Fractional Flow Reserve-Guided PCI as Compared with Coronary Bypass Surgery.

BACKGROUND: Patients with three-vessel coronary artery disease have been found to have better outcomes with coronary-artery bypass grafting (CABG) than with percutaneous coronary intervention (PCI), but studies in which PCI is guided by measurement of fractional flow reserve (FFR) have been lacking. METHODS: In this multicenter, international, noninferiority trial, patients with three-vessel coronary artery disease were randomly assigned to undergo CABG or FFR-guided PCI with current-generation zotarolimus-eluting stents. The primary end point was the occurrence within 1 year of a major adverse cardiac or cerebrovascular event, defined as death from any cause, myocardial infarction, stroke, or repeat revascularization. Noninferiority of FFR-guided PCI to CABG was prespecified as an upper boundary of less than 1.65 for the 95% confidence interval of the hazard ratio. Secondary end points included a composite of death, myocardial infarction, or stroke; safety was also assessed. RESULTS: A total of 1500 patients underwent randomization at 48 centers. Patients assigned to undergo PCI received a mean (±SD) of 3.7±1.9 stents, and those assigned to undergo CABG received 3.4±1.0 distal anastomoses. The 1-year incidence of the composite primary end point was 10.6% among patients randomly assigned to undergo FFR-guided PCI and 6.9% among those assigned to undergo CABG (hazard ratio, 1.5; 95% confidence interval [CI], 1.1 to 2.2), findings that were not consistent with noninferiority of FFR-guided PCI (P = 0.35 for noninferiority). The incidence of death, myocardial infarction, or stroke was 7.3% in the FFR-guided PCI group and 5.2% in the CABG group (hazard ratio, 1.4; 95% CI, 0.9 to 2.1). The incidences of major bleeding, arrhythmia, and acute kidney injury were higher in the CABG group than in the FFR-guided PCI group. CONCLUSIONS: In patients with three-vessel coronary artery disease, FFR-guided PCI was not found to be noninferior to CABG with respect to the incidence of a composite of death, myocardial infarction, stroke, or repeat revascularization at 1 year. (Funded by Medtronic and Abbott Vascular; FAME 3 ClinicalTrials.gov number, NCT02100722.).

Fractional Flow Reserve-Guided PCI or Coronary Bypass Surgery for 3-Vessel Coronary Artery Disease: 3-Year Follow-Up of the FAME 3 Trial.

BACKGROUND: Previous studies comparing percutaneous coronary intervention (PCI) with coronary artery bypass grafting (CABG) in patients with multivessel coronary disease not involving the left main have shown significantly lower rates of death, myocardial infarction (MI), or stroke after CABG. These studies did not routinely use current-generation drug-eluting stents or fractional flow reserve (FFR) to guide PCI. METHODS: FAME 3 (Fractional Flow Reserve versus Angiography for Multivessel Evaluation) is an investigator-initiated, multicenter, international, randomized trial involving patients with 3-vessel coronary artery disease (not involving the left main coronary artery) in 48 centers worldwide. Patients were randomly assigned to receive FFR-guided PCI using zotarolimus drug-eluting stents or CABG. The prespecified key secondary end point of the trial reported here is the 3-year incidence of the composite of death, MI, or stroke. RESULTS: A total of 1500 patients were randomized to FFR-guided PCI or CABG. Follow-up was achieved in >96% of patients in both groups. There was no difference in the incidence of the composite of death, MI, or stroke after FFR-guided PCI compared with CABG (12.0% versus 9.2%; hazard ratio [HR], 1.3 [95% CI, 0.98-1.83]; P=0.07). The rates of death (4.1% versus 3.9%; HR, 1.0 [95% CI, 0.6-1.7]; P=0.88) and stroke (1.6% versus 2.0%; HR, 0.8 [95% CI, 0.4-1.7]; P=0.56) were not different. MI occurred more frequently after PCI (7.0% versus 4.2%; HR, 1.7 [95% CI, 1.1-2.7]; P=0.02). CONCLUSIONS: At 3-year follow-up, there was no difference in the incidence of the composite of death, MI, or stroke after FFR-guided PCI with current-generation drug-eluting stents compared with CABG. There was a higher incidence of MI after PCI compared with CABG, with no difference in death or stroke. These results provide contemporary data to allow improved shared decision-making between physicians and patients with 3-vessel coronary artery disease. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02100722.

Redo aortic valve replacement versus valve-in-valve trans-catheter aortic valve implantation: a UK propensity-matched analysis.

This study sought to compare the morbidity and mortality of redo aortic valve replacement (redo-AVR) versus valve-in-valve trans-catheter aortic valve implantation (valve-in-valve TAVI) for patients with a failing bioprosthetic valve. A multicenter UK retrospective study of redo-AVR or valve-in-valve TAVI for patients referred for redo aortic valve intervention due to a degenerated aortic bioprosthesis. Propensity score matching was performed for confounding factors. From July 2005 to April 2021, 911 patients underwent redo-AVR and 411 patients underwent valve-in-valve TAVI. There were 125 pairs for analysis after propensity score matching. The mean age was 75.2±8.5 years. In-hospital mortality was 7.2% (n=9) for redo-AVR versus 0 for valve-in-valve TAVI, p=0.002. Surgical patients suffered more post-operative complications, including intra-aortic balloon pump support (p=0.02), early re-operation (p<0.001), arrhythmias (p<0.001), respiratory and neurological complications (p=0.02 and p=0.03) and multi-organ failure (p=0.01). The valve-in-valve TAVI group had a shorter intensive care unit and hospital stay (p<0.001 for both). However, moderate aortic regurgitation at discharge and higher post-procedural gradients were more common after valve-in-valve TAVI (p<0.001 for both). Survival probabilities in patients who were successfully discharged from the hospital were similar after valve-in-valve TAVI and redo-AVR over the 6-year follow-up (log-rank p=0.26). In elderly patients with a degenerated aortic bioprosthesis, valve-in-valve TAVI provides better early outcomes as opposed to redo-AVR, although there was no difference in mid-term survival in patients successfully discharged from the hospital.

Total arterial coronary artery bypass grafting in patients with preoperative anemia.

OBJECTIVES: Blood transfusions after coronary artery bypass grafting (CABG) has been associated to adverse outcomes, especially in anemic patients. However, little is known about the influence of the modality of revascularization. Total arterial revascularization (TAR) was shown to reduce postoperative transfusion when compared to saphenous vein-based (SV)-CABG (LIMA plus one/more SV grafts). We, therefore, aimed to investigate the impact of TAR-CABG versus SV-CABG on blood products use and perioperative outcomes in patients with preoperative anemia, normally at higher risk for postoperative transfusions. METHODS: From a cohort of 936 patients with mild preoperative anemia undergoing primary elective on-pump CABG, 166 matched pairs of patients undergoing either TAR- or SV-CABG were obtained. Anemia was defined as hemoglobin level <13 g/dl for men and <12 g/dl for women. The primary endpoint was the evaluation of red packed cells (RPC) use over the entire hospital stay. RESULTS: TAR patients showed significantly reduced RPC usage compared with SV (mean difference 0.45 units). TAR patients had a reduced intubation time (mean difference 7.6 h) and were discharged 1.24 days earlier than SV patients. Pneumonia and acute kidney injury were doubled among SV patients. Adjusted regression showed that TAR technique is a predictor of reduced RPC unit use regardless of age and EuroSCORE II (odds ratio: 0.63, p < .01). CONCLUSION: Patients with preoperative anemia might benefit from TAR regardless of age or calculated operative risk. TAR-CABG was associated to reduced postoperative use of blood products and postoperative length of stay in comparison with SV-CABG in this subset of patients.

The impact of the SARS-CoV-2 pandemic and COVID-19 on lung transplantation in the UK: Lessons learned from the first wave.

BACKGROUND: Lung transplantation is particularly susceptible to the impact of the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) pandemic, and evaluation of changes to practice is required to inform future decision-making. METHODS: A retrospective review of the UK Transplant Registry (UKTR) and national survey of UK lung transplant centers has been performed. RESULTS: There was geographic variation in the prevalence of COVID-19 infection across the UK. The number of donors fell by 48% during the early pandemic period. Lung utilization fell to 10% (compared with 24% for the same period of 2019). The number of lung transplants performed fell by 77% from 53, March to May 2019, to 12. Seven (58%) of these were performed in a single-center, designated "COVID-light." The number of patients who died on the lung transplant waiting list increased, compared to the same period of 2019 (p = .0118). Twenty-six lung transplant recipients with confirmed COVID-19 infection were reported during the study period. CONCLUSION: As the pandemic continues, reviewing practice and implementing the lessons learned during this period, including the use of robust donor testing strategies and the provision of "COVID-light" hospitals, are vital in ensuring the safe continuation of our lung transplant program.

Heart transplantation in the UK during the first wave of the SARS-CoV-2 pandemic.

BACKGROUND: We aim to evaluate practice and understand the impact of the first wave of the SARS-CoV-2 pandemic on heart transplantation in the UK. METHODS: A retrospective review of the UK Transplant Registry (UKTR) and a national survey of UK heart transplant centers have been performed. The early pandemic period is defined here as 1 March to 31 May 2020. RESULTS: There was geographic variation in the prevalence of COVID-19 across the UK. All centers reported adaptations to maintain the safety of their staff, candidate, and recipient populations. The number of donors fell by 31% during the early pandemic period. Heart utilization increased to 35%, compared to 26% during the same period of 2019. The number of heart transplants was well maintained, across all centers, with 38 performed, compared to 41 during the same period of 2019, with no change in 30-day survival. Twenty-seven heart transplant recipients with confirmed COVID-19 infection were reported during the study period. CONCLUSION: All UK heart transplant centers have successfully adapted their programs to overcome the challenges of staff redeployment and ICU and hospital resource limitation, associated with the pandemic, whilst continuing heart transplant activity. On-going evaluation of practice changes, with sharing of lessons learned, is required as the pandemic continues.

PREDICTA: A Model to Predict Primary Graft Dysfunction After Adult Heart Transplantation in the United Kingdom.

BACKGROUND: Primary graft dysfunction (PGD) is a major cause of morbidity and mortality post-heart transplantation. The rates of PGD across Europe are higher than North America possibly because of the increasing use of extended criteria donors because of organ shortage. Our aim was to derive a novel scoring system based on data collected nationally in the UK over a 3-year period. We compared this scoring system to a previously validated (RADIAL) score in a contemporary cohort of patients. METHODS: Medical records of all adult patients who underwent heart transplantation between October 1, 2012 and September 30, 2016 in the 6 UK heart transplant centers were analyzed. Preoperative donor and recipient characteristics, intraoperative details and post-transplant complications were compared between the PGD and non-PGD groups using the International Society of Heart and Lung Transplant definition. Multivariable logistic regression was used to build the predictive model. An area under receiver operating characteristics curve was used to test the novel scoring system (PREDICTA) versus the RADIAL score. RESULTS: Six hundred and thirteen heart transplants were included in the study. There were 233 patients who had PGD. The variables included in the model were recipient diabetes mellitus, preoperative mechanical circulatory support (short-term ventricular assist devices/extracorporeal membrane oxygenation), implant time, donor age, and bypass time >180 minutes. The C statistic of the PREDICTA score was 0.704 versus 0.547 for the RADIAL score indicating an acceptable discriminatory value. CONCLUSION: The PREDICTA score is a novel scoring tool with improved ability to predict the development of PGD compared with the RADIAL score. Its application in the prevention and early management of PGD needs further evaluation.

Primary graft dysfunction after heart transplantation: a thorn amongst the roses.

Primary graft dysfunction (PGD) remains the leading cause of early mortality post-heart transplantation. Despite improvements in mechanical circulatory support and critical care measures, the rate of PGD remains significant. A recent consensus statement by the International Society of Heart and Lung Transplantation (ISHLT) has formulated a definition for PGD. Five years on, we look at current concepts and future directions of PGD in the current era of transplantation.

Preoperative assessment of left ventricular diastolic function and right ventricular systolic function have independent and incremental prognostic value in prediction of early postoperative mortality in redo valve surgery.

OBJECTIVES: Redo valve surgery is associated with increased risk of mortality that may be underestimated by current risk scores. In this study, we hypothesized that additional echocardiographic assessment of left ventricular diastolic and right ventricular systolic function would have independent prognostic value in the prediction of early postoperative mortality in patients undergoing redo valve surgery. METHODS: We prospectively evaluated 145 patients who underwent redo mitral or aortic valve surgery at our center. All patients underwent comprehensive preoperative echocardiography. The primary outcome was all-cause mortality at 30 days. RESULTS: The 30-day mortality rate was 11.7%. Independent of EuroSCORE II both preoperative left ventricular diastolic dysfunction and right ventricular systolic dysfunction were a significant multivariable predictors of 30-day mortality (HR 5.47; 95% CI 1.12-26.74, P = 0.036 and HR 4.09; 95% CI 1.11-15.07, P = 0.035, respectively) in addition to EuroSCORE II. Diastolic dysfunction remained significant when added to other clinically significant variables. The assessment of both parameters increased the discriminatory power of EuroSCORE II for prediction of early mortality and the combination identified a group at very high risk of mortality. CONCLUSIONS: Comprehensive preoperative echocardiography including assessment of left ventricular diastolic and right ventricular systolic function has independent prognostic value over and above EuroSCORE II in the prediction of early postoperative mortality in patients undergoing redo valve surgery. The results of preoperative echocardiography should be taken into account during the selection and perioperative management of patients undergoing redo valvular surgery.

Downsizing annuloplasty in ischemic mitral regurgitation: double row overlapping suture to avoid ring disinsertion in valve repair.

The long-term outcomes of undersizing annuloplasty for the treatment of ischemic mitral regurgitation (IMR) is affected by the progressive dilation of the annulus, which carries increased risk for ring disinsertion. Reasons underlying this phenomenon might be found in the excess of physical stress on the annuloplasty sutures during the ventricular remodeling process. We report a technique based on the placement of a double row of overlapping sutures aiming at reducing the potential for ring disinsertion. Eleven patients with IMR undergoing mitral valve repair associated with coronary bypass grafting were treated with this technique and echocardiographically followed up at 6 and 12 months. The overall annular dimension decreased significantly with a significant reduction of the tenting area and no recurrence of mitral regurgitation at 1 year. A double row of overlapping sutures allowed firm attachment of the prosthetic ring while downsizing the annulus in IMR, limiting the consequences of changes in subannular ventricular geometry. This technique might therefore be considered a useful aid during mitral valve repair.

Aortic valve homograft: 10-year experience.

The first aortic valve homograft was implanted by Sir Donald Ross in 1962. Since then, over 25,000 aortic homografts have been implanted worldwide. Unfortunately, the current cryopreservation method promotes a degenerative process leading to progressive homograft fibrosis and calcification. Valve durability of fresh allografts appears to be superior to cryopreserved grafts. The main indications of aortic valve replacement with a homograft are endocarditis, rheumatic disease, bicuspid and dystrophic aortopathies. Our experience with 210 aortic homografts implanted over a 10-year period is reported. We describe the different implantation techniques with particular emphasis on the current technique of choice, namely homograft root replacement. Approximately one-fourth of all aortic homografts will experience structural valve deterioration at 12 years. Structural homograft valve deterioration translates predominately into valve insufficiency and less frequently into stenosis. Young recipient age it appears is the major determinant of reoperation. Predictors of early and late mortality are discussed.

Determinants of cerebral lesions in endocarditis on systematic cerebral magnetic resonance imaging: a prospective study.

BACKGROUND AND PURPOSE: Cerebral lesions are frequent complications of infective endocarditis (IE) and have a prognostic impact. Cerebral MRI identifies lesions in a high number of patients. However, their determinants have not been identified. The aim of the study was to define the determinants of cerebral lesions in patients with IE undergoing systematic cerebral MRI. METHODS: Determinants of ischemic lesions and of microbleeds were prospectively analyzed in 120 patients with left-sided IE, using systematic cerebral MRI. RESULTS: Median age was 60 years (interquartile range 51-72); IE occurred on a prosthetic valve in 37 patients (30.8%) and was due to Streptococci in 47 patients and Staphylococci in 36; 15 (12.5%) had neurological symptoms. MRI detected ischemic lesions in 64 patients (53.3%; territorial lesions in 32 and small lesions in 57) and microbleeds in 72 (60.0%). In multivariate analysis, ischemic lesions were associated with vegetation length (odds ratio 1.10/mm; 95% confidence interval 1.03-1.16; P=0.003) and Staphylococcus aureus IE (odds ratio 2.65; 95% confidence interval 1.01-6.96; P=0.05). A vegetation length >4 mm identified ischemic lesions with a sensitivity of 74.6% and a specificity of 51.5%. Microbleeds were associated with prosthetic IE (odds ratio 8.01; 95% confidence interval 2.58-24.90; P=0.0003) and not with prior anticoagulant therapy (P=0.67). CONCLUSIONS: Systematic cerebral MRI frequently detects ischemic lesions and microbleeds during acute IE. The high sensitivity of MRI shows that each millimeter increase in vegetation length is associated with a 10% increase in the rate of ischemic lesions. Conversely, microbleeds are associated only with prosthetic IE in this study. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00144885.

Delayed aortic dissection after transcatheter aortic valve implantation.

In selected high-risk patients with aortic stenosis, transcatheter aortic valve implantation (TAVI) can provide comparable functional improvement and early survival after surgical aortic valve replacement. However, the long-term outcome after TAVI is still to be determined and the occurrence of aortic dissection has not been systematically reported. Herein, a case is presented of delayed aortic dissection and rupture several months after an uneventful TAVI in a patient with bicuspid aortic valve stenosis.

Analysis of Incidence and Reasons for Re-intervention After Aortic Valve Replacement Using the Trifecta Aortic Bioprosthesis.

Trifecta bioprosthesis claims favorable hemodynamic performance. However, reports of structural valve deterioration (SVD) raise concerns of its long-term durability. We assessed outcomes with the Trifecta valve over a 10-year period. All patients receiving Trifecta bioprostheses between October 2011 and October 2020 were included. Perioperative and survival characteristics were prospectively collated in an independent database. Re-intervention was recorded as a surrogate for SVD. Nine hundred and forty-four patients (mean age 72.82 years ± 8.13, 58% male) underwent aortic valve replacement with the Trifecta valve. At 10-years, 1.4% of patients required a redo operation, giving an overall freedom from re-intervention of 98.6%. The mean time to re-intervention was 48.87 months. Survival was 73.58% and 76.92% in patients who did not require re-intervention vs re-intervention group, respectively. In a large, single-center cohort, the Trifecta aortic bioprosthesis had a 1.4% all-cause re-intervention rate at 10-years, with insignificant impact on survival.

Andexanet alfa in acute aortic syndrome: first UK experience.

Andexanet alfa was employed to reverse the anticoagulant effect of direct oral anticoagulants in 3 patients who required emergent surgery for repair of type A aortic dissection. Its use was instrumental in securing haemostasis. However, we caution against the administration of Andexanet alfa prior to cardiopulmonary bypass as it can induce heparin resistance and complicate the perioperative monitoring of anticoagulation during cardiopulmonary bypass.

Safety and Hemostatic Effectiveness of SURGICEL® Powder in Mild and Moderate Intraoperative Bleeding.

This postmarket clinical study evaluated the safety and effectiveness of the novel adjunctive topical hemostat SURGICEL® Powder (SURGICEL®-P), a powdered form of oxidized regenerated cellulose. In a prospective, open-label, single-arm multicenter trial, adult surgical subjects with mild-to-moderate bleeding for which conventional hemostatic methods were impractical/ineffective were treated with SURGICEL®-P. Descriptive analyses included hemostatic success rate at 3, 5, and 10 min, rebleeding and thromboembolic events, SURGICEL®-P-related serious adverse events requiring surgical intervention, and SURGICEL®-P ease of use (questionnaire). In 8 centers, 103 subjects were enrolled with a median (range) age of 64.0 (33.0-88.0) years. Surgeries were open (53.4%) or laparoscopic/thoracoscopic (46.6%) and mostly urological (37.9%) and abdominal (32.0%) procedures. Bleeding sites included various tissue types, with a median (range) surface area of 4 (0.02-72.0) cm2. Hemostatic success rates were 77.7%, 87.4%, and 92.2% at 3, 5, and 10 min, respectively. In 7 subjects (6.8%), investigators reverted to standard of care. No safety signals were identified. Two deaths occurred with causes unrelated to SURGICEL®-P. Investigators favorably evaluated the ease of use of the SURGICEL®-P device. SURGICEL®-P is safe and effective in controlling mild-to-moderate bleeding in a broad range of surgical procedures. The trial was registered at https://clinicaltrials.gov as NCT03762200.

Multidisciplinary paper on patient blood management in cardiothoracic surgery in the UK: perspectives on practice during COVID-19.

The coronavirus (COVID-19) pandemic disrupted all surgical specialties significantly and exerted additional pressures on the overburdened United Kingdom (UK) National Health Service. Healthcare professionals in the UK have had to adapt their practice. In particular, surgeons have faced organisational and technical challenges treating patients who carried higher risks, were more urgent and could not wait for prehabilitation or optimisation before their intervention. Furthermore, there were implications for blood transfusion with uncertain patterns of demand, reductions in donations and loss of crucial staff because of sickness and public health restrictions. Previous guidelines have attempted to address the control of bleeding and its consequences after cardiothoracic surgery, but there have been no targeted recommendations in light of the recent COVID-19 challenges. In this context, and with a focus on the perioperative period, an expert multidisciplinary Task Force reviewed the impact of bleeding in cardiothoracic surgery, explored different aspects of patient blood management with a focus on the use of haemostats as adjuncts to conventional surgical techniques and proposed best practice recommendations in the UK.

Treatment of Anomalous Coronary Arteries-Surgical Revascularisation Using the Pure Internal Thoracic Artery Technique.

OBJECTIVES: To evaluate the use of CABG utilising an isolated pedicled Right Internal Thoracic Artery (RITA) or Left Internal Thoracic Artery (LITA) or the Pure Internal Thoracic Artery (PITA) technique to treat anomalous aortic origin of coronary artery (AAOCA). METHODS: A retrospective review of all patients at our institution over an 8-year period (2013-2021) who underwent surgery for AAOCA was performed. Data assessed included patient demographics, initial presentation, morphology of coronary anomaly, surgical procedure, cross-clamp time, cardiopulmonary bypass time, and long-term outcome. RESULTS: A total of 14 patients underwent surgery, including 11 males (78.5%) with a median logistic EuroSCORE of 1.605 (IQR 1.34). The median age was 62.5 years (IQR 48.75). Presentation was angina (7 patients), acute coronary syndrome (5 patients), incidental findings in aortic valve pathology (2 patients). AAOCA morphology varied: RCA from left coronary sinus (6), RCA from left main stem (3), left coronary artery from the right coronary sinus (1), left main stem arising from right coronary sinus (2) and circumflex artery arising from the right coronary sinus (2). Overall, 7 patients had co-existing flow-limiting coronary artery disease. CABG was performed using either a pedicled skeletonized RITA, LITA or PITA technique. There was no perioperative mortality. Overall median follow-up time was 43 months. One patient presented with recurrent angina secondary to graft failure at 2 years and there were two non-cardiac-related deaths at 4 and 35 months. CONCLUSION: The use of internal thoracic artery grafts can provide a durable treatment option in patients with anomalous coronary arteries. The potential risk of graft failure in patients with no flow-limiting disease should be very carefully considered. However, a proposed benefit of this technique is the use of a pedicle flow to increase the long-term patency. More consistent results are obtained when ischaemia can be demonstrated preoperatively.