Effect of Transcatheter Aortic Valve Implantation vs Surgical Aortic Valve Replacement on All-Cause Mortality in Patients With Aortic Stenosis: A Randomized Clinical Trial.

Importance: Transcatheter aortic valve implantation (TAVI) is a less invasive alternative to surgical aortic valve replacement and is the treatment of choice for patients at high operative risk. The role of TAVI in patients at lower risk is unclear. Objective: To determine whether TAVI is noninferior to surgery in patients at moderately increased operative risk. Design, Setting, and Participants: In this randomized clinical trial conducted at 34 UK centers, 913 patients aged 70 years or older with severe, symptomatic aortic stenosis and moderately increased operative risk due to age or comorbidity were enrolled between April 2014 and April 2018 and followed up through April 2019. Interventions: TAVI using any valve with a CE mark (indicating conformity of the valve with all legal and safety requirements for sale throughout the European Economic Area) and any access route (n = 458) or surgical aortic valve replacement (surgery; n = 455). Main Outcomes and Measures: The primary outcome was all-cause mortality at 1 year. The primary hypothesis was that TAVI was noninferior to surgery, with a noninferiority margin of 5% for the upper limit of the 1-sided 97.5% CI for the absolute between-group difference in mortality. There were 36 secondary outcomes (30 reported herein), including duration of hospital stay, major bleeding events, vascular complications, conduction disturbance requiring pacemaker implantation, and aortic regurgitation. Results: Among 913 patients randomized (median age, 81 years [IQR, 78 to 84 years]; 424 [46%] were female; median Society of Thoracic Surgeons mortality risk score, 2.6% [IQR, 2.0% to 3.4%]), 912 (99.9%) completed follow-up and were included in the noninferiority analysis. At 1 year, there were 21 deaths (4.6%) in the TAVI group and 30 deaths (6.6%) in the surgery group, with an adjusted absolute risk difference of -2.0% (1-sided 97.5% CI, -∞ to 1.2%; P < .001 for noninferiority). Of 30 prespecified secondary outcomes reported herein, 24 showed no significant difference at 1 year. TAVI was associated with significantly shorter postprocedural hospitalization (median of 3 days [IQR, 2 to 5 days] vs 8 days [IQR, 6 to 13 days] in the surgery group). At 1 year, there were significantly fewer major bleeding events after TAVI compared with surgery (7.2% vs 20.2%, respectively; adjusted hazard ratio [HR], 0.33 [95% CI, 0.24 to 0.45]) but significantly more vascular complications (10.3% vs 2.4%; adjusted HR, 4.42 [95% CI, 2.54 to 7.71]), conduction disturbances requiring pacemaker implantation (14.2% vs 7.3%; adjusted HR, 2.05 [95% CI, 1.43 to 2.94]), and mild (38.3% vs 11.7%) or moderate (2.3% vs 0.6%) aortic regurgitation (adjusted odds ratio for mild, moderate, or severe [no instance of severe reported] aortic regurgitation combined vs none, 4.89 [95% CI, 3.08 to 7.75]). Conclusions and Relevance: Among patients aged 70 years or older with severe, symptomatic aortic stenosis and moderately increased operative risk, TAVI was noninferior to surgery with respect to all-cause mortality at 1 year. Trial Registration: isrctn.com Identifier: ISRCTN57819173.

Surgery during COVID-19 crisis conditions: can we protect our ethical integrity against the odds?

COVID-19 is reducing the ability to perform surgical procedures worldwide, giving rise to a multitude of ethical, practical and medical dilemmas. Adapting to crisis conditions requires a rethink of traditional best practices in surgical management, delving into an area of unknown risk profiles. Key challenging areas include cancelling elective operations, modifying procedures to adapt local services and updating the consenting process. We aim to provide an ethical rationale to support change in practice and guide future decision-making. Using the four principles approach as a structure, Medline was searched for existing ethical frameworks aimed at resolving conflicting moral duties. Where insufficient data were available, best guidance was sought from educational institutions: National Health Service England and The Royal College of Surgeons. Multiple papers presenting high-quality, reasoned, ethical theory and practice guidance were collected. Using this as a basis to assess current practice, multiple requirements were generated to ensure preservation of ethical integrity when making management decisions. Careful consideration of ethical principles must guide production of local guidance ensuring consistent patient selection thus preserving equality as well as quality of clinical services. A critical issue is balancing the benefit of surgery against the unknown risk of developing COVID-19 and its associated complications. As such, the need for surgery must be sufficiently pressing to proceed with conventional or non-conventional operative management; otherwise, delaying intervention is justified. For delayed operations, it is our duty to quantify the long-term impact on patients' outcome within the constraints of pandemic management and its long-term outlook.

Bilateral versus Single Internal-Thoracic-Artery Grafts at 10 Years.

BACKGROUND: Multiple arterial grafts may result in longer survival than single arterial grafts after coronary-artery bypass grafting (CABG) surgery. We evaluated the use of bilateral internal-thoracic-artery grafts for CABG. METHODS: We randomly assigned patients scheduled for CABG to undergo bilateral or single internal-thoracic-artery grafting. Additional arterial or vein grafts were used as indicated. The primary outcome was death from any cause at 10 years. The composite of death from any cause, myocardial infarction, or stroke was a secondary outcome. RESULTS: A total of 1548 patients were randomly assigned to undergo bilateral internal-thoracic-artery grafting (the bilateral-graft group) and 1554 to undergo single internal-thoracic-artery grafting (the single-graft group). In the bilateral-graft group, 13.9% of the patients received only a single internal-thoracic-artery graft, and in the single-graft group, 21.8% of the patients also received a radial-artery graft. Vital status was not known for 2.3% of the patients at 10 years. In the intention-to-treat analysis at 10 years, there were 315 deaths (20.3% of the patients) in the bilateral-graft group and 329 deaths (21.2%) in the single-graft group (hazard ratio, 0.96; 95% confidence interval [CI], 0.82 to 1.12; P=0.62). Regarding the composite outcome of death, myocardial infarction, or stroke, there were 385 patients (24.9%) with an event in the bilateral-graft group and 425 patients (27.3%) with an event in the single-graft group (hazard ratio, 0.90; 95% CI, 0.79 to 1.03). CONCLUSIONS: Among patients who were scheduled for CABG and had been randomly assigned to undergo bilateral or single internal-thoracic-artery grafting, there was no significant between-group difference in the rate of death from any cause at 10 years in the intention-to-treat analysis. Further studies are needed to determine whether multiple arterial grafts provide better outcomes than a single internal-thoracic-artery graft. (Funded by the British Heath Foundation and others; Current Controlled Trials number, ISRCTN46552265 .).

Feasibility of hybrid off pump artery bypass grafting and transaortic transcatheter aortic valve implantation: A case series.

INTRODUCTION: Patients with complex coronary artery disease and severe aortic stenosis unsuitable for conventional cardiac surgery pose a significant treatment challenge. This is especially difficult for patients where percutaneous revascularization is technically very challenging and/or would not offer as complete revascularisation compared to surgical revascularisation. In addition, patients who are unsuitable for transfemoral transcatheter aortic valve implantation (TAVI) pose an additional technical challenge, particularly with dual antiplatelet therapy (DAPT) following percutaneous coronary intervention (PCI). As a potential solution we describe the first case series of hybrid off-pump coronary artery bypass grafting (CABG) combined with transaortic TAVI. METHODS AND RESULTS: Over a ten-month-period, four patients underwent hybrid off-pump CABG combined with transaortic TAVI. A full sternotomy allowed off-pump arterial and vein graft anastomosis to significantly stenosed coronaries. The first three patients had severe aorto-iliac disease precluding femoral access; the fourth patient was deemed unsuitable for PCI. Transaortic TAVI using Edwards Sapien 3 valves were performed without complication in all four patients. CONCLUSION: The hybrid off-pump CABG and transaortic TAVI procedure allows for more complete coronary revascularization, negates the need for DAPT, and minimizes treatment delay of a TAVI procedure, particularly in patients unsuitable for transfemoral access. We propose this as an important treatment option for the heart team to consider. © 2016 Wiley Periodicals, Inc.

Long-Term Survival After Off-Pump Coronary Artery Bypass Grafting.

BACKGROUND: The aim of this study was to compare the long-term survival rates of patients undergoing isolated first-time coronary artery bypass grafting (CABG) by off-pump CABG with the long-term survival rates in patients undergoing CABG using cardioplegic cardiopulmonary bypass techniques. METHODS: All patients undergoing isolated CABG at a single center (Manchester Heart Centre, Manchester, United Kingdom) between 2000 and 2014 were included. Propensity score matching was performed on the basis of on demographic variables. The in-hospital morbidity and long-term all-cause mortality rates for matched patients were compared. RESULTS: A total of 8,055 patients were identified, with a median follow-up of 7.0 years. With patients matched for preoperative patient characteristics, there was no significant difference in long-term survival between cardiopulmonary bypass and off-pump CABG (n = 2,082 each; 11.5 years vs 11.3 years; p = 0.178). In the off-pump CABG group, there were significantly fewer in-hospital cerebrovascular complications (0.5% vs 1.1%; p = 0.017), and mean length of stay was shorter (7.6 days vs 8.1 days; p < 0.0001). Arterial conduit use was significantly higher in the off-pump group, with more right mammary artery grafts (16.3% vs 4.3%; p < 0.0001) and sequential grafts (27.1% vs 13.5%; p < 0.0001). The mean number of grafts was higher in the on-pump group (3.28 ± 0.94 vs 3.10 ± 1.10; p < 0.0001). CONCLUSIONS: Long-term survival after off-pump CABG is not inferior to long-term survival after on-pump CABG despite a lower mean number of grafts. A statistically significant difference in cerebrovascular complications may be related to conduit choice and reduced aortic manipulation.

Pseudoaneurysm of the Right Internal Mammary Artery Post Vacuum-Assisted Closure Therapy: A Rare Complication and Literature Review.

Vacuum-assisted closure (VAC) therapy in the management of sternal wound infection post cardiac surgery has gained popularity since last decade. It is very cost effective and has survival benefit compared with conventional management. Although there are few complications associated with VAC therapy including right ventricular free wall rupture and infectious erosion to aorta, there are now isolated reports of vein graft pseudoaneurysm associated with it. We describe an extremely rare complication of right internal mammary artery pseudoaneurysm post VAC therapy in a 56-year-old man which was successfully managed surgically. We also did a literature review on the possible complications of VAC therapy post cardiac surgery and its management.

Mechanical aortic valve-on-valve replacement in previous Bentall procedure: an alternate technique.

Acute aortic valve regurgitation due to thrombosed prosthetic valve can present as a surgical emergency. This article reports a successful and unusual management of a young pregnant female patient who presented with acute aortic valve regurgitation due to a thrombosed mechanical aortic valve. As the patient had previous multiple cardiac surgeries, the options were limited for repeat aortic valve or aortic root replacement. The patient had caesarean section followed by implantation of a mechanical valve-on-valve in a previously placed composite valved conduit. This technique may be useful for reoperative valve replacement in the setting of a prior mechanical Bentall patient.

Brucella melitensis sternal osteomyelitis following median sternotomy.

Human brucellosis, a zoonotic infection, may present with a range of symptoms but is rarely described as a cause of surgical site infections. We present the first reported case of Brucella melitensis causing sternal osteomyelitis of a midline sternotomy for a coronary artery bypass graft. The operation was performed in a non-endemic country but the patient had travelled to Syria immediately before surgery, where the infection was assumed to have been acquired. The infection resolved following treatment with doxycycline, rifampicin and gentamicin. We review the literature for surgical site infections related to Brucella species and discuss the infection control implications. Human brucellosis has the potential to cause surgical site infections and it should be in the differential diagnosis of any patient with a relevant exposure history presenting with a febrile illness and musculoskeletal findings.

The mechanism of endocardial lead-induced tricuspid regurgitation.

Using this case report we attempt to define the mechanism of endocardial lead-induced tricuspid regurgitation (TR) in particular the direct effect of endocardial pacing leads on the competence of the tricuspid valve. We recommend a high index of suspicion and an early diagnostic strategy in order to reduce long-term morbidity which is associated with this condition and the need for a potentially avoidable surgery.

Transient severe aortic regurgitation and left ventricular dysfunction due to a stuck leaflet in a patient undergoing percutaneous transcatheter aortic valve implantation.

We report the case of a 78-year-old patient who underwent transcatheter aortic valve implantation. During the deployment, the leaflets of the implanted valve appeared to be stuck in calcium protruding from the native aortic leaflets, resulting in transient severe aortic regurgitation leading to cardiac arrest with successful cardiac resuscitation. Transient severe aortic regurgitation secondary to the mechanical failure of the deployed valve can lead to serious clinical consequences.

Aortic valve fibroelastoma masquerading as transient ischaemic attack.

The following paper is on a 49-year-old man who presented to accident and emergency department having experienced five hours of left-sided chest pain, tightness in the chest, and shortness of breath. He also reported paresthesia and an ache in the left arm. Further investigations revealed an aortic valve papillary fibroelastoma. Although histologically papillary fibroelastomas are described as benign, they carry with them considerable risk of morbidity and mortality. This patient experienced recurrent transient ischemic attacks (TIAs'). He was taken to theatre on urgent basis to remove the papillary fibroelastoma. His aortic valve was preserved during the operation. The patient had an uneventful recovery following the surgery. His neurologic symptoms resolved following the operation. The operation was curative and no further symptoms were reported at followup.

Pulmonary valve replacement through a left thoracotomy approach.

We report here the first case, to our knowledge, of pulmonary valve replacement being performed via a left thoracotomy approach in a patient with pectus excavatum who had 3 previous sternotomies. The merit of this approach and its feasibility are discussed.

Off-pump coronary artery bypass grafting in a patient with Bernard-Soulier syndrome.

We report a case of a patient with Bernard-Soulier syndrome who underwent off-pump coronary artery bypass grafting. Bernard-Soulier syndrome is a rare bleeding disorder caused by an abnormality or absence of a platelet membrane receptor (GPIb-IX-V) resulting in prolonged bleeding time, macrothrombocytes, and thrombocytopenia. We describe the strategy for a patient with Bernard-Soulier syndrome undergoing successful coronary artery bypass grafting.

Association of IL6 and IL10 with renal dysfunction and the use of haemofiltration during cardiopulmonary bypass.

OBJECTIVE: Assessment of the effects of haemofiltration during cardiopulmonary bypass (CPB) in coronary artery bypass grafting (CABG) on the renal function and correlation with interleukin 6 (IL6) and interleukin 10 (IL10) levels. METHODS: Seventy-nine patients scheduled for elective CABG were prospectively randomised into two groups. Group A with a haemofilter attached to arterial line of the CPB circuit and group B without a haemofilter. The two groups were comparable in their symptoms, sex, and previous history of myocardial infarction, left ventricular function, cross-clamp time, bypass time and total grafting per patients. Blood urea and creatinine levels were measured the day before operation, 12h after operation and on the 3rd postoperative day. IL6 and IL10 were measured in blood samples collected 1h before surgery, on arrival to ITU and after 12h. IL6 and IL10 levels were measured using ELISA test. RESULTS: High levels of IL6 (>100 pg/ml) postoperatively were associated with increased incidence of renal dysfunction (p<0.017). Additionally, high IL10 (>30 pg/ml) levels postoperatively were associated with increased incidence of renal dysfunction (p<0.014). There were no effects of the haemofilter on postoperative IL6 and IL10 levels. Use of haemofiltration during CPB was found not to be protective against renal dysfunction (p<0.071). CONCLUSIONS: Haemofilter use during cardiopulmonary bypass does not have a protective effect on postoperative kidney function. Haemofilter has no effect on the level of IL6 and IL10.

Edge-to-edge repair of tricuspid valve in a corrected transposition of the great vessels.

We describe the case of a 27-year-old Caucasian woman with corrected transposition of the great vessels, who presented with cardiac failure. She had severe regurgitation of the systemic tricuspid valve with a huge annulus that was not suitable for annuloplasty. She underwent a successful repair using the Alfieri edge-to-edge technique and was asymptomatic 15 months after surgery. Such a repair has not been reported in the past.

Coronary surgery in patients with peripheral vascular disease: effect of avoiding cardiopulmonary bypass.

BACKGROUND: An increasing number of patients with peripheral vascular disease are undergoing coronary artery bypass grafting. Such patients have an increased risk of adverse outcomes. Our aim was to quantify the effect of avoiding cardiopulmonary bypass in this group of patients. METHODS: Between April 1997 and March 2002, 3,771 consecutive patients underwent coronary artery bypass grafting performed by five surgeons. Four hundred and twenty-two (11.2%) had peripheral vascular disease and of these, 211 (50%) received off-pump surgery. We used multivariate logistic regression analysis to assess the effect of off-pump surgery on in-hospital mortality and morbidity, while adjusting for treatment selection bias. Treatment selection bias was controlled for by constructing a propensity score, which was the probability of receiving off-pump surgery and included core patient characteristics. The C statistic for this model was 0.8. RESULTS: Off-pump patients were more likely to have preoperative renal dysfunction, previous gastrointestinal surgery, and less extensive disease. The left internal mammary artery was used more in off-pump compared to on-pump cases (90.1% vs 82.9%; p = 0.033). In the univariate analyses, off-pump patients were less likely to have a postoperative stroke (p = 0.007), and had shorter postoperative hospital stays (p < 0.001). However, the incidence of new atrial arrhythmia was higher (p = 0.028). After adjustment for differences in case-mix (propensity score), avoidance of cardiopulmonary bypass was still associated with a significant reduction in postoperative stroke (adjusted odds ratio 0.09 [95% confidence interval 0.02 to 0.50]; p = 0.005), and shorter postoperative hospital stay (p = 0.001). CONCLUSIONS: Off-pump coronary surgery is safe in patients with peripheral vascular disease, with acceptable results. The incidence of postoperative stroke is substantially reduced when avoiding cardiopulmonary bypass in patients with peripheral vascular disease.