A comprehensive guide on pacemaker implantation

One of the most common diseases associated with mortality is cardiovascular problems. Due to the lack of physical activity, urbanized lifestyle, unhealthy eating habits, lack of nutrition, and various other socio-economic conditions – cardiovascular problems have steeply risen. While there are multiple medical treatments available for heart problems, a pacemaker remains one of the most important advances in providing care for patients. A pacemaker is not merely a device that cures heart problems, but is also essential in retaining the patient’s peace of mind, ensuring them a quality of life and providing assurance of safety. Technically, a pacemaker is a device that continuously monitors the heartbeat to record any erratic movements and sends electrical impulses to the heart muscle to maintain a healthy heart rate. Your doctor may recommend a pacemaker in conditions such as arrhythmia, fainting spells and congestive heart failure. Depending on the severity of the heart problem, an appropriate pacemaker from the three types is recommended:

  • Single chamber: Carries electrical impulses to the right ventricle
  • Dual-chamber: Carries electrical impulses to the right ventricle and atrium
  • Biventricular: Corrects abnormal electrical systems by stimulating lower chambers of the heart. 

Purpose of a Pacemaker Implantation

The main purpose of a pacemaker is to control the irregular heartbeat. These can be temporarily implanted to treat a slow heartbeat post a heart attack, surgery or a drug overdose. In other cases, permanent transplantation of a pacemaker is made to correct a prolonged irregular heartbeat or to treat heart failure.

An implanted pacemaker mimics the natural action of the heart’s electrical system, and typically comprises of two parts:

Pulse Generator: A small metal container which hosts the battery and electrical circuitry which regulates the electrical pulse rate sent to the heart.

Leads (Electrodes): These are insulated wires which are placed in the chambers of the heart or in one particular chamber to deliver the electrical pulses to adjust the irregular heart rate.

Pacemakers only function when needed. In case, the heart starts beating slowly, the pacemaker sends electrical signals to the heart to correct the beat. Also, recent advancements in technology have offered sensory pacemakers which detect the body motion and breathing rate and send signals accordingly.

Risks of a Pacemaker Implantation

Risks of complications from a pacemaker implantation surgery are very rare, but can include:

  • Infection at the site of pacemaker implantation
  • Allergy or reaction to the dye or anaesthesia used during the procedure
  • Swelling, bruising or extensive bleeding at the site
  • Damage to the surrounding blood vessels and tissues
  • Collapsed lungs

Preparation for a Pacemaker Implantation

Before deciding the need and type of pacemaker required, the doctor will conduct several tests to know the cause of irregularity in the heartbeat. These tests include:

  • Electrocardiogram (ECG)
  • Holter monitoring
  • Echocardiogram
  • Stress test

The procedure of a Pacemaker Implantation

Before the commencement of the procedure, the doctor will place an intravenous line to provide medication to ease pain and help the patient relax. The patient will mostly be awake during the procedure and will be administered with local anaesthesia to numb the incision area.

Once the chest is sanitized and the patient is sedated, the surgeon inserts one or more flexible, insulated wires into a major vein located under or near the collarbone. Once placed, the wires are guided to the heart through X-ray images. On the end of the insulated wire is attached to the pulse generator that is implanted under the collarbone skin.

After the procedure, the patient is kept under observation for a day or more depending on the recovery and general health. The pacemaker is set to fit the pacing needs of the patient. Once the patient is stabilized, he/she is discharged but advised to be accompanied by a close friend or family to be driven home safely.

The pacemaker’s condition including the battery life, the heart rate and rhythm are monitored by the surgeon remotely. In many cases, heavy exercises or physical exertion will need to be avoided. Also, one has to not apply any pressure at the implantation site and in case of discomfort or pain, medical advice must be taken immediately.

On the other hand, the patient will be asked to take several precautions such as:

  • Using the cellphone at least at a distance of 6 inches from the pacemaker
  • Avoid unnecessary lingering near or leaning against a metal detector
  • Inform all doctors and medical professionals about your pacemaker and ensure it is registered well before any surgery, test or medical treatment
  • Keep at least a distance of 2 feet from power-generating equipment such as welding equipment, high-voltage transformers or motor-generator systems

Results of a Pacemaker Implantation

A pacemaker tends to positively improve the heart condition and rectify symptoms caused due to slow heartbeat such as fatigue, fainting, lightheadedness, etc. The pacemaker condition should be assessed every three to six months and the patient must inform the doctor about any troubling symptoms after the implantation such as puffy ankles, swollen legs, fainting, dizziness, unexplainable weight gain, etc.

Most pacemakers today last for 10-15 years, post which their battery needs to be replaced. The battery changing procedure is simple, fast and requires less recovery time as compared to the implantation one. Since most pacemakers today adjust the heartbeat according to the physical activity of the body, the overall quality of life is not hampered and the patient can resume an active lifestyle.

Understand congenital heart defects (CDC)

Congenital heart defects are problems present at birth, which impact the structure of the baby’s heart and the way it functions. These heart defects can impact the way blood flows through the heart and reaches the rest of the body. Congenital heart defects vary from mild such as a small hole in the heart to extreme ones such as missing or poorly developed parts of the heart. These defects are the most common type of birth defects found in children.

Causes of Congenital Heart Defects

The exact cause of congenital heart defects in children is not known. Some babies have defects because of changes in their genes or chromosomes. However, in other cases, the defects are a result of a combination of genes, accompanied by other factors such as the environment, the diet of the mother, mother’s general health condition and medication during pregnancy, smoking during pregnancy, etc. Such as, in some cases, the expecting mother has diabetes or obesity, which can cause heart issues and defects in the child.

Types of Congenital Heart Defects

Atrial Septal Defect or ASD: This type of heart hole is present in the portion of the septum that separates the right and left chambers of the heart, causing oxygen-rich blood from the left chamber (atrium) to flow into the right chamber rather than flowing into the left ventricle as per normal process. This leads to oxygen-rich blood flowing back into the lungs instead of flowing into the body. ASD could be small or large depending on condition. A small ASD is often harmless and does not require any special treatment closes on its own as the child grows. Whereas a large ASD is caused more blood leakage and could cause potential harm to the baby. These heart holes do not fill up on their own instead require special treatment and care. Most of the babies do not show any signs of a heart hole up until 30 years or later. But if a large ASD is not repaired in time, it might cause right heart failure, irregular heartbeats, stroke, pulmonary hypertension leading to severe complications.

Ventricular Septal Defect or VSD:  A VSD is a type of heart hole where there is an opening in the septum that divides the lower chambers of the heart – the ventricles. This heart hole causes the oxygen-rich blood from the left ventricle to flow into the right ventricle and mix up with the oxygen-poor blood, instead of flowing out of the body through the aorta. A baby might have more than one VSD but in most cases, VSD close as the baby grows up and do not cause any trouble. Large size VSD, however, might cause some symptoms and would require surgery if they do not close on their own. A large VSD could result in heart failure, growth failure, irregular heartbeats, and pulmonary hypertension.

Coarctation of the Aorta: This is a serious congenital defectwhich indicates a narrowing of the aorta. The aorta is the large blood vessel which branches off the heart to deliver oxygen-rich blood to the rest of the body. When a child develops Coarctation of the aorta, the heart is forced to pump harder to force the blood through the narrowed aorta, which tends to impact the efficiency and thereby, the general health of the child. The condition, usually present at birth, can be mild or severe, depending on the child. Some cases might go unnoticed until adulthood, depending on how much the aorta is narrowed. While the treatment for this condition is easily available and is successful but it requires life-long follow-up and precautions.

Double-outlet Right Ventricle (DORV): A serious congenital heart defect in which the aorta of the child’s heart, which is normally connected to the left ventricle (the chamber which pumps oxygen-rich blood to the body) is instead by default connected to the right ventricle (the chamber which oxygen-poor blood to the lungs). This causes both arteries to flow out of the right ventricle, which implies that oxygen-poor blood is circulated to the entire body, causing serious health issues.

D-Transposition of the Great Arteries: A serious congenital heart condition in which the aorta and the pulmonary artery of the child’s heart are switched from their normal position. This is in turn, causes the aorta to come off the right ventricle and pulmonary artery to come from the left ventricle. This implies that the oxygen-rich blood from the lungs goes back to the lungs, while the poor-oxygen blood from the body goes back to the body instead of heading to the lungs to be enriched with oxygen. 

Ebstein Anomaly: This is a rare congenital malformation of the child heart in which the valve between the right atrium and the right ventricle of the heart (known as a tricuspid valve) is the wrong place and its leaflets are of an incorrect shape than usual. This causes the valve to malfunction leading to leaking of the blood back to the valve and into the right atrium.

Hypoplastic Left Heart SyndromeA severe and complex type of defect which affects the normal blood flow of the heart. This condition happens when the baby’s left side of the heart does not develop properly during pregnancy. This leads the left-side incapable of pumping oxygen-rich blood to the rest of the body properly. A surgery or another medical treatment is required in such case, as soon as the baby is born and shows symptoms of the disorder.

Symptoms of Congenital Heart Defects

Symptoms and signs of heart defects in babies depend on the type of problem; in some cases, there may be no symptoms at all. However, some common signs include:

  • Blue-tinted nails
  • Blue lips
  • Tiredness when feeding
  • Sleepiness

Most congenital heart defects are detected during pregnancy; however, the others are detected post-birth or later in life during early childhood years or adulthood.

What happens in beating heart bypass surgery?

When the arteries cannot supply the required blood to the heart, the patient needs to be treated via a heart bypass surgery or coronary artery bypass graft surgery (CABG). Coronary artery bypass grafting (CABG) is a surgical procedure to improve poor blood flow to the heart caused by narrowing or blocking of arteries due to build-up of plaque. These arteries called coronary arteries are blood vessels responsible for supplying blood, oxygen and nutrients to the heart tissue. When these arteries are blocked or narrowed due to accumulation of plaque – fatty material within the walls of the arteries – the heart is restricted or limited of supply of oxygen-rich blood, causing severe symptoms including a heart attack in severe cases. This plaque is formed in the arteries when the inner walls of the arteries are damaged or injured due to several factors such as unhealthy diet, smoking, high blood pressure, high cholesterol, diabetes, and a sedentary lifestyle. This plaque – a build-up of fat, cholesterol, calcium, and other substances – tends to stick to the inner walls of the arteries, restricting the blood flow and thereby causing a system malfunction. 

A heart bypass surgery redirects the blood flow to the narrowed or blocked artery by using healthy blood vessels from the leg veins, arm or chest and connecting them with the blood vessels that are beyond the blocked or narrowed artery – causing a bypass for the compromised artery to relive the blood flow as a new passage can supply oxygen-rich blood to the blocked area. Depending on the severity of the case, one or more blood vessels may be used to bypass the affected artery. In one case, four major blocked arteries can be bypassed at once. 

There are particularly three types of heart bypass surgery:

Traditional heart bypass grafting: This is the most common methods used to treat blockages of the main artery by opening the chest bone to access the heart and stop it to connect it to a heart-lung bypass machine. This machine keeps supplying blood and oxygen to the tissue to keep the heart alive, meanwhile allowing the surgeon to relieve the blockage. Post the surgery, blood flow is restored and the heart starts beating properly.

Off-pump heart bypass surgery: This is similar to a traditional heart bypass surgery, the heart is accessed via an incision in the chest bone but it is not stopped and neither is placed on a bypass machine, instead the blockage is treated on the beating heart.

Minimally-invasive heart bypass surgery: A fairly new but minimally invasive procedure that uses several small incisions on the left side of the chest, between the ribs to access the heart instead of a large cut in the chest bone. This procedure primarily restores blood flow to the blood vessels in front of the heart. However, it is not effective in severe cases or cases that have more than one or two blocked or narrowed arteries.

The procedure of a Beating Heart Bypass Surgery

Before the procedure, the doctor will assess the condition of the patient via several tests such as chest x-rays, blood, electrocardiogram (ECG) and a coronary angiogram. The doctor will advise the patient on what to eat or how long to stay empty stomach before the surgery. Moreover, medications will also be controlled by the doctor.

Usually, a beating heart bypass surgery can take 3 to 6 hours, depending on how many arteries are involved. The patient is given general anaesthesia and a breathing tube. Then the surgeon makes an incision down the chest to access the heart.

In this type of heart bypass surgery, the surgeon removes a section of the healthy vein or artery from a healthy area of the body. This process is known as a graft. One end of this graft is then attached to a part of the heart, which is above the blockage in the artery. The other end of the graft is linked to the part below the blockage. Once the ends of the graft are attached, the blood flow to the heart is restored.

In a general heart bypass surgery, during this procedure, the heart is stopped and connected a heart-lung bypass machine, which keeps supplying blood and oxygen to the tissue. Thus, keeping the heart alive and meanwhile, allowing the surgeon to relieve the blockage. However, in case of a beating heart bypass surgery, the heart is neither stopped nor placed on a bypass machine; instead, the surgeons operate on the beating heart.

One of the major challenges in a beating heart bypass surgery is that it is very difficult to suture on a beating heart; hence, the surgeons use a stabilization system to keep the heart steady. This stabilization system comprises of a heart positioner and a tissue stabilizer. The former directs and holds the heart in a position to allow easy access to the blocked arteries. On the other hand, the tissue stabilizer holds a small part of the heart, allowing the surgeon to operate on it. This allows the surgeon to perform the heart bypass surgery without actually stopping the heart or using the heart-lung bypass machine.

After the procedure, the patient is kept under observation and is discharged when stabilized. The doctor will also instruct the patient on the diet, lifestyle habits, medications, post-operative care, etc.  

Advantages and Disadvantages of a Beating Heart Bypass Surgery

Advantages

  • Fewer blood transfusions
  • Can be minimally invasive
  • Reduced chances of abnormalities in heart rhythm
  • Reduced stay in the hospital
  • Alternative treatment for certain patients with health problems and issues

Overall, beating heart bypass surgery is a great alternative treatment for patients who cannot undergo traditional heart bypass surgery. Certain factors such as advancing age, previous stroke, vascular disease, liver disease, or any other critical health issues – can make the heart-lung machine bypass surgery very risky.

Sutureless Valve Surgery

Sutureless valve surgery is a recent medical advancement in the field of minimally-invasive valve surgeries. Up till now minimally invasive aortic valve replacement and the transcatheter aortic valve replacement (TAVR/TAVI) were considered the safest options in comparison to general invasive valve replacement surgeries, which caused a lot of surgical stress and trauma for the patient.

The new advanced method of valve replacement avoids the placement and tying of sutures and hence, is referred to as the sutureless valve surgery and even rapid deployment of aortic valves. The new method is advantageous over others because it reduces cross-clamp and cardiopulmonary bypass duration. This helps to carry out complex cardiac interventions with much more ease and while maintaining hemodynamic outcomes and low paravalvular leak rates. However, since the method is fairly new, the applicability of the procedure is limited to certain specific patient cases, as deemed fit by the surgeon.

The concept of sutureless valve surgery was introduced more than 50 years ago; however, they have been just recently redeveloped based on the learnings and experiences from TAVI. However, even until now, a majority of valve replacement procedures are conducted using the sutured biological valves.

Advantages of Sutureless Valve Surgery

Some of the common advantages of sutureless valve surgery over other invasive, as well as minimally-invasive methods, include:

  • Minimally-invasive
  • Excellent hemodynamic performance
  • The high rate of freedom from structural valve degeneration (up to 15 years)
  • Low paravalvular leak rates
  • Less surgical stress and trauma
  • High recovery rate
  • Shorter hospital stay
  • Reduced cross-clamp and cardiopulmonary bypass duration
  • Perceval prosthetic valve is easy to implant and safe
  • Reduced operative time
  • Simplified surgical implantation
  • Fewer post-operative complications
  • Comparatively reasonable
  • Rapid deployment

Challenges of Sutureless Valve Surgery

Since the method is fairly new, there are a couple of unexplored dimensions and challenges. Some of the common challenges in sutureless valves surgeries include:

  • Lack of enough information on the new generation of prostheses
  • Rare chances of dislodgement, malposition, leakage, aortic tear
  • Could require multiple attempts

But given the advantages of the sutureless valve surgeries over other methods, surgeons increasingly prefer the former since it represents a natural evolution. Also, when patients suffer from multiple comorbidities or poor ventricular function, a sutureless valve surgery may be the ideal choice of treatment. Additionally, sutureless valve surgery is an optimal choice for multiple valve or concomitant procedures. Since sutureless valves produce lower gradients as compared to the sutured alternatives, this method works well in patients that have small aortic root.

Types of Sutureless Valves

Currently, there are two types of sutureless valves available for treatment, namely Sorin’s Perceval and Edwards’ Intuity. Both use bovine tissue but the former uses a nitinol stent, whereas the latter uses a stainless steel one. The Perceval stent requires no suture at all, while the Intuity one requires three basic sutures. Also, Perceval is a collapsible valve but Intuity is not.

The Intuity stent is based on expandable stainless steel and cloth-covered frame, which is placed with the help of a balloon catheter and expands the frame within the right annular position. This requires three sutures.

On the other hand, the Perceval sutureless prosthesis uses the ‘memory’ of the nitinol metal frame, helping it to deploy and position the valve without any sutures.

Similarities between Sutureless Valve Surgery and Traditional Methods

Sutureless valve surgery has several similarities with traditional valve surgeries such as conventional prostheses. These include:

  • Both procedures need surgical incisions, either full median sternotomy incision or minimally invasive incisions such as mini-sternotomy and mini-thoracotomy
  • Sutureless valve surgery does not preclude the need for CPB and aortic cross-clamping completely.
  • Both approaches excise the diseased valve

Difference between Sutureless Valve Surgery and Traditional Methods

There are critical differences between sutureless valve surgery and other traditional methods, such as:

  • Sutureless valves do not require extensive placement and tying of sutures
  • Unlike the traditional methods, the sutureless valves are sized and deployed with a maximum of three sutures to perfectly attach to the aortic root orifice
  • Sutureless valve surgery is a shorter duration operation unlike the traditional long procedures
  • Even though both sutureless valve surgery and the TAVI prosthesis follow the same principle, yet the former does not need crimping of the pericardium like the TAVI process
  • A TAVI procedure gains indirect visualization of the implantation and target location through fluoroscopy; whereas the sutureless valve surgery has direct visualization of the implantation and target office location
  • The current TAVI protocols exclude excision of the diseased calcified aortic valve, in contrast to that of the sutureless valve surgery

Overall, even though there is a high demand for minimally-invasive procedures and sutureless valve surgery is a great choice, yet there is low patient adoption of the novel technique of valve repair or replacement.

Know the different kinds of valve replacement surgeries commonly done

Heart valve replacement surgeries are medical procedures done to treat the diseased heart valves. Heart valve disease implies a condition where at least one of the four heart valves is not functioning properly, thus, restricting the flow of blood through the heart.

The human heart has four valves, each with a set of flaps known as leaflets and cusps. Normally, these flaps open and close in a heartbeat but when the valves are compromised, these flaps do not open or close properly. This disrupts the flow of blood through the heart to the rest of the body.

Thus, in a heart valve surgery, the doctor repairs or replaces the valve, depending on the severity of the condition. Multiple surgical approaches can be used for valve replacement including open-heart surgeries, as well as minimally invasive procedures. However, the type of treatment depends on the condition of the patient, the age, general health, and the underlying problem.

Some common valve replacement procedures include:

Surgical Aortic Valve Replacement (SAVR): Surgical aortic valve replacement istraditional,open chest surgery that replacesdamaged valves and is recommended for patients whose condition is strong enough to manage this surgery and the recovery.  A SAVR is preferred for patients with low-risk. In a SAVR procedure, an incision is made in the chest to reach the heart; once through, the heart is placed on a heart-lung bypass machine, while the damaged aortic valve is replaced with a new one. The heart is the restored and the incision is closed. SAVR has shown great results on patients who are suitable for the surgery. Though the recovery time post a SAVR procedure is long and approximately requires 5-7 days of hospitalization, plus at least 6 weeks of full recovery.

Benefits of choosing to a surgical aortic valve replacement are:

  • Lower chances of a permanent pacemaker
  • Matured method
  • The long span of the valve

A SAVR procedure may involve certain risks such as:

  • Infection
  • Blood clots
  • Stroke
  • Irregular heart rate
  • Longer recovery time
  • Acute kidney injury
  • Blood transfusion

Transcatheter Aortic Valve Replacement (TAVR) or Transcatheter Aortic Valve Implantation (TAVI): TAVR or TAVIis a surgical method performed to repair a compromised, blocked or narrowed artery which was disrupting the blood and oxygen supply to the heart. This surgical procedure is recommended for patients who have a higher risk or are too sick or suffer from severe aortic stenosis, or too old for open-heart surgery. This breakthrough procedure is advanced than a standard valve replacement.

The Transcatheter Aortic Valve Replacement (TAVI/TAVR) procedure involves the implantation of the aortic valve via a catheter without removing the damaged, old valve. Instead, TAVI/TAVR wedges another valve into the aortic valve’s place (valve-within-valve). The approach is very similar to the placement of a stent – a stainless steel mesh – in the artery. In a TAVI/TAVR procedure, a small incision either through the upper chest or groin is made to place a small, hollow fine tube (sheath) that provides access to the aortic valve by placing a catheter mounted with a balloon. Once, the catheter is in place, the balloon is inflated at the termination point to push the plaque to the sides.

Once the compromised valve is opened, a completely collapsible valve (artificial, biological or a combination of the two) in replacement, on the site of the old valve is placed through the catheter. Once, the placement is made, the new valve expands and drives the old one out of the place, enabling the new tissue in the valve to become the primary medium of regulating blood flow in the heart. Post successful positioning, the balloon is deflated and removed.

Where a standard valve replacement surgery involves an open heart surgery by a sternotomy via a surgically opened chest, a TAVI/TAVR process is less invasive and involves small openings that do not harm the chest bones.

A TAVI/TAVR procedure can be performed in two ways:

Transfemoral Approach: In this, the doctor enters through the large artery in the groin, without any surgical incision in the chest.

Transapical Approach: In this one, the doctor enters through the large artery in the chest by making small incisions on the chest.

Even after 20 years of existence, TAVI/TAVR procedure is continually being studied and advanced upon with newer techniques and refinements in technology and procedure, enhanced devices, post-operation care, newer approaches, and more.

That said, a TAVI/TAVR treatment has both benefits and risks involved. Some of the benefits include:

  • Reliable alternative to open-heart surgery
  • High survival rate
  • Less invasive
  • Less damage or chances of infection
  • Faster recovery period

Risks involved in a TAVI/TAVR procedure include:

  • Bleeding
  • Abnormal heartbeat and rhythm
  • Kidney disease
  • Adjustment problems with replaced valve
  • Stroke

Though uncommon, these risks are important to be aware of before evaluating all options of treatment. Even the doctor will conduct several tests such as an ultrasound, echocardiogram, cardiac CT scan, and cardiac catheterization to determine if a TAVI/TAVR or SAVR procedure is best suited to your condition.

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