Background:
Transcatheter mitral valve replacement using aortic transcatheter heart valves has recently become an alternative for patients with degenerated mitral bioprostheses, failed surgical repairs with annuloplasty rings or severe mitral annular calcification who are poor surgical candidates. Outcomes of these procedures are collected in the Society of Thoracic Surgeons/American College of Cardiology/Transcatheter Valve Therapy Registry. A comprehensive analysis of mitral valve-in-valve (MViV), mitral valve-in-ring (MViR), and valve-in-mitral annular calcification (ViMAC) outcomes has not been performed. We sought to evaluate short-term outcomes of early experience with MViV, MViR, and ViMAC in the United States.
Methods:
Retrospective analysis of data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.
Results:
Nine hundred three high-risk patients (median Society of Thoracic Surgeons score 10%) underwent MViV (n=680), MViR (n=123), or ViMAC (n=100) between March 2013 and June 2017 at 172 hospitals. Median age was 75 years, 59.2% female. Technical and procedural success were higher in MViV. Left ventricular outflow tract obstruction occurred more frequently with ViMAC (ViMAC=10%, MViR=4.9%, MViV=0.7%;
P
<0.001). In-hospital mortality (MViV=6.3%, MViR=9%, ViMAC=18%;
P
=0.004) and 30-day mortality (MViV=8.1%, MViR=11.5%, ViMAC=21.8%;
P
=0.003) were higher in ViMAC. At 30-day follow-up, median mean mitral valve gradient was 7 mm Hg, most patients (96.7%) had mitral regurgitation grade ≤1 (+) and were in New York Heart Association class I to II (81.7%).
Conclusions:
MViV using aortic balloon-expandable transcatheter heart valves is associated with a low complication rate, a 30-day mortality lower than predicted by the Society of Thoracic Surgeons score, and superior short-term outcomes than MViR and ViMAC. At 30 days, patients in all groups experienced improvement of symptoms, and valve performance remained stable.
Registration:
URL:
https://www.clinicaltrials.gov
; Unique identifier: NCT02245763.
Percutaneous repair of paravalvular prosthetic regurgitation can lead to durable symptom relief in selected patients. Nonetheless, mortality remains significant in symptomatic patients with paravalvular prosthetic regurgitation. Long-term clinical efficacy is highly dependent on residual regurgitation.
Background—
Off-label use of transcatheter aortic and pulmonary valve prostheses for tricuspid valve-in-valve implantation (TVIV) within dysfunctional surgical tricuspid valve (TV) bioprostheses has been described in small reports.
Methods and Results—
An international, multicenter registry was developed to collect data on TVIV cases. Patient-related factors, procedural details and outcomes, and follow-up data were analyzed. Valve-in-ring or heterotopic TV implantation procedures were not included. Data were collected on 156 patients with bioprosthetic TV dysfunction who underwent catheterization with planned TVIV. The median age was 40 years, and 71% of patients were in New York Heart Association class III or IV. Among 152 patients in whom TVIV was attempted with a Melody (n=94) or Sapien (n=58) valve, implantation was successful in 150, with few serious complications. After TVIV, both the TV inflow gradient and tricuspid regurgitation grade improved significantly. During follow-up (median, 13.3 months), 22 patients died, 5 within 30 days; all 22 patients were in New York Heart Association class III or IV, and 9 were hospitalized before TVIV. There were 10 TV reinterventions, and 3 other patients had significant recurrent TV dysfunction. At follow-up, 77% of patients were in New York Heart Association class I or II (
P
<0.001 versus before TVIV). Outcomes did not differ according to surgical valve size or TVIV valve type.
Conclusions—
TVIV with commercially available transcatheter prostheses is technically and clinically successful in patients of various ages across a wide range of valve size. Although preimplantation clinical status was associated with outcome, many patients in New York Heart Association class III or IV at baseline improved. TVIV should be considered a viable option for treatment of failing TV bioprostheses.
Transfemoral percutaneous transvenous mitral valve implantation in high-risk patients with degenerated bioprosthesis is safe, effective, and associated with rapid improvement in hemodynamics, short length of stays, and improved functional status. Percutaneous mitral valve implantation in patients with failed annuloplasty rings and severe MAC is a promising therapy with significant short-term morbidity and mortality that requires further study.
Paravalvular regurgitation affects 5% to 17% of all surgically implanted prosthetic heart valves. Patients who have paravalvular regurgitation can be asymptomatic or present with hemolysis or heart failure, or both. Reoperation is associated with increased morbidity and is not always successful because of underlying tissue friability, inflammation, or calcification. Comprehensive echocardiographic imaging with transthoracic and real-time 3-dimensional transesophageal echocardiography is key for characterizing the defect location, size, and shape. For paramitral defects, an antegrade transseptal approach can usually be guided by biplane fluoroscopy, and real-time 3-dimensional transesophageal echocardiography can usually be performed successfully. Alternative approaches to paramitral defects include retrograde transaortic cannulation or transapical access and retrograde cannulation. For oblong or crescentic defects, the simultaneous or sequential deployment of 2 smaller devices, as opposed to 1 large device, results in a higher degree of procedural success and safety because the risk of impingement on the prosthetic leaflets is minimized. Most para-aortic defects can be approached in a retrograde manner and closed with a single device. With careful anatomical assessment, procedural planning, and procedural execution, successful closure rates of 90% or more should be attainable with a low risk of device impingement on the prosthetic valve or embolization.
This first prospective, real-world experience with the Melody TPV in the United States demonstrates continued high procedural success, excellent short-term TPV function, and low reintervention and reoperation rates at 1 year. (Melody Transcatheter Pulmonary Valve Post-Approval Study; NCT01186692).
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