Joseph Lindsay

Incidence, predictors, and prognostic implications of bleeding and blood transfusion following percutaneous coronary interventions

Bleeding related to percutaneous coronary intervention (PCI) occurs relatively frequently. We retrospectively investigated the incidence, predictors, and prognostic impact of periprocedural bleeding and transfusion in 10,974 patients who underwent PCI. Bleeding definitions were based on Thrombolysis In Myocardial Infarction (TIMI) criteria: (1) major bleeding (n = 588; 5.4%): if patients had a hemorrhagic stroke or if hematocrit decreased >15 points or by 10 to 15 points with clinical bleeding; (2) minor bleeding (n = 1,394; 12.7%): if hematocrit decreased <10 points with clinical bleeding or by 10 to 15 points without clinical bleeding; and (3) no bleeding (n = 8,992; 81.9%): if hematocrit decreased <10 points without clinical bleeding. Patients with major bleeding were older than patients with minor or no bleeding (67.8 +/- 11 vs 65.9 +/- 11 vs 63.6 +/- 11 years, respectively; p <0.001) and more often experienced intraprocedural complications, such as emergency use of an intra-aortic balloon pump (13.6% vs 6.5% vs 2.3%, respectively; p <0.001). Multivariate logistic regression analysis identified the use of an intra-aortic balloon pump (odds ratio [OR] 3.0, p <0.0001), procedural hypotension (OR 2.9, p <0.001), and age >80 years (OR 1.9 compared with age <50 years, p = 0.001) as the strongest predictors for major bleeding. Patients who had major bleeding had higher in-hospital and 1-year mortality compared with patients with minor or no bleeding. Bleeding was an independent predictor of in-hospital death. Thus, periprocedural major bleeding occurs relatively frequently and is associated with adverse outcomes. Patients >80 years of age who experience intraprocedural complications are at particularly high risk.

The impact of obesity on the short-term andlong-term outcomes after percutaneous coronary intervention: the obesity paradox?

OBJECTIVES The purpose of this study was to assess the impact of body mass index (BMI) on the short- and long-term outcomes after percutaneous coronary intervention (PCI). BACKGROUND Obesity is associated with advanced coronary artery disease (CAD). However, the relation between BMI and outcome after PCI remains controversial. METHODS We studied 9,633 consecutive patients who underwent PCI between January 1994 and December 1999. Patients were divided into three groups according to BMI: normal, BMI between 18.5 and 24.9 (n = 1,923); overweight, BMI between 25 and 30 (n = 4,813); and obese, BMI >30 (n = 2,897). RESULTS Obese patients were significantly younger and had consistently worse baseline clinical characteristics than normal or overweight patients, with a higher incidence of hypertension, diabetes, hypercholesterolemia and smoking history (p < 0.0001). Despite similar angiographic success rates among the three groups, normal BMI patients had a higher incidence of major in-hospital complications, including cardiac death (p = 0.001). At one-year follow-up, overall mortality rates were significantly higher for normal BMI patients compared with overweight or obese patients (p < 0.0001). Myocardial infarction and revascularization rates did not differ among the three groups. By multivariate Cox regression analysis, diabetes, hypertension, age, BMI and left ventricular function were independent predictors of long-term mortality. CONCLUSIONS In patients with known CAD who undergo PCI, very lean patients (BMI <18.5) and those with BMI within the normal range are at the highest risk for in-hospital complications and cardiac death and for increased one-year mortality.

The potential clinical utility of intravascular ultrasound guidance in patients undergoing percutaneous coronary intervention with drug-eluting stents

AIMS To assess the impact on clinical outcomes of intravascular ultrasound (IVUS) guidance during drug-eluting stent (DES) implantation. IVUS guidance during percutaneous coronary intervention (PCI) has been demonstrated to be useful in optimizing stent deployment. However, it is not proved that routine use of IVUS guidance with DES implantation can prevent stent thrombosis or restenosis. METHODS AND RESULTS The clinical outcomes of 884 patients undergoing IVUS-guided intracoronary DES implantation from April 2003 to May 2006 were compared with the outcomes of a propensity-score matched population undergoing DES implantation with angiographic guidance alone. The primary endpoint of the study was definite stent thrombosis at 12 months. The secondary endpoint was major adverse cardiac events (MACE). After propensity-score matching, the two groups were well matched for clinical and angiographic characteristics. Patients undergoing IVUS-guided DES implantation underwent less direct stenting, more post-dilation, and had greater cutting balloon and rotational atherectomy use. At 30 days and at 12 months, a higher rate of definite stent thrombosis was seen in the No IVUS group (0.5 vs. 1.4%; P = 0.046) and (0.7 vs. 2.0%; P = 0.014), respectively. There were no major differences in late stent thrombosis and MACE (14.5 vs. 16.2%; P = 0.33) at 12 month follow-up between the groups. Rates of death and Q-wave myocardial infarction were similar, and there was no significant difference between groups in target vessel revascularization. However, a trend was seen in favour of the IVUS group in target lesion revascularization (5.1 vs. 7.2%; P = 0.07). IVUS guidance was an independent predictor of freedom from cumulative stent thrombosis at 12 months (adjusted HR 0.5, CI 0.1-0.8; P = 0.02). CONCLUSION IVUS guidance during DES implantation has the potential to influence treatment strategy and reduce both DES thrombosis and the need for repeat revascularization.

Complications and Outcome of Balloon Aortic Valvuloplasty in High-Risk or Inoperable Patients

OBJECTIVES This study aimed to determine the success, complications, and survival of patients after balloon aortic valvuloplasty (BAV). BACKGROUND The introduction of transcatheter aortic valve implantation (TAVI) BAV has led to a revival in the treatment of patients with severe aortic stenosis. METHODS A cohort of 262 patients with severe aortic stenosis underwent 301 BAV procedures. Of these, 39 (14.8%) patients had ≥2 BAV procedures. Clinical, hemodynamic, and follow-up mortality data were collected. RESULTS The cohort mean age was 81.7 ± 9.8 years, and the mean Society of Thoracic Surgeons and logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) was 13.3 ± 6.7 and 45.6 ± 21.6, respectively. BAV was performed as a bridge to TAVI or to surgical aortic valve replacement in 28 patients (10.6%) and for symptom relief in 234 (89.4%). The mean aortic valve area (AVA) increased from 0.58 ± 0.3 cm(2) to 0.96 ± 0.3 cm(2) (p < 0.001). Of these, 111 (45.0%) had final AVA >1 cm(2), and in 195 patients (79%), AVA increased by >40%. De novo BAV resulted in a higher mean increase in AVA 0.41 ± 0.24 cm(2) versus 0.28 ± 0.24 cm(2) in redo BAV (p = 0.003). Serious adverse events occurred in 47 patients (15.6%), intraprocedural death in 5 (1.6%), stroke in 6 (1.99%), coronary occlusion in 2 (0.66%), severe aortic regurgitation in 4 (1.3%), resuscitation/cardioversion in 5 (1.6%), tamponade in 1 (0.33%), and permanent pacemaker in 3 (0.99%). A vascular complication occurred in 21 patients (6.9%); 34 (11.3%) had a post-procedure rise in creatinine >50%; and 3 (0.99%) required hemodialysis. During median follow-up of 181 days, the mortality rate was 50% (n = 131). The mortality rate in the group with final AVA >1 cm(2) was significantly lower than in the group with final AVA of <1 cm(2) (36.4% vs. 57.9%, p < 0.001). Final AVA was associated with lower mortality (hazard ratio: 0.46, p = 0.03). BAV as a bridge to TAVI or surgical aortic valve replacement had a better outcome compared with BAV alone: mortality rate 7 (25%) versus 124 (52.9%), respectively (p < 0.0001). CONCLUSIONS Long-term survival is poor after BAV alone. BAV as a bridge to percutaneous or surgical aortic valve replacement is feasible, safe, and associated with better outcome than BAV alone.

Major noncardiac surgery following coronary stenting: when is it safe to operate?

The optimal timing for elective noncardiac surgery (NCS) after coronary stenting is uncertain. We identified 47 patients who underwent elective NCS within 90 days of coronary stent placement between January 1995 and December 2000. Twenty‐seven patients had NCS within 3 weeks of coronary stenting. Six of the seven in whom thienopyridine antiplatelet therapy was discontinued died postoperatively in a manner suggestive of stent thrombosis. In contrast, only 1 of the 20 patients in whom the thienopyridine was continued through the NCS died. The frequency of perioperative hemorrhage was similar whether or not the antiplatelet agent was continued. Only 1 perioperative death occurred in the 20 patients with NCS more than 3 weeks following stenting. Catheter Cardiovasc Interv 2004;63:141–145.

Prolonged Antiplatelet Therapy to Prevent Late Thrombosis After Intracoronary γ-Radiation in Patients With In-Stent Restenosis Washington Radiation for In-Stent Restenosis Trial Plus 6 Months of Clopidogrel (WRIST PLUS)

Background—Intracoronary &ggr;-radiation reduces recurrent in-stent restenosis. Late thrombosis (>30 days after radiation therapy) is identified as a serious complication. The Washington Radiation for In-Stent Restenosis Trial (WRIST) PLUS, which involved 6 months of treatment with clopidogrel and aspirin, was designed to examine the efficacy and safety of prolonged antiplatelet therapy for the prevention of late thrombosis. Methods and Results—A total of 120 consecutive patients with diffuse in-stent restenosis in native coronary arteries and vein grafts with lesions <80 mm underwent percutaneous coronary transluminal angioplasty, laser ablation, and/or rotational atherectomy. Additional stents were placed in 34 patients (28.3%). After the intervention, a closed-end lumen catheter was introduced into the artery, a ribbon with different trains of radioactive 192Ir seeds was positioned to cover the treated site, and a dose of 14 Gy to 2 mm was prescribed. Patients were discharged with clopidogrel and aspirin for 6 months and followed angiographically and clinically. All patients but one tolerated the clopidogrel. The late occlusion and thrombosis rates were compared with the &ggr;-radiation-treated (n=125) and the placebo patients (n=126) from the WRIST and LONG WRIST studies (which involved only 1 month of antiplatelet therapy). At 6 months, the group receiving prolonged antiplatelet therapy had total occlusion and late thrombosis rates of 5.8% and 2.5%, respectively; these rates were lower than those in the active &ggr;-radiation group and similar to those in the placebo historical control group. Conclusions—Six months of clopidogrel and aspirin and a reduction in re-stenting for patients with in-stent restenosis treated with &ggr;-radiation is well tolerated and associated with a reduction in the late thrombosis rate compared with a similar cohort treated with only 1 month of clopidogrel and aspirin.

Incidence, management, and outcome of coronary artery perforation during percutaneous coronary intervention

We have analyzed the incidence, management, and outcome of 84 cases of coronary artery perforation in patients who underwent percutaneous coronary intervention at our institution. This complication was more frequent in female patients and in patients who underwent lesion modification with atheroablative devices. A total of 8 patients (9.5%) died after the procedure. They were usually older and had a higher incidence of cardiac tamponade; a larger percentage of these patients underwent emergency surgery than those who survived.

Percutaneous coronary intervention-associated nephropathy foreshadows increased risk of late adverse events in patients with normal baseline serum creatinine

In patients with chronic renal insufficiency, further decline in renal function (DRF) after percutaneous coronary intervention (PCI) is accompanied not only by adverse in‐hospital events but also by increased risk of mortality and myocardial infarction at 1 year. This analysis was undertaken to determine if patients with normal renal function who develop DRF after PCI have a comparable increase in risk of death and myocardial infarction at 1 year, and whether this risk is independent of in‐hospital complications (death, myocardial infarction, urgent coronary artery bypass grafting). We performed a retrospective analysis of all patients from a single center who underwent successful PCI with no major in‐hospital complications who had pre‐PCI serum creatinine (SCr) ≤ 1.2 mg/dl and no history of renal insufficiency. One‐year follow‐up was obtained by mail or telephone. There were 5,967 consecutive patients who met the inclusion criteria. Of these, 208 (3.5%) developed DRF (an increase in SCr ≥ 50% of baseline). They were more likely to be older, female, non‐Caucasian, diabetic and/or hypertensive. They reported more prior cerebral or peripheral vascular events. They had undergone more complex PCI and were exposed to more radiographic contrast than the 96.5% who did not develop DRF. After adjustment for baseline variables, DRF remained an independent predictor of 1‐year mortality, myocardial infarction, and target vessel revascularization. In patients without prior renal impairment, DRF post‐PCI is rare but is associated with an increased risk of late adverse cardiac events similar to that in chronic renal insufficiency patients. Cathet Cardiovasc Intervent 2003;59:338–343.

Intracoronary radiation therapy improves the clinical and angiographic outcomes of diffuse in-stent restenotic lesions: Results of the Washington Radiation for In-Stent Restenosis Trial for long lesions (Long WRIST) studies

Background—The Washington Radiation for In-Stent Restenosis Trial for long lesions (Long WRIST) was designed to determine the safety and efficacy of vascular brachytherapy for the treatment of diffuse in-stent restenosis. Methods and Results—A total of 120 patients with diffuse in-stent restenosis in native coronary arteries (lesion length, 36 to 80 mm) were randomized for either radiation with 192Ir with 15 Gy at 2 mm from the source axis or placebo. After enrollment, 120 additional patients with the same inclusion criteria were treated with 192Ir with 18 Gy and included in the Long WRIST High Dose registry. Antiplatelet therapy was initially prescribed for 1 month and was extended to 6 months in the last 60 patients of the Long WRIST High Dose registry. At 6 months, the binary angiographic restenosis rate was 73%, 45%, and 38% in the placebo, 15 Gy, and 18 Gy radiated groups, respectively (P <0.05). At 1 year, the primary clinical end point of major cardiac events was 63% in the placebo group and 42% in the radiated group with 15 Gy (P <0.05). The major cardiac event rate was further reduced with 18 Gy (22%;P <0.05 versus 15 Gy). Late thrombosis was 12%, 15%, and 9% in the placebo group, 15 Gy group with 1 month of antiplatelet therapy, and 18 Gy group with 6 months of antiplatelet therapy, respectively. Conclusions—Vascular brachytherapy with 192Ir is safe and reduces the rate of recurrent restenosis in diffuse in-stent restenosis. The efficacy of vascular brachytherapy on angiographic and clinical outcomes is enhanced with a radiation dose of 18 Gy and prolonged antiplatelet therapy.

Coarctation of the aorta, biscuspid aortic valve and abnormal ascending aortic wall

B ecause bicuspid aortic valve (BAV) and coarctation of the aorta (COA) frequently coexist,1-3 it is reasonable to believe that these malformations result from a single developmental diathesis. In 1972 McKusick4 added a third component. He suggested that manifestations of an abnormal aortic media are so frequently encountered in patients with COA and with BAV as to allow postulation of a common underlying defect. In his clinical note he said ‘I... BAV may be an expression of a developmental defect of the arterial tree which is also expressed in COA in some, in cystic medial necrosis in others, or in various combinations of these three.‘14 If McKusick’s suggestion is true, aortic aneurysm, rupture and dissection join valvular aortic stenosis and infective endocarditis as potential hazards for patients with BAV and continue to threaten patients with COA even after successful surgical repair. Numerous investigators have described one or another of these combinations, yet their clinical significance does not seem to be widely appreciated. This essay will examine the information that supports McKusick’s concept. “Cystic medial necrosis,” McKusick’s marker of an intrinsically abnormal aortic media, is commonly identified in patients with COAn5 This finding may not, however, be a definite marker of intrinsic weakness, for this histologic pattern is seen in older patients with no gross abnormality of the aortas.7 and may be absent in other patients with clear evidence of intrinsic fragility of the aortic wal1.8vg Schlatmann and Becker778 suggested that it is a nonspecific consequence of injury to the aortic wall resulting from hydraulic stress and subsequent repair. The wall stress may, in this construct, result either from externally generated forces (e.g., hypertension] or from dilatation attendant on intrinsic