<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;">Algorithm for step-by–step analysis of the ECG for AFD</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&nbsp;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>

<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