Prediction of Mortality and Heart Failure Hospitalization After Transcatheter Tricuspid Valve Interventions: Validation of TRISCORE.

BACKGROUND: Data on the prognostic role of the TRI-SCORE in patients undergoing transcatheter tricuspid valve intervention (TTVI) are limited. OBJECTIVES: The aim of this study was to evaluate the performance of the TRI-SCORE in predicting outcomes of patients undergoing TTVI. METHODS: TriValve (Transcatheter Tricuspid Valve Therapies) is a large multicenter multinational registry including patients undergoing TTVI. The TRI-SCORE is a risk model recently proposed to predict in-hospital mortality after tricuspid valve surgery. The TriValve population was stratified based on the TRI-SCORE tertiles. The outcomes of interest were all-cause death and all-cause death or heart failure hospitalization. Procedural complications and changes in NYHA functional class were also reported. RESULTS: Among the 634 patients included, 223 patients (35.2%) had a TRI-SCORE between 0 and 5, 221 (34.8%) had 6 or 7, and 190 (30%) had ≥8 points. Postprocedural blood transfusion, acute kidney injury, new atrial fibrillation, and in-hospital mortality were more frequent in the highest TRI-SCORE tertile. Postprocedure length of stay increased with a TRI-SCORE increase. A TRI-SCORE ≥8 was associated with an increased risk of 30-day all-cause mortality and all-cause mortality and the composite endpoint assessed at a median follow-up of 186 days (OR: 3.00; 95% CI: 1.38-6.55; HR: 2.17; 95% CI: 1.78-4.13; HR: 2.08, 95% CI: 1.57-2.74, respectively) even after adjustment for procedural success and EuroSCORE II or Society of Thoracic Surgeons Predicted Risk of Mortality. The NYHA functional class improved across all TRI-SCORE values. CONCLUSIONS: In the TriValve registry, the TRI-SCORE has a suboptimal performance in predicting clinical outcomes. However, a TRISCORE ≥8 is associated with an increased risk of clinical events and a lack of prognostic benefit after successful TTVI.

Transcatheter Tricuspid Valve Intervention in Patients With Previous Left Valve Surgery.

BACKGROUND: Scarce data exist on patients with previous left valve surgery (PLVS) undergoing transcatheter tricuspid valve intervention (TTVI). This study sought to investigate the procedural and early outcomes in patients with PLVS undergoing TTVI. METHODS: This was a subanalysis of the multicenter TriValve registry including 462 patients, 82 (18%) with PLVS. Data were analyzed according to the presence of PLVS in the overall cohort and in a propensity score-matched population including 51 and 115 patients with and without PLVS, respectively. RESULTS: Patients with PLVS were younger (72 ± 10 vs 78 ± 9 years; p < 0.01) and more frequently female (67.1% vs 53.2%; P = 0.02). Similar rates of procedural success (PLVS 80.5%; no-PLVS 82.1%; P = 0.73), and 30-day mortality (PLVS 2.4%, no-PLVS 3.4%; P = 0.99) were observed. After matching, there were no significant differences in both all-cause rehospitalisation (PLVS 21.1%, no-PLVS 26.5%; P = 0.60) and all-cause mortality (PLVS 9.8%, no-PLVS 6.7%; P = 0.58). At last follow-up (median 6 [interquartile range 1-12] months after the procedure), most patients (81.8%) in the PLVS group were in NYHA functional class I-II (P = 0.12 vs no-PLVS group), and TR grade was ≤ 2 in 82.6% of patients (P = 0.096 vs no-PVLS group). A poorer right ventricular function and previous heart failure hospitalization determined increased risks of procedural failure and poorer outcomes at follow-up, respectively. CONCLUSIONS: In patients with PLVS, TTVI was associated with high rates of procedural success and low early mortality. However, about one-third of patients required rehospitalisation or died at midterm follow-up. These results would support TTVI as a reasonable alternative to redo surgery in patients with PLVS and suggest the importance of earlier treatment to improve clinical outcomes.

Clinical impact of intervention strategies after failed transcatheter mitral valve repair.

AIMS: Failure of transcatheter mitral valve repair (fTMVR) therapy has a decisive prognostic influence, and complex retreatment is of higher risk. The aim of this analysis was to evaluate the survival outcome following percutaneous procedures and surgery after unsuccessful TMVR interventions for different aetiologies. METHODS AND RESULTS: Of 824 consecutive patients who had been treated with the MitraClip device at our institution, between September 2009 and May 2019, 63 (7.6%) symptomatic patients with therapy failure and persistent or recurrent mitral regurgitation (MR) underwent reinterventions. An outcome analysis for primary (PMR) and secondary mitral regurgitation (SMR) and subsequent percutaneous versus surgical treatment was carried out. MitraClip reinterventions were performed in 36 patients (57.1%; n=26 SMR, n=10 PMR), while 27 (42.9%; n=13 SMR, n=14 PMR) underwent open heart surgery. Surgical patients with PMR showed lower mortality than patients with SMR (p<0.0001) and ReClip patients with PMR (p=0.073). Atrial fibrillation (HR 2.915, 95% CI: [1.311, 6.480]), prior open heart surgery (2.820 [1.215, 6.544]) and chronic obstructive pulmonary disease (2.506 [1.099, 5.714]) increased the risk of death. The level of post-interventional MR had no relevant impact on survival. CONCLUSIONS: We conclude that, after SMR and failed TMVR, reclipping is an appropriate treatment option for symptomatic patients. For PMR patients, surgery must be favoured over a reclipping procedure. However, patients with atrial fibrillation, prior open heart surgery and chronic obstructive pulmonary disease are at risk of reduced survival after reinterventions.

1-Year Outcomes After Edge-to-Edge Valve Repair for Symptomatic Tricuspid Regurgitation: Results From the TriValve Registry.

OBJECTIVES: The purpose of this study was to evaluate procedural and 1-year clinical and echocardiographic outcomes of patients treated with tricuspid edge-to-edge repair. BACKGROUND: Transcatheter edge-to-edge repair has been successfully performed in selected patients with symptomatic tricuspid regurgitation (TR) and high risk for surgery, but outcome data are sparse. METHODS: This analysis of the multicenter international TriValve (Transcatheter Tricuspid Valve Therapies) registry included 249 patients with severe TR treated with edge-to-edge repair in compassionate and/or off-label use. Clinical and echocardiographic outcomes were prospectively collected and retrospectively analyzed. RESULTS: In 249 patients (mean age 77 ± 9 years; European System for Cardiac Operative Risk Evaluation II score 6.4% [interquartile range: 3.9% to 13.9%]), a successful procedure with TR reduction to grade ≤2+ was achieved in 77% by placement of 2 ± 1 tricuspid clips. Concomitant treatment of severe TR and mitral regurgitation was performed in 52% of patients. At 1-year follow-up, significant and durable improvements in TR severity (TR ≤2+ in 72% of patients) and New York Heart Association functional class (≤II in 69% of patients) were observed. All-cause mortality was 20%, and the combined rate of mortality and unplanned hospitalization for heart failure was 35%. Predictors of procedural failure included effective regurgitant orifice area, tricuspid coaptation gap, tricuspid tenting area, and absence of central or anteroseptal TR jet location. Predictors of 1-year mortality were procedural failure, worsening kidney function, and absence of sinus rhythm. CONCLUSIONS: Transcatheter tricuspid edge-to-edge repair can achieve TR reduction at 1 year, resulting in significant clinical improvement. Predictors of procedural failure and 1-year mortality identified here may help select patients who will benefit most from this therapy.

Management of arrhythmia recurrence in patients with pulmonary vein stenosis following atrial fibrillation ablation.

AIMS: Arrhythmia recurrence is a common clinical problem in patients with pulmonary vein stenosis (PVS) following catheter ablation of atrial fibrillation. The study sought to analyse the management of arrhythmia recurrence in patients with PVS. METHODS AND RESULTS: Retrospective analysis was performed on 29 patients with high-degree PVS. Follow-up contained clinical visits, Holter-electrocardiogram recordings and invasive pulmonary vein (PV) angiography and electrophysiological studies. Arrhythmia recurrence was observed in 18 patients (62%) after PVS formation. Fifteen of 18 patients (83.3%) with and 1 of 11 patients (9.1%) without arrhythmia recurrence had electrical PV reconnection (P = 0.0003). In 14 of 16 patients repeat pulmonary vein isolation (PVI) was conducted (radiofrequency ablation in 12 and cryoballoon ablation in 2 cases). Repeat PVI was successful in all PVs in nine patients and incomplete in five patients (failed attempt in two patients with stent implantation, no attempt in three patients with stenotic PVs). Freedom from arrhythmia recurrence was estimated at 56.3% [95% confidence interval (CI) 36.4-72.0%] after 24 months. At the end of the follow-up, complete PVI was documented in 19 of 23 patients (82.6%) with stable sinus rhythm and in 2 of 6 patients with arrhythmia recurrence (33.3%) (P = 0.0335). The Kaplan-Meier estimate of recurrence-free survival of restenosis after interventional PVS treatment was similar in patients without and with repeat ablation [75.6% (95% CI 57.0-94.3%) and 67.0% (95% CI 43.2-90.7%) after 500 days, P = 0.77]. CONCLUSIONS: Pulmonary vein reconnection is the major driver of arrhythmia recurrence in PVS patients. Repeat PVI is feasible and does not lead to progression of PVS or restenosis if the procedure is carefully performed.

Predictive impact of previous coronary artery bypass grafting on mortality after MitraClip implantation for ischemic functional mitral regurgitation.

BACKGROUND: Many candidates with ischaemic functional mitral regurgitation (FMR) have previously undergone coronary artery bypass grafting (CABG), in which transcatheter mitral valve repair can be reasonable for ameliorating the deteriorated hemodynamic and heart failure symptoms. We sought to elucidate the outcomes of MitraClip (MC) implantation in patients with symptomatic ischaemic FMR after CABG. METHODS: We investigated clinical characteristics, outcomes and predictive impact of previous CABG on mortality in ischaemic FMR patients who underwent MC implantation from two high-volume centres in Germany. RESULTS: We enrolled 159 patients who previously underwent CABG. Compared with a reference group that did not previously undergo CABG (n = 182), the cohort consisted of more elderly patients (75.0, standard deviation [SD] 7.7 versus 72.9, SD 9.6 years, p = 0.028), more men (84% vs. 69%, p < 0.001), and reduced tricuspid annular plane systolic excursion (14.0, SD 4.0, vs. 16.6, SD 4.6 mm, p < 0.0001). The CABG group showed similar outcomes regarding procedural success (91% vs. 94%, p = 0.24) and 30-day mortality (5.0% vs. 6.0%, p = 0.68), but worse survival after MC implantation (log-rank p = 0.019, hazard ratio 1.56 [95% confidence interval (CI) 1.08-2.26]). After propensity score matching (n = 224), the hazard ratio was 1.18 [95%CI 0.76-1.84] without statistical significance (p = 0.46). CONCLUSIONS: Transcatheter mitral valve repair using the MC is a viable treatment option for patients with symptomatic ischaemic FMR after CABG. Although the baseline characteristics seemed to point to sick patients, CABG itself had only a modest impact on survival.

Is Surgical or Catheter-based Interventions an Option After an Unsuccessful Mitral Clip?

The objective of this study was to assess the results of catheter-based and surgical reinterventions in primary mitral regurgitation after failed MitraClip therapy. We report on 21 consecutive symptomatic patients with primary mitral regurgitation (median age 78 years) who underwent either repeat MitraClip therapy (n = 7) or mitral valve surgery (n = 14) after failure of the index procedure with 1-2 MitraClip implantations. At the time of reinterventions, 193 (interquartile range [IQR]: 32-622) days after the index procedure, patients had recurrent or persistent grade 3 mitral regurgitation. Early mortality at 30 days was 4.8%. Cardiac-related survival at 2 years was 85.4% (4 cardiac and 4 noncardiac deaths). Three of 7 patients with percutaneous reintervention were converted to surgery at 34, 52, and 56 days because repeat MitraClip therapy was ineffective because of pre-existing clip detachment or leaflet tear. Final therapy was biological mitral valve replacement in 14 of 21 patients (66.7%); 4 were treated with percutaneous repeat MitraClip repair (19%), and in 3 patients, surgical repairs were performed (14.3%). At follow-up with a median of 708 days, New York Heart Association class had improved significantly to class 2 (IQR: 1.0-2.5) (P = 0.0004), and the left ventricular end-diastolic diameter had decreased from 56 (IQR: 52-59) mm to 51 (48-58) mm (P = 0.0378), respectively. Recurrence of significant mitral regurgitation was absent in all but 1 patient with unsuccessful repeat MitraClip therapy who was deemed inoperable. Our data show that both repeat MitraClip and also mitral valve surgery are feasible and safe alternatives in patients without an excessively increased perioperative risk. We conclude that whenever leaflet insertion is not compromised, repeat catheter-based repair is a reasonable redo concept; in the remaining cases, surgery should be offered to the patient.

Histological Findings and Predictors of Cerebral Debris From Transcatheter Aortic Valve Replacement: The ALSTER Experience.

BACKGROUND: Histopathological analyses of debris captured by a cerebral protection system during transcatheter aortic valve replacement have been reported, but the origin of the captured debris was not determined and risk factors were not defined. METHODS AND RESULTS: Embolic debris was analyzed from 322 filters used in a dual-cerebral-filter protection system implemented during transcatheter aortic valve replacement for 161 patients (mean age 81 years, 82 male [51%], logistic EuroSCORE 19% [interquartile range 12-31%]). The debris capture rate was high, with debris from 97% of all patients (156 of 161). No differences by filter location were found (brachiocephalic trunk 86% [139 of 161], left carotid artery 91% [147 of 161]; adjusted P=0.999). Five prevalent types of debris were identified: thrombus (91%), arterial wall tissue (68%), valve tissue (53%), calcification (46%), and foreign material (30%). Female sex (P=0.0287, odds ratio 1.364, 95% CI 1.032-1.812) and diabetes mellitus (P=0.0116, odds ratio 1.474, 95% CI 1.089-2.001) were significant risk factors for embolic debris. Additional analysis showed significantly more valve tissue in patients with predilation (P=0.0294). Stroke and transient ischemic attack rates were 0.6% each (1 of 161). CONCLUSION: This study showed a high rate of embolic debris consisting of typical anatomic structures known to be altered in patients with aortic stenosis undergoing transcatheter aortic valve replacement. Female patients with diabetes mellitus have increased risk of embolic debris and should be protected by a cerebral protection system during transcatheter aortic valve replacement. Because valve tissue embolizes more often in patients with predilation, procedural planning should consider this finding. Both cerebral arteries (brachiocephalic trunk, left carotid artery) should be protected in the same way.

Redo TAVI: initial experience at two German centres.

AIMS: The aim of this study was to assess the feasibility and early outcomes of transcatheter aortic valve implantation (TAVI) in dysfunctional TAVI prostheses (redo TAVI). METHODS AND RESULTS: Nineteen redo TAVI procedures were performed between October 2011 and November 2015 at two German centres. Mean age was 78 years, 13 (68%) were male, and the mean logistic EuroSCORE was 32%. Median time elapsed since index TAVI was 644 days (interquartile range 191-1,831). Failure mode of the index TAVI prosthesis was regurgitation (AR) in 16 patients (n=12 paravalvular AR, n=3 combined paravalvular/valvular AR, n=1 valvular AR) and stenosis in three patients. Device success was achieved in 89% (17/19). Median invasive post-interventional transprosthetic gradient was 3.0 mmHg. No severe prosthesis-patient mismatch (PPM) was observed. At one year, mean pressure gradient was 9±1.2 mmHg and no relevant PPM was documented in 90% of the cases. All-cause mortality at 30 days and one year was 11% and 33% (6/18, five non-cardiac deaths), respectively. Mean follow-up time was 404 days. CONCLUSIONS: Redo TAVI appears to be feasible. Paravalvular regurgitation was the most common indication for a redo procedure. Rates of device success were high with low post-interventional gradients and no severe PPM. Good functional status of the prosthesis was maintained after 12 months, but mortality rates were high in this small comorbid patient population.

MitraClip® via direct right atrial access in case of a missing inferior vena cava.

The presence of mitral regurgitation (MR) in patients with heart failure represents an independent predictor of mortality. Until now, the standard therapy for severe MR has been cardiac surgery in order to perform mitral valve replacement or mitral valve repair. With the introduction of the MitraClip® system (Abbott Vascular - Structural Heart, Menlo Park, CA, USA) in 2008, there is now an alternative percutaneous treatment option available for high-risk patients. We report on an 84-year-old male patient who was admitted to the emergency room with increasing shortness of breath due to severe functional MR, at stage NYHA III. In the following days the patient developed cardiogenic shock due to failure of the diuretic medication. The case first described here demonstrates an alternative transseptal route of access via a direct atrial puncture of the RA in a patient with absent inferior vena cava. This approach was successfully used to perform a MitraClip® procedure in this patient with functional MR and cardiogenic shock. It was possible to treat mitral regurgitation and the consecutive cardiogenic shock by implanting two MitraClips®.