Fortis Memorial Research Institute (FMRI), Gurugram has successfully implanted the Pivot Extend System, a permanent transcatheter device for treating severe tricuspid regurgitation (TR), in a 35-year-old woman from Trinidad and Tobago suffering from advanced heart failure. 

The procedure marks the first implantation of the device in an international patient in India, the first in Delhi-NCR, and only the third reported implantation in the country.

The patient, Carveann Carleash David, was admitted with severe breathlessness and was diagnosed with torrential tricuspid valve regurgitation, significantly reduced heart function, and a history of specialised pacemaker implantation nearly a decade ago. She had also undergone a procedure earlier this year to drain excess fluid around her heart.

Over the past three years, she experienced progressively worsening breathlessness, swelling of the legs and abdomen, and advanced right-sided heart failure caused by persistent valve leakage, leading to congestion in the liver, abdomen, and lower limbs.

Although a heart transplant was considered the definitive treatment, her clinical condition and cardiac anatomy ruled out conventional minimally invasive structural heart interventions. Following evaluation by a multidisciplinary cardiac team and discussions with the patient and her family, the medical team opted for the Pivot Extend System, obtaining special approval from the Government of India to import the device.

The patient first underwent replacement of her pacemaker pulse generator on July 22, 2026, followed by successful implantation of the Pivot Extend System on July 24 without complications. The device uses a balloon spacer positioned between the leaking valve leaflets, enabling better valve closure and reducing the backward flow of blood. While not a definitive cure, the therapy is designed to relieve symptoms and improve quality of life in carefully selected patients with limited treatment options.

A follow-up echocardiogram performed on July 25 showed that the valve leakage had reduced from torrential to moderate. After receiving comprehensive medical therapy and supportive care, the patient was discharged in stable condition on guideline-directed treatment with scheduled follow-up.

Dr. (Col.) Manjinder Singh Sandhu, Principal Director, Cardiology, FMRI, said the patient had reached end-stage right-sided heart failure due to severe tricuspid valve leakage and a markedly weakened heart. 

Dr. Sandhu noted that with limited alternatives, the team secured special permission to use the Pivot Extend System, which significantly reduced the severity of the valve leak and offers a promising option for critically ill patients with few remaining treatment choices.

Yash Rawat, Senior Vice President and Facility Director, FMRI, said the successful procedure highlights the hospital's commitment to expanding access to advanced, evidence-based therapies for patients with complex cardiovascular conditions. 

He added that performing the first Pivot Extend System implantation in an international patient in India and the first in Delhi-NCR underscores the strength of the institute's multidisciplinary expertise while reinforcing India's growing position as a destination for advanced cardiac care.