Patient Characteristics and Outcomes Associated with Sentinel Protection Device Use in Patients with Aortic Valve Disease Undergoing TAVR in a "Real-World" Setting.

Background: Transcatheter aortic valve replacement (TAVR) has become the dominant treatment for aortic valve disease. While TAVR safety has improved over time, concern remains over the occurrence of cerebrovascular accidents (CVA) secondary to device placement, which is associated with increased morbidity and mortality. The Sentinel Cerebral Protection System (CPS) was developed to reduce the risk of embolic strokes associated with debris produced during TAVR. Studies evaluating Sentinel CPS efficacy have produced conflicting results, and there is little understanding of which patients are selected for device placement in "real-world" settings. With no existing guidelines on device use, the purpose of this study was to describe and compare the characteristics of patients who receive CPS with those who do not in a "real-world" setting of consecutive TAVR patients and evaluate its impact on postoperative complications, namely stroke. Methods: This was a single-center, retrospective study of all patients undergoing TAVR between July 1, 2019, and December 31, 2020. Patient demographics, baseline, and perioperative characteristics were collected prospectively using the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry and our institution's TAVR database for analysis. Postoperative outcomes were assessed using primary endpoints of in-hospital/30-day stroke and the composite of death, stroke, and bleeding/vascular events at one-year. To adjust for baseline differences, a propensity score was developed including all factors that were different between groups, and Multivariate Cox Regression analysis was used to control for these differences. Patient follow-up was 97% complete at 12 months with 100% echocardiographic follow-up. Results: A total of 242 consecutive patients (57.9% male) were analyzed, with a mean age of 79.9 ± 9 years. Of these patients, 134 (55.4%) received the Sentinel CPS and 108 (44.6%) did not. Sentinel CPS patients were more likely to be male, not on dialysis, without prior CVA or pacemaker, had less severe chronic lung disease, and were lower operative risk compared to concurrent non-CPS patients. CPS patients were also found to have higher hemoglobin and albumin levels, lower creatinine, and were less likely to be on immunosuppressant therapy. The incidence of in-hospital/30-day stroke after TAVR did not differ between CPS and non-CPS patients (0.0% vs. 1.9%; p = 0.198). Unadjusted analyses at one-year showed a lower occurrence of the composite endpoint in CPS patients compared non-CPS patients (8.3% vs. 17.0%; p = 0.034). After adjustment, the hazard ratio (Adj HR) for the CPS group was no longer significantly associated with a lower composite endpoint (Adj HR = 0.609, 95% CI 0.244-1.523; p = 0.289). Both unadjusted (p = 0.233) and adjusted (p = 0.132) analyses showed no difference in the incidence of stroke at one-year. Conclusions: Our study demonstrates that in a "real-world" setting, the Sentinel CPS device is more likely to be used in healthier and less complex patients. In analyses adjusted for illness severity and patient complexity, CPS use did not have a significant effect on the incidence of in-hospital/30-day stroke or the composite endpoint of death, stroke, and bleeding/vascular events at one-year.

Using Ping-pong technique along with rapid inflate-deflate ballooning to solve total left main occlusion during transcatheter aortic valve replacement procedure.

Coronary obstruction during transcatheter aortic valve replacement (TAVR) poses a significant threat, prompting a closer examination of prevention and bailout strategies. Following TAVR deployment with a coronary artery obstruction complication and recognizing the complexities involved in engaging the left main coronary artery through TAVR cells. This case introduces the "Ping-pong" technique using a second guide catheter. When faced with difficulty in engaging the catheter through TAVR cells, an innovative solution is proposed. Inserting a wire into the valsalva and utilizing a rapid inflate-deflate balloon maneuver successfully facilitates catheter access into the left main, offering a promising intervention for challenging scenarios. In conclusion, this study emphasizes the severe implications of coronary obstruction during TAVR. The innovative "Ping-pong" technique and rapid inflate-deflate balloons emerge as valuable interventions, showcasing their potential in challenging catheter engagement scenarios. These insights offer a promising avenue for enhancing patient outcomes in TAVR procedures.

Atrial electrical remodeling and function after transcatheter aortic valve replacement in patients with aortic stenosis.

To examine reverse atrial electrical remodeling in patients with aortic stenosis (AS) after trans-catheter aortic valve replacement (TAVR). In 65 consecutive patients with severe AS (83 ± 4 years, 47 (72.3%) females), we analyzed ECG records for the P wave duration (PWD) in lead II and P-terminal force (PTFV1) in V1, and measured cardiac dimensions and function by echocardiography (ECHO) following TAVR. Biomarkers were measured to assess myocardial injury by TAVR. TAVR was successfully performed without major complications: the aortic valve area increased from 0.62 ± 0.14 cm2 to 1.52 ± 0.24cm2, and the trans-aortic pressure gradient decreased from 58.4 ± 15.9 mmHg to 15.0 ± 19.6 mmHg. PWD and PTFV increased immediately after TAVR and returned to the pre-TAVR levels on the next day. Then, the PWD declined toward 6 months after TAVR non-significantly in all patients, but significantly in 25 patients with baseline PWD ≥ 130 ms (P = 0.039). PTFV1 showed no long-term change. Improvement was observed in the ejection fraction, all thickness of the left ventricle and in the left atrial dimensions on ECHO. After recovery from transient aggravation by TAVR procedure, PWD reversed slowly, and the change was significant in those with baseline PWD ≥ 130 ms while change in PTFV1 was not significant at 6 months of follow-up. ECHO showed a reversal of remodeling in the left ventricle and in the left atrial dimension after TAVR.

30-Day Outcomes With the Portico Transcatheter Heart Valve: Insights From a Multi-Centre Australian Observational Study.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is an established therapy for the treatment of aortic valve disease in appropriately selected patients. Previous studies using the self-expanding Portico transcatheter heart valve (THV), (Abbott Structural Heart, St Paul, MN, USA) have demonstrated the technical feasibility of this system albeit in the hands of relatively inexperienced Portico users. The objective of this study was to assess the real-world safety and efficacy of the Portico THV (with and without the FlexNav delivery system, Abbott Structural Heart) at the 30-day timepoint in an Australian cohort. METHODS AND RESULTS: This study was a retrospective real-world cohort analysis of 269 consecutive patients with severe aortic valve disease who underwent TAVI at multiple centres within Australia between February 2015 and April 2021. Of the 269 patients, 51.7% were female, mean Society of Thoracic Surgeons (STS) score was 5.2 (±6.8) and 98.5% had successful implantations. Thirty (30)-day post-implantation all-cause mortality was observed in one (0.4%) patient, major vascular complications in two (0.7%) patients, more-than-mild paravalvular leak in six (2.2%) patients and requirement for new permanent pacemaker implantation in 27 (10.2%) patients. Haemodynamic parameters at 30 days included mean effective orifice area (EOA) of 2.3 (±0.9) cm2 and mean aortic valve gradient (AVG) of 9.6 (±6.2) mmHg. CONCLUSION: This analysis of the Portico THV in a real-world setting suggested that the system is associated with satisfactory safety and efficacy parameters. Previously published datasets may not have found similar findings owing to lower operator experience with the Portico THV system.

Rationale and design of the SMall Annuli Randomized To Evolut or SAPIEN Trial (SMART Trial).

BACKGROUND: The SMall Annuli Randomized To Evolut or SAPIEN (SMART) Trial was designed to compare the performance of the two most widely available commercial transcatheter aortic valve replacement (TAVR) devices in patients with symptomatic severe native aortic stenosis with a small aortic valve annulus undergoing transfemoral TAVR. Patients with small aortic valve annuli are typically female and are often underrepresented in clinical trials. METHODS: The SMART Trial is an international, prospective, multi-center, randomized controlled, post-market trial. The trial will be conducted in approximately 700 subjects at approximately 90 sites globally. Inclusion criteria include severe aortic stenosis, aortic valve annulus area of ≤430 mm2 based on multi-detector computed tomography, and appropriate anatomy for both the Medtronic Evolut PRO/PRO+ self-expanding and Edwards SAPIEN 3/3 Ultra balloon-expandable devices. The primary clinical outcome composite endpoint is defined as mortality, disabling stroke or heart failure rehospitalization at 12 months. The co-primary valve function composite endpoint is defined as bioprosthetic valve dysfunction at 12 months which includes hemodynamic structural valve dysfunction, defined as a mean gradient ≥20 mmHg, non-structural valve dysfunction, defined as severe prothesis-patient mismatch or ≥moderate aortic regurgitation, thrombosis, endocarditis, and aortic valve re-intervention. Powered secondary endpoints will be assessed hierarchically. CONCLUSIONS: The SMART trial will be the largest head-to-head comparative trial of transfemoral TAVR using the two most widely available contemporary TAVR devices in the setting of small aortic annuli and the largest trial to enroll primarily women. CLINICAL TRIAL REGISTRATION: URL: www.clinicaltrials.gov, Unique identifier: NCT04722250.

A systematic review and meta-analysis of non-vitamin K antagonist oral anticoagulants vs vitamin K antagonists after transcatheter aortic valve replacement in patients with atrial fibrillation.

PURPOSE: Transcatheter aortic valve replacement (TAVR) is increasingly carried out in patients with aortic valvular conditions. Atrial fibrillation (AF) is a common comorbidity among patients undergoing TAVR. Despite this, there remains a paucity of data and established guidelines regarding anticoagulation use post-TAVR in patients with AF. METHODS: Four databases were searched from inception until 12 October 2021. A title and abstract sieve, full-text review and data extraction were conducted by independent authors, and articles including patients without AF were excluded. The Review Manager (Version 5.4) was utilised in data analysis. RESULTS: A total of 25,199 post-TAVR patients with AF were included from seven articles, with 9764 patients on non-vitamin K antagonist oral anticoagulants (NOAC) and 15,435 patients on vitamin K antagonists (VKA). In this analysis, there was a significantly lower risk of all-cause mortality at 1 year (RR: 0.75, CI: 0.58-0.97, p = 0.04, I2 = 56%), and bleeding at 1 year (RR: 0.73, CI: 0.68-0.79, p = < 0.00001, I2 = 0%), between patients on NOAC and VKA. There were no detectable differences between patients on NOAC and VKA for all-cause mortality at 2 years, stroke within 30 days, stroke within 1 year, ischaemic stroke at 1 year and life-threatening bleeding at 30 days. CONCLUSION: While the results of this analysis reveal NOAC as a potential alternate treatment modality to VKA in post-TAVR patients with AF, further research is needed to determine the full safety and efficacy profile of NOAC (PROSPERO: CRD42021283548).

Preprocedural and procedural variables that predict new-onset conduction disturbances after transcatheter aortic valve replacement.

BACKGROUND: Conduction disturbances are a common complication after transcatheter aortic valve replacement (TAVR). The aim of this study was to investigate the preprocedural and procedural variables that predict new-onset conduction disturbances post-TAVR (hereafter CD/CDs). METHODS: Consecutive patients who underwent TAVR during December 2009-March 2021 at the Faculty of Medicine Siriraj Hospital, Mahidol University-Thailand's largest national tertiary referral center-were enrolled. Patients with prior implantation of a cardiac device, periprocedural death, or unsuccessful procedure were excluded. Clinical and electrocardiographic data, preprocedural imaging, including membranous septum (MS) length, and procedural variables, including implantation depth (ID), were analyzed. CD was defined as new left or right bundle branch block, significant intraventricular conduction disturbance with QRS interval ≥ 120 ms, new high-grade atrioventricular block, or complete heart block. Multivariate binary logistic analysis and receiver operating characteristic (ROC) curve analysis were used to identify independent predictors and the optimal ∆MSID (difference between the MS length and ID) cutoff value, respectively. RESULTS: A total of 124 TAVR patients (mean age: 84.3 ± 6.3 years, 62.1% female) were included. The mean Society of Thoracic Surgeons score was 7.3%, and 85% of patients received a balloon expandable transcatheter heart valve. Thirty-five patients (28.2%) experienced a CD, and one-third of those required pacemaker implantation. The significant preprocedural and procedural factors identified from univariate analysis included intraventricular conduction delay, mitral annular calcification, MS length ≤ 6.43 mm, self-expanding device, small left ventricular cavity, and ID ≥ 6 mm. Multivariate analysis revealed MS length ≤ 6.43 mm (adjusted odds ratio [aOR] 9.54; 95% CI 2.56-35.47; p = 0.001) and ∆MSID < 0 mm (adjusted odds ratio [aOR] 10.77; 95% CI 2.86-40.62; p = < 0.001) to be independent predictors of CD. The optimal ∆MSID cutoff value for predicting conduction disturbances was less than 0 mm (area under the receiver operating characteristic curve [AuROC]: 0.896). CONCLUSION: This study identified MS length ≤ 6.43 mm and ∆MSID < 0 mm as independent predictors of CDs. ∆MSID < 0 was the strongest and only modifiable predictor. Importantly, we expanded the CD criteria to cover all spectrum of TAVR-related conduction injury to lower the threshold of this sole modifiable risk. The optimal ∆MSID cutoff value was < 0 mm. TRIAL REGISTRATION: TCTR, TCTR20210818002. Registered 17 August 2021-Retrospectively registered, http://www.thaiclinicaltrials.org/show/TCTR 20210818002.

Update on Minimalist TAVR Care Pathways: Approaches to Care in 2022.

PURPOSE OF REVIEW: This review summarizes current data supporting a minimalist TAVR approach and identifies the need for additional study to optimize TAVR care. The authors discuss future directions of the TAVR landscape and how this necessitates evolution of minimalist care pathways. RECENT FINDINGS: Transcatheter aortic valve replacement (TAVR) has become a mainstay in the treatment of aortic stenosis since the initial procedure in 2002. Recently, attention has shifted to TAVR optimization and the minimalist approach with a focus on minimizing procedural sedation, protocolization of perioperative management, and prioritization on early discharge. This approach has been shown to be safe and reduce procedure time, length of stay, and overall cost for hospital systems. The minimalist care pathway avoids general anesthesia, shortens procedure time and length of stay, and reduces cost without changing mortality or readmission rates at 30 days. A variety of protocols have been proposed without a clear consensus on specific components or patient eligibility. There is a continued need for data regarding patient risk stratification, valve selection, and discharge strategy as TAVR becomes increasingly common.

Emergency bailout surgery saves lives in high-risk patients with complications after TAVR.

INTRODUCTION: With the expansion of the indication for transcatheter aortic valve implantation (TAVR), the value of access to on-site emergency heart surgery at performing centers needs to be assessed. AIMS: To evaluate postoperative mortality after surgical rescue post-TAVR, in a population at high surgical risk. METHODS: Retrospective analysis of a cohort of patients included in the France-TAVI registry who had undergone TAVR with the latest generation valves between January 2017 and February 2020. RESULTS: Among the 968 patients undergoing TAVR, 6 patients (0.62%) were identified as candidates for surgery: 3 in the peri-operative context and 3 during hospitalization. Four subjects were managed in a salvage situation, two due to tamponade, one due to aortic dissection, and one due to aortic annulus rupture. One patient died of a delayed aortic annulus rupture and one patient presented a right coronary occlusion which was medically treated. All patients who underwent emergency surgery were discharged alive from the hospital. CONCLUSIONS: In TAVR patients initially contraindicated for surgery, emergency bailout surgery could be performed successfully with all patients discharged alive. Access to on-site heart surgery represents a life-saving resource for TAVR centers.

Transcatheter heart valve selection in patients with low ejection fraction and aortic stenosis.

OBJECTIVE: The aim of this study was to compare outcomes of transcatheter heart valve (THV) choice in patients with left ventricular (LV) systolic dysfunction. BACKGROUND: The management congestive heart failure with combined LV systolic dysfunction and severe aortic stenosis (AS) is challenging, yet transcatheter aortic valve replacement (TAVR) has emerged as a suitable treatment option in such patients. Head-to-head comparisons among the balloon-expandable (BEV) and self-expandable (SEV) THV remain limited in this subgroup of patients. METHODS: In this retrospective study, we included patients with severe AS with LV systolic dysfunction (LVEF ≤40%) who underwent TAVR at four high volume centers. Two thousand and twenty-eight consecutive patients were analyzed, of which 335 patients met inclusion criteria. One hundred fourty-six patients (43%) received a SEV, and 189 patients (57%) received a BEV. RESULTS: Baseline characteristics were similar except for a higher proportion of females in the SEV group. The primary composite endpoint of in-hospital mortality, moderate or greater paravalvular (PVL), stroke, conversion to open surgery, aortic valve reintervention, and/or need for permanent pacemaker (PPM) was no different among THV choice. There was more PVL in the SEV group, but higher transaortic gradients in the BEV group. Clinical outcomes and quality of life measures were similar up to 1 year follow-up. CONCLUSION: The choice of THV in patients with severe AS and systolic dysfunction must be weighed on a case-by-case basis.

Combination Use of Inoue-Balloon and Self-Expandable Transcatheter Valves in Managing Aortic Stenosis Not Amenable to Balloon-Expandable Valves.

Data on the combined use of aortic Inoue-Balloon catheter and self-expandable transcatheter valve for patients undergoing transcatheter aortic valve replacement (TAVR) are lacking. This study aimed to assess the feasibility and safety of this combination, particularly in patients who cannot be safely managed with balloon-expandable valves.Between 2018 and 2021, 140 consecutive patients who had Inoue-Balloon catheters with self-expandable valves were retrospectively examined. Self-expandable transcatheter valves were deployed using the heart team approach in patients with calcification on the left ventricular outflow tract, which could not be safely addressed with the current-generation balloon-expandable valves.The 20- and 22 mm Inoue-Balloon catheters were used with the 26- and 29 mm Evolut valves, respectively. According to the Valve Academic Research Consortium-2 criteria, the procedural success rate was 95.0%, with an early safety at 30 days rate of 6.5%. A total of 27 patients required post-dilation with the same Inoue-Balloon catheter used for pre-dilation after adjustment to appropriate sizes. Post-dilation, with balloon size adjusted to be 1.4 ± 0.9 mm larger than that in pre-dilation, was effective in 19 out of 27 patients (70.3%) for decreasing paravalvular leak after transcatheter valve deployment. The procedural complication rates between patients with and without post-dilation were not different.The combined use of the size-adjustable Inoue-Balloon catheter and self-expandable valve is safe, particularly in patients who cannot be safely managed with balloon-expandable valves. However, further studies are warranted to elucidate concerns regarding the durability of self-expandable transcatheter valves after post-dilation using the Inoue-Balloon catheter.

Rare Cause of Severe Mitral Regurgitation after TAVI: Case Report and Literature Review.

Pre-procedure mitral regurgitation (MR) is a frequent coexistent finding in patients undergoing transcatheter aortic valve replacement (TAVR), and most of them (up to 55%) experience a significant improvement in MR after the procedure. Although seldom described, mitral valve perforation after TAVR is a potentially serious complication that physicians should be aware of, as moderate or severe MR in TAVR recipients is associated with a high early mortality rate. We herein describe the case of a 65-year-old man presenting with worsening heart failure symptoms 5 months after TAVR due to an intraprocedural anterior mitral leaflet perforation and discuss the diagnostic process and therapeutic course of the case. Furthermore, we draw attention to the essential role of echocardiography in the management of TAVR procedures, taking into account its ability in detecting early complications, and emphasize the value of CT as a main determinant to predict long-term MR improvement after TAVR and to assess the potential candidates for double valve repair with percutaneous techniques.

Transcatheter Aortic Valve Replacement vs. Surgical Aortic Valve Replacement for Long-Term Mortality Due to Stroke and Myocardial Infarction: A Meta-Analysis during the COVID-19 Pandemic.

Background and objectives: One of the leading causes of mortality and morbidity in people over the age of 50 is stroke. The acceptance of transcatheter aortic valve replacement (TAVR) as a treatment option for severe symptomatic aortic stenosis (AS) has increased as a result of numerous randomized clinical trials comparing surgical aortic valve replacement (SAVR) and TAVR in high- and intermediate-risk patients, showing comparable clinical outcomes and valve hemodynamics. Materials and Methods: An electronic search of Medline, Google Scholar and Cochrane Central was carried out from their inception to 28 September 2022 without any language restrictions. Results: Our meta-analysis demonstrated that, as compared with SAVR, TAVR was not linked with a lower stroke ratio or stroke mortality. It is clear from this that the SAVR intervention techniques applied in the six studies were successful in reducing cardiogenic consequences over time. Conclusions: A significantly decreased rate of mortality from cardiogenic causes was associated with SAVR. Additionally, when TAVR and SAVR were compared for stroke mortality, the results were nonsignificant with a p value of 0.57, indicating that none of these procedures could decrease stroke-related mortality.

Annular and supra-annular structure assessments for transcatheter aortic valve replacement in patients with bicuspid aortic stenosis.

The clinical use indications for transcatheter aortic valve replacement (TAVR) for the treatment of severe symptomatic aortic stenosis (AS) have expanded from patients at high surgical risk to those at low risk based on the results of multiple large-scale randomized trials. However, patients with bicuspid AS have traditionally been excluded from clinical trials due to their unfavorable morphological characteristics. Bicuspid aortic valve (BAV) is the most frequent congenital heart disease, occurring in 1% to 2% of the total population and affects more than 20% of octogenarians undergoing isolated aortic valve replacement for AS. In recent years, TAVR in patients with bicuspid AS has been the focus of research, especially with respect to the standard of prosthesis size selection. Annulus-based prosthesis size selection using computed tomography (CT) is the standard sizing strategy for tricuspid AS, but no standard sizing for bicuspid AS has been developed thus far. According to Western TAVR experiences, transcatheter heart valve (THV) size selection for BAV patients should be based on the annular structure assessment by CT measurement, whereas Chinese experiences favor adopting the supra-annulus structure assessment for THV size selection. This article will review annular and supra-annular sizing for prosthesis size selection in patients with bicuspid AS before TAVR and discuss which has more favorable clinical outcomes.

Computed tomography analysis of coronary ostia location following valve-in-valve transcatheter aortic valve replacement with the ACURATE neo valve: Implications for coronary access.

BACKGROUND: Valve-in-valve transcatheter aortic valve replacement (ViV-TAVR) is an emerging alternative to re-do surgery. However, the challenge of coronary access (CA) following ViV-TAVR is a potential limitation as TAVR expands to younger lower-risk populations. OBJECTIVES: Using post-implantation computed tomography (CT) scans to evaluate the geometrical relationship between coronary ostia and valve frame in patients undergoing ViV-TAVR with the ACURATE neo valve. METHODS: Post-implant CT scans of 18 out of 20 consecutive patients treated with the ACURATE neo valve were analyzed. Coronary ostia location in relation to the highest plane (HP) (highest point of the ACURATE neo or surgical valve) was determined. Ostia located below the highest plan were further subclassified according to the gap available between the transcatheter heart valve frame and ostium (transcatheter-to-coronary [TTC] distance). The impact implantation depth has on these geometrical relationships was evaluated. RESULTS: A total of 21 out of 36 coronary ostia (58%) were located below the level of the HP with the left coronary artery (36%) more likely to be affected than the right (22%). Further sub-classification of these ostia revealed a large (>6 mm), moderate (4-6 mm), and small (<4 mm) TTC distance in 57% (12/21), 38% (8/21), and in 6% (1/18) of cases, respectively. At an implantation depth <4 mm compared to >4 mm, all ostia were located below the HP with no difference in post-procedural mean gradients (14.5 mmHg ± 4.7 vs. 12.6 mmHg ± 5.8; p = .5, 95%CI 3.8-7.5). CONCLUSIONS: CA following ACURATE neo implantation for ViV-TAVR could potentially be challenging in a significant proportion of patients and specific consideration should be given to the implantation depth.

Hemodynamic comparison of transcatheter aortic valve replacement with the SAPIEN 3 Ultra versus SAPIEN 3: The HomoSAPIEN registry.

OBJECTIVES: The study aims to compare the hemodynamic and clinical outcomes of the SAPIEN 3 Ultra (S3-Ultra) with the SAPIEN 3 (S3) system in patients who underwent transfemoral transcatheter aortic valve replacement (TF-TAVR). BACKGROUND: The new balloon-expandable S3-Ultra system incorporates new features to reduce paravalvular leakage (PVL). However, the data after the S3-Ultra implantation is very limited. METHODS: A total of 282 consecutive patients who underwent TF-TAVR with the S3-Ultra and the S3 were evaluated. The primary outcome of this study was to compare the incidence of ≥mild PVL after the S3-Ultra and S3 implantation. RESULTS: Between June 2017 and November 2019, 141 patients with the S3-Ultra and 141 patients with the S3 were identified with similar baseline and preprocedural imaging characteristics (mean age: 79.6 ± 6.7 years and mean aortic annulus area: 492.5 ± 91.2 mm2 ). In total, 83 patients (29.4%) were treated with 29-mm valve. Predischarge echocardiography demonstrated a significantly lower incidence of ≥mild PVL (the total cohort: 7.2 vs. 22.3%, p < .001, and the cohort excluding 29-mm valve: 4.0 vs. 21.4%, p = .03) for the S3-Ultra. The S3-Ultra system, especially 20-, 23-, and 26-mm valve, was associated with significantly lower risk of ≥mild PVL compared with the S3 system in multivariate analysis. There were no significant differences in clinical outcomes at 30-day between these groups, except for the lower incidence of major vascular complication (4.5 vs. 11.4%, p = .05) in patients with the S3-Ultra. CONCLUSIONS: In this registry, the S3-Ultra system performed superiorly to the S3, as demonstrated by reduced ≥mild PVL, with comparable safety.

Transcatheter aortic valve replacement in aortic regurgitation: The U.S. experience.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) can be an effective option for high-risk Aortic Regurgitation (AR) patients. Although international experiences of TAVR for AR are published, U.S. data are limited. This study sought to report the short-term outcomes of TAVR in AR in the U.S. METHODS: Study cohorts were derived from the Nationwide Inpatient Sample (NIS) and Nationwide Readmissions Database (NRD) 2016-17. TAVR and AR were identified using ICD-10-CM-codes. The key outcomes were all-cause mortality, disabling stroke, valvular complications, complete heart block (CHB)/permanent pacemaker placement (PPM), open-heart surgery, acute kidney injury (AKI) requiring dialysis, and vascular complications. Multivariate logistic regression was used to adjust for confounders. RESULTS: 915 patients from the NIS (male-71%, age ≥65-84.2%) and 822 patients from the NRD (male-69.3%, age ≥65-80.5%) underwent TAVR for AR. The median length of stay (LOS) was 4 days for both cohorts. In-hospital mortality was 2.7%, and 30-day mortality was 3.3%. Disabling strokes were noted in 0.6% peri-procedurally and 1.8% at 30-days. Valve-related complications were 18-19% with paravalvular leak (4-7%) being the most common. Approximately 11% of patients developed CHB and/or needed PPM in both cohorts. In NRD, 2.2% of patients required dialysis for AKI, 1.5% developed vascular complications, and 0.6% required open-heart surgery within 30-days post-procedure. Anemia was predictive of increased overall complications and valvular complications, whereas peripheral vascular disease was a predictor of increased valvular complications and CHB/PPM. CONCLUSION: TAVR is a promising option in AR. Further studies are necessary for the expansion of TAVR as the standard treatment in AR.

Cardiac structural changes after transcatheter aortic valve replacement: systematic review and meta-analysis of cardiovascular magnetic resonance studies.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is increasingly used to treat patients with severe aortic stenosis (AS). Cardiovascular magnetic resonance imaging (CMR) provides reliable and reproducible estimates for assessment of cardiac structure and function after TAVR. The goal of this study was to conduct a systematic review and meta-analysis of the literature to assess left ventricular (LV) volumes, mass and function by CMR after TAVR. METHODS: Using Meta-analysis of Observational Studies in Epidemiology (MOOSE) guidelines, we searched PubMed and Embase for studies reporting CMR findings before and at least 1 month after TAVR. Main factors of interest were LV end-diastolic volume index (LVEDVi), LV end-systolic volume index (LVESVi), LV mass index (LVMi), and left ventricular ejection fraction (LVEF). Standardized mean differences (SMD) were pooled by random effects meta-analytic techniques. RESULTS: Of 453 screened publications, 10 studies (published between 2012 and 2018) were included. A total of 305 patients completed pre- and post-TAVR follow-up CMR (mean age range 78.6-85.0 years, follow-up range 6-15 months). Random effects analysis showed TAVR resulted in reduced LVEDVi (SMD: -0.25, 95% CI: - 0.43 to - 0.07, P = 0.006), LVESVi (SMD: -0.24, 95% CI: - 0.44 to - 0.05, P = 0.01), LVMi (SMD: -0.82, 95% CI: - 1.0 to - 0.63, P < 0.001) and increased LVEF (SMD: 22, 95% CI: 6 to 38%, P = 0.006). Heterogeneity across studies was low (I2: 0%, Pheterogeneity > 0.05 for all). The median reduction was 4 ml/m2 (IQR: 3.1 to 8.2) for LVEDVi, 5 ml/m2 (IQR: 3.0 to 6.0) for LVESVi, and 15.1 g/m2 (IQR: 11.8 to 18.3) for LVMi. The median increase for LVEF was 3.4% (IQR 1.0 to 4.6%). CONCLUSIONS: CMR demonstrates reverse LV remodeling occurrs within 6-15 months after TAVR, with reductions in LVEDVi, LVESVi and LVMi, and increased LVEF.

Paravalvular Leak Assessment: Challenges in Assessing Severity and Interventional Approaches.

PURPOSE OF REVIEW: With increasing use of prosthetic valves to treat degenerative valvular heart disease (VHD) in an aging population, the incidence and adverse consequences of paravalvular leaks (PVL) are better recognized. The present work aims to provide a cohesive review of the available literature in order to better guide the evaluation and management of PVL. RECENT FINDINGS: Despite gains in operator experience and design innovation, significant PVL remains a significant complication that may present with congestive heart failure and/or hemolytic anemia. To date, clear consensus or guidelines on the evaluation and management of PVL remain lacking. Although the evolution of transcatheter valve therapies has had a tremendous impact on the management of patients with VHD, the limitations and complications of such techniques, including PVL, present further challenges. Incidence of PVL, graded as moderate or greater, ranges from 4 to 7.4% in surgical and transcatheter valve replacements, respectively. Improved imaging modalities and the advent of novel surgical and percutaneous therapies have undoubtedly yielded a better understanding of PVL including its anatomical location, mechanism, severity, and treatment options. Echocardiography, used in conjunction with cardiac computed tomography and cardiac magnetic resonance, provides essential details for diagnosis and management of PVL. Transcatheter intervention has become a favored approach in lieu of surgical intervention in select patients after previous surgical or percutaneous valve replacement. PVL treatment with vascular plugs, balloon post-dilation, and the valve-in-valve methods have shown technical success with promising clinical outcomes in appropriately selected patients.

Different dynamics of new-onset electrocardiographic changes after balloon- and self-expandable transcatheter aortic valve replacement: Implications for prolonged heart rhythm monitoring.

BACKGROUND: New onset electrocardiographic (ECG) changes after transcatheter aortic valve replacement (TAVR) are used to assess the risk for late atrioventricular block. However, the time of ECG evaluation remains controversial. We aimed to compare the time course and dynamics of new onset ECG changes according to valve design in balloon- (BEV) and self-expandable (SEV) TAVR. METHODS AND RESULTS: This single center study enrolled 133 consecutive TAVR patients (28.6% SEV, 71.4% BEV). Patients with pre-existent permanent pacemaker implant (PPMI), procedural death or incomplete ECG registration were excluded. Standard 12­lead ECG was performed before the procedure, at 1, 24, 48 and 120 h and 1 month. In BEV patients, no significant PR prolongation occurred, whereas in SEV patients the PR interval prolonged significantly with 33.7 ± 22.0 ms (p < 0.001, compared to pre-TAVR) but only after 48 h after TAVR. Widening of QRS duration was comparable among both BEV and SEV patients (6.7 ± 21.5 versus 17.0 ± 26.9 ms, p = 0.061) and occurred immediately after TAVR. New-onset left bundle branch block was seen in 18.5% of BEV and 30.8% of SEV patients (p = 0.120) and occurred within 24 h after TAVR in both groups. Late PPMI (>24 h after TAVR) was higher in SEV compared to BEV patients (15.3% versus 1.5%, p = 0.008). CONCLUSION: Self-expandable valves cause more impairment in atrioventricular conduction with a delayed time course compared to balloon expandable valves. This might explain the higher pacemaker need beyond 24 h after TAVR. Our findings suggest that patients with self-expandable valves require at least 48 h ECG monitoring post TAVR.