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Operators reported the initial success of a novel transcatheter technique for treating complex paravalvular leaks (PVLs) after transcatheter aortic valve replacement (TAVR) or transcatheter mitral valve replacement (TMVR) in a small case series.

Testing various combinations of Viabahn covered stents and Amplatzer vascular plugs, researchers found that all device sizes resulted in immediate elimination of target PVL associated with transcatheter heart valve (THV) implants in eight patients. There were no intraprocedural complications for the approach, dubbed the "Tootsie Roll" technique by Vasilis Babaliaros, MD, of Emory University Hospital Midtown in Atlanta, and colleagues.

One patient died before 30 days -- due to a complication of valve-in-mitral annular calcification TMVR -- and the remaining seven patients had no recurrent PVL at 30 days detected by transthoracic echocardiography, the authors reported in .

"As outlined in our report, this technique can be applied to PVLs related to various types of THVs and can achieve a reduction of PVLs to none/trace," the authors wrote of their single-center case series. "Given the increasing number of THVs being implanted, both in the aortic and mitral positions, the occurrence of THV-related PVL cases may be expected to rise."

Tootsie Roll describes the technique of covering the PVL with a covered stent to create a seal between the THV and the annulus. This cylinder then becomes the landing zone for a vascular plug going inside the stent to block the leak, according to Babaliaros' group.

Following the Tootsie Roll procedure -- named after the shape of the American chocolate-flavored candy -- symptoms decreased to New York Heart Association (NYHA) functional class I/II in six out of seven surviving patients. One person with mitral regurgitation, awaiting a subsequent valve replacement procedure, was left with NYHA class III symptoms.

"Importantly, this straightforward technique follows the same steps required for transcatheter PVL closures with other devices and can be performed by any interventional cardiologist skilled in transcatheter PVL closure," the authors noted.

Ignacio Amat-Santos, MD, PhD, of Hospital Clínico Universitario de Valladolid, and Clara Fernández-Cordón, MD, of Instituto de Salud Carlos III in Madrid, both in Spain, agreed that the technique seems simple and user-friendly without requiring hard-to-find equipment.

"Besides preliminary safety and effectiveness, these [three] factors -- simplicity, user friendliness, and device availability -- could add to its expansion into clinical practice. Probably, the key to success is the correct selection of patients, using multimodality imaging to look for anatomical defects that can be transformed into a cylindrical shape and then occluded," they wrote in an .

Prosthetic-related PVL is common after transcatheter valve implantation, with data suggesting an incidence of 40% in the contemporary era. PVL is associated with heart failure and hemolysis; data also suggest greater long-term mortality for affected patients after TAVR.

For those hoping to avoid the complications of PVL surgery, turning to off-label transcatheter closure has been associated with its own challenges due to the complex interaction between the calcified native annulus remaining after TAVR or TMVR and the THV -- resulting in multiple, irregular, or crescent-shaped defects.

Dedicated transcatheter PVL closure devices, namely the Amplatzer Valvular Plug III and Occlutech Paravalvular Leak Device Occluder, have obtained the CE mark in Europe but are still considered investigational stateside.

"Unmet needs in the field of percutaneous PVL closure certainly exist, including procedure simplification, consistency of the intervention (i.e., making it less operator-dependent), and overall improvement in the success rate," Amat-Santos and Fernández-Cordón wrote.

They pointed out that Babaliaros' group had a lot of preprocedural planning and selected patients with tunneled tracts or crescent-shaped PVL that were deemed unsuitable for closure with conventional devices.

Babaliaros and colleagues cautioned that there is a risk of stent migration during or after Tootsie Roll deployment. There are also concerns of device-related thrombus, stent embolization, and interference with the THV, Amat-Santos and Fernández-Cordón warned.

"Prospective multicentric studies to assess the safety, efficacy, and long-term results will help to determine the true value of this promising new technique for PVL closure," the editorialists concluded.

The present report covered Tootsie Roll procedures performed from July 2021 to May 2023 at Emory.

The series comprised eight consecutive patients who underwent PVL closure after TAVR (three Sapien and one Evolut) or TMVR (two Sapien in mitral annular calcification and two M3 TMVR). Eligible participants had to be at high surgical risk and have complicated PVL morphology unsuitable for simple closure with available devices. Defects longer than 11 mm were deemed too large for the Tootsie Roll.

Participants had a median age of 77 years, and the median Society of Thoracic Surgeons score was 5.3.

Preprocedural planning included ECG-gated CT on top of transesophageal echocardiography for anatomical evaluation and device size selection.

After Tootsie Roll-ing, there was zero postprocedure hemolysis. All patients were discharged alive after a median 3.5 days. At discharge, there was no residual PVL in the cohort except for one person who had 1+ PVL "due to an untreated PVL location that could not be crossed with a guidewire during the procedure," Babaliaros and colleagues said.

Study authors acknowledged the small sample, the possibility of selection bias, and the lack of a comparison group in their report.

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