Breaking news: First subcutaneous shock device to prevent sudden cardiac death implanted in Sub-Saharan Africa

21st November 2016

IN A FIRST IN SUB-SAHARAN AFRICA, A NEW-GENERATION SHOCK DEVICE TO PREVENT SUDDEN CARDIAC DEATH WAS IMPLANTED AT MEDICLINIC PANORAMA TODAY

img_2418Panorama – On Monday 21 November 2016 Dr Razeen Gopal, Cardiac Electrophysiologist at the Cape Town AF Centre located at Mediclinic Panorama, implanted a shock device under the skin without a single wire touching the heart of the patient. Mr.Jan Wiehman (55) of Welgemoed, Bellville became the first patient in Africa to receive a subcutaneous shock device, also known as a Subcutaneous Cardioverter Defibrillator (S-ICD), to prevent sudden cardiac death in the patient.

The second procedure is currently in progress, and Dr Gopal will perform the third tomorrow (Tuesday 22 November 2016), to complete the first series of subcutaneous cardioverter defibrillator implants in Sub-Saharan Africa.

Sudden cardiac arrest (SCA) is a serious, life-threatening medical emergency that happens abruptly and without warning. During SCA, the heart’s electrical system malfunctions, and the heart is no longer able to pump blood effectively to the rest of the body. The lack of blood to the brain causes the person to lose consciousness quickly. If the heart is not shocked back into normal rhythm within less than three minutes, brain damage and death can occur.

The first patient, Jan Wiehman, an ardent cyclist, suffered sudden cardiac arrest three years ago on 1 December 2013 during a cycle race in Stellenbosch. He was in the leading pack when he suddenly collapsed. “My brain was awake, but I could not move”, he told us during an interview. Miraculously his life was saved by paramedics on duty, who transported him to a hospital in Paarl where his heart was shocked into normal rhythm in time. Doctors who studied the ECG which were taken during his cardiac arrest, could not believe that he had survived this near- fatal event. Jan remained asymptomatic for two and a half years. He eventually developed symptoms such as sudden palpitations and lightheadedness. After a battery of tests and assessments, doctors recommended the implantation of a cardioverter fibrillator due to his high risk for sudden cardiac arrest.

The EMBLEM S-ICD System is the first and only FDA approved product with both the device and the leads inserted beneath the skin, with no leads inserted through any veins, and thus with no leads placed inside or even touching the heart at all. “This leaves the heart and blood vessels untouched and so provides a safer alternative to conventional implantable defibrillators without the complications associated with cardiac wires,” explains Dr Gopal.

“Unlike traditional implantable defibrillators, it does not require leads in the venous system, eliminating potential sources of complications related to such leads or pockets, the most feared being infection,” said Dr Gopal.

This is of particular importance in young patients, since the new, subcutaneous device can simply be pulled out and removed. A traditional transvenous system can only be removed during delicate surgery since the wires tend to become submerged and entwined in scar tissue.
Dr Gopal explains more about the indications for the implant and the benefits:

Patients at risk of sudden cardiac arrest (and thus sudden cardiac death), include patients with the following heart rhythm defects:

  • Patients with ventricular tachycardia (VT) may suffer from a sudden fast heart beat exceeding 100 beats per minute. Symptoms include shortness of breath, palpitations, lightheadedness, chest pain, and fainting. In an adult patient VT may arise due to scar tissue in the heart after a heart attack;
  • Patients at risk for ventricular fibrillation – characterised by a fast, but weak and unco-ordinated heart beat – and heart failure; Ventricular fibrillation is a non-perfusing rhythm and not compatable with life.
  • Patients (mostly children) with Wolf-Parkinson-White syndrome and other ventricular arrhytmias (mostly congenital), where an ablation did not suffice to prevent sudden fast heart rates (of 160 – 220, and even 250 – 300 beats per minute in stead of the normal rate of 60 – 90 beats per minute) which may lead to sudden death.
  • Patients with Long QT syndrome. Undiagnosed, this defect in the conduction tissue of the heart, may lead to sudden death of a healthy, young individual, often while swimming or collapsing on a sports field.

 

deviceandelectrode2_overallThe Subcutaneous Implantable Cardioverter Defibrillator shock device is 83.1mm wide, 69,1mm high and 12.77mm thick and weighs 130 gram and is implanted in a space between two muscles on the left side of the patient’s body.

The procedure is explained in this video:

The ten steps of the procedure are:

Step 1: Draping and preparation of patient for general anaesthesia and the procedure. The patient thorax is marked for precision incisions. The patient was wheeled into theater at 10:00 after some preparatory tests.
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Dr Razeen Gopal (left) and prof Tim Betts from Oxford

Dr Razeen Gopal (left) and prof Tim Betts from Oxford

Step 2: The first incision is made on the lower left breast line of the patient. The first incision was performed at 11:oo after the doctors plotted the incisions meticulously.
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Step 3: The device is placed in a space between two muscles in the left flank (the Latissimus dorsi muscle and the Serratus anterior muscle).

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Step 4: A tunnel is created underneath the skin adjacent to the sternum (breast bone).
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Step 5: The shock lead is positioned to run firstly from the device underneath the skin, to the bottom of the sternum – thus from the left side of the thorax to the centre of the thorax.

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Step 6: Then the lead is pulled upwards through the tunnel under the skin. The second half of the lead makes a 90 degree turn and runs straight upwards adjacent to the sternum, but below the skin.
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Step 7: Dr Gopal and team check that there is no air trapped in the tunnel. They also check that the lead is positioned as close as possible to the bone. This is of particular importance in a patient with a high body fat content, since fat around the lead will increase electrical resistance and may disrupt the electrical signals.
Step 8: With the device and lead in place, the doctor stimulates the heart to create ventricular tachycardia in the patient, to check if the device will recognise and diagnose a potentially fatal heart rhythm immediately and deliver an appropiate shock to the heart in order for the heart to regain normal (sinus) rhythm. The shock was administer at 13:21 and the device reacted 14 seconds later to shock the heart back into normal rhythm.

The patient's heart was stimulated and beats at 300 betas per minute.

The patient’s heart was stimulated and beats at 300 betas per minute.

Step 9: If the doctors are happy that the device reacts appropiately, they close the incisions and will wake the patient soon afterwards. The patient was wheeled to the cardiac ICU at 14:00.
Step 10: Most patients will be discharged a day later. At 17:00 the patient was sitting up and smiling for a picture. He was not in pain and quite chirpy. He talked about his cardiac arrest three years ago and his close brush with death. “Now I have a safety net in the form of a inplanted fibrillator,” he said.

The first patient, three hours after the procedure, with nursing sister Melinda Schutte.

The first patient, Jan Wiehman (55) from Welgemoed, three hours after the procedure, with nursing sister Melinda Schutte.

Mediclinic Panorama Hospital General Manager, Riaan Vorster, reinforces the importance of such a procedure “It is important for our patients that they can benefit from such technology; the research has shown that the Subcutaneous Implantable Cardioverter Defibrillator has very low complication rates. The cost to patients is almost the same as for the transvenous system, thus we can offer new technology at a similar price.

We need to offer solutions that are going to positively impact our patients’ lifestyles.”

“Mediclinic is always investigating how the needs of our patients can be answered through innovation and we believe that Dr Gopal’s introduction of this technology into our hospital is one of these remarkable situations,” Vorster concludes.

Some facts about the Subcutaneous Implantable Cardioverter Defibrillator in a nutshell:

  • This device provides protection against sudden cardiac death without touching the heart or any blood vessels;
  • It is the world’s only subcutaneous ICD;
  • It is a less invasive way to protect patients from Sudden Cardiac Arrest (SCA);
  • EMBLEM S-ICD is 20% thinner and is projected to last 40% longer than the previous S-ICD1,2;
  • EMBLEM S-ICD is enabled for remote monitoring;
  • Panorama Mediclinic is the 1st hospital in Africa to implant the EMBLEM S-ICD System in a patient at risk for sudden cardiac arrest.

 

Also note:
This week, Dr Gopal and his team will also implant the Watchman device. This device is implanted in the left atrial appendage and acts as filter to prevent blood clots from entering the bloodstream and potentially causing a stroke. This device now offers hope for patients with atrial fibrillation who cannot tolerate anti-clotting medication. This treatment modality will now be available at Panorama Mediclinic.

[1] National Heart, Lung, and Blood Institute. What is Sudden Cardiac Arrest? http://www.nhlbi.nih.gov/health/health-topics/topics/scda. Accessed May 18, 2015.

[1] Himmrich E, et al. Is ICD programming for double intraoperative defibrillation threshold energy safe and effective during long-time follow-up? Results of a prospective randomized multicenter study (Low-Energy ENDOTAK Trial – LEFT). Z Kardiol. 1999;88:103-12 [German language edition].

For more information on the procedure, the device and Dr Gopal, visit www.capetownafcentre.co.za.

More videos on the procedure:
https://www.youtube.com/watch?v=hxsapcieF50
https://www.youtube.com/watch?v=cpni75ErW20