19 aimradial2016 thu S Lavi PRACTICAL study

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International Chair on Interventional Cardiology and Transradial Approach

This study compared radial artery clamp times of 20 minutes versus 60 minutes after transradial cardiac catheterization. The primary outcome was radial artery occlusion (RAO) on the same day. Secondary outcomes included hemostasis and RAO at 1 week. The study found no difference in same day or 1 week RAO between groups. However, the 20 minute clamp time required more retightening and was associated with more bleeding and hematomas. Thus, the investigators concluded that a 60 minute clamp duration is preferable to an ultra-short 20 minute duration following transradial cardiac catheterization.

Health & Medicine

Postcath Radial Arterial
Clamp Time In the Cath Lab
S. Lavi, A. Cheema, A. Yadegari, J. Syed, Z. Israeli, Y. Levi, S. Wall,
M. Alemayehu, Y. Parviz, B. Murariu, T. McPherson, R. Bagur
London Health Sciences Centre, Ontario, Canada

Radial Artery Occlusion (RAO)
• Uncommon but not rare
• Usually clinically silent
• Potentially clinically significant
– Ischemic symptoms of hand
– Precludes use of artery for future procedures

Increased with:
- Large catheters
- No anticoagulation
- Prolonged compression
Reduced with:
- Patent hemostasis
- Vasodilators
Radial Artery Occlusion (RAO) RiskRISK

Radial Artery Clamp Duration
Bleed
RAO
Optimal compression duration
• Current practice variable
• Most start to release clamp after 2-4 h
• In our institution 15-180 mins
• No “standard” time exists

Aim
• Assess the safety and efficacy of ultra-short
duration of clamp application after TRA

Study Methods
• RCT
• 2 sites: LHSC and St. Mikes
• Inclusion criteria:
– Elective & ACS patients
– Patency of ulnopalmar circulation (Barbeau type A, B,
C)
• Exclusion criteria
– Urgent cath (STEMI)
– Barbeau type D
– Prior RAO
– Prior surgery close to access site

Protocol
• Standard techniques, diagnostic or PCI
• 5 or 6 F sheath
• Intra-arterial nitroglycerin 200 mcg and
Verapamil 2.5 mg
• UFH 50 units/kg for diagnostic. 70 units/kg &
according to ACT for PCI
• Procedure completed prior to randomization
• Patent hemostasis

Hemostatic Clamp (RadARTM)
• Clamp at full pressure
– 20 vs. 60 mins
– Patent hemostasis
• 5 min timer

Clamp Removal
Clamp
Applied
Clamp
Removed1
Releases
20 5
2
5
3
5
4
5
Clamp
Applied
60
Clamp
Removed1
Releases
5
2
5
3
5
4
5

Clamp Removal
• Document bleeding during/after release
– Retighten x 10 mins
– Restart 20 min release procedure (q 5 mins x 4)

Study endpoints
• Primary : RAO same day (pulse-oximeter and a
reverse Barbeau ± US)
• Hemostasis- EASY scale
• RAO at 1 week

Baseline Clinical Characteristics
20 minutes (n=283) 60 minutes (n=285)
Age 64.7±12 63.8±10.1
Females 28.6 % 30.9 %
BMI (kg/m2) 32.2±18.2 30.4±8.96
Hypertension 73.5 % 73 %
Diabetes 29.3 % 27 %
Creatinine (µmol/L) 84.5±32.8 87.2±43.2
Prior PCI 16.3 % 18.9 %
Prior radial approach 9.2 % 13.7 %
Barbeau’s type
A / B 87.6 % 91.2 %
C 3.5% 1.8 %

Procedural characteristics
20 minutes (n=283) 60 minutes (n=285)
Sheath size 5/6 33 / 67 % 35 / 65 %
PCI 27.6 % 27.0 %
UFH 99.6 % 99.6 %
GP IIbIIIa 4.9 % 3.9 %
Bivalirudin 0 0
Clopidogrel 41.3 % 43.2 %
Ticagrelor / prasugrel 8.8 % 8.8%
Aspirin 92.2 % 89.8 %

Results - RAO
0
1
2
3
4
5
Same day 1 week
4.9
2.92.8
0.9
20 min
60 min
P=0.19
P=0.36
%

Hemostasis during clamp
0
1
2
3
Hematoma < 5 cm Hematoma > 5cm
1.4
0.4
2.5
1.4 20 min
60 min
P=0.37
P=0.37
%

Hemostasis following clamp removal
0
2
4
6
8
10
Hematoma < 5 cm Hematoma > 5cm
6.7
1.8
2.5
1.4
20 min
60 min
P=0.01 P=0.75
%

Hemostasis
0
2
4
6
8
10
12
14
16
18
20
22
Any bleeding Retightening
19.8 20.5
14
12.3
20 min
60 min
P=0.13 P<0.01
%

Summary
• Ultra-short clamp release after 20 minutes
post TRA is not associated with reduction in
the incidence of RAO
• Rapid release required more retightening of
the clamp
• Rapid release associated with more bleeding
or hematoma.
• Retightening was independent predictor for
RAO

Conclusion
• The short (60 min) clamp duration is
preferable compared to the ultra-short (20
min)

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1) Post-operative radiotherapy (PORT) can reduce the risk of prostate cancer recurrence after radical prostatectomy for patients with adverse features like positive surgical margins or extracapsular extension. 2) Large randomized trials have shown that adjuvant radiotherapy (ART) within 6 months of surgery improves outcomes compared to observation or early salvage radiotherapy initiated at first signs of recurrence. 3) Salvage radiotherapy is an option for patients with rising PSA after surgery but no metastases, and can improve biochemical progression-free survival and cancer-specific survival when initiated promptly at low PSA levels.

Endovenous or surgical treatment of cvi

uvcd

This document discusses various treatment options for chronic venous insufficiency (CVI), including endovenous ablation techniques (radiofrequency ablation (RFA) and endovenous laser ablation (EVLA)) and surgical treatment. It provides data on the increasing use of RFA and EVLA compared to surgery based on number of procedures performed in the US from 2002-2008. It summarizes evidence that RFA and EVLA provide similar clinical results as surgery with less post-operative pain, faster recovery times, and earlier return to normal activities. However, long-term data on recurrence rates beyond 3 years is still limited.

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PCI & AimRadial 2018 | Innovation in Cardiovascular Medicine - Tim A. Fischell

International Chair on Interventional Cardiology and Transradial Approach

This document summarizes Tim Fischell's presentation on innovation in cardiovascular medicine. It discusses Fischell's history of medical device innovations, including the Arrow-Fischell sheath, brachytherapy devices, stents, and the AngelMed Guardian system. It provides guidance on developing new ideas into real innovations, including evaluating intellectual property, regulatory pathways, prototype testing, and clinical trials. Fischell emphasizes the importance of understanding unmet clinical needs and having a team approach to translating ideas into impactful new technologies.

PCI & AimRadial 2018 | A novel stent concept for South America - Ramses Galaz

International Chair on Interventional Cardiology and Transradial Approach

This document discusses opportunities for developing and manufacturing medical devices in Latin America, including coronary stents with an estimated $500M annual market. It outlines the roadmap needed to design, test, manufacture, and gain regulatory approval for a novel stent concept, including requirements for structure and flow, deployability and patency, and clinical performance. Design considerations are discussed such as structural rigidity, flexural rigidity, surface finish, and hemodynamic simulations. The potential for low-cost manufacturing and animal studies are also mentioned.

PCI & AimRadial 2018 | Biomechanics of biodegradable stents: a primer for car...

International Chair on Interventional Cardiology and Transradial Approach

PCI & AimRadial 2018 | Radial vs Femoral: Review of the Evidence in 2018 - Ia...

International Chair on Interventional Cardiology and Transradial Approach

This document summarizes the evidence from multiple randomized clinical trials that support a Class IA recommendation for the use of radial artery access (TRA) over femoral artery access (TFA) for cardiac catheterization procedures. The data show that TRA is associated with lower rates of major vascular complications and major bleeding compared to TFA, with numbers needed to treat of 21 and 47 respectively. TRA may also reduce mortality in patients with acute coronary syndrome, with a number needed to treat of 100. Both the 2018 AHA guidelines and ESC/EACTS guidelines were updated to strongly recommend a radial-first approach in light of the overwhelming data demonstrating benefits of TRA over TFA.

PCI & AimRadial 2018 | Best practices in same day discharge - Ivo Bernat

International Chair on Interventional Cardiology and Transradial Approach

This document discusses best practices for same day discharge after cardiac procedures. It provides an overview of the history and evidence supporting same day discharge. Key points include: - Same day discharge has been shown to be safe and effective in studies dating back to the 1990s. - Dedicated lounges and infrastructure improve outcomes for same day discharge by allowing for close monitoring and care in the immediate post-procedure period. - The author's hospital has successfully performed over 7,000 same day discharge procedures over 10 years using a dedicated radial lounge with trained nursing staff who provide care and arrange discharge. Complication rates are low with their protocol.

PCI & AimRadial 2018 | Even the big boss fail - Zoltán Ruzsa

International Chair on Interventional Cardiology and Transradial Approach

This document describes a case of critical hand ischemia treated through multiple endovascular interventions over several years. Initially, the patient underwent brachial artery recanalization and stenting from left radial access, but presented two days later with stent thrombosis. A second procedure recanalized the stent and treated a brachial dissection with another stent. However, two years later the patient returned with re-occlusion of arm vessels and iliac arteries. Further interventions were needed to recanalize stenosed iliac and brachial arteries over time. In conclusion, long term patency of arm interventions is unknown, and stent CTO recanalization in the arms poses similar challenges to the legs.

PCI & AimRadial 2018 | Contemporary Transradial Access Practices: Results of ...

International Chair on Interventional Cardiology and Transradial Approach

PCI & AimRadial 2018 | A Growing Population in the Cath Lab: Patient Identifi...

International Chair on Interventional Cardiology and Transradial Approach

This document discusses expanding the FDA indication for protected PCI procedures using the Impella heart pump. Key points include: 1. A study of 891 patients found that those with mildly/moderately reduced ejection fraction (LVEF >35%) undergoing protected PCI had favorable outcomes similar to those with severely reduced LVEF, despite being older with more comorbidities and complex coronary disease. 2. Protected PCI with Impella led to improved LVEF and quality of life in multiple studies. The Protect II trial showed Impella reduced MACCE by 29% compared to IABP at 30 days. 3. Guidelines recommend protected PCI for patients with severe/moderate/mild reduced LVE

PCI & AimRadial 2018 | Treating Cardiogenic Shock with Impella with Escalatio...

International Chair on Interventional Cardiology and Transradial Approach

PCI & AimRadial 2018 | LEFT MAIN PCILessons from the BCIS registry - Jim Nolan

International Chair on Interventional Cardiology and Transradial Approach

This document summarizes the findings of a study analyzing 19,482 left main stem percutaneous coronary intervention (LMS-PCI) procedures from the British Cardiovascular Intervention Society National Database between 2007-2014: 1) Use of radial artery access for LMS-PCI increased significantly over time and radial access was associated with reduced vascular complications, major bleeding, and shorter hospital stays. 2) Radial access was independently associated with lower in-hospital mortality and major adverse cardiac and cerebrovascular events (MACE) compared to femoral access. 3) Independent predictors of 12-month mortality following LMS-PCI included acute kidney injury, older age, chronic renal failure, acute coronary syndrome presentation, and

PCI & AimRadial 2018 | Left Ventricular Endomyocardial Biopsy by Transradial...

International Chair on Interventional Cardiology and Transradial Approach

PCI & AimRadial 2018 | Right Heart Access by Radial - Ian C Gilchrist

International Chair on Interventional Cardiology and Transradial Approach

This document discusses accessing the right heart and central venous system through the radial vein as a safer alternative to traditional femoral access. It provides tips for establishing venous access through the forearm, including using ultrasound or no-touch technology to locate veins and heparin locks to improve efficiency. Challenges like low venous pressure, valves, and junctions are addressed. Images demonstrate techniques for navigating the radial artery into the right atrium, including using flushes of saline. Potential contraindications like arm trauma or breast cancer are noted. The document argues learning both arterial and venous radial techniques will improve cardiologist skills and safety.

PCI & AimRadial 2018 | Radial Artery Puncture - Ian C Gilchrist

International Chair on Interventional Cardiology and Transradial Approach

This document discusses techniques for radial artery puncture for cardiovascular procedures. It notes that the radial artery is smaller in diameter than the femoral artery. Successful radial access requires correctly positioning and securing the wrist. Ultrasound guidance can help find and access the radial artery, especially for trainees. The initial puncture approach can be anterior wall only or use a counterpuncture technique. Sheath size, length, and coating impact radial artery spasm and occlusion. Cocktails including nitroglycerine and calcium channel blockers are commonly used but acid in the cocktail may damage the artery if felt by the patient.

PCI & AimRadial 2018 | Post-PCI FFR: Time is coming - Olivier F. Bertrand

International Chair on Interventional Cardiology and Transradial Approach

This document summarizes a presentation given by Dr. Olivier Bertrand on post-PCI FFR measurement. It discusses studies showing that a post-PCI FFR of 0.90 or higher is associated with lower rates of re-PCI and major adverse cardiac events. It then outlines the proposed PREDICT randomized study to evaluate whether routine post-PCI FFR measurement can guide PCI strategy and completion. The study would measure FFR after successful PCI in all-comers and randomize patients to clinical follow-up alone or with guidance from the post-PCI FFR results. The goal is to establish if physiology-guided PCI optimization can improve outcomes and reduce costs.

PCI & AimRadial 2018 | Lessons from iFR-SWEDEHEART and DEFINE-FLAIR - Hitoshi...

International Chair on Interventional Cardiology and Transradial Approach

This document summarizes lessons learned from the DEFINE-FLAIR and iFR-SWEDEHEART clinical trials. The trials found: 1) Decision-making based on instantaneous wave-free ratio (iFR) was non-inferior to fractional flow reserve (FFR) for guiding revascularization and reducing major adverse cardiac events over 1-2 years. 2) iFR-guided decisions resulted in significantly less revascularization procedures compared to FFR. 3) Subgroup analysis found increased event rates among diabetic patients evaluated with FFR compared to iFR. 4) iFR has been upgraded to a Class IA recommendation in European Society of Cardiology guidelines based on these trials

PCI & AimRadial 2018 | Use of physiology in ACS - Colin Berry

International Chair on Interventional Cardiology and Transradial Approach

1. The document discusses the use of physiology in acute coronary syndrome (ACS) patients, including trials evaluating fractional flow reserve (FFR) and index myocardial resistance (IMR) measurements. 2. Several trials showed that FFR-guided revascularization in multivessel disease STEMI patients reduced major cardiac events compared to culprit-only PCI or medical therapy. Ongoing trials are further evaluating FFR in ACS. 3. IMR predicts mortality and heart failure in STEMI patients and adversely remodeling post-STEMI. 4. Incomplete revascularization is common in ACS and associated with worse outcomes; FFR may help guide more complete revascularization. The clinical utility of physiology in ACS

PCI & AimRadial 2018 | FFR using 4Fr catheters: Can Slender Technique Work He...

International Chair on Interventional Cardiology and Transradial Approach

This document discusses the potential use of 4 French (4F) catheters for fractional flow reserve (FFR) measurements as a less invasive alternative to larger catheters. It notes that 4F catheters have a smaller profile but can lack the ability to directly perform percutaneous coronary intervention if needed. The document outlines key considerations for using 4F catheters, including ensuring the catheter lumen is well flushed and the pressure transducer is not damped. It concludes that improvements are still needed, such as reducing friction between the pressure wire and catheter, in order to maximize the benefits of using the smallest catheter size possible.

PCI & AimRadial 2018 | FFR in Left Main Disease - William F. Fearon

International Chair on Interventional Cardiology and Transradial Approach

This document discusses using fractional flow reserve (FFR) to evaluate ambiguous left main coronary artery disease. It presents a case of an 82-year-old woman with chest pain and a recent stent in the circumflex artery. FFR measurements of the left main and left anterior descending artery were 0.64, indicating significance. Intravascular ultrasound also suggested significance. The left main and proximal left anterior descending artery were stented, and post-procedure FFR measurements improved. The document reviews evidence that FFR can safely guide decisions about revascularization of ambiguous left main lesions.

PCI & AimRadial 2018 | FFR-CT - Colin Berry

International Chair on Interventional Cardiology and Transradial Approach

This document summarizes a presentation on CT-derived fractional flow reserve (FFR-CT). It discusses how FFR-CT increases the positive predictive value of coronary CT angiography (CTCA). Several landmark studies are summarized that evaluated the diagnostic accuracy of FFR-CT compared to CTCA. The PACIFIC trial findings showing high diagnostic accuracy of FFR-CT are described. Ongoing and upcoming clinical trials using FFR-CT like PRECISION and DECISION are mentioned. Novel applications of FFR-CT for biomechanics analysis and PCI planning are presented. Finally, new methods like user-generated CT-FFR that may reduce processing time are introduced, though accuracy needs further evaluation.

PCI & AimRadial 2018 | Image based FFR during coronary angiography - Hitoshi...

International Chair on Interventional Cardiology and Transradial Approach

This document summarizes the results of a study evaluating the diagnostic accuracy of quantitative flow ratio (QFR) compared to fractional flow reserve (FFR) as the reference standard. The study included 317 lesions in 273 patients. Key results included: - QFR showed superior sensitivity and specificity for detecting functionally significant lesions compared to 2D quantitative coronary angiography. - QFR values correlated well with invasive FFR measurements. - QFR could be computed within a similar time frame as FFR measurements. - A hybrid approach using QFR and FFR may allow pressure wire-free assessment in 68% of lesions while maintaining high diagnostic accuracy.

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