New combined treatment improves heart function in CTEPH cases
Strategy begins with medication, followed by BPA then PEA surgery: Study
A new sequential strategy successfully treats people with severe chronic thromboembolic pulmonary hypertension (CTEPH), significantly reducing high blood pressure and improving heart function, a study finds.
The three-step regimen — medication, balloon pulmonary angioplasty (BPA), and pulmonary endarterectomy (PEA) surgery — is designed for people facing unacceptably high surgical risk and complex blood clot locations, researchers found.
When followed, this regimen significantly reduced blood pressure in the pulmonary arteries and a marker of heart failure, improved functionality, and led to a 95% survival rate, the data showed.
The study, “Combined Multimodal Therapy in High-Risk Patients with Chronic Thromboembolic Pulmonary Hypertension and Both Distal and Proximal Lesions: A Prospective Observational Cohort Study,” was published in The Journal of Heart and Lung Transplantation.
CTEPH is a type of pulmonary hypertension (PH) marked by high pressure in the pulmonary arteries, the blood vessels that carry blood through the lungs, caused by blood clots and scar-like tissue (lesions) that restrict blood flow. This makes the right heart work harder to pump blood, increasing the risk of heart failure.
PEA, BPA, and current treatment options
PEA is currently the treatment of choice for CTEPH, particularly for people with lesions in surgically accessible pulmonary arteries, such as those in the larger arteries closest to the heart (proximal). PEA is a complex open-heart procedure that removes blood clots and scar tissue from the pulmonary arteries.
BPA is recommended for people with surgically inaccessible lesions, such as those in the small arteries farthest from the heart (distal), who have a high surgical risk, or persistent or recurrent PH after PEA. This procedure involves temporarily inflating a small balloon in the pulmonary arteries to help widen them and improve blood flow.
PH-specific medications are also used before BPA in patients with severely impaired blood flow.
Despite these available treatment options, “the best strategy for such patients remains unclear and, as a result, practices vary across centers,” wrote researchers in France, who assessed the impact of a sequential strategy in patients with a high surgical risk and proximal and distal lesions in the pulmonary arteries.
Study outlines sequential strategy
The sequential regimen involved starting with PH-specific medications, then BPA for lungs with distal lesions, and PEA surgery for lungs with proximal lesions. The researchers compared outcomes before intervention (baseline), before BPA, before PEA, and six months after PEA.
The team enrolled 61 people with CTEPH, all of whom eventually underwent BPA and PEA. At baseline, most (83.6%) showed markedly high pulmonary vascular resistance (PVR), a measure of the heart’s workload in pumping blood through the lungs.
Nearly all participants (86.9%) received at least one PH-specific medication within a month after blood clots formed in the pulmonary arteries. Forty people (65.6%) received two therapies, usually riociguat and bosentan (brand names Adempas and Tracleer, respectively), while a single patient with severe blood flow impairments received a triple combination of PH-specific therapies.
Six months after PEA, about one-fourth (23.6%) of people were off PH medication, about one-third (34.6%) were taking a single medication, and less than half (41.8%) received two therapies. Six (10.6%) stopped PH medications altogether.
BPA was usually performed on the left lung, leading to 19 adverse events in 13 people. The most common were mild to moderate, including coughing up blood, damage to the pulmonary artery due to the catheter that carries the balloon, and lung injury requiring oxygen supplementation.
Of the 61 people with CTEPH, five underwent PEA on both sides of the lungs after the team identified proximal lesions accessible to surgery during the first BPA session on the side with distal lesions. PEA managed these proximal lesions.
After PEA, the most common complications included acute kidney injury, pulmonary edema (too much fluid in the lungs), and supraventricular tachycardia (fast heart rhythms). Three people needed extra-corporeal membrane oxygenation to pump and oxygenate blood outside the body.
Significant improvements after final surgery
Compared with baseline, there was a significant decrease in PVR and the mean pulmonary artery pressure (mPAP), alongside a substantial drop in blood levels of NT-pro-BNP, a marker for heart failure. Improvements were also observed in measures of functionality, including the distance walked in six minutes and the New York Heart Association functional class.
Six months after PEA, one-fifth of patients (20.7%) had residual PH. Additional BPA was scheduled for 10 of these. The reasons for the additional sessions included persistent shortness of breath, post-PEA identification of distal lesions accessible by BPA, residual PH, or the physician’s aim to stop PH medications.
Three (5.2%) people died after PEA, all of whom had severe blood flow impairment at baseline. The remaining people were alive after a median follow-up of 14 months after PEA, leading to an overall survival rate of 95%.
“Our multimodal strategy was safe and effective in selected patients with severe CTEPH in whom upfront PEA was deemed unacceptably hazardous due to a high surgical risk and mixed anatomical lesions,” the researchers concluded. “Both the efficacy and the safety outcomes were highly encouraging, warranting further investigation of combined treatments in specific patient sub-groups.”
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