Surgical Versus Transcatheter Aortic Valve Replacement in Patients With Malignancy

BackgroundPatients with aortic stenosis (AS) and malignancy experience poor clinical outcomes with challenging decisions regarding aortic valve replacement (AVR). We sought to compare the outcomes of transcatheter (TAVR) versus surgical (SAVR) AVR in patients with AS and malignancy.MethodsBased on the Nationwide Readmission Database, we compared all patients with malignancy who underwent isolated SAVR vs. TAVR in 2016 for severe AS. We performed univariate and multivariate analyses for baseline characteristics and clinical outcomes. A total of 2566 patients were included, 1952 (76%) had TAVR and the remaining 614 (24%) had isolated SAVR. Patients who underwent TAVR were older (82 vs 72 years, p < .001), had more metastasis (19 vs 14%, p = .004), heart failure (72% vs 34%, p < .001), coronary artery disease (72% vs 52%, p < .001), anemia (28% vs 22%, p = .006), chronic lung (30% vs 22%, p < .001) and renal disease (35% vs 14%, p < .001), and shorter length of stay (3 vs 7 days, p < .001).ResultsIn multivariate regression, TAVR and SAVR had similar in-patient mortality (HR = 1.08; 95%CI 0.61 ̶ 1.94) and 30-day readmission (HR = 1.26; 95%CI 0.95 ̶ 1.67). TAVR was associated with lower vascular complications (HR = 0.59; 95%CI 0.41 ̶ 0.86), acute deep venous thrombosis (HR = 0.25, 95%CI 0.1 ̶ 0.59), acute kidney injury (HR = 0.24, 95%CI 0.17 ̶ 0.33), blood transfusion (HR = 0.22, 95%CI 0.16 ̶ 0.3), cardiogenic shock (HR = 0.48, 95%CI 0.26 ̶ 0.89), and respiratory complications (HR = 0.26, 95%CI 0.2 ̶ 0.35).ConclusionsIn patients with malignancy, TAVR is a viable and safe option compared to SAVR with better clinical outcomes, especially thromboembolic events.     

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.     

Effect of Transcatheter Aortic Valve Replacement on Concomitant Mitral Regurgitation and Its Impact on Mortality

ObjectivesThe purpose of this study was to examine the impact of residual mitral regurgitation (MR) on mortality in patients undergoing transcatheter aortic valve replacement (TAVR).BackgroundMR is common in patients undergoing TAVR. Data on optimal management of patients with significant MR after TAVR are limited.MethodsThe registry consisted of 16 TAVR centers (n = 7,303). Outcomes of patients with ≥ moderate versus lesser grade MR after TAVR were compared.ResultsIn 1,983 (27.2%) patients, baseline MR grade was ≥ moderate. MR regressed in 874 (44.1%) patients and persisted in 1,109 (55.9%) after TAVR. Four-year mortality was higher for those with MR persistence, but not for those with MR regression after TAVR, compared with nonsignificant baseline MR (43.8% vs. 35.1% vs. 32.4%; hazard ratio [HR]: 1.38; p = 0.008; HR: 1.02; p = 0.383, respectively). New York Heart Association functional class III to IV after TAVR was more common in those with MR persistence vs. regression (14.4% vs. 3.9%; p < 0.001). In a propensity score–matched cohort (91 patients’ pairs), with significant residual MR after TAVR who did or did not undergo staged mitral intervention, staged intervention was associated with a better functional class through 1 year of follow-up (82.4% vs. 33.3% New York Heart Association functional class I or II; p < 0.001), and a numerically lower 4-year mortality, which was not statistically significant (64.6% vs. 37.5%; HR: 1.66; p = 0.097).ConclusionsRisk stratification based on improvement in MR and symptoms after TAVR can identify patients at increased mortality risk after TAVR. These patients may benefit from a staged transcatheter mitral intervention, but this requires further proof from future studies. (Transcatheter Treatment for Combined Aortic and Mitral Valve Disease. The Aortic+Mitral TRAnsCatheter [AMTRAC] Valve Registry [AMTRAC]; NCT04031274).     

The Effect of Coronary Lesion Complexity and Preprocedural Revascularization on 5-Year Outcomes After TAVR

BackgroundAortic stenosis and coronary artery disease (CAD) frequently coincide. However, the management of coexisting CAD in patients undergoing transcatheter aortic valve replacement (TAVR) remains controversial.ObjectivesThis study sought to determine whether the presence of CAD, its complexity, and angiography-guided percutaneous coronary intervention (PCI) are associated with outcomes after TAVR.MethodsAll patients undergoing TAVR at a tertiary referral center between 2008 and 2020 were included in a prospective observational study. Baseline SYNTAX (Synergy between PCI with Taxus and Cardiac Surgery) score (SS) and, whenever applicable, a residual SS after PCI were calculated. A multivariate analysis was performed to determine the effect of CAD, stratified according to complexity, and PCI on 5-year outcomes.ResultsIn 604 patients, the presence of CAD and its complexity were significantly associated with worse 5-year survival (SS 0: 67.9% vs SS 1-22: 56.1% vs SS >22: 53.0%; log-rank P = 0.027) and increased cardiovascular mortality (SS 0: 15.1% vs SS 1-22: 24.0% vs SS >22: 27.8%; log-rank P = 0.024) after TAVR. Having noncomplex CAD (SS 1-22) was an independent predictor for increased all-cause mortality (HR: 1.43; P = 0.046), while complex CAD (SS >22) increased cardiovascular mortality significantly (HR: 1.84; P = 0.041). Angiography-guided PCI or completeness of revascularization was not associated with different outcomes.ConclusionsThe presence of CAD and its anatomical complexity in patients undergoing TAVR are associated with significantly worse 5-year outcomes. However, angiography-guided PCI did not improve outcomes, highlighting the need for further research into physiology-guided PCI.     

Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Complex Coronary Artery Disease

ObjectivesThe aim of this study was to compare, in a cohort of patients with complex coronary artery disease (CAD) and severe aortic stenosis (AS), the clinical outcomes associated with transfemoral transcatheter aortic valve replacement (TAVR) (plus percutaneous coronary intervention [PCI]) versus surgical aortic valve replacement (SAVR) (plus coronary artery bypass grafting [CABG]).BackgroundPatients with complex CAD were excluded from the main randomized trials comparing TAVR with SAVR, and no data exist comparing TAVR + PCI vs SAVR + CABG in such patients.MethodsA multicenter study was conducted including consecutive patients with severe AS and complex CAD (SYNTAX [Synergy Between PCI with Taxus and Cardiac Surgery] score >22 or unprotected left main disease). A 1:1 propensity-matched analysis was performed to account for unbalanced covariates. The rates of major adverse cardiac and cerebrovascular events (MACCE), including all-cause mortality, nonprocedural myocardial infarction, need for new coronary revascularization, and stroke, were evaluated.ResultsA total of 800 patients (598 undergoing SAVR + CABG and 202 undergoing transfemoral TAVR + PCI) were included, and after propensity matching, a total of 156 pairs of patients were generated. After a median follow-up period of 3 years (interquartile range: 1-6 years), there were no significant differences between groups for MACCE (HR for transfemoral TAVR vs SAVR: 1.33; 95% CI: 0.89-1.98), all-cause mortality (HR: 1.25; 95% CI: 0.81-1.94), myocardial infarction (HR: 1.16; 95% CI: 0.41-3.27), and stroke (HR: 0.42; 95% CI: 0.13-1.32), but there was a higher rate of new coronary revascularization in the TAVR + PCI group (HR: 5.38; 95% CI: 1.73-16.7).ConclusionsIn patients with severe AS and complex CAD, TAVR + PCI and SAVR + CABG were associated with similar rates of MACCE after a median follow-up period of 3 years, but TAVR + PCI recipients exhibited a higher risk for repeat coronary revascularization. Future trials are warranted.     

Transcatheter Aortic Valve Replacement Outcomes Based on the Presence of Chronic Total Occlusion

AimsChronic total occlusion (CTO) has been linked to worse survival. While controversial and limited to observational data, successful CTO percutaneous coronary intervention (PCI) has been associated with improved left ventricular (LV) function and mortality. However, the role of CTO PCI prior to transcatheter aortic valve replacement (TAVR) is not clear. We sought to explore the prognostic impact of a pre-TAVR CTO on post-TAVR outcomes.Methods and resultsWe retrospectively reviewed 783 consecutive TAVR cases performed at a single tertiary care medical center. Pre-TAVR angiograms were analyzed for the presence of a CTO. At the time of TAVR, 12.6% (n = 99) patients had a CTO. At one-year post-TAVR, there was no significant association between the presence of a CTO and death (14.2% vs 13.1%, p = 0.75), functional status, quality of life, or adverse events. There was also no difference in long-term survival (4.1 years vs 4.1 years, p = 0.55). LV ejection fraction was lower in the CTO group at baseline and one year (p < 0.01).ConclusionsThe presence of a CTO did not have any prognostic impact on mortality, change in LV function, or improvement in functional status and angina scores following TAVR in our cohort of elderly, high-risk patients. CTO before TAVR was associated with decreased ejection fraction at baseline and at one year.     

ST-Segment Elevation Myocardial Infarction Following Transcatheter Aortic Valve Replacement

BackgroundAmong patients with acute coronary syndrome following transcatheter aortic valve replacement (TAVR), those presenting with ST-segment elevation myocardial infarction (STEMI) are at highest risk.ObjectivesThe goal of this study was to determine the clinical characteristics, management, and outcomes of STEMI after TAVR.MethodsThis was a multicenter study including 118 patients presenting with STEMI at a median of 255 days (interquartile range: 9 to 680 days) after TAVR. Procedural features of STEMI after TAVR managed with primary percutaneous coronary intervention (PCI) were compared with all-comer STEMI: 439 non-TAVR patients who had primary PCI within the 2 weeks before and after each post-TAVR STEMI case in 5 participating centers from different countries.ResultsMedian door-to-balloon time was higher in TAVR patients (40 min [interquartile range: 25 to 57 min] vs. 30 min [interquartile range: 25 to 35 min]; p = 0.003). Procedural time, fluoroscopy time, dose-area product, and contrast volume were also higher in TAVR patients (p < 0.01 for all). PCI failure occurred more frequently in patients with previous TAVR (16.5% vs. 3.9%; p < 0.001), including 5 patients in whom the culprit lesion was not revascularized owing to coronary ostia cannulation failure. In-hospital and late (median of 7 months [interquartile range: 1 to 21 months]) mortality rates were 25.4% and 42.4%, respectively (20.6% and 38.2% in primary PCI patients), and estimated glomerular filtration rate <60 ml/min (hazard ratio [HR]: 3.02; 95% confidence interval [CI]: 1.42 to 6.43; p = 0.004), Killip class ≥2 (HR: 2.74; 95% CI: 1.37 to 5.49; p = 0.004), and PCI failure (HR: 3.23; 95% CI: 1.42 to 7.31; p = 0.005) determined an increased risk.ConclusionsSTEMI after TAVR was associated with very high in-hospital and mid-term mortality. Longer door-to-balloon times and a higher PCI failure rate were observed in TAVR patients, partially due to coronary access issues specific to the TAVR population, and this was associated with poorer outcomes.     

Comparison of Transfemoral Transcatheter Aortic Valve Replacement Performed in the Catheterization Laboratory (Minimalist Approach) Versus Hybrid Operating Room (Standard Approach): Outcomes and Cost Analysis

ObjectivesThe aim of this study was to compare transfemoral transcatheter aortic valve replacement (TF TAVR) performed in a catheterization laboratory (minimalist approach [MA]) with TF TAVR performed in a hybrid operating room (standard approach [SA]).BackgroundA MA-TF TAVR can be performed without general anesthesia, transesophageal echocardiography, or a surgical hybrid room. The outcomes and cost of MA-TF TAVR compared with those of the SA have not been described.MethodsPatients who underwent elective, percutaneous TF TAVR using the Edwards Sapien valve (Edwards Lifesciences, Irvine, California) were studied. Baseline characteristics, outcomes, and hospital costs of MA-TF TAVR and SA-TF TAVR were compared.ResultsA total of 142 patients were studied (MA-TF TAVR, n = 70 and SA-TF TAVR, n = 72). There were no differences in baseline comorbidities (Society of Thoracic Surgeons score, 10.6 ± 4.3 vs. 11.4 ± 5.8; p = 0.35). All procedures in the MA-TF TAVR group were successful; 1 patient was intubated. Three patients in the SA-TF TAVR group had procedure-related death. Procedure room time (150 ± 48 min vs. 218 ± 56 min, p < 0.001), total intensive care unit time (22 h vs. 28 h, p < 0.001), length of stay from procedure to discharge (3 days vs. 5 days, p < 0.001), and cost ($45,485 ± 14,397 vs. $55,377 ± 22,587, p < 0.001) were significantly less in the MA-TF TAVR group. Mortality at 30 days was not significantly different in the MA-TF TAVR group (0 vs. 6%, p = 0.12) and 30-day stroke/transient ischemic attack was similar (4.3% vs. 1.4%, p = 0.35). Moderate or severe paravalvular leak and device success were similar in the MA-TF TAVR and SA-TF TAVR groups (3% vs. 5.8%, p = 0.4 and 90% vs. 88%, p = 0.79, respectively) at 30 days. At a median follow-up of 435 days, there was no significant difference in survival (MA-TF TAVR, 83% vs. SA-TF TAVR, 82%; p = 0.639).ConclusionsMA-TF TAVR can be performed with minimal morbidity and mortality and equivalent effectiveness compared with SA-TF TAVR. The shorter length of stay and lower resource use with MA-TF TAVR significantly lowers hospital costs.     

Long-Term Outcomes in Patients With New-Onset Persistent Left Bundle Branch Block Following TAVR

ObjectivesThe aim of this study was to determine the impact of new-onset persistent (NOP) left bundle branch block (LBBB) on long-term (>2 year) outcomes after transcatheter aortic valve replacement (TAVR).BackgroundThe impact of NOP-LBBB after TAVR remains controversial and no data exist regarding long-term outcomes.MethodsA total of 1,020 consecutive patients without pre-existing LBBB or permanent pacemaker implantation (PPI) undergoing TAVR were included. NOP-LBBB was defined as any new LBBB post-TAVR that persisted at hospital discharge. Follow-up clinical and echocardiographic data were obtained at a median of 3 years (interquartile range: 2 to 5 years) post-TAVR.ResultsNOP-LBBB occurred in 212 patients (20.1%) following TAVR. There were no differences between NOP-LBBB and no NOP-LBBB groups, except for a higher use of the self-expandable CoreValve system in the NOP-LBBB group (p < 0.001). At follow-up, there were no differences between NOP-LBBB and no NOP-LBBB groups in all-cause mortality (45.3% vs. 42.5%; adjusted hazard ratio [HR]:1.09; 95% confidence interval [CI]: 0.82 to 1.47; p = 0.54), cardiovascular mortality (14.2% vs. 14.4%; adjusted HR: 1.02; 95% CI: 0.56 to 1.87; p = 0.95), or heart failure rehospitalization (19.8% vs. 15.6%; adjusted HR: 1.44; 95% CI: 0.85 to 2.46; p = 0.18). NOP-LBBB was associated with an increased risk of permanent pacemaker implantation at follow-up (15.5% vs. 5.4%; adjusted HR: 2.45; 95% CI: 1.37 to 4.38; p = 0.002), with the highest risk within the first 12 months. Left ventricular ejection fraction increased over time in patients with no NOP-LBBB but slightly decreased in those with NOP-BBB (p < 0.001 for changes in left ventricular ejection fraction between groups).ConclusionsAfter a median follow-up of 3 years post-TAVR, NOP-LBBB was not associated with a higher mortality or heart failure rehospitalization. However, NOP-LBBB increased the risk of permanent pacemaker implantation and negatively impacted left ventricular function over time. These results should inform future efforts for improving the management of patients with NOP-LBBB post-TAVR.     

Nationally Representative Repeat Transcatheter Aortic Valve Replacement Outcomes: Report From the Centers for Medicare and Medicaid Services

ObjectivesThe aim of this study was to examine real-world experience with repeat transcatheter aortic valve replacement (TAVR) in a population-based national database.BackgroundRepeat TAVR is a growing option in patients requiring reintervention for TAVR. However, large-scale studies with longitudinal follow-up are limited.MethodsAll Medicare beneficiaries who underwent TAVR from 2012 to 2017 were included. Outcomes included 30-day and longitudinal mortality and major adverse cardiovascular events, defined as death, stroke, pacemaker insertion, major bleeding, acute kidney injury, or cardiac arrest. Outcomes of repeat TAVR were compared with surgical explantation after TAVR (TAVR explantation) in a matched analysis.ResultsOf 133,250 patients who underwent TAVR, 617 (0.46%) underwent subsequent repeat TAVR at a median interval of 154 days (interquartile range: 58-537 days). Mortality at 30 days and 1 year was 6.0% and 22.0%, respectively. Rates of 30-day stroke and pacemaker insertion were 1.8% and 4.2%. Mortality at 30 days was lower in those who underwent their first TAVR during the later era (2015-2017) compared with earlier years (2012-2014) (4.6% vs 8.7%; P = 0.049). Repeat TAVR was associated with lower 30-day mortality compared with a matched group undergoing TAVR explantation (6.2% vs 12.3%; P = 0.05), although 1-year mortality was similar (21.0% vs 20.8%; P = 1.000). The incidence of 30-day major adverse cardiovascular events was higher with TAVR explantation compared with repeat TAVR (risk ratio: 2.92; 95% CI: 1.88-4.99; P ≤ 0.001).ConclusionsRepeat TAVR was performed with acceptable 30-day mortality in this high-risk population. Short-term outcomes were superior to surgical explantation, but 1-year outcomes were similar. Repeat TAVR will likely be an important option for aortic valve reintervention after TAVR.     

Procedural Characteristics and Late Outcomes of Percutaneous Coronary Intervention in the Workup Pre-TAVR

ObjectivesThis study sought to determine, in patients undergoing percutaneous coronary intervention (PCI) during the work-up pre–transcatheter aortic valve replacement (TAVR): 1) the clinical and peri-procedural PCI characteristics; 2) the long-term outcomes; and 3) the clinical events in those patients with complex coronary features.BackgroundA PCI is performed in about 25% of TAVR candidates, but procedural features and late outcomes of pre-TAVR PCI remain largely unknown.MethodsMulticenter study including 1197 consecutive patients who had PCI in the work-up pre-TAVR. A total of 1,705 lesions (1.5 ± 0.7 lesions per patient) were included. Death, stroke, myocardial infarction, and major adverse cardiovascular and cerebrovascular events (MACCE) were recorded, as well as target lesion failure (TLF) and target vessel failure (TVF).ResultsOne-half of patients exhibited a multivessel disease and the mean SYNTAX (SYNergy between PCI with TAXUS and Cardiac Surgery) score was 12.1 ± 9.1. The lesions were of B2/C type, calcified, bifurcation, and ostial in 49.9%, 45.8%, 21.4%, and 19.3% of cases, respectively. After a median follow-up of 2 (interquartile range: 1 to 3) years, a total of 444 (37.1%) patients presented an MACCE. Forty patients exhibited TVF (3.3%), with TLF identified in 32 (2.7%) patients. By multivariable analysis, previous peripheral artery disease (p < 0.001), chronic obstructive pulmonary disease (p = 0.002), atrial fibrillation (p = 0.003), diabetes mellitus (p = 0.012), and incomplete revascularization (p = 0.014) determined an increased risk of MACCE. In patients with unprotected left main or SYNTAX score >32 (n = 128), TLF, TVF, and MACCE rates were 3.9%, 6.3%, and 35.9%, respectively (p = 0.378; p = 0.065, and p = 0.847, respectively, vs. the rest of the population).ConclusionsPatients undergoing PCI in the work-up pre-TAVR frequently exhibited complex coronary lesions and multivessel disease. PCI was successful in most cases, and TLF and TVF rates at 2-year follow-up were low, also among patients with high-risk coronary features. However, overall MACCE occurred in about one-third of patients, with incomplete revascularization determining an increased risk. These results should inform future studies to better determine the optimal revascularization strategy pre-TAVR.     

Predictors and Impact of Low Diastolic Blood Pressure and Widened Pulse Pressure Following Transcatheter Aortic Valve Replacement

BackgroundThe association between post-operative diastolic blood pressure (DBP) and pulse pressure (PP) with outcomes following transcatheter aortic valve replacement (TAVR) remains unclear. We sought to assess the prevalence, predictors, and impact of post-operative DBP and PP on presence of post-procedural aortic insufficiency (AI) and mortality in adults undergoing TAVR.MethodsThe study population included 194 patients who underwent TAVR from 2016 to 2017 at an academic tertiary medical center, of which 176 had invasive arterial pressures available postoperatively. Low DBP and widened PP were defined as ≤40 mmHg and ≥80 mmHg respectively on invasive arterial line on post-operative day 1. Clinical outcomes of interest included post-procedural AI and 1-year all-cause mortality.ResultsPost-operative low DBP and widened PP were noted in 32.4% and 58.5% of the study population. No significant association between post-operative AI and low DBP (p = 0.82) or widened PP (p = 0.32) was noted. There was a trend toward higher rates of mortality in patients with low DBP (19.3% vs 9.2%, p = 0.06) but no difference in mortality in patients with widened PP (10.7% vs 15.1%, p = 0.39) or those with ≥1+ post-procedural AI (16.7% vs 10.7%, p = 0.32). In multivariable analysis, low DBP was associated with a trend toward higher rates of 1-year mortality [odds ratio (OR) 2.43, 95% confidence interval (CI) 0.97–6.11, p = 0.06]. When excluding patients with a post-operative invasive systolic blood pressure < 80 mmHg, low DBP was associated with significantly higher risk-adjusted mortality at 1 year [OR 2.75, 95% CI (1.07–7.07), p = 0.04].ConclusionsIn this contemporary study of adults undergoing TAVR, low DBP and widened PP were widely prevalent post TAVR. Low DBP was associated with a trend toward higher rates of 1-year mortality but not with post-procedural AI.     

Comparative Effectiveness and Safety of New-Generation Versus Early-Generation Drug-Eluting Stents According to Complexity of Coronary Artery Disease: A Patient-Level Pooled Analysis of 6,081 Patients

ObjectivesThe purpose of this study was to compare the 2-year safety and effectiveness of new- versus early-generation drug-eluting stents (DES) according to the severity of coronary artery disease (CAD) as assessed by the SYNTAX (Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery) score.BackgroundNew-generation DES are considered the standard-of-care in patients with CAD undergoing percutaneous coronary intervention. However, there are few data investigating the effects of new- over early-generation DES according to the anatomic complexity of CAD.MethodsPatient-level data from 4 contemporary, all-comers trials were pooled. The primary device-oriented clinical endpoint was the composite of cardiac death, myocardial infarction, or ischemia-driven target-lesion revascularization (TLR). The principal effectiveness and safety endpoints were TLR and definite stent thrombosis (ST), respectively. Adjusted hazard ratios (HRs) with 95% confidence intervals (CIs) were calculated at 2 years for overall comparisons, as well as stratified for patients with lower (SYNTAX score ≤11) and higher complexity (SYNTAX score >11).ResultsA total of 6,081 patients were included in the study. New-generation DES (n = 4,554) compared with early-generation DES (n = 1,527) reduced the primary endpoint (HR: 0.75 [95% CI: 0.63 to 0.89]; p = 0.001) without interaction (p = 0.219) between patients with lower (HR: 0.86 [95% CI: 0.64 to 1.16]; p = 0.322) versus higher CAD complexity (HR: 0.68 [95% CI: 0.54 to 0.85]; p = 0.001). In patients with SYNTAX score >11, new-generation DES significantly reduced TLR (HR: 0.36 [95% CI: 0.26 to 0.51]; p < 0.001) and definite ST (HR: 0.28 [95% CI: 0.15 to 0.55]; p < 0.001) to a greater extent than in the low-complexity group (TLR p_int = 0.059; ST p_int = 0.013). New-generation DES decreased the risk of cardiac mortality in patients with SYNTAX score >11 (HR: 0.45 [95% CI: 0.27 to 0.76]; p = 0.003) but not in patients with SYNTAX score ≤11 (p_int = 0.042).ConclusionsNew-generation DES improve clinical outcomes compared with early-generation DES, with a greater safety and effectiveness in patients with SYNTAX score >11.     

Permanent Pacemaker Implantation Following Valve-in-Valve Transcatheter Aortic Valve Replacement: VIVID Registry

BackgroundPermanent pacemaker implantation (PPI) remains one of the main drawbacks of transcatheter aortic valve replacement (TAVR), but scarce data exist on PPI after valve-in-valve (ViV) TAVR, particularly with the use of newer-generation transcatheter heart valves (THVs).ObjectivesThe goal of this study was to determine the incidence, factors associated with, and clinical impact of PPI in a large series of ViV-TAVR procedures.MethodsData were obtained from the multicenter VIVID Registry and included the main baseline and procedural characteristics, in-hospital and late (median follow-up: 13 months [interquartile range: 3 to 41 months]) outcomes analyzed according to the need of periprocedural PPI. All THVs except CoreValve, Cribier-Edwards, Sapien, and Sapien XT were considered to be new-generation THVs.ResultsA total of 1,987 patients without prior PPI undergoing ViV-TAVR from 2007 to 2020 were included. Of these, 128 patients (6.4%) had PPI after TAVR, with a significant decrease in the incidence of PPI with the use of new-generation THVs (4.7% vs. 7.4%; p = 0.017), mainly related to a reduced PPI rate with the Evolut R/Pro versus CoreValve (3.7% vs. 9.0%; p = 0.002). There were no significant differences in PPI rates between newer-generation balloon- and self-expanding THVs (6.1% vs. 3.9%; p = 0.18). In the multivariable analysis, older age (odds ratio [OR]: 1.05 for each increase of 1 year; 95% confidence interval [CI]: 1.02 to 1.07; p = 0.001), larger THV size (OR: 1.10; 95% CI: 1.01 to 1.20; p = 0.02), and previous right bundle branch block (OR: 2.04; 95% CI: 1.00 to 4.17; p = 0.05) were associated with an increased risk of PPI. There were no differences in 30-day mortality between the PPI (4.7%) and no-PPI (2.7%) groups (p = 0.19), but PPI patients exhibited a trend toward higher mortality risk at follow-up (hazard ratio: 1.39; 95% CI: 1.02 to 1.91; p = 0.04; p = 0.08 after adjusting for age differences between groups).ConclusionsIn a contemporary large series of ViV-TAVR patients, the rate of periprocedural PPI was relatively low, and its incidence decreased with the use of new-generation THV systems. PPI following ViV-TAVR was associated with a trend toward increased mortality at follow-up.     

Safety and Efficacy of Protamine Administration for Prevention of Bleeding Complications in Patients Undergoing TAVR

ObjectivesThe aim of this study was to evaluate whether protamine administration for heparin reversal after transcatheter aortic valve replacement (TAVR) reduces bleeding complications and affects patient outcomes.BackgroundOccurrence of major bleeding complications in patients undergoing TAVR is associated with increased morbidity and mortality.MethodsThis study included 873 patients undergoing TAVR, of whom 677 received protamine for heparin reversal. Standard access management included the use of pre-closure devices, manual compression, and percutaneous transluminal angioplasty or implantation of a covered stent graft, if necessary. The study complied with Good Clinical Practice guidelines and was approved by the local ethics committee. Written informed consent was obtained from all patients.ResultsThe primary endpoint, a composite of 30-day all-cause mortality and life-threatening and major bleeding, occurred less frequently in the protamine administration group (3.2%) compared with the control group (8.7%) (p = 0.003). This was driven mainly by lower rates of life-threatening and major bleeding in the protamine group (0.1% vs. 2.6% [p < 0.001] and 1.0% vs. 4.1% [p = 0.008], respectively). Furthermore, protamine administration resulted in a significantly shorter hospital stay (11.1 ± 5.8 days vs. 12.7 ± 7.8 days; p = 0.05). In the overall cohort, stroke was observed in 1.9% and myocardial infarction in 0.2% of patients, with no significant difference between the groups (p > 0.05). Multivariate analysis revealed that only protamine administration (odds ratio: 0.24; 95% confidence interval: 0.10 to 0.58; p = 0.001) and acute kidney injury (odds ratio: 5.82; 95% confidence interval: 2.02 to 16.77; p = 0.001) were independently associated with the primary endpoint.ConclusionsProtamine administration resulted in significantly lower rates of life-threatening and major bleeding complications compared with patients without heparin reversal. Occurrence of stroke and myocardial infarction was not increased by protamine administration.     

The Effect and Relationship of Frailty Indices on Survival After Transcatheter Aortic Valve Replacement

ObjectivesThis study sought to evaluate the ability of individual markers of frailty to predict outcomes after transcatheter aortic valve replacement (TAVR) and of their discriminatory value in different age groups.BackgroundAppropriate patient selection for TAVR remains a dilemma, especially among the most elderly and potentially frail.MethodsThe study evaluated patients ≥65 years of age in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy registry, linked to Centers for Medicare and Medicaid administrative claims data, receiving elective TAVR from November 2011 to June 2016 (n = 36,242). Indices of frailty included anemia, albumin level, and 5-m walk speed. We performed Cox proportional hazards regression for 30-day and 1-year mortality, adjusting for risk factors known to be predictive of 30-day mortality in the Transcatheter Valve Therapy registry, as well as survival analysis.ResultsThese indices are independently associated with mortality at 30 days and 1 year and provide incremental value in risk stratification for mortality, with low albumin providing the largest value (hazard ratio: 1.52). Those with low albumin and slower walking speed had longer lengths of stay and higher rates of bleeding and readmission (p < 0.001). Those with anemia also had higher rates of bleeding, readmission, and subsequent myocardial infarction (p < 0.001).ConclusionsThis represents the largest study to date of the role of frailty indices after TAVR, further facilitating robust modeling and adjusting for a large number of confounders. These simple indices are easily attainable, and clinically relevant markers of frailty that may meaningfully stratify patients at risk for mortality after TAVR.     

Outcomes Following Transcatheter Aortic Valve Replacement for Degenerative Stentless Versus Stented Bioprostheses

ObjectivesA large comprehensive analysis of transcatheter aortic valve replacement (TAVR) was performed for failed stentless bioprostheses.BackgroundValve-in-valve (ViV) transcatheter aortic replacement (TAVR) is an alternative to redo surgery for patients with a failing aortic bioprosthesis.MethodsUnadjusted outcome data were collected from the VIVID (Valve-in-Valve International Data) registry between 2007 and 2016 from a total of 1,598 aortic ViV procedures (291 stentless, 1,307 stented bioprostheses).ResultsBioprosthetic failure was secondary to aortic regurgitation in 56% of stentless and 20% stented devices (p < 0.001). ViV-TAVR access was transfemoral in 71.1% stentless and 74.2% stented ViV-TAVR. Self-expanding devices were more frequently used in stentless ViV-TAVR (56.0% vs. 39.9%; p = 0.05), but there was no difference between balloon-expanding and self-expanding TAVR devices for stented ViV-TAVR (48.6% vs. 45.1%). The degree of oversizing for all mechanisms of bioprosthesis failure was 9 ± 10% for stentless ViV-TAVR vs. 6 ± 9% for stented ViV-TAVR (and 8 ± 10% for stentless ViV-TAVR vs. 3 ± 9% for stented ViV-TAVR in patients with predominant aortic regurgitation; both p < 0.001). Initial device malposition (10.3% vs. 6.2%; p = 0.014), second transcatheter device (7.9% vs. 3.4%), coronary obstruction (6.0% vs. 1.5%), and paravalvular leak occurred more frequently in stentless ViV-TAVR (all p < 0.001). Hospital stay duration (median 7 days) was no different, and 30-day (6.6% vs. 4.4%; p = 0.12) and 1-year mortality year (15.8% vs. 12.6%; p = 0.15) were numerically higher, but not statistically different, after stentless ViV-TAVR.ConclusionsStentless ViV-TAVR is associated with greater periprocedural complications (initial device malposition, second transcatheter device, coronary obstruction, paravalvular leak), but no difference in 30-day and 1-year outcome.     

Predictors and Prognostic Impact of Nutritional Changes After Transcatheter Aortic Valve Replacement

BackgroundLittle is known about changes in nutritional status as an index of frailty on clinical outcomes after transcatheter aortic valve replacement (TAVR). This study aimed to assess the clinical impact of serum albumin changes after TAVR.MethodsChanges in serum albumin levels from baseline to 1 year after TAVR were evaluated in 1524 patients who were classified as having hypoalbuminemia (<3.5 g/dl) and normoalbuminemia (≥3.5 g/dl) at each timepoint. The patients were categorized into 4 groups: NN (baseline normoalbuminemia, 1-year normoalbuminemia: n = 1119), HN (baseline hypoalbuminemia, 1-year normoalbuminemia: n = 202), NH (baseline normoalbuminemia, 1-year hypoalbuminemia: n = 121), and HH (baseline hypoalbuminemia, 1-year hypoalbuminemia: n = 82). We also defined late hypoalbuminemia as hypoalbuminemia identified at the 1-year assessment. Clinical outcomes were compared among 4 groups. Multivariable analysis was driven to assess the variables associated with late hypoalbuminemia and long-term mortality.ResultsThe cumulative 3-year mortality was significantly different among the 4 groups (NN: 11.4%, HN: 10.7%, NH: 25.4%, HH: 44.4%, p < 0.001). Multivariable Cox regression analysis revealed that the NH group had a higher mortality risk (hazard ratio [HR]; 2.80 and 3.53, 95% confidence interval [CI]; 1.71–4.57 and 2.06–6.06, p < 0.001 and p < 0.001, respectively), whereas the HN group had a similar risk (HR; 1.16, 95% CI; 0.66–2.06, p = 0.61) compared with the NN group. Baseline hypoalbuminemia, low body mass index, liver disease, peripheral artery disease, and hospital readmission within 1 year were predictors of late hypoalbuminemia (all p < 0.05).ConclusionSerial albumin assessment may identify poor prognostic subsets in patients with persistent and late acquired malnutrition after TAVR.     

Impact of Pulmonary Hypertension Hemodynamic Status on Long-Term Outcome After Transcatheter Aortic Valve Replacement

ObjectivesThe aim of this study was to investigate the prognostic impact and development of pulmonary hypertension (PH) in the different hemodynamic subtypes of PH in patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR).BackgroundPH is a frequent finding in patients with severe AS and predicts outcome after TAVR. Nevertheless, outcomes among PH subtypes and the impact of residual PH after TAVR are controversial.MethodsA total of 1,400 patients with symptomatic AS and full invasive hemodynamic assessment before and after TAVR were included. Patients were stratified into 4 groups: no PH (n = 658); isolated pre-capillary PH (n = 139), isolated post-capillary PH (Ipc-PH; n = 534), and combined post-capillary and pre-capillary PH (n = 69).ResultsThe mean overall patient age was 81.5 ± 6.8 years, and 46.3% were men. Acute device success was achieved in 94.9%. Patients without PH showed significantly lower mortality rates compared with patients with PH (1 year, 13.8% vs. 22.4% [p < 0.001]; 4 years, 37.2% vs. 51.5% [p < 0.001]). Patients with pre-capillary PH showed 1.9-fold increased 1-year mortality and those with Ipc-PH showed 1.5-fold increased 1-year mortality compared with patients without pH (p = 0.001). No differences regarding survival were found among the subgroups. Only in patients with Ipc-PH, residual PH was associated with 2.1-fold increased mortality (p = 0.010). All patients benefited in terms of functional capacity after TAVR.ConclusionsPatients with pre-capillary PH and those with Ipc-PH showed significantly higher risk for death after TAVR compared with those without PH. Reversible PH had no benefit for survival except in patients with Ipc-PH. Hemodynamic stratification of PH is helpful for risk and response prediction in patients with AS undergoing TAVR.     

Impact of Lipoprotein(a) concentrations on long-term cardiovascular outcomes in patients undergoing percutaneous coronary intervention: A large cohort study

Background and aimsTill now, the prognostic value of lipoprotein(a) [Lp(a)] in patients with coronary artery disease (CAD) who underwent percutaneous coronary intervention (PCI) remains controversial. We therefore conducted this study to evaluate the effect of Lp(a) levels on clinical outcomes in this population.Methods and resultsA total of 10,059 CAD patients who underwent PCI were prospectively enrolled in this cohort study, of which 6564 patients had Lp(a) ≤30 mg/dl and 3495 patients had Lp(a) > 30 mg/dl. The primary endpoint was major adverse cardiovascular and cerebrovascular event (MACCE), defined as a composite of all-cause death, myocardial infarction, stroke or unplanned revascularization. Multivariate Cox regression analysis and propensity-score matching analysis were performed. After propensity-score matching, 3449 pairs of patients were identified, and post-matching absolute standardized differences were <10% for all the covariates. At 2.4 years, the risk of MACCE was significantly higher in patients with elevated Lp(a) levels than those with normal Lp(a) levels in both overall population (13.0% vs. 11.4%; adjusted hazard ratio [HR] 1.142, 95% confidence interval [CI] 1.009–1.293; P = 0.040) and propensity-matched cohorts (13.0% vs. 11.2%; HR 1.167, 95%CI 1.019–1.337; P = 0.026). Of note, the predictive value of Lp(a) levels on MACCE tended to be more evident in individuals >65 years or those with left main and/or three-vessel disease. On the contrary, elevated Lp(a) levels had almost no effect on clinical outcomes in patients ≤65 years (P _interaction = 0.021) as well as those who had one- or two-vessel coronary artery disease (P _interaction = 0.086).ConclusionIn CAD patients who underwent PCI, elevated Lp(a) levels were positively related to higher risk of MACCE at 2.4-year follow-up, especially in patients >65 years and those with left main and/or three-vessel disease.Registration numbernot applicable.