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Biomedical subjects

David R Holmes

Publications and source records attributed to David R Holmes.

At least 109 records · Page 6Linked to original sources
PubMed2004

Cutting balloon angioplasty vs. conventional balloon angioplasty in patients receiving intracoronary brachytherapy for the treatment of in-stent restenosis.

The objective of this study was to evaluate the safety and efficacy of cutting balloon angioplasty (CBA) for the treatment of in-stent restenosis prior to intracoronary brachytherapy (ICB). Cutting balloon angioplasty may reduce the incidence of uncontrolled dissection requiring adjunctive stenting and may limit "melon seeding" and geographic miss in patients with in-stent restenosis who are subsequently treated with ICB. We performed a retrospective case-control analysis of 134 consecutive patients with in-stent restenosis who were treated with ICB preceded by either CBA or conventional balloon angioplasty. We identified 44 patients who underwent CBA and ICB, and 90 control patients who underwent conventional percutaneous transluminal coronary angioplasty (PTCA) and ICB for the treatment of in-stent restenosis. Adjunctive coronary stenting was performed in 13 patients (29.5%) in the CBA/ICB group and 41 patients (45.6%; P < 0.001) in the PTCA/ICB group. There was no difference in the injury length or active treatment (ICB) length. The procedural and angiographic success rates were similar in both groups. There were no statistically significant differences in the incidence of death, myocardial infarction, recurrent angina pectoris, subsequent target lumen revascularization, or the composite endpoint of all four clinical outcomes (P > 0.05). Despite sound theoretical reasons why CBA may be better than conventional balloon angioplasty for treatment of in-stent restenosis with ICB, and despite a reduction in the need for adjunctive coronary stenting, we were unable to identify differences in clinical outcome.

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PubMed2004

Flat-panel detectors in the cardiac catheterization laboratory: revolution or evolution-what are the issues?

Continuous developments in digital imaging technology have contributed to the vital role held today by digital X-ray imaging in the cardiac catheterization laboratory. Foremost among these developments is the replacement of cine film with digital data equivalents as the procedure record. Other improvements include software innovations and processing algorithms, along with new types of hardware capable of delivering required functionality more rapidly. A significant recent development is that of the flat-panel X-ray detector as a replacement for the image intensifier, which has served the needs of the cardiac catheterization laboratory for nearly 5 decades. Clinical users must evaluate the respective technologies and determine whether one or the other meets the needs of their own laboratories. In this review, the two competing detector technologies are reviewed and a summary of general advantages and disadvantages of each is provided. A qualitative description is provided of parameters that can be used to assess quantitatively the performance of detectors and imaging systems. Using such objective measurements, together with standard techniques for evaluating imaging systems, angiographers and managers can better arrive at informed decisions for their own situation.

Cardiac Catheterization↗
PubMed2004

A view from within.

Explore the source record for details and available documents.

Carotid Arteries↗
PubMed2004

Safety and efficacy of aspirin, clopidogrel, and warfarin after coronary stent placement in patients with an indication for anticoagulation.

BACKGROUND: Dual antiplatelet therapy with aspirin and clopidogrel has replaced aspirin and systemic anticoagulation with warfarin as the preferred antithrombotic therapy after percutaneous coronary intervention (PCI) with stent placement. However, a number of patients have indications for all 3 drugs. We sought to determine the frequency and type of hemorrhagic complications in patients who undergo systemic anticoagulation with warfarin while receiving aspirin and clopidogrel after a PCI with stent placement. METHODS: We performed a retrospective analysis of the Mayo Clinic PCI database and identified 66 consecutive patients who were discharged from hospital after PCI between January 2000 and August 2002 (inclusive) receiving a combination of dual antiplatelet therapy (aspirin and clopidogrel) and systemic anticoagulation (warfarin) to determine the incidence of bleeding and other clinical events during the treatment period. RESULTS: Six patients (9.2%; 95% CI, 3.5-19.0) reported a bleeding event; 2 patients required a blood transfusion. No patient died or sustained a myocardial infarction or stent thrombosis. CONCLUSIONS: The risk of bleeding may be increased in patients treated with aspirin, a thienopyridine, and warfarin early after PCI with stent placement.

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PubMed2004

Outcomes of elderly patients with cardiogenic shock treated with early percutaneous revascularization.

BACKGROUND: Subgroup analysis from the Should We Emergently Revascularize Occluded Coronaries for Cardiogenic Shock (SHOCK) trial indicated that patients with acute myocardial infarction (MI) complicated by cardiogenic shock (CS) who were > or =75 years old did not benefit from early revascularization and may have been harmed; their mortality rate at 30 days was 75%. The applicability of this subset analysis from a select patient population enrolled in a randomized trial to the general population is unclear. METHODS: At the Mayo Clinic between 1991 and 2000, we evaluated the outcome of all patients > or =75 years old with CS caused by MI who underwent urgent percutaneous coronary intervention (PCI). RESULTS: The study included 61 patients with a mean age of 79.5 +/- 3 years; 21% of these patients had a history of prior coronary artery bypass grafting (CABG), 41% had had a prior MI, 28% had diabetes mellitus, and 18% had a history of a cerebrovascular accident (CVA). PCI was performed 8.0 +/- 7.2 hours after onset of MI. Angiographic success (<50% residual stenosis) was achieved in 91% of the lesions that were dilated. In hospital outcomes included death (44%), CABG (1.6%), and CVA (4.9%). The 30-day mortality rate was 47%. The estimated survival rate 1 year after discharge (Kaplan Meier method) was 75%. CONCLUSIONS: These data confirm a high early mortality rate among patients > or =75 years old with MI complicated by CS, but suggest that among patients referred for angiography, outcomes may be better than previously believed when early revascularization is performed. In this population, 56% of patients survived to be discharged from the hospital, and of the hospital survivors, 75% were alive at 1 year.

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PubMed2004

Impact of coronary artery stents on mortality and nonfatal myocardial infarction: meta-analysis of randomized trials comparing a strategy of routine stenting with that of balloon angioplasty.

BACKGROUND: A strategy of routine stenting has been shown to reduce the need for target-vessel revascularization compared with a strategy of balloon angioplasty alone; however, the impact on mortality and frequency of nonfatal myocardial infarction is unclear. The aim of this study was to provide a quantitative comparison of the impact of coronary stenting on the rates of mortality and myocardial infarction with that of balloon angioplasty with provisional stenting. METHODS: We performed a meta-analysis of randomized trials comparing routine coronary stenting to percutaneous transluminal coronary angioplasty (PTCA), including only those trials that used combination antiplatelet therapy (aspirin and a thienopyridine) as an adjuvant to stenting. Such trials included: the Belegian Netherlands Stent Study (BENESTENT) II, Optimal Coronary Balloon Angioplasty With Provisional Stenting Versus Primary Stent (OCBAS), Balloon Optimization vs Stent Study (BOSS), Evaluation of Platelet IIb/IIIa Inhibitor for Stenting (EPISTENT), Optimum Percutaneous Transluminal Coronary Angioplasty Compared With Routine Stent Strategy (OPUS-1), French Optimal Stenting Trial (FROST), Angioplasty or Stent (AS), and Doppler Endpoint Stenting International Investigation (DESTINI) trials for de novo coronary artery lesions; the Stent vs Percutaneous Angioplasty in Chronic Total Occlusion (SPACTO), Total Occlusion Study of Canada (TOSCA), Stent or Angioplasty after Recanalization of Chronic Coronary Occlusions (SARECCO), and Mayo-Japan Investigation for Chronic Total Occlusion (MAJIC) trials for coronary occlusions; the Primary Angioplasty Versus Stent Implantation in Acute Myocardial Infarction (PASTA), Gianturco-Roubin in Acute Myocardial Infarction (GRAMI), Florence Randomized Elective Stenting in Acute Coronary Occlusions (FRESCO), Immediate Coronary Angioplasty with Elective Wiktor Stent Implantation Compared with Conventional Balloon Angioplasty in Acute Myocardial Infarction (STENTUIM-2), Stent Primary Angioplasty in MI (Stent-PAMI), Zwolle, and Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications (CADILLAC) trials for acute ST-segment elevation myocardial infarction; and the Intracoronary Stenting or Angioplasty for Restenosis Reduction in Small Arteries (ISAR-SMART), Park, Stenting in Small Arteries (SISA), and Bestent in Small Arteries (BESMART) trials for small vessels. RESULTS: The 23 trials enrolled 10,347 patients, with 5130 patients randomized to receive stent and 5217 patients randomized to receive balloon angioplasty. A total of 902 (17 %) of patients crossed over from a strategy of balloon angioplasty to stent placement because of the inability to achieve a satisfactory result with a balloon. No significant difference was observed between the stent group and PTCA group in the rates of death or myocardial infarction, despite a significant reduction in the frequency of major adverse cardiac events (odds ratio, 0.59; 95% CI, 0.50-0.70; P <.001), which was driven entirely by a reduction in target vessel revascularization. CONCLUSIONS: An initial strategy of stent placement versus balloon angioplasty with provisional stenting is associated with a similar mortality rate and frequency of nonfatal myocardial infarction after a mean follow-up period of 12.8 months. Patients who underwent stent placement had a significantly lower risk of major adverse cardiac events only when target revascularization is included as an end point.

Angioplasty, Balloon, Coronary↗
PubMed2004

Conflict of interest.

The clinical research enterprise is increasingly scrutinized, in part because of the issue of conflict of interest. The issue is broad and its implications touch on a wide range of concerns, from the safety of patient care to the viability of a large industry. Numerous constituencies are affected by conflict of interest, and representatives of all of them convened in November 2002 for a one-and-a-half day discussion of the issues as well as possible solutions to both the perception and the actuality of such conflict. Participants included medical journal editors, news reporters, physician investigators, representatives of institutional conflict-of-interest oversight committees, representatives of the medical products industry, and Federal regulators. The resulting manuscript provides a review of the issues as well as desirable ways for each of the players to monitor themselves; each section thus contains provocative recommendations for eliminating conflict of interest to ensure that our vibrant health care system continues to foster exciting new advances to improve patient care.

Academic Medical Centers↗
PubMed2004

Routine intravascular ultrasound scanning guidance of coronary stenting is not associated with improved clinical outcomes.

PURPOSE: The purpose of the current study was to determine whether there is any incremental benefit to routine intravascular ultrasound (IVUS) guidance of percutaneous coronary intervention. METHODS AND RESULTS: We compared the outcome of 796 patients who underwent an IVUS study (IVUS group) during the index stent procedure with 8274 patients who did not have an IVUS study (angiography group). The primary end point was the composite end point of death, myocardial infarction, or ischemia-driven target vessel revascularization within 9 months of the index stent procedure. There were statistically significant differences in multiple procedural characteristics. Most importantly, those patients who underwent an IVUS study had a larger postprocedural minimal lumen diameter and smaller postprocedural percent diameter stenosis. However, there was no significant difference between the IVUS group and the angiography group with respect to the primary end point (RR 1.10, 95% CI 0.91, 1.32) or any of the individual clinical end points. Adjustment for multiple clinical and procedural characteristics did not significantly alter these findings. CONCLUSIONS: These data suggest that the routine performance of IVUS during stent placement influences the performance of the procedure, as judged by differences in procedural characteristics, but does not improve clinical outcome at 9 months.

Angioplasty, Balloon, Coronary↗
PubMed2004

Patent foramen ovale, systemic embolization and closure.

The recognition, evaluation and treatment of patent foramen ovale has attracted increasing interest as the importance and frequency of paradoxical embolism has become better understood. The interest in this field has been driven largely by the widespread application of echocardiography with identification of a patent foramen ovale and/or an atrial septal aneurysm. The evaluation of the role of a patent foramen ovale in patients with a neurologic event is complex because the patent foramen ovale or atrial septal aneurysm may either be an innocent bystander or could be the etiologic mechanisms involved in the paradoxical embolus. In patients younger than 55 years, a causal relationship between a patent foramen ovale/atrial septal aneurysm and a neurologic ischemic event is considerably stronger than in those patients older than 55 years. In patients with a presumed diagnosis of paradoxical embolus in the setting of a patent foramen ovale, percutaneous closure is now possible and 2 devices are relatively widely used. Both of these devices reliably close the defect with a very acceptable risk profile and have been found in the longer term to be associated with excellent outcome. The exact role, however, that these devices play vis a vis continued medical therapy for prevention of recurrent events is being tested in 2 randomized clinical trials. The field continues to change with new technology being developed and with new applications. A recently exciting finding has been the identification that closure of a patent foramen ovale may be associated with dramatic improvement in symptoms of patients with disabling migraine headaches. Other potential applications of these devices include those patients who are deep-sea divers, in whom the potential for "bends" exists, or high altitude airplane pilots.

Echocardiography↗
PubMed2004

Incidence, correlates, management, and clinical outcome of coronary perforation: analysis of 16,298 procedures.

BACKGROUND: Coronary perforation is a serious but uncommon complication of percutaneous coronary intervention (PCI) and is associated with significant morbidity and mortality. METHODS: We performed an analysis of the Mayo Clinic PCI database. Clinical records, procedural reports, and angiographic studies were reviewed. Multiple logistic regression analysis was performed to identify clinical, procedural, anatomic, and angiographic correlates of coronary perforation. RESULTS: A total of 16,298 PCI procedures were performed between January 1990 and December 2001. We identified 95 coronary perforations (0.58%; 95% CI, 0.47-0.71). The incidence of coronary perforation varied with time. Correlates of coronary perforation included the use of an atheroablative device and female sex. Twelve patients (12.6%) sustained an acute myocardial infarction, and cardiac tamponade developed in 11 patients (11.6%). Management strategies included reversal of heparin, pericardiocentesis, placement of a covered stent, and surgical repair. Seven patients died (7.4%). CONCLUSIONS: Coronary perforation during PCI is rare, but is associated with significant morbidity and mortality. The variable frequency of perforation may be explained by temporal variations in the use of atheroablative devices.

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PubMed2004

Percutaneous coronary intervention for ST-segment and non-ST-segment elevation myocardial infarction at hospitals with and without on-site cardiac surgical capability.

OBJECTIVE: To compare the safety and efficacy of percutaneous coronary intervention (PCI) for acute myocardial infarction performed at a hospital without cardiac surgical capability with PCI performed for acute myocardial infarction at a center with on-site surgery. PATIENTS AND METHODS: We included patients with acute myocardial infarction in whom PCI was performed from March 1, 2000, through May 31, 2002, at a community hospital (Immanuel St Joseph's) without on-site surgery. The procedural success, in-hospital adverse cardiac events, and 6-month follow-up were compared with those of PCI performed for acute myocardial infarction in matched controls from January 1, 2000, through February 28, 2002, at a center with cardiac surgery (Saint Marys Hospital). RESULTS: One hundred sixty patients (and 160 matched controls) underwent PCI for acute myocardial infarction. The procedural success rate was high and similar for the 2 groups (96% vs 95%; P=.79). In-hospital mortality, Q-wave myocardial infarction, and target vessel revascularization were low and similar for the 2 groups. No patient was referred for emergency coronary artery bypass graft surgery for failed PCI. Six-month survival from all-cause mortality was 96% for the Immanuel St Joseph's group and 94% for the Saint Marys Hospital group (P=.92). Subgroup analysis of patients with primary PCI for ST-segment elevation acute myocardial infarction revealed high procedural success and low and similar rates of major cardiac adverse events in the 2 groups. CONCLUSION: This study shows that PCI for acute myocardial infarction can be performed safely and effectively in a community hospital without on-site cardiac surgery.

Angioplasty, Balloon, Coronary↗
PubMed2004

Anticipated impact of drug-eluting stents on referral patterns for coronary artery bypass graft surgery: a population-based angiographic analysis.

OBJECTIVES: To determine the clinical and angiographic characteristics of patients who underwent coronary artery bypass graft (CABG) surgery before the availability of drug-eluting stents (DES) and to project the potential impact of percutaneous coronary intervention using DES. PATIENTS AND METHODS: We reviewed the coronary angiograms obtained between March 1999 and December 2001 of 192 consecutive patients from Olmsted County, Minnesota, who had undergone isolated CABG surgery for the first time. Three interventional cardiologists categorized the patients into 1 of 4 groups on the basis of technical feasibility of complete revascularization by percutaneous coronary intervention with DES. RESULTS: The study population consisted primarily of men (78%), with a mean age of 67 years. Of the 192 patients, 58 (30%) had diabetes mellitus, and 124 (65%) had 3-vessel disease. Twelve patients (6%) had lesions suitable for stents that matched the inclusion criteria for DES in recently published trials; 77 (40%) had lesions suitable for stents but had lesion characteristics not included in the initial DES trials. Thirty-two patients (17%) had target lesions considered technically difficult, but feasible, for stent placement. Seventy-one patients (37%) had lesions unsuitable for percutaneous coronary intervention (75% of these due to chronic occlusions) with the current stent delivery technology. CONCLUSION: This population-based analysis suggests that only a small proportion of patients undergoing CABG surgery meets the strict angiographic eligibility criteria for DES on the basis of recent trials. However, up to 46% of current CABG patients may ultimately undergo conversion to DES. The remaining 54% of this patient population may still not be ideal candidates for DES with the current stent delivery technology.

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PubMed2004

Effect of peripheral arterial disease in patients undergoing percutaneous coronary intervention with intracoronary stents.

OBJECTIVE: To compare the short-term and long-term outcomes of patients with coronary artery disease and peripheral arterial disease (PAD) who underwent intracoronary (IC) stent Implantation during percutaneous coronary intervention (PCI) with the outcomes of patients with isolated coronary artery disease but without PAD who underwent IC stent implantation. PATIENTS AND METHODS: We analyzed the outcomes of 7696 patients who underwent IC stent implantation during PCI at the Mayo Clinic in Rochester, Minn, between January 1996 and December 2002. Outcomes of 6299 patients (82%) with Isolated coronary artery disease and without PAD who underwent IC stent implantation (group 1) were compared with outcomes of 1397 patients (18%) with coronary artery disease and PAD (group 2) who underwent PCI with IC stent implantation. RESULTS: Patients in group 2 were older (71.1+/-10.2 years vs 65.0+/-12.0 years; P<.001) and had a higher prevalence of hypertension (79% vs 61%; P<.001), diabetes mellitus (33% vs 20%; P<.001), hyperlipidemia (76% vs 70%; P<.001), and history of smoking (70% vs 63%; P<.001) compared with group 1. Prevalence of multivessel disease was higher in group 2 (79% vs 68%; P<.001). Procedural success was significantly lower In group 2 (95% vs 97%; P<.001). In-hospital complications were higher in group 2: death (3% vs 1%; P<.001), any myocardial Infarction (MI) (8% vs 5%; P<.001), death/MI/coronary artery bypass grafting (CABG)/target vessel revascularization (11% vs 7%; P<.001), and blood loss requiring transfusion (11% vs 5.8%; P<.001). After adjustment for other risk factors, the odds ratio for in-hospital death was 1.84 (95% confidence interval [CI], 1.16-2.90; P=.009), and for death/MI/CABG/target vessel revascularization, the odds ratio was 1.25 (95% CI, 1.00-1.55; P=.048) in patients with PAD treated with IC stents. Median follow-up was 3.1 years. Six-month, 1-year, and 2-year Kaplan-Meier estimates of survival free of death/MI/CABG/target vessel revascularization were 84%, 77%, and 69%, respectively, for group 2 and were significantly worse compared with group 1 (89%, 85%, and 80%, respectively; P<.001). This effect remained after adjustment for other risk factors (hazard ratio, 1.36; 95% CI, 1.22-1.51). CONCLUSIONS: Compared with patients who had isolated coronary artery disease but no PAD, patients with coronary artery disease and PAD had lower procedural success and higher in-hospital major cardiovascular complications, including higher blood loss requiring transfusion, after PCI with stent Implantation. On follow-up, the short-term and long-term outcomes of patients with PAD were worse, with higher mortality, MI, and need for repeated target vessel revascularization.

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PubMed2003

Validation of Mayo Clinic risk adjustment model for in-hospital complications after percutaneous coronary interventions, using the National Heart, Lung, and Blood Institute dynamic registry.

OBJECTIVES: We sought to validate the recently proposed Mayo Clinic risk score model for complications after percutaneous coronary interventions (PCI), using an independent data set. BACKGROUND: The Mayo Clinic risk score has eight simple clinical and angiographic variables for the prediction of complications defined as either death, Q-wave myocardial infarction, emergent or urgent coronary artery bypass graft surgery, or cerebrovascular accident after PCI. External validation using an independent data set is lacking. METHODS: A total of 3,264 patients undergoing PCI at each of the 17 sites in the National Heart, Lung, and Blood Institute's Dynamic Registry during two enrollment periods (July 1997 to February 1998 and February to June 1999) were studied. Logistic regression was used to model the calculated risk score and major procedural complications. The expected number of complications, with 95% confidence bounds (CBs), was also calculated. RESULTS: There were 96 (2.94%) observed procedural complications, and the Mayo Clinic risk score predicted 93.5 events (2.86%; 95% CB 2.32% to 3.41%; p = NS). The Hosmer-Lemeshow goodness-of-fit p value was 0.28, and the area under the receiver operating curve was 0.76, indicating excellent overall discrimination. There were no statistical differences between observed and predicted procedural complications using the Mayo Clinic risk score among the most selected high- and low-risk subgroups. CONCLUSIONS: Eight variables were combined into a convenient risk scoring system that accurately predicts cardiovascular complications after PCI. The Mayo clinic predictive model for procedural complications yielded excellent results when applied to a multi-center external data set.

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PubMed2003

Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery.

BACKGROUND: Preliminary reports of studies involving simple coronary lesions indicate that a sirolimus-eluting stent significantly reduces the risk of restenosis after percutaneous coronary revascularization. METHODS: We conducted a randomized, double-blind trial comparing a sirolimus-eluting stent with a standard stent in 1058 patients at 53 centers in the United States who had a newly diagnosed lesion in a native coronary artery. The coronary disease in these patients was complex because of the frequent presence of diabetes (in 26 percent of patients), the high percentage of patients with longer lesions (mean, 14.4 mm), and small vessels (mean, 2.80 mm). The primary end point was failure of the target vessel (a composite of death from cardiac causes, myocardial infarction, and repeated percutaneous or surgical revascularization of the target vessel) within 270 days. RESULTS: The rate of failure of the target vessel was reduced from 21.0 percent with a standard stent to 8.6 percent with a sirolimus-eluting stent (P<0.001)--a reduction that was driven largely by a decrease in the frequency of the need for revascularization of the target lesion (16.6 percent in the standard-stent group vs. 4.1 percent in the sirolimus-stent group, P<0.001). The frequency of neointimal hyperplasia within the stent was also decreased in the group that received sirolimus-eluting stents, as assessed by both angiography and intravascular ultrasonography. Subgroup analyses revealed a reduction in the rates of angiographic restenosis and target-lesion revascularization in all subgroups examined. CONCLUSIONS: In this randomized clinical trial involving patients with complex coronary lesions, the use of a sirolimus-eluting stent had a consistent treatment effect, reducing the rates of restenosis and associated clinical events in all subgroups analyzed.

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PubMed2003

Myocardial bridging in adult patients with hypertrophic cardiomyopathy.

OBJECTIVES: This investigation examined the risk of sudden cardiac death and other mortality in adult patients with hypertrophic cardiomyopathy (HCM) who have myocardial bridging diagnosed at coronary angiography. BACKGROUND: Several reports have associated myocardial bridging with an adverse prognosis in pediatric HCM patients, but the prognosis of myocardial bridging in adult patients with HCM is unknown. METHODS: The coronary angiograms of 425 patients with HCM (mean age 60 +/- 15 years [range 18 to 89 years]) at the Mayo Clinic were examined for the presence of myocardial bridging. Clinical follow-up was conducted to assess mortality. Survival of patients with bridging was compared with HCM patients who also underwent angiography but who did not have evidence of bridging. RESULTS: A total of 64 patients (15%) had myocardial bridging. The mean follow-up for the entire study was 6.8 +/- 5.4 years. There was no difference in survival free of all-cause mortality (5-year estimate, bridging vs. no bridging, 91% vs. 85%; p = 0.42), all cardiac death (93% vs. 89%; p = 0.60), and sudden cardiac death (95% vs. 97%; p = 0.72). Univariate and multivariate proportional hazards models also did not identify the presence of bridging or specific characteristics of the degree or extent of bridging with a poor outcome. CONCLUSIONS: This study observed no increased risk of death, including sudden cardiac death, among adult patients with HCM who had myocardial bridging diagnosed at coronary angiography.

Adolescent↗