8th Annual C3 Conference (Complex Cardiovascular Catheter Therapeutics) Advanced Endovascular and Coronary Intervention Global Summit

C3- 001
Expected Outcomes and Hospital Costs Associated With Percutaneous Coronary Intervention and Atherectomy in Treatment of Moderate to Severely Calcified Coronary Lesions 

Richard Shlofmitz, MD

Background: Treatment of de novo, moderately to severely calcified coronary lesions may be performed using percutaneous coronary intervention and stenting (PCI) or with atherectomy and stenting (atherectomy); hospitals should understand both the clinical and cost consequences associated with their treatment choice. This analysis examines the expected value to the hospital of the decision to use PCI vs atherectomy in the treatment of moderately to severely calcified coronary lesions. Methods: A model was developed to calculate the expected hospital costs associated with PCI vs atherectomy in the treatment of calcified lesions. Where possible, data regarding the occurrence of in-hospital major adverse cardiac events (MACE) and hospital costs associated with complicated and uncomplicated PCIs and atherectomies were taken from the peer-reviewed literature. Data gaps were filled using expert opinion; the model’s dependence on unsubstantiated data values was explored using sensitivity analyses. Results: For patients with moderately to severely calcified lesions, the expected inpatient hospital costs of a PCI is approximately $1900 higher than the expected inpatient hospital costs of an atherectomy, despite atherectomy’s higher equipment costs. The increased frequency of in-hospital MACE in PCI vs atherectomy procedures, and the attendant higher costs associated with patients experiencing in-hospital MACE, more than offset atherectomy equipment costs. Conclusions: For patients with de novo moderately to severely calcified lesions, use of atherectomy vs PCI may result in fewer MACE events and lower hospital costs.

C3- 002
Initial Clinical Experience With a Novel Closure Device (FISH) in Diagnostic and Interventional Catheterization

Murad Abdelsalam, MD

Peripheral and coronary diagnostic angiography is associated with a certain risk of access site. The Femoral Introducer Sheath and Hemostasis (FISH) device is a patching device using porcine biomaterial, known as small intestinal sub mucosa (SIS), that combines one sheath as both an introducer and closure device; it favors early healing and prevents scar tissue as the vessel wall is remodeled within 30 days. Objective: To assess the type and frequency of the short-term complications as well as the failure rates associated with the use of the novel closure device  in patients during their hospital stay. Methods: We performed a single-center retrospective chart review analysis of 216 patients, from April 2010 to June 2010, for whom a FISH device was utilized for either coronary or peripheral angiography. VCD failure was defined as unsuccessful deployment or failure to achieve hemostasis. Major vascular complication was defined as any bleeding requiring blood transfusion or associated with hemodynamic compromise, limb ischemia, or any surgical repair. Minor vascular complication was defined as hematoma (≥6 cm), pseudoaneurysm, or arteriovenous fistula. Results: Four out of 216 devices failed (1.85%), 3 patients had major vascular complication (1.38%); 1 patient with bleeding required blood transfusion, 2 patients required surgical thrombectomy. Hematomas were diagnosed in 8 patients (3.7%); pseudoaneurysm occurred in 3 patients (1.38%), no cases of AV fistula were diagnosed (0%). Conclusion: Initial evaluation of the FISH device shows device failure rates and major complication rates similar to published complication rates with other vascular closure devices of 1%-2%. Limitation exists due to retrospective nature of the evaluation and longer term data are needed to evaluate the accuracy of these findings.

C3- 003
Use of Orbital Atherectomy System in an Office-Based Laboratory versus Hospital Setting

Guy Mayeda, MD

Currently, limited data exist evaluating varied technologies used in an office-based endovascular suite or office-based laboratory (OBL) setting. Analysis of orbital atherectomy in OBL settings was conducted to determine whether outcomes in safety and procedural success could be maintained in an outpatient OBL setting compared to traditional hospital settings when matched for similar patient demographics. Methods: Cardiovascular Systems Inc. conducted the CONFIRM Series clinical study that included 3135 patients (pts) treated with Orbital Atherectomy System (OAS). From these 3135 pts, 75 pts (108 lesions) were treated in OBL settings (OBL group) and compared to 3060 pts (4658 lesions) treated in traditional hospital settings (hospital group). The comparative cost associated with OAS treatment in each setting is being evaluated. Results: No differences in gender, age, smoking habits, diabetes, history of CAD, renal disease, hypertension, or hyperlipidemia were seen between the 2 retrospectively analyzed groups. Rutherford category 3 was predominant in both populations (36% for OBL vs 35% for hospital group). Average lesion length was 53.5 mm (OBL group) and 73.8 mm (hospital group, P=.006). Treated lesions were located in the similar locations for OBL and hospital groups: above the knee (ATK) only (40% vs 42%); popliteal only (4% vs 7%); below the knee (BTK) only (32% vs 28%); and multiple locations including ATK and BTK treated in the same procedural setting (17% vs 21%). Plaque morphology consisted predominantly of moderate to severe calcification (88% for OBL group vs 81% for hospital group). No differences were seen in pre- and postprocedural stenosis, number of devices used per lesion, or run (spinning) time of the device for each of the 2 analyzed groups. Dissections related to OAS crown occurred in 2.8% of lesions (OBL group) and 1.8% (hospital group, P=.51). There were no cases of perforation or embolism reported in the OBL group, while these rates were 0.7% (P=.37) and 2.3% (P=.11), respectively, in the hospital group. Conclusion: Utilization of OAS in office-based settings has high procedural success and low complication rates comparable to outcome data collected in hospital settings.

C3- 004
CONFIRM Series I & II: Treatment Outcome of Nearly 2000 Patients With Calcified Peripheral Arteries Treated with Two Designs of the Orbital PAD System  

Raymond Dattilo, MD

Calcified plaque in peripheral arteries may contribute to poor endovascular outcomes, including dissections, malpositioned stent placement that may lead to stent fractures, and difficult-to-treat in-stent restenosis (ISR). ISR is becoming an increasing clinical and technical problem due to the more liberal use of stents particularly in femoro-popliteal and infra-popliteal interventions. Methods: The CONFIRM I and II registries were conducted prospectively at over 200 sites in the US under a common protocol to evaluate the success of varied orbital PAD systems (CSI) in plaque modification in real-world patients (pts) with calcified infra-inguinal disease; no exclusion criteria was applied. In the CONFIRM I registry, 733 pts/1146 lesions were treated with the Diamondback 360 (DB360), the earliest version of the device that consisted of a pneumatic-driven handle with classic or stainless-steel solid crowns. In the CONFIRM II registry, 1127 pts/1734 lesions were treated with Predator 360 (Predator) orbital atherectomy system, the newer version of the device consisting of a pneumatic handle with 15 cm travel and the Predator Tungsten crown. Procedural safety and efficacy were analyzed for each PAD system to determine optimal treatment regimen. Results: No statistical differences in demographics, length, or plaque morphology were noted between DB and Predator registries, respectively: 72 vs 71 years; 59% vs 61% male; 36% vs 37% renal disease; 61% vs 60% diabetes; 90% vs 93% hypertension; 80% vs 81% hyperlipidemia; 41% vs 43% critical limb ischemia; 76% vs 82% presented with moderate to severe calcification. Lesion location also was similar between DB and Predator registries: 43% vs 46% above the knee (SFA, CFA, profunda, iliac), 8% vs 6% popliteal, 25% vs 24% below the knee (TPT, AT, PT, peroneal, DP) and 24% vs 21% in multiple locations (eg, ATK and BTK treated with the same device). Average lesion length was 77 mm vs 72 mm for DB and Predator, respectively. The registry with the newer version of the device had more frequent use of the smallest crown (ie, 1.25 mm, Predator 22% vs DB 7%) and less frequent use of the largest crown (ie, 2.25 mm, Predator 11% vs DB 21%). The average total crown run (spinning) time was longer in the DB registry compared to Predator (161 s vs 103 s). Regardless of treatment differences, the final residual stenosis was similar:  DB 12% and Predator 10%. Each registry reported a low rate of acute complications. The Predator registry had a reduction in multiple procedural complications compared to DB: 0.6% vs 0.9% perforations, 4.1% vs 7.2% slow flow, 1.2% vs 2.1% abrupt vessel closure. The stent placement rate was low for both registries (3%-5%). Conclusions: The outcome in these difficult to treat patients demonstrated a low rate of procedural events and a reduced need for stent placement. As re-emphasized by the Predator registry, smaller size crown and shorter run times lead to similar or slightly improved acute results. Therefore, longer spinning time (trying to create a larger vessel lumen) should be avoided as it may lead to higher procedural complications without achieving additional clinical benefit. This large database of real-world patients shows consistent, repeatable acute results for each PAD system version that may be an indicator of improved long-term outcome and durability.

C3- 005
Local Intracoronary Eptifibatide Injection via Special Infusion Catheter at the Site of Thrombus Versus Conventional Intracoronary Injection via Guiding Catheter During Primary Percutaneous Coronary Intervention

Salwa Labib, Adel El-Itriby, Maged El-Abbady, Wail Nammas, Wael El-Kilany, Tarek Rashid, Ayman Mortada, Mohamed Abdel-Kader, Wael Abu-Shokka, Gamal Sheiban, Abdel-Rahman Hassan, Hany Ragy, Tarek Zaki

Distal embolization of atherothrombotic debris during primary percutaneous coronary intervention (PCI) is associated with impaired microvascular perfusion, unpredictable no-reflow, abnormal left ventricular function, and increased mortality. Intracoronary bolus administration of eptifibatide during primary PCI was safe and demonstrated high rates of normal myocardial perfusion. Aims: We tested the hypothesis of whether local intracoronary administration of eptifibatide at the site of thrombus by means of a specific infusion catheter during primary PCI would achieve superior myocardial perfusion and clinical outcome as compared with conventional intracoronary injection via guiding catheter. Methods: Prospectively, we enrolled 62 patients (pts) with acute ST elevation myocardial infarction (STEMI) eligible for primary PCI who had variable degrees of thrombus burden at initial coronary angiography. Pts received double intracoronary bolus (180 μgm) eptifibatide injection (75% of the dose after wire passage; 25% after stent deployment), either by local intracoronary injection at the site of thrombus by means of a specific infusion catheter (ClearWay RX, Atrium Medical) (group I, 31 pts), or by conventional intracoronary injection through the guiding catheter (group II, 31 pts). No maintenance eptifibatide was given intravenously in either group. Additionally, all pts received intracoronary verapamil (300 μgm) (75% of the dose after wiring; 25% after stenting), either by the same infusion catheter (group I), or through the guiding catheter (group II). Pts were followed up for 30 days. The primary angiographic endpoint was final TIMI myocardial perfusion grade 0/1 at the end of the procedure. The primary clinical endpoint was a composite of death, re-infarction, and target vessel revascularization at 30-day follow-up. Results: The mean age was 51.7 ± 9.1 years (13.4% females). The primary angiographic endpoint occurred in 0 (0%) vs 7 pts (22.6%), in groups I and II, respectively (P=.022). The primary clinical composite endpoint occurred in 0 (0%) versus 4 pts (12.9%), in groups I and II, respectively, P=.039. Final TIMI grade 3 flow occurred in 26 (83.9%) versus 16 pts (51.6%), in groups I and II, respectively (P=.035). Final corrected TIMI frame count was 21.1 ± 4.4 versus 24.0 ± 3.9, in groups I and II, respectively (P=.01). Complete resolution of ST-segment elevation at 6 hours occurred in 22 (71%) versus 14 pts (45.2%), in groups I and II, respectively (P =.053). No bleeding complications occurred in either group. Conclusion: In patients with acute STEMI and variable degrees of thrombus burden undergoing primary PCI, local intracoronary administration of eptifibatide at the site of thrombus by means of a specific infusion catheter achieved superior myocardial perfusion, and better clinical outcome at 30 days, as compared with conventional intracoronary injection via guiding catheter.

C3- 006
Three-Year Follow-Up Data of Orbital Atherectomy System for the Treatment of De Novo Calcified Coronary Lesions — A Single-Center Experience

Keyur Parikh¹, Roosha Parikh¹, Apurva Patel², Milan Chag^1
1Care Institute of Medical Sciences, Ahmedabad, India; ²Smt. N. H. L. Municipal Medical College (V. S. Hospital), Ahmedabad, India

Coronary artery disease is a widespread and growing problem worldwide. Performing PCI on calcified lesions can lead to higher MACE rates and stent underexpansion/malapposition. The Orbit I trial was conducted to evaluate the safety and performance of the Diamondback 360 Orbital Atherectomy System (OAS) (Cardiovascular Systems, Inc.) for the treatment of calcified coronary lesions. Methods: A subset of 33 non-consecutive patients (pts) enrolled May-July 2008 in Orbit I were followed up at CIMS Hospital Pvt. Ltd., India, based on several criteria, including a de novo, coronary lesion with stenosis ≥50% and ≤100% and at least one quadrant of calcification via IVUS. Pts were treated with OAS prior to stent placement. The safety endpoint was MACE rate, and pts were followed to 3 yrs. Results: Of the 33 pts, 90.90% (n=30/33) were male (average 54.9 yrs). The ACC/AHA lesion class was: Type A 6.06% (n=2/33); Type B1 33.33% (n=11/33); Type B2 60.60% (n=20/33). Percent diameter stenosis was 85.75%; lesion length was 15.90 mm. Procedural success was 97% (32/33) with 1 case where IVUS/device could not cross a severely calcified lesion. The observed MACE rate was 6.06% in-hospital (n=2/33); 30 days 9.09% (n=3/33); 6 months 12.12% (n=4/33); 2 yrs 15.15% (n=5/33); and 3 yrs 18.18% (n=6/33). MACE comprised 2 pts with a non Q-wave MI in-hospital; 1 patient with non-Q wave MI at 30 days that led to TLR; and 1 patient with cardiac death at 6 months, 2 yrs, and 3 yrs, respectively. All stents were successfully deployed with 0.3 ± 1.8% residual stenosis. Conclusion: This series demonstrates that OAS safely and effectively modified calcified lesions and facilitated stent delivery in this difficult-to-treat plaque morphology, which continues up to 3 yrs postprocedure.

C3- 007
A Guideline-Based Approach of Percutaneous Coronary Intervention in Acute Myocardial Infarction: Single-Center Experience

M. Sadaka, M. Loutfi, A. Zaki, M. Sobhy
Alexandria University, Faculty of Medicine, Cardiovascular Department

Aim: To determine the outcomes of percutaneous coronary intervention (PCI) in patients presenting with ST-segment elevation myocardial infarction (STEMI). The primary outcomes were a composite of death, reinfarction, stroke, or target vessel revascularization (TVR) in-hospital, at 30 days, and at 6 months.  Methods: This study was conducted at a tertiary care hospital (International Cardiac Centre [ICC], Alexandria, Egypt) during the period of January 1, 2008 to December 31, 2010. A total of 450 consecutive patients presenting with STEMI were transferred from 19 community hospitals and underwent PCI: 288 patients who presented within 12 hours of the onset of symptoms underwent primary PCI, and 162 patients underwent non-primary PCI (95 patients underwent rescue PCI within 12 hours after failed thrombolytic therapy, 35 patients underwent coronary angiography and PCI within 24 hours after successful thrombolytic therapy, while 32 patients underwent late PCI after 24 hours and less than 48 hours without thrombolytic therapy driven by persistent chest pain, dynamic ECG changes, preserved systolic function, or cardiogenic shock). Results: Cardiovascular risk factors were mainly smoking (57.6%), dyslipidemia (52.4%), diabetes (50%), and hypertension (38%).The mean age at presentation was 55 ± 11.10 years and 89.8% were male. The median time from onset of symptoms to presentation was 240 minutes and the median door-to-balloon time was 60 minutes in the primary PCI group (288 patients). The median time between end of failed thrombolytic therapy and the rescue PCI was 420 minutes (95 patients), while the median time between end of successful thrombolytic therapy and PCI was 810 minutes (35 patients). Only 32 patients underwent late PCI ≥24 hours and ≤48 hours without thrombolytic therapy; median time was 2160 minutes. 

Thrombus aspiration was done in 41% of patients in the primary PCI group and 12.3% in the non-primary PCI group. Bare-metal stents (BMS) were used in 71.3% of patients, while drug-eluting stents (DES) were used in 28.5% of patients. Multivessel PCI at the same setting was done in 8.2% of the entire patient population. Procedural success was achieved in 98.9% of patients. Major bleeding occurred in 1.4% of patients in the primary PCI group and 2.4% in the non-primary PCI group. 3.1% of patients developed contrast-induced nephropathy (CIN) during the in-hospital course. In-hospital, 30-day, and 6-month mortality were 2.1%, 0.7%, and 1.1%, respectively, in the primary PCI group and 2.5%, 3.2%, and 2.6%, respectively, in the non-primary PCI group. In-hospital, 30-day, and 6-month re-infarction occurred in 0.3%, 1.1%, and 0.7% of patients, respectively, in the primary PCI group and 0.0%, 1.3%, and 0.7%, respectively, in the non-primary PCI group. In-hospital, 30-day, and 6-month TVR occurred in 0.7%, 0.7%, and 1.1%, respectively, of patients in the primary PCI group and 0.0%, 1.3%, and 0.7%, respectively, in the non-primary PCI group. There was no emergent coronary artery bypass graft (CABG) surgery. Conclusions: (1) This is the first report from ICC at Alexandria to provide a comprehensive review of patient characteristics and outcomes of a guideline-based approach of PCI for STEMI. (2) We reported a high initial success rate, and excellent short- and intermediate-term outcomes; our results compared favorably to Western data despite many differences in facilities and patient characteristics. (3) As we believe in the importance of primary PCI as the mainstay in treatment of STEMI, Egypt is currently contributing to the European project of stent for life (SFL) as one of ten target countries in the next few years. 

C3- 008
Safety and Feasibility of Performing Staged Non-culprit Vessel Percutaneous Intervention Within the Index Hospitalization for Patients with ST-Segment Elevation Myocardial Infarction and Multivessel Disease

Joshua P Loh, Hironori Kitabata, Gabriel Sardi, Ana Laynez-Carnicero, Salem Badr, Israel Barbash, Danny Dvir, Rebecca Torguson, Kenneth M. Kent, Lowell F. Satler, William O. Suddath, Augusto D. Pichard, Ron Waksman, Washington Hospital Center, Washington, DC

In patients with ST-segment elevation myocardial infarction (STEMI) and multivessel disease (MVD) undergoing primary percutaneous coronary intervention (PCI), staged non-culprit vessel PCI at a separate session is recommended. It is unknown whether it is safe to perform staged PCI of the non-culprit vessel within the same hospitalization. Objectives: To compare the immediate-term outcomes of patients (pts) with STEMI and MVD undergoing staged non-culprit vessel PCI within the same hospitalization of the primary PCI vs staged non-culprit vessel PCI later. Methods: We conducted a retrospective cohort study of 163 consecutive STEMI pts with MVD who were treated with primary PCI followed by staged PCI of the non-culprit vessel. Pts were categorized into staged PCI in the same hospitalization (n=105) and staged PCI at a separate hospitalization within 8 weeks of primary PCI (n=57). Procedural characteristics as well as in-hospital outcomes following the staged PCI were analyzed. Results: Baseline demographics and procedural characteristics of the index primary PCI and subsequent staged PCI were similar. Angiographic success was similar (99.4% following staged PCI in the same hospitalization, 98.8% following staged PCI at a separate hospitalization), with similar rates of vascular complications (2.9% vs 1.8%; P=NS), major bleeding (1.0% vs 1.8%; P=NS) and in-hospital renal insufficiency (5.8% vs 4.3%; P=NS). Following staged PCI, in-hospital mortality was similar in both groups (2.9% vs none; P=.553). Composite major in-hospital complications of death, Q-wave MI, urgent CABG and urgent TVR were also similar (2.9% vs none; P=.553). Conclusions: It is safe and feasible to perform staged PCI of the non-culprit vessel within the same hospitalization for patients with STEMI and MVD undergoing primary PCI, with similar procedural success and in-hospital outcomes as compared to staged PCI at a separate hospitalization.

C3- 009
Drug-Eluting Stents Versus Bare-Metal Stents in Patients With Acute ST-Elevation Myocardial Infarction: A Single-Center Experience With One-Year Follow-Up

Anand Deshmukh, Dan Hilleman, Sehr Haroon, Ratna Priya Gangi, Ojas Bansal, Aiman Smer, Swapna Kanuri, Michael White, William Biddle, Mark Woodruff, Thomas Lanspa, Michael DelCore,
The Cardiac Center of Creighton University, Omaha, Nebraska

There are conflicting data regarding use of drug-eluting stent (DES) versus bare-metal stent (BMS) in patients with acute ST-elevation myocardial infarction (STEMI). Methods: We conducted a retrospective analysis of all patients undergoing percutaneous coronary intervention (PCI) at our center from January 2003 through May 2010. We collected demographic, clinical, and procedural characteristics on these patients (pts). The pts were divided into two groups based on the type of stent (DES vs BMS). Patients who received angioplasty only and those who received both DES and BMS during the index PCI were excluded from the analysis. The primary endpoint was a major adverse cardiac event (MACE), which was a composite of annual incidence of hard clinical endpoints including all cause mortality, recurrent acute coronary syndrome (RACS), and cerebrovascular accident (CVA)/transient ischemic attack (TIA). Secondary endpoints were annual incidence target vessel revascularization (TVR), definite/probable ST, and in-hospital major bleeding. Results: 370 pts qualified for the study (167 in BMS group, 203 in DES group). There were no significant differences between groups in regard to major demographic, clinical, or procedural characteristics such as age, gender, diabetes mellitus, infarct-related artery, total door-to-balloon time, and left ventricular ejection fraction. The primary endpoints occurred in 16% (BMS group) and 17% (DES group, P=.82) of pts. Among the secondary endpoints, the annual incidence of TVR was 10% in the BMS and 6.4% in the DES group (P=.72); ST was 0.6% in the BMS group and 2% in the DES group (P=.61) and in-hospital major bleeding was 4% (BMS group) and 1.5% (DES group, P=.78). Conclusion: DES appear to be as safe as BMS in the setting of STEMI patients with no increase in MACE at 1 year.

C3- 010
CALCIUM360: Debulking Prior to Angioplasty is Safe and Effective in CLI Patients Involving BTK Vessels

J.A. Mustapha, MD
Metro Health Hospital, Wyoming, MI, Michigan State University

Background: Patients with limb-threatening ischemia in the lower extremities are at increased risk of amputation. Methods: This prospective multicenter study evaluated short- and long-term outcomes in 50 patients with confirmed calcified lesions randomized, 1:1, to Diamondback 360º Orbital Atherectomy System (OAS; Cardiovascular Systems, Inc.) followed by plain old balloon angioplasty (POBA), and POBA alone. Scheduled visits were conducted according to a common protocol. Statistical comparisons were not planned. All patients had severe (≥50% stenosis with Rutherford classification 4-6) peripheral arterial disease (PAD) in popliteal and tibial arteries. Results: Overall procedural success (final residual stenosis <30% AND no bail-out stent AND no arterial dissection types C through F prior to bail-out stenting, if needed) was 83% (25/30 lesions) for OAS+POBA patients and 60% (20/33 lesions) for POBA alone.  The bail-out stents were used in 2/29 lesions (6.9%) in the OAS+POBA arm and in 5/35 lesions (14.3%) in the POBA arm (P=.44). The average final percent stenosis was 9 ± 12% in the OAS+POBA arm and 20 ± 24% in the POBA arm (P=.03). Survival outcomes at 3, 6, and 12 months are shown in the table. Significant differences in survival curves were observed for all-cause mortality (P=.01, log-rank test) and major serious adverse events (defined as cumulative amputation, mortality from all causes, and TLR/TVR) (P=.006) in favor of the OAS+POBA treatment group. Conclusion: Debulking with OAS appeared to increase the chance of reaching a desirable result of angioplasty. Negative correlation between procedure success and risk of severe adverse outcomes observed in this study encourages larger confirmatory studies.