Rationale and design of a randomized study comparing the agent drug coated balloon to plain old balloon angioplasty in patients with In-stent restenosis.

BACKGROUND: Drug-coated balloon (DCB) technology was developed as an alternative treatment for obstructive coronary artery disease (CAD) and in-stent restenosis (ISR). Management of coronary ISR is clinically challenging and frequently encountered in practice. The Agent DCB uses an inactive excipient to effectively deliver a targeted, therapeutic dose of paclitaxel to the vessel wall. STUDY DESIGN: AGENT IDE is a prospective, multicenter, randomized controlled trial to evaluate superiority of the Agent DCB to balloon angioplasty in treating patients with ISR. A total of 480 patients with ISR of a previously treated lesion length <26 mm and reference vessel diameter >2.0 mm to ≤4.0 mm will be initially randomized. Subjects presenting with recent myocardial infarction (MI), complex lesions, or thrombus in the target vessel will be excluded. An adaptive group sequential design with one formal interim analysis for sample size re-estimation will be conducted, and the sample size may be increased to a maximum of 600 subjects. The primary endpoint is the rate of 12-month target lesion failure (TLF; composite of any ischemia-driven revascularization of the target lesion (TLR), target vessel related MI, or cardiac death) and will be tested for superiority in the test arm against the control. Functional status and general health-related quality of life will be measured by changes in the EQ-5D scores. Subjects will be followed for 5 years following the index procedure. CONCLUSION: This study will prospectively evaluate the safety and efficacy of Agent DCB in patients treated for coronary ISR.

Medical Devices; Cardiovascular Devices; Classification of the Temporary Catheter for Embolic Protection During Transcatheter Intracardiac Procedures. Final order.

The Food and Drug Administration (FDA or we) is classifying the temporary catheter for embolic protection during transcatheter intracardiac procedures into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the temporary catheter for embolic protection during transcatheter intracardiac procedures' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Transradial Coronary Angiography--Insights to the One-Catheter Concept.

Transradial coronary angiography (TRC) can be performed applying only one catheter fitting into the right and left coronary ostia (R/LCO). In this bicentric study (n = 2953), we analyzed the ostial performance of the Tiger_II_catheter widely used in TRC. Compared to Judkins catheters, the Tiger_II is frequently associated with ostial instability within the LCO but fits better into the RCO-irrespective of tube size. Judkins catheters generally need more peri-procedural contrast and radiation exposure. TRC may be started using a 5F_Tiger_II on the right side in order to be switched to 5F Judkins in case of propable LCO instability.

Safety and efficacy of second-generation versus first-generation cryoballoons for treatment of atrial fibrillation: a meta-analysis of current evidence.

BACKGROUND: The newer second-generation cryoballoons (CB-2 or Arc-Adv-CB) have been shown to achieve significantly lower temperature and faster pulmonary vein isolation (PVI) time in comparison with first-generation cryoballoons (CB-1 or Arc-CB). To test the premise that second-generation cryoballoons can improve clinical outcomes in comparison to first-generation cryoballoons in terms of safety and efficacy, we pooled data for systemic review and meta-analyses from all available literature comparing their clinical performance. METHODS: The Cochrane Library, PubMed, Google Scholar, and studies presented at various meetings were searched for any published literature comparing safety and efficacy of the second-generation cryoballoons (Arctic Front Advance cryoballoons) with first-generation cryoballoons (Arctic Front Cryoballoons). A total of ten published studies, with 2310 patients, were included in this meta-analysis with 957 patients in second-generation cryoballoon group and 1237 patients in first-generation cryoballoon group. RESULTS: The pooled analysis showed significant superiority of second-generation cryoballoons in terms of less procedure time, less fluoroscopic time, and fewer incidences of arrhythmia recurrences compared to first-generation cryoballoons at the cost of higher incidence of persistent and transient phrenic nerve palsy. The differences in the rate of pericardial effusion and incidence of access site complications were not statistically significant. CONCLUSIONS: Second-generation cryoballoons are associated with a shorter procedure time and fluoroscopy time, along with lower arrhythmia recurrence rates, reflecting higher procedure efficacy when compared to first-generation cryoballoons. However, they are also associated with a higher incidence of transient and persistent phrenic nerve palsies with a non-significant difference in rates of access site complications and pericardial effusion.

Clinical and Procedural Outcomes of 5-French versus 6-French Sheaths in Transradial Coronary Interventions.

The radial artery has been increasingly used for its favorable safety profile. However, no conclusive data are available on the optimal sheath size. In particular, it is seemingly difficult to weight both advantages and disadvantages of narrower versus larger sheaths size. Despite several studies were performed to compare the use of 6-Fr to the smaller 5-Fr sheaths, these were mostly small, single center-studies, yielding various results.We performed a comprehensive meta-analysis of all available studies comparing the use of 5-Fr versus 6-Fr sheaths in coronary procedures through the TRA.Studies comparing a 5-Fr versus a 6-Fr sheaths were searched for in PubMed, the Cochrane Library, and ISI Web of Knowledge databases.Studies were deemed eligible if they only included patients undergoing transradial cardiac catheterization with 5-Fr or 6-Fr system and reported at least one of these parameters: contrast dye volume, procedural success, procedural time, access complications, radial artery occlusion, and bleedings.Odds ratio (OR) and the mean difference (MD) were respectively used for dichotomous and continuous variables as summary measures. Both the random-effects model and the fixed effect models were used for computation of meta-analyses. Heterogeneity was assessed by means of the Cochrane Q test. Metaregression was calculated using the unrestricted maximal likelihood random effects model.The use of a 5-Fr system is associated with a significant lower contrast medium administration (MD = -22.20 [-36.43 to -7.96], P < 0.01) and significantly reduces bleedings (OR = 0.58 [0.38-0.90], P = 0.02), without compromising procedural success (OR = 0.95 [0.53-1.69], P = 0.86) or procedure length (OR = 0.55 [-2.58 to 3.69], P = 0.73), compared to the 6-Fr system. Despite no significant difference was observed between the groups (OR = 0.88 [0.50-1.56], P = 0.67), at metaregression RAO incidence in the 5-Fr group was increasingly lower as the percentage of women included into the study increased (P = 0.02).Some potentially interesting technical details, such as sheath length, hydrophilic coating, or periprocedural anticoagulation, were not homogeneously reported in individual studies.Results of the present meta-analysis confirm the excellent safety profile of transradial procedures both with 5-Fr and 6-Fr system. A 5-Fr system could be preferred in patients with a higher bleeding propensity or kidney injury.

A new technique for coronary guide catheter exchange over coronary guidewire using GuideLiner catheter.

Guide catheter exchange over coronary guidewire can be challenging, yet is necessary in certain clinical scenarios. At the same time, maintaining coronary guidewire position across a predilated lesion is important to prevent vessel lumen closure. We present a technique of guide catheter exchange over a coronary guidewire with GuideLiner support.

The 4-in-5 mother-child technique: 5 Fr transradial coronary intervention for complex lesions using a 4 Fr child catheter.

Small 5 Fr guiding catheters are now used in percutaneous coronary intervention (PCI). However, when treating severely calcified and/or tortuous complex coronary lesions, the back-up support of a 5 Fr guiding catheter is often insufficient. We previously developed a 4 Fr child catheter (Kiwami ST-01; Terumo Corporation) and proposed a 4 Fr double-coaxial technique ("mother-child" configuration) to facilitate stent implantation in treating complex coronary lesions. In this manuscript, we report 2 cases of 5 Fr transradial coronary intervention in which stent delivery failed with conventional techniques. In these 2 cases, our 4 Fr double-coaxial technique was employed, and stents were successfully delivered to the target lesions. To the best of our knowledge, this is the first report demonstrating the potential of the 4-in-5 technique during 5 Fr PCI.

Challenges associated with use of the GuideLiner catheter in percutaneous coronary interventions.

The GuideLiner catheter is an easy-to-use guide catheter extension that can facilitate vessel engagement and equipment delivery. We present two cases that illustrate two potential challenges associated with use of the GuideLiner catheter: (1) stent loss and deformation during attempts to advance it through the GuideLiner catheter collar; and (2) displacement of the GuideLiner catheter distal marker into a coronary artery. Awareness of these potential complications may render safer the use of this valuable interventional tool.

An alternative approach in tortuous coronary artery and distal stenosis during transradial percutaneous coronary intervention: deep engagement by a 5-Fr guiding catheter.

Transradial approach for percutaneous interventions has emerged as an alternative to transfemoral access which is known to be more associated with vascular local complications. However, lack of guiding-catheter support via the radial access is one of the problems encountering the operators. Many solutions have been proposed to overcome this problem. We report on a 62-year-old man with tight stenosis of the distal part of the right coronary artery. He underwent coronary angiography and then percutaneous angioplasty via the right radial artery. During the procedure, attempts to advance a stent beyond a tortuosity at the level of the second segment failed due to lack of support of the 6-Fr Judkins right 4 guiding catheter, even with the buddy wire technique. Then, switching to a 5-Fr Judkins right 4 guiding catheter allowed safe deep engagement and resulted in successful advancement and deployment of the stent.

Alternative method for accessing the target coronary artery in patients with difficult coronary anatomy: exchanging the diagnostic catheter with a guiding catheter.

We report a method of the placement of the guiding catheter in two cases in which the diagnostic catheter could be easily engaged to the target coronary arteries but not a guiding catheter, due to a distorted aortic sinus and an osteal subtotal occlusion, respectively. After engaging to the target coronary artery with a diagnostic catheter, a coronary guidewire was advanced through the diagnostic catheter, and exchanged with a guiding catheter over the guidewires. The procedures were completed with success.