<p style="text-align: center;">Determine&nbsp;<strong>independent ECG</strong>&nbsp;predictors of AFD</p>

<p style="text-align: center;"><strong>Validate an ECG scoring system</strong>&nbsp;for differential diagnosis of AFD</p>

<table align="center" border="1" cellpadding="1" cellspacing="1" style="width:1000px;">
 <tbody>
  <tr>
   <td rowspan="13">
    <h3 style="text-align: center;">Score calculation</h3></td>
   <td colspan="1" rowspan="3" style="text-align: center;">PR interval</td>
   <td style="text-align: center;">&lt;120 ms</td>
   <td style="text-align: center;">1</td>
  </tr>
  <tr>
   <td style="text-align: center;">120- 199 ms</td>
   <td style="text-align: center;">0</td>
  </tr>
  <tr>
   <td style="text-align: center;">≥200 ms</td>
   <td style="text-align: center;">2</td>
  </tr>
  <tr>
   <td colspan="1" rowspan="4" style="text-align: center;">QRS duration</td>
   <td style="text-align: center;">&lt;100 ms</td>
   <td style="text-align: center;">0</td>
  </tr>
  <tr>
   <td style="text-align: center;">100–119 ms</td>
   <td style="text-align: center;">1</td>
  </tr>
  <tr>
   <td style="text-align: center;">120–139 ms</td>
   <td style="text-align: center;">2</td>
  </tr>
  <tr>
   <td style="text-align: center;">≥140 ms</td>
   <td style="text-align: center;">3</td>
  </tr>
  <tr>
   <td colspan="1" rowspan="2" style="text-align: center;">RBBB (complete and incomplete)</td>
   <td style="text-align: center;">Yes</td>
   <td style="text-align: center;">2</td>
  </tr>
  <tr>
   <td style="text-align: center;">No</td>
   <td style="text-align: center;">0</td>
  </tr>
  <tr>
   <td colspan="1" rowspan="2" style="text-align: center;">R in aVL ≥11 mV</td>
   <td style="text-align: center;">Yes</td>
   <td style="text-align: center;">1</td>
  </tr>
  <tr>
   <td style="text-align: center;">No</td>
   <td style="text-align: center;">0</td>
  </tr>
  <tr>
   <td colspan="1" rowspan="2" style="text-align: center;">Inferior ST-segment depression</td>
   <td style="text-align: center;">Yes</td>
   <td style="text-align: center;">3</td>
  </tr>
  <tr>
   <td>
    <p style="text-align: center;">No</p></td>
   <td style="text-align: center;">0</td>
  </tr>
 </tbody>
</table>

<h3 style="text-align: center;"><span style="color:#7a00e6;">Algorithm for step-by–step analysis of the ECG for AFD</span></h3>

<p style="text-align: center;"><strong>Independent predictors of AFD diagnosis</strong></p>

black

<p><strong>Good</strong><br>
  diagnostic performance</p>

<p>Providing clinical and therapeutic implications</p>

<p data-font="legal">AFD: Anderson–Fabry disease; aVF: Augmented vector foot; aVL: Augmented vector left; ECG: Electrocardiogram; HCM: Hypertrophic cardiomyopathy; LVH: Left ventricular hypertrophy; MS: Millisecond; mV: Millivolt; RBBB: Right bundle branch block.</p>

Reference

ROLE OF ECG IN DIFFERENTIAL DIAGNOSIS OF ANDERSON–FABRY DISEASE WITH HCM

FABRY

RARE-DISEASE

Better care for Fabry

<p>Every Moment Matters on the Fabry Journey</p>

Fabry Disease from Cardiology Perspective

<p>In&nbsp;this video, Dr. Tamer Ghazy is sharing some data and highlights about the cardiovascular complications in Fabry disease.</p>

<h2>Classical FD (&lt;3% enzyme activity)</h2>

<p>Neuropathic pain, angiokeratomas, and/or cornea verticillata are absent in females.</p>

<p><strong>Childhood and adolescence</strong></p>

<table border="0" cellpadding="1" cellspacing="1">
 <tbody>
  <tr>
   <td>
    <h3><strong>Nonclassical or late-onset FD (3%–30% enzyme activity)</strong></h3></td>
  </tr>
  <tr>
   <td>Variable disease course and single organ involvement</td>
  </tr>
  <tr>
   <td>Cardiac variant is common in late-onset FD</td>
  </tr>
  <tr>
   <td>Identified in patients with stroke, renal failure, or cardiomyopathy</td>
  </tr>
  <tr>
   <td>No neuropathic pain, angiokeratomas, and/or cornea verticillata</td>
  </tr>
 </tbody>
</table>

<p><strong>FD diagnosis requires a multidisciplinary team approach involving:</strong></p>

<table border="1" cellpadding="1" cellspacing="1" style="width:100%;">
 <tbody>
  <tr>
   <td style="text-align: center;"><strong>Biochemist</strong></td>
  </tr>
 </tbody>
</table>

<table border="1" cellpadding="1" cellspacing="1" style="width:100%;">
 <tbody>
  <tr>
   <td style="text-align: center;"><strong>Pediatrician</strong></td>
  </tr>
 </tbody>
</table>

<table border="1" cellpadding="1" cellspacing="1" style="width:100%;">
 <tbody>
  <tr>
   <td style="text-align: center;"><strong>Neurologist</strong></td>
  </tr>
 </tbody>
</table>

<table border="1" cellpadding="1" cellspacing="1" style="width:100%;">
 <tbody>
  <tr>
   <td style="text-align: center;"><strong>Cardiologist</strong></td>
  </tr>
 </tbody>
</table>

<table border="1" cellpadding="1" cellspacing="1" style="width:100%;">
 <tbody>
  <tr>
   <td style="text-align: center;"><strong>Dermatologist</strong></td>
  </tr>
 </tbody>
</table>

<table border="1" cellpadding="1" cellspacing="1" style="width:100%;">
 <tbody>
  <tr>
   <td style="text-align: center;"><strong>Nephrologist</strong></td>
  </tr>
 </tbody>
</table>

<table border="1" cellpadding="1" cellspacing="1" style="width:100%;">
 <tbody>
  <tr>
   <td style="text-align: center;"><strong>Geneticist</strong></td>
  </tr>
 </tbody>
</table>

<p><strong>Suggested diagnostic algorithm for patient with clinically suspected FD</strong></p>

<h3><strong>1.&nbsp;Lyso-Gb3 indicates severity of FD</strong></h3>
<p><strong>2.&nbsp;Endomyocardial and renal biopsies are used</strong></p>
<p><strong>3.&nbsp;Genetic testing</strong></p>

<h3><strong>Testing for FD</strong></h3>

<ul>
 <li>Causative mutation</li>
 <li>Affected family members</li>
 <li>Eligibility for treatment with migalastat</li>
</ul>

<p><strong>LSD referral centers to manage FD from diagnosis to long-term follow-up</strong></p>

<table border="0" cellpadding="1" cellspacing="1">
 <tbody>
  <tr>
   <td>
    <p><strong>Rare but underdiagnosed</strong></p></td>
   <td>
    <p><strong>To be known and recognized by internal medicine physicians</strong></p></td>
   <td>
    <p><strong>Early treatment can change the natural course of the disease.</strong></p></td>
  </tr>
 </tbody>
</table>

<strong>FD:</strong>

<p data-font="legal"><sup>*</sup>Eye involvement includes cornea verticillata, tortuous retinal vessels, cataracts, and conjunctival lymphangiectasia.<br>
  Rare but To be known and recognized by underdiagnosed internal medicine physicians α-Gal A: Alpha-galactosidase; eGFR: Estimated glomerular filtration rate; GLA: α-Galactosidase A; FD: Fabry disease; GI: Gastrointestinal; LSD: Lysosomal storage disease; Lyso-Gb3: Globotriaosylsphingosine; TIA: Transient ischemic attack.</p>

DIAGNOSING FABRY DISEASE IN CLINICAL PRACTICE

<h2>Study objective and method</h2>
<p>To demonstrate</p>

<p>The benefits of adding lyso-GL-3&nbsp;to&nbsp;►</p>

<p>Primary diagnostic for testing for&nbsp;►</p>

<p>Improving detection rate of potential females with FD</p>

<p>Avoiding unnecessary genetic testing</p>

<table align="center" border="1" cellpadding="1" cellspacing="1" style="width: 1120px;">
 <tbody>
  <tr>
   <td>
    <p style="text-align: center;"><strong>First large prospective study</strong></p></td>
  </tr>
 </tbody>
</table>

<p><strong>11,948</strong>&nbsp;females with suspicion of FD</p>
<p>&nbsp;</p>
<p>tested for</p>

<p><strong>Biochemical tests</strong></p>
<ul>
 <li>α-Gal A activity</li>
 <li>Lyso-GL-3 levels</li>
</ul>
<p>&nbsp;</p>
<p>followed by</p>

<p>Genetic confirmatory testing in&nbsp;<strong>883</strong>&nbsp;females</p>

<table align="center" border="1" cellpadding="1" cellspacing="1" style="width:100%;">
 <tbody>
  <tr>
   <td rowspan="7">
    <h3 style="text-align: center;">Groups</h3></td>
   <td style="text-align: center; vertical-align: top;"><strong>01.</strong>&nbsp;Low α-Gal A activity High lyso-GL-3</td>
   <td style="text-align: center; vertical-align: top;"><strong>02.</strong>&nbsp;Low α-Gal A activity Normal lyso-GL-3</td>
   <td style="text-align: center; vertical-align: top;"><strong>03.</strong>&nbsp;Normal α-Gal A activity High lyso-GL-3</td>
   <td style="text-align: center; vertical-align: top;"><strong>04.</strong>&nbsp;Normal α-Gal A activity Normal lyso-GL-3</td>
  </tr>
  <tr>
   <td colspan="1" style="text-align: center; vertical-align: top;">Classical FD very likely (n=61)</td>
   <td style="text-align: center; vertical-align: top;">Classical FD unlikely (n=184)</td>
   <td style="text-align: center; vertical-align: top;">
    <p>FD very likely (n=256)</p></td>
   <td style="vertical-align: top;">
    <p style="text-align: center;">95.8 had normal results (n=11,447*)</p></td>
  </tr>
  <tr>
   <td colspan="3" rowspan="1" style="text-align: center;"><strong>Genetic confirmatory test</strong></td>
   <td style="text-align: center;"><strong>No further testing required</strong></td>
  </tr>
 </tbody>
</table>

<p>(184/883) females were identified with one or two&nbsp;<em>GLA&nbsp;</em>variants.</p>

<table align="center" border="1" cellpadding="1" cellspacing="1" style="width:500px;">
 <tbody>
  <tr>
   <td style="text-align: center;"><strong>Distribution of genetically positive samples</strong></td>
  </tr>
 </tbody>
</table>

<p><strong>Better indicator of FD</strong></p>

<p>Elevated lyso-GL-3 levels (39% PPV)</p>

<p><strong>Clearly negative results for both biochemical parameters:</strong></p>
<p>Unlikely to have FD, even in clinically highly suspicious cases</p>

<table align="center" border="1" cellpadding="1" cellspacing="1" style="width: 1120px;">
 <tbody>
  <tr>
   <td style="text-align: center;"><strong>Proposed diagnosis decision tree</strong></td>
  </tr>
 </tbody>
</table>

<h3><strong>STEP 2</strong></h3>
<p>Once enzyme deficiency is confirmed, molecular testing is performed to identify GLA genetic variants.</p>

<h3><strong>STEP 2</strong></h3>
<p>Once enzyme activity (deficient or not) together with elevated biomarker is confirmed, molecular testing is performed to identify GLA genetic variants.</p>

<p data-font="legal">*Mutation analysis performed in 389 cases.</p>
<p data-font="legal">α-Gal A: Alpha-galactosidase A; dbFGP: Fabry disease genotype–phenotype database; FD: Fabry disease; Lyso-GL-3: Globotriaosylsphingosine; PPV: Positive predictive value; DBS: Dried blood spotting; GLA: Galactosidase alpha; VUS: Variant of unknown significance.</p>

BIOCHEMICAL DIAGNOSTIC STRATEGY IN FEMALES SUSPECTED OF FABRY DISEASE

<h3>Fabry Disease Can Result in Substantial Heart Damage<sup>1</sup></h3>
<p>Fabry disease is a rare, progressive, and potentially life-threatening disorder that starts in early childhood and affects men and women.<sup>1-3</sup><br>
  As an X-linked lysosomal storage disorder that is multisystemic, Fabry disease is caused by complete or partial deficiency of the lysosomal enzyme α-GAL A, leading to GL-3 and lyso-GL-3 accumulation that can result in damage to the heart, kidneys, and cerebrovascular system.<sup>2,3</sup></p>

<h3>Early Diagnosis and Management Are Critical as Fabry Disease Can Decrease Life Expectancy Due to Heart and Organ Damage<sup>2,4-6</sup></h3>

<h2>Understanding Fabry Disease</h2>
<p>Worldwide Incidence<sup>7</sup></p>
<p><strong>1 in 40,000</strong></p>
<p>FD is an X-linked disease caused due to deficiency of α-galactosidase A. An average diagnostic delay of 15–18 years is seen in FD.</p>
<p><strong>Test for diagnosis</strong></p>
<ul>
 <li>Enzyme assays to detect α-Gal activity</li>
 <li>Genetic testing to confirm diagnosis</li>
</ul>

<h2>Cardiac Disease is the Leading cause of Death in Patients with Fabry Disease<sup>1</sup></h2>
<h3><strong>Consider Fabry Disease in your Differential Diagnosis when</strong><sup>10</sup>:</h3>
<p><strong>Presentation:</strong>&nbsp;Unexplained HCM and/or LVH, fibrosis in the lateral wall of the left ventricle, low native T1 values, elevated hs-troponin in the absence of acute event<sup>9,11</sup></p>
<p><strong>Family history:</strong>&nbsp;Cardiomyopathy, premature stroke, sudden cardiac death, and renal failure<sup>10,12</sup></p>
<p><strong>ECG:</strong>&nbsp;Bradycardia, short PR interval (young age), AV block (cardiac clinical manifestations in the 3rd decade of life onward), voltage criteria for LVH, ST segment changes, T-wave inversion<sup>8,10</sup></p>

<h3>If you see Unexplained Cardiomyopathy, Consider Fabry Disease.<sup>13</sup></h3>
<p><strong>Cardiologists have the tools to screen for, diagnose, and manage Fabry disease.</strong></p>

<div>
 <table border="1" cellpadding="10" cellspacing="1">
  <tbody>
   <tr>
    <td colspan="2" rowspan="1"><strong>Testing is Straightforward</strong><sup>8,14,15</sup></td>
    <td rowspan="3"><strong>In patients with unexplained HCM, conduct genetic testing that includes the&nbsp;GLA&nbsp;gene.</strong></td>
    <td colspan="1" rowspan="2">Treatment is Available for your Patients with Fabry Disease</td>
   </tr>
   <tr>
    <td><strong>Males</strong></td>
    <td><strong>α-GAL A enzyme assay</strong><br>
      and/or<br><strong>GLA&nbsp;gene sequencing</strong></td>
   </tr>
   <tr>
    <td><strong>Females</strong></td>
    <td>
     <p><strong>GLA&nbsp;gene sequencing</strong></p>
     <p>Affected females may have normal to low enzyme<br>
       activity in plasma or leukocytes; therefore,&nbsp;GLA&nbsp;gene<br>
       sequencing is required to confirm diagnosis in females.</p></td>
    <td><strong>Stabilizing disease progression is an<br>
       important goal.</strong><sup>8</sup></td>
   </tr>
  </tbody>
 </table>
</div>
<p>Damage to cardiac, renal, and cerebrovascular systems can have life-threatening impact. Monitor patients in accordance with published management guidelines and clinicians’ medical expertise.<sup>8</sup></p>

Abbreviations

References

<h2>Discover Fabry Disease:</h2>
<h2>The Role of the Nephrologist</h2>

<h3>Renal Manifestations of Fabry Disease are common and can be Life Threatening.<sup>1,2</sup></h3>
<p>Fabry disease is a rare, progressive, and potentially life-threatening disorder that starts in early childhood and affects men and women.<sup>2-4</sup><br>
  As an X-linked lysosomal storage disorder that is multisystemic, Fabry disease is caused by complete or partial deficiency of the lysosomal enzyme α-GAL A, leading to GL-3<sup>*</sup>&nbsp;and lyso-GL-3 accumulation that can result in damage to the kidneys, heart, and cerebrovascular system.<sup>4</sup></p>

<h3>Early Diagnosis and Management are Critical as Fabry Disease can Decrease Life Expectancy due to Organ Damage.<sup>4-7</sup></h3>

<h2>Understanding Fabry Disease</h2>
<p><strong>Worldwide Incidence<sup>7</sup></strong></p>
<p><strong>1 in 40,000</strong></p>
<p>FD is an X-linked disease caused due to deficiency of α-galactosidase A. An average diagnostic delay of 15–18 years is seen in FD.</p>
<p><strong>Test for diagnosis</strong></p>
<ul>
 <li>Enzyme assays to detect α-Gal activity</li>
 <li>Genetic testing to confirm diagnosis</li>
</ul>

<h2>Renal Manifestations are a Prominent Indication of Fabry Disease and can be Life Threatening<sup>10</sup></h2>
<p><strong>Presentation:</strong>&nbsp;Microalbuminuria, proteinuria, reduced GFR, hematuria (rare), renal cysts (mainly parapelvic), and (in early disease) reduced systemic BP and glomerular hyperfiltration<sup>11</sup></p>
<p><strong>Family history:</strong>&nbsp;Cardiomyopathy, premature stroke, sudden cardiac death, and renal failure<sup>12,13</sup></p>
<p><strong>Laboratory and Biopsy Findings</strong><br><strong>Urinalysis:</strong>&nbsp;“Maltese cross,” “urinary mulberry cells,” biomarkers GL3<sup>*</sup>&nbsp;and lyso-GL3<sup>11</sup><br><strong>Biopsy:</strong>&nbsp;Glomerulosclerosis, vascular lesions, vacuolation, and lysosomal GL3 deposits<sup>11</sup></p>
<p><strong>Rule out Fabry disease in your patients with unexplained CKD.</strong></p>

<div>
 <table border="1" cellpadding="10" cellspacing="1">
  <tbody>
   <tr>
    <td colspan="2" rowspan="1"><strong>Renal Best Practice Screening Recommendations</strong><sup>14</sup></td>
    <td colspan="1"><strong>Testing is Straightforward</strong><sup>9,15</sup></td>
   </tr>
   <tr>
    <td><strong>Males</strong></td>
    <td><strong>Screening&nbsp;MALES&nbsp;&lt;50 years of age with unexplained CKD</strong></td>
    <td colspan="1"><strong>α-GAL A enzyme assay</strong><br>
      and/or<br><strong>GLA&nbsp;gene sequencing</strong></td>
   </tr>
   <tr>
    <td><strong>Females</strong></td>
    <td><strong>Screening&nbsp;FEMALES&nbsp;at any age with unexplained CKD and other symptoms associated with Fabry disease</strong></td>
    <td>
     <p><strong>GLA&nbsp;gene sequencing</strong><br>
       Affected females may have normal-to-low enzyme activity in plasma or leukocytes; therefore, GLA gene sequencing is required to confirm diagnosis in females.</p></td>
   </tr>
  </tbody>
 </table>
</div>
<p>Damage to renal, cardiac, and cerebrovascular systems can have a life-threatening impact. Monitor patients in accordance with published management guidelines and clinicians’ medical expertise.<sup>9</sup></p>
<p><sup>*</sup>GL-3 and Gb3 are interchangeable terms for globotriaosylceramide.</p>

Fabry

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Fabry

Latest Articles

ROLE OF ECG IN DIFFERENTIAL DIAGNOSIS OF ANDERSON–FABRY DISEASE WITH HCM

Better care for Fabry

Fabry Disease from Cardiology Perspective

DIAGNOSING FABRY DISEASE IN CLINICAL PRACTICE

BIOCHEMICAL DIAGNOSTIC STRATEGY IN FEMALES SUSPECTED OF FABRY DISEASE

Fabry