AbstractBackgroundTranscatheter edge‐to‐edge repair with MitraClip is only approved for treatment of mitral regurgitation but is increasingly used to treat concomitant tricuspid regurgitation (TR) due to its common coexistence and association with poor outcomes. This study aimed to describe the learning curve associated with the challenge of off‐label treatment of concomitant TR.MethodsThis is a retrospective review of initial and consecutive patients who underwent combined edge‐to‐edge repair of mitral and tricuspid valves (TVs) at our institution from August 2017 to October 2019.ResultsRepair of both valves with MitraClip was performed in 22 patients (median age 81.5 years, 32% female). Mean procedure time was 176 ± 47 min; mean fluoroscopy time was 65 ± 24 min. Procedure duration in the first tertile was significantly longer (223 ± 13 min) than in the third tertile (143 ± 23 min, p = .0003). Median number of total clips placed per case was 3; in 15 patients (68%), the anterior and septal leaflets of the TV were clipped. The average changes in mean right atrial (RA) and left atrial (LA) pressures were −1.7 ± 2.5 mmHg (p = .0080) and −3.2 ± 4.6 mmHg (p = .0045), respectively. The average changes in RA and LA V‐wave heights were −3.3 ± 4.0 mmHg (p = .0009) and −8.1 ± 9.9 mmHg (p = .038), respectively. There was a significant trend toward decreasing residual TR over the course of the series (p = .046). At 30 days, survival was 100% and mean NYHA class decreased from 2.8 to 1.8 (p < .0001).ConclusionsCombined edge‐to‐edge tricuspid and mitral valve repair is safe and feasible. With experience, procedure duration and residual TR decreased.
Alcohol septal ablation in patients with concomitant hypertrophic cardiomyopathy and aortic valvular stenosis
AbstractObjectiveTo 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).BackgroundAlcohol 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.MethodsIn 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.ResultsFour (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.ConclusionsAlcohol 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.
Hemodynamic and clinical response to transseptal mitral valve‐in‐valve and valve‐in‐ring
AbstractObjectiveTo understand the clinical and hemodynamic response of patients with stenotic versus regurgitant prosthetic mitral valve degeneration to transseptal transcatheter mitral valve‐in‐ring/‐valve replacement (TMVR).BackgroundPatients with prosthetic mitral valve repair/replacement failure frequently present high‐risk surgical challenges. TMVR has been employed as an alternative to surgery.MethodsForty‐four patients with stenotic/regurgitant degeneration of prior prosthetic mitral annuloplasty and replacement (38) underwent mitral TMVR. Clinical, echocardiographic, and invasive hemodynamic monitoring was conducted at baseline and follow‐up.ResultsRelative to patients with regurgitant degeneration (28), patients with stenotic degeneration had baseline higher mitral valve gradients (12 ± 4 vs. 7 ± 3 mmHg, p < 0.01) and smaller areas (1.0 ± 0.4 vs. 1.5 ± 0.4 cm2, p = 0.01). TMVR yielded significant reduction in left atrial v‐wave pressures in stenotic and regurgitant cohorts (−7 ± 11, p = 0.03, and −11 ± 12 mmHg, p < 0.01, respectively) and significant, sustained symptomatic improvement. Intracardiac pressures overall, including left ventricular end diastolic pressures, remained elevated.ConclusionDespite baseline differences in valvular disease, TMVR leads to significant hemodynamic and clinical improvement in both stenotic and regurgitant prosthetic mitral valve disease. In both cohorts, TMVR reduced intracardiac pressures to similar postprocedural levels, but pressures remained supranormal. This outcome suggests a multifactorial process defines the pathophysiology of patients undergoing TMVR, including contributions from prosthetic degeneration, changes in left atrial compliance, and diastolic dysfunction, and highlights the need to consider such factors in patient evaluation and treatment.
Left ventricular remodeling and function after transapical versus transfemoral transcatheter aortic valve replacement
AbstractBackgroundThe effect of utilizing transapical (TA) access for transcatheter aortic valve replacement (TAVR) on cardiac function has not been well studied.AimsThe aim of this retrospective study is to determine the direct effects of TA access for TAVR on myocardial function parameters and their correlation with 4‐year survival.MethodsThree hundred and thirty propensity matched patients, who underwent TAVR using Sapien valve (Edwards Lifesciences Corp, Irvine, CA) between February 15, 2012 and June 17, 2016 (115 TA and 115 transfemoral [TF] routes) were studied. The pre‐ and 1 month post‐TAVR echocardiographic features of both groups were compared. The 4‐year survival in both groups was analyzed.ResultsBaseline clinical characteristics, diastolic function parameters, left ventricular (LV) chamber size, and ejection fraction were similar between matched TA and TF groups. At 1 month following TAVR, there was a significant increase in stroke volume index (SVI) in both TA (mean increase 7 cm3/m2; P = 0.03) and TF groups (mean increase 7 cm3/m2; P < 0.001). Left ventricular ejection fraction (LVEF) significantly increased post TF TAVR (mean increase 2%; P = 0.008), but no significant increase was observed post TA TAVR (mean increase 1%; P = 0.27). Both groups had significant improvement in aortic valve (AV) hemodynamics post‐TAVR (P < 0.001). Overall, there were no significant differences in the mean change of SVI, LVEF, or left ventricular end diastolic dimensions (LVEDDs) post TA versus TF TAVR. There was no significant difference in 4‐year survival in the TF compared to TA group (49% vs 50%, P = 0.43).ConclusionBoth TA and TF TAVR were equally associated with favorable changes in LV SVI and AV hemodynamics in 30 days. TA TAVR patients had similar 4 year survival to propensity matched TF TAVR; therefore, TA TAVR remains an acceptable alternative access route in patients not amenable to TF TAVR.
Effect of percutaneous paravalvular leak closure on hemolysis
AbstractObjectiveTo study the effect of percutaneous paravalvular leak closure on hemolysis.BackgroundAlthough transcatheter PVL closure reduces heart failure and mortality in symptomatic patients with paravalvular leaks (PVL), little is known about its effect on hemolysis.MethodsWe retrospectively analyzed patients undergoing transcatheter mitral or aortic PVL closure (January 2005–December 2016) at Mayo Clinic. Patients with anemia or abnormal hemolysis markers (LDH, haptoglobin) were included in the analysis. The primary outcome was defined as hemoglobin increase ≥ 1.5 mg/dL, decrease in LDH above median or improvement in haptoglobin. Univariate and multivariate binary logistic regression modeling were used to determine predictors of successful treatment of hemolysis.ResultsFinal study population included 168 patients (130 [77%] mitral, 38 [23%] aortic PVL). Primary outcome occurred in 70 patients (42%). Hemoglobin increased by 1.74 ± 1.69 mg/dL in patients who reached primary outcome. 57/168 (34%) patients required blood transfusion prior to PVL closure compared to 35/168 (21%) postprocedure. The mean reduction in LDH was 403 U/L. Multivariate regression showed that patients with mechanical valves were more likely to have successful outcome (P = 0.044).ConclusionPercutaneous PVL closure is associated with modest improvement in hemolysis markers, increase in hemoglobin levels and reduction in blood transfusion requirements. This benefit is most significant in patients with mechanical valves.
Procedural trends, outcomes, and readmission rates pre‐and post‐FDA approval for MitraClip from the National Readmission Database (2013–14)
AbstractBackgroundThere are sparse clinical data on the procedural trends, outcomes and readmission rates following FDA approval and expansion of Transcatheter mitral valve repair/MitraClip®. Whether a complex new technology can be disseminated safely and quickly is controversial.MethodsThe study cohort was derived from the National Readmission Data (NRD) 2013–14. MitraClip® was identified using appropriate International Classification of Diseases, 9th Revision, Clinical Modification (ICD‐9‐CM) codes. The primary outcome was a composite of in‐hospital mortality + procedural complications. Secondary outcome included 30‐day readmissions. Hierarchical two level logistic models were used to evaluate study outcomes.ResultsOur analysis included 2003 MitraClip® procedures. Overall in‐hospital mortality was 3.9%. As expected, there was a significant increase in procedural volume post‐FDA approval. Importantly, a corresponding downward trend in mortality and procedural complications was observed. Significant predictors of in‐hospital mortality and procedural complications included the use of vasopressors (P <0.001) and hemodynamic support (P < 0.001). Higher hospital volume (≥10 MitraClips/year) was associated with lower in‐hospital mortality and complications (P = 0.02). There were 304 (15.1%) 30‐day readmissions, with heart failure being the most common cause of readmission. Elective procedures had lower in‐hospital mortality (P < 0.001) and lower readmission rates (P = 0.011) compared with nonelective procedures.ConclusionA significant increase in MitraClip® procedural volumes occurred post‐FDA approval. Overall morbidity and mortality were low and trended downwards. Hospital procedure volume ≥10 cases were associated with lower mortality and overall complication rates. These data suggest a successful roll out of a very complex novel structural heart procedure.
Techniques and outcomes of paravalvular leak repair after transcatheter aortic valve replacement
AbstractObjectivesTo investigate the feasibility, procedural success, and outcomes of paravalvular leak (PVL) closure in patients with prior transcatheter aortic valve replacement (TAVR).BackgroundPVL after TAVR is associated with adverse patient outcomes and increased mortality. Percutaneous PVL closure has emerged as a therapeutic strategy for addressing this issue, but data for transcatheter PVL repair after TAVR remains limited.MethodsThis is a single center retrospective review of PVL closure after TAVR. Patients with balloon‐expandable or self‐expanding prostheses were included. Baseline patient demographics, procedural characteristics, complications, and clinical outcomes were reviewed.ResultsA total of 18 patients with clinically significant PVL after TAVR referred for PVL closure were identified during the study period. Procedural success resulting in successful transcatheter occluder plug delivery was 78% (14 cases). Balloon postdilatation (2/4) and valve‐in‐valve (2/4) were used effectively in the remaining patients after an unsuccessful PVL closure attempt. PVL grading by echocardiography decreased from moderate or severe to < moderate in 13 patients (72%). Adverse events including cardiac tamponade and acute kidney injury occurred in 1 case each. One‐month all‐cause mortality was 11%.ConclusionIn selected patients, percutaneous PVL repair following TAVR is feasible and effective for both balloon‐expandable and self‐expanding prostheses. Most patients undergoing PVL closure after TAVR require a single occluder plug placement for reduction in PVL to mild or less.
Left atrial pressure and predictors of survival after percutaneous mitral paravalvular leak closure
AbstractBackgroundData on the clinical utility of left atrial (LA) hemodynamic monitoring during percutaneous mitral interventions are limited.ObjectivesTo evaluate the association between intraprocedural LA pressures during percutaneous mitral paravalvular leak (PVL) closure and long term survival.MethodsPatients who underwent mitral PVL repair with invasive LA pressure monitoring were divided at baseline to three tertiles based on their mean final LA pressure (<25%; 25‐30%; >30% of mean systolic blood pressure). Primary outcome was all‐cause mortality.Results134 patients (mean age 68 ± 12 years) were studied. Over 3 year mean follow‐up, 81 (38%) patients died. The cumulative probability of death at 3 years was significantly higher among patients in the highest LA pressure tertile (56 ± 8% vs. 28 ± 5%, log rank P < 0.001). More than mild residual mitral regurgitation (MR) by transesophageal echocardiography (TEE) was associated with a 2.5‐fold increased risk of death and patients in the highest LA pressure tertile had 2.2‐fold higher mortality (P < 0.001 and = 0.003 respectively). After adjustment for residual MR by TEE, each 10% acute procedural reduction in LA pressures was associated with a significant 9% reduced risk of death (P = 0.023). Multivariate Cox regression with adjustment for multiple predictors of death showed that patients in lower LA pressure tertiles had 59% lower mortality (P = 0.003).ConclusionLower LA pressure following mitral PVL closure is an independent predictor of improved survival, even after adjustment for residual MR. LA pressure monitoring may be a useful tool for procedural guidance during mitral PVL closure.