Introduction

Medical malpractice insurance is a type of insurance that protects healthcare providers from legal claims of medical malpractice. Medical malpractice occurs when a healthcare provider fails to provide the standard of care required for a patient, resulting in injury or harm. In this article, we will discuss three major topics related to medical malpractice insurance.

1. Types of Medical Malpractice Insurance

There are two main types of medical malpractice insurance: claims-made and occurrence-based. Claims-made insurance provides coverage for claims made while the policy is in effect, regardless of when the alleged incident occurred. Occurrence-based insurance provides coverage for claims that arise from incidents that occur during the policy period, regardless of when the claim is made.

Additionally, healthcare providers can purchase either individual coverage or group coverage. Individual coverage provides insurance for a single healthcare provider, while group coverage provides insurance for an entire group or organization.

2. Coverage Limits

Medical malpractice insurance policies typically have two types of coverage limits: per claim and aggregate. The per-claim limit is the maximum amount of coverage provided for individual claims. The aggregate limit is the maximum amount of coverage provided for all claims made during the policy period. It is important to carefully consider these limits when selecting a medical malpractice insurance policy.

3. Importance of Medical Malpractice Insurance

Medical malpractice insurance is an important aspect of protecting healthcare providers from financial ruin. Without insurance coverage, healthcare providers may be responsible for paying out immense amounts of money in the event of a malpractice claim. Additionally, insurance can provide peace of mind and allow healthcare providers to focus on providing quality care to their patients.

Conclusion

Medical malpractice insurance is a critical aspect of protecting healthcare providers from legal claims and financial repercussions. By understanding the types of insurance available, coverage limits, and the importance of obtaining insurance, healthcare providers can ensure that they are protected in the event of a malpractice claim. It is important to work with an experienced insurance agent or broker to determine the best insurance policy to meet your needs as a healthcare provider.

What is Medical Malpractice Insurance?

• Medical malpractice insurance is a financial-based instrument available only to physicians or those individuals involved in healthcare. By purchasing a medical malpractice policy, the physician or medical professional is protected in the event of a judgment against them for medical negligence, malfeasance, or in general malpractice.

• The majority of states in America require that physicians have some form of medical malpractice insurance to protect them from a faulty or negligent action. In addition to a state mandate, the majority of hospitals or medical institutions will require physicians to be obtain a form of coverage—institutions will require the obtainment of a policy to protect them against costly settlements.

How Medical Malpractice Insurance Works

• A physician will purchase a medical malpractice policy from either a commercial insurance company or a mutual insurance company that is operated by a health care provider or medical professional. The physician can either choose individual coverage or be a part of a policy that incorporates the underlying practice or institution in which the doctor is employed.

• The form of coverage purchased is dictated by the individual physician’s employer. Those doctors or medical professionals employed by the United States Federal Government will not be required to purchase a medical malpractice insurance policy—any lawsuit against the federal government is self-insured.

How is the Medical Malpractice Premium Determined?

• The majority of physicians are rarely sued or sued infrequently. As a result, the data attached to a premium calculation is actuarially unsound. This characteristic makes it impossible for a physician to be “rated” or “classified” based on past history. In addition, the claims filed against a doctor are based on circumstance, making the issues concerning with a premium determinant difficult to gauge.

• As oppose to past histories, the premiums associated with medical malpractice insurance are determined based on specialty. All physicians are classified based on their medical field or their specialty.  Each classification is attached to a rate based on the probability of an occurrence of a medical malpractice issue. For example, orthopedic surgeons are more susceptible (as a result of the skill required to perform surgery) to negligent actions or mistakes, and as a result, are more likely to face a medical malpractice suit. As a result of this general susceptibility, orthopedic surgeons will face higher premiums for their medical malpractice insurance policies. In addition, the location of the physicians or medical professionals practice, will affect the premium level.

• As a result of the rising number of medical malpractice cases, insurance companies are realizing that the business of offering medical malpractice insurance is not indisputably profitable. This realization has increased premiums and placed a strain on the medical field.

Introduction

Medical negligence claims can arise when a healthcare provider, such as a doctor, nurse, or hospital, fails to provide the standard of care required for a patient, resulting in injury or harm. If you or a loved one have been a victim of medical negligence, it is important to understand how to handle the claim to ensure that you receive the compensation and justice that you deserve. In this article, we will discuss some key steps to take when handling a medical negligence claim.

Seek Medical Attention

If you or a loved one have been a victim of medical negligence, the first step is to seek medical attention. It is important to address any injuries or harm that may have resulted from the negligence and to document any relevant medical records.

Gather Evidence

Gathering evidence is an important part of handling a medical negligence claim. This may include medical records, photographs of injuries, witness statements, and any other relevant documentation. It is important to keep all of this evidence organized and readily accessible, as it will be needed throughout the legal process.

Consult with an Attorney

Consulting with an experienced attorney is crucial when handling a medical negligence claim. Attorneys who specialize in medical malpractice and negligence can navigate the complex legal system and help you understand your legal options. They can also gather evidence, negotiate with insurance companies, and represent you in court if necessary.

File a Complaint

If you believe that you or a loved one have been a victim of medical negligence, it is important to file a complaint with the appropriate regulatory body. This may include the state medical board or the hospital where the negligence occurred.

Negotiations and Settlements

In many cases, medical negligence claims can be settled outside of court through negotiations with the negligent party or their insurance company. It is important to consult with an attorney before accepting any settlement offers to ensure that you are receiving fair compensation for your injuries or harm.

Conclusion

Medical negligence can have serious consequences for patients and their families. If you believe that you have been a victim of medical negligence, it is important to seek medical attention, gather evidence, consult with an attorney, file a complaint, and navigate the legal process. By taking these steps, you can ensure that you receive the compensation and justice that you deserve.

What is a Medical Negligence Claim?

• A medical negligence claim is a direct legal action taken by a patient who falls victim to the negligent or wrongful actions of a medical provider or medical professional. All medical professionals work under a code of ethics. Considering the importance of their role, all physicians and medical professionals are required to provide suitable support and medical advice to their patients. These actions must be delivered in the patient’s best interest to accurately treat, diagnosis, or rehabilitate the individual. A failure to deliver this expected course of conduct may result in the filing of a medical negligence claim.

• To be considered medical negligence, the patient in question must suffer from an injury or some form of damage that arose from the medical professional’s actions.  These actions are not always direct; a misdiagnosis or a faulty prescription can result in long-term effects. Regardless of the specifics, all medical negligent claims are filed because the patient (who expected to receive suitable care) was injured, harmed, or suffered some form of loss as a result of the doctor’s negligent or wrongful actions.

• Medical negligent claims are filed through the civil court system of the particular jurisdiction in which the negligent or wrongful action took place. A medical negligent claim is filed by the patient to recoup finances from their injury. When an individual falls victim to a negligent or fraudulent medical action they will invariably suffer from sort of pain—emotional or physical pain must be present which results in the loss of wages or emotional distress.

• The laws associated with medical negligence claims–meaning the grounds for what constitute a medical negligent action—are dictated through state interpretation. Medical negligence is not always a direct issue; similar to other personal injury claims the negligent actions must be directly linked to the patient’s suffering.

• In addition to the varying interpretations, all states possess different statues of limitations that regulate when a medical negligence suit can be filed.

How to File a Medical Negligence Case

• To recoup finances lost from an injury or emotional distress caused by a doctor’s actions, you must gather all information regarding your particular case. A list of the doctor’s actions, all appointments with the underlying medical provider, prescriptions, diagnoses, and a proof of wages or time lost due to the injury must be presented at the medical negligence trial.

• After all information has been gathered and you understand your particular state’s interpretive laws regarding medical negligence, you must hire a medical malpractice attorney to facilitate your claim. Utilize all resources (the yellow pages, the Internet, word of mouth) before hiring a medical malpractice attorney.

• When an attorney is hired, develop a strategy that will give your case the best opportunity to reach a favorable settlement. The most important aspect of developing a strong case is the obtainment of information and evidence.

Introduction

Misdiagnosis is a serious issue that can have negative impacts on patients and their families. When a healthcare provider fails to accurately diagnose a medical condition, it can result in a delay in treatment, inappropriate treatment, or no treatment at all. In this article, we will discuss some crucial information that patients should know to avoid misdiagnosis.

Understanding Misdiagnosis

Misdiagnosis occurs when a healthcare provider fails to accurately diagnose a medical condition. This can include a failure to recognize or interpret symptoms, a misinterpretation of test results, or a failure to consider all possible diagnoses. Misdiagnosis can have serious consequences for patients and can result in unnecessary treatments or procedures, a delay in treatment, or even death.

Commonly Misdiagnosed Conditions

There are some medical conditions that are commonly misdiagnosed by healthcare providers. These can include cancer, heart disease, stroke, and infections. It is important to understand the symptoms of these conditions and to advocate for your own health if you suspect that you may be experiencing symptoms.

Causes of Misdiagnosis

There are many different factors that can contribute to misdiagnosis. These can include incomplete or insufficient medical history, errors in interpretation of diagnostic tests, limited time for patient evaluation, lack of communication between healthcare providers, and a failure to consider all possible diagnoses.

Preventing Misdiagnosis

Preventing misdiagnosis starts with being an informed patient. This means being aware of your own medical history and symptoms, asking questions, and communicating clearly with your healthcare provider. It is important to be persistent when seeking a diagnosis and to seek a second opinion if necessary.

Legal Options for Misdiagnosis

If you believe that you or a loved one have been a victim of misdiagnosis, it is important to consult with an experienced attorney. An attorney can help you understand your legal options and navigate the complex legal system. They can also gather evidence, negotiate with insurance companies, and represent you in court if necessary.

Conclusion

Misdiagnosis is a serious issue that can have negative impacts on patients and their families. By understanding the causes of misdiagnosis, being an informed patient, and seeking legal representation if necessary, you can protect yourself and ensure that you receive the appropriate treatment and care that you deserve. If you believe that you or a loved one have been a victim of misdiagnosis, do not hesitate to seek medical attention and consult with an experienced attorney.

What is a Misdiagnosis?

• A misdiagnosis is an inaccurate diagnosis of a medical ailment. Medical professionals can misdiagnose an individual depending on a number of factors; however, in most instances a misdiagnosis is delivered through a negligent action taken by the medical provider or physician. An erroneous diagnosis can take on a number of forms—sometimes a medical problem is identified when the patient has no such ailments, or a diagnosis can be classified incorrectly. Examples of the latter include a doctor who diagnoses a tumor as benign when it is in fact malignant.

• A misdiagnosis is a medical error, and although it may be difficult to gauge given varying symptoms or the presence of inaccurate statistics, all forms of misdiagnoses will portray some form of externalities or adverse side effect.
Contact a medical-malpractice-lawyer to acquire legal advice and assistance.

Reasons for a Misdiagnosis?

• There are a number of reasons that will cause a misdiagnosis. People often times blame negligent actions or laziness for an inaccurate diagnosis; however, a misdiagnosis can arise for a number of medical reasons. That being said, the presence of a misdiagnosis may award an individual the right to file a medical malpractice suit.

• Reasons that would not necessitate or warrant a medical malpractice suit for a misdiagnosis include: faulty or malfunctioning medical equipment, a patient’s discretion to conceal critical information, a language barrier between the medical professional and the patient, or a situation in which the symptoms of the ailment did not match the universal diagnosis.

• Reasons that would necessitate or warrant a medical malpractice suit for a misdiagnosis: a negligent action taken by a doctor, a failure to adhere to the code of conduct necessary for all doctors to abide by, or a blatant wrongdoing that stems from laziness or the doctor’s inability to deliver a routine medical action.

Consequences of a Misdiagnosis

• The consequences of a misdiagnosis are variable; for example if a patient’s biopsied tumor is misdiagnosed as malignant when it is in fact benign, he or she will undergo unnecessary medical operations. This obviously would adversely affect the individual’s health and would invariably result in a medical malpractice suit.

• In order for the misdiagnosis to be considered malpractice, the individual must suffer a direct loss through a physical damage. Undergoing unnecessary surgery or chemotherapy will inevitably result in a negative effect in the form of unwarranted scars, sickness, and the loss of wages. These instances are grounds for medical malpractice suits; the individual will file a medical malpractice suit to obtain a recoupment for the losses suffered.

• In these instances, the individual must hire a medical malpractice attorney to facilitate their medical malpractice case. The individual must demonstrate to the local court system that the misdiagnosis directly lead to a loss in the form of finances, physical pain, or emotional distress.

Introduction

Medical malpractice is a serious issue that affects patients across the country, including in New York. It is a complex legal issue that can be difficult to navigate. However, recent changes made by New York courts have streamlined the process for medical malpractice claims and made it easier for patients to seek justice and compensation when they have been harmed by a healthcare provider’s negligence.

What are the Changes?

In 2020, New York courts implemented changes to streamline the process for medical malpractice claims. One of the most significant changes was the creation of designated judges and rules for medical malpractice cases. This means that medical malpractice cases are now heard in front of judges who have specialized training and experience in this area of law.

Another change was the modification of the discovery process. Discovery is the process of gathering evidence in a legal case. The changes made to the discovery process aim to limit the scope of discovery and reduce the burden on plaintiffs. This can help to speed up the litigation process and make it more efficient.

Why are these Changes Important?

These changes are important because they make it easier for patients to pursue medical malpractice claims. By creating designated judges and rules, patients can be assured that their claim will be heard by a judge with specialized knowledge and experience in medical malpractice cases. This can help to ensure that the case is handled efficiently and fairly.

The modifications to the discovery process can also help to speed up the litigation process, which can be a benefit to both plaintiffs and defendants. This can help to reduce the overall costs of litigation and make it easier for plaintiffs to pursue their claim without undue burden.

What does this Mean for Patients?

For patients who have been harmed by medical malpractice, these changes mean that the process of seeking justice and compensation may be easier and more efficient. Patients can now be assured that their case will be heard by a judge with specialized knowledge and experience in medical malpractice cases, which can help to ensure a fair outcome.

Additionally, the modifications to the discovery process can help to reduce the burden on plaintiffs, making it easier for them to pursue their claim. Overall, these changes can help to make the process of seeking justice and compensation for medical malpractice claims more accessible and efficient.

Conclusion

Medical malpractice is a serious issue that affects patients across the country, including in New York. The changes made by New York courts in 2020 have streamlined the process for medical malpractice claims, making it easier for patients to seek justice and compensation when they have been harmed by a healthcare provider’s negligence. Patients can now be assured that their case will be heard by a judge with specialized knowledge and experience in medical malpractice cases, and the modifications to the discovery process can help to reduce the burden on plaintiffs. These changes represent an important step forward in ensuring that patients receive the justice and compensation that they deserve in cases of medical malpractice.

New York courts specializing in the state’s 4,000 medical malpractice cases filed annually have begun expanding following the success of a Bronx judge in expediting the settlement process.

The approach, which has shown to save money by reducing court backlogs, has been extended to the other boroughs, through the implementation of training and educational programs.

Starting December 1st, New York Chief Administrative Judge, Ann Pfau, will become the coordinating judge of the court system’s medical malpractice segment. The program is using a $3 million federal grant to train more judges in expediting the process.

Bronx Justice Douglas McKeon, who has focused on malpractice cases for over 15 years, said he helped settle over 1,000 malpractice suits in his career. The efficacy in settling such cases is attributed to the city’s Health and Hospitals Corporation—an entity which runs 11 public hospitals and uses its own claims and law department to settle cases in a streamlined fashion.

Courpration deputy counsel Suzzane Blundi stated that the entity revamped their commitment to patient safety, developing programs to manage claims, improve care and decrease payouts. The effort also investigates malpractice claims early on to help expedite settlements.

Introduction

Birth complications are common around the world, but they are on the rise in the United States. Death or injury during childbirth can have serious consequences for both mothers and children. In this article, we will discuss severe birth complications on the rise in the United States, what could be causing the increase, and what can be done to address the issue.

What are Severe Birth Complications?

Severe birth complications refer to life-threatening events that occur during pregnancy, childbirth or in the postpartum period. These complications can include hemorrhage, sepsis, preeclampsia, and eclampsia. According to the Centers for Disease Control and Prevention (CDC), these complications can lead to death or long-term disability.

Rise in Severe Birth Complications

In the United States, there has been a significant increase in severe birth complications in recent years. According to a report from NPR, the rate of severe maternal morbidity has more than doubled since 1993. Additionally, the maternal mortality rate in the United States is higher than in most other developed countries.

Research suggests that there are several factors contributing to this increase in severe birth complications. These factors include a rise in chronic health conditions among pregnant women, an increase in the number of older mothers, and a lack of access to quality prenatal and postpartum care.

Impact on Mothers and Children

Severe birth complications can have a devastating impact on both mothers and children. Mothers may experience long-term health problems, including chronic pain, infection, infertility, and post-traumatic stress disorder. Additionally, children may be born premature, have low birth weights, or experience developmental delays.

What Can Be Done?

To address the issue of severe birth complications, there are several steps that can be taken. First, there needs to be a greater focus on providing high-quality prenatal and postpartum care. This can include increasing access to healthcare for pregnant women and improving the quality of care provided by healthcare providers.

Secondly, more research needs to be done to identify risk factors for severe birth complications and how to prevent them. This can include studying the impact of chronic health problems on pregnant women and understanding how to identify and treat pregnancy complications early.

Conclusion

Severe birth complications are on the rise in the United States, and it is important to understand the causes and consequences of this trend. By improving access to quality prenatal and postpartum care and investing in research, we can work to ensure that mothers and children have the best possible outcomes during childbirth.

Severe complications like kidney failure and heart attacks during and immediately after labor and delivery are rising nationwide, says a CDC report.  The report, published in the November issue of Obstetrics & Gynecology, has serious implications for pregnant women, attorneys in the malpractice field, obstetricians, midwives, and other birth professionals.

Because the study the report was based on was conducted by the Centers for Disease Control, it could examine a very large, nationwide sample of births.  The Nationwide Inpatient Sample, used by the study, includes information on over five million patients annually at approximately 1,000 hospitals.  According to these samples, having a baby is the single most common thing that Americans do in hospitals—labor and delivery accounted for more hospital intakes than any other single cause.

Out of about 50 million births recorded during the period from 1998 to 2009, about 600,000 involved severe complications in delivery or in the immediate period after delivery.  Women were recorded as having severe complications if they had to receive a blood transfusion or had a serious infection or other illness.

Some of these events had seen a significant increase over the eleven year timespan.  For example, the rates of blood transfusion went up over 180 percent.  Embolisms were also more common, as were tracheotomies and heart attacks.

However, not all of the news was negative.  Maternal death rates are on the decline even as overall complication rates have gone up.  The rate of in-hospital maternal death is just over one in 10,000—a 37 percent reduction overall from what the maternal death rate was at the beginning of the study.

Several theories have been proposed to explain the increasing rates of complications.  One of the reasons for the increase may be that minority women are still unable to get equal access to healthcare.  They experience both fetal and maternal death more frequently than white women across the board.

Uninsured mothers are another component of the increase in complications, because the greatest risks for complications occur in women who have not received routine prenatal care.  Higher rates of obesity in the American population have also led to an increase in complications like high blood pressure and diabetes, which can make giving birth significantly more risky even with modern medical technologies.

Older women are also significantly more likely to experience birth related complications, especially women over the age of 40 who are giving birth for the first time.  In recent years, more women in this age group have been able to successfully conceive and give birth thanks to assisted reproductive technologies.  While these technologies have benefited many people, they also put more high-risk patients into obstetrics wards every year.

According to the CDC,  the best ways for women to avoid pregnancy related complications and maternal mortality involve taking good care of their bodies before getting pregnant.  Losing weight, stopping smoking, and getting untreated diabetes or hypertension under control before becoming pregnant is critical to a healthy mother and baby.

Source: cdc.gov

Introduction

The position in which a baby is born can have a significant impact on their health and wellbeing. In most cases, a baby is born head-first, known as a vertex position. However, there are cases where a baby is born bottom-first, known as a breech position. Historically, breech births have been considered more dangerous and often resulted in a cesarean section delivery. However, a new study published in the American Journal of Obstetrics and Gynecology has found that head-first births before 32 weeks of gestation are safe, even if the baby is in a breech position. In this article, we will explore the study’s findings and what they could mean for the management of breech births.

The Study

The study looked at the outcomes of nearly 1,500 premature babies who were born between 28 and 32 weeks of gestation in breech or vertex positions. The researchers found that there was no significant difference in the rates of complications or mortality between babies born head-first or bottom-first. Additionally, the study found that babies born head-first in the breech position were not at a higher risk of complications or mortality compared to those born in the vertex position.

Implications for Breech Birth Management

The findings of this study have important implications for the management of breech births, particularly for premature babies. Historically, breech births have been considered more dangerous and often resulted in a cesarean section delivery. However, this study suggests that head-first births before 32 weeks of gestation can be safely managed through spontaneous vaginal delivery, even if the baby is in a breech position.

Importantly, the study highlights the need for personalized care and careful consideration of each individual case. While head-first births may be safe in certain circumstances, there are factors such as the baby’s size, the mother’s health, and the presence of other complications that may warrant a cesarean delivery. Women should work closely with their healthcare providers to ensure that the safest delivery method is chosen for their individual circumstances.

Conclusion

The study published in the American Journal of Obstetrics and Gynecology suggests that head-first births before 32 weeks of gestation are safe, even if the baby is in a breech position. This has important implications for the management of breech births, particularly for premature babies. While head-first births may be safe in certain circumstances, personalized care and careful consideration of each individual case are important. Women should work closely with their healthcare providers to ensure that the safest delivery method is chosen for their individual circumstances. As research in this area continues to develop, it is important that best practices for breech births are based on the best available evidence and tailored to each individual’s unique needs.

On September 21, 2012, the National Institutes of Health reported that infants delivered head-first in standard deliveries before the 32^nd term are just as likely to survive as infants delivered by a planned cesarean.

Infants born before the 32^nd week face an increased risk of “death, cerebral palsy, developmental delays, infections and vision and hearing problems.”  Many studies have argued that infants delivered vaginally before the 32^nd week face an increased risk of injury or other health risks once passing through the birth canal, and many of the same studies have promoted cesarean deliveries in such situations.

However, the NIH argues otherwise.  In the recent study, the NIH compared results between about 3,000 women who underwent a head-first, standard delivery and those who chose a planned cesarean delivery.

The NIH reports, “Nearly 80 percent of the women with a fetus positioned head-first attempted a vaginal delivery, and 84 percent of them were successful.  The remainder ultimately delivered by cesarean.”  The success rate was the same for planned cesareans.

The survival rate for breached infants under 32 weeks is significantly higher during a planned cesarean.  Uma M. Reddy, M.D., M.P.H., of the Eunice Kennedy Shriver National Institute of Child Health and Human Development states, “The decision to deliver vaginally or by cesarean is an individual one, and must be made carefully by the woman, in close consultation with her physician”

The NICHD conducted the study, and their next goal is to understand the results from “extremely preterm” deliveries and the neurological and physical disabilities associated with such deliveries.

The study presents several challenges in medical malpractice law.  A doctor is now less liable if they suggest a head-first, standard delivery before the 32^nd week.  Still, the link between preterm deliveries and neurological disabilities needs studied further.

Source: National Institutes of Health

Introduction

Heart valve replacement surgery has been a lifesaving procedure for thousands of patients over the years. Traditional heart valve replacement surgery involves an open-heart procedure, which can be risky and require a long recovery time. However, the development of the Sapien artificial heart valve has revolutionized heart valve replacement surgery. The Sapien valve is inserted into the heart through a small incision, making the procedure much less invasive and reducing recovery time. In October 2012, the use of the Sapien valve was expanded to include patients who are not candidates for traditional heart valve surgery. In this article, we will explore the features of the Sapien valve and the implications of its expanded use.

The Sapien Valve

The Sapien valve is a bioprosthetic valve that is made from animal tissue and mounted on a stent frame. The valve is designed to be inserted into the heart through a small incision in the leg or chest, using a catheter. Once in place, the valve expands to fit the patient’s natural valve, effectively replacing the damaged or diseased valve.

The Sapien valve has been used successfully in patients with aortic stenosis, a condition where the heart’s aortic valve becomes narrow and obstructs blood flow. The valve has been shown to reduce symptoms and improve survival rates in patients with this condition compared to medical management alone.

Expanded Use

In October 2012, the U.S. Food and Drug Administration (FDA) approved the expanded use of the Sapien valve for patients who are not candidates for traditional heart valve surgery. This includes patients who are considered high-risk for open-heart surgery due to factors such as their age, frailty, or other medical conditions.

The expanded use of the Sapien valve opens up new treatment options for these patients, who may have previously been deemed too high-risk for surgery. With the use of the Sapien valve, these patients can undergo heart valve replacement without the high risks associated with open-heart surgery.

Implications for Patients and Healthcare Providers

The expanded use of the Sapien valve has important implications for patients and healthcare providers. Patients who are not candidates for traditional heart valve surgery can now receive life-saving treatment with a less invasive procedure. This can improve their quality of life and potentially extend their lifespan.

For healthcare providers, the expanded use of the Sapien valve offers a new treatment option for high-risk patients. The minimally invasive procedure and reduced recovery time also mean that patients can be treated more efficiently, which can lead to cost savings for the healthcare system as a whole.

Conclusion

The expanded use of the Sapien artificial heart valve offers new treatment options for patients who are not candidates for traditional heart valve surgery. The minimally invasive procedure and reduced recovery time can improve patient outcomes and potentially extend their lifespan. For healthcare providers, the expanded use of the Sapien valve offers a new treatment option for high-risk patients and can lead to cost savings. As the use of the Sapien valve continues to expand, it is important to carefully evaluate patient suitability and ensure that best practices are followed for the safe and effective use of this innovative technology.

On October 19, 2012, the Food and Drug Administration approved the expanded use of the Sapien Transcatheter Heart Valve (THV).  Patients with aortic valve stenosis who can receive surgery but appear at risk of serious complications during surgery are now approved for the heart valve.

The Sapien THV was first approved in 2011 for patients who could not undergo surgery for aortic valve stenosis.  The condition occurs when calcium deposits occur on the aortic valve and cause it to narrow.  The heart will eventually work harder to push blood through the reduced opening, and aortic valve stenosis can eventually lead to fainting, chest pain, heart failure, arrhythmias, or even cardiac arrest.

The Sapien THV does not require a surgeon to open the chest or heart.  Instead, the THV is compressed into a small tube referred to as a delivery catheter.  The delivery catheter and the THV are then placed in the femoral artery in the leg and threaded to the bad valve.  Lastly, the THV is released from the delivery catheter and then increased to normal size with a balloon.  The inserted THV begins working right away.

The use of the Sapien THV was expanded after a clinical study compared results between 348 patients who received the THV through the delivery catheter and 351 patients who received a valve replacement during open-heart surgery.  The groups experienced similar death rates during the first month, first year, and first two years.  THV recipients are at an increased risk of artery dissection or perforation, and the same patients are at risk of stroke during the first month after the procedure.

Christy Foreman, the director at the FDA’s Center for Devices and Radiological Health, stated, “Any procedure to replace the aortic valve carries the risk for serious complications, but for some patients with coexisting conditions or diseases that risk may be especially high.  The THV serves as an alternative for some very high-risk patients.”

Source: U.S. Food and Drug Administration