Contemporary 1-Year Outcomes of Mitral Valve-in-Ring With Balloon-Expandable Aortic Transcatheter Valves in the U.S.

BACKGROUND: Adequate valve performance after surgical mitral valve repair with an annuloplasty ring is not always sustained over time. The risk of repeat mitral valve surgery may be high in these patients. Transcatheter mitral valve-in-ring (MViR) is emerging as an alternative for high-risk patients. OBJECTIVES: The authors sought to assess contemporary outcomes of MViR using third-generation balloon-expandable aortic transcatheter heart valves. METHODS: Patients who underwent MViR and were enrolled in the STDS/ACC TVT (Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy) Registry between August 2015 and December 2022 were analyzed. RESULTS: A total of 820 patients underwent MViR at 236 sites, mean age was 72.2 ± 10.4 years, 50.9% were female, mean STS score was 8.2% ± 6.9%, and most (78%) were in NYHA functional class III to IV. Mean left ventricular ejection fraction was 47.8% ± 14.2%, mean mitral gradient was 8.9 ± 7.0 mm Hg, and 75.5% had ≥ moderate mitral regurgitation. Access was transseptal in 93.9% with 88% technical success. All-cause mortality at 30 days was 8.3%, and at 1 year, 22.4%, with a reintervention rate of 9.1%. At 1-year follow-up, 75.6% were NYHA functional class I to II, Kansas City Cardiomyopathy Questionnaire score increased by 25.9 ± 29.1 points, mean mitral valve gradient was 8.4 ± 3.4 mm Hg, and 91.7% had ≤ mild mitral regurgitation. CONCLUSIONS: MViR with third-generation balloon-expandable aortic transcatheter heart valves is associated with a significant reduction in mitral regurgitation and improvement in symptoms at 1 year, but with elevated valvular gradients and a high reintervention rate. MViR is a reasonable alternative for high-risk patients unable undergo surgery who have appropriate anatomy for the procedure. (STS/ACC TVT Registry Mitral Module [TMVR]; NCT02245763).

5-Year Prospective Evaluation of Mitral Valve-in-Valve, Valve-in-Ring, and Valve-in-MAC Outcomes: MITRAL Trial Final Results.

BACKGROUND: The MITRAL (Mitral Implantation of Transcatheter Valves) trial is the first prospective trial to evaluate the safety and feasibility of balloon-expandable aortic transcatheter heart valves in patients with failed surgical bioprostheses or annuloplasty rings and severe mitral annular calcification treated with mitral valve-in-valve (MViV), valve-in-ring (MViR), or valve-in-mitral annular calcification (ViMAC). OBJECTIVES: The aim of this study was to evaluate 5-year outcomes among these patients. METHODS: A multicenter prospective study was conducted among patients at high surgical risk at 13 U.S. sites. Patients underwent MViV (n = 30), MViR (n = 30), or ViMAC (n = 31) and were followed annually for 5 years. Kansas City Cardiomyopathy Questionnaire scores were obtained at baseline and follow-up visits. Echocardiograms were analyzed at independent core laboratories. RESULTS: A total of 91 patients underwent transcatheter mitral valve replacement (February 2015 to December 2017). The mean age was 74.3 ± 8.9 years. At 5-year follow-up, the lowest all-cause mortality was observed in the MViV group (21.4%), 94.7% of patients were in NYHA functional class I or II, and the mean mitral gradient was 6.6 ± 2.5 mm Hg. The MViR and ViMAC groups had higher all-cause mortality (65.5% and 67.9%), most survivors were in NYHA functional classes I and II (50% and 55.6%), and mean mitral gradients remained stable (5.8 ± 0.1 and 6.7 ± 2.5 mm Hg). Significant improvements in Kansas City Cardiomyopathy Questionnaire scores were observed when all 3 arms were pooled. CONCLUSIONS: MViV, MViR, and ViMAC procedures were associated with sustained improvement of heart failure symptoms and quality of life among survivors at 5 years. Transcatheter heart valve function remained stable in all 3 groups. Patients treated with MViV had excellent survival at 5 years, whereas survival was lower in the MViR and ViMAC groups, consistent with underlying disease severity. Patients with more residual mitral regurgitation had higher mortality.

Diagnosis, Classification, and Management Strategies for Mitral Annular Calcification: A Heart Valve Collaboratory Position Statement.

Mitral annular calcium (MAC) with severe mitral valvular dysfunction presents a complex problem, as valve replacement, either surgical or transcatheter, is challenging because of anatomy, technical considerations, concomitant comorbidities, and advanced age. The authors review the clinical and anatomical features of MAC that are favorable (green light), challenging (yellow light), or prohibitive (red light) for surgical or transcatheter mitral valve interventions. Under the auspices of the Heart Valve Collaboratory, an expert working group of cardiac surgeons, interventional cardiologists, and interventional imaging cardiologists was formed to develop recommendations regarding treatment options for patients with MAC as well as a proposed grading and staging system using both anatomical and clinical features.

Emerging Approaches to Management of Left Ventricular Outflow Obstruction Risk in Transcatheter Mitral Valve Replacement.

An increasing number of patients with mitral valve disease are high risk for surgery and in need of less invasive treatments including transcatheter mitral valve replacement (TMVR). Left ventricular outflow tract (LVOT) obstruction is a predictor of poor outcome after TMVR, and its risk can be accurately predicted using cardiac computed tomography analysis. Novel treatment strategies that have shown efficacy in reducing risk of LVOT obstruction after TMVR include pre-emptive alcohol septal ablation, radiofrequency ablation, and anterior leaflet electrosurgical laceration. This review describes recent advances in the management of LVOT obstruction risk after TMVR, provides a new management algorithm, and explores forthcoming studies that will further advance the field.

Predictors of hemodynamic response to mitral transcatheter edge-to-edge repair.

BACKGROUND: Improvement in left atrial pressure (LAP) during transcatheter edge-to-edge repair (TEER) is associated with improved outcomes. We sought to investigate the predictors of optimal hemodynamic response to TEER. METHODS: We identified patients who underwent TEER at Mayo Clinic between May 2014 and February 2022. Patients with missing LAP data, an aborted procedure, and those undergoing a concomitant tricuspid TEER were excluded. We performed a logistic regression analysis to identify predictors of optimal hemodynamic response to TEER (defined as LAP ≤ 15 mmHg). RESULTS: A total of 473 patients were included (Mean age 78.5 ± 9.4 years, 67.2% males). Overall, 195 (41.2%) achieved an optimal hemodynamic response after TEER. Patients who did not achieve an optimal response had higher baseline LAP (20.0 [17-25] vs. 15.0 [12-18] mmHg, p < 0.001), higher prevalence of AF (68.3% vs. 55.9%, p = 0.006), functional MR (47.5% vs. 35.9%, p = 0.009), annular calcification (41% vs. 29.2%, p = 0.02), lower left ventricular EF (55% vs. 58%, p = 0.02), and more frequent postprocedural severe MR (11.9% vs. 5.1%, p = 0.02) and elevated mitral gradient >5 mmHg (30.6% vs. 14.4%, p < 0.001). In the multivariate logistic regression analysis, AF (OR = 0.58; 95% CI = 0.35-0.96; p = 0.03), baseline LAP (OR = 0.80; 95% CI = 0.75-0.84; p < 0.001) and postprocedural mitral gradient <5 mmHg (OR = 0.35; 95% CI = 0.19-0.65; p < 0.001), were independent predictors of achieving an optimal hemodynamic response. In the multivariate model, residual MR was not independently associated with optimal hemodynamic response. CONCLUSIONS: Optimal hemodynamic response is achieved in 4 in 10 patients undergoing TEER. AF, higher baseline LAP, and higher postprocedural mitral gradient were negative predictors of optimal hemodynamic response after TEER.

2-Year Outcomes of Transcatheter Mitral Valve Replacement in Patients With Annular Calcification, Rings, and Bioprostheses.

BACKGROUND: The MITRAL (Mitral Implantation of Transcatheter Valves) trial is the first prospective study for valve-in-mitral annular calcification (ViMAC), mitral valve-in-ring (MViR), and mitral valve-in-valve (MViV) using balloon-expandable aortic transcatheter heart valves. Procedural outcomes beyond 1 year are not well described. OBJECTIVES: This study evaluated 2-year outcomes in ViMAC, MViR, and MViV in the MITRAL trial. METHODS: This multicenter prospective study enrolled patients with severe MAC, prior failed mitral annuloplasty ring repair, or prior failed bioprosthetic MV replacement who were at high surgical risk at 13 U.S. sites. RESULTS: Between February 1, 2015, and December 31, 2017, 91 patients were enrolled (31 with ViMAC, 30 with MViR, and 30 with MViV). In the ViMAC group, 2-year all-cause mortality was 39.3%, 66.7% were New York Heart Association (NYHA) functional class I-II, and mean MV gradient was 5.6 ± 2.0 mm Hg. In the MViR group, 2-year all-cause mortality was 50%, 65% were NYHA functional class I-II, and mean MV gradient was 6.5 ± 2.7 mm Hg. In the MViV group, 2-year all-cause mortality was 6.7%, 85% were NYHA functional class I-II, and mean MV gradient was 6.9 ± 2.4 mm Hg. At 2 years, all patients had ≤mild mitral regurgitation and survivors in all 3 arms showed sustained improvement in Kansas City Cardiomyopathy Questionnaire scores compared to baseline. CONCLUSIONS: Use of balloon-expandable aortic transcatheter heart valves in selected patients with severe MAC, failed annuloplasty ring, and bioprosthetic MV dysfunction is associated with improvements in symptoms, quality of life, and stable prosthesis function at 2-year follow-up. Between 1 and 2 years, the MViR group experienced higher mortality rates than the MViV and ViMAC groups.

Early outcomes following transatrial transcatheter mitral valve replacement in patients with severe mitral annular calcification.

OBJECTIVE: Implantation of a transcatheter valve-in-mitral annular calcification (ViMAC) has emerged as an alternative to traditional surgical mitral valve (MV) replacement. Previous studies evaluating ViMAC aggregated transseptal, transapical, and transatrial forms of the procedure, leaving uncertainty about each technique's advantages and disadvantages. Thus, we sought to evaluate clinical outcomes specifically for transatrial ViMAC from the largest multicenter registry to-date. METHODS: Patients with symptomatic MV dysfunction and severe MAC who underwent ViMAC were enrolled from 12 centers across the United States and Europe. Clinical characteristics, procedural details, and clinical outcomes were abstracted from the electronic record. The primary end point was all-cause mortality. RESULTS: We analyzed 126 patients who underwent ViMAC (median age 76 years [interquartile range {IQR}, 70-82 years], 28.6% female, median Society of Thoracic Surgeons score 6.8% [IQR, 4.0-11.4], and median follow-up 89 days [IQR, 16-383.5]). Sixty-one (48.4%) had isolated mitral stenosis, 25 (19.8%) had isolated mitral regurgitation (MR), and 40 (31.7%) had mixed MV disease. Technical success was achieved in 119 (94.4%) patients. Thirty (23.8%) patients underwent concurrent septal myectomy, and 8 (6.3%) patients experienced left ventricular outflow tract obstruction (7/8 did not undergo myectomy). Five (4.2%) patients of 118 with postprocedure echocardiograms had greater than mild paravalvular leak. Thirty-day and 1-year all-cause mortality occurred in 16 and 33 patients, respectively. In multivariable models, moderate or greater MR at baseline was associated with increased risk of 1-year mortality (hazard ratio, 2.31; 95% confidence interval, 1.07-4.99, P = .03). CONCLUSIONS: Transatrial ViMAC is safe and feasible in this selected, male-predominant cohort. Patients with significant MR may derive less benefit from ViMAC than patients with mitral stenosis only.

Renal function changes associated with transcatheter aortic valve-in-valve for prosthetic regurgitation compared to stenosis.

Background: Renal dysfunction is frequently encountered in patients with aortic prosthesis degeneration requiring valve-in-valve (VIV) transcatheter aortic valve replacement (TAVR). The effect of VIV TAVR on renal function in patients with bioprosthetic aortic regurgitation (AR) and stenosis (AS) is unknown. Objectives: The aims of this study were to describe the change in renal function after VIV TAVR and to compare differences in renal function changes in those with predominant prosthetic regurgitation compared to stenosis. Methods: All VIV TAVR between June of 2014, and October 2019 (n = 141) at a single institution were reviewed. Baseline renal function parameters including estimated glomerular filtration rate (eGFR) were compared with post-discharge follow-up values in both prosthetic AR and AS patient groups. Linear regression analysis was performed to determine correlates of renal function change. Results: Mean baseline eGFR was lower in the AR group (55 SD21 vs. 64 SD24 ml/min/1.73 m2 p = 0.0495). At post-discharge follow-up there was an increase in mean eGFR in the AR group which was not present in the AS group (8 SD12 vs. 0 SD11 ml/min/1.73 m2 respectively p = 0.0006). There were strong correlations between change in creatinine (ß = -0.57, R2 = 0.64, p < 0.0001) and BUN (ß = -0.61, R2 = 0.51, p < 0.0001), and pre-procedure values in the AR group. Conclusions: Patients who underwent VIV TAVR for AR experienced significant improvement of renal function at post-discharge follow-up. More advanced renal dysfunction at baseline was associated with greater improvement in renal function at post discharge in AR patients.

Effect of eliminating pre-discharge transthoracic echocardiogram on outcomes after TAVR.

OBJECTIVES: The aim of this study was to determine the safety of eliminating the pre-discharge transthoracic echocardiogram (TTE) on 30-day outcomes in patients undergoing transcatheter aortic valve replacement (TAVR). BACKGROUND: TTE is utilized before, during, and after TAVR. Post-procedural, pre-discharge TTE assists in assessment of prosthesis function and detection of clinically significant paravalvular leak (PVL) after TAVR. METHODS: Patients who underwent TAVR at Mayo Clinic from July 2018 to July 2019 were included in a prospective institutional registry. Patients undergoing TAVR prior to February 2019 received a pre-discharge TTE, while those undergoing TAVR after February 2019 did not. Both cohorts were evaluated with TTE at 30 days post-TAVR. RESULTS: A total of 330 consecutive patients were included. Of these, 160 patients (age 81.1 ± 7.6) had routine pre-discharge TTE, while 170 patients (age 78.9 ± 7.5) were dismissed without routine pre-discharge TTE. Mortality at 30 days was similar between the two groups (0% and 1.2%, respectively). One episode of PVL requiring intervention (0.6%) occurred in the pre-discharge TTE group and none in the group without pre-discharge TTE at 30-day follow-up. There was a similar incidence of total composite primary and secondary adverse events between the cohort receiving a pre-discharge TTE and those without (28.1% vs. 25.3%, P = 0.56) at 30 days. The most common event was need for permanent pacemaker or ICD implantation in both groups (13.1% vs. 11.8%, P = 0.71). CONCLUSIONS: Elimination of the pre-discharge TTE is safe and associated with comparable 30-day outcomes to routine pre-discharge TTE. These findings have implication for TAVR practice cost-efficiency and health care utilization.

Transcatheter mitral valve replacement for degenerated mitral bioprostheses: a systematic review.

BACKGROUND: Treatment of degenerated mitral bioprostheses with transcatheter mitral valve-in-valve (MVIV) implantation is increasingly used. The goal of this review was to evaluate the one-year outcomes of this therapy using the most recent evidence. METHODS: A MEDLINE, Cochrane database and SCOPUS search was performed of published observational studies involving patients undergoing transcatheter MVIV for degenerated bioprosthesis to determine procedural success, thirty-day and one-year survival. RESULTS: A total of 2,684 patients undergoing transcatheter MVIV were identified from five studies with mean age of 73-75 years, 57-63% female and Society for Thoracic Surgery (STS) risk score ranging from 9-13%. Procedural technical success ranged from 94-98%, with 1-3% rates of periprocedural death, 0-2% stroke and 1-5% risk of left ventricular outflow tract (LVOT) obstruction. Thirty-day post-procedure mean mitral prosthetic gradient ranged from 6-7 mmHg and residual mitral regurgitation was mild or less in 96-100% of patients. Thirty-day survival and one-year survival ranged from 93-97% and 83-89% respectively. CONCLUSIONS: Transcatheter MVIV is an effective treatment for structural degeneration of biologic mitral valve replacement with low complication rates and favorable one-year outcomes. Accordingly, MVIV should be considered as a reasonable alternative to re-do surgical mitral valve replacement in high risk patients with comorbidities. Further study of long-term outcomes of this treatment is needed.

Hemolysis after transcatheter mitral valve replacement in degenerated bioprostheses, annuloplasty rings, and mitral annular calcification: Incidence, patient characteristics, and clinical outcomes.

OBJECTIVES: To determine the incidence, characteristics, and outcomes of patients with hemolysis after transcatheter mitral valve replacement (TMVR). BACKGROUND: Hemolysis is an increasingly recognized complication of TMVR. Clinical outcomes and optimal management for patients with hemolysis after TMVR are unclear. METHODS: Patients that underwent mitral valve-in-valve (MViV), valve-in-ring (MViR), and valve-in-mitral annular calcification (ViMAC) at a single center were retrospectively assessed. RESULTS: A total of 101 patients had TMVR, including 69 with MViV, 14 with MViR, and 18 with ViMAC. ViMAC patients had an increased frequency of mild or greater paravalvular leak (PVL) (ViMAC, 72.2%; MViR, 14.3%; MViV, 13.0%; p < .001). Hemolysis occurred in eight patients and was more common after ViMAC (ViMAC, 33.3%; MViR, 7.1%; MViV, 1.5%; p < .001). This required transfusion in five (ViMAC, 4; MViV, 1) and was associated with acute kidney injury in five with ViMAC. Among the ViMAC patients, four had transcatheter re-intervention to treat hemolysis with resolution of anemia in three and mild residual anemia in one with persistent mild PVL. The two ViMAC patients without re-intervention had persistent anemia and died within 6 months. Both MViV and MViR patients with hemolysis did not have PVL but had turbulent flow from left ventricular outflow tract narrowing and their hemolysis was self-limited. CONCLUSIONS: Hemolysis occurs with greater frequency and increased clinical severity after ViMAC as compared to MViV or MViR and is likely related to increased incidence of PVL. These findings demonstrate the need to investigate novel strategies that can reduce the burden of hemolysis with ViMAC.

Effect of a fourth-generation transcatheter valve enhanced skirt on paravalvular leak.

OBJECTIVES: The aim of this study was to assess the 30 day incidence of paravalvular leak (PVL) and need for aortic valve reintervention of a fourth generation balloon expandable transcatheter valve with enhanced skirt (4G-BEV) (SAPIEN 3 Ultra) compared with a third generation balloon expandable transcatheter valve (3G-BEV) (SAPIEN 3). BACKGROUND: The incidence of PVL has steadily declined with iterative improvements in transcatheter aortic valve replacement (TAVR) technology and implantation strategies. METHODS: Patients who underwent TAVR at Mayo Clinic from 7/2018 to 7/2019 were included in a prospective institutional registry. 4G-BEV has been utilized since 2/2019, and, after this date, 3G-BEV and 4G-BEV were simultaneously used. 4G-BEV had three sizes (20, 23, and 26 mm) while 3G-BEV included four sizes (20, 23, 26, and 29 mm). Both cohorts were evaluated at 30 days post-TAVR with a transthoracic echocardiogram to assess for PVL. RESULTS: A total of 260 consecutive patients were included. Of these, 101 patients received a 4G-BEV and 159 patients received a 3G-BEV. There were more females (p = .0005) and a lower aortic valve calcium score (p = .02) in the 4G-BEV cohort at baseline. Age, STS risk score, NYHA Class, and aortic valve mean gradient did not differ between groups. 4G-BEV was associated with a lower incidence of mild PVL (10.8 vs. 36.5%; p < .0001) and moderate PVL (0 vs. 5.8%) compared to the 3G-BEV at 30 days. There was no association between PVL and valve size in either cohort. CONCLUSIONS: Utilization of 4G-BEV is associated with reduced PVL at 30 days post-TAVR compared with 3G-BEV.

Acute fulminant hemolysis after transcatheter mitral valve replacement for mitral annular calcification.

Transcatheter mitral valve replacement (TMVR) is emerging as an alternative treatment strategy to surgery for patients with severe mitral annular calcification (MAC) who are not candidates for traditional mitral valve surgery. Paravalvular leak (PVL) is common following TMVR for severe MAC and can lead to heart failure symptoms and/or intravascular hemolysis, the latter of which usually is clinically stable. We report the case of a 67-year-old woman with symptomatic severe aortic stenosis and mitral stenosis with MAC in the setting of prior chest irradiation who was treated initially with transcatheter aortic valve replacement followed by TMVR at a later date (Sapien S3 system; Edwards Lifesciences). Immediately following TMVR, she developed acute profound hemolysis which manifested with hemoglobinuria, transfusion-dependent anemia, and acute renal failure requiring renal replacement therapy. She was treated with post-dilation balloon valvuloplasty after failed transcatheter PVL closure 10 days following TMVR with resulting improvement in the PVL. The hemolytic anemia resolved and renal function recovered without the need for continued hemodialysis 2 months later and stabilization of glomerular filtration rate at 6 months. This case highlights a potential severe complication of TMVR in MAC and suggests that improvement in hemolysis and late recovery of renal function may occur following treatment of PVL.

Alcohol septal ablation in patients with concomitant hypertrophic cardiomyopathy and aortic valvular stenosis.

OBJECTIVE: To describe the hemodynamic and early clinical outcomes of percutaneous alcohol septal ablation in patients with concomitant dynamic left ventricular outflow tract (LVOT) obstruction and aortic valvular stenosis (AS). BACKGROUND: Alcohol septal ablation is an established method to relieve dynamic LVOT obstruction in patients with hypertrophic cardiomyopathy (HCM). However, the feasibility, safety, and efficacy of alcohol septal ablation in patients with serial obstructions from HCM and AS remain unclear. METHODS: In this case series, we describe the early outcomes of alcohol septal ablation in six patients with significant dynamic LVOT obstruction and AS. All patients had evidence of severe dynamic LVOT obstruction (resting or provoked gradient ≥50 mmHg), mild to severe AS, and NYHA class III symptoms or greater. RESULTS: Four (66.7%) patients had septal ablation performed in the setting of concomitant native valvular AS and two (33.3%) patients had TAVR performed prior to septal ablation. Successful alcohol septal ablation was performed in all patients and was associated with an immediate reduction of the dynamic LVOT gradient with a residual fixed obstruction related to AS. Four (66.7%) patients had follow-up at 1 month and of these, three (75%) had NYHA Class I-II symptoms and one (25%) Class III. CONCLUSIONS: Alcohol septal ablation is a feasible method of relieving dynamic LVOT obstruction in patients with concomitant HCM and AS. Further study is required to determine the optimal treatment approach in these patients.

Paravalvular leak repair after balloon-expandable transcatheter mitral valve implantation in mitral annular calcification: Early experience and lessons learned.

BACKGROUND: Treatment of hemodynamically significant mitral annular calcification (MAC) using transcatheter approaches is in the early learning phase. The occurrence of paravalvular leak (PVL) following transcatheter mitral valve in MAC is common. AIMS: To report the initial experience and techniques of percutaneous PVL closure after transcatheter valve in MAC. METHODS: This series includes five consecutive patients who underwent percutaneous PVL closure following transcatheter balloon expandable SAPIEN S3 valve in MAC. RESULTS: Mean patient age was 73.6 ± 5.4 years (4 [80%] female), with average Society of Thoracic Surgeons score of 8.1 ± 2.8%. Three patients had a single PVL defect while two patients had two defects; all were located at the commissural sites. Closure was performed primarily for heart failure in four patients and hemolytic anemia in one patient. Transfemoral transseptal antegrade approach and Amplatz Vascular Plug (AVP)-II occluders were utilized in all patients. Procedure success was achieved in three patients. One patient developed significant occluder related leaflet impingement and subsequent severe prosthetic mitral regurgitation requiring a second transcatheter mitral valve in valve implantation. The procedure was aborted in one patient due to difficulty crossing PVL defect after balloon post-dilatation of SAPIEN prosthesis with 10 mL of additional volume. There was no in hospital or 30 day mortality or the need for emergent surgery. CONCLUSION: Early experience with percutaneous PVL closure of SAPIEN valve in MAC demonstrated feasibility of this approach. Careful procedure planning and monitoring for SAPIEN prosthesis leaflet impingement and frame instability is of utmost importance to increase the chances of procedural success.

Mid-Term Valve-Related Outcomes After Transcatheter Tricuspid Valve-in-Valve or Valve-in-Ring Replacement.

BACKGROUND: Transcatheter aortic and pulmonary valves have been used to treat stenosis or regurgitation after prior surgical tricuspid valve (TV) replacement or repair. Little is known about intermediate-term valve-related outcomes after transcatheter tricuspid valve replacement (TTVR), including valve function, thrombus, and endocarditis. OBJECTIVES: The authors sought to evaluate mid-term outcomes in a large cohort of patients who underwent TTVR after surgical TV repair or replacement, with a focus on valve-related outcomes. METHODS: Patients who underwent TTVR after prior surgical TV replacement or repair were collected through an international registry. Time-related outcomes were modeled and risk factors assessed. RESULTS: Data were collected for 306 patients who underwent TTVR from 2008 through 2017 at 80 centers; 52 patients (17%) had a prior history of endocarditis. Patients were followed for a median of 15.9 months after implantation (0.1 to 90 months), with 64% of patients estimated to be alive without TV reintervention or a valve-related event at 3 years. The cumulative 3-year incidence of death, reintervention, and valve-related adverse outcomes (endocarditis, thrombosis, or significant dysfunction) were 17%, 12%, and 8%, respectively. Endocarditis was diagnosed in 8 patients 2 to 29 months after TTVR, for an annualized incidence rate of 1.5% per patient-year (95% confidence interval: 0.45% to 2.5%). An additional 8 patients were diagnosed with clinically relevant valve thrombosis, 3 in the short term, 2 within 2 months, and 3 beyond 6 months. Only 2 of these 8 patients received anticoagulant therapy before thrombus detection (p = 0.13 vs. patients without thrombus). Prior endocarditis was not a risk factor for reintervention, endocarditis, or valve thrombosis, and there was no difference in valve-related outcomes according to TTVR valve type. CONCLUSIONS: TV dysfunction, endocarditis, and leaflet thrombosis were uncommon after TTVR. Patients with prior endocarditis were not at higher risk for endocarditis or other adverse outcomes after TTVR, and endocarditis occurred with similar frequency in different valve types. Though rare, leaflet thrombosis is an important adverse outcome, and further study is necessary to determine the appropriate level of prophylactic therapy after TTVR.

Open atrial transcatheter mitral valve replacement in patients with mitral annular calcification.

BACKGROUND: Mitral valve replacement in the setting of severe mitral annular calcification remains a surgical challenge. Transcatheter mitral valve replacement (TMVR) using an aortic balloon-expandable transcatheter heart valve is emerging as a potential treatment option for high surgical risk patients. Transseptal, transapical, or transatrial access is not always feasible, so an understanding of alternative implantation techniques is important. OBJECTIVES: The authors sought to present a step-by-step description of a contemporary transatrial TMVR technique using balloon-expandable aortic transcatheter heart valves. This procedure has evolved over time to address valve migration, left ventricular outflow tract obstruction, and paravalvular leak. The authors present a refined technique that has been associated with the most reproducible outcomes. METHODS: A step-by-step description of the TMVR technique and outcomes of 8 patients treated using this technique are described. Baseline patient clinical and echocardiographic characteristics and 30-day post-TMVR outcomes are presented. RESULTS: Eight patients underwent transatrial TMVR at a single institution. Five had previous cardiac surgery. Mean STS score was 8%. Technical success by MVARC (Mitral Valve Academic Research Consortium) criteria was 100%. There was zero in-hospital and 30-day mortality. Procedural success by MVARC criteria at 30 days was 100%. Paravalvular leak immediately post-implant was none or trace in 6 and mild in 1. CONCLUSIONS: The technique described is reproducible and was associated with favorable outcomes in this early experience. It represents a useful technique for the treatment of mitral valve disease in the setting of severe annular calcification. A structured and defined implantation technique is critical to investigators as this field evolves.

Open Atrial Transcatheter Mitral Valve Replacement in Patients With Mitral Annular Calcification.

BACKGROUND: Mitral valve replacement in the setting of severe mitral annular calcification remains a surgical challenge. Transcatheter mitral valve replacement (TMVR) using an aortic balloon-expandable transcatheter heart valve is emerging as a potential treatment option for high surgical risk patients. Transseptal, transapical, or transatrial access is not always feasible, so an understanding of alternative implantation techniques is important. OBJECTIVES: The authors sought to present a step-by-step description of a contemporary transatrial TMVR technique using balloon-expandable aortic transcatheter heart valves. This procedure has evolved over time to address valve migration, left ventricular outflow tract obstruction, and paravalvular leak. The authors present a refined technique that has been associated with the most reproducible outcomes. METHODS: A step-by-step description of the TMVR technique and outcomes of 8 patients treated using this technique are described. Baseline patient clinical and echocardiographic characteristics and 30-day post-TMVR outcomes are presented. RESULTS: Eight patients underwent transatrial TMVR at a single institution. Five had previous cardiac surgery. Mean STS score was 8%. Technical success by MVARC (Mitral Valve Academic Research Consortium) criteria was 100%. There was zero in-hospital and 30-day mortality. Procedural success by MVARC criteria at 30 days was 100%. Paravalvular leak immediately post-implant was none or trace in 6 and mild in 1. CONCLUSIONS: The technique described is reproducible and was associated with favorable outcomes in this early experience. It represents a useful technique for the treatment of mitral valve disease in the setting of severe annular calcification. A structured and defined implantation technique is critical to investigators as this field evolves.