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.

Renal artery stenosis and ischemic nephropathy.

Renal artery stenosis (RAS), in its most severe form, can result in diminished renal function and loss of kidney mass. The prevalence of ischemic nephropathy is greatly under-appreciated in the elderly population and is the source of substantial morbidity and mortality. Diagnostic tests for RAS in patients with renal insufficiency are problematic, and medical therapy does little to slow the natural progression of the disease. Renal artery stenting can achieve long-term vessel patency and has been shown to preserve renal function. Proper technique and careful case selection are critical to the success of such procedures. Large-scale trials are needed to clearly identify groups of patients who will benefit most from percutaneous revascularization.

Percutaneous arterial aortoiliac intervention.

Historically reconstructive vascular surgery, has been a cornerstone of treatment for symptomatic obliterative aortoiliac disease. Surgical results include a reported aortobifemoral bypass 5-year patency rate from 85% to 90% and a 10-year patency rate of 70% to 75%. Operative mortality for aortoiliac reconstruction ranges from 1.6% to 3.3%, with an aggregated systemic morbidity of 8.3%. Clinical indications for surgical intervention are well-established and are limited primarily to severe claudication and limb-threatening ischemia. Broader application of surgical intervention is not recommended because of significant morbidity and mortality associated with the procedure. As balloon angioplasty and endovascular stenting technologies evolve, they are proving to be an effective modality for the treatment of aortoiliac disease. These lower risk procedures have allowed expansion of traditional indications for intervention. Treatment is recommended presently for patients with clinical symptoms that impact lifestyle and professional requirements. Less conventional indications include allowing access for coronary intervention or for placement of an intra-aortic balloon pump, or improving inflow prior to a distal surgical bypass procedure. Results of aortoiliac percutaneous interventions are difficult to compare with surgical data since methods and technology continue to improve and evolve, and randomized studies are limited. It is clear that as long as outcomes of percutaneous interventions are predictable and secondary patency rates acceptable, the low complication rates of a percutaneous intervention are clearly preferable to a riskier surgical alternative.

Analysis of the relation between stent implantation pressure and expansion. Optimal Stent Implantation (OSTI) Investigators.

Palmaz-Schatz stents were implanted in 79 lesions in 76 patients, and serially expanded at 12, 15, and 18 atm of pressure using noncompliant balloons. By core lab analysis, intravascular ultrasound demonstrated marked stent expansion as pressure was raised, which was not apparent by angiography.

Bilateral aortoostial coronary artery disease: moyamoya of the heart?

Moyamoya is a vascular occlusive disease typically limited to the cerebral arterial system. We report a case of severe stenosis of the left main and right coronary arteries occurring in association with moyamoya disease, supporting the concept that moyamoya may be an intracranial manifestation of a systemic arterial disorder.

Clinical and angiographic follow-Up after primary stenting in acute myocardial infarction: the Primary Angioplasty in Myocardial Infarction (PAMI) stent pilot trial.

BACKGROUND: Restenosis has been reported in as many as 50% of patients within 6 months after PTCA in acute myocardial infarction (AMI), which necessitates repeat target-vessel revascularization (TVR) in approximately 20% of patients during this time period. Routine (primary) stent implantation after PTCA has the potential to further improve late outcomes. METHODS AND RESULTS: Primary stenting was performed as part of a prospective study in 236 consecutive patients without contraindications who presented with AMI of <12 hours' duration at 9 international centers. A mean of 1.4+/-0.7 stents were implanted per patient (97% Palmaz-Schatz) at 17.3+/-2.4 atm. During a clinical follow-up period of 7.4+/-2.6 months, death occurred in 4 patients (1.7%), reinfarction occurred in 5 patients (2.1%), and TVR was required in 26 patients (11.1%). By Cox regression analysis, small reference-vessel diameter and the number of stents implanted were the strongest determinants of TVR. Angiographic restenosis occurred in 27.5% of lesions. By multiple logistic regression analysis, the number of stents implanted and the absence of thrombus on the baseline angiogram were independent determinants of binary restenosis. CONCLUSIONS: A strategy of routine stent implantation during mechanical reperfusion of AMI is safe and is associated with favorable event-free survival and low rates of restenosis compared with primary PTCA alone.

Prospective, multicenter study of the safety and feasibility of primary stenting in acute myocardial infarction: in-hospital and 30-day results of the PAMI stent pilot trial. Primary Angioplasty in Myocardial Infarction Stent Pilot Trial Investigators.

OBJECTIVES: The goals of this study were to examine the safety and feasibility of a routine (primary) stent strategy in acute myocardial infarction (AMI). BACKGROUND: Limitations of reperfusion by primary percutaneous transluminal coronary angioplasty (PTCA) in AMI include in-hospital recurrent ischemia or reinfarction in 10% to 15% of patients, restenosis in 37% to 49% and late infarct-related artery reocclusion in 9% to 14%. By lowering the residual stenosis and sealing dissection planes created by PTCA, primary stenting may further improve short- and long-term outcomes after mechanical reperfusion. METHODS: Three hundred twelve consecutive patients treated with primary PTCA for AMI at nine international centers were prospectively enrolled. After PTCA, stenting was attempted in all eligible lesions (vessel size 3.0 to 4.0 mm; lesion length < or = 2 stents; and the absence of giant thrombus burden after PTCA, major side branch jeopardy or excessive proximal tortuosity or calcification). Patients with stents were treated with aspirin, ticlopidine and a 60-h tapering heparin regimen. RESULTS: Stenting was attempted in 240 (77%) of 312 patients, successfully in 236 (98%), with Thrombolysis in Myocardial Infarction grade 3 flow restored in 230 patients (96%). Patients with stents had low rates of in-hospital death (0.8%), reinfarction (1.7%), recurrent ischemia (3.8%) and predischarge target vessel revascularization for ischemia (1.3%). At 30-day follow-up, no additional deaths or reinfarctions occurred among patients with stents, and target vessel revascularization was required in only one additional patient (0.4%). CONCLUSIONS: Primary stenting is safe and feasible in the majority of patients with AMI and results in excellent short-term outcomes.

Minimally invasive mitral valve surgery.

Because of advances in video-assisted general and thoracic surgery, minimally invasive cardiac surgery has been successfully performed experimentally and clinically. Recently described techniques of less invasive mitral valve surgery include limited right thoracotomy, parasternal incision, and partial sternotomy. These methods have been coupled to video-assisted thoracoscopy to further decrease the incision size. Cardiopulmonary bypass (central or peripheral) and either hypothermic fibrillatory arrest or cardioplegic arrest are used. The Port-Access approach is a catheter-based system that provides effective cardiopulmonary bypass, cardioplegic arrest, and ventricular decompression. At Stanford University, 10 Port-Access mitral valve procedures were performed between May 1996 and January 1997. The mean age of the patients (eight men and two women) was 54 +/- 7 (SD) years. Nine patients had severe mitral regurgitation from myxomatous degeneration, and one suffered from severe mitral regurgitation and moderate mitral stenosis from a rheumatic etiology. Five patients underwent mitral valve replacement, and five underwent mitral valve repair. There was no operative mortality. The mean incision length was 8.1 +/- 2.5 cm. The aortic "cross-clamp" time was 99 +/- 22 minutes, and the cardiopulmonary bypass time was 151 +/- 52 minutes. The total hospitalization averaged 4.3 +/- 1.4 days. One patient developed third-degree atrioventricular block, requiring a prolonged stay in the intensive care unit and pacemaker placement; the same patient was found to have a perivalvular leak on follow-up, requiring reoperation at 3 months. Port-Access mitral valve procedures can be performed safely with satisfactory outcome. Greater clinical experience and long-term follow-up are necessary to fully assess these less invasive techniques of mitral valve surgery.

Monitoring considerations for port-access cardiac surgery.

BACKGROUND: A method for monitoring patients was evaluated in a clinical trial of minimally invasive port-access cardiac surgery with closed chest endovascular cardiopulmonary bypass. METHODS AND RESULTS: Cardiopulmonary bypass was conducted in 25 patients through femoral cannulas. An endovascular pulmonary artery vent was placed in the main pulmonary artery through a jugular vein. For mitral valve surgery, a catheter was placed in the coronary sinus for delivery of cardioplegia. A balloon catheter ("endoaortic clamp," EAC) used for occlusion of the ascending aorta, delivery of cardioplegia, aortic root venting, and pressure measurement was inserted through a femoral artery and initially positioned by use of fluoroscopy and transesophageal echocardiography (TEE). Potential migration of the EAC was monitored by (1) TEE of the ascending aorta, (2) pulsed-wave Doppler of the right carotid artery, (3) balloon pressure, (4) comparison of aortic root pressure and right radial artery pressure, and (5) fluoroscopy. TEE, fluoroscopy, and pressure measurement were effective in monitoring catheter insertion and position. With inadequate balloon inflation, migration of the EAC toward the aortic valve could be detected with TEE. During administration of cardioplegia, TEE showed movement of the balloon away from the aortic valve, and migration into the aortic arch was detectable with loss of carotid Doppler flow. Stability of EAC position was demonstrated with appropriate balloon volume. Cardioplegic solution was visualized in the aortic root, and aortic root pressure changed appropriately during administration of cardioplegia. Venous cannula position was optimized with TEE and endopulmonary vent flow measurement. CONCLUSIONS: An effective method has been developed for monitoring patients and the catheter system during port-access cardiac surgery.

Port-access cardiac operations with cardioplegic arrest.

BACKGROUND: A less invasive approach to cardiac surgery has been propelled by recent advances in video-assisted surgery. Previous obstacles to minimally invasive cardiac operations with cardioplegic arrest included limitations in operative exposure, inadequate perfusion technology, and inability to provide myocardial protection. METHODS: Port-access technology allows endovascular aortic occlusion, cardioplegia delivery, and left ventricular decompression. The endoaortic clamp is a triple-lumen catheter with an inflatable balloon at its distal end. Antegrade cardioplegia is delivered through a central lumen, which also acts as an aortic root vent, a second lumen is used as an aortic root pressure monitor, and a third lumen is used for balloon inflation to provide aortic occlusion. RESULTS: Experimental and clinical studies have demonstrated the feasibility of port-access coronary artery bypass grafting and port-access mitral valve procedures. Endovascular cardiopulmonary bypass using the endoaortic clamp was effective in achieving cardiac arrest and myocardial protection to allow internal mammary artery to coronary artery anastomosis in a still and bloodless field. Intracardiac procedures, such as mitral valve replacement or repair, have been successfully performed clinically. CONCLUSION: The port-access system effectively achieves cardiopulmonary bypass and cardioplegic arrest, thereby enabling the surgeon to perform cardiac procedures in a minimally invasive fashion. This system provides for endovascular aortic occlusion, cardioplegia delivery, and left ventricular decompression.

Closed-chest cardiopulmonary bypass and cardioplegia: basis for less invasive cardiac surgery.

BACKGROUND: We developed a method of closed-chest cardiopulmonary bypass to arrest and protect the heart with cardioplegic solution. This method was used in 54 dogs and the results were retrospectively analyzed. METHODS: Bypass cannulas were placed in the right femoral vessels. A balloon occlusion catheter was passed via the left femoral artery and positioned in the ascending aorta. A pulmonary artery vent was placed via the jugular vein. In 17 of the dogs retrograde cardioplegia was provided with a percutaneous coronary sinus catheter. RESULTS: Cardiopulmonary bypass time was 111 +/- 27 minutes (mean +/- standard deviation) and cardiac arrest time was 66 +/- 21 minutes. Preoperative cardiac outputs were 2.9 +/- 0.70 L/min and postoperative outputs were 2.9 +/- 0.65 L/min (p = not significant). Twenty-one-French and 23F femoral arterial cannulas that allowed coaxial placement of the ascending aortic balloon catheter were tested in 3 male calves. Line pressures were higher, but not clinically limiting, with the balloon catheter placed coaxially. CONCLUSIONS: Adequate cardiopulmonary bypass and cardioplegia can be achieved in the dog without opening the chest, facilitating less invasive cardiac operations. A human clinical trial is in progress.

Improved procedural results of coronary angioplasty with intravascular ultrasound-guided balloon sizing: the CLOUT Pilot Trial. Clinical Outcomes With Ultrasound Trial (CLOUT) Investigators.

BACKGROUND: Indiscriminate use of balloons larger than the angiographic reference segment lumen results in high rates of ischemic complications after percutaneous transluminal coronary angioplasty (PTCA). We hypothesized that angiographically unsuspected atheromatous remodeling with vessel expansion (the Glagov phenomenon) at and adjacent to PTCA target lesions would safely accommodate oversized balloons in selected patients undergoing PTCA with intravascular ultrasound (IVUS) guidance. METHODS AND RESULTS: After angiographically guided PTCA of 104 lesions in 102 patients, IVUS was performed, and if atheromatous remodeling was present, PTCA was repeated with larger balloons sized halfway between the lumen and external elastic membrane. Plaque occupied a mean of 51+/-15% of the angiographically "normal" reference segments. Further balloon upsizing by 0.25 to 1.25 mm was therefore performed in 76 lesions (73%), increasing the nominal balloon-to-artery ratio from 1.12+/-0.15 after standard PTCA to 1.30+/-0.17 after IVUS-guided PTCA (P<.0001). As a result, the angiographic minimal luminal diameter further increased from 1.95+/-0.49 to 2.21+/-0.47 mm, the % diameter stenosis fell from 28+/-15% to 18+/-14%, and the IVUS lumen area rose from 3.16+/-1.04 to 4.52+/-1.14 mm2 (all P<.0001). The incidence of angiographic dissection was not increased after IVUS-guided balloon upsizing (37% versus 40%, P=.67), and major complications occurred in only 2 patients (1.9%). CONCLUSIONS: The demonstration by IVUS of atheromatous remodeling permits the safe use of balloons traditionally considered oversized, resulting in significantly improved luminal dimensions without increased rates of dissection or ischemic complications.

Port-access bilateral internal mammary artery grafting for left main coronary artery disease: canine feasibility study.

BACKGROUND: To extend the applications of minimal access cardiac surgery, an endovascular cardiopulmonary bypass (CPB) system that allows cardioplegia delivery and cardiac venting was used to perform bilateral internal mammary artery (IMA) bypass grafting in six dogs. METHODS: The left IMA (LIMA) was taken down thoracoscopically from three left lateral chest ports, followed by the right IMA (RIMA) from the right side. One left-sided port was extended medially 5 cm with or without rib resection, to expose the pericardium. Both IMAs were divided and exteriorized through the left anterior mediastinotomy. Flow and pedicle length were satisfactory in all cases. Femoral-femoral bypass was used and the heart arrested with antegrade delivery of cardioplegic solution via the central lumen of a balloon catheter inflated to occlude the ascending aorta. All anastomoses were made through the mediastinotomy under direct vision. In five studies the RIMA was attached to the left anterior descending artery (LAD) and the LIMA to the circumflex, and in one study the RIMA was tunneled through the transverse sinus to the circumflex and the LIMA was anastomosed to the LAD. All animals were weaned from CPB in sinus rhythm without inotropes. CPB duration was 108 +/- 27 minutes (mean +/- SD) and the clamp duration was 54 +/- 10 minutes. RESULTS: Preoperative and postoperative cardiac outputs were 2.9 +/- 0.71/min and 2.4 +/- 0.31/min, respectively (p = NS), and corresponding pulmonary artery occlusion pressures were 6 +/- 3 mmHg and 7 +/- 2 mmHg, respectively (p = NS). All 12 grafts were demonstrated to be fully patent. Postmortem examination revealed well aligned pedicles and correctly grafted target vessels. CONCLUSION: This canine model demonstrates the potential for a less invasive approach to the surgical management of left main coronary artery disease in humans.

Port-access cardiac surgery with cardiopulmonary bypass and cardioplegic arrest.

In the past decade, laparoscopic and thoracoscopiC technology have significantly and irreversibly altered the approach to many general and thoracic surgical diseases. With advances in laparoscopy and thoracoscopy, the concept of a minimally invasive approach to cardiac surgery has been realized.

Port-access coronary artery bypass with cardioplegic arrest: acute and chronic canine studies.

BACKGROUND: Our goal is to perform minimally invasive coronary artery bypass grafting without sacrificing the benefits of myocardial protection with cardioplegia. METHODS: Twenty-three dogs underwent acute studies and 4 dogs underwent survival studies. The left internal mammary artery was taken down using a thoracoscope. Cardiopulmonary bypass was conducted via femoral cannulas and using an endovascular balloon catheter for ascending aortic occlusion, root venting, and delivery of antegrade blood cardioplegia. Pulmonary artery venting was achieved with a jugular vein catheter. An internal mammary artery-to-coronary artery anastomosis was performed using a microscope through a 10 mm port. RESULTS: All animals were weaned from cardiopulmonary bypass in sinus rhythm without inotropes. Cardiopulmonary bypass duration was 104 +/- 28 minutes and aortic clamp duration was 61 +/- 22 minutes. Cardiac output and pulmonary artery occlusion pressure were unchanged. The internal mammary artery was anastomosed to the left anterior descending artery (25) or the first diagonal (2) with patency shown in 25 of 27. One dog in the survival study had a very short internal mammary artery pedicle under tension and was euthanized for excessive postoperative hemorrhage. Three weeks postoperatively the remaining dogs had angiographically patent anastomoses, normal transthoracic echocardiograms, and histologically normal healing and patent grafts. CONCLUSIONS: Endovascular cardiopulmonary bypass using a balloon catheter is effective in arresting and protecting the heart to allow thoracoscopic internal mammary artery-to-coronary artery anastomosis.

Initial clinical experience with a novel low-profile integrated ultrasound-angioplasty catheter.

This report is the first clinical description of the use of a new low-profile integrated ultrasound-angioplasty catheter (the Oracle Micro, Endosonics Corp.), which has recently been approved by the FDA for routine use during percutaneous transluminal coronary angioplasty (PTCA). PTCA was performed in 44 patients at two clinical sites. With this device, PTCA was accomplished in 47 of 55 (85%) lesions ultimately successfully dilated with balloon angioplasty. No major procedural complications occurred. Adequate ultrasound images were obtained in 51 of 57 lesions (89%). Ultrasound imaging revealed significant morphologic information not apparent by angiography in 51% of imaged lesions and altered the dilatation strategy in 33% of cases. In 10 lesions in which greater inflation pressure or balloon upsizing was performed based solely on an inadequate post-PTCA ultrasound appearance, the minimal lumen diameter further increased from 2.3 +/- 0.3 mm to 2.7 +/- 0.5 mm (P < .001), with no dissections or complications. PTCA may be performed safely in the majority of patients currently undergoing balloon angioplasty with a new low-profile integrated ultrasound-angioplasty catheter. Ultrasound imaging during PTCA provides significant information complementary to angiography and may favorably affect the dilatation strategy of experienced operators.

Spontaneous coronary dissection resulting in acute myocardial infarction: successful treatment with primary angioplasty.

Spontaneous coronary dissection is an unusual cause of acute myocardial infarction for which the optimal therapy has not been established. We report the case of a 63-year-old man with acute lateral wall myocardial infarction resulting from spontaneous dissection of the major diagonal branch of the left anterior descending artery in whom acute and long-term patency was restored by primary PTCA.

Port-access coronary artery bypass grafting: a proposed surgical method.

Minimally invasive surgical methods have been developed to provide patients the benefits of open operations with decreased pain and suffering. We have developed a system that allows the performance of cardiopulmonary bypass and myocardial protection with cardioplegic arrest without sternotomy or thoracotomy. In a canine model, we successfully used this system to anastomose the internal thoracic artery to the left anterior descending coronary artery in nine of 10 animals. The left internal thoracic artery was dissected from the chest wall, and the pericardium was opened with the use of thoracoscopic techniques and single lung ventilation. The heart was arrested with a cold blood cardioplegic solution delivered through the central lumen of a balloon occlusion catheter (Endoaortic Clamp; Heartport, Inc., Redwood City, Calif.) in the ascending aorta, and cardiopulmonary bypass was maintained with femorofemoral bypass. An operating microscope modified to allow introduction of the 3.5x magnification objective into the chest was positioned through a 10 mm port over the site of the anastomosis. The anastomosis was performed with modified surgical instruments introduced through additional 5 mm ports. In the cadaver model (n = 7) the internal thoracic artery was harvested and the pericardium opened by means of similar techniques. A precise arteriotomy was made with microvascular thoracoscopic instruments under the modified microscope on four cadavers. In three other cadavers we assessed the exposure provided by a small anterior incision (4 to 6 cm) over the fourth intercostal space. This anterior port can assist in dissection of the distal internal thoracic artery and provides direct access to the left anterior descending, circumflex, and posterior descending arteries. We have demonstrated the potential feasibility of grafting the internal thoracic artery to coronary arteries with the heart arrested and protected, without a major thoracotomy or sternotomy.

Minimally invasive cardiopulmonary bypass with cardioplegic arrest: a closed chest technique with equivalent myocardial protection.

Thoracoscopic cardiac surgery is presently under intense investigation. This study examined the feasibility and efficacy of closed chest cardiopulmonary bypass and cardioplegic arrest in comparison with standard open chest methods in a dog model. The minimally invasive closed chest group (n = 6) underwent percutaneous cardiopulmonary bypass and cardiac venting, as well as antegrade cardioplegic arrest through use of a specially designed percutaneous endovascular aortic occluder and cardioplegic solution delivery system. The control group (n = 6) underwent standard sternotomy and conventional open chest cardiopulmonary bypass, aortic crossclamping, and antegrade cardioplegia. Ischemic arrest time was 1 hour in each group. Ventricular pressures and sonomicrometer segment lengths were recorded before bypass and at 30 and 60 minutes after bypass. Left ventricular function did not differ significantly between the two groups, as demonstrated by measurements of elastance and end-diastolic stroke work. Also, the preload recruitable work area was 69% and 60% of baseline at 30 and 60 minutes after bypass in the minimally invasive group versus 65% and 62% in the conventional control group (p = not significant); the stroke work end-diastolic length relationship was 78% and 71% of baseline in the minimally invasive group at these intervals versus 77% and 74% in the conventional control group (p = not significant). Myocardial temperatures were similar throughout bypass in the two groups, and ultrastructural examination of prebypass and postbypass biopsy specimens showed no differences between groups. These results demonstrate that minimally invasive cardiopulmonary bypass with cardioplegic arrest is as feasible, safe, and effective as conventional open chest cardiopulmonary bypass. Thus current technology may allow wider clinical application of closed chest cardiac surgery.

Interventional strategies for managing acute myocardial infarction.

The management of acute myocardial infarction has evolved greatly with the development of interventional cardiology and thrombolytic therapy. Interventional strategies in the setting of thrombolytic therapy include immediate, delayed, and elective PTCA. Randomized trials suggest no benefit to these approaches; however, primary PTCA without adjunctive lytics when compared to lytic therapy alone may improve both survival and costs. Newer catheter-based technology may also enhance outcomes in patients with acute myocardial infarction.