Variations in Practice Patterns and Consistency With Published Guidelines for Balloon Aortic and Pulmonary Valvuloplasty: An Analysis of Data From the IMPACT Registry.

OBJECTIVES: The authors sought to study variation in the practice of balloon aortic (BAV) and pulmonary valvuloplasty (BPV). BACKGROUND: The IMPACT (IMProving Adult and Congenital Treatment) registry provides an opportunity to study practice variation in transcatheter interventions for congenital heart disease. METHODS: The authors studied BAV and BPV in the IMPACT registry from January 1, 2011, to September 30, 2015, using hierarchical multivariable models to measure hospital-level variation in: 1) the distribution of indications for intervention; and 2) in cases with "high resting gradient" as the indication, consistency with published guidelines. RESULTS: A total of 1,071 BAV cases at 60 hospitals and 2,207 BPV cases at 75 hospitals were included. The indication for BAV was high resting gradient in 82%, abnormal stress test or electrocardiogram (2%), left ventricular dysfunction (11%), and symptoms (5%). Indications for BPV were high resting gradient in 82%, right-left shunt (6%), right ventricular dysfunction (7%), and symptoms (5%). No association between hospital characteristics and distribution of indications was demonstrated. Among interventions performed for "high resting gradient," there was significant adjusted hospital-level variation in the rates of cases performed consistently with guidelines. For BAV, significant differences were seen across census regions, with hospitals in the East and South more likely to practice consistently than those in the Midwest and West (p = 0.005). For BPV, no association was found between hospital factors and rates of consistent practice, but there was significant interhospital variation (median rate ratio: 1.4; 95% confidence interval: 1.2 to 1.6; p < 0.001). CONCLUSIONS: There is measurable hospital-level variation in the practice of BAV and BPV. Further research is necessary to determine whether this affects outcomes or resource use.

Impact of percutaneous mitral valvuloplasty on left ventricular function in patients with mitral stenosis assessed by 3D echocardiography.

BACKGROUND: The status of intrinsic left ventricular (LV) contractility in patients with isolated rheumatic mitral stenosis (MS) has been debated. The acute changes in loading conditions after percutaneous mitral valvuloplasty (PMV) may affect LV performance. We aimed to examine the acute effects of PMV on LV function and identify factors associated with LV ejection fraction (LVEF) changes, and determinants of long-term events following the procedure. METHODS: One hundred and forty-two patients who underwent PMV for symptomatic rheumatic MS (valve area of 0.99±0.3cm2) were prospectively enrolled. LV volumes and LVEF were measured by three-dimensional (3D) echocardiography. Long-term outcome was a composite endpoint of death, mitral valve (MV) replacement, repeat PMV, new onset of atrial fibrillation, and stroke. RESULTS: The mean age was 42.3±12.1years, and 125 patients were women (88%). After PMV, LVEF increased significantly (51.4 vs 56.5%, p<0.001), primary due to a significant increase in LV end-diastolic volume (65.8mL vs 67.9mL, p=0.002), and resultant increase in the stroke volume (33.9mL vs 39.6mL, p<0.001). Changes in cardiac index and systolic pulmonary artery pressure were associated with LVEF changes after PMV. During a mean follow-up period of 30.8months, 28 adverse clinical events were observed. Postprocedural mitral regurgitation, MV area, and mean gradient were independent predictors of composite endpoints. CONCLUSIONS: In patients with rheumatic MS, PMV resulted in a significant improvement in LV end-diastolic volume, stroke volume and consequently increased in LVEF. Changes in cardiac index and systolic pulmonary artery pressure were associated with LVEF changes after PMV. The predictors of long-term adverse events following PMV were post-procedural variables, including mitral regurgitation, valve area, and mean gradient.

Morbidity and Mortality Associated With Balloon Aortic Valvuloplasty: A National Perspective.

BACKGROUND: The introduction of transcatheter aortic valve replacement (TAVR) led to renewed interest in balloon aortic valvuloplasty (BAV). We sought to assess contemporary trends in BAV utilization and their outcomes. METHODS AND RESULTS: The Nationwide Inpatient Sample was used to identify patients who underwent BAV between 2004 and 2013. In-hospital morbidity and mortality, and predictors of death after BAV were assessed. Outcomes of propensity-matched groups of patients undergoing elective BAV or TAVR were evaluated. BAV utilization increased from 707 cases in 2004 to 3715 cases in 2013 (national estimates). Procedural and in-hospital mortality were 1.4% and 8.5%, respectively. Vascular complications occurred in 7.0% of cases, blood transfusion in 17.5%, clinical stroke in 1.8%, and pacemaker implantation in 3.0%. The strongest predictors of in-hospital death were cardiogenic shock (odds ratio, 6.01; 95% confidence interval, 4.19-8.61; P<0.001), need for left ventricular assist device (odds ratio, 3.48; 95% confidence interval, 2.25-5.36; P<0.001), coagulopathy (odds ratio, 2.19; 95% confidence interval, 1.51-3.18; P<0.001), and low institutional volume of BAV (odds ratio, 1.58; 95% confidence interval, 1.06-2.37; P=0.03). In propensity-matched patients undergoing elective BAV or TAVR, rates of in-hospital mortality (2.9% versus 3.5%; P=0.60), clinical stroke (1.6% versus 3.1%; P=0.10), and vascular complications (8.2% versus 10.9%; P=0.14) were similar. However, BAV was associated with lower rates of pacemaker implantation (2.9% versus 8.0%; P<0.001) and blood transfusion (12.8% versus 22.9%; P<0.001). CONCLUSIONS: In a contemporary national registry, BAV is associated with significant morbidity and mortality that are similar to TAVR. With the substantial increase in BAV utilization and the continuous improvement in TAVR outcomes, these data have important implications to aid clinicians in the selection of appropriate BAV candidates.

Outcomes of hemodynamic support with Impella in very high-risk patients undergoing balloon aortic valvuloplasty: Results from the Global cVAD Registry.

BACKGROUND: Reports on the role of hemodynamic support devices in patients with severe aortic stenosis (AS) and left ventricular (LV) dysfunction undergoing balloon aortic valvuloplasty (BAV) are limited. METHODS: Patients were identified from the cVAD registry, an ongoing multicenter voluntary registry at selected sites in North America that have used Impella in >10 patients. RESULTS: A total of 116 patients with AS who underwent BAV with Impella support were identified. Mean age was 80.41±9.03years and most patients were male. Mean STS score was 18.77%±18.32, LVEF was 27.14%±16.07, and 42% underwent concomitant PCI. In most cases Impella was placed electively prior to BAV, whereas 26.7% were placed as an emergency. The two groups had similar baseline characteristics except for higher prevalence of CAD and lower LVEF in the elective group, and higher STS score in the emergency group. Elective strategy was associated higher 1-year survival compared to emergency placement (56% vs. 29.2%, p=0.003). One-year survival was higher when BAV was used as a bridge to definitive therapy as opposed to palliative treatment (90% vs. 28%, p<0.001). On multivariate analysis, STS score and aim of BAV (bridge to definitive therapy vs. palliative indication) were independent predictors of mortality. CONCLUSION: In this large cohort of patients with AS and severe LV dysfunction undergoing BAV, our results demonstrates feasibility and promising long-term outcomes using elective Impella support with the intention to bridge to a definitive therapy.

1-Year Outcomes After Transcatheter Aortic Valve Replacement With Balloon-Expandable Versus Self-Expandable Valves: Results From the CHOICE Randomized Clinical Trial.

BACKGROUND: The use of a balloon-expandable transcatheter heart valve previously resulted in a greater rate of device success compared with a self-expandable transcatheter heart valve. OBJECTIVES: The aim of this study was to evaluate clinical and echocardiographic outcome data at longer term follow-up. METHODS: The investigator-initiated trial randomized 241 high-risk patients with symptomatic severe aortic stenosis and anatomy suitable for treatment with both balloon- and self-expandable transcatheter heart valves to transfemoral transcatheter aortic valve replacement with either device. Patients were followed-up for 1 year, with assessment of clinical outcomes and echocardiographic evaluation of valve function. RESULTS: At 1 year, the rates of death of any cause (17.4% vs. 12.8%; relative risk [RR]: 1.35; 95% confidence interval [CI]: 0.73 to 2.50; p = 0.37) and of cardiovascular causes (12.4% vs. 9.4%; RR: 1.32; 95% CI: 0.63 to 2.75; p = 0.54) were not statistically significantly different in the balloon- and self-expandable groups, respectively. The frequencies of all strokes (9.1% vs. 3.4%; RR: 2.66; 95% CI: 0.87 to 8.12; p = 0.11) and repeat hospitalization for heart failure (7.4% vs. 12.8%; RR: 0.58; 95% CI: 0.26 to 1.27; p = 0.19) did not statistically significantly differ between the 2 groups. Elevated transvalvular gradients during follow-up were observed in 4 patients in the balloon-expandable group (3.4% vs. 0%; p = 0.12); all were resolved with anticoagulant therapy, suggesting a thrombotic etiology. More than mild paravalvular regurgitation was more frequent in the self-expandable group (1.1% vs. 12.1%; p = 0.005). CONCLUSIONS: Despite the higher device success rate with the balloon-expandable valve, 1-year follow-up of patients in CHOICE (Randomized Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis: Medtronic CoreValve Versus Edwards SAPIEN XT Trial), with limited statistical power, revealed clinical outcomes after transfemoral transcatheter aortic valve replacement with both balloon- and self-expandable prostheses that were not statistically significantly different. (A Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis: The CHOICE Trial; NCT01645202).

[Interventional therapy of heart valve diseases: future perspectives]. / Interventionelle Therapie von Herzklappenerkrankungen : Ein Ausblick.

Transcatheter procedures have been adopted as novel treatment strategy for patients with valvular heart disease, particularly for those who are inoperable or at high risk for surgical valve procedures. Significant technological advances have resulted in an improvement of devices for transcatheter aortic valve replacement (TAVI) with downsizing of crossing profiles, reduction in the rate of paravalvular leakage and conduction abnormalities as well as a lower short- and mid-term mortality and a higher patient acceptance. In the near future, TAVI may potentially develop as first-line treatment for the majority of patients with aortic valve disease. For patients with mitral and pulmonary stenosis, balloon valvuloplasty is effective and well established and should be preferred over valve replacement, last but not least also for economic reasons. For treatment of mitral regurgitation, several transcatheter devices aiming to restore or replace mitral valve function are currently under investigation. This review summarizes the current state of interventional treatment of valvular heart disease along with implications for the future.

Twenty year follow-up after successful percutaneous balloon mitral valvuloplasty in a large contemporary series of patients with mitral stenosis.

BACKGROUND: Percutaneous balloon mitral valvuloplasty (PMV) is currently considered the standard of care for suitable patients with rheumatic mitral stenosis. We sought to assess very long-term outcome after PMV. METHODS: Between 1991 and 2010, 482 consecutive patients underwent successful PMV in a single center. Procedural success was defined as post-procedural valve area ≥ 1.5 cm(2) and regurgitation moderate or less, without in-hospital major adverse cardiac and cerebro-vascular events. The primary endpoint was 20-year incidence of major adverse cardiac events (MACE), including cardiovascular death and need for mitral surgery or repeat PMV. RESULTS: Long-term follow-up (mean 11.6 ± 4.9 years; range 0.5 to 20) was completed in 441 (91.5%) patients. The incidence of the primary endpoint was 41.9% (95% confidence interval [CI]: 37.3 to 46.7%). The rate of cardiovascular death, need for mitral surgery or repeat PMV was 9.1% (95% CI: 6.6 to 12.1), 27% (95% CI: 22.9 to 31.4), and 5.9% (95% CI: 3.9 to 8.5), respectively. Cumulative MACE-free survival at 20 years was 35.9 ± 4.7%. At multivariate analysis, male gender (hazard ratio [HR]: 1.99; 95% CI: 1.4-2.8, p < 0.001), echocardiographic score > 8 (HR: 2.19; 95% CI: 1.6-2.9, p < 0.001), atrial fibrillation (HR: 1.54; 95% CI: 1.2-2.1, p = 0.003) and valve area ≤ 1.75 cm(2) after PMV (HR: 3.1; 95% CI: 2.3-4.2, p < 0.001) were identified as independent predictors of the primary endpoint. CONCLUSIONS: Up to 20 years after successful PMV, a sizeable proportion of patients still exhibit a good clinical result.

Balloon mitral valvuloplasty in the United States: a 13-year perspective.

BACKGROUND: Incidence and prevalence of mitral stenosis is declining in the US. We performed this study to determine recent trends in utilization, complications, mortality, length of stay, and cost associated with balloon mitral valvuloplasty. METHODS: Utilizing the nationwide inpatient sample database from 1998 to 2010, we identified patients using the International Classification of Diseases, 9th Revision, Clinical Modification procedure code for "percutaneous valvuloplasty." Patients ≥18 years of age with mitral stenosis were included. Patients with concomitant aortic, tricuspid, or pulmonic stenosis were excluded. Primary outcome included death and procedural complications. RESULTS: A total of 1308 balloon mitral valvuloplasties (weighted n = 6540) were analyzed. There was a 7.5% decrease in utilization of the procedure from 24.6 procedures/10 million population in 1998-2001 to 22.7 procedures/10 million population in 2008-2010 (P for trend = .098). We observed a 15.9% overall procedural complication rate and 1.7% mortality rate. The procedural complication rates have increased in recent years (P = .001), corresponding to increasing age and burden of comorbidities in patients. The mean cost per admission for balloon mitral valvuloplasty has gone up significantly over the 10 years, from $11,668 ± 1046 in 2001 to $23,651 ± 301 in 2010 (P <.001). CONCLUSIONS: In a large cross-sectional study of balloon mitral valvuloplasty in the US, we have reported trends of decreasing overall utilization and increasing procedural complication rates and cost over a period of 13 years.

Evolution of percutaneous balloon aortic valvuloplasty in the treatment of patients with aortic stenosis.

Symptomatic, severe aortic stenosis (AS) is associated with a dismal prognosis with conservative management only; the mortality rate is >50% at two years with medical treatment alone. In 1986, Cribier first introduced the percutaneous balloon aortic valvuloplasty (BAV) concept in patients with acquired severe AS. The initial enthusiasm surrounding this technique, touted as an alternative to surgical aortic valve replacement (SAVR) in older patients with AS, waned with subsequent large registries, which showed failure of the procedure to alter the natural history of calcific AS and its associated procedural morbidity. For many years BAV has been used as palliative treatment for short-term symptom relief in elderly, non-surgical patients. The timely surge in transcatheter aortic valve replacement (TAVR) rejuvenated and resurrected the dormant field of BAV. By its use to predilate the stenosed valve for easier delivery of the prosthesis, valvuloplasty now plays an integral role in the majority of TAVR procedures. BAV is successfully used as a bridge to SAVR and TAVR with better outcomes and is used as a standalone treatment for symptom relief in high-risk patients and for temporary stabilization of hemodynamically unstable patients. BAV can be used as a selection tool to determine if the patient will benefit from valve replacement if they have other comorbidities, such as severe pulmonary hypertension, severe lung disease, very poor ejection fraction, or frailty.

Current trends in mitral valve repair techniques in North America.

BACKGROUND AND AIM OF THE STUDY: The current trends in the surgical technique of mitral valve repair (MVR) among North American medical centers participating in the Sorin Valve Repair Registry are described. METHODS: A total of 2,314 MVR procedures was performed and documented between 2003 and 2009 at 89 North American medical centers. Surgical procedure characteristics on all mitral valve annuloplasty and valve reconstructions were collected by participating surgeons, and documented in the registry. RESULTS: Early in the reporting period (between 2003 and 2007), posterior leaflet resection comprised 60% of all MVR procedures, but the percentage declined systematically through the years 2008 (56.1%) and 2009 (50.4%). A decrease over time was also observed in the frequency of sliding valvuloplasty procedures (from -30% in 2003 to 4.0% in 2009). Proportions of chordal repair techniques tended to increase towards the end of the reporting period, from a low of 15% in 2003 to a peak of 32% in 2008. CONCLUSION: This report documents important trends in current MVR techniques among a representative cohort of surgical centers across North America. The data obtained were consistent with a practical shift from the conventional surgical MVR techniques to methods that allow a greater leaflet preservation--and thus less resection--over the latter half of the reporting period.