Benefits

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Patients

Ultra-low profile Svelte technologies facilitate transradial access and direct stenting, enhancing patient comfort and improving clinical outcomes.

With drug-eluting stents (DES) firmly established as the standard of care for Percutaneous Coronary Intervention (PCI), interventional techniques and clinical results are increasingly converging, shifting focus for improvement toward reducing bleeding complications, enhancing patient comfort and maximizing procedural efficiency.

Svelte technologies achieve ultra-low profiles through state-of-the-art design and materials. Highly efficacious and deliverable, they are designed to facilitate Transradial Intervention (TRI) and a direct stenting approach to PCI across wider subsets of patients, providing patients:

  • Exceptional and durable clinical outcomes
  • Less procedural exposure to radiation and contrast
  • Greater comfort and quicker time to ambulation and hospital discharge
Approaches to PCI

The femoral artery (located in the groin) has been the primary (> 95%) access site employed by US physicians for PCI over most of the last 30 years. It is a large artery carrying high volumes of blood about an inch beneath the surface of the skin.

Once accessed, patients must remain supine for several hours while uncomfortable groin compression or closure devices achieve hemostasis (closure). This can be especially unpleasant for patients with chronic back problems confined to post-procedure bed rest.

The radial artery (located in the wrist), in contrast, is much smaller and superficial to the skin, and carries lower blood volumes. Heavy compression or closure devices are not necessary, as light compression via band or bandage achieves hemostasis.

Bed rest is simply not necessary after TRI, either; patients are able to ambulate immediately following PCI and have shorter hospital stays1. Back pain, hematomas and vascular surgical complications are virtually eliminated, while the inability to walk or use the bathroom post-procedure is wholly avoided. For the obese and elderly, the radial artery makes an especially convenient and safe access site2.

Patient Safety and Comfort with TRI

In the hands of experienced operators in high-volume transradial catheterization centers (i.e. hospitals primarily utilizing vascular access through the wrist), TRI offers decreased access-site complications and improved patient comfort.

Large, randomized, controlled clinical trials demonstrate TRI, compared with the transfemoral approach (i.e. vascular access through the groin), provides important patient safety benefits, including reduced:

  • Bleeding complications and blood transfusions1, 3-5
  • Death, myocardial infarction and stroke6
  • Contrast administration7

Acute Coronary Syndrome (ACS) with/without ST-Elevated Myocardial Infarction (STEMI), obese, elderly, female and left ventricular dysfunction patients especially benefit from TRI2.

Beyond the all-important aspect of patient safety, however, lies the often under appreciated issue of patient comfort.  PCI provides clear patient benefit over the surgical insult of open-chest Coronary Artery Bypass Grafting (CABG), but it is not pain-free, either.

In fact, patient forums have long documented the discomfort associated with PCI, even during ‘uneventful’ procedures.

Quality of Life (QOL) assessments conducted during clinical studies8 and include:

  • Body pain stemming from the arterial access site
  • Back and/or hip pain
  • Overall peri and post-procedural discomfort
  • Difficulty walking
  • Ability to use the bathroom
  • Impaired social function
  • Depressed mental health

ALL of the above were significantly reduced with patients undergoing TRI as opposed to intervention via transfemoral approach8.

And for those experiencing PCI via both methods, TRI was preferred by 90% of patients while transfemoral was preferred by only 2% (8% of patients expressed ambivalence)8. Given the discharge guidelines patients are typically presented prior to leaving the hospital, these results are not surprising.

TRI has been recommended as the default strategy for PCI in Europe9. Cath labs there performing TRI have already established outpatient clinics where patients are treated and discharged the same day following a short observation period in a comfortable lounge.

TRI also encompases well over 50% of procedures in Asia. And in the US, TRI has grown from less than 5% of PCI in 2007 to approximately 30% today10, representing the fastest growing segment in coronary stenting.

SLENDER IDS – Designed to Facilitate TRI

Patients clearly favor TRI.  So why is it not used for all PCI?

Transradial Intervention

Up until recently, there were 3 key reasons:

  1. Lack of randomized, controlled data demonstrating significant clinical benefit of TRI vs. the trans femoral approach
  2. The physician ‘learning curve’ – achieving access in the radial artery is technically more challenging and time consuming during the initial phases of learning
  3. As a larger vessel, the femoral artery allows easier passage of large caliber guiding catheters and bulky interventional devices than the radial artery to allow any type of PCI

While the first two reasons above are largely addressed through the publication of massive amounts of clinical data and hands-on fellowships/proctorships dedicated to teaching TRI techniques, concerns regarding the radial artery being large enough to adequately accommodate PCI remain. Technologies dedicated to TRI and achieving ultra-low profiles have been lacking. This is now changing.

The SLENDER IDS coronary stent-on-a-wire Integrated Delivery System (IDS) is the world’s lowest profile DES and indicated for use with diagnostic and small delivery catheters (0.047” ID), facilitating the transradial approach in more patients.  Smaller vascular access site size reduces risk of damage to the arterial access site and bleeding complications.  It also enhances patient comfort peri-and-post procedurally, reducing time to ambulation and better enabling same-day patient discharge.

Svelte IDS graphic

Svelte IDS delivered via 4F DX catheter to RV side branch through cells of stent implanted 4 months previously. Image courtesy of B. Meier, MD, PhD, Inselspital, Bern, Switzerland.

Selecting an appropriate PCI access strategy is critical, as certain patient populations are at increased risk for complications:

  • Women
  • Elderly
  • Diabetic
  • Obese
  • Anemic
  • Suffering from renal insufficiency

Excessive bleeding can be serious enough to require transfusion and in extreme cases, can be deadly, and the ability to minimize the puncture site and access the radial artery significantly reduces the risk of bleeding complications1, 3-5.

With its ultra-low profile, SLENDER IDS allows physicians to downsize catheter size in more patients, conveying important clinical benefits while enhancing overall patient experience.

Clinical and Procedural Benefits of Direct Stenting

Direct stenting, or the deployment of stents without balloon pre-dilatation of the target lesion, is used in 30-40% of PCI procedures, and can be combined with TRI. A recent meta-analysis conducted by Piscione et al11 demonstrated a 23% relative reduction in death and myocardial infarction (heart attack) associated with direct stenting compared to conventional stenting, possibly driven by reduced vessel trauma and microcirculatory injury12.

Piscione et al chart graphic

In addition to conferring important clinical benefits, direct stenting reduces the steps involved with a conventional approach to PCI, streamlining steps, reducing contrast use (and the risk of contrast-induced nephropathy for renal-impaired patients) and shortening procedure times.

Over 95% of patients were successfully direct stented in Svelte clinical studies, 74% via transradial approach, despite many of these patients presenting with challenging lesions for treatment.  Svelte technologies are specifically designed to optimize direct stenting, allowing patients to realize quicker procedures and enhanced clinical outcomes compared with conventional stenting.

SLENDER IDS is the first advance in coronary stent delivery in more than 20 years designed to deliver optimal outcomes and improve procedural efficiency.

Downsize Catheters.  Facilitate TRI.  Enhance Patient Comfort.

References:

  1. Jolly S et al. Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial. Lancet. 2011 Apr 23. 377(9775):1409-20.
  2. Valgimigli M et al. Radial versus femoral access in patients with acute coronary syndromes undergoing invasive management: a randomised multicentre trial (MATRIX).  Lancet. 2015 Jun 20. 385(9986): 2465-2476.
  3. Kiemeneij F et al. A randomized comparison of percutaneous transluminal coronary angioplasty by the radial, brachial and femoral approaches (ACCESS). J Am Coll Cardiol. 1997;29:1269-1275.
  4. Agostoni F et al. Radial versus femoral approach for percutaneous coronary diagnostic and interventional procedures; systematic overview and meta-analysis of randomized trials. J Am Coll Cardiol. 2004;44:349-56.
  5. Rao S et al. Trends in the prevalence and outcomes of radial and femoral approaches to percutaneous coronary intervention: a report from the national cardiovascular data registry. J Am Coll Cardiol Intv. 2008;1:379-86.
  6. Romagnoli et al. Radial versus femoral randomized investigation in ST-segment elevation acute coronary syndrome (RIFLE-STEACS). J Am Coll Cardiol. 2012;60:2481-9.
  7. Bernat I et al. ST-segment elevation myocardial infarction treated by radial or femoral approach in a multicenter randomized clinical trial (STEMI-RADIAL). J Am Coll Cardiol. 2014;63(10):964-972.
  8. Cooper C et al. Effect of transradial access on quality of life and cost of cardiac catheterization: a randomized comparison. Am Heart J. 1999 Sep. 138(3 Pt 1):430-6.
  9. Kiemeneij F et al. Consensus document on the radial approach in percutaneous cardiovascular interventions: position paper by the european association of percutaneous cardiovascular interventions and working groups on acute cardiac care and thrombosis of the european society of cardiology. EuroIntervention. 2013;8: 1242-51.
  10. Sunil Rao, Update on US transradial access adoption at TCT 2015.  Diagnostic and Interventional Cardiology, October 30, 2015.
  11. Piscione F et al. Is direct stenting superior to stenting with predilation in patients treated with percutaneous coronary intervention? results from a meta-analysis of 24 randomised controlled trials. Heart 2010;96:588-594.
  12. Cuisset T et al. Direct stenting for stable angina pectoris is associated with reduced periprocedural microcirculatory injury compared with stenting after pre-dilation. J Am Coll Cardiol. 2008;51:1060-5.

 

CAUTION: The law restricts SLENDER IDS to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. SLENDER IDS is CE approved. DIRECT RX is an investigational device not approved for commercial use. SLENDER IDS and DIRECT RX are not available for sale in the US.