Cardiovascular disease is the leading cause of death and disability in the United States.
This has been the case for decades and as of 2024, nearly half of Americans have a cardiovascular condition, and those conditions cause one in four deaths, according to the American Heart Association. However, thanks to the efforts of surgeons and doctors as well as advancements in medical science, treatments for these conditions continue to become safer, more effective and available to a broader population of patients.
Through St. Luke’s University Health Network and Lehigh Valley Health Network many new, lifesaving treatments for conditions affecting the heart, blood and vascular system are available in the Lehigh Valley.
Here’s what doctors at both health networks say are the most impactful new treatments for cardiovascular conditions now being offered in the Lehigh Valley.
Advancements in ablation have ‘completely changed what we do’
Something that has been hailed as a game changer by doctors at both networks is pulsed-field ablation, a new type of treatment for atrial fibrillation that takes less time to perform, has fewer risks for complications and results in a shorter recovery time than more traditional forms of ablation.
St. Luke’s was the first in the Lehigh Valley to offer the procedure, starting May 6, and it is now performed by five doctors in the network. LVHN treated its first patient with pulsed-field ablation June 10.
“I’ve been doing this for 10 years and nothing’s ever changed us this much,” said Dr. Steve Stevens, a cardiologist and electrophysiologist for St. Luke’s. “We’ve never seen anything like this. It completely changed what we do.”
Atrial fibrillation is the most common form of abnormal heart rhythm and is caused by signaling issues in the processes that make the heart beat. The condition can be caused by genetic conditions, viral infections, other heart or vascular issues or complications from other health problems. Obesity, sleep apnea, alcohol use, heart valve disorders, heart failure and the simple act of aging all put people at a high risk for developing atrial fibrillation.
If untreated, AFib can cause the formation of blood clots, stroke or congestive heart failure. It affects about 3 million to 6 million people in the U.S. at any given time and results in roughly 450,000 hospitalizations per year.
Until now, the condition has been treated primarily through rate-control therapies such as blood thinning medications or ablation, a procedure that involves scarring certain tissues and cells involved in the electrical signaling that causes the heart to beat, disrupting those pathways in a way that returns the heartbeat to normal.
Ablation typically is performed using radio waves to create heat that scars the tissue, or cryoablation, which uses cold to to create the scarring.
Ablation is associated with decreased risk of all-cause mortality, stroke, and hospitalization due to heart failure, a 2022 meta-analysis showed. But the procedure does come with a roughly 3% risk of major complications, a 2013 meta-analysis found. Stevens said one of these risks is the possibility of damaging two important structures near the heart — the esophagus, the tube that moves food to the stomach, and the phrenic nerve, which controls the diaphragm, the muscle that allows us to breathe. Due to the nature of the procedure, it was not suited for higher-risk patients, Stevens said.
But pulsed field ablation, which received approval from the U.S. Food and Drug Administration in late 2023, doesn’t have the same risk of damaging non-targeted cells, Stevens said. Instead, the high-voltage electrical impulses used in the procedure are just strong enough to kill the damaged heart tissue that causes AFib episodes while sparing everything else.
Stevens said this makes the procedure a much better fit for those patients who weren’t suited for traditional forms of ablation, allowing a greater population of patients to benefit. Not only is pulsed-field ablation safer, it’s also faster; it only takes 30 minutes to an hour versus other forms of ablation which can take up to three hours. St. Luke’s is doing two to three of these procedures per day, Stevens said.
Pulsed-field ablation also results in significantly shorter recovery times for patients.
“One of the things that gets us so excited, gets me so excited, is how well patients look after this versus traditional ablation. Patients [after the traditional procedure] can look a little bit like anyone does after surgery, a little beat up, they have chest discomfort, they feel really tired. A lot of things are gonna get better but they just don’t feel that great. After this [pulsed-field] procedure, people wake up like nothing happened. They feel great, they feel better,” Stevens said.
He added he expects pulsed-field ablation will become the preferred form of ablation but for now, the major limitation is that not all insurance plans cover the procedure. He said most plans already do, as does Medicare, but there are some plans that are still refusing to pay for the procedure. He also said that for other types of arrhythmia, other forms of ablation are still relevant.
“It’s like an electric car or an iPhone moment, everybody has got to do this,” Stevens said.
Dr. Eric Elgin, interventional cardiologist and chief of cardiology at LVHN’s Lehigh Valley Heart and Vascular Institute, said about a year ago the network also started offering cardio-neural ablation as a treatment for vasovagal syncope.
Vasovagal syncope is a condition that causes people to pass out because of overactivity or due to a stimulus that leads to reduced blood flow to the brain.
“If you think about the people who pass out at the sight of blood, that’s like your classic vasovagal patient,” Elgin said. “Turns out as people are trying to understand a little more about how to take care of atrial fibrillation, they kind of stumbled on certain areas where the heart has a high level of innervation from this vagus nerve that contributes to this vasovagal syncope.”
The condition primarily affects young people and while the fainting episodes are usually not serious by themselves, they aren’t ideal and the person could injure themselves while falling, he said. By age 60, about 42% of women and nearly a third of men experience at least one episode of syncope, according to a 2006 study.
Elgin said in the past, different treatments were attempted such as pacemakers or medications, but none of these were effective. However cardio-neural ablation has been a breakthrough for this condition.
The procedure uses radiofrequency ablation to scar certain nerve cells preventing the parasympathetic nervous system from triggering the alterations in blood pressure and heartbeat that lead to syncopal episodes.
“So far they’ve been one and done and very effective in taking care of a patient population we really didn’t have any other tools for,” Elgin said.
Vascular surgery advances cut risk
In the world of vascular procedures, within the last few months, St. Luke’s debuted a new type of incisionless procedure that bypasses blockages and restores blood supply in the leg, alleviates pain and saves the leg from potential amputation.
Dr. Shavril Sheth, St. Luke’s chief of vascular surgery, said this procedure is called percutaneous transmural arterial bypass, and is for people with lower extremity peripheral arterial disease, a narrowing or total blockage in the arteries that carry blood through the legs.
Most commonly this condition is caused by atherosclerosis, a build-up of fatty plaques in the artery. A common symptom of the condition is mild to severe muscle pain or cramping that occurs when using the leg with the blocked artery. However, symptoms can progress to foot wounds that won’t heal and gangrene, and partial or complete amputation of the foot or leg may be necessary.
Peripheral arterial disease affects about 12 million Americans, and people with type 2 diabetes or who smoke are at the highest risk of developing the condition.
Though the condition can be treated with medicine and healthier lifestyle changes, there are times when the blockage becomes too serious. In these cases, the condition is treated with a surgical bypass, where multiple incisions are made in the leg and a new path is created around the blocked artery. The alternative is angioplasty and stent placement, a less invasive procedure where a balloon is used to widen the blocked artery and a stent is placed to keep the artery open.
Sheth said for certain patients, like those with diabetes, kidney disease, a history of smoking, emphysema or previous heart attacks, bypass surgery is too risky of an option. He added some patients undergo a balloon and stent procedure but that doesn’t fix the blockage. These are the people to whom St. Luke’s is offering the percutaneous transmural arterial bypass treatment.
During this procedure, a surgeon passes a stent from a healthy femoral artery in the groin into the nearby femoral vein and then re-enters into a healthy artery near the knee. Sheth said the principle of the procedure is similar to a detour on a highway.
“It combines the beauties of a minimally invasive stent and a surgical bypass,” Sheth said.
Percutaneous transmural arterial bypass has a higher chance of success because the body’s vascular system no longer needs to deal with the blockage. It’s also minimally invasive, less risky for patients with comorbid conditions and has a shorter recovery time than surgery. On average the procedure takes two hours and 30 minutes to complete and after a few hours of post-procedure observation patients are discharged the same day.
As of last month, St. Luke’s surgeons had treated three patients with the procedure.
Dr. Ben Jackson, chief of vascular and endovascular surgery for LVHN’s Lehigh Valley Heart and Vascular Institute, said one of the biggest new vascular surgery procedures for the network is a type of thoracic branch stent graft. This procedure is for thoracic aortic aneurysms, a widening of a section of the aorta, the largest artery in the body. These aneurysms can rupture or tear leading to sudden death.
Jackson said network’s vascular surgeons started performing the procedure about a year ago and they have performed four or five total.
He said there was a time when aneurysms in the chest required invasive surgeries involving large incisions and potentially serious complications, including paralysis. He said conventional endovascular aortic repair became preferable because they were less invasive and less risky.
However, this had its limitations, such as not being very effective at addressing aneurysms in segments of the aorta that branch off to one of the arteries that carry blood to the brain or arms. In these cases, either a bypass surgery or a sternotomy, a procedure where surgeons cut through the sternum to gain access to the heart or blood vessels, were only ways to go, he said.
However, these new types of stent grafts are also minimally invasive and can address aneurysms that traditional stent graft placements couldn’t treat.
“It’s a step that takes us further on a sort of progressive path toward being able to treat all aortic aneurysms with endovascular stent grafts,” Jackson said.
This procedure involves threading two wires, one in the groin and the other in the arm, to the aorta and placing a device called the GORE TBE thoracic branch endoprosthesis, a tube supported by stents, which seals off the aneurysm, preventing it from rupturing any further and stopping any bleeding, while maintaining blood flow to those other arteries. The procedure itself only takes about two hours.
Jackson said recovery times from the procedure are also fairly short with patients usually able to return home after two to three days.
“You spend less time in the ICU and less time in the hospital and they recover quickly,” Jackson said. “They can go back to work after a week or two as opposed to going back to work after a month.”
Cardiac catheterization
St. Luke’s also has a new tool for treating failing heart valves in a minimally invasive way instead of open heart surgery, Dr. Stephen Olenchock, the network’s head of cardiovascular surgery, said.
Olenchock said the PASCAL Precision System from Edwards Lifesciences received FDA approval toward the end of 2022 and St. Luke’s began using the system and implanting patients this past May.
When the heart beats, the left ventricle carries oxygenated blood out of the heart to the rest of the body and small flaps called the mitral valve prevent blood from flowing backward. But in people suffering from mitral regurgitation, those small flaps, also called leaflets, don’t close properly and blood leaks backward. This can result in inadequate blood flow to the rest of the body and the heart working harder than normal to compensate. It can also lead to increased pressure in the heart and pulmonary veins. Neither situation is good, as each increases the risk for other cardiovascular conditions. Shortness of breath and heart palpitations are common symptoms.
“If you were to ignore this, over time the upper chamber, the atrium gets enlarged and the ventricle can slowly fail. Years of mitral regurgitation over time will eventually result in you being very short of breath and we have secondary things like pulmonary hypertension or heart failure,” Olenchock said.
Olenchock said although some medicines can help treat the condition, outcomes for mitral valves with severe leaks are better when patients undergo a procedure that addresses it directly. He said most undergo mitral valve surgery, which directly repairs the valve, but for some people, the risk of surgery is too high. In these cases, the next best option is the placement of a catheter, a minimally invasive procedure.
In this procedure, a catheter is inserted and run up the femoral vein, and guided to the left side of the heart where the catheter delivers a device that repairs the valve at the point where it’s leaking.
The PASCAL implant is placed the same way, but Olenchock said the system differs from previous catheters St. Luke’s has used because it is more versatile in how and where it can be placed. He said this allows doctors to treat a wider range of patients with differing anatomies and also makes the jobs of surgeons easier.
The PASCAL implant also does not replace the mitral valve, instead helping it work properly again.
“The PASCAL Precision system allows us to staple the leaflets of the mitral valve together — usually in the area where the valve is leaking the most. By repairing those two edges and bringing them together we keep that valve tighter. The leaflets then meet together, and they don’t result in the gap that lets blood go backward,” Olenchock said.
He said as of early June they had treated four patients with the procedure and all of them got to go home the next day, which would not have been the case had these patients undergone surgery.
“The best we can say is that this allows us to treat more patients because this device allows us to treat more difficult types of valves,” Olenchock said.
