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Background: Mechanical circulatory support (MCS) devices are increasingly used for hemodynamic support in cardiogenic shock or high-risk percutaneous coronary interventions. Vascular complications remain a major source of morbidity and mortality despite technological advances with percutaneous techniques. Little is known about the rates and predictors of vascular complications with large-bore access MCS in the contemporary era., Methods: The study cohort was derived from National Inpatient Sample using data from 2015 to 2019 for cardiac hospitalizations with the use of: intra-aortic balloon pump (IABP) Impella, and/or extracorporeal membrane oxygenation (ECMO). The rates of vascular complications and in-hospital outcomes were analyzed using multivariable logistic regression., Results: Of 221,700 hospitalizations with MCS use, the majority had only IABP (68%). The rates of vascular complications were greatest with ECMO (15.8%) when compared with IABP (3.0%) and Impella (5.6%). Among patients with vascular complications, in-hospital mortality was higher with ECMO (56.3%) when compared with IABP (26.2%) and Impella (33.8%). Peripheral arterial disease (PAD) was the strongest predictor of vascular complications, with 10 times higher odds when present (adjusted odds ratio [aOR] 10.96, p < 0.001). In risk-adjusted models, when compared with IABP, the use of Impella (aOR: 1.73, p < 0.001), ECMO (aOR: 5.35, p < 0.001), or a combination of MCS devices (aOR: 3.47, p < 0.001) was associated with higher odds of vascular complications., Conclusions: In contemporary practice, the use of MCS is associated with significant vascular complications and in-hospital mortality. Predictors of vascular complications include larger arteriotomy size, female gender, and peripheral arterial disease. Vascular access management remains essential to prevent major complications., (© 2022 Wiley Periodicals LLC.)

Background: Increasing vasopressor dose is associated with increasing mortality in patients presenting with acute myocardial infarction and cardiogenic shock (AMICS). It is unknown whether the use of vasopressors is independently harmful or if their use is secondary to decreasing intrinsic cardiac power output (CPO). Mechanical circulatory support (MCS) devices enhance CPO. We sought to evaluate the independent impact of increasing vasopressor dose on survival in the National Cardiogenic Shock Initiative (NCSI)., Methods: The NCSI is a single arm prospective trial evaluating outcomes associated with the use of MCS using Impella in patients with AMICS. Early initiation of MCS placement before percutaneous coronary intervention (PCI) and rapid de-escalation of vasopressors guided by systematic use of invasive hemodynamic measures led to 70% in-hospital survival for the first 300 patients enrolled from July 2016 to December 2019 in 57 U.S. sites., Results: Hemodynamic measures were obtained immediately after MCS and PCI. Survival curves were constructed based on CPO and use of vasopressors. For patients with CPO ≤0.6 W, survival was 77.3%, 45.0%, and 35.3% when 0, 1, or ≥ 2 vasopressors were used (p = 0.02). Similarly, for patients with CPO >0.6 W survival was 81.7%, 72.6%, and 56.8%, respectively (p = 0.01). Logistic regression analysis demonstrated that increasing vasopressor requirements were independently associated with increasing mortality (p = 0.02)., Conclusion: Increasing vasopressor requirement is associated with increased mortality in AMICS independent of underlying CPO. Methods to decrease the need for vasopressors may enhance survival in AMICS., (© 2021 Wiley Periodicals LLC.)

Purpose: To assess device and procedural safety and technical success associated with the use of the AngioVac System to remove vascular thrombi and cardiac masses., Materials and Methods: The Registry of AngioVac Procedures in Detail (RAPID) study prospectively collected data for 234 patients receiving treatment with AngioVac at 21 sites between March 2016 and August 2019: 84 (35.9%) with caval thromboemboli (CTEs), 113 (48.3%) with right heart masses (RHMs), 20 (8.5%) with catheter-related thrombi (CRTs), and 4 (1.7%) with pulmonary emboli (PEs). Thirteen patients had a combination of procedures during the same admission., Results: Using the AngioVac system, 70%-100% thrombus or mass removal was achieved in 73.6% of patients with CTEs, 58.5% of patients with RHMs, 60% of patients with CRTs, and 57.1% of patients with PEs. Extracorporeal bypass time was < 1 hour for 176 (75.2%) procedures. Estimated blood loss was < 250 mL for 179 procedures (76.5%). Mean hemoglobin decreased from 10.4 g/dL ± 2.9 preoperatively to 9.4 g/dL ± 2.6 postoperatively. Transfusions were administered in 59 procedures (25.2%) with 47 transfusions (78.2%) being ≤ 2 U. There were 36 procedure-related complications, including 1 death., Conclusions: The RAPID registry data demonstrate that the AngioVac System can be safely and effectively used to remove vascular thrombi and cardiac masses across a broad range of patient populations. The limited use of the device to remove pulmonary emboli in the present series precludes recommending the use of the AngioVac device for this indication., (Copyright © 2020 SIR. Published by Elsevier Inc. All rights reserved.)

Objectives: The purpose of this study was to evaluate tip-to-base intentional laceration of the anterior mitral leaflet to prevent left ventricular outflow tract obstruction (LAMPOON) in patients undergoing transcatheter mitral valve replacement (TMVR) in annuloplasty rings or surgical mitral valves., Background: LAMPOON is an effective adjunct to TMVR that prevents left ventricular outflow tract obstruction (LVOTO). Laceration is typically performed from the base to the tip of the anterior mitral leaflet. A modified laceration technique from leaflet tip to base may be effective in patients with a prosthesis that protects the aortomitral curtain., Methods: This is a multicenter, 21-patient, consecutive retrospective observational cohort. Patients underwent tip-to-base LAMPOON to prevent LVOTO and leaflet overhang, or therapeutically to lacerate a long anterior mitral leaflet risking or causing LVOTO. Outcomes were compared with findings from patients in the LAMPOON investigational device exemption trial with a prior mitral annuloplasty., Results: Twenty-one patients with a annuloplasty or valve prosthesis-protected mitral annulus underwent tip-to-base LAMPOON (19 preventive, 2 rescue). Leaflet laceration was successful in all and successfully prevented or treated LVOTO in all patients. No patients had significant LVOTO upon discharge. There were 2 cases of unintentional aortic valve injury (1 patient underwent emergency transcatheter aortic valve replacement and 1 patient underwent urgent surgical aortic valve replacement). In both cases, the patients had a supra-annular ring annuloplasty, and the retrograde aortic guiding catheter failed to insulate the guidewire lacerating surface from the aortic root. All patients survived to 30 days. Compared with classic retrograde LAMPOON, there was a trend toward shorter procedure time., Conclusions: Tip-to-base laceration is a simple, effective, and safe LAMPOON variant applicable to patients with an appropriately positioned mitral annular ring or bioprosthetic valve. Operators should take care to insulate the lacerating surface from adjacent structures., Competing Interests: Funding Support and Author Disclosures This work was supported by the Emory Structural Heart and Valve program intramural funds and by National Institutes of Health Grant No. Z01-HL006040. Dr. Lisko’s employer has contracts for BASILICA analysis with Medtronic and Edwards Lifesciences. Dr. Babaliaros has served as a consultant for Edwards Lifesciences and Abbott Vascular; has an employer with research contracts for clinical investigation of transcatheter aortic, mitral, and tricuspid devices from Edwards Lifesciences, Abbott Vascular, Medtronic, and Boston Scientific; and owns equity interest in Transmural Systems. Drs. Khan and Rogers have served as a proctor for Edwards Lifesciences and Medtronic. Drs. Khan, Lederman, and Rogers are co-inventors on patents, assigned to the National Institutes of Health, on devices for electrosurgical leaflet laceration. Dr. Paone has served as a consultant and proctor for Edwards Lifesciences. Dr. McCabe has served as consultant for Edwards Lifesciences, Boston Scientific, and Teleflex. Dr. Grubb has served as a speaker, proctor, and principal investigator for Edwards Lifesciences; served as a speaker, proctor, and advisory board member for Boston Scientific; and served as a speaker, proctor, principal investigator, advisory board member, and national principal investigator for Medtronic. Dr. Lederman has served as the principal investigator on a cooperative research and development agreement between National Institutes of Health and Edwards Lifesciences for transcatheter modification of the mitral valve. Dr. Greenbaum has served as a proctor for Edwards Lifesciences, Medtronic, and Abbott Vascular; owns an equity interest in Transmural Systems; and has an employer with research contracts for clinical investigation of transcatheter aortic, mitral, and tricuspid devices from Edwards Lifesciences, Abbott Vascular, Medtronic, and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021. Published by Elsevier Inc.)

Objectives: This study sought to compare outcomes of patients enrolled in the NCSI (National Cardiogenic Shock Initiative) trial who were treated using a revascularization strategy of percutaneous coronary intervention (PCI) of multivessel PCI (MV-PCI) versus culprit-vessel PCI (CV-PCI)., Background: In patients with multivessel disease who present with acute myocardial infarction and cardiogenic shock (AMICS), intervening on the nonculprit vessel is controversial. There are conflicting published reports and lack of evidence, particularly in patients treated with early mechanical circulatory support (MCS)., Methods: From July 2016 to December 2019, patients who presented with AMICS to 57 participating hospitals were included in this analysis. All patients were treated using a standard shock protocol emphasizing early MCS, revascularization, and invasive hemodynamic monitoring. Patients with multivessel coronary artery disease (MVCAD) were analyzed according to whether CV-PCI or MV-PCI was undertaken during the index procedure., Results: Of 198 patients with MVCAD, 126 underwent MV-PCI (64%) and 72 underwent CV-PCI (36%). Demographics between the cohorts were similar with respect to age, sex, history of diabetes, prior PCI or coronary artery bypass grafting, and prior history of myocardial infarction. Patients who underwent MV-PCI had a trend toward more severe impairment of cardiac output and worse lactate clearance on presentation, and cardiac performance was significantly worse at 12 h. However, 24 h from PCI, the hemometabolic derangements were similar. Survival and rates of acute kidney injury were not significantly different between groups (69.8% MV-PCI vs. 65.3% CV-PCI; p = 0.51; and 29.9% vs. 34.2%; p = 0.64, respectively)., Conclusions: In patients with MVCAD presenting with AMICS treated with early MCS, revascularization of nonculprit lesions was associated with similar hospital survival and acute kidney injury when compared with culprit-only PCI. Selective nonculprit PCI can be safety performed in AMICS in patients supported with mechanical circulatory support., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Pulmonary arterial hypertension (PAH) is a chronic disease that ultimately progresses to right-sided heart failure (HF) and death. Close monitoring of pulmonary artery pressure (PAP) and right ventricular (RV) function allows clinicians to appropriately guide therapy. However, the burden of commonly used methods to assess RV hemodynamics, such as right heart catheterization, precludes frequent monitoring. The CardioMEMS HF System (Abbott) is an ambulatory implantable hemodynamic monitor, previously only used in patients with New York Heart Association (NYHA) class III HF. In this study, we evaluate the feasibility and early safety of monitoring patients with PAH and right-sided HF using the CardioMEMS HF System., Methods: The CardioMEMS HF sensors were implanted in 26 patients with PAH with NYHA class III or IV right-sided HF (51.3 ± 18.3 years of age, 92% women, 81% NYHA class III). PAH therapy was tracked using a minimum of weekly reviews of CardioMEMS HF daily hemodynamic measurements. Safety, functional response, and hemodynamic response were tracked up to 4 years with in-clinic follow-ups., Results: The CardioMEMS HF System was safely used to monitor PAH therapy, with no device-related serious adverse events observed and a single preimplant serious adverse event. Significant PAP reduction and cardiac output elevation were observed as early as 1 month postimplant using trends of CardioMEMS HF data, coupled with significant NYHA class and quality of life improvements within 1 year., Conclusions: The CardioMEMS HF System provided useful information to monitor PAH therapy, and demonstrated short- and long-term safety. Larger clinical trials are needed before its widespread use to guide therapy in patients with severe PAH with right-sided HF., (Copyright © 2019 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.)

Background: The National Cardiogenic Shock Initiative is a single-arm, prospective, multicenter study to assess outcomes associated with early mechanical circulatory support (MCS) in patients presenting with acute myocardial infarction and cardiogenic shock (AMICS) treated with percutaneous coronary intervention (PCI)., Methods: Between July 2016 and February 2019, 35 sites participated and enrolled into the study. All centers agreed to treat patients with AMICS using a standard protocol emphasizing invasive hemodynamic monitoring and rapid initiation of MCS. Inclusion and exclusion criteria mimicked those of the "SHOCK" trial with an additional exclusion criteria of intra-aortic balloon pump counter-pulsation prior to MCS., Results: A total of 171 consecutive patients were enrolled. Patients had an average age of 63 years, 77% were male, and 68% were admitted with AMICS. About 83% of patients were on vasopressors or inotropes, 20% had a witnessed out of hospital cardiac arrest, 29% had in-hospital cardiac arrest, and 10% were under active cardiopulmonary resuscitation during MCS implantation. In accordance with the protocol, 74% of patients had MCS implanted prior to PCI. Right heart catheterization was performed in 92%. About 78% of patients presented with ST-elevation myocardial infarction with average door to support times of 85 ± 63 min and door to balloon times of 87 ± 58 min. Survival to discharge was 72%. Creatinine ≥2, lactate >4, cardiac power output (CPO) <0.6 W, and age ≥ 70 years were predictors of mortality. Lactate and CPO measurements at 12-24 hr reliably predicted overall mortality postindex procedure., Conclusion: In contemporary practice, use of a shock protocol emphasizing best practices is associated with improved outcomes., (© 2019 Wiley Periodicals, Inc.)

Background: Stroke and transient ischemic attack after transcatheter aortic valve replacement results in significantly higher morbidity and mortality. Severe carotid artery disease may be a contributing factor to this increased risk. We report our technique and outcomes of combined carotid endarterectomy (CEA) with transcatheter aortic valve replacement (TAVR)., Methods: From March 2013 to November 2017 a total of 753 TAVRs were performed at our institution for symptomatic severe aortic stenosis. Of this group, 16 patients underwent concomitant TAVR and CEA. A retrospective review was performed to assess risk, outcomes, and short-term survival., Results: Sixteen patients underwent concomitant CEA/TAVR procedures for severe carotid and severe aortic stenosis. The mean Society of Thoracic Surgeons (STS) Risk Score was 7.0 ± 4.7. All patients had severe carotid artery stenosis and aortic stenosis. Nine patients had a transfemoral TAVR approach and eight patients had a transapical TAVR approach. The mean length of stay was 6.4 ± 3.7 days. At 30 days there were no cerebrovascular events and no mortalities., Conclusions: The use of concomitant CEA and TAVR in patients with severe aortic stenosis and severe carotid stenosis can be done safely without increased risk of complications. This approach may reduce the risk of stroke associated with TAVR in appropriately selected patients., (© 2018 Wiley Periodicals, Inc.)

Computational fluid dynamics (CFD) modeling of the pulmonary vasculature has the potential to reveal continuum metrics associated with the hemodynamic stress acting on the vascular endothelium. It is widely accepted that the endothelium responds to flow-induced stress by releasing vasoactive substances that can dilate and constrict blood vessels locally. The objectives of this study are to examine the extent of patient specificity required to obtain a significant association of CFD output metrics and clinical measures in models of the pulmonary arterial circulation, and to evaluate the potential correlation of wall shear stress (WSS) with established metrics indicative of right ventricular (RV) afterload in pulmonary hypertension (PH). Right Heart Catheterization (RHC) hemodynamic data and contrast-enhanced computed tomography (CT) imaging were retrospectively acquired for 10 PH patients and processed to simulate blood flow in the pulmonary arteries. While conducting CFD modeling of the reconstructed patient-specific vasculatures, we experimented with three different outflow boundary conditions to investigate the potential for using computationally derived spatially averaged wall shear stress (SAWSS) as a metric of RV afterload. SAWSS was correlated with both pulmonary vascular resistance (PVR) (R(2)=0.77, P<0.05) and arterial compliance (C) (R(2)=0.63, P<0.05), but the extent of the correlation was affected by the degree of patient specificity incorporated in the fluid flow boundary conditions. We found that decreasing the distal PVR alters the flow distribution and changes the local velocity profile in the distal vessels, thereby increasing the local WSS. Nevertheless, implementing generic outflow boundary conditions still resulted in statistically significant SAWSS correlations with respect to both metrics of RV afterload, suggesting that the CFD model could be executed without the need for complex outflow boundary conditions that require invasively obtained patient-specific data. A preliminary study investigating the relationship between outlet diameter and flow distribution in the pulmonary tree offers a potential computationally inexpensive alternative to pressure based outflow boundary conditions., (Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.)

Pulmonary hypertension (PH) is a devastating disease affecting approximately 15-50 people per million, with a higher incidence in women. PH mortality is mostly attributed to right ventricle (RV) failure, which results from RV hypotrophy due to an overburdened hydraulic workload. The objective of this study is to correlate wall shear stress (WSS) with hemodynamic metrics that are generally accepted as clinical indicators of RV workload and are well correlated with disease outcome. Retrospective right heart catheterization data for 20 PH patients were analyzed to derive pulmonary vascular resistance (PVR), arterial compliance (C), and an index of wave reflections (Γ). Patient-specific contrast-enhanced computed tomography chest images were used to reconstruct the individual pulmonary arterial trees up to the seventh generation. Computational fluid dynamics analyses simulating blood flow at peak systole were conducted for each vascular model to calculate WSS distributions on the endothelial surface of the pulmonary arteries. WSS was found to be decreased proportionally with elevated PVR and reduced C. Spatially averaged WSS (SAWSS) was positively correlated with PVR (R (2) = 0.66), C (R (2) = 0.73), and Γ (R (2) = 0.5) and also showed promising preliminary correlations with RV geometric characteristics. Evaluating WSS at random cross sections in the proximal vasculature (main, right, and left pulmonary arteries), the type of data that can be acquired from phase-contrast magnetic resonance imaging, did not reveal the same correlations. In conclusion, we found that WSS has the potential to be a viable and clinically useful noninvasive metric of PH disease progression and RV health. Future work should be focused on evaluating whether SAWSS has prognostic value in the management of PH and whether it can be used as a rapid reactivity assessment tool, which would aid in selection of appropriate therapies.

Calcific aortic stenosis is the most common valvular heart disease in the Western world. Although definitive treatment is valve replacement, many patients are not replacement candidates due to high surgical risk from older age and comorbid illness or lack of desire for a surgical or replacement procedure. Percutaneous balloon aortic valvuloplasty (BAV) is an option for palliative treatment in nonsurgical patients, although this procedure is complicated during the immediate postprocedure period by bleeding requiring transfusion for about 1 in 5 patients and subsequent restenosis. This report describes BAV using a smaller profile balloon designed to withstand higher pressures, rapidly inflated with a power injector. Twenty consecutive high-risk patients with severe aortic stenosis were treated. In all cases, New York Heart Association (NYHA) class improved from IV before BAV to I or II at 30 days follow-up. Six-month posttreatment follow-up data were available for 19 of 20 patients: 15 patients were either NYHA class I or II, 1 patient was class III, and 3 deaths occurred unrelated to aortic stenosis. One patient was lost to follow-up. Average systolic gradient peak-to-peak pressure decreased by 40.0% (range 18.0-70.0%) and mean gradient decreased by 30.0% (range 13.7-70.8%). Aortic valve area increased from 0.59 ± 0.16 cm(2) to 0.92 ± 0.23 cm(2), representing a mean increase of 30.0% (range 7.8%-58.2%). There were no significant bleeding complications. The only procedural complication was a single case of pericardial tamponade. There were no other complications during the first 24 hours post-BAV. These data support that the reported BAV technique may offer an effective alternative for patients with severe aortic stenosis who are not surgical candidates or prefer to avoid aortic valve replacement., (©2010, Wiley Periodicals, Inc.)

Right to left shunting through a patent foramen ovale (PFO) or atrial septal defect (ASD) can cause platypnea-orthodeoxia even in a setting of normal pulmonary artery pressures. However, the late onset of symptoms despite the congenital origin of the anatomical defects is not well understood. We report a case series of patients presenting with dyspnea and orthodeoxia who developed right to left shunting as a result of associated anatomical changes that occur with aging such as tortuosity and elongation of the aorta. We propose that these acquired anatomical changes can favor right to left shunting in the setting of congenital abnormalities, therefore explaining the late onset of symptoms.

Diagnostic cardiac catheterizations are predominantly performed using access through the femoral artery. To improve patient comfort and early mobilization, a number of percutaneous closure devices have been developed. One such device using the nitinol clip was developed by Abbott Vascular Devices and was approved for use on the basis of the results of the Clip Closure In Percutaneous Procedures (CLIP) study. The safety of repuncture through a previously deployed device has not been established in humans. We present the case of a patient who had an arterial line placed for post-operative monitoring after cardiac surgery at the site of a previous arteriotomy closed with the Starclose device. The catheter traversed through the central portion, tethered to the periphery of the ninitol clip, and required surgery for extraction., ((c) 2009 Wiley-Liss, Inc.)

Background: The mortality of cardiogenic shock (CGS) remains high despite currently available pharmacological and mechanical treatment options. The standard of care in medically refractory situations has been the insertion of an intra-aortic balloon pump. The purpose of this study was to investigate the feasibility, safety, and hemodynamic impact of the TandemHeart percutaneous left ventricular assist device (pVAD) in CGS., Methods: Thirteen patients from five centers in the US with the diagnosis of CGS were enrolled in the study. Hemodynamic measurements, including cardiac index (CI), mean arterial pressure (MAP), pulmonary capillary wedge pressure (PCWP), and central venous pressure (CVP) were performed presupport, during support and after device removal. Patients were monitored for 6 months., Results: The pVAD was successfully implanted in all 13 patients, with duration of support averaging 60 +/- 44 hr. During support, CI increased from 2.09 +/- 0.64 at baseline to 2.53 +/- 0.65 (P = 0.02), MAP increased from 70.6 +/- 11.1 to 81.7 +/- 14.6 (P = 0.01), PCWP decreased from 27.2 +/- 12.2 to 16.5 +/- 4.8 (P = 0.01), and CVP from 12.9 +/- 3.7 to 12.6 +/- 3.6 (P = NS). Ten patients survived to device explant, 6 of whom were bridged to another therapy. Seven patients survived to hospital discharge and were all alive at 6 months. The two most common adverse events were distal leg ischemia (n = 3) and bleeding from the cannulation site (n = 4)., Conclusion: The TandemHeart PTVA System may be a useful complementary treatment for patients with CGS, especially as a bridge to another treatment. Further study is needed to definitively establish safety and efficacy.

Rotational atherectomy is used to debulk calcified or complex coronary stenoses. Whether aggressive burr sizing with minimal balloon dilation (<1 atm) to limit deep wall arterial injury improves results is unknown. Patients being considered for elective rotational atherectomy were randomized to either an "aggressive" strategy (n = 249) (maximum burr/artery >0.70 alone, or with adjunctive balloon inflation < or = 1 atm), or a "routine" strategy (n = 248) (maximum burr/artery < or =0.70 and routine balloon inflation > or =4 atm). Patient age was 62 +/- 11 years. Fifty-nine percent routine and 60% aggressive strategy patients had class III to IV angina. Fifteen percent routine and 16% aggressive strategy patients had a restenotic lesion treated; lesion length was 13.6 versus 13.7 mm. Reference vessel diameter was 2.64 mm. Maximum burr size (1.8 vs 2.1 mm), burr/artery ratio (0.71 vs 0.82), and number of burrs used (1.9 vs 2.7) were greater for the aggressive strategy, p <0.0001. Final minimum lumen diameter and residual stenosis were 1.97 mm and 26% for the routine strategy versus 1.95 mm and 27% for the aggressive strategy. Clinical success was 93.5% for the routine strategy and 93.9% for the aggressive strategy. Creatine kinase-myocardial band (CK-MB) was >5 times normal in 7% of the routine versus 11% of the aggressive group. CK-MB elevation was associated with a decrease in rpm of >5,000 from baseline for a cumulative time >5 seconds, p = 0.002. At 6 months, 22% of the routine patients versus 31% of the aggressive strategy patients had target lesion revascularization. Angiographic follow-up (77%) showed minimum lumen diameter to be 1.26 mm in the routine group versus 1.16 mm in the aggressive group, and the loss index 0.54 versus 0.62. Dichotomous restenosis was 52% for the routine strategy versus 58% for the aggressive strategy. Multivariable analysis indicated that left anterior descending location (odds ratio 1.67, p = 0.02) and operator-reported excessive speed decrease >5,000 rpm (odds ratio 1.74, p = 0.01) were significantly associated with restenosis. Thus, the aggressive rotational atherectomy strategy offers no advantage over more routine burr sizing plus routine angioplasty. Operator technique reflected by an rpm decrease of >5,000 from baseline is associated with CK-MB elevation and restenosis.

Objectives: This registry collected the 30-day and 9-month clinical outcomes of patients whose coronary stent implantation was suboptimal, and compared them with the cohort of patients with "optimal" stenting in the randomized portion of the STent Anti-thrombotic Regimen Study (STARS) trial., Background: Although "optimal" stenting combined with an aspirin and ticlopidine regimen carries a low (0.5%) incidence of subacute stent thrombosis, only limited data are available for patients in whom stents are deployed suboptimally., Methods: In the STARS, 312 (15.9%) of 1,965 patients enrolled were excluded from participation in the randomized trial based on a perceived "suboptimal" result of coronary stenting. Of these, 265 patients met prespecified criteria for suboptimal stenting, and were followed in a parallel registry, which was compared with the randomized STARS optimal stenting cohort. The primary end point was a 30-day composite of death, emergent target lesion revascularization, angiographic thrombosis of the target vessel without revascularization and nonfatal myocardial infarction (MI) unrelated to direct procedural complications., Results: Registry patients had a similar frequency of the primary end point compared with the overall randomized cohort (3.0% vs. 2.2%), with this end point correlating to use of multiple stents, smaller final lumen diameter and absence of ticlopidine from the poststent regimen. Overall 30-day mortality (1.1% vs. 0.06%, p = 0.009) and periprocedural non-Q wave MI (8.7% vs. 4.2%, p = 0.003) were more frequent in registry patients, and appeared to be related to acute procedural complications. Clinical restenosis was significantly higher for registry patients (26.8% vs. 16.0%, p = 0.001), relating to greater prevalence of independent predictors such as smaller final lumen diameter and multiple stent use., Conclusions: In the STARS registry, the inability to perform optimal stenting correlated with smaller final lumen diameter and longer stent length. With ticlopidine-containing regimens, the acute clinical results of "suboptimal" stent deployment are clinically acceptable, although they are not quite as good as those of optimal stenting using similar drug therapy.

The feasibility and safety of local heparin delivery during acute infarct angioplasty was evaluated in a prospective, multicenter, 120-patient series. Angioplasty was performed using standard techniques, after which heparin (4,000 U) was delivered locally; 25% of patients received stents. Procedural success was reported in 98% of patients; 6.7% of patients suffered death, reinfarction, recurrent ischemia, or stroke during the index hospitalization. The 6-month target vessel revascularization rate was 12.5%. Local heparin therapy with provisional stenting in acute myocardial infarction patients is safe, feasible, associated with a low rate of infarct artery revascularization at 6 months, and may potentially eliminate the need for systemic heparin following the procedure.

Background: Antithrombotic drugs are used after coronary-artery stenting to prevent stent thrombosis. We compared the efficacy and safety of three antithrombotic-drug regimens - aspirin alone, aspirin and warfarin, and aspirin and ticlopidine - after coronary stenting., Methods: Of 1965 patients who underwent coronary stenting at 50 centers, 1653 (84.1 percent) met angiographic criteria for successful placement of the stent and were randomly assigned to one of three regimens: aspirin alone (557 patients), aspirin and warfarin (550 patients), or aspirin and ticlopidine (546 patients). All clinical events reflecting stent thrombosis were included in the prespecified primary end point: death, revascularization of the target lesion, angiographically evident thrombosis, or myocardial infarction within 30 days., Results: The primary end point was observed in 38 patients: 20 (3.6 percent) assigned to receive aspirin alone, 15 (2.7 percent) assigned to receive aspirin and warfarin, and 3 (0.5 percent) assigned to receive aspirin and ticlopidine (P=0.001 for the comparison of all three groups). Hemorrhagic complications occurred in 10 patients (1.8 percent) who received aspirin alone, 34 (6.2 percent) who received aspirin and warfarin, and 30 (5.5 percent) who received aspirin and ticlopidine (P<0.001 for the comparison of all three groups); the incidence of vascular surgical complications was 0.4 percent (2 patients), 2.0 percent (11 patients), and 2.0 percent (11 patients), respectively (P=0.01). There were no significant differences in the incidence of neutropenia or thrombocytopenia (overall incidence, 0.3 percent) among the three treatment groups., Conclusions: As compared with aspirin alone and a combination of aspirin and warfarin, treatment with aspirin and ticlopidine resulted in a lower rate of stent thrombosis, although there were more hemorrhagic complications than with aspirin alone. After coronary stenting, aspirin and ticlopidine should be considered for the prevention of the serious complication of stent thrombosis.

Prompted by severe cardiogenic shock, impending or manifest, three cases from the United States Retroperfusion Clinical Trials utilized intraaortic balloon counterpulsation combined with retroperfusion. Temporary stabilization and improvement was noted in all three cases and long-term survival was seen in two of the cases. The clinical and physiologic bases for combined use of these modalities is discussed.

Objectives: The purpose of this study was to compare measures of coronary flow reserve by an intracoronary Doppler guide wire with results of stress single-photon emission computed tomographic (SPECT) thallium-201 imaging in patients with intermediate coronary artery disease (40% to 70% stenosis)., Background: Visual assessment of the coronary arteriogram as a means of predicting the physiologic significance of intermediate coronary stenoses is inaccurate. Coronary flow reserve is a reliable marker of the functional importance of a coronary lesion. The recent development of an intracoronary Doppler guide wire permits routine assessment of coronary flow reserve distal to coronary artery stenoses., Methods: We prospectively evaluated coronary flow reserve in 30 subjects with intermediate stenoses using an intracoronary Doppler guide wire during elective coronary angiography. Patients subsequently underwent stress SPECT thallium-201 testing, and the blinded interpretations were correlated. Coronary flow reserve in a control group with normal coronary arteries classified our sample into group 1 (abnormal flow reserve, < 2.0) and group 2 (normal flow reserve, > or = 2.0)., Results: As defined, the coronary flow reserve of 16 vessels in group 1 was diminished in comparison to that of 19 vessels in group 2 (p = 0.0001). Qualitative and quantitative analysis of stress SPECT thallium-201 images confirmed perfusion defects in 15 of 16 vascular territories in group 1 in contrast to 1 of 19 regions in group 2. The sensitivity, specificity and overall predictive accuracy of Doppler-determined coronary flow reserve for stress SPECT thallium-201 results were 94%, 95% and 94%, respectively., Conclusions: In appropriately selected patients with intermediate coronary artery stenoses, Doppler guide wire determination of lesion significance provides equivalent data to those acquired by stress SPECT thallium-201 imaging.

The diagnosis of pseudoaneurysm of the ascending aorta is of paramount importance because of its propensity to rupture. As the frequency of surgical procedures involving the aortic root and valve increases, an increase in the incidence of aortic pseudoaneurysm may be anticipated. We recently studied a patient who developed pseudoaneurysm of the ascending aorta following repair of a Type I aortic dissection, utilizing a composite graft. Two-dimensional echocardiography with color flow and pulsed Doppler imaging showed a large perigraft cavity communicating with the aorta. Echocardiography provides a safe noninvasive diagnostic tool for the evaluation of the aorta postoperatively and for screening for pseudoaneurysm formation in the follow-up period.

In this case report of a patient presenting with an acute inferior wall myocardial infarction, the infarct conduit was a saphenous vein graft. Extraction atherectomy using the TEC successfully reestablished patency and reversed the patient's clinical symptoms. Extraction atherectomy is a feasible procedure during acute coronary events and deserves further investigation.

Left ventricular pseudoaneurysms are a rare complication of myocardial rupture. The diagnosis is paramount because of the propensity of pseudoaneurysms to rupture. Color flow imaging has been reported to be an aid in the diagnosis of pseudoaneurysms. We recently studied a patient with a myocardial infarction who developed a left ventricular pseudoaneurysm. Diagnosis was made by two-dimensional imaging with color flow imaging. He subsequently had a repair procedure with a gortex graft. One week after repair, repeat echocardiography with color flow imaging showed flow into the aneurysmal sac at multiple sites, consistent with recurrence of the pseudoaneurysm. Echocardiography with color flow imaging provides a safe noninvasive diagnostic tool for evaluating pseudoaneurysms preoperatively and in assessing the competency of the repair postoperatively.