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Biomedical subjects

Mark Reisman

Publications and source records attributed to Mark Reisman.

At least 19 recordsLinked to original sources

Effects of a statewide physician-led quality-improvement program on the quality of cardiac care.

BACKGROUND: Several states have implemented mandatory public reporting of outcomes of cardiac revascularization procedures. Washington is the first to develop a nonmandatory, physician-led reporting program with public accountability and universal hospital participation. The purpose of this study was to determine whether quality improvement interventions resulted in the correction of data deficiencies and performance outliers for cardiac revascularization procedures. METHODS: From 1999 through 2003, there were 18 hospitals with coronary bypass surgery and interventional cardiology programs and 12 with only the latter. All patients > or =18 years undergoing 24372 isolated coronary bypass surgeries and 59,656 percutaneous coronary interventions were included. After 1999 to 2001 data were analyzed in early 2002, the Clinical Outcomes Assessment Program implemented a 6-step quality-improvement intervention to measure and remeasure data quality, process compliance, and performance. RESULTS: In 2003, 4 of the 18 surgery programs had 1 statistical outlier with respect to 4 performance measures, whereas 2 of 30 coronary intervention programs were mortality outliers. For bypass surgery, all programs maintained full compliance with program standards by adhering to timely and reliable submission of data, developing plans to address performance outliers, and demonstrating that outlier status did not persist from baseline to remeasurement. For coronary interventions, 1 program was a persistent outlier for mortality in 2002 and 2003. CONCLUSIONS: The Clinical Outcomes Assessment Program has successfully monitored cardiac care patterns in Washington State over a 5-year period. Most hospitals that perform coronary revascularization procedures meet acceptable performance standards.

Aged↗

Patent foramen ovale and cerebrovascular diseases.

Patent foramen ovale (PFO) has been linked to ischemic strokes of undetermined cause (cryptogenic strokes). PFO-a remnant of fetal circulation when the foramen ovale does not seal after birth-can permit microemboli to escape the pulmonary filter into the intracranial circulation, causing stroke. Coexistent atrial septal aneurysm, pelvic deep vein thrombosis and inherited clotting factor deficiencies could potentiate stroke risk in patients with PFO. Transcatheter PFO closure, a minimally invasive procedure, is one technique used to prevent recurrent cerebrovascular events. A connection between PFO and migraine headache has been conceptualized from retrospective evidence of reduced migraine frequency and severity after PFO closure; however, prospective randomized trials are needed to verify the efficacy of PFO closure on migraine prevention. In this review we discuss embryologic origins, diagnostic techniques and treatment options for prevention of paradoxical embolism thought to be related to PFO, and the relation of PFO to cryptogenic stroke and migraine.

Brain Ischemia↗

Patent foramen ovale: current pathology, pathophysiology, and clinical status.

Patent foramen ovale (PFO) is experiencing increased clinical interest as a congenital cardiac lesion persisting into adulthood. It is implicated in several serious clinical syndromes, including stroke, myocardial infarction, and systemic embolism. The PFO is now amenable to percutaneous interventional therapies, and multiple novel technologies are either available or under development for lesion closure. The PFO should be better understood to take advantage of emerging percutaneous treatment options. This paper reviews PFO anatomy, pathology, pathophysiology, and clinical impact and discusses current therapeutic options.

Heart Septal Defects, Atrial↗

Percutaneous left atrial appendage transcatheter occlusion (PLAATO system) to prevent stroke in high-risk patients with non-rheumatic atrial fibrillation: results from the international multi-center feasibility trials.

OBJECTIVES: These studies were conducted to evaluate the feasibility of percutaneous left atrial appendage (LAA) occlusion using the PLAATO system (ev3 Inc., Plymouth, Minnesota). BACKGROUND: Patients with atrial fibrillation (AF) have a five-fold increased risk for stroke. Other studies have shown that more than 90% of atrial thrombi in patients with non-rheumatic AF originate in the LAA. Transvenous closure of the LAA is a new approach in preventing embolism in these patients. METHODS: Within two prospective, multi-center trials, LAA occlusion was attempted in 111 patients (age 71 +/- 9 years). All patients had a contraindication for anticoagulation therapy and at least one additional risk factor for stroke. The primary end point was incidence of major adverse events (MAEs), a composite of stroke, cardiac or neurological death, myocardial infarction, and requirement for procedure-related cardiovascular surgery within the first month. RESULTS: Implantation was successful in 108 of 111 patients (97.3%, 95% confidence interval [CI] 92.3% to 99.4%) who underwent 113 procedures. One patient (0.9%, 95% CI 0.02% to 4.9%) experienced two MAEs within the first 30 days: need for cardiovascular surgery and in-hospital neurological death. Three other patients underwent in-hospital pericardiocentesis due to a hemopericardium. Average follow-up was 9.8 months. Two patients experienced stroke. No migration or mobile thrombus was noted on transesophageal echocardiogram at one and six months after device implantation. CONCLUSIONS: Closing the LAA using the PLAATO system is feasible and can be performed at acceptable risk. It may become an alternative in patients with AF and a contraindication for lifelong anticoagulation treatment.

Aged↗

Influence of stent length to lesion length ratio on angiographic and clinical outcomes after implantation of bare metal and drug-eluting stents (the TAXUS-IV Study).

Longer bare metal stent lengths have been associated with greater restenosis. However, the effect of the ratio of stent length to lesion length on clinical and angiographic restenosis after implantation of bare metal and drug-eluting stents has not been clearly defined. Patients in the TAXUS-IV study who underwent single-study stent placement were categorized into tertiles based on ratios of stent length to lesion length. Clinical results at 1 year and angiographic outcomes at 9 months were compared across the 3 groups. The median ratios of stent length to lesion length were 1.20, 1.58, and 2.27 in the 3 tertiles. Analysis segment restenosis rates at 9 months were similar across the 3 tertiles with bare metal stents (24.7% vs 26.7% vs 23.8%, respectively, p = 0.90 for trend) and paclitaxel-eluting stents (11.7% vs 6.5% vs 5.4%, respectively, p = 0.24). Similarly, there were no differences in 1-year rates of target lesion revascularization across the 3 tertiles for bare metal stents (14.6% vs 14.8% vs 13.7%, respectively, p = 0.91) or paclitaxel-eluting stents (6.1% vs 3.6% vs 4.0%, respectively, p = 0.38). By multivariate analysis, the ratio of stent length to lesion length was an independent predictor of neither 9-month angiographic restenosis nor 1-year target lesion revascularization in the bare metal stent arm (odds ratio 1.21, p = 0.36, and hazard ratio 0.80, p = 0.31, respectively) or in the paclitaxel-eluting stent arm (odds ratio 0.86, p = 0.76, and hazard ratio 0.58, p = 0.21, respectively). These data do not support the arbitrary use of larger ratios of stent length to lesion length in patients who undergo implantation of drug-eluting stents.

Angioplasty, Balloon, Coronary↗

Migraine headache relief after transcatheter closure of patent foramen ovale.

OBJECTIVES: The purpose of this study was to determine the effects of transcatheter patent foramen ovale (PFO) closure on migraine frequency in patients with paradoxical cerebral embolism. BACKGROUND: The prevalence of migraine headache is higher in cryptogenic stroke patients with PFO than in the general population. Previous studies have suggested that closure of the PFO may reduce migrainous symptoms. METHODS: Between April 2001 and December 2003, 162 consecutive patients with paradoxical cerebral embolism underwent transcatheter PFO closure for prevention of recurrent cryptogenic stroke or transient ischemic attack. A one-year retrospective analysis of migraine symptoms before and after PFO closure was performed. RESULTS: Active migraine was present in 35% (57 of 162) of patients, and 68% (39 of 57) experienced migrainous aura; 50 patients were available for analysis at one year. Complete resolution of migraine symptoms occurred in 56% (28 of 50) of patients, and 14% (7 of 50) of patients reported a significant (>or=50%) reduction in migraine frequency. Patients reported an 80% reduction in the mean number of migraine episodes per month after PFO closure (6.8 +/- 9.6 before closure vs. 1.4 +/- 3.4 after closure, p < 0.001). Results were independent of completeness of PFO closure at one year. CONCLUSIONS: In patients with paradoxical cerebral embolism, migraine headaches are more frequent than in the general population, and transcatheter closure of the PFO results in complete resolution or marked reduction in frequency of migraine headache.

Cardiac Catheterization↗

Two-year clinical follow-up of 90Sr/90 Y beta-radiation versus placebo control for the treatment of in-stent restenosis.

BACKGROUND: It is an ongoing concern that intracoronary brachytherapy may possibly just delay the problem of in-stent restenosis ("late catch up"). For gamma-radiation, 3 placebo-controlled studies have shown the maintenance of the initially positive effect after 2 years, but similar data do not exist for beta-radiation. STents And Restenosis Trial (START) was the first placebo-controlled randomized trial for in-stent restenosis with beta-radiation; herein, we report the 2-year clinical follow-up. METHODS AND RESULTS: Two hundred and forty-four patients were randomized to active treatment, 232 patients to placebo (nonactive source train) treatment. The primary end point of efficacy was target vessel revascularization (TVR); primary safety end point was any major adverse cardiac event (MACE) at 8 months and 2 years. Two-year clinical outcome in patients receiving brachytherapy was based on 195 of 244 original patients (79.9%) and in the placebo arm on 183 of 232 original patients (78.9%). TVR was significantly reduced by 25%; from 36.6% (placebo) to 27.5% (brachytherapy) remained significant after 2 years (RR .7 [.57-.98], 95% CI -9.2 [-17.5-0.8]). The Kaplan-Meier analysis for TVR and MACE showed improvement beginning approximately 90 days after radiation and remained almost constant for the 2 following years. Freedom from TVR was significantly increased from 62.4% +/- 3.8% to 71.6% +/- 3.3% (P = .027) and freedom from MACE from 58.9% +/- 3.7% to 68.0% +/- 3.4% (P = .035). CONCLUSIONS: The START trial shows for the first time that the initial beneficial effects of intracoronary brachytherapy with beta-radiation using 90 Sr/ 90 Y are maintained at 2-year clinical follow-up period.

Aged↗

Left atrial structure and function after percutaneous left atrial appendage transcatheter occlusion (PLAATO): six-month echocardiographic follow-up.

OBJECTIVES: This study was designed to evaluate the effects of percutaneous left atrial appendage transcatheter occlusion (PLAATO) on the anatomic and hemodynamic properties of the mitral valve (MV) and left upper pulmonary vein (LUPV). BACKGROUND: PLAATO is a device designed to seal the neck of the left atrial (LA) appendage and reduce embolization in patients with atrial fibrillation intolerant of warfarin. The impact of deployment of this device on adjacent structures has not been reported. METHODS: Patients with atrial fibrillation participating in the ongoing study for evaluation of PLAATO were enrolled. Transesophageal echocardiographies at baseline, one, and six months were reviewed to measure LA and LUPV dimensions, degree of mitral regurgitation, stability of the device, peak MV E-wave velocity, and peak systolic and diastolic flow velocities in the LUPV. Data were analyzed by a linear mixed model for repeated measures. RESULTS: Eleven patients (mean age of 72 +/- 7 years) completed six months of follow-up. Left upper pulmonary vein diameter (mean: 1.55, 1.61, 1.54 cm, p = 0.13) and peak systolic (mean: 0.38, 0.34, 0.31 m/s, p = 0.72) and diastolic flow velocities (mean: 0.39, 0.40, 0.42 m/s, p = 0.46) did not differ over the follow-up period. Left atrial size, mitral regurgitation severity, and MV peak E-wave velocities (mean: 0.94, 0.94, 0.82 m/s, p = 0.58) showed no significant change from baseline. The devices remained stable at their sites of deployment with minimal residual flow around them. CONCLUSIONS: PLAATO achieved an adequate seal of the neck of the left atrial appendage without significant effect on the structure or function of the LA and LUPV.

Aged↗

Validation of viability assessment by electromechanical mapping by three-dimensional reconstruction with dobutamine stress echocardiography in patients with coronary artery disease.

We evaluated the ability of electromechanical mapping (EMM) to discriminate between normal, viable, and nonviable (scarred) myocardium in patients with coronary artery disease versus dobutamine stress echocardiography (DSE) when the correspondence between the test and reference data sets is established via a common 3-dimensional reconstruction of the left ventricle. We studied 21 patients with coronary artery disease who underwent angiography, biplane ventriculography, and EMM within 1 month of DSE. A 3-dimensional left ventricular (LV) reconstruction was prepared from the ventriculogram and spatially aligned with EMM. EMM measurements of unipolar voltage, bipolar voltage, and local linear shortening were projected onto the three-dimensional left ventricle, averaged in each of 16 segments, and compared with DSE viability (normal, viable, scar) assessed at a core laboratory. All of the EMM measurements varied significantly (p <0.001) between the normal, viable, and scarred myocardium as assessed by DSE. Local linear shortening for normal, viable, and scarred segments was 10.4 +/- 6.5%, 7.8 +/- 5.6%, and 4.8 +/- 4.4%, respectively. In discriminating between these 3 groups, local linear shortening was more powerful than unipolar voltage or bipolar voltage (F = 20.765, F = 10.655, F = 4.795, respectively). Local linear shortening correlated best with viability, perhaps because it shares the same cognitive function as DSE. Three-dimensional analysis provides an anatomic framework that enables direct comparison of data from multiple imaging modalities rather than assuming segmental correspondence. Our results show that EMM provides significant on-line, diagnostic information on myocardial viability assessed by DSE on a segment-by-segment basis.

Aged↗

Power m-mode transcranial Doppler for diagnosis of patent foramen ovale and assessing transcatheter closure.

BACKGROUND AND PURPOSE: Transcatheter closure of patent foramen ovale (PFO) can benefit from a less invasive diagnostic method than transesophageal echocardiography (TEE). Thirty-three gate power m-mode transcranial Doppler (pmTCD) was evaluated for its accuracy in diagnosis of PFO and utility in evaluating residual intracardiac right-to-left shunt (RLS) following transcatheter closure. METHODS: The sensitivity of pmTCD and single-gate TCD (sgTCD) to detect contrast bubble emboli through RLS was compared during transcatheter PFO closure. During 100 preclosure diagnostic evaluations and in 81 postclosure assessments, embolic tracks on pmTCD were counted following intravenous contrast injections and were graded using a 6-level logarithmic scale. The accuracy of TEE and pmTCD was separately compared to PFO anatomical findings during transcatheter closures. RESULTS: There were significantly more microemboli detectable on pmTCD (322 +/- 166; 95% confidence interval [CI], 388-257) than on sgTCD (186 +/- 109; 95% CI, 229-143; P < .001). McNemar change tests suggest that the diagnostic capabilities of pmTCD and TEE for detecting PFO are comparable and correspond to the anatomical findings determined during cardiac catheterization (P = .69 and .45, respectively). During 6-month postclosure evaluation (mean = 185 days), 66% of the patients demonstrated successful closure without significant RLS (ie, grades 0, I, or II), and 34% were found to have incomplete closure with significant RLS (ie, grades III, IV, or V). CONCLUSIONS: pmTCD provides greater sensitivity to contrast bubble emboli than does sgTCD. Among candidates for transcatheter closure, pmTCD provides an improved noninvasive method for diagnosing PFO and evaluating transcatheter closure.

Adolescent↗

Incidence of aspirin nonresponsiveness using the Ultegra Rapid Platelet Function Assay-ASA.

We report the incidence of aspirin nonresponsiveness in a prospective, multicenter registry (n=422 patients) to be 23% using the Ultegra Rapid Platelet Function Assay-ASA, and determined a history of coronary artery disease to be associated with twice the odds of being an aspirin nonresponder (odds ratio 2.01, 95% confidence interval 1.189 to 3.411, p=0.009). Further prospective studies are needed to correlate aspirin nonresponsiveness to adverse clinical events.

Aspirin↗

Comparison of rotational atherectomy with conventional balloon angioplasty in the prevention of restenosis of small coronary arteries: results of the Dilatation vs Ablation Revascularization Trial Targeting Restenosis (DART).

BACKGROUND: The optimum treatment of obstructive coronary disease in small (<3.0 mm diameter) arteries remains unknown. Rotational atherectomy is an approved treatment that might reduce the vascular injury during percutaneous coronary intervention compared with angioplasty. We report on a multicenter, randomized, blinded end point trial comparing rotational atherectomy with balloon angioplasty in the prevention of restenosis of obstructed small coronary arteries. METHODS: A total of 446 patients with myocardial ischemia associated with an angiographic stenosis in a native coronary artery 2 to 3 mm in diameter and < or =20 mm in length without severe calcification were randomly assigned to receive rotational atherectomy (n = 227) or balloon angioplasty (n = 219). The primary end point was target vessel failure at 12 months (defined as the composite of death, Q-wave myocardial infarction, and clinically driven repeat revascularization of the target vessel). RESULTS: The mean reference vessel diameter was 2.46 +/- 0.40 mm, the mean lesion length was 9.97 +/- 5.59 mm, and the prevalence of diabetes mellitus was 32%. Acute procedural success (91.6% for rotational atherectomy, 94.1% for balloon angioplasty, P =.36) and target vessel failure at 12 months were not significantly different (30.5% vs 31.2%, P =.98). At 8 months, there were no significant differences in minimum lumen diameter (1.28 +/- 0.63 mm vs 1.19 +/- 0.54 mm, P =.26), percent diameter stenosis (28% +/- 12% vs 29% +/- 15%, P =.59), binary restenosis rate (50.5% vs 50.5%, P = 1.0), or late loss index (0.57 vs 0.62, P =.7). No Q-wave myocardial infarctions occurred in either arm of the study, and non-Q-wave myocardial infarctions (defined as creatine kinase level >2 times normal with an elevated creatine kinase-myocardial band isoenzyme level) occurred in 2.2% and 1.4% of the patients in the rotational atherectomy and balloon angioplasty groups, respectively (P =.72). CONCLUSION: Rotational atherectomy was found to be safe in the treatment of obstructed small arteries, but lower rates of target vessel failure were not achieved compared with balloon angioplasty. Because the acute gain and loss index ratios of the 2 treatments were similar, there was no evident beneficial antirestenosis mechanism seen for rotational atherectomy.

Angioplasty, Balloon, Coronary↗

Adjusting for patient differences in predicting hospital mortality for percutaneous coronary interventions in the Clinical Outcomes Assessment Program.

BACKGROUND: The Clinical Outcomes Assessment Program (COAP) is a coordinated quality improvement program for percutaneous coronary interventions (PCIs) performed in Washington State hospitals. This study describes the development and testing of models for predicting hospital mortality in patients undergoing PCI. METHODS: The COAP PCI database contains extensive demographic, medical history, and procedural information. This study included 19,358 consecutive PCIs performed in 27 Washington hospitals in 1999 and 2000. The study population was randomly assigned to development (n = 11,591) and test (n = 7614) sets. Logistic regression mortality models were run in the development set and evaluated in the test set. RESULTS: The test and development sets were similar in demographic, medical history, and procedural characteristics. The overall hospital mortality rate was 1.6% and was similar in the test and development sets. By means of stepwise logistic regression analysis, cardiogenic shock, age, nonelective priority, elevated creatinine level, ejection fraction, number of diseased vessels, myocardial infarction <24 hours from admission, history of chronic obstructive pulmonary disease, male sex, history of peripheral vascular disease, history of PCI, and history of congestive heart failure were identified as predictors of hospital mortality. When applied to the test set, this model had excellent discrimination (c statistic = 0.87, 95% CI = 0.84-0.90). The model was also evaluated in the Northern New England PCI Registry, with very good results (c statistic = 0.85). CONCLUSION: Developing risk-adjusted models of mortality and other outcomes is an essential part of the quality improvement process for cardiac revascularization procedures. Because of the rapidly changing nature of PCI, modification of these models in the years to come will be required.

Aged↗

Vascular brachytherapy and the strontium90 vascular brachytherapy system.

Restenosis remains a vexing problem in patients undergoing percutaneous coronary interventions (PCI). This phenomenon is related to a combination of events, including elastic recoil, negative remodeling and fibrointimal tissue proliferation. While stenting (bare metal and drug eluting) has made a dramatic impact in preventing recoil and remodeling, restenosis still occurs. Once restenosis occurs, it presents its own set of challenges due to the excess tissue proliferation. Major predicators of restenosis include diabetes, small stent diameter and long stented lesions. Vascular brachytherapy is the only proven therapy associated with a significant reduction in angiographic restenosis and the need for target vessel revascularization for the treatment of in-stent restenosis.

Angioplasty, Balloon, Coronary↗