Transesophageal echocardiography complications associated with interventional cardiology procedures.

BACKGROUND: Although there have been several reports documenting complications related with transesophageal echocardiography (TEE) manipulation following cardiac surgery, there is a paucity of data regarding the safety of TEE used to guide catheter-based interventions. The aim of this study was to determine the prevalence, types and risk factors of complications associated with procedures requiring active TEE guidance. METHODS: This study included 1249 consecutive patients undergoing either transcatheter aortic valve implantation (TAVI), Mitraclip, left atrial appendage occlusion (LAAO) or paravalvular leak closure (PVLC). Patients were divided into 2 cohorts based on the degree of probe manipulation required to guide the procedure and the risk of developing a TEE-related complication: low-risk (TAVI, n = 1037) and high-risk (Mitraclip, LAAO and PVLC, n = 212). Patients were further analyzed according to the occurrence of major and minor TEE-related complications. RESULTS: The overall incidence of TEE-related complications was 0.9% in the TAVI group and 6.1% in the rest of the cohort (P < .001). Patients in the high-risk cohort had also a higher incidence of major-complications (2.8% vs 0.6%, P = .008), and factors associated with an increased risk were being underweight, having a prior history of gastrointestinal bleeding and the use of chronic steroids/immunosuppressive medications. Procedural time under TEE-manipulation was longer in patients exhibiting complications and was an independent predictor of major complications (OR = 1.13, 95% CI 1.01-1.25, for each 10 minutes increments in imaging time). Patients with major complications undergoing Mitraclip had the longest median time under TEE-manipulation (297 minutes) and a risk of developing a major-complication that was 10.64 times higher than the rest of the cohort (95% CI 3.30-34.29, P < .001). CONCLUSION: The prevalence of TEE-related complications associated with interventional procedures is higher than previously reported. Undergoing a prolonged procedure, particularly in the setting of Mitraclip, was the main factor linked to TEE-related complications.

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.

Clinical and Technical Characteristics of Coronary Angiography and Percutaneous Coronary Interventions Performed before and after Transcatheter Aortic Valve Replacement with a Balloon-Expandable Valve.

OBJECTIVES: To report on the feasibility and technical differences between coronary procedures performed before and after TAVR with the balloon-expandable Edwards-SAPIEN or the SAPIEN XT valves. BACKGROUND: Coronary artery disease (CAD) and aortic stenosis often coexist. Transcatheter aortic valve replacement (TAVR) is emerging as a treatment for younger and lower surgical risk patients who might not present with clinically evident CAD before TAVR. The demand for performing post-TAVR coronary angiograms (CAs) and percutaneous coronary interventions (PCIs) will thus increase, posing new technical challenges. METHODS: Over 1000 TAVRs were performed at the Quebec Heart and Lung Institute, of which 616 with the abovementioned valves. Of these, 28 patients had an analyzable pre- and post-TAVR CAs and 13 patients had pre- and post-TAVR PCIs performed. Procedural characteristics were gathered from all coronary procedures and subsequently compared amongst the same type of procedure performed at these two distinct time periods. RESULTS: Neither CAs-nor PCIs-performed after valve implantation revealed significant differences regarding arterial access site, catheter diameter, number of diagnostic or guiding catheters used, procedural duration, fluoroscopy time, or achievement of selective coronary injection. Lesion location and classification, as well as the preference of using a drug-eluting stent, remained unchanged. During post-TAVR CA, the amount of contrast delivered and the radiation dose area product were significantly lower compared with pre-TAVR CA values. CONCLUSIONS: Performance of CA and PCI after TAVR with a balloon-expandable valve appears unaffected by its presence.

Independent Clinical and Echocardiographic Predictors of Restenosis After Percutaneous Mitral Balloon Commissurotomy in a Large, Consecutive Cohort Followed for 24 Years.

OBJECTIVE: To enlighten preprocedural risk factors of mitral valve restenosis in a large, single-center cohort of patients submitted to percutaneous mitral balloon commissurotomy (PMBC) for the treatment of mitral stenosis (MS) secondary to rheumatic heart disease. METHODS: This is a database analysis of a single-center, high-volume tertiary institution involving all consecutive PMBC procedures performed in the mitral valve (MV). Restenosis was diagnosed when MV area was <1.5 cm² and/or loss of 50% or more of the immediate procedural result aligned with the return/worsened symptoms of heart failure. The primary endpoint was to determine the preprocedural independent predictors of restenosis after PMBC. RESULTS: Among a total of 1921 PMBC procedures, 1794 consecutive patients without previous intervention were treated between 1987 and 2010. Throughout 24 years of follow-up, MV restenosis was observed in 483 cases (26%). Mean age was 36 years and most (87%) were female. Median follow-up duration was 9.03 years (interquartile range, 0.33-23.38). Restenosis population, however, presented a significantly lower age at the procedure time as well as a higher Wilkins-Block score. At multivariate analysis, independent preprocedure predictors of restenosis were left atrium diameter (hazard risk [HR], 1.03; 95% confidence interval [CI], 1.02-1.05; P<.04), preprocedure maximum gradient (HR, 1.02; 95% CI, 1.00-1.03; P=.04), and higher Wilkins-Block score (>8) (HR, 1.38; 95% CI, 1.14-1.67; P<.01). CONCLUSIONS: At long-term follow-up, MV restenosis was observed in a quarter of the population undergoing PMBC. Preprocedure echocardiographic findings, including left atrial diameter, maximum MV gradient, and Wilkins-Block score were found to be the only independent predictors.

Clinical Characteristics and Outcomes of Patients Screened for but Deemed Clinically Not Suitable for Transcatheter Mitral Valve Replacement: DECLINE-TMVR Registry.

BACKGROUND: Transcatheter therapies are a recognized alternative intervention in patients with severe mitral regurgitation who are at high surgical risk. The purpose of this study was to characterize patients screened for transcatheter mitral valve replacement (TMVR), establish the clinical and anatomic reasons for unsuitability, and determine clinical course and early outcomes. METHODS: International multicentre registry was conducted of consecutive patients screened for TMVR at 12 centres in Europe, the United States, and Canada between April 2015 and September 2018. Patient-level retrospective data were collected for all patients screened. RESULTS: From a total of 294 patients, 87 (30%) patients were suitable for and underwent TMVR, whereas 207 (70%) patients were unsuitable for TMVR. There was no difference in Society of Thoracic Surgeons predicted risk of mortality (6.3% ± 4.3% vs 6.7 ± 6.1%, P = 0.52) for mitral valve replacement between the groups. The most common reasons for TMVR unsuitability were mitral annular size outside therapeutic range (28%) and small predicted neo-LVOT (25%). Preprocedural multidetector computed tomographic demonstrated that patients unsuitable for TMVR had smaller predicted neo-left ventricular outflow tract (LVOT) area (318 ±192 mm2 vs 495 ± 202 mm2, P = 0.04). At 30 days, there was no difference in rates of rehospitalization (8% vs 8%, P = 0.21), stroke (1% vs 2%, P = 0.42), or mortality (4% vs 10%, P = 0.10), unadjusted for procedural risk, between unsuitable for TMVR and TMVR groups, respectively. CONCLUSIONS: Two-thirds of patients failed screening as anatomically unsuitable for TMVR. The findings of this study have important clinical implications, highlighting an unmet clinical need and provide a target for design innovation in future iterations of TMVR devices.

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.

Multimodality evaluation of transcatheter structural valve degeneration at long-term follow-up.

INTRODUCTION AND OBJECTIVES: We assessed the long-term hemodynamic performance of transcatheter heart valve (THV) by paired transthoracic echocardiography (TTE), and the incidence, characteristics and factors associated with THV structural valve degeneration (SVD). METHODS: A total of 212 patients who underwent transcatheter aortic valve replacement and had a potential follow-up >5 years with at least 1 TTE ≥ 1-year postprocedure were included. All patients had a TTE at 1 to 5 years and 36 had another one at 6 to 10 years. SVD was defined as subclinical (increase >10mmHg in mean transvalvular gradient+decrease >0.3cm2 in valve area and/or new-onset mild or moderate aortic regurgitation) and clinically relevant (increase> 20mmHg in mean transvalvular gradient+decrease> 0.6cm2 in valve area and/or new-onset moderate-to-severe aortic regurgitation). Fifteen patients had a transesophageal echocardiography at the time of SVD diagnosis, and 85 an opportunistic computed tomography examination at 1 (0.5-2) years. RESULTS: Transvalvular mean gradient increased and valve area decreased over time (P<.01). At 8 years of follow-up, SVD occurred in 30.2% of patients (clinically relevant: 9.3%). Transesophageal echocardiography revealed thickened and reduced-mobility leaflets in 80% and 73% of SVD cases, respectively. No baseline or procedural factors were associated with SVD. THV underexpansion (3.5%) or eccentricity (8.2%) had no impact on valve hemodynamics/SVD at follow-up. CONCLUSIONS: A gradual THV hemodynamic deterioration occurred throughout a 10-year period, leading to SVD in ∼30% of patients (clinically relevant in < 10%). Leaflet morphology/mobility were frequently impaired in SVD cases, but THV geometry did not influence valve hemodynamics or SVD.

Device profile of the AltaValve system for transcatheter mitral valve replacement: overview of its safety and efficacy.

INTRODUCTION: In patients with severe mitral regurgitation (MR), transcatheter mitral valve replacement (TMVR) has recently emerged as an alternative to surgery. However, compared with transcatheter aortic valve replacement, TMVR faces several technical challenges and a high screening failure rate, mainly due to a more complex mitral annulus geometry and the potential interaction with the sub-valvular apparatus and the left ventricular outflow tract (LVOT). The AltaValve system is a device intended for TMVR with unique design features that may overcome most anatomical limitations for this therapy. AREAS COVERED: A summary of the current evidence regarding TMVR is presented, followed by a review of the main technical challenges. The main features, differential characteristics, and potential advantages of the AltaValve system are discussed. Finally, we describe the first-in-human procedures with AltaValve and the main details of the upcoming feasibility trial. EXPERT OPINION: A high number of high-risk surgical patients with MR remain undertreated. TMVR is continuously evolving, and AltaValve constitutes another step forward in this field. Its unique design avoiding annular and LVOT engagement represents a clear potential benefit, along with its recently incorporated trans-septal approach system. However, more evidence is warranted regarding its feasibility in different clinical settings and mid-term performance.

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.

Characteristics and Outcomes of Patients Who Are Denied From a Percutaneous Edge-to-Edge Mitral Valve Repair After Being Referred to a Transcatheter Mitral Valve Program: Impact of a Dedicated Multidisciplinary Mitral Heart Team Approach.

BACKGROUND: Many patients referred for a MitraClip intervention are finally refused for this intervention, and data are very scarce on their outcomes. Our study sought to determine the characteristics and outcomes of patients who are referred to a mitral valve clinic and are finally denied from a percutaneous mitral edge-to-edge repair. METHODS: A total of 210 patients referred to our clinic for severe mitral regurgitation were retrospectively analyzed. Fifty-seven patients underwent a MitraClip procedure. For exploratory purposes, a propensity-matched cohort comparing the patients accepted for a MitraClip procedure and those refused for any mitral intervention was analyzed. RESULTS: Among the 153 patients who were refused for MitraClip, 46% had functional MR, 42% had degenerative MR, and 11% had mixed disease. Reasons for denial included unfavorable anatomy, patient refusal, mitral valve surgery referral, cardiac resynchronization therapy, other advanced heart failure therapies, and palliative care. After a mean follow-up of 13 months, 50% were in New York Heart Association class I or II, 63% had less than severe MR, and mortality rate was 29%. In the propensity-matched cohort, there was no difference in symptoms improvement, but there was less overall mortality (P=.01), cardiovascular mortality (P<.01) and severe MR (P<.01) in the MitraClip group. CONCLUSIONS: A multidisciplinary heart team evaluation for complex MR patients can be useful not solely for selecting the ideal MitraClip eligible patients, but also to select the best treatment strategy in each individualized context.

Transcatheter aortic valve replacement with the balloon-expandable SAPIEN 3 valve: Impact of calcium score on valve performance and clinical outcomes.

BACKGROUND: Aortic valve calcification severity has been associated with higher rates of aortic regurgitation (AR) following TAVR, but scarce data exist on its impact with the use of newer generation transcatheter heart valves. METHODS: This was a multicenter study including 626 patients with severe aortic stenosis who underwent TAVR with the SAPIEN 3 valve. Patients were divided in 2 groups according to the median index calcium score (iCS) for each sex: high CS (HCS, iCS ≥ median), and low iCS (LCS, iCS < median). Another analysis was performed in those patients with extreme iCS (ECS, iCS >75th percentile for each sex). Clinical and echocardiographic data were collected prospectively in a dedicated database. RESULTS: The mean CS was 3758 ±â€¯1417 AU and 1616 ±â€¯691 AU in the HCS and LCS groups, respectively (p < 0.001). There were no differences between groups in 30-day mortality (HCS:2.6%, LCS:1.0%, p = 0.13) and stroke (HCS:2.6%,LCS:2.6%, p = 1.0) rates, but all cases (n = 5) of annulus rupture occurred in the HCS group (1.6% vs. 0%, p = 0.061). The incidence of moderate-severe AR post-TAVR was low in both groups (HCS:1.6%,LCS:1.6%, p = 1.0), and valve gradient and area were similar between groups. The results remained similar in the ECS group (mean CS:4607 ±â€¯1424 AU), but a mildly increased mean transvalvular gradient post-TAVR was observed in ECS patients (12.1 ±â€¯5.6 vs 11.0 ±â€¯4.3 mmHg; p = 0.015). CONCLUSION: Aortic valve calcification severity failed to impact mortality/stroke rates following TAVR with the SAPIEN 3 valve. Low rates of significant AR were observed irrespective of CS, and a mild increase in transvalvular gradient was observed in ECS patients.

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.

Late Cerebrovascular Events Following Transcatheter Aortic Valve Replacement.

OBJECTIVES: This study sought to determine the incidence, clinical characteristics, associated factors, and outcomes of late cerebrovascular events (LCVEs) (>30 days post-procedure) following transcatheter aortic valve replacement (TAVR). BACKGROUND: Scarce data exist on LCVEs following TAVR. METHODS: This was a multicenter study including 3,750 consecutive patients (mean age, 80 ± 8 years; 50.5% of women) who underwent TAVR and survived beyond 30 days. LCVEs were defined according to the Valve Academic Research Consortium 2 (VARC 2) criteria. RESULTS: LCVEs occurred in 192 (5.1%) patients (stroke, 80.2%; transient ischemic attack, 19.8%) after a median follow-up of 2 (1 to 4) years. Late stroke was of ischemic, hemorrhagic, and undetermined origin in 80.5%, 18.8%, and 0.7% of patients, respectively. Older age, previous cerebrovascular disease, higher mean aortic gradient at baseline, the occurrence of stroke during the periprocedural TAVR period, and the lack of anticoagulation (novel oral anticoagulants or vitamin K antagonists) post-TAVR were independent factors associated with late ischemic stroke/transient ischemic attack (p < 0.05 for all). Echocardiographic data at the time of the LCVE showed no signs of valve thrombosis or degeneration in the vast majority (97%) patients. Late stroke was disabling in 107 (69.5%) patients (ischemic, 68%; hemorrhagic, 79%), and associated with an in-hospital mortality rate of 29.2%. CONCLUSIONS: LCVEs occurred in 5.1% of TAVR recipients after a median follow-up of 2 years. LCVEs were ischemic in most cases, with older age, previous cerebrovascular events, higher mean aortic gradient at baseline, the occurrence during the periprocedural TAVR period, and lack of anticoagulation (but not valve thrombosis/degeneration) determining an increased risk. Late stroke was disabling in most cases and associated with dreadful early and midterm outcomes.

Third-Generation Balloon and Self-Expandable Valves for Aortic Stenosis in Large and Extra-Large Aortic Annuli From the TAVR-LARGE Registry.

BACKGROUND: Currently, 2 third-generation transcatheter valves, 29-mm Sapien-3 and 34-mm Evolut-R (ER), are indicated for large sized aortic annuli. We analyzed short and 1-year performance of these valves in patients with large (area ≥575 mm2 or perimeter ≥85 mm) and extra-large (≥683 mm2 or ≥94.2 mm) aortic annuli undergoing transcatheter aortic valve replacement. METHODS: A total of 833 patients across 12 centers with symptomatic aortic stenosis and large aortic annuli underwent transcatheter aortic valve replacement with 29-mm Sapien-3 (n=640) or 34-mm ER (n=193). Clinical, anatomic, and procedural characteristics were collected, and Valve Academic Research Consortium-2 outcomes were reported. RESULTS: Median aortic annulus area and perimeter were 617 mm2 (591-657) and 89.1 mm (87.0-92.1), respectively (704 mm2 [689-743] and 96.0 mm [94.5-97.9] in the subgroup of 124 patients with extra-large annuli). Overall device success was 94.3% (Sapien-3, 95.8% and ER, 89.3%; P=0.001), with a higher rate of significant paravalvular leak (P=0.004), second valve implantation (P=0.013), and valve embolization (P=0.009) in the ER group. Thirty-day and 1-year mortality was 2.4% and 9.2%, respectively, without differences between groups. Valve hemodynamics were excellent (mean gradient, 8.8±3.6 mm Hg; 3.3% rate of moderate-severe paravalvular leak) in the extra-large annulus, without differences compared with the large annulus group. CONCLUSIONS: In patients with large and extra-large aortic annuli, transcatheter aortic valve replacement using 29-mm Sapien-3 and 34-mm ER is safe and feasible. Observed differences in clinical outcomes and hemodynamic performance may guide valve choice in this cohort of patients undergoing transcatheter aortic valve replacement.

Early Experience With Transcatheter Mitral Valve Replacement: A Systematic Review.

Background Transcatheter mitral valve replacement (TMVR) has emerged as an alternative therapeutic option for the treatment of severe mitral regurgitation in patients with prohibitive or high surgical risk. The aim of this systematic review is to evaluate the clinical procedural characteristics and outcomes associated with the early TMVR experience. Methods and Results Published studies and international conference presentations reporting data on TMVR systems were identified. Only records including clinical characteristics, procedural results, and 30-day and midterm outcomes were analyzed. A total of 16 publications describing 308 patients were analyzed. Most patients (65.9%) were men, with a mean age of 75 years (range: 69-81 years) and Society for Thoracic Surgery Predicted Risk of Mortality score of 7.7% (range: 6.1-8.6%). The etiology of mitral regurgitation was predominantly secondary or mixed (87.1%), and 81.5% of the patients were in New York Heart Association class III or IV. A transapical approach was used in 81.5% of patients, and overall technical success was high (91.7%). Postprocedural mean transmitral gradient was 3.5 mm Hg (range: 3-5.5 mm Hg), and only 4 cases (1.5%) presented residual moderate to severe mitral regurgitation. Procedural and all-cause 30-day mortality were 4.6% and 13.6%, respectively. Left ventricular outflow obstruction and conversion to open heart surgery were reported in 0.3% and 4% of patients, respectively. All-cause and cardiovascular-related mortality rates were 27.6% and 23.3%, respectively, after a mean follow-up of 10 (range: 3 to 24) months. Conclusions TMVR was a feasible, less invasive alternative for treating severe mitral regurgitation in patients with high or prohibitive surgical risk. TMVR was associated with a high rate of successful valve implantation and excellent hemodynamic results. However, periprocedural complications and all-cause mortality were relatively high.

Coronary Artery Disease and Transcatheter Aortic Valve Replacement: JACC State-of-the-Art Review.

About one-half of transcatheter aortic valve replacement (TAVR) candidates have coronary artery disease (CAD), and controversial results have been reported regarding the effect of the presence and severity of CAD on clinical outcomes post-TAVR. In addition to coronary angiography, promising data has been recently reported on both the use of computed tomography angiography and the functional invasive assessment of coronary lesions in the work-up pre-TAVR. While waiting for the results of ongoing randomized trials, percutaneous revascularization of significant coronary lesions has been the routine strategy in TAVR candidates with CAD. Also, scarce data exists on the incidence, characteristics, and management of coronary events post-TAVR, and increasing interest exist on potential coronary access challenges in patients requiring coronary angiography/intervention post-TAVR. This review provides an updated overview of the current landscape of CAD in TAVR recipients, focusing on its prevalence, clinical impact, pre- and post-procedural evaluation and management, unresolved issues and future perspectives.

How does new-onset left bundle branch block affect the outcomes of transcatheter aortic valve repair?

INTRODUCTION: Transcatheter aortic replacement (TAVR) has revolutionized the treatment of aortic stenosis during the last years. Despite improvements in transcatheter heart valve systems, the rate of conduction disturbances after TAVR, particularly new-onset left bundle branch block (new-onset LBBB), has not decreased over time. AREAS COVERED: Overview of the current data regarding new-onset LBBB post-TAVR focusing on clinical outcomes. EXPERT OPINION: New-onset LBBB remains the most common complication after TAVR, occurring in 6-77% of cases with the use of newer generation transcatheter valve systems. The most consistent factor determining new-onset LBBB post-TAVR has been prosthesis implantation depth. The potential evolution to high degree atrioventricular block (HAVB) and the chronic effect on left ventricular ejection fraction (LVEF) may impact the clinical outcomes in this subset of patients. New-onset LBBB has been associated with an increased risk of PPM after TAVR. Conversely, inconsistent results have been reported regarding the impact of LBBB on hospitalization for heart failure and mortality. Current data do not support an indication for 'prophylactic' PPM in all new-onset LBBB patients. However, a specific subset of patients (those with either a very long PR or wide QRS) may benefit from a PPM to prevent HAVB or sudden death.

Transcatheter aortic valve replacement in low risk patients.

Transcatheter aortic valve replacement (TAVR) is a relatively new technology that has grown exponentially over the past decade. Although it was initially restricted to elderly patients at very high or prohibitive surgical risk, it is currently being evaluated as a treatment option in younger and lower risk patients. The increasing experience of the Heart Teams, along with the continued refinement of transcatheter valve technology has resulted in TAVR achieving results comparable to those of surgery for treating intermediate-risk patients. Furthermore, promising preliminary results have been obtained from observational and propensity matched studies in low risk patients, and a small randomized trial showed the non-inferiority of TAVR vs. SAVR regarding early and late (up to 6 years) outcomes. Three ongoing randomized trials will provide the definite response about the safety and efficacy of TAVR for treating low risk patients with severe aortic stenosis in the near future. The (expected) positive results of these studies would establish the basis for TAVR as the preferred treatment for the majority of patients with aortic stenosis. However, continuous research efforts for better determining valve durability among TAVR recipients, as well as reducing some of the genuine and frequent complications of TAVR (e.g. conduction disturbances) are important in this final effort for making TAVR the default treatment for aortic stenosis.

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.

Transcatheter aortic valve replacement: relative safety and efficacy of the procedure with different devices.

INTRODUCTION: Transcatheter aortic valve replacement (TAVR) is a well-established treatment for patients with severe aortic stenosis and intermediate-to-high surgical risk. The increasing clinical experience along with technical and design iterations of transcatheter valve systems have contributed to reducing adverse events and improving clinical outcomes. AREAS COVERED: Overview of the latest generation transcatheter heart valves (THVs), focusing on early safety and efficacy outcomes. EXPERT COMMENTARY: Improvements in valve repositionability, reducing the size of valve delivery systems, and antiparavalvular leak iterations have contributed to improving the safety and clinical outcomes following TAVR. However, while certain complications like major vascular events and residual paravalvular leaks have significantly decreased with the arrival of newer generation THVs, no major changes in thromboembolic events (particularly stroke) have been observed, whereas other complications like conduction disturbances requiring pacemaker implantation have slightly increased over time. Also, no major progress on device retrievability has been observed in the last years. The expansion of TAVR toward the treatment of younger and lower risk patients, as well as newer indications (e.g. asymptomatic patients) will likely require an extra-effort involving additional device iterations and complementary therapies (e.g. embolic protection, newer vascular closure devices) to further improve safety and clinical outcomes.