortic valve replacement with balloon-expandable valve : Analysis of initial experience in China.

BackgroundTranscatheter aortic valve replacement (TAVR) is widely applied for the treatment of severe aortic stenosis (AS) in developed countries; however, in China, it is still in the early stage of utilization. On the basis of previous studies, this work explored the feasibility of TAVR in patients with severe AS in China and analyzed the cause of death in four cases.MethodsThis retrospective study included 20 patients who had severe AS and underwent TAVR with a balloon-expandable system (Edwards SAPIEN XT) in our hospital from January 2011 to June 2016. The valve and heart functions of 16 survivors before and after the TAVR procedure were compared. TAVR endpoints, device success, and adverse events were assessed according to the definitions of the Valve Academic Research Consortium-2 (VARC-2).ResultsThere were 13 male and seven female patients aged 65–81 years (average, 73.15) who underwent TAVR. The TAVR approach was transfemoral in 19 patients and transapical in one patient. Four patients died (two of coronary artery occlusion and two of aortic annulus rupture) during the TAVR procedure or shortly after; six patients had mild paravalvular leakage, and the rest of the patients showed a significant improvement in cardiac function. During the follow-up period (2–62 months), one patient died of lung cancer 13 months after the TAVR procedure.ConclusionTAVR with a balloon-expandable system is safe and effective and can be used for patients with severe AS in China. It requires careful patient selection and preoperative assessment so as to reduce the 30-day postoperative mortality rate.

The impact of waiting for intervention on costs and effectiveness: the case of transcatheter aortic valve replacement.

The economic crisis in Europe might have limited access to some innovative technologies implying an increase of waiting time. The purpose of the study is to evaluate the impact of waiting time on the costs and benefits of transcatheter aortic valve replacement (TAVR) for the treatment of severe aortic stenosis. This is a cost-utility analysis from the perspective of the Spanish National Health Service. Results of two prospective hospital registries (158 and 273 consecutive patients) were incorporated into a probabilistic Markov model to compare quality adjusted life years (QALYs) and costs for TAVR after waiting for 3-12months, relative to immediate TAVR. We simulated a cohort of 1000 patients, male, and 80years old; other patient profiles were assessed in sensitivity analyses. As waiting time increased, costs decreased at the expense of lower survival and loss of QALYs, leading to incremental cost-effectiveness ratios for eliminating waiting lists of about 12,500 € per QALY. In subgroup analyses prioritization of patients for whom higher benefit was expected led to a smaller loss of QALYs. Concerning budget impact, long waiting lists reduced spending considerably and permanently. A shorter waiting time is likely to be cost-effective (considering commonly accepted willingness-to-pay thresholds in Europe) relative to 3months or longer waiting periods. If waiting lists are nevertheless seen as unavoidable due to severe but temporary budgetary restrictions, prioritizing patients for whom higher benefit is expected appears to be a way of postponing spending without utterly sacrificing patients' survival and quality of life.

Abstract 21150: Surgical Treatment of Asymptomatic Severe Aortic Stenosis: Impact of Surgical Timing on Long-Term Survival

Introduction: Aortic valve (AV) replacement (AVR) is regarded as the only effective treatment for severe aortic stenosis (AS). The current guidelines, however, agree with watchful waiting in asymptomatic AS patients with normal left ventricular (LV) function. Hypothesis: This study aims to assess the hypothesis that timely surgical intervention is associated with the improved long-term survival in asymptomatic severe AS patients. Methods: Between 2000 and 2015 in our institution, we identified 505 patients (aged 63.9±13.1 years, 252 females) having asymptomatic severe AS (aortic valve area [AVA] ≤ 1.0cm 2 , peak trans-AV velocity [V max ] ≥ 4.0m/s or mean AV pressure gradient [PG] ≥ 40mmHg) with preserved LV function (ejection fraction ≥ 50%). Among them, very severe AS (AVA ≤ 0.6cm 2 , V max ≥ 5.0m/s or mean PG ≥ 60mmHg) was found in 152 (29.9%) patients. AVR was performed in 231 (45.7%) patients within 3 months after diagnosis (n=145) or during follow-up (n=86) thereafter either by surgical AVR (n=214) or by trans-catheter AVR (n=17). Time-varying Cox-proportional hazard models were used to determine the impact of surgical therapy on survival outcomes. Results: During a median follow-up of 58.3 months (Q1-Q3, 29.6-104.6 months), 163 (32.3%) patients died. On time-varying Cox-hazard models, surgical therapy was associated with a significant risk reduction in overall death (hazard ratio [HR], 0.63; 95% confidence interval [CI], 0.43-0.94; P=0.022) after adjusting with 32 significant risk factors for mortality. Survival benefits by AVR were consistently demonstrated in most risk subgroups of patients based on ages, severity of AS and the morphology of the AV (bicuspid) (Figure). Conclusions: Timely AVR in asymptomatic severe AS patients resulted in marked survival benefits. These study results may suggest that early robust recruitment for surgical therapy may be warranted in asymptomatic severe AS patients before developing ventricular deterioration or onset of symptoms.

Approaches to the Role of The Heart Team in Therapeutic Decision Making for Heart Valve Disease

ABSTRACTMultidisciplinary decision making is becoming increasingly important in health care with ever growing therapeutic options available in complex cases. This is also true for cardiovascular medicine, where the introduction of percutaneous coronary intervention caused a revolution in the treatment of coronary artery disease. Currently, with the development of transcatheter procedures to repair or replace heart valves, the treatment of valvular heart disease is subject to a similar transition. Especially the treatment of severe aortic stenosis in high- and intermediate-surgical-risk patients has changed significantly, with the emergence of the transcatheter aortic valve replacement (TAVR) as an accepted treatment. In order to oversee the extensive set of diagnostic and therapeutic options it is suggested that decision making is performed in a multidisciplinary team, i.e. a Heart Team. This review gives a summary of the changes that have taken place and continue to take place in the treatment of aortic, tricuspid and mitral valve disease. Furthermore, an overview is provided of the advantages and limitations of shared decision making. Three possible models of decision making in the treatment of patients with severe aortic stenosis are discussed in detail. Subsequently, surgical risk scores, the assessment of frailty in possible TAVR candidates and the necessity of Heart Team reimbursement are discussed.

Transcatheter Aortic Valve Replacement: Outcomes, Indications, Complications, and Innovations.

Transcatheter aortic valve replacement (TAVR) has become the standard of care for the treatment of severe aortic stenosis in individuals who are at prohibitive surgical risk and presents a viable alternative to surgery in selected patients who are at high operative risk. To date, outcomes from the PARTNER (Placement of AoRtic TraNscathetER Valve) and Medtronic CoreValve® US Pivotal trials continue to show the benefits of TAVR in these high-risk subgroups out to 5 and 3years, respectively (as reported by Mack et al. Lancet. 85:2477-2484 2015; Kapadia et al. Lancet. 385:2485-2491 2015; Deeb et al. J Am Coll Cardiol. 67:2565-2574 2016). Furthermore, the recent release of the PARTNER-2 and SURTAVI trial results among other international data suggest that clinical outcomes for intermediate risk patients may be promising for TAVR compared to surgical aortic valve replacement (SAVR) (as reported by Leon et al. N Engl J Med. 374:1609-1620 2016; Reardon et al. N Engl J Med. 376:1321-1331 2017). However, several questions persist regarding TAVR-specific complications as well as long-term durability. Paravalvular regurgitation, permanent pacemaker implantation, stroke, vascular access injury, and renal failure in post-TAVR patients remain adversaries in the quest to perfect this groundbreaking, game-changing technology (as reported by Khatri et al. Ann Intern Med. 158:35-46 2013). In this review, we provide an up-to-date synopsis of results from landmark clinical trials that cumulatively attest to the comparability of TAVR to best medical therapy and SAVR in extreme-risk, high-risk, and intermediate-risk patient populations. We continue with a review of studies that seek to compare transcatheter vs. surgical valve implantation in lower-risk subgroups. We also introduce ongoing efforts to optimize the peri-procedural management of TAVR and conclude with a presentation of management strategies and new generation valve platforms that seek to address some of the current limitations of transcatheter valve implantation.

How TAVI registries report clinical outcomes-A systematic review of endpoints based on VARC-2 definitions.

IntroductionTranscatheter aortic valve implantation (TAVI) has been demonstrated to be an alternative treatment for severe aortic stenosis in patients considered as high surgical risk. Since its first human implantation by Cribier et al., TAVI has been shown to increase survival rate and quality of life for high surgical risks patients. The objective of this study is to provide an overview of TAVI registries and the reporting clinical outcomes based on the VARC-2 definitions. In addition, the comparability and adherence of VARC-2 reporting within the identified TAVI registries was reviewed.Materials and methodsA systematic review of TAVI registries reporting VARC-2 definitions has been performed in line with PRISMA guidelines in PubMed, ScienceDirect, Scopus databases and EMBASE. Based on VARC-2, patients’ characteristics and procedure characteristics, 30-day clinical outcomes, 1-year mortality and composited endpoints were extracted from each registry’s publications.ResultsThis review identified 466 studies that were potentially relevant, and 20 TAVI registries reported VARC-2 definitions involved in our present review. Of all 20 registries, an overall sample size of 12,583 patients was involved. The 30-day all-cause mortality ranged from 0 to 12.7%. From 20 registries, 14 registries reported the cardiovascular mortality at 30 days. 9 registries reported myocardial infarction (MI) rate based on VARC-2 definitions, and 7 registries reported peri-procedural MI rate (<72h). In our review, most of registries presented MI rates ranging from 0.5% to 2%. The majority of registries have reported complications such as bleeding, vascular complications and new pacemaker implantation.ConclusionSince the introduction of VARC definitions from 2011, VARC and VARC-2 definitions are still not systematically used by all TAVI studies. These endpoint definitions warrant a concise and systemic analysis of outcome measures. Reporting TAVI-outcome uniformly makes study result comparison feasible. This definitely will increase patient safety, additionally to provide sufficient evidence to support decision makers like regulatory bodies, HTA agencies, payers.

Transcatheter aortic valve implantation: Present and development trend

Currently, although surgical aortic valve replacement (SAVR) is still the golden standard in treatment of severe aortic stenosis according to the guideline, transcatheter aortic valve implantation (TAVI) is gradually becoming a common treatment for patients who are prohibitive or in high risk for SAVR. Recently, the valve manufacturers, including medical companies in China, are making their utmost to develop valve device, leading remarkable results achieved by TAVI. With the complications being controlled, TAVI displays promising future. It is likely that TAVI is expected to become a substitute for SAVR to treat patients with aortic stenosis or even aortic regurgitation.

Final 5-year clinical and echocardiographic results for treatment of severe aortic stenosis with a self-expanding bioprosthesis from the ADVANCE Study.

AimsThe ADVANCE study was designed to evaluate the safety and effectiveness of transcatheter aortic valve implantation (TAVI) with a self-expanding bioprosthesis in real-world patients with symptomatic, severe aortic stenosis at high surgical risk for valve replacement.Methods and resultsStudy participants were enrolled from 44 experienced centres in 12 countries. Patient eligibility, treatment approach, and choice of anaesthesia were determined by the local Heart Team. The study was 100% monitored, and adverse events were adjudicated by an independent clinical events committee using Valve Academic Research Consortium (VARC-1) criteria. There were 1015 patients enrolled with 996 attempted TAVI procedures. Mean age was 81 years, and mean logistic EuroSCORE was 19.3 ± 12.3%. Five-year follow-up was available on 465 (46.7%) patients. At 5 years, the rate of all-cause mortality was 50.7% (95% confidence interval: 46.7%, 54.5%), and the rate of major stroke was 5.4%. Haemodynamic measures remained consistent for paired patients with a mean aortic valve gradient of 8.8 ± 4.4 mmHg (n = 198) and an effective orifice area of 1.7 ± 0.4 cm2 (n = 123). Aortic regurgitation (AR) decreased over time and among paired patients dropped from 12.8% to 8.0% moderate AR at 5 years (n = 125). Of the 860 patients with echocardiographic data or a reintervention after 30 days, there were 22 (2.6%) patients meeting the VARC-2 criteria for valve dysfunction and 10 (1.2%) patients with a reintervention >30 days.ConclusionFive-year results in real-world, elderly, high-risk patients undergoing TAVI with a self-expanding bioprosthesis provided evidence for continued valve durability with low rates of reinterventions and haemodynamic valve dysfunction.Trial registrationClinicalTrials.gov, NCT01074658.

Prótesis sin sutura Perceval S en la cirugía valvular aórtica de alto riesgo. Una herramienta fundamental para el cirujano

ObjectiveSutureless aortic valve replacement has emerged as an innovative alternative for treatment of severe aortic stenosis. Patients and methodsBetween March 2012 and October 2016 Perceval S (Livanova, Saluggia, Italia) prosthesis was implanted in 262 patients (mean age: 77.97±6.12 years; 56.22% women). In 176 cases (67.18%) isolated aortic valve replacement was performed, 36.9% was minimally invasive approach. Clinical and echocardiographic follow-up was performed at discharge, 6 months and yearly after surgery. ResultsThe expected risk of mortality was 14.19±1.31% (Euroscore log I) and 7.47±1.11% (Euroscore log II). Observed hospital mortality was 4.23%. Neurological complications in 2 patients (0.94%), one transient, and moderate paravalvular leak 2 patients.Mean follow-up of 26±6.2 months. Follow-up mortality 1.9% (4 patients); leaks grade II in 2 patients. Mean transprosthetic gradient of 10.2mmHg; 95% of patients in functional class I-II. ConclusionsThe use of the sutureless Perceval S (Livanova, Saluggia, Italia) prosthesis for surgical treatment of severe aortic stenosis has shown to be feasible, safe and effective. This valve is a very useful tool in high risk aortic patients, with low mortality and low complications rates, and highly versatile has allowed us to solve very complex cases.

Osteopontin predicts clinical outcome in patients after treatment of severe aortic stenosis with transcatheter aortic valve implantation (TAVI)

ObjectiveOsteopontin (OPN) is an extracellular matrix protein that plays an integral role in myocardial remodelling and has previously been shown to be a valuable biomarker in cardiovascular disease. Because of...