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The COMMENCE trial was conducted to evaluate the safety and effectiveness of aortic valve replacement using a bioprosthesis with novel RESILIA tissue (Edwards Lifesciences). RESILIA tissue is incorporated in the INSPIRIS RESILIA aortic valve (Edwards Lifesciences).Patients underwent clinically indicated surgical aortic valve replacement with a bovine pericardial bioprosthesis (model 11000A; Edwards Lifesciences) in a prospective, multinational, multicenter (n = 27), US Food and Drug Administration Investigational Device Exemption trial. Events were adjudicated by an independent clinical events committee, and echocardiograms were analyzed by an independent core laboratory. Outcomes through an observational period of 5 years are reported.Between January 2013 and March 2016, 689 patients received the study valve. Mean patient age was 66.9 ± 11.6 years; Society of Thoracic Surgeons Predicted Risk of Mortality was 2.0% ± 1.8%; and 23.8%, 49.9%, and 24.4% of patients were New York Heart Association functional class I, II, and III at baseline, respectively. Through December 11, 2020 the follow-up duration was 4.3 ± 1.4 years, and the completeness of follow-up over the observational period was 95.5%. Early (30 days) all-cause mortality was 1.2%, stroke 1.6%, and major paravalvular leak 0.1%. Five-year actuarial freedom from all-cause mortality, structural valve deterioration, and all-cause reintervention were 89.2%, 100%, and 98.7%, respectively. At 5 years the effective orifice area was 1.6 ± 0.5 cmThe safety and hemodynamic performance of this aortic bioprosthesis with RESILIA tissue through 5 years are encouraging, with clinically stable hemodynamics, minimal regurgitation, and no evidence of structural valve deterioration.

Transcatheter mitral valve replacement (TMVR) is a new therapy for treating symptomatic mitral regurgitation (MR) and stenosis. The proposed benefit of TMVR is the predictable, complete elimination of MR, which is less certain with transcatheter repair technologies such as TEER (transcatheter edge-to-edge repair). The potential benefit of MR elimination with TMVR needs to be rigorously evaluated against its risks which include relative procedural invasiveness, need for anticoagulation, and chronic structural valve deterioration. Randomized controlled trials (RCTs) are a powerful method for evaluating the safety and effectiveness of TMVR against current standard of care transcatheter therapies, such as TEER. RCTs not only help with the assessment of benefits and risks, but also with policies for determining operator or institutional requirements, resource utilization, and reimbursement. In this paper, the authors provide recommendations and considerations for designing pivotal RCTs for first-in-class TMVR devices.

OBJECTIVES: A North American prospective, 15-centre Food and Drug Administration (FDA) valve trial was designed to assess the safety and effectiveness of the Freedom SOLO stentless pericardial aortic valve in the treatment of surgical aortic valve disease. METHODS: Beginning in 2010, 251 patients (mean: 74.7 ± 7.5 years), were recruited in the Freedom SOLO aortic valve trial. One hundred eighty-nine patients have been followed for at least 1 year and are the basis for this review. Preoperatively, 54% of patients had NYHA functional class III or IV symptoms, and the majority of patients had a normal ejection fraction (EF) (median EF = 61%). Concomitant procedures were performed in 61.9% of patients, with coronary artery bypass grafting (CABG) (48.7%) being the most common followed by a MAZE procedure (13.7%). Reoperations were performed in 8.5% of patients in the study. RESULTS: The entire cohort of 251 patients enrolled had 7 deaths prior to 30 days, 2 of which were valve-related (aspiration pneumonia and sudden death) and 5 were not valve-related. There were 11 deaths after 30 days, 1 valve-related (unknown cardiac death) and 10 not valve-related. Five valves were explanted, 3 early (endocarditis, acute insufficiency and possible root dissection) and 2 late (endocarditis). Thirty-day adverse events include arrhythmias requiring permanent pacemaker (4.2%), thromboembolic events (3.7%) and thrombocytopenia (7.4%). One-year follow-up of all 189 patients demonstrated mean gradients for valve sizes 19, 21, 23, 25 and 27 mm of 11.7, 7.8, 6.3, 4.6 and 5.0 mmHg, respectively. Effective orifice areas for the same valve sizes were 1.2, 1.3, 1.6, 1.8 and 1.9 cm 2 , respectively. Ninety-six percent of patients (181/189) were in NYHA class I or II at the 1-year follow-up. CONCLUSIONS: The Freedom SOLO stentless pericardial aortic valve demonstrated excellent haemodynamics and a good safety profile out to the 1 year of follow-up.

Background Incorporating amiodarone into an existing postoperative atrial fibrillation (AF) prevention pathway may reduce postoperative AF and length of stay (LOS). Methods From July 2002 through December 2002, 476 consecutive cardiac surgical patients were managed with an AF prevention protocol using aggressive potassium replacement, intraoperative/ postoperative magnesium supplementation, and postoperative resumption of β-blockers. From January 2003 through June 2003, 592 additional patients were subjected to the same protocol except amiodarone was initiated intraoperatively (150 mg intravenously) and continued postoperatively until discharge (200 mg orally three times daily). Incidence of AF, postoperative LOS, and AF risk factors were collected prospectively and compared using regression models with propensity scores to adjust for dissimilarities between groups. Results Incorporating amiodarone into an existing AF protocol resulted in a 45% reduction in postoperative AF (29% [136/476] versus 16% [94/592], P < 0.0001). After adjustment for covariates and propensity score, the relative risk reduction with amiodarone in this protocol remained significant (P = 0.001, RR 0.65, 95% CI 0.5–0.8). Multivariate risks for postoperative AF included no amiodarone (P = 0.0001), age (P < 0.0001), ejection fraction 24 hours (P = 0.002), no postoperative β-blocker (P = 0.002), and mitral valve procedure (P = 0.03). When postoperative AF did occur, risk adjusted LOS was less in patients on the amiodarone protocol (mean 9.4 days versus 13.1 days, P = 0.06). Readmission after discharge for any reason (10% [49/476] versus 8% [45/592], P = 0.1) or for AF (1.1% [5/476] versus 0.7% [4/592], P = 0.5) was similar between groups. Conclusion Amiodarone initiated intraoperatively followed by oral dosing significantly reduces postoperative AF and tends to reduce LOS if AF occurs.

The authors' institution participated in a 28-center FDA Investigational Device Exemption study to evaluate the Sorin Mitroflow pericardial aortic bioprosthesis. Six high-enrolling sites evaluated patients on an annual basis as part of an ongoing hemodynamic study. These data represent patients followed for an average of five years after implant, with annual echocardiography.Seventy-one patients were entered into the study and constitute the basis of this review. Mean follow up was 3.3 +/- 2.0 years (range: 0-5.5 years), with a cumulative follow up of 233 patient-years. The mean patient age was 73.8 years (range: 45-89 years), and 52% were males. The majority of aortic valve lesions were stenosis (63%) or mixed (30%), and nine patients (12.7%) were reoperations. Sixty-one patients (86%) had concomitant procedures, the most common being coronary artery bypass grafting (70%).A total of 281 echocardiograms was obtained from the patients over a five-year period. The largest number of echocardiograms was obtained with 23-mm valve implants (n = 122), followed by 25 mm valve implants (n = 87). The early baseline (30-day) mean gradient wasor = 10 mm in all patients. The mean gradient decreased as the valve size increased (21 mm valve gradient = 10.0 +/- 5.6 mmHg; 27 mm valve gradient = 6.2 +/- 2.2 mmHg). The mean increase in gradient at five years was7 mmHg, with a trend towards increased gradients at smaller valve sizes. The effective orifice area (EOA) showed a trend to decline slightly with 21 mm valves (from 1.5 to 1.2 cm2) and 23 mm valves (1.4 to 1.2 cm2), but there was either no change or a slight increase in larger-size valves. Left ventricular mass regression occurred mainly within the first year (18.9%), but then remained stable throughout the study period. No greater than mild prosthetic aortic valve regurgitation was observed over the study period.The Sorin Mitroflow aortic valve provides excellent hemodynamic results up to five years, with minimal increase in mean gradients, acceptable peak gradients, and good EOAs with all valves sizes.

Background . Saphenous vein harvested with a traditional longitudinal technique often results in leg wound complications. An alternative endoscopic harvest technique may decrease these complications. Methods . One hundred twelve patients scheduled for elective coronary artery bypass grafting were prospectively randomized to have vein harvested using either an endoscopic (group A, n=54) or traditional technique (group B, n=58). Groups A and B, respectively, were similar with regard to length of vein harvested (41 ± 8 cm versus 40 ± 14 cm), bypasses done (4.1 ± 1.1 versus 4.2 ± 1.4), age, preoperative risk stratification, and risks for wound complication (diabetes, sex, obesity, preoperative anemia, hypoalbuminemia, and peripheral vascular disease). Results . Leg wound complications were significantly ( p ≤ 0.02) reduced in group A (4% [2 of 51] versus 19% [11 of 58]). Univariate analysis identified traditional incision ( p ≤ 0.02) and diabetes ( p ≤ 0.05) as wound complication risk factors. Multiple logistic regression analysis identified only the traditional harvest technique as a risk factor for leg wound complications with no significant interaction between harvest technique and any preoperative risk factor ( p ≤ 0.03). Harvest rate (0.9 ± 0.4 cm/min versus 1.2 ± 0.5 cm/min) was slower for group A ( p ≤ 0.02) and conversion from endoscopic to a traditional harvest occurred in 5.6% (3 of 54) of patients. Conclusions . In a prospective, randomized trial, saphenous vein harvested endoscopically was associated with fewer wound complications than the traditional longitudinal method.

Background . Conventional reoperative (redo) coronary artery bypass grafting (CABG) is associated with significant morbidity. This retrospective study compared perioperative outcomes of conventional single-vessel redo CABG versus redo CABG done by a minimally invasive technique. Methods . Group A consisted of 23 consecutive patients from September 1995 to July 1996 who underwent single vessel redo CABG of the left anterior descending artery with the left internal mammary artery using a limited anterior thoracotomy without cardiopulmonary bypass; group B consisted of 12 consecutive patients from November 1984 to July 1994 who underwent the same procedure using a median sternotomy with cardiopulmonary bypass. The two groups were similar with regard to age, sex, preoperative ejection fraction, and risk stratification. Results . Mortality, cerebrovascular accidents, myocardial infarctions, and reoperations for bleeding were not significantly different between the groups. However, the patients in group A had significant reductions in atrial fibrillation, time to extubation, transfusions required, and length of cardiac recovery and hospital stay. With a mean of 12 ± 6 months of follow-up, 87% of the patients in group A (20 of 23) are alive and asymptomatic. Actuarial survival rates for the patients in group B at 1, 2, and 10 years are 83%, 83%, and 72%, respectively. Conclusions . Minimally invasive single-vessel redo CABG can be performed safely and may reduce the morbidity associated with conventional single-vessel redo CABG.

Endoscopic harvesting of the greater saphenous vein is increasingly used during cardiac surgery to improve patient satisfaction and reduce the wound complications associated with traditional open techniques. Although histologic studies suggest no significant difference in vein quality between these two techniques, long-term follow-up is lacking to address whether graft patency and event-free survival are influenced by the harvest method.A total of 112 isolated coronary artery bypass patients were prospectively randomized to have veins harvested using either an endoscopic (n = 54) or traditional (n = 58) technique. Groups were demographically similar with regard to preoperative risk stratification and coronary procedures performed. Event-free survival (freedom from death, myocardial infarction, or recurrent angina) and use of outpatient resources for resolution of wound complications were determined. Follow-up was 100% at 5 years.Five-year actual event-free survival was similar in patients with endoscopic versus traditionally harvested v e ins (75% versus 74%, P =.85). The number of outpatient office visits required to manage each wound complication to complete resolution was significantly less following endoscopic versus traditional vein harvest (1.5 versus 6 visits, P =.001).Wound complication management following endoscopic versus traditional vein harvest requires less resource utilization. Five-year follow-up of a prospective randomized trial demonstrates that use of endosco pic versus traditionally harvested saphenous veins does not influence event-free survival.

Wound complications are uncommon following endoscopic saphenous vein harvest. However, closed space infections within the endoscopic tunnel may occur and are difficult to manage. We describe the management of closed space infection in 3 patients and a method that allows drainage without unroofing the endoscopic tunnel.

Background —Transmyocardial laser revascularization (TMR) has been shown to improve refractory angina not amenable to conventional coronary interventions. However, the mechanism of action remains controversial, because improved myocardial perfusion has not been consistently demonstrated. We hypothesized that TMR relieves angina by causing myocardial sympathetic denervation. Methods and Results —PET imaging of resting and stress myocardial perfusion with [ 13 N]ammonia (NH 3 ) and of sympathetic innervation with [ 11 C]hydroxyephedrine (HED) was performed before and after TMR in 8 patients with class IV angina ineligible for CABG or PTCA. A mean of 50±11 channels were created in the left ventricle (LV) with a holmium:YAG laser. A semiautomated program was used to determine NH 3 uptake and HED retention in the LV. Perfusion and innervation defects were defined as the percentage of LV with tracer uptake or retention >2 SD below normal mean values. All patients experienced improvement in their angina by 2.4±0.5 angina classes after surgery, P =0.008. Sympathetic innervation defects exceeded resting perfusion defects in all patients before TMR (34.6±27.3% for HED versus 9.4±10.8% for NH 3 , P =0.008). TMR did not significantly affect resting or stress myocardial perfusion but increased the extent of sympathetic denervation in 6 of 8 patients by 27.5±15.9%, P =0.03. In the remaining 2 patients, both sympathetic denervation and stress perfusion defects decreased after surgery. Conclusions —TMR causes decreased myocardial HED uptake in most patients without significant change in resting or stress myocardial perfusion, suggesting that the improvement in angina may be at least in part due to sympathetic denervation.

Objective: To evaluate the efficacy of transmyocardial revascularization performed on patients with refractory class IV or unstable angina with a holmium:yttrium-aluminum-garnet laser. Methods: Transmyocardial revascularization with a holmium:yttrium-aluminumgarnet laser was performed in 42 patients with refractory angina who were not candidates for percutaneous transluminal coronary angioplasty or coronary artery bypass grafting. Patients had either Canadian Heart Association class IV angina ( n = 23) or unstable angina (n = 19) and were unable to be weaned from intravenous nitroglycerin. Preoperative thallium studies identified the extent and location of reversible ischemia. Operative exposure was via a limited left anterior thoracotomy. An average of 45 ∠ 11 laser channels were created with a mean operative time of 106 ∠ 38 min. Results: Perioperative mortality was 12% (5/42) with no late deaths. Complications included ventricular 7.1%(3/42) and atrial 4.7% (2/42) arrhythmias, reoperation for chest-wall hemorrhage 2% (1/42), and respiratory failure requiring reintubation 2% (1/42). Intra-aortic balloon pump placement was required in 12% (5/42). The mean postoperative length of stay was 5.5 ∠ 4.9 (1‐25) days. Mean follow-up on 100% of patients is 5.4 ∠ 3.0 (1‐12) months. At 3 (n = 33) and 6 (n = 21) months follow-up the mean angina class was 1.5 ∠ 0.1 (P , 0.002) and 1.1 ∠ 0.1 (P , 0.001), respectively. Conclusions: Transmyocardial revascularization utilizing a holmium:yttrium-aluminum-garnet laser resulted in a significant reduction in angina class and was beneficial in patients with refractory angina untreatable by conventional methods. © 1998 Elsevier Science B.V. All rights reserved

Background Transplant programs use routine surveillance endomyocardial biopsies (RSEMB), which are performed at preset intervals to diagnose cardiac rejection. This retrospective study determined the incidence of graft rejection detected by RSEMB. Methods The records of 95 patients who underwent heart transplantation between 1987 and 1995 were reviewed. Rejection incidence was recorded for 80 patients who survived at least 30 days, with a mean follow-up of 35 months. Results One thousand five hundred sixteen total biopsies were performed; 1,170 were RSEMB. Four hundred seventy-five total rejection episodes occurred and 269 (56%) were diagnosed by RSEMB. Two distinct patient groups were identified. The majority (70 patients), had a decline in the incidence of rejection and no rejection episodes were identified by RSEMB after 36 months. In contrast, the high rejection group (10 patients) had a significantly higher ongoing rejection rate ( p ≤ 0.04 to p ≥ 0.001) throughout their postoperative course up to 72 months. Conclusions The majority of our transplant patients demonstrate a decrease in rejection with time and do not require RSEMB beyond 30 months. We identified a group of patients who exhibited a higher rate of rejection and need continued RSEMB.

Bronchoplastic surgical techniques may allow resectional therapy for non-small cell lung carcinoma in select patients in whom preoperative pulmonary function demonstrates prohibitive risk for pneumonectomy. We report an otherwise poor candidate for pneumonectomy in whom coronal magnetic resonance imaging demonstrated the potential for distal bronchial salvage.