5-Year Outcomes Comparing Surgical Versus Transcatheter Aortic Valve Replacement in Patients With Chronic Kidney Disease

ObjectivesThe aim of this study was to compare 5-year cardiovascular, renal, and bioprosthetic valve durability outcomes in patients with severe aortic stenosis (AS) and chronic kidney disease (CKD) undergoing transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR).BackgroundPatients with severe AS and CKD undergoing TAVR or SAVR are a challenging, understudied clinical subset.MethodsIntermediate-risk patients with moderate to severe CKD (estimated glomerular filtration rate <60 mL/min/m²) from the PARTNER (Placement of Aortic Transcatheter Valve) 2A trial (patients randomly assigned to SAPIEN XT TAVR or SAVR) and SAPIEN 3 Intermediate Risk Registry were pooled. The composite primary outcome of death, stroke, rehospitalization, and new hemodialysis was evaluated using Cox regression analysis. Patients with and without perioperative acute kidney injury (AKI) were followed through 5 years. A core laboratory–adjudicated analysis of structural valve deterioration and bioprosthetic valve failure was also performed.ResultsThe study population included 1,045 TAVR patients (512 SAPIEN XT, 533 SAPIEN 3) and 479 SAVR patients. At 5 years, SAVR was better than SAPIEN XT TAVR (52.8% vs 68.0%; P = 0.04) but similar to SAPIEN 3 TAVR (52.8% vs 58.7%; P = 0.89). Perioperative AKI was more common after SAVR than TAVR (26.3% vs 10.3%; P < 0.001) and was independently associated with long-term outcomes. Compared with SAVR, bioprosthetic valve failure and stage 2 or 3 structural valve deterioration were significantly greater for SAPIEN XT TAVR (P < 0.05) but not for SAPIEN 3 TAVR.ConclusionsIn intermediate-risk patients with AS and CKD, SAPIEN 3 TAVR and SAVR were associated with a similar risk for the primary endpoint at 5 years. AKI was more common after SAVR than TAVR, and SAPIEN 3 valve durability was comparable with that of surgical bioprostheses.     

Cardiovascular Outcomes with Transcatheter vs. Surgical Aortic Valve Replacement in Low-Risk Patients: An Updated Meta-Analysis of Randomized Controlled Trials

BackgroundTAVR is an established treatment option in high and intermediate-risk patients with severe AS. There is less data regarding the efficacy of TAVR in low-risk patients. This meta-analysis evaluated efficacy and safety outcomes of transcatheter aortic valve replacement (TAVR) in comparison to surgical aortic valve replacement (SAVR) in low-risk patients with severe aortic stenosis (AS).MethodsDatabases were searched for randomized controlled trials (RCTs) that compared TAVR with SAVR for the treatment of low-risk patients with severe AS. We calculated pooled odds ratios (ORs) and 95% confidence intervals (CIs) using the random-effects model.ResultsThe final analysis included 2953 patients from 5 studies. Compared to SAVR, TAVR was associated with similar mid-term mortality [OR 0.67; 95% CI 0.37–1.21; p = 0.18], as well as similar short-term mortality [OR 0.51; 95% CI 0.24–1.11; p = 0.09]. Randomization to TAVR was associated with a reduced risk of developing acute kidney injury [OR 0.26; 95% CI 0.13–0.52; p < 0.001], short-term major bleeding [OR 0.27; 95% CI 0.12–0.60; p < 0.001] and new-onset atrial fibrillation [OR 0.17; 95% CI 0.14–0.21; p < 0.001]. However, TAVR was associated with a higher risk of requiring permanent pacemaker implantation [OR 4.25; 95% CI 1.86–9.73; p < 0.001]. There was no significant difference in the risk of myocardial infarction, stroke, endocarditis or aortic valve re-intervention between the two groups.ConclusionsOur meta-analysis showed that TAVR has similar clinical efficacy to SAVR, with a more favorable safety profile, in patients with severe AS who are at low-surgical risk.     

Clinical Outcomes and Revascularization Strategies in Patients With Low-Flow,Low-Gradient Severe Aortic Valve Stenosis According to the Assigned Treatment Modality

ObjectivesThis study compared clinical outcomes and revascularization strategies among patients presenting with low ejection fraction, low-gradient (LEF-LG) severe aortic stenosis (AS) according to the assigned treatment modality.BackgroundThe optimal treatment modality for patients with LEF-LG severe AS and concomitant coronary artery disease (CAD) requiring revascularization is unknown.MethodsOf 1,551 patients, 204 with LEF-LG severe AS (aortic valve area <1.0 cm², ejection fraction <50%, and mean gradient <40 mm Hg) were allocated to medical therapy (MT) (n = 44), surgical aortic valve replacement (SAVR) (n = 52), or transcatheter aortic valve replacement (TAVR) (n = 108). CAD complexity was assessed using the SYNTAX score (SS) in 187 of 204 patients (92%). The primary endpoint was mortality at 1 year.ResultsLEF-LG severe AS patients undergoing SAVR were more likely to undergo complete revascularization (17 of 52, 35%) compared with TAVR (8 of 108, 8%) and MT (0 of 44, 0%) patients (p < 0.001). Compared with MT, both SAVR (adjusted hazard ratio [adj HR]: 0.16; 95% confidence interval [CI]: 0.07 to 0.38; p < 0.001) and TAVR (adj HR: 0.30; 95% CI: 0.18 to 0.52; p < 0.001) improved survival at 1 year. In TAVR and SAVR patients, CAD severity was associated with higher rates of cardiovascular death (no CAD: 12.2% vs. low SS [0 to 22], 15.3% vs. high SS [>22], 31.5%; p = 0.037) at 1 year. Compared with no CAD/complete revascularization, TAVR and SAVR patients undergoing incomplete revascularization had significantly higher 1-year cardiovascular death rates (adj HR: 2.80; 95% CI: 1.07 to 7.36; p = 0.037).ConclusionsAmong LEF-LG severe AS patients, SAVR and TAVR improved survival compared with MT. CAD severity was associated with worse outcomes and incomplete revascularization predicted 1-year cardiovascular mortality among TAVR and SAVR patients.     

Transcatheter versus surgical aortic valve replacement in low-risk surgical patients: A meta-analysis of randomized clinical trials

BackgroundTranscatheter aortic valve replacement (TAVR) is a valid option for patients with high or intermediate surgical risk. However, clinical outcomes of TAVR in low-risk patients are lacking. Our aim was to evaluate the efficacy and safety of TAVR versus surgical aortic valve replacement (SAVR) in low-surgical-risk patients.MethodsElectronic database review was conducted for all randomized clinical trials (RCTs) that compared TAVR versus SAVR in low-risk patients. We calculated risk ratios (RRs) and 95% confidence intervals (CIs) using a random-effects model.ResultsWe included 3 RCTs totaling 604 patients (310 TAVR and 294 SAVR). Our results showed no significant difference in mortality between TAVR compared with SAVR (RR = 0.71; 95% CI = 0.22–2.30; P = 0.56), however, there was a significantly increased risk of pacemaker implantation (RR = 7.28; 95% CI = 3.94–13.42; P < 0.01) and moderate/severe paravalvular leakage (PVL) (RR = 6.74; 95% CI = 1.31–34.65; P = 0.02) with TAVR. Nevertheless, TAVR demonstrated a significantly reduced risk of post-procedural bleeding (RR = 0.40; 95% CI = 0.30–0.54; P < 0.01) and new-onset atrial fibrillation (RR = 0.36; 95% CI = 0.27–0.47; P < 0.01). Other clinical outcomes were not significantly different between the groups and included cardiovascular mortality, stroke, transient ischemic attack, and myocardial infarction.ConclusionsAmong low-risk patients, TAVR offered comparable efficacy outcomes and fewer bleeding events compared with SAVR. There were increased risks of pacemaker implantation and PVL associated with TAVR, though lower atrial fibrillation risks.     

Pre-existing chronic kidney disease and acute kidney injury among critically ill patients

BackgroundThe impact of pre-existing chronic kidney disease (CKD) and acute kidney injury (AKI) on health outcomes in critically ill patients is unclear. Yet, CKD complicated by AKI in critically ill patients is common.Objectives: To compare risk of death within one-month of admission in critically ill patients with and without pre-existing CKD who developed AKI.MethodsA multicenter retrospective comparative study using medical records review was conducted. Study participants consisted of 826 adult patients who received mechanical ventilation for at least 6 h in the critical care units from January 2012 to December 2017. Assessment of kidney function was established by serum creatinine. Severity and staging of AKI were defined using RIFLE criteria: Risk, Injury, Failure, Loss and End stage of renal disease. Chronic kidney disease was defined as eGFR > 60 ml/mg/1.73 m² on admission.ResultsPre-existing CKD was present in 55% of patients and 7% had AKI within 7 days of admission. The overall mortality rate among these patients was 87.3%. The mortality rate was highest in patients with CKD (70.1%) followed by that of patients without pre-existing CKD but with AKI (20.7%) and that of patients with pre-existing CKD (7.1%) and AKI. Risks associated with mortality were APACHE II score (1.03; 95% CI 1.02–1.05;(P<0.001) and AKI (1.68; 95% CI 1.12–2.5;P<0.01) in patients with pre-existing CKD. Only APACHI-II (1.03; 95% CI 1.0–1.1; p < 0.001) was predictive of death in patients without pre-existing CKD.Conclusion: Pre-existing comorbid CKD increases risks of death among critically ill patients compared to patients without CKD and regardless of whether they develop AKI or not. Early identification of CKD and recognition of the risk for mortality among these patients may result in earlier intervention that could reduce mortality.     

Outcomes of Transcatheter Versus Surgical Aortic Valve Replacement in Patients <60 Years of Age

BackgroundTranscatheter aortic valve replacement (TAVR) is an alternative therapeutic modality to surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis (AS). In the current analysis, we compare the characteristics and outcomes of AVR procedures in patients <60 years of age.MethodsWe queried the Nationwide Readmissions Database for all AVR hospitalizations in patients 18–59 years of age between January 2012 and December 2017. We performed a propensity score matching analysis (1:1) and compared baseline characteristics, procedural complications, and outcomes between TAVR and SAVR patients.ResultsA total of 72,356 hospitalizations for AVR were identified in patients <60 years of age. Compared to their SAVR counterparts, TAVR patients were older (52.5 ± 7.6) vs. 48.8 ± 9.6, p < 0.001), more likely to be women (37.9% vs. 28.0%, p < 0.001), and have history of prior radiation (8.3% vs. 0.7%, p < 0.001).After propensity score matching, TAVR patients had lower procedural complications, but a similar mortality rate compared to SAVR patients (2.9% vs. 3.0%, p = 0.77). TAVR was associated with a shorter length of hospital stay [4 [2–9] vs. 6 [5–11], p < 0.001), but no significant difference in the 30-day readmission rate was noted (16.2% vs. 16.8%, p-value = 0.49).ConclusionOur study demonstrates favorable short-term outcomes in younger patients undergoing TAVR, which improved over time. Further investigation of long-term outcomes in TAVR performed younger patients is warranted to draw a comprehensive picture of TAVR safety and efficacy in low-risk patients.     

Outcomes Following Shock Aortic Valve Replacement: Transcatheter Versus Surgical Approaches

ObjectivesTo compare transcatheter aortic valve replacement (TAVR) with surgical aortic valve replacement (SAVR) for patients in shock.BackgroundThere are minimal data on the clinical and echocardiographic outcomes for patients in shock that undergo TAVR and no data comparing these outcomes to similar patients undergoing SAVR.MethodsThis is a single center, retrospective cohort study of patients having Society of Thoracic Surgeons (STS)-defined urgent or emergent AVR for aortic stenosis with clinical signs and symptoms of shock. Inclusion criteria were based on the Society of Cardiovascular Angiography & Interventions (SCAI) shock consensus statement and included: the need for inotropic or vasopressor agents, mechanical ventilation, continuous renal replacement therapy or newly initiated hemodialysis, and/or utilization of mechanical hemodynamic support. Clinical and echocardiographic outcomes for TAVR and SAVR were compared.ResultsThirty-seven patients met the inclusion criteria for this study (17 TAVR, 20 SAVR). TAVR patients had a higher STS Predicted Risk of Mortality (PROM) score of 22.3% compared to 11.8% for SAVR patients (p = 0.001). No significant differences were found in baseline echocardiographic results. TAVR procedures required less procedure room time (185.9 min TAVR, 348.5 min SAVR, p < 0.001) and fewer intraoperative packed red blood cell (pRBC) transfusions (0.2 units TAVR, 3.4 units SAVR, p < 0.001). TAVR patients also had lower rates of prolonged postoperative ventilation compared to SAVR patients (38.5% TAVR, 75.0% SAVR, p = 0.047). TAVR and SAVR had similar rates of mortality at discharge (2 TAVR, 1 SAVR, p = 0.584), 30-days (2 TAVR, 1 SAVR, p = 0.584), and 1-year (8 TAVR, 5 SAVR, p = 0.149).ConclusionsDespite a higher risk TAVR group, patients in shock undergoing either TAVR or SAVR have similar 30-day mortality. At one year, SAVR patients have a numerically better, though not statistically significant, survival. These findings support the use of TAVR for patients in shock with aortic stenosis.     

Prosthetic Valve Endocarditis in Patients Undergoing TAVR Compared to SAVR: A Systematic Review and Meta-Analysis

BackgroundThe risk of prosthetic valve endocarditis (PVE) in patients who underwent transcatheter aortic valve replacement (TAVR) is presumed to be high.MethodsElectronic databases were searched to identify articles comparing the rate of PVE in post-TAVR and post-surgical aortic valve replacement (SAVR) patients. Pooled adjusted odds ratio (OR) was computed using a random-effects model.ResultsA total of 19 studies consisting of 84,288 patients, were identified. There was no significant difference in the odds of PVE between patients undergoing TAVR and SAVR, at 30-day (OR 0.62, 95% confidence interval (CI) 0.20–1.92, p = 0.41), 1-year (OR 0.99 95% CI 0.89–1.11, p = 0.84), 2-year (OR 1.02 95% CI 0.68–1.54, p = 0.92) and 5-year (OR 1.03 95% CI 0.80–1.33, p = 0.81). A subgroup sensitivity analysis also showed no significant inter-group differences in the rate of PVE at all time points, when stratified by the study design (clinical trial vs. observational), type of TAVR valves used (self-expanding bioprosthetic valves vs. balloon expanded bioprosthetic valves) and surgical risk of patients (high vs. intermediate vs. low). There was no heterogeneity (I2 = 0%) in the outcomes of the included studies at 30-day, 1-year and 2-year, while the heterogeneity in studies at 5-year was minimal (I2 = 22%).ConclusionsIn comparison to SAVR, both short and long-term risk of prosthetic valve endocarditis appears to be identical in patients undergoing TAVR. This risk is unaffected by the type of valve, duration of follow-up, study design and surgical risk of the patients.     

The Effect of Psychosocial Risk Factors on Outcomes After Aortic Valve Replacement

BackgroundPsychosocial risk factors (PSRFs) have emerged as important nontraditional risk factors that are associated with worse surgical outcomes but have not been well-characterized in valvular disease.ObjectivesThis study evaluates the impact of PSRFs on 30-day outcomes following surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR).MethodsAll adult patients (≥18 years of age) who underwent isolated TAVR or SAVR in the Nationwide Readmissions Database from 2016 to 2018 were included. Patients were classified as having 0 PSRFs vs ≥1 PSRF. PSRFs included limited cognitive understanding, substance use, psychiatric disease, low socioeconomic status, or uninsured status. Primary outcomes included 30-day mortality, readmission, and composite morbidity (stroke, pulmonary embolus, pacemaker implantation, bleeding complications, acute kidney injury, myocardial infarction, or new atrial fibrillation).ResultsA nationally weighted total of 74,763 SAVR and 87,142 TAVR patients met inclusion criteria. For SAVR, patients with PSRFs had significantly higher 30-day mortality (4.2% vs 3.7%; P = 0.048) and readmissions (13.1% vs 11.3%; P < 0.001), but there was no difference in composite morbidity. For TAVR, patients with PSRFs had significantly higher 30-day readmission (11.7% vs 10.7%; P = 0.012) but no difference in 30-day mortality or composite morbidity. On risk-adjusted analysis, presence of PSRFs was a significant predictor of higher 30-day readmissions following SAVR (adjusted OR: 1.10; 95% CI: 1.02-1.19).ConclusionsThe presence of PSRFs is associated with worse short-term outcomes following SAVR and TAVR, with a more profound impact in SAVR. This study highlights the importance of identifying at-risk patients and suggests that TAVR may be beneficial in patients with less social support.     

Comparison of postprocedural new-onset atrial fibrillation between transcatheter and surgical aortic valve replacement: A systematic review and meta-analysis based on 16 randomized controlled trials

Background:Presently, transcatheter aortic valve replacement (TAVR) as an effective and convenient intervention has been adopted extensively for patients with severe aortic disease. However, after surgical aortic valve replacement (SAVR) and TAVR, the incidence of new-onset atrial fibrillation (NOAF) is prevalently found. This meta-analysis was designed to comprehensively compare the incidence of NOAF at different times after TAVR and SAVR for patients with severe aortic disease.Methods:A systematic search of PubMed, Embase, Cochrane Library, and Web of Science up to October 1, 2020 was conducted for relevant studies that comparing TAVR and SAVR in the treatment of severe aortic disease. The primary outcomes were the incidence of NOAF with early, midterm and long term follow-up. The secondary outcomes included permanent pacemaker (PM) implantation, myocardial infarction (MI), cardiogenic shock, as well as mortality and other complications. Two reviewers assessed trial quality and extracted the data independently. All statistical analyses were performed using the standard statistical procedures provided in Review Manager 5.2.Results:A total of 16 studies including 13,310 patients were identified. The pooled results indicated that, compared with SAVR, TAVR experienced a significantly lower incidence of 30-day/in-hospital, 1-year, 2-year, and 5-year NOAF, with pooled risk ratios (RRs) of 0.31 (95% confidence interval [CI] 0.23–0.41; 5725 pts), 0.30 (95% CI 0.24–0.39; 6321 pts), 0.48 (95% CI 0.38–0.61; 3441 pts), and 0.45 (95% CI 0.37–0.55; 2268 pts) respectively. In addition, TAVR showed lower incidence of MI (RR 0.62; 95% CI 0.40–0.97) and cardiogenic shock (RR 0.34; 95% CI 0.19–0.59), but higher incidence of permanent PM (RR 3.16; 95% CI 1.61–6.21) and major vascular complications (RR 2.22; 95% CI 1.14–4.32) at 30-day/in-hospital. At 1- and 2-year after procedure, compared with SAVR, TAVR experienced a significantly higher incidence of neurological events, transient ischemic attacks (TIA), permanent PM, and major vascular complications, respectively. At 5-year after procedure, compared with SAVR, TAVR experienced a significantly higher incidence of TIA and re-intervention respectively. There was no difference in 30-day, 1-year, 2-year, and 5-year all-cause or cardiovascular mortality as well as stroke between TAVR and SAVR.Conclusions:Our analysis showed that TAVR was superior to SAVR in decreasing the both short and long term postprocedural NOAF. TAVR was equal to SAVR in early, midterm and long term mortality. In addition, TAVR showed lower incidence of 30-day/in-hospital MI and cardiogenic shock after procedure. However, pooled results showed that TAVR was inferior to SAVR in reducing permanent pacemaker implantation, neurological events, TIA, major vascular complications, and re-intervention.     

Trans-Catheter Aortic Valve Replacement and Surgical Aortic Valve Replacement Outcomes in Patients with Dialysis: Systematic Review and Meta-Analysis

BackgroundDialysis is associated with higher rate of aortic valve calcification and higher cardiovascular mortality. Transcatheter aortic valve replacement (TAVR) is an established alternative for surgical aortic valve replacement (SAVR) in patients with higher and intermediate co-morbidities including dialysis.MethodsTwo independent investigators systematically searched Medline, Cochrane, and Web of Science. The ROBINS-I tool was used to analyze and assess the bias from the selected studies.ResultsThe search resulted in 4 observational studies with a total of 966 patients. TAVR in dialysis patients was associated with no significant difference in in-hospital mortality [8.1% vs 10.3%; OR (95% CI) 0.74 (0.35, 1.60), I2 = 50%, P = 0.45], risk-of-strokes at 30 days [2% vs 4.4%; OR (95% CI) 0.49 (0.22, 1.09), I2 = 0%, P = 0.08], vascular complications [12.7% vs 13.2%; OR (95% CI) 0.96 (0.55, 1.67), I2 = 0%, P = 0.89], need of blood transfusion [43.1% vs 66.4%; OR (95% CI) 0.27 (0.05, 1.39), I2 = 89%, P = 0.12], or bleeding risk [5.6% vs 6.8%; OR (95% CI) 0.91 (0.18, 4.64), I2 = 5%, P = 0.91] when compared to SAVR. TAVR was associated with significantly shorter length of stay [8.5 days vs 14.2 days; mean difference (95% CI) ?5.89 (?9.13, ?2.64), I2 = 76%, P < 0.0001] and higher pacemaker implantation [11.4% vs 6.8%; OR (95% CI) 1.74 (1.07, 2.81), I2 = 5%, P = 0.02].ConclusionTAVR outcomes were comparable to SAVR but had a significantly shorter length of stay and a higher pacemaker implantation rate in dialysis patients.     

Acute Kidney Injury Following Transcatheter Edge-to-Edge Mitral Valve Repair: A Systematic Review and Meta-Analysis

BackgroundAim of this study was to perform a systematic review a meta-analysis of the literature in order to identify predictors of acute kidney injury (AKI) in patients with mitral regurgitation (MR) undergoing transcatheter edge-to-edge repair (TEER) and assess its effect on in-hospital outcomes and mortality. Although iodinated contrast is not typically used in TEER, these patients are still at risk for developing AKI.MethodsStudies reporting on the effect of incident AKI on mortality following TEER for MR were included. Random-effects meta-analysis was performed, comparing clinical outcomes between the patients with or without incident AKI.ResultsSix studies including a total of 2057 patients (377 AKI and 1680 No-AKI) were included and analyzed. AKI was significantly associated with 30-day mortality after TEER (Odds ratio (OR): 8.06; 95% CI: 3.20, 20.30, p < 0.01; I² = 18.4%) and all-cause mortality over a mean follow-up time of 30 months (Hazard ratio (HR): 2.48; 95% CI: 1.89, 3.24, p < 0.01; I² = 23.7%). AKI after TEER was associated with prolonged hospitalization (Mean difference (in days): 1.41; 95% CI: 0.52, 2.31, p < 0.01; I² = 82.4%). Stage 4 chronic kidney disease (CKD), device failure and history of chronic obstructive pulmonary disease (COPD) were significant predictors of AKI following TEER (CKD stage 4: OR: 2.38; 95% CI: 1.18, 4.78, p = 0.02; I² = 0.0%; Device failure: OR: 3.15; 95% CI: 1.94, 5.12, p < 0.01; I² = 0.0%; COPD: OR: 1.92; 95% CI: 1.16, 3.17; I² = 26.7%).ConclusionsOur findings highlight the renal vulnerability of the TEER population to renal injury and the associated deterioration in clinical outcomes and survival.     

Valve-in-Valve Transcatheter Aortic Valve Replacement Versus Redo Surgical Aortic Valve Replacement: An Updated Meta-Analysis

ObjectivesThe aim of this study was to evaluate early results of valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) versus redo surgical aortic valve replacement (SAVR) for structural valve degeneration (SVD).BackgroundViV TAVR has been increasingly used for SVD, but it remains unknown whether it produces better or at least comparable results as redo SAVR.MethodsObservational studies comparing ViV TAVR and redo SAVR were identified in a systematic search of published research. Random-effects meta-analysis was performed, comparing clinical outcomes between the 2 groups.ResultsTwelve publications including a total of 16,207 patients (ViV TAVR, n = 8,048; redo SAVR, n = 8,159) were included from studies published from 2015 to 2020. In the pooled analysis, ViV TAVR was associated with lower rates of 30-day mortality overall (odds ratio [OR]: 0.52; 95% confidence interval [CI]: 0.39 to 0.68; p < 0.001) and for matched populations (OR: 0.419; 95% CI: 0.278 to 0.632; p = 0.003), major bleeding (OR 0.48; 95% CI: 0.28 to 0.80; p = 0.013), as well as with shorter hospital stay (OR: ?3.30; 95% CI: ?4.52 to ?2.08; p < 0.001). In contrast, ViV TAVR was associated with higher rates of severe patient-prosthesis mismatch (OR: 4.63; 95% CI: 3.05 to 7.03; p < 0.001). The search revealed an important lack of comparative studies with long-term results.ConclusionsViV TAVR is a valuable option in the treatment of patients with SVD because of its lower incidence of post-operative complications and better early survival compared with redo SAVR. However, ViV TAVR is associated with higher rates of myocardial infarction and severe patient-prosthesis mismatch.     

Impact of Transcatheter Aortic Valve Replacement on Risk Profiles of Surgical Aortic Valve Replacement Patients

BackgroundThe advent of transcatheter aortic valve replacement (TAVR) has changed which patients undergo surgical aortic valve replacement (SAVR). We sought to understand the impact of TAVR on the characteristics of SAVR patients in the United States.MethodsA cohort of 2959 patients who underwent isolated SAVR at 11 US hospitals that perform both TAVR and SAVR from 2013 through 2017 were grouped by the Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database version (v)2.73 (2011–2014), v2.81 (2014–2017), and v2.9 (2017) to assess temporal trends in patient characteristics.ResultsOver time, SAVR patients were younger with fewer preoperative comorbidities. There was a significant decrease in median STS predicted risk of mortality (PROM) score (2.0 vs. 1.8 vs. 1.3, p < 0.001, in v2.73 vs. v2.81 vs. v2.9). Specifically, there were fewer high-risk (STS PROM > 8%: 4.3% vs. 4.7% vs. 1.2%, p = 0.03) and intermediate-risk (STS PROM 4% to 8%: 16.3% vs. 11.7% vs. 4.3%, p < 0.001) patients. The proportion of patients with bicuspid aortic valve disease increased significantly (11.2% vs. 26.9% vs. 36.6%, p < 0.001). There were no differences in operative mortality (1.9% vs. 2.1% vs. 1.4%, p = 0.75).ConclusionsThe introduction of TAVR has already impacted the demographics, clinical characteristics and risk profiles of patients undergoing SAVR in the US. Now that TAVR is approved for low-risk patients, SAVR is likely to be reserved for younger patients who are willing to receive a mechanical valve and for patients with aortopathy, coronary artery disease, or concomitant mitral or tricuspid pathology.     

Kidney dysfunction and short term all-cause mortality after transcatheter aortic valve implantation

BackgroundAcute kidney injury (AKI) after transcatheter aortic valve implantation (TAVI) has been associated with worse outcomes. However, the impact on outcome of AKI in TAVI-patients is not well established.MethodsInoperable patients with severe aortic stenosis (AS) undergoing TAVI in 2010-2018 were enrolled in this study. AKI and chronic kidney disease (CKD) were defined according to KDIGO guidelines. Patients were divided in two groups according to post-procedural AKI development. The primary endpoint was 30-day all-cause mortality across the two groups.ResultsA total of 373 patients (mean age 82.3 ± 6) were analyzed. Compared to non-AKI patients, those who developed AKI, were treated more frequently with trans-apical TAVI (66% vs 35%, p<0.01), with greater amount of contrast medium (200.6 vs 170.4 ml, p=0.02) and in presence of clinically significant peripheral artery disease (PAD, 33% vs 21%, p=0.04). Trans-apical access (OR 3.24, 95% CI 1.76-5.60, p<0.01) was associated with a 3-fold risk of AKI. After adjustment for age, Society of Thoracic Surgery risk score (STS), PAD, access type, EF and contrast medium amount, patients with AKI presented an increased risk of 30-day all-cause mortality (HR=1.25, 95%CI 1.09-1.69, p=0.008). Patients with CKD IV and V, who developed AKI, presented a 9-fold 30-day mortality risk (HR=9.71, 95% CI 2.40-39.2, p=0.001).ConclusionIn our analysis, AKI was a strong predictor of 30-day all-cause mortality. Particularly, patients with severe CKD with AKI showed the highest 30-day mortality risk. Thus, this group of patients might benefit from closer monitoring and specific kidney protection therapies.     

Low-Risk Transcatheter Versus Surgical Aortic Valve Replacement – An Updated Meta-Analysis of Randomized Controlled Trials

ObjectivesTo perform a meta-analysis including all available randomized controlled trials (RCTs) to date comparing transcatheter aortic valve replacement (TAVR) to surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis (AS) and low surgical risk.BackgroundCurrent guidelines recommend SAVR for patients with severe symptomatic AS and low surgical risk. A few RCTs have evaluated TAVR in low surgical risk patients but equipoise exists related to TAVR valve durability, paravalvular leak (PVL) and role of TAVR in younger, low surgical risk patients.MethodsFive databases were analyzed from January-2000 to March-2019 for RCTs comparing SAVR to TAVR in low-risk severe AS patients.ResultsFour RCTs on low-risk TAVR patients with 2887 patients were included. Mean follow-up was ~24.1 ± 24 months. Early mortality was lower with TAVR compared to SAVR (RR: 0.44, 95% CI: 0.20–0.95, P = 0.038) whereas long-term mortality was similar (RR: 0.67, 95% CI: 0.39–1.14, P = 0.141). Both early and long-term stroke rates were similar. TAVR was associated with lower risk of atrial fibrillation, major bleeding, acute kidney injury (AKI) and rehospitalization, but higher rates of permanent pacemaker implantation (PPM) and moderate or severe PVL. There was no difference in major vascular complications, myocardial infarction, endocarditis, aortic valve gradients and valve area at follow-up.ConclusionsIn low-risk patients with severe AS, TAVR has a lower early mortality compared to SAVR with no difference in long-term mortality. Although complication rates varied between TAVR and SAVR, our study findings suggest that transfemoral-TAVR is an appropriate treatment option for severe symptomatic AS in patients with low surgical risk.     

Risk Factors for Long-Term Mortality and Progressive Chronic Kidney Disease Associated With Acute Kidney Injury After Cardiac Surgery

The aim of the study was to evaluate risk factors for long-term mortality and progressive chronic kidney disease (CKD) after cardiac surgery in patients with normal preoperative renal function and postoperative acute kidney injury (AKI). From April 2009 to December 2012, we prospectively enrolled 3245 cardiac surgery patients of our hospital. The primary endpoints included survival rates and the secondary endpoint was the incidence of progressive chronic kidney disease (CKD) in a follow-up period of 2 years. Acute kidney injury was staged by KDIGO classification. Progressive CKD was defined as GFR ≤ 30 mL/min/1.73 m² or end-stage renal disease (ESRD) (starting renal replacement therapy or renal transplantation).The AKI incidence was 39.9% (n = 1295). The 1 and 2 year overall survival (OS) rates of AKI patients were significantly lower than that for non-AKI patients (85.9% and 82.3% vs 98.1% and 93.7%, P < 0.001), even after complete recovery of renal function during 2 years after intervention (P < 0.001). The 2-year overall survival (OS) rates of patients with AKI stage 1, 2, and 3 were 89.9%, 78.6%, and 61.4% (P < 0.001), respectively. Multivariate Cox regression analysis of factors for 2-year survival rates revealed that besides age (P < 0.001), chronic cardiac failure (P < 0.001), diabetes (P < 0.001), cardiopulmonary bypass time (P < 0.01), and length of intensive care unit (ICU) stay (P = 0.004), AKI was a significant risk factor for reducing 2-year survival rates even after complete recovery of renal function (P < 0.001). The accumulated progressive CKD prevalence was significantly higher in AKI than in non-AKI patients (6.8% vs 0.2%, P < 0.001) in the 2 years after surgery. Even with complete recovery of renal function at discharge, AKI was still a risk factor for accumulated progressive CKD (RR 1.92, 95% CI 1.37–2.69).The 2-year mortality and progressive CKD incidence even after complete recovery of renal function were significantly increased in cardiac surgery patients with postoperative AKI.     

Prosthesis-Patient Mismatch After Aortic Valve Replacement in the PARTNER 2 Trial and Registry

ObjectivesThis study aimed to compare incidence and impact of measured prosthesis-patient mismatch (PPM_M) versus predicted PPM (PPM_P) after surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR).BackgroundTAVR studies have used measured effective orifice area indexed (EOAi) to body surface area (BSA) to define PPM, but most SAVR series have used predicted EOAi. This difference may contribute to discrepancies in incidence and outcomes of PPM between series.MethodsThe study analyzed SAVR patients from the PARTNER (Placement of Aortic Transcatheter Valves) 2A trial and TAVR patients from the PARTNER 2 SAPIEN 3 Intermediate Risk registry. PPM was classified as moderate if EOAi ≤0.85 cm²/m² (≤0.70 if obese: body mass index ≥30 kg/m²) and severe if EOAi ≤0.65 cm²/m² (≤0.55 if obese). PPM_M was determined by the core lab–measured EOAi on 30-day echocardiogram. PPM_P was determined by 2 methods: 1) using normal EOA reference values previously reported for each valve model and size (PPM_P1; n = 929 SAVR, 1,069 TAVR) indexed to BSA; and 2) using normal reference EOA predicted from aortic annulus size measured by computed tomography (PPM_P2; n = 864 TAVR only) indexed to BSA. Primary endpoint was the composite of 5-year all-cause death and rehospitalization.ResultsThe incidence of moderate and severe PPM_P was much lower than PPM_M in both SAVR (PPM_P1: 28.4% and 1.2% vs. PPM_M: 31.0% and 23.6%) and TAVR (PPM_P1: 21.0% and 0.1% and PPM_P2: 17.0% and 0% vs. PPM_M: 27.9% and 5.7%). The incidence of severe PPM_M and severe PPM_P1 was lower in TAVR versus SAVR (P < 0.001). The presence of PPM by any method was associated with higher transprosthetic gradient. Severe PPM_P1 was independently associated with events in SAVR after adjustment for sex and Society of Thoracic Surgeons score (hazard ratio: 3.18;95% CI: 1.69-5.96; P < 0.001), whereas no association was observed between PPM by any method and outcomes in TAVR.ConclusionsEOAi measured by echocardiography results in a higher incidence of PPM following SAVR or TAVR than PPM based on predicted EOAi. Severe PPM_P is rare (<1.5%), but is associated with increased all-cause death and rehospitalization after SAVR, whereas it is absent following TAVR.     

The impact of mitral stenosis on outcomes of aortic valve stenosis patient undergoing surgical aortic valve replacement or transcatheter aortic valve replacement

Background

The concomitant presence of mitral stenosis (MS) in the setting of symptomatic aortic stenosis represent a clinical challenge. Little is known regarding the outcome of mitral stenosis (MS) patients undergoing transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). Therefore, we sought to study the outcome of MS patients undergoing aortic valve replacement (AVR).

Method

Using weighted data from the National Inpatient Sample (NIS) database between 2011 and 2014, we identified patients who were diagnosed with MS. Patients who had undergone TAVR as a primary procedure were identified and compared to patients who had SAVR. Univariate and multivariate logistic regression analysis were performed for the outcomes of in‐hospital mortality, length of stay (LOS), blood transfusion, postprocedural hemorrhage, vascular, cardiac and respiratory complications, permanent pacemaker placement (PPM), postprocedural stroke, acute kidney injury (AKI), and discharge to an outside facility.

Results

A total of 4524 patients were diagnosed with MS, of which 552 (12.2%) had TAVR and 3972 (87.8%) had SAVR. TAVR patients were older (79.9 vs 70.0) with more females (67.4% vs 60.0%) and African American patients (7.7% vs 7.1%) (P < 0.001). In addition, the TAVR group had more comorbidities compared to SAVR in term of coronary artery disease (CAD), congestive heart failure (CHF), chronic lung disease, hypertension (HTN), chronic kidney disease (CKD), and peripheral vascular disease (PVD) (P < 0.001 for all). Using Multivariate logistic regression, and after adjusting for potential risk factors, TAVR patients had lower in‐hospital mortality (7.9% vs 8.1% adjusted Odds Ratio [aOR], 0.615; 95% confidence interval [CI], 0.392–0.964, P = 0.034), shorter LOS. Also, TAVR patients had lower rates of cardiac and respiratory complications, PPM, AKI, and discharge to an outside facility compared with the SAVR group.

Conclusion

In patients with severe aortic stenosis and concomitant mitral stenosis, TAVR is a safe and attractive option for patients undergoing AVR with less complications compared with SAVR.

     

Long-Term Follow-Up of Hypoattenuated Leaflet Thickening After Transcatheter Aortic Valve Replacement

BackgroundEarly hypoattenuated leaflet thickening (HALT) occurs in at least 10% of all transcatheter aortic valve replacement (TAVR) patients. The long-term prognostic impact of HALT is uncertain.ObjectivesThe aim of this study was to assess the long-term risk of early HALT post-TAVR.MethodsWe report outcome data from our prospective observational registry with post-TAVR computed tomography angiography performed between May 2012 and December 2017. The outcomes were survival, cardiovascular mortality, ischemic cerebrovascular events, and symptomatic hemodynamic valve deterioration.ResultsEarly HALT was diagnosed in 115 (16.0%) of 804 patients. During a median follow-up of 3.25 years, survival rates did not differ significantly between patients with and without HALT (Kaplan-Meier 3-year estimates for survival 70.1% vs 74.0%, P = 0.597). The 3-year cardiovascular mortality rate was 13.2% versus 11.3% (with vs without HALT, P = 0.733). The 3-year event rate for cerebrovascular events was 2.0% versus 4.4% (with vs without HALT, P = 0.246), and the 3-year event rate of symptomatic hemodynamic valve deterioration was 9.4% versus 1.5% (with vs without HALT, P < 0.001). Multivariable analysis revealed the following predictors of symptomatic hemodynamic valve deterioration: HALT (HR: 6.10; 95% CI: 2.59-14.29; P < 0.001), the mixed valve–type group (HR: 6.51; 95% CI: 2.38-17.81; P < 0.001), and prosthesis diameter (HR valve size per 3 mm [HR: 0.37; 95% CI: 0.17-0.79]; P = 0.011).ConclusionsDuring a median follow-up of more than 3 years, HALT was not associated with mortality or cerebrovascular events. However, we observed an association of HALT with symptomatic hemodynamic valve deterioration.