World-first, China-born: four sutures solve a 20-year cardiac puzzle
Release time:
2025-07-22
On July 17, just one day after the procedure, Ms. Luo’s follow-up showed that the large right-to-left shunt previously seen in her heart had completely disappeared, and her dizziness and headaches had markedly improved.
On July 17, just one day after the procedure, Ms. Luo’s follow-up showed that the large right-to-left shunt previously seen in her heart had completely disappeared, and her dizziness and headaches had markedly improved.
The operation that changed her life was China’s first-in-human transcatheter “cross-stitch” closure for patent foramen ovale (PFO).
This novel transcatheter cross-suturing technique can achieve a surgical-like closure of the small intracardiac defect without implanting any occluder, delivering a truly “watertight” seal.
“I’d always thought it was just migraines—never imagined it was a stroke, let alone one rooted in my heart.”
Thirty-two-year-old Ms. Luo never expected to be haunted by cerebral infarction. She had no hypertension, diabetes, dyslipidemia or family history; a simple visit for migraines revealed that her headaches were actually caused by strokes triggered by a tiny, unsealed hole in her heart—a patent foramen ovale (PFO).
After learning the problem was cardiac, Ms. Luo went straight to Zhongnan Hospital of Wuhan University and sought help from Prof. Zhang Gangcheng, director of the Structural Heart Disease Center.
Prof. Zhang explained that the foramen ovale is a normal fetal channel that should close after birth, yet nearly one in four adults retains it. Most of the time it remains a silent “hidden danger” requiring no treatment. But when right-atrial pressure exceeds left-atrial pressure, micro-thrombi in venous blood can slip through this opening into the arterial system and travel to the brain, causing stroke. Ms. Luo’s dizziness and headaches were precisely the mischief of this “little hole.”
Globally, the mainstream solution is transcatheter PFO closure: a catheter delivers a “double-umbrella” metal occluder that stays in the heart for life, together with at least six months of antiplatelet therapy. In late 2023 China approved the world’s first fully absorbable occluder; after 8–12 months it breaks down into carbon dioxide and water, yet antiplatelet drugs are still required for about a year. Whether metal or absorbable, these devices remain imperfect: some patients experience transient palpitations, premature beats or paroxysmal atrial fibrillation; thrombus can form on the device surface, and residual shunts are not uncommon.
Surgical suturing of the PFO has been around for decades; when done by a surgeon under direct vision, residual shunt is almost unheard of. Departing from the passive “plug-the-hole” concept of conventional occlusion, the transcatheter “cross-stitch” technique ingeniously imports the open-heart “figure-of-eight” stitch into the interventional suite. The idea had germinated in the minds of structural-heart specialists for more than 20 years, yet yielded few tangible results—until a Chinese physician-engineer team refused to let it die. They overcame four critical hurdles: precise targeting, secure capture, reliable suturing and knot-tying. Thus the world’s first transcatheter cross-stitch PFO closure was born. In animal studies, the cross-stitch group recorded a residual-shunt rate of zero. The device is now in first-in-human trials, and Ms. Luo is among its earliest beneficiaries.
During the procedure, Prof. Zhang Gangcheng advanced four surgical sutures through a catheter and crossed them from four directions; once the knots were cinched, the shunt vanished instantly. “It’s like tying a firm knot over the tiny hole in the heart—almost no foreign body remains, yet closure is immediate and watertight,” Zhang noted.
This wholly Chinese innovation introduces an “intervention-without-implant” paradigm that shatters the technical ceiling of PFO therapy, heralding a new era of transcatheter cardiac suturing and offering patients a fresh therapeutic option. From clinical breakthrough to industrial autonomy, the technology is both a testament to China’s medical-innovation prowess and a Chinese solution now available to the world.
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