Theodore Schreiber

Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery

OBJECTIVES This study sought to evaluate the safety and efficacy of the CoreValve transcatheter heart valve (THV) for the treatment of severe aortic stenosis in patients at extreme risk for surgery. BACKGROUND Untreated severe aortic stenosis is a progressive disease with a poor prognosis. Transcatheter aortic valve replacement (TAVR) with a self-expanding bioprosthesis is a potentially effective therapy. METHODS We performed a prospective, multicenter, nonrandomized investigation evaluating the safety and efficacy of self-expanding TAVR in patients with symptomatic severe aortic stenosis with prohibitive risks for surgery. The primary endpoint was a composite of all-cause mortality or major stroke at 12 months, which was compared with a pre-specified objective performance goal (OPG). RESULTS A total of 41 sites in the United States recruited 506 patients, of whom 489 underwent attempted treatment with the CoreValve THV. The rate of all-cause mortality or major stroke at 12 months was 26.0% (upper 2-sided 95% confidence bound: 29.9%) versus 43.0% with the OPG (p < 0.0001). Individual 30-day and 12-month events included all-cause mortality (8.4% and 24.3%, respectively) and major stroke (2.3% and 4.3%, respectively). Procedural events at 30 days included life-threatening/disabling bleeding (12.7%), major vascular complications (8.2%), and need for permanent pacemaker placement (21.6%). The frequency of moderate or severe paravalvular aortic regurgitation was lower 12 months after self-expanding TAVR (4.2%) than at discharge (10.7%; p = 0.004 for paired analysis). CONCLUSIONS TAVR with a self-expanding bioprosthesis was safe and effective in patients with symptomatic severe aortic stenosis at prohibitive risk for surgical valve replacement. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902).

Outcome of Patients with Acute Myocardial Infarction Who Are Ineligible for Thrombolytic Therapy

OBJECTIVE To determine what proportion of patients with acute myocardial infarction are not eligible for thrombolytic therapy and to assess their natural history. DESIGN Retrospective chart review. SETTING A large community-based hospital. PATIENTS All patients with acute myocardial infarction hospitalized during a 27-month period. MEASUREMENTS Of 1471 patients with acute myocardial infarction, 230 (16%) received thrombolytic therapy according to the protocol and an additional 97 (7%) received nonprotocol thrombolytic therapy, primary coronary balloon angioplasty, or both because of contraindications. The other 1144 patients (78%) did not receive reperfusion therapy. MAIN RESULTS The patients who did not receive thrombolytic therapy were older, more likely to be women, and more likely to have a history of hypertension, previous myocardial infarction, or chronic angina (all comparisons, P less than 0.002). An average of 1.9 reasons for exclusion were identified per patient among the ineligible patients. Mortality was fivefold higher among ineligible patients (19%; Cl, 16% to 21%) than among protocol-treated patients (4%; Cl, 1% to 6%) (P less than 0.001). In-hospital mortality rates for excluded patients were 28% (Cl, 23% to 32%) in elderly patients (age, greater than 76 years; n = 396); 29% (Cl, 23% to 35%) in patients with stroke or bleeding risk (n = 209); 17% (Cl, 14% to 20%) in patients with delayed presentation (greater than 4 hours after the onset of chest pain; [n = 599]); 14% (Cl, 11% to 16%) in patients with an ineligible electrocardiogram (ECG) (n = 673); and 26% (Cl, 21% to 32%) in patients with a miscellaneous reason for exclusion (n = 243). Independent predictors of increased mortality were: age greater than 76 years, stroke or other bleeding risk, ineligible ECG, or the presence of two or more exclusion criteria. CONCLUSIONS Thrombolytic therapy is currently used in the United States for only a minority of patients with acute myocardial infarction: those who have low-risk prognostic characteristics.

Cardiologist versus internist management of patients with unstable angina: Treatment patterns and outcomes

OBJECTIVES This study sought to assess the impact of generalist versus specialist direction on the pattern of care and outcome in patients admitted to the hospital for unstable angina. BACKGROUND Physicians trained as internists or as cardiologists may have different approaches to treating patients with unstable angina. METHODS We reviewed a prospectively collected cohort of patients discharged with a diagnosis-related group (DRG) diagnosis of unstable angina from William Beaumont Hospital, a large community-based hospital in southeast Michigan. Of 890 consecutive patients, 225 were treated by internists and 665 by cardiologists. We compared these two groups with respect to patterns of use of established pharmacotherapies for unstable angina, diagnostic testing and clinical outcome. RESULTS Patients treated by internists less often had a previous cardiac history (53% vs. 80%, p < or = 0.0001). Internists were less likely to use aspirin (68% vs. 78%, p = 0.032), heparin (67% vs. 84%, p < or = 0.001) or beta-adrenergic blocking agents (18% vs. 30%, p < or = 0.004) in their initial management. Exercise tests were performed more frequently by internist-treated patients (37% vs. 22%, p < or = 0.001), but catheterization (27% vs. 61%, p < or = 0.0001) and angioplasty (7% vs. 40%, p < or = 0.0001) were utilized less frequently. The incidence of myocardial infarction was similar (11% vs. 9%) in the two groups, but the mortality rate tended to be higher (4.0% vs. 1.8%, p = 0.06) in the internist group. CONCLUSIONS Patients with unstable angina treated by internists were less likely to receive effective medical therapy or revascularization procedures and experienced a trend to poorer outcome. This study does not support a positive gatekeeper role for generalists in the treatment of unstable angina.

Stenting and angioplasty with protection in patients at high-risk for endarterectomy: SAPPHIRE Worldwide Registry first 2,001 patients.

Previously, the Stenting and Angioplasty with Protection of Patients with High Risk for Endarterectomy (SAPPHIRE) randomized trial showed that carotid artery stenting (CAS) was not inferior to carotid endarterectomy (CEA) in the treatment of high‐surgical risk patients.

The Current Use of Impella 2.5 in Acute Myocardial Infarction Complicated by Cardiogenic Shock: Results from the USpella Registry

Objectives To evaluate the periprocedural characteristics and outcomes of patients supported with Impella 2.5 prior to percutaneous coronary intervention (pre-PCI) versus those who received it after PCI (post-PCI) in the setting of cardiogenic shock (CS) complicating an acute myocardial infarction (AMI). Background Early mechanical circulatory support may improve outcome in the setting of CS complicating an AMI. However, the optimal timing to initiate hemodynamic support has not been well characterized. Methods Data from 154 consecutive patients who underwent PCI and Impella 2.5 support from 38 US hospitals participating in the USpella Registry were included in our study. The primary end-point was survival to discharge. Secondary end-points included assessment of patients’ hemodynamics and in-hospital complications. A multivariate regression model was used to identify independent predictors for mortality. Results Both groups were comparable except for diabetes (P = 0.02), peripheral vascular disease (P = 0.008), chronic obstructive pulmonary disease (P = 0.05), and prior stroke (P = 0.04), all of which were more prevalent in the pre-PCI group. Patients in the pre-PCI group had more lesions (P = 0.006) and vessels (P = 0.01) treated. These patients had also significantly better survival to discharge compared to patients in the post-PCI group (65.1% vs.40.7%, P = 0.003). Survival remained favorable for the pre-PCI group after adjusting for potential confounding variables. Initiation of support prior to PCI with Impella 2.5 was an independent predictor of in-hospital survival (Odds ratio 0.37, 95% confidence interval: 0.17–0.79, P = 0.01) in multivariate analysis. The incidence of in-hospital complications included in the secondary end-point was similar between the 2 groups. Conclusions The results of our study suggest that early initiation of hemodynamic support prior to PCI with Impella 2.5 is associated with more complete revascularization and improved survival in the setting of refractory CS complicating an AMI.

Clinical and angiographic results of transluminal extraction coronary atherectomy in saphenous vein bypass grafts.

BACKGROUND Transluminal extraction coronary (TEC) atherectomy is a relatively new device that has recently been approved by the Food and Drug Administration. Because of its ability to aspirate clot and atheromatous material, TEC atherectomy may be useful in patients with stenoses in saphenous vein bypass grafts. METHODS AND RESULTS TEC atherectomy was performed on 158 saphenous vein graft lesions in 146 consecutive patients with a mean age of 65 +/- 8 years (78% men). Clinical indications for atherectomy included stable angina (37%), unstable angina (54%), and postinfarction angina after recent (< 1 month) myocardial infarction (8%). Patients with acute myocardial infarction and target vessels < 2 mm in diameter were excluded. The mean age of the bypass graft was 8.3 +/- 3.0 years, and 17% were diffusely diseased and degenerated. Complex lesion morphology included total occlusion (6%), eccentricity (64%), ulceration (18%), and thrombus (28%). The TEC atherectomy cutter was successfully advanced through 144 lesions (91%), but technical failures occurred in 14 lesions (9%), and these were subsequently managed by successful balloon angioplasty. Quantitative angiography revealed an increase in lumen diameter from 0.9 +/- 0.5 mm, to 1.5 +/- 0.7 mm after TEC atherectomy, to 2.3 +/- 0.8 mm after percutaneous transluminal coronary angioplasty (PTCA) (P < .001), which corresponded to decreases in diameter stenosis from 75 +/- 14%, to 58 +/- 20% after TEC atherectomy, to 36 +/- 22% after PTCA (P < .001). Device success was achieved in 39.2% (post-TEC atherectomy decrease in diameter stenosis > or = 20%), and procedural success was achieved in 84% (final diameter stenosis < 50% in the absence of a major complication). Angiographic complications were evident in 33 lesions (20.7%) immediately after TEC atherectomy and in 8 lesions (5%) after PTCA, including distal embolization (11.9%), no-reflow (8.8%), and abrupt closure (5.0%), but no perforations. Adjunctive PTCA (and other medical therapy) successfully managed 61% of angiographic complications. Serious clinical complications included in-hospital death in 3 patients (2.0%), emergency bypass surgery in 1 patient who died (0.7%), Q wave myocardial infarction in 3 patients (2.0%), non-Q wave myocardial infarction in 4 patients (2.7%), vascular injury requiring surgical repair and/or blood transfusion in 9 patients (6.1%), and hemorrhagic cerebral infarction in 4 patients (2.7%). Using a composite clinical end point defined as in-hospital death, emergency bypass surgery, or myocardial infarction, the strongest independent correlate (P < .001) of a severe clinical complication was the development of one or more serious angiographic complications (no-reflow, distal embolization, or abrupt closure) immediately after TEC atherectomy. Complete clinical follow-up was available in 118 (92%) of 128 eligible patients at an interval of 6.0 +/- 2.5 months after discharge. Late cardiac outcome included recurrent angina treated with medical therapy (18%), repeat percutaneous intervention on the original target lesion (26%), repeat coronary artery bypass surgery (5%), Q wave myocardial infarction (4%), and late cardiac death (7%). Angiographic follow-up in 105 (80%) of 132 eligible lesions revealed a restenosis rate of 69% (defined as a diameter stenosis > 50%), including 30 lesions (29%) with total occlusion of the original lesion. CONCLUSIONS In patients with stenoses in saphenous vein bypass grafts, TEC atherectomy is limited by the frequent need for adjunctive balloon angioplasty to achieve adequate lumen enlargement and to manage TEC atherectomy-induced complications. Although the incidence of serious clinical complications is similar to that of other percutaneous interventions in vein grafts, there is a high incidence of restenosis and late vessel occlusion. Prospective randomized studies are needed to determine the best revascularization strategy for high-risk patients with old degenerated vein

A randomized trial of low osmolar ionic versus nonionic contrast media in patients with myocardial infarction or unstable angina undergoing percutaneous transluminal coronary angioplasty

OBJECTIVES The purpose of this study was to determine prospectively whether the differences in anticoagulant and antiplatelet effects of ionic and nonionic contrast media after angiographic or clinical outcomes in patients with unstable ischemic syndromes undergoing percutaneous transluminal coronary angioplasty. BACKGROUND The interaction of platelets and thrombin with the endothelium of injured vessels contributes to thrombosis and restenosis after coronary angioplasty. Case reports and retrospective observations have reported an increased risk of thrombosis with the use of nonionic contrast media. METHODS A total of 211 patients with acute myocardial infarction or unstable angina undergoing coronary angioplasty were randomized to receive nonionic or ionic low osmolar contrast media. Coronary angiograms were assessed by a technician blinded to the study contrast media, and clinical events were monitored by an independent nurse for 1 month. RESULTS Patients receiving the ionic media were significantly less likely to experience decreased blood flow during the procedure (8.1% vs. 17.8%, p = 0.04). After the angioplasty, residual stenosis, vessel patency, the incidence of moderate to large thrombi and use of adjunctive thrombolytic therapy were similar between the two groups. However, patients receiving ionic media had fewer recurrent ischemic events requiring repeat catheterization (3.0% vs. 11.4%, p = 0.02) and repeat angioplasty during the initial hospital stay (1.0% vs. 5.8%, p = 0.06). One month after angioplasty, patients receiving ionic contrast media reported significantly fewer symptoms of any angina (8.5 vs. 20.0%, p = 0.04) or of angina at rest (1.4% vs. 11.8%, p = 0.01) and a reduced need for subsequent bypass surgery (0% vs. 5.9%, p = 0.04), compared with patients receiving the nonionic media. CONCLUSIONS These findings demonstrate that in patients with unstable ischemic syndromes undergoing coronary angioplasty, the use of ionic low osmolar contrast media reduces the risk of ischemic complications acutely and at 1 month after the procedure. Therefore, low osmolar ionic contrast media should be strongly considered when performing interventions in patients with unstable angina or myocardial infarction.

Randomized prospective evaluation of prolonged versus abbreviated intravenous heparin therapy after coronary angioplasty

OBJECTIVES This study was designed to prospectively evaluate the routine use of continuous heparin therapy after successful uncomplicated coronary angioplasty. BACKGROUND The use of such therapy varies among institutions and may increase the incidence of complications. Evaluation of the risks and benefits of abbreviated heparin therapy combined with early sheath removal after coronary angioplasty is necessary to determine optimal postprocedure care. METHODS We prospectively studied 284 patients who were scheduled for elective coronary angioplasty. Historical, clinical, physiologic and angiographic data were gathered. All patients received an initial bolus of heparin and then were randomized during the procedure to receive either no additional heparin therapy or an adjusted 24-h infusion. On the basis of specific criteria, additional heparin was not withheld if procedural results suggested an increased risk for complications. RESULTS Two hundred thirty-eight patients completed the study; 46 others were excluded in the catheterization laboratory because of unfavorable procedural results. The patients with abbreviated (n = 118) and 24-h (n = 120) therapy did not differ with respect to demographic and angiographic findings. However, the former had fewer bleeding complications (0% vs. 7%, p < 0.001) and were discharged earlier (mean +/- SD 23 +/- 11 h vs. 42 +/- 24 h, p < 0.001). One patient in this group had a major complication shortly after angioplasty. The mean savings in hospital charges in the abbreviated therapy group was

Impact of Annual Operator and Institutional Volume on Percutaneous Coronary Intervention Outcomes A 5-Year United States Experience (2005–2009)

1,370 (

Retrograde percutaneous aortic valve implantation for critical aortic stenosis.

6,093 +/-