Treatment Of Severe Aortic Stenosis Research Articles

Value of basal HV Interval prior TAVR as predictor of permanent pacemaker implantation

Abstract Background/Introduction Transfemoral aortic valve replacement (TAVR) is an effective and safe treatment for severe aortic stenosis (SAoS) even in low risk patients (1,2). As population ages, the volume of TAVR procedure increases and although improvements in technology and technique, new onset persistent disturbances in the electrocardiogram (ECG) are present up to 34,8% of patients at hospital discharge(3) and the secondary need of permanent pacemaker implantation (PPM) remains high, being of 4-24% with balloon-expanding valves (BEV) and 14.7-26.7% with self-expanding valves (SEV)(3). According to ESC guidelines, an electrophyisiologic study (EPS) centered in HV interval measure with a cutoff of ≥70ms is a useful tool to assess the risk of progression to high auriculoventricular block (HAVB) in specific groups with persistent ECG abnormalities to consider PPM(4-5), but this only applies in post TAVR scenario. Measuring HV interval at the intervention day prior procedure could help optimize and assess risk for PPM post TAVR. Purpose To measure basal HV interval prior TAVR and correlate it to risk of PPM implantation before discharge and 30 days after discharge. Methods Single-center prospective cohort study, patients with SAoS scheduled for TAVR, sinus rhythm at intervention day, without PPM or history of PPM indication were included. At time of TAVR, a tetrapolar catheter was placed at the septal aspect of tricuspid valve. A mobile polygraph was used to measure ECG parameters and HV interval before TAVR. Then, tetrapolar catheter was advanced to ventricle to perform rapid stimulation as part of habitual valve implantation protocol. After procedure, a rhythm monitorization for >48-72 hrs, was made to decide, PPM, HV interval measure or clinical daily ECG vigilance with posterior discharge was performed. A 30-day post discharge follow up was expected. Results 38 patients were enrolled, median age 83.5 ± 5.5 years, 23 females (60,5%). 37 patients had SEV implanted and 1 patient had BEV implanted. Median HV interval was 54.4ms. 18 patients (47.4%) had a mild abnormal HV interval, of whom 11 had a narrow QRS. Post TAVR procedure, 15 patients (39.5%) persisted with "de novo" LBB at discharge. 5 women and 7 men, had PPM implanted before discharge. 1 woman was implanted 6 days after discharge due to HAVB (66ms HV interval prior TAVR). In a multivariate analysis including sex, age, PR, QRS and HV interval >55ms, the RR (IC 95% 1.9-70.3) risk of PPM was 13.42 folds higher (p=0.008). At a bivariate quantitative HV analysis, a higher HV period persisted significantly related to PPM outcome (p=0.001). Conclusions In our study population, a pre-existing mild to moderate prolongation of HV interval prior TAVR substantially elevates the risk of requiring PPM before discharge. 61.1% of these basal mild prolongation HV interval patients had a narrow QRS prior TAVR.HV measure prior TAVR in narrow QRSTable 1

An interactive, online decision aid assessing patient goals and preferences for treatment of aortic stenosis to support physician-led shared decision-making: Early feasibility pilot study.

Guidelines recommend shared decision making when choosing treatment for severe aortic stenosis but implementation has lagged. We assessed the feasibility and impact of a novel decision aid for severe aortic stenosis at point-of-care. This prospective multi-site pilot cohort study included adults with severe aortic stenosis and their clinicians. Patients were referred by their heart team when scheduled to discuss treatment options. Outcomes included shared decision-making processes, communication quality, decision-making confidence, decisional conflict, knowledge, stage of decision making, decision quality, and perceptions of the tool. Patients were assessed at baseline (T0), after using the intervention (T1), and after the clinical encounter (T2); clinicians were assessed at T2. Before the encounter, patients reviewed the intervention, Aortic Valve Improved Treatment Approaches (AVITA), an interactive, online decision aid. AVITA presents options, frames decisions, clarifies patient goals and values, and generates a summary to use with clinicians during the encounter. 30 patients (9 women [30.0%]; mean [SD] age 70.4 years [11.0]) and 14 clinicians (4 women [28.6%], 7 cardiothoracic surgeons [50%]) comprised 28 clinical encounters Most patients [85.7%] and clinicians [84.6%] endorsed AVITA. Patients reported AVITA easy to use [89.3%] and helped them choose treatment [95.5%]. Clinicians reported the AVITA summary helped them understand their patients' values [80.8%] and make values-aligned recommendations [61.5%]. Patient knowledge significantly improved at T1 and T2 (p = 0.004). Decisional conflict, decision-making stage, and decision quality improved at T2 (p = 0.0001, 0.0005, and 0.083, respectively). Most patients [60%] changed treatment preference between T0 and T2. Initial treatment preferences were associated with low knowledge, high decisional conflict, and poor decision quality; final preferences were associated with high knowledge, low conflict, and high quality. AVITA was endorsed by patients and clinicians, easy to use, improved shared decision-making quality and helped patients and clinicians arrive at a treatment that reflected patients' values. Trial ID: NCT04755426, Clinicaltrials.gov/ct2/show/NCT04755426.

Simultaneous Transcatheter Aortic Valve Implantation and Endovascular Aneurysm Repair for Severe Aortic Stenosis and Symptomatic Abdominal Aortic Aneurysm: Mini Review.

Background: The treatment of patients with severe aortic stenosis (SAS) who concomitantly present with abdominal aortic aneurysm (AAA) is not defined. Aortic valve replacement surgery, performed alone, increases the risk of AAA rupture. Transcatheter aortic valve replacement (TAVR) and endovascular abdominal aortic aneurysm repair (EVAR) in the same intervention, especially in high-risk patients, is a safe alternative. Purpose: We report a case of simultaneous endovascular treatment of SAS and AAA and a mini literature review of nineteen cases with similar characteristics. Research design: Case report and literature review. Data Collection: An electronic search of PubMed and Scopus was performed from inception to December 2023. Results: Nineteen case reports of simultaneous transcatheter aortic valve repair and endovascular aneurysm repair for SAS and symptomatic AAA were identified published in the literature. Conclusions: We regard the simultaneous endovascular approach to both pathologies as a promising treatment alternative for selected patients with severe aortic stenosis and abdominal aortic aneurysm. We highlight the need to conduct randomized clinical trials in this patient population.

Effects of process parameters and geometry on dimensional accuracy and surface quality of thin strut heart valve frames manufactured by laser powder bed fusion

AbstractLaser powder bed fusion (LPBF) is one of the most popular metal additive manufacturing technologies, which has found its applications in high-value sectors such as aerospace and biomedical devices. Some recent studies on the LPBF of stents have demonstrated its feasibility in the fabrication in thin strut structures including heart valve frames, as used in transcatheter aortic valve implantation (TAVI) for the treatment of severe aortic stenosis. The state of the art method of laser cutting TAVI frame limits the scope for novel concepts which are made possible by additive manufacturing. However, the surface quality and dimensional accuracy of LPBF parts are lower than that produced by laser cutting. To start the development of new TAVI concepts, the feasibility of manufacturing thin frames by LPBF has been investigated based on the SAPIEN 3 frame by Edwards Lifesciences. In this study, simplified frames with strut size from 0.3 to 0.5 mm have been successfully manufactured. The effects of strut size, strut angle, laser power and scan speed on the dimensional accuracy and surface quality were systemically studied. In addition, a representative SAPIEN 3 frame was manufactured and assessed with high-resolution X-ray CT scans. Good overall dimensional accuracy and low porosity were obtained for the SAPIEN 3 frame. However, inclined struts were found to have relatively low dimensional accuracy and poor surface quality.

Direct vs. staged TAVI in the acute management of decompensated severe aortic stenosis

Abstract Funding Acknowledgements None. Background Transcatheter aortic valve implantation (TAVI) has emerged as a preferred treatment for severe aortic stenosis across a spectrum of surgical risks, potentially diminishing the role of balloon aortic valvuloplasty (BAV) as a transient solution or a bridge to definitive intervention. With advancements in TAVI technology and expertise, patients even in unstable conditions are increasingly receiving direct, definitive TAVI, avoiding the risks associated with staged, multiple procedures. Aims The study set out to assess whether immediate TAVI is safer and more effective than BAV followed by elective aortic valve replacement (AVR) in acute severe aortic stenosis. Methods Conducted as a retrospective analysis at a single center, this study encompassed a cohort of consecutive patients who received either urgent or emergency BAV, as bridge to AVR, or TAVI to manage decompensated severe aortic stenosis from May 2012 to May 2023. The primary outcomes were mortality rates at both 30 days and one year following the procedures. Results In this cohort, 258 cases of urgent or emergent percutaneous aortic valvuloplasty were evaluated. BAV was performed in 47 patients, whereas 211 received direct TAVI. A significantly higher proportion of the BAV group (36%) was treated due to cardiogenic shock as the primary indication, compared with just 11% in the TAVI group (p< 0.001). Demographic parameters and comorbid condition profiles were equivalently balanced across both groups. The median age was 81 years (interquartile range: 74-85, p= 0.40), and males constituted 56% of the patient population (p= 0.72). Most patients (65%) presented with left ventricular systolic dysfunction, and nearly half (49%) were diagnosed with obstructive coronary artery disease. The reduction in peak aortic valve gradient was significantly more pronounced in the TAVI group (-56±25 mmHg) compared to the BAV group (-27±19 mmHg, p< 0.001). TAVI recipients also had a higher incidence of VARC-2 minor and major bleeding events (26% versus. 6% for BAV, p<0.001), and a greater occurrence of advanced atrioventricular block necessitating temporary pacing (19% vs. 9% for BAV, p= 0.02). Thirty-day survival rates favored the TAVI group (93%) over BAV (86%). This trend persisted at the one-year mark, with survival rates of 84% for TAVI and 70% for BAV. Furthermore, the one-year hazard ratio for mortality among patients undergoing BAV was 2.01 (95% confidence interval: 1.34–3.01, p< 0.001). Conclusion The data from this retrospective analysis indicate that for patients with decompensated severe aortic stenosis, immediate TAVI may confer a mortality benefit over BAV followed by elective procedures. Despite a higher rate of procedural complications, the direct TAVI approach was associated with better survival rates at both 30 days and one year. These outcomes suggest a potential reevaluation of treatment strategies in acute settings may be warranted.

Sarcopenia and aortic valve disease.

Valvular heart disease, including calcific or degenerative aortic stenosis (AS), is increasingly prevalent among the older adult population. Over the last few decades, treatment of severe AS has been revolutionised following the development of transcatheter aortic valve replacement (TAVR). Despite improvements in outcomes, older adults with competing comorbidities and geriatric syndromes have suboptimal quality of life outcomes, highlighting the cumulative vulnerability that persists despite valve replacement. Sarcopenia, characterised by loss of muscle strength, mass and function, affects 21%-70% of older adults with AS. Sarcopenia is an independent predictor of short-term and long-term outcomes after TAVR and should be incorporated as a prognostic marker in preprocedural planning. Early diagnosis and treatment of sarcopenia may reduce morbidity and mortality and improve quality of life following TAVR. The adverse effects of sarcopenia can be mitigated through resistance training and optimisation of nutritional status. This is most efficacious when administered before sarcopenia has progressed to advanced stages. Management should be individualised based on the patient's wishes/preferences, care goals and physical capability. Exercise during the preoperative waiting period may be safe and effective in most patients with severe AS. However, future studies are needed to establish the benefits of prehabilitation in improving quality of life outcomes after TAVR procedures.

Long-Term Assessment of Survival After Transcatheter Aortic Valve Implantation - Insights From the International Transcatheter Aortic Valve Implantation Registry.

Transcatheter aortic valve implantation (TAVI) is an established treatment for severe aortic stenosis (AS), but despite estimates of life expectancy after TAVI being essential in heart team discussion, these data are scarce. Therefore, the current study sought to assess long-term survival and its trends in relation to chronological age, surgical risk, and treatment period.Methods and Results: We included 2,414 consecutive patients who underwent TAVI for severe symptomatic AS between 2008 and 2021 at 2 international centers. For the analysis, long-term survival was evaluated according to age, surgical risk, and treatment period categorized into 3 groups, respectively. The longest follow-up was 13.5 years. Overall survival was 67.6% at 5 years and 26.9% at 10 years. Younger patients, lower surgical risk, and later treatment period showed better survival (log-rank P<0.001, respectively). In the multivariate analysis, age <75years, lower surgical risk, and later time period were significantly associated with better survival. The incidence of paravalvular leakage ≥moderate, red blood cell transfusion, and acute kidney injury were independently associated with increasing risk of 5-year death. In a real-world registry, survival was substantial following TAVI, especially in younger and lower surgical-risk patients, with improving outcomes over time. This should be considered in heart team discussions of life-long management for AS patients after TAVI.

Long-Term Outcomes After Transcatheter Aortic Valve Implantation in Patients With Chronic Inflammatory Disease.

Chronic inflammatory disease (CID) accelerates atherosclerosis and the development of aortic stenosis. Data on long-term outcomes after transcatheter aortic valve implantation (TAVI) in those patients are missing. The aim of this study was to investigate the clinical long-term outcomes of patients with and without autoimmune-related CID undergoing TAVI for the treatment of severe aortic stenosis. From a prospective registry, consecutive patients with TAVI were included. Baseline clinic and imaging data (echocardiographic and computed tomography) were analyzed. Long-term (up to 5 years) clinical and echocardiographic outcomes were studied. Of 1000 consecutive patients (mean age 81±6 years, 46% female), 107 (11%) had CID; the most frequent entities included polymyalgia rheumatica (31%) and rheumatoid arthritis (28%). Patients with CID were predominantly female (60% versus 44%, P=0.002) and more often had pulmonary disorders (21% versus 13%, P=0.046) and atrial fibrillation (32% versus 20%, P=0.003). The presence of CID was associated with a higher rate of postinterventional infection (5% versus 1%, P=0.007) and further emerged as a risk factor for rehospitalization for bleeding or infection (hazard ratio, 1.93 and 1.62, respectively). Premature valve degeneration, endocarditis, and all-cause mortality were not increased among patients with CID. This real-world analysis found that patients with CID undergoing TAVI were associated with a higher risk of postinterventional infectious complications and rehospitalization due to infection. However, valve durability and survival seem not to differ between patients with TAVI with versus without CID.

Impact on clinical outcome of ventricular arrhythmias in patients undergoing transcatheter aortic valve implantation.

Transcatheter aortic valve implantation (TAVI) has become a largely used treatment for severe aortic stenosis. There are limited data, however, about predictors of long-term prognosis in this population. In this study, we assessed whether ventricular arrhythmias may predict clinical outcomes in patients undergoing TAVI. We performed a 24 h ECG Holter monitoring in 267 patients who underwent TAVI for severe aortic stenosis within 30 days from a successful procedure. The occurrence of frequent premature ventricular complexes (PVCs; ≥30/h), polymorphic PVCs and nonsustained ventricular tachycardia (NSVT) was obtained for each patient. Clinical outcome was obtained for 228 patients (85%), for an average follow-up of 3.5 years (range 1.0-8.6). Cardiovascular events (CVEs; cardiovascular death or resuscitated cardiac arrest) occurred in 26 patients (11.4%) and 63 patients died (27.6%). Frequent PVCs but not polymorphic PVCs and NSVT were found to be associated with CVEs at univariate analysis. Frequent PVCs were indeed found in 12 patients with (46.2%) and 35 without (17.3%) CVEs [hazard ratio 2.30; 95% confidence interval (CI) 1.03-5.09; P = 0.04], whereas polymorphic PVCs were found in 11 (42.3%) and 54 (26.7%) patients of the two groups, respectively (hazard ratio 1.44; 95% CI 0.64-3.25; P = 0.38), and NSVT in 9 (34.6%) and 43 patients of the two groups, respectively (hazard ratio 1.18; 95% CI 0.48-2.87; P = 0.72). Frequent PVCs, however, were not significantly associated with CVEs at multivariate Cox regression analysis (hazard ratio 1.53; 95% CI 0.37-6.30; P = 0.56). Both frequent PVCs, polymorphic PVCs and NSVT showed no significant association with mortality. In our study, the detection of frequent PVCs at Holter monitoring after TAVI was a predictor of CVEs (cardiovascular death/cardiac arrest), but this association was lost in multivariable analysis.

TransCatheter aortic valve implantation and fractional flow reserve-guided percutaneous coronary intervention versus conventional surgical aortic valve replacement and coronary bypass grafting for treatment of patients with aortic valve stenosis and multivessel or advanced coronary disease: The transcatheter valve and vessels trial (TCW trial): Design and rationale

Background: Patients with severe aortic stenosis (AS) frequently present with concomitant obstructive coronary artery disease (CAD). In those, current guidelines recommend combined coronary artery bypass grafting (CABG) and surgical aortic valve replacement (SAVR) as the preferred treatment option, although this surgical approach is associated with a high rate of clinical events. Combined transcatheter aortic valve implantation (TAVI) and percutaneous coronary intervention (PCI) with or without FFR have evolved as a valid alternative for cardiac surgery in patients with AS and multivessel or advanced CAD. To date, no dedicated trial has prospectively evaluated the outcomes of a percutaneous versus surgical treatment for patients with both severe AS and CAD. Aims: To investigate whether fractional-flow reserve (FFR)-guided PCI and TAVI is non-inferior to combined CABG and SAVR for the treatment of severe AS and multivessel or advanced CAD. Methods: The Transcatheter Valve and Vessels (TCW) trial (clinicaltrial.gov: NCT03424941) is a prospective, randomized, controlled, open label, international trial. Patients ≥ 70 years with severe AS and multivessel (≥ 2 vessels) or advanced CAD, deemed feasible by the heart team for both; a full percutaneous or surgical treatment, will be randomised in a 1:1 fashion to either FFR-guided PCI followed by TAVI (intervention arm) vs. CABG and SAVR (control arm). The primary endpoint is a patient-oriented composite of all-cause mortality, myocardial infarction, disabling stroke, unscheduled clinically-driven target vessel revascularization, valve re-intervention, and life threatening or disabling bleeding at one year. The TCW trial is powered for non-inferiority, and if met, superiority will be tested. Assuming a primary endpoint rate of 30% in the CABG-SAVR arm, with a significance level α of 5%, a non-inferiority limit delta of 15% and a loss to follow-up of 2%, a total of 328 patients are needed to obtain a power of 90%. The primary endpoint analysis is performed on an intention-to-treat basis. Summary: The TCW Trial is the first prospective randomized trial that will study if a less invasive percutaneous treatment for severe AS and concomitant advanced CAD (i.e., FFR-guided PCI - TAVI) is non-inferior to the guidelines recommended approach (CABG-SAVR).

A Rare Complication of Transcatheter Aortic Valve Replacement: Delayed Down Migration of a Portico Valve.

There are some complications after transcatheter aortic valve replacement (TAVR), which is an alternative to surgery for the treatment of severe aortic stenosis. Valve migration, an unusual but life-threatening complication of TAVR, usually occurs during or several hours after the procedure and is associated with poor outcome. Therefore, operators must be experienced in rescue treatments. Placement of a second prosthesis as a salvage strategy appears to be a safe method to avoid the need for conversion to surgery.

Computed Tomography of Transcatheter Aortic Valve Replacement-Related Complications

Transcatheter aortic valve replacement (TAVR) has revolutionized the treatment of severe aortic stenosis, with an impressive reduction in mortality and complication rates over the last decade, becoming a safer alternative in patients at high/moderate risk for surgical treatment. Complications are rare but can be life-threatening; thus, cardiac imagers must be familiar with their imaging findings. TAVR-related complications often require multimodality imaging, although ECG-gated cardiac computed tomography (CCT) is the technique of choice, given its high spatial resolution and multiplanar image reconstruction. This review will discuss the imaging findings of the most important post-TAVR complications and novel preventive measures.

Rural versus urban outcomes following transcatheter aortic valve implantation: The importance of the heart team

BackgroundRural patients face known healthcare disparities and worse cardiovascular outcomes compared to urban residents due to inequitable access and delayed care. Few studies have assessed rural-urban differences in outcomes following Transcatheter Aortic Valve Implantation (TAVI). We compared short-term post-TAVI outcomes between rural and urban patients. MethodsWe performed a retrospective analysis of n = 413 patients who underwent TAVI at our large academic medical center, between 2011 and 2020 (rural/urban patients = 93/320. Rural/urban males = 53/173). Primary outcomes were all-cause mortality and cardiovascular mortality. Secondary outcomes included stroke/transient ischemic attack, myocardial infarction, atrial fibrillation, acute kidney injury, bleeding, vascular complications, and length of stay. ResultsThe mean age in years was 77 [IQR 70–82] for rural patients and 78 [IQR 72–84] for urban patients. Baseline characteristics were similar between groups, except for a greater frequency of active smokers and diabetics as well as a greater body mass index in the rural group. There were no statistically significant differences in all-cause or cardiovascular mortality between the groups. There was also no statistically significant difference in secondary outcomes. ConclusionRural and urban patients had no statistically significant difference in all-cause mortality or cardiovascular mortality following TAVI. Given its minimally invasive nature and quality-centric, multidisciplinary care provided by the TAVI Heart Teams, TAVI may be the preferred modality for the treatment of severe aortic stenosis in rural populations.

Simultaneous replacement of the aortic valve and hip joint in a patient with critical aortic stenosis and femoral neck fracture

Concomitant cardiovascular diseases in elderly patients with a hip fracture significantly increase the risk of developing postoperative complications. Developing the treatment algorithm for a combination of two or more diseases in this category of patients is the main task. The advantages of simultaneous surgery are one-stage repair of two or more surgical diseases, the implementation of one anesthetic procedure, the reduction in the total time of the patient’s stay in the hospital and the reduction in rehabilitation time. This paper presents the clinical observation of simultaneous surgical treatment of severe aortic stenosis and femoral neck fracture in an elderly patient.

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.

Clinical outcomes after transcatheter aortic valve implantation in patients older than 90 years of age

Abstract Background The prevalence of severe aortic valve stenosis is increasing due to the prolonged life expectancy. Transcatheter aortic valve implantation (TAVI) is a minimally invasive treatment for severe aortic stenosis that is particularly attractive for elderly patients. However, there are limited data evaluating clinical outcomes in patients older than 90 years of age undergoing TAVI. Purpose The aim of this study was to compare in-hospital clinical outcomes between nonagenarians undergoing TAVI versus patients younger than 90 years of age and to evaluate 2-year clinical outcomes of all-cause death, stroke, and hospitalization for heart failure among nonagenarians. Methods and results A total of 57 nonagenarians (12%) and 418 patients younger than 90 years of age (mean 82.5 years of age) undergoing TAVI from February 2014 to February 2023 in our institution were included. Among nonagenarians, 83.7% had hypertension, 8.9% had diabetes mellitus, 17.9% had atrial fibrillation, and 10.5% had malignant diseases. Self-expanding valves were more often implanted in nonagenarians (43.9% vs. 29.0%, p=0.02) and nonagenarians were likely to undergo transfemoral TAVI (89.5% vs. 84.0%, p=0.28) Mean hospitalization days after TAVI was almost similar between nonagenarians and patients younger than 90 years of age (12.5 days vs. 12.8 days, p=0.90). Rates of in-hospital disabling stroke (3.6% vs. 1.8%, p = 0.38) and need for permanent pacemaker implantation (8.8% vs. 5.7%, p = 0.37) tended to be higher in nonagenarians. The rate of major vascular complication was almost similar between two groups (3.5% vs. 4.8%, p=0.66). The 2-year survival rates of all-cause death, stroke and hospitalization for heart failure, composites of all-cause death and stroke and composites of all-cause death, stroke and hospitalization for heart failure among nonagenarians were 86.3%, 87.5%, 88.9%, 80.6% and 74.0%, respectively. During an average 1.6-year follow-up period, nine deaths occurred among nonagenarians. Of those, seven patients died from non-cardiovascular causes. Conclusion In this single center analysis, clinical outcomes in nonagenarians undergoing TAVI were acceptable compared with patients younger than 90 years of age.

Sex differences and survival after TAVI for severe aortic stenosis

Abstract Background There is still controversy about survival rates and clinical response of women versus men who undergo transcatheter aortic valve implantation (TAVI) for the treatment of severe aortic stenosis (SAS). Purpose Assess mortality and heart failure (HF) symptoms following TAVI for SAS, according to sex. Methods A retrospective analysis of a single-center database including all TAVI performed in 2011-2019 was performed. Clinical, echocardiographic, and blood-analysis data were determined, and all-cause mortality over the five years after the procedure was compared based on sex. A reduction of at least one New York Heart Association (NYHA) class after TAVI was the secondary endpoint. Results Of the 488 cases analyzed, 252 (51.6%) were women. They were older (84 vs. 80 years-old, p&amp;lt;0.001), had a lower body surface area, and had a higher estimated surgical risk, as determined by EuroSCORE II (4.5 vs. 3.8, p=0.011) and STS-mortality (4.46 vs. 3.44, p&amp;lt;0.001). However, they had a lower prevalence of diabetes mellitus, coronary artery disease, and peripheral artery disease, a lower estimated creatinine clearance, and a lower frequency of previous pacemaker implantation. Women had more frequently a phenotype of high gradient severe aortic stenosis, with lower functional aortic valve areas. While there was no difference in TAVI design, smaller valves were implanted in women. Median follow-up was 46 months and there was a 40% mortality rate over the five years after treatment, with no statistically significant differences according to sex in both univariate and multivariate analysis, after adjusting for estimated surgical risk. EuroSCORE II had a statistically significant association with the primary endpoint (hazard ratio 1.03 (1.01-1.05), p=0.004). Despite having a similar NYHA class before TAVI, women experienced a lower frequency of functional class improvement (61% vs. 72%, p=0.034). Conclusions Although women had a higher estimated surgical risk, no differences were found regarding survival after TAVI for SAS. However, improvement in HF symptoms was less frequent in this subset.Table 1Figure 1

Impact on clinical outcome of ventricular arrhythmias in patients undergoing transcatheter aortic valve implantation (TAVI)

Abstract Background Transcatheter aortic valve implantation (TAVI) in the treatment of severe aortic stenosis has considerably grown in the latest years. There are limited data, however, about predictors of long-term prognosis in this population. Particularly, whether ventricular arrhythmic burden is associated with clinical outcome has poorly been investigated. Purpose The aim of our study was to investigate the association between ventricular arrhythmias and adverse clinical outcomes in patients undergoing TAVI. Methods We performed a 24-hour 3-channel ECG Holter monitoring (HM) in 267 consecutive patients who underwent TAVI for severe aortic stenosis at our Centre within 30 days from a successful procedure (average 10.2 days, range 2-30). For each patient we obtained the number of premature ventricular complexes (PVCs) and the presence of non-sustained ventricular tachycardia (NSVT, &amp;gt;3 PVCs with a rate &amp;gt;100 bpm). Frequent PVCs were defined as the presence of at least 30 PVCs per hour. We also collected clinical and echocardiographic findings for each patient. Assessment of clinical events at follow-up was performed by clinical visits or telephone interviews of patients or relatives (in case of fatal events). The primary endpoint of the study was the occurrence of cardiovascular events (CVE), a composite of cardiovascular death and resuscitation from cardiac arrest. All-cause-mortality was assessed as secondary endpoint. Survival Cox regression was applied to assess the univariate and multivariate association of clinical, echocardiographic and HM variables with endpoints. Results Clinical outcome could be obtained for 228 patients (85%), for an average follow-up of 3.5 years (range 1.0-8.6). Among these patients, frequent PVCs (≥30/hour) and episodes of NSVT at HM were found in 47 (20.6%) and 52 (22.4%) patients, respectively. CVE occurred in 26 patients (11.4%) and 63 patients died (27.6%). Frequent PVCs at HM were detected in 12 patients with (46.2%) and 35 patients without (17.3%) CVE (HR 2.29; 95% CI 1.03-5.09; p=0.04). One or more episodes of NSVT were detected in 9 patients with (34.6%) and 43 patients without (21.3%) CVE (HR 2.29; 95% CI 1.03-5.09; p=0.04), although it was not predictive of all-cause mortality (HR 1.18; 95% CI 0.48-2.77; p=0.52). Both the presence of PVCs&amp;gt;30/hour (HR 1.19; 95% CI 0.69-2.08; p=0.53) and NSVT (HR 0.93; 95% CI 0.52-1.65; p=0.22) were not significantly associated with all-cause mortality. Moreover, no clinical (age, gender, cardiovascular risk factors) and echocardiographic (aortic valve area, trans-aortic mean gradient, left ventricle mass and ejection fraction) variable showed significant association with both the primary and secondary outcome in our patients. Conclusions In our study the detection of frequent PVCs at HM after TAVI was a major predictor of CVE (cardiovascular death/cardiac arrest), suggesting that a 24-hour HM after TAVI can be helpful for risk stratification of these patients.

Abstract 13177: The Association Between Insufficient Valve Expansion and Aortic Valve Calcification for Transcatheter Valve Implantation With Self-Expandable Valve

Background: Transcatheter aortic valve implantation (TAVI) has emerged as the preferred treatment for severe aortic stenosis. Nevertheless, severe calcification remains a factor leading to insufficient valve expansion and paravalvular leakage (PVL) after TAVI, mainly when using the self-expandable valve. We aimed to investigate the relationship between calcification and valve expansion using pre- and post-operative computed tomography (CT) scans, by comparing with valve phantoms as a reference standard. Methods: We enrolled 62 consecutive patients (mean age: 84.2 ± 4.4 years, 23 male) who underwent TAVI with the Evolut PRO+. We measured the aortic valve's calcium volume (Ca-Vol) by contrast-enhanced CT. The shorter diameter (mm) and the area (cm 2 ) of the base of the implanted valve were measured. We performed CT scans of valve phantoms for each size and defined the measured shorter diameter and the base area as the reference standard. We calculated the insufficiency of valve expansion as the ratio of the patient valve's shorter diameter and base area to that of the phantom valve. PVL was defined as more than mild regurgitation by transthoracic echocardiography. Results: The base area of valve phantoms was 3.6, 4.1, 6.4, and 8.4 cm 2 for 23, 26, 29, and 34 mm, respectively. The shorter diameter and base area of the implanted valve were 15.7 ± 2.6, 15.2 ± 2.8, 17.3 ± 4.0, 23.9 ± 1.8 mm, and 2.7 ± 0.7, 2.5 ± 0.6, 3.4 ± 1.0, and 6.2 ± 1.6 cm 2 for 23, 26, 29, and 34 mm (n=4, 31, 24, and 3, respectively). Significant inverse correlations were observed between Ca-Vol and shorter diameter ratio (r 2 = 0.1, P = 0.009), area ratio (r 2 = 0.1, P = 0.006), and PVL (r 2 = 0.4, P &lt; 0.001), respectively. On the other hand, there was no significant correlation between area ratio and PVL (r 2 = 0.004, P = 0.6). Conclusion: Severe calcification in the aortic valve was associated with insufficient valve expansion and PVL for the Evolut PRO+.

Abstract 12686: Serious Complications Occur in Patients With Transcatheter Aortic Valve Replacement Who Develop In-Hospital Infective Endocarditis

Introduction: Transcatheter aortic valve replacement (TAVR) is a well-recognized treatment for severe aortic stenosis. One potentially life-threatening complication of TAVR is infective endocarditis (IE). There is limited contemporary data on the clinical characteristics and outcomes of patients undergoing TAVR who develop in-hospital IE. Aim: Describe the clinical characteristics and outcomes of patients undergoing TAVR who develop in-hospital IE. Methods: The National Inpatient Sample Database was queried from 2016 to 2020 for relevant ICD-10 procedural and diagnostic codes. Baseline characteristics and in-hospital outcomes of adult (≥18 years) patients undergoing TAVR who developed in-hospital IE were compared to that of patients who did not develop IE. Multivariate logistic-regression analyses adjusting for age, race, gender, and statistically significant comorbidities between cohort's were performed. A p-value &lt;0.05 was considered significant. Results: A total of 314,250 hospitalizations for patients undergoing TAVR were identified. Of them, 1065 (0.3%) developed in-hospital IE. Overall, mean age of IE patients was 70.3 ± 15.0. Patients were predominantly (62%) males and white (79.5%) ( Table 1) . IE patients had a higher risk of in-hospital all-cause mortality (adjusted odds ratio [95% CI]: 2.07 [1.50-2.86]), septic shock (3.73 [2.71-5.13]), acute respiratory failure (2.59 [2.19-3.06]), ischemic stroke (4.4 [3.48-5.51]), acute kidney injury (3.05 [2.61-3.57]), cardiac arrest (2.82 [1.83-4.37] and cardiogenic shock 3.70 [2.98-4.57]). All p values were &lt;0.01. Conclusion: Patients undergoing TAVR who develop in-hospital IE had higher in-hospital complications when compared to those of patients who did not develop IE. Although the rate of in-hospital IE was low, the number of patients identified in the NIS database was sizable and the syndrome deserves investigation due to its associated complications.