Transcatheter aortic valve implantation: durability of clinical and hemodynamic outcomes beyond 3 years in a large patient cohort.

BACKGROUND: Although short- and medium-term outcomes after transcatheter aortic valve implantation are encouraging, long-term data on valve function and clinical outcomes are limited. METHODS AND RESULTS: Consecutive high-risk patients who had been declined as surgical candidates because of comorbidities but who underwent successful transcatheter aortic valve implantation with a balloon-expandable valve between January 2005 and December 2006 and survived past 30 days were assessed. Clinical, echocardiographic, and computed tomographic follow-up examinations were performed. Seventy patients who underwent successful procedures and survived longer than 30 days were evaluated at a minimum follow-up of 3 years. At a median follow-up of 3.7 years (interquartile range 3.4 to 4.3 years), survival was 57%. Survival at 1, 2, and 3 years was 81%, 74%, and 61%, respectively. Freedom from reoperation was 98.5% (1 patient with endocarditis). During this early procedural experience, 11 patients died within 30 days, and 8 procedures were unsuccessful. When these patients were included, overall survival was 51%. Transaortic pressure gradients increased from 10.0 mm Hg (interquartile range 8.0 to 12.0 mm Hg) immediately after the procedure to 12.1 mm Hg (interquartile range 8.6 to 16.0 mm Hg) after 3 years (P=0.03). Bioprosthetic valve area decreased from a mean of 1.7±0.4 cm(2) after the procedure to 1.4±0.3 cm(2) after 3 years (P<0.01). Aortic incompetence after implantation was trivial or mild in 84% of cases and remained unchanged or improved over time. There were no cases of structural valvular deterioration, stent fracture, deformation, or valve migration. CONCLUSIONS: Transcatheter aortic valve implantation demonstrates good medium- to long-term durability and preserved hemodynamic function, with no evidence of structural failure. The procedure appears to offer an adequate and lasting resolution of aortic stenosis in selected patients.

Association of the arterial access site at angioplasty with transfusion and mortality: the M.O.R.T.A.L study (Mortality benefit Of Reduced Transfusion after percutaneous coronary intervention via the Arm or Leg).

BACKGROUND: Bleeding and transfusion after percutaneous coronary intervention (PCI) are known predictors of mortality. Transradial arterial access reduces bleeding and transfusion related to femoral access complications, although its association with mortality is unknown. OBJECTIVE: To determine the association of arterial access site (radial or femoral) with transfusion and mortality in unselected PCIs. DESIGN, SETTING AND PATIENTS: By data linkage of three prospectively collated provincial registries, 38,872 procedures in 32,822 patients in British Columbia were analysed. The association between access site, transfusion and outcomes was assessed by logistic regression, propensity score matching and probit regression. MAIN OUTCOME MEASURES: 30-Day and 1-year mortality. RESULTS: 1134 (3.5%) patients had at least one blood transfusion. Transfused patients had a significantly increased 30-day and 1-year mortality, adjusted odds ratio (95% CI) 4.01 (3.08 to 5.22) and 3.58 (2.94 to 4.36), respectively. By probit regression the absolute increase in risk of death at 1 year associated with receiving a transfusion was 6.78%. The number needed to treat was 14.74 (prevention of 15 transfusions required to "avoid" one death). Radial access halved the transfusion rate. After adjustment for all variables, radial access was associated with a significant reduction in 30-day and 1-year mortality, odds ratio = 0.71 (95% CI 0.61 to 0.82) and 0.83 (0.71 to 0.98), respectively (all p<0.001). CONCLUSIONS: In a registry of all comers to PCI, transradial access was associated with a halving of the transfusion rate and a reduction in 30-day and 1-year mortality.

Incidence, predictors, and significance of abnormal cardiac enzyme rise in patients treated with bypass surgery in the arterial revascularization therapies study (ARTS).

BACKGROUND: Although it has been suggested that elevation of CK-MB after percutaneous coronary intervention is associated with adverse clinical outcomes, limited data are available in the setting of coronary bypass grafting. The aim of the present study was to determine the incidence, predictors, and prognostic significance of CK-MB elevation following multivessel coronary bypass grafting (CABG). METHODS AND RESULTS: The population comprises 496 patients with multivessel coronary disease assigned to CABG in the Arterial Revascularization Therapies Study (ARTS). CK-MB was prospectively measured at 6, 12, and 18 hours after the procedure. Thirty-day and 1-year clinical follow-up were performed. Abnormal CK-MB elevation occurred in 61.9% of the patients. Patients with increased cardiac-enzyme levels after CABG were at increased risk of both death and repeat myocardial infarction within the first 30 days (P=0.001). CK-MB elevation was also independently related to late adverse outcome (P=0.009, OR=0.64). CONCLUSIONS: Increased concentrations of CK-MB, which are often dismissed as inconsequential in the setting of multivessel CABG, appear to occur very frequently and are associated with a significant increase in both repeat myocardial infarction and death beyond the immediate perioperative period.

Parity and carotid artery atherosclerosis in elderly women: The Rotterdam Study.

BACKGROUND AND PURPOSE: It has been postulated that physiological changes in the cardiovascular system, lipids, and glucose metabolism during pregnancy may increase subsequent risk of cardiovascular disease. Examination of the association between parity and risk factors for atherosclerosis may contribute information regarding possible mechanisms. METHODS: The relationship of parity with cardiovascular risk factors and the presence of carotid atherosclerosis was examined in the Rotterdam Study, a population-based study comprising 4878 women aged 55 years and older. Carotid atherosclerosis was assessed by ultrasonographic detection of plaques in the common carotid artery and bifurcation. Logistic regression models were used to compute odds ratios and 95% confidence intervals, adjusted for confounding factors. RESULTS: Parity was inversely associated with high-density lipoprotein cholesterol, and alcohol intake. Parity was positively associated with body mass index, total/HDL cholesterol ratio, insulin resistance, age at menopause, and socioeconomic status. Relative to nulliparous women, parous women had 36% (9% to 71%) greater risk of carotid atherosclerosis, rising to 64% in women with >/=4 children (19% to 127%). Adjustment for known cardiovascular risk factors, including insulin resistance and current lipid levels, did not diminish the magnitude of this association. CONCLUSIONS: Data demonstrated that there is a positive association between parity and risk of carotid artery plaques in elderly women and, further, that high parity is associated with lower HDL cholesterol levels and higher glucose/insulin ratios long after childbearing has ceased.

Predictors of improvement in left ventricular function after percutaneous revascularization of occluded coronary arteries: a report from the Total Occlusion Study of Canada (TOSCA).

BACKGROUND: The Total Occlusion Study of Canada (TOSCA) is a multicenter, randomized trial evaluating the effect of stenting with > =1 heparin-coated stent on long-term patency after percutaneous coronary intervention by balloon angioplasty of occluded coronary arteries. The purpose of the current study was to compare the effect of stenting and balloon angioplasty on global left ventricular ejection fraction (LVEF) and regional wall motion and to examine what clinical and angiographic factors may have an effect on left ventricular function in this setting. METHODS AND RESULTS: Analysis at the core angiographic laboratory of paired baseline and follow-up left ventricular angiograms, as well as target vessel patency, was possible in 244 of 410 cases. An improvement in LVEF was observed in the entire group (59.4% +/- 11% to 61.0% +/- 11%, P =.003). The LVEF change was +1.84 +/- 7.54 in the stent group (P =.009) and 1.28 +/- 8.16 in the percutaneous transluminal coronary angioplasty group (P =.085). There was no significant intergroup difference. Patients with duration of occlusion < or =6 weeks had an improvement in LVEF (+2.98 +/- 8.68, P =.0006), whereas those with an occlusion duration of > 6 weeks had no improvement (+0.48 +/- 7.01, P not significant). Multivariate analysis revealed baseline LVEF <60%, duration of occlusion < or =6 weeks, and Canadian Cardiology Society angina class I or II to be independent predictors of improvement in LVEF. CONCLUSIONS: The restoration of coronary patency of nonacute occluded coronary arteries is associated with a small but significant improvement in regional and global left ventricular function, especially in patients with recent occlusions and depressed left ventricular function. In spite of significant effect on long-term patency, stenting of nonacute coronary occlusions does not result in significantly better left ventricular function compared with balloon angioplasty in this setting.

Unprotected left main coronary artery stenting for cardiac allograft vasculopathy.

Cardiac allograft vasculopathy is the leading cause of death after the first year of transplantation. Treatment outcomes with medication, balloon angioplasty, bypass surgery, and retransplantation have been disappointing. We present our initial experience with stenting of the left main coronary artery in the setting of allograft vasculopathy.

Percutaneous coronary intervention for cardiogenic shock in the SHOCK Trial Registry.

BACKGROUND: The SHOCK Registry prospectively enrolled patients with cardiogenic shock complicating acute myocardial infarction in 36 multinational centers. METHODS: Cardiogenic shock was predominantly attributable to left ventricular pump failure in 884 patients. Of these, 276 underwent percutaneous coronary intervention (PCI) after shock onset and are the subject of this report. RESULTS: The majority (78%) of patients undergoing angiography had multivessel disease. As the number of diseased arteries rose from 1 to 3, mortality rates rose from 34.2% to 51.2%. Patients who underwent PCI had lower in-hospital mortality rates than did patients treated medically (46.4% vs 78.0%, P < .001), even after adjustment for patient differences and survival bias (P = .037). Before PCI, the culprit artery was occluded (Thrombolysis In Myocardial Infarction grade 0 or 1 flow) in 76.3%. After PCI, the in-hospital mortality rate was 33.3% if reperfusion was complete (grade 3 flow), 50.0% with incomplete reperfusion (grade 2 flow), and 85.7% with absent reperfusion (grade 0 or 1 flow) (P < .001). CONCLUSIONS: This prospective, multicenter registry of patients with acute myocardial infarction complicated by cardiogenic shock is consistent with a reduction in mortality rates as the result of percutaneous coronary revascularization. Coronary artery patency was an important predictor of outcome. Measures to promote early and rapid reperfusion appear critically important in improving the otherwise poor outcome associated with cardiogenic shock.

Correlation of remote ST segment depression and coronary anatomy during acute coronary occlusion.

BACKGROUND: The appearance of remote ST segment depression (RSTD) on an electrocardiogram (ECG) is associated with more extensive infarction and a worse clinical outcome than when RSTD is absent. OBJECTIVE: To determine whether RSTD predicts coronary anatomy during acute coronary occlusion. It was hypothesized that RSTD is associated with the occlusion of a proximal lesion, an extensive artery and an artery without distal collateralization. PATIENTS AND METHODS: In 113 consecutive patients with single vessel disease undergoing percutaneous transluminal coronary angioplasty (PTCA), 12-lead ECGs (recorded at baseline and during balloon inflation) and angiographical data were analyzed independently. Patients with ST segment elevation in the primary territory and RSTD (greater than 1 mm ST depression at 80 ms after the J point) (group A) were compared with patients without RSTD (group B). Proximal lesions were defined as lesions located in the segments proximal to the acute marginal branch, first diagonal artery or first obtuse marginal branch. An extensive right coronary artery (RCA) was one that supplied the posterolateral wall; an extensive left anterior descending (LAD) artery was one that supplied the inferoapical wall; and an extensive circumflex artery was one that supplied the posterior descending artery. RESULTS: Fifty-four patients (48%) had PTCA of the proximal vessels, 43 patients (38%) had extensive target vessels and 11 patients (9.7%) had collaterals. Target vessels included 33% in RCA, 44% in LAD artery and 23% in circumflex artery. Forty-five patients (40%) developed RSTD during balloon inflation (group A). Patients in group A were more likely to have extensive vessels on the angiogram than those in group B (group A 49%, group B 31%; P=0.05). None of the patients in group A had collaterals to the culprit artery, while 16% of patients in group B did (P=0.003). The two groups were not significantly different with respect to the number of proximal lesions (group A 58%, group B 42%; P=0.08). Analysis performed according to the target artery revealed that RSTD was associated with occlusion of an extensive RCA during RCA occlusion (extensive RCA in group A 100%, group B 57%; P=0.006). For the LAD artery, RSTD was associated with proximal lesions (group A 74%, group B 41%; P=0.02) and absence of collaterals (group A 100%, group B 74%; P=0.01). CONCLUSIONS: During acute coronary occlusion, the presence of RSTD on 12-lead ECG was specific for the absence of collaterals. The presence of RSTD during RCA occlusion was strongly associated with an extensive RCA, suggestive of posterolateral wall ischemia. During LAD artery occlusion, the presence of RSTD was associated with proximal occlusion, which resulted in ischemia of the LAD artery and the major diagonal artery territories.

Facilitation of stent retention and retrieval with an emboli containment device.

A potential consequence of unsuccessful stent delivery is dislodgment of the stent from the delivery catheter resulting in embolization. Recently, an angioplasty guidewire incorporating a distal occlusion balloon (GuardWire) has become available. We describe how, when used for the prevention of distal embolization of atheromatous or thrombotic particles, this device may facilitate retention and retrieval of undeployed stents.

Co-morbidity data in outcomes research: are clinical data derived from administrative databases a reliable alternative to chart review?

Evaluation of co-morbidity data is essential in health outcomes research. Co-morbidity data derived from administrative databases has been criticized for lacking the accuracy required for clinical research. We compared co-morbidity data derived from a Canadian provincial hospitalization database with chart review in 817 adults treated with a percutaneous coronary intervention at a single tertiary care hospital between 1994 and 1995. While the administrative database tended to under-estimate the prevalence of some co-morbid conditions, the agreement between chart review and administrative data was good to very good for most conditions. Asymptomatic conditions were noted to have lower levels of agreement. Multivariate risk models for all-cause mortality constructed from both data sources were almost identical, suggesting minimal misclassification. The results indicate that clinical data abstracted from most Canadian hospitalization databases can provide reliable information regarding baseline co-morbid conditions believed to influence survival in a population undergoing percutaneous coronary interventions.

Coronary stenting without predilatation in a broad spectrum of clinical and angiographic situations.

BACKGROUND: Direct coronary stenting without balloon predilatation has the potential benefits of a reduced risk of extended dissections, reduced fluoroscopy exposure, reduced procedural time, and potential cost savings. With the availability of superior stents and delivery systems, we review our experience with direct stent deployments in a large selected patient cohort. METHODS: We prospectively studied 158 consecutive cases of attempted coronary stenting without balloon predilatation over a 1-year period. RESULTS: Indications for the procedure included unstable angina (71%), stable angina (24%) and acute myocardial infarction (5%). Target vessels were the anterior descending artery (56%), right coronary artery (30%), circumflex artery (8%), and vein grafts (6%). Pre-procedural TIMI flows were grade 3 (91.7%), grade 2 (5.8%), grade 1 (1.3%) and 0 (1.3%). Lesion types were graded A (27%), B (61%), and C (12%). Stent types included NIR Primo (80.4%), ACS Multi-Link RX Duet (10.1%), NIR (5.1%), and others (4.4%). Stents ranged from 3.0Eth 4.0 mm in diameter (median = 3 mm) and 8Eth 32 mm in length (median = 16 mm). Stents were successfully deployed in 155 cases (98.1%); 2 (1.3%) required predilatation and 1 (0.6%) deployed stent could not be expanded and was opened by rotablation. All except the rotablator case achieved final TIMI grade 3 flow, and 66% did not require further balloon dilatation. There were no deaths or cases of urgent bypass surgery. Case duration and radiation exposure in direct stenting (32.8 +/- 18.9 minutes and 6.7 +/- 6.2 minutes, respectively) compared favorably to those in a matched group of patients in conventional stenting (47 +/- 18 minutes and 11 +/- 7 minutes) and coronary angioplasty (40 +/- 12 minutes and 10 +/- 6 minutes) for single-lesion cases (p < 0.005). Creatine kinase elevation related to the procedure was observed in 5 patients. Subacute stent thrombosis occurred in 2 (1.3%) cases. CONCLUSION: Direct coronary stenting was successfully and safely accomplished in a variety of clinical situations in selected patients.

Suture closure of femoral arterial puncture sites after coronary angioplasty followed by same-day discharge.

BACKGROUND: The purpose of this study was to determine whether immediate suture closure of 8F femoral arterial puncture sites can facilitate same-day discharge after coronary angioplasty. METHODS AND RESULTS: After coronary angioplasty, 100 patients were randomly assigned to immediate sheath removal with the double-suture Prostar-Plus device or delayed sheath removal with application of a c-clamp. After suture closure, mobilization at 4 hours after sheath removal and discharge 4 hours later were planned. Patients treated with the c-clamp had sheaths removed 4 hours after percutaneous transluminal coronary angioplasty, were mobilized 6 hours later, and discharged the following day. Patients were assessed for groin complications at 8, 24, and 72 hours. Overall, patients who received suture closure were mobilized at 7.1 +/- 5.3 hours and discharged 11. 15 +/- 6.22 hours after sheath removal versus 15.49 +/- 3.9 hours and 21.9 +/- 3.8 hours for patients with the c-clamp (P <.001). Initial failure of the suture device occurred in 5 patients, with 1 requiring surgery for an entrapped device. After the procedure, patients with suture closure more frequently had an ooze of blood (55% vs 24%, P <.001) and a trend to more overt external bleeding (10% vs 2%, P = not significant). Hematomas were reported by 20% of patients in both groups at 72 hours. Overall, patients preferred the suture closure method of sheath removal when assessed by a simple questionnaire. An economic analysis by cost minimization demonstrated potential hospital cost saving. CONCLUSIONS: Suture closure of 8F arterial puncture sites can facilitate early mobilization and same-day discharge and is considered acceptable by more patients compared with application of the c-clamp. There is potential to realize cost savings with a strategy of same-day discharge.

Multicenter evaluation of the phosphorylcholine-coated biodivYsio stent in short de novo coronary lesions: The SOPHOS study.

AIMS: The BiodivYsio trade mark stent (Biocompatibles Ltd, Farnham, UK) is coated with a phosphorylcholine (PC)-containing copolymer to confer biocompatibility. The SOPHOS (Study Of PHosphorylcholine coating On Stents) study was designed to assess the safety and efficacy of this novel coronary stent and by indirect comparison to indicate equivalence with other formal stent studies. METHODS AND RESULTS: Patients with angina and a single short (#x2A7F;12 mm) de novo lesion in a native coronary artery of >/=2.75 mm diameter were included. A total of 425 patients were allocated in 24 centers. Clinical data were collected at one-, six- and nine-month follow-up. Angiography was performed before and after the stent implantation. In addition, in the first 200 patients (SOPHOS A) angiography was routinely performed at six months. The following 225 patients (SOPHOS B) were merely followed up clinically. The primary end-point of the study, the six-month MACE-rate (MACE = Major Adverse Cardiac Events) was 13.4% (two cardiac death; five Q-wave/nine non-Q-wave myocardial infarctions (MI); nine CABG and 32 target lesion revascularization (TLR), which is similar to the calculated 15% MACE-rate in comparable reference studies. Secondary end-points included among others restenosis at six months in the SOPHOS A population. The target vessel diameter was 2.98 +/- 0.48 mm. Minimal lumen diameter pre/post procedure and at follow-up was 1.00 +/- 0.32, 2.69 +/- 0.37, 1.91 +/- 0.71 mm, respectively. The binary restenosis rate (>/=50% diameter stenosis at follow-up) was 17.7%. CONCLUSION: The coronary BiodivYsio stent is safe and effective as a primary device for the treatment of native coronary artery lesions in patients with stable or unstable angina pectoris. Clinical and angiographic results are in the statistical range of equivalence with comparable studies with other current stents.

Improved clinical outcome after widespread use of coronary-artery stenting in Canada.

BACKGROUND: The introduction and refinement of coronary-artery stenting dramatically changed the practice of percutaneous coronary revascularization in the mid-1990s. We analyzed one-year follow-up data for all percutaneous coronary interventions performed in a large, unselected population in Canada to determine whether the use of coronary stenting has been associated with improved outcomes. METHODS: Prospectively collected data on all percutaneous coronary interventions performed on residents of British Columbia, Canada, between April 1994 and June 1997 were linked to province-wide health care data bases to provide the date of the following end points: subsequent target-vessel revascularization, myocardial infarction, and death. Baseline characteristics and procedural variables were identified and Kaplan-Meier survival curves were generated for 9594 procedures divided into seven groups, one for each sequential half-year period. RESULTS: The overall burden of coexisting illnesses remained stable throughout the study period. A large increase in the rate of coronary stenting (from 14.2 percent in the period from April to June 1994 to 58.7 percent in the period from January to June 1997) was associated with a significant reduction in the rate of adverse cardiac events at one year (from 28.8 percent to 22.8.percent; adjusted relative risk, 0.79; 95 percent confidence interval, 0.69 to 0.90; P<0.001). This reduction in adverse events was exclusively due to a large reduction in subsequent target-vessel revascularization (from 24.4 percent to 17.0 percent; adjusted relative risk, 0.72; 95 percent confidence interval, 0.62 to 0.83; P<0.001) without significant changes in the overall rates of myocardial infarction (5.4 percent, P=0.28) or death (3.9 percent, P=0.65). CONCLUSIONS: The need for target-vessel revascularization during one year of follow-up decreased after percutaneous coronary intervention during the mid-1990s. The reduction was coincident with the introduction and subsequent widespread use of coronary stenting.

Effect of contrast media on coronary vascular resistance: contrast-induced coronary vasodilation.

STUDY OBJECTIVES: To determine if the vasodilatory response to the intracoronary injection of ionic and nonionic contrast media in intact pigs is dependent on nitric oxide (NO). The mechanisms responsible for inducing the increase in coronary blood flow in response to the intracoronary injection of contrast media during angiography are still not entirely understood. There is evidence to suggest that the response could be partially mediated by NO. PARTICIPANTS: We studied 14 anesthetized, open-chested pigs receiving ventilation. MEASUREMENTS AND RESULTS: Changes in coronary blood flow and coronary vascular resistance were measured in response to the coronary artery injection of saline solution (0.5 mol/L, isosmolar with plasma) and three different contrast agents: meglumine sodium ioxaglate (Hexabrix; Mallinckrodt Medical; Point-Claire, Quebec, Canada), a low osmolar ionic contrast agent; iohexol (Omnipaque 300; Sanofi Winthrop; Markham, Ontario, Canada), a nonionic contrast agent; and diatrizoate meglumine 66%, diatrizoate sodium 10% (MD-76; Mallinckrodt Medical), an ionic contrast agent. Measurements were made during three experimental conditions: the coronary artery infusion of (1) saline solution, control; (2) L-nitro-arginine (LNNA; 10(-3) mol/L and 10(-2) mol/L), a competitive inhibitor of NO synthase; and (3)L-arginine 10(-1) mol/L, a substrate for NO synthase. The infusion of LNNA produced an increase in baseline coronary vascular resistance (p < 0.001), but it did not attenuate the vasodilatory response to the infusion of the contrast agents. Both the high and low osmolar ionic and nonionic contrast media caused a decrease in baseline coronary vascular resistance. For all three conditions, MD-76, which has the highest osmolality, produced the greatest decrease in coronary vascular resistance. CONCLUSION: The vasodilatory response of the coronary vasculature to contrast agents is directly related to osmolality and is not mediated by NO.

Adverse events associated with balloon rupture during percutaneous coronary intervention.

BACKGROUND: Balloon rupture is a potential complication of coronary angioplasty. The literature is inconsistent regarding associated adverse consequences. The experience of St Paul's Hospital, University of British Columbia, Vancouver, British Columbia, with balloon rupture is reviewed. PATIENTS AND METHODS: All patients who underwent percutaneous coronary intervention complicated by balloon rupture at St Paul's Hospital from April 1992 to March 1996 were identified from the hospital's database (Seattle Systems, Seattle, Washington). Procedural logs, database records, clinical charts and all cineangiograms were reviewed in detail. RESULTS: A total of 2984 patients had percutaneous coronary revascularization and 110 patients experienced balloon rupture. These occurred in 101 (92%) native coronary arteries and 9 (8%) occurred in saphenous vein grafts. Stents were deployed in 44 (40%) patients; 34 of the stents used were half Johnson & Johnson PS153 stents (Johnson & Johnson Interventinal Systems, Peterborough, Ontario). An event-free postangioplasty course during the index hospitalization was observed in 102 patients (93%); eight patients (7%) had one or more important adverse events postprocedure. These included three deaths (one following a dissection and out-of-catheterization laboratory occlusion, a second following an abrupt occlusion of another target artery and emergency bypass surgery, and another with cardiogenic shock postmyocardial infarction and an unaltered course following angioplasty); one urgent bypass surgery after a left main dissection; and two nonfatal myocardial infarctions (one patient had tamponade and one patient experienced congestive heart failure). Four of the eight events were directly related to the procedure. The rate of death and emergency bypass surgery with balloon rupture did not differ from that of patients without balloon rupture in the authors' centre (1.8% versus 1.4%, not significant). CONCLUSIONS: The majority of patients did not experience any adverse clinical outcomes and demonstrated good angiographic results after balloon rupture. The data did not detect an excess of major adverse events beyond that expected in a diverse general angioplasty population.

Retrieval and analysis of particulate debris after saphenous vein graft intervention.

OBJECTIVES: This study was designed to evaluate the composition and quantity of particulate debris resulting from vein graft intervention. BACKGROUND: Distal embolization and "no reflow" are frequent and important complications resulting from angioplasty of diseased saphenous vein grafts. Little is known about the composition and quantity of embolic particulate debris associated with vein graft intervention, and no intervention has been shown to protect against its clinical consequences. METHODS: A catheter system, designed to contain, retrieve and protect against distal embolization of this material, was evaluated during 27 percutaneous interventional saphenous vein graft procedures. Clinical, angiographic and pathologic analyses were performed. RESULTS: The duration of distal graft occlusion required to allow intervention and subsequent debris removal was 150 +/- 54 s, decreasing as experience was gained. Thrombolysis in Myocardial Infarction trial (TIMI) flow grade increased from 2.6 +/- 0.8 to 3.0 +/- 0.0. Creatine kinase (CK) rose above normal in three patients (11.1%) exceeding 3x normal in one (3.7%) resulting in the diagnosis of non-Q-myocardial infarction. Particulate material was identified following 21 of 23 procedures suitable for analysis. Particle size was 204 +/- 57 microm in the major axis and 83 +/- 22 microm in the minor axis. Particles consisted predominantly of soft acellular atheromatous material, such as that typically found under a fibrous cap. Semiquantitative analysis suggested that the quantity of particulate material was less following stenting than following balloon dilation. CONCLUSIONS: Particulate matter is commonly present following routine angioplasty and stenting of saphenous vein grafts. Containment, retrieval and analysis of this particulate debris are all feasible. Comparison to prior clinical experience is limited by small sample size. However, to the extent that these particles may contribute to distal embolization, no-reflow and infarction, such a system may contribute to the reduction of complications following vein graft intervention.

Primary stenting versus balloon angioplasty in occluded coronary arteries: the Total Occlusion Study of Canada (TOSCA).

BACKGROUND: Balloon angioplasty (PTCA) of occluded coronary arteries is limited by high rates of restenosis and reocclusion. Although stenting improves results in anatomically simple occlusions, its effect on patency and clinical outcome in a broadly selected population with occluded coronary arteries is unknown. METHODS AND RESULTS: Eighteen centers randomized 410 patients with nonacute native coronary occlusions to PTCA or primary stenting with the heparin-coated Palmaz-Schatz stent. The primary end point, failure of sustained patency, was determined at 6-month angiography. Repeat target-vessel revascularization, adverse cardiovascular events, and angiographic restenosis (>50% diameter stenosis) constituted secondary end points. Sixty percent of patients had occlusions of >6 weeks' duration, baseline flow was TIMI grade 0 in 64%, and median treated segment length was 30.5 mm. With 95.6% angiographic follow-up, primary stenting resulted in a 44% reduction in failed patency (10.9% versus 19.5%, P=0.024) and a 45% reduction in clinically driven target-vessel revascularization at 6 months (15.4% versus 8.4%, P=0.03). The incidence of adverse cardiovascular events was similar for both strategies (PTCA, 23.6%; stent, 23.3%; P=NS). Stenting resulted in a larger mean 6-month minimum lumen dimension (1.48 versus 1.23 mm, P<0.01) and a reduced binary restenosis rate (55% versus 70%, P<0.01). CONCLUSIONS: Primary stenting of broadly selected nonacute coronary occlusions is superior to PTCA alone, improving late patency and reducing restenosis and target-vessel revascularization.

The use of milrinone in pre-transplant assessment of patients with congestive heart failure and pulmonary hypertension.

BACKGROUND: Pulmonary hypertension in patients with congestive heart failure (CHF) is a risk factor for increased mortality after orthotopic cardiac transplantation. Reversibility of elevated pulmonary vascular resistance (PVR) by pharmacologic agents predicts improved outcomes. Milrinone, a phosphodiesterase inhibitor with vasodilating and positive inotropic properties, has been shown to lower PVR in one previous study. However, no study has documented outcomes after cardiac transplantation in patients in whom reversibility of pulmonary hypertension was demonstrated after administration of milrinone. METHODS: We retrospectively reviewed 19 patients with CHF and pulmonary hypertension defined as PVR > or = 3 Wood units, PVRI (pulmonary vascular resistance index) > or = 4 resistance units, or TPG (transpulmonary gradient = mean pulmonary artery pressure--mean capillary wedge pressure) > or = 12 mmHg being assessed for cardiac transplantation. A sub-group of 14 patients with severe pulmonary hypertension defined as PVR > or = 4, PVRI > or = 6 and TPG > or = 15 was also examined. Milrinone was administered as a bolus (50 ug/kg) and hemodynamic parameters were measured at 5, 10 and 15 minutes. Six patients received cardiac transplants. RESULTS: Administration of milrinone significantly lowered PVR, PVRI, mean pulmonary artery pressure (PAM)(all p = 0.002) and pulmonary capillary wedge pressure (PCWP)(p = 0.006). Cardiac output (CO) increased significantly (p = 0.001). TPG did not change (p = 0.33). In patients with severe pulmonary hypertension, the magnitude of these changes was greater. In addition, TPG was significantly lowered (p = 0.02). CONCLUSION: Milrinone lowered PVR by decreasing PAM and increasing CO significantly. In addition, PCWP was significantly lowered. These finding confirm both vasodilatory and inotropic effects of milrinone. Patients with severe pulmonary hypertension had more pronounced effects. There were no deaths in the group of patients proceeding to cardiac transplantation. Our study demonstrates the efficacy of milrinone in lowering PVR as well as suggesting safety in use in patients undergoing cardiac transplantation.

Balloon entrapment during side-branch angioplasty through a stent.

Entrapment of the distal tip of a balloon catheter occurred during attempted passage between the struts of a stent into a side branch. Traction on the balloon resulted in fracture of the catheter shaft requiring extraction with percutaneous retrieval forceps.