Transcatheter Aortic Valve Implantation Valve Research Articles

Transcatheter aortic valve implantation in failed bioprosthetic or native valves: a systematic review and meta analysis

Abstract Background and purpose Currently, there is no comparative assessment of pooled clinical outcomes between valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) for either failed transcatheter or surgical bioprosthetic aortic valves (TAV or SAV) and native aortic valve TAVI (NV-TAVI) for aortic stenosis. Thus, this systematic review investigated the clinical outcomes of ViV-TAVI compared with NV-TAVI. Methods A meta-analysis was conducted according to Cochrane Handbook and the PRISMA statement. A systematic literature search was performed, using EMBASE and MEDLINE from inspection to December 25, 2023, to explore the comparative outcomes between ViV-TAVI and NV-TAVI. RStudio software was used to calculate pooled odds ratio (OR) with 95% confidence intervals (CI). Random-effects model was used to allow a more conservative assessment. Results Eighteen cohort studies (n=65,350) met eligibility criteria. Studies were categorized into 2 groups according to initially implanted bioprosthetic valve: TAV-in-TAV (5 studies, n=14490) and TAV-in-SAV implantation (13 studies, n=50860). Each ViV-TAVI group was compared with NV-TAVI. TAV-in-TAV implantation: There were no significant differences in all-cause mortality or stroke rates at ≥ 12 months between groups. The follow-up period was 12 months in all studies except in one (i.e., 24 months). Sensitivity analyses, by removing that study, did not show difference for both outcomes [(OR=1.25, 95%CI: 0.72-2.18) and (OR=1.14, 95%CI: 0.59-2.20), respectively]. TAV-in-TAV implantation was associated with higher rates of permanent pacemaker (PPM) insertion (OR=1.78, 95%CI: 1.10-2.88) within 30-day of follow-up. PPM insertion rate remained higher by 34% (OR=1.34, 95%CI: 1.02-1.76) even after removing the study that reported PPM insertion during index admission. Early conversion to open heart surgery and coronary occlusion (OR=3.75, 95%CI: 0.99-1417) did not differ between groups. TAV-in-SAV implantation: TAV-in-SAV implantation did not significantly reduce the risk of all-cause mortality, but stroke risk was reduced by 19% at ≥ 12 months follow-up. Sensitivity analyses by removing the studies with 24 months follow-up yielded comparable results [(OR=0.88, 95%CI: 0.64-1.21) and (OR=0.81, 95%CI: 0.70-0.94), respectively]. TAV-in-SAV implantation was associated with lower rates of PPM insertion compared with NV-TAVI (OR=0.33, 95%CI: 0.17-0.62) within 30-day of follow-up. The risk remained significantly lower by 69% (OR=0.31, 95%CI: 0.10-0.92) upon removing the studies that reported PPM insertion during the index admission. Early conversion to open heart surgery and coronary occlusion (OR=1.88, 95%CI: 0.82-4.32) did not differ between groups. Conclusion In comparison with NV-TAVI, TAV-in-TAV implantation was associated with higher PPM insertion rates, whereas, TAV-in-SAV implantation was associated with lower stroke and PPM insertion rates without an impact on mortality.

Early Structural Valve Deterioration of Balloon Expandable Transcatheter Aortic Valve Leaflets Due to Intrinsic and Extrinsic Nodular Calcification in a Hemodialysis Patient: A Case Report

Abstract Background Several reports have shown that transcatheter aortic valves are comparable in durability to surgical aortic valves. However, early structural valve deterioration (SVD) is rarely reported to occur, especially in hemodialysis patients. Case Summary We present a case of rapidly progressive bioprosthetic aortic valve stenosis in a patient with end-stage renal disease (ESRD) secondary to diabetic nephropathy in an 83-year-old female admitted due to progressive dyspnea and orthopnea. A 23-mm sized SAPIEN3 bioprosthetic aortic valve showed normal function for the first year after transcatheter aortic valve implantation (TAVI), but then rapidly developed stenosis and required acute hospitalization for heart failure a year and a half after surgery. Emergent surgical aortic valve replacement (SAVR) with a 19-mm On-X valve (CryoLife, Kennesaw, GA, USA) was performed. Pathological examination of the explanted SAPIEN 3 valve demonstrated severely degenerated bioprosthetic pericardial leaflets with severe intrinsic and extrinsic nodular calcification, which could limit the leaflet motion. Discussion There is a lack of reports on the long-term procedural outcomes of TAVI in hemodialysis patients. The development of SVD in patients undergoing dialysis is multifactorial and has yet to be fully elucidated. In the presented case, the removed TAVI valve had severe extrinsic calcified nodules alongside a fibrin thrombus. Considering these pathological findings, antithrombotic therapy to prevent fibrin thrombus from adhering to the TAVI valve may be important to avoid early SVD.

Randomized comparison of TAVI valves: The Compare-TAVI trial

Based on technical advancements and clinical evidence, transcatheter aortic valve implantation (TAVI) has been widely adopted. New generation TAVI valve platforms are continually being developed. Ideally, new valves should be superior or at least non-inferior regarding efficacy and safety, when compared to best-in-practice contemporary TAVI valves. The Compare-TAVI trial (ClinicalTrials.gov NCT04443023) was launched in 2020, to perform a 1:1 randomized comparison of new vs contemporary TAVI valves, preferably in all comers. Consecutive cohorts will be launched with sample sizes depending on the choice of interim analyses, expected event rates, and chosen superiority or non-inferiority margins. Enrollment has just been finalized in cohort B, comparing the Sapien 3/Sapien 3 Ultra Transcatheter Heart Valve (THV) series (Edwards Lifesciences, Irvine, California, USA) and the Myval/Myval Octacor THV series (Meril Life Sciences Pvt. Ltd., Vapi, Gujarat, India) balloon expandable valves. This non-inferiority study was aimed to include 1062 patients. The 1-year composite safety and efficacy endpoint comprises death, stroke, moderate-severe aortic regurgitation, and moderate-severe valve deterioration. Patients will be followed until withdrawal of consent, death, or completion of 10-year follow-up, whichever comes first. Secondary endpoints will be monitored at 30 days, 1, 3, 5, and 10 years. The Compare-TAVI organization will launch consecutive cohorts wherein patients scheduled for TAVI are randomized to one of two valves. The aim is to ensure that the short- and long-term performance and safety of new valves being introduced is benchmarked against what achieved by best-in-practice contemporary valves.

Differences in life expectancy within and between countries: implications for domestic TAVI guidelines in Australia and Aotearoa New Zealand.

The advent of transcatheter aortic valve implantation (TAVI) has caused a paradigm shift in the management of aortic stenosis away from traditional surgical aortic valve replacement (SAVR). However, uncertainty remains about the long-term (>10 year) durability of TAVI valves, especially in younger patients. This viewpoint collates life expectancy data from Australia and Aotearoa New Zealand to propose sex-specific age-based recommendations for choice of SAVR versus TAVI in their respective general populations and among Aboriginal and Torres Strait Islander people in Australia and both Māori and Pacific peoples living in Aotearoa New Zealand.

Acute Kidney Injury Following Transcatheter Aortic Valve Implantation—A Contemporary Perspective of Incidence, Predictors, and Outcomes

Acute kidney injury (AKI) is a known complication following transcatheter aortic valve implantation (TAVI), associated with increased morbidity and mortality. Most of this data relates to higher-risk patients with early-generation TAVI valves. With TAVI now established as a safe and cost-effective procedure for low-risk patients, there is a distinct need for updated analysis. We aimed to assess the incidence, predictors, and outcomes of AKI in a contemporary cohort of TAVI patients, concurrently examining the role of temporal evolution on AKI. A total of 2,564 patients undergoing TAVI from 2008-2023 included in the Alfred-Cabrini-Epworth (ACE) TAVI Registry were analysed. Patients were divided into AKI and no AKI groups. Outcomes were reported according to the Valve Academic Research Consortium-3 (VARC-3) criteria. Of 2,564 patients, median age 83 (78-87) years, 57.4% men and a median Society of Thoracic Surgeons score of 3.6 (2.4-5.5), 163 (6.4%) patients developed AKI with incidence falling from 9.7% between 2008-2014 to 6% between 2015-2023 (p=0.022). On multivariable analysis, independent predictors of AKI were male sex (adjusted odds ratio [aOR] 1.89, p=0.005), congestive cardiac failure (aOR 1.52, p=0.048), estimated glomerular filtration rate 30-59 (aOR: 2.79, p<0.001), estimated glomerular filtration rate <30 (aOR 8.65, p<0.001), non-femoral access (aOR 5.35, p<0.001), contrast volume (aOR 1.01, p<0.001), self-expanding valve (aOR 1.60, p=0.045), and bleeding (aOR 2.88, p=0.005). Acute kidney injury was an independent predictor of 30-day (aOR: 6.07, p<0.001) and 12-month (aOR: 3.01, p=0.002) mortality, an association that remained consistent when excluding TAVIs performed prior to2015. Acute kidney injury remains a relatively common complication of TAVI, associated with significant morbidity and mortality even in less comorbid, contemporary practice patients.

In vitro investigation of the blood flow downstream of a 3D-printed aortic valve

The hemodynamics in the aorta as well as the durability of aortic valve prostheses vary greatly between different types of devices. Although placement and sizing of surgical aortic valve prostheses are excellent, the valve geometry of common devices cannot be customized to fit the patient’s anatomy perfectly. Similarly, transcatheter aortic valve implantation (TAVI) devices are not customizable and may be orientated unfavorably during implantation. Imperfect fit of an aortic valve prosthesis may result in suboptimal performance and in some cases the need for additional surgery. Leveraging the advent of precision, multi-material 3D-printing, a bioinspired silicone aortic valve was developed. The manufacturing technique makes it fully customizable and significantly cheaper to develop and produce than common prostheses. In this study, we assess the hemodynamic performance of such a 3D-printed aortic valve and compare it to two TAVI devices as well as to a severely stenosed valve. We investigate the blood flow distal to the valve in an anatomically accurate, compliant aorta model via three-dimensional particle tracking velocimetry measurements. Our results demonstrate that the 3D-printed aortic valve induces flow patterns and topology compatible with the TAVI valves and showing similarity to healthy aortic blood flow. Compared to the stenosis, the 3D-printed aortic valve reduces turbulent kinetic energy levels and irreversible energy losses by over 75%, reaching values compatible with healthy subjects and conventional TAVIs. Our study substantiates that the 3D-printed heart valve displays a hemodynamic performance similar to established devices and underscores its potential for driving innovation towards patient specific valve prostheses.

Temporal changes in biomarker levels and their association with the early degeneration stage of transcatheter aortic valves in 18F-fluorodeoxyglucose and 18F-sodium fluoride positron emission tomography studies.

As transcatheter aortic valve implantation (TAVI) indications expand, understanding the valve degeneration process and potential influencing biomarkers becomes increasingly important. To investigate temporal changes in biomarker levels and their potential association with 18F-fluorodeoxyglucose (18F-FDG) and 18F-sodium fluoride (18F-NaF) uptake, assessed using positron emission tomography/computed tomography (PET/CT) studies as markers for native aortic annulus calcifications and early-stage TAVI valve degeneration. A total of 71 TAVI patients underwent blood sampling and transthoracic echocardiography at baseline (pre-TAVI) and 6, 12, 18, and 24 months after the procedure. PET/CT using 18F-NaF and 18F-FDG was performed at 6 and 24 months. Serum levels of matrix metalloproteinase-3 (MMP-3), matrix metalloproteinase-9 (MMP-9), and osteopontin (OPN) were measured. In addition, plasma levels of osteoprotegerin (OPG), lipoprotein a (Lp(a)), and oxidized LDL (ox-LDL) were assessed. Finally, 31 patients (median age: 84.0 years) completed the study. Valve function improved after TAVI and remained stable during follow-up. Over 24 months, OPN levels decreased (p = 0.010), while MMP-3 and MMP-9 levels increased (p = 0.046 and p = 0.041). MMP-3 and MMP-9 showed multiple positive correlations across time points. OPN, ox-LDL, and OPG demonstrated significant negative correlations with follow-up effective orifice area index and effective orifice area (EOA). No significant correlations were found between biomarkers and PET/CT uptake. Significant biomarker changes over 24 months and negative correlations with EOA suggest potential roles in aortic valve function. However, no correlations between biomarkers and PET/CT results were observed.

18F-fluorodeoxyglucose and 18F-sodium fluoride positron emission tomography imaging in assessing early stages of aortic valve degeneration after transcatheter aortic valve implantation.

Transcatheter aortic valve implantation (TAVI) is a standard treatment for severe aortic stenosis, primarily in elderly patients. With an increasing number of procedures and younger patients, understanding the valve degeneration and its risk factors becomes crucial. We aimed to utilize 18F‑sodium fluoride (18F‑NaF) and 18F‑fluorodeoxyglucose (18F‑FDG) positron emission tomography/computed tomography (PET/CT) to evaluate early TAVI valve degeneration. In this prospective study with a prespecified follow‑up protocol, 71 TAVI patients underwent baseline transthoracic and transesophageal echocardiography, and PET/CT with 18F‑NaF and 18F‑FDG. Of these, 31 patients completed 24‑month control examinations, while the others were lost to mortality and the COVID‑19 pandemic. We measured PET tracer activity and compared 18F‑NaF and 18F‑FDG PET/CT uptake at baseline and 24‑month follow‑up. PET/CT and echocardiography data were analyzed for 31 of the 71 enrolled TAVI patients at a median age of 84 years (interquartile range, 80-86). After TAVI, an improvement in the valve function was observed. During follow‑up, the valve function remained stable. PET/CT demonstrated an increase in 18F‑FDG maximal uptake in the inner (tissue‑to‑background ratio, P = 0.009) and outer (P = 0.01) sides of the TAVI valve stent, but no difference in 18F‑NaF maximal activity (inner, P = 0.17; outer, P = 0.57). Twenty‑four months post‑TAVI, an increase in 18F‑FDG uptake, indicative of inflammation, was observed in the valve, while the uptake of the calcification marker (18F‑NaF) remained stable. Theseobservations might suggest early stages of TAVI valve degeneration, although further investigation is required to confirm this interpretation.

Real-world outcome and long-term survival analysis after trans-catheter aortic valve implantation (TAVI) - does age matter?

Abstract Background Transcatheter aortic valve implantation (TAVI) is the treatment of choice in elderly patients irrespective of surgical risk. Since a clear cut-off in age is still a matter of debate during heart team decision making between TAVI and surgical aortic valve replacement (SAVR), outcome data of younger patients undergoing TAVI due to high surgical risk are of great clinical interest. Thus, the current study aimed to compare outcome and long-term survival data in typical elderly versus younger TAVI patients. Methods and Results This single-center outcome and up to 2-year survival analysis reports data of 619 patients (mean age: 79 ± 7 years; 50% female; mean STS score 4.7 ± 3.9%) that underwent transfemoral TAVI between August 2016 and September 2020. The cohort was classified into typical elderly (&amp;gt; 70 years, n=542) and younger (≤ 70 years, n=77) patients. Mortality rates were available for all patients at 30 days, 1 year and 2 years after TAVI. The STS score was 5.0 ± 4.0% in elderly compared to 2.8 ± 2.2% in younger subjects (p &amp;lt; 0.001). The main devices implanted were the balloon-expandable Edwards Sapien 3 (61% in) and the self-expanding Medtronic EvolutR (36%) device without differences between the groups (p=n.s.). The procedural success rate in the total cohort was &amp;gt; 99% and we identified the following prevalence rates of peri- and postprocedural complications (each in comparison between elderly vs. younger patients): acute vascular complications - 6.1% vs. 5.4% (p=n.s.); bleedings requirement of transfusion - 9.2% vs. 2.7% (p=0.059); disabling strokes - 2.3% vs. 1.4% (p=n.s.); requirement of new pacemakers - 11.1% vs. 3.9% (p=0,052) and acute kidney injuries - 2.7% vs. 1.4% (p=n.s.). At the 6 weeks follow-up, both, elderly and younger patients reported improvement of symptoms (NYHA class), which was underlined by a significant decrease in brain natriuretic peptide (BNP) and improved 6-minutes’ walk distances (SMWD) (p&amp;lt;0.001 for each parameter). While there were no differences between the groups for NYHA class and BNP (p=n.s.), SMWD was higher in younger patients (p&amp;lt;0.001). Interestingly, Kaplan Meier analysis revealed the following short- and long-term mortality rates (each in comparison between elderly vs. younger patients): 3.4% vs. 1.3% after 30 days (p=n.s.); 17.2% vs. 10.5% after 1 year (p=n.s.) and 25.2% vs. 17.1% after 2 years (p=n.s.; figure 1). Conclusion The results of this real-world analysis demonstrate that TAVI in younger patients not eligible for surgery after heart team evaluation is safe and not inferior compared to a typical elderly cohort, especially regarding complication rates, clinical outcomes and mortality until 2 years after implantation. Thus, younger age alone should not discard TAVI as therapeutic option for AS in cases with either high surgical risk or other individual factors speaking against surgery at the time when treatment is indicated.

Patient characteristics and long-term outcomes in patients undergoing transcatheter aortic valve implantation in a failed surgical prosthesis versus in a native valve

Abstract Background Valve-in-valve transcatheter aortic valve implantation (TAVI) is an increasingly used treatment for failed surgical aortic prosthesis, but data from clinical practice are limited. Purpose We examined patient characteristics and outcomes of patients undergoing TAVI in a surgical valve compared with patients undergoing TAVI in a native valve. Methods Patients undergoing TAVI from January 1, 2008, to December 31, 2020, were identified using Danish nationwide registries. Results In total, 6070 patients undergoing TAVI were identified; 247 (4%) patients had a history of SAVR (The valve-in-valve cohort). Patients with valve-in-valve-TAVI were younger but had a greater burden of cardiovascular comorbidities compared with patients with native-valve-TAVI. The cumulative 30-day risk of death was 2.4% (95% CI: 1.0% to 5.0%) in patients with valve-in-valve-TAVI and 2.7% (95% CI: 2.3% to 3.1%) in patients with native-valve-TAVI (Figure 1A). Correspondingly, the cumulative 5-year risk of death was 42.5% (95% CI: 34.2% to 50.6%) and 44.8% (95% CI: 43.2% to 46.4%), respectively. Within 30 days post-procedure, 11 (0.2%) patients with valve-in-valve-TAVI and 748 (13.8%) patients with native-valve-TAVI, had a pacemaker implantation. In multivariable Cox proportional hazard analysis, patients with valve-in-valve TAVI did not have a significantly different risk of rehospitalization from any cause compared to patients with native valve TAVI at 30 days (HR 0.80 [95% CI 0.58-1.10]) and at 5 years (HR 0.85 [95% CI 0.73-1.00]) (Figure 1B). Furthermore, in adjusted analysis, valve-in-valve-TAVI was not associated with significantly different risk of death at 30 days (Hazard ratio (HR)= 0.98, 95% CI 0.43-2.22) and 5 years (HR=0.81, 95% CI 0.64-1.03) compared with native-valve-TAVI. Conclusions TAVI in a failed surgical aortic prosthesis as compared to TAVI in a native valve, was not associated with significantly different short- and long-term mortality. Although these findings to some extent reflect thorough patient selection, valve-in-valve-TAVI appears to be a safe procedure.

Comparison of therapeutic strategies for aortic stenosis between transcatheter and surgical aortic valve implantation: a retrospective cohort study in Japanese dialysis patients

BackgroundAlthough transcatheter aortic valve implantation (TAVI) is assumed to be a less invasive therapy in high-risk patients with aortic valve stenosis (AS), there have been limited data suggesting its beneficial effects on cardiovascular mortality in Japanese patients receiving dialysis therapy.MethodsHemodialysis patients with severe AS underwent either TAVI (n = 33) or surgical aortic valve replacement (SAVR, n = 25). We compared the postoperative outcomes and perioperative complications, including dialysis-associated parameters [e.g., intradialytic hypotension (IDH)], between TAVI and SAVR.ResultsA 30-day and 1-year mortality rate was nearly the same among the TAVI and the SAVR group. Incidence of permanent pacemaker implantation or other events, including stroke, bleeding and vascular complications, in the TAVI group were not different from those in SAVR patients during the 30-day or 1-year postoperative period. The incidence of IDH was increased following SAVR (odds ratio (OR) = 11.29 [95% CI 1.29–98.89]) but was not affected by TAVI (OR = 1.55 [95% CI 0.24–9.94]). Among the patients aged 75 or older, the incidence of IDH was particularly conspicuous in the SAVR group (OR = 15.75 [95% CI 2.30–107.93]). Because there were differences in background data (age, EuroSCORE II, and dialysis duration) between these groups, propensity score-matched analysis was conducted and showed no difference in the composite event-free probability between the TAVI and the SAVR group over one year (p = 0.816).ConclusionsTAVI offers an alternative strategy to Japanese hemodialysis patients with severe AS, with nearly the same incidence of complications as SAVR during 1-year observation.

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.

PO-03-108 TEMPORAL COURSE OF CONDUCTION ABNORMALITIES AFTER PERCUTANEOUS AND SURGICAL AORTIC VALVE REPLACEMENT

Aortic valve replacement is an increasingly common procedure. With the advent of trans-catheter aortic valve implantation (TAVI), patients that would have previously been denied valve replacement are able to undergo intervention. The anatomic proximity of the aortic valve and the native conduction system can lead to significant conduction abnormalities requiring permanent pacemaker (PPM) implantation. This retrospective study aimed to compare the incidence, temporality and eventual recovery of conduction abnormalities in patients undergoing PPM implantation post TAVI and surgical aortic valve replacement (SAVR). During the 5-year study period, 1012 patients had aortic valve replacement, 746 underwent SAVR and 266 patients underwent TAVI. In this group, patients were screened for pacemaker implantation within 14 days post procedure and were included if the pacemaker implantation was due to new AV conduction abnormalities. Patients were excluded if they had a pacemaker prior to surgery or had alternate reasons for pacemaker implantation such as complications from infective endocarditis. The incidence of new AV conduction abnormalities requiring pacemaker implantation post-operatively was 5.3% (n=14) in TAVI patients and 3.4% (n=26) in SAVR patients. In the TAVI group PPM implantation occurred on average at 3.2 ± 2.1 days (median 3 days) post procedure. In the SAVR group the average time to implantation was 6 ± 3.1 days (median 5 days). To determine conduction recovery 36 patients had complete follow up, 26 patients in SAVR and 10 patients in TAVI group. After a mean follow-up of 3 months, 50% of patients in the TAVI group and 36.1% in SAVR group recovered 1:1 conduction. At 12 months, 60% of patients in the TAVI group and 41% in the SAVR group had improved conduction and by 24 months it was 50% and 34.5%, respectively. In patients who undergo PPM implant post TAVI a high rate of conduction recovery is observed during follow-up, probably emphasizing the need for better selection of pacing candidates.

Early and Mid-Term Outcomes of Transcatheter Aortic Valve Implantation versus Surgical Aortic Valve Replacement: Updated Systematic Review and Meta-Analysis.

(1) Background: The use of transcatheter aortic valve implantation (TAVI) for the treatment of severe symptomatic aortic stenosis is expanding significantly. We aimed to perform a meta-analysis comparing the safety and efficacy of TAVI versus surgical aortic valve replacement (SAVR) during the early and mid-term follow-up period. (2) Methods: We conducted a meta-analysis of randomized controlled trials (RCTs) comparing 1- to 2-year outcomes between TAVI and SAVR. The study protocol was preregistered in PROSPERO and the results were reported according to PRISMA guidelines. (3) Results: The pooled analysis included data from eight RCTs totaling 8780 patients. TAVI was associated with a lower risk of all-cause mortality or disabling stroke (OR 0.87, 95%CI 0.77-0.99), significant bleeding (OR 0.38, 95%CI 0.25-0.59), acute kidney injury (AKI; OR 0.53, 95%CI 0.40-0.69) and atrial fibrillation (OR 0.28, 95%CI 0.19-0.43). SAVR was associated with a lower risk of major vascular complication (MVC; OR 1.99, 95%CI 1.29-3.07) as well as permanent pacemaker implantation (PPI; OR 2.28, 95%CI 1.45-3.57). (3) Conclusions: TAVI compared with SAVR during early and mid-term follow-up was associated with a lower risk of all-cause mortality or disabling stroke, significant bleeding, AKI and atrial fibrillation; however, it was associated with a higher risk of MVC and PPI.

Prevention and management of paravalvular regurgitation after transcatheter aortic valve implantation.

Management of paravalvular regurgitation (PVR) after transcatheter aortic valve implantation (TAVI). Most patients with mild PVR can be managed medically with periodic imaging to detect any increase in regurgitant severity. In some patients with moderate to severe or severe PVR, medical therapy may be possible using guideline-directed medical therapy for heart failure or haemolytic anaemia. When intervention is needed, surgical aortic valve replacement (SAVR) may be considered, but many of these patients may be high risk for surgery or prefer to avoid surgical intervention. Transcatheter options include a vascular occluder device, a redo TAVI with placement of a second transcatheter valve (TAV-in-TAV), or balloon dilation of the initial TAVI valve.

Successful TAVI Despite Sudden Low Output and Ventricular Fibrillation in a Patient with Cardiac Amyloidosis

Management of patients with cardiac amyloidosis and concomitant high-grade aortic stenosis is challenging. Here, we report the case of a 79-year-old man with transcatheter aortic valve implantation (TAVI) complicated by low cardiac output during release of a Medtronic Evolut R 34 mm valve. After initiation of mechanical circulatory support, the TAVI valve was successfully implanted despite ongoing ventricular fibrillation. The ventricular fibrillation was successfully treated with injection of potassium into the aorta, with subsequent defibrillation and ventricular pacing. Moreover, pharmacological management of transient severe LV dysfunction and high-grade mitral regurgitation finally led to a favourable course.

Thai Guidelines for Transcatheter Aortic Valve Implantation, TAVI 2021

Thai Guidelines for Transcatheter Aortic Valve Implantation (TAVI) were initiated by the Thai Heart Association, Society of Thoracic Surgeons of Thailand, and Cardiovascular Intervention Association of Thailand. There are several factors in Thailand that differ from western countries, such as patient life expectancy, the types of available TAVI valves, socio-economic status, and experiences in TAVI. Therefore, Thailand-specific guidelines would be of great benefit for Thai patients. The objectives of the guidelines are to provide update recommendations regarding best practice in patients undergoing TAVI in Thailand, to emphasize the importance of a multidisciplinary heart valve team, and to emphasize the importance of data collection and follow up in patients undergoing TAVI for quality improvement. Classes of recommendation were based on standard classification and level of evidence. Recommendations were categorized into recommendation for multidisciplinary heart valve team, for perioperative risk assessment, for patient selection, for antithrombotic treatment after TAVI, for hospital and operator requirement, and for TAVI data collection. Keywords: Aortic stenosis; Transcatheter aortic valve implantation (TAVI)

Meta-Analysis on the Clinical Outcomes of Transcatheter Aortic Valve Implantation in Low-Surgical Risk Patients With Bicuspid Aortic Valves

Transcatheter aortic valve implantation (TAVI) has been widely considered for patients with aortic stenosis (AS) across all surgical risk spectra.1 Bicuspid aortic valve (BAV) is the most common congenital heart defect and can progress to moderate to severe AS in about 12% to 37% of affected patients.2 Patients with BAV have traditionally been excluded from trials comparing TAVI and surgical aortic valve replacement, mainly due to their complex valvular anatomy and higher incidence of postprocedural paravalvular leak (PVL).

Abstract 11421: Intervention With Cerebral Embolic Protection in Transcatheter Aortic Valve Implantation (INTERCEPTavi): Does Carbon-Dioxide Flushing Reduce Vascular Brain Injury?

Background: Transcatheter Aortic Valve Implantation (TAVI) is associated with 2-3% clinical stroke rate and much higher incidence of silent cerebral infarction. This study investigated the neuroprotective benefits of minimising air emboli in TAVI. It aimed to demonstrate a reduction in vascular brain injury by flushing TAVI valves with CO 2 and saline compared to saline only as per standard practise. Methods: Patients undergoing transfemoral TAVI for aortic stenosis were enrolled. Patients were randomised to CO 2 and saline (TAVI-CO 2 ) versus saline only (TAVI-S) flushing of TAVI valves during preparation. Patients underwent MRI brain following TAVI to identify new cerebral infarcts and any reduction in vascular brain injury by reducing air emboli. Results: Twenty-Two patients were enrolled in the study with a mean age of 79±10 years. Fifteen (68%) were males. Nine patients (41%) had history of hypertension, 5 (23%) had previous cerebrovascular disease and 5 (23%) had diabetes. Two (9%) patients did not have their TAVI valve implanted and hence were excluded. No patients had any procedural related complications. Three (14%) patients required permanent pacemaker insertion post procedure and could not have their MRI. Fifteen patients (68%) had MRI brain post-TAVI, 7 patients in the TAVI-CO 2 group and 8 patients in the TAVI-S group. TAVI-CO 2 group had a total of 41 new cerebral lesions compared to 66 lesions in TAVI-S group. TAVI-CO 2 had on average 6.80 new lesions/patient compared to 8.25 lesions/patients in TAVI-S (p=0.34) Cerebral infarcts were also analysed according to valve type. In self-expanding valves (n=7), TAVI-CO 2 had 8 lesions/patient compared to 10 lesions/patient in TAVI-S (p=0.46). In balloon-expanding valves (n=8), TAVI-CO 2 had 4.25 lesions/patient compared to 6.25 lesions/patient in TAVI-S (p=0.25). Conclusion: There is a trend in the reduction in the number of new cerebral lesions in the TAVI-CO 2 arm compared to the TAVI-S patients. This is the first study that identifies the importance of air emboli in TAVI and the associated potential vascular brain injury. As brain injury remains a significant concern during TAVI, a larger randomised trial is required to further investigate the neuroprotective benefit of flushing TAVI valves with CO 2 .

Abstract 11715: Valve-in-Valve Transcatheter Aortic Valve Implantation for Early Valve Degeneration

Case Presentation: A 64-year-old woman with presented to the hospital with chest pain and hypotension during hemodialyis. Three months prior to presentation, she had underwent transcatheter aortic valve implantation (TAVI) and received a 26 mm CoreValve Evolut Pro (Medtronic, MN) for severe aortic stenosis. She was admitted to the cardiac intensive care unit and underwent diagnostic testing. Transthoracic echocardiography demonstrated a new mean transaortic valve gradient of 55 mm Hg (Figure 1A), increased from her post-procedural gradient of 12 mm Hg. Despite empiric treatment with heparin anticoagulation and antibiotics, the patient did not improve clinically. CT imaging did not reveal valve thrombosis, endocarditis, or any other structural deformities (Figure 1B), and the patient’s mean transaortic valve gradient worsened to 73 mm Hg. After a multidisciplinary discussion, a decision was made to offer a valve-in-valve TAVI for early valve degeneration with a 23 mm Sapien S3 (Edwards, CA) valve (Figure 1C). After her procedure, the patient’s symptoms resolved and she was discharged from the hospital. The patient’s mean transaortic valve gradient improved to 12.6 mm Hg at her 4 month follow up visit (Figure 1D). Discussion: Early TAVI valve dysfunction is typically attributed to thrombus or infection of the valve. Here we present a case of valve dysfunction that was not related to either of these etiologies. Delineating the cause of her valve dysfunction was vital to her therapeutic decision making. Since the patient was not a surgical candidate, valve-in-valve TAVI was offered when thrombus and endocarditis were eliminated as the etiology of her valve dysfunction.