Panaich, Sidakpal S

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.

AbstractBackgroundMitraClip is an effective transcatheter therapy for mitral regurgitation (MR). However, MitraClip is challenging in commissural MR and the optimal therapeutic approach is unclear.MethodsWe describe a case series of six consecutive patients with severe commissural primary mitral regurgitation who underwent MitraClip insertion followed by an Amplatzer Vascular Plug (AVP) II occluder between the commissure and the MitraClip.ResultsThe procedure was successful in all patients. MR was reduced from severe to mild/trivial in 50% and moderate in 50% of cases. On 30‐day follow‐up, NYHA class had improved from III (6 patients) to I (2 patients), II (2 patients), and III (2 patients). The mean transmitral gradient was 2.5 ± 1.8 mmHg at baseline and 4.8 ± 2.6 mmHg following the procedure. One patient developed hemolysis immediately post procedure. The other five patients remained well during a median follow‐up of 20 months (range 5–50 months) with no reported device dislodgement.ConclusionsElective treatment of severe commissural MR with a laterally or medially placed MitraClip coupled with an AVP II occluder between the clip and the commissure is feasible and safe. This approach may provide a useful management alternative in selected patients.

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.

BackgroundSeptal ablation (SA) is a key modality for left ventricular outflow tract gradient reduction in hypertrophic obstructive cardiomyopathy (HOCM) patients with refractory symptoms. The primary objective of our study was to evaluate post‐procedural mortality, complications, length of stay (LOS), and cost of hospitalization following SA.MethodsWe queried the Nationwide Inpatient Sample (NIS) between 2005 and 2011 using the ICD9 procedure code of 37.34 for ablation of heart tissue. Only adult patients with HOCM (ICD‐9‐CM: 425.1) were included. Patients with any arrhythmia diagnosis or open surgical ablation procedure code were excluded. Hierarchical mixed effects models were generated in order to identify the independent multivariate predictors of outcomes.ResultsA total of 358 SAs were available for analysis. There was no reported mortality during the study period; permanent pacemaker implantation rate was 8.7%. Highest hospital volume tertile (OR, 95%CI, P‐ value) predicted significantly lower post‐procedural complications (0.51, 0.26–0.98, P = 0.04). Univariate analysis of highest versus lowest tertile of hospital volume showed significant decrease in LOS (2.6 days vs. 3.8 days, P<0.01) and non‐significant decrease hospitalization costs (16,800$ vs. 19,500$, P = 0.29).ConclusionsSA is a safe procedure and associated with low peri‐ procedural mortality rate. A higher burden of baseline comorbidities is associated with worse outcomes while higher annual hospital volume is associated with lower rate of post‐procedural complications, length of stay, and cost of care following SA.

ObjectiveThe aim of our study was to study the impact of glycoprotein IIb/IIIa inhibitors (GPI) on in‐hospital outcomes.BackgroundThere is paucity of data regarding the impact of GPI on the outcomes following peripheral endovascular interventions.MethodsThe study cohort was derived from Healthcare Cost and Utilization Project (HCUP) Nationwide Inpatient Sample (NIS) database between the years 2006 and 2011. Peripheral endovascular interventions and GPI utilization were identified using appropriate ICD‐9 Diagnostic and procedural codes. Two‐level hierarchical multivariate mixed models were created. The study outcomes were: primary (in‐hospital mortality and amputation studied separately) and secondary (composite of in‐hospital mortality and postprocedural complications). Hospitalization costs were also assessed.ResultsGPI utilization (OR, 95% CI, P‐value) was independently predictive of lower amputation rates (0.36, 0.27–0.49, <0.001). There was no significant difference in terms of in‐hospital mortality (0.59, 0.31–1.14, P 0.117), although GPI use predicted worse secondary outcomes (1.23, 1.03–1.47, 0.023). Following propensity matching, the amputation rate was lower (3.2% vs. 8%, P < 0.001), while hospitalization costs were higher in the cohort that received GPI ($21,091 ± 404 vs. 19,407 ± 133, P < 0.001).ConclusionsMultivariate analysis revealed GPI use in peripheral endovascular interventions to be suggestive of an increase in composite end‐point of in‐hospital mortality and postprocedural complications, no impact on in‐hospital mortality alone, significantly lower rate of amputation, and increase in hospitalization costs. © 2016 Wiley Periodicals, Inc.

Purpose: To examine the impact of intravascular ultrasound (IVUS) utilization during lower limb endovascular interventions as regards postprocedural complications and amputation. Methods: The study cohort was derived from the Healthcare Cost and Utilization Project Nationwide Inpatient Sample database between the years 2006 and 2011. Peripheral endovascular interventions were identified using appropriate ICD-9 procedure codes. Two-level hierarchical multivariate mixed models were created. The co-primary outcomes were in-hospital mortality and amputation; the secondary outcome was postprocedural complications. Model results are given as the odds ratio (OR) and 95% confidence interval (CI). Hospitalization costs were also assessed. Results: Overall, among the 92,714 patients extracted from the database during the observation period, IVUS was used in 1299 (1.4%) patients. IVUS utilization during lower extremity peripheral vascular procedures was independently predictive of a lower rate of postprocedural complications (OR 0.80, 95% CI 0.66 to 0.99, p=0.037) as well as lower amputation rates (OR 0.59, 95% CI 0.45 to 0.77, p<0.001) without any significant impact on in-hospital mortality. Multivariate analysis also revealed IVUS utilization to be predictive of a nonsignificant increase in hospitalization costs ($1333, 95% CI −$167 to +$2833, p=0.082). Conclusion: IVUS use during lower limb endovascular interventions is predictive of lower postprocedural complication and amputation rates with a nonsignificant increase in hospitalization costs.

ObjectiveThe aim of the study was to assess the utilization of catheter‐directed thrombolysis (CDT) and its comparative effectiveness against systemic thrombolysis in acute pulmonary embolism (PE).BackgroundContemporary real world data regarding utilization and outcomes comparing systemic thrombolysis with CDT for PE is sparse.MethodsWe queried the Nationwide Inpatient Sample from 2010 to 2012 using the ICD‐9‐CM diagnosis code 415.11, 415.13, and 415.19 for acute PE. We used propensity score analysis to compare outcomes between systemic thrombolysis and CDT. Primary outcome was in‐hospital mortality. Secondary outcome was combined in‐hospital mortality and intracranial hemorrhage (ICH).ResultsOut of 110,731 patients hospitalized with PE, we identified 1,521 patients treated with thrombolysis, of which 1,169 patients received systemic thrombolysis and 352 patients received CDT. After propensity‐matched comparison, primary and secondary outcomes were significantly lower in the CDT group compared to systemic thrombolysis (21.81% vs. 13.36%, OR 0.55, 95% CI 0.36–0.85, P value = 0.007) and (22.89% vs. 13.36%, OR 0.52, 95% CI 0.34–0.80, P value = 0.003), respectively. The median length of stay [7 days, interquartile range (IQR) (5–9 days) vs. 7 days, IQR (5–10 days), P = 0.17] was not significant between the two groups. The CDT group had higher cost of hospitalization [$17,218, IQR ($12,272–$23,906) vs. $23,799, IQR ($17,892–$35,338), P < 0.001]. Multivariate analysis identified increasing age, saddle PE, cardiopulmonary arrest, and Medicaid insurance as independent predictors of in‐hospital mortality.ConclusionsCDT was associated with lower in‐hospital mortality and combined in‐hospital mortality and ICH. © 2015 Wiley Periodicals, Inc.