Balloon Aortic Valvuloplasty in the Era of TAVI
From our series of 323 patients, BAV was performed as a potential bridge to definitive therapy (SAVR or TAVR) in most patients (n = 239, 74%). Forty-nine patients (15.2%) were unstable with cardiogenic shock and/or refractory congestive heart failure, and BAV was performed before urgent noncardiac surgery in 37 patients (11.4%).
Baseline demographic, clinical, and hemodynamic characteristics of the population are displayed in Table I. The patients were at high risk with a mean age of 80.5 ± 9.9 years and a mean logistic EuroSCORE of 28.7% ± 12.5%. Most patients (64.1%) were older than 80 years. All patients were symptomatic, 264 (81.7%) of them presenting with New York Heart Association (NYHA) III/IV heart failure. Common comorbidities included chronic kidney disease (30.7%), chronic obstructive pulmonary disease (27.2%), and peripheral arterial disease (12.7%). History of prior cardiac surgery was noted in 16.1% of patients.
After BAV, the mean aortic gradient decreased significantly from 44.0 ± 18.9 to 20.7 ± 11.0 mm Hg (P < .001), and the aortic valve area increased from 0.68 ± 0.25 to 1.12 ± 0.39 cm (P < .001). Procedural success was achieved in 261 patients (80.8%).
Balloon aortic valvuloplasty complications are summarized in Table II. Major complications occurred in 22 patients (6.8%). Intrahospital death occurred in 8 patients (2.5%). Death was related to severe aortic regurgitation (n = 4, 1.2%), aortic annulus rupture (n = 1, 0.31%), retroperitoneal hematoma (n = 1, 0.31%), electromechanical dissociation (n = 1, 0.31%), and tamponade related to right ventricle perforation by pacing lead (n = 1, 0.31%).
Vascular access site or access-related complications occurred in 8 patients (2.5%). Vascular complications were classified as major in 5 patients (1.5%): access-related vascular injury in 4 cases: retroperitoneal hematoma leading to death (1 case), balloon rupture requiring unplanned surgical extraction (2 cases), pseudoaneurysm leading to unplanned surgical intervention (1 case), and distal embolization requiring surgery in 1 case. Other vascular complications were classified as minor in 3 patients (1.0%): distal embolization successfully treated by embolectomy (2 cases) and failure of percutaneous access site closure resulting in successful surgical correction (1 case).
Stroke or transient ischemic attack occurred in 6 patients (1.8%). Two patients (0.6%) required permanent pacemaker for complete atrioventricular block. Finally, there was 1 additional case of severe acute aortic regurgitation successfully treated by unplanned TAVR.
Patients were discharged after a mean hospital stay of 5.6 ± 5.1 days. After discharge, follow-up was obtained in 98% of patients with a mean duration of 20.7 ± 20.0 months. Within this period, 85 patients (26.3%) were finally bridged to definitive therapy (SAVR [n = 31, 9.6%] or TAVR [n = 54, 16.7%]) after a mean delay of 7.3 ± 9.8 and 5.9 ± 6.1 months, respectively, and 238 patients (65%) unsuitable for definitive therapy remained on medical therapy alone. Interestingly, 29 patients underwent TAVR without prior BAV in our institution during the same period. Twenty-eight patients (8.7%) had repeat BAV in the medical therapy group. Baseline characteristics of patients according to final treatment after BAV are presented in Table III. Overall, SAVR patients were younger and less symptomatic and had less chronic obstructive pulmonary disease, less previous cardiac surgery, lower logistic EuroSCORE, and systolic pulmonary arterial pressure (Table III).
Long-term follow-up was evaluated using Kaplan-Meier analysis, and survival curves according to treatment after BAV are shown in Figure 1. Patients bridged to SAVR had the most favorable outcomes. Patient bridged to TAVR had better outcomes compared with those treated by single BAV. Finally, our study confirmed that survival was poor in patients treated by a single BAV. We also compared long-term follow-up in TAVR patients with (n = 54) or without (n = 29) prior BAV during this period (Figure 2). Long-term survival was not significantly different in patients with or without BAV before TAVR (23.2% vs 33.4%, P = .26).
(Enlarge Image)
Figure 1.
Kaplan-Meier estimated survival at 5 years after BAV.
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Figure 2.
Kaplan-Meier estimated survival at 5 years in TAVR patients with or without prior BAV.
Univariate analysis was performed to assess associations between preprocedural and postprocedural risk factors and long-term mortality. The results of risk factors that were statistically significant are displayed in Table IV and included in the multivariable analysis (Table V). Interestingly, a successful procedure was not a predictor of long-term mortality (hazard ratio [HR] 1.31 95% CI 0.85–2.01, P = .222).
Logistic EuroSCORE (HR 1.02, P < .001), stroke, and severe aortic regurgitation after BAV (HR 3.1, P = .014, HR 5.2, P = .001, respectively) and medical therapy post-BAV (HR 2.6, P < .001) were independent predictors of long-term mortality.
Results
From our series of 323 patients, BAV was performed as a potential bridge to definitive therapy (SAVR or TAVR) in most patients (n = 239, 74%). Forty-nine patients (15.2%) were unstable with cardiogenic shock and/or refractory congestive heart failure, and BAV was performed before urgent noncardiac surgery in 37 patients (11.4%).
Baseline Characteristics
Baseline demographic, clinical, and hemodynamic characteristics of the population are displayed in Table I. The patients were at high risk with a mean age of 80.5 ± 9.9 years and a mean logistic EuroSCORE of 28.7% ± 12.5%. Most patients (64.1%) were older than 80 years. All patients were symptomatic, 264 (81.7%) of them presenting with New York Heart Association (NYHA) III/IV heart failure. Common comorbidities included chronic kidney disease (30.7%), chronic obstructive pulmonary disease (27.2%), and peripheral arterial disease (12.7%). History of prior cardiac surgery was noted in 16.1% of patients.
Hemodynamic Results
After BAV, the mean aortic gradient decreased significantly from 44.0 ± 18.9 to 20.7 ± 11.0 mm Hg (P < .001), and the aortic valve area increased from 0.68 ± 0.25 to 1.12 ± 0.39 cm (P < .001). Procedural success was achieved in 261 patients (80.8%).
BAV Complications
Balloon aortic valvuloplasty complications are summarized in Table II. Major complications occurred in 22 patients (6.8%). Intrahospital death occurred in 8 patients (2.5%). Death was related to severe aortic regurgitation (n = 4, 1.2%), aortic annulus rupture (n = 1, 0.31%), retroperitoneal hematoma (n = 1, 0.31%), electromechanical dissociation (n = 1, 0.31%), and tamponade related to right ventricle perforation by pacing lead (n = 1, 0.31%).
Vascular access site or access-related complications occurred in 8 patients (2.5%). Vascular complications were classified as major in 5 patients (1.5%): access-related vascular injury in 4 cases: retroperitoneal hematoma leading to death (1 case), balloon rupture requiring unplanned surgical extraction (2 cases), pseudoaneurysm leading to unplanned surgical intervention (1 case), and distal embolization requiring surgery in 1 case. Other vascular complications were classified as minor in 3 patients (1.0%): distal embolization successfully treated by embolectomy (2 cases) and failure of percutaneous access site closure resulting in successful surgical correction (1 case).
Stroke or transient ischemic attack occurred in 6 patients (1.8%). Two patients (0.6%) required permanent pacemaker for complete atrioventricular block. Finally, there was 1 additional case of severe acute aortic regurgitation successfully treated by unplanned TAVR.
Follow-up
Patients were discharged after a mean hospital stay of 5.6 ± 5.1 days. After discharge, follow-up was obtained in 98% of patients with a mean duration of 20.7 ± 20.0 months. Within this period, 85 patients (26.3%) were finally bridged to definitive therapy (SAVR [n = 31, 9.6%] or TAVR [n = 54, 16.7%]) after a mean delay of 7.3 ± 9.8 and 5.9 ± 6.1 months, respectively, and 238 patients (65%) unsuitable for definitive therapy remained on medical therapy alone. Interestingly, 29 patients underwent TAVR without prior BAV in our institution during the same period. Twenty-eight patients (8.7%) had repeat BAV in the medical therapy group. Baseline characteristics of patients according to final treatment after BAV are presented in Table III. Overall, SAVR patients were younger and less symptomatic and had less chronic obstructive pulmonary disease, less previous cardiac surgery, lower logistic EuroSCORE, and systolic pulmonary arterial pressure (Table III).
Long-term follow-up was evaluated using Kaplan-Meier analysis, and survival curves according to treatment after BAV are shown in Figure 1. Patients bridged to SAVR had the most favorable outcomes. Patient bridged to TAVR had better outcomes compared with those treated by single BAV. Finally, our study confirmed that survival was poor in patients treated by a single BAV. We also compared long-term follow-up in TAVR patients with (n = 54) or without (n = 29) prior BAV during this period (Figure 2). Long-term survival was not significantly different in patients with or without BAV before TAVR (23.2% vs 33.4%, P = .26).
(Enlarge Image)
Figure 1.
Kaplan-Meier estimated survival at 5 years after BAV.
(Enlarge Image)
Figure 2.
Kaplan-Meier estimated survival at 5 years in TAVR patients with or without prior BAV.
Predictors of Long-term Mortality
Univariate analysis was performed to assess associations between preprocedural and postprocedural risk factors and long-term mortality. The results of risk factors that were statistically significant are displayed in Table IV and included in the multivariable analysis (Table V). Interestingly, a successful procedure was not a predictor of long-term mortality (hazard ratio [HR] 1.31 95% CI 0.85–2.01, P = .222).
Logistic EuroSCORE (HR 1.02, P < .001), stroke, and severe aortic regurgitation after BAV (HR 3.1, P = .014, HR 5.2, P = .001, respectively) and medical therapy post-BAV (HR 2.6, P < .001) were independent predictors of long-term mortality.