Impella-assisted balloon aortic valvuloplasty

The Impella LP 2.5 left ventricular assist device (Abiomed) is safe and effective for assisting high-risk percutaneous interventions. A 77-year-old woman with severe aortic stenosis, severe coronary artery disease, an ejection fraction of 20%, severe peripheral vascular disease, and other comorbidities presented to a private, tertiary referral hospital with shortness of breath that had been worsening over 2 weeks. The patient underwent a successful, Impella-assisted balloon aortic valvuloplasty (BAV) without complications. Impella support may be considered during BAV in high-risk patients with contraindications for a TandemHeart device (CardiacAssist, Inc.).     

Comparison of outcomes in high-risk patients>70 years of age with aortic valvuloplasty and percutaneous coronary intervention versus aortic valvuloplasty alone

The goal of this study was to compare outcomes of combined balloon aortic valvuloplasty (BAV) plus percutaneous coronary intervention (PCI) with BAV alone in a surgically high risk, older (>70 years) population with both aortic stenosis (AS) and coronary artery disease (CAD). The medical records, coronary angiograms, and procedural reports of 100 consecutive patients who underwent BAV and coronary angiography at our institution from July 2003 to November 2006 were reviewed. Seventeen patients (mean age 86.2+/-6.4 years) underwent combined (nonstaged) BAV and PCI with a calculated Society of Thoracic Surgery risk score of 13.5%+/-6.7; 13 of these underwent coronary stenting before BAV and 4 after BAV. All 17 patients were successfully treated with this combined strategy. The incidence of periprocedural mortality, myocardial infarction, and stroke was zero. An additional 25 patients (mean age 85.9+/-6.9) with CAD were identified who underwent BAV alone with a Society of Thoracic Surgery risk score of 12.6+/-5.7%. PCI in these patients was avoided primarily because of greater lesion complexity or a perceived low probability of symptomatic benefit. There was 1 procedural death, no myocardial infarction, and 1 postprocedural stroke in these 25 patients. The procedural duration and hospital length of stay for the combined BAV and PCI group was 98.8+/-17.6 minutes and 4.1+/-2.8 days, respectively, and for the BAV only group was 86.2+/-27.3 minutes and 3.3+/-2.1 days, respectively. In conclusion, with appropriate selection, BAV plus PCI was safely performed in this retrospective series of elderly, high-risk patients with severe AS and CAD.     

Balloon Aortic Valvuloplasty Followed by Impella®-Assisted Left Main Coronary Artery Percutaneous Coronary Intervention in Patients With Severe Aortic Stenosis as a Bridge to Transcatheter Aortic Valve Replacement

BackgroundThe use of Impella® to provide hemodynamic support during unprotected left main coronary artery (LMCA) percutaneous coronary intervention (PCI) has been shown to be feasible, but severe AS is a relative contraindication for its use. Balloon aortic valvuloplasty (BAV) may facilitate the use of Impella® in these patients.ObjectiveTo assess the feasibility of BAV followed by Impella®-assisted LMCA PCI in patients with severe AS as bridge to TAVR.MethodsPatients with symptomatic severe AS with LMCA stenosis ≥70% requiring PCI prior to TAVR were included. Outcomes were retrospectively collected.ResultsSeven patients underwent BAV followed by Impella®-assisted LMCA PCI. Five patients were male; mean age 86 (75–91; SD ± 5.5). Mean STS score was 6.5% (4.3–13.8; SD ± 3.4). Impella® 2.5 L was used in all cases. The procedure was successful in all patients without peri-procedure complications. At 30-day post-BAV/PCI follow up, all patients had experienced improvement in NYHA class (N = 2 NYHA IV to III, N = 5 NYHA III to II). At such interval, mean EF was 54% (30–77; SD ± 17.7). The post BAV change in AVA [0.8 cm² (0.4–1.5; SD ± 0.3; P = 0.07)], and AV mean gradient [30.8 mmHg (21–45; SD ± 8.9; P = 0.95)] after the procedure were not statistically significant. All patients underwent TAVR after a median PCI-to-TAVR interval of 62 days (33–339; SD ± 96.7).ConclusionsBAV followed by Impella®-assisted LMCA PCI appears to be a feasible strategy for intermediate and high surgical risk patients with severe AS undergoing LMCA PCI as bridge to TAVR.     

In‐hospital and long‐term outcomes of percutaneous balloon aortic valvuloplasty with concomitant percutaneous coronary intervention in patients with severe aortic stenosis

Background

Severe aortic stenosis (AS) often coexists with significant coronary artery disease.

Objective

To evaluate procedural complications and long‐term outcomes of patients with severe AS undergoing balloon aortic valvuloplasty (BAV) and percutaneous coronary intervention (PCI).

Methods

A total of 97 patients with severe AS underwent 104 BAVs as palliative procedure, bridge to definitive treatment, or before urgent non‐cardiac surgery. Patients were followed‐up for at least 12 months.

Results

Of the 97 patients, 34 (35.0%) underwent standalone BAV, 45 (46.4%) underwent BAV with coronary angiography, and 18 (18.6%) BAV with PCI. There were no differences in baseline characteristics and indications for BAV among the groups (P > 0.05). No higher risk of complications after BAV performed with concomitant coronary angiography/PCI was observed. Transcatheter aortic valve implantation was performed after BAV in 13 (13.4%) patients and surgical aortic valve replacement in three (3.1%) patients. In spite of no difference in in‐hospital mortality (5.6% vs. 8.9%; P = 0.76), patients with BAV and concomitant PCI had lower long‐term mortality than patients with BAV and concomitant coronary angiography (28.5% vs. 51.0%; P = 0.03). In multivariable Cox analysis adjusted for age, sex, and body mass index, the Society of Thoracic Surgeons Predicted Risk of Mortality score was identified as the only independent predictor of long‐term mortality for all patients (HR: 1.09, 95%CI: 1.04‐1.15, P = 0.0006).

Conclusions

Concomitant PCI or coronary angiography performed with BAV may not increase the risk of major and vascular complications. Patients with BAV and concomitant PCI may have better survival than patients with BAV and concomitant coronary angiography.     

Outcomes of concomitant percutaneous coronary intervention and balloon aortic valvuloplasty

Background: Coronary artery disease often coexists with severe aortic stenosis. The feasibility and safety of combined balloon aortic valvuloplasty (BAV) and percutaneous coronary intervention (PCI) are unknown. Aim: To compare outcomes and complications of combined BAV and PCI with BAV alone. Methods: The study cohort consisted of 409 patients with severe aortic stenosis undergoing BAV from 1/2007 to 12/2010. Overall, 329 patients underwent BAV alone and 80 underwent concomitant PCI. Clinical and hemodynamic data, as well as acute and intermediate‐term outcomes, were collected. Results: At the operator's discretion PCI was done before BAV in 66 (82.5%) and after in 14 (17.5%). Patients who underwent concomitant procedures had a higher incidence of prior stroke and a lower incidence of atrial fibrillation. Procedure time and fluoroscopic time were significantly greater in the BAV/PCI group, (90.0 ± 36.6 vs. 72.8 ± 39.8, P = 0.002 and 20.5 ± 10.9 vs. 12.9 ± 7.0, P < 0.001). Significantly more radiographic contrast was used in the BAV/PCI group (95.1 ± 45.5 vs. 36.7 ± 38.4 cm³, P < 0.001. Serious adverse events occurred with equal frequency 13.7 and 17.3%, P = 0.44). Transfusion requirement was also similar (21.2% vs. 20.0%, P = 0.81). The frequency of a periprocedural increase in troponin or creatinine was also similar. In the BAV alone group the mortality rate was 48.6% (n = 160) during a mean follow‐up of 191 days, and in the BAV/PCI group the mortality rate was 40% (n = 32) during mean follow‐up of 175.5 day, P = 0.34. Conclusion: Combined BAV and PCI are safe and are associated with similar complications as BAV alone and may offer protection against myocardial ischemia during BAV. © 2011 Wiley Periodicals, Inc.     

Stenting of the unprotected left main coronary artery in patients with severe aortic stenosis prior to percutaneous valve interventions

AimsHigh-risk patients with severe aortic stenosis (AS) who are candidates for transcatheter valve implantation (TAVI) or balloon aortic valvuloplasty (BAV) may additionally require revascularization of the unprotected left main coronary artery (UPLM). We aimed to assess the feasibility and procedural safety of UPLM stenting in such patients.Methods and ResultsTen cases of UPLM stenting prior to BAV or TAVI at three medical centers over a 2-year period were identified. Mean age was 84±4 years, aortic valve area was 0.70±0.12 cm², left ventricular ejection fraction was 58%±3%, and logistic EuroScore was 32±17. Intraaortic balloon counterpulsation was used in three patients. A single stent was used in seven patients, and two stents were used in three patients. One patient received a bare-metal stent, and the others received drug-eluting stents. No procedural complications occurred, and the patients were hemodynamically stable. Three patients subsequently underwent BAV, and seven underwent TAVI. During 6 months of follow-up, two patients died: one due to AS restenosis 6 months after BAV and one due to vascular complications 18 days after TAVI (34 days after UPLM stenting).ConclusionsStenting of the UPLM in patients with severe AS prior to percutaneous valve intervention seems feasible and safe. This approach may enable more patients to achieve comprehensive percutaneous therapy for severe coronary and valvular disease.     

The Current Use of Impella 2.5 in Acute Myocardial Infarction Complicated by Cardiogenic Shock: Results from the USpella Registry

Objectives

To evaluate the periprocedural characteristics and outcomes of patients supported with Impella 2.5 prior to percutaneous coronary intervention (pre‐PCI) versus those who received it after PCI (post‐PCI) in the setting of cardiogenic shock (CS) complicating an acute myocardial infarction (AMI).

Background

Early mechanical circulatory support may improve outcome in the setting of CS complicating an AMI. However, the optimal timing to initiate hemodynamic support has not been well characterized.

Methods

Data from 154 consecutive patients who underwent PCI and Impella 2.5 support from 38 US hospitals participating in the USpella Registry were included in our study. The primary end‐point was survival to discharge. Secondary end‐points included assessment of patients' hemodynamics and in‐hospital complications. A multivariate regression model was used to identify independent predictors for mortality.

Results

Both groups were comparable except for diabetes (P = 0.02), peripheral vascular disease (P = 0.008), chronic obstructive pulmonary disease (P = 0.05), and prior stroke (P = 0.04), all of which were more prevalent in the pre‐PCI group. Patients in the pre‐PCI group had more lesions (P = 0.006) and vessels (P = 0.01) treated. These patients had also significantly better survival to discharge compared to patients in the post‐PCI group (65.1% vs.40.7%, P = 0.003). Survival remained favorable for the pre‐PCI group after adjusting for potential confounding variables. Initiation of support prior to PCI with Impella 2.5 was an independent predictor of in‐hospital survival (Odds ratio 0.37, 95% confidence interval: 0.17–0.79, P = 0.01) in multivariate analysis. The incidence of in‐hospital complications included in the secondary end‐point was similar between the 2 groups.

Conclusions

The results of our study suggest that early initiation of hemodynamic support prior to PCI with Impella 2.5 is associated with more complete revascularization and improved survival in the setting of refractory CS complicating an AMI. (J Interven Cardiol 2014;27:1–11)     

Twenty-five year experience with balloon aortic valvuloplasty for congenital aortic stenosis

Balloon aortic valvuloplasty (BAV) is the primary therapy for congenital aortic stenosis (AS). Few reports describe long-term outcomes. In this study, a retrospective single-institution review was performed of patients who underwent BAV for congenital AS. The following end points were evaluated: moderate or severe aortic insufficiency (AI) by echocardiography, aortic valve replacement, repeat BAV, surgical aortic valvotomy, and transplantation or death. From 1985 to 2009, 272 patients who underwent BAV at ages 1 day to 30.5 years were followed for 5.8 ± 6.7 years. Transplantation or death occurred in 24 patients (9%) and was associated with depressed baseline left ventricular shortening fraction (LVSF) (p = 0.04). Aortic valve replacement occurred in 42 patients (15%) at a median of 3.5 years (interquartile range 75 days to 5.9 years) after BAV and was associated with post-BAV gradient ≥25 mm Hg (p = 0.02), the presence of post-BAV AI (p = 0.03), and below-average baseline LVSF (p = 0.04). AI was found in 83 patients (31%) at a median of 4.8 years (interquartile range 1.4 to 8.7) and was inversely related to post-BAV gradient ≥25 mm Hg (p <0.04). AI was associated with depressed baseline LVSF (p = 0.02). Repeat valvuloplasty (balloon or surgical) occurred in 37 patients (15%) at a median of 0.51 years (interquartile range 0.10 to 5.15) and was associated with neonatal BAV (p <0.01), post-BAV gradient ≥25 mm Hg (p = 0.03), and depressed baseline LVSF (p = 0.05). In conclusion, BAV confers long-term benefits to most patients with congenital AS. Neonates, patients with post-BAV gradients ≥25 mm Hg, and patients with lower baseline LVSF experienced worse outcomes.     

Impella Versus Extracorporeal Membrane Oxygenation for Acute Myocardial Infarction Cardiogenic Shock

BackgroundPercutaneous ventricular assist devices and extracorporeal membrane oxygenation (ECMO) are increasingly used for mechanical circulatory support (MCS) in patients with acute myocardial infarction with cardiogenic shock (AMI-CS) in hospitals throughout the United States.MethodsUsing the National Inpatient Sample from October 2015 to December 2017, we identified hospital admissions that underwent percutaneous coronary intervention (PCI) and non-elective Impella or ECMO placement for AMI-CS using ICD-10 codes. Propensity-score matching was performed to compare both groups for primary and secondary outcomes.ResultsWe identified 6290 admissions for AMI-CS who underwent PCI and were treated with Impella (n = 5730, 91%) or ECMO (n = 560, 9%) from October 2015 to December 2017. After propensity-match analysis, the ECMO cohort had significantly higher in-hospital mortality (43.3% vs 26.7%, OR: 2.10, p = 0.021). The incidence of acute respiratory failure and vascular complications were significantly lower in the Impella cohort. We observed a shorter duration of hospital stay and lower hospital costs in the Impella cohort compared to those who received ECMO.ConclusionsIn AMI-CS, the use of Impella was associated with better clinical outcomes, fewer complications, shorter length of hospital stay and lower hospital cost compared to those undergoing ECMO placement.     

Hemodynamic support with impella 2.5 during balloon aortic valvuloplasty in a high-risk patient

Aortic stenosis (AS) has been considered an exclusion criterion for the use of the Impella 2.5 catheter. We describe a case in which the Impella catheter was successfully implanted and used for hemodynamic support during balloon aortic valvuloplasty in a high-risk patient of severe AS with a calculated aortic valve area of 0.59 cm2 .     

Percutaneous Aortic Valve Intervention in Patients Scheduled for Noncardiac Surgery: A Japanese Multicenter Study

BackgroundThe optimal management of preexisting severe aortic stenosis (AS) in patients undergoing noncardiac surgery (non-CS) remains uncertain. This study aimed to investigate the safety and effectiveness of percutaneous aortic valve intervention (PAVI) in patients with AS before non-CS.MethodsWe analyzed pooled data within a multicenter Japanese registry from 118 patients with severe AS who underwent PAVI before non-CS. Sixty patients underwent percutaneous balloon aortic valvuloplasty (BAV) and 58 patients underwent transcatheter aortic valve replacement (TAVR). The groups' baseline characteristics, perioperative complications, and 30-day mortality and midterm mortality after non-CS were compared.ResultsThe postprocedural mean pressure gradient was higher in the BAV group than in the TAVR group (35.0 ± 11.5 mmHg vs. 11.5 ± 4.8 mmHg, p < 0.001). The non-CS operation risk did not differ between the groups (p = 0.69). One patient in each group experienced a noncardiac death (p = 0.74), and the 30-day mortality rate after non-CS was 1.7%. Heart failure occurred in 2 patients in each group (p = 0.68). One patient in the TAVR group experienced a non-disabling stroke, and no myocardial infarctions occurred. Consequently, the combined adverse events were 5.0% and 6.9% in the 2 groups (p = 0.48). The bleeding rates during the non-CS were similar in both groups (33.3% vs. 25.9%, p = 0.25). There were no differences between the groups regarding midterm mortality (p = 0.60), whereas 53.3% of the patients in the BAV group required invasive treatment of their AS during follow-up.ConclusionsAmong patients with severe AS, PAVI before non-CS reduces the AS severity and may contribute to procedural safety during non-CS.     

Safety of percutaneous coronary intervention alone in symptomatic patients with moderate and severe valvular aortic stenosis and coexisting coronary artery disease: analysis of results in 56 patients

Whether percutaneous coronary intervention (PCI) alone is safe in patients with moderate or severe aortic stenosis (AS) and coexisting coronary artery disease (CAD), and whether aortic valve replacement (AVR) can be deferred in patients with moderate AS by undergoing PCI alone is not known. We conducted a retrospective study of surgically inoperable patients with AS who underwent PCI (moderate AS, n = 28; and severe AS, n = 28) and compared to those with AVR (n = 55). The clinical characteristics, procedural complications, in-hospital and long-term clinical outcomes of PCI were compared. Baseline and procedural characteristics were similar except that lower age, hypertension, and renal impairment were seen in the AVR group. In-hospital complications were comparable among the 3 groups. Six-month and 1-year rates of myocardial infarction (MI), non-Q-wave MI, death and out-of-hospital death were similar between AVR and moderate AS patients (p = NS) and significantly high (p < 0.04) in patients with severe AS. On multivariate analysis, severe AS was the only significant predictor of 6-month and 1-year mortality. Our study suggests that PCI is safe in patients with moderate AS and coexisting CAD but is associated with poor outcomes in patients with severe AS.     

Rates and determinants of progressive aortic valve dysfunction in aortic coarctation

Purpose

Aortic valve dysfunction is common in coarctation patients(CoA). Bicuspid aortic valve (BAV) in CoA is associated with aortic valve stenosis (AS), aortic valve regurgitation (AR), and ascending aortic dilatation. The aim of this study was to evaluate the progression of and predictors for aortic valve dysfunction in CoA.

Methods

96 CoA patients prospectively underwent echocardiography twice between 2001 and 2010. AS was defined as an aortic valve gradient ≥ 20 mm Hg, AR as none/minor, or moderate/severe. Aortic dilatation as an ascending aortic diameter ≥ 37 mm.

Results

All patients (median age 28.0 years, range 17–61 years; male 57%) were followed with a median follow-up of 7.0 years. Sixty patients (63%) had BAV. At baseline 10 patients had AS (10%, 9 BAV), 6 patients AR (6%, 3 BAV) and 11 patients aortic dilatation (11%, 11 BAV). At follow-up 15 patients had AS (15%, 13 BAV) and 12 patients AR. (13%, 8 BAV).Median AS progression was 1.1 mm Hg/5 years (range — 13–28). Determinants for AS at follow-up were age (ß = 0.20, P = 0.01), aortic dilatation (ß = 4.6, P = 0.03), and baseline aortic valve gradient (ß = 0.93, P < 0.001). BAV was predictive for AR. (ß = 0.91, P = 0.049).

Conclusion

Progression of AS in adult CoA patients is mild in this young population. Older age, aortic dilatation and the baseline aortic valve gradient are determinants for AS at follow-up. BAV is predictive for AR. These findings point towards a common embryological pathway of both valvular and aortic disease in CoA.     

Outcomes After Transcatheter Aortic Valve Replacement in Bicuspid Versus Tricuspid Anatomy: A Systematic Review and Meta-Analysis

ObjectivesThe aim of this study was to compare the feasibility, safety, and clinical outcomes of transcatheter aortic valve replacement (TAVR) in bicuspid aortic valve (BAV) versus tricuspid aortic valve (TAV) stenosis.BackgroundAt present, limited observational data exist supporting TAVR in the context of bicuspid anatomy.MethodsPrimary endpoints were 1-year survival and device success. Secondary endpoints included moderate to severe paravalvular leak (PVL) and a composite endpoint of periprocedural complications; incidence rates of individual procedural endpoints were also explored individually.ResultsIn the main analysis, 17 studies and 181,433 patients undergoing TAVR were included, of whom 6,669 (0.27%) had BAV. A secondary analysis of 7,071 matched subjects with similar baseline characteristics was also performed. Device success and 1-year survival rates were similar between subjects with BAV and those with TAV (97% vs 94% [P = 0.55] and 91.3% vs 90.8% [P = 0.22], respectively). In patients with BAV, a trend toward a higher risk for periprocedural complications was observed in our main analysis (risk ratio [RR]: 1.12; 95% CI: 0.99-1.27; P = 0.07) but not in the matched population secondary analysis (RR: 1.00; 95% CI: 0.81-1.24; P = 0.99). The risk for moderate to severe PVL was higher in subjects with BAV (RR: 1.42; 95% CI: 1.29-1.58; P < 0.0001) as well as the incidence of cerebral ischemic events (2.4% vs 1.6%; P = 0.015) and of annular rupture (0.3% vs 0.02%; P = 0.014) in matched subjects.ConclusionsTAVR is a feasible option among selected patients with BAV anatomy, but the higher rates of moderate to severe PVL, annular rupture, and cerebral ischemic events observed in the BAV group warrant caution and further evidence.     

Influence of coronary artery disease and percutaneous coronary intervention on mid‐term outcomes in patients with aortic valve stenosis treated with transcatheter aortic valve implantation

BackgroundA high frequency of coronary artery disease (CAD) is reported in patients with severe aortic valve stenosis (AS) who undergo transcatheter aortic valve implantation (TAVI). However, the optimal management of CAD in these patients remains unknown.HypothesisWe hypothesis that AS patients with TAVI complicated by CAD have poor prognosis. His study evaluates the prognoses of patients with CAD and severe AS after TAVI.MethodsWe divided 186 patients with severe AS undergoing TAVI into three groups: those with CAD involving the left main coronary (LM) or proximal left anterior descending artery (LAD) lesion (the CAD[LADp] group), those with CAD not involving the LM or a LAD proximal lesion (the CAD[non‐LADp] group), and those without CAD (Non‐CAD group). Clinical outcomes were compared among the three groups.ResultsThe CAD[LADp] group showed a higher incidence of major adverse cardiovascular and cerebrovascular events (MACCEs) and all‐cause mortality than the other two groups (log‐rank p = .001 and p = .008, respectively). Even after adjustment for STS score and percutaneous coronary intervention (PCI) before TAVI, CAD[LADp] remained associated with MACCE and all‐cause mortality. However, PCI for an LM or LAD proximal lesion pre‐TAVI did not reduce the risk of these outcomes.ConclusionsCAD with an LM or LAD proximal lesion is a strong independent predictor of mid‐term MACCEs and all‐cause mortality in patients with severe AS treated with TAVI. PCI before TAVI did not influence the outcomes.     

Real-world use of the Impella 2.5 circulatory support system in complex high-risk percutaneous coronary intervention: The USpella Registry

Objectives: We report on the real-world, multicenter experience of the Impella 2.5 circulatory support system during high-risk PCI, a subset of the larger USpella Registry. Background: Standard of care for most patients with compromised ventricular function with multivessel or high-risk coronary lesions has been coronary artery bypass grafting. In poor operative candidates, high-risk PCI is increasingly considered, despite an increased risk for periprocedural hemodynamic compromise. Methods: 175 consecutive patients who underwent high-risk PCI with prophylactic support of the Impella 2.5 were evaluated. The primary safety endpoint was the incidence of major adverse cardiac events (MACE) at 30 days. Secondary endpoints included safety and efficacy related to the device and patient outcomes, including survival at 12 months. Results: Overall angiographic revascularization was successful in 99% of patients and in 90% of those with multivessel revascularization, resulting in a reduction of the mean SYNTAX score post-PCI from 36 ± 15 to 18 ± 15 (P < 0.0001) and an improvement of the ejection fraction (from 31 ± 15% to 36 ± 14%, P < 0.0001). In 51% of patients, the functional status improved by one or more NYHA class (P < 0.001). At 30-day follow-up, the rate of MACE was 8%, and survival was 96%, 91%, and 88% at 30 days, 6 months, and 12 months, respectively. Conclusions: The use of Impella 2.5 in high-risk PCI appeared feasible and safe in the real-world setting. The utilization of the Impella 2.5 was successful, resulting in favorable short- and midterm angiographic, procedural and clinical outcomes. ? 2012 Wiley Periodicals, Inc.     

Women With Cardiogenic Shock Derive Greater Benefit From Early Mechanical Circulatory Support: An Update From the cVAD Registry

Objectives

The aim of this analysis was to assess survival differences between men and women supported with Impella 2.5 (Abiomed Inc., Danvers) in the setting of acute myocardial infarction (AMI) complicated by cardiogenic shock (CS).

Background

Data on sex differences in outcomes of CS with mechanical circulatory support are sparse.

Methods

Patients enrolled in the cVAD Registry who underwent percutaneous coronary intervention (PCI) and Impella 2.5 support for CS complicating an AMI were included. Differences between men and women were examined.

Results

In total, 180 patients were analyzed. Women (n = 49, 27.2%) were older (71.0 ± 12.8 years vs 63.8 ± 13.0, P = 0.001), smaller (BSA 1.82 ± 0.22 vs 2.04 ± 0.24 m², P < 0.001), and had a higher STS mortality risk score than men (27.9 ± 17.0 vs. 20.8 ± 16.8 P = 0.01). There was no difference in survival to discharge (P = 0.3). Patients receiving the Impella 2.5 pre‐PCI had significantly lower inpatient mortality than those who received support post‐PCI (P = 0.003). However, the magnitude of the survival benefit was significantly greater in women who received the Impella pre‐PCI as compared to men. Overall, 68.8% of women survived with pre‐PCI Impella 2.5 versus 24.2% post‐PCI (P = 0.005) whereas 54.2% of men survived with pre‐PCI Impella 2.5 versus 40.3% post‐PCI (P = 0.1, p‐interaction = 0.07). No differences in timing to intervention were found between men and women.

Conclusions

Early initiation of hemodynamic support prior to PCI with Impella 2.5, in the setting of AMI complicated by CS, was associated with a greater survival benefit to hospital discharge in women compared to men, despite a higher predicted risk of mortality and a greater revascularization failure rate for women. (J Interven Cardiol 2016;29:248–256)

     

Aortic Stenosis Progression,Cardiac Damage,and Survival: Comparison Between Bicuspid and Tricuspid Aortic Valves

ObjectivesThis study sought to compare aortic stenosis (AS) progression rates, AS-related cardiac damage (AS-CD) indicator incidence and determinants, and survival between patients with tricuspid aortic valve (TAV)-AS and those with bicuspid aortic valve (BAV)-AS.BackgroundDifferences in AS progression and AS-CD between patients with BAV and patients with TAV are unknown.MethodsWe retrospectively studied consecutive patients with baseline peak aortic valve velocity (peakV) ≥2.5 m/s and left ventricular ejection fraction ≥50%. Follow-up echocardiograms (n = 4,818) provided multiparametric AS progression rates and AS-CD.ResultsThe study included 330 BAV (age 54 ± 14 years) and 581 patients with TAV (age 72 ± 11 years). At last echocardiogram (median: 5.9 years; interquartile range: 3.9 to 8.5 years), BAV-AS exhibited similar peakV and mean pressure gradient (MPG) as TAV-AS, but larger calculated aortic valve area due to larger aortic annulus (p < 0.0001). Multiparametric progression rates were similar between BAV-AS and TAV-AS (all p ≥ 0.08) and did not predict age-/sex-adjusted survival (p ≥ 0.45). Independent determinants of rapid progression were male sex and baseline AS severity for TAV (all p ≤ 0.024), and age, baseline AS severity, and cardiac risk factors (age interaction: p = 0.02) for BAV (all p ≤ 0.005). At 12 years, patients with TAV-AS had a higher incidence of AS-CD than BAV-AS patients (p < 0.0001), resulting in significantly worse survival compared to BAV-AS (p < 0.0001). AS-CD were independently determined by multiple factors (MPG, age, sex, comorbidities, cardiac function; all p ≤ 0.039), and BAV was independently protective of most AS-CD (all p ≤ 0.05).ConclusionsIn this cohort, TAV-AS and BAV-AS progression rates were similar. Rapid progression did not affect survival and was determined by cardiac risk factors for BAV-AS (particularly in patients with BAV <60 years of age) and unmodifiable factors for TAV-AS. AS-CD and mortality were significantly higher in TAV-AS. Independent determinants of AS-CD were multifactorial, and BAV morphology was AS-CD protective. Therefore, the totality of AS burden (cardiac damage) is clinically crucial for TAV-AS, whereas attention to modifiable risk factors may be preventive for BAV-AS.     

Balloon Aortic Valvuloplasty as a Bridge to Aortic Valve Replacement: A Contemporary Nationwide Perspective

ObjectivesThis study sought to use a national representative database to assess the incidence, predictors, and outcomes of balloon aortic valvuloplasty (BAV) as a bridge to transcatheter aortic valve replacement (TAVR) in contemporary practice.BackgroundNationwide data on the use and outcomes of BAV as a bridge to TAVR are limited.MethodsPatients who underwent BAV between January and June in 2015 and 2016 were identified in the National Readmission Database. We assessed rate of subsequent TAVR following BAV, and predictors and timing of subsequent TAVR. We then identified a group of patients who had direct TAVR (without prior BAV) in the original 2015 to 2016 National Readmission Database dataset. We compared in-hospital outcomes following TAVR between patients with prior bridging BAV and those undergoing direct TAVR.ResultsAmong the 3,691 included patients 1,426 (38.6%) had subsequent TAVR. Timing of TAVR was pre-discharge in 7.4%, within 30 days in 35%, between 31 and 90 days in 47%, between 91 and 180 days in 14%, and >180 days in 4%. Negative predictors of subsequent TAVR included prior defibrillator (odds ratio [OR]: 0.56; 95% confidence interval [CI]: 0.36 to 0.85), dementia (OR: 0.60; 95% CI: 0.46 to 0.79), malnutrition (OR: 0.64; 95% CI: 0.45 to 0.90), and malignancy (OR: 0.62; 95% CI: 0.47 to 0.82). In propensity-score matched cohorts of patients who underwent direct TAVR versus those with prior BAV, in-hospital mortality during TAVR admission was similar (3.7% vs. 3.5%; p = 0.91). Major complications, length of stay, and discharge disposition were also comparable. However, cost of the hospitalization was higher in the direct TAVR group.ConclusionsAbout 40% of BAV patients undergo subsequent TAVR mostly within 90 days. In-hospital outcomes of TAVR in these patients were comparable with propensity-score matched patients who underwent TAVR without prior BAV. Further investigations are needed to define the role of BAV in contemporary practice.     

Percutaneous Hemodynamic Support (Impella) in Patients with Advanced Heart Failure and/or Cardiogenic Shock Not Eligible to PROTECT II Trial

PROTECT I and II trials have tested the efficacy of Impella in patents with high-risk percutaneous coronary intervention (PCI). However, patients with severe hemodynamic instability such as cardiac arrest, ST-segment elevated myocardial infarction (STEMI), or cardiogenic shock were excluded. The objective was to investigate the efficacy of Impella in sicker patient population who were not included in PROTECT trials. These patients merit high-risk PCI who had cardiogenic shock and unstable or decompensated heart failure (HF). From December 2010 to March 2012, 10 consecutive patients with extremely high surgical risk and hemodynamic instability underwent urgent PCI with Impella 2.5 support (Abiomed Inc., Danvers, MA). These patients were presented with advance HF and/or cardiogenic shock. Among the 10 included patients, 3 patients were with cardiac arrest and 1 patient was with acute myocardial infarction. All patients had successful Impella implantation and remained hemodynamically stable during high-risk PCI. Among the 10 patients 2 patients (20%) died within 1 month and 1 patient developed limb ischemia. In high-risk population nonrandomizable to PROTECT trials with advance HF/cardiogenic shock, Impella could be an important tool for hemodynamic support to PCI or could be a bridge to left ventricle assist device to achieve good recovery. Larger studies need to be conducted on this high-risk population.