Transcatheter Aortic Valve Replacement Cohort Research Articles

Impact of cerebral protection on observed versus predicted in-hospital stroke in a high stroke risk TAVR cohort

BackgroundDespite impressive improvements in the safety profile of Transcatheter aortic valve replacement (TAVR), the risk for peri-procedural stroke after TAVR has not declined substantially. In an effort to reduce periprocedural stroke, cerebral embolic protection (CEP) devices have been utilized but have yet to demonstrate benefit in all-comers. There is a paucity of data supporting the utilization of CEP in TAVR patients with an anticipated high risk for peri-procedural stroke.MethodsThe Transcatheter Aortic Valve Replacement In-Hospital Stroke (TASK) score is a clinical risk tool for predicting the in-hospital stroke risk of patients undergoing transfemoral TAVR. This score was used to identify high-risk patients and calculate the expected in-hospital stroke risk. This was a single-centre cohort study in all consecutive TAVR patients who had placement of CEP. The observed versus expected ratio for peri-procedural stroke was calculated. To obtain 95% credible intervals, we used 1000 bootstrapped samples of the original cohort sample size without replacement and recalculated the TASK predicted scores.ResultsThe study included 103 patients. The median age was 83 (IQR 78,89). 63 were male (61.1%) and 45 (43.69%) had a history of previous Stroke or TIA. Two patients had an in-hospital stroke after TAVR (1.94%). The expected risk of in-hospital stroke based on the TASK score was 3.39% (95% CI 3.07–3.73). The observed versus expected ratio was 0.57 (95% CI 0.52–0.64).ConclusionIn this single-center study, we found that in patients undergoing TAVR with high stroke risk, CEP reduced the in-hospital stroke risk by 43% when compared with the risk-score predicted rate.Clinical trial numberN/A.

Transcatheter Versus Surgical Aortic Valve Replacement in Recipients of Solid Organ Transplants and Liver Cirrhosis: A Propensity-Matched Analysis of National Readmission Data

Transcatheter aortic valve replacement (TAVR) continues to grow in the United States. There are limited data on recipients of solid organ transplant (SOT) and patients with liver cirrhosis who undergo aortic valve replacement (AVR). Our study aims to evaluate outcomes in these populations. Using the national readmission database (2016 to 2020), we identified recipients of SOT and patients with liver cirrhosis without previous liver transplants who were admitted for severe aortic stenosis and underwent either TAVR or surgical AVR (SAVR). We used multivariable regression for adjusted analysis and the propensity score matching model, implementing complete Mahalanobis distance matching within the Propensity Score Caliper (0.2) to match TAVR and SAVR cohorts for outcomes. Of 3,394 hospitalizations for AVR in recipients of SOT, 2,181 underwent TAVR, and 1,213 underwent SAVR. On propensity-matched analysis, SAVR was associated with more adverse events than was TAVR, including in-hospital mortality (5.2% vs 1.1%, adjusted odds ratio [aOR] 4.49, p <0.001), acute kidney injury (43.7% vs 10.2%, p <0.001), cardiogenic shock (9.0% vs 1.6%, p <0.001), sudden cardiac arrest (15.9 vs 6.0%, p <0.001), major adverse cardiac and cerebrovascular events (28% vs 10.4%, p <0.001), and net adverse events (72.8 vs 37.6%, p <0.001). A greater median length of stay (10 vs 2 days, p <0.001) and adjusted cost ($80,842 vs $57,014, p <0.001) were also observed. The readmission rates were the same for both cohorts after a 6-month follow-up. Similarly, in 14,763 hospitalizations for AVR in liver cirrhosis, 7,109 patients underwent TAVR, and 7,654 underwent SAVR. In propensity-matched cohorts (n = 2,341), SAVR was found to be associated with greater adverse events, including in-hospital mortality (19.8% vs 10%), stroke (6.7% vs 2%), acute kidney injury (67.7% vs 30.3%), cardiogenic shock (41.9% vs 19.9%), sudden cardiac arrest (31.8% vs 13.2%, aOR 2.89), major adverse cardiac and cerebrovascular events (66.2% vs 35.7%), and net adverse events (86% vs 59.5%) (p <0.001). A greater median length of stay (16 vs 3 days) and cost ($500,218 vs $263,383) were also observed (p <0.001). However, the rate of readmissions at 30-day (9% vs 11.1%) and 180-day intervals (33.4% vs 39.8%) was lower for the SAVR cohort (p <0.05). In recipients of SOT and patients with liver cirrhosis, SAVR is associated with greater short-term mortality, adverse events, and healthcare burden than is TAVR. TAVR is a relatively safer alternative to SAVR in these patient populations, although further studies are warranted to compare the long-term outcomes.

Clinical Outcomes of Transcatheter Aortic Valve Replacement (TAVR) vs Surgical Aortic Valve Replacement (SAVR) in Patients With Sarcoidosis.

Introduction Data regarding clinical outcomes after transcatheter aortic valve replacement (TAVR) vs surgical aortic valve replacement (SAVR) in patients with sarcoidosis is lacking. This study aims to clarify the clinical outcomes of TAVR vs SAVR in patients with sarcoidosis. Methods Data was collected from the National Inpatient Sample database from 2016-2019 using validated ICD-10-CM codes for sarcoidosis, TAVR, and SAVR. Patients were divided into two cohorts: those who underwent TAVR and those who underwent SAVR. Statistical analysis was performed using Pearson's chi-squared test to determine clinical outcomes of TAVR vs SAVR in patients with sarcoidosis. Results The prevalence of sarcoidosis was 0.23%among total study patients (n=142,420,378). After exclusions, the prevalence of TAVR was 650 (49%) and SAVR was 675 (51%) in patients with sarcoidosis. Patients who underwent TAVR were on average older (74 vs 65 years old, p=0.001), and more likely to be female (57 vs 40%, p<0.001) compared to patients who underwent SAVR. The TAVR cohort had higher rates of congestive heart failure (CHF) (77.7 vs 42.2%, p=0.001), chronic kidney disease (CKD) (42.3 vs 24.4% p=0.001), anemia (5.4 vs 2.2%, p=0.004), percutaneous coronary intervention (PCI) (1.5 vs 0%, p=0.004), and hypothyroidism (31.5 vs 16.3%, p=0.001) compared to the SAVR cohort. Inpatient mortality post-procedure was higher in the SAVR cohort compared to the TAVR cohort (15 vs 0, p=0.001). Regarding post-procedure complications, respiratory complications were more common in the SAVR cohort (4.4 vs 0%, p=0.001), while TAVR was associated with a higher incidence of permanent pacemaker (PPM) insertion (2.15 vs 0.8%, p=0.001). There was no statistical difference in the development of acute kidney injury (AKI) (0.8 vs 1.5%, p=0.33), AKI requiring hemodialysis (0 vs. 0.7%, p=0.08), or stroke (0.8 vs 0.7, p=1) post-procedure between the two cohorts. Conclusion This study found that in the sarcoidosis population, TAVR was associated with reduced mortality, shorter hospital length of stay, and lower hospitalization costs in comparison to SAVR.

National Trends and Outcomes of Acute Myocardial Infarction After Transcatheter Aortic Valve Replacement

BackgroundPrior studies have reported decreased use of an invasive approach for acute myocardial infarction (AMI) in patients undergoing transcatheter aortic valve replacement (TAVR). ObjectivesThe aim of this study was to determine whether prior TAVR affects the use of subsequent coronary revascularization and outcomes of AMI in a contemporary national data set. MethodsConsecutive TAVR patients from 2016 to 2022 were identified from the U.S. Vizient Clinical Data Base who were hospitalized after the index TAVR hospitalization with ST-segment elevation myocardial infarction (STEMI) or non–ST-segment elevation myocardial infarction (NSTEMI). Patients with STEMI or NSTEMI with or without prior TAVR from the same time period were compared for the use of coronary angiography, revascularization, and in-hospital outcomes. Propensity score matching was used to account for imbalances in patient characteristics. ResultsAmong 206,229 patients who underwent TAVR, the incidence of STEMI was 25 events per 100,000 person-years of follow-up, and that of NSTEMI was 229 events per 100,000 person-years. After propensity matching, the use of coronary revascularization was similar in the prior TAVR and no TAVR cohorts in both the STEMI (65.3% vs 63.9%; P = 0.81) and NSTEMI (41.4% vs 41.7%; P = 0.88) subgroups. Compared with patients without prior TAVR, in-hospital mortality was higher in the prior TAVR cohort in patients with STEMI (27.1% vs 16.7%; P = 0.03) and lower in those with NSTEMI (5.8% vs 8.2%; P = 0.02). ConclusionsIn this large, national retrospective study, AMI events after TAVR were infrequent. There were no differences in the use of coronary revascularization for STEMI or NSTEMI in TAVR patients compared with the non-TAVR population. In-hospital mortality for STEMI is higher in TAVR patients compared with those without prior TAVR.

Hemostatic Profiles of Patients Who Underwent Transcatheter Versus Surgical Aortic Valve Replacement Versus Percutaneous Coronary Intervention

Guidelines for transcatheter aortic valve replacement (TAVR) antithrombotic prophylaxis are extrapolated predominantly from percutaneous coronary intervention (PCI) data. Here, we examined temporal coagulation changes occurring in the early perioperative period to determine the pathobiologic validity of this supposition. This was a prospective observational study of consecutive patients who underwent transfemoral TAVR (n=27), PCI (n=12), or surgical aortic valve replacement (SAVR) requiring cardiopulmonary bypass and cross-clamping (n=12). Blood samples were taken at 4 time points: T1 (baseline), after general anesthesia or sedation; T2, after heparin administration; T3, at the end of the procedure; and T4, 6 hours after the procedure. The samples were assessed concurrently using standard laboratory coagulation tests and viscoelastic tests of whole blood clotting, including the latest generation thromboelastometry (ROTEM sigma) and thromboelastometry (TEG 6s). Patients in the TAVR cohort were older and a had lower baseline hemoglobin level than patients in the PCI and SAVR cohorts. The baseline platelet function was similar between the TAVR and PCI cohorts and impaired in the SAVR cohort Figure S1. The baseline hemostatic measures were comparable among cohorts. Regarding the per-patient change from baseline, the TAVR cohort showed an overall more prothrombotic state than the other cohorts, with the most marked differences from the SAVR cohort after intraoperative heparin administration and from the PCI cohorts 6hours after the procedure. In addition, the ROTEM and TEG parameters were well correlated but not interchangeable. In conclusion, patients who underwent TAVR have a more prothrombotic hemostatic profile than PCI and SAVR patients. These findings question the current guidelines that extrapolate antithrombotic regimens from PCI to TAVR settings.

In-Hospital and One-Year Outcomes of Transcatheter Aortic Valve Replacement in Patients Requiring Supplemental Home Oxygen Use.

There have been limited reports with inconsistent results on the impact of long-term use of oxygen therapry (LTOT) in patients treated with transcatheter aortic valve replacement (TAVR). We compared in-hospital and intermediate TAVR outcomes in 150 patients requiring LTOT (home O2 cohort) with 2,313 non-home O2 patients. Home O2 patients were younger, and had more comorbidities including chronic obstructive pulmonary disease (COPD), diabetes, carotid artery disease, lower forced expiratory volume (FEV1) (50.3±21.1% vs. 75.0±24.7%, P < 0.001), and lower diffusion capacity (DLCO, 48.6±19.2% vs. 74.6±22.4%, P < 0.001). These differences represented higher baseline Society of Thoracic Surgeons (STS) risk score (15.5±10.2% vs. 9.3±7.0%, P < 0.001) and lower pre-procedure Kansas City Cardiomyopathy Questionnaire (KCCQ-12) scores (32.5 ± 22.2 vs. 49.1 ± 25.4, P < 0.001). The home O2 cohort required higher use of alternative TAVR vascular access (24.0% vs. 12.8%, P = 0.002) and general anesthesia (51.3% vs. 36.0%, P < 0.001). Compared to non-home O2 patients, home O2 patients showed increased in-hospital mortality (5.3% vs. 1.6%, P = 0.001), procedural cardiac arrest (4.7% vs. 1.0%, P < 0.001), and postoperative atrial fibrillation (4.0% vs. 1.5%, P = 0.013). At 1-year follow-up, the home O2 cohort had a higher all-cause mortality (17.3% vs. 7.5%, P < 0.001) and lower KCCQ-12 scores (69.5 ± 23.8 vs. 82.1 ± 19.4, P < 0.001). Kaplan-Meir analysis revealed a lower survival rate in the home O2 cohort with an overall mean (95% confidence interval (CI)) survival time of 6.2 (5.9 - 6.5) years (P < 0.001). Home O2 patients represent a high-risk TAVR cohort with increased in-hospital morbidity and mortality, less improvement in 1-year KCCQ-12, and increased mortality at intermediate follow-up.

Mortality in patients with chronic obstructive pulmonary disorder undergoing transcatheter aortic valve replacement: The importance of chronic obstructive pulmonary disease exacerbation

Severe chronic obstructive pulmonary disease (COPD) has been associated with futile outcome after transcatheter aortic valve replacement (TAVR). Data on outcomes according to COPD severity are warranted to aid identification of patients who may not benefit from TAVR. We aimed to examine the association between risk of COPD exacerbation and 1-year mortality after TAVR. Using Danish nationwide registries we identified patients undergoing first-time TAVR during 2008-2021 by COPD status. COPD severity levels were defined as low or high risk of acute exacerbation of COPD (AE-COPD) and treatment intensity levels (none or short-term, mono/dual, triple therapy, or home oxygen). Kaplan-Meier functions and adjusted Cox regression models were used to assess 1-year mortality comparing COPD severity groups with patients without COPD. We identified 7,047 patients with TAVR of whom 644 had a history of COPD (low risk of AE-COPD: 439, high risk of AE-COPD: 205). The median age of the TAVR cohort was 81.4 years (IQR: 76.8-85.1) and 55.8% were males. One-year mortality for TAVR patients without COPD was 8.5% (95% CI: 7.8-9.2) and 15.4% (95% CI: 12.5-18.2) for those with COPD (adjusted HR: 1.63 [95% CI: 1.28-2.07]). Patients with low or high risk of AE-COPD had 1-year mortality of 13.1% (95% CI: 9.8-16.3) and 20.2% (95% CI: 14.6-25.8) corresponding to adjusted HRs of 1.31 (95% CI: 0.97-1.78) and 2.44 (95% CI: 1.70-3.50) compared with patients without COPD. Patients with high risk of AE-COPD and no/short term therapy or use of home oxygen represented the subgroups of patients with the highest 1-year mortality (31.6% [95% CI: 14.5-48.7] and 30.9% [95% CI: 10.3-51.6]). Among patients undergoing TAVR, increasing risk of exacerbation with COPD was associated with increasing 1-year mortality compared with non-COPD patients. Patients with a high risk of exacerbation with COPD not using any guideline recommended COPD medication and those using home oxygen had the highest 1-year mortality.

Real-World Comparison of Transcatheter Versus Surgical Aortic Valve Replacement in the Era of Current-Generation Devices.

Few studies have reported comparisons of out-of-hospital clinical outcomes after transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis (AS) in the era of current-generation valves that reflect the real-world situation. Data on patients with severe AS aged 65 years or older who underwent TAVR or SAVR between 2015 and 2018 were obtained from the National Health Insurance Service in Korea and clinical event rate was analyzed. The primary endpoint was all-cause death at 1 year. The cohort included a total of 4623 patients over 65 years of age, of whom 1269 (27.4%) were treated with TAVR. After 1:1 propensity score matching, 2120 patients were included in the study. TAVR was associated with reduced 1-year mortality (hazard ratio (HR): 0.55; 95% confidence interval (CI): 0.42-0.70; p &lt; 0.001). There was no difference between the groups in the incidence of ischemic stroke (HR: 0.72, 95% CI: 0.43-1.20; p = 0.21) and intracranial hemorrhage (HR: 1.10; p = 0.74). Permanent pacemaker insertion was observed more frequently in the TAVR cohort (9.4% vs. 2.5%, HR: 3.95, 95% CI: 2.57-6.09; p &lt; 0.001), whereas repeat procedures were rare in both treatments (0.5% vs. 0.3%, p = 0.499). In the nation-wide real-world data analysis, TAVR with current-generation devices showed significantly lower 1-year mortality compared to SAVR in severe AS patients.

Racial Disparity Among Patients Undergoing Surgical Aortic Valve Replacement and Transcatheter Aortic Valve Replacement in the United States.

Transcatheter aortic valve replacement (TAVR) has emerged as a minimally invasive alternative to surgical aortic valve replacement (SAVR). However, racial disparities in the utilization of TAVR persist. This meta-analysis attempts to determine whether the prevalence of adverse outcomes (procedure-related complications) represent barriers to the use of TAVR among African Americans (AA). The TAVR cohort consisted of 89.6% Caucasian (C) and 4.7% AA, while the SAVR cohort included 86.9% C and 6.4% AA. The utilization rate (UR) of TAVR was 1.48 and .35 among C and AA, respectively, while the UR of SAVR was 1.44 and .48 among C and AA, respectively. Following TAVR, for AA the odds ratio (OR) was greater for stroke (OR = 1.22, P = .02) and transient ischemic attack (TIA) (OR = 1.57, P < .001) and lower for undergoing the insertion of a permanent pacemaker (OR = .81, P < .001). While there was a significant difference between C and AA in TAVR and SAVR utilization, outcomes between groups following TAVR are comparable; therefore, adverse outcomes do not appear to be a barrier to the use of TAVR among eligible AA.

The influence of metabolic syndrome in heart valve intervention. A multi-centric study.

The effect of metabolic syndrome (MetS), defined as insulin resistance along with two or more of: obesity, atherogenic dyslipidaemia and elevated blood pressure, on postoperative complications after isolated heart valve intervention remains controversial. We hypothesized that MetS may negatively influence the postoperative course in these patients. Patients from 10 cardiac units who underwent isolated valve intervention (mitral tricuspid repair/replacement (mitral valve surgery [MVS]) or surgical aortic valve replacement (SAVR), or transcatheter aortic valve replacement (TAVR) were included. MetS was defined according to the World Health Organization criteria. Primary outcome was in-hospital mortality and overall postoperative length of stay (LOS). Relevant postoperative complications were also recorded. From 2010 to 2019, 17,283 patients underwent valve intervention. The MVS, SVAR, and TAVR accounted for the 39.4%, 48.2%, and 12.3% respectively of the whole. MetS compared to no-MetS was associated to higher mortality in the MVS group (6.5% vs. 2%, p < .001), but not in the SAVR and TAVR group. In both surgical cohorts, MetS was associated with increased complications including red blood cells transfusion, renal failure, mechanical ventilation time, intensive care and overall postoperative LOS (11 (9) vs. 10 (6), p < .001 and 10 (6) versus 10 (5) days, p = .002, MVS and [SAVR]). No differences were found in the TAVR cohort, with similar mortality and complications. MetS was associated to more postoperative complications, with higher mortality in the MVS group. In the TAVR cohort, postoperative complications and mortality rate did not differ between patients with and without MetS, however LOS was longer in the MetS group.

Abstract 14282: Outcomes Following Aortic Valve Replacement Among Kidney Transplant Recipients. A Systematic Review and Meta-Analysis

Introduction: While kidney transplant recipients (KTR) are high risk candidates for valve replacements, the safety of transcatheter aortic valve replacement (TAVR) is limited among this population as they are excluded from major trials. We aimed to compare the outcomes between TAVR and surgical aortic valve replacement (SAVR) among KTR by a systematic review and meta-analysis. Methods: We comprehensively searched PubMed, Embase, and Cochrane Library from its inception until April 20, 2022 for relevant studies. Outcomes were pooled using the DerSimonian and Laird random-effects model and reported as odd ratios (OR) or standardized mean difference (SMD) and 95% confidence intervals (CI). Results: 6 studies involving 5,452 patients (1,956 TAVR, 3,496 SAVR) were included in the analysis. TAVR patients were older (69.4 years vs 62.8 years), were less likely to be male (66.7% vs 67.9%) and had a higher prevalence of most comorbidities including coronary artery diseases (78% vs 58%), heart failure (71% vs 42%) and diabetes mellitus (52% vs 45%). Compared with SAVR, KTR undergoing TAVR had significantly lower risk of in-hospital all-cause mortality (OR 0.51, 95% CI: 0.39 to 0.67, p&lt;0.001), acute kidney injury (RR 0.49, 95% CI: 0.34 to 0.71, p&lt;0.001), blood transfusion (OR 0.29, 95% CI: 0.19 to 0.55, p&lt;0.001) and a shorter length of hospital stay (SMD -0.67, 95% CI: -1.10 to -0.24, p=0.002). In contrast, there was a higher need for permanent pacemaker implantation among the TAVR cohort compared to SAVR cohort (OR 3.44, 95% CI: 2.67-4.43, p&lt;0.001). Conclusions: TAVR appeared to be a safe alternative compared to SAVR in KTR, with a lower rate of short-term mortality, AKI and length of hospitalization but a higher rate of permanent pacemaker implantation. Further studies are encouraged to study the long-term outcomes among these patients.

Abstract 9809: Clinical Outcomes of Transcatheter Aortic Valve Replacement vs.surgical Aortic Valve Replacement in Patients With Durable Left Ventricular Assist Device

Introduction: Patients with left ventricular assist device (LVAD) often develop aortic insufficiency (AI) requiring an intervention on the aortic valve. We sought to analyze the outcomes of patients with a history of LVAD who underwent either transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). Methods: The Nationwide Readmission Database (NRD) was used to extract relevant patient information from January 1, 2016, to December 31, 2018. The NRD is a nationally representative sample of all-payer discharges from U.S. non-federal hospitals. The primary outcome of interest was in-hospital mortality. Secondary outcomes included length of stay, inpatient outcomes, costs, and 30-day all-cause readmissions. Complex samples multivariable logistic and linear regression models were used to determine the association of procedure type with outcomes. Results: Among 148 hospitalizations with a history of LVAD, 87 underwent TAVR, and 61 underwent SAVR. The inpatient mortality in SAVR group was numerically higher compared to the TAVR cohort, however, it did not reach statistical significance. The use of invasive mechanical ventilation, cardiogenic shock, bleeding, and vascular complications were higher in the SAVR cohort compared to the TAVR cohort. The mean length of stay (in days) and costs were higher in the SAVR cohort compared to the TAVR cohort. The 30-day all-cause readmission rate was numerically higher in the SAVR group, however, it was not statistically significant (Table 1). Conclusions: TAVR in patients with LVAD is a viable treatment option for AI and potentially leads to better inpatient mortality and inpatient outcomes compared to patients who undergo SAVR.

Monitored Anesthesia Care Versus General Anesthesia for Transcatheter Aortic Valve Replacement.

Monitored anesthesia care (MAC) has been increasingly used in lieu of general anesthesia (GA) for transcatheter aortic valve replacement (TAVR). We sought to compare outcomes and in-hospital costs between MAC and GA for TAVR at a Veterans Affairs Medical Center. A single-center retrospective review was performed of 349 patients who underwent transfemoral TAVR (MAC, n = 244 vs GA, n = 105) from January 2014 to December 2019. Baseline patient characteristics, operating room (OR) time, intensive care unit (ICU) length of stay (LOS), and cost, total LOS, hospital cost, total cost, and complication rates were collected. Propensity matching was performed and resulted in 83 matched pairs. In the unmatched TAVR cohort, MAC TAVR was associated with reduced OR time (146 vs 198 min, P < 0.001), ICU LOS (1.4 vs 1.8 days, P < 0.001), total hospital LOS (3.4 vs 5.4 days, P < 0.001), and lower index total cost ($81,300 vs $85,400, P = 0.010). After propensity matching, MAC TAVR patients had reduced OR time (146 vs 196 min, P < 0.05), ICU LOS (1.2 vs 1.7 days, P = 0.006), total LOS (3.5 vs 5.1 days, P = 0.001), and 180-day mortality (2.4% vs 12%, P < 0.03). There was no difference in total hospitalization cost or total cost. In propensity-matched groups, TAVR utilizing MAC is associated with improved OR time efficiency, decreased LOS, and a reduction in 180-day mortality but no significant difference in cost.

Incidence of Prosthesis-Patient Mismatch in Valve-in-Valve with a Supra-Annular Valve.

Transcatheter aortic valve replacement (TAVR) for a degenerated surgical bioprosthesis (valve-in-valve [ViV]) has become an established procedure. Elevated gradients and patient-prosthesis mismatch (PPM) have previously been reported in mixed TAVR cohorts. We analyzed our single-center experience using the third-generation self-expanding Medtronic Evolut R prosthesis, with an emphasis on the incidence and outcomes of PPM. This is a retrospective analysis of prospectively collected data from our TAVR database. Intraprocedural and intrahospital outcomes are reported. Eighty-six patients underwent ViV-TAVR with the Evolut R prosthesis. Mean age was 75.5 ± 9.5 years, 64% were males. The mean log EuroScore was 21.6 ± 15.7%. The mean time between initial surgical valve implantation and ViV-TAVR was 8.8 ± 3.2 years. The mean true internal diameter of the implanted surgical valves was 20.9 ± 2.2 mm. Post-AVR, 60% had no PPM, 34% had moderate PPM, and 6% had severe PPM. After ViV-TAVR, 33% had no PPM, 29% had moderate, and 39% had severe PPM. After implantation, the mean transvalvular gradient was reduced significantly from 36.4 ± 15.2 to 15.5 ± 9.1 mm Hg (p < 0.001). No patient had more than mild aortic regurgitation after ViV-TAVR. No conversion to surgery was necessary. Estimated Kaplan-Meier survival at 1 year for all patients was 87.4%. One-year survival showed no significant difference according to post-ViV PPM groups (p = 0.356). ViV-TAVR using a supra-annular valve resulted in low procedural and in-hospital complication rates. However, moderate or severe PPM was common, with no influence on short-term survival. PPM may not be a suitable factor to predict survival after ViV-TAVR.

The PARTNER 3 Bicuspid Registry forTranscatheter Aortic Valve Replacement in Low-Surgical-Risk Patients.

The study compared 1-year outcomes between transcatheter aortic valve replacement (TAVR) patientswith bicuspid aortic valve (BAV) morphology and clinically similar patients having tricuspid aortic valve (TAV) morphology. There are limited prospective data on TAVR using the SAPIEN 3 device in low-surgical-risk patientswithsevere, symptomatic aortic stenosis and bicuspid anatomy. Low-risk, severe aortic stenosis patients with BAV were candidates for the PARTNER 3 (Placement ofAorticTranscatheter Valves 3) (P3) bicuspid registry or the P3 bicuspid continued access protocol. Patients treated in these registries were pooled and propensity score matched to TAV patients from the P3 randomized TAVR trial. Outcomes were compared between groups. The primary endpoint was the 1-year composite rate of death, stroke, and cardiovascular rehospitalization. Of 320 total submitted BAV patients, 169 (53%) were treated, and most were Sievers type 1. Theremaining 151 patients were excluded caused by anatomic or clinical criteria. Propensity score matching with the P3 TAVR cohort (496 patients) yielded 148 pairs. There were no differences in baseline clinical characteristics; however, BAV patients had larger annuli and they experienced longer procedure duration. There was no difference in the primary endpoint between BAV and TAV (10.9% vs 10.2%; P = 0.80) or in the rates of the individual components (death: 0.7% vs 1.4%; P = 0.58; stroke: 2.1% vs 2.0%; P = 0.99; cardiovascular rehospitalization: 9.6% vs 9.5%; P= 0.96). Among highly select bicuspid aortic stenosis low-surgical-risk patients without extensive raphe or subannular calcification, TAVR with the SAPIEN 3 valve demonstrated similar outcomes to a matched cohort of patientswith tricuspid aortic stenosis.

Cerebral Protection in TAVR-Can We Do Without? A Real-World All-Comer Intention-to-Treat Study-Impact on Stroke Rate, Length of Hospital Stay, and Twelve-Month Mortality.

Background: Stroke associated with transcatheter aortic valve replacement (TAVR) is a potentially devastating complication. Until recently, the Sentinel™ Cerebral Protection System (CPS; Boston Scientific, Marlborough, MA, USA) has been the only commercially available device for mechanical prevention of TAVR-related stroke. However, its effectiveness is still undetermined. Objectives: To explore the impact of Sentinel™ on stroke rate, length of hospital stay (LOS), and twelve-month mortality in a single-center, real-world, all-comers TAVR cohort. Material and Methods: Between January 2019 and August 2020 consecutive patients were assigned to TAVR with or without Sentinel™ in a 1:1 fashion according to the treating operator. We defined as primary endpoint clinically detectable cerebrovascular events within 72 h after TAVR and as secondary endpoints LOS and 12-month mortality. Logistic and linear regression analyses were used to assess associations of Sentinel™ use with endpoints. Results: Of 411 patients (80 ± 7 y/o, 47.4% female, EuroSCORE II 6.3 ± 5.9%), Sentinel™ was used in 213 (51.8%), with both filters correctly deployed in 189 (46.0%). Twenty (4.9%) cerebrovascular events were recorded, ten (2.4%) of which were disabling strokes. Patients with Sentinel™ suffered 71% less (univariate analysis; OR 0.29, 95%CI 0.11–0.82; p = 0.02) and, respectively, 76% less (multivariate analysis; OR 0.24, 95%CI 0.08–0.76; p = 0.02) cerebrovascular events compared to patients without Sentinel™. Sentinel™ use was also significantly associated with shorter LOS (Regression coefficient −2.47, 95%CI −4.08, −0.87; p < 0.01) and lower 12-month all-cause mortality (OR 0.45; 95%CI 0.22–0.93; p = 0.03). Conclusion: In the present prospective all-comers TAVR cohort, patients with Sentinel™ use showed (1) lower rates of cerebrovascular events, (2) shortened LOS, and (3) improved 12-month survival. These data promote the use of a CPS when implanting TAVR valves.

Three-year survival of transcatheter versus surgical aortic valve replacement in dialysis.

To highlight the trends of surgical (open) aortic valve replacement (SAVR) as well as to compare the outcome between transcatheter aortic valve replacement (TAVR) and SAVR in elderly dialysis patients. TAVR has evolved as an effective alternative to surgery (SAVR) for aortic stenosis. We identified dialysis-dependent patients who underwent SAVR or TAVR from 2000 to 2015 from the United States Renal Data System using ICD-9 codes. We defined high-risk surgical patients as age over 70 or older. The primary endpoint was survival at 3 years and we compared the outcome between SAVR and TAVR groups using inverse probability of treatment weighting (IPTW). A total of 4332 and 1280 dialysis patients underwent SAVR and TAVR, respectively, during the study period. Among SAVR cohort, 3312 patients underwent SAVR before June 2012 and 1020 after June 2012. In-hospital mortality was significantly worse before 2012 (14.6% vs. 11.3% after 2012, p = 0.007) as well as estimated 3-year mortality (69.1% vs. 60.3% after 2012, p < 0.001). After June 2012, the TAVR cohort was older and had more comorbidities including coronary artery disease and congestive heart failure compared to the SAVR cohort. After IPTW, in-hospital mortality was significantly lower after TAVR versus SAVR (odds ratio 0.38 [95% confidence interval [CI], 0.27-0.52], p < 0.001). However, TAVR had a significantly higher risk of 3-year mortality than SAVR (hazard ratio 1.24 [95% CI 1.1-1.39], p < 0.001). TAVR may be a reasonable and potentially preferable alternative to SAVR in the elderly dialysis population in the short-term period.

Time-of-Day and Clinical Outcomes After Surgical or Transcatheter Aortic Valve Replacement: Insights From the PARTNER Trials.

Circadian rhythms may influence myocardial tolerance to ischemia-reperfusion phenomena occurring during cardiac procedures. While conflicting results exist on the effect of time-of-day on surgical aortic valve replacement (SAVR), afternoon procedures could be associated with a reduced risk of death, rehospitalization or periprocedural myocardial infarction, compared with morning procedures. We examined the impact of procedure time-of-day on outcomes after transcatheter aortic valve replacement (TAVR) or SAVR. We analyzed patients at intermediate- or high-surgical risk who underwent elective TAVR (n=4457) or SAVR (n=1129) in the PARTNER (Placement of Aortic Transcatheter Valve) 1 and 2 trials and registries according to time-of-day (morning versus afternoon) using the Kaplan-Meier event rates and multivariable Cox proportional hazards regression models. Sensitivity analysis was conducted using 1:1 propensity-score matching. The primary end point was all-cause death or rehospitalization at 2 years. At 2 years, no difference was observed between patients operated in the morning versus the afternoon within the SAVR (32.3% versus 30.6%, adjusted hazard ratio, 1.08 [95% CI, 0.82-1.41], P=0.58) and TAVR cohorts (35.7% versus 35.4%, adjusted hazard ratio, 1.01 [95% CI, 0.89-1.14], P=0.86) with regards to the primary end point. Rates of periprocedural myocardial infarction were low and similar between morning and afternoon in SAVR (1.6% versus 1.0%, P=0.51) and TAVR (0.4% versus 0.4%, P=0.86), as were all other clinical end points. Similar results were observed in propensity-score matched analysis. Procedure time-of-day was not associated with clinical outcomes after TAVR or SAVR. Registration: URL: https://www.clinicaltrials.gov; Unique identifiers: NCT00530894, NCT01314313, NCT03222141, and NCT03222128.

Baseline mean platelet volume is a strong predictor of major and life-threatening bleedings after transcatheter aortic valve replacement

Bleeding following transcatheter aortic valve replacement (TAVR) has important prognostic implications. This study sought to evaluate the impact of baseline mean platelet volume (MPV), a routinely used marker of platelet reactivity, on bleeding events in a contemporary real-world TAVR cohort. Patients undergoing TAVR between February 2010 and May 2019 with available preprocedural MPV were included. Low MPV (L-MPV) was defined as MPV ≤ 10 fL and high MPV (H-MPV) as MPV > 10 fL. The primary endpoint was the occurrence of major/life-threatening bleeding complications (MLBCs) at one year follow-up. Among 1,111 patients, 398 (35.8%) had L-MPV and 713 (64.2%) had H-MPV. The rate of MLBCs at 1 year was higher in L-MPV patients compared with H-MPV patients (22.9% vs. 17.7% respectively, P = 0.034). L-MPV was associated with vascular access-site complications (36.2% vs. 28.9%, P = 0.012), early (< 30 days) major bleeding (15.6% vs. 9.4%, P < 0.01) and red blood cell transfusion > 2 units (23.9% vs. 17.5%, P = 0.01). No impact of baseline MPV on overall death, cardiovascular death and ischemic events (myocardial infarction and stroke) was evidenced. Multivariate analysis using Fine and Gray model identified preprocedural hemoglobin (sHR 0.84, CI95% [0.75–0.93], P = 0.001), preprocedural L-MPV (sHR 1.64, CI95% [1.16–2.32], P = 0.005) and CT-ADP post-TAVR (sHR 2.71, CI95% [1.87–3.94], P < 0.001) as predictors of MLBCs (Fig. 1, Table 1). Preprocedural MPV was identified as an independent predictor of MLBCs one year after TAVR, regardless of the extent of platelet inhibition and primary hemostasis disorders. MPV should be regarded as a simple, common and valuable biomarker of bleeding prediction after TAVR.

Quality of life after transcatheter or surgical aortic valve replacement using the Toronto Aortic Stenosis Quality of Life Questionnaire

BackgroundThe Toronto Aortic Stenosis Quality of Life Questionnaire (TASQ) is a validated instrument for assessing quality of life (QoL) in patients with severe aortic stenosis (AS). In this study, we...