Cabalka, Allison K.

AbstractObjectivesThis study reports long‐term outcomes percutaneous Melody valve (Medtronic, Minneapolis, Minnesota) valve‐in‐valve therapy in patients with prosthetic valve dysfunction.BackgroundRepeat valve surgery is associated with high morbidity and mortality. Transcatheter mitral valve‐in‐valve is a promising alternative in patients at high‐risk for cardiac surgery.MethodsWe conducted a retrospective cohort analysis of 13 patients who underwent Melody valve‐in‐valve for bioprosthetic dysfunction from July 2011 to October 2013.ResultsMean age was 74.4 years, 46% male, and STS score 13.5 ± 6.8%. All patients had NYHA class 3 or 4 symptoms with improvement to class 1 or 2 in 82% post procedure. Median follow‐up was 4.5 years with longest follow‐up of 5.5 years. Thirty‐day mortality was 15.4% with 1‐year mortality of 25% and no other reported deaths until 4.5 years. 76.9% of patients had mitral gradient of 5 mmHg or less immediately postprocedure. One patient required repeat valve procedure for structural deterioration at 4.4 years. At 1, 3, and 5 year follow‐ups 75% of patients were NYHA class 1 or 2, mean gradients were 4.5 ± 0.6, 6.8 ± 0.5, and 7.5 ± 0.7, respectively. Using 4‐point scale, mitral regurgitation postprocedure was 0.8 ± 0.6. At 1, 3, and 5 years this increased to 1.0 ± 1.1, 1.3 ± 1.3, and 2.5 ± 2.1, respectively.ConclusionsMelody valve‐in‐valve therapy was effective with 1‐year symptomatic improvement. Prosthesis deterioration requiring repeat intervention was observed in one patient. Larger cohorts with multicenter registries are needed to determine the role of this percutaneous valve‐in‐valve therapy as valve technology and procedural techniques improve.

AbstractWe present a case of a 7‐year‐old boy with a history of multiple mitral valve interventions and subsequent Melody valve placement in the mitral position, who presented with acute mitral stenosis due to complete fracture of the Melody stent. He was born early with severe mitral and tricuspid insufficiency due to valvular dysplasia, and ended up with 4 sternotomies before the age of 2 due to mitral valve dysfunction and recurrent prosthetic valve thrombosis. He then developed mixed stenosis and regurgitation at age 6, and to avoid another sternotomy, valve‐in‐valve therapy with off‐label use of a 20‐mm Melody valve was done with hybrid procedure via trans‐apical approach. Eight months later he presented with acutely worsened mitral stenosis (mean gradient 20 mm Hg), due to fracture of the proximal stent. While the safety and efficacy of the Melody valve has been well established especially in the pulmonary position, stent fracture is a known and potentially serious complication. As with any novel valve therapy, close follow‐up and frequent imaging may be warranted to watch for loss of stent integrity, particularly if clinical symptoms of valve dysfunction occur.

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.

Background— Percutaneous closure of prosthetic mitral valve paravalvular leak (PVL) has emerged as an alternative to surgical treatment in high-risk patients. Limited data exist on the impact of successful percutaneous PVL closure on midterm outcomes. Methods and Results— We examined consecutive patients who underwent percutaneous mitral PVL closure at Mayo Clinic, Rochester, MN, between January 2006 and January 2017. Procedural success, in-hospital outcomes, and midterm mortality were assessed. A total of 231 patients underwent percutaneous mitral PVL repair at a mean age of 67±12 years. Mean time from mitral valve replacement to percutaneous PVL repair was 1.25 (0.31–7.25) years. One hundred sixty-two patients (70%) had ≤mild PVL after the procedure. Compared with those who had >mild residual PVL, patients with ≤mild residual PVL had lower rates of repeat surgical interventions (6% versus 17%; P =0.004) and lower all-cause mortality at 30 days (1% versus 14%; P <0.001) and 1 year (15% versus 39%; P <0.001). Survival at 3 years was 61% in patients who had ≤mild residual leak and 47% in patients with higher grade of residual PVL ( P =0.002). Conclusions— In a large consecutive cohort of patients undergoing percutaneous mitral PVL closure, successful percutaneous reduction of the PVL to mild or less was associated with significant midterm survival benefit.

Structural heart disease is a rapidly evolving field, and approaches to procedural training are not standardized. We describe a novel modular approach to procedural training that considers each procedure as a series of building blocks that may be taught and assessed separately. Ten key structural heart disease building blocks can be identified, which, when combined with the cognitive skills of structural intervention and device-specific training, allow appropriate planning and implementation of structural procedures. Structural procedures require careful navigation of the aorta, left atrium, and right heart, including detailed understanding of relational anatomy. Component blocks include large bore vascular access, navigation within the left atrium, occlusion, snaring, and 3-dimensional relational anatomy. These building blocks also provide the foundation for new procedures through innovative use of the skill sets and devices to approach new clinical problems. The addition of device-specific training may be provided via proctoring and industry support. Using this approach, competency in less common procedures may be achieved and maintained. We discuss each building block in detail, approaches specific to the structural heart disease patient, the need for cross-discipline training, and empirical recommendations for training using this approach. We postulate that this new paradigm may be the preferred approach for training and assessment of structural heart disease interventional skills.

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.

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.

Abstract Background Interventional catheterization is central to the care of Adults with Congenital Heart Disease (ACHD). Current standards for care provision and training in ACHD intervention are lacking. We sought to examine trends in current practice and training among interventionalists. Methods We analyzed the results of two separate international surveys in June 2016. One was sent to all active members from the Society of Cardiovascular Angiography and Interventions (SCAI) who self‐identified Structural Heart Disease or Congenital Heart Disease as a practice area. The second survey was conducted through the Pediatric Interventional Early Career Society (PICES) aimed at pediatric and adult congenital interventionalists in their first seven years after training. The total survey sample sizes were 1,535 and 112, respectively. Results Response rates for the SCAI and PICES surveys were 15% (237/1,535) and 75% (84/112), respectively. Most respondents (74%) worked at institutions with pediatric and adult facilities in proximity (major medical centers). While 75% of SCAI respondents believed complex transcatheter procedures should be performed by ACHD‐trained interventionalists or multidisciplinary teams, only 32% reported such care is being provided at the present time. Most pediatric and adult cardiologists surveyed (73%) do not believe current interventional fellowships provide adequate training for proficiency in ACHD interventions. Conclusions ACHD management remains underdeveloped in relative terms, particularly in the United States. Significant gaps in interventional standards of practice and future training needs were recognized by this study. Our survey should serve as an impetus to establish training guidelines for physicians who seek to perform ACHD interventions.

BackgroundPercutaneous paravalvular leak (PVL) closure is an alternative treatment option for severely symptomatic, high‐surgical risk patients with PVL. Some patients require multiple percutaneous PVL closure procedures. However, the procedural characteristics and success rate of re‐do PVL closure have not been well studied.AimsThe aim of this study is to investigate the indications, procedural characteristics, technical success rate, and 30‐day major adverse cardiovascular events (MACE) in patients who underwent re‐do PVL closure.MethodsConsecutive patients who underwent percutaneous paramitral or paraaortic leak closure at Mayo Clinic, Rochester, Minnesota from 2004 through 2015 were studied. Clinical and procedural characteristics of patients who underwent re‐do PVL closure were compared to age‐ and sex‐matched patients who underwent their first percutaneous PVL closure. Procedure success and 30‐day MACE were compared in both the groups.ResultsAmong 223 identified percutaneous PVL closures, 16 (7%) were re‐do procedures. Patients who underwent re‐do PVL closure were predominantly men (87.5%) with a mean age of 68 ± 15 years and an estimated mean Society of Thoracic Surgery (STS) 30‐day mortality of 4.6 ± 2.8. Half of the re‐do PVL closures were performed on mechanical valves and 62.5% were performed on paramitral defects. Indications for re‐do PVL closure were: (1) emergence of new significant paravalvular defects in 50%, (2) incomplete index defect closure in 43.75%, and (3) index procedural complication in 6.25% of the cases. Procedural success was 75% in re‐do procedures vs. 85.4% in age‐ and sex‐matched control group (P = 0.45). Thirty‐day MACE was 12.5% in the re‐do group compared to 4.2% in the age‐ and‐sex matched patients who underwent PVL closure for the first time (P = 0.35).ConclusionRe‐do percutaneous PVL closure is feasible with favorable procedural success rate and low 30‐day MACE. Development of new paravalvular defects is the most common indication for re‐do PVL closure, highlighting the importance of careful longitudinal monitoring and follow‐up. © 2017 Wiley Periodicals, Inc.

ObjectivesTo develop a novel delivery technique to overcome vascular size limitations for device closure of a secundum ASD in the young patient.BackgroundThe efficacy, clinical utility, and safety of transcatheter closure in comparison to surgical closure are well established; however, access vessel size remains a potential limitation to device selection in the young patient.MethodsA retrospective medical record review of all cases of secundum ASD closure between April 2015 and April 2016 utilizing a novel delivery method described herein at two separate academic institutions. The device is disassembled allowing the delivery sheath to serve as the introducer. It is advanced to the RA with re‐introduction of the device allowing for deployment in the standard fashion.ResultsOverall, 10 patients underwent secundum ASD closure via this novel delivery technique. There were six females (60%) and the average age at time of the procedure was 4.2 years ± 1.6 years (range 2–6 years). The majority of patients had an isolated secundum ASD (70%) with the primary indication for closure being right ventricular volume overload (90%). All patients had successful placement of a GORE® CARDIOFORM® Septal Occluder (GCSO) with no or trivial residual shunt. No patients had vascular complications related to the procedure.ConclusionsWe describe a novel technique for ASD closure using the GCSO delivery sheath as the access sheath, which reduces the vascular access size requirement by 25%, thus addressing one common limitation for percutaneous device closure of a secundum ASD in young patients. © 2016 Wiley Periodicals, Inc.