Publish in this journal
Journal Information
Vol. 72. Issue 11.
Pages 980-982 (November 2019)
Scientific letter
DOI: 10.1016/j.rec.2019.05.008
Full text access
Shockwave Lithoplasty-facilitated Transfemoral Access for Transcatheter Aortic Valve Replacement. An Initial Single-center Experience in Spain
Implante percutáneo de válvula aórtica transfemoral facilitado con Shockwave Lithoplasty. Experiencia inicial en un centro español
Visits
...
Diego López Oteroa,b,c,
Corresponding author
birihh@yahoo.es

Corresponding author:
, Xoan Carlos Sanmartín Penaa,b,c, Ramiro Trillo Nouchea,b,c, Belén Cid Álvareza,b,c, Pablo Antúnez Muiñosa,b, José Ramón Gonzalez Juanateya,b,c
a Servicio de Cardiología, Complexo Hospitalario Universitario de Santiago de Compostela, Santiago de Compostela, A Coruña, Spain
b Instituto de Investigación Sanitaria (IDICHUS), Santiago de Compostela, A Coruña, Spain
c Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Santiago de Compostela, A Coruña, Spain
This item has received
...
Visits
(Daily data update)
Article information
Full Text
Bibliography
Download PDF
Statistics
Figures (1)
Tables (1)
Table 1. Baseline characteristics of the patients and the procedure
Full Text
To the Editor,

Lithoplasty has been demonstrated to be safe and effective in the treatment of moderately or severely calcified lesions of the femoropopliteal arteries, including chronic occlusions.1 Results have shown a significant reduction in stenosis, with a low need for stent implantation or revascularization at follow-up. More recently, experiences with lithoplasty have been published, with good outcomes for the treatment of calcified coronary lesions.2

There is little experience with the use of lithoplasty on peripheral vessels to allow facilitated transfemoral access in transcatheter aortic valve implantation.3 Evidence on its efficacy in this context would likely increase the percentage of patients treated via the transfemoral route—an important point given that this has been demonstrated to have a lower mortality rate and better outcomes than other access routes.4

We present our initial experience with 4 patients—which to the best of our knowledge is the largest series described so far—with severe, highly-calcified lesions in both iliac vessels, who underwent lithoplasty with the Shockwave Lithoplasty system (Shockwave Medical Inc).

The Shockwave Lithoplasty balloon (Figure 1A) is a system that allows treatment of calcified stenotic lesions in peripheral arteries using the emission of sonic pressure waves that generate high mechanical energy. This energy cracks the superficial and deep calcium in the vessel with minimal impact on healthy tissue. The end objective is to convert the calcified plaque from a rigid, undilatable plaque to a more distensible plaque through which materials can be passed, minimizing trauma to the vessel compared with conventional balloon angioplasty.

Figure 1.

A: Shockwave Lithoplasty system. B and C: computed tomography images showing extensive calcification of the common iliac artery and the origin of the right external iliac artery, as well as the common femoral artery, which also had severe lesions in all segments with a minimum lumen diameter of 5.3×2.4mm. D: extensive calcification observed on fluoroscopy. E: lithoplasty balloon inflated to 7×60mm, over a 330cm Asahi RG3 0.014-inch guidewire. F: advancing a CoreValve Evolute Pro 29mm prosthesis across the calcified lesion. G: final condition of the artery after finishing the procedure; the fracture produced in the calcium can be seen without images of associated dissection.

(0.49MB).

The device consists of a small control panel that contains the pulse generator and a small monitor where the pulses delivered are counted. The control panel is attached to a cable, which at the distal end has a button that activates and deactivates the delivery of pulses as required. This cable in turn connects to the lithoplasty balloon catheter. It is a semicompliant balloon, with an over-the-wire design, which contains 6 miniature sonic wave emitters. It is compatible with 6 or 7-Fr introducer sheaths (6.5 or 7mm balloons) and is mounted on a 0.014 inch guidewire. It is currently available in sizes from 3.5mm to 7mm, all of which have a balloon length of 60mm and total catheter length of 110mm. Each catheter can be used to deliver up to 10 cycles of 30 pulses (total 300 pulses per balloon). Once the desired position is achieved, to deliver the sonic waves, the balloon is first inflated to 4atm, 30 pulses are delivered, and then the pressure is increased to 6atm (nominal value); the burst pressure is 10atm. Since the energy propagation that leads to the calcium fragmentation is transmitted when the balloon comes into contact with the intima of the vessel, it is important to choose a balloon with a 1:1 ratio with the artery diameter to achieve good apposition between the balloon and the calcium of the lesion when the balloon is inflated to 4atm (2atm lower than the nominal value).

Table 1 shows the baseline characteristics of the patients and the procedure. Most patients were male with medium or high surgical risk, and previously undiagnosed peripheral arterial disease. All of the procedures were performed under conscious sedation, and in all bar one, radial access was chosen as secondary access, given the contralateral femoral disease. In most cases, the balloon length (60mm) covered the area to be treated and it was not necessary in any of the patients to use all of the 300 available pulses to achieve the desired result. There were no device-related complications.

Table 1.

Baseline characteristics of the patients and the procedure

  Patient 1  Patient 2  Patient 3  Patient 4 
General information
Age, y  86  83  84  84 
Sex  Male  Male  Female  Male 
BMI  25  34  29  26 
DM  No  No  No  No 
Dyslipidemia  No  Yes  Yes  Yes 
HTN  Yes  Yes  Yes  Yes 
AF  Yes  Yes  No  No 
Peripheral arterial disease  Yes  Yes  Yes  No 
Previous stroke  No  Yes  No  No 
Previous CHD  No  Yes  No  No 
COPD  No  No  No  No 
EuroSCORE II  5.4  3.2  3.5  8.8 
STS score  4.1  2.2  2.2  3.2 
Hemoglobin, g/dL  11.8  12.5  13.5  13.6 
Hematocrit, %  37.2  37.5  39.6  38.4 
Glomerular filtration rate  28.8  90.5  81.3  36.7 
Procedure
Anesthesia  CS  CS  CS  CS 
Primary access  LFA  LFA  LFA  RFA 
Calcification  Severe  Severe  Severe  Severe 
Tortuosity  Mild  Mild  Mild  Mild 
MLD, mm  5.3×2.4  4.4×4.8  4.3×6.4  4.5×5.1 
Secondary access  LRA  RRA  RFA  LRA 
Aortic valve prosthesis  Evolute R 34  Accurate M  Evolute Pro 26  Evolute R 34 
Introducer sheath  iSleeve (14-Fr)  iSleeve (14-Fr)  DrySeal (16-Fr)  DrySeal (16-Fr) 
Lithoplasty balloon, mm 
Length treated, mm  60  60  60  90 
Number of pulses  150  90  90  120 
VC associated with the device  No  No  No  No 
Implant successful  Yes  Yes  Yes  Yes 

AF, atrial fibrillation; BMI, body mass index; CHD, coronary heart disease; COPD, chronic obstructive pulmonary disease; CS, conscious sedation; DM, diabetes mellitus; HTN, hypertension; LFA, left femoral artery; LRA, left radial artery; MLD, minimum lumen diameter; RFA, right femoral artery; RRA, right radial artery; STS: Society of Thoracic Surgeons; VC, vascular complication.

Figure 1 is taken from one patient. It shows computed tomography images of the iliofemoral vascular section prior to implantation and images from the procedure.

Based on the outcomes observed in our series, we can say that this is a simple, highly reproducible procedure that is effective in the treatment of severe, highly-calcified stenosis, as it allowed transfemoral implantation in all patients. Its usefulness in different types of vascular diseases remain to be determined.

Conflicts Of Interest

R. Trillo Nouche is a proctor for Medtronic.

References
[1]
M. Brodmann, M. Werner, T.J. Brinton, et al.
Safety and performance of lithoplasty for treatment of calcified peripheral artery lesions.
J Am Coll Cardiol., 70 (2017), pp. 908-910
[2]
I. Rodríguez Costoya, H. Tizón Marcos, B. Vaquerizo Montilla, N. Salvatella Giralt, J. Martí Almor, R. Millán Segovia.
Coronary lithoplasty: Initial experience in coronary calcified lesions.
Rev Esp Cardiol., 72 (2019), pp. 788-790
[3]
I. Cruz González, R. González Ferreiro, J. Martín Moreiras, et al.
Facilitated transfemoral access by shockwave lithoplasty for transcatheter aortic valve replacement.
JACC Cardiovasc Interv., 12 (2019), pp. e35-e38
[4]
P. Overtchouk, T. Modine.
Alternate access for TAVI: Stay clear of the chest.
Interv Cardiol., 13 (2018), pp. 145-150
Idiomas
Revista Española de Cardiología (English Edition)

Subscribe to our newsletter

Article options
Tools
es en

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

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

es en
Política de cookies Cookies policy
Utilizamos cookies propias y de terceros para mejorar nuestros servicios y mostrarle publicidad relacionada con sus preferencias mediante el análisis de sus hábitos de navegación. Si continua navegando, consideramos que acepta su uso. Puede cambiar la configuración u obtener más información aquí. To improve our services and products, we use "cookies" (own or third parties authorized) to show advertising related to client preferences through the analyses of navigation customer behavior. Continuing navigation will be considered as acceptance of this use. You can change the settings or obtain more information by clicking here.