Number Of Balloon Inflations Research Articles

The safety and feasibility of retrograde balloon aortic valvuloplasty using the INOUE-BALLOON with severe aortic stenosis.

In the transcatheter aortic valve implantation (TAVI) era, the indications for balloon aortic valvuloplasty (BAV) are increasing. Previously, the INOUE-BALLOON® (IB) was used only for antegrade BAV, but recently, it has also been used for retrograde BAV. However, the safety and feasibility of retrograde BAV using an IB are not fully understood. In this study, we investigated the safety and feasibility of retrograde BAV using an IB in elderly Japanese patients with severe aortic stenosis (AS). We compared 39 cases of retrograde BAV using an IB performed from June 2018 to September 2020 and 34 cases of antegrade BAV using an IB performed from August 2013 to May 2018. The total number of complications was lower in retrograde BAV than in antegrade BAV (p = 0.020). The procedure time was significantly shorter in retrograde BAV than in antegrade BAV (p < 0.001), and the maximum balloon size and number of balloon inflations were smaller in retrograde BAV than in antegrade BAV (p = 0.002 and p < 0.001, respectively). There was no significant difference in the degree of improvement in the aortic valve area or ejection fraction between retrograde and antegrade BAV. In conclusion, the present study showed the safety and feasibility of retrograde BAV using an IB in elderly Japanese patients with severe AS compared with antegrade BAV using an IB.

Maintaining Zone 1 Occlusion is a Dynamic Process: The Effects of Proximal Pressure and Blood Transfusion During REBOA.

Resuscitative endovascular balloon occlusion of the aorta (REBOA) provides hemodynamic support to patients with non-compressible truncal hemorrhage. As cardiac output increases due to aortic occlusion (AO), aortic diameter will increase as a function of compliance, potentially causing unintended flow around the balloon. Swine (N = 10) were instrumented to collect proximal mean arterial blood pressure (pMAP), distal MAP (dMAP), balloon pressure (bP), balloon volume (bV), and distal aortic flow (Qaorta). A 7-Fr automated REBOA catheter was positioned in Zone 1. At T0, animals underwent 30% total blood volume hemorrhage over 30min followed by balloon inflation to complete AO. Automated balloon inflation occurred from T30-T60 when Qaorta was detected. Period of interest was T55-T60, while the balloon actively worked to maintain AO during transfusion of shed blood. Median weight of the cohort was 73.75 [IQR:71.58-74.45] kg. During T40-T55 and T55-T60, median pMAP was 88.95 [IQR:76.80-109.92] and 108.13 [IQR:99.13-119.51] mmHg, P = 0.07. Median Qaorta during T40-T55, and T55-T60 was 0.81 [IQR:0.41-0.96], and 1.53 [IQR:1.07-1.96] mL/kg/min, P = 0.06. Median number of balloon inflations during T40-T55 was 0.00 [IQR:0.00-0.75] and increased during active transfusion to 10.00 [IQR:5.25-14.00], P = 0.001. In clinical practice, following initial establishment of AO, progressive balloon inflations are required to maintain AO in response to intrinsic and transfusion-mediated increases in cardiac output, blood pressure, and aortic diameter.

Percutaneous Balloon Aortic Valvuloplasty and Clinical Outcomes in Severe Aortic Stenosis: Correlation of Procedural Technique and Efficacy.

Percutaneous balloon aortic valvuloplasty (PBAV) is a palliative therapeutic option for relief of severe aortic stenosis (AS) in patients that are poor surgical or transcatheter aortic valve replacement (TAVR) candidates or as a bridge to definitive therapy. The outcomes following PBAV are highly variable and studies identifying factors that correlate with outcomes are sparse. The purpose of this study was to identify predictors at the time of the index procedures that can predict 1-year survival or need for repeat PBAV. Demographic and procedural information of 505 PBAVs performed on 388 patients from January 1999 to December 2012 at the Deborah Heart and Lung Center were reviewed. Procedural data were compared across many variables and outcomes to identify predictors of outcomes. These predictors were statistically compared using chi-squared tests or Student's t-test. Of the 388 patients analyzed, 145 (37.4%) expired within 1 year following the index procedure. The cohort was then stratified into 3 groups based on the number of balloon inflations. They were similar with regard to baseline characteristics. The mean age was 81.9 ± 9 years. Males constituted 51% of the cohort. Patients who underwent 2 and 3+ inflations had a 47.6% and 93.0% increase in the postprocedural aortic valve area compared to patients who had only 1 inflation. Patients who underwent 3+ inflations were significantly less likely to require a repeat PABV within a year and the repeat procedure free survival rate of 94.5% (P = 0.009). Despite improvement in valve area, there was no statistically significant difference in 1 year mortality between the groups (28.8% vs 42.9% vs 46.1% for 1 vs 2 vs 3+ inflations, respectively). PBAV provides a modest improvement in valve function and continues to be a safe and feasible option in experienced hands for select patients that are high risk for surgery or TAVR. The use of additional inflations during PBAV resulted in better long-term outcomes.

Predictors of paravalvular aortic regurgitation following self-expanding Medtronic CoreValve implantation: The role of annulus size, degree of calcification, and balloon size during pre-implantation valvuloplasty and implant depth

ObjectivesWe sought to investigate the role of balloon size during pre-implantation valvuloplasty in predicting AR and optimal Medtronic CoreValve (MCS) implantation depth. BackgroundParavalvular aortic regurgitation (AR) is common following MCS implantation. A number of anatomical and procedural variables have been proposed as determinants of AR including degree of valve calcification, valve undersizing and implantation depth. MethodsWe conducted a multicenter retrospective analysis of 282 patients who had undergone MCS implantation with prior cardiac CT annular sizing between 2007 and 2011. Native valve minimum (Dmin), maximum (Dmax) and arithmetic mean (Dmean) annulus diameters as well as agatston calcium score were recorded. Nominal and achieved balloon size was also recorded. AR was assessed using contrast angiography at the end of each procedure. Implant depth was measured as the mean distance from the nadir of the non- and left coronary sinuses to the distal valve frame angiographically. Results29mm and 26mm MCS were implanted in 60% and 39% of patients respectively. The majority of patients (N=165) developed AR <2 following MCS implantation. AR ≥3 was observed in 16% of the study population. High agatston calcium score and Dmean were found to be independent predictors of AR ≥3 in multivariate analysis (P<0.0001). Nominal balloon diameter and the number of balloon inflations did not influence AR. However a small achieved balloon diameter-to-Dmean ratio (≤0.85) showed modest correlation with AR ≥3 (P=0.04). This observation was made irrespective of the degree of valve calcification. A small MCS size-to-Dmean ratio is also associated with AR ≥3 (P=0.001). A mean implantation depth of ≥8+2mm was also associated with AR ≥3. Implantation depth of ≥12mm was associated with small MCS diameter-to-Dmean ratio and increased 30-day mortality. ConclusionCT measured aortic annulus diameter and agatston calcium score remain important predictors of significant AR. Other procedural predictors include valve undersizing and low implantation depth. A small achieved balloon diameter-to-Dmean ratio might also predict AR ≥3. Our findings confirm that a small achieved balloon size during pre-implantation valvuloplasty predicts moderate–severe AR in addition to previously documented factors.

The index of microvascular resistance identifies patients with periprocedural myocardial infarction in elective percutaneous coronary intervention

BackgroundThis study was designed to assess whether measurement of the index of microvascular resistance (IMR) could help prospectively identify patients who develop periprocedural myocardial infarction (PPMI).Methods and resultsIMR was measured...

Abstract P162: Percutaneous Balloon Aortic Valvuloplasty: A Single-Center Experience of 357 Patients Over 10 Years

Background: Percutaneous balloon aortic valvuloplasty (PBAV) is primarily used as a palliative therapeutic option for relief of severe aortic stenosis (AS) in patients who are poor candidates for definitive surgical therapy. The rationale for limited use of PBAV in severe AS is due to poor durability and high rates of recurrence in early studies. This study describes the largest published single-center experience of PBAV with current day outcomes. Methods: We reviewed the last ten years of all patients that underwent PBAV at Deborah Heart and Lung Center totaling 357 patients. Extensive pre- and post-procedural data were tabulated on the last 100 patients, from October 2006 to January 2010, as a preliminary screening to determine current day outcomes with PBAV. Number of balloon inflations, mean gradients pre- and post-procedure, change in mean gradients, duration until repeat PBAV or surgical valve replacement, and mortality were all recorded and evaluated for correlation with outcomes. Results: Of the last 100 patients, there were no hospital or procedure-related deaths, strokes, or emergent cardiac surgery. Mean gradients (MG) across the aortic valve improved from 38.5 mmHg to 19.2 mmHg with an average change in mean gradient (ΔMG) of 19.1 mmHg. The number of inflations peformed during PBAV correlated to increase in ΔMG (1 inflation = 17.4 mmHg ΔMG; &gt;2 inflations = 20.0 mmHg ΔMG; &gt;3 inflations = 20.9 mmHg ΔMG). The number of inflations also correlated to an increased duration until repeat PBAV (1 inflation = 7.9 months; &gt;2 inflations = 10.4 months; &gt;3 inflations = 11.3 months). The average ΔMG among those that required repeat PBAV was 20.9 mmHg. The ΔMG was further linked to duration until repeat PBAV such that when ΔMG &lt; 20 mmHg, duration to PBAV = 8.7 months and when ΔMG &gt; 20 mmHg, duration to PBAV = 10.8 months. The mortality rate after PBAV was 10% with an average ΔMG within this subset of 21.5 mmHg. Conclusions: PBAV, although transient, provides a relatively modest improvement in valve function and continues to be safe and feasible in experienced hands for patient subsets that are high risk for surgery. Additional inflations during PBAV and ΔMG &gt; 20 mmHg result in better long-term outcomes and need to be further evaluated in larger prospective studies.

Use of Balloon Aortic Valvuloplasty to Size the Aortic Annulus Before Implantation of a Balloon-Expandable Transcatheter Heart Valve

Our aim was to describe the use of balloon aortic valvuloplasty (BAV) to select proper transcatheter heart valve (THV) size. Transesophageal echocardiogram (TEE) measurement alone of the aortic annulus may not be adequate to select a THV size. BAV can more accurately size the aortic annulus. We report our experience using this strategy in patients undergoing THV implantation. Twenty-seven patients underwent sizing of the aortic annulus by BAV and TEE. We implanted the minimal THV size that was greater than the annulus measured by BAV. The annulus measured by TEE was 21.3 +/- 1.6 mm and by BAV was 22.6 +/- 1.8 mm (p < 0.001). The number of balloon inflations was 2.7 +/- 0.7 (range 2 to 4), and the balloon sizes used were 22.0 +/- 1.8 mm (range 20 to 25 mm). Fourteen patients (52%) required upsizing of the initial balloon suggested by TEE; rapid pacing duration was 8 +/- 1.3 s (range 6 to 11 s). No change in aortic insufficiency or hemodynamic instability occurred with BAV. Fifteen patients (56%) received a 23-mm THV; 12 patients a 26-mm THV. No coronary occlusion, annular damage, or THV embolization occurred. Paravalvular leak was grade <or=1 in all patients. In 7 patients (26%), balloon sizing resulted in selection of a specific THV size that could not be done by TEE alone. BAV sizing of the aortic annulus is safe and is an important adjunct to TEE when selecting THV size. Implanting the minimal THV greater than the BAV annulus size resulted in no adverse events. These data suggest that use of BAV for THV selection may improve the safety and efficacy of THV implantation.

Women react with more myocardial ischemia and angina pectoris during elective percutaneous transluminal coronary angioplasty.

Women have been considered to be at higher risk of complications relating to percutaneous transluminal coronary angioplasty (PTCA) than are men. One reason for this sex-related difference could be the ischemic response of myocardium during the procedure. To investigate whether there are sex-related differences in ischemic response of myocardium during elective PTCA. Consecutive patients (n = 192, of whom 48 were women), were subjected to vectorcardiography during the PTCA procedure. Vectorcardiographic variables, magnitude of ST-segment vector (ST-VM), and magnitude of ST-segment vector change (STC-VM) were studied. Women were older (63 +/- 10 versus 56 +/- 10 years, P< 0.001) than men in our study and more often had diabetes mellitus and hypertension. Women less often had stents implanted (24 versus 50%, P < 0.01) and they were subjected to fewer balloon inflations (P < 0.001), with a total inflation time shorter than that for men (P< 0.001). Maximum STC-VM was 25% greater for women (P < 0.05). Women reported greater maximum pain (P < 0.05) and nitroglycerine was more frequently used for them during PTCA (P < 0.05). Occurrence of episodes of residual ischemic STC-VM (the difference between total number of episodes and number of balloon inflations) was more common for women (3 +/- 5 versus 1 +/- 3, P< 0.01). Duration of residual ischemic STC-VM episodes (the difference between total duration of episodes and duration of balloon inflations) was longer for women than it was for men (242 +/- 275 versus 148 +/- 233 s, P < 0.05). In a stepwise multivariate analysis and for a matched case-control group, episodes of residual STC-VM and duration of residual STC-VM episodes still indicated that there was an independent sex-related difference (P < 0.01 and P < 0.01, respectively). Women more commonly develop vectorcardiographic signs of severe myocardial ischemia, more frequently experience episodes of ischemia and report more severe angina pectoris during elective PTCA than do men.

Plasma thrombomodulin levels in coronary sinus blood in patients with coronary artery disease

Plasma thrombomodulin (TM) levels in coronary sinus blood were measured in 15 patients with coronary artery disease who underwent elective PTCA (group A). TM was also measured in eight patients with coronary artery disease (group B) and six patients without coronary artery disease (group C), who only underwent diagnostic coronary angiography. The baseline level was 21.6 +/- 3.4 U/ml in group A, and 21.0 +/- 4.9 in group B, and both levels were slightly higher (P < 0.05) than those in group C (15.1 +/- 3.3). In group A, the level increased to 27.5 +/- 8.3 (P < 0.01) immediately after PTCA and then returned to 22.2 +/- 5.1 by 24 h. In groups B and C, levels showed no change immediately after angiography. In group A, the percentage increase in the TM level immediately after PTCA from that before the procedure correlated with the number of balloon inflations (r = 0.76, P < 0.01). In conclusion, the plasma TM level in coronary sinus blood might indicate endothelial damage due to atherosclerotic coronary artery disease and an increase in the level after PTCA might directly indicate vascular injury by balloon inflation.

Beta-endorphins during coronary angioplasty in patients with silent or symptomatic myocardial ischemia

Objectives. The aims of this study were to correlate betaendorphin plasma levels and anginal pin in patients with ischemia induced by percutaneous transluminal coronary angioplasty and to detect eventual endorphin variations during balloon occlusion.Background. The opioid system appears involved in the absence of pain occurring in silent myocardial ischemia.Methods. Beta-endorphin plasma levels were measured 24 h before, just before, during and after coronary angioplasty (performed on the left anterior descending artery) in 53 men with documented coronary artery disease and exercise-induced myocardial ischemia.Results. Group 1 (33 patients) reported symptoms; group 2 (20 patients) was asymptomatic during angioplasty. In these patients, the prevalence of exercise-induced silent ischemia was 57%. The occurrence of angina during exercise or angioplasty was related to the frequency of angina during daily life when patients were subgrouped. The severity and distribution of coronary artery disease did not differ between the two groups. During angioplasty, the number of balloon inflations and the Inflation time and pressure were similar in symptomatic and asymptomatic patients. In each group, no short-term variability of baseline betaendorphin plasma levels was observed during 2 consecutive days. Corresponding beta-endorphin plasma levels (at baseline and during and after angioplasty) were significantly in Group 2. During balloon occlusion, the levels decreased significantly in the symptomatic group at the onset of angina but remained stable in the asymptomatic group.Conclusions. Methodologic variables and the severity of coronary artery disease did not influence the presence of symptoms during angioplasty-induced ischemia. Beta-endorphin plasma levels were higher and more stable in patients with silent ischemia during angioplasty, suggesting that opiate levels and their variation during ischemia are associated with individual attitude toward anginal pain.

Predictors of long-term survival after percutaneous aortic valvuloplasty: Report of the mansfield scientific balloon aortic valvuloplasty registry

Percutaneous balloon aortic valvuloplasty was used to prospectively treat 492 elderly, symptomatic, nonsurgical patients suffering from severe aortic stenosis in 27 centers in North America and Europe. At 1 year the overall survival rate was 64% and the event-free survival rate (survival free of valve replacement or repeat valvuloplasty) was 43%. Clinical, catheterization and procedural variables were assessed to define prognostic variables.Univariate analysis revealed that patients who survived had a lesser frequency of previous myocardial infarction (2% versus 6%, p < 0.005), lower incidence of severe ventricular dysfunction (22% versus 48%, p < 0.001) and lower incidence of symptoms of heart failure (60% versus 75%, p < 0.02). History of angina (56% versus 45%, p = NS) and syncope (23% versus 16%, p = NS) were similar for both groups. Values obtained at cardiac catheterization that differed in survivors and nonsurvivors included lower pulmonary artery systolic pressure (43 ± 1 versus 54 ± 2 mm Hg, p < 0.001), lower mean pulmonary artery pressure (28 ± 1.0 versus 36 ± 1.0 mm Hg, p < 0.001) and larger initial valve area (0.52 ± 0.01 versus 0.47 ± 0.02 cm2, p = 0.006).Discriminate function analysis was performed to identify variables that independently predicted improved probability of survival. Eight variables were significantly and independently predictive. These included age, initial cardiac output, initial left ventricular systolic pressures, initial left ventricular end-diastolic pressures, presence of coronary artery disease, New York Heart Association dyspnea classification, number of balloon inflations and final valve area. From this analysis, patient survival probabilities at 1 year varying between 80% and 20% could be calculated. Although both initial and final severity of aortic stenosis were prognostically important on univariate analysis, discriminant function analysis revealed that only final severity of aortic stenosis was prognostic.These observations suggest that subgroups of patients with lower or higher mortality rates can be identified after balloon aortic valvuloplasty. The presence of left ventricular dysfunction, the presence of coronary artery disease and the use of multiple balloon inflations adversely affect long-term prognosis. Conversely, effective valvuloplasty provides modest improvement in survival probability.

Factors predictive of early angiographic and functional success following percutaneous transluminal coronary angioplasty.

Baseline variables in 300 coronary angioplasty procedures were analysed to identify factors predictive of a successful outcome. Separate multivariate analyses distinguished between predictors of primary angiographic success and functional success as determined by the results of predischarge treadmill stress electrocardiography. Three independent predictors of primary angiographic success were identified: number of balloon inflations per procedure, initial stenosis, and operator experience. Of these, the number of balloon inflations per procedure and operator experience were also predictive of functional success, reflecting the dependence of a good functional result on a successful procedure. Other independent predictors of functional success were the severity of the residual stenosis and single vessel coronary artery disease suggesting that adequacy of revascularization is an important determinant of the functional result. These data illustrate the interaction between clinical, angiographic and functional variables in determining the success of PTCA. A good angiographic result may not translate into a good functional result if revascularization is incomplete.