Myocardial Injury After Transcatheter Aortic Valve Replacement According to VARC-3 Criteria.

BACKGROUND: The Valve Academic Research Consortium (VARC)-3 definition for myocardial injury after transcatheter aortic valve replacement (TAVR) lacks of clinical validation. OBJECTIVES: This study sought to determine the incidence, predictors, and clinical impact of periprocedural myocardial injury (PPMI) following TAVR as defined by recent VARC-3 criteria. METHODS: We included 1,394 consecutive patients who underwent TAVR with a new-generation transcatheter heart valve. High-sensitivity troponin levels were assessed at baseline and within 24 hours after the procedure. PPMI was defined according to VARC-3 criteria as an increase ≥70 times in troponin levels (vs ≥15 times according to the VARC-2 definition). Baseline, procedural, and follow-up data were prospectively collected. RESULTS: PPMI was diagnosed in 193 (14.0%) patients. Female sex and peripheral artery disease were independent predictors of PPMI (P < 0.01 for both). PPMI was associated with a higher risk of mortality at 30-day (HR: 2.69, 95% CI: 1.50-4.82; P = 0.001) and 1-year (for all-cause mortality, HR: 1.54; 95% CI: 1.04-2.27; P = 0.032; for cardiovascular mortality, HR: 3.04; 95% CI: 1.68-5.50; P < 0.001) follow-up. PPMI according to VARC-2 criteria had no impact on mortality. CONCLUSIONS: About 1 out of 10 patients undergoing TAVR in the contemporary era had PPMI as defined by recent VARC-3 criteria, and baseline factors like female sex and peripheral artery disease determined an increased risk. PPMI had a negative impact on early and late survival. Further studies on the prevention of PPMI post-TAVR and implementing measures to improve outcomes in PPMI patients are warranted.

Late Access Site Complications Following Transfemoral Aortic Valve Implantation.

Few data exist on late vascular complications (VCs) after transfemoral (TF) transcatheter aortic valve implantation (TAVI). The objective of this study was to evaluate the incidence and predictors of late access site VC after TF TAVI. A total of 128 patients (mean age: 80 ± 8 years, women: 52%) who underwent TF TAVI without major VC were included. A femoral US-Doppler evaluation was performed in all patients at a median of 5 (3 to 15) months after the procedure, and 76 patients (59.4%) also had a preprocedural ultrasound (US)-Doppler examination. The impact of baseline and procedural factors (including the use of simple 2 Proglides or complex additional Proglide or Angioseal device on top of the 2 Proglide technique, hemostasis techniques, and the use of balloon dilation for optimizing femoral hemostasis) were evaluated. The follow-up US-Doppler evaluation detected 2 asymptomatic VCs (1.6%), and 5 (3.9%) patients exhibited significant femoral stenosis (peak systolic velocity [PSV] ≥300 cm/s). Female gender (p <0.001) and smaller femoral diameter (p = 0.045) were associated with higher femoral PSV values. In those patients who underwent a pre-TAVI femoral US-Doppler, the median PSV values after TAVI were higher compared with those obtained pre-TAVI (p <0.001), but similar results were found for the contralateral femoral arteries. A complex hemostasis technique or the use of balloon optimization at the puncture site was not associated with any increase in PSV values. In conclusion, percutaneous femoral hemostasis after TAVI was associated with a low rate of late VC. The results were similar irrespective of the hemostasis technique and the use of balloon dilation at the puncture site, but women and a smaller femoral size were associated with increased PSV values. Further studies are needed to determine the optimal femoral hemostasis technique in TAVI procedures.

Impact of residual transvalvular gradient on clinical outcomes following valve-in-valve transcatheter aortic valve replacement.

BACKGROUND: High (≥20 mmHg) postprocedural mean transvalvular gradients are relatively common among valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) recipients, but its clinical impact remains controversial. METHODS: Observational study including 190 consecutive ViV-TAVR recipients. Patients were classified according to the presence of high (≥20 mmHg) or low (<20 mmHg) residual mean transvalvular gradient on post-procedural echocardiography. Functional status (NYHA class, DASI), exercise capacity (6MWT), and quality of life (KCCQ) were evaluated at baseline and at 1-year follow-up. RESULTS: 73 (38.4%) and 117 (61.6%) patients exhibited high (HG) and low (LG) postprocedural gradients, respectively. Baseline characteristics were well balanced between groups except for a lower rate of large (>23 mm) surgical valves, atrial fibrillation, and aortic regurgitation as mechanism of valve failure in the HG group (p < 0.05 for all). After a median follow-up of 3 (1-5) years, there were no differences between HG and LG groups in HF hospitalization (HRadj: 1.38, 95%CI 0.44-4.22, p = 0.57), cardiac death (HRadj: 0.50; 95%CI 0.11-2.41, p = 0.39), all-cause mortality (HRajd: 0.71; 95%CI 0.35-1.46, p = 0.36), or the composite endpoint of heart failure/all-cause mortality (HRadj:1.00; 95%CI 0.52-1.94, p = 0.98). At 1-year follow-up, functional status (ΔDASI score, HG: 9.9 ± 10.9, LG: 9.9 ± 12.5, padj = 0.41), exercise capacity (Δ6MWT, HG: 111 ± 67 m, LG: 103 ± 124 m, padj = 0.14), and quality of life parameters (ΔKCCQ, HG: 27 ± 18, LG: 17 ± 21, padj = 0.12) improved similarly in both groups. CONCLUSIONS: HG as evaluated by echocardiography following ViV-TAVR were not associated with a negative effect on clinical outcomes including major adverse events, functional status, exercise capacity and quality of life parameters.

Unplanned Hospital Readmissions After Transcatheter Aortic Valve Replacement in the Era of New-Generation Devices.

OBJECTIVES: Unplanned hospital readmissions after transcatheter aortic valve replacement (TAVR) are frequent and have been associated with a poor prognosis. We sought to determine the trends in the incidence and causes of unplanned hospital readmission after TAVR in patients receiving new-generation devices (NGDs) vs early-generation devices (EGDs). METHODS: The study population consisted of 1802 consecutive TAVR recipients (863 EGDs and 939 NGDs). Early and late readmissions were defined as those occurring ≤30 days and >30 days to 1-year post TAVR, respectively. RESULTS: A total of 986 unplanned hospital readmissions (cardiac cause, 38.4%; non-cardiac cause, 61.6%) were recorded at a median time of 110 days (interquartile range [IQR], 37-217) post TAVR. The rates of early (12.3% vs 9.4%; P=.046) and late (39.1% vs 31.6%; P<.01) readmission were lower in the NGD population. In the NGD group, major/life-threatening periprocedural bleeding (hazard ratio [HR], 2.40, 95% confidence interval [CI], 1.06-5.42; P=.04) and estimated glomerular filtration rate (eGFR) <60 mL/min at hospital discharge (HR, 1.80; 95% CI, 1.15-2.83; P=.01) were associated with an increased risk of early readmission post TAVR. Chronic obstructive pulmonary disease (HR, 1.42; 95% CI, 1.07-1.88; P=.02), eGFR <60 mL/min (HR, 1.43; 95% CI, 1.11-1.84; P<.01), and combining antiplatelet and anticoagulation therapy (HR, 1.37; 95% CI, 1.01-1.85; P=.04) determined an increased risk of late readmission. CONCLUSIONS: TAVR recipients receiving NGDs exhibited a significant but modest reduction in unplanned hospital readmissions, with about one-third of patients still requiring rehospitalization at 1-year follow-up in the contemporary TAVR era. Non-cardiac comorbidities, periprocedural bleeding events, and intensive antithrombotic therapy determined an increased risk.

Impact of Preexisting Left Bundle Branch Block in Transcatheter Aortic Valve Replacement Recipients

BACKGROUND: The impact of preexisting left bundle branch block (LBBB) in transcatheter aortic valve replacement (TAVR) recipients is unknown. The aim of this study was to determine the impact of preexisting LBBB on clinical outcomes after TAVR. METHODS AND RESULTS: This multicenter study evaluated 3404 TAVR candidates according to the presence or absence of LBBB on baseline ECG. TAVR complications and causes of death were defined according to Valve Academic Research Consortium-2 definitions. Follow-up outpatient visits or telephone interviews were conducted at 30 days, 12 months, and yearly thereafter. Echocardiography examinations were performed at baseline, at hospital discharge, and at 1-year follow-up. Preexisting LBBB was present in 398 patients (11.7%) and was associated with an increased risk of permanent pacemaker implantation (PPI; 21.1% versus 14.8%; adjusted odds ratio, 1.51; 95% CI, 1.12­2.04) but not death (7.3% versus 5.5%; adjusted odds ratio, 1.33; 95% CI, 0.84­2.12) at 30 days. At a mean follow-up of 22±21 months, there were no differences between patients with and without preexisting LBBB in overall mortality (adjusted hazard ratio, 0.94; 95% CI, 0.75­1.18) and cardiovascular mortality (adjusted hazard ratio, 0.90; 95% CI, 0.68­1.21). In a subanalysis of 2421 patients without PPI at 30 days and with complete follow-up about the PPI, preexisting LBBB was not associated with an increased risk of PPI or sudden cardiac death. Patients with preexisting LBBB had a lower left ventricular ejection fraction (LVEF) at baseline and at 1-year follow-up (P <0.001 for both), but those with low LVEF exhibited a similar increase in LVEF over time after TAVR compared with patients with no preexisting LBBB (P=0.327). CONCLUSIONS: Preexisting LBBB significantly increased the risk of early (but not late) PPI after TAVR, without any significant effect on overall mortality or cardiovascular mortality. Preexisting LBBB was associated with lower LVEF pre-TAVR but did not prevent an increase in LVEF post-TAVR similar to patients without LBBB.

Clinical impact of baseline right bundle branch block in patients undergoing transcatheter aortic valve replacement

This study sought to assess the influence of baseline right bundle branch block (RBBB) on all-cause and cardiovascular mortality as well as sudden cardiac death (SCD) among patients undergoing transcatheter aortic valve replacement (TAVR). Few data exist regarding the late clinical impact of pre-existing RBBB in TAVR recipients. A total of 3,527 patients (mean age 82 8 years, 50.1% men) were evaluated according to the presence of RBBB on baseline electrocardiography. Intraventricular conduction abnormalities were classified according to the American Heart Association, American College of Cardiology Foundation, and Heart Rhythm Society recommendations for standardization and interpretation of the electrocardiogram. TAVR complications and causes of death were defined according to Valve Academic Research Consortium 2 definitions. RBBB was present on baseline electrocardiography in 362 patients (10.3%) and associated with higher 30-day rates of permanent pacemaker implantation (PPI) (40.1% vs. 13.5%; p < 0.001) and death (10.2% vs. 6.9%; p » 0.024). At a mean follow-up of 20 18 months, pre-existing RBBB was independently associated with all-cause mortality (hazard ratio [HR]: 1.31; 95% confidence interval [CI]: 1.06 to 1.63; p » 0.014) and cardiovascular mortality (HR: 1.45; 95% CI: 1.11 to 1.89; p » 0.006) but not with SCD (HR: 0.71; 95% CI: 0.22 to 2.32; p » 0.57). Patients with pre-existing RBBB and without PPI at discharge from the index hospitalization had the highest 2-year risk for cardiovascular death (27.8%; 95% CI: 20.9% to 36.1%; log-rank p » 0.007). In a subanalysis of 1,245 patients without PPI at discharge from the index hospitalization and with complete follow-up regarding the need for PPI, pre-existing RBBB was independently associated with the composite of SCD and PPI (HR: 2.68; 95% CI: 1.16 to 6.17; p » 0.023)

Late cardiac death in patients undergoing transcatheter aortic valve replacement

BACKGROUND Little evidence exists of the burden and predictors of cardiac death after transcatheter aortic valvereplacement (TAVR).OBJECTIVES The purpose of this study was to assess the incidence and predictors of cardiac death from advancedheart failure (HF) and sudden cardiac death (SCD) in a large patient cohort undergoing TAVR.METHODS The study included a total of 3,726 patients who underwent TAVR using balloon (57%) or self-expandable(43%) valves. Causes of death were defined according to the Valve Academic Research Consortium–2.RESULTS At a mean follow-up of 22 18 months, 155 patients had died due to advanced HF (15.2% of total deaths,46.1% of deaths from cardiac causes) and 57 had died due to SCD (5.6% of deaths, 16.9% of cardiac deaths). Baselinecomorbidities (chronic obstructive pulmonary disease, atrial fibrillation, left ventricular ejection fraction #40%, lowermean transaortic gradient, pulmonary artery systolic pressure >60 mm Hg; p 160 ms had a greater SCD risk (HR: 4.78, 95% CI: 1.56 to 14.63; p » 0.006).CONCLUSIONS Advanced HF and SCD accounted for two-thirds of cardiac deaths in patients after TAVR.Potentially modifiable or treatable factors leading to increased risk of mortality for HF and SCD were identified. Future.