Rotational Atherectomy Systems

ROTAPRO™ and ROTABLATOR™ Rotational Atherectomy Systems

Calcium Impacts Long-Term Outcomes

Calcium is a growing problem in the treatment of coronary artery disease. Angiographic evidence indicates a high presence of target lesion calcification in patients undergoing PCI.1

Calcium Prevalence & Rotational Atherectomy

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Years of Proven Clinical Safety and Efficacy
1.1m
Procedures Performed Worldwide*
* Based on Boston Scientific sales estimate.

Calcium Impacts Long-Term Outcomes

Calcium is a growing problem in the treatment of coronary artery disease. Angiographic evidence indicates a high presence of target lesion calcification in patients undergoing PCI.1
Rotablator - Calcium is a growing problem

Pooled analysis from the HORIZONS-AMI and ACUITY Trials suggests patients with moderate/severe calcium have a significantly higher chance of death, TLR, and MACE.1

HORIZONS-AMI & ACUITY Trials

1-Year Ischemic Outcomes

HORIZONS-AMI & ACUITY Trials

2016 data from the ARRIVE Registry also shows that moderate/severe calcium is associated with higher risk of death, TVR, and MACE.2

ARRIVE Registry

1-Year Ischemic Outcomes

ARRIVE Registry
Patients with calcium tend to be older with a higher prevalence of hypertension, kidney disease, previous CABG, and congestive heart failure.
Severe calcium claim

Data Supports Rotational Atherectomy

A 2015 large, multicenter registry evaluated the outcomes of patients undergoing rotational atherectomy (RA) in 9 major Australian hospitals over an 8-year period (16,410 non-RA PCIs, 167 RA PCIs).3

In the RA cohort:

  • Patients were more likely to be older with a higher prevalence of comorbidities
  • Patients were more likely to have complex type B2 and C lesions
  • 37% of patients had a previously failed PCI

These patients represented the most complex of the PCI population where no other interventional therapy was an option.

Study Findings: Rotational atherectomy was safe and effective in resistant lesions

In Hospital Clinical Outcome:

No significant difference in angiographic success, dissections, perforations, or no reflow

1-Year Clinical Outcome:

No significant difference in MACE or TLR*

When lesions treated with DES(excluding bare metal stents) were isolated, analysis of the multicenter registry revealed a TLR rate of 2.9%.

Summary:

  • Rotational atherectomy is an important tool for treating complex lesions, with low procedural complications and MACE rates.
  • Despite the significantly more difficult patient population, there were no significant differences in procedural complications.
  • Given the excellent results, an upfront rotational atherectomy strategy for treating calcium has the potential to:
    • Shorten procedure time
    • Reduce number of overall procedures
    • Reduce risks to patients

ROTABLATOR in Calcified Lesions

Dr. Price Case Study
Rotational atherectomy allowed for substantial plaque modification that enabled successful balloon predilatation and stent deployment.

Patient History

  • 58-year-old male
  • History of coronary artery disease, diabetes, hypertension, obstructive sleep apnea, and peripheral artery disease.
  • Prior PCI to LAD and left circumflex.
  • Presented with midsternal to left-sided chest discomfort, nonradiating, lasting for several minutes, brought on with exertion, and relieved with rest.
Initial Angiogram

Diagnosis

  • EKG demonstrated sinus bradycardia with an old inferior infarct.
  • Left coronary angiogram demonstrated separate ostia of LAD and left circumflex arteries.
  • The left circumflex artery had TIMI-2 flow. There was a high grade, sub-total stenosis in its proximal portion.
  • With some difficulty, a 6F extra back-up guide catheter was used to cannulate the left circumflex.
Initial IVUS Run

Initial IVUS Run

  • A workhorse coronary wire was successfully advanced across the lesion.
  • Predilatation with a 2.0 x 12 mm RX semi-compliant balloon was attempted, but was unsuccessful because it could not cross the lesion.
  • Predilatation was successful with a 1.5 x 12 mm APEX™ Push balloon; subsequent angiogram demonstrated restoration of TIMI-3 flow.
  • Further predilatation was then performed with a 2.5 x 12 mm NC QUANTUM APEX™ MR balloon at high pressure. There was clear under expansion of the balloon by fluoroscopy.
  • Intravascular ultrasound showed a highly narrowed vessel with substantial fibro-calcific plaque. Given these findings, the decision was made to proceed with ROTABLATOR.
Angiogram Post 1.5 mm ROTABLATOR

Angiogram Post 1.5 mm ROTABLATOR

  • The original wire was exchanged over an OTW balloon for a ROTAWire™ Floppy Guidewire.
  • A 1.5 mm burr was advanced and rotational atherectomy was performed. This was followed by further high pressure dilatation with an NC QUANTUM APEX balloon with poor expansion.
  • Subsequent angiography showed TIMI-3 flow with no dissections, but still a residual significant stenosis.
6 F to 8 F Guide Exchange Part 1
6 F to 8 F Guide Exchange Part 2

6 F to 8 F Guide Exchange

  • Given the need for further rotational atherectomy with a larger burr, the decision was made to perform a guide exchange for an 8 F guide catheter.
  • The ROTAWire Floppy Guidewire was exchanged for a 300 cm extra support wire using an OTW system.
  • The 6F guide and sheath were then walked out over the extra support wire.
  • An 8F sheath and guide were re-advanced over the extra support wire.
  • The extra support wire was then exchanged for the ROTAWire Extra Support wire to bias atherectomy within the plaque.
Post-DES IVUS Run

Post-DES IVUS Run

  • ROTABLATOR was then performed with a 2.0 mm ROTABLATOR burr.
  • The lesion was assessed and pre-dilated at high pressure with a 3.25 x 15 mm NC QUANTUM APEX balloon.
  • A 3.5 x 16 mm DES stent was deployed with excellent expansion by fluoroscopy.
  • Post stent intravascular ultrasound showed focal under expansion in the proximal portion of the stent.
Physician Commentary

Study and Images Courtesy of Dr. Price

  • Post-dilatation was then performed at high pressure with a 3.75 x 12 mm NC QUANTUM APEX balloon.
  • Final angiography demonstrated TIMI-3 flow, no dissections, and no residual stenosis in the left circumflex system.

Result*

  • Rotational atherectomy allowed for substantial plaque modification that enabled successful balloon predilatation and stent deployment.

Physician Commentary

"I think this case demonstrates that it is important to have rotational atherectomy in your tool kit for cases where you do not get adequate predilatation or stent deployment. In this particular case, there was a very aggressive fibro-calcific plaque that was really resistant to even high pressure dilatation with a non-compliant balloon. We were able to do rotational atherectomy, which is a life-saver when you get in this kind of situation."

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