Jakob Schneider

Propensity Analysis of Long-Term Survival After Surgical or Percutaneous Revascularization in Patients With Multivessel Coronary Artery Disease and High-Risk Features

Background—Although most randomized clinical trials have suggested that long-term survival rates after percutaneous coronary intervention (PCI) or surgical multivessel coronary revascularization (CABG) are equivalent, some post hoc analyses in high-risk groups and adjustment for severity of coronary disease have suggested higher mortality after PCI. Methods and Results—We studied 6033 consecutive patients who underwent revascularization in the late 1990s. PCI was performed in 872 patients; 5161 underwent CABG. Half the patients had significant left ventricular dysfunction or diabetes. Propensity analysis to predict the probability of undergoing PCI according to 22 variables and their interactions was used. The C-statistic for this model was 0.90, indicating excellent discrimination between treatments. There were 931 deaths during 5 years of follow-up. The 1- and 5-year unadjusted mortality rates were 5% and 16% for PCI and 4% and 14% for CABG (unadjusted hazard ratio, 1.13; 95% CI, 1.0 to 1.4; P =0.07). PCI was associated with an increased risk of death (propensity-adjusted hazard ratio, 2.3; 95% CI, 1.9 to 2.9; P <0.0001). This difference was observed across all categories of propensity for PCI and in patients with diabetes or left ventricular dysfunction. Other independent predictors of mortality (P ≤0.01 for all) were renal dysfunction, age, diabetes mellitus, chronic lung disease, peripheral vascular disease, left main trunk stenosis, and extent of coronary disease (Duke angiographic score). Conclusions—In patients with multivessel coronary artery disease and many high-risk characteristics, CABG was associated with better survival than PCI after adjustment for risk profile.

Death Following Creatine Kinase-MB Elevation After Coronary Intervention Identification of an Early Risk Period: Importance of Creatine Kinase-MB Level, Completeness of Revascularization, Ventricular Function, and Probable Benefit of Statin Therapy

Background—Creatine kinase (CK)-MB elevation after percutaneous coronary intervention (PCI) has been associated with subsequent cardiac death. The patients at risk, the timing of risk, and potential treatment implications are uncertain. Methods and Results—Eight thousand, four hundred nine consecutive non– acute myocardial infarction patients with successful PCI and no emergency surgery or Q-wave myocardial infarction were followed for 38±25 months; 1446 (17.2%) had post-PCI CK-MB above normal on routine ascertainment. Patients were prospectively stratified into those with CK-MB 1 to 5× or CK-MB >5× normal. No patient with CK-MB 1 to 5× normal died during the first week after PCI, and excess risk of early death for patients with CK-MB elevation occurred primarily in the first 3 to 4 months. The actuarial 4-month risk of death was 8.9%, 1.9%, and 1.2% for patients with CK-MB >5×, CK-MB 1 to 5×, and CK-MB ≤1× normal (P <0.001). Death within 4 months was independently correlated with the degree of CK-MB elevation, creatinine ≥2 mg%, post-PCI C-reactive protein, low ejection fraction, age, and congestive heart failure class (P <0.01 for all). In a matched subset analysis, incomplete revascularization (P <0.001), congestive heart failure class (P =0.005), and no statin treatment at hospital discharge (P =0.009) were associated with death. Conclusions—Patients with CK-MB elevation after PCI are at excess risk of death for 3 to 4 months, although prolonging hospitalization for CK-MB 1 to 5× is unlikely to modify risk. CK-MB >5× normal, incomplete revascularization, elevated C-reactive protein, heart failure, the elderly, and hospital discharge without on statin therapy increases risk. Several of these factors suggest that inflammation may play a part in the excess risk of death.

Relation of Inflammation and Benefit of Statins After Percutaneous Coronary Interventions

Background—Beyond lipid lowering, statins are known to possess antiinflammatory and antithrombotic properties. Recent studies suggested an association between statins and early reduction in death or myocardial infarction (MI) after percutaneous coronary interventions (PCIs). We sought to examine the interrelationship between inflammation, statin use, and PCI outcomes. Methods and Results—In the year 2000, 1552 consecutive United States residents underwent elective or urgent PCI at the Cleveland Clinic and were prospectively followed for 1 year. Preprocedural serum high-sensitivity C-reactive protein (hsCRP) levels were routinely measured. Patients who had statins initiated before the procedure (39.6%) had a lower median hsCRP level (0.40 versus 0.50 mg/dL, P =0.012) independent of the baseline cholesterol levels and had less frequent periprocedural MI (defined by CKMB ≥3×upper limit of normal, 5.7% versus 8.1%, P =0.038). At 1 year, statin pretreatment was predictive of survival predominantly among patients within the highest hsCRP quartile (mortality rate with statin pretreatment versus no pretreatment when hsCRP ≥1.11 mg/dL, 5.7% versus 14.8%, P =0.009). Using multivariate analysis, preprocedural hsCRP level remained an independent predictor for 1-year death or MI only in patients without statin therapy (hazard ratio, 1.32/quartile;P =0.001). After adjusting for the propensity of receiving statins, statin pretreatment was an independent predictor for 1-year survival within the highest hsCRP quartile (hazard ratio, 0.44;P =0.039). Conclusions—Statin therapy before PCI is associated with a marked reduction in mortality among patients with high hsCRP levels. A hsCRP-guided strategy may improve targeting of statin therapy and clinical outcome among patients undergoing PCI.

Association between CK-MB elevation after percutaneous or surgical revascularization and three-year mortality

OBJECTIVES The goal of this study was to assess the long-term impact of creatine kinase-MB isoform (CK-MB) elevation after percutaneous or surgical revascularization. BACKGROUND The long-term impact of CK-MB elevation after coronary artery bypass grafting (CABG) is not as well characterized as that following percutaneous coronary intervention (PCI). METHODS The three-year cumulative survival of consecutive patients who underwent their first percutaneous or surgical revascularization procedure between January 1, 1995 and August 31, 2000 and had CK-MB determination was assessed using the Social Security Death Index. RESULTS The 3,812 patients undergoing CABG had a less favorable coronary risk profile than the 3,573 patients undergoing PCI. The incidence of CK-MB elevation above normal range was 90% and 38% for the CABG and PCI groups (p < 0.001). In 6% and 5%, respectively, the elevation surpassed 10x the upper limit of normal (ULN). At an average follow-up of three years, there were 712 deaths, 83 of which occurred within 30 days of procedure. The cumulative survival was 92% and 90% for CABG and PCI, respectively (p = 0.003). Chronic renal insufficiency (adjusted hazard ratio [HR] 3.8, [95% confidence interval 3.1 to 4.6]), age (HR 1.5 per decade [1.3 to 1.6]), ejection fraction <40% (HR 1.3 [1.1 to 1.5] and PCI (HR 1.6 [1.3 to 1.9]) were the main predictors of increased mortality. Creatine kinase-MB isoform elevation only above 10 x ULN was independently predictive of mortality in the CABG (HR 1.3 [1.1 to 1.5]) and PCI (HR 1.1 [1.0 to 1.2]) groups, p < 0.001. CONCLUSIONS Creatine kinase MB isoform elevation after revascularization is very common, particularly in CABG patients. When extensive, it is independently correlated with increased mortality over a three-year period. Identification and aggressive management of patients with high levels of CK-MB after revascularization may improve their outcome.

Effect of Clopidogrel added to aspirin before percutaneous coronary intervention on the risk associated with C-reactive protein

positive ST2 responses because of the design of our study. Only a few studies have addressed the diagnostic or prognostic value of ischemic ST2 occurring solely during recovery after exercise. Nearly all have used coronary angiography as the “gold standard,” and 1 had evaluation of myocardial perfusion by nongated planar Tl-201 scintigraphy. In the present study, Tc99m sestamibi was used, yielding high-quality gated SPECT images permitting quantitative assessment of perfusion, regional function, and measurement of left ventricular ejection fraction. Gianrossi et al indicated that the sensitivity of the exercise electrocardiogram for CAD detection is lower when performed in conjunction with Tl-201 scintigraphy, because ST monitoring during recovery is sacrificed for expediency in Tl-201 imaging. With perfusion imaging studies using Tc-99m, image acquisition commences approximately 30 minutes after exercise, so that the imaging protocol does not interfere with recovery ST-segment monitoring.

Impact of mitral regurgitation on long-term survival after percutaneous coronary intervention.

In patients with coronary artery disease, mitral regurgitation (MR) may be due to acute or chronic papillary muscle ischemia, left ventricular (LV) dilation, or papillary muscle rupture. Patients with moderate or severe MR and early LV dysfunction may benefit from surgical repair or replacement of the mitral valve, with or without coronary bypass surgery. 1‐ 4 There are reports of improvement in MR after percutaneous coronary intervention (PCI), especially in patients with acute myocardial ischemic syndromes. 5‐9 The prognostic importance of MR in patients with coronary artery disease selected to undergo PCI outside of the setting of acute myocardial infarction has not been studied. In this observational analysis we sought to determine the independent prognostic impact of moderate to severe MR on subsequent survival in a cohort of consecutive patients who underwent PCI from 1994 to 1997.

Safety of femoral closure devices after percutaneous coronary interventions in the era of glycoprotein IIb/IIIa platelet blockade.

We compared in-hospital femoral complications of Angio-Seal, Perclose, and manual compression in consecutive patients who underwent percutaneous coronary interventions in the era of glycoprotein IIb/IIIa platelet inhibition. Femoral closure devices have a similar overall risk profile as manual compression, even in patients treated with glycoprotein IIb/IIIa platelet inhibition, although certain rare complications such as retroperitoneal hemorrhage and severe access-site infection may be more common with the use of these devices.

Coronary reserve in patients with aortic valve disease before and after successful aortic valve replacement

In patients with aortic valve disease and normal coronary angiograms coronary reserve was determined by the coronary sinus thermodilution technique. Three groups of patients were studied: 37 preoperative patients; 18 different patients 12-52 months after aortic valve replacement and seven control subjects with no cardiac disease. Coronary flow ratio (dipyridamole/rest) was diminished in preoperative compared with postoperative patients (1.66 +/- 0.44 vs 2.22 +/- 0.85; P less than 0.05) as well as with controls (2.80 +/- 0.84; P less than 0.01), and corresponding coronary resistance ratio (dipyridamole/rest) was higher in preoperative patients than in both other groups (0.61 +/- 0.17 vs 0.48 +/- 0.14; P less than 0.05 vs 0.37 +/- 0.10; P less than 0.01). Differences in the flow ratio, but not in the resistance ratio, were significant (P less than 0.05) in patients after aortic valve replacement compared with controls. Total coronary sinus blood flow at rest was elevated in preoperative compared with both postoperative patients and controls (252 +/- 99 vs 169 +/- 63; P less than 0.01; vs 170 +/- 35 ml.min-1, P less than 0.05), whereas flows after maximal vasodilation did not differ among the three groups (416 +/- 184 vs 361 +/- 150 vs 488 +/- 235 ml.min-1). Postoperative patients showed a distinct, though not total regression of left ventricular angiographic muscle mass index and wall thickness. Nine of the 18 postoperative patients showed a normal coronary flow reserve and nine showed subnormal response. These two subgroups did not differ with respect to preoperative macroscopic and microscopic measures of hypertrophy. Thus in aortic valve disease, the reduced coronary vasodilator capacity is mainly due to an elevated coronary flow at rest, while the maximal coronary blood flow achieved is identical to that of postoperative patients and controls. With regression of left ventricular hypertrophy, flow at rest decreases and this leads to a distinct improvement of coronary flow reserve.

Postmortem Analysis of Encapsulation Around Long-Term Ventricular Endocardial Pacing Leads

OBJECTIVE To analyze the site and thickness of encapsulation around ventricular endocardial pacing leads and the extent of tricuspid valve adhesion, from todays perspective, with implications for lead removal and sensor location. MATERIAL AND METHODS Gross cardiac postmortem analysis was performed in 11 cases (8 female and 3 male patients; mean age, 78+/-7 years). None of the patients had died because of pacemaker malfunction. The mean implant time was 61+/-60 months (range, 4 to 184). RESULTS The observations ranged from encapsulation only at the tip of the pacing lead to complete encapsulation along the entire length of the pacing lead within the right ventricle. Substantial areas of adhesion at the tricuspid valve apparatus were noted in 7 of the 11 cases (64%). The firmly attached leads could be removed only by dissection, and in some cases, removal was possible only by damaging the associated structures. No specific optimal site for sensor placement could be identified along the ventricular portion of the pacing leads; however, the fibrotic response was relatively less prominent in the atrial chamber. CONCLUSION Extensive encapsulation is present in most long-term pacemaker leads, which may complicate lead removal. The site and thickness of encapsulation seem to be highly variable. Tricuspid valve adhesion, which is usually underestimated, may be severe. In contrast to earlier reports, our study demonstrates that the extent of fibrotic encapsulation may not be related to the duration since lead implantation. Moreover, we noted no ideal encapsulation-free site for sensors on the ventricular portion of long-term pacing leads.

Real-world bare metal stenting: Identification of patients at low or very low risk of 9-month coronary revascularization

The high cost of drug‐eluting stents (DESs) has made identification of patients who are at low risk for subsequent revascularization after treatment with bare metal stents (BMSs) highly desirable. Previous reports from randomized trials suffer from biases induced by restricted entry criteria and protocol‐mandated angiographic follow‐up. Between 1994 and 2001, 5,239 consecutive BMS patients, excluding those with coil stents, technical failure, brachytherapy, staged procedure, or stent thrombosis within 30 days, were prospectively identified from a large single‐center tertiary‐referral‐center prospective registry for long‐term follow‐up. We sought to identify characteristics of patients with very low (≤ 4%) or low (4–10%) likelihood of coronary revascularization 9 months after BMS. Nine‐month clinical follow‐up was obtained in 98.2% of patients. Coronary revascularization was required in 13.4% and did not differ significantly by stent type. On the basis of multivariate analysis identifying 11 independent correlates and previous reports, 20 potential low‐risk patient and lesion groups (228 ± 356 patients/groups) were identified (e.g, patients with all of the following: native vessel, de novo, reference diameter ≥ 3.5 mm, lesion length < 5 mm, no diabetes, not ostial in location). Actual and model‐based outcomes were analyzed. No group had both predicted and observed 9‐month revascularization ≤ 4% (very low risk). Conversely, 19 of 20 groups had a predicted and observed revascularization rate of 4–10% (low risk). In the real‐world setting, the need for intermediate‐term revascularization after BMS may be lower than expected, but it may be very difficult to identify patients at very low risk. Conversely, if the benefits of DESs are attenuated in routine practice, many groups of patients treated with BMSs may have nearly comparable results. Catheter Cardiovasc Interv 2004;63:135–140.