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About SmartCRT™ Technology
The control needed for every patient is here
SmartCRT is Boston Scientific’s approach to personalize cardiac resynchronization therapy (CRT) by providing physicians with smart solutions to optimize where, when, and how to pace to obtain CRT Response in most patients.
On this page:
Where to pace
ACUITY™ X4 Quadripolar LV Leads
Reach the site of latest activation
With the industry’s smallest lead tip and a variety of shapes, ACUITY X4 is the only family of quadripolar leads designed to optimize basal pacing, which is shown to lead to improved patient outcomes.1-3
- Fast delivery
- 99.1% stability
- Options to lessen Phrenic Nerve Stimulation (PNS)
- Low thresholds
- Multiple electrode configurations
- More proximal pacing options
- Less time under fluoroscopy
VectorGuide
Quickly provides pertinent measurements of 17 vectors options based on clinically relevant tests including right ventricular septal and left ventricular septal (RVS-LVS) delay and phrenic nerve stimulation (PNS).
- Longer RVS-LVS delay is associated with a 29% relative reduction of risk of heart failure hospitalization or death4
- RVS-LVS Delay test is automated and takes < 1 minute to help choose the best cathode
How to pace
MultiSite Pacing
Options to maximize response
More options for those who have not responded to single-site pacing. Tailor CRT therapy to your patient’s needs without lead repositioning.
- MultiSite Pacing - 216 vector combinations
- SmartVector - Vector recommendations in less than five seconds
- SmartOffset - Automated timing recommendations
Clinical data
SMART-AV/CRT Pooled Analysis 2024
Pooled data including 451 CRT-D patients from both SMART AV and SMART CRT studies demonstrated that SmartDelay was superior to Fixed AV delay to improve CRT response and reverse remodeling in patients with prolonged interventricular delays—meeting primary and all secondary endpoints.5
Figure 1
Results:
- Primary Endpoint: 11% more CRT Responders* with SmartDelay vs. Fixed AV Delay (P=0.014) (Figure 1)
Figure 2
- Secondary Endpoints: (Figure 2)
- 10% > decrease in LVESV (P=0.005)
- 3% > decrease in LVEDV (P=0.015)
- 13% > increase in LVEF (P=0.012)
Figure 3
- Post hoc analysis demonstrates 2.3 x higher odds of CRT response with SmartDelay vs. Fixed AVD in the 63% of patients where recommended AV delay fell outside the nominal range (100-120 ms) (Figure 3)
*CRT Response defined as ≥ 15% reduction in LVESV
Conclusion:
SmartDelay increases CRT response and reverse remodeling among patients with RV-LV intervals ≥ 70 ms. These results support that this algorithm provides clinical benefit to CRT patients with prolonged interventricular delay.
Watch primary investigator Dr. Michael R. Gold discuss the results in the video below.
SMART-AV clinical sub-study 2018
Baseline interventricular delay predicted CRT response. At long RV-LV durations, SmartDelay can increase the likelihood of reverse remodeling with CRT
Results:
- With long RV-LV delay, SmartDelay resulted in marked improvement in LVESV (-30.6 vs. -17.2)
- 80% response rate or a 4-fold increase in response over fixed AV timing was achieved in patients with long RV-LV delay who were programmed using SmartDelay6
View the SMART-AV clinical sub-study 2018 results
SMART-AV clinical trial 2010
Overall results showed SmartDelay was non-inferior to fixed AV and Echo. 1014 patients evaluated at 3 and 6 months.
Results:
No difference in improvement in left ventricular and end-systolic volume at 6 months was observed between the SmartDelay and echocardiography arms (P=0.52) or the SmartDelay and fixed arms (P=0.66).⁷
SMART-MSP clinical trial
The SMART-MSP clinical trial exceeded both its endpoints:
- Safety Endpoint: The MultiSite Pacing (MSP) feature-related complication-free rate at 180 days post MSP on is 99%
- Effectiveness Endpoint: 51% of the non-responders at 6 months converted to responders at 12 months8
NAVIGATE X4 clinical trial
- Prospective, single-arm, non-randomized, multicenter clinical trial
- Enrollment of 791 patients in 88 US centers
- N=520 (either Spiral L or S) / n = 218 (Straight lead)
- Primary endpoint: 6-month LV lead-related complication rates, left ventricular pacing capture thresholds (LVPCT) at 3 months
- Three lead options – thus, greater opportunity for non-apical pacing
- LVPCT on Spiral leads were lower on proximal electrodes compared to distal electrode (0.9V vs 1.3V)
- Physicians selected proximal electrode vector in most patients
- Implant success = 97%
- Low acute and chronic complication rates
- 99.1% dislodgement complication free rate
- 8% phrenic nerve stimulation (PNS) observation rate
- Proximal electrodes have lower PNS rate (5%) than distal electrode (15%)
- 0.4% re-intervention rate for PNS9
Products that feature SmartCRT
SmartCRT resources
References
1. ACUITY™X4 Physician’s Lead Manual: 359160-002 EN US 2015-07
2. ATTAIN™PERFORMA™4298 Technical Manual: M948374A001. ATTAIN™PERFORMA™STRAIGHT 4398 Technical Manual: M948374A001. ATTAIN™PERFORMA™S 4598 Technical Manual: M950705A001.
3. Quartet™User’s Manual 100042495
4. Gold MR, Yu Y, Wold N, Day JD. The role of interventricular conduction delay to predict clinical response with cardiac resynchronization therapy. Heart Rhythm. 2017;14(12):1748-1755. doi:10.1016/j.hrthm.2017.10.016
5. Gold MR et al. Atrioventricular optimization improves cardiac resynchronization response in patients with long interventricular electrical delays: A pooled analysis of the SMART-AV and SMART-CRT trials. Heart Rhythm 2024;21(9):P1686-1694. https://doi.org/10.1016/j.hrthm.2024.03.1783
6. Gold MR et al. Effect of Interventricular Electrical Delay on Atrioventricular Optimization for Cardiac Resynchronization Therapy. Circ Arrhythm Electrophysiol 2018;11:e006055. https://doi.org/10.1161/CIRCEP.117.006055
7. Ellenbogen, K., Gold, M., et al. Primary Results from the SMART-AV Trial: A Randomized Trial Comparing Empiric, Echocardiographic Guided and Algorithmic AV Delay Programming in Cardiac Resynchronization Therapy (CRT). Circulation 2010;122:2660-68.
8. Saba S, et al. Safety and Effectiveness of Multi-Site Pacing in Initial Non-Responders to Conventional Cardiac Resynchronization Therapy. LBCT presented at: 2021 Heart Rhythm Society; July 2021; Boston, MA
9. Mittal S et al. Performance of Anatomically Designed Quadripolar Left Ventricular Leads: Results from the NAVIGATE X4 Clinical Trial. J Cardiovasc Electrophysiol. 2016;27:1199-1205.