In Brief: Original Research Abstracts from the Journal of Invasive Cardiology

Safety and Efficacy of Cutting Balloon Angioplasty:The Mayo Clinic Experience James L. Orford, MBChB, MPH, Panayotis Fasseas, MD, Ali E. Denktas, MD, LaVon Hammes, Kirk N. Garratt, MD, Peter B. Berger, MD, David R. Holmes, MD, Gregory W. Barsness, MD From the Division of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota. ABSTRACT: A number of evolving clinical indications for cutting balloon angioplasty (CBA) have been described in the clinical literature, including angioplasty-resistant stenoses, in-stent restenosis, ostial lesions and small vessel disease. Methods. We analyzed the Mayo Clinic PTCA registry and report procedural and in-hospital clinical outcomes in 100 patients (103 procedures, 114 lesions) undergoing CBA. Results. CBA was successfully completed in 109 lesions (96%). The majority of lesions (73%) required additional treatment with either balloon angioplasty (39%) or stent implantation (34%). Severe intimal dissection resulting in at least 50% luminal obstruction occurred in 13 lesions (11%). A single incident of branch occlusion was documented, resulting in ST elevation myocardial infarction. There were no incidents of vessel perforation, urgent percutaneous or surgical target vessel revascularization, or in-hospital death. Conclusion. CBA is feasible and safe, with a low incidence of procedural complications and in-hospital adverse cardiac events when used primarily for in-stent restenosis. J INVAS CARDIOL 2002;14:720-724 Immediate Ambulation Following Diagnostic Coronary Angiography Procedures Utilizing a Vascular Closure Device (The Closer) Christopher H. Crocker, PAC, MPAS, Kevin T. Cragun, MD, Farris K. Timimi, MD, Robert J. Houlihan, MD, Malcolm R. Bell, MD, Ryan J. Lennon, Kirk N. Garratt, MD, David R. Holmes, MD, Henry H. Ting, MD, MBA From the Division of Cardiovascular Diseases and Internal Medicine, Mayo Clinic and Mayo Foundation, Rochester, Minnesota. ABSTRACT: Objective. We investigated the safety and efficacy of The Closer, a suture-mediated vascular closure device, to facilitate immediate ambulation after diagnostic coronary angiography. Methods and Results. We identified 487 non-consecutive patients who were eligible for an immediate ambulation protocol following vascular closure after diagnostic coronary angiography. A total of 434 patients (89%) were allowed immediate ambulation (mean time, 6.3 ± 2.4 minutes) and 34 patients (7%) were treated with intermediate duration bed rest (mean time, 105.2 ± 55.3 minutes). Of the 34 patients treated with intermediate duration bed rest, ten had minor bleeding from the arterial access tract requiring 2-5 minutes of light compression and 24 were delayed secondary to physician preference. Nineteen patients (4%) failed to achieve hemostasis with The Closer. Outpatients were followed up at 24 hours, and inpatients were followed up the next morning. Four patients (0.8%) suffered recurrent femoral artery bleeds after initially successful vascular closure. Three recurrent bleeds occurred during the observation period in-hospital and one occurred 6 days after device deployment. At follow-up, no patients developed the following: hematoma > 4 cm, ipsilateral retroperitoneal bleed, arterio-venous fistula, pseudoaneurysm, access site infection or loss of distal pulses. No patients had lower extremity ischemia or required blood transfusion. Conclusion. Use of The Closer after diagnostic angiography with subsequent immediate ambulation is safe and effective for most patients. Overall, hemostasis was achieved in 96% of patients, with 89% of our patients able to ambulate immediately and 7% able to ambulate after intermediate duration bed rest. J INVAS CARDIOL 2002;14:728-732 Treatment of Coronary Bifurcation Lesions by Stent Implantation Only in Parent Vessel and Angioplasty in Sidebranch: Immediate and Long-Term Outcome Pavel Cervinka, MD, Joseph Stasek, Miloslav Pleskot, Jaroslav Maly From the Faculty Hospital Hradec Kralove, 2nd Department of Medicine, Czech Republic. ABSTRACT: The aim of this study was to evaluate the immediate and long-term outcome of intracoronary stent implantation for the treatment of bifurcation lesions. We treated 30 patients with bifurcation stenosis with the Bx Velocity stent implanted only in the parent vessel and with balloon angioplasty of the sidebranch. Angiographic success was 86.7% (n = 26 patients) in both branches and 100% in the main branch. Clinical success was achieved in 29 patients (96.7%). One patient (3.3%) suffered from a small non-Q wave myocardial infarction. All 30 patients underwent control coronary angiography at 6 months unless performed earlier due to symptoms. After the 6-month follow-up, a total of 27 patients (90%) were asymptomatic; angiographic restenosis (> 50%) was found in four cases (13.3%). There was no sidebranch restenosis. During the follow-up, one patient (3.3%) had unstable angina and angiography revealed severe diffuse restenosis within the whole stent; this patient was referred for coronary artery bypass surgery. Two patients had mild angina (Canadian Cardiovascular Society Class II) and 1 patient had silent ischemia during exercise stress test. These patients underwent repeat coronary angioplasty. The rate of major adverse cardiac events was 16.6% and target vessel revascularization rate was 13.3%. We concluded that stent implantation only in the parent vessel with angioplasty of the sidebranch in bifurcation lesions is safe and has a high clinical success rate and low rate of target lesion revascularization. J INVAS CARDIOL 2002;14:735-740 Safety and Efficacy of a 6 French Perclose Arterial Suturing Device Following Percutaneous Coronary Interventions: A Pilot Evaluation Ran Kornowski, MD, Simcha Brandes, MD, Igal Teplitsky, MD, Eldad Rechavia, MD, Nurit Shor, RN, BA, Alexander Battler, MD, Abid Assali, MD From the Cardiac Catheterization Laboratories, Cardiology Department, Rabin Medical Center, Petach Tikva, and Sackler Faculty of Medicine, Tel Aviv University, Israel. ABSTRACT: Background. Arterial access site management after percutaneous coronary intervention (PCI) is a matter of increasing importance in this era of potent antiplatelet pharmacotherapy. We evaluated the safety and efficacy of a 6 French (Fr) Perclose suturing device in achieving rapid hemostasis of the access site after PCI and thus improving patient comfort. Methods. The 6 Fr Perclose (Prostar) device consists of a suture-based closure device delivered via introducer sheath designed for suturing of the arteriotomy puncture site. Over a 3-month period, the device was used in 48 consecutive PCI treated patients (age, 62 ± 13 years; 70% male; 44% post myocardial infarction) and in-hospital groin complication rate was compared to 48 consecutive patients (age, 64 ± 12 years; 64% male; 33% post myocardial infarction) who had manual compression hemostasis. Results. Antiplatelet glycoprotein IIb/IIIa antagonists were used more frequently during and following the procedure in 58% of Perclose-treated patients versus 42% of the manual compression group (p = 0.019). Leg immobilization duration was 3-4 hours in all patients sutured by the device; in patients with manual compression, the sheath was removed at an average of 4.8 ± 2.5 hours after termination of the PCI and an additional 6 hours of leg immobilization were subsequently required. No difference in overall major complication rate was found between groups (6.2% in suture-mediated patients versus 9.3% in manual compression group; p = 0.60). In 3 patients (6.2%) treated using the device, adjunctive manual compression was required in addition to groin suturing due to technical failure or residual oozing from the arteriotomy site. Conclusion. The 6 Fr Perclose device can be safely used to achieve rapid hemostasis and the device may hasten bed mobilization of PCI-treated patients despite frequent use of potent antiplatelet pharmacotherapy during coronary interventions. J INVAS CARDIOL 2002;14:741-745 A Randomized Comparison of Direct Stenting Versus Stenting with Predilatation in Native Coronary Artery Disease: Results from the Multicenter CROSSCUT Study Flavio Airoldi, MD, ^1,2Carlo Di Mario, MD, PhD, ¹Giorgio Gimelli, MD, ¹Antonio L. Bartorelli, MD, ⁴Francesco Bedogni, MD, ¹Carlo Briguori, MD, PhD, ⁵Arian Frasheri, MD, ⁶Luigi Inglese, MD, ⁵Nino Rubino, MD, ¹Angela Ferrari, PhD, ⁷Bernhard Reimers, MD, ^1,2Antonio Colombo, MD From ¹the Interventional Cardiology Unit, San Raffaele Hospital IRCCS, ²Emo Centro Cuore Columbus, ³Centro Cardiologico Monzino IRCCS, ⁴Interventional Cardiology, Casa di Cura Sant’Ambrogio, Milano, ⁵Invasive Cardiology Unit, Casa di Cura Villa Maria Eleonora, Palermo, ⁶Interventional Cardiology, Instituto Policlinico San Donato (MI), and ⁷Department of Cardiology, Ospedale Civile Mirano, Mirano (VE), Italy. ABSTRACT: Stenting without predilatation has become possible due to the availability of a new generation of flexible, low-profile, securely crimped, balloon-expandable stents. This study compared the feasibility, efficacy and cost-effectiveness of direct stenting (DS) to the standard predilatation technique (PS) using the premounted Crossflex LC stent (Cordis Corporation, Miami Lakes, Florida). The study is a randomized prospective multicenter evaluation including 271 patients (140 patients in the DS group and 131 patients in the PS group) with 1 or 2 de novo or restenotic lesions located in native coronary arteries. Procedural success was 98.9% and 98.7% in the DS and PS groups, respectively (p = NS); crossover to PS was required in 22/166 lesions (13.2%) enrolled in the DS group because of inability to cross the target lesion without predilatation. Nonsignificant reductions in procedural time (-10.5%), fluoroscopy time (-4.7%) and amount of contrast (-3.8%) were observed in the DS group in comparison to the PS group. The number of balloons used (-76.6%) and the global cost of the procedure (-18.8%) were significantly lower in the DS group (p Miniaturization of the Equipment for Percutaneous Coronary Interventions: A Prospective Study in 1,200 Patients Wolfgang A. Schobel, MD and *Manfred Mauser, MD From the Department of Cardiology, University of Tubingen, Tubingen, Germany and *the Dept. of Cardiology, Klinikum Lahr, Lahr, Germany. ABSTRACT: The aim of this prospective study was to analyze the technical feasibility, success rate and special complications of percutaneous coronary interventions (PCI) using a newly released 5 French (Fr) guiding catheter with an inner diameter of 0.058. The study was performed in 1,200 consecutive patients subjected to coronary angioplasty. In 92% of the patients, the intervention was started with a 5 Fr catheter; in 8% of the patients, a 6 or 7 Fr catheter was used. In 5% of the 1,105 patients, the guiding catheter had to be changed during PCI from 5 Fr to a 6 or 7 Fr catheter. In 92% of the patients, the intervention was successfully performed using a 5 Fr catheter. In 3%, the overall success rate was 95% after changing the guiding catheter. Predictors of procedural failure with the 5 Fr guiding catheter were type C lesion morphology and a diameter stenosis of 99% and 100%. The success rate was 90% in acute functional occlusions and 63% in chronic total occlusions (CTO). In CTOs, predictors of procedural failure of the recanalizations using 5 Fr guiding catheters were sidebranch at the point of the total occlusion, complex lesion morphology type C and abrupt morphology of the occlusion. This study confirms that PCI was technically feasible using a 5 Fr guiding catheter in the majority of consecutive patients (success rate: 92%). There were significant differences in the success rate depending on the lesion type and the diameter stenosis. J INVAS CARDIOL 2003;15:6-11 A Novel Percutaneous Technique for Accessing the Normal Pericardium: A Single-Center Successful Experience of 53 Porcine Procedures *Dongming Hou, MD, PhD and Keith L. March, MD, PhD From the *Krannert Institute of Cardiology, Indiana University School of Medicine, Indianapolis, Indiana and the Richard L. Roudebush Veterans Administrative Medical Center, Indianapolis, Indiana. ABSTRACT: Recently, the pericardial space has been under consideration as an ideal site for prevention and treatment of coronary artery and heart disease. Historically, safe percutaneous entry has not been possible to sample or remove pericardial fluids for diagnostic purposes or to employ therapeutic agents in the absence of a sizable pericardial effusion. A non-surgical percutaneous approach to permit rapid access to the normal or minimally effused pericardial space holds high potential for considerable diagnostic and therapeutic utility. This study examines the utility of the PerDUCER® pericardial access device, a simplistic approach to permit percutaneous access to the normal, minimal or diseased pericardial space, in a large series of animals (swine). The PerDUCER®, inserted through the introducer sheath in a sub-xiphoid position, allowed capture and delivery of the intrapericardial guidewire into the pericardial space in all animals. The procedure was well tolerated by all animals and exhibited no signs of significant adverse hemodynamic effects. Twelve animals were sacrificed immediately after the experiment, while 41 animals were sacrificed 28 days after the procedure. Histologic examination showed no occurrence of epicardial vessel or myocardial damage. In addition, no late complications were found related to pericardial access with the PerDUCER®. This initial experiment demonstrates that the PerDUCER® provides an efficient, safe and effective technique to gain pericardial access in the normal or minimal pericardial space to obtain diagnostic sampling of the pericardial fluids and renders local intrapericardial delivery of therapeutic agents a possibility. J INVAS CARDIOL 2003;15:13-16 Impact of Gender on the Incidence and Outcome of Contrast-Induced Nephropathy After Percutaneous Coronary Intervention Ioannis Iakovou, MD, George Dangas, MD, PhD, Roxana Mehran, MD, Alexandra J. Lansky, MD, Dale T. Ashby, MD, Martin Fahy, MSc, Gary S. Mintz, MD, Kenneth M. Kent, MD, PhD, Augusto D. Pichard, MD, Lowell F. Satler, MD, Gregg W. Stone, MD, Martin B. Leon, MD From the Cardiovascular Research Foundation, Lenox Hill Heart and Vascular Institute, New York, NY, and Washington Hospital Center, Washington, DC. Dr Iakovou was supported in part by grants from the Onassis Foundation, Athens, Greece. ABSTRACT: Background. Contrast-induced nephropathy (CIN) is a recognized complication after percutaneous interventions (PCI). We sought to determine the impact of gender on incidence and clinical outcome of CIN. Methods and Results. Of a total 8,628 patients who underwent PCI, there were 1,431 (16.5%) who developed CIN (defined as > 25% rise in creatinine after PCI). Patients were followed clinically for one year. CIN was present in 23.6% of female versus 17.4% of male patients (p Conclusions. Female gender is an independent predictor of CIN development after PCI and a marker of worse 1-year mortality after CIN in patients without baseline CRF. After CIN is developed, pre-PCI CRF, diabetes mellitus, age, severe heart failure (not gender) are independent predictors of one-year mortality. J INVAS CARDIOL 2003;15:18-22 Post-Cardiac Catheterization Access Site Complications and Low-Molecular-Weight Heparin Following Cardiac Catheterization Lee A. MacDonald, MD, Sheridan Meyers, MD, Charles L. Bennett, MD, PhD, Dan Fintel, MD, Neal Grosshans, MS, RPh, Raffy Syegco, RN, Charles J. Davidson, MD From Northwestern University Medical School, Divisions of Cardiology and Hematology, Department of Medicine, Chicago, Illinois. ABSTRACT: The low molecular weight heparin enoxaparin is often administered to patients on long-term anticoagulation regimens who temporarily discontinue warfarin prior to undergoing invasive procedures. The clinical outcome of all enoxaparin-treated patients who underwent cardiac catheterization or coronary artery interventional procedures (n = 119) was evaluated. A total of 5 patients (4.2%) requiring anticoagulation (3 with chronic atrial fibrillation and 2 with ventricular thrombi) developed severe late enoxaparin-associated hemorrhagic or vascular complications at the femoral arterial puncture site between 3 and 11 days post-procedure. Complications included development of femoral arterial pseudoaneurysm (n = 3), hypotension (systolic blood pressure A Comparison of Arterial Closure Devices to Manual Compression in Liver Transplantation Candidates Undergoing Coronary Angiography Lee A. MacDonald, MD, Nirat Beohar, MD, Norman C. Wang, MD, Lisa Nee, MD, Raj Chandwaney, MD, Mark J. Ricciardi, MD, Keith H. Benzuly, MD, Sheridan N. Meyers, MD, Mihai Gheorghiada, MD, Charles J. Davidson, MD From Northwestern University Medical School, Chicago, Illinois. ABSTRACT: Whether arterial closure devices can be used safely in a coagulopathic population undergoing cardiac catheterization and at high risk for groin complications, such as liver transplant candidates, is unknown. In this prospective, non-randomized consecutive series of 80 liver transplant candidates undergoing coronary angiography, manual compression and arterial closure devices were compared. Ilio-femoral angiography was performed to determine suitability for use of the closure device. Bleeding and vascular complications were recorded along with time to ambulation. Arterial closure devices were used in 31 patients (39%), whereas manual compression was used in 49 patients (50 procedures) (61%). There were no significant differences between the two groups with respect to age, sex, cardiac risk factors, peripheral vascular disease, baseline platelet count or baseline INR. There were 10 total vascular complications out of 50 procedures (20%) in the manual compression group compared to 2 vascular complications out of 31 procedures in the arterial closure device group (6%; p = 0.12). The time to ambulation was significantly less in the group receiving arterial closure devices versus manual compression (4.2 ± 1.8 hours versus 6.6 ± 3.7 hours, respectively; p = 0.0003). In coagulopathic patients at higher risk for groin complications, arterial closure devices can be safely used and decrease time to ambulation compared to manual compression. J INVAS CARDIOL 2003;15:68-70

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