Abstract
Background
In patients with high-risk anatomy, transcatheter aortic valve replacement (TAVR) risks coronary obstruction which is associated with high morbidity and mortality. Bioprosthetic or native Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction (BASILICA) is effective at preventing prevent coronary obstruction.
Objectives
To test the safety and effectiveness of TELLTALE, the first dedicated transcatheter electrosurgery leaflet modification system.
Methods
The TELLTALE trial (NCT05666713) enrolled participants with high or prohibitive surgical risk undergoing TAVR for native aortic stenosis or bioprosthetic valve failure and in whom computed tomography (CT) core laboratory confirmed high risk of coronary obstruction. The Primary Efficacy Endpoint was technical success in the catheterization lab and the Primary Safety Endpoint was inpatient safety.
Results
Ninety participants (age 79 (75, 82) years, 66% (59/90) female, 30 native aortic stenosis, 60 bioprosthetic valve failure) were enrolled at 11 centers in the United States. High risk of coronary obstruction was confirmed by CT (coronary height 8.2 (6.3, 10.8)mm, valve-to-coronary distance 3.4 (2.7, 3.7)mm, valve-to-sinotubular-junction distance 1.2 (0.7, 1.7)mm). Leaflet modification was easy and reliable with median 1 traversal and laceration attempt per participant. The Primary Efficacy Endpoint was met in 100% (95% confidence interval (CI) [95, 100]) of participants. The Primary Safety Endpoint was met in 96% (95% CI [88, 99]) of participants, including zero mortality, 3 strokes (1 disabling, 2 non-disabling) and 1 coronary obstruction from THV commissural suture post malalignment. At 30 days there was zero mortality and zero delayed coronary obstruction.
Conclusions
Electrosurgical leaflet modification using the TELLTALE system in patients undergoing TAVR for native aortic stenosis or bioprosthetic valve failure at high risk of coronary obstruction is safe and effective.
Keywords: Leaflet modification, Coronary Occlusion/diagnostic imaging/etiology/prevention & control/therapy, Transcatheter Aortic Valve Replacement/adverse effects/instrumentation, Electrosurgery/methods, Leaflet splitting, BASILICA
INTRODUCTION
Transcatheter aortic valve replacement (TAVR) risks coronary obstruction in certain patient anatomies(1). Coronary obstruction is associated with high morbidity and mortality(2). Bioprosthetic or native Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction (BASILICA) is effective at preventing coronary obstruction in patients with native aortic stenosis or bioprosthetic valve failure who are at risk of coronary obstruction due to deficient sinus of Valsalva or sinus sequestration(3). Until now, electrosurgical leaflet modification has been performed off-label using commercially available guidewires, catheters and accessories. However, these devices are not intended for electrosurgery. The TELLTALE system (Transmural Electrosurgery LeafLet Traversal And Laceration Equipment) comprises a dedicated 0.014” electrosurgery guidewire with enhanced insulation and radiopaque markers, Pachyderm guiding catheters to facilitate leaflet traversal, and accessories to selectively denude, kink and grip the guidewire during leaflet laceration. Herein we report the results of the pivotal TELLTALE Trial (NCT05666713) in high surgical risk participants undergoing TAVR for native aortic stenosis or bioprosthetic valve failure at high risk of coronary obstruction.
METHODS
Study design and participant selection
The TELLTALE trial was an investigator-initiated prospective, multicenter, open-label, single arm, Investigational Device Exemption (IDE) study sponsored by the Office of Clinical Director, National Heart Lung and Blood Institute (NHLBI), National Institutes of Health, USA (Supplemental Table 1). The TELLTALE system (guidewire, Pachyderm guiding catheters and accessories) (Figure 1) were designed by Transmural Systems, Andover, MA, which provided site support and application specialists at arms-length from the study Sponsor. The study was licensed by the US Food and Drug Administration (G220207) and approved by a central institutional research board (Advarra, Columbia, Maryland). NHLBI served as the data coordinating center. The NHLBI Data Safety Monitoring Board provided study oversight. High surgical risk patients undergoing TAVR for native aortic stenosis or bioprosthetic valve failure who were considered at risk for coronary obstruction by the institutional Heart Team at 11 enrolling centers in the United States (Supplementary Table 2) were screened for this pivotal trial. Pre-procedure cardiac computed tomography (CT) images were analyzed by an independent core laboratory to confirm risk of coronary obstruction. Anatomic suitability for leaflet modification was confirmed by a multidisciplinary study eligibility committee prior to enrollment. Figure 2 summarizes the study design and reasons for participant exclusions.
Figure 1 – TELLTALE system.
Components of the TELLTALE leaflet modification system include 0.014” TELLTALE guidewire, kinker-denuder tool, wire-gripper tool, and Pachyderm guiding catheters.
Figure 2 – TELLTALE study design.
a Comorbidity examples: active gastrointestinal bleeding, recent percutaneous coronary intervention and unable to wait protocol-mandated 30 days before TAVR, hepatic encephalopathy, extreme frailty, cardiogenic shock.
b Doppio BASILICA excluded per protocol because discordant first and second leaflet results would impact assessment of the primary efficacy endpoint.
BASILICA: Bioprosthetic or native Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction; CT: computed tomography; TAVR: transcatheter aortic valve replacement; TELLTALE: Transmural Electrosurgery LeafLet Traversal And Laceration Equipment; VTC: valve-to-coronary distance.
TELLTALE leaflet modification and TAVR procedure
TELLTALE leaflet modification is performed immediately before TAVR. Detailed procedural planning and step-by-step guidance for BASILICA leaflet modification have been published elsewhere(4).
Figure 3 and Figure 4 demonstrate key procedural steps in representative participants with native aortic stenosis and bioprosthetic valve failure respectively. In brief, the aortic valve is crossed to position a gooseneck snare through a guiding catheter in the left ventricular outflow tract (LVOT). A Pachyderm guiding catheter is positioned on the aortic surface of the target leaflet. Correct position at the base of the leaflet and alignment with the threatened coronary ostium is confirmed using fluoroscopy ± transesophageal echocardiography (TEE) at operator discretion. The 0.014” TELLTALE guidewire is energized to traverse the leaflet, and the tip is snared in the LVOT. The TELLTALE kinker-denuder tool is used to selectively remove insulation and kink the mid-point of the guidewire to create a ‘flying V’ cutting surface, which is then advanced to engage the target leaflet by externalizing the front end of the guidewire using the snare. The guidewire is secured with the TELLTALE wire grippers and re-energized while gentle traction is placed on the two guiding catheters to lacerate the leaflet. 5% dextrose is infused through the guiding catheters during laceration to minimize char and thrombus formation. Leaflet laceration is confirmed by successful removal of the guidewire and catheter ± TEE (if available). After leaflet laceration, TAVR is performed according to standard practices. Anesthesia (moderate sedation vs. general anesthesia), use of TEE, and cerebral embolic protection were not mandated per protocol, but rather were at operator discretion.
Figure 3 – Representative TELLTALE-BASILICA procedure in a patient with native aortic stenosis and high risk of left coronary obstruction.
(A) TELLTALE PAL1.0 guiding catheter with TELLTALE 0.014” guidewire positioned above the aortic valve (white arrow) and MP1.0 guiding catheter positioned in the LVOT with a gooseneck snare (black arrow). (B) Contrast injection through the aortic guiding catheter confirms wire position at the base of the target leaflet (arrow). (C) Electrosurgical leaflet traversal using the TELLTALE guidewire. (D) TELLTALE guidewire is snared in the LVOT. (E) Kinked and denuded ‘flying-V’ positioned on the target leaflet for electrosurgical laceration (arrow). (F) After TAVR, aortography demonstrates coronary opacification despite valve frame in contact with the sinotubular junction (arrow). BASILICA: Bioprosthetic or native Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction; LVOT: left ventricular outflow tract; MP: Multipurpose; PAL: Pachyderm Amplatz Left; TAVR: transcatheter aortic valve replacement; TELLTALE: Transmural Electrosurgery LeafLet Traversal And Laceration Equipment.
Figure 4 – Representative TELLTALE-BASILICA procedure in a patient with bioprosthetic valve failure and high risk of left coronary obstruction.
(A) TELLTALE PAL1.0 guiding catheter with TELLTALE 0.014” guidewire positioned above the aortic valve (white arrow) and MP1.0 guiding catheter positioned in the LVOT with a gooseneck snare (black arrow). (B) Contrast injection through the aortic guiding catheter confirms wire position at the base of the target leaflet (arrow). (C) Electrosurgical leaflet traversal using the TELLTALE guidewire. (D) TELLTALE guidewire is snared in the LVOT. (E) Kinked and denuded ‘flying-V’ positioned on the target leaflet for electrosurgical laceration (arrow). (F) After TAVR, selective coronary angiogram with diagnostic JL3.5 catheter engaging the left coronary ostium through a cell of the balloon-expandable valve (arrow). BASILICA: Bioprosthetic or native Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction; JL: Judkins Left; LVOT: left ventricular outflow tract; MP: Multipurpose; PAL: Pachyderm Amplatz Left; TAVR: transcatheter aortic valve replacement; TELLTALE: Transmural Electrosurgery LeafLet Traversal And Laceration Equipment.
Study Endpoints
The Primary Efficacy Endpoint of the trial was technical success, assessed upon exit from the cardiac catheterization laboratory and was defined as successful electrosurgical leaflet traversal using the TELLTALE guidewire; and successful electrosurgical leaflet laceration using the TELLTALE guidewire; and successful retrieval of the TELLTALE guidewire system. The Primary Safety endpoint was in-hospital safety, assessed upon discharge from the index hospitalization and was defined as a composite of freedom from all-cause mortality, stroke (both disabling and non-disabling), acute coronary artery obstruction, emergency cardiac surgery or reintervention related to the TELLTALE BASILICA procedure or device, and BASILICA-related complications including coronary artery perforation, coronary artery dissection, aortic dissection, cardiac free wall perforation, or systemic embolization of a native or bioprosthetic leaflet. The Secondary Safety endpoint was freedom from major adverse cardiovascular events at 30 days as defined by the third Valve Academic Research Consortium criteria(5). Participants self-administered the Kansas City Cardiomyopathy Questionnaire (KCCQ) at baseline and 30 days(6).
Data management and analysis
To ensure data integrity, 100% case report forms and adverse events were independently verified with source data on site or remotely using electronic medical records, clinical events were independently monitored, and all computed tomographic (CT) images were analyzed at a central core laboratory. The Primary and Secondary Efficacy and Safety Endpoints were adjudicated by an independent Clinical Events Adjudication Committee using source documentation. The investigators attest to data integrity, and the NHLBI has full custody of all data in the study. The data may be made available for specific approved analyses by the corresponding author. Data were analyzed using R version 4.4.2 (R Foundation for Statistical Computing) with the gtsummary package(7). Results are reported as mean ± standard deviation if normally distributed or otherwise as median (1st quartile, 3rd quartile). P values of <0.05 were considered to indicate statistical significance. Paired continuous data were compared using the paired t-test. Changes in NYHA class from baseline to day 30 were assessed using the Wilcoxon signed-rank test and the McNemar-Bowker test.
RESULTS
Participant selection
Between February 2023 and February 2025, a total of 157 participants were screened and after exclusions, 90 participants were enrolled into the trial, of whom 30 were undergoing TAVR for native aortic stenosis and 60 for bioprosthetic valve failure (Figure 2). The most common reasons for exclusion were CT analysis demonstrating low risk for coronary obstruction, co-morbidity (e.g., clinical instability) and need for doppio leaflet modification which was excluded per protocol because discordant first and second leaflet results would impact assessment of the primary efficacy endpoint. Relatively few were excluded for excessive target leaflet calcification. Table 1 summarizes baseline demographic and clinical characteristics. Median age was 79 (75, 82) years. Overall, 66% (59/90) participants were female, and every participant in the native aortic stenosis cohort was female. The burden of comorbidities was high. The most common mode of aortic valve failure was stenosis. Supplementary Table 3 summarizes echocardiography findings. Table 2 summarizes core laboratory analysis of baseline cardiac CT imaging which established coronary obstruction risk. All patients were high risk of coronary obstruction, with coronary height 8.2 (6.3, 10.8)mm, valve-to-coronary distance (VTC) 3.4 (2.7, 3.7)mm and valve-to-sinotubular junction distance (VTSTJ) 1.2 (0.7, 1.7)mm. The most common predicted mechanism of coronary obstruction was direct coronary ostial obstruction.
Table 1 –
Baseline demographics, clinical characteristics and aortic valve details
| All (n=90) | Bioprosthetic valves (n=60) | Native valves (n=30) | |
|---|---|---|---|
|
| |||
| Demographics and clinical characteristics | |||
|
| |||
| Age, years | 79 (75, 82) | 78 (75, 82) | 80 (76, 83) |
| Female | 59 (66%) | 29 (48%) | 30 (100%) |
| STS-PROM, % | 4.2 (3.0, 6.6) | 4.4 (3.1, 6.7) | 3.6 (2.3, 6.3) |
| BSA, m2 | 1.86 (1.67, 2.02) | 1.88 (1.71, 2.05) | 1.80 (1.64, 1.92) |
| BMI, kg/m2 | 26.6 (23.8, 32.3) | 26.6 (24.0, 31.2) | 26.1 (23.6, 35.0) |
| Diabetes mellitus | 31 (34%) | 20 (33%) | 11 (37%) |
| End-stage renal disease | 0 (0%) | 0 (0%) | 0 (0%) |
| Severe pulmonary disease | 10 (11%) | 4 (7%) | 6 (20%) |
| Home oxygen use | 5 (6%) | 2 (3%) | 3 (10%) |
| Cirrhosis | 22 (24%) | 12 (20%) | 10 (33%) |
| Permanent pacemaker | 10 (11%) | 9 (15%) | 1 (3%) |
| Hypertension | 75 (83%) | 51 (85%) | 24 (80%) |
| Coronary artery disease | 41 (46%) | 33 (55%) | 8 (27%) |
| Percutaneous coronary intervention | 12 (13%) | 9 (15%) | 3 (10%) |
| Coronary artery bypass grafting | 25 (28%) | 23 (38%) | 2 (6.7%) |
| Myocardial infarction | 8 (9%) | 5 (8%) | 3 (10%) |
| Peripheral artery disease | 17 (19%) | 12 (20%) | 5 (17%) |
| Stroke | 14 (16%) | 10 (17%) | 4 (13%) |
| Transient ischemic attack | 8 (9%) | 5 (8%) | 3 (10%) |
| Atrial fibrillation | 27 (30%) | 20 (33%) | 7 (23%) |
| Paroxysmal | 20 (22%) | 15 (25%) | 5 (17%) |
| Persistent >1 week or permanent |
7 (8%) | 5 (8%) | 2 (7%) |
|
| |||
| Aortic valve details | |||
|
| |||
| Aortic valve failure mode | |||
| Stenosis | 72 (80%) | 43 (72%) | 29 (97%) |
| Regurgitation | 10 (11%) | 10 (17%) | 0 (0%) |
| Mixed | 8 (9%) | 7 (12%) | 1 (3%) |
| Type of bioprosthetic valve | |||
| Stented, inner leaflets | – | 35 (58%) | – |
| Stented, outer leaflets | – | 23 (38%) | – |
| Stentless | – | 1 (2%) | – |
| Transcatheter valvea | – | 1 (2%) | – |
| If surgical bioprosthesis, type | |||
| Carpentier-Edwards Magna | – | 29 (48%) | – |
| family | |||
| Epic | – | 3 (5%) | – |
| Freestyle | – | 1 (2%) | – |
| Mitroflow | – | 3 (5%) | – |
| Mosaic | – | 3 (5%) | – |
| Trifecta | – | 20 (33%) | – |
Values are reported as n (%) or median (interquartile range).
n=1 Evolut self-expanding valve. BMI: body mass index; BSA: body surface area; STS-PROM: Society of Thoracic Surgeons Predicted Risk of Mortality at 30 days.
Table 2 –
NHLBI CT Core Laboratory assessment of coronary obstruction risk
| Target leaflet (n=90) |
Left leaflet (n=73) |
Right leaflet (n=17) |
|
|---|---|---|---|
|
| |||
| Mechanism of coronary obstruction risk | |||
| Coronary ostial obstruction | 56 (62%) | 43 (59%) | 13 (76%) |
| Sinus sequestration | 16 (18%) | 15 (21%) | 1 (6%) |
| Both | 18 (20%) | 15 (21%) | 3 (18%) |
| Sinotubular junction height, mm | 13.0 (12.1, 14.6) | 13.0 (11.9, 14.8) | 13.5 (13.0, 14.1) |
| Leaflet height, mm | 14.9 (13.7, 16.2) | 14.7 (13.6, 16.0) | 15.0 (14.7, 17.5) |
| Width of Sinus of Valsalva, mm | 29.9 (27.1, 30.6) | 29.0 (27.2, 30.8) | 28.4 (26.8, 29.3) |
| Height of coronary ostium, mm | 8.2 (6.3, 10.8) | 8.1 (6.1, 10.0) | 10.3 (8.0, 12.3) |
| VTC, mm | 3.4 (2.7, 3.7) | 3.4 (2.9, 3.6) | 3.4 (2.7, 3.7) |
| VTSTJ, mm | 1.2 (0.7, 1.7) | 1.2 (0.8, 1.7) | 1.0 (0.6, 1.4) |
Values are reported as n (%) or median (interquartile range). VTC: virtual valve-to-coronary ostium distance; VTSTJ: virtual valve-to-sinotubular junction distance.
Procedural details
Table 3 shows details of the TELLTALE BASILICA procedure. Cerebral embolic protection was recommended but not mandated in the TELLTALE trial. It was used in 86% (77/90) of participants, but both filters could not be deployed in every participant. Debris was recovered in less than 40% of participants in whom filter examination was performed. A median of 1 traversal and 1 laceration attempts was required in each participant. TELLTALE did not cause any leaflet avulsions. TELLTALE traversal entered a non-target chamber (typically left atrium) in 6 participants, before being redirected without sequelae. There were no cases of injury to the mitral valve or aorta. TELLTALE laceration induced modest blood pressure reduction (systolic 127 (115, 138) to 119 (109, 134) mmHg, change −7mmHg (95% CI [−11, −3]), p<0.001; diastolic 50 (44, 61) to 42 (34, 50) mmHg, change −9mmHg (95% CI [−12, −6]), p<0.001), without a change in heart rate and hemodynamics were similar between native and bioprosthetic valves. In 10% (9/90) of participants, vasopressors were initiated (n=2) or escalated (n=7) between laceration and THV implantation. Total procedure time, total fluoroscopy time and key leaflet modification procedural times were lower for native compared to bioprosthetic valves (Supplementary Table 4). Total procedure time was lower for left leaflet compared to right leaflet laceration, but the key procedural step of guiding catheter to leaflet traversal time was similar (Supplementary Table 5). Fluoroscopy time and radiocontrast volume were numerically lower for left leaflet laceration.
Table 3 –
Procedural details
| All participants (n=90) |
|
|---|---|
|
| |
| Anesthesia or sedation strategy | |
| General anesthesia | 65 (72%) |
| Moderate sedation | 25 (28%) |
| Cerebral embolic protection used* | 77 (86%) |
| Sentinel with both filters deployed | 73 (81%) |
| Sentinel with only one filter deployed | 4 (4%) |
| Debris recovered (site reported) | 29/76 (38%) |
| Target aortic valve leaflet Left |
73 (81%) |
| Right | 17 (19%) |
| Number of traversal attempts | 1 (1, 2) |
| Electrosurgery power for traversal, W | 20 (20, 20) |
| Number of laceration attempts | 1 (1, 1) |
| Electrosurgery power for laceration, W | 30 (30, 30) |
| Target leaflet avulsed by TELLTALE | 0 (0%) |
| THV implanted | |
| Evolut FX/FX+ | 43 (48%) |
| Navitor | 3 (3%) |
| Sapien 3/Ultra/Resilia | 44 (49%) |
| THV nominal diameter 20 |
8 (9%) |
| 23 | 52 (58%) |
| 26 | 25 (28%) |
| 29 | 5 (6%) |
| Bioprosthetic valve fracture (BVF) or remodeling attempted | 29/60 (48%) |
| BVF before TAVR | 19/29 (66%) |
| BVF after TAVR | 10/29 (35%) |
| Procedure stages Time from first guiding catheter to TELLTALE traversal, min |
20 (14, 28) |
| Time from TELLTALE traversal to laceration, min | 15 (11, 20) |
| Time from TELLTALE to TAVR, min | 8 (5, 11) |
| Total procedure time including TAVR, min | 84 (67, 105) |
| Total radiocontrast volume, mL | 83 (50, 149) |
| Total fluoroscopy time, min | 37 (30, 47) |
Values are reported as n (%) or median (interquartile range).
Use of cerebral embolic protection was optional per protocol. TAVR: transcatheter aortic valve replacement. THV: transcatheter heart valve.
Approximately half of participants received a balloon-expandable THV, and half received a self-expanding THV. Bioprosthetic valve fracture (BVF) was attempted in 48% (29/60) of participants with bioprosthetic valve failure.
The Primary Efficacy Endpoint of Technical Success was met in 100% (95% confidence interval (CI) [95, 100]) of participants.
In-hospital, 30-day and 90-day outcomes
The composite in-hospital Primary Safety Endpoint was met in 96% (95% CI [88, 99]) of participants (Table 4).
Table 4 –
Primary Efficacy and Safety Endpoints
| All participants (n=90) | |
|---|---|
|
| |
| Primary Efficacy Endpointa | 100% (95% CI [95, 100]) |
|
| |
| Primary Safety Endpointb, defined as freedom from | 96% (95% CI [88, 99]) |
|
| |
| All-cause mortality | 0 (0%) |
| Stroke | 3/90 (3%) |
| Disabling | 1/90 (1%) |
| Non-disabling | 2/90 (2%) |
| Coronary obstructionc | 1/90 (1%) |
| Emergency cardiac surgery or reintervention related to the TELLTALE BASILICA procedure or device | 0 (0%) |
| BASILICA-related complications including coronary artery perforation, coronary artery dissection, aortic dissection, cardiac free wall perforation, or systemic embolization of a native or bioprosthetic leaflet | 0 (0%) |
Values are reported as n/N (%). CI: confidence interval.
Technical success, assessed upon exit from the cardiac catheterization laboratory and was defined as successful electrosurgical leaflet traversal using the TELLTALE guidewire; and successful electrosurgical leaflet laceration using the TELLTALE guidewire; and successful retrieval of the TELLTALE guidewire system.
Assessed upon discharge from the index hospitalization.
Coronary obstruction was caused by randomly-aligned commissural post of the balloon-expandable valve in front of the split leaflet.
Within 30-days, there were three strokes (1 disabling and 2 non-disabling). Table 5 summarizes the timing of diagnosis, severity and relatedness (adjudicated by independent Clinical Events Adjudication Committee). Only one stroke was clearly procedure-related and occurred in a participant with bioprosthetic valve failure in whom the cerebral embolic protection device was removed after TELLTALE leaflet modification, but before TAVR and bioprosthetic valve fracture. Two additional strokes occurred in participants with native aortic stenosis and were diagnosed on post-procedure day 2 and day 5. Both participants had underlying atrial fibrillation, and oral anticoagulation was withheld peri-procedurally per standard of care.
Table 5 –
Periprocedural stroke
| Stroke #1 | Stroke #2 | Stroke #3 | |
|---|---|---|---|
|
| |||
| Native or bioprosthetic valve | Bioprosthetic | Native | Native |
| Timing of stroke post-TAVR | Day 1 | Day 5 | Day 3 |
| Disabling or non-disabling* | Non-disabling | Non-disabling | Disabling |
| Related to TELLTALE* | Unlikely | Unlikely | Unlikely |
| Related to TAVR* | Probably | Probably | Probably |
| Related to underlying disease* | Possibly | Possibly | Possibly |
| Cerebral embolic protection with both filters in place throughout TELLTALE and TAVR |
No (no debris captured) |
Yes (no debris captured) |
Yes (no debris captured) |
| Bioprosthetic valve fracture (BVF) attempted | Yes | – | – |
| History of atrial fibrillation | No | Yes | Yes |
| Description | Sentinel removed after TELLTALE but before TAVR and BVF | Anticoagulation withheld | Anticoagulation withheld |
Adjudicated by independent Clinical Events Adjudication Committee.
One participant had coronary obstruction which manifested after the procedure with shock and returned to the cath lab. Further imaging demonstrated that the randomly-aligned commissural post of the balloon-expandable THV landed in front of the split leaflet. Percutaneous coronary intervention was performed with deployment of an orthotopic stent, not otherwise possible without successful BASILICA, and the participant was discharged from hospital.
Complete 30-day clinical follow up was available for all 90 participants. Table 6 summarizes in-hospital and cumulative 30-day clinical outcomes. The only events that occurred between hospital discharge and 30-day follow up were 1 additional pacemaker implantation, 1 gastrointestinal bleed requiring transfusion and 1 vascular complication (pulmonary embolism). The corresponding Secondary Safety Endpoint was met in 89% (95% CI [80, 94]) of participants at 30 days.
Table 6 –
In-hospital and 30-day clinical outcomes
| In-hospital (n=90) |
30 days cumulative (n=90) |
|
|---|---|---|
|
| ||
| Primary Safety Endpointa | 96% (95% CI [88, 99]) | – |
| Secondary Safety Endpointb | – | 89% (95% CI [80, 94]) |
| Mortality, all-cause | 0 (0%) | 0 (0%) |
| Stroke | 3 (3%) | 3 (3%) |
| Disabling | 1 (1%) | 1 (1%) |
| Non-disabling | 2 (2%) | 2 (2%) |
| Transient ischemic attack | 0 (0%) | 0 (0%) |
| Myocardial infarctionc | 1 (1%) | 1 (1%) |
| Major or life-threatening vascular | 3 (3%) | 4 (5%) |
| complication | ||
| Major or life-threatening bleeding | 4 (4%) | 5 (6%) |
| Acute kidney injury stage 3 or 4 | 0 (0%) | 0 (0%) |
| Coronary obstructionc | 1 (1%) | 1 (1%) |
| New permanent pacemaker | 4 (4%) | 5 (6%) |
Values are reported as n/N (%).
The Primary Safety endpoint was in-hospital safety, assessed upon discharge from the index hospitalization and was defined as a composite of freedom from all-cause mortality, stroke (both disabling and non-disabling), acute coronary artery obstruction, emergency cardiac surgery or reintervention related to the TELLTALE BASILICA procedure or device, and BASILICA-related complications including coronary artery perforation, coronary artery dissection, aortic dissection, cardiac free wall perforation, or systemic embolization of a native or bioprosthetic leaflet.
The secondary endpoint was freedom from MACE (according to VARC-3) at 30 days, including freedom from all of the following: all-cause mortality, stroke (disabling and non-disabling), bleeding VARC-3 Type 2 or greater (requiring two or more units of transfused blood or hemoglobin drop >3g/dL), major vascular, access-related, or cardiac structural complication (according to VARC-3, which includes coronary obstruction), acute kidney injury stage 3 or 4, moderate or severe aortic regurgitation, new permanent pacemaker due to procedure-related conduction abnormalities, surgery or intervention related to the TELLTALE device.
The myocardial infarction corresponded to the coronary obstruction.
The New York Heart Association heart failure classification improved at 30-days (Supplementary Figure 1). The Kansas City Cardiomyopathy Questionnaire (KCCQ-23, scored 0–100, 100 is better) clinical summary score increased from 68 (52, 85) at baseline to 85 (68, 94) at 30d, p<0.001. The KCCQ overall summary score increased from 62 (44, 82) at baseline to 84 (69, 94) at 30d, p<0.001.
At 90 days, 89/90 participants were confirmed alive with no delayed coronary obstruction (n=1 withdrew consent).
DISCUSSION
This pivotal trial examined the safety and efficacy of leaflet modification using TELLTALE, a novel dedicated electrosurgical system to prevent coronary obstruction in patients undergoing TAVR for native aortic stenosis or bioprosthetic valve failure. The key findings were: I) Leaflet traversal and laceration was achieved in 100% of participants with native aortic stenosis or bioprosthetic valve failure; II) Leaflet modification was easy and reliable with median 1 traversal and laceration attempt per participant; III) Freedom from in-hospital major safety events was achieved in 96% of participants; IV) Coronary obstruction occurred in only one participant, attributed to THV commissural malalignment, which was rescued with deployment of an orthotopic stent through THV cells only possible because of successful TELLTALE laceration.
The ability of BASILICA to prevent coronary obstruction during TAVR was first proven in a prospective safety and feasibility trial(8) in high-surgical risk patients undergoing TAVR for native aortic stenosis and bioprosthetic valve failure using off-label guidewires and catheters. A larger multicenter registry subsequently confirmed efficacy of leaflet modification of both native and bioprosthetic valves(3). In a cohort of 214 high-risk patients from 25 centers in the North America and Europe, freedom from coronary obstruction was observed in 95.3% of patients. Clinical outcomes were similar between single-leaflet and doppio BASILICA, native and bioprosthetic valves, and with or without use of cerebral embolic protection.
Women are particularly at risk for coronary obstruction during TAVR because they typically have smaller aortic root dimensions than men. Strikingly, every participant in the native aortic stenosis cohort in the TELLTALE trial was female. While the need for leaflet modification in patients with bioprosthetic valve failure is predicted to grow, the absolute number of TAVR procedures for native aortic stenosis is much higher. And although coronary obstruction is less common with native aortic stenosis, even a small percentage represents a substantial number of patients.
TELLTALE is the only leaflet modification device to be tested in participants undergoing TAVR for native aortic stenosis at high risk of coronary obstruction. In the native aortic stenosis cohort leaflet modification technical success was 100% and no participants had coronary obstruction after TAVR.
Democratization of leaflet modification has been limited by procedural complexity. In contrast with off-label BASILICA, having guiding catheters with dedicated shapes to direct the TELLTALE guidewire to the base of the target leaflet made leaflet modification easy, which was evidenced by the number of traversal and laceration attempts (median 1 attempt per participant). Radiofrequency energy power required to traverse and lacerate leaflets using the fully-insulated TELLTALE guidewire was less than half of the power typically required to perform off-label BASILICA, which improves procedural safety by reducing risk of thermal injury to adjacent structures. TELLTALE accessories including the kinker-denuder tool and wire grippers further simplify key procedural steps, ensuring formation of the flying-V is reproducible and preventing the guidewire slipping during laceration. Using TELLTALE, laceration of native leaflets was ‘easier’ than bioprosthetic leaflets as evidenced by lower total procedure time, total fluoroscopy time and key leaflet modification procedural times (Supplementary Table 4). Laceration of left leaflets was ‘easier’ than right leaflets as evidenced by lower total procedure time and numerically lower fluoroscopy time and radiocontrast volume (Supplementary Table 5). Interestingly the key procedural step of guide catheter to leaflet traversal time was comparable suggesting that this step which is typically harder with off-label BASILICA is facilitated by dedicated Pachyderm guiding catheters.
A mechanical leaflet splitting device was recently tested in 60 patients with bioprosthetic valve failure at risk of coronary obstruction (ShortCut, Pi-Cardia, Rehovot, Israel)(9). Cerebral embolic protection was mandated in all participants and procedural success was defined as successful leaflet splitting. The key difference between TELLTALE and ShortCut is the mode of leaflet modification: electrosurgical vs. mechanical. There are no head-to-head studies comparing these two approaches. Theoretical advantages of electrosurgery include potential for less debris release from the degenerated leaflet compared to mechanical laceration. Another advantage of electrosurgery is that tissue vaporization enables laceration with less traction force applied to the leaflet which may lower the risk of unpredictable leaflet tear, avulsion or embolic debris release. At 30-days, 3/60 participants had coronary obstruction in the ShortCut trial, 2/60 participants died, and 1/60 had a disabling stroke. By contrast, TELLTALE participants with bioprosthetic valve failure had higher risk of coronary obstruction (TELLTALE mean VTC 3.3mm and VTSTJ 1.2mm vs. ShortCut mean VTC 3.3mm and VTSTJ 2.2mm), bioprosthetic valve fracture was performed more often (48% vs 23%), and yet outcomes compared favorably, with 1/60 coronary obstruction, 0/60 mortality and 1/60 non-disabling stroke at 30 days. As a surrogate marker of procedural complexity, TELLTALE required substantially less radiocontrast (TELLTALE 83 (50, 149) mL, ShortCut 125.6±65.5mL). The timing of TELLTALE- and ShortCut-specific procedure steps cannot be compared directly, because operators chose to perform other TAVR procedure steps (e.g, positioning cerebral embolic protection, aortography, and transesophageal echocardiographic confirmation of leaflet splitting) during the recorded time intervals in both trials. Nonetheless, the summed TELLTALE catheter-to-traversal and traversal-to-laceration times (35 (29, 48) min) resemble reported ShortCut procedure times (26.9±19.7 min). Lacerating a second leaflet in the ShortCut trial required an additional ~10min procedural time. Doppio leaflet modification was not performed in the TELLTALE trial, but we predict that second leaflet laceration would also be faster with TELLTALE because there would be no need to repeat these TAVR procedure steps. Second leaflet laceration requires a new TELLTALE guidewire and a different guiding catheter, but the other elements of the TELLTALE system (e.g., kinker-denuder tool, wire grippers and left ventricular guiding catheter) and the gooseneck snare are reused.
The number of patients presenting with bioprosthetic valve failure is predicted to increase over the coming decade, driven in part by patients presenting with surgical bioprosthetic valve failure but predominantly by patients presenting with THV failure(10). CT simulations predict that a substantial proportion of patients with THV failure may require adjunctive leaflet modification to prevent coronary obstruction(11–16).
The heightened risk of coronary obstruction during redo-TAVR compared to TAVR for native aortic stenosis or surgical bioprosthetic valve failure is due to THV design and implantation technique. Contemporary THV have taller leaflets with more redundancy than surgical bioprostheses. Supra-annular THV intentionally lift the leaflets above the annulus to maximize effective orifice area. Contemporary procedural technique emphasizes need for shallower depth of implantation to reduce risk of conduction system disturbance(17), which further lifts the leaflets above the coronary ostia. Linear laceration may not create sufficient leaflet splay in certain redo-TAVR configurations(18). Several newer leaflet modification techniques have been described (e.g., UNICORN/CLEVE)(19–21). These involve electrosurgical traversal of the base of the leaflet followed by balloon inflation to deliver a THV and then leaflet obliteration as the THV is deployed. These techniques are comparatively newer than BASILICA and lack prospective or even large-scale retrospective evidence but may have a role in redo TAVR procedures because they may displace more leaflet tissue. TELLTALE would both facilitate and improve safety of electrosurgical leaflet traversal which is the key first step of these newer leaflet modification techniques.
The most common alternative to leaflet modification is off-label ‘snorkel’ (or ‘chimney’) stenting. There is less published data on this technique, but snorkel stents risk deformation and/or compression from the THV frame and poor washout of the sinus of Valsalva after TAVR risks stent thrombosis(22). Snorkel stents make future coronary access challenging – if not impossible – and require prolonged dual antiplatelet therapy. Redo-TAVR is less amenable to snorkel stenting because the stent risks compression between the two THV frames.
Embolic debris release causing stroke is a concern with every aortic valve intervention. Routine use of cerebral embolic protection has not been shown to reduce the incidence of TAVR-related stroke(23,24), and subgroup analyses have so far failed to identify specific high-risk phenotypes (e.g., valve-in-valve or bicuspid aortic stenosis). Intuitively, leaflet modification may increase the risk of debris embolization and stroke. Cerebral embolic protection was not mandated in the TELLTALE trial and was not used in 13% of participants. Three participants were diagnosed with stroke, which were adjudicated as unlikely related to TELLTALE by the independent Clinical Events Adjudication Committee based on timing of diagnosis, brain imaging, and underlying disease. Cerebral embolic protection was in place for all or part of the procedure in all three participants with stroke.
Limitations
This was a non-randomized trial. For obvious reasons, it would be unethical to randomize patients at high risk of coronary obstruction to TAVR without leaflet modification or off-label snorkel stenting. Coronary obstruction risk was determined by independent CT core lab and concurrence of study eligibility committee which evaluated each potential participant. The most common reason for exclusion from the study was that the risk of coronary obstruction was determined to be low and therefore leaflet modification was not indicated. Participants with both coronary arteries at risk were excluded from the study because discordant first and second leaflet results would impact assessment of the primary efficacy endpoint. Operators at each enrolling center had prior experience with off-label BASILICA. However, feedback from operators highlighted availability of dedicated guiding catheters and accessories (kinker-denuder tool and wire grippers) as having the greatest impact on procedural times, fluoroscopy time and radiocontrast use. The sample size was not powered to perform subgroup comparisons, e.g., between types of bioprosthetic valves and between native and bioprosthetic cohorts.
CONCLUSIONS
Electrosurgical leaflet modification using the TELLTALE system in patients undergoing TAVR for native aortic stenosis or bioprosthetic valve failure at high risk of coronary obstruction is safe and effective.
Supplementary Material
Central Illustration: TELLTALE trial overview and findings.
* The Primary Efficacy Endpoint was technical success, assessed upon exit from the cardiac catheterization laboratory and defined as successful electrosurgical leaflet traversal using the TELLTALE guidewire; and successful electrosurgical leaflet laceration using the TELLTALE guidewire; and successful retrieval of the TELLTALE guidewire system. The Primary Safety endpoint was in-hospital safety, assessed upon discharge from the index hospitalization and was defined as a composite of freedom from all-cause mortality, stroke (both disabling and non-disabling), acute coronary artery obstruction, emergency cardiac surgery or reintervention related to the TELLTALE BASILICA procedure or device, and BASILICA-related complications including coronary artery perforation, coronary artery dissection, aortic dissection, cardiac free wall perforation, or systemic embolization of a native or bioprosthetic leaflet.
BASILICA: Bioprosthetic or native Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction; CT: computed tomography; TELLTALE: Transmural Electrosurgery LeafLet Traversal And Laceration Equipment;
CLINICAL PERSPECTIVES.
What is known
Transcatheter aortic valve replacement (TAVR) in patients with high-risk anatomy risks coronary obstruction, which is associated with high morbidity and mortality. Bioprosthetic or native Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction (BASILICA) is effective at preventing coronary obstruction.
What is new
TELLTALE, the first dedicated electrosurgical leaflet modification system, prevents coronary obstruction in patients with high-risk anatomy undergoing TAVR for native aortic stenosis or bioprosthetic valve failure and is safe, effective and easy.
What is next
The need for leaflet modification is predicted to grow exponentially over the coming decade driven predominantly by patients presenting with failing transcatheter heart valves. Purpose-built devices such as TELLTALE will enable democratization of electrosurgical leaflet modification.
ACKNOWLEDGEMENTS
The authors would like to thank members of the Data and Safety Monitoring Board, Clinical Events Adjudication Committee (Hector Garcia-Garcia, Eugene McFadden, Alexandre Kajita, Pablo Rubio, Gerbemedhin Melaku), members of the NHLBI regulatory and data monitoring teams (Irina Kolosova, Valeriy Matveev), and members of Transmural Systems (Nasser Rafiee, Kathleen Pizzuti, Rany Busold, Stuart MacDonald, Morgan House, Eric Mathews, Koosha Rafiee, Mai Diep, BiWei MacDonald, Marybeth Gamber, Arman Rafiee, Eylem Kocaturk, Yongguang Zhou, Ozgur Kocaturk, Penny Smith, Monica Cohen, and Nga Nguyen).
FUNDING
Supported by NIH Z01-HL006040 and Z01-HL006061 (to RJL), by SBIR HHSN268201800017C to Transmural Systems, and through Cooperative Research and Development Agreement for (NIH) Intramural Research HL-CTCR-22–08003 between National Heart Lung and Blood Institute and TELLTALE, LLC.
ABBREVIATIONS
- BASILICA
Bioprosthetic or native Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction
- KCCQ
Kansas City Cardiomyopathy Questionnaire
- LVOT
Left Ventricular Outflow Tract
- NHLBI
National Heart, Lung, and Blood Institute
- NYHA
New York Heart Association heart failure classification
- TAVR
Transcatheter Aortic Valve Replacement
- TEE
Transesophageal Echocardiography
- TELLTALE
Transmural Electrosurgery LeafLet Traversal And Laceration Equipment
- THV
Transcatheter Heart Valve
- VTC
Valve-To-Coronary distance
- VTSTJ
Valve-To-Sinotubular Junction distance
Footnotes
DISCLOSURES
TR: Consulting: Edwards Lifesciences, Medtronic, Boston Scientific, Abbott, Anteris, and Transmural Systems; Advisory board: Medtronic, Boston Scientific; Equity interest: Transmural Systems; Intellectual property: co-inventor on patents, assigned to NIH, for transcatheter electrosurgery devices.
JMK: Consulting/Proctorship: Edwards Lifesciences, Medtronic, Boston Scientific, Abbott, and Transmural Systems; Equity interest: Transmural Systems; Intellectual property: co-inventor on patents, assigned to NIH, for transcatheter electrosurgery devices.
RL: Grant/Consulting/Proctor: Edwards Lifesciences, Abbott, Medtronic, and Boston Scientific. VCB: Consulting: Abbott Vascular, Edwards Lifesciences, and Medtronic; Equity interest: Transmural Systems. Institutional research support: Abbott Vascular, Ancora Heart, Edwards Lifesciences, Gore Medical, JenaValve, Medtronic, Polares Medical, Transmural Systems, and 4C Medical.
ABG: Consulting: Abbott Vascular, Edwards Lifesciences, Excision Medical, and Medtronic; Equity interest: Transmural Systems and Excision Medical. Institutional research support: Abbott Vascular, Ancora Heart, Edwards Lifesciences, Gore Medical, JenaValve, Medtronic, Polares Medical, Transmural Systems, and 4C Medical.
AL: Consulting and/or advisory board: Edwards, Medtronic, Abbott, Boston Scientific, Philips, Anteris, and Tresquare.
JDR: Consulting/speaker’s bureau: Edwards Lifesciences, Medtronic, Abbott, and Terumo. JEH: Abiomed: Proctor/Speaker’s bureau: Boston Scientific, Medtronnic; Advisory board: Medtronic and Haemonetics.
JBO: Proctor: Edwards Lifesciences and Abiomed.
JMM: Consulting: Gore, Edwards Lifesciences, Abbott, and Medtronic; Equity interest: ConKay, Excision, Arcos, and Transmural SESAME.
JPD: Consulting: Edwards Lifesciences and Boston Scientific.
JRF: Proctor: Edwards Lifesciences and Medtronic.
DVD: Consulting: Edwards Lifesciences; Founder and Equity shareholder: Solo Pace Inc.
IB: Consulting: Edwards Lifesciences and Shockwave Medical. Institutional research support: Abbott Vascular, Ancora Heart, Edwards Lifesciences, Gore Medical, JenaValve, Medtronic, Polares Medical, Transmural Systems, and 4C Medical.
JAS: Consulting: Edwards Lifesciences.
RJL: Co-inventor on patents, assigned to NIH, for transcatheter electrosurgery devices.
All other authors report no disclosures.
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