Adabiah Darus had been experiencing frequent dizziness and near-fainting spells since early this year. But it never crossed the 68-year-old retired civil servant’s mind that the symptoms were warning signs of heart disease.
When she sought treatment at a government health centre here, the doctor confirmed she had heart disease after her ECG (electrocardiogram) showed abnormal readings.
The mother of six was later referred to Hospital Canselor Tuanku Muhriz (HCTM), Universiti Kebangsaan Malaysia, where specialists diagnosed her with sick sinus syndrome, a condition in which the heart's natural pacemaker, the sinoatrial node, fails to regulate the heartbeat properly.
To treat the condition, doctors recommended that she undergo implantation of a leadless pacemaker, a miniature, advanced medical device designed to treat heart rhythm disorders.
FIRST TIME IN HCTM
Adabiah underwent the procedure at HCTM on June 10. A small group of journalists, including a reporter and photographer from Bernama, were invited to observe the leadless pacemaker implantation procedure, the first of its kind performed at HCTM, led by Dr Mohd Asyiq Al-Fard Mohd Raffali, a consultant cardiologist, cardiac electrophysiologist and internal medicine specialist from the hospital’s Department of Medicine.
Adabiah Darus was interviewed by the media prior to undergoing a leadless pacemaker implantation procedure at HCTM recently.--BERNAMApix
Another patient, 64-year-old Fuziah Moksin, also underwent the same procedure the same day. Fuziah had narrowed veins as a result of previous breast cancer treatment, making it difficult for doctors to implant a conventional pacemaker using the traditional wired approach.
Unlike the conventional pacemaker, which requires a surgical pocket beneath the skin in the chest and electrical leads threaded into the heart, the leadless pacemaker offers a less invasive alternative with minimal risk of complications.
While conventional pacemakers are about the size of a matchbox, the leadless device is roughly the size of a vitamin capsule and is implanted directly into the heart without the need for electrical leads.
“In the past, leadless pacemakers could only be implanted in the lower chamber of the heart (ventricle). With the latest technology, however, we can now implant them in the upper chamber (atrium),” said Dr Mohd Asyiq Al-Fard.
The device is particularly beneficial for patients with bradycardia, a condition in which the heart beats too slowly, he added.
“Patients with bradycardia usually have a heart rate of fewer than 60 beats per minute, which means the body may not receive enough oxygen. The device (leadless pacemaker) is equipped with intelligent sensors that continuously monitor the patient’s heart rhythm in real time.
“If it detects that the heart is beating too slowly or has briefly stopped, it delivers a small, safe electrical impulse to stimulate the heart muscle and restore a normal heartbeat,” he said.
Elaborating on the differences between conventional and leadless pacemakers, Dr Mohd Asyiq Al-Fard said the main distinction lies in their structure and implantation method.
“A conventional pacemaker consists of two components – a pulse generator and one or more electrical leads. A leadless pacemaker, on the other hand, is a single capsule-shaped device with no leads.
“The implantation site is also different. A leadless pacemaker is inserted directly into the heart through a vein in the leg, while a conventional pacemaker is implanted beneath the skin in the chest,” he explained.
Dr Mohd Asyiq Al-Fard Mohd Raffali.--BERNAMApix
Among the key advantages of the leadless pacemaker over the conventional approach is its significantly lower risk of infection as there is no surgical pocket in the chest that could become infected.
“It also eliminates the long-term risks associated with leads, such as blockages, fractures or damage to the heart valves. From an aesthetic and comfort perspective, there are no visible scars or bulges on the chest.
“People will not even know that a patient has a cardiac device. The procedure also carries a lower risk of bleeding because it does not require a large surgical incision in the chest," he said.
INSERTION
According to Dr Mohd Asyiq Al-Fard, the implantation of a leadless pacemaker is carried out in a catheterisation laboratory. The device is implanted through a small, flexible tube known as a catheter, which is inserted through a large vein (femoral vein) in the patient’s groin area.
“Using X-ray imaging guidance (fluoroscopy), the catheter is carefully navigated through the blood vessel until it reaches the lower right chamber of the heart (right ventricle).
“The leadless pacemaker is then released from the catheter and attached to the heart muscle wall using a specialised micro-hook. Once its position is confirmed to be stable and functioning properly, the catheter is removed and pressure is applied to the puncture site in the groin to stop any bleeding,” he said.
The specialist added that the procedure usually takes about 30 to 45 minutes, although the duration may vary, extending to an hour or more depending on the anatomy of the blood vessels and internal heart structure.
“If the patient’s heart structure is somewhat unique or enlarged, additional time may be needed to identify the safest and most optimal position for the device,” he said.
Leadless pacemaker technology offers a safer alternative with a minimal risk of complications.--BERNAMApix
Dr Mohd Asyiq Al-Fard added that this treatment significantly improves patients’ quality of life, particularly in terms of comfort and convenience.
“With traditional pacemakers, patients are usually advised not to lift their arms above shoulder level or carry heavy objects for several weeks to prevent the leads from dislodging. However, with a leadless pacemaker, there are no such restrictions. Patients can return to their normal activities sooner. Psychologically, they also feel more at ease without the sensation of a ‘foreign object’ protruding in the chest,” he said.
Regarding risks during and after the procedure, Dr Mohd Asyiq Al-Fard said although the procedure is generally very safe, all medical interventions carry some level of risk.
“During the procedure, there is a risk of heart wall injury (perforation), which can lead to fluid accumulation around the heart (cardiac tamponade) or temporary heart rhythm disturbances while the device is being implanted.
“After the procedure, patients may experience bruising or bleeding at the groin puncture site, or (in very rare cases) device dislodgement,” he said.
On battery lifespan, he explained that for dual-chamber leadless pacemakers, the devices have different battery durations: approximately 15 to 20 years for the ventricular device and 10 to 15 years for the atrial device.
“When the battery runs out, a new device can be implanted next to the old one, or the existing device can be removed (extracted), depending on the doctor’s assessment,” he said.
WHO NEEDS THE TREATMENT
On patients eligible for the implantation of leadless pacemakers, Dr Mohd Asyiq Al-Fard said elderly patients or those with chronic conditions such as diabetes and kidney failure and undergoing haemodialysis are recommended for this approach as they face a higher risk of infection with conventional pacemakers.
Patients with heart block or those who have previously undergone chemotherapy via arm veins may also benefit from the procedure.
“Children or adolescents with heart conduction disorders, such as congenital complete heart block, may also undergo this procedure as their growing anatomy makes conventional lead implantation more challenging.
“However, the size of their groin blood vessels must first be assessed to determine whether they can accommodate the catheter size,” he said.
The procedure generally takes between 30 and 45 minutes to complete, although it may extend to an hour or more, depending on the patient's vascular anatomy and cardiac structure.--BERNAMApix
He added that several factors are carefully evaluated before recommending a leadless pacemaker, including clinical need, that is, whether a single- or dual-chamber device is required, as not all patients need dual chambers, particularly those with atrial fibrillation.
Other considerations include vascular anatomy to ensure the femoral vein is free from blockage or clotting, the patient’s immune status, and cost, as the newer leadless pacemaker technology is more expensive than the conventional one. The leadless pacemaker alone costs about RM50,000.
On the two patients who underwent the procedure at HCTM recently, Dr Mohd Asyiq Al-Fard said Fuziah showed remarkable improvement. Within days, she reported feeling more energetic, no longer experiencing dizziness or near-fainting episodes. Her groin wound healed without complications.
He said after the procedure, patients are required to lie flat for about four to six hours to ensure the groin puncture site heals properly and there is no bleeding.
“Patients are usually able to walk the next day and are discharged within 24 to 48 hours. Normal daily activities such as walking, office work and light household chores can be resumed within three to five days.
“For strenuous physical activity or sports, we advise waiting one to two weeks to ensure full healing of the groin wound,” he said, adding that patients must attend follow-up checks six weeks after the procedure is done, and subsequently every six months and later yearly.
Dr Mohd Asyiq Al-Fard, meanwhile, hoped the leadless pacemaker technology would become more widely accessible, despite challenges such as the cost.
“We may even see (the emergence of) smaller devices with battery life exceeding 20 years, and full integration with remote monitoring via smartphone applications, allowing doctors to track their patients’ heart rhythms automatically from home,” he said.
He also advised the public on the importance of early detection of heart rhythm disorders.
The pacemaker features smart sensors that continuously track the patient's heart rhythm in real time.--BERNAMApix
“Never ignore symptoms such as frequent dizziness, fatigue or palpitations. Many people dismiss these as signs of ageing or tiredness, when in fact they may indicate serious electrical disturbances in the heart.
“Early detection through simple tests like an ECG at a clinic or hospital can save lives. Do not be afraid to seek specialist care as early treatment can restore your quality of life,” he said.
