Volume-outcome relationship in balloon aortic valvuloplasty: results of a consecutive, patient-level data analysis from a Japanese nationwide multicentre registry (J-SHD).

OBJECTIVE: Transcatheter balloon aortic valvuloplasty (BAV) remains an important alternative treatment for severe, symptomatic aortic stenosis. With increasing numbers of BAVs being performed, the need for large-scale volume-outcome relationship assessments has become evident. Here, we aimed to explain such relationships by analysing consecutive, patient-level BAV data recorded in a prospective Japanese nationwide multicentre registry. DESIGN: Prospective study. SETTING: Data of 1920 BAVs performed in 200 Japanese hospitals from January 2015 to December 2019. PARTICIPANTS: The mean patient age was 85 years, and 36.9% of procedures involved male patients. METHODS: The efficacy of BAV was assessed by reducing the mean transaortic valve gradient after the procedure. We also assessed in-hospital complication rates, including in-hospital death, bleeding, urgent surgery, distal embolism, vessel rupture and contrast-induced nephropathy. Based on the distribution of case volume (median 20, IQR 10-46), we divided the patients into high-volume (≥20) and low-volume (<20) groups. In-hospital complication risk was assessed with adjustment by logistic regression modelling. RESULTS: Indications for BAV included palliative/destination (44.2%), bridge to transcatheter aortic valve replacement (34.5%), bridge to surgical aortic valve replacement (7.4%) and salvage (9.7%). Reduction of the mean transaortic valve gradient was similar between the high-volume and low-volume groups (20 mm Hg vs 20 mm Hg, p=0.12). The proportion of in-hospital complications during BAV was 4.2%, and the incidence of complications showed no difference between the high-volume and low-volume groups (4.2% vs 4.1%, p=1.00). Rather than hospital volume, salvage procedure was an independent predictor of in-hospital complications (OR, 4.04; 95% CI, 2.03 to 8.06; p<0.001). CONCLUSION: The current study demonstrated that procedural outcomes of BAV were largely independent of its institutional volume.

Safety and efficacy of repeated balloon aortic valvuloplasty in patients with symptomatic severe aortic stenosis.

BACKGROUND: Long-term outcomes of balloon aortic valvuloplasty (BAV) in patients with severe symptomatic aortic stenosis (AS) are poor, and this procedure needs to be repeated in selected cases. AIMS: We aimed to investigate the safety and efficacy of repeated BAV (reBAV). METHODS: We included consecutive patients who underwent reBAV in three Polish centers between 2010 and 2019. Baseline clinical, echocardiographic, procedural, and outcome data were analyzed. RESULTS: Thirty-five patients (median age 81.5 years, 57.1% women) who underwent reBAV were enrolled. In 42.9% of the patients, index BAV was considered a palliative treatment, and in 54.3% a bridge to definitive treatment. Index BAV decreased peak aortic valve gradient (pAVG) from a median of 78.0 mm Hg to 46.0 mm Hg (P <0.001). After a mean of 255.8 days, reBAV was performed. In most cases (71.4%), the reason for reBAV was the worsening of heart failure symptoms and in 54.3% of patients, reBAV was still considered a palliative option. A decrease in pAVG max from a median of 73.0 mm Hg to 45.0 mm Hg (P <0.001), comparable to index BAV, was observed. The frequency of complications were numerically higher for repeated procedures. During the median (IQR) follow-up of 403.0 (152.0-787.0) days from the index procedure, 80.0% of the patients died. CONCLUSIONS: Acute hemodynamic results of reBAV are comparable to those achieved during index BAV. However, reBAV may carry an increased risk of complications. Moreover, mortality is high due to unfavorable risk profiles or delays in receiving definitive therapy.

Late gestation predictors of a postnatal biventricular circulation after fetal aortic valvuloplasty.

OBJECTIVES: Fetal aortic valvuloplasty (FAV) for severe aortic stenosis (AS) has shown promise in averting progression to hypoplastic left heart syndrome. After FAV, predicting which fetuses will achieve a biventricular (BiV) circulation after birth remains challenging. Identifying predictors of postnatal circulation on late gestation echocardiography will improve parental counseling. METHODS: Liveborn patients who underwent FAV and had late gestation echocardiography available were included (2000-2017, n = 96). Multivariable logistic regression and classification and regression tree analysis were utilized to identify independent predictors of BiV circulation. RESULTS: Among 96 fetuses, 50 (52.1%) had BiV circulation at the time of neonatal discharge. In multivariable analysis, independent predictors of biventricular circulation included left ventricular (LV) long axis z-score (OR 3.2, 95% CI 1.8-5.7, p < 0.001), LV ejection fraction (OR 1.3, 95% CI 1.0-1.8, p = 0.023), anterograde aortic arch flow (OR 5.0, 95% CI 1.2-20.4, p = 0.024), and bidirectional or right-to-left foramen ovale flow (OR 4.6, 95% CI 1.4-15.8, p = 0.015). CONCLUSION: Several anatomic and physiologic parameters in late gestation were found to be independent predictors of BiV circulation after FAV. Identifying these predictors adds to our understanding of LV growth and hemodynamics after FAV and may improve parental counseling.

Early Real-World Experience with CoreValve Evolut PRO and R Systems for Transcatheter Aortic Valve Replacement.

OBJECTIVES: The purpose of this study was to compare the efficacy and safety of the Evolut PRO to the Evolut R valve in a real-world setting. BACKGROUND: The next-generation self-expanding transcatheter aortic valve replacement (TAVR) system, the CoreValve Evolut PRO was designed with an outer pericardial skirt to improve valve-sealing performance. Safety and efficacy of this valve have not previously been compared to its predecessor, the Evolut R valve. METHODS: We retrospectively studied 134 patients who underwent TAVR with the Evolut PRO or Evolut R valve over one year at a tertiary center. Endpoints, defined by the Valve Academic Research Consortium-2 criteria, included device success, paravalvular leak (PVL), and a composite safety endpoint including mortality, stroke, major vascular complications, life-threatening bleeding, acute kidney injury, coronary artery obstruction, and repeat procedure for valve-related dysfunction. RESULTS: 60 Evolut PRO and 56 Evolut R patients met the study criteria. Both groups had similar device success rates (90 vs. 89%, p=0.44). Incidence of moderate PVL was similar on discharge (5 vs. 11%, p=0.68) and at 30 days (11 vs. 13%, p=0.79), with nil incidence of severe PVL. There were no mortalities, and the VARC-2 safety endpoint at 30 days was comparable. CONCLUSION: Despite the additional pericardial skirt and larger sheath size of Evolut PRO, outcomes were comparable between the two Evolut systems, supporting adoption of the newest generation valve in the management of severe aortic stenosis as well as continued use of the Evolut R in patients with smaller vasculature warranting a lower profile device.

Outcomes of hypoplastic left heart syndrome and fetal aortic valvuloplasty in a country with suboptimal postnatal management.

BACKGROUND: Fetal aortic stenosis (AoS) may progress to hypoplastic left heart syndrome (HLHS) in utero. There are currently no data, prenatal or postnatal, describing survival of fetuses or neonates with AoS or HLHS in a country with suboptimal postnatal management. STUDY DESIGN: Prospective cohort study performed in Mexico, including cases diagnosed with AoS and HLHS within a 6-year period. AoS patients fulfilling previously published criteria for evolving HLHS (eHLHS) were offered fetal aortic valvuloplasty. Outcome variables were perinatal mortality, postnatal management, type of postnatal circulation, and overall survival. RESULTS: Fifty-four patients were included: 16 AoS and 38 HLHS. Eighteen patients had associated anomalies and/or an abnormal karyotype. Seventy-four percent of HLHS received comfort measures, with only three cases reporting an attempt at surgical palliation, and one survivor of the first stage. Fetal aortic valvuloplasty was performed successfully in nine cases of eHLHS. Overall postnatal survival was 44% in AoS with fetal aortic valvuloplasty, and one case (ongoing) in the HLHS group. CONCLUSIONS: HLHS in Mexico carries more than a 95% risk of postnatal death, with little or no experience at surgical palliation in most centers. Fetal aortic valvuloplasty in AoS may prevent progression to HLHS and in this small cohort was associated with ≈50% survival.

Comparison of Transcarotid vs. Transfemoral Transcatheter Aortic Valve Implantation.

BACKGROUND: Recently, the carotid artery has been used as an alternative approach for transcatheter aortic valve implantation (TAVI). The aim of this study was to prove the safety and feasibility of transcarotid (TC) vs. transfemoral (TF) TAVI. Methods and Results: This retrospective study enrolled 726 consecutive patients with severe symptomatic aortic stenosis. All patients underwent TC-TAVI or TF-TAVI at Hôpital Haut-Lévèque, Bordeaux Heart University Hospital between September 2012 and October 2017. The TC-TAVI (n=83) and TF-TAVI (n=643) groups were compared statistically. The EuroSCORE II was significantly higher (8.2±6.7 vs. 6.4±5.5; P=0.007) and rates of current smoking, dyslipidemia and peripheral arterial disease were higher in the TC-TAVI than TF-TAVI group. All TC-TAVIs and 9.3% of TF-TAVIs were performed under general anesthesia. Radiation time was significantly shorter in the TC-TAVI than TF-TAVI group (14.5±6.0 vs. 23.0±10.8 min; P<0.001). Postimplant balloon valvuloplasty was performed more frequently in the TF-TAVI than TC-TAVI group (7.2% vs. 19.4%; P=0.006). Postoperative echocardiographic data were similar between the 2 groups, and there were no significant differences in 30-day mortality (8.4% vs. 5.0%; P=0.189) or stroke rate (1.2% vs. 2.6%; P=0.428) between the TF-TAVI and TC-TAVI groups. CONCLUSIONS: The feasibility and 30-day safety of TC-TAVI and TF-TAVI are similar. When TF-TAVI is not suitable anatomically for a particular patient, TC-TAVI is a preferable alternative.

Cronología y evolución de los trastornos de conducción asociados con el implante percutáneo de válvula aórtica: impacto de la valvuloplastia aórtica con balón / Timing of onset and outcome of new conduction abnormalities following transcatheter aortic valve implantation: role of balloon aortic valvuloplasty

Introducción y objetivos: La cronología y la evolución de los trastornos de conducción (TdC) asociados con el implante percutáneo de válvula aórtica (TAVI) expandible con balón son poco conocidas. Este estudio examina la cronología de los TdC y el impacto de la valvuloplastia aórtica con balón (VAB) en su persistencia. Métodos: Se incluyó a 347 pacientes, y a 75 de ellos se les realizó una monitorización continua durante la TAVI y un electrocardiograma de 6 derivaciones en cada paso del procedimiento. Resultados: En los pacientes monitorizados, se registraron 48 (64%) bloqueos de rama izquierda (BRI) y 16 (21,3%) bloqueos auriculoventriculares completos, de los que el 51,5% apareció antes de implantar la válvula. Los BRI que aparecieron antes del implante valvular persistieron con mayor frecuencia al alta (el 53,8 frente al 22,7%; p = 0,028) y en el seguimiento a 30 días (el 38,5 frente al 13,6%; p = 0,054). Se realizó una VAB en 264 de los 347 pacientes (76,1%). En total, 78 pacientes (22,5%) presentaron un BRI o bloqueo auriculoventricular completo que requirió marcapasos permanente. Un BRI persistente o el bloqueo auriculoventricular no resuelto se observó más frecuentemente entre los pacientes con VAB (el 76,1 frente al 47,6%; p = 0,021), y la VAB se asoció con la persistencia del TdC (OR = 3,5; IC95%, 1,17-10,43; p = 0,021). Conclusiones: Más de la mitad de los TdC observados después de una TAVI ocurren antes del implante de la válvula. La aparición precoz de los TdC se asocia con una mayor persistencia del mismo a los 30 días. El uso de VAB se asocia con un aumento del riesgo de persistencia de los TdC (AU)

Introduction and objectives: Little is known about the timing of onset and outcome of conduction abnormalities (CA) following balloon-expandable transcatheter aortic valve implantation. The aim of this study was to examine the timing of CA and determine the impact of balloon aortic valvuloplasty (BAV) on the persistence of these abnormalities. Methods: A total of 347 patients were included. Of these, 75 had a continuous electrocardiogram recording and a 6-lead electrocardiogram at each step of the procedure. Results: In the transcatheter aortic valve implantation population undergoing continuous electrocardiogram monitoring, new-onset left bundle branch block (LBBB) or third-degree atrioventricular block occurred in 48 (64%) and 16 (21.3%) patients, with 51.5% of CA occurring before valve implantation. Left bundle branch block persisted more frequently at hospital discharge (53.8 vs 22.7%; P = .028) and at 1-month follow-up (38.5 vs 13.6%; P = .054) when occurring before valve implantation. Balloon aortic valvuloplasty prior to valve implantation was used in 264 (76.1%) patients, and 78 (22.5%) had persistent LBBB or complete atrioventricular block requiring pacemaker implantation. Persistent LBBB or unresolved atrioventricular block at 1 month occurred more frequently in the BAV group (76.1 vs 47.6%; P = .021), and the use of BAV was associated with a lack of CA resolution (OR, 3.5; 95%CI, 1.17-10.43; P = .021). Conclusions: In patients undergoing a balloon-expandable transcatheter aortic valve implantation, more than half of CA occurred before valve implantation. Early occurrence of CA was associated with a higher rate of persistence at 1-month follow-up. The use of BAV was associated with an increased risk of CA persistence (AU)

Clinical Frailty as an Outcome Predictor After Transcatheter Aortic Valve Implantation.

Society of Thoracic Surgeons (STS) score and frailty index are calculated routinely as part of transcatheter aortic valve implantation (TAVI) assessment to determine procedure risk. We aim to evaluate the incremental improvement of STS risk score using frailty status in predicting short- and long-term outcome after TAVI. Study population included 544 consecutive TAVI patients who completed full frailty assessment and STS score calculation before the procedure. Frailty is defined by the presence of any 3 of the following 5 criteria: algorithm-defined grip strength and 15-foot walking tests, body mass index < 20 kg/m2, Katz activity of daily living ≤ 4/6, serum albumin < 3.5 g/dl. Multivariable logistic analysis of 30-day and 1-year mortality was performed using a logistic regression model that comprised the STS risk score model as a single variable. Based on frailty definition, 242 patients were frail and 302 patients were not. STS score was higher in the frail group than in the nonfrail group. Compared with STS risk score alone, frailty status was a significant predictor of 1-year mortality after TAVI procedure (odds ratio 1.0, 95% confidence interval [CI] 1.0 to 1.1, p = 0.029 vs 2.75, 95% CI 1.55 to 4.87, p <0.001, respectively). Although the c-statistic of the 1-year STS risk prediction model only changed from 0.62 to 0.66 (p = 0.08), the net reclassification improvement increased significantly to 52.8% after adding frailty to the prediction model (95% CI 0.28 to 0.77, p <0.0001). Frailty status is associated with higher mortality in TAVI cohort and incrementally improves the well-validated STS risk prediction model. Frailty assessment should continue to be part of the preprocedural assessment to further improve patient outcomes after TAVI.

Pacemaker implantation rate after transcatheter aortic valve implantation with early and new-generation devices: a systematic review.

Aims: The incidence of new-onset conduction abnormalities requiring permanent pacemaker implantation (PPI) after transcatheter aortic valve implantation (TAVI) with new-generation prostheses remains debated. This systematic review analyses the incidence of PPI after TAVI with new-generation devices and evaluates the electrical, anatomical, and procedural factors associated with PPI. In addition, the incidence of PPI after TAVI with early generation prostheses was reviewed for comparison. Methods and results: According to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist, this systematic review screened original articles published between October 2010 and October 2017, reporting on the incidence of PPI after implantation of early and new-generation TAVI prostheses. Of the 1406 original articles identified in the first search for new-generation TAVI devices, 348 articles were examined for full text, and finally, 40 studies (n = 17 139) were included. The incidence of a PPI after the use of a new-generation TAVI prosthesis ranged between 2.3% and 36.1%. For balloon-expandable prostheses, the PPI rate remained low when using an early generation SAPIEN device (ranging between 2.3% and 28.2%), and with the new-generation SAPIEN 3 device, the PPI rate was between 4.0% and 24.0%. For self-expandable prostheses, the PPI rates were higher with the early generation CoreValve device (16.3-37.7%), and despite a reduction in PPI rates with the new Evolut R, the rates remained relatively higher (14.7-26.7%). When dividing the studies according to the highest (>26.0%) and the lowest (<12.1%) quintile of PPI rate, patients within the highest quintile were more frequently women when compared with the lowest quintile group (50.9% vs. 46.3%, P < 0.001). Pre-existent conduction abnormalities (electrical factor), calcification of the left ventricular outflow tract (anatomical factor), and balloon valvuloplasty and depth of implantation (procedural factors) were associated with increased risk of PPI. Conclusion: The rate of PPI after TAVI with new-generation devices is highly variable. Specific recommendations for implantation of each prosthesis, taking into consideration the presence of pre-existent conduction abnormalities and anatomical factors, may be needed to reduce the risk of PPI.

Fetal Aortic Valvuloplasty: Experience and Results of Two Tertiary Centers in Spain.

OBJECTIVE: Fetal aortic valvuloplasty (FAV) may avoid progression of critical aortic stenosis (CAS) to hypoplastic left ventricle, improving the options for biventricular circulation (BVC). We describe the results of FAV in 2 referral centers in Spain. METHODS: We analyzed all FAVs performed in the period 2007-2015. The selection of candidates, the technique, and postnatal management were made following an agreed protocol. A descriptive analysis of survival, type of circulation after birth, and complications was made, considering all deaths in the first 48 h after FAV as FAV-related. RESULTS: FAV was performed in 28 fetuses at a median gestational age (GA) of 23 weeks (range, 20-32). FAV was technically successful in 22 (78.6%), of whom 11 were born alive and with intention to treat. Eight (72.7%) resulted in BVC and 3 (27.3%) in univentricular circulation. The rate of FAV-related deaths was 32%. These patients underwent FAV earlier than live-born fetuses (median GA at FAV 22 weeks [range, 20.0-25.0] vs. 24.5 weeks [range, 21.0-32.0], respectively, p = 0.031). CONCLUSIONS: A significant proportion of fetuses with CAS who undergo technically successful FAV have BVC postnatally. However, FAV implies a high risk of fetal death, which highly depends on the GA at which this intervention is required.

Procedural results and safety of common interventional procedures in congenital heart disease: initial report from the National Cardiovascular Data Registry.

BACKGROUND: The National Cardiovascular Data Registry (NCDR) launched the IMPACT (Improving Pediatric and Adult Congenital Treatment) Registry in 2010. By 2013, its patient enrollment exceeded that of other current and historical congenital catheterization registries. OBJECTIVES: This study sought to describe procedural results and safety of 6 common congenital interventions performed in patients enrolled during the IMPACT Registry's initial periods. METHODS: With specified exclusions, we compiled registry data from patients enrolled in the IMPACT Registry from January 2011 through March 2013 who underwent 1 of the following isolated procedures: device closure of atrial septal defect (ASD); device closure of patent ductus arteriosus (PDA); pulmonary valvuloplasty; aortic valvuloplasty; coarctation of the aorta angioplasty and stenting; and pulmonary artery stenting. Patient data, procedural data and results, and adverse events (AEs) were reviewed and described. RESULTS: In 4,152 catheterizations, 1 isolated procedure was reported. There were 1,286 single-ASD procedures, 1,375 PDA procedures, 270 "typical" pulmonary valve procedures, 305 aortic valve procedures, 671 aortic procedures, and 245 pulmonary artery procedures. The reported procedure was performed in >95% of catheterizations. Stated outcomes were accomplished in >98% of ASD and PDA procedures, but less commonly in the others, with coarctation angioplasty procedures being the least successful (51%). Reported major AE rates ranged from 0% to 3.3%; total AE rates ranged from 5.3% to 24.3%. CONCLUSIONS: Contemporary community practice, procedural outcomes, and safety for 6 common congenital interventional procedures are reported. These benchmarks may be compared with individual center results and historical single-center and multicenter results.

Balloon mitral valvuloplasty in the United States: a 13-year perspective.

BACKGROUND: Incidence and prevalence of mitral stenosis is declining in the US. We performed this study to determine recent trends in utilization, complications, mortality, length of stay, and cost associated with balloon mitral valvuloplasty. METHODS: Utilizing the nationwide inpatient sample database from 1998 to 2010, we identified patients using the International Classification of Diseases, 9th Revision, Clinical Modification procedure code for "percutaneous valvuloplasty." Patients ≥18 years of age with mitral stenosis were included. Patients with concomitant aortic, tricuspid, or pulmonic stenosis were excluded. Primary outcome included death and procedural complications. RESULTS: A total of 1308 balloon mitral valvuloplasties (weighted n = 6540) were analyzed. There was a 7.5% decrease in utilization of the procedure from 24.6 procedures/10 million population in 1998-2001 to 22.7 procedures/10 million population in 2008-2010 (P for trend = .098). We observed a 15.9% overall procedural complication rate and 1.7% mortality rate. The procedural complication rates have increased in recent years (P = .001), corresponding to increasing age and burden of comorbidities in patients. The mean cost per admission for balloon mitral valvuloplasty has gone up significantly over the 10 years, from $11,668 ± 1046 in 2001 to $23,651 ± 301 in 2010 (P <.001). CONCLUSIONS: In a large cross-sectional study of balloon mitral valvuloplasty in the US, we have reported trends of decreasing overall utilization and increasing procedural complication rates and cost over a period of 13 years.

Staged balloon aortic valvuloplasty before standard aortic valve replacement in selected patients with severe aortic valve stenosis.

This study evaluated preoperative balloon aortic valvuloplasty (BAV) as a technique to decrease aortic valve replacement (AVR) risk in patients who have severe symptomatic aortic valve stenosis with substantial comorbidity. We report the outcomes of 18 high-risk patients who received BAV within 180 days before AVR from November 1993 through December 2011. Their median age was 78 years (range, 51-93 yr), and there were 11 men (61%). The pre-BAV median calculated Society of Thoracic Surgeons Predicted Risk of Mortality (STS PROM) was 18.3% (range, 9.4%-50.7%). Preoperative left ventricular ejection fraction measured a median of 0.23 (range, 0.05-0.68), and the median aortic valve area index was 0.4 cm(2)/m(2) (range, 0.2-0.7 cm(2)/m(2)). The median interval from BAV to AVR was 28 days (range, 1-155 d). There were no strokes or deaths after BAV; however, 4 patients (22%) required mechanical circulatory support, 3 (17%) required femoral artery operation, and 1 (6%) developed severe aortic valve regurgitation. After BAV, the median STS PROM fell to 9.1% (range, 2.6%-25.7%) (compared with pre-BAV, P <0.001). Echocardiography before AVR showed that the median left ventricular ejection fraction had improved to 0.35 (range, 0.15-0.66), and the aortic valve area index to 0.5 cm(2)/m(2) (range, 0.3-0.7 cm(2)/m(2)) (compared with pre-BAV, both P <0.05). All patients received AVR. Operative death occurred in 2 patients (11%), and combined operative death and morbidity in 7 patients (39%). Staged BAV substantially reduces the operative risk associated with AVR in selected patients.

Comparative risk of cardiac catheterisations performed on low birth weight neonates.

To determine whether cardiac catheterisation procedures for low birth weight neonatesr < or = 2.5 kg carries a greater risk of complications compared with neonates > 2.5 kg, we conducted a single-centre retrospective case­control study. From 01/03 to 01/09, 46 consecutive neonates < 2.5 kg at the time of cardiac catheterisation were identified. For each low birth weight case, three control patients > or = 2.5 kg were randomly selected from our heart centre database during the same time period. Data included demographic characteristics, type of intervention, fluoroscopy time, contrast volume, pre- and post-blood urea nitrogen to creatinine ratio, physician performing procedure, procedural risk category, and all major and minor complications. The overall incidence of complications was higher in neonates < or = 2.5 kg compared with neonates > 2.5 kg (34.8% versus 17.6%, p = 50.023) because of a greater proportion of minor complications (34.8% versus 16.9%, p = 50.021). When specific minor complications were stratified, there was a greater incidence of hypotension requiring intravenous fluids in neonates < or = 2.5 kg (6.5% versus 0%, p50.015). After controlling for physician performing procedure and risk category, neonates < or = 2.5 kg remained at a higher risk for any complication (adjusted odds ratio = 3.2, 95% confidence interval 1.4­7.2, p = 0.005). The percentage of neonates having at least one major complication was not higher in the < or = 2.5-kg group (2.2% versus 2.2%). No procedural deaths occurred in either group.