The Role of Impella for Hemodynamic Support in Patients With Aortic Stenosis

PURPOSE OF REVIEW: The goal of this review is to discuss the effects of Impella (Abiomed, Danvers, MA), to support in the hemodynamics of patients with severe aortic stenosis, and to explore the clinical scenarios in which the use of Impella may be beneficial in this setting. RECENT FINDINGS: The management of patients with severe aortic stenosis who go on to develop left ventricular failure and cardiogenic shock remains an important clinical challenge associated with increased morbidity and mortality. Once considered a relative contraindication, the use of Impella in severe aortic stenosis has now been proven feasible and demonstrated promising results in selected high-risk patients. The use of Impella to provide hemodynamic support maybe considered in patients with aortic stenosis in cardiogenic shock or those with severe left ventricular dysfunction and CAD who require high-risk PCI and or balloon aortic valvuloplasty. Impella is also an attractive option in selected cases of hemodynamic collapse during TAVR

Coarctation of the Aorta: Management, Indications for Intervention, and Advances in Care

Opinion statement Coarctation of the aorta (CoAo) accounts for 9 % of congenital heart defects. Balloon angioplasty has been the conventional endovascular treatment of choice for both native and recurrent coarctation in adults. Recent advancement in stent technology with the development of the covered stents has enhanced the scope for percutaneous management of both native CoAo and post-surgical CoAo. Stent implantation provides better hemodynamic results with larger acute diameter gain and better long-term hemodynamic benefit. Stenting also decreases the incidence of aneurysm formation. The development of biodegradable stents may revolutionize the percutaneous management of coarctation, as the degradation of the stent scaffold within 6 months of implantation will further decrease the incidence of restenosis. In the future stenting may suffice and obviate the need for open repair. Until then, surgical repair of CoAo is the preferred method in both infants and complicated lesions, leaving stenting to adults with focal and uncomplicated disease

Residual Shunt After Patent Foramen Ovale Closure and Long-Term Stroke Recurrence: A Prospective Cohort Study.

BackgroundResidual shunt is observed in up to 25% of patients after patent foramen ovale (PFO) closure, but its long-term influence on stroke recurrence currently is unknown.ObjectiveTo investigate the association of residual shunt after PFO closure with the incidence of recurrent stroke and transient ischemic attack (TIA).DesignProspective cohort study comparing stroke or TIA recurrence in patients with and without residual shunt after PFO closure.SettingSingle hospital center.Participants1078 consecutive patients (mean age, 49.3 years) with PFO-attributable cryptogenic stroke who were undergoing percutaneous PFO closure were followed for up to 11 years.MeasurementsResidual shunt was evaluated by transthoracic echocardiography with saline contrast. Primary outcome was a composite of the first recurrent ischemic stroke or TIA after PFO closure.ResultsCompared with complete closure, the presence of residual shunt after PFO closure was associated with an increased incidence of recurrent stroke or TIA: 2.32 versus 0.75 events per 100 patient-years (hazard ratio [HR], 3.05 [95% CI, 1.65 to 5.62]; P < 0.001). This result remained robust after adjustment for important covariates, namely age; study period; device; presence of atrial septal aneurysm, hypertension, hyperlipidemia, diabetes, hypercoagulability, or hypermobile septum; and medication use (HR, 3.01 [CI, 1.59 to 5.69]; P < 0.001). Further stratification based on shunt size revealed that moderate or large residual shunts were associated with a higher risk for stroke or TIA recurrence (HR, 4.50 [CI, 2.20 to 9.20]; P < 0.001); the result for small residual shunts was indeterminate (HR, 2.02 [CI, 0.87 to 4.69]; P = 0.102).LimitationNonrandomized study with potential unmeasured confounding.ConclusionAmong patients undergoing PFO closure to prevent future stroke, the presence of residual shunt, particularly a moderate or large residual shunt, was associated with an increased risk for stroke or TIA recurrence.Primary funding sourceNational Institutes of Health

Ventricular Septal Defect Complicating ST-Elevation Myocardial Infarctions: A Call for Action

BACKGROUND: Ventricular septal defect is a lethal complication after an acute myocardial infarction, which has become infrequent with the advent of reperfusion strategies; however, it remains a major contributor to mortality. METHODS: We identified patients using the International Classification of Diseases, 9th Revision, Clinical Modification procedure codes from the Nationwide Inpatient Sample between the years 2001 and 2013. A multivariate hierarchical logistic regression model was used to identify significant predictors of in-hospital mortality. RESULTS: We identified 3,373,206 ST-elevation myocardial infarctions, out of which 10,012 (0.3%) were complicated with ventricular septal defects. Most of the patients (60%) were older than 65 years, male (55%), and white (63%). Inferior (49.7%) and anterior (41.1%) myocardial infarctions were more commonly implicated with the development of ventricular septal defects. The median (interquartile range) hospitalization length was 7 (3.0-13.5) days. Only 7.65% of patients underwent some intervention, with 7% surgical and 0.65% minimally invasive. Mechanical support devices were used in 36.5% of patients, with intra-aortic balloon pump (96%) being the most common. In-hospital mortality remained high at 30.5% (downward trending from 41.6% in 2001 to 23.3% in 2013). Age, cardiogenic shock, and in-hospital cardiac arrest were statistically significant predictors of in-hospital mortality. The utilization of corrective procedures significantly declined. The use of mechanical support devices and performing a corrective procedure were associated with higher mortality, length of stay, and cost. CONCLUSIONS: Ventricular septal defects after acute myocardial infarctions remain associated with significantly high mortality rates. Highly specialized regional centers with individual expertise in the management of septal ruptures are required to improve outcomes of these patients

Comparison of Outcomes of Transcatheter Aortic Valve Replacement Plus Percutaneous Coronary Intervention Versus Transcatheter Aortic Valve Replacement Alone in the United States

Transcatheter aortic valve replacement (TAVR) with percutaneous coronary intervention (PCI) has emerged as a less-invasive therapeutic option for high surgical risk patients with aortic stenosis and coronary artery disease. The aim of this study was to determine the outcomes of TAVR when performed with PCI during the same hospitalization. We identified patients using the International Classification of Diseases, Ninth Revision, Clinical Modification procedure codes from the Nationwide Inpatient Sample between the years 2011 and 2013. A total of 22,344 TAVRs were performed between 2011 and 2013. Of these, 21,736 (97.3%) were performed without PCI (TAVR group) while 608 (2.7%) along with PCI (TAVR + PCI group). Among the TAVR + PCI group, 69.7% of the patients had single-vessel, 22.2% had 2-vessel, and 1.6% had 3-vessel PCI. Drug-eluting stents were more commonly used than bare-metal stents (72% vs 28%). TAVR + PCI group witnessed significantly higher rates of mortality (10.7% vs 4.6%) and complications: vascular injury requiring surgery (8.2% vs 4.2%), cardiac (25.4% vs 18.6%), respiratory (24.6% vs 16.1%), and infectious (10.7% vs 3.3%),

Outcomes of transcatheter and surgical aortic valve replacement in high-risk patients with aortic stenosis and left ventricular dysfunction : results from the placement of aortic transcatheter valves (PARTNER) trial (cohort A).

BACKGROUND: The Placement of Aortic Transcatheter Valves (PARTNER) trial demonstrated similar survival after transcatheter and surgical aortic valve replacement (TAVR and SAVR, respectively) in high-risk patients with symptomatic, severe aortic stenosis. The aim of this study was to evaluate the effect of left ventricular (LV) dysfunction on clinical outcomes after TAVR and SAVR and the impact of aortic valve replacement technique on LV function. METHODS AND RESULTS: The PARTNER trial randomized high-risk patients with severe aortic stenosis to TAVR or SAVR. Patients were stratified by the presence of LV ejection fraction (LVEF) <50%. All-cause mortality was similar for TAVR and SAVR at 30-days and 1 year regardless of baseline LV function and valve replacement technique. In patients with LV dysfunction, mean LVEF increased from 35.7±8.5% to 48.6±11.3% (P<0.0001) 1 year after TAVR and from 38.0±8.0% to 50.1±10.8% after SAVR (P<0.0001). Higher baseline LVEF (odds ratio, 0.90 [95% confidence interval, 0.86, 0.95]; P<0.0001) and previous permanent pacemaker (odds ratio, 0.34 [95% confidence interval, 0.15, 0.81]) were independently associated with reduced likelihood of =10% absolute LVEF improvement by 30 days; higher mean aortic valve gradient was associated with increased odds of LVEF improvement (odds ratio, 1.04 per 1 mm Hg [95% confidence interval, 1.01, 1.08]). Failure to improve LVEF by 30 days was associated with adverse 1-year outcomes after TAVR but not SAVR. CONCLUSIONS: In high-risk patients with severe aortic stenosis and LV dysfunction, mortality rates and LV functional recovery were comparable between valve replacement techniques. TAVR is a feasible alternative for patients with symptomatic severe aortic stenosis and LV dysfunction who are at high risk for SAVR

Transcatheter aortic valve replacement and standard therapy in inoperable patients with aortic stenosis and low EF.

OBJECTIVES: The aims of this study were to evaluate the effect of left ventricular (LV) dysfunction on clinical outcomes after transcatheter aortic valve replacement (TAVR) and standard therapy for severe aortic stenosis (AS) and to assess LV ejection fraction (LVEF) recovery and its impact on subsequent clinical outcomes. METHODS: Cohort B of the Placement of AoRtic TraNscathetER Valves trial randomised 342 inoperable patients with severe AS to TAVR or standard therapy. We defined LV dysfunction as an LVEF <50% and LVEF improvement as an absolute increase in LVEF =10% at 30 days. RESULTS: Baseline LV dysfunction did not affect survival after TAVR but was associated with increased cardiac mortality at 1 year with standard therapy (59.3% vs 45.8% with normal LVEF; HR=1.71 (95% CI 1.08 to 2.71); p=0.02). In those with LV dysfunction, LVEF improvement occurred in 48.7% and 30.4% of TAVR and standard therapy patients, respectively (p=0.08), and was independently predicted by relative wall thickness and receipt of TAVR. LVEF improvement with standard therapy portended reduced all-cause mortality at 1 year (28.6% vs 65.6% without LVEF improvement; HR=0.32 (95% CI 0.11 to 0.93); p=0.03) but not at 2 years. CONCLUSIONS: In inoperable patients with severe AS, mild-to-moderate LV dysfunction is associated with higher cardiac mortality with standard therapy but not TAVR. A subset of patients undergoing standard therapy with LV dysfunction demonstrates LVEF improvement and favourable 1-year but not 2-year survival. TAVR improves survival and should be considered the standard of care for inoperable patients with AS and LVEF >20%

Transcatheter Edge-to-Edge Repair in Patients With Anatomically Complex Degenerative Mitral Regurgitation

BACKGROUND: Mitral valve transcatheter edge-to-edge repair is safe and effective in treating degenerative mitral regurgitation (DMR) patients at prohibitive surgical risk, but outcomes in complex mitral valve anatomy patients vary. OBJECTIVES: The PASCAL IID registry assessed safety, echocardiographic, and clinical outcomes with the PASCAL system in prohibitive risk patients with significant symptomatic DMR and complex mitral valve anatomy. METHODS: Patients in the prospective, multicenter, single-arm registry had 3+ or 4+ DMR, were at prohibitive surgical risk, presented with complex anatomic features based on the MitraClip instructions for use, and were deemed suitable for the PASCAL system by a central screening committee. Enrolled patients were treated with the PASCAL system. Safety, effectiveness, and functional and quality-of-life outcomes were assessed. Study oversight also included an echocardiographic core laboratory and clinical events committee. RESULTS: The study enrolled 98 patients (37.2% ≥2 independent significant jets, 15.0% severe bileaflet/multi scallop prolapse, 13.3% mitral valve orifice area \u3c4.0 cm2, and 10.6% large flail gap and/or large flail width). The implant success rate was 92.9%. The 30-day composite major adverse event rate was 11.2%. At 6 months, 92.4% patients achieved MR ≤2+ and 56.1% achieved MR ≤1+ (P \u3c 0.001 vs baseline). The Kaplan-Meier estimates for survival, freedom from major adverse events, and heart failure hospitalization at 6 months were 93.7%, 85.6%, and 92.6%, respectively. Patients experienced significant symptomatic improvement compared with baseline (P \u3c 0.001). CONCLUSIONS: The outcomes of the PASCAL IID registry establish the PASCAL system as a useful therapy for prohibitive surgical risk DMR patients with complex mitral valve anatomy. (PASCAL IID Registry within the Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial [CLASP IID] NCT03706833)