Evaluation of a lateral thoracotomy implant approach for a centrifugal-flow left ventricular assist device: The LATERAL clinical trial.

BACKGROUND: The HeartWare centrifugal-flow ventricular assist device system (HVAD) is a viable option for treatment of advanced heart failure. There is a growing trend toward the use of less invasive techniques in cardiac surgery, and the thoracotomy technique for HVAD implantation may provide benefits not available with conventional approaches. METHODS: The LATERAL trial is a multicenter, prospective, non-randomized, single-arm trial that utilized data from 144 patients enrolled in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) database at 26 centers in the United States and Canada. The primary composite end-point was success at 180 days defined as alive on the originally implanted device and free from disabling stroke (modified Rankin Scale score >3), transplanted or explanted for recovery. The key secondary end-point was mean length of initial hospital stay. RESULTS: The primary end-point was successfully achieved in 88.1% of patients and was significantly greater than the pre-defined performance goal of 77.5% set from historical sternotomy data (p = 0.0012). The key secondary end-point-mean length of initial hospital stay -was 18 days and was significantly shorter than the pre-defined performance goal of 26.1 days obtained from historical sternotomy data (p < 0.0001). The adverse event profile further demonstrated the safety of the thoracotomy approach. The overall patient survival was good, and bleeding requiring reoperation was significantly less frequent than that observed in previous studies using the sternotomy approach. CONCLUSIONS: This prospective clinical trial provides validation that implantation of the HVAD system via the thoracotomy approach used in the LATERAL study represents a safe and effective alternative to median sternotomy in selected patients intended for a bridge-to-transplant indication.

HVAD: The ENDURANCE Supplemental Trial.

OBJECTIVES: The aim of this study was to prospectively evaluate the impact of blood pressure management on stroke rates in patients receiving the HeartWare HVAD System. BACKGROUND: The ENDURANCE trial demonstrated noninferiority of the HeartWare HVAD System versus control (HeartMate II) in patients with advanced heart failure ineligible for heart transplantation. However, stroke was more common in HVAD subjects. Post hoc analyses demonstrated increased mean arterial blood pressure as a significant independent risk factor for stroke. METHODS: The ENDURANCE Supplemental Trial was a prospective, multicenter evaluation of 465 patients with advanced heart failure ineligible for transplantation, randomized 2:1 to HVAD (n = 308) or control (n = 157). The primary endpoint was the 12-month incidence of transient ischemic attack or stroke with residual deficit 24 weeks post-event. Secondary endpoints included the composite of freedom from death, disabling stroke, and need for device replacement or urgent transplantation, as well as comparisons of stroke or transient ischemic attack rates in HVAD cohorts in ENDURANCE Supplemental and ENDURANCE. RESULTS: The enhanced blood pressure protocol significantly reduced mean arterial blood pressure. The primary endpoint was not achieved (14.7% with HVAD vs. 12.1% with control, noninferiority [margin 6%] p = 0.14). However, the secondary composite endpoint demonstrated superiority of HVAD (76.1%) versus control (66.9%) (p = 0.04). The incidence of stroke in HVAD subjects was reduced 24.2% in ENDURANCE Supplemental compared with ENDURANCE (p = 0.10), and hemorrhagic cerebrovascular accident was reduced by 50.5% (p = 0.02). CONCLUSIONS: The ENDURANCE Supplemental Trial failed to demonstrate noninferiority of HVAD versus control regarding the pre-specified primary endpoint. However, the trial confirmed that BP management is associated with reduced stroke rates in HVAD subjects. HVAD subjects, relative to control subjects, more commonly achieved the composite endpoint (freedom from death, disabling stroke, and device replacement or urgent transplantation). (A Clinical Trial to Evaluate the HeartWare™ Ventricular Assist System [ENDURANCE SUPPLEMENTAL TRIAL] [DT2]; NCT01966458).

Evaluation of Hemodynamic Performance of Aortic Valve Bioprostheses in a Model of Oversizing.

BACKGROUND: The risk of patient-prosthesis mismatch drives most surgeons to select the largest bioprosthesis possible during aortic valve replacement, but interactions between the native aortic annulus and valve prosthesis remain poorly defined. We examined the hemodynamic and functional consequences of oversizing contemporary bioprostheses in an in vitro model. METHODS: Three sizes each (21, 23, and 25 mm) of 5 aortic bioprostheses (Magna, Edwards Lifesciences, Irvine, CA; Trifecta and Epic, St. Jude, St. Paul, MN; and Mosaic and Hancock II, Medtronic, Minneapolis, MN) were tested on a mock annulus in a pulsatile aortic simulator. After the annulus was sized to match each valve, the annulus was decreased by 3 mm and then by 6 mm to simulate oversizing. We measured the effective orifice area and the mean pressure gradient. Changes in prosthetic leaflet behavior and geometric orifice area were assessed with slow-motion video. Statistical analysis used mixed-effects models for repeated-measures data, allowing comparison within and between groups. RESULTS: For each valve model and size, oversizing resulted in decreased effective orifice areas and geometric orifice areas and increased pressure gradients. This was more pronounced with smaller valve sizes and higher flow rates but varied between valve types. Slow-motion imaging revealed this change in geometric orifice area was a result of an inward shift of the valve leaflet hinge point. CONCLUSIONS: Bioprosthetic oversizing impairs hemodynamic performance of aortic valve bioprostheses. The magnitude of this effect varies by valve model and size. Clinically, these data suggest that during aortic valve replacement, placing a valve whose internal orifice closely matches the aortic annulus will provide the optimal hemodynamic performance.

Hybrid Coronary Revascularization for the Treatment of Multivessel Coronary Artery Disease: A Multicenter Observational Study.

BACKGROUND: Hybrid coronary revascularization (HCR) combines minimally invasive surgical coronary artery bypass grafting of the left anterior descending artery with percutaneous coronary intervention (PCI) of non-left anterior descending vessels. HCR is increasingly used to treat multivessel coronary artery disease that includes stenoses in the proximal left anterior descending artery and at least 1 other vessel, but its effectiveness has not been rigorously evaluated. OBJECTIVES: This National Institutes of Health-funded, multicenter, observational study was conducted to explore the characteristics and outcomes of patients undergoing clinically indicated HCR and multivessel PCI for hybrid-eligible coronary artery disease, to inform the design of a confirmatory comparative effectiveness trial. METHODS: Over 18 months, 200 HCR and 98 multivessel PCI patients were enrolled at 11 sites. The primary outcome was major adverse cardiac and cerebrovascular events (MACCE) (i.e., death, stroke, myocardial infarction, repeat revascularization) within 12 months post-intervention. Cox proportional hazards models were used to model time to first MACCE event. Propensity scores were used to balance the groups. RESULTS: Mean age was 64.2 ± 11.5 years, 25.5% of patients were female, 38.6% were diabetic, and 4.7% had previous stroke. Thirty-eight percent had 3-vessel coronary artery disease, and the mean SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) score was 19.7 ± 9.6. Adjusted for baseline risk, MACCE rates were similar between groups within 12 months post-intervention (hazard ratio [HR]: 1.063; p = 0.80) and during a median 17.6 months of follow-up (HR: 0.868; p = 0.53). CONCLUSIONS: These observational data from this first multicenter study of HCR suggest that there is no significant difference in MACCE rates over 12 months between patients treated with multivessel PCI or HCR, an emerging modality. A randomized trial with long-term outcomes is needed to definitively compare the effectiveness of these 2 revascularization strategies. (Hybrid Revascularization Observational Study; NCT01121263).

Hybrid coronary revascularization versus coronary artery bypass surgery with bilateral or single internal mammary artery grafts.

OBJECTIVE: Hybrid coronary revascularization (HCR) combines minimally invasive left internal mammary artery (LIMA)-left anterior descending artery (LAD) bypass with percutaneous intervention of non-LAD vessels. The purpose of this study was to compare outcomes of HCR to conventional coronary artery bypass graft (CABG) surgery with single internal mammary artery (SIMA) or bilateral internal mammary artery (BIMA) grafting. METHODS: Between October 2003 and September 2013, 306 consecutive patients who underwent HCR were compared with 8254 patients who underwent CABG with SIMA (7381; 89.4%) or BIMA (873; 10.6%) at a US academic center. The primary outcome was a composite of 30-day death, myocardial infarction, and stroke (major cerebrovascular and cardiac event [MACCE]). In addition to multiple logistic and linear regression analysis, a propensity score-matched analysis was used to compare HCR with SIMA and with BIMA. RESULTS: The Society of Thoracic Surgeons-predicted risk of mortality was 1.6% for HCR, 2.1% for SIMA, and 1.1% for BIMA (P < .001). Factors associated with HCR use were older age, lower body mass index, history of percutaneous coronary intervention, and 2-vessel disease. In propensity-matched groups, 30-day MACCE rates were comparable (3.3% for HCR vs 1.3% for BIMA [odds ratio (OR), 2.50; P = .12] and vs 3.6% for SIMA [OR, 1.00; P = 1.00]). In-hospital complications were lower after HCR versus SIMA or BIMA (OR, 0.59; P = .033 and OR, 0.55; P = .015, respectively), as was the need for blood transfusion (OR, 0.44; P < .001 and OR, 0.57; P < .001). HCR was associated with shorter hospital stay compared with SIMA (OR, 1.28; P = .038) or BIMA (OR, 1.40; P = .006). No survival difference between matched groups was found at midterm follow-up (HCR vs SIMA: hazard ratio [HR], 0.66; 95% confidence interval [CI], 0.32-1.38; P = .66; HCR vs BIMA: HR, 1.05; 95% CI, 0.48-2.29; P = .91). CONCLUSIONS: HCR may represent a safe, less invasive alternative to conventional CABG in carefully selected patients, with similar short-term and midterm outcomes as CABG performed with either SIMA or BIMA grafting.

Comparative Effectiveness of Hybrid Coronary Revascularization vs Coronary Artery Bypass Grafting.

BACKGROUND: Hybrid coronary revascularization (HCR) combines minimally invasive left internal mammary artery to left anterior descending bypass with percutaneous coronary intervention of non-left anterior descending vessels. Its safety and effectiveness compared with conventional CABG have been under studied. STUDY DESIGN: Patients with multivessel disease and/or left main disease who underwent HCR at a US academic center between October 2003 and September 2013 were included. These patients were matched 1:3 to patients treated with CABG using a propensity-score matching algorithm. Conditional logistic regression and Cox regression analyses stratified on matched pairs were performed to evaluate the adjusted association between HCR and short- and long-term outcomes. RESULTS: The 30-day composite of death, MI, or stroke after HCR and CABG was 3.3% and 3.1% (odds ratio = 1.07; 95% CI, 0.52-2.21; p = 0.85) in the matched cohort of 1,224 patients (HCR, n =306; CABG, n = 918). Hybrid coronary revascularization was associated with lower rates of in-hospital major morbidity (8.5% vs 15.5%; p = 0.005), lower blood transfusion use (21.6% vs 46.6%; p < 0.001), lower chest tube drainage (690 mL; 25th to 75th percentile: 485 to 1,050 mL vs 920 mL, 25th to 75th percentile: 710 to 1,230 mL; p < 0.001), and shorter postoperative length of stay (<5-day stay: 52.6% vs 38.1%; p = 0.001). During a 3-year follow-up period, mortality was similar after HCR and CABG (8.8% vs 10.2%; hazard ratio = 0.91; 95% CI, 0.55-1.52; p = 0.72). Subgroup analyses in patients stratified by 2-vessel, 3-vessel, left main disease, and by Society of Thoracic Surgeons risk scores rendered similar results. CONCLUSIONS: The use of HCR appeared to be safe, with faster recovery and similar outcomes when compared with conventional CABG. These findings were consistent irrespective of anatomic or predicted procedural risk.

Clinical outcomes of hybrid coronary revascularization versus coronary artery bypass surgery in patients with diabetes mellitus.

BACKGROUND: Hybrid coronary revascularization (HCR) involves minimally invasive left internal mammary artery to left anterior descending coronary artery grafting combined with percutaneous coronary intervention (PCI) of non-left anterior descending vessels. The safety and efficacy of HCR among diabetic patients are unknown. METHODS: Patients with diabetes were included who underwent HCR at a US academic center between October 2003 and September 2013. These patients were matched 1:5 to similar patients treated with coronary artery bypass grafting (CABG) using a propensity score (PS)-matching algorithm. Conditional logistic regression and Cox regression stratified on matched pairs were performed to evaluate the association between HCR and inhospital complications, a composite measure of 30-day mortality, myocardial infarction and stroke, and up to 3-year all-cause mortality. RESULTS: Of 618 patients (HCR = 103; CABG = 515) in the PS-matched cohort, the 30-day composite of death, MI, or stroke after HCR and CABG was 4.9% and 3.9% (odds ratio: 1.25; 95% CI [0.47-3.33]; P = .66). Compared with CABG, HCR also had similar need for reoperation (7.6% versus 6.3%; P = .60) and renal failure (4.2% versus 4.9%; P = .76) but required less blood products (31.4% versus. 65.8%; P < .0001), lower chest tube drainage (655 mL [412-916] versus 898 mL [664-1240]; P < .0001), and shorter length of stay (<5 days: 48.3% versus 25.3%; P < .0001). Over a 3-year follow-up period, mortality was similar after HCR and CABG (12.3% versus 14.9%, hazard ratio: 0.94, 95% CI [0.47-1.88]; P = .86). CONCLUSION: Among diabetic patients, the use of HCR appears to be safe and has similar longitudinal outcomes but is associated with less blood product usage and faster recovery than conventional CABG surgery.

Comparison of hybrid coronary revascularization versus coronary artery bypass grafting in patients≥65 years with multivessel coronary artery disease.

Hybrid coronary revascularization (HCR) combines minimally invasive left internal mammary artery-to-left anterior descending coronary artery grafting with percutaneous coronary intervention of non-left anterior descending coronary arteries. The safety and efficacy of HCR in patients≥65 years of age is unknown. In this study, patients aged≥65 years were included who underwent HCR at an academic center from October 2003 to September 2013. These patients were matched 1:4 to similar patients treated with coronary artery bypass grafting (CABG) using a propensity-score matching algorithm. Conditional logistic regression and Cox regression stratified on matched pairs were performed to evaluate the association between HCR and CABG, and 30-day major adverse cardiovascular and cerebrovascular events (a composite of mortality, myocardial infarction, and stroke), periprocedural complications, and 3-year all-cause mortality. Of 715 patients (143 of whom underwent HCR and 572 CABG) in the propensity score-matched cohort, rates of 30-day major adverse cardiovascular and cerebrovascular events were comparable after HCR and CABG (5.6% vs 3.8%, odds ratio 1.46, 95% confidence interval 0.65 to 3.27, p=0.36). Compared with CABG, HCR resulted in fewer procedural complications (9.1% vs 18.2%, p=0.018), fewer blood transfusions (28.0% vs 53.3%, p<0.0001), less chest tube drainage (838±484 vs 1,100±579 cm3, p<0.001), and shorter lengths of stay (<5 days: 45.5% vs 27.4%, p=0.001). Over a 3-year follow-up period, mortality rates were similar after HCR and CABG (13.2% vs 16.6%, hazard ratio 0.81, 95% confidence interval 0.46 to 1.43, p=0.47). Subgroup analyses in high-risk patients (Charlson index≥6, age≥75 years) rendered similar results. In conclusion, although the present data are limited, we found that in older patients, the use of HCR is safe, has fewer procedural complications, entails less blood product use, and results in faster recovery with similar longitudinal outcomes relative to conventional CABG.

The impact of clopidogrel therapy on postoperative bleeding after robotic-assisted coronary artery bypass surgery.

OBJECTIVES: The purpose of this study was to determine whether patients undergoing robotic-assisted coronary artery bypass graft surgery (CABG) on clopidogrel had an increased risk of bleeding complications compared with those not on clopidogrel. METHODS: From 2008 to 2011, 322 patients underwent robotic-assisted CABG either as an isolated procedure or as part of a hybrid coronary revascularization procedure (HCR). Patients were classified according to whether they received clopidogrel within 5 days of surgery or intraoperatively (n = 64) compared with those who never received or who had discontinued clopidogrel therapy >5 days before surgery (n = 258). A propensity analysis using 31 preoperative variables was used to control for confounding variables. In a subgroup analysis, patients undergoing one-stage HCR (clopidogrel load 600 mg in odds ratio (OR) prior to stenting) were compared with patients in the clopidogrel group who underwent two-stage HCR. RESULTS: In the Clopidogrel group, the mean interval between surgery and last dose of clopidogrel was 2.1 ± 1.5 days. Compared with the No Clopidogrel group, the Clopidogrel group had greater 24-h chest tube drainage (1003 ± 572 vs 782 ± 530 ml, P = 0.004) and more blood transfusions (35.9%, 23 of 64 patients vs 20.9%, 54 of 258 patients, P = 0.01). On logistic regression analysis, there was greater 24-h chest tube drainage in the Clopidogrel group (+198 ml, P = 0.02) and a significantly higher incidence of blood transfusion (OR = 2.30, P = 0.01). In the subgroup analysis, patients undergoing one-stage HCR (n = 17) had greater 24-h chest tube drainage compared with patients undergoing two-stage HCR (1262 vs 909 ml, P = 0.03). CONCLUSIONS: Patients undergoing robotic-assisted CABG on clopidogrel had more postoperative bleeding and a higher incidence of blood transfusion. Therefore, despite a less invasive approach, surgery should be delayed in these patients when possible.

Clinical and angiographic results after hybrid coronary revascularization.

BACKGROUND: With hybrid coronary revascularization (HCR), minimally invasive left internal mammary artery (LIMA) to left anterior descending coronary artery (LAD) grafting is combined with percutaneous coronary intervention (PCI) of non-LAD vessels. The purpose of this study was to examine the short-term clinical and angiographic results in one of the largest HCR series to date. METHODS: From 2003 to 2012, 300 consecutive patients (aged 64±12 years, female 31.7%, predicted risk of mortality 1.6%±2.1%) underwent HCR on an intent-to-treat basis at a single institution. After robotic or thoracoscopic LIMA harvest, off-pump LIMA to LAD grafting was performed through a 3- to 4-cm sternal-sparing, non-rib-spreading thoracotomy. PCI was utilized to treat non-LAD lesions either before, after, or concomitant with the surgical procedure. RESULTS: Of the 300 patients undergoing HCR on an intent-to-treat basis, HCR was performed with surgery first in 192 patients (64.0%), PCI first in 56 (18.7%), and as a concomitant procedure in 21 (7.0%). Of the 31 patients (10.1%) who did not undergo HCR, 24 patients (8.0%) did not have PCI and thus were incompletely revascularized. For all patients, 30-day mortality, stroke, and nonfatal myocardial infarction occurred in 4 (1.3%), 3 (1.0%), and 4 (1.3%), respectively. Angiographic LIMA evaluation was performed in 248 patients and revealed a FitzGibbon A LIMA patency rate of 97.6% (242 of 248 patients). Repeat revascularization was required in 13 of 300 patients (4.3%). CONCLUSIONS: Hybrid coronary revascularization represents an alternative approach for patients with multivessel coronary disease with excellent short-term outcomes. It provides a minimally invasive alternative to traditional coronary artery bypass graft surgery and may prove more durable than multivessel PCI.

Sternotomy versus nonsternotomy LIMA-LAD grafting for single-vessel disease.

BACKGROUND: Single-vessel disease of the left anterior descending (LAD) coronary artery may be surgically revascularized by left internal mammary artery (LIMA) grafting either through a sternotomy or a nonsternotomy approach. Nonsternotomy approaches are used in the hope of achieving a less invasive operation. It is unknown whether nonsternotomy approaches impact in-hospital or midterm outcomes. METHODS: The institutional Society of Thoracic Surgeons (STS) database at a single US academic center was reviewed for 597 consecutive patients treated surgically for single-vessel LAD disease from January 1, 2002 to June 30, 2011. In-hospital adverse events and length of stay (LOS) were compared between patients who had LIMA-LAD grafting performed through a sternotomy (sternotomy patients) versus patients who had this procedure performed through a nonsternotomy approach (nonsternotomy patients), adjusted for propensity score (likelihood of receiving sternotomy, calculated on 33 variables). Midterm survival between groups was compared using Kaplan-Meier and Cox regression analysis by referencing the National Social Security Death Index. RESULTS: There were 597 consecutive patients who underwent single-vessel grafting by LIMA-LAD coronary artery grafting. Of these patients, 234 underwent sternotomy, whereas 363 patients had nonsternotomy procedures: 239 patients had endoscopic LIMA harvest and left anterolateral thoracotomy, 106 patients had robot LIMA harvest and left anterolateral thoracotomy, and 18 patients had minimally invasive direct coronary artery bypass. There were no strokes in the nonsternotomy group and 3 (1.3%) in the sternotomy group (p = 0.031). Thirty-day mortality, incidence of myocardial infarction, hospital LOS, and midterm survival were similar between groups. Operative time was significantly longer in the nonsternotomy group (1.8 hours, 95% confidence interval [CI], 1.5-2.1). CONCLUSIONS: In this propensity-adjusted comparison, sternal-sparing incisions were associated with similar 30-day adverse events and midterm survival compared with sternotomy for single-vessel LIMA-LAD artery grafting.

Bilateral internal thoracic artery grafting is associated with significantly improved long-term survival, even among diabetic patients.

BACKGROUND: This study examines if bilateral internal thoracic artery (BITA) grafting provides improved outcomes compared with single internal thoracic artery (SITA) grafting, in the modern era, in which diabetes mellitus and obesity are more prevalent. METHODS: The Society of Thoracic Surgeons database at a single large academic center was reviewed for all consecutive isolated coronary artery bypass grafting patients with two or more distal anastomoses from January 1, 2002, through December 31, 2010. Propensity-adjusted logistic and Cox regression models were used to estimate the effect of BITA on short-term outcomes and long-term survival for diabetic and nondiabetic patients. RESULTS: A total of 3,527 coronary artery bypass grafting operations (812 BITA, 2,715 SITA) were performed. Fewer BITA than SITA patients had diabetes (28.6% vs 44.7% p<0.001). There was no significant difference in 30-day rates of death, stroke, or myocardial infarction between nondiabetic patients who had BITA vs SITA, or between diabetic patients who had BITA vs SITA. BITA grafting conferred a 35% reduction (95% confidence interval, 12% to 52%, p=0.006) in the long-term hazard of death equally for nondiabetic and diabetic patients (p=0.93). Deep sternal wound infection was more common among diabetic than among nondiabetic patients (1.5% vs 0.7%), but was similar within nondiabetic (1.0% vs 0.6%) and diabetic patients (1.7% vs 1.5%) who had BITA vs SITA. Overall, BITA and SITA patients had similar rates of deep sternal wound infection (1.2% vs 1.0%). CONCLUSIONS: BITA grafting confers a long-term survival advantage and should be performed whenever suitable coronary anatomy exists and patient risk factors allow an acceptable risk of deep sternal wound infection.

Prospective evaluation of elastic restraint to lessen the effects of heart failure (PEERLESS-HF) trial.

BACKGROUND: Left ventricular (LV) remodeling predicts poor outcomes in heart failure (HF) patients. The HeartNet(®) cardiac restraint device (Paracor Medical Inc., Sunnyvale, CA) may reduce LV remodeling and improve functional capacity, quality of life, and outcomes in HF patients. To evaluate the safety and efficacy of the HeartNet Ventricular Support System in HF patients receiving optimal medical therapy. METHODS AND RESULTS: Prospective, randomized, controlled, multicenter trial in patients with symptomatic HF and LV ejection fraction ≤35% on optimal medical and device therapy. The primary efficacy end points were changes in peak VO(2), 6-minute walk (6MW) distance, and Minnesota Living with Heart Failure (MLWHF) quality of life score at 6 months. The primary safety end point was all-cause mortality at 12 months. Because the planned adaptive interim analysis of the first 122 subjects with a completed 6-month follow-up indicated futility to reach the peak VO(2) end point, trial enrollment was suspended. Hence, the results on the 96 treatment and 114 control subjects are reported. Groups were similar at baseline. At 6 months, responder frequency for a prespecified improvement was similar between groups for peak VO(2) (P = .502) and MLWHF score (P = .184) but borderline higher for improvement in 6MW distance in the treatment compared with the control group (33 [38%] vs. 25 [25%]; P = .044). At 6 months, the treatment group had a significantly greater improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) (P < .001) and decrease in LV mass (P = .032), LV end-diastolic diameter (P = .015), LV end-systolic diameter (P = .032), and LV end-diastolic volume (P = .031) as compared with controls. At 12 months, all-cause mortality and responder rates were similar in the 2 groups. Success rate for the HeartNet implantation was 99%. CONCLUSION: Enrollment in the trial was stopped because an interim analysis showed futility of reaching the peak VO(2) end point. However, because of the device safety and favorable signals for LV remodeling and quality of life, further investigation of this device is warranted.

Hybrid coronary revascularization for the treatment of left main coronary stenosis: a feasibility study.

OBJECTIVE: To determine the feasibility of a hybrid coronary revascularization (HCR) approach for the treatment of left main (LM) coronary artery stenosis. BACKGROUND: The recommended therapy for significant LM stenosis is coronary artery bypass grafting (CABG). Percutaneous coronary intervention (PCI) of unprotected LM lesions is reserved for patients at high risk for complications with CABG. HCR in LM disease has not been studied. METHODS: Twenty-two consecutive patients with LM stenosis >70% underwent staged HCR. Following a robotic or thoracoscopic-assisted minimally invasive left internal mammary artery (LIMA) to left anterior descending artery (LAD) coronary bypass, PCI of the LM, and non-LAD targets was performed after angiographic confirmation of LIMA patency. Intravascular ultrasound confirmed optimal stent deployment. Thirty-day adverse outcomes and long term follow up was obtained. RESULTS: In the 22 patients with LM lesions, 6 were ostial, 5 mid, and 11 distal. LIMA patency was FitzGibbon A in all cases. LM stenting was successful in all patients with drug-eluting stents (DES) placed in 21 of 22 cases. Three patients underwent stent implantation in the right coronary artery. There were no 30-day major adverse cardiac or cerebrovascular events. At a mean of 38.8 ± 22 months postprocedure, 21 patients were alive without reintervention; one death occurred at 454 days. CONCLUSIONS: HCR for LM coronary disease is a feasible alternative to CABG and unprotected LM PCI. This approach combines the long-term durability of a LIMA-LAD bypass with the less invasive option of PCI in non-LAD targets with DES.

Hybrid coronary revascularization versus off-pump coronary artery bypass for the treatment of left main coronary stenosis.

BACKGROUND: Coronary artery bypass grafting is standard of care for left main (LM) coronary artery stenosis. Hybrid coronary revascularization (HCR) is an alternative therapy, combining a minimally invasive, sternal-sparing, off-pump left internal mammary artery to left anterior descending coronary anastomosis with percutaneous coronary stent placement through the LM into the circumflex coronary artery. METHODS: From October 8, 2003, to April 23, 2010, 27 patients with LM coronary disease had HCR at a US academic center. These patients were matched 3:1 to 81 contemporaneous patients treated with off-pump coronary artery bypass grafting through a sternotomy by an optimal matching algorithm using seven preoperative variables. In-hospital major adverse cardiac and cerebrovascular events and repeat revascularization during the study period were compared between groups. All-cause mortality was compared using the National Social Security Death Index. RESULTS: Patency of the left internal mammary artery to left anterior descending coronary anastomosis was confirmed in all cases before LM stenting, which was successful in all patients. There was no perioperative death, stroke, or myocardial infarction among the HCR patients. Major adverse cardiac and cerebrovascular events were similar between groups. During a median of 3.2 years of follow-up, patients treated with HCR had a higher incidence of repeat revascularization than those treated with off-pump coronary artery bypass grafting (2 of 27, 7.4% versus 1 of 81, 1.2%; p = 0.09), but this was not statistically significant. The incidence of blood transfusion was higher with off-pump coronary artery bypass grafting (50 of 81, 61.7% versus 9 of 27 33.3%; p = 0.01). CONCLUSIONS: Hybrid revascularization is a safe, feasible, and minimally invasive alternative to off-pump coronary artery bypass grafting for the treatment of LM coronary disease. Further investigation into the comparative effectiveness of this alternative strategy is warranted to identify optimal candidates for HCR.

Hybrid coronary revascularization versus off-pump coronary artery bypass grafting for the treatment of multivessel coronary artery disease.

BACKGROUND: Hybrid coronary revascularization (HCR) combines a minimally invasive (3-cm anterolateral thoracotomy), sternal-sparing, off-pump left internal mammary artery-left anterior descending (LIMA-LAD) coronary artery anastomosis with percutaneous coronary intervention (PCI) to non-LAD coronary arteries. We compared outcomes of HCR versus traditional off-pump coronary artery bypass grafting (OPCAB) for the treatment of multivessel coronary artery disease (CAD). METHODS: Between October 8, 2003 and April 23, 2010, 147 patients with multivessel coronary disease were treated with HCR at a US academic center. These were matched 4:1 to 588 contemporaneous patients treated with multivessel OPCAB by sternotomy using an optimal matching algorithm with 8 preoperative variables: age, gender, ejection fraction, presence of diabetes, myocardial infarction (MI), number of diseased vessels, left main coronary artery disease, and Society of Thoracic Surgeons (STS) predicted risk of mortality (PROM) score. In-hospital major adverse events (MACCE) and the need for repeated revascularization during follow-up were compared between groups. All-cause mortality was determined using the Social Security Death Index (SSDI). RESULTS: Matching produced groups with similar coronary anatomy and statistically similar preoperative risk factors. The incidence of MACCE was similar between groups (3/147 HCR versus 12/588 OPCAB). During a median 3.2 years of follow up, the need for repeated revascularization was higher for HCR than for OPCAB (18/147 [12.2%] versus 22/588 [3.7%]; p < 0.001). The incidence of blood transfusion was higher for the OPCAB group. Estimated 5-year survival was similar between groups (OPCAB, 84.3% versus HCR, 86.8%; p = 0.61). CONCLUSIONS: Hybrid coronary revascularization is a minimally invasive treatment for multivessel CAD. Although repeated revascularization was greater with HCR, both in-hospital and midterm outcomes were comparable with those of traditional OPCAB. Further investigation into the comparative effectiveness of this alternative strategy is warranted.

Moderate hypothermia and unilateral selective antegrade cerebral perfusion: a contemporary cerebral protection strategy for aortic arch surgery.

BACKGROUND: Cerebral protection techniques during aortic arch surgery include deep hypothermic circulatory arrest, retrograde cerebral perfusion, and (or) antegrade cerebral perfusion. It is unclear whether unilateral selective antegrade cerebral perfusion (uSACP) in the setting of moderate hypothermic circulatory arrest (MHCA) constitutes an effective cerebral protective strategy during aortic arch reconstruction. METHODS: A retrospective review was performed for all aortic arch cases involving uSACP between January 2004 and December 2009. Of these 412 patients, 97 (24%) were treated emergently. Adverse outcomes included operative mortality, permanent neurologic dysfunction, temporary neurologic dysfunction, and renal failure requiring dialysis. Potential selection bias was controlled by the inclusion of 11 covariates. Multivariable logistic regression analysis was used to model adverse outcome as a function of MHCA and the covariates. Adjusted odds ratios were formulated along with 95% confidence intervals. RESULTS: Three hundred forty-four patients underwent hemiarch reconstruction and 68 patients underwent total arch replacement. The mean core body temperature at the initiation of uSACP was 25.7 degrees C + or - 2.8 degrees C with a uSACP time of 30 + or - 15 minutes. Overall operative mortality occurred in 29 (7.0%) patients. The incidence of permanent neurologic dysfunction and temporary neurologic dysfunction were 3.6% and 5.1%, respectively. Nineteen (4.6%) patients suffered postoperative renal failure requiring dialysis. In the adjusted analysis, MHCA was not found to be an independent predictor of mortality, permanent neurologic dysfunction, temporary neurologic dysfunction, or renal failure requiring dialysis. CONCLUSIONS: The MHCA with adjunctive uSACP is not an independent risk factor for adverse outcomes after aortic arch surgery. These data suggest that MHCA combined with uSACP represents an effective cerebral protective strategy in patients undergoing arch reconstruction in both the elective and emergent settings.

Use of balloon aortic valvuloplasty to size the aortic annulus before implantation of a balloon-expandable transcatheter heart valve.

OBJECTIVES: Our aim was to describe the use of balloon aortic valvuloplasty (BAV) to select proper transcatheter heart valve (THV) size. BACKGROUND: Transesophageal echocardiogram (TEE) measurement alone of the aortic annulus may not be adequate to select a THV size. BAV can more accurately size the aortic annulus. We report our experience using this strategy in patients undergoing THV implantation. METHODS: Twenty-seven patients underwent sizing of the aortic annulus by BAV and TEE. We implanted the minimal THV size that was greater than the annulus measured by BAV. RESULTS: The annulus measured by TEE was 21.3 +/- 1.6 mm and by BAV was 22.6 +/- 1.8 mm (p < 0.001). The number of balloon inflations was 2.7 +/- 0.7 (range 2 to 4), and the balloon sizes used were 22.0 +/- 1.8 mm (range 20 to 25 mm). Fourteen patients (52%) required upsizing of the initial balloon suggested by TEE; rapid pacing duration was 8 +/- 1.3 s (range 6 to 11 s). No change in aortic insufficiency or hemodynamic instability occurred with BAV. Fifteen patients (56%) received a 23-mm THV; 12 patients a 26-mm THV. No coronary occlusion, annular damage, or THV embolization occurred. Paravalvular leak was grade