Current State of Transcatheter MVR With the Mitraclip
Current State of Transcatheter MVR With the Mitraclip
Background: Many patients affected with mitral valve regurgitation suffer from multiple comorbidities. The MitraClip device provides a safe means of transcatheter valve repair in patients with suitable mitral valve anatomy who are at prohibitive risk for surgery. We describe our early procedural outcomes and present a summary of the current state of MitraClip technology in the United States.
Methods: We performed a retrospective chart review of initial high-risk or inoperable patients who underwent MitraClip placement at our institution after completion of the EVEREST II study. We examined the primary outcome of 30-day mortality, and secondary outcomes included extent of reduction of mitral regurgitation (MR), New York Heart Association (NYHA) functional class improvement, length of stay, and major complications.
Results: A total of 115 high-risk patients (mean Society of Thoracic Surgeons predicted risk of mortality 9.4%±6.1%) underwent the MitraClip procedure at our institution between March 2009 and April 2014. Co-morbidities including coronary artery disease (67.8%), pulmonary disease (39.1%) and previous cardiac surgery (44.3%) were common. The device was placed successfully in all patients with a 30-day mortality of 2.6%. All patients demonstrated 3+ or 4+ MR on preoperative imaging, and 80.7% of patients had trace or 1+ MR at hospital discharge. NYHA class improved substantially, with 79% of patients exhibiting class III or IV symptoms pre-procedure and 81% reporting class I or II symptoms at one month follow-up.
Conclusions: The MitraClip procedure provides a safe alternative to surgical or medical management for high-risk patients with MR and suitable valve anatomy. A comprehensive heart team approach is essential, with surgeons providing critical assessment of patient suitability for surgery versus percutaneous therapy as well as performance of the valve procedure.
Mitral valve disease is relatively common, affecting approximately 1.7% of the United States population. Several techniques have been developed for surgical correction of clinically significant moderate or severe mitral valve disease, but until the past decade, patients who were at extreme surgical risk or inoperable had no options beyond medical therapy. The MitraClip device (Abbott Vascular, Menlo Park, CA, USA) has significantly broadened the treatment options for patients with mitral regurgitation (MR). This device was developed from the concept of the surgical edge-to-edge leaflet repair technique, pioneered in the 1990s by Alfieri and adapted as a percutaneous therapy. Success of the MitraClip program depends on a comprehensive valve team approach to ensure thorough evaluation of the valve disorder and co-morbidities, followed by selection of the most appropriate therapy for each patient.
The device is currently approved in the United States for patients with symptomatic primary (degenerative) MR who are at prohibitive risk for surgery, and remains under study to determine its efficacy in functional MR [via the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy (COAPT) trial]. Our objectives are to: (I) describe the patient selection process and procedural techniques; (II) describe our institution's early results and outcomes from MitraClip repair in high-risk patients; and (III) discuss the current state of MitraClip technology and the role of cardiothoracic surgeons in a MitraClip program.
Abstract and Introduction
Abstract
Background: Many patients affected with mitral valve regurgitation suffer from multiple comorbidities. The MitraClip device provides a safe means of transcatheter valve repair in patients with suitable mitral valve anatomy who are at prohibitive risk for surgery. We describe our early procedural outcomes and present a summary of the current state of MitraClip technology in the United States.
Methods: We performed a retrospective chart review of initial high-risk or inoperable patients who underwent MitraClip placement at our institution after completion of the EVEREST II study. We examined the primary outcome of 30-day mortality, and secondary outcomes included extent of reduction of mitral regurgitation (MR), New York Heart Association (NYHA) functional class improvement, length of stay, and major complications.
Results: A total of 115 high-risk patients (mean Society of Thoracic Surgeons predicted risk of mortality 9.4%±6.1%) underwent the MitraClip procedure at our institution between March 2009 and April 2014. Co-morbidities including coronary artery disease (67.8%), pulmonary disease (39.1%) and previous cardiac surgery (44.3%) were common. The device was placed successfully in all patients with a 30-day mortality of 2.6%. All patients demonstrated 3+ or 4+ MR on preoperative imaging, and 80.7% of patients had trace or 1+ MR at hospital discharge. NYHA class improved substantially, with 79% of patients exhibiting class III or IV symptoms pre-procedure and 81% reporting class I or II symptoms at one month follow-up.
Conclusions: The MitraClip procedure provides a safe alternative to surgical or medical management for high-risk patients with MR and suitable valve anatomy. A comprehensive heart team approach is essential, with surgeons providing critical assessment of patient suitability for surgery versus percutaneous therapy as well as performance of the valve procedure.
Introduction
Mitral valve disease is relatively common, affecting approximately 1.7% of the United States population. Several techniques have been developed for surgical correction of clinically significant moderate or severe mitral valve disease, but until the past decade, patients who were at extreme surgical risk or inoperable had no options beyond medical therapy. The MitraClip device (Abbott Vascular, Menlo Park, CA, USA) has significantly broadened the treatment options for patients with mitral regurgitation (MR). This device was developed from the concept of the surgical edge-to-edge leaflet repair technique, pioneered in the 1990s by Alfieri and adapted as a percutaneous therapy. Success of the MitraClip program depends on a comprehensive valve team approach to ensure thorough evaluation of the valve disorder and co-morbidities, followed by selection of the most appropriate therapy for each patient.
The device is currently approved in the United States for patients with symptomatic primary (degenerative) MR who are at prohibitive risk for surgery, and remains under study to determine its efficacy in functional MR [via the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy (COAPT) trial]. Our objectives are to: (I) describe the patient selection process and procedural techniques; (II) describe our institution's early results and outcomes from MitraClip repair in high-risk patients; and (III) discuss the current state of MitraClip technology and the role of cardiothoracic surgeons in a MitraClip program.
