Scientific letter
Start-up of the program of transcatheter aortic valve implantation using a balloon-expandable Edwards Sapien XT transcatheter heart valve. Description of the first case in Mexico
Puesta en marcha del programa de implantación transcatéter de válvula aórtica empleando la válvula expandible por balón Edwards Sapien XT. Informe del primer caso en México
Guering Eid-Lidta,
, Jorge Gaspara, Antonio Ariasb, Samuel Ramírezc, Félix Damasa, Valentín Herrerac, Javier Molinad, Joseph Rodés-Cabaue
Corresponding author
eidguering@yahoo.com
Corresponding author at: Juan Badiano 1, Tlalpan, CP 14080, Mexico City, Mexico. Tel.: +52 55 55732911x1235\1236.
Corresponding author at: Juan Badiano 1, Tlalpan, CP 14080, Mexico City, Mexico. Tel.: +52 55 55732911x1235\1236.
a Department of Interventional Cardiology, Instituto Nacional de Cardiología Ignacio Chávez, Mexico City, Mexico
b Department of Echocardiography, Instituto Nacional de Cardiología Ignacio Chávez, Mexico City, Mexico
c Department of Cardiothoracic Surgery, Instituto Nacional de Cardiología Ignacio Chávez, Mexico City, Mexico
d Department of Cardiovascular Anesthesiology, Instituto Nacional de Cardiología Ignacio Chávez, Mexico City, Mexico
e Quebec Heart Institute and Lung Institute, Laval University, Quebec City, Quebec, Canada
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Tel.: +52 55 55732911x1235\1236." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Puesta en marcha del programa de implantación transcatéter de válvula aórtica empleando la válvula expandible por balón Edwards Sapien XT. Informe del primer caso en México" ] ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:7 [ "identificador" => "fig0005" "etiqueta" => "Figure 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 1290 "Ancho" => 1291 "Tamanyo" => 196665 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Transcatheter aortic valve implantation.</p>" ] ] ] "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">Degenerative aortic valve stenosis (AS) is the most common valvular heart disease. About two-thirds of all valve operations are for aortic valve replacement (AVR). After onset of symptoms (angina, syncope or heart failure) severe aortic stenosis has a poor prognosis with an average survival of two or three years and a high risk of sudden death.<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> According to the ACC/AHA and the European Society of Cardiology/European Association for Cardio-Thoracic Surgery Guidelines for management of patients with heart valve disease, surgical aortic valve replacement is an indication class I in symptomatic patients with AS, and for patients with severe AS undergoing CABG or surgery of the aorta or other heart valves, and patients with severe AS and LV systolic dysfunction (ejection fraction<span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>50%).<a class="elsevierStyleCrossRefs" href="#bib0005"><span class="elsevierStyleSup">1,2</span></a> It is generally accepted that surgical AVR can improve the functional class and prolong survival. Nevertheless, 30% of elderly patients with symptomatic severe aortic valve stenosis do not undergo AVR, attributed to “inoperable” conditions or extremely high surgical risk, such as advanced age, pulmonary, renal, hepatic disease, prior cerebrovascular event, weakness or frailty, that increases the risk of poor outcomes.<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a> Recently, transcatheter aortic valve implantation (TAVI) has become a treatment option for patients with high or prohibitive surgical risk. The concept of transcatheter valve implantation was evaluated by Andersen in 1992 in a porcine model.<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a> In 2002 the first TAVI was accomplished by Dr. Alan Cribier, via a transeptal antegrade delivery technique using a balloon-expandable aortic valve.<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a> After this pioneering procedure, several registries and one multicenter randomized control trial have been published worldwide (<a class="elsevierStyleCrossRef" href="#fig0005">Fig. 1</a>).<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a> We describe the first case of TAVI performed in Mexico using a balloon-expandable Edwards Sapien XT transcatheter heart valve, which means the beginning of the program of TAVI with this kind of valve in our institution.</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0010" class="elsevierStylePara elsevierViewall">A 77-year-old woman with severe symptomatic aortic stenosis was referred to our hospital for treatment. She was in NYHA functional class II, with a background of systemic arterial hypertension, hyperuricemia, cervical spine surgery, lumbar spine trauma treated with surgical fixation, fibromyalgia, chronic deep venous insufficiency, and chronic renal failure with a creatinine level of 2.0<span class="elsevierStyleHsp" style=""></span>mg/dL. Furthermore, six months ago, she was diagnosed with a sick sinus syndrome (bradycardia-tachycardia syndrome), and underwent permanent pacemaker implantation.</p><p id="par0015" class="elsevierStylePara elsevierViewall">Transesophageal echocardiography (TEE) demonstrated a severe degenerative aortic stenosis with a left ventricular ejection fraction of 40%. The mean aortic pressure gradient was 40<span class="elsevierStyleHsp" style=""></span>mmHg and the calculated aortic valve area was 0.4<span class="elsevierStyleHsp" style=""></span>cm<span class="elsevierStyleSup">2</span>, which was corroborated with TEE planimetry. The screening showed no significant coronary artery stenosis and mildly calcified aortic annulus diameter of 24.6<span class="elsevierStyleHsp" style=""></span>mm. CT angiography demonstrated a suitable anatomy for a transfemoral approach having moderate aortic tortuosity and mildly calcified femoroiliac arteries with a diameter >6.5<span class="elsevierStyleHsp" style=""></span>mm. She was considered at high risk for surgical treatment by the heart team due to frailty, thoracic deformity (hostile chest), Logistic EuroScore of 15%, and severe comorbidities.</p><p id="par0020" class="elsevierStylePara elsevierViewall">On February 5, 2013, the TAVI procedure was performed using transfemoral approach with surgical back-up under general anesthesia and TEE guidance in a standard catheterization laboratory (<a class="elsevierStyleCrossRef" href="#fig0010">Fig. 2</a>). We punctured the left femoral artery and vein and inserted a 6<span class="elsevierStyleHsp" style=""></span>Fr pigtail in the ascending aorta and a 6<span class="elsevierStyleHsp" style=""></span>Fr temporary pacing wire in the right ventricle. Intravenous antibiotics and heparin were administrated as per protocol. The right femoral artery was surgically exposed, punctured and a Novaflex<span class="elsevierStyleSup">®</span> plus delivery system was deployed. Initial angiography confirmed the optimum view with the alignment of the three aortic leaflets. The aortic valve was crossed with a hydrophilic wire with the support of a 5<span class="elsevierStyleHsp" style=""></span>Fr Amplatz left one catheter and was subsequently exchanged for a previously preformed an Amplatz super stiff guidewire (Boston Scientific, MA). Predilatation of the aortic valve was done with a 20<span class="elsevierStyleHsp" style=""></span>mm Edwards balloon catheter (Edwards Lifesciences, Irvine, CA, USA) and rapid ventricular pacing. After predilatation a 26<span class="elsevierStyleHsp" style=""></span>mm Edwards Sapien XT prosthesis (Edwards Lifesciences, Irvine, CA, USA) was brought into its position by using a dynamic expansion mechanism of the delivery system, and was successfully implanted. The control aortography and TEE demonstrated a well positioned aortic valve prosthesis with a mild perivalvular leak. The patient remained hemodynamically stable throughout the procedure and was taken to the cardiac surgery intensive care unit extubated and in stable condition. TEE performed after the procedure revealed a mean pressure gradient of 5<span class="elsevierStyleHsp" style=""></span>mmHg, and adequate left ventricular function. After two days in the critical care unit, she was discharged from the hospital three days later. At two months of follow-up the patient persisted without of any cardiovascular event and in NYHA class I. Transthoracic echocardiography confirmed an aortic valve area of 1.7<span class="elsevierStyleHsp" style=""></span>cm<span class="elsevierStyleSup">2</span>, with a mean pressure gradient of 5<span class="elsevierStyleHsp" style=""></span>mmHg.</p><elsevierMultimedia ident="fig0010"></elsevierMultimedia><p id="par0025" class="elsevierStylePara elsevierViewall">TAVI has emerged as a highly effective procedure for aortic valve stenosis in patients with high surgical risk or “inoperable” state.<a class="elsevierStyleCrossRefs" href="#bib0035"><span class="elsevierStyleSup">7–10</span></a> Until now, two different TAVI systems are widely used, the balloon-expandable Edwards Sapien transcatheter heart valve (Edwards Lifesciences, Irvine, CA, USA) and the self-expandable Medtronic CoreValve (Medtronic, Minneapolis, MN, USA).<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a> After the innovative procedure of Dr. Cribier, several registries and one randomized trial have demonstrated that TAVI is feasible and safe for patients with severe aortic valve stenosis and high or prohibitive surgical risk.<a class="elsevierStyleCrossRefs" href="#bib0030"><span class="elsevierStyleSup">6–10</span></a></p><p id="par0030" class="elsevierStylePara elsevierViewall">Several series and registries have reported a technical success of 95% and 30-day survival over 90%, using a balloon-expandable Edwards Sapien transcatheter heart valve (Edwards Lifesciences, Irvine, CA, USA).<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a></p><p id="par0035" class="elsevierStylePara elsevierViewall">According to the study PARTNER trial (Placement of AoRTic TraNscathetER valves Trial), which is the only randomized trial, global mortality at one year of follow-up on inoperable patients was higher in the group that received standard treatment as compared with TAVI (50.7% vs. 30.7%, <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>0.001). Major stroke and vascular complications rates were higher in the TAVI group at 30-day.<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">7</span></a> Overall mortality was significantly reduced at two years with TAVI (43.3% vs. 68.0%, <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>0.001). During the two years of follow-up, 83.1% with TAVI were in functional class NYHA I–II compared with 42.5% of standard treatment.<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">8</span></a></p><p id="par0040" class="elsevierStylePara elsevierViewall">In high-risk patients, the PARTNER trial reported an early mortality of 3.4% with TAVI and 6.5% with surgery (<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>0.07). Vascular complications were higher in the TAVI group and major bleeding and new-onset atrial fibrillation in the surgical group.<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">9</span></a> Two-year mortality was similar between the groups (33.9% TAVI vs. 35.0% surgery, <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>0.78). The high risk of stroke with TAVI in the early phase was reduced over time. However, the association of paravalvular regurgitation with increased late mortality was documented.<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a></p><p id="par0045" class="elsevierStylePara elsevierViewall">TAVI has proven to improve symptoms, reduce valvular gradient, and the death rate in inoperable patients. In selected patients at high surgical risk, TAVI is an alternative to surgery.</p><p id="par0050" class="elsevierStylePara elsevierViewall">We are sure that the refinement of the technique and technological development will reduce the complications related with this procedure.</p><p id="par0055" class="elsevierStylePara elsevierViewall">TAVI has emerged as a real alternative for patients with high surgical risk or unsuitable for surgery. We reported the first case in Mexico of this relative new technique using a balloon-expandable Edwards Sapien XT transcatheter heart valve, which is widely used in highly qualified centers only.</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Financing</span><p id="par0060" class="elsevierStylePara elsevierViewall">No type of support was received to perform this article.</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Conflicts of interest</span><p id="par0065" class="elsevierStylePara elsevierViewall">The authors declare having no conflicts of interest.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:3 [ 0 => array:2 [ "identificador" => "sec0005" "titulo" => "Financing" ] 1 => array:2 [ "identificador" => "sec0010" "titulo" => "Conflicts of interest" ] 2 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "multimedia" => array:2 [ 0 => array:7 [ "identificador" => "fig0005" "etiqueta" => "Figure 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 1290 "Ancho" => 1291 "Tamanyo" => 196665 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Transcatheter aortic valve implantation.</p>" ] ] 1 => array:7 [ "identificador" => "fig0010" "etiqueta" => "Figure 2" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr2.jpeg" "Alto" => 1714 "Ancho" => 1650 "Tamanyo" => 267637 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Echocardiography guidance.</p>" ] ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:10 [ 0 => array:3 [ "identificador" => "bib0005" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Focused update incorporated into the ACC/AHA 2006 Guidelines for the Management of Patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 1998 Guidelines for the Management of Patients with valvular heart disease). 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| Year/Month | Html | Total | |
|---|---|---|---|
| 2024 November | 2 | 0 | 2 |
| 2024 October | 12 | 8 | 20 |
| 2024 September | 20 | 6 | 26 |
| 2024 August | 16 | 3 | 19 |
| 2024 July | 20 | 6 | 26 |
| 2024 June | 20 | 4 | 24 |
| 2024 May | 29 | 4 | 33 |
| 2024 April | 29 | 2 | 31 |
| 2024 March | 28 | 4 | 32 |
| 2024 February | 23 | 6 | 29 |
| 2024 January | 15 | 3 | 18 |
| 2023 December | 38 | 3 | 41 |
| 2023 November | 33 | 2 | 35 |
| 2023 October | 33 | 12 | 45 |
| 2023 September | 27 | 2 | 29 |
| 2023 August | 18 | 3 | 21 |
| 2023 July | 30 | 3 | 33 |
| 2023 June | 50 | 1 | 51 |
| 2023 May | 76 | 11 | 87 |
| 2023 April | 54 | 3 | 57 |
| 2023 March | 51 | 0 | 51 |
| 2023 February | 36 | 6 | 42 |
| 2023 January | 31 | 4 | 35 |
| 2022 December | 38 | 6 | 44 |
| 2022 November | 44 | 5 | 49 |
| 2022 October | 44 | 8 | 52 |
| 2022 September | 42 | 7 | 49 |
| 2022 August | 48 | 8 | 56 |
| 2022 July | 38 | 8 | 46 |
| 2022 June | 22 | 8 | 30 |
| 2022 May | 29 | 3 | 32 |
| 2022 April | 35 | 13 | 48 |
| 2022 March | 68 | 7 | 75 |
| 2022 February | 36 | 7 | 43 |
| 2022 January | 56 | 7 | 63 |
| 2021 December | 54 | 10 | 64 |
| 2021 November | 38 | 12 | 50 |
| 2021 October | 41 | 8 | 49 |
| 2021 September | 33 | 8 | 41 |
| 2021 August | 33 | 6 | 39 |
| 2021 July | 24 | 9 | 33 |
| 2021 June | 19 | 5 | 24 |
| 2021 May | 32 | 7 | 39 |
| 2021 April | 99 | 13 | 112 |
| 2021 March | 45 | 3 | 48 |
| 2021 February | 33 | 6 | 39 |
| 2021 January | 32 | 13 | 45 |
| 2020 December | 24 | 11 | 35 |
| 2020 November | 25 | 7 | 32 |
| 2020 October | 38 | 6 | 44 |
| 2020 September | 21 | 10 | 31 |
| 2020 August | 34 | 7 | 41 |
| 2020 July | 16 | 8 | 24 |
| 2020 June | 23 | 3 | 26 |
| 2020 May | 26 | 6 | 32 |
| 2020 April | 18 | 3 | 21 |
| 2020 March | 30 | 4 | 34 |
| 2020 February | 17 | 3 | 20 |
| 2020 January | 14 | 3 | 17 |
| 2019 December | 25 | 4 | 29 |
| 2019 November | 11 | 10 | 21 |
| 2019 October | 21 | 2 | 23 |
| 2019 September | 15 | 6 | 21 |
| 2019 August | 19 | 2 | 21 |
| 2019 July | 43 | 10 | 53 |
| 2019 June | 50 | 18 | 68 |
| 2019 May | 128 | 59 | 187 |
| 2019 April | 72 | 31 | 103 |
| 2019 March | 13 | 6 | 19 |
| 2019 February | 28 | 3 | 31 |
| 2019 January | 12 | 7 | 19 |
| 2018 December | 24 | 7 | 31 |
| 2018 November | 23 | 10 | 33 |
| 2018 October | 29 | 19 | 48 |
| 2018 September | 15 | 5 | 20 |
| 2018 August | 7 | 4 | 11 |
| 2018 July | 6 | 9 | 15 |
| 2018 June | 12 | 2 | 14 |
| 2018 May | 9 | 2 | 11 |
| 2018 April | 9 | 0 | 9 |
| 2018 March | 3 | 0 | 3 |
| 2018 February | 5 | 0 | 5 |
| 2018 January | 12 | 0 | 12 |
| 2017 December | 5 | 1 | 6 |
| 2017 November | 9 | 1 | 10 |
| 2017 October | 8 | 1 | 9 |
| 2017 September | 10 | 1 | 11 |
| 2017 August | 15 | 4 | 19 |
| 2017 July | 15 | 1 | 16 |
| 2017 June | 31 | 2 | 33 |
| 2017 May | 30 | 7 | 37 |
| 2017 April | 24 | 6 | 30 |
| 2017 March | 31 | 54 | 85 |
| 2017 February | 21 | 4 | 25 |
| 2017 January | 25 | 2 | 27 |
| 2016 December | 36 | 5 | 41 |
| 2016 November | 24 | 3 | 27 |
| 2016 October | 32 | 6 | 38 |
| 2016 September | 65 | 11 | 76 |
| 2016 August | 40 | 9 | 49 |
| 2016 July | 17 | 4 | 21 |
| 2016 June | 25 | 4 | 29 |
| 2016 May | 30 | 6 | 36 |
| 2016 April | 16 | 7 | 23 |
| 2016 March | 20 | 10 | 30 |
| 2016 February | 28 | 17 | 45 |
| 2016 January | 26 | 17 | 43 |
| 2015 December | 22 | 19 | 41 |
| 2015 November | 26 | 16 | 42 |
| 2015 October | 27 | 10 | 37 |
| 2015 September | 23 | 3 | 26 |
| 2015 August | 14 | 3 | 17 |
| 2015 July | 7 | 2 | 9 |
| 2015 June | 11 | 14 | 25 |
| 2015 May | 16 | 16 | 32 |
| 2015 April | 17 | 16 | 33 |
| 2015 March | 24 | 7 | 31 |
| 2015 February | 9 | 3 | 12 |
| 2015 January | 41 | 4 | 45 |
| 2014 December | 27 | 12 | 39 |
| 2014 November | 28 | 11 | 39 |
| 2014 October | 38 | 17 | 55 |
| 2014 September | 52 | 18 | 70 |
| 2014 August | 47 | 14 | 61 |
| 2014 July | 26 | 25 | 51 |
| 2014 June | 12 | 6 | 18 |
Show all