Impact of the Commercial Introduction of Transcatheter Mitral Valve Repair on Mitral Surgical Practice.

Background There has been uncertainty regarding the effect of transcatheter mitral valve repair (TMVr) with MitraClip on cardiac surgical practice. Our aim was to examine the impact of the commercial introduction of TMVr to a comprehensive mitral program. Methods and Results We evaluated 875 patients (aged 69±14 years; 58% men) who underwent transcatheter or mitral surgical procedures over a 6-year period at our institution. Main outcomes were changes in surgical procedural volume after TMVr introduction and short-term mortality for surgical and TMVr procedures. The numbers of patients treated with MitraClip, isolated mitral repair, and any mitral surgery were 249, 292, and 626 patients, respectively. Compared with surgery, patients with MitraClip were older (aged 82±8 versus 64±12 years; P<0.001) and had more severe morbidity. Following the introduction of MitraClip, surgical volumes steadily increased to a rate of 10 (95% CI, 3-7) procedures per year for isolated mitral procedures and 17 (95% CI, 13-20) procedures per year for all mitral surgeries. Both MitraClip and surgical volumes increased at the same rate (P=0.42). In-hospital mortality was 3.2% for MitraClip and 2.1% for all mitral surgeries (P=0.33). At 30 days, survival free of all mortality (P=0.17) and freedom from heart failure rehospitalization (P=0.75) were similar for transcatheter and surgical procedures. Conclusions The commercial introduction of TMVr may be associated with growth in cardiac surgery, without detracting from other therapies, and favorable clinical outcomes for all treated mitral regurgitation patients. These findings demonstrate the potential benefits of complementary therapies in the treatment of patients with mitral regurgitation.

Transcatheter therapy for residual mitral regurgitation after MitraClip therapy.

AIMS: We aimed to examine the effectiveness and the optimal technique for transcatheter therapy for residual mitral regurgitation (MR) after MitraClip therapy with the AMPLATZER Vascular Plug II (AVP-II). METHODS AND RESULTS: Nine patients (mean age, 78±4 years) underwent transcatheter therapy with the AVP-II for residual MR after MitraClip therapy. We examined procedural, in-hospital, and 30-day outcomes. Our technique was successful in all cases, with treatment of different types of residual MR, including paraclip, interclip, and leaflet perforation. MR grade decreased significantly from 4+ to 1+ (p<0.0001), with final residual MR being mild or none in seven patients. Mitral stenosis did not occur with plug placement. The optimal deployment technique for reduction of MR was placement with only one segment on the left atrial side of the mitral valve leaflets (n=8). During clinical follow-up (median 155 days), symptom improvement had occurred in all patients (NYHA class, baseline vs follow-up, 3.2±0.4 vs 2.3±0.8; p=0.01) with mild or no symptoms in six patients. There was no procedural mortality, major adverse event(s), device embolisation, haemolysis or need for cardiac surgery. CONCLUSIONS: For patients with residual MR after MitraClip therapy, this technique may be effective and safe, especially when deployed with only one segment on the left atrial side of the mitral leaflets.

Transcatheter Mitral Valve Replacement with Tendyne.

Mitral regurgitation is the most commonly occurring valvular heart disease in developed countries. Transcatheter mitral valve replacement (TMVR) has emerged as a novel potential therapy for patients with severe mitral valve disease who are unsuitable candidates for conventional surgery or transcatheter edge-to-edge mitral repair. TMVR with the Tendyne prosthesis has shown potential at short-term follow-up to be an effective and safe treatment alternative for high-risk patients with severe mitral valve disease.

Causes and Clinical Outcomes of Patients Who Are Ineligible for Transcatheter Mitral Valve Replacement.

OBJECTIVES: The aim of this study was to gain insight into the causes and outcomes of patients who do not qualify for transcatheter mitral valve replacement (TMVR). BACKGROUND: Despite the increasing availability of TMVR, patients with severe mitral regurgitation may not be eligible. Thus far, no investigation has examined ineligible patients and their clinical outcomes. METHODS: A total of 203 patients (mean age 79 ± 9 years, 48% men) who were ineligible for participation in early feasibility studies of TMVR were examined. RESULTS: The ineligibility rate for TMVR was 89.0%. The most common reasons for TMVR exclusion were excessive frailty (15.3%), severe tricuspid regurgitation (15.3%), and prior aortic valve therapy (14.2%). Mitral anatomic exclusions were present in 15.8%, with severe annular calcification in 7.4%, and risk for left ventricular outflow tract obstruction was notably infrequent (4.4%). Overall, 76 patients (37.4%) did not undergo subsequent commercial surgical or transcatheter mitral therapy. Patients not eligible for TMVR and not treated commercially had high rates of cardiac death (11.8%) and death or heart failure hospitalization (22.4%) at 1 year. These rates were significantly higher than those who underwent surgery (2.4% for cardiac death; p < 0.001; 5.5% for heart failure hospitalization; p = 0.003) and remained worse after excluding patients with excessive frailty or medical futility and in multivariate modeling that adjusted for baseline differences. CONCLUSIONS: Patients ineligible for TMVR and treated medically have poor outcomes. These data and the high rate of TMVR screen failure support the need for therapy iteration as well as development of alternative means of management, with the goal of improving the prognosis of these patients.

Outcomes of transcatheter mitral valve replacement for degenerated bioprostheses, failed annuloplasty rings, and mitral annular calcification.

Aims: We sought to evaluate the outcomes of transcatheter mitral valve replacement (TMVR) for patients with degenerated bioprostheses [valve-in-valve (ViV)], failed annuloplasty rings [valve-in-ring (ViR)], and severe mitral annular calcification [valve-in-mitral annular calcification (ViMAC)]. Methods and results: From the TMVR multicentre registry, procedural and clinical outcomes of ViV, ViR, and ViMAC were compared according to Mitral Valve Academic Research Consortium (MVARC) criteria. A total of 521 patients with mean Society of Thoracic Surgeons score of 9.0 ± 7.0% underwent TMVR (322 patients with ViV, 141 with ViR, and 58 with ViMAC). Trans-septal access and the Sapien valves were used in 39.5% and 90.0%, respectively. Overall technical success was excellent at 87.1%. However, left ventricular outflow tract obstruction occurred more frequently after ViMAC compared with ViR and ViV (39.7% vs. 5.0% vs. 2.2%; P < 0.001), whereas second valve implantation was more frequent in ViR compared with ViMAC and ViV (12.1% vs. 5.2% vs. 2.5%; P < 0.001). Accordingly, technical success rate was higher after ViV compared with ViR and ViMAC (94.4% vs. 80.9% vs. 62.1%; P < 0.001). Compared with ViMAC and ViV groups, ViR group had more frequent post-procedural mitral regurgitation ≥moderate (18.4% vs. 13.8% vs. 5.6%; P < 0.001) and subsequent paravalvular leak closure (7.8% vs. 0.0% vs. 2.2%; P = 0.006). All-cause mortality was higher after ViMAC compared with ViR and ViV at 30 days (34.5% vs. 9.9% vs. 6.2%; log-rank P < 0.001) and 1 year (62.8% vs. 30.6% vs. 14.0%; log-rank P < 0.001). On multivariable analysis, patients with failed annuloplasty rings and severe MAC were at increased risk of mortality after TMVR [ViR vs. ViV, hazard ratio (HR) 1.99, 95% confidence interval (CI) 1.27-3.12; P = 0.003; ViMAC vs. ViV, HR 5.29, 95% CI 3.29-8.51; P < 0.001]. Conclusion: The TMVR provided excellent outcomes for patients with degenerated bioprostheses despite high surgical risk. However, ViR and ViMAC were associated with higher rates of adverse events and mid-term mortality compared with ViV.

Contemporary Reasons and Clinical Outcomes for Patients With Severe, Symptomatic Aortic Stenosis Not Undergoing Aortic Valve Replacement.

BACKGROUND: Although aortic valve replacement (AVR) can be lifesaving, many patients with symptomatic aortic stenosis do not undergo appropriate therapy. This study sought to examine the characteristics, outcomes, and reasons for not pursuing AVR in a contemporary cohort. METHODS AND RESULTS: We examined 548 patients with severe, symptomatic aortic stenosis not treated with AVR through March 2017. Patients were grouped according to AVR appropriateness based on the presence of medical futility. Demographics, rationale for no AVR therapy, and outcomes were assessed. There were 359 (65.5%) potentially appropriate candidates for AVR and 189 (34.5%) others patients with futility. Among potentially appropriate patients, 62.1% had severe symptoms, 74.4% had not been referred for AVR, and 40.1% were low risk. Patient refusal was common (54.6%), with incorrect symptom assignment or aortic stenosis severity classification accounting for nearly all other explanations. Compared with patients with futility, potentially appropriate AVR patients had lower rates of both referral to cardiology or surgery (85.2% versus 92.6%; P=0.01) and complete heart team evaluations (10.6% versus 17.5%; P=0.02). Palliative consultation occurred in only 124 patients (22.6%) overall and in only 10.0% of those without futility. Overall, the 1-year mortality was 54.7%, with heart failure hospitalization occurring in 19.3%. CONCLUSIONS: In this contemporary study, two-thirds of patients with symptomatic aortic stenosis treated medically were potentially appropriate AVR candidates and had poor outcomes. Most had incomplete heart team evaluations, commonly had severe symptoms or lesion severity misinterpreted, and were not evaluated by palliative care. Given the potential for beneficial outcomes among those untreated, further efforts to address these shortcomings are needed.