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Percutaneous mitral valve implantation effective in patients with failed mitral bioprosthesis
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In high-risk patients with degenerated mitral bioprosthesis, percutaneous antegrade transvenous mitral valve implantation appears to be a minimally invasive and highly effective strategy that has been linked with rapid hemodynamic improvement, short length of hospital stays and improved functional status.
Researchers conducted a retrospective study of 48 patients who underwent percutaneous transfemoral antegrade transseptal implantation of the Sapien, Sapien XT or Sapien 3 valves (Edwards Lifesciences) into the mitral position at Mayo Clinic; New York University Medical Center; Intermountain Heart Institute in Birmingham, Alabama, or St. Michael’s Hospital in Toronto from 2014 to 2015.
Eligible candidates for the procedure had significant bioprosthetic mitral valve degeneration (n = 33) or annuloplasty ring dysfunction (n = 9) or severe mitral stenosis due to mitral annular calcification (n = 6). The mean age of the patients was 76 years, and 29 patients were female. The mean Society of Thoracic Surgery risk score of the patient population was 13.2%.
Adverse events, both in-hospital and postdischarge, were prospectively documented. All patients initiated a regimen of oral anticoagulation (warfarin) with a target INR of 2 to 3 and single antiplatelet therapy. Follow-up medical assessments took place at 30 days and 1 year at the treatment site or the patient’s local practitioner. The researchers also collected 30-day and 1-year transthoracic echocardiogram data.
In the overall group, procedural success was attained in 88% of patients. Of the 33 patients who underwent percutaneous transseptal implantation of a Sapien valve within a dysfunctional mitral bioprosthesis, 94% attained successful procedural outcomes, whereas 6% died during valve deployment of left ventricular apical perforation due to wire/catheter nosecone injury. There were no strokes or MIs after the procedure. One death occurred 7 days after the procedure, during infusion of vancomycin; autopsy revealed no acute cardiac abnormalities, indicating that the death was caused by a drug reaction. Of the nine patients who underwent percutaneous Sapien valve implantation for failed annuloplasty rings, seven (78%) attained acute procedural success. Two of these cases were complicated by migration of the valve into the left atrium within minutes of deployment. In both cases, the patients remained hemodynamically stable and underwent conventional open sternotomy surgery to remove the Sapien valve and replace the mitral valve. Of the six cases in which percutaneous Sapien valve implantation was performed for patients with calcific mitral stenosis, four (67%) were successful and without complication. Of the two unsuccessful procedures, one that was performed in a woman aged 80 years was complicated by apical perforation from the delivery system nosecone after valve deployment. The other, which was performed in a woman aged 85 years with severe mitral annular calcification, was complicated by severe valve regurgitation of the initial valve, necessitating a second valve, which embolized in the left atrium.
At the 30-day follow-up, survival free of mortality and CV surgery was 85% in the overall group and 91% in the failed bioprosthetic mitral valve subgroup. To date, five patients have reached 1-year follow-up, and all of these patients have maintained functional status and prosthesis function.
“Percutaneous antegrade transvenous mitral valve implantation in failed surgical prostheses is a minimally invasive, feasible and highly effective treatment for either prosthetic stenosis or regurgitation,” the researchers wrote. “Larger-scale studies and data on long-term outcomes of patients undergoing percutaneous mitral valve in valve implantation are needed, as well as the development of dedicated devices for transseptal mitral valve implantation.” – by Jennifer Byrne
Disclosure: The researchers report no relevant financial disclosures.
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