Single-stage hybrid coronary revascularization with long-term follow-up.

OBJECTIVES: Hybrid coronary revascularization, performing a left internal thoracic artery (LITA) to left anterior descending (LAD) bypass followed by percutaneous coronary intervention (PCI) in a non-LAD coronary artery lesion, represents an evolving revascularization strategy. It utilizes the survival benefit of the LITA-to-LAD bypass, while providing complete revascularization with PCI to a non-critical vessel to decrease procedural morbidity. However, quantitative patency results and clinical outcomes remain understudied. The objective of this study was to assess clinical follow-up and graft and stent patency at 6 months and 5 years in a single-stage hybrid revascularization population. METHODS: From 2004 to 2012, a total of 96 patients (64 ± 12 years; 70 males and 26 females) consented to robotic-assisted LITA harvesting and a small left anterior thoracotomy for off-pump coronary artery bypass anastomosis onto the LAD. This was followed immediately by PCI in a non-LAD vessel in the same fluoroscopy-equipped hybrid operating room. Patients underwent a yearly clinical follow-up and a protocol-directed assessment of graft patency via a coronary angiogram at 6 months and cardiac computed tomography (CT) angiography with single-photon emission computed tomography myocardial perfusion scintigraphy (MPS) at 5 years. RESULTS: Successful single-stage hybrid revascularization occurred in 94 of the 96 patients (2 patients required intraoperative conversion to conventional coronary bypass). Six-month protocol coronary angiogram follow-up has been performed in 85 patients. Fitzgibbon Grade A or B LITA-to-LAD patency at 6-month follow-up was 94% in those studied. A total of 105 stents were deployed (89 drug-eluting stents (DES) and 16 bare metal), and at 6-month follow-up in 85 patients, 79 stents were widely patent; 8 had in-stent restenosis, and 2 were completely occluded. To date, 19 patients have undergone 5-year coronary CT angiography and MPS. The LITA-to-LAD anastomosis was patent in 17 of the 19 patients. Of the 19 lesions in which PCI was performed, 17 were widely patent, while 2 circumflex DES were occluded. Five-year clinical outcome demonstrated 91% survival, 94% freedom from angina and 87% freedom from any form of coronary revascularization. CONCLUSIONS: A single-stage hybrid revascularization strategy appears to have acceptable 6-month and angiographic patency results for both LITA-LAD grafts and PCI interventions. Survival, freedom from angina and freedom from revascularization also appear favourable at the 5-year clinical follow-up.

The early inflammatory response in a mini-cardiopulmonary bypass system: a prospective randomized study.

OBJECTIVE: The aim of this study was to compare the early systemic inflammatory response of the Resting Heart System (RHS; Medtronic, Minneapolis, MN USA), a miniaturized cardiopulmonary bypass (CPB) system, with two groups using a standard extracorporeal circulation system during on-pump coronary artery bypass grafting (CABG) surgery. METHODS: A total of 60 consecutive patients requiring CABG were prospectively randomized to undergo on-pump CABG using conventional CPB without cardiotomy suction (group A), conventional CPB with cardiotomy suction (group B), or the RHS (group C). Blood samples were collected at five time points: immediately before CPB, 30 minutes into CPB, immediately at the end of CPB, 30 minutes post-CPB, and 1 hour post-CPB. Inflammation was analyzed by changes in (a) levels of plasma proteins, including inflammatory cytokines (interleukin-6 [IL-6], IL-10, and tumor necrosis factor-α), chemokines (IL-8, monokine induced by interferon-γ, monocyte chemotactic protein-1, regulated on activation normal T cell expressed and secreted, and interferon-inducible protein-10), and acute phase proteins (C-reactive protein and complement protein 3); (b) biochemical variables (cardiac troponin I, hematocrit, and immunoglobulin G); and (c) cell numbers (leukocytes, neutrophils, and thrombocytes). RESULTS: The RHS showed more delayed secretion of the cytokines tumor necrosis factor-α and IL-10, chemokines monokine induced by interferon-γ (P < 0.001); IL-8, and interferon-inducible protein-10; and complement protein 3 than conventional CPB systems did. Median thrombocyte numbers were higher in the RHS group. Levels of cardiac troponin I, monocyte chemotactic protein-1, and IL-6 were lower in both the RHS and conventional CPB without suction than with suction. Levels of C-reactive protein and regulated on activation normal T cell expressed and secreted, plus leukocyte and neutrophil numbers, were similar in all groups. CONCLUSIONS: The Medtronic RHS may induce less systemic inflammation than conventional CPB systems, particularly when cardiotomy suction was used, but it did not result in improved clinical benefit.

Comparison of MAX-ACT and K-ACT values when using bivalirudin anticoagulation during minimally invasive hybrid off-pump coronary artery bypass graft surgery.

OBJECTIVE: To compare the kaolin-activated coagulation time (K-ACT) to the MAX-ACT for monitoring anticoagulation with bivalirudin in patients undergoing hybrid off-pump coronary artery revascularization procedures. DESIGN: A prospective, observational study. SETTING: A cardiac surgical operating room of a university-affiliated hospital. PARTICIPANTS: Twelve patients undergoing off-pump coronary artery bypass graft surgery and percutaneous coronary intervention during the same procedure anticoagulated with bivalirudin to a target K-ACT of >300 seconds. INTERVENTION: At baseline and at frequent intervals during anticoagulation, K-ACT and MAX-ACT assays were run contemporaneously, and the pairs of results were analyzed with descriptive statistics, by correlation analysis, and with Bland-Altman analysis. MEASUREMENTS AND MAIN RESULTS: The MAX-ACT and K-ACT assays were highly correlated, but the MAX-ACT assay consistently reported significantly lower ACT values compared with the K-ACT. The mean bias (K-ACT minus MAX-ACT) was 94 seconds (limits of agreement, 51-138 seconds). CONCLUSION: To maximize patient safety, centers using bivalirudin for anticoagulation during cardiac surgical procedures need to be aware of the different performance characteristics of ACT assay subtypes.

Consensus statement: minimal criteria for reporting the systemic inflammatory response to cardiopulmonary bypass.

The lack of established cause and effect between putative mediators of inflammation and adverse clinical outcomes has been responsible for many failed anti-inflammatory interventions in cardiopulmonary bypass (CPB). Candidate interventions that impress in preclinical trials by suppressing a given inflammation marker might fail at the clinical trial stage because the marker of interest is not linked causally to an adverse outcome. Alternatively, there exist examples in which pharmaceutical agents or other interventions improve clinical outcomes but for which we are uncertain of any antiinflammatory mechanism. The Outcomes consensus panel made 3 recommendations in 2009 for the conduct of clinical trials focused on the systemic inflammatory response. This panel was tasked with updating, as well as simplifying, a previous consensus statement. The present recommendations for investigators are the following: (1) Measure at least 1 inflammation marker, defined in broad terms; (2) measure at least 1clinical end point, drawn from a list of practical yet clinically meaningful end points suggested by the consensus panel; and(3) report a core set of CPB and perfusion criteria that maybe linked to outcomes. Our collective belief is that adhering to these simple consensus recommendations will help define the influence of CPB practice on the systemic inflammatory response, advance our understanding of causal inflammatory mechanisms, and standardize the reporting of research findings in the peer-reviewed literature.

Bivalirudin as an anticoagulant for simultaneous integrated coronary artery revascularization - a novel approach to an inherent concern.

BACKGROUND: Simultaneous integrated coronary artery revascularization combines coronary artery bypass surgery and percutaneous coronary intervention into a single procedure. This approach provides immediate, complete and optimal myocardial revascularization in a less invasive manner. Because simultaneous integrated coronary revascularization necessitates two distinct anticoagulation protocols for the surgical and percutaneous aspects of the procedure, combining these anticoagulation protocols carries a bleeding risk. Using a single anticoagulant to facilitate the necessities of both aspects of the integrated approach may alleviate this risk. CASE PRESENTATION: A 45-year-old man with an occluded left anterior descending artery and a moderately stenotic circumflex artery underwent simultaneous integrated coronary revascularization. Bivalirudin was used to achieve anticoagulation for the duration of the procedure. The patient was asymptomatic with excellent patency of both the bypass graft and the stented circumflex artery via angiography at 10 months. CONCLUSION: Bivalirudin can be used to effectively achieve a unified anticoagulation protocol for simultaneous integrated revascularization.

Hybrid coronary artery bypass grafting.

Owing to the high prevalence of atherosclerotic coronary artery disease, treatment has proceeded along three separate paths: medical, surgical, and percutaneous intervention. Medical treatment is now routinely combined with both surgical treatment and percutaneous methods; however, the surgical and percutaneous routes are often viewed as in competition. Hybrid coronary revascularization, also called robotic assisted integrated coronary revascularization (RAICER), is a way of combining these two approaches. Whether any hybrid procedure will prove beneficial to patients remains unproven; however, RAICER has promise for reducing short-term complications while providing excellent and enduring treatment for coronary artery disease. Much work remains to be done on the benefits of hybrid revascularization in comparison with conventional bypass surgery or percutaneous coronary procedures.

Simultaneous integrated coronary artery revascularization with long-term angiographic follow-up.

OBJECTIVE: Traditionally integrated coronary artery revascularization has been described as a 2-stage procedure. We evaluated the safety and feasibility of 1-stage, simultaneous, hybrid, robotically assisted coronary artery bypass grafting surgery and percutaneous coronary intervention. METHODS: Fifty-eight patients underwent simultaneous, integrated coronary artery revascularization in an operating theater equipped with angiographic equipment. Forty-five patients were men. The mean age was 59 years. All internal thoracic arteries were harvested with robotic assistance. All anastomoses were manually constructed through a small anterior non-rib-spreading incision without cardiopulmonary bypass on the beating heart. Immediately after and within the same operative suite, both angiographic confirmation of graft patency and percutaneous coronary intervention were performed. In 52 patients therapeutic anticoagulation was achieved with the direct thrombin inhibitor bivalirudin. RESULTS: There were no deaths or wound infections. There was 1 perioperative myocardial infarction. One patient had a stroke, and 3 patients required re-exploration for bleeding. The median lengths of intensive care and hospital stay were 1 and 4 days, respectively. All patients were alive and symptom free at follow-up (mean, 20.2 months; range, 1.1-40.8 months). Long-term angiographic follow-up in 54 patients showed 49 (91%) patent grafts (mean, 9.0 months; range, 4.3-40.8 months). There were 7 in-stent restenoses and 2 occluded stents. CONCLUSION: For multivessel coronary artery disease, simultaneous integrated coronary artery revascularization with bivalirudin is safe and feasible. This approach enables complete multivessel revascularization with decreased surgical trauma and postoperative morbidity. Further studies are necessary to better determine patient selection and long-term outcomes.

Consensus statement: Defining minimal criteria for reporting the systemic inflammatory response to cardiopulmonary bypass.

The causal factors of the systemic inflammatory response to cardiopulmonary bypass (CPB) were correctly identified in the early 1990 s: "... activation of complement, coagulation, fibrinolytic, and kallikrein cascades, activation of neutrophils with degranulation and protease enzyme release, oxygen radical production, and the synthesis of various cytokines from mononuclear cells" [Butler 1993]. Why therefore have clinical advances to curb the systemic inflammatory response proven such a disappointment? Part of the problem is that cardiac surgery has never taken intellectual ownership of this issue, borrowing its diagnosis from critical care medicine and failing to define the minimal criteria that should be measured when reporting on the systemic inflammatory response. An evidence based review of the current literature by many of the coauthors on this paper found that the majority of studies on the systemic inflammatory response did not measure a single one of the causal factors listed above - thus hindering our ability to identify mechanisms of causation and identify drug targets [Landis 2008]. A panel of experts convened at the Outcomes XII meeting, Barbados 2008, drafted the present consensus document in order to provide a framework to guide future studies and interdictions of the systemic inflammatory response. Herein, we have recommended: 1) mandatory reporting of minimal CPB and perfusion criteria that may affect outcomes, 2) reporting of a minimal set of causal inflammatory markers linked to adverse sequelae, and 3) reporting of at least one clinical end-point of organ injury, from a list of endpoints and markers of organ injury that balance practicality with clinical meaningfulness. It is our collective belief that this document will serve as a foundation for furthering our understanding of the influence of CPB practice with the systemic inflammatory response by standardizing the reporting of research findings in the peer-reviewed literature.

Prospective angiographic comparison of direct, endoscopic, and telesurgical approaches to harvesting the internal thoracic artery.

BACKGROUND: The purpose of this study was to compare the quality of left internal thoracic arteries harvested by the conventional open approach versus minimally invasive videoscopic and robotic-assisted telesurgical techniques. METHODS: One hundred and fifty consecutive patients with single vessel coronary artery disease were prospectively studied. The left internal thoracic artery was harvested using three different approaches, with 50 patients consecutively assigned to each group. The off-pump coronary artery bypass (OPCAB) group underwent median sternotomy with direct visualization. The automated endoscopic system for optimal positioning (AESOP) group employed the AESOP 3000 system (Computer Motion Inc, Goleta, CA) for robotic-assisted visualization with endoscopic manual left internal thoracic artery harvesting. The Zeus group used the Zeus robotic telesurgical system (Computer Motion Inc) and internal thoracic artery harvesting was performed remotely from a surgical console. Postanastomotic left internal thoracic artery flows and day one postoperative angiography were used to assess internal thoracic artery quality and patency. RESULTS: Average left internal thoracic artery harvest times were 23 +/- 2.5, 63.3 +/- 20.3, and 66.1 +/- 17.9 minutes in the OPCAB, AESOP, and Zeus groups, respectively (p < 0.001, OPCAB vs AESOP and Zeus). Intraoperative graft flows averaged 28.1 +/- 11.9, 33.7 +/- 19.3, and 36.9 +/- 24.6 mL/minute, respectively in the OPCAB, AESOP, and Zeus groups (p = 0.317, OPCAB vs AESOP and Zeus). There was no significant angiographic difference in the patency rate of the harvested left internal thoracic arteries in the three groups (p = 0.685, overall). CONCLUSIONS: The left internal thoracic artery can be harvested safely and effectively using minimally invasive videoscopic and robotic-assisted telesurgical techniques. Although the less invasive approaches require specialized equipment and training as well as increased operative time, they offer the potential for less traumatic myocardial revascularization through smaller incisions and reduced postoperative morbidity.

Concurrent robotic hybrid revascularization using an enhanced operative suite.

Hybrid myocardial revascularization combines coronary surgery with percutaneous intervention as an alternative therapy for ischemic heart disease. The order and sequence of the hybrid approach is not yet clearly defined. We report on the benefits of an enhanced surgical suite equipped with a carbon fiber operating table and digital C-arm for robotic-assisted hybrid revascularization in a single operative sequence. To our knowledge, this is the first reported case of concurrent robotic-assisted hybrid revascularization utilizing an enhanced operative suite.

Early experience with robotically assisted internal thoracic artery harvest.

We sought to determine the efficacy of using robotic assistance to facilitate endoscopic harvesting of internal thoracic arteries (ITAs). A total of 104 patients had ITAs harvested endoscopically with use of both the AESOP 3000 system (Computer Motion, Goleta, CA, U.S.A.) and Zeus robotic telesurgical system (Computer Motion). All ITAs were harvested with a harmonic scalpel (Ethicon Endosurgery, Cincinnati, OH, U.S.A.). With the left lung collapsed, ITAs were harvested with CO2 insufflation through three 5-mm ports in the left chest. All patients tolerated insufflation without hemodynamic compromise. Average ITA harvest time was 61.3 +/- 20.9 minutes. Intraoperative graft flows averaged 36.3 +/- 22.4 mL/min. There were three distal ITA injuries; all other vessels were patent after harvesting and demonstrated no angiographic evidence of injury. This article demonstrates a technique by which ITA can be safely harvested totally endoscopically with use of computer-enhanced robotic systems and a harmonic scalpel, allowing complete pedicle dissection through 5-mm ports with minimal ITA manipulation.