Author + information
- Jonathan Curio@CurioJonathan,
- Giuseppe Lanzillo, MD@g_lanzillo,
- Antonio Mangieri, MD@AntonioMangieri,
- Matteo Pagnesi, MD,
- Claudio Montalto, MD,
- Ozan M. Demir, MD,
- Michele De Bonis, MD,
- Eustachio Agricola, MD,
- Antonio Colombo, MD and
- Azeem Latib, MD∗ (, )@azeemlatib
- ↵∗Department of Cardiology, Montefiore Medical Center, 111 East 210th Street, Bronx, New York 10467-2401
In the community setting, moderate or severe tricuspid regurgitation (TR) affects over 5% of individuals (1). This is important, as moderate-to-severe TR is an independent predictor of mortality (2). However, targeted TR treatment has been neglected, as surgical mortality is high, and some patients are at prohibitive surgical risk (1,3). Percutaneous devices might be able to address this currently unmet clinical need (4). Therefore, based on current guidelines and the assessment of patients’ surgical risk, we aimed to identify the particular subset of patients with severe TR in need of and eligible for percutaneous treatment approaches.
We retrospectively reviewed 11,943 echocardiograms performed at our institution (a tertiary-level referral center in Milan, Italy) between October 2014 and May 2016 to identify all patients with severe (4+) TR. Then, a stepwise screening process was conducted (Figure 1). First, 5 distinct groups with specific characteristics were derived from European Society of Cardiology/European Association for Cardio-Thoracic Surgery guidelines to identify patients with indication(s) to undergo intervention (5). In a second step, the surgical risk was assessed. As established risk scores are lacking, we based this estimation on criteria suggested by cardiac surgeons and cardiologists of our institution (unacceptable surgical risk: age ≥75 years, systolic pulmonary artery pressure [SPAP] >50 mm Hg, prohibitive general conditions, significant right ventricular [RV] dilation, RV dysfunction, tricuspid annular plane systolic excursion [TAPSE] <20 mm, left ventricular dysfunction). In a third step, eligibility to undergo transcatheter approaches was assessed (eligible: age ≤90 years, SPAP ≤60 mm Hg, TAPSE ≥12 mm, LVEF ≥30). Prohibitive general conditions, frailty, and life expectancy <6 months were reasons for exclusion.
Severe TR was identified in 241 patients. Most common reasons to undergo echocardiography were screening purposes (52.3%), follow-up after percutaneous procedures (16.6%), and electrophysiological reasons (10.8%). Mean age was 75.3 ± 11.1 years, 58.5% were women, and TR was secondary in 80.1%. A total of 73 patients (30.3%) fulfilled the criteria of at least 1 guideline-based indication. Compared to patients without a guideline-indication, they had significantly worse baseline characteristics, including serum creatinine, liver dysfunction, prevalence of coronary artery disease, and previous cardiac decompensation. Furthermore, RV function (TAPSE and tissue Doppler imaging) was worse. Patients with a guideline indication had a significantly higher proportion of previous valve interventions (60.3% vs. 26.2%) and need to undergo left-sided surgery (69.9% vs. 3.6%).
Applying the criteria of acceptable surgical risk to the 73 patients with a guideline indication for correction of severe TR, only 1 patient (1.4%) could be identified as a potential surgical candidate. This patient noticeably was free from most of the comorbidities (other heart valve diseases, diabetes, chronic kidney disease, liver dysfunction) frequently present in the remaining 72 patients with a guideline indication.
According to our criteria, 32 (44.4%) of these 72 patients were found to be eligible to undergo a transcatheter approach (i.e., 13.3% of the total cohort of severe TR patients). This step seemed to identify patients with less comorbidities at an earlier disease stage (significantly lower prevalence of liver dysfunction, chronic pulmonary disease, insulin-dependent diabetes, previous cardiac decompensation). Need for left-sided surgery (46.9% vs. 90.0%) and moderate-to-severe concomitant mitral regurgitation (46.9% vs. 85.0%) were less frequent.
In a straightforward approach where patients with severe TR would potentially be treated irrespective of a guideline indication, only 5 patients would have had an acceptable surgical risk, and 128 (54.2%) of the inoperable patients would have been eligible to undergo a percutaneous approach.
In summary, patients with severe TR at a tertiary-level center have multiple comorbidities and present at advanced TR stages, and current strict guidelines appear to identify a high-risk cohort to undergo intervention, with the majority of patients not being good surgical candidates. These data highlight an obviously unmet clinical need of a group of patients with severe TR at prohibitive surgical risk lacking treatment options. Transcatheter devices may be feasible in up to one-half of these patients. Thus, this study highlights the potential important role of such devices in the future, stressing the need for earlier identification and referral, better evaluation, and most importantly, more clinical data, ideally showing a survival benefit, to support guideline-recommended earlier treatment of patients with severe TR. Additionally, further refinements and efficacy improvements of transcatheter devices will be crucial for such an earlier treatment.
Please note: Dr. De Bonis has served as a consultant for Abbott and Medtronic. Dr. Latib has served as a consultant for Medtronic, Abbott Vascular, and Millipede; and has served on the Advisory Boards of Medtronic and Abbott Vascular. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- 2019 American College of Cardiology Foundation
- Topilsky Y.,
- Maltais S.,
- Medina Inojosa J.,
- et al.
- Nath J.,
- Foster E.,
- Heidenreich P.A.
- Asmarats L.,
- Puri R.,
- Latib A.,
- Navia J.L.,
- Rodés-Cabau J.