Adnan K. Chhatriwalla

Use of the Kansas City Cardiomyopathy Questionnaire for Monitoring Health Status in Patients With Aortic Stenosis

Background— Improving functional status and quality of life are important goals of treatment for patients with severe aortic stenosis. The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a heart failure health status measure and has been used in studies of patients with aortic stenosis. However, its psychometric properties have not yet been evaluated in these patients. Methods and Results— We analyzed data from 955 patients, enrolled in the PARTNER trial of transcatheter aortic valve replacement, to evaluate the reliability, responsiveness, validity, and prognostic importance of the KCCQ in patients with severe aortic stenosis. The KCCQ was administered at baseline and at 1, 6, and 12 months after randomization to medical therapy, transcatheter aortic valve replacement, or surgical valve replacement. Among clinically stable patients, there were only small changes in the KCCQ domain scores over time (mean differences 0.1–4.2 points), and the intraclass correlation coefficients showed good agreement between paired assessments (0.65–0.76). However, the domain scores of patients who underwent transcatheter aortic valve replacement showed large changes after treatment (mean differences 13–30 points). Construct validity was demonstrated by comparing each domain against a relevant reference measure (Spearman correlations 0.46–0.69). Finally, among 157 patients randomized to medical management, lower KCCQ overall summary scores at baseline were strongly associated with an increased risk of mortality during the following 12 months. Conclusions— The KCCQ is a highly reliable, responsive, and valid measure of symptoms, functional status, and quality of life in patients with severe, symptomatic aortic stenosis.

Low Levels of Low-Density Lipoprotein Cholesterol and Blood Pressure and Progression of Coronary Atherosclerosis

OBJECTIVES We investigated coronary atheroma progression in patients with low levels of low-density lipoprotein cholesterol (LDL-C) and systolic blood pressure (SBP). BACKGROUND Low LDL-C and SBP beneficially impact coronary atherosclerosis. However, the association between intensive control of both risk factors and coronary plaque progression remains unclear. METHODS Changes in atheroma burden monitored by intravascular ultrasound were studied in 3,437 patients with coronary artery disease (CAD) who were stratified according to on-treatment LDL-C and SBP. RESULTS Patients with very low LDL-C (< or =70 mg/dl) and normal SBP (< or =120 mm Hg) had less progression in percent atheroma volume (PAV) (p < 0.001) and total atheroma volume (TAV) (p < 0.001), more frequent plaque regression (p = 0.01), and less frequent plaque progression (p < 0.001). In patients with SBP >120 mm Hg, very low LDL-C was associated with less progression of PAV (+0.30%, 95% confidence interval [CI]: -0.17% to 0.77% vs. +0.61%, 95% CI: 0.17% to 1.05%, p = 0.01) and TAV (-3.9 mm3, 95% CI: -7.24 to -0.63 mm3 vs. -1.2 mm3, 95% CI: -4.31 to 1.92 mm3, p = 0.001). In patients with LDL-C >70 mg/dl, normal SBP was not associated with less progression of PAV (+0.51%, 95% CI: 0.04% to 0.99% vs. +0.61%, 95% CI: 0.17% to 1.05%, p = 0.159) or TAV (-2.3 mm3, 95% CI: -5.59 to 1.05 mm3 vs. -1.2 mm3, 95% CI: -4.31 to 1.92 mm3, p = 0.617). CONCLUSIONS Very low LDL-C and normal SBP are associated with the slowest progression of coronary atherosclerosis. Although a greater beneficial association is observed in patients with very low LDL-C, these findings suggest the need for intensive control of global risk in patients with CAD.

Precision medicine to improve use of bleeding avoidance strategies and reduce bleeding in patients undergoing percutaneous coronary intervention: prospective cohort study before and after implementation of personalized bleeding risks

Objective To examine whether prospective bleeding risk estimates for patients undergoing percutaneous coronary intervention could improve the use of bleeding avoidance strategies and reduce bleeding. Design Prospective cohort study comparing the use of bleeding avoidance strategies and bleeding rates before and after implementation of prospective risk stratification for peri-procedural bleeding. Setting Nine hospitals in the United States. Participants All patients undergoing percutaneous coronary intervention for indications other than primary reperfusion for ST elevation myocardial infarction. Main outcome measures Use of bleeding avoidance strategies, including bivalirudin, radial approach, and vascular closure devices, and peri-procedural bleeding rates, stratified by bleeding risk. Observed changes were adjusted for changes observed in a pool of 1135 hospitals without access to pre-procedural risk stratification. Hospital level and physician level variability in use of bleeding avoidance strategies was examined. Results In a comparison of 7408 pre-intervention procedures with 3529 post-intervention procedures, use of bleeding avoidance strategies within intervention sites increased with pre-procedural risk stratification (odds ratio 1.81, 95% confidence interval 1.44 to 2.27), particularly among higher risk patients (2.03, 1.58 to 2.61; 1.41, 1.09 to 1.83 in low risk patients, after adjustment for control sites; P for interaction=0.05). Bleeding rates within intervention sites were significantly lower after implementation of risk stratification (1.0% v 1.7%; odds ratio 0.56, 0.40 to 0.78; 0.62, 0.44 to 0.87, after adjustment); the reduction in bleeding was greatest in high risk patients. Marked variability in use of bleeding avoidance strategies was observed across sites and physicians, both before and after implementation. Conclusions Prospective provision of individualized bleeding risk estimates was associated with increased use of bleeding avoidance strategies and lower bleeding rates. Marked variability between providers highlights an important opportunity to improve the consistency, safety, and quality of care. Study registration Clinicaltrials.gov NCT01383382.

Drug-eluting stent fracture and acute coronary syndrome ☆ ☆☆

BACKGROUND Coronary stent fracture is an underrecognized entity but has been reported more frequently in the drug-eluting stent (DES) era. Nevertheless, the clinical implications of coronary stent fracture remain unclear. METHODS AND MATERIALS A literature search for reports of DES fracture was conducted via MEDLINE, and the US Food and Drug Administration Manufacturer and User facility Device Experience (MAUDE) database was accessed via the internet and interrogated for reports of stent fracture between January 1, 2003, and April 30, 2008. Each report was reviewed, and clinical information was extracted for analysis. RESULTS The MEDLINE search identified 202 cases of coronary DES fracture, with 95% of cases involving Cypher sirolimus-eluting stents. Clinical information regarding patient presentation was available in 96 cases. Patients presented with ST-elevation myocardial infarction (STEMI) or stent thrombosis in six cases (6%) and with unstable angina or non-STEMI (NSTEMI) in 40 cases (42%). The MAUDE database search identified 337 stent fracture reports, with 97% of cases involving Cypher stents. Clinical information regarding patient presentation was available 193 cases. Patients presented with STEMI or stent thrombosis in 24 cases (12%) and with unstable angina or NSTEMI in 36 cases (19%). CONCLUSIONS Most reports of drug-eluting stent fracture involve Cypher stents. DES fracture can be associated with stent thrombosis, myocardial infarction and angina. However, whether the incidence of such events reported in the literature and in the MAUDE database is representative of all patients experiencing stent fracture remains unclear.

Bioprosthetic Valve Fracture Improves the Hemodynamic Results of Valve-in-Valve Transcatheter Aortic Valve Replacement

Background— Valve-in-valve (VIV) transcatheter aortic valve replacement (TAVR) may be less effective in small surgical valves because of patient/prosthesis mismatch. Bioprosthetic valve fracture (BVF) using a high-pressure balloon can be performed to facilitate VIV TAVR. Methods and Results— We report data from 20 consecutive clinical cases in which BVF was successfully performed before or after VIV TAVR by inflation of a high-pressure balloon positioned across the valve ring during rapid ventricular pacing. Hemodynamic measurements and calculation of the valve effective orifice area were performed at baseline, immediately after VIV TAVR, and after BVF. BVF was successfully performed in 20 patients undergoing VIV TAVR with balloon-expandable (n=8) or self-expanding (n=12) transcatheter valves in Mitroflow, Carpentier-Edwards Perimount, Magna and Magna Ease, Biocor Epic and Biocor Epic Supra, and Mosaic surgical valves. Successful fracture was noted fluoroscopically when the waist of the balloon released and by a sudden drop in inflation pressure, often accompanied by an audible snap. BVF resulted in a reduction in the mean transvalvular gradient (from 20.5±7.4 to 6.7±3.7 mm Hg, P<0.001) and an increase in valve effective orifice area (from 1.0±0.4 to 1.8±0.6 cm2, P<0.001). No procedural complications were reported. Conclusions— BVF can be performed safely in small surgical valves to facilitate VIV TAVR with either balloon-expandable or self-expanding transcatheter valves and results in reduced residual transvalvular gradients and increased valve effective orifice area.

Fulminant Myocarditis Due to H1N1 Influenza

We report 2 cases of fulminant myocarditis caused by the H1N1 strain of influenza. As the incidence of H1N1 influenza infection continues to rise, physicians should be aware of this rare and potentially fatal complication because early diagnosis and aggressive supportive measures are imperative. A 52-year-old woman presented with a 3-day history of chest pain, dyspnea, diffuse myalgias, and fever. The ECG demonstrated low voltage with diffuse ST segment elevation (Figure 1). The troponin I was 5 ng/mL (0 to 0.75 ng/mL), and B-type natriuretic peptide was 1629 pg/mL (0 to 100 pg/mL). The patient was transferred to our facility for urgent left heart catheterization. On presentation, her blood pressure was 87/50 mm Hg. Coronary angiography demonstrated normal coronary arteries. Dopamine was started for blood pressure support. The patient was treated with oseltamivir 150 mg twice a day and IV ceftriaxone for suspected viral and/or bacterial myocarditis and pneumonitis. A transthoracic echocardiogram demonstrated global left ventricular systolic dysfunction with an ejection fraction of 29% and a trivial pericardial effusion. Blood cultures and rapid influenza A and B antigen tests were negative. On …

Should dual antiplatelet therapy after drug-eluting stents be continued for more than 1 year? Dual Antiplatelet Therapy After Drug-Eluting Stents Should Be Continued for More Than One Year and Preferably Indefinitely

Since its introduction, percutaneous coronary intervention (PCI) has been limited by 2 major factors: restenosis and vessel closure attributable to thrombosis. The use of coronary stents has had a marked beneficial impact on rates of restenosis.1,2 However, the vessel trauma that occurs during PCI induces platelet activation, and all currently available coronary stents are made of metal and are therefore thrombogenic. The use of drug-eluting stents (DES) can reduce restenosis and target vessel revascularization by 70% compared with bare metal stents (BMS).3,4 However, the polymer coatings and other aspects of DES may result in increased thrombogenicity compared with BMS.5Since its introduction, percutaneous coronary intervention (PCI) has been limited by 2 major factors: restenosis and vessel closure attributable to thrombosis. The use of coronary stents has had a marked beneficial impact on rates of restenosis.1,2 However, the vessel trauma that occurs during PCI induces platelet activation, and all currently available coronary stents are made of metal and are therefore thrombogenic. The use of drug-eluting stents (DES) can reduce restenosis and target vessel revascularization by >70% compared with bare metal stents (BMS).3,4 However, the polymer coatings and other aspects of DES may result in increased thrombogenicity compared with BMS.5 Response by Colombo and Gerber p 217 Early PCI studies reported rates of acute and subacute vessel closure approaching 25%.6,7 As a result, many antithrombotic and antiplatelet regimens have been investigated to maximize benefit and to reduce complications in patients undergoing PCI. The addition of dipyridamole to aspirin showed no benefit in reducing acute PCI complications compared with aspirin alone.8 Similarly, very high–dose aspirin (1500 mg/d) did not reduce rates of myocardial infarction (MI) or need for surgical revascularization compared with low-dose aspirin therapy (80 mg/d).9 The addition of warfarin to aspirin therapy has been shown to slightly reduce the risk of cardiovascular events; however, this is accompanied by a significant increase in the risk of hemorrhagic complications.1 Dual antiplatelet therapy with aspirin in combination with thienopyridine agents, which have complementary mechanisms of action (Figure 1),10 has resulted in the greatest improvements in PCI outcomes. In the Stent Anticoagulation Restenosis Study (STARS), the incidence of death, target lesion revascularization, vessel thrombosis, or MI at 30 days was 0.5% with aspirin+ticlopidine therapy compared with 2.7% and 3.6%, respectively, with aspirin+warfarin and aspirin alone.11 More recently, because of the rare but severe complication …

Impact of Drug-Eluting Versus Bare-Metal Stents on Mortality in Patients With Anemia

OBJECTIVES Our aim was to assess the incidence of all-cause mortality in patients with anemia undergoing percutaneous coronary intervention (PCI) receiving drug-eluting stents (DES) or bare-metal stents (BMS). BACKGROUND Anemia has been associated with poor clinical outcomes in patients undergoing PCI. However, it is unknown whether stent selection (DES or BMS) has a differential outcome in this high-risk group. METHODS Anemia was defined as a hematocrit below 36% for female subjects and below 40% for male subjects as defined by the World Health Organization. All patients undergoing PCI with DES or BMS alone from March 2003 to June 2007 were included. The primary end point was all-cause mortality. Anemia was further characterized using mean corpuscular volume as microcytic, normocytic, or macrocytic. RESULTS A total 11,181 patients underwent PCI over a 4.5-year interval; of these, 2,172 met our inclusion criteria. There were a total of 429 deaths. The majority of patients had normocytic anemia (n = 1,931). Of the 3 anemia subtypes, macrocytic anemia (DES 26%, BMS 44%) had the highest mortality followed by normocytic (DES 17%, BMS 25%) and microcytic (DES 13%, BMS 18%) anemia, respectively. All-cause mortality was significantly lower with DES in unadjusted and multivariable adjusted Cox proportional models (adjusted hazard ratio: 0.66, 95% confidence interval: 0.54 to 0.82; p < 0.001). CONCLUSIONS In an adjusted analysis, the use of DES as compared with the use of BMS was associated with decreased mortality in patients with anemia. Additionally, among anemia subtypes, macrocytic anemia had the highest mortality.

Preliminary Data on the Diagnostic Accuracy of Rubidium-82 Cardiac PET Perfusion Imaging for the Evaluation of Ischemia in a Pediatric Population

Evaluation of myocardial perfusion is sometimes necessary in children with congenital heart disease or acquired coronary artery abnormalities. Limited information is available regarding the clinical utility of myocardial perfusion imaging in children. PET imaging with rubidium-82 may provide a convenient clinical means of assessing regional circulatory compromise in pediatric patients with small hearts, due to its improved spatial resolution. Clinically indicated cardiac PET studies obtained in 22 pediatric patients were reviewed by two blinded observers and assigned myocardial perfusion scores using a standard 17-segment model. PET results were correlated with coronary angiography, available in 15 cases, to determine the accuracy of PET scanning for evaluating compromise of the myocardial circulation. Reversible defects consistent with myocardial ischemia were present in 6 of 15 (40%) PET cases. The sensitivity and specificity of cardiac PET for the detection of significant coronary artery disease were 100% and 82%, respectively. The positive predictive value of cardiac PET was 67%, while the negative predictive value was 100%. Cardiac PET imaging with rubidium-82 appears promising for the noninvasive assessment of myocardial perfusion in the pediatric population. The findings from this small series suggest that prospective study in a larger patient cohort merits consideration.

Should dual antiplatelet therapy after drug-eluting stents be continued for more than 1 year?Response to Chhatriwalla and Bhatt

Since its introduction, percutaneous coronary intervention (PCI) has been limited by 2 major factors: restenosis and vessel closure attributable to thrombosis. The use of coronary stents has had a marked beneficial impact on rates of restenosis.1,2 However, the vessel trauma that occurs during PCI induces platelet activation, and all currently available coronary stents are made of metal and are therefore thrombogenic. The use of drug-eluting stents (DES) can reduce restenosis and target vessel revascularization by 70% compared with bare metal stents (BMS).3,4 However, the polymer coatings and other aspects of DES may result in increased thrombogenicity compared with BMS.5Since its introduction, percutaneous coronary intervention (PCI) has been limited by 2 major factors: restenosis and vessel closure attributable to thrombosis. The use of coronary stents has had a marked beneficial impact on rates of restenosis.1,2 However, the vessel trauma that occurs during PCI induces platelet activation, and all currently available coronary stents are made of metal and are therefore thrombogenic. The use of drug-eluting stents (DES) can reduce restenosis and target vessel revascularization by >70% compared with bare metal stents (BMS).3,4 However, the polymer coatings and other aspects of DES may result in increased thrombogenicity compared with BMS.5 Response by Colombo and Gerber p 217 Early PCI studies reported rates of acute and subacute vessel closure approaching 25%.6,7 As a result, many antithrombotic and antiplatelet regimens have been investigated to maximize benefit and to reduce complications in patients undergoing PCI. The addition of dipyridamole to aspirin showed no benefit in reducing acute PCI complications compared with aspirin alone.8 Similarly, very high–dose aspirin (1500 mg/d) did not reduce rates of myocardial infarction (MI) or need for surgical revascularization compared with low-dose aspirin therapy (80 mg/d).9 The addition of warfarin to aspirin therapy has been shown to slightly reduce the risk of cardiovascular events; however, this is accompanied by a significant increase in the risk of hemorrhagic complications.1 Dual antiplatelet therapy with aspirin in combination with thienopyridine agents, which have complementary mechanisms of action (Figure 1),10 has resulted in the greatest improvements in PCI outcomes. In the Stent Anticoagulation Restenosis Study (STARS), the incidence of death, target lesion revascularization, vessel thrombosis, or MI at 30 days was 0.5% with aspirin+ticlopidine therapy compared with 2.7% and 3.6%, respectively, with aspirin+warfarin and aspirin alone.11 More recently, because of the rare but severe complication …