Transcatheter Aortic Valve Implantation Group Research Articles

TRANSCATHETER AORTIC VALVE IMPLANTATION AND OPEN AORTIC SURGERY: COMPARATIVE ASSESSMENT OF RESULTS

Aim. The aim of this study is to compare hospital and long-term outcomes in patients with low surgical risk after aortic stenosis correction in surgical aortic valve replacement (SAVR) and transcatheter aortic valve implantation (TAVI).Materials and methods. Patients with aortic stenosis (AS) were included in the study. The main criterion for inclusion - the presence of indications for surgical correction of an isolated aortic valve defect. The first group included patients after TAVI (n = 11). As a control group, patients who underwent surgical correction aortic stenosis (n = 23). The TAVI group used non-repositories CoreValve (Medtronic) and repositioned Lotus (Boston Scientific) valves. Biological prosthesis Uniline (KemKor) was used in the group of surgical patients. The efficacy of the interventions was evaluated at the hospital and annual follow-up, based on the analysis of the combined endpoint, and major adverse cardiovascular events.Results. The mean age of the patients was 66.9±5.7 years in the SAVR group and 75.3±4.1 years in the TAVI group (р=0,003). The average score for EuroSCORE II was 3.49±0.3 in the SAVR group and 3.93±1.2 in the TAVI group (р=0,31). Repositionable and non-repositionable valves were implanted in 2 and 9 cases, respectively. The combined endpoint was noted in one patient in the TAVI group and in four patients in the SAVR group according to the annual observation results. There are three (13%) fatal outcomes in the surgical prosthesis group.Conclusion. The possibility of using TAVI in low-risk patients with aortic stenosis was demonstrated on the basis of comparable results of evaluating efficacy and safety with SAVR in 1-year follow-up.

Comparative results of surgical and transcatheter (TAVI) treatment of aortic stenosis in patients over 75 years old

Aim. To assess the results of transcatheter aortic valve implantation (TAVI) in comparison with open surgery for aortic stenosis in patients over 75 years old. Material and methods. We analyzed the results of 33 operations of aortic valve replacement in patients with aortic stenosis performed in the Moscow Municipal Clinical Hospital No. 15 in the period from June 2012 to September 2017. The first group included 21 TAVI operations. In 15 patients TAVI was performed through the femoral artery, 6 — transthoracic through the cardiac apex. All patients with transcatheter intervention were implanted with SAPIEN valves. In the postoperative period all patients showed a decrease in the systolic pressure gradient on the valve to 9,8±4,06 mm Hg. Aortic valve area after the operation has increased on average from 0,72±0,1 cm2 to 1,9±0,3 cm2. For comparison, a control group of 12 patients who underwent aortic valve replacement under cardiopulmonary bypass was formed. All patients had a high operative risk. Euroscore II 6,3±4,9, STS 5,2±3,4.Results. There were no cases of death in the TAVI group. These patients had the following postoperative complications: 3 patients (13,6%) — complete atrioventricular block, which required permanent pacemaker implantation; it was a significantly more frequent complication of transcatheter interventions. Less frequently in the postoperative period patients had severe acute cardiovascular failure (p=0,001), acute renal failure (p=0,05), paroxysmal atrial fibrillation (p=0,001). The volume of intraoperative blood loss was significantly less in the TAVI group: 147,6±84,4 ml and 666,7±322,9 ml (p=0,05). Mortality in the surgical group was 33% (4 patients). In the surgical group in 2 cases the cause of death was multiple organ failure, in two cases — acute cardiovascular failure. Patients from this group patients had the following postoperative complications: bleeding requiring a resternotomy — 2 (16,7%), pneumonia — 1 (8,3%), heart failure in the postoperative period, requiring prolonged cardiotonic support — 9 (75%), one patient underwent mechanical hemodynamic support, renal failure requiring renal replacement therapy in one patient.Conclusion. Even though surgical aortic valve replacement is the “gold standard” for treating patients with aortic stenosis, the results of operations in the older age group is not sufficient due to the high frequency of postoperative complications. TAVI, proposed by Cribier A, et al. in 2002, gives better results in patients over 75 age group due to the lower incidence of complications in the postoperative period, less intraoperative blood loss. We suppose that it is an alternative for patients of the older age group and high operative risk.

Simultaneous Transcatheter Aortic Valve Implantation and Left Atrial Appendage Occlusion versus both Interventions as Stand-Alone Procedures

ABSTRACT Background: Patients with atrial fibrillation undergoing transcatheter aortic valve implantation (TAVI) have a worse prognosis than those in sinus rhythm. The bleeding risk associated with oral anticoagulation accounts for some of this difference. Left atrial appendage occlusion (LAAO) omits the need for oral anticoagulation in patients with atrial fibrillation. We investigated the feasibility of simultaneous TAVI and LAAO with Lotus and Watchman and compared the results to both interventions as stand-alone procedures. Methods: Fifty-two consecutive patients who underwent either TAVI with Lotus (n = 19), LAAO with Watchman (n = 23) or both procedures simultaneously (n = 10) were investigated. Procedural characteristics, in-hospital- and 30-day-outcomes defined by VARC-2 criteria were compared. Results: There was no significant difference in the amount of contrast medium used between the three groups (TAVI: 89 ± 29 mL; LAAO: 98 ± 54 mL; TAVI + LAAO: 86 ± 29mL; p = 0.923). The total procedural time was significantly longer in the combined group (TAVI: 57.1 ± 18.0 minutes; LAAO: 42.7 ± 16.0 minutes; TAVI + LAAO: 82.0 ± 18.6 minutes; p = 0.001). Procedural and device success was achieved in all patients. The length of hospital stay was lower in the isolated LAAO group but did not differ significantly in the two groups including TAVI (TAVI: 9.7 ± 4.3 days; LAAO: 2.0 ± 2.1 days; TAVI + LAAO: 10 ± 4 days; p < 0.001). One sudden cardiac death occurred in the combined group at home on day 28. There was one cerebrovascular event and one major bleeding event in the isolated TAVI group. Conclusion: Combining TAVI and LAAO with Lotus and Watchman is feasible and was comparable to both interventions as stand-alone procedures.

Comparison of Complication and Success Rates of ProGlide Closure Device in Patients Undergoing TAVI and Endovascular Aneurysm Repair.

Introduction Usage of the Perclose ProGlide® (PP: Abbott Laboratories, Chicago, IL, USA) closure device is becoming increasingly prevalent during percutaneous endovascular aortic repair (EVAR) and transcatheter aortic valve implantation (TAVI). The respective conditions treated via these procedures, abdominal aortic aneurysm and aortic valve stenosis, share risk factors but are two different physiopathological problems. Aim Our aim was to compare the complication and success rates of PP closure device use in patients undergoing EVAR and TAVI. Materials and Methods A total of 74 patients, including 58 undergoing TAVI and 16 undergoing EVAR, were analysed in our study. Results Of the TAVI patients treated using the PP closure device, two (3.4%) had access to site-related bleeding complications and two (3.4%) experienced device failure. Of the EVAR patients who received the PP closure device, three (18.8%) had bleeding complications and three (18.8%) experienced device failure. Conclusion Due to the underlying diffuse aortic wall pathology, the success rate of PP closure device use was lower and the complication rate of PP closure device was higher in the EVAR group versus the TAVI group.

Transcatheter aortic valve implantation versus conservative treatment in chronic kidney disease patients.

There are no studies comparing transcatheter aortic valve implantation (TAVI) to conservative management in patients with chronic kidney disease stage 3-5 and severe aortic stenosis. We sought to compare the mortality rate and change in renal function in this patient population. This was a single-centre retrospective cohort study that included all patients with chronic kidney disease stage 3-5 and severe aortic stenosis who underwent TAVI or were treated conservatively between 2010 and 2015. Three hundred and sixty patients were included (162 TAVI and 198 conservatively treated patients). Several statistical methods were used, including propensity score matching and inverse probability weighting. Mean follow-up was 1.9 years. Conservative management was associated with a hazard ratio of 3.95 (95% CI: 2.59-6.02) for mortality compared with TAVI. After one year there was a significant decrease in renal function in the control group (39.6±13.9 ml/min to 34.4±15.3 ml/min), but not in the TAVI group (41.7±13 ml/min to 42.9±14.5 ml/min) (p-value=0.001). TAVI is associated with improved survival in patients with aortic stenosis and chronic kidney disease stage 3-5 compared to conservative management and protects from further decline in renal function up to one-year follow-up.

Feasibility and safety of combined percutaneous coronary intervention among high-risk patients with severe aortic stenosis undergoing transcatheter aortic valve implantation: a systematic review and meta-analysis.

Recent reports indicated that percutaneous coronary intervention (PCI) may be correlated with increased mortality in patients undergoing transcatheter aortic valve implantation (TAVI). Therefore, we performed a meta-analysis to determine the feasibility and safety of combined PCI in high-risk patients with severe aortic stenosis undergoing TAVI. A comprehensive literature search was performed using PubMed, Embase and the Cochrane Central Register of Controlled trials through June 2016. Five clinical trials including 1634 patients were identified. The pooled analysis revealed no significant differences in 30-day all-cause mortality [odds ratio (OR) 1.25, 95% confidence interval (CI) 0.52-3.05; P = 0.62], 30-day cardiovascular mortality rate (OR 1.59, 95% CI 0.52-4.88; P = 0.41) and 1-year mortality rate (OR 1.16, 95% CI 0.85-1.59; P = 0.34) among the patients assigned to TAVI and those undergoing TAVI+PCI. The incidence of myocardial infarction (OR 2.96, 95% CI 1.03-8.45; P = 0.04) was slightly higher in the TAVI+PCI group. Other complications, such as stroke, kidney injury, bleeding and vascular complications, were not significantly increased in the TAVI+PCI group. Patients treated with a staged procedure of TAVI and PCI but not simultaneous TAVI+PCI showed higher 30-day all-cause mortality as compared to those undergoing isolated TAVI. Combined TAVI+PCI showed similar rates of death from any cause at 30 days and 1 year as compared to isolated TAVI. Except for myocardial infarction, the rate of operative complications in the TAVI+PCI group was not detrimental as compared to the isolated TAVI group. The simultaneous treatment of significant coronary artery lesions may be preferred in selected patients undergoing TAVI.

Infections after transcatheter versus surgical aortic valve replacement: mid-term results of 200 consecutive patients

Transcatheter aortic valve implantation (TAVI) is the standard therapy for high-risk patients with aortic stenosis (AS). TAVI-outcomes are widely investigated in comparison to surgical aortic valve replacement (SAVR), but less is known about infectious complications after TAVI. We aimed to compare early and mid-term infectious outcomes of patients undergoing TAVI or SAVR. The present study is a prospective single-centre study including 200 consecutive patients between 06/2014-03/2015 undergoing TAVI (either transfemoral or transapical and transaortic, n=47+53=100) or SAVR (either isolated or concomitant with CABG, n=52+48=100). The mean age and log. EuroSCORE were significantly different between both groups (81±6 versus 69±11 years, P<0.001 and 23.1%±13.8% versus 8.7%±9.5%, P<0.001). Primary endpoints included wound healing disorders, respiratory and urinary tract infections and incidence of endocarditis or sepsis within hospital stay. Secondary endpoints included infectious parameters, infectious related rehospitalisation and 2-year mortality. Primary endpoints showed no difference in overall TAVI- versus SAVR-groups regarding respiratory- (14% versus 19%, P=0.45), urinary-tract (7% versus 4%, P=0.54) infections, sepsis (5% versus 6%, P=1.0), endocarditis (0% versus 1%, P=1.0) or 30-day mortality (10% versus 4%, P=0.09), except for wound disorders, which were significantly lower in the TAVI-group (1% versus 8%, P=0.035), respectively. Secondary endpoints reported no difference regarding infectious related rehospitalisation (4% versus 4%, P=1.0), but significantly higher 2-year mortality (28% versus 16%, P=0.048) in the TAVI-group. So far, little has been studied about infectious complications after TAVI. This study reports no difference between the overall TAVI and SAVR groups regarding infectious complications. However, SAVR group show more wound healing disorders but less mortality than TAVI group.

Comparison of Causes and Associated Costs of 30-Day Readmission of Transcatheter Implantation Versus Surgical Aortic Valve Replacement in the United States (A National Readmission Database Study)

Our current knowledge about comparative differences in 30-day readmissions and the impact of readmissions on overall costs after transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) is largely derived from clinical trials. The objectives of this study were to compare readmissions and costs for TAVI and SAVR in a nationally representative population-based sample. The Healthcare Cost and Utilization Project's National Readmission Database was used for the study. Hierarchical multivariable regression analyses were used to examine differences in the propensity score 1:1 matched cohort. The matched cohort included 4,682 patients who survived index procedures done from January through November 2013. Compared with SAVR, the rate of 30-day readmission was not significantly different for endovascular TAVI (16% vs 18%; p = 0.19); and was higher for the transapical TAVI (22% vs 17%; p <0.01) group. The 30-day cumulative costs were higher for the 2 endovascular TAVI ($51,025 vs $46,228; p = 0.03) and transapical TAVI ($59,575 vs $45,792; p <0.01). In multivariable analyses, the risk of 30-day readmission was similar for endovascular TAVI (odds ratio [OR] 0.93; 95% confidence interval [CI] 0.78 to 1.12) and was 27% higher for transapical TAVI (OR 1.27; 95% CI 1.02 to 1.57). Cumulative costs (index plus readmission costs) were 13% (β 0.13; 95% CI 0.10 to 0.15) and 19% (β 0.19; 95% CI 0.16 to 0.23) higher for the endovascular TAVI and transapical TAVI, respectively. In conclusion, the rate of readmissions was similar for endovascular TAVI and SAVR but the costs were 26% higher for TAVI than for SAVR.

Minimally invasive versus transapical versus transfemoral aortic valve implantation: A one-to-one-to-one propensity score–matched analysis

ObjectivesAlthough transcatheter aortic valve implantation was the treatment of choice in inoperable and high-risk patients, the effect of transcatheter aortic valve implantation relative to conventional aortic valve replacement via ministernotomy in patients with moderate surgical risk remains unclear. MethodsWe consecutively enrolled patients who underwent minimally invasive aortic valve replacements via ministernotomy (n = 1929), transapical (n = 607), and transfemoral (n = 1273) aortic valve implantations from a single center during the period from July 2009 to July 2017. Of those, we conducted a 1:1:1 propensity score matching according to 23 preoperative risk factors. ResultsWe were able to find 177 triplets (n = 531). The median European System for Cardiac Operative Risk Evaluation II was 3.0% versus 3.4% versus 2.9%, and Society of Thoracic Surgeons Predicted Risk of Mortality was 3.2% versus 3.6% versus 3.4%, respectively. According to the Valve Academic Research Consortium 2 criteria, there were no significant periprocedural differences regarding 30-day mortality (2.3% minimally invasive aortic valve replacement vs 4.5% transapical transcatheter aortic valve implantation vs 1.7% transfemoral transcatheter aortic valve implantation, P = .34), stroke (1.1% minimally invasive aortic valve replacement vs 0.6% transapical transcatheter aortic valve implantation vs 1.7% transfemoral transcatheter aortic valve implantation, P = .84), or myocardial infarction (0.6% minimally invasive aortic valve replacement vs 0.0% transapical transcatheter aortic valve implantation vs 0.0% transfemoral transcatheter aortic valve implantation, P = .83). Both intensive care and hospitalization times were significantly longer in the transapical group. Regarding midterm survival, transapical transcatheter aortic valve implantation was associated with a tendency toward a less favorable outcome (hazard ratio, 1.48; 95% confidence interval, 0.95-2.31; P = .17) compared with minimally invasive aortic valve replacement. ConclusionsIn this real-world propensity score–matched minimally invasive aortic valve replacement, transapical transcatheter aortic valve implantation, transfemoral transcatheter aortic valve implantation cohort of intermediate-risk patients, early mortality was not significantly different, whereas the rates of periprocedural complications were different depending on the approach. During follow-up, there was a tendency in the transapical transcatheter aortic valve implantation group toward a less favorable survival outcome, although there was no significant difference among the 3 groups.

Updated clinical indications for transcatheter aortic valve implantation in patients with severe aortic stenosis: expert opinion of the Italian Society of Cardiology and GISE.

: The introduction of percutaneous treatment of severe aortic stenosis with transcatheter aortic valve implantation (TAVI) remains one of the greatest achievements of interventional cardiology. In fact, TAVI emerged as a better option than either medical therapy or balloon aortic valvuloplasty for patients who cannot undergo surgical aortic valve replacement (SAVR) or are at high surgical risk. Recently, increased operator experience and improved device systems have led to a worldwide trend toward the extension of TAVI to low-risk or intermediate-risk patients. In this expert opinion paper, we first discuss the basic pathophysiology of aortic stenosis in different settings then the key results of recent clinical investigations on TAVI in intermediate-risk aortic stenosis patients are summarized. Particular emphasis is placed on the results of the nordic aortic valve intervention, placement of aortic transcatheter valves (PARTNER) 2 and Surgical Replacement and Transcatheter Aortic Valve Implantation Randomized trials. The PARTNER 2 was the first large randomized trial that evaluated the outcome of TAVI in patients at intermediate risk. The PARTNER 2 data demonstrated that TAVI is a feasible and reasonable alternative to surgery in intermediate-risk patients (Society of Thoracic Surgeons 4-8%), especially if they are elderly or frail. There was a significant interaction between TAVI approach and mortality, with transfemoral TAVI showing superiority over SAVR. Moreover, we examine the complementary results of the recently concluded Surgical Replacement and Transcatheter Aortic Valve Implantation trial. This prospective randomized trial demonstrated that TAVI is comparable with surgery (primary end point 12.6% in the TAVI group vs. 14.0% in the SAVR group) in severe aortic stenosis patients deemed to be at intermediate risk. We review the most relevant clinical evidence deriving from nonrandomized studies and meta-analyses. Altogether, clinical outcome available data suggest that TAVI with a newer generation device might be the preferred treatment option in this patient subgroup. Finally, the differences between the latest European and American Guidelines on TAVI were reported and discussed. The conclusion of this expert opinion article is that TAVI, if feasible, is the treatment of choice in patients with prohibitive or high surgical risk and may lead to similar or lower early and midterm mortality rates compared with SAVR in intermediate-risk patients with severe aortic stenosis.

Contemporary management of aortic stenosis in the elderly. Insights from a recent French registry

Indications for transcatheter aortic valve implantation (TAVI) are being extended towards patients who are not at high risk for surgery. Elderly patients are frequently considered at high risk for surgery; however, little is known about their contemporary management. This prospective multicentre registry was designed to assess the therapeutic decision in elderly patients with severe symptomatic aortic stenosis (AS), according to age and surgical risk. From 1st September to 31st October 2016, consecutive patients aged ≥ 75 years and referred for severe symptomatic AS were included in 32 French centres with on-site TAVI and surgery facilities. The primary endpoint was Heart Team therapeutic decision between medical management, TAVI and surgery. In total, 1101 patients were included, of whom 1049 had a therapeutic decision (pending decision in 52) and form the population of the study. Mean age was 84 ± 5 years, 560 patients (53%) were female; 235 patients were aged < 80 years, 364 between 80 and 85 and 450 ≥ 85. Mean EuroSCORE I was 17.8 ± 12.8% and mean EuroSCORE II (ESII) 5.9 ± 6.0%. Surgical risk was assessed using ES II and was classified as high (ESII > 8%) in 188 patients (18%), intermediate (ESII 4–8%) in 340 (32%), and low (ESII < 4%) in 521 (50%). Decision was medical therapy in 102 patients (9.7%), including balloon valvuloplasty in 23, surgery in 199 (19.0%) and TAVI in 748 (71.3%). Mean ES II was 9.1 ± 9.1% in the medical group, 2.9 ± 2.1% in the surgery group and 6.2 ± 5.8% in the TAVI group. TAVI was chosen for 79% of high-risk patients, 80% for intermediate-risk patients and 63% for low-risk patients. When considering the 947 patients who had a decision of TAVI or surgery, the choice of TAVI over surgery was associated with older age ( P < 0.0001), higher ES II ( P = 0.008) and an interaction between age and ES II ( P = 0.02). The significant interaction means that the influence of surgical risk on the therapeutic decision depends on age. Indeed, in the 521 low-risk patients, surgery was the choice in the majority of patients aged between 75 and 80, while TAVI was the most frequent intervention after 80 ( Fig. 1 ). This contemporary survey shows that either TAVI or surgery is considered in 90% of patients aged ≥ 75 years with severe symptomatic AS. At the end of 2016, Heart Teams already extended indications for TAVI towards elderly patients at intermediate risk. The impact of risk scores on the choice between TAVI and surgery strongly depends on age. Even in low-risk patients, TAVI is now the most frequent intervention after the age of 80.

Management of radiation-induced valvular heart disease in the modern area

Mediastinal irradiation for Hodgkin's lymphoma, may cause, years later, cardiac damages, termed “radiation-induced heart disease”. The objective of this study was to report the management of symptomatic radiation-induced valvular heart disease in the modern area with the development of transcatheter therapies. We retrospectively enrolled all patients who underwent a surgical or transcatheter procedure between January 2006 and January 2016 at our institution for a symptomatic radiation-induced valvular heart disease due to Hodgkin's lymphoma. Clinical preoperative characteristics, procedural data, immediate and mid-term outcomes were reported according to the procedure decided by the Heart Team. Thirty-seven patients (mean age 56 years, 70% men) were included: seventeen underwent a surgical valvular replacement, 16 a Transcatheter Aortic Valve Implantation (TAVI) and 4 a Transcatheter Mitral Valve Implantation (TMVI). In hospital and mid term outcomes are summarized in Table 1 . Surgery was mostly used in combined procedures ( P < 0.001). In-hospital mortality was 14%: 25% in surgical group, 6% in TAVI group and 0% in TMVI group ( P = 0.19). Twenty-two patients (59%) underwent some in-hospital complications, without significant difference between the 3 groups ( P = 0.44). In-hospital stay was lower in transcatheter groups (surgery: 14 days [10–17], TAVI: 7 days [5.5–14.5], TMVI: 6 days [5–12]). One-year mortality was 24%: 25% in surgical group, 18% in TAVI group and 50% in TMVI group ( P = 0.4). Cardiac outcome was acceptable in survivors. Survival curves are presented in Fig. 1 . Valvular replacement in radiation-induced valvular heart disease is associated with high rate of morbidity and mortality. Transcatheter interventions appeared a reasonable alternative to surgery, particularly in case of isolated valve disease although experience with TMVI was limited and require further validation.

Effectiveness and Safety of Transcatheter Aortic Valve Implantation for Aortic Stenosis in Patients With “Porcelain” Aorta

Surgical aortic valve replacement (SAVR) in patients with porcelain aorta is considered a high-risk procedure. Hence, transcatheter aortic valve implantation (TAVI) is emerging as the intervention of choice. However, there is a paucity of data directly comparing TAVI with SAVR in patients with porcelain aorta. We compared outcomes of TAVI versus SAVR in high-risk patients with porcelain between March 2012 and June 2015. The TAVI group included 54 patients, whereas 130 SAVR patients with porcelain aorta were identified (operated on between 2004 and 2015). Both groups were matched 1:1 based on the Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score with a 0.5% a priori caliper, resulting in 52 matched pairs. The mean STS-PROM was 7.3 ± 3.9 for both groups (p = 0.98), whereas mean age was 77.5 years for TAVI and 78.8 years for SAVR (p = 0.46). Compared with SAVR, TAVI patients had lower operative mortality (3.8% vs 17.3%; p = 0.052), significantly shorter median intensive care unit (40 vs 107 hours; p < 0.001) and hospital (5 vs. 7 days; p < 0.001) length of stay (LOS), but similar postoperative stroke rates (7.7% vs 11.5%; p = 0.74). One-year unadjusted survival was 81.7% (95% confidence interval [CI]: 69.8% to 93.5%) in the TAVI group versus 71.2% (95% CI: 61.0% to 85.1%) in the SAVR group, p = 0.093. Cox proportional hazard modeling identified preoperative chronic kidney disease (hazard ratio: 2.63 [95% CI: 1.03 to 6.70]; p = 0.043) and SAVR (hazard ratio: 2.641 [95% CI: 1.07 to 6.51]; p = 0.035) as significant predictors for decreased survival. Overall, TAVI was associated with reduced operative mortality, increased survival, and shorter intensive care unit and hospital length of stay compared with SAVR in patients with porcelain aorta. This study demonstrates that TAVI is a safe intervention in this high-risk population.

Sutureless aortic valve replacement versus transcatheter aortic valve implantation: a meta-analysis of comparative matched studies using propensity score matching.

The aim of this meta-analysis was to compare outcomes of patients undergoing transcatheter aortic valve implantation (TAVI) with those undergoing surgical aortic valve replacement using sutureless valves. A systematic review and meta-analysis in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement was performed. No randomized controlled trials were identified. Six comparative studies using propensity score matching met the inclusion criteria. This meta-analysis identified 1462 patients in that 731 patients underwent surgical aortic valve replacement using sutureless valves (SU) and 731 patients underwent a TAVI. The 30-day or in-hospital mortality was lower in the SU group [odds ratio (OR) 0.54, 95% confidence interval (CI) 0.36-0.80; P = 0.003]. In the TAVI group, the incidence of postoperative stroke was higher (OR 0.36, 95% CI 0.17-0.79; P = 0.01). The incidence of moderate or severe paravalvular regurgitation was higher in the TAVI group (OR 0.22, 95% CI 0.14-0.35; P = 0.001). There were neither differences in the postoperative renal failure (OR 1.44, 95% CI 0.46-4.58; P = 0.53) nor in the number of patients requiring postoperative pacemaker implantation (OR 1.06, 95% CI 0.54-2.08; P = 0.86). Patients in the SU group required more transfusions (OR 4.47, 95% CI 2.77-7.21; P = 0.0001), whereas those in the TAVI group had higher major vascular complications (OR 0.06, 95% CI 0.01-0.25; P = 0.0001). Intensive care unit stay was not different (mean difference 0.99, 95% CI - 1.22 to 1.40; P = 0.53). One-year survival was better in the SU group (Peto OR 0.35, 95% CI 0.18-0.67; P = 0.001), as was the 2-year survival (Peto OR 0.38, 95% CI 0.17-0.86; P = 0.001). Surgical aortic valve replacement using sutureless valves is associated with better early and mid-term outcomes compared with TAVI in high- or intermediate-risk patients.

Outcomes of Aortic Valve Replacement According to Surgical Approach in Intermediate and Low Risk Patients: A Propensity Score Analysis

Previous trials have shown that, among high-risk patients with aortic stenosis, survival rates are similar for transcatheter aortic-valve implantation (TAVI) and surgical aortic valve replacement. The study aimed to compare the outcomes of aortic valve replacement according to the adopted surgical approach in intermediate and low risk patients. This is a retrospective, observational, cohort study of prospectively collected data from 421 patients undergoing isolated aortic valve replacement between 2011 and 2015. A multinomial logit propensity score model based on preoperative risk factors was used to match patients 1:1:1 between conventional replacement (CAVR), minimally invasive (MIAVR) and TAVI groups, resulting in 50 matched three cohorts. After multinomial logit propensity score, the three groups were comparable in terms of preoperative characteristics. Mean age and Logistic EuroSCORE I of CAVR, MIAVR and TAVI groups were (84.2±5.1 vs. 82.3±4.8 vs. 85.6±4.9 years; p=0.002) and (11.4±3.6% vs. 8.3±3.4% vs. 15.8±5.4%; p<0.001) respectively. Overall mortality rates were similar for the three patient cohorts at one year. There were no significant differences related to stroke to 30 days. In the TAVI cohort, pacemaker implantation for new-onset total atrioventricular block became necessary in 30% of patients (p<0.001) and 16% of patients had some degree of paravalvular aortic regurgitation, which was more than mild (p<0.001). Total length of stay was shorter in the TAVI group when compared with surgical groups (11.5±5.3 vs. 10.1±6.9 vs 8.5±3.7 days; p=0.023). After discharge, the survival rate follow-up (average follow up: 46.7 months) was 70%, 84% and 72% for three cohorts (log Rank x2=2.40, p=0.3). In our experience, the three aortic valve replacement approaches offer very good results. Differences in the rate of complications were found between groups. Depending on patient's characteristics the Heart-Team group must offer the best surgical approach for each patient.

Enumeration of circulating endothelial cell frequency as a diagnostic marker in aortic valve surgery - a flow cytometric approach

BackgroundThe frequency of circulating endothelial cells (CEC) in patients’ peripheral blood can be assessed as a direct marker of endothelial damage. However, conventional enumeration methods are extremely challenging. We developed a novel, automated approach to determine CEC frequencies and tested this method on two groups of patients undergoing conventional (CAVR) versus trans-catheter aortic valve implantation (TAVI).MethodsCEC frequencies were assessed by a flow cytometric approach, including automated pre-enrichment of CD34 positive blood cell subpopulation and isotype controls. The efficacy and reproducibility of the CEC enumeration method was validated by spiking blood samples of healthy control donors with defined numbers of endothelial cells.ResultsCEC frequencies were significantly higher in the TAVI group before (9.8 ± 4.1 vs. 5.5 ± 2.2, p = 0.019) and 1 h after surgery (13.4 ± 5.1 vs. 8.2 ± 4.1, p = 0.030) corresponding to higher Euroscore, STS score in higher risk patients from the TAVI group. Five days after surgery, CEC frequencies became significantly higher in the more invasive CAVR group (39.0 ± 13.0 vs. 14.3 ± 4.4, p < 0.001) compared to minimally invasive TAVI approach.ConclusionsThe new flow cytometric approach might be a robust and reliable method for CEC enumeration. Initial results show that CEC frequency is a valid clinical marker for the assessment of pre-operative risk, invasiveness of surgical procedure and clinical outcome. Further studies are necessary to validate the practical clinical usefulness and the potential superiority compared to conventional markers.

Transcatheter aortic valve implantation versus surgical aortic valve replacement in patients over 85 years old.

Surgical aortic valve replacement (SAVR) for the treatment of in very old patients with severe aortic stenosis is associated with a high risk of morbidity and mortality. Transcatheter aortic valve implantation (TAVI) has become the preferred alternative. Therefore, we sought to evaluate outcomes in very old patients who underwent SAVR versus TAVI. A total of 169 consecutive patients aged ≥85 years underwent TAVI (n = 68) or SAVR (n = 101). A propensity score adjustment was used to compare outcomes including cost analysis. The propensity score generated 40 pairs of patients with similar baseline characteristics. The TAVI group experienced atrioventricular block (37.5% vs 5%, P < 0.01) more frequently, a longer stay in the intensive care unit (median 5 days, range 1-35 vs median 2 days, range 1-6, P < 0.01) but a lower rate of new-onset atrial fibrillation (15% vs 47.5%, P < 0.01). The 30-day mortality rate was similar in the unmatched and matched cohorts (8.8% vs 5.0%, P = 0.32; 10% vs 7.5%, P = 0.69). One, 3- and 5-year overall survival rates (80% vs 90%, 56% vs 79%, 37% vs 71%, P < 0.01) and freedom from major adverse cardiac and cardiovascular events (72% vs 90%, 46% vs 76%, 17% vs 68%, P < 0.01) were lower in the TAVI group. An overall cost analysis indicated that TAVI was more expensive (€2084 vs €19 891). In patients 85 years and older, SAVR seems to offer good short- and mid-term clinical outcomes compared to TAVI. Advanced age alone would not be an indication for TAVI in old-old patients.

Post-procedural myocardial infarction following surgical aortic valve replacement and transcatheter aortic valve implantation

Myocardial injury assessed using cardiac biomarker release is ubiquitous following surgical aortic valve replacement (SAVR) and transcatheter aortic valve implantation (TAVI), preventing accurate discrimination between focal myocardial infarction (MI) and global injury. Cardiovascular magnetic resonance (CMR) late gadolinium enhancement (LGE) imaging was used to compare rates of new MI following SAVR and TAVI. Identical CMR scans were obtained at baseline and six months post procedure in ninety-six patients undergoing SAVR (n=39) and TAVI (n=57). The rate of new MI was greater following SAVR than TAVI (SAVR, n=10 [26%] vs. TAVI, n=3 [5%], p=0.004). Infarct mass was similar between groups (SAVR 1.1±0.6 vs. TAVI 2.0±1.4 g, p=0.395). New MI did not impact on change in LV ejection fraction (SAVR:LGE[+]2.2±4.7 vs. LGE[-]0.9±8.0%, p=0.437, TAVI:LGE[+]-0.9±6.0 vs. LGE[-]2.0±7.8%, p=0.420). Thirty-four patients (60%) in the TAVI group had non-revascularised coronary artery disease (CAD) at the time of TAVI, of whom three (9%) had new MI. MI is an infrequent complication of TAVI but is more common following SAVR. Infarct size is small following both procedures. The low new infarct rate in TAVI, especially in the context of high rates of non-revascularised CAD, strengthens data from previous studies suggesting that coronary revascularisation pre-TAVI may be unnecessary.

Transcatheter aortic valve implantation in patients on corticosteroid therapy.

Transcatheter aortic valve implantation (TAVI) is recommended for patients who are inoperable or at high risk for surgical aortic valve replacement (SAVR). Corticosteroid therapy is considered to be a risk factor for SAVR, but there is a paucity of information about TAVI in patients taking corticosteroids. The aim of this study is to elucidate the outcome of TAVI in patients on chronic corticosteroid therapy, compared with SAVR. We retrospectively analyzed patients on corticosteroid therapy who underwent TAVI (n=21) or SAVR (n=30) for severe aortic stenosis in Sakakibara Heart Institute. Primary outcome was a 30-day composite endpoint consisting of early safety endpoints (death, stroke, life-threatening bleeding, acute kidney injury, coronary obstruction, major vascular complication, and valve-related dysfunction) and corticosteroid-specific endpoints (adrenal insufficiency, sepsis, and hyperglycemic complication). There were no differences between two groups in background factors, other than patient age and serum albumin level (age 81.0±5.5 vs. 74.7±9.9years, p=0.0061, albumin 3.6±0.4 vs. 4.0±0.4g/dl, p=0.0076). Device success rate for TAVI was 95.2%. In TAVI group, operative time was shorter (100.2±46.2 vs. 250.0±92.2min, p<0.0001), and the amount of blood transfusion was less (0.67±1.8 vs. 3.5±2.4 units, p<0.0001) than in SAVR group. There was no difference in primary outcome (19.0 vs. 20.0%, p=1.0). Rate of prosthesis-patient mismatch was lower in TAVI group (4.8 vs. 33.3%, p=0.017), and no moderate or severe post-procedural aortic regurgitation was observed in both groups. The post-procedural survival was similar in the two groups (p=0.67, mean follow-up 986±922days). TAVI may be a viable therapeutic option in patients taking corticosteroids.

Transcatheter Aortic Valve Implantation in Intermediate Surgical Risk Patients With Severe Aortic Stenosis: A Systematic Review and Meta-Analysis

Recent data from randomised and observational studies have reported non-inferior outcomes for transcatheter aortic valve implantation (TAVI) compared to surgical aortic valve replacement (SAVR) in intermediate-risk patients. We performed a systematic review to evaluate the mortality of TAVI compared to SAVR in intermediate-risk patients. A comprehensive search of four major databases (Embase, Ovid MEDLINE, PubMed, and Google Scholar) was performed from their inception to 29 April 2016. We included original research studies reporting data on TAVI and SAVR in intermediate-risk patients. We compared the outcomes of TAVI to SAVR. A total of 2,375 and 2,377 intermediate-risk patients underwent TAVI and SAVR respectively. The 30-day all-cause (p=0.07), 30-day cardiac (p=0.53), and 12-month all-cause mortality (p=0.34) was similar between the two groups. However, TAVI through transfemoral access had a significantly lower mortality than SAVR (OR 0.58, p=0.006). The incidence of ≥moderate aortic incompetence (p<0.00001) and pacemaker implantation (p<0.0001) was higher in the TAVI group. In the intermediate-risk patients, the 30-day and 12-month mortality are similar between TAVI and SAVR. Increased operator experience and improved device technology have led to a significant reduction in mortality in intermediate-risk patients undergoing TAVI.