Benefits

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Physicians

Svelte technologies downsize catheters, enhance direct stenting and simplify the treatment of complex lesions while extracting steps and time from coronary stent procedures.

Time is a precious commodity, especially to those responsible for providing ever increasing standards of care to greater numbers of patients.

The ability to consistently streamline procedures while achieving the best possible outcomes for patients is a meaningful asset and competitive advantage in the modern healthcare environment.

Ultra-low profile, highly deliverable Svelte technologies downsize catheters and extract steps and time from stenting procedures, optimizing clinical outcomes, enhancing patient experience and shortening lab time.

Hourglass

Downsizing – the Future of Interventional Cardiology

With interventional techniques and clinical results increasingly converging, focus for improvement in PCI is shifting toward reducing bleeding complications, enhancing patient comfort and maximizing procedural efficiency.

Downsizing catheters for PCI helps address these needs and confers a number of clinical benefits1, including reduced:

  • Vascular complications
  • Contrast administration
  • Fluoroscopy time
  • Time to haemostasis

Whether using the transfemoral or transradial approach, reducing catheter size has also been shown to result in early ambulation and enhanced patient comfort without significantly reducing the quality of coronary angiography.2,3

There are also certain clinical indications where downsizing catheters can be advantageous. Where severely calcified lesions or tortuous vessels resist stent advancement due to lack delivery catheter support, switching from a 6F to 5F catheter may allow safer and deeper engagement of the target vessel.4

However the greatest benefit in reducing catheter size is realized with TRI, where the ability to consistently use 5F or smaller delivery catheters greatly reduces the risk of trauma to the radial artery, patient discomfort, bleeding complications and radial artery occlusion.5

In a 1999 study, 20% of male patients and 40% of female patients had a radial artery inner diameter < the outer diameter of a 6F compatible introducer, indicating that in some patients use of 6F catheters may be painful, cumbersome and potentially unsafe.6

Downsizing is the future of interventional cardiology.  SLENDER IDS is the world’s lowest profile DES, attaining crimped cross sectional areas approximately HALF those of conventional stents*, and is the only stent approved for use through diagnostic and smaller catheters (0.047” ID).

Incorporating an ASAHI guide wire tip and specialized balloon technology designed for direct stenting, SLENDER IDS is highly deliverable and provides the flexibility to perform complex PCI via smaller catheters, facilitating TRI in more patients to consistently realize the clinical and procedural benefits of this approach.

The Growth of Transradial Intervention

Excessive bleeding is the most common complication following coronary intervention and is associated with mortality5. Women, the elderly and those who are diabetic, anemic, obese, or suffer renal insufficiency are at greatest risk. TRI has been shown to reduce bleeding complications and improve survival, especially in the setting of primary PCI for acute myocardial infarction.7

The ability to reduce catheter size facilitates TRI in more patients.  Use of smaller catheters reduces trauma to the radial artery, reducing vascular access complications, attaining improved clinical outcomes and enhancing 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 transfusions7
  • Death, myocardial infarction and stroke8
  • Contrast administration9

In 2013, the European Society of Cardiology (ESC) officially recommended the radial approach as the preferred vascular access site for coronary interventions, making it a Class IIa, level B recommendation.10  Shortly thereafter, the Society for Coronary Angiography and Interventions (SCAI) declared in a consensus statement that TRI is preferred over transfemoral intervention.11 It is therefore unsurprising that TRI is expanding rapidly, encompassing well over 50% of PCIs in most of Europe and Asia.

In the US, TRI has grown from less than 5% of PCI in 2007 to approximately 30% today12, representing the fastest growing segment in coronary stenting. This is being driven in large part by quality of clinical outcomes, and in particular reduced bleeding complications, particularly in ACS patients.

Achieve Exceptional Clinical Outcomes

Since 2009 the Centers for Medicare and Medicaid Services (CMS) is publicly reporting hospital readmission rates to increase the transparency of hospital care, with the goal of helping consumers choose a care venue and provide hospitals with a benchmark in their quality improvement efforts.

CMS went further in 2012, launching the Hospital Readmissions Reduction Program (HRRP), in which hospitals with high rates of readmissions for acute myocardial infarction, heart failure, and pneumonia are penalized with a 3% reduction in Medicare payments.  HRRP is expected to expand in the coming years to include penalties for PCI readmissions.

Svelte technologies achieve ultra-low profiles and unsurpassed deliverability through state-of-the-art design and materials.

The SLENDER IDS  stent-on-a-wire incorporating ASAHI wire tip technology and a reinforced proximal shaft facilitates TRI  and a direct stenting approach across wider subsets of patients.

Despite 50% of investigators in Svelte clincial studies being first-time users of SLENDER IDS, exceptional clinical outcomes were achieved:

  • 74% of patients were treated via transradial approach
  • 96% of lesions were direct stented
  • 98% of cases were free of device failure

svelte-des-outcomes

DIRECT II Trial 2-Year Clinical Results

The first advance in stent delivery since the introduction of the rapid-exchange catheter, SLENDER IDS  combines state-of-the-art design and materials which deliver unmatched clinical outcomes with enhanced patient comfort and procedural efficiency.

Enhance Patient Experience

Beyond the all-important aspect of patient safety lies the often underappreciated issue of patient comfort.  Patient forums have long documented the discomfort associated with PCI, even during ‘uneventful’ procedures.  These have been further evaluated through Quality of Life (QOL) assessments conducted during clinical studies 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 approach.13  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).

With patient satisfaction an increasingly important component in determining the success and financial health of U.S. hospitals as well as cardiology practices, enhancing patient experience is a critical success factor in the modern healthcare environment.

The HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) survey, a voluntary collection when started in 2006, is now regulated by the Centers for Medicare & Medicaid Services (CMS) and directly impacts reimbursement provided by CMS to hospitals.

Measuring patients’ perceptions and hospital experience, these data often point as much to patient comfort and happiness as to quality of clinical outcomes. Results are posted online and updated regularly: www.medicare.gov/hospitalcompare/search.html

The Growth of TRI

TRI is growing and expected to expand significantly in the US, driven in no small part by its ability to enhance overall patient experience. Improving patient comfort peri and post-procedurally, shortening time to ambulation and expediting hospital discharge enhance patient experience with the added benefit of improved lab throughput.

Several other medical disciplines have witnessed the development of outpatient programs, a direct consequence of improved care with planned surgical procedures. PCI will be no exception, as pressure to improve patient satisfaction and bed turnover while reducing cost of cardiac care increases.

Same-day discharge  is already occurring with increasing frequency in parts of Europe and North America where a transradial approach is used to facilitate intervention14,15.

Cath labs at the forefront of innovation seeking improved patient experience and striving to optimize operational efficiency are increasingly turning to TRI.

The SLENDER IDS stent-on-a-wire is the world’s lowest profile DES*, attaining approximately HALF the crimped area of conventional stents, and is the only stent approved for use through diagnostic and smaller catheters (0.047” ID).

Incorporating an ASAHI guide wire tip and specialized balloon technology designed for direct stenting, SLENDER IDS is highly deliverable, and provides the flexibility to perform complex PCI via smaller catheters, facilitating TRI in more patients to consistently realize the clinical and procedural benefits of this approach.

Shorten Procedure Time

The SLENDER IDS  stent-on-a-wire Integrated Delivery System (IDS) represents the first advance in coronary stent delivery since the rapid-exchange catheter more than 20 years ago.  By mounting a stent on a wire, profiles are substantially reduced, catheters are downsized, use of additional wires and balloons are obviated and procedures are streamlined.

The clinical benefits of direct stenting are well documented.  Recent prospective as well as meta-analyses demonstrate significant reductions in restenosis, TLR, MI and death associated with direct stenting compared to conventional stenting.

These superior outcomes observed with direct stenting may be driven by:

  • Reduced wall damage and inflammatory response from vessel preparation (balloon pre-dilatation)16
  • Greater preservation of residual endothelium16
  • Better longitudinal centering of the stent on the lesion with more uniform axial redistribution of plaque17
  • Reduced microcirculatory dysfunction and/or distal embolization18

Today direct stenting is used in 30-40% of PCI worldwide and is routinely combined with TRI. Direct stenting reduces the steps involved with a conventional approach to PCI, streamlining procedures, reducing contrast use (and the risk of contrast-induced nephropathy for renal-impaired patients) and shortening procedure times.

Over 95 percent of patients were successfully direct stented in Svlete clinical studies, despite many of these patients presenting with challenging lesions for treatment.

SLENDER IDS eliminates multiple steps and ancillary products associated with stenting procedures, optimizing direct stenting, expediting procedures and enhancing clinical outcomes.

Reduce Procedural Steps, Simplify PCI

From its soft, flexible distal tip incorporating Asahi wire tip technology to its reinforced distal shaft for enhanced pushability, SLENDER IDS incorporates years of improvement in guide wire, balloon, stent and drug coating technologies.

In multiple registry as well as randomized clinical studies, SLENDER IDS has been delivered through standard guiding catheters, diagnostic catheters and sheathless guides, consistently demonstrating reduced:

  • Contrast use and radiation exposure 10 – 23%19,20
  • Procedure and device time 20 – 55%21,22
  • Material costs $119 – $592 per case19,20,23

Svelte technologies achieve ultra-low profiles and unsurpassed deliverability through state-of-the-art design and materials.  Facilitating Transradial Intervention (TRI) and a direct stenting approach to PCI across wider subsets of patients, they provide exceptional procedural and clinical outcomes while enhancing patient comfort.

Reducing vascular access complications, shortening lab time, minimizing radiation exposure and simplifying the treatment of complex lesions are all tangible benefits of Svelte technologies.

Downsize Catheters.  Facilitate TRI.  Enhance Patient Comfort.  Optimize Outcomes.

References:

  1. Amoroso G. Downsizing – the future of interventional cardiology. Interventional Cardiology. 2012;7(1):28-32.
  2. Grossman P et al. Blue cross blue shield of Michigan cardiovascular consortium (BMC2), percutaneous coronary intervention complications and guide catheter size: bigger is not better. JACC Cardiovasc Interv. 2009;2:636-44.
  3. Khoukaz S et al. Coronary angiography using 4 Fr catheters with acisted power injection: a randomized comparison to 6 Fr manual technique and early ambulation. Catheter Cardiovasc Interv. 2001;52:393-8.
  4. Matsukage T et al. Successful transradial intervention by switching from 6 French to 5 French guiding catheter. J Invasive Cardiol. 2011;23:E153-5.
  5. Gwon H et al. A 5Fr catheter approach reduces patient discomfort during transradial coronary intervention compared with a 6Fr approach: a prospective randomized study. J Interv Cardiol. 2006;19:141-7.
  6. Saito S et al. Influence of the ratio between radial artery inner diameter and sheath outer diameter on radial artery flow after transradial coronary intervention. Catheter Cardiovasc Interv. 1999;46:173–8.
  7. Romagnoli E et al. Radial versus femoral randomized investigation in ST-segment elevation acute coronary syndrome: the RIFLE-STEACS study. J Am Coll Cardiol. 2012;60:2481-9.
  8. 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.
  9. 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.
  10. 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.
  11. Hamon M et al. European Association of Percutaneous Cardiovascular Interventions; Working Group on Acute Cardiac Care of the European Society of Cardiology; Working Group on Thrombosis on the European Society of Cardiology. Consensus documnent on the radial approach in percutaneous cardiovascular interventions: position paper by the European Assocaiation of Percutaneous Cardiovascular Interventions and Working Groups on Acute Cardiac Care and Thrombosis of the European Society of Cardiology. EuroIntervention. 2013;8:1242-51.
  12. Sunil Rao, Update on US transradial access adoption at TCT 2015.  Diagnostic and Interventional Cardiology, October 30, 2015.
  13. 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.
  14. Brayton K et al. Same-day discharge after percutaneous coronary intervention: a meta-analysis. J Am Coll Cardiol. 2013;62(4):275-285.
  15. Nascimento F et al. Same-day discharge or overnight stay after percutaneous coronary intervention: comparison of net adverse cardiovascular events. J Invasive Cardiol. 2014;26(5):204-208.
  16. Rogers C et al. Endogenous cell seeding. Remnant endothelium after stenting enhances vascular repair. Circulation. 1996;94:2909-2914.
  17. Finet G et al. Comparison of luminal enlargement by direct coronary stenting versus predilatation coronary stenting by three-dimentional volumetric intravascular analysis. Am J Cardiol. 2001;88:1179-1182.
  18. 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.
  19. Diletti R et al. Clinical and angiographic outcomes following first-in-man implantation of a novel thin-strut low-profile fixed-wire stent: the Svelte coronary stent Integrated Delivery System first-in-man trial. EuroIntervention. 2013;9:125-134.
  20. Devito F et al. Evaluation of the safety and efficacy of the novel Svelte Acrobat Integrated Delivery System via radial approach with 5 French catheters. J Invasive Cardiol. 2015;27:Epub ahead of print.
  21. Khattab A et al. New approach to direct stenting using a novel “all-in-one” coronary stent system via 5 French diagnostic catheters: a pilot study. Cath and Cardiovasc Interv. 2013;82:E403-E410.
  22. Verheye S et al. 12-Month outcomes from the DIRECT II randomized, controlled clinical study presented at EuroPCR 2015.
  23. Khattab A et al. Svelte Integrated Delivery System performance examined through diagnostic coronary catheter delivery: the SPEED registry. Cath and Cardiovasc Interv. 2015;85:E23-E31.

* Data on file at Svelte.  The DIRECT I and DIRECT II clinical studies.

 

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.