Prognostic impact of secondary prevention after coronary artery bypass grafting-insights from the TiCAB trial.

OBJECTIVES: There are disparities in the adherence to guideline-recommended therapies after coronary artery bypass graft (CABG). We therefore sought to evaluate the effect of guideline-adherent medical secondary prevention on 1-year outcome after CABG. METHODS: Data were taken from the randomized 'Ticagrelor in CABG' trial. From April 2013 until April 2017, patients who underwent CABG were included. For the present analysis, we compared patients who were treated with optimal medical secondary prevention with those where 1 or more of the recommended medications were missing. RESULTS: Follow-up data at 12 months were available in 1807 patients. About half (54%) of them were treated with optimal secondary prevention. All-cause mortality [0.5% vs 3.5%, hazard ratio (HR) 0.14 (0.05-0.37), P < 0.01], cardiovascular mortality [0.1% vs 1.7%, HR 0.06 (0.01-0.46), P = 0.007] and major adverse events [6.5% vs 11.5%, HR 0.54 (0.39-0.74), P < 0.01] were significantly lower in the group with optimal secondary prevention. The multivariable model for the primary end point based on binary concordance to guideline recommended therapy identified 3 independent factors: adherence to guideline recommended therapy [HR 0.55 (0.39-0.78), P < 0.001]; normal renal function [HR 0.99 (0.98-0.99), P = 0.040]; and off-pump surgery [HR 2.06 (1.02-4.18), P = 0.045]. CONCLUSIONS: Only every second patient receives optimal secondary prevention after CABG. Guideline adherent secondary prevention therapy is associated with lower mid-term mortality and less adverse cardiovascular events after 12 months.

Transcatheter valve-in-valve implantation versus surgical redo aortic root replacement in patients with degenerated freestyle aortic bioprosthesis.

BACKGROUND: Transcatheter aortic valve-in-valve implantation (ViV TAVI) represents a new treatment option for patients with degenerated aortic bioprosthesis. Comparative data to redo surgical aortic valve replacement (redo SAVR) are limited. OBJECTIVE: We investigated feasibility and outcome of ViV TAVI versus redo SAVR in patients with symptomatic degenerated Medtronic Freestyle aortic bioprosthesis (FSB). METHODS: Between January 2002 and February 2020, 25 patients with failed FSB underwent ViV TAVI and 10 patients with failed FSB underwent redo SAVR. Endpoints were defined according to the Valve Academic Research Consortium-2 (VARC-2) criteria. RESULTS: Age and logistic EuroSCORE II were higher in patients with ViV TAVI (75.4 ± 1.7 vs. 62.9 ± 5.1 years, p = .019; 11.5 ± 1.6 vs. 5.6 ± 5.6%, p = .007). Valve implantation was successful in all cases. Mean transvalvular pressure gradients were significantly lower in patients with redo SAVR than ViV TAVI (7.6 ± 1.0 vs. 10.3 ± 0.8 mmHg, p = .037). Aortic valve regurgitation was absent in 91% and 100% of patients with ViV TAVI and redo SAVR, respectively. Thirty-day mortality rates were 12% in the ViV TAVI cohort versus 0% in the redo SAVR cohort (p = .542). Within the first year after hospital discharge, one patient after ViV TAVI had redo surgical intervention. CONCLUSIONS: ViV TAVI and redo SAVR lead to excellent functional results in patients with degenerated FSB. Post-procedural early complications must be considered particularly in patients with ViV TAVI because of higher clinical risk profiles.

Randomized trial of ticagrelor vs. aspirin in patients after coronary artery bypass grafting: the TiCAB trial.

AIMS: The antiplatelet treatment strategy providing optimal balance between thrombotic and bleeding risks in patients undergoing coronary artery bypass grafting (CABG) is unclear. We prospectively compared the efficacy of ticagrelor and aspirin after CABG. METHODS AND RESULTS: We randomly assigned in double-blind fashion patients scheduled for CABG to either ticagrelor 90 mg twice daily or 100 mg aspirin (1:1) once daily. The primary outcome was the composite of cardiovascular death, myocardial infarction (MI), repeat revascularization, and stroke 12 months after CABG. The main safety endpoint was based on the Bleeding Academic Research Consortium classification, defined as BARC ≥4 for periprocedural and hospital stay-related bleedings and BARC ≥3 for post-discharge bleedings. The study was prematurely halted after recruitment of 1859 out of 3850 planned patients. Twelve months after CABG, the primary endpoint occurred in 86 out of 931 patients (9.7%) in the ticagrelor group and in 73 out of 928 patients (8.2%) in the aspirin group [hazard ratio 1.19; 95% confidence interval (CI) 0.87-1.62; P = 0.28]. All-cause mortality (ticagrelor 2.5% vs. aspirin 2.6%, hazard ratio 0.96, CI 0.53-1.72; P = 0.89), cardiovascular death (ticagrelor 1.2% vs. aspirin 1.4%, hazard ratio 0.85, CI 0.38-1.89; P = 0.68), MI (ticagrelor 2.1% vs. aspirin 3.4%, hazard ratio 0.63, CI 0.36-1.12, P = 0.12), and stroke (ticagrelor 3.1% vs. 2.6%, hazard ratio 1.21, CI 0.70-2.08; P = 0.49), showed no significant difference between the ticagrelor and aspirin group. The main safety endpoint was also not significantly different (ticagrelor 3.7% vs. aspirin 3.2%, hazard ratio 1.17, CI 0.71-1.92; P = 0.53). CONCLUSION: In this prematurely terminated and thus underpowered randomized trial of ticagrelor vs. aspirin in patients after CABG no significant differences in major cardiovascular events or major bleeding could be demonstrated. CLINICALTRIALS.GOV IDENTIFIER: NCT01755520.

Safety of Simultaneous Coronary Artery Bypass Grafting and Carotid Endarterectomy Versus Isolated Coronary Artery Bypass Grafting: A Randomized Clinical Trial.

BACKGROUND AND PURPOSE: The optimal operative strategy in patients with severe carotid artery disease undergoing coronary artery bypass grafting (CABG) is unknown. We sought to investigate the safety and efficacy of synchronous combined carotid endarterectomy and CABG as compared with isolated CABG. METHODS: Patients with asymptomatic high-grade carotid artery stenosis ≥80% according to ECST (European Carotid Surgery Trial) ultrasound criteria (corresponding to ≥70% NASCET [North American Symptomatic Carotid Endarterectomy Trial]) who required CABG surgery were randomly assigned to synchronous carotid endarterectomy+CABG or isolated CABG. To avoid unbalanced prognostic factor distributions, randomization was stratified by center, age, sex, and modified Rankin Scale. The primary composite end point was the rate of stroke or death at 30 days. RESULTS: From 2010 to 2014, a total of 129 patients were enrolled at 17 centers in Germany and the Czech Republic. Because of withdrawal of funding after insufficient recruitment, enrolment was terminated early. At 30 days, the rate of any stroke or death in the intention-to-treat population was 12/65 (18.5%) in patients receiving synchronous carotid endarterectomy+CABG as compared with 6/62 (9.7%) in patients receiving isolated CABG (absolute risk reduction, 8.8%; 95% confidence interval, -3.2% to 20.8%; PWALD=0.12). Also for all secondary end points at 30 days and 1 year, there was no evidence for a significant treatment-group effect although patients undergoing isolated CABG tended to have better outcomes. CONCLUSIONS: Although our results cannot rule out a treatment-group effect because of lack of power, a superiority of the synchronous combined carotid endarterectomy+CABG approach seems unlikely. Five-year follow-up of patients is still ongoing. CLINICAL TRIAL REGISTRATION: URL: https://www.controlled-trials.com. Unique identifier: ISRCTN13486906.

A Decade of Transapical Aortic Valve Implantation.

BACKGROUND: Transcatheter-based aortic valve procedures have undergone tremendous evolution during the past decade and have led to great changes in the treatment of valvular heart disease. The Hospital of the Johann Wolfgang Goethe University, Frankfurt am Main, Germany is one of the three pioneering centers that started performing transapical transcatheter aortic valve implantation (TA-TAVI) back in 2005, and this study reviews the 10-year institutional experience with this approach. METHODS: From January 2005 through January 2015, 312 consecutive high-risk patients underwent TA-TAVI. Echocardiographic follow-up at discharge, at 6 and 12 months, and yearly thereafter was 100% complete. Structural behavior of the balloon-expandable valves in 11 patients with a mean follow-up time beyond 8 years was additionally evaluated at latest follow-up using computed tomography measurements. RESULTS: The age of the patients in this study was 79.8 ± 5.8 years, and the mean logistic EuroSCORE II and The Society of Thoracic Surgeons score were 23.9% ± 17.2% and 9.8% ± 8.6%, respectively. Perioperative, 30-day, and in-hospital mortality rates were 1.3%, 8.2%, and 9.5%, respectively, with a decrease in 30-day mortality to 4.2% in 2014. The incidence of neurologic complications was 3.2%. Mean length of hospital stay was 8.7 ± 4.3 days. Echocardiographic results demonstrated a significant and persistent increase of effective aortic valve orifice area (preoperative: 0.69 ± 0.1 cm(2) vs. late-follow-up: 1.52 ± 0.2 cm(2); p = 0.04) and a decrease in mean transvalvular gradient (preoperative: 49.5 ± 8.2 mm Hg vs. late-follow-up: 13.8 ± 4.3 mm Hg; p = 0.03) after a mean follow-up time of 4.1 ± 2.3 years. Overall survival rates were 73% ± 2% and 56% ± 6% at 3 and 5 years, respectively. Computed tomography measurements have not shown any signs of stress fracture of balloon-expandable stents up to 8 years of follow-up. CONCLUSIONS: A decade after clinical introduction of TA-TAVI, procedural and technical advances have made it an established alternative to classic aortic valve replacement in high-risk patients with aortic valve stenosis. Despite limited worldwide data on hemodynamic and structural valve behavior beyond 8 years, 11 patients from our early experience who were followed up for 8 years in the current report did not have any signs of structural valve dysfunction.

Cardiac reoperations in octogenarians: Do they really benefit?

AIM: According to the demographic development of our society, the numbers of octogenarians referred to cardiac surgery are continuously growing. Although the benefit of first-time cardiac procedures for these patients is well documented, the fate of octogenarians after redo-procedures, with special regard to long-term survival, functional status and quality of life, is poorly investigated. METHODS: We retrospectively identified 84 consecutive patients aged ≥80 years, who underwent a cardiac reoperation at the department for Cardiothoracic Surgery in the Heart & Vessel Center Bad Bevensen between January 2007 and 2013. Demographic profiles as well as operative data were analyzed, and the patients were prospectively followed. Patient's functional status and quality of life were assessed with the Barthel Index, New York Heart Association class and the short form-12 questionnaire. RESULTS: The mean age of the study group (61 men, 23 women) was 81.9 ± 1.9 years. Most redo-procedures were carried out after primary coronary artery bypass grafting (65%), primary aortic valve replacement (21%) and primary mitral valve replacement (6%). The most frequent actual surgical procedures were combined coronary artery bypass grafting and aortic valve replacement (26%), isolated coronary artery bypass grafting (19%), and isolated aortic valve replacement (19%). The mean length of hospital stay was 17 ± 15 days. In-hospital mortality counted for 32.1%. During follow up (29 ± 20 months) a further 19.0% of the patients died. The Barthel Index of the survivors was 89 ± 17 and their mean New York Heart Association class was 2 ± 1. A total of 93% of the patients were living at home. Summary scores of physical and mental health of the short form-12 questionnaire equalled those of an age- and sex-matched normative population. CONCLUSIONS: Despite high perioperative mortality, results document a sustainable recovery of the survivors offering the prospect of a highly independent and satisfying life. Therefore, advanced age alone should not be a contraindication for redo cardiac interventions. Geriatr Gerontol Int 2016; 16: 1138-1144.

Non-elective cardiac surgery in octogenarians: Do these patients benefit in terms of clinical outcomes and quality of life?

AIM: The general assumption that non-elective cardiac procedures in octogenarians are related to poor postoperative outcomes and quality of life (QOL) might lead to a non-justified exclusion of elderly patients from surgical treatment. The aim of the present study was to assess survival, functional outcome and quality of life of octogenarians undergoing non-elective cardiac surgery. METHODS: Between 2009 and 2011, 62 consecutive octogenarians (mean age 83.5 ± 3.5 years) underwent urgent (n = 33) or emergency (n = 29) cardiac surgery. In 69% of patients, coronary artery bypass grafting was carried out, and 24% of patients underwent coronary artery bypass grafting plus valve surgery. Preoperative risk, as well as the postoperative course, was analyzed. All discharged patients were contacted to gain information about survival, functional capacity and QOL using the Barthel Mobility Index and the Short Form 12 Health Survey questionnaire. Results were compared with age-adjusted population data. RESULTS: In-hospital mortality was 32.3% overall, 9.3% in urgent cases and 56.7% in emergency cases. After a mean follow-up period of 447 ± 359 days, survival of the discharged patients was 93.1% (urgent) and 76.9% (emergency), respectively. QOL measures of the survivors were equivalent to those of the general elderly population. Functional capacity, calculated with Barthel Index, was high in both groups (86 ± 13 and 81 ± 21). A total of 92% of the patients were living at home. CONCLUSIONS: Although non-elective cardiac surgery in the elderly is related to high in-hospital mortality, physical and psychological recovery of the survivors is encouraging. QOL equals that of the general elderly population, and good functional status offers a highly independent life. Therefore, age per se should not disqualify patients from urgent or emergency cardiac surgery.

Distortion of a hybrid stent graft following a frozen elephant trunk procedure.

We describe a case of an acute type A dissection, where technical problems during the frozen elephant trunk technique led to a distortion of the hybrid stent graft with severe stenosis of the thoracic aortic endoprosthesis. Interventional aortoplasty was performed to re-establish flow. This new technique bears some risk of technical failure and therefore should be applied only after careful considerations.

European experience of the convergent atrial fibrillation procedure: multicenter outcomes in consecutive patients.

BACKGROUND: The objective of this collaborative, multicenter, European effort was to evaluate the outcomes of the convergent procedure for the treatment of persistent and long-standing persistent atrial fibrillation (AF) in consecutive patients at 4 European centers. METHODS: Outcomes of consecutive patients, undergoing the convergent procedure at 4 European centers, were evaluated in this study. Epicardial ablation was performed before endocardial ablation. Convergent procedure outcomes were recorded by interrogation of implanted loop recorders or Holter monitors. Rhythm status and required interventions (antiarrhythmic drugs, cardioversions, and repeat ablations) were quantified 6 and 12 months after the procedure. Outcomes, monitoring type, and patient baseline characteristics were analyzed and reported. RESULTS: Seventy-three consecutive patients presenting with persistent AF (30.1%) or long-standing persistent AF (69.9%) underwent the convergent procedure between January 2010 and December 2011. At 6 months, 82% (56/68) were in sinus rhythm. At 12 months, 80% (53/66) were in sinus rhythm; single-procedure maintenance of sinus rhythm without postblanking period interventions was 76% (50/66); 52% (34/66) were in sinus rhythm and not receiving antiarrhythmic drugs. CONCLUSIONS: This multicenter European collaborative effort demonstrated that the convergent procedure is a safe and efficacious treatment option for persistent and long-standing persistent AF.

Prolonged intensive care treatment of octogenarians after cardiac surgery: a reasonable economic burden?

OBJECTIVES: In accordance with the rising prevalence of octogenarians undergoing cardiac surgery, these patients utilize an increasing portion of intensive care unit (ICU) capacities, provoking economic and ethical concerns. In this study, we evaluated the outcomes and costs generated by the prolonged postoperative ICU treatment of octogenarians. METHODS: Between July 2009 and August 2010, 109 of 1063 patients required ICU treatment of at least 5 days after cardiac surgery. Patients were retrospectively assigned to either Group A (age <80, n = 86) or Group B (age ≥80, n = 23). Operative risk, mortality, length and costs of ICU treatment were analysed and compared. After 1 year, survival, quality of life (QOL) and functional status were assessed. RESULTS: Hospital mortality was 31.4% in Group A and 56.5% in Group B. Survivals of discharged patients after 1 year were 83% (Group A) and 80% (Group B), respectively. Log EuroSCORE I of octogenarians was significantly higher (30 ± 17 vs 20 ± 16, P < 0.001). No significant differences (Group A vs Group B) were found between the groups concerning length of ICU treatment (20 ± 21 vs 16 ± 14 days, P = 0.577) or costs (27 205 ± 29 316€ vs 21 821 ± 16 259€, P = 0.812). Functional capacity, calculated by using Barthel index, was high (Group A: 87 ± 22 and Group B: 67 ± 31, P = 0.108) and did not differ significantly between groups. QOL, measured with the short form-12 health survey, did not differ significantly between groups (physical health summary score: P = 0.27; mental health score: P = 0.885) and was comparable with values of the age-adjusted general population. CONCLUSIONS: Presented data propose that advanced age is correlated with a higher mortality, but not with prolonged ICU treatment or higher costs after cardiac surgery. Considering the encouraging functional status and QOL of the survivors, the financial burden caused by octogenarians is justified.

Survival, functional capacity, and quality of life after cardiac surgery followed by long-term intensive care stay.

BACKGROUND: The rising prevalence of multimorbid patients undergoing cardiac surgery often leads to prolonged postoperative intensive care unit (ICU) treatment. The fate of these patients after discharge is poorly investigated. This study is aimed to assess survival, functional outcome, and quality of life (QOL) in patients after an ICU stay of at least 5 days. MATERIALS AND METHODS: Between August 2009 and July 2010, 1,092 patients underwent various cardiac procedures. Of these patients, 119 required ICU treatment of at least 5 days. Preoperative characteristics as well as postoperative course were analyzed and the discharged patients were contacted after 1 year to gain information about survival, functional capacity, and QOL. RESULTS: European system for cardiac operative risk evaluation I of the patients was 22.3 ± 16.7. Mean ICU stay was 19 ± 20 days. Forty three patients (36.1%) died in the hospital, 1-year overall survival was 46.2%, and 1-year survival of the discharged patients was 72.4%. Barthel mobility index was 85, showing a satisfactory mobilization. QOL, assessed with short form 12 questionnaire, was comparable with the reference group. CONCLUSION: Long-term ICU treatment after cardiac surgery is related to a high in-hospital and follow-up mortality. The physical and psychological recovery of the survivors is encouraging, justifying the extensive engagement of hospital resources.

Suction-irrigation drainage: an underestimated therapeutic option for surgical treatment of deep sternal wound infections.

OBJECTIVES: Deep sternal wound infections are significant and severe complications following cardiac surgery and substantially influence perioperative morbidity and mortality. We present the experience of our department using two different surgical treatments over a three-year period. METHODS: Between January 2009 and December 2011, a total of 3274 cardiac procedures with complete median sternotomy were performed in our department. In 94 patients (3%), a deep sternal wound infection occurred, including sternal instability with consecutive surgical treatment. The patients either received wound debridement with sternum refixation and suction-irrigation drainage (SID; n = 72) or sternum refixation only (RF; n = 22) if there was sternal instability with limited signs of infection. SID was routinely installed for 7 days: the irrigation solution contained neomycin. In all cases, swabs were taken and analysed. The different methods were evaluated in respect of their clinical outcomes. RESULTS: The success rate-defined as single, uncomplicated procedure-of the SID treatment was 74%, compared with 59% of the isolated sternum refixation. Complications included continuous infection, recurrence of sternal instability and wound necrosis. Eighty-eight percent of the swabs in the SID group were positive, compared with 32% in the sternal refixation only group. The dominating pathogenic germs were coagulase-negative staphylococci and staphylococcus aureus. Mortality was 10% for the SID group and 5% for the RF group. CONCLUSIONS: Contrary to accepted opinion, the suction-irrigation drainage is an appropriate therapy for deep sternal wound infections. Nevertheless, deep sternal wound infections after cardiac surgery remain severe complications and are related to increased morbidity and mortality.

One-year multicentre outcomes of transapical aortic valve implantation using the SAPIEN XT™ valve: the PREVAIL transapical study.

OBJECTIVES: The study aimed to evaluate 1-year outcomes of the multicentre PREVAIL transapical (TA) study of TA-aortic valve implantation (AVI) in high-risk patients. METHODS: From September 2009 to August 2010, a total of 150 patients, aged 81.6 ± 5.8 years, 40.7% female, were included at 12 European TA-AVI experienced sites. Patients received 23 (n = 36), 26 (n = 57) and 29 mm (n = 57) second-generation SAPIEN XT™ (Edwards Lifesciences, Irvine, CA, USA) valves. The mean logistic EuroSCORE was 24.3 ± 7.0, and mean Society Thoracic Surgeons score was 7.5 ± 4.4%. RESULTS: Survival was 91.3% at 30 days and 77.9% at 1 year. Subgroup analysis revealed survivals of 91.7/88.9, 86.0/70.2, 96.55/91.2% for patients receiving 23-, 26- and 29-mm valves at 30 days and at 1 year, respectively. Transthoracic echocardiography revealed preserved left ventricular ejection fraction and low gradients. Aortic incompetence was none in 41/48, trace 30/36, mild 22/12 and moderate in 7/4% at discharge and 1 year. Walking distance increased from 221 (postimplant) to 284 m (at 1 year, P = 0.0004). Three patients required reoperation due to increasing aortic incompetence during follow-up. Causes of mortality at 1 year were cardiac (n = 7), stroke (n = 1) and others (n = 5). CONCLUSIONS: The European PREVAIL multicentre trial demonstrates good functionality and good outcomes for TA-AVI using the second-generation SAPIEN XT prosthesis and the ASCENDRA-II delivery system. The 29-mm SAPIEN XT valve was successfully introduced and showed excellent results.

Presternal false aneurysm due to osseous arrosion of the right ventricle.

Right ventricular rupture after open heart surgery is a rare but severe postoperative complication. In most cases, right ventricular bleeding is associated with mediastinitis and either directly caused by inflammatory processes or iatrogenically through penetration of dehiscent sternal edges or vacuum-assisted closure therapy. We describe a case of right ventricular rupture due to osseous arrosion in a closed chest in the absence of mediastinitis which led to the creation of a massive presternal false aneurysm.

Surgery of the ascending aorta, root remodelling and aortic arch surgery with circulatory arrest through partial upper sternotomy: results of 50 consecutive cases.

OBJECTIVES: Partial upper sternotomy is a routine approach to aortic valve surgery. For surgery of the ascending aorta or the aortic arch, this method is not well established yet. METHODS: From October 2007 to October 2010, 50 consecutive patients underwent procedures of the ascending aorta and the aortic arch using partial upper sternotomy. Thirty-six patients underwent replacement or tightening of the ascending aorta, 11 patients received additional replacement of the proximal arch and in 3 cases, a complete replacement of the aortic arch was performed. Thirty-nine patients underwent additional aortic valve surgery. RESULTS: Mean operation time was 249 ± 51 min. Mean aortic cross-clamp and cardiopulmonary bypass time were 95 ± 27 and 141 ± 35 min, respectively. No conversion to conventional sternotomy was performed. All valves appeared competent on postoperative echocardiography. Survival was 100%. One re-exploration for bleeding was necessary. One stroke (2%) occurred, one pacemaker was implanted due to third-degree AV block and 16 patients (32%) experienced atrial fibrillation. One patient suffered from sternal wound infection. One patient needed reoperation due to severe aortic insufficiency on postoperative day 13. Median postoperative ventilation time was 13 h, median intensive care unit (ICU) and hospital stay were 22 h and 7 days, respectively. CONCLUSIONS: Results show that minimally invasive surgical procedures of the ascending aorta and the aortic arch may be performed safely, with an excellent clinical outcomes and superior cosmesis. Short ICU and hospital stay indicate the beneficial effects of reduced surgical trauma for patient recovery.

PREVAIL TRANSAPICAL: multicentre trial of transcatheter aortic valve implantation using the newly designed bioprosthesis (SAPIEN-XT) and delivery system (ASCENDRA-II).

OBJECTIVES: Transapical (TA) aortic valve implantation (AVI) has evolved as an alternative procedure for high-risk patients. We evaluated the second-generation SAPIEN XT™ prosthesis in a prospective multicentre clinical trial. METHODS: A total of 150 patients (age: 81.6 ± 5.8 years; 40.7% female) were included. Prosthetic valves (diameter: 23 mm (n = 36), 26 mm (n = 57) and 29 mm (n = 57)) were implanted. The ASCENDRA-II™ modified delivery system was used in the smaller sizes. Mean logistic EuroSCORE was 24.3 ± 7.0%, and mean STS score 7.5 ± 4.4%. All patients gave written informed consent. RESULTS: Off-pump AVI was performed using femoral arterial and venous access wires as a safety net. All but two patients received TA-AVI, as planned. The 29-mm valve showed similar function as the values of two other diameters did. Three patients (2%) required temporary cardiopulmonary bypass support. Postoperative complications included renal failure requiring long-term dialysis in four, bleeding requiring rethoracotomy in four, respiratory complication requiring reintubation in eight and sepsis in four patients, respectively. Thirty-day mortality was 13 (8.7%) for the total cohort and 2/57 (3.5%) for patients receiving the 29-mm valve, respectively. Echocardiography at discharge showed none or trivial aortic incompetence (AI) in 71% and mild-AI in 22% of the patients. Post-implantation AI was predominantly paravalvular and ≥ 2+ in 7% of patients. One patient required reoperation for AI within 30 days. CONCLUSIONS: The PREVAIL TA multicentre trial demonstrates good functionality and good outcomes for TA-AVI, using the SAPIEN XT™ prosthesis and its second-generation ASCENDRA-II™ delivery system, as well successful introduction of the 29-mm SAPIEN XT™ valve for the benefit of high-risk elderly patients.

Importance of evaluating conduction block in radiofrequency ablation for atrial fibrillation.

OBJECTIVE: Atrial fibrillation (AF) is the most frequently diagnosed cardiac arrhythmia. Anti-arrhythmic drugs may be used to suppress ectopic foci and interrupt reentry circuits, but are often insufficient to treat recurrent AF and have a number of adverse effects. Alternative therapies, such as catheter and surgical ablation, have been explored. This investigation examines the importance of assessing exit block when performing surgical ablation during beating-heart treatment of AF. METHODS: This was an evaluation of pooled data from multicenter prospective results obtained in AF patients who received ablation with a new, irrigated, vacuum-integrated device that creates linear lesions during beating-heart/open-chest or minimally invasive, port-access procedures. Electrocardiogram or Holter data were collected intra-operatively and at 1, 3, 6, and 12 months. Outcomes were also evaluated for patients who were or 'were not' tested for exit block following the ablation procedure. RESULTS: A total of 93 patients were treated (61 open-chest surgeries, 32 port-access procedures). There were no device-related complications and no operative mortality. At 341 days' average follow-up, 71/86 (83%) patients were free from AF, 66/86 (77%) were in sinus rhythm, and 60/86 (70%) were free from AF and off Class I and III anti-arrhythmic drugs (AADs). At 12 months, 23/23 (100%) patients with exit block confirmed were AF free compared with 13/21 (62%) patients with exit block not tested (p≤0.01, Fisher's exact test); 20/23 (87%) were in sinus rhythm compared with 12/21 (57%) patients with exit block not tested (p≤0.05, Fisher's exact test); and 20/23 (87%) were AF free without Class I and III AADs compared with 10/21 (48%) patients with exit block not tested (p≤0.01, Fisher's exact test). Both open-chest and port-access procedures yielded decreases in left-atrial size from baseline to 6 months' follow-up. Patients undergoing port-access procedures also observed an increase in left-ventricular ejection fraction, which was also significant at 6 months. CONCLUSION: Patients in whom exit block was confirmed following an ablation procedure were more likely to have successful clinical outcomes. Since testing for exit block must be performed on a beating heart, total epicardial beating-heart ablation may provide an important treatment for AF, providing intra-operative feedback indicative of long-term outcomes.

Randomized clinical trial comparing a thermosensitive polymer (LeGoo) with conventional vessel loops for temporary coronary artery occlusion during off-pump coronary artery bypass surgery.

BACKGROUND: During off-pump coronary artery bypass graft (OPCABG) surgery, a bloodless surgical field is mandatory for visualization and construction of optimal coronary anastomoses. Presently used temporary vascular occluders are known to cause endothelial dysfunction and vessel injury. The present prospective multicenter randomized clinical trial evaluates safety and efficacy of a novel thermosensitive polymer (LeGoo) as an atraumatic temporary vascular occluder. METHODS: Between July 2008 and February 2010, 110 patients undergoing OPCABG were randomized between LeGoo (LG) and conventional vessel loops (VL) for coronary artery occlusion during construction of the distal anastomosis. A semiquantitative 4-point scale was used to evaluate the degree of bloodless surgical field and surgical comfort. Duration of coronary artery occlusion was also recorded. Safety during the operation and ensuing 30 days was evaluated by a composite endpoint of major adverse cardiac events that consisted of death from all causes, graft occlusion, myocardial infarction, and low cardiac output. RESULTS: Fifty-six patients (117 distal anastomoses) were randomly assigned to LG and 54 patients (122 anastomoses) to VL. There were 2 anastomoses crossed over from LG to the control arm, and 3 from control to LG. Five anastomoses in LG patients were treated with an alternative device (shunts). Satisfactory hemostasis was achieved in 88.0% of LG anastomoses (103 of 117) compared with 60.7% of VL anastomoses (74 of 122; p < 0.001). Mean total anastomotic time was 12.8 minutes in the LG group and 15.1 minutes in the VL group (p < 0.001). This difference was more pronounced for arteries on the posterior and lateral than on the anterior walls of the heart. Composite adverse events were similar in the two groups: 3 of 48 LG patients and 3 of 46 VL patients. There was 1 death in the LG group. One patient in the LG group and 1 in the VL arm had a myocardial infarction. No operation was converted from OPCABG to CABG with cardiopulmonary bypass. CONCLUSIONS: LeGoo is a safe and effective temporary coronary occluder during OPCABG. It provided a dry surgical field for visualization of the anastomotic field and surgical comfort more frequently than conventional vessel loops. In addition, anastomotic times were shorter with LG. Major cardiac adverse events were similar in the LG and VL arms.

One-year interim follow-up results of the TRAVERCE trial: the initial feasibility study for trans-apical aortic-valve implantation.

OBJECTIVES: To evaluate the interim results of the initial multicenter feasibility trial for trans-apical aortic-valve implantation (TA-AVI) in high-risk elderly patients with severe aortic stenosis. METHODS: A total of 168 patients were prospectively included in three European centers between February 2006 and April 2008. The Cribier-Edwards or Edwards SAPIEN™ Trans-catheter Heart Valve (23 mm and 26 mm) was implanted using an oversizing concept. Interventions were performed in a hybrid operative room (OR) (one center), with a mobile C-arm in the OR (one) and in the catheterization laboratory (one). Inclusion criteria included age ≥70 years and an increased risk profile (additive European System for Cardiac Operative Risk Evaluation (EuroSCORE) ≥9). RESULTS: Patient age was 82.1±5.6 years, 76% were female and the EuroSCORE was 11.3±1.8 (additive) and 27±12.7% (logistic). Cardiopulmonary bypass was used by intention in 14.2% during the initial phase, secondarily in 10.1% and 75% of the patients were treated off-pump. Valve implantation led to a good immediate result in 161 (95.8%) patients and problems were encountered in seven patients (malposition (two patients), migration (three patients) and severe incompetence (two patients)). Nine patients were converted to conventional surgery, early stroke occurred in two (1.2%) patients and 10 (6%) patients received a new pacemaker. At 30 days, 25 patients died, 48% of them due to cardiac-related causes. Overall survival at 30 days, 6 months and 1 year was 85%, 70% and 63%, respectively. CONCLUSIONS: The initial multicenter feasibility trial for TA-AVI (TRAVERCE) shows acceptable results of this promising technique, especially in view of the high-risk profile of the patients.