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.

Independent clinical and echocardiographic predictors of restenosis after percutaneous mitral balloon commissurotomy in a large, consecutive cohort followed for 24 years

OBJECTIVES: 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.

Independent clinical and echocardiographic predictors of restenosis after percutaneous mitral balloon commissurotomy followed for 24 years

BACKGROUND: Mitral valve stenosis (MVS) is one of the most common structural heart diseases in developing countries, primarily due to rheumatic disease. Percutaneous mitral balloon valvuloplasty (PMBV) has been, since its introduction in 1984, the preferred option of treatment for such disease. However, restenosis is presented with an approximate incidence of 20%. Echocardiographic scoring of the mitral apparatus has been the main tool used to indicate and foresee the possible result of the procedure. The objective of this study was to enlight risk factors of mitral valvular restenosis in a significant number of patients submitted to percutaneous mitral balloon commissurotomy for the treatment of mitral stenosis (MS), particularly when secondary to rheumatic heart disease. METHODS: This study reports the vast experience of a single center high volume tertiary institution where 1.794 consecutive patients were treated with PMBC between 1987 and 2011. The primary endpoint was to determine the independent predictors of this untoward event, defined as loss of over 50% of the original increase in maximum valve area (MVA) or MVA< 1.5 cm2. RESULTS: Mitral valve restenosis was observed in 26% of the cases (n=483). Mean population age was 36 years old, with most patients being female (87%). Mean follow up duration was 4.8 years. At multivariate analysis independent pre-procedural predictors of restenosis were: left atrial diameter (HR: 1.03, 95% ci: 1.01-1.04, p<0.01), pre procedure maximum gradient (HR: 1.01, 95% ci: 1.00-1.03, p=0.02) and higher wilkins scores (HR: 1.37, 95% ci: 1.13-1.66, p<0.01). CONCLUSION: In the very long term follow-up, mitral valve restenosis was observed in a quarter of the population undergoing PMBC. Preprocedure echocardiographic findings, including left atrial diameter, maximum valve gradient and high Wilkins scores were found to be the only independent predictors of this deleterious event.

Preditores independentes de reestenose da valva mitral após valvoplastia mitral percutânea por balão em uma grande coorte consecutiva com seguimento clínico por mais de duas décadas / Independent predictors of mitral valve restenosis after percutaneous balloon mitral valvuloplasty in a large consecutive cohort with clinical follow-up for more than two decades

INTRODUÇÃO: A valvoplastia mitral percutânea com balão (VMPB), sempre que tecnicamente viável, é a opção de tratamento preferencial para a estenose mitral, particularmente aquelas secundárias à doença cardíaca reumática. No entanto, a reestenose valvar mitral pode se desenvolver em um número significativo de pacientes submetidos a esse procedimento, com fatores de risco ainda pouco claros para tal ocorrência. OBJETIVOS: O objetivo deste estudo foi elucidar os fatores de risco da reestenose valvar mitral em um número significativo de pacientes submetidos à comissurotomia mitral percutânea por balão para tratamento da estenose mitral (EM), principalmente quando secundária à cardiopatia reumática. MÉTODOS: Trata-se de uma análise de centro único de uma coorte grande e consecutiva de pacientes tratados com VMP entre 1987 e 2010, que desenvolveram reestenose. O desfecho primário foi determinar os preditores independentes desse evento, definido como perda de mais de 50% do aumento original na área valvar mitral máxima (AVM) ou AVM menor que 1,5cm2. RESULTADOS: Um total de 1.794 pacientes consecutivos submetidos a VMP em um único centro, instituição terciária de alto volume, foram incluídos neste registro. Reestenose da valva mitral foi observada em 26% dos casos (n=483). A média de idade da população foi de 36 anos, com a maioria dos pacientes sendo do sexo feminino (87%). A duração média do acompanhamento foi de 4,8 anos. Na análise multivariada, os preditores independentes de reestenose foram: diâmetro atrial esquerdo [RR (risco relativo): 1,03; IC (intervalo de confiança) 95%: 1,01-1,04; p <0,01]; gradiente máximo pré-procedimento (RR: 1,01; IC 95%: 1,00-1,03; p=0,02) e Wilkinsscore > 8 (RR: 1,37; IC 95%: 1,13-1,66; p<0,01). CONCLUSÕES: No seguimento em longo prazo, a reestenose da valva mitral foi observada em até 25% da população submetida à VMP. Os achados ecocardiográficos pré-procedimento, incluindo o diâmetro do átrio esquerdo, o gradiente valvar máximo e o escore de Wilkins, foram os únicos preditores independentes desse desfecho desfavorável.

Independent clinical and echocardiographic predictors of restenosis after percutaneous mitral balloon commissurotomy followed for 24 years

INTRODUCTION: Mitral valve stenosis (MVS) is one of the most common structural heart diseases in developing countries, primarily due to rheumatic disease. Percutaneous mitral balloon valvuloplasty (PMBV) has been, since its introduction in 1984, the preferred option of treatment for such disease. However, restenosis is presented with an approximate incidence of 20%. Echocardiographic scoring of the mitral apparatus has been the main tool used to indicate and foresee the possible result of the procedure. OBJECTIVE: The objective of this study was to enlight risk factors of mitral valvular restenosis in a significant number of patients submitted to percutaneous mitral balloon commissurotomy for the treatment of mitral stenosis (MS), particularly when secondary to rheumatic heart disease. METHODS: This study reports the vast experience of a single center high volume tertiary institution where 1.794 consecutive patients were treated with PMBC between 1987 and 2011. The primary endpoint was to determine the independent predictors of this untoward event, defined as loss of over 50% of the original increase in maximum valve area (MVA) or MVA < 1.5 cm2. RESULTS: Mitral valve restenosis was observed in 26% of the cases (n = 483). Mean population age was 36 years old, with most patients being female (87%). Mean follow up duration was 4.8 years. At multivariate analysis independent pre-procedural predictors of restenosis were: left atrial diameter (HR: 1.03, 95% ci: 1.01-1.04, p < 0.01), pre procedure maximum gradient (HR: 1.01, 95% ci: 1.00-1.03, p = 0.02) and higher wilkins scores (HR: 1.37, 95% ci: 1.13-1.66, p < 0.01). CONCLUSION: In the very long term follow-up, mitral valve restenosis was observed in a quarter of the population undergoing PMBC. Preprocedure echocardiographic findings, including left atrial diameter, maximum valve gradient and high Wilkins scores were found to be the only independent predictors of this deleterious event.

Independent mitral valve predictors of restenosis after percutaneous mitral balloon commissurotomy in a large, consecutive cohort followed for more than two decades

AIMS: the objective of this study was to enlight risk factors of mitral valvular restenosis in a significant number of patients submitted to percutaneous mitral balloon commissurotomy for the treatment of mitral stenosis (ms), particularly when secondary to rheumatic heart disease. METHODS AND RESULTS: this study reports the vast experience of a single center high volume tertiary institution where 1,794 consecutive patients were treated with PMBC between 1987 and 2011. the primary endpoint was to determine the independent predictors of this untoward event, defined as loss of over 50% of the original increase in maximum valve area (mva) or mva < 1.5 cm2. mitral valve restenosis was observed in 26% of the cases (n=483). average population age was 36 years old, with most patients being female (87%). mean follow up duration was 4.8 years. at multivariate analysis independent pre-procedural predictors of restenosis were: left atrial diameter (hr: 1.03, 95% ci: 1.01-1.04, p<0.01). pre procedure maximum gradient (hr: 1.01, 95% ci: 1.00-1.03, p=0.02) and higher wilkins scores (hr: 1.37, 95% ci: 1.13-1.66, p<0.01). CONCLUSIONS: In the very long term follow-up, mitral valve restenosis was observed in a quarter of the population undergoing PMBC. Preprocedure echocardiographic findings, including left atrial diameter, maximum valve gradient and high wilkins scores were found to be the only indepen dent predictors of this deleterious event.

Long-term follow-up in patients with rheumatic mitral stenosis and severe pulmonary artery hypertension submitted to percutaneous mitral balloon commissurotomy

AIMS: Percutaneous balloon mitral commissurotomy (PMBC) is an attractive therapeutic approach in patients with mitral stenosis. The aim of this study was to assess the immediate and long-term clinical, echocardiographic and haemodynamic outcomes of PMBC in patients with severe pulmonary hypertension (PH). METHODS AND RESULTS: Among all procedures (in more than two decades of experience), PMBC was performed from 1987 until 2011 at a single-center in 147 patients who had significant PH defined as baseline pulmonary artery mean pressure (PAMP) (systolic pulmonary pressure > 75 mmHg). All-cause mortality, need for mitral valve replacement (MVR) or new PMBC, and valve restenosis were evaluated during follow-up yearly. Mean age was 33.8 ± 12.8 years and 83.6% (123 patients) were women. Primary success was achieved in 89.8% of the patients (132 patients). Mitral valve area (MVA) increased from 0.83 ± 0.17 cm2 to 2.03± 0.35 cm2 (p<0.001), and at 20-years, mitral valve area was 1.46 ± 0.34 cm2 (p=0.235). Systolic pulmonary artery pressure decreased from 87.0 ± 6.0 mmHg to 60.0 ± 0.9 mmHg (p<0.0001). The rates of all-cause mortality, need for MVR, new PMV, and valve restenosis were 0.67%, 20.0%, 8.78% and 30.4%, respectively, in long-term follow- up (mean 15.6 ± 4.9 years). CONCLUSIONS: PMBC is a safe and effective technique for the treatment of patients with mitral stenosis and PH. A significant decrease in pulmonary pressure was observed after commissurotomy. Although there was a gradual decrease of MVA at long-term follow-up, most patients remained asymptomatic and without major adverse events.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Preditores independentes de reestenose da valva mitral após valvoplastia mitral percutânea por balão em uma grande coorte consecutiva com seguimento clínico por mais de duas décadas / Independent predictors of mitral valve restenosis after percutaneous balloon mitral valvuloplasty in a large consecutive cohort with clinical follow-up for more than two decades

INTRODUÇÃO: A valvoplastia mitral percutânea com balão (VMP), sempre que tecnicamente viável, é a opção de tratamento preferencial para a estenose mitral, particularmente aquelas secundárias à doença cardíaca reumática. No entanto, a reestenose valvar mitral pode se desenvolver em um número significativo de pacientes submetidos a esse procedimento, com fatores de risco ainda pouco claros para tal ocorrência. MÉTODOS: Trata-se de uma análise de centro único de uma coorte grande e consecutiva de pacientes tratados com VMP entre 1987 e 2010, que desenvolveram reestenose. O desfecho primário foi determinar os preditores independentes desse evento, definido como perda de mais de 50% do aumento original na área valvar mitral máxima (AVM) ou AVM menor que 1,5 cm2. RESULTADOS: Um total de 1.794 pacientes consecutivos submetidos a VMP em um único centro, instituição terciária de alto volume, foram incluídos neste registro. Reestenose da valva mitral foi observada em 26% dos casos (n = 483). A média de idade da população foi de 36 anos, com a maioria dos pacientes sendo do sexo feminino (87%). A duração média do acompanhamento foi de 4,8 anos. Na análise multivariada, os preditores independentes de reestenose foram: diâmetro atrial esquerdo [RR (risco relativo): 1,03; IC (intervalo de confiança) 95%: 1,01-1,04; p <0,01]; gradiente máximo pré-procedimento (RR: 1,01; IC 95%: 1,00-1,03; p = 0,02 ) e Wilkins score maior que 8 (RR: 1,37; IC 95%: 1,13-1,66; p <0,01). CONCLUSÕES: No seguimento em longo prazo, a reestenose da valva mitral foi observada em até 25% da população submetida à VMP. Os achados ecocardiográficos pré-procedimento, incluindo o diâmetro do átrio esquerdo, o gradiente valvar máximo e o escore de Wilkins, foram os únicos preditores independentes desse desfecho desfavorável. (AU)