Balloon rupture during transcatheter aortic valve replacement.

A distinctive complication with balloon-expandable (BE) THV platforms such as the Edwards Sapien (Edwards Lifescience) is the possibility of balloon rupture during THV deployment. Balloon rupture is a rare occurrence that can result in stroke due to fragment embolism, incomplete THV expansion, and/or vascular injury upon retrieval of the balloon. Careful evaluation of preoperative computed tomography is essential to identify high-risk cases. While annular and left ventricular outflow tract (LVOT) calcification are widely acknowledged as common risks for balloon injury, it's essential to note that balloon injury can manifest at various anatomical sites. In this review, we discuss the mechanism behind balloon rupture, methods to identify cases at a heightened risk of balloon injury, approaches to mitigate the risk of rupture, and percutaneous retrieval strategies.

The use of semi-compliant versus non-compliant balloon systems for predilatation during the implantation of self-expandable transcatheter aortic valves: Data from the VIenna CardioThOracic Aortic Valve RegistrY (VICTORY).

BACKGROUND: This study aimed to evaluate the differences in outcome arising from the use of semi-compliant (SCB) versus non-compliant balloon (NCB) systems for predilatation during self-expanding transcatheter aortic valve replacement (TAVR). METHODS: 251 TAVR procedures with the implantation of self-expanding valves after predilatation were analyzed. SCB systems were used in 166 and NCB systems in 85 patients. The primary endpoint was defined as device success, a composite endpoint comprising the absence of procedural mortality, correct valve positioning, adequate valve performance and the absence of more than a mild paravalvular leak. The secondary endpoints were chosen in accordance with the valve academic research consortium (VARC-2) endpoint definitions. RESULTS: No significant differences were observed with regard to procedural device success between the SCB- and NCB cohort (SCB: 142 [85.5%%] vs. NCB: 77 [90.6%]; P = .257). There was a notable difference between the rates of conversion to open surgery and the postdilatation rate, both of which were higher for the NCB group (SCB: 1 [0.6%] vs. NCB: 4 [5.1%]; P = .042; SCB: 30 [18.1%] vs. NCB: 34 [40%]; P < .001). In a multivariate logistic regression analysis, the use of semi-compliant balloon systems for predilatation was associated with a lower risk for postdilatation (OR: 0.296; 95% CI: 0.149-0.588) and conversion to open surgery (OR: 0.205; 95% CI: 0.085-0.493; P = .001) but not for device success. CONCLUSION: While the balloon compliance did not affect the procedural mortality, device success or the rate of paravalvular leakage, the use of semi-compliant balloons for predilatation during TAVR should be investigated in larger randomized trials in the light of the lower rates of postdilatation and conversion to open surgery compared to their non-compliant counterparts.

Use of Large Balloon Catheter to Treat Infants With Pulmonary Valve Stenosis.

Balloon pulmonary valvuloplasty is a safe and effective treatment for isolated pulmonary valve stenosis. Several balloon catheters are available for this procedure in neonates and infants. However, obtaining additional vascular access for the double-balloon technique in this population is troublesome, and tricuspid valve injury is a concern. We used a TMP PED balloon catheter to perform valvuloplasty in 2 infants with isolated pulmonary valve stenosis. This thin-walled, relatively large 12-mm balloon catheter can be delivered through a small-diameter sheath. In both cases, the transpulmonary pressure gradient was reduced without causing any valvular or vascular injuries. Neither patient had recurrent pulmonary valve stenosis. Together, these cases highlight the suitability and feasibility of using the 12-mm TMP PED balloon catheter for treating young infants with valvular stenosis.

Transcatheter Approach for Critical Pulmonary Stenosis or Pulmonary Atresia with Intact Ventricular Septum in Young Infants Using the Simmons Catheter.

METHODS AND RESULTS: We retrospectively reviewed 52 young infants, 41 of whom had CPS and 11 had PA/IVS, in a single center from June 2009 to October 2017. Patients were divided into three groups according to the type of catheter used to enter through the RVOT. The unique structure of the Simmons catheter allowed it to be maneuvered directly into the RVOT within a few minutes. Compared with the other two groups, the Simmons catheter group had a significantly shorter fluoroscopy time entering through the RVOT (P < 0.001) and a shorter total X-ray exposure time (P < 0.001). Furthermore, compared with the floating catheter group, the success rate of surgery was much higher in the Simmons catheter group (P < 0.001). CONCLUSIONS: The Simmons catheter is a safe and effective method to enter through the RVOT in infants with CPS or PA/IVS. Therefore, the Simmons catheter could be an alternative catheter when entering through the RVOT in young infants, especially neonates with low birth weight.

A novel double-balloon catheter for percutaneous balloon pulmonary valvuloplasty under echocardiographic guidance only.

BACKGROUND: Percutaneous balloon pulmonary valvuloplasty (PBPV) is the procedure of choice for uncomplicated severe or symptomatic pulmonary stenosis. Echocardiography (echo)-guided PBPV can completely avoid the use of radiation and contrast agents compared to fluoroscopy-guided PBPV. Although we have confirmed that echo-guided PBPV is feasible in humans, the poor visibility of the traditional catheter under echo greatly limits the promotion of this new technology. METHODS: We produced a novel double-balloon catheter to make the catheter easy to be detected by echo through adding a guiding balloon at the distal end of the catheter. Echo-guided PBPV was performed on thirty healthy swine using either a novel catheter or a traditional catheter to evaluate the feasibility and safety of the novel double-balloon catheter. The feasibility was evaluated by the success rate of balloon inflation at the pulmonary valve annulus and the operating time. The safety was evaluated by the frequency of balloon slippage and the incidence of complications. RESULTS: There were no significant between-group differences in terms of weight and the ratio of balloon diameter to pulmonary annulus diameter. The success rate was 93.3% and 60% in the novel and traditional groups, respectively. The novel group had significantly (p<0.05) lower mean procedure time (6.33±6.86min vs 24.8±9.79min) and lower frequency of balloon slippage (0.07±0.26 vs 0.53±0.52), arrhythmia (0.07±0.26 vs 0.47±0.52), and tricuspid regurgitation (6.7% vs 40%) than the traditional group. No myocardial hematoma or pericardial tamponade occurred in the novel catheter group. CONCLUSION: Although further studies and improvements are required, the study results indicate that the novel double-balloon catheter for echo-guided PBPV is feasible and safe.

Evaluation of the NuCLEUS-X™ balloon valvuloplasty catheter for severe pulmonic stenosis in dogs.

INTRODUCTION/OBJECTIVES: Balloon instability is commonly encountered during balloon pulmonary valvuloplasty (BPV) and may result in an unsuccessful procedure. The NuCLEUS-X™ catheter is a recently developed BPV catheter with a unique barbell shape and an ordered pattern of inflation that stabilizes the balloon to span the valve annulus before expansion of the balloon center. ANIMALS: Ten client-owned dogs with severe valvular pulmonic stenosis (PS). MATERIALS AND METHODS: Prospective observational study. The BPV procedure was performed by standard technique with use of NuCLEUS-X™ catheters targeting a balloon-to-annulus ratio between 1.2 and 1.5. Balloon stability, safety, and procedural success were assessed. Procedural success was defined as either a reduction in the Doppler transpulmonic PG by at least 50% of the pre-procedural PG or <80 mmHg one month post procedure. RESULTS: Balloon stability centered at the pulmonic valve on the first inflation was achieved in 10/10 cases. The mean PG before BPV was 141 mmHg ±41 mmHg, and the PG after BPV at one month was 83 mmHg ±41 mmHg. Procedural success was achieved in 56% of patients. All dogs survived the BPV, and no major procedural complications were encountered using the NuCLEUS-X™ catheter. CONCLUSIONS: The use of the NuCLEUS-X™ catheter is feasible for BPV in dogs with severe PS. The unique balloon shape provided catheter stability on the first inflation in all dogs, which may be beneficial when stabilization of a conventional BPV catheter cannot be achieved.

Impact of Predilatation Prior to Transcatheter Aortic Valve Implantation With the Self-Expanding Acurate neo Device (from the Multicenter NEOPRO Registry).

Safety and feasibility of transfemoral Acurate neo implantation without systematic predilatation are not fully investigated. Our aim was to evaluate the use and impact of pre-implantation balloon aortic valvuloplasty (pre-BAV) before transcatheter aortic valve implantation (TAVI) with Acurate neo. The NEOPRO Registry retrospectively included 1,263 patients who underwent transfemoral TAVI with Acurate neo at 18 centers between January 2012 and March 2018. Information on pre-BAV was available for 1,262 patients (99.9%). Primary end points were pre-discharge moderate-to-severe paravalvular aortic regurgitation (PAR II+), 30-day new permanent pacemaker implantation, and 30-day all-cause mortality or stroke. A total of 1,262 patients who underwent TAVI with (n = 1,051) or without predilatation (n = 211) were included. A reduction in the pre-BAV rate was observed during the study period (from 95.7% in the first date quintile to 78.4% in the last date quintile). Patients who underwent pre-BAV had higher degrees of aortic valve (AV) and left ventricular outflow tract (LVOT) calcification. Primary endpoints were similar between pre-BAV and no pre-BAV groups (PAR II+ 5.5% vs 3.4%, p = 0.214; 30-day permanent pacemaker implantation 9.0% vs 8.0%, p = 0.660; 30-day death or stroke 4.9% vs 4.4%, p = 0.743). The need for postdilatation and other procedural outcomes were comparable between groups. Predilatation did not have a significant impact on primary endpoints across AV and LVOT calcification subgroups (subgroup analyses) and was not independently associated with primary endpoints (multivariate analyses). In conclusion, transfemoral Acurate neo implantation without predilatation appears to be feasible and safe, especially in patients with milder degrees of AV and LVOT calcification.

Simplifying transfemoral ACURATE neo implantation using the TrueFlow nonocclusive balloon catheter.

OBJECTIVES: This study aimed to investigate the safety and efficacy of ACURATE neo transcatheter aortic valve replacement (TAVR) facilitated by predilatation with the nonocclusive TrueFlow balloon catheter. BACKGROUND: Now that TAVR is moving forward, physicians have attempted to simplify and streamline the procedure and the so-called minimalist approach has become more popular. METHODS: We enrolled 142 patients (mean age: 82 ± 5 years, 61% female) in a prospective registry. Patients at low risk for intraprocedural third-degree atrioventricular block (AVB) underwent TAVR with the TrueFlow balloon without rapid pacing and without insertion of a provisional pacemaker (n = 121). The remaining 21 patients were predilated with rapid pacing using a provisional pacemaker and a standard balloon. RESULTS: Predilatation with the TrueFlow balloon was successful in all 121 patients. Postdilatation was less frequently required after predilatation with the TrueFlow (25% vs. 57%, p = .003). Moreover, median procedural duration with the TrueFlow was significantly shorter (42 [interquartile range, IQR: 34-53] vs. 55 [IQR: 46-61] min, p = .004). In-hospital outcomes were similar. At 30 days, there was no mortality, two (1%) patients had suffered a stroke and only four (3%) had required implantation of a new pacemaker. CONCLUSION: Among patients with a low risk for intraprocedural third-degree AVB, the TrueFlow nonocclusive balloon catheter facilitates implantation of the ACURATE neo without the necessity of rapid pacing and a provisional pacemaker.

Reshaping bicuspid aortic valve stenosis with an hourglass-shaped balloon for transcatheter aortic valve replacement: A pilot study.

OBJECTIVES: We evaluated the safety and usefulness of preparatory anatomical reshaping with a geometric hourglass-shaped balloon to optimize transcatheter aortic valve replacement (TAVR) outcomes in bicuspid aortic valve (BAV) stenosis. BACKGROUND: TAVR has been increasingly performed for BAV stenosis; however, technical challenges remain. Procedural results are suboptimal given unfavorable valvular anatomies. METHODS: Eligible patients with BAV stenosis were enrolled to undergo aortic valve predilatation with the hourglass-shaped TAV8 balloon before TAVR using the self-expandable Venus A-Valve. Procedural details and outcomes were compared to a sequential group of patients with BAV who underwent TAVR with the same device following preparatory dilatation using a cylindrical balloon. RESULTS: A total of 22 patients were enrolled in the TAV8 group and 53 were included in the control group. Valve downsizing was less common in the TAV8 group (36.4 vs. 67.9%; p = .012). Stable valve release and optimal implant depth were consistently achieved in the TAV8 group with no requirement for a second valve (0 vs. 17.0%; p = .039) and with higher device success rates (100.0 vs 77.4%; p = .014). Residual aortic regurgitation graded as ≥mild was less common in the TAV8 group (13.6 vs 45.3%; p = .009). Mortality was similar (0 vs. 3.8%; p = 1); no major/disabling stroke or conversion to open-heart surgery was seen in either group within 30 days. CONCLUSIONS: Compared with standard cylindrical balloon valvuloplasty, preparatory reshaping with the hourglass-shaped balloon before self-expandable TAVR in BAV was associated with significantly better procedural results and may encourage more promising outcomes.

Performance of the TRUE dilatation balloon valvuloplasty catheter beyond rated burst pressure: A bench study.

OBJECTIVES: We undertook an independent bench test assessing the performance of the TRUE dilatation (TD) balloon valvuloplasty catheter (Bard Vascular Inc., Tempe, AZ) beyond its rated burst pressure (RBP). BACKGROUND: The TD balloon has a RBP of six atmospheres (atm), and its performance beyond this RBP is poorly understood. Techniques such as bioprosthetic valve fracture require inflation pressures beyond manufacturer recommendations. METHODS: A 20, 22, 24, 26, and 28 mm TD balloon were inflated to increasing pressures in increments of 3 atm until balloon failure. Measurements were performed at the proximal, middle, and distal balloon segments with scientific digital calipers. Z-MED balloons (Braun Interventional Systems Inc., Bethlehem, PA) were used as a comparator. RESULTS: The mean diameter at the middle of the 20, 22, 24, 26, and 28 mm TD balloon at nominal pressure (3 atm) was 20.02 ± 0.09, 21.77 ± 0.07, 23.9 ± 0.06, 25.82 ± 0.08, and 27.62 ± 0.08 mm, respectively. The maximal mean diameter at the middle of the 20, 22, 24, 26, and 28 mm TD balloon was 20.39 ± 0.03 mm (15 atm), 22.35 ± 0.03 mm (15 atm), 24.55 ± 0.02 mm (15 atm), 26.48 ± 0.02 mm (12 atm), and 28.39 ± 0.03 mm (12 atm), respectively. The 20/22/24 and 26/28 mm balloon failed when inflated beyond 15 atm and 12 atm, respectively. Failure was due to either leakage or longitudinal balloon rupture. TD balloons were more likely to maintain dimensions similar to their labeled size and less likely to fail at higher pressures as compared to Z-MED balloons. CONCLUSION: The TD balloon catheter maintains a similar diameter to its labeled size, when inflated beyond its RBP. When inflated beyond 12 atm, the TD balloon can fail due to either leakage or rupture. This has implications for percutaneous structural heart interventions.

Balloon Aortic Valvuloplasty Using a Non-Occlusive Balloon Catheter: First Animal Experience.

BACKGROUND: Transcatheter aortic valve implants (TAVI) have revolutionised the treatment of elderly patients requiring aortic valve replacement. These patients often do not tolerate balloon valvuloplasty well, and a valvuloplasty balloon that would allow a degree of continued cardiac output during expansion would be beneficial. We tested such a balloon and describe our results in the sheep model. METHODS AND RESULTS: We developed a non-occlusive balloon (NOB) catheter. An acute experiment was performed where the NOB was inflated in six sheep in the aortic valve position without any attempt to arrest cardiac output. Two inflations were performed per animal: the first for 30 s and the second for 2-3 min. Standard occlusive balloons were inflated in two animals under rapid ventricular pacing to serve as controls. Mean pressure gradient across the NOB was 9.7 ± 5 mmHg during the inflations and all animals remained hemodynamically stable during NOB inflations. CONCLUSIONS: The novel non-occlusive balloon catheter, which permitted uninterrupted cardiac output for a prolonged period without the need for pacing-induced temporary cessation of cardiac output, is both feasible and well tolerated in the acute sheep model.

Reverse-Loop Technique for Percutaneous Transvenous Mitral Commissurotomy in a Patient With Huge Left Atrium.

A 34-year-old man was referred for percutaneous transvenous mitral commissurotomy (PTMC); he had undergone 2 PTMC attempts at another institute, but both attempts failed because of inability to cross the mitral valve with the balloon. We present an alternative reverse-loop technique for PTMC in patients with large left atrium.

A rare cause of stroke after transcatheter aortic valve replacement: Retained foreign body.

The field of transcatheter aortic valve replacement (TAVR) has matured significantly with the outcome and durability data now supporting use in lower-risk patients. We present a preventable complication from early in our experience (5 years ago) that illustrates the importance of heart team communication and cautious multidiscipline cross-pollination during the formative years of a program. An 87-year old female developed confusion, slurred speech and left upper extremity weakness 1 day following TAVR with inconclusive findings on carotid artery duplex and transthoracic echocardiography. Subsequent CT-scan disclosed a linear, ring-like, structure in the ascending aorta. The foreign body (FB) was radiolucent and successfully snared via tactile sensation and anatomic landmarks informed by the CT. The extricated FB was the valvuloplasty balloon guard (BG) that was inadvertently introduced into the patient via ascending aortic large sheath access. The failure mode was traced back to the first time use of a new balloon system and unrecognized BG by the surgical physician and technician components of the Heart Team who took the lead role in device insertion due to the open chest access. Subsequently, the heart team made changes to mitigate similar future complications by sharing multidiscipline responsibility for all procedural steps and ensuring the use of all new adjuvant devices are preceded by a procedural pause and team consensus regarding device preparation and use. Additionally, the manufacturer addition of a radiopaque marker or flair on the valvuloplasty BG may be warranted.

Valvuloplasty balloon entrapment in a self-expanding aortic valve stent frame after inadvertent wire passage through the outflow struts.

Transcatheter aortic valve replacement (TAVR) is a leading-edge therapy option for patients with severe aortic stenosis (AS) and high surgical risk. However, this minimally invasive procedure is associated with specific complications that may be life-threatening. Valvuloplasty balloon entrapment during postdilatation in transcatheter self-expanding aortic valve stent frames has not yet been a focus of interest in this context. Although it is a rare event, it may critically influence outcome, and different management strategies can be considered. Hereafter, we present the case of a 67-year-old male who underwent transfemoral TAVR and subsequent postdilatation. The valvuloplasty balloon was entrapped in the self-expanding aortic valve stent frame after inadvertent wire passage through the outflow struts. Since surgical risk was high, we preferred a percutaneous approach and extracted the entrapped balloon with high traction force under rapid pacing after valve stabilization with another balloon, which was placed in the annular position.

Transcatheter aortic valve implantation utilizing a non-occlusive balloon for predilatation.

BACKGROUND: Balloon aortic valvuloplasty (BAV) is routinely performed preceding transcatheter aortic valve implantation (TAVI). Among risks inherent in BAV is low cardiac output due to rapid ventricular pacing (RVP), especially in patients with severely impaired left ventricular function. We herein report early experience utilizing a non-occlusive balloon for BAV (TrueFlow™, BARD, Peripheral Vascular, Tempe, AZ, US), which does not require RVP. METHODS: Between 11/2016 and 10/2017, 27 consecutive patients received TAVI using a non-occlusive balloon valvuloplasty catheter for predilatation and a self-expandable transcatheter heart valve (77.8% female, 81.7 ±â€¯6.6 years, logEuroSCORE I 15.8 ±â€¯10.3%, STS Prom Score 2.5 ±â€¯0.5%). Hemodynamic measurements and acute outcome data were analyzed according to updated Valve Academic Research Consortium definitions. RESULTS: Procedure time, fluoroscopy time and amount of contrast agent were 74.5 ±â€¯17.4 min, 16.7 ±â€¯6.9 min and 156.9 ±â€¯92.7 ml. Device success and early combined safety were 100% and 92.6% (25/27). Effective BAV without RVP after the first inflation was achieved in 92.6% of the patients (25/27). Continuous recording of hemodynamics documented no relevant systemic pressure drop during BAV. Postdilatation with a regular balloon was required in 10/27 patients. No death was observed during 30-day follow-up. Resultant mean transvalvular gradient was 6.0 ±â€¯3.5 mm Hg. In one patient a moderate paravalvular leakage was seen. CONCLUSIONS: In this series of TAVI utilizing a novel non-occlusive balloon, safety and efficacy were demonstrated. Adequate predilatation was achieved in all cases without need for RVP and with stable hemodynamics. These results will have to be confirmed in larger patient cohorts.

New Pulmonary Valvuloplasty Technique by Use of an Hourglass-Shaped Balloon in 3 Adults with Severe Pulmonary Valve Stenosis.

Percutaneous balloon pulmonary valvuloplasty is the preferred therapy for pulmonary valve stenosis. However, the designs of the cylindrical balloons historically used for valvuloplasty have limitations, especially in patients who have large pulmonary annular diameters. The hourglass-shaped V8 Aortic Valvuloplasty Balloon may prove to be an effective alternative. The balloon has 2 large bulbous segments that are separated by a narrowed waist. The geometric shape is maintained throughout inflation, improving fixation and enabling broader leaflet opening. We present our first experience with the V8 balloon in 3 adults who had severe, symptomatic pulmonary valve stenosis. In addition to describing their cases, we detail our sizing technique for pulmonary valvuloplasty with the V8 balloon. Our successful results suggest that the V8 balloon is efficient and safe for balloon pulmonary valvuloplasty in adults with severe pulmonary valve stenosis.