1. Percutaneous Repair With the MitraClip Device for Severe Secondary Mitral Regurgitation: The MITRA-FR Study

Presented by Jean François Obadia

Objective

• To evaluate the clinical efficacy of percutaneous mitral valve repair (MitraClip [Abbott; Abbott Park, IL]) in addition to medical treatment in patients with heart failure (HF) and severe functional/secondary mitral regurgitation (MR) versus optimal medical treatment (OMT) alone.

Characteristics

• Inclusion citeria: symptomatic despite OMT (New York Heart Association [NYHA] class ≥II), at least one hospitalization for HF within 12 months preceding randomization, severe secondary MR (effective regurgitant orifice > 20 mm² or R.vol >30 mL/beat), left ventricular ejection fraction 15-40%, and not eligible for surgery.
• 452 patients screened, 304 patients enrolled: 152 in Mitraclip + OMT versus 152 in OMT only (intention-to-treat analysis).
• Baseline characteristics were well-balanced between both groups.
• 60% had ischemic cardiomyopathy, 2/3 of patients had NYHA class III and IV, mean ejection fraction was 33%, and mean effective regurgitant orifice area was 31 mm².
• There was no difference in the use of medical therapy or implantable cardioverter defibrillators between both groups.

Key Findings

• Technical success achieved in 96%. There were no cases of urgent conversion to surgery or peri-procedural mortality within 3 days. 3.5% had vascular injury requiring surgery or transfusion, 1.4% had cardiac embolism, and 1.4% had tamponade.
• 46% of those randomized to Mitraclip had 1 clip, 45% had 2 clips, 9% had 3+ clips.
• The primary outcome of all-cause mortality and HF hospitalization occurred in 54.6% of the MitraClip group versus 51.3% in the OMT-only group (odds ratio [OR] 1.16, 95% confidence interval [CI] 0.73, 1.84).
• All-cause mortality occurred in 24.3% of MitraClip versus 22.4% in the OMT-only group (hazard ratio [HR] 1.11, 95% CI 0.69, 1.77).
• Unplanned HF hospitalization occurred in 48.7% in the MitraClip group versus 47.4% in the OMT-only group (HR 1.13, 95% CI 0.81, 1.56).
• In those treated with MitraClip, MR severity data at baseline and at 1 year was available in 97 patients.

Implications

• Despite its apparent safety and a high technical success rate, MitraClip implantation was not associated with a reduction in clinical endpoints in patients with moderate to severe secondary MR on OMT.
• Compared with the COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation), there were some key differences in the populations studied (see below).
• A comparison with the COAPT trial is beyond the scope of this summary, but patients in the MITRA-FR trial had less severe MR, larger ventricles, and less substantial reduction (and less sustained reduction) of MR with the MitraClip compared with those enrolled in the COAPT trial; these differences may explain the difference in outcomes between the two trials.

2. Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic Severe Aortic Stenosis: The LRT Trial

Presented by Ron Waksman

Objective

• To assess the safety and feasibility of transcatheter aortic valve replacement (TAVR) with commercially available valves in patients with symptomatic severe aortic stenosis (AS) who are low risk (Society of Thoracic Surgeons [STS] score ≤3%) for surgical aortic valve replacement (SAVR).

Characteristics

• TAVR group (n = 200): prospective, multicenter registry of low-risk patients with symptomatic severe AS undergoing transfemoral TAVR using a commercially available TAVR device.
• SAVR group (n = 719): historical cohort of low-risk patients who underwent isolated SAVR at the same institutions from the STS database.
• 30-day follow-up.
• In TAVR versus SAVR, baseline characteristics were well-balanced except for peripheral artery disease (16.6% vs. 5.5%, p < 0.001), ejection fraction (63.2% vs. 58.7%, p < 0.001), pre-existing permanent pacemaker or implantable cardioverter-defibrillator (2.0% vs. 5.2%, p = 0.01), and prior myocardial infarction (3.3% vs. 7.7%, p = 0.006).
• 24.5% of TAVR patients underwent general anesthesia, 100% had transfemoral access, and 88.2% had an S3 valve.

Key Findings

• All 200 patients undergoing TAVR were alive at 30 days, and none suffered a disabling stroke.
• 1.7% of SAVR patients died at 30 days.
• In TAVR versus SAVR, length of stay was 2.0 versus 6.4 days, Valve Academic Research Consortium 2 life-threatening or major bleeding occurred in 2.5% versus 10.3%, and new-onset atrial fibrillation (AF) occurred in 3% versus 40.8% (all p < 0.001).
• 194 patients with TAVR underwent four-dimensional computed tomography scan or transesophageal echocardiography at 30 days. Hypo-attenuated leaflet-thickening occurred in 27/193 (14%). Reduced leaflet motion occurred in 11.2%, and hypoattenuation affecting motion occurred in 7.4%.
• Hypo-attenuated leaflet-thickening occurred in 15.8% of patients on antiplatelets compared with 7.7% of patients on oral anticoagulants.

Implications

• Promising non-randomized observational data on patients with low risk undergoing TAVR.
• The use of historical controls and the short duration of follow-up represent major limitations of this study.
• Ongoing andomized controlled trials (to be reported in 2019) will shed light on TAVR performance in low-risk patients.

3. FRANCE-2 Registry: 5-Year Clinical Outcome and Valve Durability After Transcatheter Aortic Valve Implantation in High-Risk Patients

Presented by Martine Gilard

Objective

• To asses the 5-year clinical outcomes and valve durability after transcatheter aortic valve implantation (TAVI).

Characterisics

• All implanted TAVI from January 2010 to January 2012 in participating sites.
• Primary endpoint: 30 day mortality, 6 month mortality, and up to 5 years mortality.
• Secondary endpoint: major adverse cardiac events and valve hemodynamics.
• 4,201 patients were enrolled.
• Mean age was 82.5 years, 49.4% were females, and logistic EuroSCORE was 22.3%.
• 68% of valves were Edwards Lifesciences (Irvine, CA), 32% were Medtronic CoreValve Evolut R (Medtronic; Dublin, Ireland).
• Access: 74% transfemoral, 19% transapical, and 5% subclavian.
• Device success in 97.2%.
• Vital status was available in 95.5%.
• Structural valve deterioration was classified according to a previously published criteria.¹

Key Findings

• All-cause mortality occurred in 60.8% over 5 years. The HR for patients with logistic EuroSCORE ≥20% (compared to ≤10%) was 1.41 (95% CI 1.27, 1.57).
• Complications: the majority occurred in the first month. After the first month, the incidence of cardiovascular complications (including myocardial infarction, HF, stroke, major bleeding, major vascular injury, endocarditis, and new pacemaker) remained stable at <2% per year up to 5 years.
• Infective endocarditis incidence was ≤0.6% in the first year and ≤0.3% afterwards.
• 1,139 patients were alive at 5 years; 459 echocardiograms were available for review to determine valve performance and hemodynamics.
  • 13.3% had moderate to severe structural valve deterioration.
  • 2.5% had severe structural valve deterioration.
    • 50% mean gradient ≥40 mmHg
    • 36.7% gradient between 20 and 40 mmHg
    • 23.5% aortic regurgitation (AR) grade ≥II
  • In patients with severe structural valve deterioration, 1.7% had stroke and13.3% had HF.
  • No difference in incidence according to valve type.
• At 5 years, among the 459 patients with echocardiograms available for analysis, 2% showed central AR grade II and 0.8% had AR grade III or IV.
• Limitations: clinical outcomes were reported by sites, and no core laboratory was available to review echocardiograms.

Implications

• In surviving patients, the low rates of clinical events and of severe hemodynamic structural valve deterioration after 1 year support the long-term efficacy of TAVI in the valves used in this study.
• Longer term follow-up will be required as we move toward lower-risk patients.
• Whether anticoagulation could decrease the incidence of structural valve deterioration is currently being investigated.

4. TAVI-PM: Post-Mortem Observation Study of TAVI

Presented by Mahir Karakas

Objective

• To systematically explore TAVI prostheses post-mortem.
• To assess TAVI post-mortem immunohistologically.

Characteristics

• 451 TAVI patients gave consent for post-mortem examination.
• 39 post-mortem TAVIs examined so far.
• Time from implantation to death: 36% <1 year, 23% 1-2 years, 20.5% 2-4 years, 20.5% >4 years.
• 69% self-expandable valves.

Key Findings

• Post-mortem examination revealed worse macroscopic and microscopic (increased fragmentation and irregularity) changes in the valves that were explanted more than 4 years after TAVI compared with less than 4 years after TAVI.
• There were no cases of patient-prosthesis mismatch or grade III/IV paravalvular regurgitation. There was one case of prosthesis malposition.
• There was one case of thrombus development on the valven and no cases of thromboembolism.
• There were no cases of valve vegetation, dehiscence, or paravalvular abscess. There was one case of leaflet perforation.

Implications

• Early data on the outcomes of the valves used in TAVI when examined post-morte show that the macroscopic and microscopic valve deterioriation did not result in increased valve dysfunction (prior to explantation).
• Further studies are needed to compare the performance of TAVI valves with SAVR bioprosthetic valves.

5. Patients at Low Surgical Risk Undergoing Isolated Interventional or Surgical Aortic Valve Implantation: In-Hospital Data and One-Year Results From the German Aortic Valve Registry (GARY)

Presented by Raffi Bekeredjian

Objective

• To analyze outcome data on isolated SAVR and TAVI patients with an STS score <4%.

Characteristics

• Patients who presented in 2014-2015 had STS <4% and completed 1 year of follow-up were included.
• A total of 20,549 patients was included in this analysis; 29.5% underwent TAVI.
• The groups were different in all baseline characterisics. Mean STS score was 1.79% in SAVR compared with 2.86% in TAVI (p < 0.001).

Key Findings

• Unadjusted survival in TAVI versus SAVR:
  • In hospital: 98.5% versus 98.5%
  • 30 day: 98.1% versus 98.31%
  • 1 year: 90.0% versus 95.2%
• Adjusted survival in TAVI versus SAVR:
  • In hospital: 98.5% versus 97.3%, p = 0.003
  • 30 day: 98.1% versus 97.1%, p = 0.014
  • 1 year: 90% versus 91.2%, p = 0.158

Implications

• Although not randomized, in low-risk patients, TAVI was associated with superior short-term outcomes and comparable 1-year outcomes in an adjusted comparison with SAVR.
• Randomized clinical trials are ongoing to compare TAVI with SAVR in low-risk patients with longer follow-up.

6. Outcomes of TMVR for Degenerated Biprostheses, Failed Annuloplasty Rings and Mitral Annular Calcification

Presented by Sung-Han Yoon

Objective

• To evaluate and compare the procedural and clinical outcomes of patients undergoing transcatheter mitral valve repair (TMVR) for degenerated bioprostheses (valve-in-valve [ViV]), failed annuloplasty rings (valve-in-rings [ViR]), and severe mitral annular calcification (valve-in-MAC [ViMAC]).

Characteristics

• International multicenter registry of TMVR including 40 European and American centers.
• There were 512 patients: ViV = 322, ViR = 141, ViMAC = 58.
• Mean age was 73 years, 54% were females, and STS risk score was 9±7%.
• MR 46%, mitral stenosis 33%, combined 21%.
• Access: transapical 60%, transseptal 40%.
• Edwards SAPIEN/XT/S3 (Edwards Lifesciences; Irvine, CA) valve was used in 90%; LOTUS Valve System (Boston Scientific; Marlborough, MA) in 6%.

Key Findings

• Technical success occurred in 87% (defined as absence of procedural mortality; successful access, delivery, and retrieval of the device delivery system; successful deployment and correct positioning of the first intended device; freedom from emergent surgery or reintervention).

Outcomes

• MR ≥ moderate in 10% (5.6% in ViV, 18.4% in ViR, and 13.8% in ViMAC).
• Reintervention 14% (3.5% paravalvular leak closure, 1.9% alcohol septal ablation, 6.9% atrial septal defect closure, and 1.9% surgical mitral valve repair).
• Mortality at 30 days was 10.4% (6.2% in ViV, 9.9% in ViR, and 34.5% in ViMAC), stroke was 1.7%, life threatening or fatal bleeding was 3.5%, and major vascular complications were 2.7%.
• Complications: conversion to surgery occurred in 2.3%, valve embolization in 1.7%, left ventricle perforation in 0.8%, need for a second valve in 5.4% (12% in ViR), and left ventricular outflow tract obstruction in 7% (40% of ViMAC).
• Mid-term outcomes:
  • Over 1 year, all-cause mortality occurred in 23.5% (20.2% cardiovascular mortality).
  • All-cause mortality occurred in 14% ViV, 30.6% ViR, and 62.8% ViMAC.
  • All-cause mortality occurred in 41.5% with post-procedural MR ≥ moderate compared with 21.4% with MR <moderate (p < 0.01).
  • No difference in mortality in transseptal versus trasapical access.
  • Valve thrombosis occurred in 1.6% of patients on anticoagulation compared with 6.6% in those without anticoagulation (p = 0.019).
  • Predictors of all-cause mortality were STS score (1.02, 95% CI 1.01, 1.06), chronic obstructive pulmonary disease (1.54, 95% CI 1.06, 2.24), post-procedural MR ≥ moderate (HR 1.72, 95% CI 1.06, 2.81), ViR (HR 1.99, 95% CI 1.27, 3.12), and ViMAC (HR 5.29, 95% CI 3.29, 8.51).

Implications

• Promising results with ViV; sub-optimal results with ViR and ViMAC.
• Anticoagulation is associated with lower incidence of valve thrombosis.

7. Anti-Thrombotic Treatment After TAVR: Insights From the FRANCE-TAVI Registry

Presented by Jean-Philippe Collet

Objective

• To investigate whether anti-thrombotic treatment influences long-term mortality and early bioprosthetic valve dysfunction (defined as prosthetic gradient ≥10 mmHg or new gradient ≥20 mmHg).
• To explore independent correlates of long-term mortality and early bioprosthetic valve dysfunction after TAVI.

Characteristics

• There were 11,469 patients included; 33% were on oral anticoagulants (OAC).
• Mean age was 82.8 years, 49.6% were males, and logistic EuroSCORE I was 17.8%.
• In those on OAC compared with those not: 47.9% versus 42.3% had chronic kidney disease (CKD), 70.8% versus 14% had AF, and 63.4% versus 93.3% were discharged on aspirin.
• In those on OAC, dual therapy was prescribed in 54.7% and triple therapy in 8.6%.

Key Findings

• Over 3.3 years of follow-up, survival was lower for patients discharged on OAC (HR 1.50, 95% CI 1.35, 1.66).
• Predictors of long-term mortality were OAC on discharge (HR 1.18, 95% CI 1.04, 1.35), moderate-severe CKD (HR 1.37, 95% CI 1.23, 1.53), AF (HR 1.41, 95% CI 1.23, 1.62), non-femoral access (HR 1.18, 95% CI 1.04, 1.35), and moderate to severe prosthetic regurgitation (HR 1.28, 95% CI 1.11, 1.50).
• Predictors of prosthetic valve dysfunction were lack of OAC on discharge (OR 0.54, 95% CI 0.35, 0.82), prior TAVR (OR 2.96, 95% CI 1.15, 7.64), body mass index (OR 1.05, 95% CI 1.02, 1.09), moderate-severe CKD (OR 1.46, 95% CI 1.03, 2.08), and prosthesis ≤23 mm (OR 3.43, 95% CI 2.41, 4.89).

Implications

• Observational data might reflect the underlying indication for OAC outcomes and patient characteristics rather than OAC itself.
• OAC is associated with less prosthetic valve dysfunction.
• Trials investigating OAC strategies in TAVR are ongoing.

8. EORP VHD II Registry - Contemporary Management of Heart Valve Disease

Presented by Bernard Iung

Objective

• To analyse existing practices in the management of patients with native heart valve disease or any previous valvular intervention.
• To compare these practices with existing European Society of Cardiology guidelines.

Characteristics

• Inclusion criteira: all patients ≥18 years who had severe native valve disease or had prior intervention (percutaneous balloon dilatation, transcatheter intervention, valve repair, or valve replacement).
• In 222 centers, 7,247 patients across 28 countries were included.

Key Findings

• 72% of patients had native valve disease, 41% had AS, 25% had multiple left-sided valves, 21% had MR, 5% had aortic insufficiency, 4% had mitral stenosis, 3% had isolated right-sided valve disease.
• Underutilization of quantitative methods in regurgitant lesions.
• Rare use of stress testing in asymptomatic patients.
• Good concordance between guidelines and intervention especially in aortic diseases.
• Late referral to intervention especially in mitral valve disease.

Implications

• Emphasizes the importance of continued monitoring and education to ensure guidelines implementation, early recognition, and timly referral to intervention.
• Longitudinal epidemiological studies of valvular heart diseases are needed.

References

1. Capodanno D, Petronio AS, Prendergast B, et al. Standardized definitions of structural deterioration and valve failure in assessing long-term durability of transcatheter and surgical aortic bioprosthetic valves: a consensus statement from the European Association of Percutaneous Cardiovascular Interventions (EAPCI) endorsed by the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J 2017;38:3382-90.

Keywords: ESC Congress, ESC18, Heart Valve Diseases, Heart Valves, Percutaneous Coronary Intervention, Mitral Valve Insufficiency, Transcatheter Aortic Valve Replacement, Aortic Valve Stenosis

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