TRI-SCORE and benefit of intervention in patients with severe tricuspid regurgitation.

BACKGROUND AND AIMS: Benefit of tricuspid regurgitation (TR) correction and timing of intervention are unclear. This study aimed to compare survival rates after surgical or transcatheter intervention to conservative management according to a TR clinical stage as assessed using the TRI-SCORE. METHODS: A total of 2,413 patients with severe isolated functional TR were enrolled in TRIGISTRY (1217 conservatively managed, 551 isolated tricuspid valve surgery, and 645 transcatheter valve repair). The primary endpoint was survival at 2 years. RESULTS: The TRI-SCORE was low (≤3) in 32%, intermediate (4-5) in 33%, and high (≥6) in 35%. A successful correction was achieved in 97% and 65% of patients in the surgical and transcatheter groups, respectively. Survival rates decreased with the TRI-SCORE in the three treatment groups (all P < .0001). In the low TRI-SCORE category, survival rates were higher in the surgical and transcatheter groups than in the conservative management group (93%, 87%, and 79%, respectively, P = .0002). In the intermediate category, no significant difference between groups was observed overall (80%, 71%, and 71%, respectively, P = .13) but benefit of the intervention became significant when the analysis was restricted to patients with successful correction (80%, 81%, and 71%, respectively, P = .009). In the high TRI-SCORE category, survival was not different to conservative management in the surgical and successful repair group (61% and 68% vs 58%, P = .26 and P = .18 respectively). CONCLUSIONS: Survival progressively decreased with the TRI-SCORE irrespective of treatment modality. Compared to conservative management, an early and successful surgical or transcatheter intervention improved 2-year survival in patients at low and, to a lower extent, intermediate TRI-SCORE, while no benefit was observed in the high TRI-SCORE category.

Predictors of Clinical Success After Transcatheter Paravalvular Leak Closure: An International Prospective Multicenter Registry.

BACKGROUND: Transcatheter closure of a symptomatic prosthetic paravalvular leak (PVL) is feasible, but there is presently no conclusive evidence to show consistent efficacy. We aimed to identify predictors of clinical success after transcatheter PVL closure. METHODS: Consecutive patients referred to 24 European centers for transcatheter PVL closure in 2017 to 2019 were included in a prospective registry (Fermeture de Fuite ParaProthétique, FFPP). Clinical success was absence of any of the following within 1 month: re-admission for heart failure, blood transfusion, open-heart valvular surgery, and death. RESULTS: We included 216 symptomatic patients, who underwent 238 percutaneous PVL closure procedures on the mitral (64.3%), aortic (34.0%), or tricuspid (1.7%) valve. Symptoms were heart failure, hemolytic anemia, or both in 48.9%, 7.8%, and 43.3% of patients, respectively. One, 2, and 3 leaks were treated during the same procedure in 69.6%, 26.6%, and 3.8% of patients, respectively. The PVL was pinpoint or involved 1/8 or 1/4 of the valve circumference in 18.6%, 52.4%, and 28.1% of cases, respectively. The most frequently used devices were the Vascular Plug 3, Ventricular Septal Defect Occluder, Vascular Plug 2, and Paravalvular Leak Device (45.0%, 16.6%, 14.2%, and 13.6% of cases, respectively). Successful device(s) implantation with leak reduction to ≤grade 2 was obtained in 85.0% of mitral and 91.4% of aortic procedures, respectively (P=0.164); with major periprocedural adverse event rates of 3.3% and 1.2%, respectively (P=0.371); and clinical success rates of 70.3% and 88.0%, respectively (P=0.004). By multivariate analysis, technical failure, mechanical valve, and hemolytic anemia were independently associated with absence of clinical success (odds ratios [95% CIs], 7.7 [2.0-25.0]; P=0.002; 3.6 [1.1-11.1]; P=0.036; and 3.7 [1.2-11.9]; P=0.025; respectively). CONCLUSIONS: Transcatheter PVL closure is efficient and safe in symptomatic patients but is associated with a lower clinical success rate in patients with hemolysis and/or a mechanical valve. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifiers: NCT05089136.

ST-Segment Elevation Myocardial Infarction Following Transcatheter Aortic Valve Replacement.

BACKGROUND: Among patients with acute coronary syndrome following transcatheter aortic valve replacement (TAVR), those presenting with ST-segment elevation myocardial infarction (STEMI) are at highest risk. OBJECTIVES: The goal of this study was to determine the clinical characteristics, management, and outcomes of STEMI after TAVR. METHODS: This was a multicenter study including 118 patients presenting with STEMI at a median of 255 days (interquartile range: 9 to 680 days) after TAVR. Procedural features of STEMI after TAVR managed with primary percutaneous coronary intervention (PCI) were compared with all-comer STEMI: 439 non-TAVR patients who had primary PCI within the 2 weeks before and after each post-TAVR STEMI case in 5 participating centers from different countries. RESULTS: Median door-to-balloon time was higher in TAVR patients (40 min [interquartile range: 25 to 57 min] vs. 30 min [interquartile range: 25 to 35 min]; p = 0.003). Procedural time, fluoroscopy time, dose-area product, and contrast volume were also higher in TAVR patients (p < 0.01 for all). PCI failure occurred more frequently in patients with previous TAVR (16.5% vs. 3.9%; p < 0.001), including 5 patients in whom the culprit lesion was not revascularized owing to coronary ostia cannulation failure. In-hospital and late (median of 7 months [interquartile range: 1 to 21 months]) mortality rates were 25.4% and 42.4%, respectively (20.6% and 38.2% in primary PCI patients), and estimated glomerular filtration rate <60 ml/min (hazard ratio [HR]: 3.02; 95% confidence interval [CI]: 1.42 to 6.43; p = 0.004), Killip class ≥2 (HR: 2.74; 95% CI: 1.37 to 5.49; p = 0.004), and PCI failure (HR: 3.23; 95% CI: 1.42 to 7.31; p = 0.005) determined an increased risk. CONCLUSIONS: STEMI after TAVR was associated with very high in-hospital and mid-term mortality. Longer door-to-balloon times and a higher PCI failure rate were observed in TAVR patients, partially due to coronary access issues specific to the TAVR population, and this was associated with poorer outcomes.

The Choice of Treatment in Ischemic Mitral Regurgitation With Reduced Left Ventricular Function.

BACKGROUND: Ischemic mitral regurgitation is a condition characterized by mitral insufficiency secondary to an ischemic left ventricle. Primarily, the pathology is the result of perturbation of normal regional left ventricular geometry combined with adverse remodeling. We present a comprehensive review of contemporary surgical, medical, and percutaneous treatment options for ischemic mitral regurgitation, rigorously examined by current guidelines and literature. METHODS: We conducted a literature search of the PubMed database, Embase, and the Cochrane Library (through November 2018) for studies reporting perioperative or late mortality and echocardiographic outcomes after surgical and nonsurgical intervention for ischemic mitral regurgitation. RESULTS: Treatment of this condition is challenging and often requires a multimodality approach. These patients usually have multiple comorbidities that may preclude surgery as a viable option. A multidisciplinary team discussion is crucial in optimizing outcomes. There are several options for treatment and management of ischemic mitral regurgitation with differing benefits and risks. Guideline-directed medical therapy for heart failure is the treatment choice for moderate and severe ischemic mitral regurgitation, with consideration of coronary revascularization, mitral valve surgery, cardiac resynchronization therapy, or a combination of these, in appropriate candidates. The use of transcatheter mitral valve therapy is considered appropriate in high-risk patients with severe ischemic mitral regurgitation, heart failure, and reduced left ventricular ejection fraction, especially in those with hemodynamic instability. CONCLUSIONS: The role of mitral valve surgery and transcatheter mitral valve therapy continues to evolve.

How to treat severe symptomatic structural valve deterioration of aortic surgical bioprosthesis: transcatheter valve-in-valve implantation or redo valve surgery?

The optimal management of aortic surgical bioprosthesis presenting with severe symptomatic structural valve deterioration is currently a matter of debate. Over the past 20 years, the number of implanted bioprostheses worldwide has been rapidly increasing at the expense of mechanical prostheses. A large proportion of patients, however, will require intervention for bioprosthesis structural valve deterioration. Current options for older patients who often have severe comorbidities include either transcatheter valve-in-valve (TVIV) implantation or redo valve surgery. The emergence of TVIV implantation, which is perceived to be less invasive than redo valve surgery, offers an effective alternative to surgery for these patients with proven safety and efficacy in high-risk patient groups including elderly and frail patients. A potential caveat to this strategy is that results of long-term follow-up after TVIV implantation are limited. Redo surgery is sometimes preferable, especially for young patients with a smaller-sized aortic bioprosthesis. With the emergence of TVIV implantation and the long experience of redo valve surgery, we currently have 2 complementary treatment modalities, allowing a tailor-made and patient-orientated intervention. In the heart team, the decision-making should be based on several factors including type of bioprosthesis failure, age, comorbidities, operative risk, anatomical factors, anticipated risks and benefits of each alternative, patient's choice and local experience. The aim of this review is to provide a framework for individualized optimal treatment strategies in patients with failed aortic surgical bioprosthesis.

Early Outcomes of Percutaneous Transvenous Transseptal Transcatheter Valve Implantation in Failed Bioprosthetic Mitral Valves, Ring Annuloplasty, and Severe Mitral Annular Calcification.

OBJECTIVES: The aim of this study was to examine 1-year outcomes of transseptal balloon-expandable transcatheter heart valve implantation in failed mitral bioprosthesis, ring annuloplasty, and mitral annular calcification (MAC). BACKGROUND: Immediate outcomes following transseptal mitral valve implantation in failed bioprostheses are favorable, but data on subsequent outcomes are lacking. METHODS: Percutaneous transseptal implantation of balloon-expandable transcatheter heart valves was performed in 87 patients with degenerated mitral bioprostheses (valve in valve [VIV]) (n = 60), previous ring annuloplasty (valve in ring) (n = 15), and severe MAC (valve in MAC) (n = 12). RESULTS: The mean Society of Thoracic Surgeons risk score was 13 ± 8%, and the mean age was 75 ± 11 years. Acute procedural success was achieved in 78 of 87 patients (90%) in the overall group and 58 of 60 (97%) in the VIV group, with a success rate of 20 of 27 (74%) in the valve in ring/valve in MAC group. Thirty-day survival free of death and cardiovascular surgery was 95% (95% confidence interval [CI]: 92% to 97%) in the VIV subgroup and 78% (95% CI: 70% to 86%) in the valve in ring/valve in MAC group (p = 0.008). One-year survival free of death and cardiovascular surgery was 86% (95% CI: 81% to 91%) in the VIV group compared with 68% (95% CI: 58% to 78%) (p = 0.008). At 1 year, 36 of 40 patients (90%) had New York Heart Association functional class I or II symptoms, no patients had more than mild residual mitral prosthetic or periprosthetic regurgitation, and the mean transvalvular gradient was 7 ± 3 mm Hg. CONCLUSIONS: One-year outcomes following successful transseptal balloon-expandable transcatheter heart valve implantation in high-risk patients with degenerated mitral bioprostheses are excellent, characterized by durable symptom relief and prosthesis function. Although mitral valve in ring and valve in MAC have higher operative morbidity and mortality, 1-year outcomes after an initially successful procedure are favorable in carefully selected patients.

First-in-man full percutaneous transfemoral valve-in-valve implantations using Edwards SAPIEN 3 prostheses to treat a patient with degenerated mitral and aortic bioprostheses.

We report the case of a 64-year old man presenting with pulmonary oedema due to the degeneration of mitral and aortic bioprostheses. Baseline transthoracic and 3D transoesophageal echocardiography showed severe stenotic degeneration of the mitral bioprosthesis (Carpentier-Edwards bioprosthesis n°31), severe intraprosthetic aortic regurgitation (Perimount bioprosthesis n°27), left ventricular dilatation, decreased left ventricular ejection fraction at 50% and pulmonary hypertension. Because of severe comorbidities, the patient was denied redo surgery by the Heart Team (logistic EuroSCORE 2: 23, 85%). Transcatheter transfemoral mitral valve-in-valve implantation was first performed using a 29-mm SAPIEN 3 valve. Two weeks later, aortic valve-in-valve implantation was performed with the same approach using a 26-mm SAPIEN 3 valve. Four months later, the patient remained asymptomatic with good haemodynamic results for both prostheses. This case report illustrates that valve-in-valve implantations using a full percutaneous transfemoral approach may be a valuable alternative to conventional surgery in high-risk patients presenting with concomitant mitral and aortic bioprosthesis dysfunction.

Transfemoral implantation of transcatheter heart valves after deterioration of mitral bioprosthesis or previous ring annuloplasty.

OBJECTIVES: This study sought to evaluate the feasibility of transfemoral transcatheter heart valve (THV) implantation in failed mitral bioprostheses and ring annuloplasties. BACKGROUND: Redo mitral surgery may be high risk or contraindicated due to comorbidity. THV implantation has been recently reported in this setting. METHODS: Transfemoral implantation of Edwards Sapien prosthesis was performed in 17 patients for degenerated mitral bioprosthesis or previous ring annuloplasty (6 bioprostheses, 11 ring annuloplasties). The procedure was elective for 14 patients and attempted as a rescue in 3 patients. Mean age was 61 ± 24 years. All patients were in New York Heart Association class ≥III, and the surgical risk was high (EuroSCORE [European System for Cardiac Operative Risk Evaluation]: 37 ± 29%, Society of Thoracic Surgeons score: 18 ± 22%). RESULTS: Procedure was successful in 14 patients (82%). Two complications occurred during rescue procedures: 1 procedural death and 1 THV migration. One patient had moderate paraprosthetic regurgitation following the procedure, whereas residual regurgitation was trace or less in 11 patients (69%) and mild in 4 patients (25%). Mean gradient decreased from 12 ± 6 mm Hg to 8 ± 3 mm Hg. During a mean follow-up of 22 months, 4 patients died, 3 from cardiac cause. The 18-month survival was 68 ± 14% in the overall population and 78 ± 14% for patients with elective procedure. One patient underwent mitral valve replacement due to periprosthetic mitral regurgitation. At last follow-up, 12 patients were in New York Heart Association class ≤II (75%) and 4 in class III (25%). CONCLUSIONS: This single-center series suggests that transfemoral THV implantation for deterioration of mitral bioprosthesis or surgical repair is feasible in selected patients and improves early hemodynamic and midterm functional status.