Transaortic Valve Implantation Research Articles

Systematic review and meta-analysis on the effects of physical activity-based interventions on frailty status and clinical outcomes in adults with long-term cardiac conditions

Abstract Introduction Frailty is common in patients with long-term cardiac conditions and is associated with poor clinical outcomes, but limited treatment options are available. Previous studies investigating interventions for frailty have shown positive results with physical activity interventions, however, these studies were largely based on general elderly populations. Aim To assess the impact of physical activity-based interventions on frailty and clinical outcomes in frail patients with long-term cardiac conditions. Methods A systematic review and meta-analysis was conducted based on the PRISMA guideline, using Medline, Embase, CENTRAL, PEDro, CINAHL electronic databases for articles published between 2000 and 2023. Studies which recruited adults >18 years with long-term cardiac conditions (including angina, acute coronary syndrome (ACS), valve disease, heart failure (HF), atrial fibrillation, cardiac surgery and congenital heart disease) who underwent physical activity-based interventions were included. The primary outcome was change in frailty (measured using a validated tool) post intervention. We also assessed the effect of interventions on mortality and hospitalisation. Results We screened 2697 records and reviewed 91 full-text articles; 12 studies (14 articles) were included, involving 1394 patients. Median age of participants ranged from 64 to 82 years. Five studies recruited participants with HF, 3 evaluated participants post transaortic valve implantation, 3 recruited cardiac surgical patients and 1 study evaluated participants post ACS. Physical activity-based interventions were multi-domain, including a mixture of aerobic, strength, balance, endurance and respiratory muscle training; the majority (N=10) had individualised exercise prescription. Meta-analysis of 8 randomised controlled trials (RCTs) showed statistically significant improvement in frailty associated with physical activity-based interventions compared to controls [pooled standardised mean difference (95% CI) = -0.34 (-0.59 to -0.08), p = 0.01, I2 = 48%]. Seven RCTs evaluated change in frailty by short physical performance battery (SPPB). Meta-analysis of these studies showed a statistically significant improvement in SPPB associated with physical activity-based interventions compared to controls [pooled mean difference (95% CI) = 0.83 (0.31-1.34), p = 0.002, I2 = 49%]. (Figure) The magnitude of improvement in SPPB exceeded the minimally clinically significant improvement of 0.5. Three studies evaluated the effect of physical activity-based intervention on clinical outcomes, all of which showed neutral effect on mortality and hospitalisation. Conclusion Physical activity-based interventions in patients with frailty and long-term cardiac conditions were associated with significant improvement in frailty status, with neutral effect on mortality and hospitalisation. Figure: Meta-analysis of 7 RCTs assessing effect of physical activity-based interventions on SPPB

Atrial refractoriness early after transcatheter aortic valve implantation TAVI in patients with severe aortic stenosis and sinus rhythm.

Aortic valve stenosis (AS) is a common valvular heart disease, especially in the elderly, and is associated with a high prevalence of atrial fibrillation. Although the risk of atrial fibrillation is expected to decrease after the intervention, atrial fibrillation develops in many patients undergoing surgical or percutaneous transaortic valve implantation. We aimed to evaluate atrial refractoriness since it may play a key role in the occurrence of atrial fibrillation after transaortic valve implantation. Seventy-nine consecutive patients who underwent TAVI between October 2021 and May 2023 were enrolled in this trial. Sixty-seven patients underwent electrophysiology study before and after TAVI. We evaluated the changes in PA and AH intervals, as well as atrial effective refractory periods. Besides the hemodynamic changes, atrial effective refractory periods increased, and atrial effective refractory period dispersion (39.8±21.6 vs. 31.1±18.0) decreased significantly after TAVI. The change in atrial effective refractory period dispersion after TAVI was correlated only with the changes in left ventricular end-diastolic pressure (r=0.77, P=0.001) and the changes in aortic gradient (r=0.4, P=0.001). The independent variables affecting the changes in atrial effective refractory period dispersion were basal pro-BNP levels, besides the changes in left ventricular end-diastolic pressure and aortic gradient after transaortic valve implantation. Our results show an acute improvement in atrial refractoriness after TAVI, though high atrial fibrillation rates are reported in the literature. The timing of aortic valve replacement is important, as irreversible maladaptive changes might have already developed by the time of intervention.

Marital status, educational level, and mid-term mortality risk in 5924 patients after transcatheter aortic valve implantation.

There is scarce knowledge about the association between social factors and mid-term outcome in older patients undergoing transaortic valve implantation (TAVI). Our aim in this study is to explore associations between marital status, educational level, and mortality risk in patients after TAVI. Patients aged ≥65 who underwent TAVI in Sweden during 2014-2020 were identified from the SWEDEHEART registry. Social factors and comorbidities were collected from mandatory national registries. Cox regression models adjusted for baseline comorbidities, age, sex, year of TAVI, social factors, and smoking were used to estimate mortality risk. Median follow-up was 1.9 years (interquartile range: 0.9-3.3). Overall, 5924 patients were included (47.3% women), with a mean age of 82.1 years (standard deviation: 6.1). Of the 1410 (23.8%) deaths during follow-up, 721 (51.2%) were related to cardiovascular causes. Patients with low education (<10 years) had a higher risk of mortality than patients with the highest education level [>12 years; adjusted hazard ratio (aHR): 1.20, 95% confidence interval (CI): 1.03-1.41]. Never being married/cohabiting was associated with an increased risk of mortality in comparison with being married/cohabiting (aHR: 1.32, 95% CI: 1.05-1.65). A separate analysis of men and women showed an increased risk among never-married men (aHR: 1.63, 95% CI: 1.23-2.14) but not among never-married women (aHR: 0.85, 95% CI: 0.56-1.30). Disadvantage in social factors was associated with an increased mortality risk after TAVI in older patients. These findings emphasize the importance of developing strategies to increase health literacy and social support after TAVI in older patients with unfavourable social factors.

Cardiac amyloidosis prevalence and 1-year outcome in patients with aortic stenosis undergoing transaortic valve implantation: Findings from the CAMPOS-TAVI study

BackgroundTransthyretin amyloid cardiomyopathy (ATTR-CM) can manifest as rhythm disorders, heart failure, but also valvular degeneration. Despite aortic stenosis (AS) being prevalent among the elderly, data on ATTR-CM prevalence and outcome in patients with AS undergoing transaortic valve implantation (TAVI) remain scarce. AimTo determine ATTR-CM prevalence and evaluate 1-year survival in patients undergoing TAVI. MethodsBetween December 2020 and September 2021, 100 consecutive patients underwent TAVI and were screened prospectively for ATTR-CM using bone scintigraphy (BS). Monoclonal gammopathy was ruled out in case of cardiac uptake on BS. All patients were followed prospectively for 1year after TAVI. ResultsThe proportion of patients aged≥75years or with a EuroSCORE II>8% and possible femoral access was 99%. The abnormal cardiac uptake rate on BS was 7% (95% confidence interval: 2–12%); 86% of these patients were male. The RAISE (remodelling, age, injury, system and electrical) score, indicative of ATTR-CM risk, was higher in case of positive BS (P=0.04). Patients with positive BS were older and exhibited wider QRS complexes on electrocardiography (P=0.003), a higher frequency of reduced LVEF (57% vs. 17%), impaired basal LV strain (P=0.02) and a lower voltage/mass ratio (P=0.01). History of pacemaker implantation before TAVI was higher in the positive BS group (P=0.0004) and remained the only statistically significant factor after adjustment using the Holm–Bonferroni method. One-year survival of patients with positive BS did not differ from that of patients with isolated AS. ConclusionsPrevalence of ATTR-CM in patients treated with TAVI, underscoring the need for continued surveillance for potential development of ATTR-CM after TAVI. Caution is warranted regarding the 1-year survival because of the lack of study power. Further investigations are needed to define long-term prognosis of AS with ATTR-CM.

Socioeconomic factors and long-term mortality risk after transcatheter aortic valve implantation

Abstract Background There is scarce knowledge about the association between socioeconomic factors and outcome in patients undergoing transaortic valve implantation (TAVI). Therefore, the aim was to explore the association between marital status, educational level and long-term mortality risk in patients who underwent TAVI. Methods The SWEDEHEART registry was used to identify all patients who underwent TAVI due to aortic stenosis in Sweden from 2014 to 2020. Socioeconomic factors and comorbidities were collected from mandatory national registries. Cox regression models adjusted for baseline comorbidities, age, sex, smoking, education and marital status were used to estimate the mortality risk. Median follow-up were 1.9 years (interquartile range 0.8-3.2 years). Results In total, 6280 patients were included (47.1% women) with a mean age of 81.5 years (SD 7.1). Common baseline characteristics were hypertension (84.4%), heart failure (45.9%) and history of smoking (51.0%). During follow-up, 1584 (25.6%) of the patients died, of these, 860 (54.3%) deaths were related to cardiovascular causes. Lowest educational level (&amp;lt;10 years) was associated with a higher risk of mortality compared to patients with the highest education level (&amp;gt;12 years) (adjusted hazard ratio (aHR) 1.17 (95% Confidence interval (CI 1.01–1.35). Never being married/cohabiting, compared to married/cohabiting was not associated with an increased risk of mortality, (aHR 1.21 (95% CI 0.98-1.50)). The risk was increased for men (aHR of 1.45 (95% CI 1.12–1.88)), but not for women (aHR 0.81 (95% CI 0.55–1.19)). Conclusions Disadvantage in socioeconomic status was associated with an increased risk of mortality after TAVI. These findings emphasize the importance to develop strategies to increase health literacy and social support after TAVI, to patients with unfavorable socioeconomic factors.

Novel Techniques and Technologies for Surgical Aortic Valve Replacement: A Large Retrospective Cohort Analysis.

Background/Objectives: In an era of growing evidence for transaortic valve implantation (TAVI), our research topic was the evaluation of how surgical aortic valve replacements (SAVRs) are performing in terms of short- and long-term outcomes in different risk categories. Methods: This was a single centre, prospective, and observational cohort study of consecutive patients with aortic valve stenosis, undergoing isolated aortic valve replacement using a biological or mechanical prosthesis, Freestyle™ (Medtronic, Minneapolis, MN, USA) graft, homograft, or Ross procedure. The participant data were collected by review of an internal database. The primary endpoints were all-cause operative mortality (in hospital and at 30 days) and late mortality at the follow-up date. The secondary composite endpoint was the incidence of postoperative complications. Results: 1501 patients underwent SAVR; the mean age was 67 years (SD: 12.6). The in-hospital mortality was 1% (n = 16). At a median follow-up of 60 months, the survival rate was 98.7%. The main predictors for mortality were operative urgency and cardiogenic shock. The overall incidence of PPM was 2.3% (n = 34). Patients who underwent Ross procedure were younger (mean age: 20 years (SD: 1.7)), had a lower incidence of postoperative complications, and were all alive at follow-up. Conclusions: SAVR shows an excellent survival rate and a low rate of postoperative complications despite an increasing surgical risk. Recent advancements in technology, like sutureless/rapid deployment prostheses and minimally invasive techniques, are shown to have favourable effects on outcomes.

A new and easy parameter to predict the requirement for permanent pacemaker implantation after transaortic valve implantation: aortic knob calcification.

One of the predictable and preventable complications that may occur after transaortic valve implantation (TAVI) is the requirement for permanent pacemaker (PPM) implantation. To evaluate the relationship between aortic knob calcification (AKC) assessed by preoperative chest X-ray and the requirement for post-procedure PPM implantation for patients who underwent TAVI. This study was conducted with 110 patients who underwent TAVI with a Myval transcatheter heart valve in our center between June 2020 and December 2022. The patients' electrocardiograms were monitored after the procedure. The patients were evaluated in two groups according to whether they required PPM. The AKC grading was performed by examining the routine posterior-anterior chest radiographs of all patients participating in the study. A PPM was placed in 17 (15.4%) patients after TAVI. The remaining 93 patients formed the control group. AKC (p = 0.002) and membranous septum (p = 0.013) statistically significantly differed between the PPM and control groups; however, no significant difference was detected in relation to the other parameters. In the univariable (p = 0.004) and multivariable (p = 0.024) regression analyses performed to identify predictors of PPM requirement after TAVI, AKC was found to be both a dependent and independent predictor. AKC can be used as a cost-effective and easily accessible parameter for predicting the post-procedure PPM requirement in patients who have undergone TAVI.

Outcomes of the Transaortic Valve Implantation Procedure in North Cyprus

Outcomes of the Transaortic Valve Implantation Procedure in North Cyprus

Multi-modality cardiac image computing: A survey.

Multi-modality cardiac imaging plays a key role in the management of patients with cardiovascular diseases. It allows a combination of complementary anatomical, morphological and functional information, increases diagnosis accuracy, and improves the efficacy of cardiovascular interventions and clinical outcomes. Fully-automated processing and quantitative analysis of multi-modality cardiac images could have a direct impact on clinical research and evidence-based patient management. However, these require overcoming significant challenges including inter-modality misalignment and finding optimal methods to integrate information from different modalities. This paper aims to provide a comprehensive review of multi-modality imaging in cardiology, the computing methods, the validation strategies, the related clinical workflows and future perspectives. For the computing methodologies, we have a favored focus on the three tasks, i.e., registration, fusion and segmentation, which generally involve multi-modality imaging data, either combining information from different modalities or transferring information across modalities. The review highlights that multi-modality cardiac imaging data has the potential of wide applicability in the clinic, such as trans-aortic valve implantation guidance, myocardial viability assessment, and catheter ablation therapy and its patient selection. Nevertheless, many challenges remain unsolved, such as missing modality, modality selection, combination of imaging and non-imaging data, and uniform analysis and representation of different modalities. There is also work to do in defining how the well-developed techniques fit in clinical workflows and how much additional and relevant information they introduce. These problems are likely to continue to be an active field of research and the questions to be answered in the future.

PO-03-021 HIS BUNDLE PACING SUCCESS AND ELECTRICAL PARAMETERS STABILITY REGARDLESS OF THREE-DIMENSIONAL TRANSTHORACIC ECHOCARDIOGRAPHY LEAD LOCALIZATION

His bundle pacing (HBP) is the most physiological form of ventricular pacing. Few prospective studies have analyzed lead localization using imaging techniques and its relationship with electrical parameters and capture patterns. To examine the correlation between electrical parameters and lead localization using three-dimensional transthoracic echocardiography (3D-TTE). This single-center, prospective, nonrandomized clinical research study (January 2018-June 2020) included patients with an indication of permanent pacing, in whom 3D-TTE was performed to define lead localization as supravalvular or subvalvular. A total of 92 patients were included: 56.5% of leads were supravalvular and 43.5% were subvalvular (Figure 1), which resembles previous anatomic descriptions of autopsied hearts of His bundle localization within the triangle of Koch (ToK). Most of our patients (98.9%) did not need a right ventricular backup lead in addition to the His lead. Only in one patient, with alternating BBB after transaortic valve implantation, we implanted a backup lead. R-wave sensing was higher when the His lead was localized subvalvular instead of supravalvular. His lead localization was not associated with HBP threshold or impedance differences, nor with the two different HBP patterns of capture (Table 1). HBP was attempted in 56 patients with baseline broad QRS, and we successfully corrected the baseline conduction disturbance in 45 patients (80.4%); lead localization was not associated with the ability of HBP to correct baseline BBB. The median HBP threshold at implantation was 1.25 V [0.75–2] @0.4ms, with no differences depending on lead localization. The thresholds remained stable during the follow-up visits at 1 and 6 months, regardless of His lead localization. R-wave sensing showed a significant change at follow-up, with higher - but no clinically relevant - R-wave sensing compared to that at baseline, which was mainly observed in the subvalvular His leads (4mV at baseline and 4.3mV at 6-months, p<0.001). However, lead impedances in both positions were decreased at follow-up (median difference -110 Ω). Clinically relevant p-wave oversensing was not observed. Lead localization in relation to the tricuspid valve did not influence the electrical performance of HBPs. Wide anatomical variations of the His bundle within the ToK explain our findings, reinforcing the idea that the technique for HBP should be fundamentally guided by electrophysiological and not anatomical parameters.

Aortic valve replacement using a polytetrafluoroethylene leaflet valve in patients with a history of the Bentall–De Bono procedure: a case series

Objective: To analyze outcomes of 4 transcatheter aortic valve replacements using a polytetrafluoroethylene leaflet valve in patients with a history of the Bentall–De Bono procedure.Methods: We retrospectively analyzed a series of 4 cases. From February 2019 to March 2022 in Federal Center for Cardiovascular Surgery (Penza, Russia), patients with a history of the Bentall–De Bono procedure underwent transaortic aortic valve implantation of the MedLAB-CT balloon-expandable valve under cardiopulmonary bypass and cardioplegia. Valve No. 25 was implanted in 3 patients, and 1 patient received valve No. 23.Results: According to echocardiography, valve hemodynamic performance improved in the postoperative period: mean and peak pressure gradients were 11.5 and 24 mm Hg, respectively; the median value of effective orifice area was 1.9 cm2, while mitral regurgitation in all cases did not exceed grade 1. Median cardiopulmonary bypass and myocardial ischemia times were 59 and 31 minutes, respectively. There was no immediate and remote mortality. No complications were reported in the postoperative period.Conclusion: The proposed replacement of the valved conduit’s compromised part after the Bentall–De Bono procedure can significantly reduce the extent of surgery, cardiopulmonary bypass and myocardial ischemia times, as well as simplify the procedure. Received 1 December 2022. Revised 10 February 2023. Accepted 16 February 2023. Informed consent: The patient’s informed consent to use the records for medical purposes is obtained. Funding: The study did not have sponsorship. Conflict of interests: The authors declare no conflict of interest. Contribution of the authorsLiterature review: V.A. Karnakhin, I.D. PotopalskiyDrafting the article: V.V. Bazylev, A.B. Voevodin, I.D. Potopalskiy, V.A. KarnakhinCritical revision of the article: A.A. Kuznetsova, M.P. PatelSurgical treatment: V.V. Bazylev, A.B. VoevodinFinal approval of the version to be published: V.V. Bazylev, A.B. Voevodin, I.D. Potopalskiy, V.A. Karnakhin, M.P. Patel, A.A. Kuznetsova

Fluoroscopically guided vascular and cardiac transcatheter procedures: a comparison of occupational and patient dose by anatomical region

X-ray guided procedures are being performed by an increasing variety of medical specialties. Due to improvements in vascular transcatheter therapies, there is an increasing overlap of imaged anatomy between medical specialties. There is concern that non-radiology fluoroscopic operators may not have sufficient training to be well informed of the potential implications of radiation exposure and mitigation strategies to reduce dose. This was a prospective, observational, single center study to compare occupational and patient dose levels when imaging different anatomical regions during fluoroscopically guided cardiac and endovascular procedures. Occupational radiation dose was measured at the level of the temple of 24 cardiologists and 3 vascular surgeons (n = 1369), 32 scrub nurses (n = 1307) and 35 circulating nurses (n = 885). The patient dose was recorded for procedures (n = 1792) performed in three angiography suites. Abdominal imaging during endovascular aneurysm repair (EVAR) procedures was associated with a comparatively high average patient, operator and scrub nurse dose despite additional table-mounted lead shields. Air kerma was relatively high for procedures performed in the chest, and chest + pelvis. Higher dose area product and staff eye dose were recorded during procedures of the chest + pelvis due to the use of digital subtraction angiography to evaluate access route prior to/during transaortic valve implantation. Scrub nurses were exposed to higher average radiation levels than the operator during some procedures. Staff should be cognizant of the potentially higher radiation burden to patients and exposed personnel during EVAR procedures and cardiac procedures using digital subtraction angiography.

Evaluation of the Effect of Transcatheter Aortic Valve Implantation on Left Ventricular Function by 4-Dimensional Echocardiography.

Bene���cial e���ects of transaortic valve implantation on left ventricular hemodynamics and prognosis of patients have been demonstrated. Although left ventricular systolic and diastolic function following transaortic valve implantation procedure have been examined in previous studies, 4-dimensional echocardiographic parameters have not been extensively studied, especially in patients with preserved ejection fraction aortic stenosis. In our study, we planned to evaluate the e���ect of transaortic valve implantation on myocardial deformation using 4-dimensional echocardiography. A total of 60 consecutive patients who underwent transaortic valve implantation for severe aortic stenosis with preserved ejection fraction were prospectively enrolled in the study. Standard 2-dimensional echocardiography and 4-dimensional echocardiography were performed in all patients before and 6 months after the transaortic valve implantation procedure. Six months after valve implantation, signi���cant improvement was observed in global longitudinal strain (P < 0.001), spherical circumferential strain (P = 0.022), global radial strain (P = 0.008), and global area strain (P < 0.001). In the regression analysis, global area strain and absence of diabetes mellitus were determined as independent predictors to show a 10% increase in the left ventricular ejection fraction. In patients with preserved ejection fraction who underwent transaortic valve implantation, left ventricle deformation parameters have improved after 6 months, especially by using 4-dimensional echocardiography. The use of 4-dimensional echocardiography should be more common in daily practice.

INCIDENCE AND PREDICTORS OF PERMANENT PACEMAKER IMPLANTATION AFTER TRANS AORTIC VALVE IMPLANTATION (TAVI) – A SINGLE CENTER EXPERIENCE

Objectives: The objective of the study is to evaluate the incidence and predictors of permanent pacemaker (PPM) implantation in patients undergoing transaortic valve implantation (TAVI). Methodology: This study was conducted at the “National Institute of Cardiovascular Diseases (NICVD) Karachi, Pakistan”. All the consecutive patients who underwent TAVI between July 2015 and February 2020 were included in the study. Patient data were extracted from Hospital TAVI Registry. We included patients with severe symptomatic aortic stenosis (AS) with moderate to high surgical risk as per “society of thoracic surgeon score (STS)” and “EURO II score”, underwent TAVI. Patients were stratified into two groups based on the implantation of PPM, demographic characteristics, clinical characteristics, co-morbid conditions, valve pathology, and procedural characteristics were compared between both groups. Results: Among 100 patients included only 22 patients (22%) underwent PPM implantation. The indication for implantation of PPM for all patients was complete heart block. Clinical characteristics which shows statistical significance for PPM implantation are preprocedural left ventricular dysfunction (p=0.015), right bundle branch block (RBBB) p&lt;0.001, and left anterior hemiblock (p&lt;0.001) noted on ECG and post-deployment valve area post-procedure (p&lt;0.001). Multivariate analysis showed that pre-procedure RBBB and large post-deployment valve area are independent predictors for PPM implantation in Post TAVI patients. Conclusion: The incidence of PPM implantation in patients who underwent TAVI at NICVD is 22%. Preprocedural left ventricular dysfunction, RBBB, and post-procedure large post-deployment valve area were noted to be significant predictors for PPM implantation.

209 A COMMON CASE OF AORTIC STENOSIS IN A UNIQUE QUADRICUSPID ANATOMY: MANAGEMENT IN REAL LIFE

Abstract A 85-year-old lady with severe dyspnea presented in emergency dept. of our institution in Reggio Emilia last July. Typical signs and symptoms of heart failure were associated with high voltage at ECG and echocardiographic findings show a reduced EF (40%) with trans-aortic mean gradient of 42 mmHg, aortic valvular area of 0.8 cm2 and moderate aortic regurgitation. At CT scan analysis, a dismorphic quadricuspid aortic valve (QAV) was detected. This is a rare congenital heart disease generally unrelated to other cardiac abnormalities and usually diagnosed incidentally. Due to QAV stenosis rarity, many considerations in Trans Aortic Valve Implantation (TAVI) in QAV are unclear. Some individuals with QAV develop aortic regurgitation and rarely other cardiovascular complications such as aortic aneurysm. Because of its infrequency, it is difficult to characterize these patients and standardize their management. Tailored therapy is more than ever necessary. Our patient also had bicameral pacemaker for grade II Mobitz 2 atrioventricular blockage. At coronarography angiography mild atheromasia was detected; AngioCT reconstructions in figure 1 panel A and B show the presence of QAV. Severe wall atheromasia along the entire course of the aorta was also detected. A few days later the patient underwent the TAVI procedure. A coronary guidewire was positioned in right coronary artery in order to protect its ostium that was slightly lower and, as known from literature, QAV has a longer leaflet height and a shallower cusp depth. After implantation of a Balloon Expandable Valve, a chimney stenting was also performed. An excellent final result was achieved with a safe deployment and a 90/10 final position (last aortography frame in Figure 2, where both coronary arteries are well visible). Post-procedural echo follow-up showed a well functioning aortic prosthesis (with mean gradient of 9 mmHg). The case presented is particularly interesting mainly for three reasons: Extreme rarity of this condition that can be challenging especially in the elderly people with calcific valve affected by stenosis and regurgitation;Paucity of procedural data in literature on QAV;It is a real life management example with subsequent successful implantation of the BEV and chimney stenting in QAV;

Apixaban and Valve Thrombosis After Transcatheter Aortic Valve Replacement: The ATLANTIS-4D-CT Randomized Clinical Trial Substudy.

Subclinical obstructive valve thrombosis after transcatheter aortic valve replacement (TAVR) is of uncertain frequency and clinical impact. The aim of this study was to determine the effects of apixaban vs standard of care on post-TAVR valve thrombosis detected by 4-dimensional (4D) computed tomography. The randomized ATLANTIS (Anti-Thrombotic Strategy to Lower All Cardiovascular and Neurologic Ischemic and Hemorrhagic Events After Trans-Aortic Valve Implantation for Aortic Stenosis) trial demonstrated that apixaban 5mg twice daily was not superior to standard of care (vitamin K antagonists or antiplatelet therapy) after successful TAVR and was associated with similar safety but with more noncardiovascular deaths. Three months after randomization, 4D computed tomography was proposed to all patients to determine the percentage of patients with≥1 prosthetic valve leaflet with grade 3 or 4 reduced leaflet motion or grade 3 or 4 hypoattenuated leaflet thickening (the primary endpoint) in the intention-to-treat population. Seven hundred sixty-two participants had complete multiphase datasets and were included in the 4D computed tomographic analysis. The primary endpoint occurred in 33 (8.9%) and 51 (13.0%) patients in the apixaban and standard-of-care groups, respectively. It was reduced with apixaban vs antiplatelet therapy (OR: 0.51; 95%CI: 0.30-0.86) but not vs vitamin K antagonists (OR: 1.80; 95%CI: 0.62-5.25) (Pinteraction=0.037). The composite of death, myocardial infarction, any stroke, or systemic embolism at 1 year occurred in 10.7% (n=9 of 84) and 7.1% (n=48 of 178) of patients with and without subclinical valve thrombosis at 90days, respectively (HR: 1.68; 95%CI: 0.82-3.44). Apixaban reduced subclinical obstructive valve thrombosis in the majority of patients who underwent TAVR without having an established indication for anticoagulation. This study was not powered for clinical outcomes. (Anti-Thrombotic Strategy After Trans-Aortic Valve Implantation for Aortic Stenosis [ATLANTIS]; NCT02664649).

Transcatheter aortic valve implantation via transaortic surgical access

We report a case of an 80-years&amp;ndash;old patient with a severe, symptomatic aortic valve stenosis and history of ischemic heart disease, previously treated by coronary artery bypass graft surgery. The patient was contraindicated for conventional surgical aortic valve replacement (SAVR) due to advanced age and underlying comorbidity, therefore transcatheter aortic valve implantation (TAVI) has been offered. The access options for the procedure were restricted by the underlying generalized atherosclerosis process causing peripheral vessel disease. We have chosen transaortic access for the patient which in that case was the only possible option. The transaortic valve implantation was successful with satisfactory hemodynamic results, improvement in functional class heart failure of the patient and preserving the function and anatomy of the coronary artery bypass graft. This case report demonstrates that the lack of favorable transfemoral access for TAVI should not be a limitation by itself for the procedure, rather than be stimulus for searching and using new and alternative access for it.

The predictive role of fully revascularized coronary artery disease in patients undergoing transaortic valve implantation

In the modern days and the era of the rapid development of medical technology, the introduction of innovative invasive methods of treatment is gradually displacing traditional conventional surgery. In 2002 was performed the fi rst transcatheter implantation of an aortic valve. Over the next twenty years, with the advancement of technology and the accumulation of experience in clinical centers, transcatheter aortic valve implantation has become the standard in adult and high-risk patients with high-grade Ao stenosis. In a large percentage of cases enrolled under the transcatheter aortic valve protocol a concomitant ischemic heart disease is detected or known. Globally, there is no signifi cant difference in overall mortality on the thirtieth day after TAVI in patients with ischemic heart disease. However, the overall mortality was signifi cantly higher in one &amp;ndash; year follow - up of patients after transcatheter aortic valve implantation with underlying coronary pathology. We conducted a study comparing the number of late and early adverse events in patients with concomitant fully revascularized ischemic heart disease and those with insignifi cant coronary atherosclerosis. Based on the data collected, analyzed and summarized in our clinical center, fully revascularized ischemic heart disease does not increase the percentage of major adverse events after transcatheter aortic valve implantation. It can be considered when assessing the risk of transcatheter aortic implantation, as part of the individual approach for each case.

Advantages and disadvantages of drug challenge during electrophysiological study in patients with new left bundle branch block after transaortic valve implantation.

AimsElectrophysiological study (EPS) is recommended in case of new-onset persistent left bundle branch block (NOP-LBBB) after transaortic valve implantation (TAVI) to identify patients at high risk of delayed atrioventricular block (D-AVB). We evaluated the added value of drug challenge, after normal baseline EPS, to predict D-AVB in such patients.MethodsWe conducted a comparative single-centre study of two successive periods, during which we used baseline EPS alone (first period) or drug challenge in case of normal baseline EPS (second period), for patients with NOP-LBBB after TAVI. The primary endpoint was a composite of pacemaker use, documented D-AVB, cardiac syncope, sudden death, or delayed pacemaker implantation.ResultsAmong 736 patients with TAVI implantation between January 2016 and September 2019, 64 with NOP-LBBB were included. During the first period, 4/22 (18.2%) presented with a positive baseline EPS. After a mean (standard deviation [SD]) of 15.6 (8.3) months, 7/22 (31.8%) reached the primary endpoint. During the second period, 19/42 (45.2%) presented with a positive EPS. After a mean (SD) of 12.8 (3.5) months, 8/42 (19.0%) reached the primary endpoint. There was a tendency to increased sensitivity (42.9–87.5%; P = 0.12) and negative predictive value (77.8–95.7%; P = 0.15) of the EPS, respectively during the first to the second period. However, the specificity decreased (93.3–64.7%; P = 0.04).ConclusionDiagnostic yield improved with drug challenge in case of normal baseline EPS. However, the decrease in specificity led to a high rate of unnecessary pacemaker implantation.

Direct transaortic transcather valve-in-valve implantation into a mechanical aortic valve prosthesis during left ventricular assist device implantation: description of a surgical technique.

The presence of a mechanical aortic valve prosthesis is considered a relative contraindication for left ventricular assist device implantation (LVAD) due to the occurrence of thromboembolic events. Five patients were operated on for LVAD implantation with status post mechanical aortic valve implantation (n = 3 with status post Bentall procedure). After removal of the leaflets, a transcatheter balloon-expandable valve was placed within the mechanical ring in all patients. Three patients were discharged from hospital with a maximum follow-up of 3.3 years. Transaortic transcatheter valve implantation into a mechanical aortic valve during LVAD implantation is a feasible option. It reduces operative times and might also prevent thromboembolic events.