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Trailing behind: Limitations on transcatheter aortic valve implantation in Portugal
Na cauda do cometa. Limitações para implantação de válvulas aórticas percutâneas transcatéter em Portugal
Rui Campante Teles
Unidade de Intervenção Cardiovascular, Hospital de Santa Cruz, Centro Hospitalar Lisboa Ocidental, Oeiras, Portugal
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Limitações para implantação de válvulas aórticas percutâneas transcatéter em Portugal" ] ] "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">Transcatheter aortic valve implantation (TAVI) is an unparalleled therapeutic innovation in cardiology. The first valve was developed by Andersen et al. in 1989, but two decades passed before the first randomized trial was performed, in which at 24-month follow-up, there was an absolute reduction in mortality from 51% under medical therapy to 31% with TAVI.<a class="elsevierStyleCrossRefs" href="#bib0005"><span class="elsevierStyleSup">1–4</span></a> Following the first implantation in humans by Cribier et al. in 2002, Webb et al. introduced the retrograde approach in 2005 and Walther et al. the transapical approach in 2006, which sparked a meteoric rise in use of the technique.<a class="elsevierStyleCrossRefs" href="#bib0025"><span class="elsevierStyleSup">5–7</span></a> These developments have reduced 30-day mortality to 6.5–9.7%,<a class="elsevierStyleCrossRefs" href="#bib0040"><span class="elsevierStyleSup">8–10</span></a> and it is still progressing, concomitantly with significant gains in quality of life.<a class="elsevierStyleCrossRefs" href="#bib0055"><span class="elsevierStyleSup">11,12</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">There are considerable differences in Europe in access to TAVI for severe aortic stenosis, particularly in Portugal.<a class="elsevierStyleCrossRefs" href="#bib0065"><span class="elsevierStyleSup">13,14</span></a> The prevalence of aortic stenosis increases with age, and based on an estimated prevalence of 3.4% among the 924<span class="elsevierStyleHsp" style=""></span>000 Portuguese aged over 75, around 32<span class="elsevierStyleHsp" style=""></span>000 will have severe stenosis, of whom 75% (24<span class="elsevierStyleHsp" style=""></span>000) will be symptomatic.<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">15</span></a> Assuming that around 40% of those considered inoperable and 80% of those at high surgical risk are eligible for TAVI, this amounts to 4600 individuals.<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">16</span></a> However, the data for Portugal show that 265 TAVI procedures were performed in the last five years, only 5% of potential candidates.</p><p id="par0015" class="elsevierStylePara elsevierViewall">Portugal has the lowest annual rate of TAVI per million population in the European Union – seven compared to an average of 45. Adoption of the 2012 guidelines of the Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology and the European Association for Cardio-Thoracic Surgery could help bring Portugal more in line with the rest of Europe in the use of this new technique.<a class="elsevierStyleCrossRef" href="#bib0085"><span class="elsevierStyleSup">17</span></a> There are 3 areas in which the guidelines are of particular relevance to aortic stenosis:<ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005"><span class="elsevierStyleLabel">(1)</span><p id="par0020" class="elsevierStylePara elsevierViewall">Screening and diagnosis, which needs to be earlier and more accurate:<ul class="elsevierStyleList" id="lis0010"><li class="elsevierStyleListItem" id="lsti0010"><span class="elsevierStyleLabel">(a)</span><p id="par0025" class="elsevierStylePara elsevierViewall">in terms of primary health care, paying particular attention to symptoms that are extremely common in the elderly, such as exertional dyspnea, asthenia and dizziness;</p></li><li class="elsevierStyleListItem" id="lsti0015"><span class="elsevierStyleLabel">(b)</span><p id="par0030" class="elsevierStylePara elsevierViewall">in terms of echocardiographic assessment, which is hampered in many cases by the lack of Doppler study;</p></li></ul></p></li><li class="elsevierStyleListItem" id="lsti0020"><span class="elsevierStyleLabel">(2)</span><p id="par0035" class="elsevierStylePara elsevierViewall">Appropriate therapeutic indications, favoring surgical or percutaneous valve replacement over medical therapy alone:<ul class="elsevierStyleList" id="lis0015"><li class="elsevierStyleListItem" id="lsti0040"><span class="elsevierStyleLabel">a.</span><p id="par0055" class="elsevierStylePara elsevierViewall">appropriate referral on the part of cardiologists, including of patients with severe aortic stenosis who appear asymptomatic and particularly those with comorbidities that reduce their quality of life and/or prevent referral for surgical valve replacement<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">18</span></a>;</p></li><li class="elsevierStyleListItem" id="lsti0065"><span class="elsevierStyleLabel">b.</span><p id="par0130" class="elsevierStylePara elsevierViewall">on the part of cardiac surgeons, when stratifying the potential benefit of conventional surgery and determining operative risk, which is higher in the elderly and women, and in cases of left ventricular dysfunction, comorbidities, higher functional class, pulmonary hypertension or coronary artery disease, and emergency operation<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">19</span></a>;</p></li><li class="elsevierStyleListItem" id="lsti0070"><span class="elsevierStyleLabel">c.</span><p id="par0135" class="elsevierStylePara elsevierViewall">predictors of risk in TAVI, the subject of much research into anatomical evaluation for selection of vascular access and type of prosthesis, especially of the aortic annulus, which is rarely circular and often deformed by severe calcification.</p></li></ul></p></li><li class="elsevierStyleListItem" id="lsti0075"><span class="elsevierStyleLabel">(3)</span><p id="par0140" class="elsevierStylePara elsevierViewall">Organization and expertise of multidisciplinary teams using the latest technology available within budgetary constraints:<ul class="elsevierStyleList" id="lis0020"><li class="elsevierStyleListItem" id="lsti0045"><span class="elsevierStyleLabel">(a)</span><p id="par0060" class="elsevierStylePara elsevierViewall">establishment of a multidisciplinary ‘heart team’ including cardiologists, cardiac surgeons, imaging specialists, interventional cardiologists, anesthetists, geriatricians, heart and lung specialists, nursing staff and rehabilitation specialists;</p></li><li class="elsevierStyleListItem" id="lsti0050"><span class="elsevierStyleLabel">(b)</span><p id="par0065" class="elsevierStylePara elsevierViewall">patient-centered management on an individual basis, with preference given to conventional surgery but, when appropriate, respecting patients’ wishes for the least invasive approach (the PARTNER trial showed that 8% of patients withdrew their consent for conventional surgery compared to 0.3% in the TAVI group<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a>);</p></li><li class="elsevierStyleListItem" id="lsti0055"><span class="elsevierStyleLabel">(c)</span><p id="par0070" class="elsevierStylePara elsevierViewall">prosthesis characteristics, an area that is developing rapidly within two main types of delivery and release systems (self-expanding and balloon-expandable) and two types of biological material (bovine or porcine pericardium) currently available, in four sizes suitable for annulus diameters of 18–29 mm;</p></li><li class="elsevierStyleListItem" id="lsti0060"><span class="elsevierStyleLabel">(d)</span><p id="par0075" class="elsevierStylePara elsevierViewall">assessment of the economic burden to society through studies of improvements in quality of life and cost-effectiveness.<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">20</span></a></p></li></ul></p></li></ul></p><p id="par0080" class="elsevierStylePara elsevierViewall">The article by Sousa et al. in this issue of the <span class="elsevierStyleItalic">Journal</span> focuses on the penultimate point, concluding that all currently available vascular approaches and three sizes of two types of prosthesis – Medtronic CoreValve and Edwards Sapien – give a significantly wider range of anatomical alternatives, making TAVI an almost universal treatment option.</p><p id="par0085" class="elsevierStylePara elsevierViewall">The study population was a reasonable size, reflecting the experience of the team that began TAVI procedures at the Centro Hospitalar de Vila Nova de Gaia in August 2007, when they performed the first implantation of a self-expanding CoreValve prosthesis via transfemoral access in the Iberian Peninsula.<a class="elsevierStyleCrossRef" href="#bib0105"><span class="elsevierStyleSup">21</span></a></p><p id="par0090" class="elsevierStylePara elsevierViewall">Few anthropometric data are presented to indicate that most patients had small annulus diameters, which is to be expected since the mean height of the Portuguese population is 165.5 cm, shorter than the European Union average of 169.9 cm.<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">16</span></a></p><p id="par0095" class="elsevierStylePara elsevierViewall">The study was retrospective and focused on the data that was most relevant to the study's objectives, using two complementary imaging techniques.</p><p id="par0100" class="elsevierStylePara elsevierViewall">Determining the aortic annulus diameter is essential in procedure planning in order to minimize paravalvular leak,<a class="elsevierStyleCrossRef" href="#bib0110"><span class="elsevierStyleSup">22</span></a> embolization (0.5–8% of cases), annulus rupture (although rare), and need for permanent pacemaker (3–40%), which appears to be more frequent with larger valves.<a class="elsevierStyleCrossRefs" href="#bib0110"><span class="elsevierStyleSup">22–25</span></a> As stated above, the aortic annulus is often oval and much effort has gone into developing software to increase the accuracy of valve area measurements, which is increasingly important in the choice of prosthesis size.<a class="elsevierStyleCrossRefs" href="#bib0130"><span class="elsevierStyleSup">26,27</span></a> Three-dimensional transesophageal echocardiography (3D TEE) has advantages over transthoracic echocardiography and two-dimensional TEE in this respect.<a class="elsevierStyleCrossRef" href="#bib0140"><span class="elsevierStyleSup">28</span></a> Sousa et al. used TEE by preference, although they do not state whether this was performed prior to or during the procedure, nor what proportion of patients underwent 3D TEE. The study did not assess the anatomy of the ascending aorta or the coronary sinuses, the proximity of the coronary arteries to the valve plane, the degree and distribution of aortic and mitral calcification, or left ventricular outflow tract diameter. Although there are no unequivocal exclusion criteria, information on sinus of Valsalva dimensions or severe septal hypertrophy with intraventricular gradient would have been relevant to the study's objectives since it might have excluded implantation of at least one of the types of prosthesis assessed.</p><p id="par0105" class="elsevierStylePara elsevierViewall">The main predictors of major vascular complications, which occur in 4–20% of cases, are the relationship between the caliber of the introducer and the native artery, vessel calcification and operator experience.<a class="elsevierStyleCrossRef" href="#bib0145"><span class="elsevierStyleSup">29</span></a> Sousa et al. assessed femoral artery diameters by multidetector computed tomography but ignore the importance of calcification, which is critical, although the center does have wide experience of this imaging technique.<a class="elsevierStyleCrossRef" href="#bib0150"><span class="elsevierStyleSup">30</span></a> It would be of interest to know what equipment was used and the type and reproducibility of the protocol, together with data on the degree and distribution of calcification, particularly circumferential, and on 3D assessment of aortic and iliofemoral anatomy.</p><p id="par0110" class="elsevierStylePara elsevierViewall">The important point is that there were solutions to cover 98.6% of the patients. The study showed that this was only possible based on a multiple device strategy, since each type of prosthesis could not treat 2.8% and 6.2% of cases, respectively. Moreover, use of multiple approaches significantly extended this treatment option to a further 5.2% of patients.</p><p id="par0115" class="elsevierStylePara elsevierViewall">One remark is that the term “anatomically suitable” slightly overestimates the real number of candidates. Detailed anatomical evaluation for planning the procedure will usually exclude some patients, for example due to vessel tortuosity in a transfemoral approach or the association of calcification and proximity of the coronary arteries in a transapical approach.</p><p id="par0120" class="elsevierStylePara elsevierViewall">Since 98.6% of implantations were with a single type of prosthesis, nothing can be concluded as to the link between anatomical variables and the type of valve and access chosen. It would be interesting to analyze the prognostic implications of these procedure-related variables in terms of adverse events according to the standardized endpoint definitions proposed by the Valvular Academic Research Consortium,<a class="elsevierStyleCrossRef" href="#bib0145"><span class="elsevierStyleSup">29</span></a> in which device success is defined as correct positioning of the device and mean anterograde valve gradient of <20 mmHg, with no moderate or severe prosthetic valve regurgitation, and absence of procedural mortality.<a class="elsevierStyleCrossRef" href="#bib0155"><span class="elsevierStyleSup">31</span></a> Early (30-day) safety criteria are defined as absence of mortality, stroke, life-threatening bleeding, stage 2 or 3 acute renal failure (contrast nephropathy), coronary artery obstruction requiring intervention, major vascular complications, and valve-related dysfunction requiring repeat procedure.</p><p id="par0125" class="elsevierStylePara elsevierViewall">In conclusion, the study by Sousa et al. is original because it shows that anatomy is not a limiting factor with current percutaneous aortic valves if multiple devices and multiple access approaches are considered. The most important factors now governing the treatment of aortic stenosis are screening, diagnosis, comorbidities, multidisciplinary therapeutic management, technological advances and cost. Each represents a challenge that, if overcome, may eventually mean that even patients at low or intermediate surgical risk can be treated by TAVI.</p></span>" "pdfFichero" => "main.pdf" "tienePdf" => true "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as: Campante Teles R. Na cauda do cometa. Limitações para implantação de válvulas aórticas percutâneas transcatéter em Portugal. 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| Year/Month | Html | Total | |
|---|---|---|---|
| 2024 November | 10 | 6 | 16 |
| 2024 October | 41 | 31 | 72 |
| 2024 September | 39 | 21 | 60 |
| 2024 August | 41 | 27 | 68 |
| 2024 July | 44 | 31 | 75 |
| 2024 June | 23 | 16 | 39 |
| 2024 May | 28 | 15 | 43 |
| 2024 April | 31 | 22 | 53 |
| 2024 March | 68 | 22 | 90 |
| 2024 February | 46 | 21 | 67 |
| 2024 January | 28 | 27 | 55 |
| 2023 December | 16 | 26 | 42 |
| 2023 November | 25 | 21 | 46 |
| 2023 October | 19 | 18 | 37 |
| 2023 September | 21 | 18 | 39 |
| 2023 August | 25 | 15 | 40 |
| 2023 July | 17 | 17 | 34 |
| 2023 June | 22 | 13 | 35 |
| 2023 May | 37 | 26 | 63 |
| 2023 April | 20 | 5 | 25 |
| 2023 March | 26 | 26 | 52 |
| 2023 February | 24 | 20 | 44 |
| 2023 January | 20 | 19 | 39 |
| 2022 December | 42 | 19 | 61 |
| 2022 November | 38 | 30 | 68 |
| 2022 October | 23 | 11 | 34 |
| 2022 September | 27 | 44 | 71 |
| 2022 August | 30 | 28 | 58 |
| 2022 July | 25 | 32 | 57 |
| 2022 June | 18 | 20 | 38 |
| 2022 May | 26 | 29 | 55 |
| 2022 April | 27 | 28 | 55 |
| 2022 March | 23 | 24 | 47 |
| 2022 February | 24 | 22 | 46 |
| 2022 January | 20 | 19 | 39 |
| 2021 December | 12 | 27 | 39 |
| 2021 November | 28 | 35 | 63 |
| 2021 October | 26 | 35 | 61 |
| 2021 September | 13 | 24 | 37 |
| 2021 August | 27 | 24 | 51 |
| 2021 July | 16 | 18 | 34 |
| 2021 June | 17 | 27 | 44 |
| 2021 May | 20 | 33 | 53 |
| 2021 April | 25 | 29 | 54 |
| 2021 March | 46 | 17 | 63 |
| 2021 February | 85 | 13 | 98 |
| 2021 January | 25 | 11 | 36 |
| 2020 December | 26 | 5 | 31 |
| 2020 November | 25 | 20 | 45 |
| 2020 October | 19 | 14 | 33 |
| 2020 September | 42 | 9 | 51 |
| 2020 August | 17 | 7 | 24 |
| 2020 July | 32 | 7 | 39 |
| 2020 June | 28 | 4 | 32 |
| 2020 May | 38 | 2 | 40 |
| 2020 April | 31 | 11 | 42 |
| 2020 March | 38 | 5 | 43 |
| 2020 February | 31 | 13 | 44 |
| 2020 January | 27 | 4 | 31 |
| 2019 December | 26 | 3 | 29 |
| 2019 November | 18 | 5 | 23 |
| 2019 October | 32 | 3 | 35 |
| 2019 September | 17 | 7 | 24 |
| 2019 August | 23 | 5 | 28 |
| 2019 July | 44 | 9 | 53 |
| 2019 June | 15 | 6 | 21 |
| 2019 May | 31 | 9 | 40 |
| 2019 April | 13 | 13 | 26 |
| 2019 March | 27 | 10 | 37 |
| 2019 February | 47 | 4 | 51 |
| 2019 January | 24 | 4 | 28 |
| 2018 December | 87 | 11 | 98 |
| 2018 November | 130 | 7 | 137 |
| 2018 October | 269 | 15 | 284 |
| 2018 September | 68 | 9 | 77 |
| 2018 August | 40 | 17 | 57 |
| 2018 July | 28 | 3 | 31 |
| 2018 June | 44 | 6 | 50 |
| 2018 May | 69 | 7 | 76 |
| 2018 April | 74 | 6 | 80 |
| 2018 March | 79 | 5 | 84 |
| 2018 February | 91 | 4 | 95 |
| 2018 January | 74 | 3 | 77 |
| 2017 December | 95 | 4 | 99 |
| 2017 November | 46 | 5 | 51 |
| 2017 October | 29 | 7 | 36 |
| 2017 September | 34 | 13 | 47 |
| 2017 August | 32 | 14 | 46 |
| 2017 July | 26 | 9 | 35 |
| 2017 June | 36 | 7 | 43 |
| 2017 May | 28 | 18 | 46 |
| 2017 April | 19 | 13 | 32 |
| 2017 March | 27 | 8 | 35 |
| 2017 February | 33 | 6 | 39 |
| 2017 January | 20 | 2 | 22 |
| 2016 December | 31 | 9 | 40 |
| 2016 November | 16 | 4 | 20 |
| 2016 October | 27 | 2 | 29 |
| 2016 September | 14 | 5 | 19 |
| 2016 August | 4 | 2 | 6 |
| 2016 July | 5 | 1 | 6 |
| 2016 June | 7 | 3 | 10 |
| 2016 May | 9 | 2 | 11 |
| 2016 April | 28 | 2 | 30 |
| 2016 March | 36 | 6 | 42 |
| 2016 February | 62 | 20 | 82 |
| 2016 January | 54 | 10 | 64 |
| 2015 December | 42 | 9 | 51 |
| 2015 November | 41 | 9 | 50 |
| 2015 October | 39 | 16 | 55 |
| 2015 September | 51 | 11 | 62 |
| 2015 August | 43 | 16 | 59 |
| 2015 July | 46 | 4 | 50 |
| 2015 June | 27 | 2 | 29 |
| 2015 May | 39 | 11 | 50 |
| 2015 April | 38 | 11 | 49 |
| 2015 March | 19 | 6 | 25 |
| 2015 February | 31 | 6 | 37 |
| 2015 January | 34 | 10 | 44 |
| 2014 December | 40 | 14 | 54 |
| 2014 November | 25 | 6 | 31 |
| 2014 October | 36 | 9 | 45 |
| 2014 September | 27 | 6 | 33 |
| 2014 August | 33 | 9 | 42 |
| 2014 July | 28 | 15 | 43 |
| 2014 June | 33 | 2 | 35 |
| 2014 May | 34 | 10 | 44 |
| 2014 April | 37 | 11 | 48 |
| 2014 March | 52 | 13 | 65 |
| 2014 February | 42 | 12 | 54 |
| 2014 January | 56 | 12 | 68 |
| 2013 December | 44 | 9 | 53 |
| 2013 November | 57 | 17 | 74 |
| 2013 October | 44 | 13 | 57 |
| 2013 September | 47 | 16 | 63 |
| 2013 August | 70 | 20 | 90 |
| 2013 July | 82 | 25 | 107 |
| 2013 June | 22 | 7 | 29 |
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