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- ↵∗Charité–Universitätsmedizin Berlin, Chariteplatz 1, D-10117 Berlin, Germany
We appreciate the comments by Dr. Lauten and colleagues on our caval vein approaches with the Edwards Sapien XT valve (Edwards Lifesciences, Irvine, California) to treat severe secondary tricuspid regurgitation (STR) (1), and we welcome the opportunity to reply to their letter. Since the publication of our letter, we have performed 4 additional procedures, with the result that our experience now includes 7 patients, with follow-ups ranging between 1 and 14 months.
We agree that caval valve implantation (CAVI) is restricted to STR. Relevant regurgitation into hepatic and caval veins can easily be verified by clinical examination and ultrasound Doppler flow profiles. Indeed, although CAVI does not affect tricuspid regurgitation, the allegedly compromising heterotopic inferior vena cava (IVC) single-vein approach offers a number of important advantages over complete valve replacement in anatomic valve position. First, provided that CAVI primarily represents a tool in advanced heart failure, frequently under conditions of impaired right ventricular (RV) function and pulmonary hypertension (PH), the IVC single-valve approach provides a safety valve by leaving the superior vena cava untreated. Also, the majority of patients with heart failure have transvalvular RV-pacemaker and/or implantable cardioverter-defibrillator leads, a fact that renders catheter-based valve replacement in anatomic position virtually impossible. In heterotopic IVC position, however, the leads do not interfere in any way.
The stipulations voiced by Dr. Lauten and colleagues to apply CAVI only under a condition of normal RV function and pulmonary vascular resistance are based on an absolutely valid, established safety approach. At the same time, one can hardly find a patient with this constellation in advanced stages of heart failure. Our experience, which is admittedly limited, has shown, conversely, that CAVI can very well be conducted with pathological right-heart and pulmonary hemodynamics. Indeed, 5 of our 6 patients exhibited PH (and 2 with systolic pulmonary artery pressure >60 mm Hg). CAVI did not further increase pulmonary artery pressure and was well tolerated. Five of the 6 patients suffered from impaired RV systolic function. In all patients, tricuspid annular plane systolic excursion significantly increased (from a mean of 14.5 mm to 18.6 mm), which indicates partial reversibility of longitudinal systolic RV function.
Finally, Dr. Lauten and colleagues are correct in stating that in STR, the FCI diameter is actually too large for the available valve types. In our patients, the diameters were between 28 and 33 mm, which meant that direct valve implantation was not possible, primarily for this reason. Therefore, we prepared a landing zone, with 2 stents implanted 1 over the other. This method enables successful stabilization and downsizing, and implantation of the 29-mm Edwards Sapien XT becomes possible. Approximately 10% of the screened patients had larger diameters (>35 mm) and were not able to be treated. The occurrence of large vein diameters should actually prompt design of an appreciably larger dedicated valve.
Dr. Lauten and colleagues request further echo and pressure parameters to support our concept. The space limitation involved here in this Reply prevented their presentation; these data will be included in a publication of ours to appear later.
Please note: Dr. Laule has served as a transcatheter aortic valve implantation proctor for Edwards Lifesciences and Medtronic Inc. Dr. K. Stangl has served as a lecturer and transcatheter aortic valve implantation proctor for Edwards Lifesciences and Medtronic Inc. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- American College of Cardiology Foundation