Balloon Aortic Valvuloplasty in the Transcatheter Aortic Valve Implantation Era.

As the population continues to grow, and life expectancy has increased, aortic stenosis (AS) has become the most common valvular disease requiring surgical treatment. The evolution of valve replacement therapies has progressed significantly since 1960. In the last 20 years, transcatheter aortic valve implantation (TAVI) has been a game changer, and has potential to become the standard of care. Despite uncertain prognosis benefits, balloon aortic valvuloplasty (BAV) can be useful in a broad range of patients with AS, as well as being a bridging therapy to valve replacement, or as a destination therapy, besides its role in TAVI procedures. This review describes the contemporary role of BAV in AS treatment, and focuses on technical improvements that reframe BAV as an effective tool in a variety of clinical scenarios. One of these improvements is transradial BAV, either with the conventional approach of BAV or applying the bilateral technique with two balloons.

Balloon rupture during aortic valvuloplasty with compliant balloon: predictors and outcomes.

Objectives of the study were the prevalence and clinical consequences of balloon rupture with compliant balloons in balloon aortic valvuloplasty (BAV). Compliant low-profile balloons have been developed to reduce access site complications. Made by thinner materials, these balloons are more prone to rupture. This is a single-center retrospective analysis (2016-2018) of patients undergoing BAV with compliant balloons. Baseline echocardiography and computed tomography (CT) were analyzed. Best cutoff point for calcium score was assessed. Long-term mortality was analyzed with Kaplan-Maier. In vitro test was performed. Rupture occurred in 30/90 (33%) of BAVs independent of risk factors, surgical risk and frailty scores. Patients experiencing rupture had increased mean gradient [53.5 (44-64) vs 44 (35-49) mmHg, p < 0.05] and reduced aortic valve area [0.61 (0.46-0.76) vs 0.76 (0.64-0.83) mm2, p < 0.05]. Valve calcium score on CT > 2686 AU was more frequent in the rupture group (41% vs 10%, p < 0.05) and more patients in the third tertile of calcium score experienced rupture (75% vs 23% vs 41% for second and first tertile, p < 0.05). Median gradient reduction from baseline was similar among groups [30 (20-50) vs 30 (17-39) mmHg]. No patient with rupture had any complication. One-month and long-term mortality were similar (rupture 0% vs 3.5% no rupture from 1 month). In vitro test required more volume and strength to rupture the balloon than used in BAV. Balloon rupture is frequent in BAV using compliant balloons, occurs with more severe aortic stenosis, does not affect BAV efficacy and does not impair outcomes.

Valvuloplastia aórtica percutánea en la estenosis aórtica severa del adulto: indicaciones y morbimortalidad. Análisis del registro de valvuloplastias aórticas de un centro cardiovascular universitario / Percutaneous aortic valvuloplasty in severe adult aortic stenosis: indications, morbidity and mortality. Analysis of the aortic valvuloplasty registry of an university cardiovascular center / Valvoplastia aórtica percutânea na estenose aórtica adulta grave: indicações e morbimortalidade. Análise do registro de valvoplastia aórtica do um centro cardiovascular da universidade

Resumen: Introducción: la estenosis aórtica severa es una enfermedad frecuente, y la sustitución valvular es el único tratamiento eficaz. La valvuloplastia aórtica percutánea (VAP) tiene beneficios transitorios y su indicación está restringida a pacientes inestables como terapia puente o paliativa. A nivel nacional existe escasa evidencia sobre los resultados de esta técnica. Objetivo: determinar la indicación, eficacia, complicaciones y mortalidad de las VAP realizadas en nuestro centro entre enero de 2006 y setiembre de 2018. Secundariamente, determinar la terapia definitiva aplicada y el tiempo transcurrido hasta la misma. Método: estudio retrospectivo y descriptivo. Incluyó los pacientes a los que se le realizó VAP en el período. Se revisaron las historias clínicas para extracción de variables. Las variables cualitativas se presentan en valor absoluto y porcentaje; cuantitativas en mediana e intervalo intercuartilo. Se utilizó prueba de Wilcoxon para variables dependientes, tomando p<0,05 como nivel de significación. Para sobrevida se realizaron curvas de Kaplan-Meier. Protocolo aprobado por el Comité de Ética institucional. Resultados: 28 casos; 17 (60,7%) mujeres; la mediana de edad fue de 79,5 años (IQ 73-85,5). El objetivo de la VAP fue: puente a la decisión en 11 casos (39,2%), al tratamiento definitivo en 12 (42,8%) y paliativo en 5 (18%). La VAP fue considerada exitosa en 57,1% de los casos. Las indicaciones más frecuentes fueron: insuficiencia cardíaca refractaria en 10 casos (35,7%) y shock cardiogénico en 9 (32,1%). Diecinueve pacientes fallecieron (67,8%). La sobrevida fue 59 días (IQ 5-412). Seis pacientes recibieron tratamiento definitivo (cuatro recibieron implante valvular percutáneo y dos cirugía cardíaca). El tiempo de la VAP al implante percutáneo fue 233 días y 47 días a la cirugía abierta. Conclusiones: las indicaciones más frecuentes de la VAP fueron puente a tratamiento definitivo y decisión. La VAP fue exitosa en más del 50% de los casos. Las complicaciones mayores marcaron el pronóstico. La mortalidad fue elevada en el seguimiento. Un número reducido accedió al tratamiento definitivo (predominando el implante percutáneo).

Summary: Introduction: severe aortic stenosis is frequent and valve replacement is the only effective treatment. Percutaneous aortic valvuloplasty has transient benefits, and its indication is restricted to unstable patients as a bridge to other treatment or palliative therapy. In our country, there is a few evidence of this technique. Objective: to determine the indication, efficacy, complications and mortality of percutaneous aortic valvuloplasty performed in our center between January 2006 - September 2018. Secondarily, to determine which was the definitive therapy and it´s delay. Method: retrospective and descriptive study. All patients who received valvuloplasty during the study period were included. Clinical histories were reviewed. Qualitative variables were presented in absolute value and percentage; the quantitative ones, in median and interquartile interval. Wilcoxon test was applied to dependent variables, p <0.05. Kaplan Meier curves were performed to analize survival. Protocol was approved by ethics committee. Results: 28 cases. 17 (60.7%) were female. Average age was 79.5 years (IQ 73-85.5). The objective of percutaneous aortic valvuloplasty was bridge therapy to decision in 11 cases (39.2%), bridge to definitive treatment in 12 (42.8%) and palliative in 5 (18%). The most frequent indications were: refractory heart failure in 10 cases (35.7%) and cardiogenic shock in 9 (32.1%). Valvuloplasty was successful in 57.1% of cases. 19 patients died (67.8%). The median survival was 59 days (IQ 5-412). 6 patients received definitive treatment (4 percutaneous implantation and 2 open cardiac surgery). The time from percutaneous aortic valvuloplasty to percutaneous aortic valve implantation was 233 days and 47 days to open surgery. Conclusions: the most frequent indications for percutaneous aortic valvuloplasty were bridge therapy to definitive treatment and decision. Percutaneous aortic valvuloplasty was successful in more than 50% of cases. Major complications determined the prognosis. Mortality was high at follow-up. A small number acceded to definitive treatment (predominantly percutaneous implantation).

Resumo: Introdução: a estenose aórtica grave é frequente, a substituição valvar é o único tratamento efetivo. A valvoplastia aórtica percutânea tem resultados transitórios, sua indicação é restrita a pacientes instáveis como ponte ou terapia paliativa. Em nível nacional, há poucas evidências. Objetivo: determinar a indicação, eficácia, complicações e mortalidade das valvoplastias aórticas percutâneas realizadas em nosso centro entre janeiro de 2006 a setembro de 2018. Determinar secundariamente a terapia definitiva e o tempo até ela. Método: estudo retrospetivo, descritivo. Todos os pacientes que receberam valvuloplastia aórtica percutânea durante o período do estudo foram incluídas. Histórias clínicas foram revisadas. As variáveis qualitativas são apresentadas em valor absoluto e percentagem; os quantitativos em intervalo mediano e interquartil. O teste de Wilcoxon foi utilizado para variáveis dependentes, p <0,05. Para sobrevivência, as curvas de Kaplan Meier foram realizadas. Protocolo aprobado pelo comitê de ética. Resultados: 28 casos. 17 (60,7%) eram mulheres e a idade média foi de 79,5 anos (QI 73-85,5). O objectivo da valvoplastia foi ponte para decisão terapêutica em 11 casos (39,2%), ponte para tratamento definitivo em 12 casos (42,8%) e paliativo em 5 casos (18%). As indicações mais frequentes foram: insuficiência cardíaca refratária em 10 casos (35,7%) e choque cardiogênico em 9 casos (32,1%). A valvuloplastia foi bem sucedida em 57.1% dos casos. 19 pacientes morreram (67,8%). A mediana de sobrevivência é de 59 dias (IQ 5-412). 6 pacientes receberam tratamento definitivo (4 implantes percutâneos e 2 por cirurgia cardíaca aberta). A mediana do tempo de valvoplastia aórtica percutânea para implante de valva aórtica percutânea foi de 233 dias e cirurgia aberta de 47 dias. Conclusões: as indicações mais frequentes para valvoplastia aórtica percutânea foram a terapia ponte para tratamento e para decisão definitiva. A valvoplastia aórtica percutânea foi bem sucedida em mais de 50%. As complicações principais marcaram o prognóstico. A mortalidade foi alta no follow-up. Um pequeno número concordou com o tratamento definitivo (predominantemente implante percutâneo).

Estabilización del balón mediante estimulación cardíaca en la valvuloplastía aórtica / Balloon stabilization by means of cardiac stimulation during aortic valvuloplasty

Objetivo: Evaluar la estimulación ventricular rápida en la Valvuloplastía Aórtica Percutánea como estrategia para obtener estabilidad del balón. Material y métodos: En septiembre de 2004 se inició un protocolo prospectivo. Tres enfermos masculinos consecutivos con estenosis valvular aórtica significativa fueron tratados con este método. Las edades fueron 13, 6 y 5 años. En todos se colocó un electrodo bipolar en el ventrículo derecho. Durante el procedimiento se registró la presión arterial sistémica con un catéter en la aorta descendente. La estimulación ventricular se inició a una frecuencia de 150 por minuto y se aumentó hasta obtener un descenso del 50% en la presión arterial sistémica y entonces el balón se infló para realizar la valvuloplastía aórtica. La estimulación se suspendió hasta que el balón fue completamente desinflado. Resultados: Los gradientes transvalvulares antes de la valvuloplastía fueron 90 y 110 mmHg. Las presiones en aorta fueron de 90, 110 y 55 mmHg. Se obtuvo una reducción del 50% de la presión sistémica con 170, 250 y 220 por minuto de estimulación. La duración de la estimulación rápida en los tres casos fue de 15 segundos. Se logró estabilización del balón sin movimientos en los dos casos. Los gradientes obtenidos después de la valvuloplastía fueron 23, 28 y 15 mmHg. No hubo modificación en el grado de insuficiencia aórtica después del procedimiento. En el primero se mantuvo grado I y en el segundo y tercer casos, no se observó regurgitación en el aortograma. Conclusiones: La estimulación cardíaca rápida estabiliza el balón durante la valvuloplastía, es segura, efectiva y puede disminuir la incidencia de insuficiencia aórtica.

Objective: To evaluate rapid ventricular pacing in balloon aortic valvuloplasty, an initial strategy to achieve balloon stability. Material and methods: From September to December 2004, a prospective protocol was started: three male consecutive patients with aortic valve stenosis were treated by this strategy. Age of the patients were 13, 6 and 5 years old. All had a bipoplar pacing catheter placed in the right ventricle. Invasive systemic pressures were documented with a catheter in the descending aorta. Rapid ventricular pacing was initiated at the rate of 150 per minute and increased to a rate required to achieve a drop in systemic pressure by 50%. The balloon was inflated only after the pacing rate was reached and the blood pressure dropped. Pacing was continued until the balloon was completely deflated. Results: The systolic gradients across the aortic valve before balloon dilatation were 90, 110 and 55 mmHg. The systolic pressures in aorta were 90 and 110 mmHg. The pacing rate to drop the pressure by 50% were 170, 250 and 220 per minute. The pacing time was 15 seconds in all patients. Balloon stability at time of inflation was achieved in all cases with no balloon movement. The post-ballooning gradients were 23, 28 and 15 mmHg. Angiogram performed post balloon dilatation showed no change compared with the pre-balloning angiogram in aorta: trivial aortic incompetence in the first case and none in the second and third cases. Conclusions: Rapid ventricular pacing to stabilise the balloon during balloon aortic valvuloplasty seems to be safe and effective and may decrease the incidence of aortic incompetence.

Valvuloplastia aórtica percutánea en 70 enfermos con estenosis valvular aórtica congénita: Resultados a mediano plazo / Congenital Percutaneous Aortic Valvuloplasty in 70 Subjects with Congenital Aortic Stenosis: Mid-Term Results

Objetivo: evaluar los resultados a mediano plazo de la VAP. Material y métodos: se analizaron los enfermos con estenosis valvular aórtica congénita con VAP de 1988 al 2001 que tuvieran por lo menos seis meses de seguimiento. Resultados: fueron sometidos a VAP 70 enfermos. Cuarenta del sexo masculino (63%) y 26 del femenino (37%). Margen de edad de tres meses a 36 años, media de 10.5 ± 10.6 años. El gradiente sistólico pico-pico disminuyó de 84 ±20 a 31 ± 16 mmHg (P<0.01). El porcentaje de reducción varió de 25 a 100%, media 60 ± 22%. El índice balón/anillo aórtico fue de 0.9'±0.17. Después del procedimiento la insuficiencia aórtica grado III o IV se presentó en 10 (14.2%). El seguimiento varió de 6 a 168 meses, media 51 ± 48 meses. Al final del seguimiento hubo: fracasos 21 enfermos (30%) y éxitos 49 (70%) pacientes. Un enfermo murió tardíamente (1.4%). Conclusiones: este trabajo es la serie con seguimiento más largo después de VAP en latinoamérica. Se requieren nuevos estudios prospectivos y multicéntricos en la región.

Objective: To evaluate mid-term results with Percutaneous aortic valvulopasty (PAV). Material and Methods: Records of 70 patients treated with percutaneous aortic valvuloplasty with at least 6 months follow-up were reviewed. Results: The 70 patients with PA Vaged 3 months to 36years, mean 10.5 ± 10.6 years, 40) 63%) were male and 26 (37%) female. Initial systolic peak gradient decreased from 84 ± 20 to 31 ± 16 mmHg (p < 0.05), while the reduction percentage ranged from 25 to 100%, mean 60 ± 22. Balloon/aortic annulus index was 0.9 ±0.17. Ten (14.1 %) patients developed aortic insufficiency after PA V. Follow-up ranged from 6 to 168 months, mean ± 48 months. At end of follow-up, 21 patients (30%) were considered failed cases and 49 (70%) patients had a successful outcome. Conclusions: This study showed a series with the longest follow-up in latin America with PA V. New prospective and multicentric studies are needed in this region.

Seguimento clínico e ecodopplercardiográfico de idosos submetidos a valvuloplastia aórtica por cateter-baläo / Clinical and Doppler echocardiographic follow-up of elderly patients subjected to aortic balloon valvuloplasty

Purpose­To evaluate the evolution of patients with critical aortic stenosis (AS) submitted to balloon aortic valvuloplasty (BAV). Patients and Methods­sixteen patients (mean age 74.0 ± 5.1 years), 11 (68.7%) women. The study periods consisted during the 3 rd (post-1) and 15th month (post-2) after dilatation. Results­The functional class of angina and dyspnea persisted in all patients during period post-1, in 75% of theo patients, during period post-2 in relation to intra-hospital evaluation. However, in period post-1, 53% of the patients had significant reduction of aortic valve area, trend which remained in period post-2. Simultaneously, progressive (insignificant) elevation of the left ventricular aortic peak to peak gradient was noticed in the periods post-1 and post-2. Two deaths and two aortic valve replacements occurred during the study. Conclusion­BAV is associated to maintenance of functional class improvement obtained immediatly after dilatation despite the aortic valve restenosis registered by echodopplercardiography