Outcomes Of Transcatheter Aortic Valve Implantation Research Articles

5-year outcome comparison among aortic stenosis patients underwent transcatheter aortic valve implantation with or without permanent pacemaker

Abstract Background The occurrence of atrioventricular block due to local damage to the atrioventricular and infranodul tissues, requiring permanent pacemaker (PMI), is one of major complications of transcatheter aortic valve implantation (TAVI). Previous studies show conflicting results regarding impact of PMI on outcomes in TAVI patients. Purpose The purpose of this study was to compare the 5-year survival rate and CV mortality of TAVI patients without PM, patients with PMI before TAVI, and patients underwent PMI after TAVI. In addition, we also assessed the influence of early- and new-generation prostheses on the prevalence of PMI after TAVI and related outcomes. Methods A total of 778 patients who underwent TAVI in our hospital between 2009 and 2021 were included in this study (mean age 81.4±5.7 years, 50.9% male). Patients were divided into 3 groups: no PMI (n=614), PMI before TAVI (n=76), and PMI after TAVI (n=88). Primary endpoints were defined as all-cause death and cardiovascular (CV) death up to 5 years after TAVI. Results The prevalence of PMI after and before TAVI were 11.3% (88/778) and 9.8% (76/778), respectively. During a median follow-up time of 30 (18-49) months, the survival rate at 1, 2, and 5 years was 90.7%, 83.1%, and 69.2% in the no PMI group, 92.0%, 86.4%, and 76.1% in the PMI after TAVI group, and 89.5%, 86.8%, and 75.0% in the PMI before TAVI group. There was no significant difference in survival rate and CV mortality among the 3 groups (P>0.05, Figure 1). Of 778 patients, 251 (32.3%) patients received early-generation prostheses (Edwards SAPIEN or SAPIEN XT), 527 (67.7%) patients received new-generation prostheses (Edwards SAPIEN 3, SAPIEN 3 Ultra, or ACURATE neo). As compared with TAVI patients who received early-generation prostheses, the prevalence of PMI after TAVI was significantly higher (13.3% vs. 7.2%, P=0.012), while the 5-year all-cause mortality (20.7% vs. 47.8%, P<0.001) or CV mortality (14.8% vs. 31.1%, P<0.001) was significantly lower in those who received new-generation prostheses. TAVI patients with new-generation prostheses was associated with a better 5-year survival rate as compared with early-generation prostheses, irrespective of age, sex, and PMI (hazard ratio=0.654, 95% CI 0.500-0.855, P=0.002, Figure 2). New-generation prostheses (relative risk=1.784, 95% CI=1.089-2.922, P=0.022) and greater prostheses diameter (per 1 mm increase, relative risk=1.144, 95% CI=1.017-1.287, P=0.025) were independently associated with increased risk of PMI after TAVI. Conclusion There is no significant difference in survival rate and CV mortality between patients who underwent PMI after or before TAVI and those who did not. New-generation prostheses is related to higher risk of PMI and better 5-year survival in TAVI patients.Figure 1Figure 2

General versus Local Anesthesia with Intravenous Sedation in Transcatheter Aortic Valve Implantation

Background. Monitored anesthesia care (MAC) may offer better outcomes than general anesthesia (GA) in transcatheter aortic valve implantation (TAVI). We compared TAVI outcomes between patients who received MAC versus GA. Methods. We retrospectively reviewed data from all patients (N = 659), as well as 216 propensity-matched patients, who underwent TAVI at our institution during 2014–2019. Results. MAC and GA did not differ significantly in mortality (1.6% MAC vs. 4.2% GA, p = 0.05) or stroke (2.2% MAC vs. 2.4% GA, p = 0.96); however, median length of stay (LOS) was shorter in the MAC group (2 d MAC vs. 7 d GA, p < 0.0001). In propensity-matched patients, mortality (2.8% MAC vs. 4.6% GA, p = 0.7) and stroke (3.7% MAC vs. 1.9% GA, p = 0.7) did not differ significantly between groups. LOS remained shorter in the MAC group (2 d MAC vs. 7 d GA, p < 0.0001). Conclusions. In this large, single-center, retrospective study, MAC was associated with shorter hospital stay after TAVI.

Automatic Assessment of Transcatheter Aortic Valve Implantation Results on Four-Dimensional Computed Tomography Images Using Artificial Intelligence.

Transcatheter aortic valve implantation (TAVI) is a procedure to treat severe aortic stenosis. There are several clinical concerns related to potential complications after the procedure, which demand the analysis of computerized tomography (CT) scans after TAVI to assess the implant's result. This work introduces a novel, fully automatic method for the analysis of post-TAVI 4D-CT scans to characterize the prosthesis and its relationship with the patient's anatomy. The method enables measurement extraction, including prosthesis volume, center of mass, cross-sectional area (CSA) along the prosthesis axis, and CSA difference between the aortic root and prosthesis, all the variables studied throughout the cardiac cycle. The method has been implemented and evaluated with a cohort of 13 patients with five different prosthesis models, successfully extracting all the measurements from each patient in an automatic way. For Allegra patients, the mean of the obtained inner volume values ranged from 10,798.20 mm3 to 18,172.35 mm3, and CSA in the maximum diameter plane varied from 396.35 mm2 to 485.34 mm2. The implantation of this new method could provide information of the important clinical value that would contribute to the improvement of TAVI, significantly reducing the time and effort invested by clinicians in the image interpretation process.

Evaluation of Anaesthetic Approaches in Transcatheter Aortic Valv Implantation Procedures.

Transcatheter aortic valve implantation (TAVI) has emerged as an alternative to surgical aortic valve replacement and has become a popular treatment modality for inoperable or patients at high surgical risk with severe aortic stenosis. We aimed to evaluate our perioperative anaesthetic experiences with patients undergoing TAVI under sedation or general anaesthesia (GA). One hundred and fifty-nine patients who underwent TAVI procedures were enrolled. Effects on TAVI outcomes of sedation and GA were compared. The duration of surgery and anaesthesia was significantly longer in patients who received GA. Insertion site complication and post-TAVI pacemaker implantation rates were similar between the groups, but the frequency of intraoperative complications (10% vs. 0.8%; P=0.015), intraoperative hypotension (35.3% vs. 70%; P < 0.001), and acute kidney injury (12.6% vs. 27.5%; P=0.028) was significantly higher in the GA group. Stroke occurred in seven patients, and all were in the sedation group. GA is related to increased procedure time and acute kidney injury; therefore, local anaesthesia and sedation may be the first option in patients undergoing TAVI.

A Propensity-Matched National Analysis of Transcatheter Aortic Valve Implantation Outcome in Patients With Gastrointestinal Bleeding

Gastrointestinal (GI) bleeding is often observed in severe aortic stenosis, which can be attributed to the presence of arteriovenous malformations and von Willebrand's factor deficiency. GI is one of the most common complications in patients who underwent transcatheter aortic valve implantation (TAVI). The outcome of the TAVI procedure with GI bleeding is unknown. We performed an International Classification of Diseases, Tenth Revision-based national cohort analysis using the national readmission database from 2016 to 2020. We compared cardiovascular outcomes, mortality, and readmission rates of patients with TAVI who developed GI bleeding compared with those who had no GI bleeding. A total of 320,353 hospitalizations with TAVI were identified from the year 2016 to 2020. Patients with TAVI with GI bleeding were 6,193.37 and without GI bleeding were 314,160. The median age of the patients with TAVI with GI or without GI bleeding was 80. GI bleed patients had statistically significantly higher readmission rates at 30, 90, and 180 days and they had higher odds of in-hospital mortality (adjusted odds ratio [aOR]=6.35; 95% confidence interval [CI]: 5.37 to 7.52; p<0.0001), acute kidney injury (aOR=5.22; 95% CI:4.75 to 5.74; p<0.0001), stroke (aOR=2.83; 95% CI 2.05 to 3.91 p:0.0001, postprocedural bleeding (aOR: 1.76; 95% CI: 1.35 to 2.30; p:0.0001), cardiac tamponade (aOR=2.54; 95% CI 1.86 to 3.49; p<0.0001), use of mechanical circulatory support (aOR: 5.33; 95% CI:4.13 to 6.86; p<0.0001), and heart failure (aOR:1.73; 95%CI: 1.54 to 1.94; p<0.0001). The total cost of hospitalization and length of stay was higher in the GI bleed group. Patients with TAVI with GI bleeding have worse clinical outcomes and higher in-hospital mortality and readmission rates compared with patients with no GI bleeding.

Transcatheter aortic valve implantation results are not superimposable to surgery in patients with aortic stenosis at low surgical risk.

The aim of this meta-analysis was to compare the impact of transcatheter aortic valve implantation (TAVI) vs. surgical aortic valve replacement (SAVR) in patients with severe aortic valve stenosis (AS) at low surgical risk. All randomized controlled trials (RCTs) and observational studies (Obs) published from January 2014 until March 31st, 2020 were retrieved through the PubMed computerized database and at the site https://www. com. The relative risk (RR) with the 95% confidence interval (CI) was used to evaluate the effect of the intervention under comparison. The primary endpoints were all-cause 30-day mortality and 1-year mortality. The 30-day safety endpoints were: stroke, acute kidney injury stage 2 or 3, major bleeding, moderate/severe paravalvular leak, need for new permanent pacemaker (PM) implantation. After detailed review 9 studies, related to 4 RCTs and 5 Obs, were selected. The overall analysis of RCTs plus Obs showed a significantly lower 30-day mortality for TAVI (RR = 0.55; 95% CI 0.45-0.68, p < 0.00001; I2 = 0%). However, an increased risk of new PM implantation (RR = 2.87; 95% CI 2.01-3.67, p < 0.00001, I2 = 0%) and of paravalvular leak (RR = 7.28; 95% CI 3.83-13.81, p < 0.00001, I2 = 0%) was observed in TAVI compared to SAVR. On the contrary, a lower incidence of major bleeding (RR = 0.38; 95% CI 0.27-0.54, p < 0.00001, I2 = 0%) and of acute kidney injury was observed (RR = 0.33; 95% CI 0.19-0.56, p < 0.0001, I2 = 0%) in TAVI. TAVI and SVAR in the treatment of AS in the patients at low surgical risk are not superimposable. In particular, if 30-day and 1-year mortality, major bleeding and acute kidney injury were significantly lower for TAVI, the need of new PM implantation and paravalvular leak were significantly lower in SAVR. Consequently, we suggest the need of more trials to evaluate the effectiveness of TAVI as routine therapeutic procedure in the treatment of patients with low surgical risk AS.

Simultaneous hybrid off-pump coronary artery bypass grafting and transcatheter aortic valve implantation in elderly patients.

Optimal strategy for transcatheter aortic valve implantation (TAVI) in patients with coronary artery disease (CAD) is unresolved. We evaluated the surgical outcomes of hybrid coronary artery bypass grafting (CABG) and TAVI in elderly patients. We retrospectively evaluated patients who underwent simultaneous TAVI and CABG at Wakayama Medical University, Japan. All patients underwent off-pump CABG (OPCAB) including minimally invasive cardiac surgery (MICS-CABG). In an earlier period, OPCAB + transfemoral TAVI (TF-TAVI) was the only method used, while in a later period, we introduced MICS-CABG and alternative approaches for TAVI. Twenty-seven patients were enrolled, the average age was 83.6 ± 5.1years. In the MICS-CABG and TAVI group, average patient age was higher (87.0 ± 3.1years) than in the earlier group. Thirty-day and in-hospital mortalities were zero. Incomplete revascularization rate was 33.3% and one patient required percutaneous coronary intervention after the operation. Graft patency rate was 100%. In MICS-CABG group, the number of distal anastomoses was smaller (1.29, range 1-2), but the number of days required to re-starting walking and postoperative hospital stay were shorter, and the rate of discharge to home was higher (100%) than in the other groups. Although 33.3% of patients did not achieve complete revascularization, there was no 30-day or in-hospital mortality. TAVI and hybrid OPCAB, including MICS-CABG, were suggested to be feasible treatment in elderly patients.

Outcomes of Patients With Very Severe Aortic Stenosis Treated With Transcatheter Aortic Valve Implantation

Symptoms of aortic stenosis (AS) are not proportional to its severity and patients with very severe AS (VSAS) remain asymptomatic for a long time. The appropriate time for intervention in patients with VSAS and the effects of transcatheter aortic valve implantation (TAVI) on left ventricular hypertrophy (LVH) remain debated. Our aim was to compare the procedural and 30-day outcomes of TAVI between patients with VSAS and patients with severe AS (SAS) and the changes in LVH. We selected patients with an aortic peak velocity ≥5 m/s (VSAS) and those with aortic peak velocity 4 to 5 m/s (SAS) treated with TAVI. Patients with reduced left ventricular ejection fraction (<45%) were excluded. The primary end point was the incidence of all-cause death at 30 days. The secondary end points included the 30-day incidence of cardiac death, cardiac rehospitalization, and stroke/transient ischemic attack and the changes in LVH from baseline to 30 days. A total of 102 patients in the VSAS group and 535 in the SAS group were included. Patients in the VSAS group had a thicker septal wall (p <0.001) and a higher Agaston score (p <0.001) and calcium volume (p=0.007). No differences were observed regarding the primary and secondary clinical end points. However, patients with VSAS showed a significantly greater improvement in concentric LVH, although the prevalence of concentric LVH remained higher than in patients with SAS. TAVI in patients with VSAS showed similar procedural and clinical outcomes to patients with SAS and experienced a more pronounced improvement in the prevalence of concentric LVH.

Transcatheter Aortic Valve Implantation in Mixed Aortic Valve Disease: A Multicenter Study

Mixed aortic valve disease (MAVD), defined by the concurrent presence of aortic stenosis (AS) and insufficiency is frequently seen in patients who have undergone transcatheter aortic valve implantation (TAVI). However, studies comparing the outcomes of TAVI in MAVD versus isolated AS have demonstrated conflicting results. Therefore, we aim to assess the outcomes of TAVI in patients with MAVD in comparison with those with isolated severe AS. Patients who underwent native valve TAVI for severe AS at 3 tertiary care academic centers between January 2012 and December 2020 were included and categorized into 3 groups based on concomitant aortic insufficiency (AI) as follows: group 1, no AI; group 2, mild AI; and group 3, moderate to severe AI. Outcomes of interest included all-cause mortality and all-cause readmission rates at 30days and 1year. Other outcomes include bleeding, stroke, vascular complications, and the incidence of paravalvular leak at 30days after the procedure. Of the 1,588 patients who underwent TAVI during the study period, 775 patients (49%) had isolated AS, 606 (38%) had mild AI, and 207 (13%) had moderate to severe AI. Society of Thoracic Surgeons risk scores were significantly different among the 3 groups (5% in group 1, 5.5% in group 2, and 6% in group 3, p=0.003). Balloon-expandable valves were used in about 2/3 of the population. No statistically significant differences in 30-day or 1-year all-cause mortality and all-cause readmission rates were noted among the 3 groups. Post-TAVI paravalvular leak at follow-up was significantly lower in group 1 (2.3%) and group 2 (2%) compared with group 3 (5.6%) (p=0.01). In summary, TAVI in MAVD is associated with comparable outcomes at 1 year compared with patients with isolated severe AS.

Urgent versus Non-Urgent Transcatheter Aortic Valve Implantation Outcomes

Introduction: There are limited data about the outcomes of nonelective transcatheter aortic valve implantation (TAVI). Some studies suggest that these patients (pts) have worst results. Our purpose was to compare outcomes in pts submitted to urgent versus elective TAVI. Methods: Retrospective analysis of 298 consecutive pts submitted to TAVI between 2018 and 2021 in a single tertiary center. Baseline characteristics and outcomes were collected and compared between elective and nonelective TAVI. Results: Pts submitted to urgent TAVI (79 pts) had worse baseline characteristics, with higher EuroScore risk (9.26 vs. 5.17%, p < 0.0001), STS score (7.09 vs. 4.4%, p < 0.0001), and NT pro-natriuretic peptide B (10,168 vs. 3,241 pg/mL, p = 0.001), lower left ventricle ejection fraction (45 vs. 52%, p = 0.003), more diabetes (46.8 vs. 32.4%, p = 0.0.22), peripheral artery disease (21.5 vs. 6.8%, p < 0.0001), and poor vascular accesses (18.4 vs. 7.4%, p = 0.007). Urgent TAVI was associated with higher mortality (25.3 vs. 15.1%, p = 0.043), 30-day cardiovascular mortality (17.5 vs. 4%, p = 0.001), life-threatening bleeding (11.5 vs. 4.1%, p = 0.018), vascular complications (11.5 vs. 4.6%, p = 0.031), and longer hospital stay (28 vs. 12 days, p < 0.0001), but not with intensive care unit or post-TAVI hospital stay (5 vs. 4 days, p = 0.197 and 11 vs. 10 days, p = 0.572). When adjusted to differences in baseline characteristics, urgent TAVI was only associated with longer hospital stay (p < 0.0001). Conclusion: Pts submitted to urgent TAVI have worse short-term outcomes, but this seems to be attributable to the worse baseline characteristics instead of the urgent nature of the procedure.

30-Day Valve-in-Valve Transcatheter Aortic Valve Implantation Outcomes, From ACE-TAVI Registry

30-Day Valve-in-Valve Transcatheter Aortic Valve Implantation Outcomes, From ACE-TAVI Registry

Immediate outcomes of transcatheter aortic valve implantation in patients with horizontal aorta

Background: Transcatheter aortic valve implantation (TAVI) is an effective and safe procedure for severe aortic stenosis. Increased aortic root angulation is an important anatomical feature that may cause technical difficulties and negatively affect immediate and long-term outcomes.Objective: To evaluate immediate outcomes of TAVI in patients with increased aortic root angulation.Methods: Our retrospective single-center study included 412 patients with severe aortic stenosis who underwent TAVI using self-expanding bioprostheses from 2015 to 2022. Patients with aortic root angulation ≥ 49° were included in group 1 (n = 200), and those with aortic root angulation &lt; 49° comprised group 2 (n = 212).Results: The mean age of the patients was 75.2 ± 7.2 years. In a subgroup with the first-generation CoreValve prosthesis and a ≥ 49° angle, we observed moderate aortic regurgitation significantly more often (7.4% vs 0.0%, P = .010) and technical success significantly less often (90.1% vs 98.9%, P = .010) compared with a similar subgroup with a &lt; 49° angle. In subgroups with CoreValve Evolute R and ACURATE neo prostheses, there were no significant differences in terms of the mentioned parameters. Independent predictors of technical failure were the aortic root angle [OR for each degree increase: 0.44, 95% CI: 0.30-0.63, P &lt; .001], no postdilation [OR: 5.0, 95% CI: 1.33-20.00, P = .074], indexed mass of the left ventricular myocardium [OR: 1.02, 95% CI: 1.01-1.03, P = .003], and higher implantation relative to the aortic annulus [OR for every 1 mm decrease in implantation depth: 0.44, 95% CI: 0.30-0.63, P &lt; .001].Conclusion: Increased aortic angulation ≥ 49° negatively affected the technical success of TAVI only in patients with the first-generation CoreValve prostheses. Independent predictors of technical failure in TAVI were the aortic root angle, no postdilation, indexed mass of the left ventricular myocardium, and higher implantation relative to the aortic annulus. Received 9 January 2023. Revised 10 May 2023. Accepted 30 May 2023. Funding: The study did not have sponsorship. Conflict of interest: The authors declare no conflict of interest. Contribution of the authorsConception and study design: A.A. Baranov, O.V. Krestyaninov, D.A. Khelimskii, A.G. BadoianData collection and analysis: A.A. Baranov, O.V. Krestyaninov, D.A. Khelimskii, A.G. BadoianStatistical analysis: A.A. Baranov, O.V. Krestyaninov, D.A. Khelimskii, A.G. BadoianDrafting the article: A.A. Baranov, O.V. Krestyaninov, D.A. Khelimskii, A.G. Badoian, S.N. Manukian, A.Yu. Tsydenova, M.A. MakhmudovCritical revision of the article: A.A. Baranov, O.V. Krestyaninov, D.A. Khelimskii, A.G. Badoian, S.N. Manukian, A.Yu. Tsydenova, M.A. MakhmudovFinal approval of the version to be published: A.A. Baranov, O.V. Krestyaninov, D.A. Khelimskii, A.G. Badoian, S.N. Manukian, A.Yu. Tsydenova, M.A. Makhmudov

Efficacy and Safety of Low-Dose Protamine in Reducing Bleeding Complications during TAVI: A Propensity-Matched Comparison

Objectives: We aimed to evaluate the efficacy and safety of low-dose protamine in reducing access site-related complications during Transcatheter Aortic Valve Implantation (TAVI) as compared to full-dose protamine. Background: Access site-related complications represent an independent predictor of poor outcomes of TAVI. Data regarding heparin reversal with protamine and the dosage needed to prevent bleeding complications are scarce among patients undergoing TAVI. Methods: A total of 897 patients were retrospectively included in the study. Patients who underwent percutaneous coronary intervention within 4 weeks before or concomitantly with TAVI (n = 191) were given 0.5 mg protamine for each 100 units of unfractionated heparin. All other patients (n = 706) were considered as a control group and 1 mg protamine for each 100 units of heparin was administered. Results: The combined intra-hospital endpoint of death, life-threatening major bleeding, and major vascular complications were significantly more frequent in patients receiving low-dose protamine [29 (15.2%) vs. 50 (7.1%), p &lt; 0.001]. After propensity matching (n = 130 for each group) for relevant clinical characteristics including anti-platelet therapy [19 (14.6%) vs. 6 (4.6%), p = 0.006], low-dose protamine predicted the combined endpoint (OR 3.54, 95%-CI 1.36–9.17, p = 0.009), and even in multivariable analysis, low-dose protamine continued to be a predictor of the combined endpoint in the matched model (OR 3.07, 95%-CI 1.17–8.08, p = 0.023) alongside baseline hemoglobin. Conclusions: In this propensity-matched retrospective analysis, a low-dose protamine regime is associated with a higher rate of major adverse events compared to a full-dose protamine regime following transfemoral TAVI.

Aortic Stenosis Phenotypes and Precision Transcatheter Aortic Valve Implantation.

Patients with a clinical indication for aortic valve replacement can either undergo surgical aortic valve replacement (SAVR) or Transcatheter Aortic Valve Implantation (TAVI). There are many different factors that go into determining which type of replacement to undergo, including age, life expectancy, comorbidities, frailty, and patient preference. While both options offer significant benefits to patients in terms of clinical outcomes and quality of life, there is growing interest in expanding the indications for TAVI due to its minimally invasive approach. However, it is worth noting that there are several discrepancies in TAVI outcomes in regards to various endpoints, including death, stroke, and major cardiovascular events. It is unclear why these discrepancies exist, but potential explanations include the diversity of etiologies for aortic stenosis, complex patient comorbidities, and ongoing advancements in both medical therapies and devices. Of these possibilities, we propose that phenotypic variation of aortic stenosis has the most significant impact on post-TAVI clinical outcomes. Such variability in phenotypes is often due to a complex interplay between underlying comorbidities and environmental and inherent patient risk factors. However, there is growing evidence to suggest that patient genetics may also play a role in aortic stenosis pathology. As such, we propose that the selection and management of TAVI patients should emphasize a precision medicine approach.

Impact of early changes in cardiac damage following transcatheter aortic valve implantation.

The staging classification of aortic stenosis (AS) which characterises the extent of cardiac damage has been validated in patients undergoing transcatheter aortic valve implantation (TAVI). Short-term changes in cardiac damage after TAVI and their association with long-term prognosis remain unknown. This study aims to investigate the early evolution of cardiac damage after TAVI and the association of residual cardiac damage with clinical outcomes in TAVI recipients. AS patients undergoing TAVI were consecutively enrolled and classified into five stages of cardiac damage (0-4). Early change in cardiac damage was defined as any change of stage at 30 days (Δcardiac damage between baseline pre-TAVI and 30 days post-TAVI). Within 30 days post-TAVI, the baseline cardiac damage stage had changed in 22.2% of 644 TAVI recipients, accompanied by improvements in the degree of dyspnoea and left ventricular ejection fraction (LVEF). Two-year mortality was associated with residual cardiac damage within 30 days post-TAVI (hazard ratio [HR] 2.97, 95% confidence interval [CI]: 2.07-4.25; p<0.001). Compared to unchanged cardiac damage post-TAVI, further cardiac damage within 30 days was associated with a higher crude risk of 2-year mortality (HR 22.04, 95% CI: 9.87-49.20; p<0.001). Cardiac deterioration within 30 days post-TAVI was an independent risk factor for 2-year mortality (HR 19.564, 95% CI: 8.047-47.565; p<0.001). This investigation provided insight into the early evolution of cardiac damage in TAVI recipients and confirmed the predictive value of both residual and early changes in cardiac damage post-TAVI. Cardiac deterioration within 30 days is associated with poor clinical prognosis.

A Systematic Review and Statistical Analysis of Factors Influencing the Cost-Effectiveness of Transcatheter Aortic Valve Implantation for Symptomatic Severe Aortic Stenosis.

Transcatheter aortic valve implantation (TAVI) is a disruptive technology recommended for patients with symptomatic severe aortic stenosis (sSAS). Despite being available for over 15 years in Europe, with an extensive volume of clinical and economic evaluations across all surgical risk groups, there is little evidence on the identification of the key drivers of TAVI's cost-effectiveness. This study sought to identify these factors and quantify their role. A systematic literature review was conducted to identify published economic evaluations of TAVI. This was supplemented by health technology assessment reports. The primary outcome was the likelihood of TAVI being found cost-effective. Secondary outcomes of TAVI being dominant, and the incremental health benefits of TAVI were also explored. Forty-two studies, reporting 65 unique analyses, were identified. TAVI was found to be cost-effective and dominant in 74% and 20% of analyses, respectively. The latest generation balloon-expandable TAVI device (SAPIEN 3) was more likely to be found cost-effective, as was TAVI use in low-risk populations and when performed via transfemoral access route. There was heterogeneity in the approach taken to economic modelling, which may also influence estimates of cost-effectiveness. Analyses that found TAVI to be dominant always compared it to surgery and usually considered the latest generation balloon-expandable TAVI device. Largest health benefits were observed for the inoperable risk group. For patients with sSAS, TAVI is typically a cost-effective treatment option. There are important differences by device generation, risk group and access route. It is crucial to consider these differences when appraising the health economic evidence-base for TAVI.

Outcomes of Transcatheter Aortic Valve Implantation in Nonagenarians and Octogenarians (Analysis from the National Inpatient Sample Database)

Risks among nonagenarian (age ≥90 years) and octogenarian (age 80 to 89 years) patients who underwent transcatheter aortic valve implantation (TAVI) compared with clinically similar septuagenarian (age 70 to 79 years) patients remain unclear. This study aimed to assess the outcomes of TAVI in nonagenarians and octogenarians compared with septuagenarians. We conducted a retrospective cohort study using the National Inpatient Sample database to identify patients aged ≥70 years hospitalized for TAVI from 2016 to 2020 and to compare outcomes in nonagenarians and octogenarians versus septuagenarians. The primary outcome was in-hospital mortality. Secondary outcomes included procedural complications, length of stay (LOS), and total costs. The trends in in-hospital outcomes were evaluated. Results were adjusted for demographic/clinical factors. The total cohort included 263,325 patients hospitalized for TAVI, of whom 11.9% were nonagenarians, 51.1% octogenarians, and 37.0% septuagenarians. After adjustment, nonagenarians and octogenarians had higher odds of in-hospital mortality (adjusted odds ratio 1.80, 95% confidence interval 1.34 to 2.41 for nonagenarians; adjusted odds ratio 1.65, 95% confidence interval 1.35 to 2.01 for octogenarians), heart block, permanent pacemaker insertion, stroke, major bleeding, blood transfusion, and palliative care consultation than septuagenarians (all p <0.01). LOS was longer and the total costs were higher for nonagenarians and octogenarians (both p <0.01). Over the study period, in-hospital mortality decreased in nonagenarians (ptrend=0.04), and major bleeding, permanent pacemaker insertion, LOS, and costs decreased in all patients aged ≥70years (ptrend <0.01). In conclusion, nonagenarians and octogenarians who underwent TAVI have higher rates of mortality and procedure-related complications than clinically similar septuagenarians. Further research is necessary to optimize outcomes in this frail population.

The Place of Transaxillary Access in Transcatheter Aortic Valve Implantation (TAVI) Compared to Alternative Routes-A Systematic Review Article.

Transfemoral transcatheter aortic valve implantation (TAVI) has proven non-inferior or superior against surgical aortic valve replacement (SAVR) for patients at high, intermediate or low surgical risk. However, transfemoral access is not always feasible in patients with severely atherosclerotic or tortuous iliofemoral arteries. For these cases, alternative access techniques have been developed, such as transcarotid, transcaval, direct aortic or transaxillary access. In recent years, growing preference towards the transaxillary access has emerged. To provide a summary of data available on transaxillary TAVI and compare this approach to other alternative access techniques. A literature search was performed in PubMed by two independent reviewers. Studies reporting the outcome of at least 10 patients who underwent transaxillary TAVI, either in case series or in comparative studies, were included in this review. Articles not reporting outcomes according to the Valve Academic Research Consortium (VARC) 1-3 definitions were excluded. In total 193 records were found of which 18 were withheld for inclusion in this review. This review reports on the combined data of the 1519 patients who underwent transaxillary TAVI. Procedural success was achieved in 1203 (92.2%) of 1305 cases. Life-threatening, major, and minor bleeding occurred respectively in 4.5% (n = 50 in 1112 cases), 12.9% (n = 143 in 1112 cases) and 8.8% (n = 86 in 978 cases). Major and minor vascular complications were reported in respectively 6.6% (n = 83 in 1256 cases) and 10.0% (n = 105 in 1048 cases) of patients. 30-day mortality was 5.2% (n = 76 out of 1457 cases). At one year follow-up, the mortality rate was 1% (n = 184 out of 1082 cases). Similar 30-day and 1-year mortality is observed in studies that compare with transaxillary, transfemoral or other alternative access techniques (p 0.05). A wide application of transaxillary access as an alternative approach for TAVI has emerged. This technique has an excellent procedural success rate up to 92.0%, with low procedural complication rates. Clinical outcome of transaxillary TAVI is comparable to the other alternative TAVI approaches. However, these conclusions are solely based on observational data.

Ultra-low radiation dose and contrast volume CT protocol and TAVI-CT score for TAVI planning and outcome.

To investigate the feasibility of an ultra-low radiation dose and contrast volume protocol using third-generation dual-source (DS) CT for transcatheter aortic valve implantation (TAVI) planning with coronary artery disease (CAD) assessment, coronary artery calcium score (CACS) and aortic valve calcium score (AVCS) quantification and to evaluate their relationship with TAVI outcome. In this retrospective study were selected 203 patients (131 males, 79.4 ± 5.4 years) underwent to TAVI and at 30- and 90-day follow-up. All patients had performed a third-generation 2 × 192-slices DSCT. The CT protocol included a non-contrast and a contrast high-pitch aortic acquisition for TAVI planning and CAD assessment. Semi-qualitative and quantitative image analysis were performed; the performance in CAD assessment was compared with ICA; the relationship between AVCS and CACS and paravalvular aortic regurgitation (PAR) and major cardiovascular events (MACEs) were evaluated. Mean radiation dose were calculated. Non-parametric tests were used. Semi-qualitative image analysis was good. Contrast enhancement >500 Hounsfield unit (HU) and contrast-to-noise ratio <20 were obtained in all segments. The diagnostic accuracy in CAD was 89.0%. AVCS was significantly higher in patients with 30-day severe PAR. AVCS and CACS were higher in patients with 90-day MACE complications, respectively, 1904.5 ± 621.3 HU (p < 0.0001) and 769.2 ± 365.5 HU (p < 0.0230). Mean radiation dose was 2.8 ± 0.3 mSv. A TAVI planning ultra-low radiation dose and contrast volume protocol using third-generation DSCT provides highly diagnostic images with CAD assessment, AVCS and CACS quantification and these latter were related with TAVI outcomes. The proposed protocol using third-generation 2 × 192-slices DSCT allows with an ultra-low radiation dose and contrast volume the TAVI planning and the coronary artery assessment.

Contemporary Trends, Characteristics, and Outcomes of Transcatheter Aortic Valve Implantation Among Extreme Elderly Patients

Transcatheter aortic valve implantation (TAVI) has been increasingly performed among extreme elderly patients with symptomatic severe aortic stenosis. We aimed to study the trends, characteristics, and outcomes of TAVI among extreme elderly. The National Readmission Database for the years 2016 to 2019 was queried for extreme elderly who underwent TAVI. Linear regression analysis was used to calculate the temporal trends in outcomes. A total of 23,507 TAVI extreme elderly admissions (50.3% women and 95.9% Medicare insurance) were included. The in-hospital mortality and all-cause 30-day readmissions were 2% and 15% and have been stable over years of analysis (p trend = 0.79 and 0.06, respectively). We evaluated complications, such as permanent pacemaker implantation (12%) and stroke (3.2%). Stroke rates did not decrease (3.4% vs 2.9% in 2016 and 2019 [p trend = 0.24]). The mean length of stay improved from 5.5 days in 2016 to 4.3 days in 2019 (p trend <0.01). The rates of early discharge (day ≤3) has improved from 49% in 2016 to 69% in 2019 (p trend <0.01). In conclusion, this nationwide contemporary observational analysis showed that TAVI was associated with low rates of complications in the extreme elderly. Transcatheter aortic valve implantation (TAVI) has been increasingly performed among extreme elderly patients with symptomatic severe aortic stenosis. We aimed to study the trends, characteristics, and outcomes of TAVI among extreme elderly. The National Readmission Database for the years 2016 to 2019 was queried for extreme elderly who underwent TAVI. Linear regression analysis was used to calculate the temporal trends in outcomes. A total of 23,507 TAVI extreme elderly admissions (50.3% women and 95.9% Medicare insurance) were included. The in-hospital mortality and all-cause 30-day readmissions were 2% and 15% and have been stable over years of analysis (p trend = 0.79 and 0.06, respectively). We evaluated complications, such as permanent pacemaker implantation (12%) and stroke (3.2%). Stroke rates did not decrease (3.4% vs 2.9% in 2016 and 2019 [p trend = 0.24]). The mean length of stay improved from 5.5 days in 2016 to 4.3 days in 2019 (p trend <0.01). The rates of early discharge (day ≤3) has improved from 49% in 2016 to 69% in 2019 (p trend <0.01). In conclusion, this nationwide contemporary observational analysis showed that TAVI was associated with low rates of complications in the extreme elderly.