Author + information
- Received September 21, 2016
- Revision received January 23, 2017
- Accepted January 27, 2017
- Published online April 3, 2017.
- John Jose, MD, DMa,b,
- Dmitriy S. Sulimov, MDa,
- Mohamed El-Mawardy, MDa,
- Takao Sato, MDa,c,
- Abdelhakim Allali, MDa,
- Erik W. Holy, MDa,
- Björn Becker, MDa,
- Martin Landt, MDa,
- Julia Kebernik, MDa,
- Bettina Schwarz, MDa,
- Gert Richardt, MDa and
- Mohamed Abdel-Wahab, MDa,∗ ()
- aHeart Center, Segeberger Kliniken (Academic Teaching Hospital of the Universities of Kiel, Lübeck, and Hamburg), Bad Segeberg, Germany
- bChristian Medical College Hospital, Vellore, Tamil Nadu, India
- cTachikawa General Hospital, Nagaoka, Japan
- ↵∗Address for correspondence:
Dr. Mohamed Abdel-Wahab, Heart Center, Segeberger Kliniken, Am Kurpark 1, 23795 Bad Segeberg, Germany.
Objectives The aim of this study was to determine the incidence, characteristics, and treatment outcomes of patients diagnosed with clinical transcatheter heart valve thrombosis.
Background Limited data exists on clinical or manifest transcatheter heart valve thrombosis. Prior studies have focused on subclinical thrombosis.
Methods A retrospective analysis was conducted of prospectively collected data from a single-center registry that included 642 consecutive patients who underwent transcatheter aortic valve replacement between 2007 and 2015 (305 patients had self-expanding valves; balloon-expandable, n = 281; mechanically expanding, n = 56). Long-term oral anticoagulation (OAC) was indicated in 261 patients, while 377 patients received dual-antiplatelet therapy post-procedure. All patients underwent scheduled clinical and echocardiographic follow-up.
Results The overall incidence of clinical valve thrombosis was 2.8% (n = 18). No patient on OAC developed thrombosis. Of the detected thrombosis cases, 13 patients had balloon-expandable, 3 had self-expanding, and 2 had mechanically expanding valves. Thrombosis occurred significantly more often with balloon-expandable valves (odds ratio: 3.45; 95% confidence interval: 1.22 to 9.81; p = 0.01) and following valve-in-valve procedures (odds ratio: 5.93; 95% confidence interval: 2.01 to 17.51; p = 0.005). Median time to diagnosis of valve thrombosis was 181 days. The median N-terminal pro–brain natriuretic peptide level was 1,318 pg/ml (interquartile range: 606 to 1,676 pg/ml). The mean transvalvular gradient and valve area were 34 ± 14 mm Hg and 1.0 ± 0.46 cm2, respectively. Computed tomography showed hypoattenuating areas with reduced leaflet motion. Initiation of OAC resulted in significant reduction of transvalvular gradient and clinical improvement. No deaths were related to valve thrombosis.
Conclusions Clinical transcatheter heart valve thrombosis is more common than previously considered, characterized by imaging abnormalities and increased gradients and N-terminal pro–brain natriuretic peptide levels. It occurred more commonly after balloon-expandable transcatheter aortic valve replacement and valve-in-valve procedures. OAC appeared to be effective in the prevention and treatment of valve thrombosis. Randomized control trials are needed to define optimal antithrombotic therapy after transcatheter aortic valve replacement.
- aortic stenosis
- clinical thrombosis
- oral anticoagulation
- transcatheter aortic valve replacement
- transcatheter heart valve thrombosis
Drs. Abdel-Wahab and Richardt have received institutional research grants from St. Jude Medical and Biotronik. Dr. Abdel-Wahab is a proctor for Boston Scientific. Dr. Richardt has received lecture fees from Edwards Lifesciences and Boston Scientific. Drs. Jose and Holy were supported by European Association of Percutaneous Cardiovascular Interventions grants in interventional cardiology, which were partially sponsored by Medtronic and Edwards Lifesciences, respectively. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received September 21, 2016.
- Revision received January 23, 2017.
- Accepted January 27, 2017.
- 2017 American College of Cardiology Foundation