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ASPECTOS TÉCNICOS EN TAVI�ACURATE NEO2 EN ANATOMÍAS DIFÍCILES

Iván J. Núñez Gil; MD, PhD, FESC

Hospital Clínico San Carlos

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Características prótesis.

ACURATE neo vs ACURATE neo2™

Cambios:

Falda sellado +60% más larga
Marcador posicionamiento radiopaco
Introductor de bajo perfil 14F iSLEEVE™

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Características prótesis.

ACURATE neo2™

Stent autoexpandible de nitinol con velos de pericardio porcino.
Supra-anular (minimizar gradientes)
Despliegue en 2 pasos (top-down -> predecible)
Anillos entre 21mm y 27mm
Tallas S – 23 mm, M – 25 mm, L – 27 mm

Arcos estabilizadores

Axial; autoalineamiento

Corona superior

Captura velos nativos para mejorar el acceso a coronarias

Corona inferior

Protrusión minima en tracto salida VI

Tecnología “Advanced Sealing”

Falda de pericardio interna y externa (externa cubre cintura del stent)
Mejora conformabilidad en anatomia irregular y calcificada, para reducir leaks.

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EL PROBLEMA

Comorbilidades.
Acceso vascular.
Disposición aorta.
Válvula aórtica.

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EL PROCEDIMIENTO

Paso a paso.

INDICACIÓN TAVI

ESTUDIO PACIENTE

PLAN CUIDADOSO

ACCESO VASCULAR

IMPLANTE

CUIDADOS POST

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EL PROCEDIMIENTO

INDICACIÓN TAVI

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EL PROCEDIMIENTO

Valoración perfil riesgo.
Comorbilidades.
Anatomía.
Tipo de prótesis y tamaño.
Plan de ruta.

ESTUDIO PACIENTE

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EL PACIENTE

Varón de 83 años (Amaro DR)
HTA, DM2, DLP, (ex)fumador.
HDB Ingreso 2017 por anemia.
EPOC Moderado. Gota.
HCV

FA persistente.
SCC (2019, SCASEST-> 3 v -DAm, ramo intermedio prox, OM ostial, CD media y distal, PL. ACTP Stent CDm)

TTO: dabigatrán 150/12h, torasemida, digoxina, serevent, onbrez, pantoprazol, enalapril, atorvastativa, amlodipina, eucreas.

ESTUDIO PACIENTE

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EL PACIENTE

EA: Disnea progresiva, NYHA II-III.

ECG: FA. QRS estrecho.
ETT: de bajo flujo y bajo gradiente con FEVI 48%. HVI. Acinesia anteroapical.

Se inicia estudio TAVI oct 2022. Pero:

-Ingresa por dolor torácico (ligera elevación Tn) e ICC. Asocia cefalea hemicraneal con dolor hemicara izq.

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EL PACIENTE

EA: Disnea progresiva, NYHA II-III.

ECG: FA. QRS estrecho.
ETT: de bajo flujo y bajo gradiente con FEVI 48%. HVI. Acinesia anteroapical. AVA 0,86.

Se inicia estudio TAVI oct 2022. Pero:

-Ingresa por dolor torácico (ligera elevación Tn) e ICC. Asocia cefalea hemicraneal con dolor hemicara izq.

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EL PACIENTE

EA: Disnea progresiva, NYHA II-III.

ECG: FA. QRS estrecho.
ETT: de bajo flujo y bajo gradiente con FEVI 48%. HVI. Acinesia anteroapical. AVA 0,86.

Se inicia estudio TAVI oct 2022. Pero:

-Ingresa por dolor torácico (ligera elevación Tn) e ICC. Asocia cefalea hemicraneal con dolor hemicara izq.

Rmn CEREBRAL:

- Focos milimétricos con restricción a la difusión, sugerentes de isquemia aguda.

- Enfermedad de pequeño vaso (Fazekas 3).

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EL DIAGNÓSTICO

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EL DIAGNÓSTICO

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LA VÁLVULA

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LA VÁLVULA

Ca score: 2671

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LA VÁLVULA

Tamaño válvula.

Muy grande.
Muy pequeña.

Tamaño tracto salida / electrocardiograma (PR y QRS)
Calcificación velos y aorta.
Estenosis /área valvular.
Tortuosidad y angulación aorta. Angulación anillo aórtico.
Tricúspide/bicúspide.
Otras prótesis (ej. Prótesis mecánica mitral).
Coronariopatía?
Altura coronarias / enfermedad coronaria /tamaño senos –longitud velos/stent protuye ostium?.
Otras condiciones (ej. Insuficiencia aórtica predominante).
Datos disponibles en estas circunstancias con cada prótesis.
Experiencia local operadores.

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LA VÁLVULA

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LA VÁLVULA

Tamaño válvula.

Muy grande.
Muy pequeña.

Tamaño tracto salida / electrocardiograma (PR y QRS)
Calcificación velos y aorta.
Estenosis /área valvular.
Tortuosidad y angulación aorta. Angulación anillo aórtico.
Tricúspide/bicúspide.
Otras prótesis (ej. Prótesis mecánica mitral).
Coronariopatía?
Altura coronarias / enfermedad coronaria /tamaño senos –longitud velos/stent protuye ostium?.
Otras condiciones (ej. Insuficiencia aórtica predominante).
Datos disponibles en estas circunstancias con cada prótesis.
Experiencia local operadores.

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LA VÁLVULA

Cao D. et al. Interventional Cardiology Review 2018

After diagnosis, the prognostic impact of CAD and role of revascularisation in TAVI patients have been unclear. Initial studies have shown differing results – likely from population heterogeneity and limited sample sizes – varying from increased mortality post-TAVI to a neutral impact.^30–33

In more recent years, larger registries have offered modern, real-world evidence. UK and German TAVI registry studies, as well as a study from Toulouse University Hospital, did not suggest pre-existing CAD had any impact on mortality.^34–36 However, a TAVI registry from Bern, Switzerland, published increased ischaemic events and cardiovascular mortality at 1 year in patients with CAD compared to those without (HR 1.75; 95% CI [1.06–2.89]; p=0.030), although there was no signal for increased mortality when analysed by itself (HR 1.35; 95% CI [0.85–2.15]; p=0.21).³⁷

In an aggregation of the above mixed results, a meta-analysis of performed in 2017 studied 8013 patients undergoing TAVI with both self-expanding and balloon-expandable THVs. This showed no increase in 30-day mortality but an odds ratio of 1.21 (95% CI [1.07–1.36]; p=0.002) of all-cause mortality at 1 year

A SYNTAX score of >22 was more likely to be associated with increased death, stroke and MI, although another study identified a cut-off of 9 for worse outcomes.^40–42 This stands in contrast with results of a recent ischaemia trial, which did not suggest benefits in revascularisation for patients with stable CAD.⁴³ Therefore, the usefulness of SYNTAX score to guide revascularisation for patients with severe AS is still uncertain.

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LA VÁLVULA: ACTP PREVIO

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LA VÁLVULA: ACTP DA PREVIO

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LA VÁLVULA

Tamaño válvula.

Muy grande.
Muy pequeña.

Tamaño tracto salida / electrocardiograma (PR y QRS)
Calcificación velos y aorta.
Estenosis /área valvular.
Tortuosidad y angulación aorta. Angulación anillo aórtico.
Tricúspide/bicúspide.
Otras prótesis (ej. Prótesis mecánica mitral).
Altura coronarias / enfermedad coronaria /tamaño senos –longitud velos/stent protuye ostium?.
Otras condiciones (ej. Insuficiencia aórtica predominante).
Datos disponibles en estas circunstancias con cada prótesis.
Experiencia local operadores.

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LA VÁLVULA

OBJECTIVES The aims of this study were to investigate the feasibility of coronary ostia cannulation after transcatheter

aortic valve replacement (TAVR) and to assess potential predictors of coronary access impairment.

BACKGROUND Certain data concerning the feasibility and reproducibility of coronary cannulation after TAVR are

lacking.

METHODS RE-ACCESS (Reobtain Coronary Ostia Cannulation Beyond Transcatheter Aortic Valve Stent) was an

investigator-driven, single-center, prospective, registry-based study that enrolled consecutive patients undergoing TAVR

using all commercially available devices. All patients underwent coronary angiography before and after TAVR. The primary

endpoint was the rate of unsuccessful coronary ostia cannulation after TAVR. Secondary endpoints were the

identification of factors associated with the inability to selectively cannulate coronary ostia after TAVR.

RESULTS Among 300 patients enrolled in the RE-ACCESS study from December 2018 to January 2020, a total of 23

cases (7.7%) of unsuccessful coronary cannulation after TAVR were documented. This issue occurred in 22 of 23 cases

with the use of Evolut R/PRO transcatheter aortic valves (TAVs) (17.9% vs. 0.4%; p < 0.01). In multivariate analysis, the

use of Evolut R/PRO TAVs (odds ratio [OR]: 29.6; 95% confidence interval [CI]: 2.6 to 335.0; p < 0.01), the TAV–sinus

of Valsalva relation (OR: 1.1 per 1-mm increase; 95% CI: 1.0 to 1.2; p < 0.01), and the mean TAV implantation depth

(OR: 1.7 per 1-mm decrease; 95% CI: 1.3 to 2.3; p < 0.01) were found to be independent predictors of unsuccessful

coronary cannulation after TAVR. A model combining these factors was demonstrated to predict with very high accuracy

the risk for unsuccessful coronary cannulation after TAVR (area under the curve: 0.94; p < 0.01).

CONCLUSIONS Unsuccessful coronary cannulation following TAVR was observed in 7.7% of patients and occurred

almost exclusively in those receiving Evolut TAVs. The combination of Evolut TAV, a higher TAV–sinus of Valsalva

relation, and implantation depth predicts with high accuracy the risk for unsuccessful coronary cannulation after TAVR.

(Reobtain Coronary Ostia Cannulation Beyond Transcatheter Aortic Valve Stent [RE-ACCESS]; NCT04026204)

EN REACCESSHABIA 72 ACURATES Y EL 100% SE CANULARON

Background The success rate of coronary angiography (CA) after transcatheter aortic valve implantation (TAVI) is

variable. Our aim was to investigate CA difficulty, outcomes, and predictors of difficult CA after TAVI.

Method This was an international multicentric retrospective cohort study that included patients with TAVI and

subsequent CA between January 2010 and December 2019. Difficulty with CA was graded as 1 (normal), 2

(partial engagement, complete vessel opacification), 3 (partial engagement, incomplete vessel opacification),

and 4 (unsuccessful angiography). Patients were grouped as (a) “easy” (grade 1 for left and right) or

(b) “difficult” (grade .1 for either). We compared baseline characteristics and outcomes, and performed

multivariate logistic regression for predictors of difficult CA.

Results Of 96 patients included (mean age 77.468.7 years, 48 [50%] male), 88 (92%) had successful CA. Right CA

was successful in 80 (83%) patients and left CA in 91 (95%) (p,0.0001). The “difficult” group (n=41 [43%])

had higher Society of Thoracic Surgery (STS) scores (7.664.9 vs 5.464.0; p=0.022), smaller annulus perimeters

(72.465.4 mm vs 76.269.4 mm; p=0.049), greater use of self-expanding valves (83% vs 18%;

p,0.0001), increased valve size (26.862.1 mm vs 25.663.0 mm; p=0.032), and increased oversizing for area

(44.3%617.4% vs 23.6%622.0%; p=0.0002) and perimeter (17.5%68.2% vs 7.1%610.8%; p,0.0001). There

was no difference in outcomes except for increased major bleeding (7.3% vs 0.0%; p=0.042). The strongest

predictor for “difficult” CA was self-expanding valves when compared to balloon-expandable valves

(adjusted odds ratio [aOR], 15.23; 95% confidence interval [CI], 2.27–102.40). Society of Thoracic Surgery

score was borderline predictive (aOR, 1.26; 95% CI, 1.04–1.52).

Conclusions Our results show that after TAVI, CA success rate is high, right CA is more difficult than left, selfexpanding

valves predispose to difficult CA, and STS score weakly predicts difficult CA. This study is

hypothesis-generating and more research is required to confirm these findings.

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LA VÁLVULA

Tamaño válvula.

Muy grande.
Muy pequeña.

Tamaño tracto salida / electrocardiograma (PR y QRS)
Calcificación velos y aorta.
Estenosis /área valvular.
Tortuosidad y angulación aorta. Angulación anillo aórtico.
Tricúspide/bicúspide.
Otras prótesis (ej. Prótesis mecánica mitral).
Altura coronarias / enfermedad coronaria /tamaño senos –longitud velos/stent protuye ostium?.
Otras condiciones (ej. Insuficiencia aórtica predominante).
Datos disponibles en estas circunstancias con cada prótesis.
Experiencia local operadores.

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LA VÁLVULA

Lanz J, et al. TCT 2022

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LA VÁLVULA

Möllmann H, et al. Clin Res Cardiol. 2021

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LA VÁLVULA

Pellegrini C, et al. Eurointervention. 2022

Abstract

Background: No comparative data exist with the latest generation self-expanding ACURATE neo2 (Neo2)

and the balloon-expandable SAPIEN 3 Ultra (Ultra) transcatheter heart valves (THV).

Aims: We aimed to compare the outcomes after transcatheter aortic valve implantation (TAVI) using the

Neo2 and the Ultra THV.

Methods: A total of 1,356 patients at 4 centres were treated either with the Neo2 (n=608) or the Ultra

(n=748). The primary endpoint was device success according to the latest Valve Academic Research

Consortium definitions. The association of the THV used and the primary endpoint was assessed using

inverse probability treatment weighting (IPTW) and 1:1 propensity score matching (PSM), which identified

472 matched pairs.

Results: After PSM, there were no relevant differences between the groups. While rates of moderate to

severe paravalvular leakage (PVL) were overall low (0.6% vs 1.1%; p=0.725), elevated transvalvular gradients

(≥20 mmHg) were less frequent with the Neo2 (2.4% vs 7.7%; p<0.001), which translated into a significantly

higher rate of device success with the Neo2 compared with the Ultra (91.9% vs 85.0%; p<0.001).

Consistently, the Neo2 was associated with higher rates of device success in the IPTW analysis (odds ratio

[OR] 1.961, 95% confidence interval [CI]: 1.269-3.031; p=0.002). Rates of mild PVL were significantly

lower with the Ultra compared with the Neo2 (20.0% vs 32.8%; p<0.001). Clinical events at 30 days were

comparable between the 2 groups.

Conclusions: Short-term outcomes after TAVI using the Neo2 or Ultra THV were excellent and, overall,

comparable. However, transvalvular gradients were lower with the Neo2, which translated into higher rates

of device success. Rates of mild PVL were significantly lower with the Ultra THV.

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LA PRÓTESIS

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LA PRÓTESIS

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EL PROCEDIMIENTO

Sedación.

PLAN CUIDADOSO

Background: Transcatheter aortic valve replacement (TAVR) is typically performed under general

anesthesia (GA). However, there is increasing data supporting the safety of performing TAVR

under local anesthesia/conscious sedation (LA). We performed a meta-analysis to gain better

understanding of the safety and efficacy of LA versus GA in patients with severe aortic stenosis

undergoing TAVR.

Methods and Results: We comprehensively searched EMBASE, PubMed, and Web of Science.

Effect sizes were summarized using risk ratios (RRs) difference of the mean (DM), and 95% CIs

(confidence intervals) for dichotomous and continuous variables respectively. Twenty-six studies

and 10,572 patients were included in the meta-analysis. The use of LA for TAVR was associated

with lower overall 30-day mortality (RR, 0.73; 95% CI, 0.57–0.93; P50.01), use of inotropic/

vasopressor drugs (RR, 0.45; 95% CI, 0.28–0.72; P<0.001), hospital length of stay (LOS) (DM,

22.09; 95% CI, 23.02 to 21.16; P<0.001), intensive care unit LOS (DM, 20.18; 95% CI, 20.31

to 20.04; P50.01), procedure time (DM, 225.02; 95% CI, 232.70 to 217.35; P<0.001); and

fluoroscopy time (DM, 21.63; 95% CI, 23.02 to 20.24; P50.02). No differences were observed

between LA and GA for stroke, cardiovascular mortality, myocardial infarction, permanent

Catheter Cardiovasc Interv. 2017;1–13. wileyonlinelibrary.com/journal/ccd VC 2017 Wiley Periodicals, Inc. | 1

Received: 17 May 2017 | Accepted: 15 June 2017

DOI: 10.1002/ccd.27207

pacemaker implantation, acute kidney injury, paravalvular leak, vascular complications, major

bleeding, procedural success, conduction abnormalities, and annular rupture.

Conclusion: Our meta-analysis suggests that use of LA for TAVR is associated with a lower 30-

day mortality, shorter procedure time, fluoroscopy time, ICU LOS, hospital length of stay, and

reduced need for inotropic support.

KEYWORDS

transcatheter aortic valve replacement, meta-analysis, general anesthesia, local anesthesia, severe

aortic stenosis

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EL PROCEDIMIENTO

Sedación.
Accesos

ARD/ARI 6F.
AFD 14F. Precierre proglidex2
VFD 6F.

Protección embólica.
Estimulación guía Safari XS.
Predilatación balón 23.
Acurate neo2 L.
LO MAS SIMPLE POSIBLE

PLAN CUIDADOSO

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EL PROCEDIMIENTO

Sedación.
Accesos

ARD 6FARD/ARI 6F.
AFD 14F. Precierre proglide x2
VFD 6F.

Acceso secundario RADIAL

N=217
Seguro
< sangrado (17.0% vs. 9.2%, P = 0.026)
< complics vasculares (18.0% vs. 9.7%, P = 0.014)

PLAN CUIDADOSO

Fernandez-Lopez L, et al. Catheter Cardiovasc Interv. 2019 Jun 1;93(7):1367-1373

Implementation of the transradial approach as an alternative vascular access for transcatheter aortic valve replacement guidance: Experience from a high-volume center.Fernandez-Lopez L, Chevalier B, Lefèvre T, Spaziano M, Unterseeh T, Champagne S, Benamer H, Sanguineti F, Garot P, Hovasse T.

Objective

This study sought to assess the potential benefits of the transradial approach (TRA) as an alternative vascular access to the classical contralateral femoral approach for transcatheter aortic valve replacement (TAVR).

Background

Vascular and bleeding complications in TAVR have gradually decreased owing to operator experience and downsizing of the delivery system. However, about 1/4 of vascular access site complications are related to the transfemoral (TF) secondary access.

Methods

We compared the outcomes at 30 days according to VARC-2 after TAVR of a prospective cohort of 217 consecutive patients undergoing right or left TRA as the second vascular access (TRA-TF TAVR) and a retrospective cohort of 194 consecutive patients undergoing TF approach as a second vascular access (TF-TF TAVR).

Results

Baseline clinical characteristics and risk scores were well matched in both groups. Procedural success rate was 99.7%. Fluoro time was significantly lower in the TF-TF TAVR group (16.9 ± 7.2 vs. 19.1 ± 7.8 min, P = 0.003); however, there was no significant difference in x-ray exposure, procedure time or amount of contrast used. In the TRA-TF TAVR group, there were no complications related to the TRA access and there were less vascular and bleeding complications (18.0% vs. 9.7%, P = 0.014; 17.0% vs. 9.2%, P = 0.026, respectively), although blood transfusion requirement or hospitalization duration stay were similar in both groups.

Conclusions

TRA approach as alternative secondary vascular access in TAVR is safe and feasible and is associated with a significant decrease in vascular and bleeding complications. Further, large-scale studies are warranted to confirm the potential benefit of this approach.

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EL PROCEDIMIENTO

ACCESO VASCULAR

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EL PROCEDIMIENTO

Protección vascular (guía?)
Punción apoyada eco /escopia.
Precierre proglide (2± angioseal 8f).
Acceso radial apoyo.
Otras alternativas (biradial, ipsilat).

ACCESO VASCULAR

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EL PROCEDIMIENTO

2 introductores radiales 6/5F.

Introductores A y V femoral der 6F.

Guiado por eco y escopia.

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EL PROCEDIMIENTO

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EL PROCEDIMIENTO

HNF y Sentinel

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EL PROCEDIMIENTO

Introductor, navegación.
Cruze válvula.
Predilatación (Acurate siempre)
Alineamiento comisural

IMPLANTE

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EL ALINEAMIENTO

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EL ALINEAMIENTO

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EL ALINEAMIENTO (en estudio)

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EL PROCEDIMIENTO

Implante

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EL PROCEDIMIENTO

Introductor, navegación.
Cruze válvula.
Predilatación (Acurate siempre)
Alineamiento comisural
Posicionamiento preciso

Varias proyecciones.
Estimulación (102-140).
Control TA y sedación.

IMPLANTE

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EL PROCEDIMIENTO

Proglide x2

Angioseal 8F

No debris en Sentinel

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EL RESULTADO

VI 155/7 PTDVI 21 Ao 154/78 Índice Ao 0,37

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EL RESULTADO

3 CUSP

CUSP OVERLAP

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EL RESULTADO

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EL RESULTADO

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EL PROCEDIMIENTO

UCOR o planta.
Monitorización

Ritmo/PR-QRS

Sangrado/complicaciones
Tto. Antitrombótico
Alta en 3 días.
Revisiones

CUIDADOS POST

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EL SEGUIMIENTO

CUIDADOS POST

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EN CONCLUSIÓN

INDICACIÓN TAVI

ESTUDIO PACIENTE

PLAN CUIDADOSO

ACCESO VASCULAR

IMPLANTE

CUIDADOS POST

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