Transcatheter or Surgical Aortic Valve Replacement in Patients With Severe Aortic Stenosis and Small Aortic Annulus: A Randomized Clinical Trial.

BACKGROUND: The optimal treatment in patients with severe aortic stenosis and small aortic annulus (SAA) remains to be determined. This study aimed to compare the hemodynamic and clinical outcomes between transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) in patients with a SAA. METHODS: This prospective multicenter international randomized trial was performed in 15 university hospitals. Participants were 151 patients with severe aortic stenosis and SAA (mean diameter <23 mm) randomized (1:1) to TAVR (n=77) versus SAVR (n=74). The primary outcome was impaired valve hemodynamics (ie, severe prosthesis patient mismatch or moderate-severe aortic regurgitation) at 60 days as evaluated by Doppler echocardiography and analyzed in a central echocardiography core laboratory. Clinical events were secondary outcomes. RESULTS: The mean age of the participants was 75.5±5.1 years, with 140 (93%) women, a median Society of Thoracic Surgeons predicted risk of mortality of 2.50% (interquartile range, 1.67%-3.28%), and a median annulus diameter of 21.1 mm (interquartile range, 20.4-22.0 mm). There were no differences between groups in the rate of severe prosthesis patient mismatch (TAVR, 4 [5.6%]; SAVR, 7 [10.3%]; P=0.30) and moderate-severe aortic regurgitation (none in both groups). No differences were found between groups in mortality rate (TAVR, 1 [1.3%]; SAVR, 1 [1.4%]; P=1.00) and stroke (TAVR, 0; SAVR, 2 [2.7%]; P=0.24) at 30 days. After a median follow-up of 2 (interquartile range, 1-4) years, there were no differences between groups in mortality rate (TAVR, 7 [9.1%]; SAVR, 6 [8.1%]; P=0.89), stroke (TAVR, 3 [3.9%]; SAVR, 3 [4.1%]; P=0.95), and cardiac hospitalization (TAVR, 15 [19.5%]; SAVR, 15 [20.3%]; P=0.80). CONCLUSIONS: In patients with severe aortic stenosis and SAA (women in the majority), there was no evidence of superiority of contemporary TAVR versus SAVR in valve hemodynamic results. After a median follow-up of 2 years, there were no differences in clinical outcomes between groups. These findings suggest that the 2 therapies represent a valid alternative for treating patients with severe aortic stenosis and SAA, and treatment selection should likely be individualized according to baseline characteristics, additional anatomical risk factors, and patient preference. However, the results of this study should be interpreted with caution because of the limited sample size leading to an underpowered study, and need to be confirmed in future larger studies. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03383445.

Safety and Efficacy of TAVR With a Pressure Sensor and Pacing Guidewire: SAFE-TAVI Trial.

BACKGROUND: The SavvyWire (OpSens Inc) is a 0.035-inch preshaped guidewire with dedicated pacing properties and a distal pressure sensor allowing for continuous hemodynamic pressure monitoring. OBJECTIVES: This study sought to determine the efficacy and safety of the guidewire during transcatheter aortic valve replacement (TAVR) procedures. METHODS: This prospective, multicenter clinical study included patients with severe aortic stenosis undergoing TAVR in 8 European centers. The primary efficacy endpoint was defined as effective left ventricular rapid pacing runs with the guidewire translating into a significant systemic pressure drop (below 60 mm Hg). The safety outcome included the absence of major procedural complications related to the guidewire. RESULTS: A total of 121 patients (mean age: 82.2 ± 5.9 years, 50% women) were included in the study, and 119 (98.3%) patients were finally treated with the study device. A balloon-expandable valve was implanted in 45 (37.8%) patients. Predilatation and postdilatation were performed in 89 (74.8%) and 14 (11.8%) patients, respectively. The primary efficacy endpoint was achieved in 116 (98.3%) patients, and the mean aortic systolic arterial pressure achieved during rapid pacing was 46.6 ± 11.3 mm Hg. Hemodynamic assessment with the use of the OptoMonitor 3 (OpSens Inc) without additional catheter exchange was achieved in 117 (99.2%) patients. The safety endpoint was achieved in 117 (99.2%) patients. No procedural mortality, stroke, or ventricular perforation was reported. CONCLUSIONS: The use of the guidewire during TAVR procedures appeared to be efficacious and safe. This device could help minimize interventions during the procedure and improve the clinical decision making after transcatheter heart valve deployment. (SavvyWire Efficacy and Safety in Transcatheter Aortic Valve Implantation Procedures [SAFE-TAVI]; NCT05492383).

Balloon- vs Self-Expanding Transcatheter Valves for Failed Small Surgical Aortic Bioprostheses: 1-Year Results of the LYTEN Trial.

BACKGROUND: Data comparing valve systems in the valve-in-valve transcatheter aortic valve replacement (ViV-TAVR) field have been obtained from retrospective studies. OBJECTIVES: The authors sought to compare the 1-year hemodynamic performance and clinical outcomes between balloon-expandable valves (BEV) SAPIEN 3/ULTRA (Edwards Lifesciences) and self-expanding valves (SEV) Evolut R/PRO/PRO+ (Medtronic) in ViV-TAVR. METHODS: Patients with a failed small (≤23 mm) surgical valve undergoing ViV-TAVR were randomized to receive a SEV or a BEV. Patients had a clinical and valve hemodynamic (Doppler echocardiography) evaluation at 1-year follow-up. Study outcomes were defined according to VARC-2/VARC-3 criteria. Intended performance of the valve was defined as mean gradient <20 mm Hg, peak velocity <3 m/s, Doppler velocity index ≥0.25 and less than moderate AR. RESULTS: A total of 98 patients underwent ViV-TAVR (46 BEV, 52 SEV). At 1-year follow-up, patients receiving a SEV had a lower mean transaortic gradient (22 ± 8 mm Hg BEV vs 14 ± 7 mm Hg SEV; P < 0.001), and a higher rate of intended valve performance (BEV: 30%, SEV:76%; P < 0.001). There were no cases of greater than mild aortic regurgitation. There were no differences in functional status (NYHA functional class >II, BEV: 7.3%, SEV: 4.1%; P = 0.505) or quality of life (Kansas City Cardiomyopathy Questionnaire, BEV: 77.9 ± 21.2, SEV: 81.8 ± 14.8; P = 0.334). No differences in all-cause mortality (BEV: 6.5%, SEV: 3.8; P = 0.495), heart failure hospitalization (BEV: 6.5%, SEV: 1.9%; P = 0.214), stroke (BEV: 0%, SEV: 1.9%; P = 0.369), myocardial infarction (BEV: 0%, SEV: 1.9%; P = 0.347), or pacemaker implantation (BEV: 2.2%, SEV: 1.9%; P = 0.898) were found. CONCLUSIONS: In patients who underwent ViV-TAVR for failed small aortic bioprostheses, those receiving a SEV exhibited a better valve hemodynamic profile at 1-year follow-up. There were no differences between SEV and BEV regarding functional status, quality of life, or clinical outcomes.

Balloon- vs Self-Expanding Valve Systems for Failed Small Surgical Aortic Valve Bioprostheses.

BACKGROUND: Data comparing valve systems in the valve-in-valve transcatheter aortic valve replacement (ViV-TAVR) field have been obtained from retrospective studies. OBJECTIVES: The purpose of this study was to compare the hemodynamic results between the balloon-expandable valve (BEV) SAPIEN (3/ULTRA, Edwards Lifesciences) and self-expanding valve (SEV) Evolut (R/PRO/PRO+, Medtronic) in ViV-TAVR. METHODS: Patients with a failed small (≤23 mm) surgical valve were randomized to receive a BEV or an SEV. The primary endpoint was valve hemodynamics (maximal/mean residual gradients, severe prosthesis patient mismatch [PPM], or moderate-severe aortic regurgitation) at 30 days as evaluated by Doppler echocardiography. RESULTS: A total of 102 patients were randomized, and of these, 98 patients finally underwent a ViV-TAVR procedure (BEV: n = 46, SEV: n = 52). The procedure was successful in all cases, with no differences in clinical outcomes at 30 days between groups (no death or stroke events). Patients in the SEV group exhibited lower mean and maximal transvalvular gradient values (15 ± 8 mm Hg vs 23 ± 8 mm Hg; P ˂ 0.001; 28 ± 16 mm Hg vs 40 ± 13 mm Hg, P ˂ 0.001), and a tendency toward a lower rate of severe PPM (44% vs 64%; P = 0.07). There were no cases of moderate-severe aortic regurgitation. In total, 55 consecutive patients (SEV: n = 27; BEV: n = 28) underwent invasive valve hemodynamic evaluation during the procedure, with no differences in mean and peak transvalvular gradients between both groups (P = 0.41 and P = 0.70, respectively). CONCLUSIONS: In patients with small failed aortic bioprostheses, ViV-TAVR with an SEV was associated with improved valve hemodynamics as evaluated by echocardiography. There were no differences between groups in intraprocedural invasive valve hemodynamics and 30-day clinical outcomes (Comparison of the Balloon-Expandable Edwards Valve and Self-Expandable CoreValve Evolut R or Evolut PRO System for the Treatment of Small, Severely Dysfunctional Surgical Aortic Bioprostheses. The 'LYTEN' Trial; NCT03520101).

Late arrhythmias in patients with new-onset persistent left bundle branch block after transcatheter aortic valve replacement using a balloon-expandable valve.

BACKGROUND: The arrhythmic burden after discharge in patients with new-onset left bundle branch block (LBBB) undergoing transcatheter aortic valve replacement (TAVR) with the balloon-expandable SAPIEN 3 (S3) valve remains largely unknown. OBJECTIVE: The purpose of this study was to determine the incidence of late arrhythmias in patients with new-onset LBBB undergoing TAVR with the balloon-expandable S3 valve. METHODS: This was a multicenter, prospective study that included 104 consecutive TAVR patients with new-onset persistent LBBB following TAVR with the S3 valve. An implantable cardiac monitor (Reveal XT, Reveal LINQ) was implanted before discharge. The primary endpoint was the incidence of high-degree atrioventricular block or complete heart block (HAVB/CHB). RESULTS: A total of 40 patients (38.5%) had at least 1 significant arrhythmic event, leading to a treatment change in 17 (42.5%). Significant bradyarrhythmias occurred in 20 of 104 patients (19.2%) (34 HAVB/CHB episodes, 252 severe bradycardia episodes), with 10 of 20 patients (50%) exhibiting at least 1 episode of HAVB/CHB. Most HAVB/CHB episodes (60%) occurred within 4 weeks after discharge. Nine patients (8.7%) underwent permanent pacemaker implantation at 12 months based on the Reveal findings (6 HAVB/CHB, 3 severe bradycardia). CONCLUSION: S3 valve recipients with new-onset LBBB have a high arrhythmic burden, with more than one-third of patients exhibiting at least 1 significant arrhythmic episode within 12 months (HAVB/CHB in 10% of patients). About one-half of bradyarrhythmic events occurred within 4 weeks after discharge. These results should inform future strategies on the use of continuous electrocardiographic monitoring in TAVR S3 patients with new conduction disturbances following the procedure.

Cerebral Embolism After Transcarotid Transcatheter Aortic Valve Replacement: Factors Associated With Ipsilateral Ischemic Burden.

BACKGROUND: Transcarotid transcatheter aortic valve replacement (TAVR) recipients may be exposed to a higher ipsilateral subclinical cerebral ischemic burden compared with the contralateral hemisphere. We sought (1) to compare the cerebral ischemic burden of the 2 hemispheres after transcarotid TAVR, as evaluated by diffusion weighted-magnetic resonance imaging (DW-MRI), and (2) to identify the factors associated with ipsilateral ischemic burden. METHODS: This prospective study included 52 patients undergoing transcarotid TAVR, followed by a DW-MRI examination. All DW-MRIs were analyzed offline by a radiologist blinded to the clinical data. RESULTS: TAVR was performed through the left (n = 50) or right (n = 2) carotid artery. Procedural success was achieved in all patients, carotid dissection requiring patch closure occurred in 1 patient, and there were no periprocedural stroke events. At least 1 cerebral ischemic lesion was identified in the ipsilateral and contralateral hemisphere in 84.6% and 63.5% of patients, respectively (P = .005), and the number of ischemic lesions per patient was higher in the ipsilateral vs the contralateral hemisphere (2 [interquartile range, 1-5] vs 1 [interquartile range, 0-3], P = .005). The lesion volume (per lesion) and the average lesion volume (per patient) did not differ between the 2 hemispheres. A larger sheath/catheter size (≥18F vs ≤16F) was associated with a higher ipsilateral ischemic burden (P = .026). CONCLUSIONS: Carotid artery access for TAVR was associated with a higher number of cerebral ischemic lesions in the ipsilateral (vs contralateral) cerebral hemisphere. The use of a larger sheath/delivery system (≥18F) was associated with an increased ipsilateral ischemic burden.

Arrhythmic burden in patients with new-onset persistent left bundle branch block after transcatheter aortic valve replacement: 2-year results of the MARE study.

AIMS: We determined the incidence and type of arrhythmias at 2-year follow-up in patients with new-onset persistent left bundle branch block (LBBB) following transcatheter aortic valve replacement (TAVR). METHODS AND RESULTS: Multicentre prospective study including 103 consecutive patients with new-onset persistent LBBB post-TAVR (SAPIEN XT/3: 53; CoreValve/Evolut R: 50). An implantable cardiac monitor (Reveal XT, Reveal Linq) was implanted before hospital discharge and patients had continuous monitoring for up to 2 years. Arrhythmic events were adjudicated in a central core lab. 1836 new arrhythmic events (tachyarrhythmias: 1655 and bradyarrhythmias: 181) occurred at 2 years. Of these, 283 (15%) occurred beyond 1 year (tachyarrhythmias 212, bradyarrhythmias 71) in 33 (36%) patients, without differences between valve type. Most late (>1 year) arrhythmic events were asymptomatic (94%) and led to a treatment change in 17 (19%) patients. A total of 71 late bradyarrhythmias [high-degree atrioventricular block (HAVB): 3, severe bradycardia: 68] were detected in 17 (21%) patients. At 2 years, 18 (17%) patients had received a permanent pacemaker (PPM) or implantable cardiac-defibrillator. PPM implantation due to HAVB predominated in the early phase post-TAVR, with only 1 HAVB event requiring PPM implantation after 1 year. CONCLUSION: Patients with new-onset LBBB post-TAVR exhibited a very high burden of arrhythmic events within the 2 years post-procedure. While new tachyarrhythmic events were homogeneously distributed over time, the vast majority of new HAVB episodes leading to PPM implantation occurred early after the procedure. These results should help to guide the management of this challenging group of patients. (clinicaltrials.gov: NCT02153307).

Prolonged Continuous Electrocardiographic Monitoring Prior to Transcatheter Aortic Valve Replacement: The PARE Study.

OBJECTIVES: This study sought to determine, using continuous electrocardiographic monitoring (CEM) pre-transcatheter aortic valve replacement (TAVR), the incidence and type of unknown pre-existing arrhythmic events (AEs) in TAVR candidates, and to evaluate the occurrence and impact of therapeutic changes secondary to the detection of AEs pre-TAVR. BACKGROUND: Scarce data exist on the arrhythmic burden of TAVR candidates (pre-procedure). METHODS: This was a prospective study including 106 patients with severe aortic stenosis and no prior permanent pacemaker screened for TAVR. A prolonged (1 week) CEM was implanted within the 3 months pre-TAVR. Following heart team evaluation, 90 patients underwent elective TAVR. RESULTS: New AEs were detected by CEM in 51 (48.1%) patients, leading to a treatment change in 14 of 51 (27.5%) patients. Atrial fibrillation or tachycardia was detected in 8 of 79 (10.1%) patients without known atrial fibrillation or tachycardia, and nonsustained ventricular arrhythmias were detected in 31 (29.2%) patients. Significant bradyarrhythmias were observed in 22 (20.8%) patients, leading to treatment change and permanent pacemaker in 8 of 22 (36.4%) and 4 of 22 (18.2%) patients, respectively. The detection of bradyarrhythmias increased up to 30% and 47% among those patients with pre-existing first-degree atrioventricular block and right bundle branch block, respectively. Chronic renal failure, higher valve calcification, and left ventricular dysfunction determined (or tended to determine) an increased risk of AEs pre-TAVR (p = 0.028, 0.052, and 0.069, respectively). New onset AEs post-TAVR occurred in 22.1% of patients, and CEM pre-TAVR allowed early arrhythmia diagnosis in one-third of them. CONCLUSIONS: Prolonged CEM in TAVR candidates allowed identification of previously unknown AEs in nearly one-half of the patients, leading to prompt therapeutic measures (pre-TAVR) in about one-fourth of them. Pre-existing conduction disturbances (particularly right bundle branch block) and chronic renal failure were associated with a higher burden of AEs.

Hemodynamic performance of the balloon-expandable SAPIEN 3 valve as assessed by cardiac magnetic resonance.

BACKGROUND: Scarce data exist on transcatheter heart valve (THV) performance evaluated by cardiac magnetic resonance (CMR) in newer generation THV patients. Furthermore, it has been suggested that echocardiographic evaluation after TAVR may inaccurately assess residual AR in some patients. This study aimed to determine the incidence and severity of aortic regurgitation (AR) assessed by CMR in patients undergoing TAVR with the SAPIEN 3 valve, and evaluate the agreement between CMR and transthoracic echocardiography (TTE) on the assessment of AR severity in such patients. METHODS: This multicentric observational study included 146 SAPIEN 3 patients with TTE and CMR within the month following their procedure. According to the CMR regurgitation fraction (RF), AR was considered mild and moderate-severe if the RF was 15-<30% and ≥ 30%, respectively. TTE exams followed VARC-2 recommendations. RESULTS: By CMR, SAPIEN 3 recipients displayed a mean RF of 5.0 ± 6.1%, and mild and moderate-severe AR rates of 3.4% and 0.7%, respectively. The agreement between CMR-TTE was modest (weighted κ = 0.2640, p<0.001), due to an overestimation of AR severity by TTE. A historical cohort of 139 SAPIEN XT patients with a post-procedure CMR, displayed a mean RF of 9.6 ± 10.7% and mild and moderate-severe AR rates of 18.7% and 3.6%, respectively (p < .001 vs. SAPIEN 3 group). CONCLUSIONS: SAPIEN 3 recipients exhibited very low rates of residual AR by CMR, suggesting a surgical-like performance regarding AR with this newer generation THV. TTE tended to overestimate the severity of AR, particularly among mild AR patients.

Mitral Regurgitation in Low-Flow, Low-Gradient Aortic Stenosis Patients Undergoing TAVR: Insights From the TOPAS-TAVI Registry.

OBJECTIVES: This study sought to determine the incidence, clinical impact, and changes over time of mitral regurgitation (MR) in patients with low-flow, low-gradient aortic stenosis (LFLG-AS) undergoing transcatheter aortic valve replacement (TAVR). BACKGROUND: Few data exist on the clinical impact and changes in severity over time of MR in patients with LFLG-AS undergoing TAVR. METHODS: A total of 308 TAVR candidates with LFLG-AS were included. Patients were categorized according to MR severity at baseline, and presence of MR improvement at 12-month follow-up. Clinical outcomes were assessed at 1 and 12 months (+ echocardiography), and yearly thereafter. RESULTS: Baseline mild and moderate-to-severe MR were present in 118 (38.3%) and 115 (37.3%) patients, respectively. MR was of functional and mixed etiology in 77.2% and 22.7% of patients, respectively. A total of 131 patients (42.5%) died after a median follow-up of 2 (1 to 3) years. Baseline moderate-or-greater MR had no impact on mortality (hazard ratio [HR]: 1.34; 95% confidence interval [CI]: 0.72 to 2.48) or heart failure hospitalization (HR: 1.02; 95% CI: 0.49 to 2.10). At 1-year follow-up, MR improved in 44.3% of patients and remained unchanged/worsened in 55.7%. The lack of MR improvement was associated with a higher risk of all-cause and cardiac mortality (HR: 2.02; 95% CI: 1.29 to 3.17; HR: 3.03; 95% CI: 1.27 to 7.23, respectively), rehospitalization for cardiac causes (HR: 1.50; 95% CI: 1.04 to 2.15), and an increased overall-mortality/heart failure rehospitalization (HR: 1.94; 95% CI: 1.25 to 3.02). A higher baseline left ventricular end-diastolic diameter and a higher increase in left ventricular ejection fraction were found to be independent predictors of MR improvement at 1-year follow-up (odds ratio: 0.69; 95% CI: 0.51 to 0.94; and odds ratio: 0.81; 95% CI: 0.67 to 0.96, respectively). CONCLUSIONS: Most TAVR candidates with LFLG-AS had some degree of MR, of functional origin in most cases. MR improved in about one-half of patients, with larger left ventricular size and a higher increase in left ventricular ejection fraction post-TAVR determining MR improvement over time. The lack of MR improvement at 1 year was associated with poorer outcomes.

Late Electrocardiographic Changes in Patients With New-Onset Left Bundle Branch Block Following Transcatheter Aortic Valve Implantation.

This study sought to determine, in patients with new-onset persistent left bundle branch block (NOP-LBBB) after transcatheter aortic valve implantation (TAVI), the incidence and factors associated with (i) LBBB recovery and (ii) permanent pacemaker implantation (PPI) at 1-year follow-up. This was a multicenter study including 153 patients (mean age: 81 ± 5 years, 56% of women) with NOP-LBBB post-TAVI (balloon-expandable valve in 112 patients). Delta PR (ΔPR) and delta QRS (ΔQRS) were defined as the difference in PR and QRS length between baseline and hospital discharge ECG, and the relative ΔPR and ΔQRS as absolute ΔPR and ΔQRS divided by baseline PR and QRS length, respectively. The patients had a clinical visit and 12-lead ECG at 1-year follow-up. LBBB recovery was observed in 50 patients (33%), and 14 patients (9%) had advanced conduction disturbances requiring PPI during the follow-up period. No clinical or ECG variables were associated with LBBB recovery, including prosthesis type (self- or balloon-expandable valve, p = 0.563), QRS width at baseline/discharge or absolute/relative ΔQRS (p >0.10 for all). The presence of atrial fibrillation at baseline (0.026), a longer PR interval at discharge (0.009), and a longer absolute and relative ΔPR (p = 0.002 and p = 0.004, respectively) were associated with an increased risk of PPI at 1-year follow-up. In conclusion, NOP-LBBB post-TAVI resolved in one-third of patients at 1-year follow-up, but no clinical or ECG variables were associated with LBBB recovery. Conversely, a nonsinus rhythm at baseline and a longer ΔPR were associated with an increased risk of PPI within the year after TAVI.

Effect of Aortic Regurgitation by Cardiovascular Magnetic Resonance After Transcatheter Aortic Valve Implantation.

Cardiovascular magnetic resonance (CMR) has demonstrated a high accuracy for evaluating the severity of aortic regurgitation (AR). However, scarce data exist on the impact of AR as evaluated by CMR on clinical outcomes following transcatheter aortic valve implantation (TAVI). The objective of this study was to evaluate the impact of AR as determined by CMR on clinical outcomes (mortality, heart failure [HF] hospitalization) post-TAVI. A total of 448 TAVI recipients from 2 centers (mean age: 80 ± 7 years, mean STS: 5.8 ± 5.4%) who survived the periprocedural period with no pacemaker implantation were included. A newer generation transcatheter valve system was used in 213 patients (48%). The CMR examination was performed at a median of 12 (IQR: 7 to 21) days post-TAVI. After a mean follow-up of 24 ± 19 months, a total of 94 patients (21%) had died and 72 patients (16%) had at least 1 hospitalization because of decompensated HF. The aortic regurgitation fraction (RF) as determined by CMR was an independent predictor of mortality (hazard ratio[HR]:1.06 for each increase of 10%, 95% confidence interval [CI]: 1.01 to 1.12, p = 0.03) and HF hospitalization (HR:1.15 for each increase of 10%, 95% CI:1.02 to 1.30, p = 0.02). The rate of moderate-severe CMR-AR defined as a RF ≥30% was 3%, and this was associated with an increased risk of mortality (HR: 2.63, 95% CI: 2.30 to 2.99, p <0.001) and HF hospitalization (HR: 2.96, 95% CI: 1.62 to 5.42, p ˂0.001). A stepwise increase in the risk of mortality and HF hospitalization was observed with an increase in AR severity, with a peak increase among patients with RF ≥30%. In conclusion, our results showed the clinical usefulness of evaluating AR severity by CMR post-TAVI. CMR would be particularly helpful in doubtful cases or those with discordances between echocardiography and clinical data.

Outcomes From Transcatheter Aortic Valve Replacement in Patients With Low-Flow, Low-Gradient Aortic Stenosis and Left Ventricular Ejection Fraction Less Than 30%: A Substudy From the TOPAS-TAVI Registry.

Importance: In low-flow, low-gradient aortic stenosis (LFLG AS), the severity of left ventricular dysfunction remains a key factor in the evaluation of aortic valve replacement. Objective: To evaluate the clinical outcomes and changes in left ventricular ejection fraction (LVEF) after transcatheter aortic valve replacement (TAVR) in patients with LFLG AS and severe left ventricular dysfunction. Design, Setting, and Participants: This multicenter registry is a substudy of the True or Pseudo-Severe Aortic Stenosis-TAVI registry that included patients with classic LFLG AS, defined as a mean transvalvular gradient less than 35 mm Hg, an effective orifice area less than 1.0 cm2, and an LVEF of 40% or less. Patients were divided in groups with very low (<30%) LVEF and low (30%-40%) LVEF. Dobutamine stress echocardiography (DSE) was performed before TAVR in a subset with very low LVEF, and presence of contractile reserve was defined as an increase of 20% or more in stroke volume. Clinical outcomes were assessed at 1 and 12 months and yearly thereafter, and echocardiography was performed at 1-year follow-up. Retrospective data were collected from 2007 to 2013 and prospective data from January 2013 to March 2018. Data were analyzed from March to October 2018. Exposures: Transcatheter aortic valve replacement in patients with LFLG AS. Main Outcomes and Measures: Changes in LVEF over time; periprocedural and late mortality. Results: A total of 293 patients were included, including 128 (43.7%) with very low LVEF and 165 with low LVEF (56.3%). Their mean (SD) age was 80 (7) years, and most (214 [73.0%]) were men. The mean (SD) LVEF in the very low LVEF group was 22% (5%), compared with 37% (7%) in the low LVEF group (P < .001). There were no differences between groups in rates of periprocedural mortality and late mortality (median [interquartile range], 23 [6-38] months). Patients with very low LVEF displayed a greater increase in LVEF at the 1-year follow-up examination (mean absolute increase, 11.9% [95% CI, 8.8%-15.1%]), than the low LVEF group (3.6% [95% CI, 1.1%-6.1%]; P < .001). In 92 patients with very low LVEF who had preprocedural DSE, results showed a lack of contractile reserve in 45 (49%), but this had no effect on clinical outcomes or changes in LVEF over time. Conclusions and Relevance: In patients with LFLG AS and severe left ventricular dysfunction, TAVR was associated with similar clinical outcomes as in counterparts with milder left ventricular dysfunction. The TAVR procedure was associated with a significant increase in LVEF, irrespective of contractile reserve. These results support TAVR for LFLG AS, irrespective of the severity of left ventricular dysfunction and DSE results.

Arrhythmic Burden as Determined by Ambulatory Continuous Cardiac Monitoring in Patients With New-Onset Persistent Left Bundle Branch Block Following Transcatheter Aortic Valve Replacement: The MARE Study.

OBJECTIVES: The authors sought to determine: 1) the global arrhythmic burden; 2) the rate of arrhythmias leading to a treatment change; and 3) the incidence of high-degree atrioventricular block (HAVB) at 12-month follow-up in patients with new-onset persistent left bundle branch block (LBBB) following transcatheter aortic valve replacement (TAVR). BACKGROUND: Controversial data exist on the occurrence of significant arrhythmias in patients with LBBB post-TAVR. METHODS: This was a multicenter prospective study including 103 consecutive patients with new-onset persistent LBBB post-TAVR with the balloon-expandable SAPIEN XT/3 valve (n = 53), or the self-expanding CoreValve/Evolut R system (n = 50). An implantable cardiac monitor (Reveal XT, Reveal Linq) was implanted at 4 (3 to 6) days post-TAVR, and patients had continuous electrocardiogram monitoring for 12 months. All arrhythmic events were adjudicated in a central electrocardiography core lab. Primary endpoints were the incidence of arrhythmias leading to a treatment change, and the incidence of HAVB at 12-month follow-up. RESULTS: A total of 1,553 new arrhythmic events were detected in 44 patients (1,443 episodes of tachyarrhythmia in 26 patients [atrial fibrillation/flutter/atrial tachycardia: 1,427, ventricular tachycardia 16]; 110 episodes of bradyarrhythmia in 21 patients [HAVB 54, severe bradycardia 56]). All arrhythmic events were silent in 34 patients (77%), the arrhythmic event led to a treatment change in 19 patients (18%), and 11 patients (11%) required pacemaker or implantable cardioverter-defibrillator implantation (due to HAVB, severe bradycardia, or ventricular tachycardia episodes in 9, 1, and 1 patient, respectively). A total of 12 patients died at 1-year follow-up, 1 from sudden death. CONCLUSIONS: A high incidence of arrhythmic events was observed at 1-year follow-up in close to one-half of the patients with LBBB post-TAVR. Significant bradyarrhythmias occurred in one-fifth of the patients, and PPM was required in nearly one-half of them. These data support the use of a cardiac monitoring device for close follow-up and expediting the initiation of treatment in this challenging group of patients. (Ambulatory Electrocardiographic Monitoring for the Detection of High-Degree Atrio-Ventricular Block in Patients With New-onset PeRsistent LEft Bundle Branch Block After Transcatheter Aortic Valve Implantation [MARE study]: NCT02153307).

Percutaneous coronary intervention for treating de-novo lesions in small coronary vessels: initial experience with the Essential paclitaxel-coated balloon.

BACKGROUND: Paclitaxel-coated balloon (PCB) coronary angioplasty is an alternative treatment for de-novo coronary lesions in small vessels. This study with the new Essential PCB aimed to evaluate early and mid-term clinical outcomes following angioplasty with the Essential PCB in the treatment of de-novo lesions in small vessels. PATIENTS AND METHODS: We included all patients who underwent PCB angioplasty for treating de-novo coronary lesions in small vessels (reference diameter <2.5 mm) between October 2015 and June 2016 in 2 centres. The primary endpoint was the 12-month target lesion failure (TLF) rate: a composite of cardiac death, target vessel-related myocardial infarction, and target lesion revascularization. The secondary endpoints were rates of target vessel failure and global major adverse cardiac events (MACE). RESULTS: A total of 71 patients (comprising 71 lesions) were included, with a mean age of 66±11 years. A 56% were diabetic and 70% had an acute coronary syndrome as an indication for coronary revascularization. The mean vessel diameter and lesion length were 2.21±0.41 and 20.7±9.2 mm, respectively. Predilatation was performed in 85.9% of patients. The median diameter, length, and inflation pressure of the Essential balloon were 2.0 [interquartile range (IQR): 2.0-2.5] mm, 20 (IQR: 15-30) mm, and 12±2 atmospheres, respectively. Angiographic success was achieved in 97.2% of cases, and bail-out stenting was required in nine (12.7%) cases. The incidence of TLF at the 12-month follow-up was 4.2%, with a target lesion revascularization rate of 4.2%. Target vessel failure and global MACE rates were 4.2 and 9.9%, respectively. CONCLUSION: Use of the Essential PCB for treating de-novo coronary lesions in small vessels was safe, with low TLF and MACE rates at the 12-month follow-up.

Transcatheter Aortic Valve Replacement in Patients With Low-Flow, Low-Gradient Aortic Stenosis: The TOPAS-TAVI Registry.

BACKGROUND: Few data exist on patients with low-flow, low-gradient aortic stenosis (LFLG-AS) undergoing transcatheter aortic valve replacement (TAVR). Also, very scarce data exist on the usefulness of dobutamine stress echocardiography (DSE) before TAVR in these patients. OBJECTIVES: The authors sought to evaluate clinical outcomes and changes in left ventricular ejection fraction (LVEF) following TAVR in patients with classical LFLG-AS. METHODS: This multicenter registry included 287 patients with LFLG-AS undergoing TAVR. DSE was performed before TAVR in 234 patients and the presence of contractile reserve was defined as an increase of ≥20% in stroke volume. Transthoracic echocardiography was repeated at hospital discharge and at 1-year follow-up. Clinical follow-up was obtained at 1 and 12 months, and yearly thereafter. RESULTS: The median Society of Thoracic Surgeons score of the study population was 7.7% (interquartile range 5.3% to 12.0%), and the mean LVEF and transvalvular gradient were 30.1 ± 9.7% and 25.4 ± 6.6 mm Hg, respectively. The presence of contractile reserve was observed in 45% of patients at DSE. Mortality rates were 3.8%, 20.1%, and 32.3% at 30 days, 1 year, and 2 years, respectively. On multivariable analysis, chronic obstructive pulmonary disease (p = 0.022) and lower hemoglobin values (p < 0.001) were associated with all-cause mortality. Lower hemoglobin values (p = 0.004) and moderate-to-severe aortic regurgitation post-TAVR (p = 0.018) were predictors of the composite of mortality and rehospitalization due to heart failure. LVEF increased by 8.3% (95% confidence interval: 6% to 11%) at 1-year follow-up, and the lack of prior coronary artery bypass graft (p = 0.004), a lower LVEF at baseline (p < 0.001), and a lower stroke volume index at baseline (p = 0.019) were associated with greater increase in LVEF. The absence of contractile reserve at baseline DSE was not associated with any negative effect on clinical outcomes or LVEF changes at follow-up. CONCLUSIONS: TAVR was associated with good periprocedural outcomes in patients with LFLG-AS. However, approximately one-third of LFLG-AS TAVR recipients died at 2-year follow-up, with pulmonary disease, anemia, and residual paravalvular leaks associated with poorer outcomes. LVEF improved following TAVR, but DSE failed to predict clinical outcomes or LVEF changes over time. (Multicenter Prospective Study of Low-Flow Low-Gradient Aortic Stenosis [TOPAS Study]; NCT01835028).

Three- and 6-month optical coherence tomographic surveillance following percutaneous coronary intervention with the Angiolite® drug-eluting stent: The ANCHOR study.

BACKGROUND: Pre-clinical results of a novel open-cell, thin strut, durable polymer, laser cut cobalt chromium sirolimus-eluting stent (Angiolite) were promising. Using quantitative optical coherence tomographic (OCT) analyses, we explored the healing characteristics of the Angiolite DES system at 3- and 6-months post implantation. METHODS: A total of 103 patients with de novo coronary lesions underwent percutaneous coronary intervention with the Angiolite DES and were randomized 1:3 into two cohorts for angiographic and OCT follow-up, with 28 and 70 patients returning for 3- or 6-month post-PCI surveillance, respectively. The primary endpoints were the 6-month rates of OCT-derived neointimal proliferation, strut coverage and incomplete strut apposition (ISA), whilst the secondary endpoints were 3-month OCT-derived measures of strut coverage and ISA, as well as 6-month quantitative coronary angiographic-derived measures [late lumen loss (LLL), binary restenosis]. RESULTS: The Angiolite stent was successfully implanted in all patients, without periprocedural complications. At 3- and 6-months follow-up, OCT strut coverage was evident in 86.3% and 83.3% of struts, mean neointimal thickness was 73.7 ± 46.5 µm and 73.9 ± 54.3 µm, mean neo-intimal area obstruction of 5.8% ±10.3% and 4.4% ± 11.3%, and ISA rates were 1.3% ± 7.3% and 1.1% ± 6.2%, respectively. In-stent LLL at 6 months was 0.07 ± 0.37 mm, with a binary in-stent angiographic restenosis rate of 0% without any stent thrombosis, myocardial infarction or cardiovascular death, with 1 patient undergoing ischemia-driven target-lesion revascularization. CONCLUSIONS: At 6 months, the Angiolite DES was safe with high rates of strut coverage, modest degrees of neointimal hyperplasia and very low rates of strut malapposition. These data coupled with the absence of in-stent binary restenosis and a very low 6-month in-stent LLL point towards an efficacious DES. Future studies are required to evaluate its efficacy in broader lesion subsets with longer follow-up.