Safety and effects of volume loading during transesophageal echocardiography in the pre-procedural work-up for left atrial appendage closure.

BACKGROUND: In patients undergoing left atrial appendage (LAA) closure, an accurate sizing of the LAA is key to optimize device sizing, procedural success and reduce complications. Previous studies have shown that intraprocedural volume loading increases LAA dimensions and improves device sizing. However, the safety and effects on LAA and device sizing of administering a fluid bolus during pre-procedural transesophageal echocardiography (TEE) are unknown. The aim of this study was to determine the safety and impact on LAA dimensions and device sizing of an intravenous (IV) fluid bolus administered during TEE in the setting of the pre-procedural work-up for LAA closure. METHODS: The study included a total of 72 patients who underwent TEE to assess suitability for LAAC and received a 500 ml IV bolus of normal saline. The LAA landing zone (LZ) and depth were measured by TEE before and after volume loading, and these measurements were used to predict the device size implanted during a subsequent percutaneous LAAC procedure. RESULTS: There were no complications associated with volume loading. The baseline mean LZ was 19.6 ± 3.6 mm at 90o, and 20.2 ± 4.1 mm at 135o. Following fluid bolus, the maximum diameter increased 1.5 ± 1.0 mm at 90o (p<0.001), and 1.3 ± 1.0 mm at 135o (p<0.001). The baseline mean depth of the LAA was 26.5 ± 5.5 mm at 90o, and 23.9 ± 5.8 mm at 135o. After fluid bolus, the mean depth increased by 1.5 ± 1.8 mm (p<0.001) and 1.6 ± 2.0 (p<0.001), at 90o and 135o, respectively. Sizing based on post-bolus measurements of the LZ significantly improved the agreement with the final device size selection during the procedure in 71.0% of cases (vs. 42.0% with pre-bolus measurements). CONCLUSIONS: Volume loading during ambulatory TEE as part of the pre-procedural work-up of LAAC is safe and significantly increases LAA dimensions. This strategy may become the new standard, particularly in centers performing LAAC with no TEE guidance, as it improves LAA sizing and more accurately predicts the final device size.

Intraprocedural high-degree atrioventricular block or complete heart block in transcatheter aortic valve replacement recipients with no prior intraventricular conduction disturbances.

BACKGROUND: Conduction disturbances are the most frequent complication of transcatheter aortic valve replacement (TAVR). However, no data exists regarding the outcomes of intraprocedural high-degree atrioventricular block (HAVB) or complete heart block (CHB) in patients without previous conduction disturbances. OBJECTIVES: The aim of this study was to evaluate the outcomes of intraprocedural-HAVB/CHB in patients without previous intraventricular conduction disturbances. METHODS: The occurrence of intraprocedural-HAVB/CHB was assessed in 676 consecutive patients undergoing TAVR, and two groups were established according to its duration: persistent-HAVB/CHB (PHAVB/CHB) and transient-HAVB/CHB (THAVB/CHB), not present at the end of the procedure. RESULTS: Intraprocedural-HAVB/CHB occurred in 50 patients (7.4%), being persistent in 32 (64.0%), and transient in 18 (36.0%). The use of Medtronic Corevalve Revalving System (MCRS) and a greater oversizing of the valve increased the risk of intraprocedural-HAVB/CHB (p < 0.001). Permanent pacemaker implantation (PPI) was more frequent in the PHAVB/CHB than in the THAVB/CHB group (96.9% vs. 33.3%; p < 0.001). At 1-month follow-up, the PHAVB/CHB group showed a 98% ventricular pacing rate (VPR) compared to 16% in the THAVB/CHB group (p < 0.001), and similar VPR were observed at 1-year follow-up (98% vs. 37%, p < 0.001). Left ventricular ejection fraction (LVEF) decreased at 1-year follow-up in patients with PHAVB/CHB (-3.9 ± 1.8%, p = 0.003). CONCLUSIONS: In TAVR recipients with no prior intraventricular conduction disturbances, intraprocedural-HAVB/CHB occurred in 7.4% of cases. HAVB/CHB was persistent in most cases and determined a high rate of PPI post-TAVR. Very high VPR at 1- and 12-month follow-up were observed, which in turn was associated with a negative effect on LVEF. These results support early PPI and close follow-up in patients developing intraprocedural-PHAVB/CHB.

Timing and evolution of advanced conduction disturbances in patients with right bundle branch block undergoing transcatheter aortic valve replacement.

AIMS: This study sought to determine the timing and evolution over time of advanced conduction disturbances (CDs) in patients with baseline right bundle branch block (RBBB) undergoing transcatheter aortic valve replacement (TAVR). METHODS AND RESULTS: One hundred and ten consecutive patients with pre-existing RBBB were included (out of 1341, 8.2%). All arrhythmias during the hospitalization period were recorded. Follow-up was performed at 30 days, 1 year, and yearly thereafter. Conduction recovery and ventricular pacing percentage (VPP) was evaluated at 30 days in those patients with permanent pacemaker implantation (PPMI). Sixty-one (55.5%) patients suffered advanced CDs [97% complete or high-degree atrioventricular block (CHB/HAVB)], and the vast majority (98%) occurred within the first 3 days post-procedure (intraprocedural: 85%). Fifty-two (47.3%) patients had PPMI (vs. 11.0% in non-RBBB patients, P < 0.001). Ventricular pacing percentage at 1 month was higher in patients with persistent-intraprocedural CHB/HAVB compared to those with transient-intraprocedural or post-procedural CHB/HAVB [99 (interquartile range, IQR 97-100)% vs. 72 (IQR 30-99)%, P = 0.02]. Complete recovery (VPP < 1%) was observed in only one patient (2%) with CHB/HAVB. After hospital discharge, no symptomatic bradyarrhythmias or sudden death occurred within 30 days. Patients with pre-existing RBBB exhibited a higher risk of PPMI at 4-year follow-up (26% vs. 8% in non-RBBB patients, P < 0.001). CONCLUSION: In patients with pre-existing RBBB, the vast majority of advanced CDs occurred within the 3 days following TAVR, and most did not recover at 1-month, particularly those with intra-procedural persistent CHB/HAVB. These results should help to determine the hospitalization length and timing of PPMI in RBBB patients undergoing TAVR.

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.

Results of transcarotid compared with transfemoral transcatheter aortic valve replacement.

OBJECTIVES: The femoral artery is the preferred vascular access to perform transcatheter aortic valve replacement (TAVR). However, the optimal alternative approach has not been elucidated in patients who are not candidates for a transfemoral (TF) access. The objective of this study was to compare the outcomes of TAVR performed by the transcarotid (TC) compared with the TF approach. METHODS: This was a single-center study that included 526 consecutive patients who underwent TAVR between 2015 and 2019. TC-TAVR was performed in 127 and TF-TAVR in 399 patients. Postprocedural and 30-day clinical events were evaluated according to main access (TC vs TF) using a multivariate logistic regression model. One-year survival and freedom from neurological events were also evaluated. RESULTS: The prevalence of diabetes, chronic obstructive pulmonary disease, coronary artery disease, and peripheral vascular disease was higher in the TC group. In-hospital mortality (3.2% vs 2.0%, adjusted odds ratio, 1.83; 95% confidence interval, 0.47-7.15; P = .39), and 30-day stroke (2.4% vs 3.3%; odds ratio, 0.84; 95% confidence interval, 0.21-3.41; P = .81), were similar between groups as were other outcomes: procedural success (98.4% vs 97.0%; P = .52), 30-day cumulative mortality (4.8% vs 2.8%; P = .26), major vascular complication (2.4% vs 4.5%; P = .25), and major/life-threatening bleeding (4.7% vs 6.0%; P = .41) (TC vs TF, respectively). No differences were found among groups regarding survival or neurological events at 1-year follow-up. CONCLUSIONS: The TC approach is a safe alternate-access strategy for TAVR, and is associated with similar outcomes compared with TF-TAVR, despite a higher disease burden in TC patients.

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.

Radiation Exposure During Transcatheter Aortic Valve Replacement: Impact of Arterial Approach and Prosthesis Type.

BACKGROUND: The impact of novel alternative access and valve type on radiation exposure during transcatheter aortic valve replacement (TAVR) has not yet been evaluated. This study sought to determine the impact of a transarterial approach and prosthesis type on physician and patient exposure to radiation during TAVR. METHODS: This was a prospective study including 140 consecutive patients undergoing TAVR by transfemoral (n = 102) or transcarotid (TC) (n = 38) access at 2 centers. Implanted valves were the self-expanding Evolut R/PRO system (Medtronic, Minneapolis, MN; n = 38) and the balloon-expandable SAPIEN 3 valve (Edwards Lifesciences, Irvine, CA; n = 102). The primary endpoint was first operator radiation exposure. The secondary endpoint was patient radiation exposure. RESULTS: First operator radiation exposure was 4-fold greater during TC TAVR (P < .001). The use of a self-expanding valve was associated with a longer x-ray time (P = .015) and a 2-fold greater first operator radiation dose (P = .018). Patient radiation dose was not significantly affected by arterial approach (P = .055) or valve type (P = .095). After adjustment for potential confounders, the TC approach remained associated with a 174.8% (95% confidence interval, 80.6-318.3, P < .001) increase in first operator radiation dose, whereas the use of a self-expanding valve no longer influenced the first operator dose (P = .630). CONCLUSIONS: TC access and the use of a self-expanding valve were associated with a 4- and 2-fold greater first operator radiation exposure during TAVR procedures, respectively. Unlike the arterial approach, the effect of bioprosthesis type on radiation exposure was mainly related to x-ray time and was no longer significant after adjustment.

Secondary Femoral Access Hemostasis During Transcatheter Aortic Valve Replacement: Impact of Vascular Closure Devices.

BACKGROUND: Vascular and bleeding complications related to secondary femoral access site are frequent in patients undergoing transcatheter aortic valve replacement (TAVR), and their occurrence is associated to poorer outcomes. We aimed to evaluate the clinical impact of vascular closure devices (VCDs) for secondary femoral access hemostasis in TAVR procedures. METHODS: This was a multicenter study including 4031 patients who underwent TAVR (mean age, 81 ± 8 years; mean Society of Thoracic Surgeons [STS] score, 4.9 [interquartile range, 3.3-7.6]), and had a secondary femoral access. The 30-day clinical outcomes were analyzed according to femoral access-site hemostasis (manual compression vs VCD), and according to the type of VCD (Perclose [Abbott Cardiovascular] vs Angio-Seal [Terumo Interventional Systems]) using a propensity-matched, multivariable, logistic regression model. RESULTS: Manual compression was used in 941 patients (23.3%) and VCDs were used in 3090 patients (76.7%; Perclose in 1549 patients [38.4%] and Angio-Seal in 1541 patients [38.2%]) for secondary femoral access hemostasis. Vascular complications related to secondary access site occurred in 162 patients (4%), and were more frequent in patients who underwent manual compression (7.2%) compared with VCD hemostasis (3%; adjusted P<.001). In the VCD group, the use of Angio-Seal (vs Perclose) was associated with a higher rate of vascular complications (3.7% vs 2.4%, respectively; adjusted P=.02), femoral artery pseudoaneurysm (1.3% vs 0.4%, respectively; adjusted P<.01), invasive treatment requirement for treating vascular complications (surgery: 0.8% vs 0.3%, respectively [adjusted P=.03]; and thrombin injection: 0.9% vs 0%, respectively [adjusted P<.001]). CONCLUSION: VCDs represented a safer and more effective alternative compared with manual compression for secondary femoral access-site hemostasis in patients undergoing TAVR procedures, and the Perclose VCD was associated with the lowest risk of vascular complications. Future randomized studies are warranted.

Clinical Impact of Crossover Techniques for Primary Access Hemostasis in Transfemoral Transcatheter Aortic Valve Replacement Procedures.

OBJECTIVES: To determine the occurrence of vascular complications (VCs) following transfemoral transcatheter aortic valve replacement (TAVR) with new-generation devices according to the use of a crossover technique (COT). BACKGROUND: The use of a COT (with/without balloon) has been associated with a reduction of VCs in TAVR patients. However, scarce data support its use with second-generation devices. Also, its potential benefit in obese patients (at high-risk of VCs) has not been elucidated. METHODS: A multicenter study including 2214 patients who underwent full percutaneous transfemoral TAVR (COT, 1522 patients; no COT, 692 patients). Thirty-day events were evaluated according to the use of a COT using a multivariate logistic regression model. A subanalysis was performed in obese patients. RESULTS: Primary access major VCs (3.5% COT vs 3.9% no COT; P=.19), major/life-threatening bleeding (3.4% COT vs 2.0% no COT; P=.33), and mortality rates (2.4% COT vs 2.6% no COT; P=.23) were similar between groups. However, minor VCs (11.7% COT vs 5.9% no COT; P<.001) and postprocedural acute renal failure (8.9% COT vs 3.9% no COT; P<.001) were higher in patients undergoing the COT. In the overall cohort, percutaneous closure device failure was more frequent in obese patients (4.0% in the obese group vs 1.9% in the non-obese group; P<.01), but these differences were no longer significant in those undergoing a COT (3.4% in the obese group vs 2.0% in the non-obese group; P=.12). Indeed, in the subset of obese patients, the COT tended to be associated with fewer VCs (3.4% COT vs 5.9% no COT; P=.09). CONCLUSIONS: The use of a COT was not associated with a reduction of major VCs or improved outcomes. However, some patient subsets, such as those with higher body mass index, may benefit from the use of a COT. These findings would suggest the application of a tailored strategy, following a risk-benefit assessment in each TAVR candidate.

Overcoming the transcatheter aortic valve replacement Achilles heel: conduction abnormalities-a systematic review.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) has been shown to be a good alternative to surgery for treating severe symptomatic aortic stenosis (AS) across the whole range of surgical risk patients. Whereas most periprocedural TAVR complications have significantly decreased over time, conduction disturbances remain high. Approaches to decrease this shortcoming are under continuous investigation. METHODS: We conducted a systematic review focusing on modifiable factors impacting post-TAVR conduction disturbances, such as balloon aortic valvuloplasty (BAV), type of new-generation transcatheter valve and implantation depth (ID). Search strategies were based on the best available evidence from each study. Primary endpoints were post-TAVR need of permanent pacemaker implantation (PPI) and new onset left bundle branch block (NOLBBB). RESULTS: Data from 35 studies with a total of 29,982 patients were analyzed. BAV did not negatively impact PPI rates after TAVR. In propensity-matched and randomized trials, the Evolut R valve was associated with higher rates of PPI compared to the Sapien 3 valve (25% vs. 19.2% in propensity-matched studies; 22.9% vs. 19% in a randomized trial). The Acurate Neo valve was associated with the lowest PPI rate in observational studies (10.4%), but a PPI rate similar to Sapien 3 was reported in a randomized trial (10% vs. 9%). The Portico valve system was associated with a higher PPI risk (PPI rate of 21.9% and 27.7% in propensity-matched and randomized studies, respectively). ID and its relation with the membranous septum (MS) length predicted post-TAVR conduction disturbances, particularly with Evolut R and Sapien 3 valves. CONCLUSIONS: Pre-TAVR BAV did not increase the risk of conduction disturbances post-TAVR. Among the new-generation transcatheter valve systems, Sapien 3 and Acurate Neo valves were associated with the lowest PPI rates followed by the Evolut and Portico valves. A deeper valve implantation and a shorter MS length determined an increased risk of conduction disturbances post-TAVR.

Can we reduce conduction disturbances following transcatheter aortic valve replacement?

Introduction: Transcatheter aortic valve replacement (TAVR) has been demonstrated to be a good alternative to surgery for treating severe aortic stenosis (AS) across the whole range of surgical risk patients. Whereas most periprocedural TAVR complications have significantly decreased over time, conduction disturbances remain high. Approaches to decrease this shortcoming are under continuous investigation.Areas covered: Overview of the actual evidence regarding conduction disturbances in the TAVR setting, focusing on modifiable factors. PubMed and Embase databases were used for literature search.Expert opinion: Several factors have been associated with an increased risk of conduction disturbances post-TAVR, and some of them may be modifiable. While some transcatheter valve systems have been associated with higher rates of conduction disturbances, additional randomized data are needed to draw definite conclusions about newer generation transcatheter valve systems. Nowadays, good hemodynamic valve function can be obtained without excessive valve oversizing, which has been associated with an increased risk of conduction disturbances in some studies. Also, contemporary data regarding valve implantation depth and new anatomical landmarks such as membranous septum length have provided valuable insights for procedural planning. Finally, homogenization of the management of conduction abnormalities post-TAVR should be emphasized to allow a better understanding and generalization of available evidence.

Long-Term Electrocardiographic Changes and Clinical Outcomes of Transcatheter Aortic Valve Implantation Recipients Without New Postprocedural Conduction Disturbances.

The objective of this study was to determine the long-term (>1 year) electrocardiographic (ECG) and clinical outcomes of patients without significant changes in their electrocardiogram after transcatheter aortic valve implantation (TAVI; including patients with pre-existing ECG abnormalities). Among 772 consecutive patients who underwent TAVI in our institution, 397 patients (51%) without new ECG changes were included. TAVI patients were divided into 2 groups according to the presence of pre-existing ECG-conduction disturbances (ECG-CD: 140 patients, non-ECG-CD: 257 patients). Clinical follow-up (median: 35 [22 to 57] months) was complete in all patients but 5 (1.2%), and ECG data were available in 291 patients (84.3% of patients at risk) at a median of 29 (20 to 50) months. In the non-ECG-CD group, most patients (79.8%) remained without significant ECG changes at follow-up, and 16.9% developed first-degree atrioventricular block and/or bundle branch block over time. The rate of permanent pacemaker (PPM) implantation at follow-up was 3.5% (1.1%/year) in the non-ECG-CD group versus 15.7% (5.5%/year) in the ECG-CD group (p <0.001). The presence of pre-existing CD was an independent predictor of PPM at follow-up (hazard ratio [HR] 4.67, 95% confidence interval [CI] 2.15 to 10.16, p <0.001). The ECG-CD group exhibited a higher risk of heart failure hospitalization (non-ECG-CD: 25%, ECG-CD: 29%, log-rank p = 0.01), but not mortality (non-ECG-CD: 50%, ECG-CD: 46%, log-rank p = 0.60) at 5-year follow-up. In conclusion, the ECG remained unchanged in most TAVI recipients without new postprocedural CD. Pre-existing ECG-CD was associated with an increased risk of PPM and heart failure hospitalization at long-term follow-up. These results provide reassuring data in the era of TAVI expanding toward candidates with a longer life expectancy, and highlight the importance of a closer follow-up of those patients with pre-existing ECG-CDs.

Short-Term Oral Anticoagulation Versus Antiplatelet Therapy Following Transcatheter Left Atrial Appendage Closure.

BACKGROUND: The impact of antithrombotic therapy on coagulation system activation after left atrial appendage closure (LAAC) remains unknown. This study sought to compare changes in coagulation markers associated with short-term oral anticoagulation (OAC) versus antiplatelet therapy (APT) following LAAC. METHODS: Prospective study including 78 atrial fibrillation patients undergoing LAAC with the Watchman device. F1+2 (prothrombin fragment 1+2) and TAT (thrombin-antithrombin III) were assessed immediately before the procedure, and at 7, 30, and 180 days after LAAC. RESULTS: Forty-eight patients were discharged on APT (dual: 31, single: 17) and 30 on OAC (direct anticoagulants: 26, vitamin K antagonists: 4), with no differences in baseline-procedural characteristics between groups except for higher spontaneous echocardiography contrast in the OAC group. OAC significantly reduced coagulation activation within 7 days post-LAAC compared with APT (23% [95% CI, 5%-41%] versus 82% [95% CI, 54%-111%] increase for F1+2, P=0.007; 52% [95% CI, 15%-89%] versus 183% [95% CI, 118%-248%] increase for TAT, P=0.048), with all patients in both groups progressively returning to baseline values at 30 and 180 days. Spontaneous echocardiography contrast pre-LAAC was associated with an enhanced activation of the coagulation system post-LAAC (144 [48-192] versus 52 [24-111] nmol/L, P=0.062 for F1+2; 299 [254-390] versus 78 [19-240] ng/mL, P=0.002 for TAT). Device-related thrombosis occurred in 5 patients (6.4%), and all of them were receiving APT at the time of transesophageal echocardiography (10.2% versus 0% if OAC at the time of transesophageal echocardiography, P=0.151). Patients with device thrombosis exhibited a greater coagulation activation 7 days post-LAAC (P=0.038 and P=0.108 for F1+2 and TAT, respectively). CONCLUSIONS: OAC (versus APT) was associated with a significant attenuation of coagulation system activation post-LAAC. Spontaneous echocardiography contrast pre-LAAC associated with enhanced coagulation activation post-LAAC, which in turn increased the risk of device thrombosis. These results highlight the urgent need for randomized trials comparing OAC versus APT post-LAAC.

Femoral Versus Nonfemoral Subclavian/Carotid Arterial Access Route for Transcatheter Aortic Valve Replacement: A Systematic Review and Meta-Analysis.

Background Some concerns remain regarding the safety of transcarotid and transsubclavian approaches for transcatheter aortic valve replacement. We aimed to compare the risk of 30-day complications and death in transcarotid/transsubclavian versus transfemoral transcatheter aortic valve replacement recipients. Methods and Results Data from 20 studies, including 79 426 patients (16 studies) and 3992 patients (4 studies) for the evaluation of the unadjusted and adjusted impact of the arterial approach were sourced, respectively. The use of a transcarotid/transsubclavian approach was associated with an increased risk of stroke when using unadjusted data (risk ratio [RR], 2.28; 95% CI, 1.90-2.72) as well as adjusted data (odds ratio [OR], 1.53; 95% CI, 1.05-2.22). The pooled results deriving from unadjusted data showed an increased risk of 30-day death (RR, 1.46; 95% CI, 1.22-1.74) and bleeding (RR, 1.53; 95% CI, 1.18-1.97) in patients receiving transcatheter aortic valve replacement through a transcarotid/transsubclavian access (compared with the transfemoral group), but the associations between the arterial access and death (OR, 1.22; 95% CI, 0.89-1.69), bleeding (OR, 1.05; 95% CI, 0.68-1.61) were no longer significant when using adjusted data. No significant effect of the arterial access on vascular complication was observed in unadjusted (RR, 0.84; 95% CI, 0.66-1.06) and adjusted (OR, 0.79; 95% CI, 0.53-1.17) analyses. Conclusions Transcarotid and transsubclavian approaches for transcatheter aortic valve replacement were associated with an increased risk of stroke compared with the transfemoral approach. However, these nonfemoral arterial alternative accesses were not associated with an increased risk of 30-day death, bleeding, or vascular complication when taking into account the confounding factors.

Interaction Between Balloon-Expandable Valves and Coronary Ostia: Angiographic Analysis and Impact on Coronary Access.

OBJECTIVES: We sought to evaluate the position of balloon-expandable valves in relation to the coronary ostia using an angiographic- and computed tomography (CT)-based analysis, and to determine the impact of valve position on coronary angiography (CA)/percutaneous coronary intervention (PCI) feasibility and results. METHODS: A total of 533 patients who received a Sapien XT or Sapien 3 valve were included in the angiographic analysis. Of these, 49 benefited from an opportunistic electrocardiography-gated CT after transcatheter aortic valve replacement (TAVR) and were included in the CT analysis. RESULTS: Regarding the left coronary artery (LCA) ostium, the top of the transcatheter heart valve (THV) frame was infraostial in 49% of cases, and the valve totally covered the LCA ostium in 27% of patients. The stent frame of the Sapien 3 valve completely covered the LCA ostium more frequently than the Sapien XT valve (43% vs 12%, respectively; P<.001) and the relative implantation depth was significantly less ventricular in the Sapien 3 group than in the Sapien XT group (28.0 ± 12.3% vs 36.8 ± 12.6%, respectively; P<.001). The CT evaluation found similar results to angiographic evaluation. A total of 53 patients (10%) underwent CA (± PCI) following TAVR, and valve position did not influence CA performance/quality and PCI results. CONCLUSIONS: The stent frame of balloon-expandable Sapien valves exceeded the coronary ostia in about one-fourth of patients, and this percentage was >40% with the new-generation Sapien 3 valve. However, THV position did not affect the feasibility, quality, and results of CA/PCI post TAVR.

Interaction Between Self-Expanding Transcatheter Heart Valves and Coronary Ostia: An Angiographically Based Analysis of the Evolut R/Pro Valve System.

OBJECTIVES: We sought to assess the position of the CoreValve Evolut R/Pro (Medtronic) with respect to the left coronary artery (LCA) ostium and evaluate the impact of implantation depth on this relationship. METHODS: One hundred consecutive patients who received an Evolut R/Pro valve and had an adequate angiography following valve implantation were included. Angiographic measurements included valve implantation depth, the position of the Evolut R/Pro with respect to the LCA, and the distance between the neo-valve cusp and the LCA ostium. Coronary access issues following TAVR were also recorded. RESULTS: Regarding the LCA ostium, the neo-valve of the Evolut R/Pro was supraostial, at the ostial level, and infraostial in 3%, 12%, and 85% of cases, respectively. When beneath the LCA ostium, the mean distance between the neo-valve and the floor of the LCA ostium was 4.1 ± 5.2 mm. An implantation depth ≤6 mm was associated with a higher rate of neo-valve at the ostial level or above (25% vs 4% for implantation depth >6 mm; P=.01). Accessing the coronary arteries was required in 10% of the patients at 12 ± 8 months post TAVR, and selective coronary angiography of the left and right coronary arteries was achieved in 60% and 40% of the cases, respectively. CONCLUSIONS: The Evolut R/Pro neo-valve was positioned below the LCA ostium in the vast majority of cases (85%), but an implantation depth ≤6mm was associated with a higher rate of neo-valve positioning at or above the coronary ostia level. Considering the current tendency of very high (aortic) valve implants to avoid conduction disturbances, future studies should determine the impact of high Evolut R/Pro positioning on coronary access issues post TAVR.

Valve Hemodynamics Following Transcatheter or Surgical Aortic Valve Replacement in Patients With Small Aortic Annulus.

This study aimed to compare the hemodynamic performance of transcatheter and surgical aortic valves in patients with severe symptomatic aortic stenosis and small aortic annulus (SAA) and to determine the valve hemodynamics according to transcatheter valve type. Consecutive surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR) patients with SAA were case-matched (1:1) on the basis of sex, body surface area, aortic annulus diameter, and left ventricular ejection fraction. A total of 357 patients in each group constituted the final study population. A second match on the basis of aortic annulus diameter and valve/annulus calcium burden was performed within the TAVR group to compare the valve performance between balloon- (n = 52) and self-expanding (n = 52) transcatheter valve systems (BEV, SEV). The echocardiograms performed at hospital discharge were used for evaluating valve hemodynamics. The mean annulus diameter of the study population was 19.2 ± 0.3 mm. The TAVR group (vs SAVR) exhibited lower mean gradient (12 ± 7 mm Hg vs 15 ± 6 mm Hg, p <0.001), larger effective orifice area (1.46 ± 0.39 cm2 vs 1.25 ± 0.37 cm2, p <0.001) and a lower rate of severe prosthesis-patient mismatch (PPM) (14% vs 24%, p = 0.001). Moderate-severe AR was present in 2.5% of the TAVR recipients versus none patient in the SAVR group. There were no differences in valve hemodynamics between balloon-expanding transcatheter valve system and self-expanding transcatheter valve system, and similar rates of severe PPM were observed in both groups (p = 0.488). In conclusion, TAVR presented superior valve hemodynamics and lower incidence of severe PPM compared with SAVR in SAA patients. Similar valve performance results were observed between transcatheter valve types.

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.

Safety of Transesophageal Echocardiography to Guide Structural Cardiac Interventions.

BACKGROUND: Despite the widespread use of transesophageal echocardiography (TEE) to guide structural cardiac interventions, studies evaluating safety in this context are lacking. OBJECTIVES: This study sought to determine the incidence, types of complications, and factors associated with esophageal or gastric lesions following TEE manipulation during structural cardiac interventions. METHODS: This was a prospective study including 50 patients undergoing structural cardiac interventions in which TEE played a central role in guiding the procedure (mitral and tricuspid valve repair, left atrial appendage closure, and paravalvular leak closure). An esophagogastroduodenoscopy (EGD) was performed before and immediately after the procedure to look for new injuries that might have arisen during the course of the intervention. Patients were divided in 2 cohorts according to the type of injury: complex lesions (intramural hematoma, mucosal laceration) and minor lesions (petechiae, ecchymosis). The factors associated with an increased risk of complications were assessed. RESULTS: Post-procedural EGD showed a new injury in 86% (n = 43 of 50) of patients, with complex lesions accounting for 40% (n = 20 of 50) of cases. Patients with complex lesions presented more frequently with an abnormal baseline EGD (70% vs. 37%; p = 0.04) and had a higher incidence of post-procedural dysphagia or odynophagia (40% vs. 10%; p = 0.02). Independent factors associated with an increased risk of complex lesions were a longer procedural time under TEE manipulation (for each 10-min increment in imaging time, odds ratio: 1.27; 95% confidence interval: 1.01 to 1.59) and poor or suboptimal image quality (odds ratio: 4.93; 95% confidence interval: 1.10 to 22.02). CONCLUSIONS: Most patients undergoing structural cardiac interventions showed some form of injury associated with TEE, with longer procedural time and poor or suboptimal image quality determining an increased risk. Imaging experts performing this technique should be aware of the nature of potential complications, to take the necessary precautions to prevent their occurrence and facilitate early diagnosis and treatment.

Transradial Crossover Balloon Occlusion Technique for Primary Access Hemostasis During Transcatheter Aortic Valve Replacement: Initial Experience With the Oceanus 140 cm and 200 cm Balloon Catheters.

OBJECTIVES: The crossover balloon occlusion technique (CBOT) facilitates primary access hemostasis in patients undergoing transfemoral transcatheter aortic valve replacement (TAVR). The CBOT is usually performed through the contralateral femoral artery. The aim of this study was to evaluate, in patients undergoing TAVR, the safety and feasibility of transradial CBOT using the new Oceanus balloon dilatation catheter (iVascular). METHODS: This multicenter study included 104 patients (mean age, 81 ± 7 years; 43% women) undergoing transfemoral TAVR. A modified CBOT through the radial artery was performed in all patients with the Oceanus balloon catheter. Data regarding transradial CBOT, balloon performance, vascular complications, and 30-day clinical events were recorded. RESULTS: Up to 21% of patients had a height >170 cm and 17% presented with severe aortic/iliofemoral tortuosity. The transradial CBOT (left radial 74%, right radial 26%) was performed using either the 140 cm Oceanus (37.5%) or the 200 cm Oceanus (62.5%) balloon catheter. The balloon reached the femoral artery in all patients, and balloon inflation achieved an appropriate vessel closure in 98%. There were no complications related to the balloon catheter, and only 1 patient (1.0%) suffered a minor vascular complication related to the secondary radial access. The 30-day rates of primary access major vascular complications and death were 3.8% and 1.9%, respectively. CONCLUSION: In patients undergoing transfemoral TAVR, transradial CBOT with the Oceanus balloon dilatation catheter was feasible and safe. A balloon length up to 200 cm allowed the use of this technique (from right or left radial access) in all patients regardless of patient height or the presence of a challenging vascular anatomy.