There are few sounds sweeter to the ear of a cardiologist than the beautifully monotonous beat of a healthy heart. That "lub-DUP" noise, signaling the steady closing of heart valves, is what every physician wants to hear and every person hopes to ignore.
Yet, for many cardiac patients, the path to that constant rhythm is far from steady. It is paved with numerous, iterative technological innovations built on an increasingly solid and wide-ranging scientific foundation. It is a world in search of dull continuity through exciting medical science disruptions.
So, how many ways can one build a "better mousetrap" for the human heart?
It turns out, quite a few. Because while the heart is roughly only the size of a fist, it is the home of many potential challenges for its person. For this reason, scientists in Abbott's cardiovascular business are constantly developing new technologies to add to our portfolio of life-changing and -saving products.
From stents and valves to occluders, delivery systems and more, we are always evolving our heart technology portfolio to better serve cardiac patients and their doctors. Improvements and solutions to long-standing issues are being approved and made available on a regular basis, including the following over just the past few months:
XIENCE Skypoint Stent
Heart stents are small tubes placed to support arteries and improve blood flow to the heart muscle. They can help open blood vessels clogged by calcium or fatty deposits. Dual anti-platelet therapy (DAPT) is often prescribed to help prevent clots after the stent is placed, as clots can lead to heart attack, or even death.
However, DAPT can lead to increased bleeding risk for some patients with that propensity (potentially as many as one in five of those receiving stents), so physicians want to optimize the length of time DAPT is used. Our newest stent, XIENCE™ Skypoint™ received FDA and CE Mark approval for those patients at high bleeding risk, with labeling for DAPT as short as 28 days.
Also, XIENCE Skypoint is easy to place and allows physicians to treat larger blood vessels through improved stent expansion and ensure that clogged vessels are opened effectively. These new improvements further support the effectiveness and safety of the XIENCE stent family which has seen more than 15 million stent implants over more than ten years.
Amplatzer Amulet Left Atrial Appendage (LAA) Occluder
Abbott's Structural Heart team has likewise continued its efforts to reduce the risks of blood clots and strokes. The recently FDA-approved Amplatzer™ Amulet™ LAA Occluder is the first and only minimally invasive treatment that closes the left atrial appendage immediately. The LAA is a small pouch connected to the upper left chamber of the heart and, for people with atrial fibrillation (AFib), the most common form of irregular heartbeat, the blood may pool in the LAA increasing the risk of clotting. In turn, that may lead to that clot entering the blood stream, where it could travel to the brain, causing a stroke.
The ability to immediately close the LAA means that blood-thinning medication isn't needed after the device is implanted, which can be a benefit to patients with AFib who aren't able to take blood-thinners long-term.
"As the world's population continues to age, we're seeing a surge in AFib cases, and with that comes an increased risk of stroke," said Dhanunjaya Lakkireddy, M.D., who served as principal investigator for the study that led to FDA approval. "This device provides physicians with a treatment option that reduces the risk of stroke and eliminates the need for blood-thinning medication immediately after the procedure, which is incredibly valuable given the bleeding risks associated with these medicines."
Meanwhile, the good news continues as data presented at the ESC Congress 2021, organized by the European Society of Cardiology, showed the Amulet Occluder was superior in LAA closure compared to Boston Scientific's Watchman device.
Amplatzer Talisman PFO Occluder
As it turns out, the LAA is not the only potential location in the heart that could benefit from an Abbott Amplatzer occlusion device. Abbott's Amplatzer™ Talisman™ system builds on the Amplatzer PFO Occluder, already the world's leading PFO closure device.
A patent foramen ovale (PFO) is a hole in the heart where the foramen ovale – a flap-like opening that is a normal part of fetal development, allowing oxygenated blood to pass through a baby's heart and bypass the lungs – doesn't close as it should following birth. When this flap remains open or "patent," it may allow blood clots to pass from the right side of the heart to the left, from where they can travel to the brain, causing a stroke.
Patients who have suffered such a stroke may choose closure of the PFO through a minimally invasive procedure using the Talisman system to seal off the opening, reducing the risk of another stroke. Recently approved by the FDA, the Talisman occluder comes pre-attached to its delivery cable, reducing prep time and making it easier for physicians to use. The Talisman system is yet another example of advancing science and design to make effective procedures simpler and faster.
Portico with FlexNav TAVR System
When people think of heart disease symptoms, they often picture those associated with aortic stenosis, one of the most common and life-threatening heart valve diseases. When the aortic valve's opening narrows and restricts blood flow from the left ventricle to the aorta, patients can have breathlessness, chest pressure, fainting and even heart murmurs, ultimately leading to heart failure.
While many patients are treated through open-heart surgery, others are at high or extreme risk for this type of procedure. Abbott is dedicated to developing our expanding portfolio of structural heart solutions that offer innovative, minimally invasive therapies that can repair or replace damaged heart valves or close openings in the heart.
Recent FDA approval of the Portico™ with FlexNav™ transcatheter aortic valve replacement (TAVR) system puts Abbott in the position of offering the most comprehensive portfolio of structural heart solutions available in the U.S.
Portico is a self-expanding TAVR valve with leaflets within the native valve that help provide optimal blood flow when placed in a patient's natural valve. The replacement valve also preserves access to coronary arteries in case future treatment is necessary. The Portico device is placed using the FlexNav delivery system, which is slim, flexible and provides ease of tracking, as well as precise placement.
Epic Plus Tissue Valves
It would seem that when you start off as Epic, it might be challenging to improve.
But with FDA approval of the Epic™ Plus Stented Tissue Valves, the new enhancements to the Epic line seem justified. These devices build on Abbott's history of surgical valve replacement as a reliable and critical therapy option for people with valvular heart disease.
The Epic Plus and Epic Plus Supra Stented Tissue Valves are the next-generation devices built off this platform, which not only has a decades-long history of safety and strong clinical results, but includes innovations that make valve implantation and future cardiac interventions easier.
Heart valve disease occurs when one or more of the heart's four valves doesn't open or close properly, disrupting blood flow, most commonly impacting the aortic and mitral valves. When diseased or damaged valves can't be repaired, they may be surgically replaced with either mechanical or tissue valves in an open-heart procedure.
Epic Plus valves, like other products discussed above, do not require long-term use of blood thinners, making them a recommended option for older patients or others at increased bleeding risk. In addition, "Physicians can be assured of a reliable, longer-term solution for patients needing a replacement heart valve that will also allow for future cardiac interventions if necessary due to the valve's accommodating design," said Vinayak Bapat, M.D., chief of Cardiothoracic Surgery at Abbott Northwestern Hospital.
The Continuing Evolution of Heart Technology
Is there a foreseeable end to the evolution of heart technology? Will we ever reach a point where the human mind can no longer conceive of a way to extend or meaningfully improve a life?
If the innovations of the recent past are any indicator, the answer is probably no. Bioprosthetics, pea-sized pediatric devices and alternatives to open-heart surgery are likely only the beginning. But, regardless of the incredible, jaw-dropping advances to come, the most desired result will sound the same: