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<article article-type="abstract" dtd-version="1.0" xml:lang="en" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:mml="http://www.w3.org/1998/Math/MathML">
<front>
<journal-meta>
<journal-id journal-id-type="publisher-id">CC</journal-id>
<journal-id journal-id-type="nlm-ta">Cardiol Croat</journal-id>
<journal-title-group>
<journal-title>Cardiologia Croatica</journal-title>
<abbrev-journal-title abbrev-type="pubmed">Cardiol. Croat.</abbrev-journal-title>
</journal-title-group>
<issn pub-type="ppub">1848-543X</issn>
<issn pub-type="epub">1848-5448</issn>
<publisher><publisher-name>Croatian Cardiac Society</publisher-name></publisher>
</journal-meta>
<article-meta>
<article-id pub-id-type="publisher-id">CC 2023 18_11-12_290-1</article-id>
<article-id pub-id-type="doi">10.15836/ccar2023.290</article-id>
<article-categories><subj-group subj-group-type="heading"><subject>Extended Abstract</subject></subj-group>
<subj-group subj-group-type="subheading"><subject>Valvular Heart Disease</subject></subj-group>
</article-categories>
<title-group>
<article-title>Clinical outcomes of percutaneous treatment of access site-related vascular injury after transfemoral transcatheter aortic valve implantation</article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-2308-3518</contrib-id><name><surname>Han&#x017E;ek</surname><given-names>Antonio</given-names></name><xref ref-type="aff" rid="aff1"><sup>1</sup></xref><xref ref-type="corresp" rid="cor1">*</xref></contrib>
<contrib contrib-type="author"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-1762-9270</contrib-id><name><surname>Ostoji&#x0107;</surname><given-names>Zvonimir</given-names></name><xref ref-type="aff" rid="aff1"><sup>1</sup></xref></contrib>
<contrib contrib-type="author"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-4519-5940</contrib-id><name><surname>&#x0160;afradin</surname><given-names>Ivica</given-names></name><xref ref-type="aff" rid="aff1"><sup>1</sup></xref></contrib>
<contrib contrib-type="author"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-2599-553X</contrib-id><name><surname>Jurin</surname><given-names>Hrvoje</given-names></name><xref ref-type="aff" rid="aff1"><sup>1</sup></xref></contrib>
<contrib contrib-type="author"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-4689-1673</contrib-id><name><surname>Kr&#x010D;mar</surname><given-names>Tomislav</given-names></name><xref ref-type="aff" rid="aff1"><sup>1</sup></xref><xref ref-type="aff" rid="aff2"><sup>2</sup></xref></contrib>
<contrib contrib-type="author"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-1482-6503</contrib-id><name><surname>Bulum</surname><given-names>Jo&#x0161;ko</given-names></name><xref ref-type="aff" rid="aff1"><sup>1</sup></xref></contrib>
<aff id="aff1"><label>1</label><institution content-type="dept">University Hospital Centre Zagreb</institution>, <institution>University of Zagreb School of Medicine</institution>, <addr-line>Zagreb</addr-line>, <country country="hr">Croatia</country></aff>
<aff id="aff2"><label>2</label><institution>University of Rijeka</institution>, <institution content-type="dept">Faculty of Medicine</institution>, <addr-line>Rijeka</addr-line>, <country country="hr">Croatia</country></aff>
</contrib-group>
<author-notes>
<corresp id="cor1"><label>*</label>ADDRESS FOR CORRESPONDENCE: Antonio Han&#x017E;ek, Klini&#x010D;ki bolni&#x010D;ki centar Zagreb, Ki&#x0161;pati&#x0107;eva 12, HR-10000 Zagreb, Croatia. / Phone: +385-1-2388-888 / E-mail: <email xlink:href="antoniohanzek0@gmail.com">antoniohanzek0@gmail.com</email></corresp></author-notes>
<pub-date pub-type="epub-ppub"><month>09</month><year>2023</year></pub-date>
<volume>18</volume>
<issue>11-12</issue>
<fpage>290</fpage>
<lpage>291</lpage>
<history>
<date date-type="received"><day>14</day><month>08</month><year>2023</year></date>
<date date-type="accepted"><day>27</day><month>09</month><year>2023</year></date>
</history>
<permissions>
<copyright-statement>Croatian Cardiac Society</copyright-statement>
<copyright-year>2023</copyright-year>
<copyright-holder>Croatian Cardiac Society</copyright-holder>
</permissions>
<kwd-group kwd-group-type="author"><title>KEYWORDS: </title><kwd>transcatheter aortic valve implantation</kwd><kwd>access site-related vascular injury</kwd><kwd>stent-graft</kwd></kwd-group>
</article-meta>
</front>
<body>
<p><bold>Introduction:</bold> Percutaneous transfemoral transcatheter aortic valve implantation (pTF-TAVI) is an established method for the treatment of aortic stenosis in elderly patients. Despite improvements in this approach, access site-related vascular injury (ASRVI) remains a common complication (<xref ref-type="bibr" rid="r1"><italic>1</italic></xref>). Although the implantation of a stent-graft (SG) in the common femoral artery (CFA) is not recommended, it is used to treat ASRVI despite the lack of clinical evidence (<xref ref-type="bibr" rid="r2"><italic>2</italic></xref>). The aim is to evaluate the clinical outcomes in patients undergoing peripheral intervention for ASRVI related to pTF-TAVI.</p>
<p><bold>Patients and Methods</bold>: This single-center retrospective analysis included all patients undergoing pTF-TAVI who experienced ASRVI treated with either balloon angioplasty or SG implantation in the CFA. Patient demographics, comorbidities, as well as procedural data during TAVI were collected. Patient clinical follow-up (FUP) data was collected during FUP interviews.</p>
<p><bold>Results</bold>: A total of 197 patients underwent pTF-TAVI with MANTA as the primary vascular closure device. A total of 31 patients (15.7%) had ASRVI, the majority of whom (N=30, 96.7%) were successfully treated percutaneously and included in the study. The general patient and procedural characteristics are shown in <xref ref-type="table" rid="t1"><bold>Table 1</bold></xref>. Of the 30 patients, 8 (26.6%) underwent balloon angioplasty and 22 (73.4%) underwent SG implantation. The mean FUP was 11 &#x00B1; 6.3 months. The mean diameter of the balloon or SG used was 8.04 &#x00B1; 1.13 mm. In the cases in which SG was implanted, most were balloon-expanding SG (N=19, 86.36). At FUP, 2 (6.67%) patients reported intermittent claudication, 6 (20%) had nonspecific limb pain, and the majority (N=23, 76.67%) had a walking distance of &gt; 500 m. One patient initially treated with balloon angioplasty developed limiting claudication and underwent stent implantation. A comparison of clinical outcomes between patients treated with BD or SG is shown in <xref ref-type="table" rid="t2"><bold>Table 2</bold></xref>.</p>
<table-wrap id="t1" position="float">
<label>TABLE 1</label><caption><title>General and procedural characteristics of patients undergoing percutaneous treatment of access site-related vascular injury after transfemoral transcatheter aortic valve implantation.</title>
</caption>
<table frame="hsides" rules="groups">
<col width="61.52%"/>
<col width="38.48%"/>
<thead>
<tr>
<th valign="top" align="left" scope="col" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.25pt"></th>
<th valign="top" align="center" scope="col" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.25pt"><bold>N=30</bold></th>
</tr>
</thead>
<tbody>
<tr>
<td valign="top" align="left" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.25pt" scope="row">Female - n (%)</td>
<td valign="top" align="center" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.25pt">16 (53.33)</td>
</tr>
<tr>
<td valign="top" align="left" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.25pt" scope="row">Age &#x2013; mean &#x00B1; SD</td>
<td valign="top" align="center" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.25pt">81.38 &#x00B1; 6.55</td>
</tr>
<tr>
<td valign="top" align="left" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.25pt" scope="row">Coronary artery disease*, n (%)</td>
<td valign="top" align="center" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.25pt">17 (56.67)</td>
</tr>
<tr>
<td valign="top" align="left" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.25pt" scope="row">Atrial fibrillation, n (%)</td>
<td valign="top" align="center" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.25pt">8 (26.67)</td>
</tr>
<tr>
<td valign="top" align="left" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.25pt" scope="row">Chronic obstructive pulmonary disease, n (%)</td>
<td valign="top" align="center" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.25pt">4 (13.33)</td>
</tr>
<tr>
<td valign="top" align="left" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.25pt" scope="row">Chronic renal insufficiency**, n (%)</td>
<td valign="top" align="center" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.25pt">13 (43.33)</td>
</tr>
<tr>
<td valign="top" align="left" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.25pt" scope="row">Peripheral artery disease, n (%)<break/>Occlusive PAD***, n (%)</td>
<td valign="top" align="center" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.25pt">17 (56.67)<break/>8 (26.67)</td>
</tr>
<tr>
<td valign="top" align="left" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.25pt" scope="row">Aortic valve replacement before TAVI, n (%)</td>
<td valign="top" align="center" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.25pt">3 (10)</td>
</tr>
<tr>
<td valign="top" align="left" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.25pt" scope="row">Mean left ventricular ejection fraction &#x00B1; SD</td>
<td valign="top" align="center" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.25pt">51.72 &#x00B1; 12.41</td>
</tr>
<tr>
<td valign="top" align="left" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.25pt" scope="row">Self-expanding valve, n (%)</td>
<td valign="top" align="center" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.25pt">20 (66.6)</td>
</tr>
<tr>
<td valign="top" align="left" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.25pt" scope="row">Mean valve size &#x00B1; SD</td>
<td valign="top" align="center" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.25pt">29.27 &#x00B1; 6.23</td>
</tr>
<tr>
<td colspan="2" valign="top" align="left" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.75pt" scope="col">*defined with coronary angiography; **defined as estimated glomerular filtration rate &lt;60 ml/min/1.73 m<sup>2</sup>; ***Occlusive peripheral artery disease defined with CT angiography; SD standard deviation</td>
</tr>
</tbody></table></table-wrap>
<table-wrap id="t2" position="float">
<label>TABLE 2</label><caption><title>Comparison of clinical outcomes of patients treated with balloon angioplasty or stent-graft implantation.</title>
</caption>
<table frame="hsides" rules="groups">
<col width="37.54%"/>
<col width="18.03%"/>
<col width="21.04%"/>
<col width="23.39%"/>
<thead>
<tr>
<th valign="top" align="left" scope="col" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.25pt"><bold>Clinical outcome</bold></th>
<th valign="top" align="center" scope="col" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.25pt"><bold>General (N=30)</bold></th>
<th valign="top" align="center" scope="col" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.25pt"><bold>Balloon angioplasty (N=8)</bold></th>
<th valign="top" align="center" scope="col" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.25pt"><bold>Stent-graft implantation (N=22)</bold></th>
</tr>
</thead>
<tbody>
<tr>
<td valign="top" align="left" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.25pt" scope="row"><bold>Intermittent claudication</bold>, n (%)</td>
<td valign="top" align="center" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.25pt">2 (6.66)</td>
<td valign="top" align="center" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.25pt">1 (12.5)</td>
<td valign="top" align="center" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.25pt">1 (4.54)</td>
</tr>
<tr>
<td valign="top" align="left" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.25pt" scope="row"><bold>Non-specific limb pain</bold>, n (%)</td>
<td valign="top" align="center" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.25pt">6 (20)</td>
<td valign="top" align="center" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.25pt">0 (0)</td>
<td valign="top" align="center" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.25pt">6 (27.27)</td>
</tr>
<tr>
<td valign="top" align="left" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.25pt" scope="row"><bold>Additional vascular procedure</bold>*, n (%)</td>
<td valign="top" align="center" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.25pt">1 (3.33)</td>
<td valign="top" align="center" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.25pt">1 (12.5)</td>
<td valign="top" align="center" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.25pt">0 (0)</td>
</tr>
<tr>
<td valign="top" align="left" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.25pt" scope="row"><bold>Walking distance</bold> (m), n (%)<break/>&lt; 100<break/>100 &#x2013; 200<break/>&#x2013; 500<break/>500 or more</td>
<td valign="top" align="center" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.25pt">1 (3.33)<break/>2 (6.66)<break/>3 (10)<break/>23 (76.66)</td>
<td valign="top" align="center" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.25pt">1 (12.5)<break/>0 (0)<break/>0 (0)<break/>7 (87.5)</td>
<td valign="top" align="center" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.25pt">0 (0)<break/>2 (9.09)<break/>3 (13.63)<break/>16 (72.72)</td>
</tr>
<tr>
<td valign="top" align="left" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.25pt" scope="row"><bold>Mortality</bold>**, n (%)</td>
<td valign="top" align="center" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.25pt">4 (13.33)</td>
<td valign="top" align="center" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.25pt">1 (12.5)</td>
<td valign="top" align="center" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.25pt">3 (13.63)</td>
</tr>
<tr>
<td valign="top" align="left" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.25pt" scope="row"><bold>CVI</bold>***, n (%)</td>
<td valign="top" align="center" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.25pt">1 (3.33)</td>
<td valign="top" align="center" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.25pt">1 (12.5)</td>
<td valign="top" align="center" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.25pt">0 (0)</td>
</tr>
<tr>
<td valign="top" align="left" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.25pt" scope="row"><bold>Permanent pacemaker implantation</bold>, n (%)****</td>
<td valign="top" align="center" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.25pt">1 (3.33)</td>
<td valign="top" align="center" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.25pt">0 (0)</td>
<td valign="top" align="center" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.25pt">1 (4.54)</td>
</tr>
<tr>
<td colspan="4" valign="top" align="left" style="border-left: solid 0.75pt; border-top: solid 0.25pt; border-right: solid 0.75pt; border-bottom: solid 0.75pt" scope="col">*Need for additional vascular intervention (percutaneous or surgery) during clinical follow-up, at the access site-related vascular injury site; **Mortality during clinical follow-up; ***Cerebrovascular insult during transcatheter aortic valve implantation procedure; ****Need for permanent pacemaker implantation after the transcatheter aortic valve implantation procedure.</td>
</tr>
</tbody></table></table-wrap>
<p><bold>Conclusion</bold>: The results of our single-center analysis demonstrate that peripheral vascular interventions, including implantation of SG in CFA, provide satisfactory 1-year clinical outcomes in elderly patients undergoing pTF-TAVI and thus can be considered as a bailout method for the treatment of ASRVI. Patients initially treated with SG did not need reintervention as they had no lifestyle-limiting claudication.</p>
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