Balloon Aortic Valvuloplasty Procedure Research Articles

Performance of the Mammoth Balloon Catheter in Patients with Severe Aortic Valve Stenosis Undergoing Percutaneous Treatment.

Background: Balloon aortic valvuloplasty (BAV) is currently used as pre-treatment for patients undergoing trans-catheter aortic valve replacement (TAVR) as well as a stand-alone option for subjects with significant contraindications to TAVR. Mammoth is a newly available non-compliant balloon catheter (BC) included in the balloon-expandable Myval THV system (Meril Life Sciences Pvt. Ltd., India). As limited data on the performance of this BC are available, we here report the results following its use for BAV as pre-dilatation during TAVR or as a stand-alone procedure. Methods: A retrospective, single-center cohort analysis was performed on patients with severe aortic valve stenosis (AS) treated with the Mammoth BC at IRCCS Ospedale Galeazzi Sant'Ambrogio, Milan, Italy. The primary endpoint was technical success defined as successful Mammoth BC advancement across the AS followed by its full and homogeneous inflation without major complications such as aortic root/left ventricular outflow tract injury and/or stroke. Results: A total of 121 patients were treated by BAV with Mammoth BC during the study period. Among these, 105 patients underwent BAV pre-dilatation before TAVR while 16 patients underwent a stand-alone BAV procedure. Mammoth BC was delivered and successfully inflated at the target site in all of the 121 cases without BC-related complications (100% technical success). However, in the BAV "stand-alone group", three patients required two different balloon sizes while in nine patients multiple rounds (two to three) of balloon inflation were needed to significantly lower the transvalvular gradient. No cases of aortic root injury or massive aortic regurgitation due to Mammoth BC-related aortic leaflet injury were reported while one major stroke occurred late after TAVR. No intra-procedural deaths occurred nor bleeding (BARC 3-4) or major vascular complication. Conclusions: Mammoth BC use in patients with severe AS proved safe and effective, either before TAVR or as a stand-alone procedure, expanding the range of available tools for structural operators.

Long-term results of percutaneous balloon aortic valvuloplasty in children with aortic stenosis: a single-center experience.

Percutaneous balloon aortic valvuloplasty (BAV) is an effective method of treatment for aortic stenosis in children. This study aimed to assess the long‑term results of BAV in various age groups in the pediatric population. This retrospective study included 68 patients (newborns, infants, and children older than 1 year). We analyzed their demographic data and measurements performed with the use of cardiac catheterization, angiography, and echocardiography at 3 time points: before, directly after, and at late follow‑up after BAV, including the invasive aortic valve peak‑to‑peak systolic pressure gradient (PGpeak), maximum systolic pressure gradient (PGmax) by Doppler echocardiography, and the severity of aortic regurgitation (AR). Long‑‑term follow‑up data were available for 57 patients. The BAV procedure led to a significant reduction in the PGpeak values. Late follow‑up revealed a progression of AR. Aortic regurgitation of grade 2 or higher directly after BAV was the strongest risk factor for severe AR at late follow‑up. After 5, 10, and 18 years after BAV, surgical treatment was not required in 90%, 77%, and 59.5% of patients, respectively. Severe AR and a residual PG less than 35 mm Hg at late follow‑up were stronger risk factors for aortic valve surgery than moderate AR and PG higher than or equal to 35 mm Hg. Balloon aortic valvuloplasty is an effective method of treatment for aortic stenosis in children, which delays the need for surgery. The progression of AR occurs at late follow‑up. A greater reduction in PGmax is a risk factor for at least moderate AR directly after BAV, which results in the progression of AR at late follow‑up.

PCV61 - Inpatient Admission Length Of Stay And Costs Among Vascular Procedure Patients Receiving Perclose Proglide Suture-Mediated Closure Compared To Patients Receiving Surgical Cutdown For Closure Of Large Bore Arterial Access

To compare length of stay (LOS) and costs among patients undergoing procedures requiring closure of large bore arterial access using the Perclose ProGlide® Suture-Mediated Closure System (ProGlide) versus manual surgical cutdown (Cutdown) in a real-world setting. This retrospective study analyzed patients undergoing procedures that require arterial closure (Transcatheter Aortic Valve Replacement/Repair (TAVR), Endovascular Abdominal Aortic Aneurysm Repair (AAA), Thoracic Endovascular Aortic Repair (TAA), or Balloon Aortic Valvuloplasty (BAV)) from 2013 -2017 in the IBM Explorys Research Database. Patients receiving ProGlide during the procedure were directly matched and compared to patients treated by the same providers that were closed via manual surgical cutdown. The LOS for the procedure admission and procedure complications were assessed. Costs per day of admission were estimated using claims data from TAVR, AAA, TAA, or BAV procedure admissions in the Truven Health MarketScan Research Database. A generalized linear model was used to quantify the cost associated with differences in LOS. A total of 839 ProGlide patients and 839 matched Cutdown patients met the inclusion criteria. Proglide patients experienced lower rates of complications, including infection. Average LOS for ProGlide patients was nearly four days shorter than Cutdown patients (mean: 9.0 vs. 5.1 days; median: 7.0 vs. 3.0; p<0.001). While controlling for index procedure, age, and gender, LOS was a significant predictor of costs, with each day associated with a 4% increase in total cost for the hospitalization (p<0.05). Using the difference in median LOS, predicted total costs for the procedure admission were $20,599 lower among ProGlide patients compared to Cutdown. The use of Perclose ProGlide was associated with significantly shorter length of stay for the procedure admission compared to surgical Cutdown. Future analyses should focus on directly quantifying the cost-savings and patient benefit from lower complication rates and shortened LOS.

Percutaneous balloon aortic valvuloplasty in the era of transcatheter aortic valve implantation: a narrative review

The role of percutaneous balloon aortic valvuloplasty (BAV) in the management of severe symptomatic aortic stenosis has come under the spotlight following the development of the transcatheter aortic valve implantation...

Contemporary use of balloon aortic valvuloplasty in the era of transcatheter aortic valve implantation.

The development of transcatheter aortic valve implantation (TAVI) has increased the use of balloon aortic valvuloplasty (BAV) in treating aortic stenosis. We evaluated our use of BAV in an academic tertiary referral center with a developing TAVI program. We reviewed 69 consecutive stand-alone BAV procedures that were performed in 62 patients (mean age, 77 ± 10 yr; 62% men; baseline mean New York Heart Association functional class, 3 ± 1) from January 2009 through December 2012. Enrollment for the CoreValve(®) clinical trial began in January 2011. We divided the study cohort into 2 distinct periods, defined as pre-TAVI (2009-2010) and TAVI (2011-2012). We reviewed clinical, hemodynamic, and follow-up data, calculating each BAV procedure as a separate case. Stand-alone BAV use increased 145% from the pre-TAVI period to the TAVI period. The mean aortic gradient reduction was 13 ± 10 mmHg. Patients were successfully bridged as intended to cardiac or noncardiac surgery in 100% of instances and to TAVI in 60%. Five patients stabilized with BAV subsequently underwent surgical aortic valve replacement with no operative deaths. The overall in-hospital mortality rate (17.4%) was highest in emergent patients (61%). The implementation of a TAVI program was associated with a significant change in BAV volumes and indications. Balloon aortic valvuloplasty can successfully bridge patients to surgery or TAVI, although least successfully in patients nearer death. As TAVI expands to more centers and higher-risk patient groups, BAV might become integral to collaborative treatment decisions by surgeons and interventional cardiologists.

Balloon aortic valvuloplasty (BAV) as a bridge to aortic valve replacement in cancer patients who require urgent non-cardiac surgery.

BackgroundBalloon aortic valvuloplasty (BAV) is a percutaneous treatment option for severe, symptomatic aortic stenosis. Due to early restenosis and failure to improve long term survival, BAV is considered a palliative measure in patients who are not suitable for open heart surgery due to increased perioperative risk. BAV can be used also as a bridge to surgical or transcatheter aortic valve implantation (TAVI) in haemodinamically unstable patients or in patients who require urgent major non-cardiac surgery.Patients and methods.We reported on 6 oncologic patients with severe aortic stenosis that required a major abdominal and gynaecological surgery. In 5 cases we performed BAV procedure alone; in one patient with concomitant coronary artery disease we combined BAV and percutaneous coronary intervention (PCI).ResultsWith angioplasty and BAV we achieved a good coronary artery flow and an increase in aortic valve area without any periprocedural complications. After the successful procedure, we observed a hemodynamic and symptomatic improvement. As a consequence the operative risk for non-cardiac surgery decreased and the surgical treatment of cancer was done without complications in all the 6 cases.ConclusionsBAV can be utilized as a part of a complex therapy in severe aortic stenosis aimed to improve the quality of life, decrease the surgical risk for major non-cardiac surgery or as a bridge to surgical or transcatheter aortic valve implantation.

Congenital aortic stenosis: A novel technique for ventricular pacing during valvuloplasty

The main objective of this study is to describe a new technique for rapid ventricular pacing to maintain balloon stability during balloon aortic valvuloplasty (BAV) without using transvenous temporary pacemaker electrode. The safety and efficacy of rapid right ventricular pacing to facilitate balloon stability during BAV has been previously reported. However, it necessitates an additional femoral venous access, an additional sheath, and a temporary pacemaker electrode. This was a prospective pilot study. Rapid ventricular pacing was performed through back-up guidewires inserted into the left ventricle for balloon advancement and by an adhesive patch placed on the back of the patient. The technique was performed during BAV procedure in all of 15 consecutive children diagnosed as congenital aortic stenosis. Pacing was performed at a rate decreasing systolic aortic pressure to the point of 40-50% of baseline. The technique was successful in all patients. Effective capture, stable pacing, and balloon stability were achieved in all children using very low outputs. No sustained arrhythmias or other procedure-related complications occurred. Mean aortic valve gradient decreased from 68.5 +/- 20.4 mm Hg to 20.4 +/- 10.2 mm Hg. Degree of aortic regurgitation progressed from grade 0 to 1 in three patients and remained unchanged in 12 patients. This study demonstrated that back-up guidewires can be used effectively and safely for pacing during BAV procedures. This technique omits probable complications related to a second vascular access and may shorten the procedure time and decreases costs by eliminating the use of an additional sheath and a temporary pacemaker electrode.

Results of repeat balloon valvuloplasty for treatment of aortic stenosis in patients aged 59 to 104 years

Balloon aortic valvuloplasty (BAV) may be considered a palliative procedure that is performed in patients who have severely symptomatic aortic stenosis and a prohibitive surgical risk. However, due to poor early survival rates, most previous studies have involved a single BAV procedure. We analyzed long-term outcomes in patients who had severe aortic stenosis and BAV that incorporated repeat procedures to maintain symptom relief and increase survival rate. We retrospectively analyzed 212 consecutive nonsurgical patients (59 to 104 years old) who had severe calcific aortic stenosis and underwent 282 cumulative BAV procedures. Demographic, procedural, and follow-up mortality data were collected. BAV was performed with single or incremental balloon dilatation to obtain a postprocedural transaortic gradient close to 1/3 of the baseline gradient. Peak transaortic gradient after BAV decreased from 55 +/- 22 to 20 +/- 11 mm Hg and aortic valve area increased from 0.6 +/- 0.2 to 1.2 +/- 0.3 cm(2). Mean follow-up duration was 32 +/- 18 months. During follow-up, 24% of patients underwent a second BAV and 9% of patients underwent a third BAV. Duration of symptom alleviation after the first, second, and third BAV procedures were 18 +/- 3, 15 +/- 4, and 10 +/- 3 months, respectively. Median survival rate after BAV was 35 months. Survival rates 1, 3, and 5 years after the procedure were 64%, 28%, and 14% respectively. Patients who underwent repeat BAV had higher 3-year survival rates than did patients who underwent 1 BAV (p = 0.01). Therefore, repeat BAV is a viable treatment strategy in nonsurgical patients who have severe calcific aortic stenosis, because it provides a median survival rate of approximately 3 years and maintains clinical improvement.

IS IT POSSIBLE TO PREDICT THE SEVERITY OF AORTIC REGURGITATION IN A POST‐VALVULOPLASTY PROCEDURE THROUGH KNOWLEDGE OF AORTIC ANATOMY BY ECHO?

Objectives: To determinate if it is possible to predict the severity of aortic regurgitation before balloon aortic valvuloplasty through knowledge of aortic anatomy by echo. Background: Twenty patients with severe aortic stenosis were evaluated by echocardiography (echo), before and after the balloon aortic valvuloplasty (BAV) procedure. Two clearly distinct types of bicuspid aorta were found: with vertical and horizontal closing. Those with the vertical closing had a significantly greater severity of aortic regurgitation than those with horizontal closings. Methodology: Before and after the BAV procedure there were recordings in 20 patients with severe aortic stenosis. At the time of the valvuloplasty procedure (BAV), the patients ranged in age from 3 days to 19 years (mean 3.3 years ± 5). Transthoracic parasternal long‐ and short‐axis views at the level of the aortic valve were used to determine cusp fusion site, and aortic regurgitation was graded using pulsed or colored Doppler or both. Criteria of regurgitation were: light (detectable jet adjacent to the valve or narrow jet of low amplitude detected near the aortic valve), moderate (easily detected, moderate amplitude jet associated with left ventricular dilatation), and severe (wide and easily detected high amplitude jet with marked left ventricular enlargement). We found two clearly distinct types of bicuspid aorta: those that had fusion of the right and noncoronary cusp (showed vertical closings in previous echo), and those with fusion of left and right coronary cusps (showed horizontal closings). Statistical Analysis: Statistical significance p &lt; 0.05. Results: Of twenty patients with severe aortic stenosis, with an average age of 4.5 ± 5 (range: 3–19 years) at the time of BAV was effective in 18, with a mean gradient of 87 ± 12 pre‐BAV / 30 ± 11 post‐BAV. Of the 20 patients with aortic BAV, 15 had horizontal closings in the previous echo, and 5 had vertical closings. Of the 15 with horizontal closings, 14 had light regurgitation. Only one patient had early moderate regurgitation and two more had moderate regurgitation later on, at 4.5 and 16 years. No patient, except the patient with early moderate regurgitation, had severe regurgitation; only in one patient BAV was not effective. While there were 5 patients with vertical closing, 4 with effective BAV had early moderate‐to‐severe regurgitation in immediate post‐procedure, 1/5 was no effective. Conclusion: A light post‐procedure insufficiency may be expected in a bicuspid aorta with horizontal closing post aortic valvuloplasty (14/15). We also expected an efficient procedure in the reduction of the aortic stenosis (14/15). A significative aortic regurgitation may be expected in a bicuspid aorta with vertical closing post BAV (4/4).

Repeat balloon aortic valvuloplasty.

This paper attempts to determine limitations and indications of performing a second balloon aortic valvuloplasty procedure (BAV2) because of restenosis, which is the major limitation of this technique. From September 1985 to December 1989, 357 patients underwent a primary BAV (BAV1) and 67 patients had a BAV2. Forty-two patients (group A) had repeat catheterization because they were markedly symptomatic 11 +/- 7 months after BAV1. Twenty-five patients (group B) came from a group of 73 patients who had been systematically scheduled for repeat catheterization in order to evaluate the hemodynamic restenosis rate 8 +/- 3 months after BAV. At time of BAV2 most of the patients of group A were severely disabled. Comparison of pre-BAV2 gradient and aortic valve area with pre-BAV1 measurements showed in a slightly less severe degree of aortic stenosis in group A and in group B with any difference in cardiac index and ejection fraction. Immediately following BAV2, the gradient decreased from 72 +/- 22 to 33 +/- 15 mm Hg (P less than 0.001) and aortic valve area increased from 0.56 +/- 0.18 to 0.85 +/- 0.28 cm2 (p less than 0.001) in group A. In group B, gradient decreased from 68 +/- 15 to 33 +/- 15 mm Hg (p less than 0.001) and aortic valve area increased from 0.70 +/- 0.16 to 0.90 +/- 0.25 cm2 (p less than 0.001).(ABSTRACT TRUNCATED AT 250 WORDS)

Balloon valvuloplasty for congenital aortic valve stenosis in an infant and children.

Percutaneous balloon aortic valvuloplasty (BAV) was performed in 14 patients, including one critically ill infant with congenital valvular aortic stenosis (AS). BAV was effective in 13 patients (except the infant). The peak systolic pressure gradient between the left ventricle (LV) and the ascending aorta decreased from 76.6 +/- 21.6 to 29.5 +/- 15.3 mmHg (P less than 0.001). Follow-up cardiac catheterization was performed for eight patients between 1 and 3 years (1.6 +/- 1.1 years) after BAV. Restenosis was found in only one patient, and the efficacy of BAV continued significantly. Aortic regurgitation developed or increased in severity in 5 of 13 children immediately after BAV. Any other severe complication was not observed. Dilatation by BAV was not sufficient for the infant with critical AS, and acute myocardial infarction (AMI) in the lateral wall of the LV occurred during the BAV procedure. The infant died 3 days after the procedure due to AMI. It was concluded that the retrograde double balloon technique was superior to the retrograde single balloon technique. In two cases, the single balloon technique was ineffective because it was impossible to fix the balloon at the aortic annulus. However, the double balloon technique was effective in every patient. BAV is effective for AS in children, and an optional repeat trial may enable BAV to be the first choice for AS. Although BAV may be effective for neonates and infants with critical AS as an emergency treatment, much attention must be paid during the procedure.

Efficacy of multiple balloon aortic valvuloplasty procedures

To determine the efficacy of a second balloon aortic valvuloplasty procedure in comparison with the original procedure, 47 patients (18 men, 29 women; mean age 77 +/- 10 years) who underwent two balloon aortic valvuloplasty procedures over a mean interval of 6.4 months between procedures (range 2 days to 15 months) were retrospectively examined. The mean pressure gradient across the aortic valve was significantly higher before the first than before the second valvuloplasty procedure (62 +/- 21 vs. 53 +/- 21 mm Hg; p less than 0.05) and after the first compared with after the second procedure (32 +/- 13 vs. 28 +/- 14 mm Hg; p less than 0.05). The cardiac output and stroke volume after the first procedure were significantly greater than the values for these variables after the second procedure (4.4 +/- 1.1 vs. 3.8 +/- 1.1 liters/min; p less than 0.05; and 54 +/- 17 vs. 47 +/- 15 ml/beat; p less than 0.05, respectively). There were no significant differences in the change observed in any variable between the first and second procedures. At a mean follow-up interval of 5.3 months (range 6 days to 15 months) after the second procedure 18 (38%) of the 47 patients had died, 12 (25%) required surgical valve replacement and 4 (8%) required a third valvuloplasty procedure. Overall, 31 (66%) of 47 patients met clinical failure end points after the second procedure. Three patients had two failure end points. The 47 patients were divided into two groups on the basis of the interval between valvuloplasty procedures.(ABSTRACT TRUNCATED AT 250 WORDS)