Treatment Of Severe Aortic Stenosis Research Articles

Modified cardiopulmonary bypass circuit for transcatheter aortic valve implantation and emergent cardiac surgery.

Transcatheter aortic valve implantation (TAVI) has revolutionized the treatment of severe aortic stenosis in high-risk patients, offering a minimally invasive alternative to open-heart surgery. However, complications such as hemodynamic instability may require mechanical circulatory support. In some cases, emergent cardiac surgery may be required, necessitating a swift transition to cardiopulmonary bypass (CPB). We modified the CPB circuit allowing for circulatory support and easy transition to CPB. No bleeding or vascular complications were observed. The modified CPB circuit minimizes hemodynamic disruptions and allows for postoperative ECMO support.

TCT-641 Time to Treatment for Severe Aortic Stenosis in a Large Community-based Health Care System

TCT-641 Time to Treatment for Severe Aortic Stenosis in a Large Community-based Health Care System

Reducing Length of Hospital Stay Following Transcatheter Aortic Valve Implantation.

Transcatheter aortic valve implantation (TAVI) has emerged as a safe and effective treatment for severe aortic stenosis across the spectrum of surgical risk cohorts. Subsequently, the dramatic increase in procedural volume worldwide has placed significant financial and logistical pressures on healthcare institutions, particularly regarding hospital length of stay (LOS), which can adversely affect patient flow. In this review article, we discuss different peri-procedural strategies developed to reduce LOS and facilitate early discharge after TAVI.

Trends in Complications Among Patients Undergoing Aortic Valve Replacement in the United States.

The treatment of severe aortic stenosis has evolved considerably since the introduction of transcatheter aortic valve replacement (TAVR), yet trends in complications for patients undergoing TAVR or surgical aortic valve replacement (SAVR) at a national level have yet to be evaluated. We performed a retrospective cohort study using Medicare data to evaluate temporal trends in complications among beneficiaries, aged ≥65 years, treated with elective isolated transfemoral TAVR or SAVR between 2012 and 2019. The study end point was the occurrence of a major complication (composite outcome) during index and up to 30 days after. Multivariable logistic regression was used to assess odds of complications for TAVR and SAVR, individually over time, and for TAVR versus SAVR, over time. The cohort included 211 212 patients (mean±SD age, 78.6±7.3 years; 45.0% women). Complication rates during index following elective isolated aortic valve replacement decreased from 49% in 2012 to 22% in 2019. These reductions were more pronounced for TAVR (41% to >19%, Δ=22%) than SAVR (51% to >47%, Δ=4%). After risk adjustment, the risk of any complication with TAVR was 47% (P<0.0001) lower compared with SAVR in 2012, and 78% (P<0.0001) lower in 2019. TAVR was independently associated with reduced odds of complications each year compared with 2012, with the magnitude of benefit increasing over time (2013 versus 2012: odds ratio [OR], 0.89 [95% CI, 0.81-0.97]; 2019 versus 2012: OR, 0.35 [95% CI, 0.33-0.38]). These findings are consistent for complications up to 30 days from index. Between 2012 and 2019, the risk of complications after aortic valve replacement among Medicare beneficiaries decreased significantly, with larger absolute and relative changes among patients treated with TAVR than SAVR.

The impact of transcatheter aortic valve implantation (TAVI) on mitral regurgitation - a single center study.

The coexistence of mitral regurgitation (MR) and severe aortic stenosis (AS) has been associated with worse outcomes in patients undergoing transcatheter aortic valve implantation (TAVI). Herein, the aim was to assess the etiology and degree of MR in an unselected TAVI population and investigate the impact of MR reduction at mid-term follow-up. Patients subjected to TAVI as a treatment for severe AS in a single center were retrospectively analyzed. The primary endpoint was the MR reduction after TAVI. The secondary endpoint was all-cause mortality and heart failure hospitalization at a 3-year follow-up. Patients undergoing TAVI (n = 283) in the years 2017-2019 were screened for the presence of hemodynamically significant MR. Sixty-nine subjects (24.4%) with severe (16, 23.2%) and moderate (53, 76.8%) MR were included. The primary MR was predominant (39 subjects, 56.5%). The median age of the patients was 82 years. MR improved in 25 patients (36.2%, p < 0.001). Baseline severe MR was more prone to reduce (8 subjects, 50%) than moderate (17 subjects, 32.1%, p = 0.04). The primary MR improved in 14 patients (35.9%), while secondary in 11 patients (36.7%, p = 1). Patients showing MR reduction had lower mortality (8 vs. 29.55%, p = 0.047) and were less frequently hospitalized (20 vs. 45.45%, p = 0.03) at 3-year follow-up. Hemodynamically significant MR improves after TAVI regardless of its etiology. Moreover, MR reduction after TAVI is associated with better clinical outcomes.

Antithrombotic Therapy in Patients Undergoing Transcatheter Aortic Valve Implantation.

Transcatheter aortic valve implantation (TAVI) now represents the mainstay of treatment for severe aortic stenosis. Owing to its exceptional procedural efficacy and safety, TAVI has been extended to include patients at lower surgical risk, thus now encompassing a diverse patient population receiving this treatment. Yet, long-term outcomes also depend on optimal medical therapy for secondary vascular prevention, with antithrombotic therapy serving as the cornerstone. Leveraging data from multiple randomized controlled trials, the current guidelines generally recommend single antithrombotic therapy, with either single antiplatelet therapy (SAPT) or oral anticoagulation (OAC) alone in those patients without or with atrial fibrillation, respectively. Yet, individualization of this pattern, as well as specific case uses, may be needed based on individual patient characteristics and concurrent procedures. This review aims to discuss the evidence supporting antithrombotic treatments in patients treated with TAVI, indications for a standardized treatment, as well as specific considerations for an individualized approach to treatment.

Impact of Neighborhood Social Deprivation on Delays to Access for Transcatheter Aortic Valve Replacement: Wait-Times and Clinical Consequences.

Transcatheter aortic valve replacement (TAVR) has become the standard of care for severe aortic stenosis treatment. Exponential growth in demand has led to prolonged wait times and adverse patient outcomes. Social marginalization may contribute to adverse outcomes. Our objective was to examine the association between different measures of neighborhood-level marginalization and patient outcomes while on the TAVR waiting list. A secondary objective was to understand if sex modifies this relationship. We conducted a population-based retrospective cohort study of 11 077 patients in Ontario, Canada, referred to TAVR from April 1, 2018, to March 31, 2022. Primary outcomes were death or hospitalization while on the TAVR wait-list. Using cause-specific Cox proportional hazards models, we evaluated the relationship between neighborhood-level measures of dependency, residential instability, material deprivation, and ethnic and racial concentration with primary outcomes as well as the interaction with sex. After multivariable adjustment, we found a significant relationship between individuals living in the most ethnically and racially concentrated areas (quintile 4 and 5) and mortality (hazard ratio [HR], 0.64 [95% CI, 0.47-0.88] and HR, 0.73 [95% CI, 0.53-1.00], respectively). There was no significant association between material deprivation, dependency, or residential instability with mortality. Women in the highest ethnic or racial concentration quintiles (4 and 5) had significantly lower risks for mortality (HR values of 0.52 and 0.56, respectively) compared with quintile 1. Higher neighborhood ethnic or racial concentration was associated with decreased risk for mortality, particular for women on the TAVR waiting list. Further research is needed to understand the drivers of this relationship.

Optimizing the treatment of severe aortic stenosis.

Optimizing the treatment of severe aortic stenosis.

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 &amp;gt;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 &amp;gt;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

LANDMARK comparison of early outcomes of newer-generation Myval transcatheter heart valve series with contemporary valves (Sapien and Evolut) in real-world individuals with severe symptomatic native aortic stenosis: a randomised non-inferiority trial

Transcatheter aortic valve implantation is an established, guideline-endorsed treatment for severe aortic stenosis. Precise sizing of the balloon-expandable Myval transcatheter heart valve (THV) series with the aortic annulus is facilitated by increasing its diameter in 1·5 mm increments, compared with the usual 3 mm increments in valve size. The LANDMARK trial aimed to show non-inferiority of the Myval THV series compared with the contemporary THVs Sapien Series (Edwards Lifesciences, Irvine, CA, USA) or Evolut Series (Medtronic, Minneapolis, MN, USA). In this prospective, multinational, randomised, open-label, non-inferiority trial across 31 hospitals in 16 countries (Germany, France, Sweden, the Netherlands, Italy, Spain, New Zealand, Portugal, Greece, Hungary, Poland, Slovakia, Slovenia, Croatia, Estonia, and Brazil), 768 participants with severe symptomatic native aortic stenosis were randomly assigned (1:1) to the Myval THV or a contemporary THV. Eligibility was primarily decided by the heart team in accordance with 2021 European Society of Cardiology guidelines. As per the criteria of the third Valve Academic Research Consortium, the primary endpoint at 30 days was a composite of all-cause mortality, all stroke, bleeding (types 3 and 4), acute kidney injury (stages 2-4), major vascular complications, moderate or severe prosthetic valve regurgitation, and conduction system disturbances resulting in a permanent pacemaker implantation. Non-inferiority of the study device was tested in the intention-to-treat population using a non-inferiority margin of 10·44% and assuming an event rate of 26·10%. This trial is registered with ClinicalTrials.gov, NCT04275726, and EudraCT, 2020-000137-40, and is closed to new participants. Between Jan 6, 2021, and Dec 5, 2023, 768 participants with severe symptomatic native aortic stenosis were randomly assigned, 384 to the Myval THV and 384 to a contemporary THV. 369 (48%) participants had their sex recorded as female, and 399 (52%) as male. The mean age of participants was 80·0 years (SD 5·7) for those treated with the Myval THV and 80·4 years (5·4) for those treated with a contemporary THV. Median Society of Thoracic Surgeons scores were the same in both groups (Myval 2·6% [IQR 1·7-4·0] vs contemporary 2·6% [1·7-4·0]). The primary endpoint showed non-inferiority of the Myval (25%) compared with contemporary THV (27%), with a risk difference of -2·3% (one-sided upper 95% CI 3·8, pnon-inferiority<0·0001). No significant difference was seen in individual components of the primary composite endpoint. In individuals with severe symptomatic native aortic stenosis, the Myval THV met its primary endpoint at 30 days. Meril Life Sciences.

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

Laser 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&amp;lt; 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&amp;lt; 0.001). TAVI recipients also had a higher incidence of VARC-2 minor and major bleeding events (26% versus. 6% for BAV, p&amp;lt;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&amp;lt; 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.

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.