Valvuloplastia Aórtica en la Estenosis Aórtica del adulto en la era del tavi Dr. Jorge Mayol Co-Director - Servicio de Hemodinamia Centro Cardiológico Americano Montevideo - Uruguay

Estenosis Aórtica Patología: Degenerativa Bícuspide Reumática 81,9% 5,4% 11,2% De las 3 entidades que generan la Eao del adulto, la DEGENERATIVA CALCIFICADA, es la que predomina en forma distanciada. Degenerativa Calcificada Bícuspide Reumática Iung B et al. A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease. European Heart Journal 2003;24:1231-1243

Sobrevida de la EAo con/sin RVA La sobrevida de los pacientes con cirugía es framcamente mejor que los que no se operan. Key Message: Patients with severe AS not undergoing AVR had a shorter life expectancy than those receiving AVR. Results from a retrospective cohort study from a large university medical center in patients with severe AS demonstrated that survival in patients who underwent AVR was significantly better than those who were managed medically. One-year, 2-year, and 5-year survival rates among patients with AVR were 87%, 78%, and 68%, respectively, compared with 52%, 40%, and 22%, respectively, in those who had no AVR (P<0.0001). Sobrevida de la EAo con/sin RVA Varadarajan P, et al. Eur J Cardiothorac Surg. 2006;30:722-727. Reference: Varadarajan P, et al. Eur J Cardiothorac Surg. 2006;30:722-727.

Estenosis Aórtica con/sin RVA 122 pacientes CACG valoración preoperatoria (2008) RVA 96 pacientes (78,7%) No RVA 26 pacientes (21,3%) Mortalidad a 1 año 10,4 % 53,8 % Mortalidad a 2 años Causas de NO intervención son numerosas, pero una frecuente es el rechazo de la cirugía por mayor riesgo 14,5% 69,2% p=0,009 EuroScore 5,2% p=0,01 9% Batista I. y col. Seguimiento a largo plazo de pacientes portadores de estenosis valvular aórtica severa y sintomática con y sin cirugía de sustitución valvular. 27o Congreso Uruguayo de Cardiología 2011

Valvuloplastia Aórtica: Rouen 1985 Propuesto como procedimiento paliativo en pacientes con EAo inoperables Cribier A et al. Percutaneous Transluminal Valvuloplasty of acquired aortic stenosis in elderly patients: An alternative to valve replacement?. The Lancet, january 11, 1986

Uso de la VPAo (1986 – 1991) x

Uso de la VPAo en 10 años Puente a TAVI Puente a Cirugía RVA Paliativa Shock Saia, F. et al. Emerging indications, in-hospital and long-term outcome of balloon aortic valvuloplasty in the transcatheter aortic valve implantation era. EuroIntervention 2013;8:1388-1397

Selección del balón Tamaño: Largo: 4 cm Diámetro: 80-90% TSVI o 20 mm de rutina; salvo anillo <18 o >24 Para lograr un mismo diámetro a nivel del plano vavlvular, con el balón con cintura, estaríamos sobredistendiendo el TSVI, con riesgo de rotura

Estrategia de inflado Marcapaso bipolar – 6 French - VD Marcapaseo Rápido Contraste 1:10 Marcapaso bipolar – 6 French - VD Estimular – 180 – 200 cpm Marcapaseo efectivo: caída de PA casi completa o a 50 mmHg Al desinflar bajar a 80 cpm Atención al “Stokes-Adams”

Mecanismo de la valvuloplastia 1. Estiramiento de anillo y valvas 2. Fractura del calcio valvular Separación comisural Provee resultados mantenidos Poco frecuente Mecanismo de la valvuloplastia. En la estenosis aórtica del añoso, la estenosis aórtica asienta sobre una válvula tricúspide, que se ha engrosado, endureciendo, calcificando. El inflado del balón logra quebrar el calcio, de topogafía impredecible, no siguiendo necesariamente la comisura de las valvas, sino que el rasgado es por la zona fibrótica, menos calcificada.

VPAo: Resultados Hemodinámicos  Gradiente 50 mmHg (50%) 30-50 mmHg (25%) <30 mmHg (25%)  Área 0.5 cm2  0.8 cm2 Δ AVA < 0.4 cm2 (77%) AVA final < 1cm2 (71%) Esta reducción del gradiente y aumento del área son suficientes para lograr la mejoría de los síntomas Area Valvular (cm2)

VPAo: Complicaciones 2014 Muerte 4 (1.2%) Complicaciones vasculares 6 (1.8%) Stroke Insuficiencia Aórtica Masiva 5 (1.5%) BAVC permanente 2 (0.6%) Bar graph shows complications of aortic valvuloplasty occumng acutely (<24 hours) or during hospitalization. Total major complications are shown. Each bar graph is subdivided into acute (<24 hours) and in-hospital complications. BVA, Balloon Valvuloplasty Registry; CVA, cerebrovascular accident; ATN, acute tubular necrosis. (See text for discussion.) Serie Rouen,

Embolia – Stroke (1.8%) VPAo durante la cirugía de RVAo No Debris No Embolización Wendt et al., Essen. Min Inv Ther 2011

VPAo: Trastornos de la conducción N=271 pts. Todos 8,5% Marcapaso definitivo 1,5% BCRI 2,6% BCRD 0,7% Fibrilación Auricular 2,9% Duración intervalo PR (181.2±48.5 vs 181.3±41.9 ms, p 0.07) Duración QRS: (113.9±33.5 vs 119.6 ±54.6 ms, p 0.001) In conclusion, BAV is associated with a low incidence of cardiac conduction disturbances and a requirement for permanent ventricular pacing. The size of the valvuloplasty balloon should be carefully selected to avoid oversizing, which can lead to the development of postprocedure conduction disturbances. Relación balón/TSVI: 1.21 ± 1.60 (ptes. que SI tuvieron alt. de la conducción) 1.15 ± 0.12 (ptes. que NO tuvieron alt. de la conducción) (p 0.032) Laynez et al Frequency of Cardiac Conduction Disturbances After Balloon Aortic Valvuloplasty The American Journal of Cardiology, Volume 108, Issue 9, 1 November 2011,1311-1315

VPAo en EAo e Insuficiencia Aórtica 416 pacientes 73 con EAo S + IAo moderada o severa 89% ptes.: IAo no cambió o mejoró 7 ptes.: IAo aguda 5 por inmovilidad de una cúspide en "posición abierta fija", corregidas con guía rígida o Pigtail Abstract: OBJECTIVES: To assess safety and effectiveness of balloon aortic valvuloplasty (BAV) in patients with symptomatic severe aortic stenosis (AS) and significant aortic regurgitation. BACKGROUND: BAV is a palliative procedure that has possibly been underused in patients with symptomatic AS not suitable for surgical aortic valve replacement or transcatheter aortic valve implantation. Significant aortic regurgitation is commonly perceived as a contraindication to BAV. METHODS: Among 416 consecutive patients undergoing BAV at our Institution, 73 patients showed moderate or severe AR before the procedure. Demographics and baseline characteristics, as well as in-hospital clinical outcome, have been prospectively collected in a dedicated database. Transthoracic echocardiography was regularly performed in all patients undergoing BAV before the procedure and at hospital discharge. RESULTS: Patients had a high-risk profile, confirmed by advanced age (77.2 +/- 11.8 years) and important comorbidity (logistic Euroscore 26.5 +/- 16.3%). Advanced heart failure was present in 73.9%. Indication to BAV was cardiogenic shock in 9.6%, palliation in 31.5%, bridge in 58.9% of the patients. BAV was performed with standard retrograde approach. Aortic valve area increased from 0.62 +/- 0.15 cm(2) at baseline to 0.83 +/- 0.17 cm(2) before discharge (P < 0.001). The degree of AR was improved or unchanged in 65 patients (89%). In-hospital mortality was 6.9%, mainly limited to terminal patients. Symptomatic status at discharge was improved in all surviving patients. Acute AR occurred in seven patients; in five of them it was successfully resolved in the catheterization laboratory. CONCLUSIONS: When clinically indicated, BAV can be safely performed in patients with combined aortic stenosis and significant aortic regurgitation. Saia, F. et al. Is balloon aortic valvuloplasty safe in patients with significant aortic valve regurgitation? Catheter Cardiovasc Interv. 2012 Feb 1;79(2):315-21

VPAo: Indicaciones ICC refractaria o Shock cardiogénico Paliativo en NO candidatos a RVA o TAVI muy sintomáticos Puente a Cirugía de RVAo Puente a TAVI Cirugía NO cardíaca inminente Test diagnóstico en EAo bajo flujo/bajo gradiente Valoración de Ins. Mitral concomitante

VPAo: Indicaciones ICC refractaria o Shock cardiogénico Paliativo en NO candidatos a RVA o TAVI muy sintomáticos Puente a Cirugía de RVAo Puente a TAVI Cirugía NO cardíaca inminente Test diagnóstico en EAo bajo flujo/bajo gradiente Valoración de Ins. Mitral concomitante

VPAo en ICC refractaria/shock

Clase Funcional NYHA post-VPAo I n=56 I n=214 II n=70 II n=124 III n=203 III n=116 78% 22% IV n=155 IV n=30 Basal 30 Días Bashore, et al. NHLBI Balloon Valvuloplasty Registry Participants Circulation 1991: vol 84 no. 6

BNP post-VPAo WHC: Ben-Dor et al. AHA 2011

Valvuloplastia Aórtica Evolución a largo plazo Angina Síncope ICC clase funcional 4 Sobrevida libre de eventos Event-free survival after balloon aortic valvuloplasty was similar for patients with syncope, angina and functional class IV congestive heart failure (FC 4 CHF).Patients with congestive heart failure tended to have events earliest. Años Lieberman et al. Balloon aortic valvuloplasty in adults: Failure of procedure to improve long term survival. JACC 1995;26:1522-8

Valvuloplastia Aórtica Evolución a largo plazo 1 año 2do año 3er año 75% 62.5% 54% 50% Sobrevida 25% 10% Libre de evento Months Kuntz R et al. Predictors of event free survival after aortic balloon valvuloplasty. NEJM 1991;325:17-23

VPAo: Indicaciones ICC refractaria o Shock cardiogénico Paliativo en NO candidatos a RVA o TAVI muy sintomáticos Puente a Cirugía de RVAo Puente a TAVI Cirugía NO cardíaca inminente Test diagnóstico en EAo bajo flujo/bajo gradiente Valoración de Ins. Mitral concomitante

Valvuloplastia Aórtica Evolución con o sin Cirugía RVA Sobrevida BAV solo BAV + Cirugía RVA Event-free survival after balloon aortic valvuloplasty was similar for patients with syncope, angina and functional class IV congestive heart failure (FC 4 CHF).Patients with congestive heart failure tended to have events earliest. Años BAV solo BAV + CRVA Lieberman et al. Balloon aortic valvuloplasty in adults: Failure of procedure to improve long term survival. JACC 1995;26:1522-8

Valvuloplastia Aórtica Evolución con o sin Cirugía RVA (2 años) VPAo puente a TAVI o Cirugía RVA P=0.08 TAVI o Cirugía RVA Sobrevida T. Médico VPAo sola La VPAo no altera la supervivencia respecto al tratamiento médico, pero puede ser usado como puente a TAVI o RVAo Tissot CM et al, Reappraisal of percutaneous aortic balloon valvuloplasty as a preliminary treatment strategy in the transcatheter aortic valve implantation era Eurointervention 2011;7:49-56

Evolución a 30 días post-“VPAo como puente a TAVI” Allocation of patients following re-evaluation one month after “bridge” balloon aortic valvuloplasty (BAV). All patients. B. Proportion of patients re-allocated to the different treatment strategies after BAV in the different subgroups. AVR: aortic valve replacement; LVEF: left ventricular ejection fraction; MT: medical therapy; MVR: mitral valve regurgitation; NCS: major non-cardiac surgery; TAVI: transcatheter aortic valve implantation See more at: http://www.pcronline.com/eurointervention/41st_issue/115/#sthash.KK8IVFyR.dpuf Saia, F. et al. The role of percutaneous balloon aortic valvuloplasty as a bridge for transcatheter aortic valve implantation . EuroIntervention 2011;7:723-729

VPAo: Indicaciones ICC refractaria o Shock cardiogénico Puente a Cirugía de RVAo Puente a TAVI Paliativo en NO candidatos a RVA o TAVI muy sintomáticos Cirugía NO cardíaca inminente Test diagnóstico en EAo bajo flujo/bajo gradiente Valoración de Ins. Mitral concomitante

Pre Cirugía NO cardíaca Conclusiones: Sugerimos que la VPAo, realizada inmediatamente antes de la cirugía NC, crea una “ventana de oportunidad” para reducir el riesgo. Roth RB, Palacios IF, Block PC. Percutaneous aortic balloon valvuloplasty: its role in the management of patients with aortic stenosis requiring major noncardiac surgery. J Am Coll Cardiol. 1989;13:1039–41.

VPAo: Indicaciones ICC refractaria o Shock cardiogénico Puente a Cirugía de RVAo Puente a TAVI Paliativo en NO candidatos a RVA o TAVI muy sintomáticos Cirugía NO cardíaca inminente Test diagnóstico en EAo bajo flujo/bajo gradiente Valoración de Ins. Mitral concomitante

¿Mejoría de la FEVI en la EAo con mala FEVI? TAVI (N=37) Cirugía (N=24) VPAo (N=109) En los pacientes con mala FEVI los 3 procedimientos de intervención sobre la válvula aórtica logran una mejoría de la FEVI, aunque la Valvuloplastia es el que menor mejoría logra. Itsik Ben-Dor, et al. Comparison of Outcome of Higher Versus Lower Transvalvular Gradients in Patients With Severe Aortic Stenosis and Low (<40%) Left Ventricular Ejection Fraction. The American Journal of Cardiology, Volume 109, Issue 7, 2012, 1031–1037

Reserva Contráctil (+) EAo con Bajo Flujo – Bajo Gradiente Eco Dobutamina Basal Dobutamina - G.Pico: 38 mmHg - G. Medio: 23 mmHg Área: 0,7 cm2 Vmax: 3.24 m/s Basal - G. Pico: 49 mmHg - G. Medio: 33 mmHg Área: 0,6 cm2 Vmax: 3.51 m/s Dobutamina La ECO-Dobutamina (a 20 /k/m) es un método eficaz para pesquisar Reserva Contráctil y definir las conductas de intervención en estos pacientes, como en este caso (mejora la FEVI; aumenta el gradiente: Reserva contractil positiva) Flujo valvular ↑ 30% Gradiente medio ↑ 10 mmHg FEVI pasó de severa a moderada Reserva Contráctil (+)

Sin Reserva Contráctil EAo con Bajo Flujo – Bajo Gradiente Cateterismo Dobutamina Basal Dobutamina Gradiente 32 mmHg AVA: 0.8cm2 FEVI  Gradiente 26 mmHg GC = FEVI  C, This patient had no change in cardiac output, and the mean aortic valvular gradient decreased from 37 to 26 mm Hg in response to dobutamine infusion. The test was terminated because of hypotension. This patient had severe aortic stenosis at the time of aortic valve replacement but died 2 years postoperatively because of heart failure. Ao indicates aortic; LA, left atrial; LV, left ventricular; and base, baseline Sin Reserva Contráctil Nishimura et al, Low-Output, Low-Gradient Aortic Stenosis in Patients With Depressed Left Ventricular Systolic Function. The Clinical Utility of the Dobutamine Challenge in the Catheterization Laboratory Circulation 2002;106:809-813

Reserva Contráctil/tratamiento 100 No Reserva (TM) No Reserva (RVAo) Reserva Contráctil (RVAo) Reserva Contráctil (TM) 75 % Sobrevida 50 25 This first multicenter study confirms the prognostic value of dobutamine stress hemodynamics for operative risk stratification and long-term outcome in the setting of low-gradient AS. Our results confirm that patients with a contractile reserve have an acceptable operative risk and that valve replacement may improve long-term survival and functional status in most cases; thus, surgery may be recommended in most of these patients. In contrast, despite a trend toward better survival after valve replacement, the outcome of patients without reserve is compromised by high operative mortality, especially in those with a baseline MPG 20 mm Hg or associated coronary artery disease Therefore, individual patients should not be denied the potential benefits of valve surgery on the basis of the absence of contractile reserve alone; however, we suggest that this important parameter should be considered, in addition to other risk factors, in the risk-benefit analysis for each patient. 0 20 40 60 80 100 Meses Monin et al. Low-Gradient Aortic Stenosis Operative Risk Stratification and Predictors for Long-Term Outcome: A Multicenter Study Using Dobutamine Stress Hemodynamics.Circulation 2003;108:319-324.

VPAo: Indicaciones ICC refractaria o Shock cardiogénico Puente a Cirugía de RVAo Puente a TAVI Paliativo en NO candidatos a RVA o TAVI muy sintomáticos Cirugía NO cardíaca inminente Test diagnóstico en EAo bajo flujo/bajo gradiente Valoración de Ins. Mitral concomitante

Insuficiencia Mitral post-VPAo 74 ptes. con IM mod-severa. STS Score:15. Edad media: 84 años In conclusion, nearly half of the patients with severe AS and coexistent MR showed improvement in the magnitude of MR after BAV. Larger left atrial and left ventricular end-diastolic dimensions and higher transaortic valve gradients were associated with lack of MR improvement. 46% mejoraron; 54% no mejoraron Maluenda G et al Changes in Mitral Regurgitation After Balloon Aortic Valvuloplasty Am J Cardiol 2011;108:1777–1782

Valvuloplastia Aórtica Conclusiones Logra una mejora efectiva del área valvular aórtica en la mayoría de los pacientes, con baja morbi-mortalidad El beneficio es temporario (promedio 6 meses) Útil para evaluar la reversibilidad de la disfunción VIzq., IMitral severa y la ICC severa Excelente herramienta como puente a una intervención definitiva (RVAo o TAVI)

VPAo: Técnica 2015 Acceso arterial retrógrado: Femoral Introductor y catéteres lo mas pequeños Dispositivo de cierre Acceso venoso para marcapaseo rápido y profiláctico Guías curvas de alto soporte 0.035´´- 260: dedicadas

Valvuloplastia reiterada BAV repetida puede producir un período libre de síntomas de 3 años en pacientes con EAo severa calcificada Ajay Agarwal et al. Results of Repeat Balloon Valvuloplasty for Treatment of Aortic Stenosis in Patients Aged 59 to 104 Years. Am J Cardiol 2005;95:43–47

Valvuloplastia reiterada En los procedimientos reiterados hay un menor incremento del área Ben Dor et al. WHC. 2010

Insuficiencia Mitral post-VPAo IM moderada-severa y severa: 26% a 9% IM moderada: 74% a 58% IM leve: 32% mejoraron (p 0.001) I II II In conclusion, nearly half of the patients with severe AS and coexistent MR showed improvement in the magnitude of MR after BAV. Larger left atrial and left ventricular end-diastolic dimensions and higher transaortic valve gradients were associated with lack of MR improvement. III III IV IV Pre-VP Post-VP Maluenda G et al Changes in Mitral Regurgitation After Balloon Aortic Valvuloplasty Am J Cardiol 2011;108:1777–1782

Estenosis Aórtica Leve EAo con Bajo Flujo – Bajo Gradiente Utilidad de la Dobutamina I.C.: 1.8 l/m/m2 I.C.: 2.8 l/m/m2 Gradiente 15 mmHg Gradiente 22 mmHg B, The patient responded to dobutamine infusion with an increase in cardiac output and an increase in mean aortic valvular gradient from 17 to 20 mm Hg. The final aortic valve area was 0.7 cm2. This patient was found to have only mild aortic stenosis at the time of operation. Estenosis Aórtica Leve Nishimura et al, Low-Output, Low-Gradient Aortic Stenosis in Patients With Depressed Left Ventricular Systolic Function. The Clinical Utility of the Dobutamine Challenge in the Catheterization Laboratory Circulation 2002;106:809-813

Estenosis Aórtica Severa EAo con Bajo Flujo – Bajo Gradiente Utilidad de la Dobutamina Gradiente 48 mmHg I.C.: 2.5 l/m/m2 I.C.: 1.4 l/m/m2 Gradiente 22 mmHg A, This patient responded to dobutamine infusion with an increase in cardiac output and an increase in aortic valvular mean gradient from 22 to 48 mm Hg. The aortic valve area (AVA) remained 0.8 cm2. This patient had severe aortic stenosis at the time of aortic valve replacement and is alive in NYHA class I after the operation. Estenosis Aórtica Severa Nishimura et al, Low-Output, Low-Gradient Aortic Stenosis in Patients With Depressed Left Ventricular Systolic Function. The Clinical Utility of the Dobutamine Challenge in the Catheterization Laboratory Circulation 2002;106:809-813

VPAo como puente a TAVI NS Sobrevida a 1 año en pacientes sometidos a TAVI con y sin VPAo previa “puente a TAVI” Kaplan-Maier 1-year survival curves following transcatheter aortic valve implantation (TAVI) in patients initially attributed to “bridge” BAV as compared to 47 consecutive other patients who underwent TAVI in our hospital. TAVI post “VPAo puente” otras TAVI Días Saia, F. et al. The role of percutaneous balloon aortic valvuloplasty as a bridge for transcatheter aortic valve implantation . EuroIntervention 2011;7:723-729

Evolución a 30 días post-“VPAo como puente a TAVI” Allocation of patients following re-evaluation one month after “bridge” balloon aortic valvuloplasty (BAV). All patients. B. Proportion of patients re-allocated to the different treatment strategies after BAV in the different subgroups. AVR: aortic valve replacement; LVEF: left ventricular ejection fraction; MT: medical therapy; MVR: mitral valve regurgitation; NCS: major non-cardiac surgery; TAVI: transcatheter aortic valve implantation See more at: http://www.pcronline.com/eurointervention/41st_issue/115/#sthash.KK8IVFyR.dpuf RVAo TAVI VPAo/TM Muerte Reasignados Saia, F. et al. The role of percutaneous balloon aortic valvuloplasty as a bridge for transcatheter aortic valve implantation . EuroIntervention 2011;7:723-729

AVR en pacientes sin Reserva Contráctil N total=81 pts. N matched=42 pts. Kaplan-Meier estimates of the probability of survival according to whether aortic valve replacement (AVR) was performed: (A) total population (n = 81), and (B) matched patients (n = 42). Abbreviations as in Figure 3. Conclusiones: En pacientes con Estenosis aórtica con bajo flujo/bajo gradiente sin RC en el Eco-Dobuta, el RVAo se asocia con mejor evolución comparada con el tratamiento médico; la cirugía no debería ser descartada en este grupo de pacientes solo por la falta de reserva contráctil. Tribouilloy et al. Outcome After Aortic Valve Replacement for Low-Flow/Low-Gradient Aortic Stenosis Without Contractile Reserve on Dobutamine Stress Echocardiography. JACC 2009;53(20):1865-1873.

VPAo: Complicaciones 1991 N=672 40 80 120 160 200 No. Pacientes 23% 8% Transfusión Muerte Cardiaca Cirugía Vascular ACV Shock Cardiogénico Muerte No cardíaca Infarto de miocardio Embolia Sistémica Tampon. Card. Cirugía Cardiaca ATN 23% 8% 7% 3% 3% 2% 2% 2% Bar graph shows complications of aortic valvuloplasty occumng acutely (<24 hours) or during hospitalization. Total major complications are shown. Each bar graph is subdivided into acute (<24 hours) and in-hospital complications. BVA, Balloon Valvuloplasty Registry; CVA, cerebrovascular accident; ATN, acute tubular necrosis. (See text for discussion.) 1% 1% 1% 40 80 120 160 200 No. Pacientes Bashore, et al. NHLBI Balloon Valvuloplasty Registry Participants. Circulation 1991: vol 84 no. 6