An Updated Meta-Analysis on Cerebral Embolic Protection in Patients Undergoing Transcatheter Aortic Valve Intervention Stratified by Baseline Surgical Risk and Device Type.

Background: Transcatheter aortic valve intervention (TAVI) can lead to the embolization of debris. Capturing the debris by cerebral embolic protection (CEP) devices may reduce the risk of stroke. New evidence has allowed us to examine the effects of CEP in patients undergoing TAVI. We aimed to assess the effects of CEP overall and stratified by the device used (SENTINEL or TriGuard) and the surgical risk of the patients. Methods: We selected randomized controlled trials using electronic databases through September 17, 2022. We estimated random-effects risk ratios (RR) with (95% confidence interval) and calculated absolute risk differences at 30 days across baseline surgical risks derived from the TAVI trials for any stroke (disabling and nondisabling) and all-cause mortality. Results: Among 6 trials (n = 3921), CEP vs. control did not reduce any stroke [RR: 0.95 (0.50-1.81)], disabling [RR: 0.75 (0.18-3.16)] or nondisabling [RR: 0.99 (0.65-1.49)] strokes, or all-cause mortality [RR: 1.23 (0.55-2.77)]. However, when analyzed by device, SENTINEL reduced disabling stroke [RR: 0.46 (0.22-0.95)], translating into 6 fewer per 1000 in high-risk, 3 fewer per 1000 in intermediate-risk, and 1 fewer per 1000 in low surgical-risk patients. CEP vs. control did not reduce the risk of any bleeding [RR: 1.03 (0.44-2.40)], major vascular complications [RR: 1.41 (0.57-3.48)], or acute kidney injury [RR: 1.36 (0.57-3.28)]. Conclusions: This updated meta-analysis showed that SENTINEL CEP might reduce disabling stroke in patients undergoing TAVI. Patients with high and intermediate surgical risks were most likely to derive benefits.

Left atrial appendage occlusion.

Prevention of stroke represents a goal of primary importance in health systems due to its associated morbidity and mortality. As several patient groups with increased stroke rates have been identified, multiple approaches have been developed and implemented: oral anticoagulation (OAC) for patients with atrial fibrillation, surgical and percutaneous revascularisation in patients with carotid disease, device closure for patients with patent foramen ovale, and now, left atrial appendage occlusion (LAAO) for selected patients with non-valvular atrial fibrillation (NVAF). The latter group of patients are the focus of this review which evaluates the pathophysiology, selection of patients, procedural performance, outcomes of treatment both during and post-procedure, adjunctive therapy, complications, and longer-term outcomes.

Readmissions After Left Atrial Appendage Closure in Patients With Previous Ischemic Stroke or Transient Ischemic Attack.

Background: We examined the frequency and risk factors associated with readmission after left atrial appendage closure (LAAC) in patients with and without previous ischemic stroke and/or transient ischemic attack (TIA). Methods: Hospitalizations for LAAC were identified from the US National Readmission Database, 2016-2018. The primary outcome was the first unplanned readmission after LAAC, with readmission times stratified into those occurring within 0 to 30 days vs within 31 to 180 days. Patients were stratified based on the history of previous stroke and/or TIA. Results: Of 12,901 discharges after LAAC, 28% had previous stroke and/or TIA, and 8.2% had a readmission within 30 days while 18% had a readmission within 31 to 180 days. The rates of in-hospital complications and readmissions at both periods were not significantly different between individuals with vs without previous stroke and/or TIA. Cardiac causes accounted for 28% of readmissions within 30 days and 32% of those within 31 to 180 days, and congestive failure, bleeding, and infections were the most common readmission diagnoses. New stroke and/or TIA accounted for 4% and 6% of the total noncardiac readmissions within 30 days and 31 to 180 days, respectively, and the incidence was higher among those with previous stroke and/or TIA. Female sex and index hospitalization length of stay (LOS) > 1 day were factors independently associated with readmission within 30 days, whereas LOS, diabetes, renal disease, chronic obstructive pulmonary disease, and anemia were among the factors associated with readmissions within 31 to 180 days. Conclusions: Unplanned rehospitalizations were common after LAAC and had similar frequency for patients with vs without previous ischemic stroke and/or TIA. Female sex and index hospitalization LOS > 1 day were among the strongest factors that were independently associated with readmission within 30 days.

Contexte: Nous avons examiné la fréquence et les facteurs de risque des réadmissions consécutives à une fermeture de l'appendice auriculaire gauche (FAOG) chez les patients ayant ou non subi un accident vasculaire cérébral (AVC) ischémique et/ou un accident ischémique transitoire (AIT). Méthodologie: Les hospitalisations pour une FAOG ont été recensées au moyen de la US National Readmission Database (base de données nationale des réadmissions aux États-Unis) pour la période 2016-2018. Le critère d'évaluation principal était la première réadmission non prévue après une FAOG, avec stratification du moment de la réadmission selon que celle-ci était survenue de 0 à 30 jours ou de 31 à 180 jours après l'intervention. Les patients ont été stratifiés en fonction des antécédents d'AVC et/ou d'AIT. Résultats: Parmi les 12 901 patients ayant reçu leur congé de l'hôpital après une FAOG, 28 % avaient des antécédents d'AVC et/ou d'AIT; 8,2 % des patients admissibles ont été réadmis dans les 30 jours et 18 %, entre le 31e et le 180e jour suivant l'intervention. Aucune différence significative n'a été observée entre les patients ayant subi un AVC et/ou un AIT et les patients qui n'en avaient pas subi en ce qui concerne les taux de complications hospitalières et de réadmission durant ces deux périodes. Les causes cardiaques représentaient 28 % des réadmissions dans les 30 jours et 32 % des réadmissions entre le 31e et le 180e jour. L'insuffisance cardiaque congestive, les hémorragies et les infections ont été les causes les plus fréquentes de réadmission. Les nouveaux cas d'AVC et/ou d'AIT ont respectivement été à l'origine de 4 % et de 6 % de l'ensemble des réadmissions de cause non cardiaque dans les 30 jours, et entre le 31e et le 180e jour, et leur fréquence a été plus élevée chez les patients ayant des antécédents d'AVC et/ou d'AIT. Le sexe féminin et une durée d'hospitalisation initiale > 1 jour ont été des facteurs indépendants associés aux réadmissions dans les 30 jours, tandis que la durée de l'hospitalisation, un diabète, une néphropathie, une maladie pulmonaire obstructive chronique et une anémie faisaient partie des facteurs associés aux réadmissions entre le 31e et le 180e jour. Conclusions: Les réhospitalisations non prévues ont été courantes après une FAOG, et leur fréquence a été similaire en présence ou en l'absence d'antécédents d'AVC ischémique et/ou d'AIT. Le sexe féminin et une durée d'hospitalisation initiale > 1 jour ont été les facteurs les plus importants associés aux réadmissions dans les 30 jours.

Left Atrial Appendage Occlusion, A Misnomer?: Where Do We Go From Here?

The importance of the left atrial appendage (LAA) as the source of thromboembolism including stroke in patients with nonvalvular atrial fibrillation is well documented, with more than 90% of ischemic strokes related to a LAA thrombus. Although oral anticoagulation has been the standard of care, approximately 50% to 60% of patients either have contraindications to oral anticoagulation or do not continue the medication beyond the first year. This led to the development of local site-specific therapy to occlude the LAA by either surgical or transcatheter means. Despite marked advancements, incomplete LAA closure with surgical and transcatheter approaches remains frequent. The etiology of incomplete LAA closure and its clinical implications remain unclear. Multiple strategies are in development including changes in deployment techniques, a new device design, and alternative approaches to leak closure.

In-hospital and Readmission Outcomes With Percutaneous Balloon Mitral Valvuloplasty.

Percutaneous balloon mitral valvuloplasty (PBMV) is primarily performed for rheumatic mitral stenosis (MS). Therefore, limited data exist on PBMV in countries with a low incidence of rheumatic disease. Using the Nationwide Readmission Database, we examined trends in in-hospital mortality and 30-day readmission among patients who received PBMV for rheumatic and non-rheumatic MS. We also examined the change in 90-day hospitalization rate before vs after PBMV. Between 2016 and 2019, there were 1109 hospitalizations in which patients received PBMV for rheumatic (n = 955, 86.1%) vs non-rheumatic MS (n = 154, 13.9%). The all-cause in-hospital mortality for rheumatic and non-rheumatic MS did not change over time (0.9% → 2.0%, P = 0.94, and 5.9% → 9.5%, P = 0.09 respectively). Similarly, the 30-day readmission for patients with rheumatic and non-rheumatic MS did not change over time (12.4% → 9.9%, P = 0.26, and 4.4% → 10.5%, P = 0.30, respectively). The 90-day all-cause hospitalization rate remained the same before vs after PBMV for rheumatic and non-rheumatic MS (25.5% → 21.8%; P = 0.14, and 24.0% → 33.7%; P = 0.19, respectively). Although no statistically significant change was noted over time for trends in in-hospital mortality, 30-day readmission, or even in the change in 90-day all-cause hospitalizations before and after PBMV for both types of MS, among those with non-rheumatic MS, there was a signal of an increase in the in-hospital mortality, and 30-day readmission, even more, there was 29% relative increase in 90-day hospitalizations after PBMV. Future studies are needed to examine the role of PBMV in patients with non-rheumatic MS.

A Preliminary Study on the Usage of a Data-Driven Probabilistic Approach to Predict Valve Performance Under Different Physiological Conditions.

Predicting potential complications after aortic valve replacement (AVR) is a crucial task that would help pre-planning procedures. The goal of this work is to generate data-driven models based on logistic regression, where the probability of developing transvalvular pressure gradient (DP) that exceeds 20 mmHg under different physiological conditions can be estimated without running extensive experimental or computational methods. The hemodynamic assessment of a 26 mm SAPIEN 3 transcatheter aortic valve and a 25 mm Magna Ease surgical aortic valve was performed under pulsatile conditions of a large range of systolic blood pressures (SBP; 100-180 mmHg), diastolic blood pressures (DBP; 40-100 mmHg), and heart rates of 60, 90 and 120 bpm. Logistic regression modeling was used to generate a predictive model for the probability of having a DP > 20 mmHg for both valves under different conditions. Experiments on different pressure conditions were conducted to compare the probabilities of the generated model and those obtained experimentally. To test the accuracy of the predictive model, the receiver operation characteristics curves were generated, and the areas under the curve (AUC) were calculated. The probabilistic predictive model of DP > 20 mmHg was generated with parameters specific to each valve. The AUC obtained for the SAPIEN 3 DP model was 0.9465 and that for Magna Ease was 0.9054 indicating a high model accuracy. Agreement between the DP probabilities obtained between experiments and predictive model was found. This model is a first step towards developing a larger statistical and data-driven model that can inform on certain valves reliability during AVR pre-procedural planning.

Device-related thrombus following left atrial appendage occlusion.

Thrombus formation on intracardiac devices remains a subject of importance, with rates in the 2-5% range. Device-related thrombus (DRT) following left atrial appendage occlusion is an area of particular concern considering its association with embolic events. DRT continues to present numerous questions, including the optimal definition, incidence, risk factors, monitoring, therapy, and clinical outcomes - all subjects of ongoing assessment. Herein, we discuss these considerations, building upon the relevant historical context and pathophysiologic insights while discussing the future considerations in this rapidly evolving field.

Outcomes of cardiac surgery in nonagenarians.

BACKGROUND: While advanced age can be considered by some a contraindication to open-heart surgery, there is a paucity of data regarding outcomes of cardiac surgery in nonagenarians. We, therefore, sought to investigate the outcomes of nonagenarians undergoing cardiac surgery. METHODS: A retrospective review of our institutional Society of Thoracic Surgeons database between 1993 and 2019 was performed. Among a total of 32,421 patients who underwent open-heart surgery, 134 patients (0.4%) were nonagenarians (50.7% females, median age 91.6 [interquartile range: 90.7-92.9]). A comparison was performed between nonagenarians and patients aged 80-89 years. A regression analysis was performed to evaluate factors associated with midterm mortality in nonagenarians. RESULTS: The incidence of cardiac surgery in nonagenarians has been stable over time, from 0.4% in (1993-2000), 0.5% in (2001-2010) to 0.4% in (2011-2019). Valve surgery and CABG+valve were higher in nonagenarians compared to octogenarians (44.8% vs. 25.6%, 39.6% vs. 30.7%, respectively), but CABG was lower (15.7% vs. 33.8%); p < .01. Urgent/emergent surgery status was similar between groups (p = .7). Operative mortality was similar in the two groups (6% vs. 4.6%, p = .5). Hospital complications were comparable between groups. CONCLUSION: Cardiac surgery in nonagenarians can be achieved with acceptable morbidity and mortality. This study can be a benchmark for risk stratification for cardiac surgery in this high-risk population.

Impact of mitral intervention on outcomes of patients with mitral valve dysfunction and annulus calcification.

OBJECTIVES: To compare all-cause mortality in patients with mitral annulus calcification (MAC) and severe mitral valve dysfunction (MVD) who received standard mitral intervention versus no intervention. BACKGROUND: Patients with MAC often have high surgical risk due to advanced age, comorbidities, and technical challenges related to calcium. The impact of a mitral intervention on outcomes of patients with MAC and severe MVD is not well known. METHODS: Retrospective review of patients with MAC by transthoracic echocardiography (TTE) in 2015 at a single institution. Patients with severe mitral stenosis (MS) or regurgitation (MR) were analyzed and stratified into two groups: surgical or transcatheter intervention performed <1 year after the index TTE, and no or later intervention. The primary endpoint was all-cause mortality. RESULTS: Of 5502 patients with MAC, 357 had severe MVD (MS = 27%, MR = 73%). Of those, 108 underwent mitral intervention (surgery = 87; transcatheter = 21). They were younger (73 ± 11 vs. 76 ± 11 years, p < 0.01) and less frequently had cardiovascular diseases compared with no-intervention. Frequency in women was similar (45% vs. 50%, p = 0.44). During median follow-up of 3.2 years, the intervention group had higher estimated survival than those without intervention (80% vs. 72% at 1 year and 55% vs. 35% at 4 year, p < 0.01). Adjusted for age, eGFR, LVEF < 50%, and pulmonary hypertension, mitral intervention was an independent predictor of lower mortality (hazard ratio = 0.66, 95% confidence interval 0.43-0.99, p = 0.046). CONCLUSION: Patients with MAC and severe MVD who underwent mitral intervention <1 year from index TTE had lower mortality than those without intervention. Mitral intervention was independently associated with lower mortality.

Muscle fat index is associated with frailty and length of hospital stay following transcatheter aortic valve replacement in high-risk patients.

BACKGROUND: Aging is associated with progressive loss of muscle mass, as well as replacement of muscle with fat and fibrous tissue. We studied the contribution of muscle fat content, a surrogate marker of biological aging, to frailty and Length of Hospital Stay (LOS) following Transcatheter Aortic Valve Replacement (TAVR). METHODS: We evaluated 415 patients who underwent TAVR from February 2012 to December 2016 at Mayo Clinic, MN, USA. Densities between -190 to -30 Hounsfield Units within the abdominal muscle area were determined as muscle fat. Muscle Fat Index (MFI) was defined as muscle fat mass divided by height squared. LOS was considered as the primary outcome. Stepwise multivariable linear regression was used to identify the predictors of LOS. RESULTS: Mean age ± SD of the study population was 81.2 ± 9.6 years and 58.07% were male. Seventy-two patients (17.35%) had frailty. Median (IQR) LOS was 4 (3-6) days. MFI was higher in patients with frailty (median (IQR); 18.1 [13.8-24.2] vs 14.4 [10.6-18.7], p < 0.001) and was positively correlated with LOS (r = 0.129, p = 0.009). In multivariable analysis of predictors of LOS, MFI (ß = 0.06, p = 0.022), pre-TAVR atrial fibrillation/flutter (ß = 0.5, p = 0.015), and post-TAVR complications (ß = 0.91, p < 0.001) were directly, and femoral access route (ß = -1.13, p < 0.001) and pre-TAVR hemoglobin (ß = -0.35, p = 0.002) were inversely associated with LOS. CONCLUSIONS: MFI can be determined from pre-TAVR CT scans and is a novel predictor of LOS following TAVR. This objective indicator can potentially be used in a pre-TAVR clinic to plan for rehabilitation programs in selected patients.

Impact of calcific aortic valve disease on valve mechanics.

The aortic valve is a highly dynamic structure characterized by a transvalvular flow that is unsteady, pulsatile, and characterized by episodes of forward and reverse flow patterns. Calcific aortic valve disease (CAVD) resulting in compromised valve function and increased pressure overload on the ventricle potentially leading to heart failure if untreated, is the most predominant valve disease. CAVD is a multi-factorial disease involving molecular, tissue and mechanical interactions. In this review, we aim at recapitulating the biomechanical loads on the aortic valve, summarizing the current and most recent research in the field in vitro, in-silico, and in vivo, and offering a clinical perspective on current strategies adopted to mitigate or approach CAVD.

Doppler Mean Gradient Is Discordant to Aortic Valve Calcium Scores in Patients with Atrial Fibrillation Undergoing Transcatheter Aortic Valve Replacement.

BACKGROUND: Doppler mean gradient (MG) may underestimate aortic stenosis (AS) severity when obtained during atrial fibrillation (AF) because of lower forward flow compared with sinus rhythm (SR). Whether AS is more advanced at the time of referral for aortic valve intervention in AF compared with SR is unknown. The aim of this study was to examine flow-independent computed tomographic aortic valve calcium scores (AVCS) and their concordance to MG in AF versus SR in patients undergoing transcatheter aortic valve replacement (TAVR). METHODS: Patients who underwent TAVR from 2016 to 2020 for native valve severe AS with left ventricular ejection fraction ≥ 50% were identified from an institutional TAVR database. MGs during AF and SR in high-gradient AS (HGAS) and low-gradient AS (LGAS) were compared with AVCS (AVCS/MG ratio). AVCS were obtained within 90 days of pre-TAVR echocardiography. RESULTS: Six hundred thirty-three patients were included; median age was 82 years (interquartile range [IQR], 76-86 years), and 46% were women. AF was present in 109 (17%) and SR in 524 (83%) patients during echocardiography. Aortic valve area index was slightly smaller in AF versus SR (0.43 cm2/m2 [IQR, 0.39-0.47 cm2/m2] vs 0.46 cm2/m2 [IQR, 0.41-0.51 cm2/m2], P = .0003). Stroke volume index, transaortic flow rate, and MG were lower in AF (P < .0001 for all). AVCS were higher in men with AF compared with SR (3,510 Agatston units [AU] [IQR, 2,803-4,030 AU] vs 2,722 AU [IQR, 2,180-3,467 AU], P < .0001) in HGAS but not in LGAS. AVCS were not different in women with AF versus SR. Overall AVCS/MG ratios were higher in AF versus SR in HGAS and LGAS (P < .03 for all), except in women with LGAS. CONCLUSIONS: AVCS were higher than expected by MG in AF compared with SR. The very high AVCS in men with AF and HGAS at the time of TAVR suggests late diagnosis of severe AS because of underestimated AS severity during progressive AS and/or late referral to TAVR. Additional studies are needed to examine the extent to which echocardiography may be underestimating AS severity in AF.

Effect of eliminating pre-discharge transthoracic echocardiogram on outcomes after TAVR.

OBJECTIVES: The aim of this study was to determine the safety of eliminating the pre-discharge transthoracic echocardiogram (TTE) on 30-day outcomes in patients undergoing transcatheter aortic valve replacement (TAVR). BACKGROUND: TTE is utilized before, during, and after TAVR. Post-procedural, pre-discharge TTE assists in assessment of prosthesis function and detection of clinically significant paravalvular leak (PVL) after TAVR. METHODS: Patients who underwent TAVR at Mayo Clinic from July 2018 to July 2019 were included in a prospective institutional registry. Patients undergoing TAVR prior to February 2019 received a pre-discharge TTE, while those undergoing TAVR after February 2019 did not. Both cohorts were evaluated with TTE at 30 days post-TAVR. RESULTS: A total of 330 consecutive patients were included. Of these, 160 patients (age 81.1 ± 7.6) had routine pre-discharge TTE, while 170 patients (age 78.9 ± 7.5) were dismissed without routine pre-discharge TTE. Mortality at 30 days was similar between the two groups (0% and 1.2%, respectively). One episode of PVL requiring intervention (0.6%) occurred in the pre-discharge TTE group and none in the group without pre-discharge TTE at 30-day follow-up. There was a similar incidence of total composite primary and secondary adverse events between the cohort receiving a pre-discharge TTE and those without (28.1% vs. 25.3%, P = 0.56) at 30 days. The most common event was need for permanent pacemaker or ICD implantation in both groups (13.1% vs. 11.8%, P = 0.71). CONCLUSIONS: Elimination of the pre-discharge TTE is safe and associated with comparable 30-day outcomes to routine pre-discharge TTE. These findings have implication for TAVR practice cost-efficiency and health care utilization.