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
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 parasympathetic nervous system (PNS).
- Longer RVS-LVS delay is associated with 30% 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
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
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 months⁶
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 PNS⁵
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.
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-AV clinical sub-study 2017
- 82% response rate achieved in patients with long RV-LV delay and SmartDelay
- 419 patient SMART-AV sub-study
With long RV-LV delay, SmartDelay resulted in a significant improvement in LVESV (-43.6 vs. -18)
82% 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 SmartDelay⁸
Physician perspective on device longevity
Products that feature SmartCRT
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 M. et al. The Role RV-LV Delay to Predict Time to First Heart Failure Hospitalization and Mortality with Cardiac Resynchronization Therapy. ESC 2014.
5. 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.
6. 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.
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. Gold, M., et al. The Effect of Interventricular Delay on AV Optimization for Cardiac Resynchronization Therapy. AHA 2017.