Benefits

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Providers

Ultra-low profile Svelte technologies facilitate transradial access and direct stenting – enhancing patient comfort, improving clinical outcomes, and maximizing efficiency in resource utilization.

Optimizing patient outcomes has historically been a physician-centered concern. Today it is an institutional concern.

With stenting long established as the standard of care for Percutaneous Coronary Intervention (PCI), stent technologies and long-term clinical results have converged. Health economics play an increasingly important role in patient care. Within the realm of interventional cardiology, providers are shifting focus toward reducing bleeding complications and readmissions, enhancing patient experience and improving overall cath lab efficiency.

Achieving optimal outcomes AND lowering the costs of care define success in the modern healthcare environment. Those providing high quality of care with the greatest efficiency will be hailed as the leaders and best.

A Changing Landscape

Not long ago, focus in interventional cardiology was solely on improving patient outcomes – using the best available resources, irrespective of cost, to achieve optimal clinical results. Resource optimization – reducing material consumption, procedure times, time to patient ambulation and discharge…while improving lab turnover, personnel management and use of overhead expenses – was secondary in importance.

With better technologies and refined interventional techniques, achieving exceptional clinical outcomes is becoming more routine, allowing greater attention to be spent on resource optimization and cost reduction.

For providers, patient care is now a multi-faceted challenge:

  • Provide the best possible clinical outcomes
  • Enhance patient experience
  • Minimize complications leading to readmissions
  • Improve resource management and patient throughput
  • Lower the material costs of PCI

The ability to maintain exceptional clinical outcomes while lowering the cost of care define success in the modern healthcare environment.

Designed to extract time and cost from stenting procedures while providing optimal clinical outcomes, Svelte technologies address this unmet need.

Optimizing Clinical Outcomes

Bleeding after PCI is associated with mortality. In the hands of experienced transradial intervention (TRI) operators, large, randomized studies have shown that compared with the transfemoral approach, TRI reduces:

  • Bleeding complications and blood transfusions1-4
  • Morbidity and mortality4
  • Contrast administration5

These clinical benefits are even more pronounced in acute myocardial infarction (AMI) patients6. TRI also improves overall patient comfort while reducing time to ambulation and discharge7.

The SLENDER IDS drug-eluting stent-on-a-wire is the world’s lowest profile DES, attaining crimped areas approximately HALF those of conventional stents*.  It allows the use of smaller catheters to facilitate TRI across wider subsets of patients. Specialized design and materials also enable safe direct stenting across more challenging anatomy, which is associated with reductions in radiation exposure, death, MI and TLR8-10.

And as the only stent approved for use through diagnostic and smaller catheters (0.047” ID), SLENDER IDS gives operators the option to perform diagnostic angiography and seamlessly continue onto a therapeutic approach through the already engaged diagnostic catheter, simplifying PCI in appropriate lesions.

Although 50% of of investigators in Svelte clinical studies were first-time users of SLENDER IDS:

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

svelte-des-outcomes

State of the art engineering – Asahi wire tip technology, specilaized balloon designs and ultra-low profile fixed wire technology – makes SLENDER IDS the first material upgrade to DES delivery in 20 years and the only DES able to reduce catheter size and facilitate a transradial and direct stenting approach consistently across wider groups of patients.

SLENDER IDS – Enhancing Patient Experience

Beyond the all-important aspect of patient outcomes, however, lies the often underappreciated issue of patient comfort. In the era of the internet, patient experience is more widely shared than ever before on patient forums, blogs and consumer websites, significantly impacting provider perception.

The HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) survey, regulated by the Centers for Medicare & Medicaid Services (CMS), 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 care.

Patients undergoing TRI as opposed to intervention via transfemoral approach expressed strong preference toward TRI across most quality of life assessments. 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)7.

And with patients suffering from left ventricular dysfunction, lung disease, back and/or hip pain, the extended bed rest required to achieve femoral hemostasis is particularly poorly tolerated.

TRI is the standard of care in Europe and much of Asia11. Its adoption in the US is expanding significantly, driven in no small part by its ability to enhance overall patient experience.

And as proficiency with TRI is achieved, the development of outpatient programs for PCI is the next logical step, given the ability of TRI to improve patient satisfaction and bed turnover while reducing the cost of cardiac care. In fact, same-day discharge is already occurring with increasing frequency in parts of Europe and North America where TRI is the current standard of care11.

The ability to enhance patient experience and facilitate outpatient procedures is shifting referral patterns in these areas, as empowered patients are increasingly aware of the therapeutic options available to them.

Cath labs at the forefront of innovation seeking improved patient experience and striving to optimize operational efficiencies are increasingly turning to TRI.  The SLENDER IDS stent-on-a-wire is the world’s lowest profile DES, attaining profiles approximately ½ those of conventional stents*, and is designed to facilitate the transradial approach in more patients.

With its ultra-low profile, SLENDER IDS allows physicians to downsize catheter size, reducing the risk of bleeding complications and enhancing patient comfort peri-and-post procedurally via TRI while reducing time to ambulation and better enabling same-day patient discharge.

Minimizing Complications Leading to Readmissions

Bleeding driven by vascular access complications significantly increases the risk of morbidity and mortality in patients and is a leading cause of patient readmissions following PCI.

Avoidable readmissions are a continuing major financial problem for the US healthcare system; one return trip to the hospital more than doubles the cost of care for Medicare patients undergoing PCI and receiving a DES, increasing costs from approximately $15,000 for an episode of care to $31,000 with a single readmission12.

Since 2009 the Centers for Medicare and Medicaid Services (CMS) are publicly reporting hospital readmission rates to increase the transparency of hospital care, with the goal of helping consumers choose a care venue while providing 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.  Today it is estimated 78% of hospitals are assessed some level of penalty by CMS13. And, HRRP is expected to expand in the coming years to include penalties for PCI readmissions.

In multiple large, randomized clinical studies, TRI has consistently demonstrated reduced bleeding complications compared with the transfemoral approach1-4, including in high-risk patients presenting with AMI5-6.  Utilizing TRI alone may reduce bleeding complications and subsequent readmissions associated with PCI by 10%14.

Ultra-low profile Svelte technologies reduce the catheter access size necessary to perform PCI, facilitating the transradial approach in greater subsets of patients (females, elders, diabetics, etc.). Reducing vascular access complications, shortening lab time, minimizing radiation exposure, and simplifying the treatment of complex lesions are all tangible benefits of Svelte technologies.

Improving Resource Management and Patient Throughput

In addition to important clinical benefits, TRI and direct stenting also positively impact the efficiency with which care is administered.

Unlike transfemoral access, where bed rest up to 6 hours following PCI is common, patients undergoing TRI are ambulated much faster, clearing bed space, enabling quicker time to discharge and enhancing facility throughput. Multiple studies have shown the ability of TRI to reduce time to hemostasis, ambulation and discharge5-7. And patients treated via TRI have less need for assistance post PCI – there is no need for manual compression and typically less pain medication and/or physician consultation required during bed rest and recovery.

Direct stenting reduces the steps involved with a conventional approach to PCI, reducing procedural steps, contrast use (and the risk of contrast-induced nephropathy for renal-impaired patients) and procedure times8.

TRI and use of a direct stenting approach to PCI facilitates lower cost of care with important benefits including

  • Reductions in radiation exposure and procedure time4-5
  • Greater patient comfort and quicker time to ambulation and hospital discharge7
  • 10-15% lower procedure cost15

Savings manifest themselves peri and post-procedurally.  Patients undergoing TRI are more quickly ambulated, more quickly discharged, experience lower complications and bleeding events, do not require manual compression or closure devices and do not require as much medication for discomfort and anxiety associated with achieving femoral hemostasis.

Svelte technologies are specifically designed to optimize TRI and direct stenting, allowing patients to realize quicker procedures and time to ambulation with enhanced clinical outcomes compared with conventional stenting.  Conventional approaches using Rapid-Exchange (RX) platforms require multiple steps and product exchanges when performing PCI.

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%16,17
  • Procedure and device time 20 – 55%18,19
  • Material costs $119 – $592 per case16,17,20

Downsizing catheters and extracting steps from stenting procedures contribute to reducing vascular access complications, shortening lab time, minimizing radiation exposure and simplifying the treatment of complex lesions. These are all tangible benefits of Svelte technologies which are designed to add value and extract time and cost from stenting procedures while enhancing patient care.

By combining a guide wire, balloon and stent into a single ‘all-in-one’ system, Svelte technologies streamline stenting procedures and achieve efficiencies unlike any other DES. Facilitating TRI and a direct stenting approach to PCI across wider subsets of patients, Svelte technologies provide exceptional clinical outcomes while enhancing procedural efficiency.

Facilitating TRI and a direct stenting approach to PCI across wider subsets of patients, Svelte technologies provide exceptional clinical outcomes while enhancing procedural efficiency.

Enhance Patient Comfort.  Optimize Outcomes.  Improve Efficiency.

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. 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.
  3. 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.
  4. 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.
  5. 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.
  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. 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.
  8. Caluk J et al. Direct coronary stenting in reducing radiation and radiocontrast consumption. Radiol Oncol. 2010 Sep;44(3): 153-7.
  9. 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. 2010;96:588-594.
  10. Ormiston, J et al. Direct stenting with the taxus liberte drug-eluting stent: results from the taxus atlas direct stent study. J Am Coll Cardiol Intv. 2008;1(2):150-160.
  11. 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.
  12. Dobson, DaVanzo et al. Baseline statistics of acute care hospital readmissions by episode type for select MS-DRGs and chronic conditions: a working paper analysis commissioned by the Alliance for Home Health Quality and Innovation (AHHQI). July 18, 2012.
  13. Dalton K. CMS penalties spur efforts to reduce 30-day hospital readmissions. Data from the American Hospital Association.  http://www.tctmd.com/show.aspx?id=129821.  July 20, 2015.
  14. Wasfy J et al. Clinical preventability of 30-day readmission after percutaneous coronary intervention. J Am Heart Assoc. 2014;3:e001290.
  15. Mitchell M et al. Systematic review and cost-benefit analysis of radial artery access for coronary angiography and intervention. Circ Cardiovasc Qual Outcomes. 2012;5:454-462.
  16. 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. 2013;9:125-134.
  17. 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.
  18. 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.
  19. Verehey S et al. 12-Month outcomes from the DIRECT II randomized, controlled clinical study presented at EuroPcr 2015.
  20. 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.

  DIRECT I clinical study.

 DIRECT II clinical study.

 

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.