First experience with hybrid percutaneous transmyocardial laser revascularization and angioplasty in patients with lesions at high risk for restenosis: Results of a phase I feasibility study.

BACKGROUND: Prior studies have suggested that percutaneous transmyocardial laser revascularization (PTMR) may be effective as a sole treatment modality in reducing angina in patients with severe coronary artery disease and no revascularization alternatives. The safety and efficacy of the hybrid or adjunctive use of PTMR during the same procedure as percutaneous intervention (PCI) has not previously been reported. METHODS: A US phase I feasibility study was therefore performed to determine whether PTMR performed in the same myocardial territory as PCI is able to ameliorate symptomatic recurrence from restenosis. RESULTS: After successful and uncomplicated PCI in 26 patients with class III-IV angina and lesion(s) at high risk for restenosis, PTMR was performed in the same myocardial territories subtended by the treated vessel(s). Major periprocedural adverse events (death, Q-wave myocardial infarction, and bypass surgery) occurred in 3 (11.5%) patients, as the result of subacute vessel closure in 2 patients, and tamponade in the third. Cumulative 6-month mortality rate was 19.2%, including 2 late deaths between 3 and 4 months after discharge (1 death caused by late stent closure and 1 unexplained death during sleep.) Late repeat revascularization for restenosis in the PCI plus PTMR treated target vessel was required in 19.2% of patients, and an additional 11.5% of patients had class III-IV angina at 6-month follow-up. CONCLUSIONS: These data demonstrate that in a patient population at high risk for restenosis, recently created PTMR channels are not protective against severe ischemia caused by acute vessel closure and that late symptomatic restenosis after PCI may still frequently occur despite PTMR in the same region.

Rotational atherectomy or balloon angioplasty in the treatment of intra-stent restenosis: BARASTER multicenter registry.

The BARASTER registry was formed to evaluate the initial success and long-term results of rotational atherectomy in the management of in-stent restenosis. Rotational atherectomy was used in 197 cases of in-stent restenosis: 46 with stand-alone rotational atherectomy or at most 1 atmosphere of balloon inflation (Rota strategy), and 151 with rotational atherectomy and adjunctive balloon angioplasty <1 atmosphere (Combination strategy). These were compared with 107 episodes of in-stent restenosis treated with balloon angioplasty alone. In this observational study, the use of Combination therapy was associated with a slightly higher initial success rate (95% vs. 87% with the Rota strategy and 89% with Balloons, P = 0.08). There was a reduction in one year clinical outcomes (death, myocardial infarction or target lesion revascularization) in the combination group (38% vs. 60% with Rota and 52% with balloons, P = 0.02). These data support a benefit of the strategy of debulking with rotational atherectomy followed by adjunctive balloon angioplasty, in the management of in-stent restenosis.

Safety, efficacy, and durability of carotid artery stenting for restenosis following carotid endarterectomy: a multicenter study.

PURPOSE: To present the results of a multicenter registry established to collect data on carotid stent procedures in patients with restenosis following carotid endarterectomy. METHODS: The procedural details, outcomes, and late follow-up results were collected from 14 centers in the United States. Thirty-day and late stroke and death rates were analyzed. RESULTS: Three hundred and thirty-eight patients (201 men; 71 +/- 8 years) underwent carotid stenting in 358 arteries. The average duration from carotid endarterectomy was 5.5 +/- 7.3 years. Sixty-one percent of the patients were asymptomatic. The overall 30-day stroke and death rate was 3.7%. The minor stroke rate was 1.7% (6/358), and the major nonfatal stroke rate was 0.8% (3/358). The fatal stroke rate was 0.3% (1/358), and the nonstroke-related death rate was 0.9% (3/338). There was 1 (0.3%) fatal and 1 (0.3%) nonfatal stroke during the follow-up period. The overall 3-year rate of freedom from all fatal and nonfatal strokes was 96% +/- 1% (+/- SE). CONCLUSIONS: Carotid artery stenting can be performed in patients with restenosis following carotid endarterectomy with 30-day complication rates comparable to those of most published studies on repeat carotid endarterectomy. Results of late follow-up suggest that this technique is durable and efficacious.

Global experience in cervical carotid artery stent placement.

The purpose of this article is to review and update the current status of carotid artery stent placement in the world. Surveys to major interventional centers in Europe, North and South America, and Asia were initially completed in June 1997. Subsequent information from these 24 centers in addition to 12 new centers has been obtained to update the information. The survey asked the various questions regarding the patients enrolled, procedure techniques, and results of carotid stenting, including complications and restenosis. The total number of endovascular carotid stent procedures that have been performed worldwide to date included 5,210 procedures involving 4,757 patients. There was a technical success of 98.4% with 5,129 carotid arteries treated. Complications that occurred during the carotid stent placement or within a 30-day period following placement were recorded. Overall, there were 134 transient ischemic attacks (TIAs) for a rate of 2.82%. Based on the total patient population, there were 129 minor strokes with a rate of occurrence of 2.72%. The total number of major strokes was 71 for a rate of 1.49%. There were 41 deaths within a 30-day postprocedure period resulting in a mortality rate of 0.86%. The combined minor and major strokes and procedure-related death rate was 5.07%. Restenosis rates of carotid stenting have been 1.99% and 3.46% at 6 and 12 months, respectively. The rate of neurologic events after stent placement has been 1.42% at 6-12-month follow-up. Endovascular stent treatment of carotid artery atherosclerotic disease is growing as an alternative for vascular surgery, especially for patients that are high risk for standard carotid endarterectomy. The periprocedure risks for major and minor strokes and death are generally acceptable at this early stage of development and have not changed significantly since the first survey results. Cathet. Cardiovasc. Intervent. 50:160-167, 2000.

Safety and efficacy of elective carotid artery stenting in high-risk patients.

OBJECTIVES: We sought to evaluate the safety and efficacy of carotid artery stenting (CAS) in high risk patients. BACKGROUND: Carotid endarterectomy (CE) has been shown to be more effective than medical therapy, but it has limitations. Carotid artery stenting may be a reasonable alternative, particularly in high-risk patients. METHODS: We prospectively evaluated the safety and efficacy of CAS in 170 consecutive patients who underwent the procedure in 192 carotid arteries. Of the patients enrolled, 129 (76%) would have been excluded from the major trials of CE and 54 (32%) were referred by vascular surgeons. This series represents a very high-risk group that included patients with unstable angina, previous ipsilateral CE, contralateral carotid artery occlusion and other severe comorbid illnesses. Only 25 (24%) of 104 symptomatic patients would have met the North American Symptomatic Carotid Endarterectomy Trial (NASCET) entry criteria. The patients' mean age was 73 +/- 8 years (95 confidence interval [CI] 57 to 89), and 42 patients (25%) were > or = 80 years old. Patients had an independent neurologic examination before and after the procedure. RESULTS: The procedural success rate was 99%, including 73 patients who had a coronary intervention. Mean carotid artery stenosis was 78 +/- 10% before (95 CI 58 to 98) and 2 +/- 3% after the procedure (95 CI -4 to 8). During the initial hospital period and 30 days after CAS, there was one major and two category 2 minor strokes, as well as two category 1 minor strokes (total 30-day stroke rate was 2.9% for treated patients or 2.6% for treated arteries). There were no myocardial infarctions or deaths during or within 30 days of CAS. None of the NASCET-eligible patients had a stroke. At a mean follow-up of 19 +/- 11 months, three patients (2%) had asymptomatic restenosis. No other major strokes or neurologic deaths occurred. CONCLUSIONS: Carotid artery stenting is feasible, can be performed even in high-risk patients and is associated with a low restenosis rate.

Percutaneous transluminal myocardial revascularization with a holmium laser system: procedural results and early clinical outcome.

Surgical transmyocardial laser revascularization has been reported to improve clinical outcome in patients with refractory angina who are not candidates for angioplasty or bypass surgery. We investigated the feasibility and safety of a nonsurgical, percutaneous technique for laser channel creation using energy from a holmium:yttrium-aluminium-garnet (YAG) laser. The laser energy was directed through a fiber enclosed in a catheter to the ventricular myocardium creating channels between the blood pool and the myocardium. Thirty-five patients with angina and coronary anatomy not amenable to revascularization with coronary angioplasty or bypass surgery underwent percutaneous transluminal myocardial revascularization. A total of 15 +/- 5 channels were formed per patient. There was no procedure-related mortality. One patient developed cardiac tamponade requiring thoracotomy and another a minor self-limiting pericardial effusion. There was no worsening of regional wall motion function in any patient. All patients were discharged alive after a postprocedure hospital stay of 2.1 +/- 1.4 days. Mean Canadian Cardiovascular Society (CCS) functional class declined from 3.68 +/- 0.4 before procedure to 0.82 +/- 0.7 at 30 days (P < 0.01). At 3 months, mean angina class was 0.94 +/- 0.65 (n = 35; P < 0.01) and at 6 months, mean angina class was 1.08 +/- 0.58 (n = 26; P < 0.01). One patient required repeat revascularization after 5 months for progression of disease in a degenerated saphenous venous graft supplying different region of myocardium. We conclude that transmyocardial revascularization using holmium:YAG laser by percutaneous technique can be carried out safely with encouraging early results and a very low complication rate. The symptomatic relief seen up to 6 months has been excellent. The long-term effects of this technique on mortality and relief of angina, however, remain to be defined. Cathet. Cardiovasc. Intervent. 47:287-291, 1999.

Procedural results and early clinical outcome of percutaneous transluminal myocardial revascularization.

A substantial number of patients present with medically refractory angina who are not candidates for angioplasty or bypass surgery. The creation of channels between the myocardium and the ventricular blood pool has been performed after thoracotomy with excellent relief of symptoms but has been associated with high perioperative mortality. We investigated the safety of a nonoperative, percutaneous technique for channel creation. Twenty-seven patients with angina and coronary anatomy not amenable to revascularization with coronary angioplasty or bypass surgery underwent percutaneous transluminal myocardial revascularization (PTMR). Energy from a Holmium:yttrium-aluminum-garnet (YAG) laser was directed through a fiber enclosed in a catheter to the ventricular myocardium creating channels between the blood pool and the myocardium. On average, 17 +/- 4 channels were formed per patient. There were no procedure-related deaths, episodes of tamponade, or other complications except for an increase in creatine phosphokinase in 1 patient. Immediately after the procedure, there was no worsening of regional wall motion function in any patient, but rather improvement in some. All patients were discharged alive after a hospital stay of 1.8 +/- 1.5 days. Mean Canadian Cardiovascular Society functional class declined from 3.6 +/- 0.5 before the procedure to 0.65 +/- 0.8 at 30 days after the procedure (p < 0.01). For 12 patients eligible for 6-month follow-up, mean functional class was 0.94 +/- 0.97. At 6-month stress testing, 9 of these 12 had no electrocardiographic evidence of ischemia. Thus, PTMR can be performed safely in the cardiac catheterization laboratory with a complication rate lower than that reported in surgical series and with excellent near-term symptomatic relief. The long-term effect of PTMR on mortality and relief of angina as well as its safety and effectiveness compared with the surgical approach remains to be defined.

Xyphoid MIDCAB: report of the technique and experience with a less invasive MIDCAB procedure.

BACKGROUND: Coronary bypass surgery on the beating heart has been in existence since the inception of coronary revascularization. The advent and evolution of the heart-lung machine and cardioplegia have greatly advanced and expanded the realm of bypass surgery, allowing surgeons to perform precise coronary anastomoses in a still field of the arrested heart. The minimally invasive direct coronary artery bypass (MIDCAB) has been used primarily for grafting the left internal mammary artery (LIMA) to left anterior descending artery (LAD) and is gaining acceptance as a less invasive option. Dr. Frederico Benetti in Argentina championed the resurgence of beating heart surgery in 1985, and pioneered the left anterior thoracotomy MIDCAB procedure, which he has further refined to a xiphoid approach. The xiphoid incision is a simpler, less painful approach than that through a left anterior thoracotomy. METHODS: An incision is made through the xiphoid and, if necessary, into the tip of the sternum allowing the left side of the chest to be elevated. The distal LIMA is identified and dissected proximally to about the third interspace to give enough distance for a tensionless anastomosis. The pericardium is opened and the heart positioned to expose the LAD. Local stabilization for the LAD is obtained and the LIMA-to-LAD anastomosis is performed. RESULTS: The xiphoid MIDCAB approach was used for LIMA-to-LAD anastomosis in ten patients ranging in age from 52 to 86 years (mean age 73 years). Three patients underwent angioplasty of additionally obstructed vessels (so-called hybrid procedures) following initial MIDCAB. Despite high preoperative-risk profiles and Parsonnet scores, there were no deaths. However, two of the three hybrid patients had major complications resulting in a prolonged hospital stay. CONCLUSIONS: Initial clinical experience with xiphoid MIDCAB proves it is a feasible alternative to intercostal MIDCAB with the possible advantages of reduced pain and chest wall complications. Further investigation into this surgical approach is warranted.

Current global status of carotid artery stent placement.

Our purpose was to review the current status of carotid artery stent placement throughout the world. Surveys were sent to major interventional centers in Europe, North and South America, and Asia. Information from peer-reviewed journals was also included and supplemented the survey. The survey asked various questions regarding the patients enrolled, procedure techniques, and results of carotid stenting, including complications and restenosis. Of the centers which were sent surveys, 24 responded. The total number of endovascular carotid stent procedures that have been performed worldwide to date included 2,048 cases, with a technical success of 98.6%. Complications that occurred during carotid stent placement or within a 30-day period following placement were recorded. Overall, there were 63 minor strokes, with a rate of occurrence of 3.08%. The total number of major strokes was 27, for a rate of 1.32%. There were 28 deaths within a 30-day postprocedure period, resulting in a mortality rate of 1.37%. Restenosis rates of carotid stenting have been 4.80% at 6 mo. Endovascular stent treatment of carotid artery atherosclerotic disease is growing as an alternative to vascular surgery, especially for patients that are at high risk for standard carotid endarterectomy. The periprocedural risks for major and minor strokes and death are generally acceptable at this early stage of development.

Percutaneous cardiopulmonary support for high-risk angioplasty.

Treatment of patients with coronary artery disease with severe left ventricular dysfunction (EF less than 25%) presents a special challenge to the health care team. The ability to revascularize coronary artery lesions using percutaneous transluminal coronary angioplasty is limited because of the risk of acute vessel closure, which can result in hemodynamic collapse, myocardial infarction, and the need for emergent coronary bypass surgery. These patients may not survive long enough to undergo emergency open-heart surgery if acute vessel closure occurs. Percutaneous cardiopulmonary support (PCPS), initiated in the catheterization laboratory before coronary revascularization, can provide the hemodynamic support needed to allow the patient to tolerate the high-risk procedure. This article describes the PCPS procedure at Washington Adventist Hospital, Takoma Park, MD, and includes the clinical applications, risks and benefits, and implications for the critical care nurse.

Percutaneous techniques for the treatment of cerebrovascular disease.

Stroke is the third leading cause of death in the United States. Carotid artery stenting is being investigated as a therapeutic strategy for the management of extracranial bifurcation stenosis and has the potential to prevent stroke in thousands of patients. Carotid endarterectomy, although effective, does have limitations, and percutaneous techniques may offer an alternative method of treatment, especially for those who are at highest risk. Although the technique is still evolving, this article describes the protocol and technique of stent-supported carotid angioplasty and care for patients undergoing this procedure at Washington Adventist Hospital in Takoma Park, MD.

Combined percutaneous carotid stenting and coronary angioplasty during acute ischemic neurologic and coronary syndromes.

This study demonstrates the feasibility of percutaneous carotid and coronary intervention in patients with unstable neurologic and coronary syndromes. Further study is warranted to determine the safety and long-term results in a large series of patients.

Percutaneous cardiopulmonary bypass-supported coronary angioplasty in patients with unstable angina pectoris or myocardial infarction and a left ventricular ejection fraction < or = 25%.

The objective of this study was to determine the acute and long-term results of percutaneous cardiopulmonary bypass-supported angioplasty in treating high-risk patients with unstable presentations and severely depressed left ventricular (LV) function (ejection fraction [EF] < or = 25%). One hundred seven consecutive patients with a mean LVEF of 19 +/- 3% were studied. Seventy-four patients (69%) had unstable angina, 60 (56%) had New York Heart Association class III or IV symptoms, 74 (69%) had recent (< 15 days) documented acute myocardial infarction, 103 (96%) had 3-vessel disease, and 58 (54%) had only 1 remaining patent artery. A total of 50 patients (47%) were deemed unsuitable for bypass surgery. Of 196 severe narrowings attempted in 166 coronary arteries, 193 (98%) were successfully dilated in 105 patients (98%), and there was no procedure-related mortality, Q-wave myocardial infarction, or urgent requirement for coronary bypass surgery. There were 5 in-hospital deaths (4.7%) and the remaining 102 patients have been followed for 24.5 +/- 1.3 (mean +/- SE) months. Twenty-three patients (21%) died between 1 and 23 months after the procedure. One- and 2-year survival free of cardiac death was 83% and 77%, respectively. Of the 79 surviving patients, 65 have survived event free of myocardial infarction and revascularization; event-free survival for 1 and 2 years was 76% and 69.5%, respectively. In the 64 patients in whom LV function was measured before and after the procedure, global EF increased from 20.6% to 29.3% (p < 0.001). Patients who remained event free had a greater improvement in LVEF than those who had a cardiac event during follow-up (p < 0.05). Thus, this study demonstrates the safety and efficacy of percutaneous cardiopulmonary bypass-supported angioplasty in the immediate treatment of high-risk unstable patients with multivessel coronary artery disease and severely depressed LV function.

Interaction of human cytomegalovirus with p53: possible role in coronary restenosis.

Restenosis occurs in 25-50% of patients. Within 1-6 months after coronary angioplasty, excessive injury-induced smooth muscle cell (SMC) proliferation contributes to the development of restenosis; its causes remain unknown. The results of this study implicate human cytomegalovirus (HCMV) and HCMV-induced abnormalities in p53 function in the restenosis process. Almost 40% of restenosis lesions, obtained by atherectomy, demonstrated increased SMC p53 levels by p53 immunopositivity; sequencing revealed the p53 to be the wild type. A strong correlation was found between p53 immunopositivity and the presence of HCMV DNA. Moreover, the HCMV IE84 protein co-immunoprecipitates with p53, and p53 transcriptional capacity is reduced by IE84. Thus, HCMV may play a causal role in restenosis, which may be at least partly mediated by inhibiting p53 suppressor effects.