Publish in this journal
Journal Information
Vol. 76. Issue 10.
Pages 767-773 (October 2023)
Visits
Not available
Vol. 76. Issue 10.
Pages 767-773 (October 2023)
Original article
Full text access
Cusp-overlap technique during TAVI using the self-expanding Portico FlexNav system
Técnica de superposición de cúspides en TAVI con el sistema autoexpandible Portico FlexNav
Visits
775
Lluis Asmaratsa,b, Lola Gutiérrez-Alonsoa,b, Luis Nombela-Francoc, Ander Regueirod, Xavier Millána,b, Gabriela Tirado-Contec, Pedro Cepasd, Chi Hion Pedro Lia,b, Estefanía Fernández-Peregrinaa,b, Pilar Jiménez-Quevedoc, Xavier Freixad, Dabit Arzamendia,b,
Corresponding author
darzamendi@santpau.cat

Corresponding author.
a Servicio de Cardiología, Hospital de la Santa Creu i Sant Pau, Instituto de Investigación Biomédica Sant Pau, Barcelona, Spain
b Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Spain
c Servicio de Cardiología, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), Madrid, Spain
d Servicio de Cardiología, Hospital Clínic Barcelona, Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain
Related content
Rev Esp Cardiol. 2023;76:755-610.1016/j.rec.2023.03.013
Won-Keun Kim
This item has received
Disponible módulo formativo: . Saber más
Article information
Abstract
Full Text
Bibliography
Download PDF
Statistics
Figures (3)
Show moreShow less
Tables (3)
Table 1. Baseline clinical characteristics
Table 2. Procedural and clinical outcomes
Table 3. Predictors of new-onset conduction disturbances after TAVI in global population
Show moreShow less
Additional material (1)
Abstract
Introduction and objectives

The cusp overlap technique (COT) has been proposed to reduce conduction disturbances (CD) after transcatheter aortic valve implantation (TAVI) with self-expanding supra-annular devices, but there are scarce data on COT with intra-annular valves. The aim of this study was to determine whether the use of the COT during Portico implantation results in higher valve implantation and lower rates of CD.

Methods

We included 85 patients undergoing TAVI with the Portico FlexNav system: 43 retrospective patients using the standard 3-cusp view and 42 prospective patients with the COT. Primary endpoints were implantation depth and new-onset CD (composite outcome of new-onset left bundle branch block and new permanent pacemaker implantation).

Results

COT resulted in a higher implantation depth (noncoronary cusp: 4.9±3.9 vs 7.4±3.0; P=.005) and lower new-onset CD (31.0% vs 58.1%; P=.012), with a tendency toward a lower need for permanent pacemaker implantation (14.3% vs 30.2%, P=.078; 7.7% vs 31.0%; P=.011 in patients without pre-existing right bundle branch block). Transvalvular aortic gradients were slightly lower with COT (8.7±3.7 vs 11.0±6.1; P=.044). There were no differences in technical success or major procedure-related complications. On multivariate analysis, COT use was associated with a lower risk of new-onset CD.

Conclusions

Use of the COT during Portico implantation is feasible and facilitates a higher valve implant, which in turn may help to reduce rates of new-onset CD.

Keywords:
Transcatheter aortic valve replacement
Pacemaker
Cardiac conduction system disease
Cusp overlap
Abbreviations:
CD
COT
PPI
STS-PROM
TAVI
Resumen
Introducción y objetivos

La técnica de superposición de cúspides (TSC) se ha propuesto para reducir los trastornos de la conducción intraventricular (TCIV) tras el implante percutáneo de válvula aórtica (TAVI) con dispositivos autoexpandibles supraanulares, pero existen pocos datos sobre la TSC con dispositivos intraanulares. El objetivo de este estudio fue determinar si el uso de la TSC durante la implantación de la válvula Portico resulta en un implante más alto de la válvula y menores tasas de TCIV.

Métodos

Se incluyó a 85 pacientes sometidos a TAVI con el sistema Portico FlexNav, 43 pacientes retrospectivos con la proyección clásica de las 3 cúspides (coplanar) y 42 pacientes prospectivos con la TSC. Los objetivos primarios fueron la profundidad de implantación y los nuevos TCIV (compuesto de bloqueo de rama izquierda y necesidad de marcapasos permanente).

Resultados

La TSC resultó en una menor profundidad de implante (cúspide no coronaria: 4,9±3.9 frente a 7,4±3.0; p=0,005) y menor tasa de TCIV (31,0% frente a 58,1%; p=0,012), con una tendencia hacia una menor necesidad de marcapasos permanente (14,3% frente a 30,2%; p=0,078; 7,7% frente a 31,0%; p=0.011 en pacientes sin bloqueo de rama derecha preexistente). Los gradientes trasvalvulares aórticos fueron ligeramente inferiores con la TSC (8,7±3,7 frente a 11,0±6,1; p=0,044). No hubo diferencias en el éxito técnico o complicaciones mayores relacionadas con el procedimiento. En el análisis multivariado, el uso de la TSC se asoció con un menor riesgo de nuevos TCIV.

Conclusiones

El uso de la TSC durante la implantación del sistema Portico FlexNav es factible y facilita un implante más alto de la válvula, lo que a su vez puede ayudar a reducir las tasas de TCIV.

Palabras clave:
Implante percutáneo de válvula aórtica
Marcapasos
Enfermedad del sistema de conducción cardiaca
Superposición de cúspides
Full Text
INTRODUCTION

During the last decade, transcatheter aortic valve implantation (TAVI) has become the first-choice therapy for treating symptomatic severe aortic stenosis in most patients older than 80 years with suitable transfemoral access.1 However, the most common complication following TAVI remain new-onset conduction disturbances (CD).2 In recent years, several studies have shown the usefulness of a novel, modified implantation technique using a cusp overlap technique (COT), which overlaps the left and right coronary cusps and isolates the noncoronary cusp.3,4 The potential benefits of using the COT during TAVI include elongation of the left ventricular outflow tract, which provides more accurate control of the real prosthesis implantation depth, thus lowering the risk of interaction with the conduction system. Whereas early experiences of this approach using self-expanding supra-annular valves have been promising, to date, no studies have assessed the use of the COT using the self-expanding intra-annular Portico FlexNav system (Abbott Vascular, United States). The present study sought to determine whether the use of the COT during Portico FlexNav system implantation results in higher implantation depth and lower CD rates.

METHODS

This was a multicenter study including consecutive patients undergoing transfemoral TAVI with the self-expanding intra-annular Portico valve with the second-generation FlexNav delivery system at 3 tertiary centers. Between July 2020 and July 2021, a total of 91 consecutive patients underwent TAVI with the Portico FlexNav system. Patients with previous permanent pacemaker implantation (PPI) were excluded (n=6), leading to a final study population of 85 patients. Of these, 42 prospective patients received a Portico valve using the COT (January-July 2021) and were compared with 43 consecutive patients who had previously received a Portico valve using the traditional coplanar 3-cusp technique (July-December 2020) (figure 1). All implantations were performed by certified operators with a previous cumulative experience of at least 25 procedures with the first-generation Portico delivery system and ≥ 5 procedures with the next-generation FlexNav delivery system. Data were collected in accordance with the ethics committee of each participating center, and all patients provided signed informed consent to undergo the procedures.

Figure 1.

Flowchart of the study population. PPI, permanent pacemaker implantation.

(0.17MB).
Portico FlexNav system

The Portico TAVI system is a self-expanding, intra-annular, repositionable transcatheter heart valve for the treatment of severe aortic stenosis showing favorable hemodynamic performance.5 The second-generation FlexNav delivery system includes a hydrophilic coated, integrated sheath (14- or 15-Fr equivalent) and a stability layer to minimize manipulations and facilitate a more gradual and controlled deployment of the valve, The system and received the CE mark approval in March 2020.6

Implantation technique

Preprocedural work-up for anatomic assessment and optimal implant projections were made with either 3Mensio Structural Heart (Pie Medical Imaging, Netherlands) or Heart Navigator (Philips Healthcare, Netherlands). Predilation with a balloon diameter equal to the average diameter of the aortic annulus was recommended. Patients in the conventional (coplanar 3-cusp) deployment technique underwent valve implantation as previously described.5 Implantation using the COT was performed as follows: the valve was deployed in a right anterior oblique/caudal view, using no rapid pacing or controlled pacing at 120 bpm at the discretion of the implanting physician, followed by a left anterior oblique projection (modified coplanar view) to measure the left coronary depth and position of the delivery catheter before final release (figure 2). Target implantation depth was defined as ranging between 3 and 5mm (distance from the noncoronary cusp to the inflow of the transcatheter heart valve frame) regardless of the working projection. In both groups, the final implantation depth was assessed in a left anterior oblique angiogram.

Figure 2.

Standard 3-cusp view (LAO) vs cusp overlap (RAO/CAU) technique. A-E: conventional 3-cusp implantation technique. A-C: cardiac computed tomography and baseline aortogram showing the classic coplanar projection with 3 cusps: NCC (yellow) on the left side, RCC (green) in the middle and LCC (red) on the right side. D-E: initial positioning of a Portico valve and final assessment under a 3-cusp view. F-J: cusp overlap implantation technique. F-H: computed tomography and angiogram in a RCC/LCC cusp overlap view: in this projection, the NCC (yellow) is on the left side and the RCC (green) and LCC (red) are overlapped on the right side. I-J: valve positioning and final assessment in a cusp overlap view. Dotted lines represent implantation depth (distance from the NCC to the ventricular end of the TAVI frame). CAU, caudal; LAO, left anterior oblique; LCC, left coronary cusp; NCC, noncoronary cusp; RAO, right anterior oblique; RCC, right coronary cusp.

(0.43MB).
Endpoints

Primary endpoints were prosthesis implantation depth and new-onset CD. Implant depth was assessed during final angiography after valve deployment removing device parallax and measuring the distance from the noncoronary and left coronary cusps to the deepest portion of the transcatheter heart valve. New-onset CD was defined as a composite outcome of new-onset left bundle branch block and new PPI. The decision for PPI was made in accordance with the 2019 consensus pathway.2 Technical success and in-hospital complications were defined according to the Valve Academic Research Consortium 3.7

Statistical analysis

Categorical variables are expressed as number (percentage) and continuous variables as mean±standard deviation (SD) or median [interquartile range (IQR)]. Group comparisons were analyzed using the Student t test or its nonparametric equivalent, the Mann-Whitney U test for continuous variables and the chi-square test or Fischer exact test for categorical variables. Multivariate analysis through logistic regression was used to evaluate independent predictors of new-onset CD in the global population. Variables with P ≤ .10 on univariate analysis and those considered clinically relevant (eg, right bundle branch block) were entered into a multivariable logistic regression; less than 1 variable for every 10 events was included to avoid overfitting. A 2-sided P <.05 was considered significant for all statistical tests. Statistical analyses were performed with STATA version 14.0 (StataCorp LP, College Station, United States).

RESULTSStudy population

Between July 2020 and July 2021, a total of 85 consecutive patients underwent TAVI with the Portico FlexNav system. The standard 3-cusp view was used in 43 patients, while in 42 patients TAVI were implanted using the COT. The main baseline and TAVI procedure characteristics of the study population are shown in table 1. The mean age was 82±6 years, with 73% of women, and a mean STS-PROM score of 4.2±2.8%. Pre-existing left or right bundle branch block was present in 13% of the patients. The mean gradient was 46.2±15.6mmHg, with an average Agatston calcium score on computed tomography of 2200±1355 AU. There were no significant differences between groups, except for a lower rate of coronary artery disease in the COT group (17% vs 44%; P=.006).

Table 1.

Baseline clinical characteristics

  OverallN=85  Three cuspsn=43  Cusp overlapn=42  P 
Age, y  81.7±6.4  81.2±7.4  82.3±5.1  .410 
Female sex  62 (72.9)  33 (76.7)  29 (69.1)  .425 
Hypertension  73 (85.9)  39 (90.7)  34 (81.0)  .197 
Diabetes  34 (40.0)  16 (37.2)  18 (42.9)  .595 
Body mass index, kg/m2  28.1±4.5  28.9±5.3  27.3±3.5  .097 
Atrial fibrillation  26 (30.6)  15 (34.9)  11 (26.2)  .384 
Coronary artery disease  26 (30.6)  19 (44.2)  7 (16.7)  .006 
Previous cardiac surgery  12 (14.1)  6 (14.0)  6 (14.3)  .965 
Previous aortic valve surgery  10 (11.8)  6 (14.0)  4 (9.5)  .738 
Stroke  7 (8.2)  3 (7.0)  4 (9.5)  .713 
STS risk score  4.2±2.8  4.5±3.3  3.9±2.0  .390 
ECG variables
LBBB  7 (8.2)  3 (7.0)  4 (9.5)  .713 
RBBB  4 (4.7)  1 (2.3)  3 (7.1)  .360 
AVB I°  13/59 (22.0)  8/31 (25.8)  5/28 (17.9)  .462 
Echocardiography
LVEF, %  61.1±10.1  62.7±10.4  59.4±9.6  .139 
Mean gradient, mmHg  46.2±15.6  46.1±14.8  46.4±16.5  .925 
Aortic valve area, cm2  0.7±0.2  0.7±0.2  0.7±0.2  .542 
Bicuspid  1 (1.2)  1 (2.3)  0 (0)  1.000 
Computed tomography
Agatston score  2200±1355  2148±1493  2249±1234  .768 
Cover index*  13.7±4.6  14.7±4.9  12.5±3.9  .029 

AVB I°, first degree atrioventricular block in patients with sinus rhythm; LBBB, left bundle branch block; LVEF, left ventricular ejection fraction; RBBB, right bundle branch block; STS, Society of Thoracic Surgeons.

The values are expressed as mean±standard deviation or No. (%).

*

Cover index was defined as 100 x ([prosthesis diameter – annulus diameter]/prosthesis diameter)

Procedural and 30-day outcomes

Procedural and 30-day data are depicted in table 2. Technical success was achieved in 97% of the patients, with no differences between groups. Predilation was used in 69 (81%) patients and postdilation was required in 33 (39%). Overall, there were no differences in major procedure-related complications. Two patients required a second valve due to device migration (1 in each group, 2.4%), one of them resulting in coronary occlusion successfully resolved by valve snaring and implantation of a second valve. There were 2 deaths at 30 days (2.4%), 1 in each group.

Table 2.

Procedural and clinical outcomes

  OverallN=85  Three cuspsn=43  Cusp overlapn=42  P 
Procedural outcomes
Technical success  82 (96.5)  41 (95.4)  41 (97.6)  .571 
Valve size        .838 
23 mm  24 (28.2)  14 (32.6)  10 (23.8)   
25 mm  31 (36.5)  15 (34.9)  16 (38.1)   
27 mm  21 (24.7)  10 (23.3)  11 (26.2)   
29 mm  9 (10.6)  4 (9.3)  5 (11.9)   
Predilation  69 (81.2)  37 (86.1)  32 (76.2)  .245 
Postdilation  33 (38.8)  20 (46.5)  13 (31.0)  .141 
Procedural length, min  113.7±43.8  121.9±45.4  105.4±40.9  .081 
Fluoroscopy time, min  24.5±9.1  27.1±9.1  22.0±8.4  .010 
Contrast, mL  172.3±65.8  176.4±71.1  168.0±60.4  .556 
Implantation depth, NCC  6.0±3.7  7.4±3.0  4.9±3.9  .005 
  5.5 [3.6-8.0]  6.8 [5.4-8.4]  4.0 [3.0-6.1]  .001 
Implantation depth, LCC  6.9±3.9  8.2±3.2  5.9±4.2  .010 
  6.1 [4.9-9.0]  8.4 [5.6-10.0]  5.4 [3.0-7.6]  .003 
In-hospital and 30-day outcomes
Major bleeding  4 (4.8)  2 (4.7)  2 (4.9)  1.000 
Major vascular complications  4 (4.8)  1 (2.3)  3 (7.3)  .354 
Valve embolization/need for second valve  2 (2.4)  1 (2.3)  1 (2.4)*  1.000 
Coronary occlusion  2 (2.4)  1 (2.3)  1 (2.4)*  1.000 
Annular rupture  0 (0)  0 (0)  0 (0) 
Stroke/TIA  1 (1.2)  0 (0)  1 (2.4)  .494 
New conduction disturbances (LBBB or PPI)  38 (44.7)  25 (58.1)  13 (31.0)  .012 
New-onset LBBB  25 (32.9)  17 (39.5)  8 (24.2)  .160 
Permanent pacemaker  19 (22.4)  13 (30.2)  6 (14.3)  .078 
CHB  17 (20.0)  11 (25.6)  6 (14.3)  .193 
AVB I° + LBBB  2 (2.4)  2 (4.6)  0 (0)  .494 
Mean gradient, mmHg  9.9±5.1  11.0±6.1  8.7±3.7  .044 
Aortic regurgitation ≥ 2  9 (10.6)  6 (14.0)  3 (7.1)  .483 
30-d mortality  2 (2.4)  1 (2.3)  1 (2.4)  1.000 

AVB I°, first degree atrioventricular block; CHB, complete heart block; LBBB, left bundle branch block; LCC, left coronary cusp; NCC, noncoronary cusp; PPI, permanent pacemaker implantation; TIA, transient ischemic attack.

The values are expressed as mean±standard deviation, median [IQR] or No. (%).

*

A single patient had coronary occlusion by the skirt after valve embolization.

Use of the COT was associated with higher prosthesis implantation depth (noncoronary cusp: 4.9±3.9 vs 7.4±3.0; P=.005; left coronary cusp: 5.9±4.2 vs 8.2±3.2; P=.010) and lower rates of new-onset CD (31.0% vs 58.1%; P=.012), with a tendency toward a lesser need for permanent pacemaker implantation (14.3% vs 30.2%; P=.078; 7.7% vs 31.0%; P=.011 in patients without pre-existing right bundle branch block) (figure 3). All pacemakers were implanted during the index TAVI admission and pacemaker requirement was more likely in patients with pre-existing right bundle branch block (3/4: 75%), all in the COT group.

Figure 3.

Central illustration. Use of the cusp overlap view resulted in higher implantation depth and lower rates of new-onset conduction disturbances compared with TAVI using the standard 3-cusp coplanar view. LBBB, left bundle branch block; NCC, noncoronary cusp; PPI, permanent pacemaker implantation.

(0.36MB).

Patients in the COT group exhibited lower transvalvular aortic gradients (8.7±3.7 vs 11.0±6.1; P=.044) and lower fluoroscopy time (22.0±8.4 vs 27.1±9.1, P=.010), with no differences in residual aortic regurgitation.

Predictors of new-onset conduction disturbances

The main predictors of new-onset CD are summarized in table 3. On multivariable analysis, use of the COT was independently associated with a decreased risk of CD post-TAVI (odds ratio, 0.331, 95% confidence interval [95%CI], 0.129-0.852 P=.022).

Table 3.

Predictors of new-onset conduction disturbances after TAVI in global population

        UnivariateMultivariate
  OverallN=85  New-onset CDn=38  No CDn=47  OR  95%CI  P  OR  95%CI  P 
Age, y  81.7±6.4  81.7±6.7  81.8±6.2  0.997  (0.932-1.066)  .925       
Female sex  62 (72.9)  26 (68.4)  36 (76.6)  0.662  (0.253-1.731)  .400       
Hypertension  73 (85.9)  34 (89.5)  39 (83.0)  1.744  (0.482-6.304)  .397       
Diabetes  34 (40.0)  17 (44.7)  17 (36.2)  1.429  (0.596-3.422)  .424       
Body mass index, kg/m2  28.1±4.5  28.6±4.5  27.8±4.6  1.042  (0.946-1.148)  .402       
Atrial fibrillation  26 (30.6)  12 (31.6)  14 (29.8)  1.088  (0.431-2.748)  .859       
Coronary artery disease  26 (30.6)  11 (29.0)  15 (31.9)  0.931  (0.363-2.387)  .882       
Previous cardiac surgery  12 (14.1)  3 (7.9)  9 (19.2)  0.362  (0.091-1.446)  .150       
Previous aortic surgery  10 (11.8)  2 (5.3)  8 (17.0)  0.271  (0.054-1.361)  .113       
Stroke  7 (8.2)  5 (13.2)  2 (4.3)  3.409  (0.623-18.666)  .157       
STS risk score  4.2±2.8  4.0±2.7  4.4±2.9  0.940  (0.798-1.107)  .456       
LBBB  7 (8.2)  2 (5.3)  5 (10.6)  0.467  (0.085-2.552)  .379       
RBBB  4 (4.7)  3 (7.9)  1 (2.1)  3.943  (0.393-39.543)  .243  5.065  (0.453-56.592)  .188 
AVB I°  13/59 (22.0)  9 (32.1)  4 (12.9)  3.197  (0.858-11.920)  .116       
LVEF, %  61.1±10.1  63.4±10.5  59.2±9.5  1.046  (0.998-1.096)  .061  1.034  (0.984-1.087)  .183 
Mean gradient, mmHg  46.2±15.6  47.6±11.9  45.1±18.1  1.011  (0.983-1.039)  .453       
Aortic valve area, cm2  0.7±0.2  0.7±0.2  0.7±0.2  2.917  (0.224-38.002)  .414       
Bicuspid  1 (1.2)  1 (2.6)  0 (0)  1.243  (0.752-20.555)  .879       
Agatston score  2200±1355  2294±1061  2112±1595  1.000  (0.999-1.000)  .590       
THV size  25.4±1.9  25.5±1.9  25.2±2.0  1.089  (0.871-1.362)  .455       
Cover index*  13.7±4.6  14.0±4.5  13.4±4.6  1.031  (0.935-1.136)  .544       
Cusp overlap technique  42 (49.4)  13 (34.2)  29 (61.7)  0.323  (0.132-0.787)  .013  0.331  (0.129-0.852)  .022 
Implantation depth, NCC  6.0±3.7  6.7±3.6  5.4±3.7  1.111  (0.971-1.272)  .126       
Postdilation  33 (38.8)  19 (50.0)  14 (29.8)  2.357  (0.966-5.750)  .059  1.623  (0.613-4.301)  .330 

AVB I°, first degree atrioventricular block in patients with sinus rhythm CD, conduction disturbances; LBBB, left bundle branch block; LVEF, left ventricular ejection fraction; NCC, noncoronary cusp; RBBB, right bundle branch block; STS, Society of Thoracic Surgeons; TAVI, transcatheter aortic valve replacement; THV, transcatheter heart valve.

Values are expressed as mean±standard deviation or No. (%).

*

Cover index was defined as 100 x ([prosthesis diameter – annulus diameter]/prosthesis diameter).

DISCUSSION

The present study specifically assessed the safety and efficacy of the COT during TAVI with the self-expanding intra-annular Portico FlexNav system. The main findings of the study can be summarized as follows: a) use of the COT was feasible, with high technical success and low rates of major complications, similar to those achieved with the conventional coplanar 3-cusp view, b) COT use resulted in a higher implantation depth, and c) COT use was independently associated with lower rates of new-onset CD.

The COT has been proposed for deployment of self-expanding valves to enable higher device implantation and reduce postprocedural CD. The rationale behind this fluoroscopic projection, which isolates the most inferior hinge point of the noncoronary cusp in a right anterior oblique/caudal view, relies on the fact that annular contact with self-expanding valves occurs mainly from the noncoronary cusp toward the left coronary cusp.8 The potential advantages of this approach are elimination of the delivery system parallax, elongation of the left ventricular outflow tract and shorter visual distance of the aortic annulus (minor axis), enabling a more precise assessment of the real implantation depth, with the potential to minimize the risk of injury to the conduction system.9 The majority of experiences reported so far with this approach have been performed with the supra-annular Evolut valve (Medtronic, United States). In a propensity score analysis of 444 patients treated with Evolut, use of the COT (compared with the classic implantation technique) reduced the rate of PPI (11.8% vs 21.7%; P=.03) without compromising TAVI outcomes.10 In the largest series of consecutive patients undergoing Evolut TAVI using COT (n=694), Gada et al.11 demonstrated a very low risk of PPI (< 5%) with this technique, with a low rate of major cardiac adverse events.

To date, there have been scarce data on the COT with the Portico valve. In a retrospective study analyzing the impact of the COT with different self-expanding valves, Mendiz et al.12 included 19 patients treated with Portico. Overall and in line with prior studies, COT reduced the rate of CD without compromising safety outcomes.

Our results also support the use of the COT with the Portico FlexNav system as a safe strategy, with comparable success rates and similar rates of major complications. Indeed, using this approach resulted in higher valve implantation and subsequent reduction in the rates of conduction abnormalities after TAVI, without increased risk of valve embolization or compromise of valve hemodynamics. Interestingly, incorporation of this modified working projection may reduce radiation exposure (lower fluoroscopy time), by providing a more precise visualization of the implant depth and accurate device placement, although it did not translate into a reduction of the overall length of the procedure.

In the present work, COT was barely used in valve-in-valve procedures (figure 1 of the supplementary data). Albeit less frequent, this method can also be used to treat degenerated surgical valves, since surgical prostheses are directly aligned with native aortic valve commissures and consequently the postsurgical anatomy usually matches the native anatomy. Akin to TAVI in native valves, the cusp overlap view can be obtained by isolating the bioprosthetic stent post between the left and right coronary cusps based on preprocedural computed tomography, as recently reported by Wong et al.13

Of note, residual transvalvular gradients were lower in the COT group, which may be explained by a higher positioning of the leaflets leading to more favorable hemodynamics, although this finding should be interpreted as hypothesis-generating only.

Importantly, patients in the COT group had significantly lower rates of conduction abnormalities, similarly to previous reports with other self-expanding valves. The need for PPI in the standard 3-cusp group was roughly twice that in the COT group (30% vs 14%; P=.078) although this difference was not statistically significant probably due to the limited sample size. The difference was much more noticeable when we excluded patients with pre-existing right bundle branch block (31.0% vs 7.7%; P=.011), who are at the highest risk of PPI regardless of the type of valve and implantation technique.

Finally, postdilation was associated with increased new-onset CD post-TAVI on univariate but not on multivariate analysis. Whereas valvuloplasty may increase the risk of conduction abnormalities after TAVI due to the mechanical trauma to the conduction system, no clear association has yet been identified between postdilation and new PPI.14

Limitations

This study has the limitations inherent to an observational retrospective study without an external adjudication event committee and a limited sample size. Implant depth was assessed by experienced, but not blinded operators, and could therefore be subject to bias. Postprocedural cardiac computed tomography was not systematically performed, so implantation depth was mainly assessed by angiography and the degree of neocommissural alignment could not be analyzed. Finally, because of the time frame of the study (and to minimize the factors that may influence the accuracy of valve placement at the desired annular position other than the implantation technique), it included only patients who received the Portico valve with the FlexNav delivery system, rather than the newer-generation Navitor valve that became commercially available in Spain in July 2021, which may limit generalizability of the findings. The newest best practice recommendations for Navitor valve implantation have incorporated the COT and clinical outcomes with the new device will be evaluated in the near future.

CONCLUSIONS

Application of the COT during implantation of the Portico FlexNav system is feasible and may help to achieve higher implantation depth and lower subsequent rates of new-onset CD without compromising safety outcomes or valve performance.

FUNDING

None.

AUTHORS’ CONTRIBUTIONS

L. Asmarats, L. Nombela-Franco, A. Regueiro and D. Arzamendi conceived and designed the analysis. L. Gutierrez-Alonso, G. Tirado-Conte, P. Cepas and E. Fernández-Peregrina collected the data. L. Asmarats and X. Millán performed the analysis. CH. Li, P. Jiménez-Quevedo and X. Freixa reviewed and edited the manuscript.

CONFLICTS OF INTEREST

L. Asmarats, L. Nombela-Franco, X. Millán, CH. Li, X. Freixa and D. Arzamendi are proctors for Abbott. A. Regueiro is proctor for Abbott and Meril Life. The other authors report no conflicts.

WHAT IS KNOWN ABOUT THE TOPIC?

  • Conduction disturbances remain the most common complication of TAVI.

  • The COT has been proposed to reduce conduction disturbances after TAVI with self-expanding supra-annular valves (mainly Evolut). However, scarce data exist on the safety and potential benefits of this new implant strategy with intra-annular devices.

WHAT DOES THIS STUDY ADD?

  • This study specifically assessed the safety and efficacy of the COT during TAVI with the self-expanding intra-annular Portico FlexNav system.

  • Use of the COT during Portico implantation is feasible and facilitates a higher valve implant, which in turn may help to reduce the rates of new-onset CD.

APPENDIX. SUPPLEMENTARY DATA

Supplementary data associated with this article can be found in the online version, at https://doi.org/10.1016/j.rec.2023.02.003

References
[1]
A. Vahanian, F. Beyersdorf, F. Praz, et al.
2021 ESC/EACTS Guidelines for the management of valvular heart disease.
Eur Heart J., 43 (2022), pp. 561-632
[2]
J. Rodes-Cabau, K.A. Ellenbogen, A.D. Krahn, et al.
Management of Conduction Disturbances Associated With Transcatheter Aortic Valve Replacement: JACC Scientific Expert Panel.
J Am Coll Cardiol., 74 (2019), pp. 1086-1106
[3]
P.M. Doldi, L. Stolz, F. Escher, J. Steffen, et al.
Transcatheter Aortic Valve Replacement with the Self-Expandable Core Valve Evolut Prosthesis Using the Cusp-Overlap vs Tricusp-View.
J Clin Med., 11 (2022), pp. 1561
[4]
Y. Chen, G. Zhu, X. Liu, et al.
Comparison of cusp-overlap projection and standard three-cusp coplanar view during self-expanding transcatheter aortic valve replacement: A systematic review and meta-analysis.
Front Cardiovasc Med., 9 (2022), pp. 927642
[5]
L. Sondergaard, J. Rodes-Cabau, A. Hans-Peter Linke, et al.
Transcatheter Aortic Valve Replacement With a Repositionable Self-Expanding Prosthesis: The PORTICO-I Trial 1-Year Outcomes.
J Am Coll Cardiol., 72 (2018), pp. 2859-2867
[6]
G.P. Fontana, F. Bedogni, M. Groh, et al.
Safety Profile of an Intra-Annular Self-Expanding Transcatheter Aortic Valve and Next-Generation Low-Profile Delivery System.
JACC Cardiovasc Interv., 13 (2020), pp. 2467-2478
[7]
C. Varc-3 Writing, P. Genereux, N. Piazza, et al.
Valve Academic Research Consortium 3: Updated Endpoint Definitions for Aortic Valve Clinical Research.
J Am Coll Cardiol., 77 (2021), pp. 2717-2746
[8]
A. Sengupta, S.L. Alexis, T. Lee, et al.
Cusp Overlap Technique: Should It Become the Standard Implantation Technique for Self-expanding Valves?.
Curr Cardiol Rep., 23 (2021), pp. 154
[9]
G.H.L. Tang, S. Zaid, I. Michev, et al.
Cusp-Overlap” View Simplifies Fluoroscopy-Guided Implantation of Self-Expanding Valve in Transcatheter Aortic Valve Replacement.
JACC Cardiovasc Interv., 11 (2018), pp. 1663-1665
[10]
I. Pascual, D. Hernandez-Vaquero, A. Alperi, et al.
Permanent Pacemaker Reduction Using Cusp-Overlapping Projection in TAVI: A Propensity Score Analysis.
JACC Cardiovasc Interv., 15 (2022), pp. 150-161
[11]
A. Aladham, H. Gada, Y. Wang, et al.
Incidence of Permanent Pacemaker Implantation Using the Cusp Overlap Technique: A Large Single-Center Analysis.
JACC Cardiovasc Interv., 15 (2022), pp. 1006-1008
[12]
O.A. Mendiz, M. Noc, C.M. Fava, et al.
Impact of Cusp-Overlap View for TAVI with Self-Expandable Valves on 30-Day Conduction Disturbances.
J Interv Cardiol., 2021 (2021), pp. 9991528
[13]
I. Wong, G. Bieliauskas, O. De Backer, L. Sondergaard.
Cusp overlap technique during valve-in-valve TAVI using the novel Navitor transcatheter heart valve.
EuroIntervention., 17 (2022), pp. 1298-1299
[14]
L. Nombela-Franco, J. Rodes-Cabau, R. DeLarochelliere, et al.
Predictive factors, efficacy, and safety of balloon post-dilation after transcatheter aortic valve implantation with a balloon-expandable valve.
JACC Cardiovasc Interv., 5 (2012), pp. 499-512
Idiomas
Revista Española de Cardiología (English Edition)

Subscribe to our newsletter

View newsletter history
Article options
Tools
Supplemental materials
es en

¿Es usted profesional sanitario apto para prescribir o dispensar medicamentos?

Are you a health professional able to prescribe or dispense drugs?