Multimorbidity, functional impairment, and mortality in older patients stable after prior acute myocardial infarction: Insights from the TIGRIS registry.

BACKGROUND: Data on the association of multimorbidity and functional impairment with cardiovascular (CV) and non-CV outcomes among older myocardial infarction (MI) patients are limited. HYPOTHESIS: Multimorbidity and functional impairment among older MI patients are associated with CV and non-CV mortality. METHODS: Patients aged ≥65 years, 1-3 years post-MI, and enrolled between June 2013 and Novemeber 2014 from 349 sites in 25 countries in the global TIGRIS registry were categorized by age, number of comorbidities, and presence and degree of functional impairment. Functional impairment was calculated using five-dimension EuroQol based on three domains-mobility, self-care, and usual activities. The association between age, number of comorbid conditions, and degree of functional impairment with 2-year incidence of CV and non-CV death was evaluated using Poisson regression analysis. RESULTS: Older age was associated with higher number of comorbidities and functional impairment; after adjustment, increasing age was significantly associated with non-CV mortality (p = .03) but not CV mortality (p = .38). Greater functional impairment was associated with a higher rate and relatively equal magnitude risk of CV (rate ratios [RR] 1.52, 95% confidence intervals [CI]: 1.29-1.79, per one-step increase) and non-CV mortality (RR 1.42, 95% CI: 1.17-1.73). Multimorbidity was more strongly associated with CV mortality (RR 1.52, 95% CI: 1.38-1.67, per additional comorbidity) versus non-CV mortality (RR 1.29, 95% CI: 1.14-1.47, per additional comorbidity). CONCLUSIONS: Multimorbidity and functional impairment are prevalent among older post-MI patients and are associated with increased CV and non-CV mortality. These findings highlight the importance of considering comorbid conditions and functional impairment as predictors of risk for adverse outcomes and aspects of medical decision making. Clinical Trial Registration: NCT01866904.

Transcatheter Tricuspid Valve Replacement With the EVOQUE System: 1-Year Outcomes of a Multicenter, First-in-Human Experience.

OBJECTIVES: The aim of this study was to report the midterm outcomes at 1 year in the expanded first-in-human experience with the transfemoral EVOQUE system (Edwards Lifesciences) for tricuspid regurgitation (TR). BACKGROUND: Untreated TR is associated with excess mortality and morbidity. The first-in-human experience with the EVOQUE tricuspid valve replacement system reported favorable 30-day outcomes with no mortality in a compassionate use population. METHODS: Twenty-seven patients with severe TR were treated with the EVOQUE system in a compassionate use experience at 7 centers between May 2019 and July 2020. All patients had clinical right-sided heart failure (HF) and were deemed inoperable and unsuitable for transcatheter edge-to-edge repair by the institutional heart teams. The clinical outcomes collected included all-cause mortality, symptom status, TR severity, HF hospitalization, and major adverse cardiovascular events. RESULTS: At baseline, all patients (age: 77 ± 8 years, 89% female) were at high surgical risk (mean Society of Thoracic Surgeons score: 8.6% ± 5.5%), with 89% New York Heart Association functional class III/IV. TR was predominantly functional in etiology (19/27, 70%). At 1 year, mortality was 7% (2/27), 70% of patients were New York Heart Association functional class I/II, and 96% and 87% of patients had a TR grade ≤2+ and ≤1+, respectively. Between 30 days and 1 year, 2 patients experienced HF hospitalizations, and 1 patient required a new pacemaker implantation. CONCLUSIONS: In this early, compassionate use experience, the transfemoral transcatheter EVOQUE tricuspid valve replacement system demonstrated durable efficacy, persistent improvement in symptom status, and low rates of mortality and HF hospitalizations at a 1-year follow-up. Further studies are underway to validate its efficacy.

The Role of Intracardiac Echocardiography in Percutaneous Tricuspid Intervention: A New ICE Age.

The prevalence of severe tricuspid regurgitation in older patients is high, and the clinical relevance is perceived more and more in recent years. Many of these patients are not suitable for surgery because of their age and comorbidities. Therefore, a variety of percutaneous interventions have been developed to address this unmet need. Procedural success strongly depends on adequate imaging during the intervention. Although transesophageal echocardiography is the standard of care, imaging may be limited due to anatomic factors and adverse acoustic shadowing. In this review, we discuss the current and future role of intracardiac echocardiography in tricuspid valve interventions.

Transfemoral Transcatheter Tricuspid Valve Replacement With the EVOQUE System: A Multicenter, Observational, First-in-Human Experience.

OBJECTIVES: The purpose of this observational first-in-human experience was to investigate the feasibility and safety of the EVOQUE tricuspid valve replacement system and its impact on short-term clinical outcomes. BACKGROUND: Transcatheter tricuspid intervention is a promising option for selected patients with severe tricuspid regurgitation (TR). Although transcatheter leaflet repair is an option for some, transcatheter tricuspid valve replacement (TTVR) may be applicable to a broader population. METHODS: Twenty-five patients with severe TR underwent EVOQUE TTVR in a compassionate-use experience. The primary outcome was technical success, with NYHA (NYHA) functional class, TR grade, and major adverse cardiac and cerebrovascular events assessed at 30-day follow-up. RESULTS: All patients (mean age 76 ± 3 years, 88% women) were at high surgical risk (mean Society of Thoracic Surgeons risk score 9.1 ± 2.3%), with 96% in NYHA functional class III or IV. TR etiology was predominantly functional, with mean tricuspid annular diameter of 44.8 ± 7.8 mm and mean tricuspid annular plane systolic excursion of 16 ± 2 mm. Technical success was 92%, with no intraprocedural mortality or conversion to surgery. At 30-day follow-up, mortality was 0%, 76% of patients were in NYHA functional class I or II, and TR grade was ≤2+ in 96%. Major bleeding occurred in 3 patients (12%), 2 patients (8%) required pacemaker implantation, and 1 patient (4%) required dialysis. CONCLUSIONS: This first-in-human experience evaluating EVOQUE TTVR demonstrated high technical success, acceptable safety, and significant clinical improvement. Larger prospective studies are needed to confirm durability and safety and the impact on long-term clinical outcomes.

Comparison of transcatheter tricuspid valve repair using the MitraClip NTR and XTR systems.

BACKGROUND: Transcatheter tricuspid leaflet repair (TTVr) using the MitraClip is a promising option for patients with severe tricuspid regurgitation (TR) and heart failure. However, no comparative studies of the NTR and XTR systems have been reported. OBJECTIVES: The aim of this study was to assess the relative efficacy, safety, and clinical outcomes of patients with severe TR treated with the MitraClip NTR and XTR systems. METHODS: Forty consecutive patients with severe TR underwent TTVr. The primary outcome was procedural success, with NYHA functional class, TR grade and major adverse cardiac and cerebrovascular events (MACCE) assessed at 30-day follow-up. RESULTS: The majority of patients had functional TR and a greater proportion of XTR patients had torrential TR with larger coaptation gaps. Procedural success was achieved in 70% vs 80% in the NTR and XTR cohorts. Single leaflet device attachment was equal in both groups (5%). At 30-day follow-up, 70% vs 85% of NTR and XTR patients were in NYHA Class I/II. The mean reduction in TR grade was greater in the XTR group (1.5 ± 0.3 vs 2.3 ± 0.4, p-0.012). In patients with torrential TR at baseline, 55% in the XTR group achieved TR ≤ 2+ compared to none in the NTR group (p < 0.001). CONCLUSIONS: In this first study comparing the MitraClip NTR and XTR systems for TTVr, we found both to be safe and effective, while the XTR system allowed treatment of larger coaptation gaps, greater mean reduction in TR grade, with more effective reduction of torrential TR.