Panaich, Sidakpal S

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.

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.

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.

Background— Data on the clinical use of left atrial (LA) hemodynamic monitoring during MitraClip procedure are limited. This study evaluated the association between intraprocedural changes in LA pressure after MitraClip and improvement in exercise capacity as documented by 6-minute walk test (6MWT). Methods and Results— Study population included 50 patients who underwent MitraClip at the Mayo Clinic (Rochester, MN), between June 2014 and July 2016 and completed both baseline and 30-day follow-up 6MWT. Primary outcome for the current analysis was defined as 6MWT improvement above the median. Mean age of the study population was 79±10 years, and 34 (68%) were men. Baseline preprocedural 6MWT distance was 308 m (interquartile range [IQR], 234–394 m). Acute, intraprocedural change in LA pressure after MitraClip was 3 mm Hg (IQR, 1–6 mm Hg), and change in V wave was 11 mm Hg (IQR, 6–19 mm Hg). Median 6MWT improvement was 25 m (IQR, 19–47 m). Univariate analysis showed that patients with ≤ mild postprocedural mitral regurgitation were 4-fold more likely to experience an improvement in 6MWT ( P =0.02). Multivariate model demonstrated that each 5 mm Hg decrease in V wave was associated with 49% increased likelihood for improvement in 6-minute walk ( P =0.04). Similar model with V-wave change as a dichotomous variable showed that patients with a V-wave decrease of ≥11 mm Hg were 3.8× more likely to improve their 6MWT ( P =0.05). Conclusions— Acute changes in LA pressure after MitraClip procedure are associated with clinical improvement as measured by 6MWT. Continuous LA pressure monitoring may be a useful tool for procedural guidance during transcatheter mitral repair.