Impact of Thoracoscopic Pulmonary Vein Isolation on Right Ventricular Function: A Pilot Study.

OBJECTIVE: Thoracoscopic surgical pulmonary vein isolation (sPVI) has been added to the treatment of atrial fibrillation (AF), showing excellent efficacy outcomes. However, data on right ventricular (RV) function following sPVI has never been studied. Our aim was to investigate RV function following sPVI and compare it to patients who underwent endocardial cryoballoon PVI. METHODS: 25 patients underwent sPVI and were pair-matched according to age, sex, and AF type with 21 patients who underwent cryoballoon PVI. RV function was measured using tricuspid annular plane systolic excursion (TAPSE) and RV strain with 2D speckle tracking. Echocardiography was performed at baseline and at median 6-month follow-up. RESULTS: Age was 54 ± 9 years and 84% were male; AF was paroxysmal in 92%. In the sPVI group, TAPSE was reduced with 31% at follow-up echocardiography (p < 0.001) and RV strain showed a 25% reduction compared to baseline (p = 0.018). In the control group, TAPSE and RV strain did not change significantly (-3% and +13%, p = 0.410 and p = 0.148). Change in TAPSE and RV strain was significantly different between groups (p ≤ 0.001 and p = 0.005). CONCLUSIONS: This study shows that RV function is significantly decreased following sPVI. This effect was not observed in the cryoballoon PVI control group.

Long-term results of surgical minimally invasive pulmonary vein isolation for paroxysmal lone atrial fibrillation.

AIMS: Transcatheter pulmonary vein ablation is the current treatment of choice for symptomatic drug-refractory atrial fibrillation (AF). Video-assisted surgical pulmonary vein isolation (sPVI) is an alternative therapy to percutaneous ablation for the treatment of AF. Long-term results of sPVI are currently unknown. The aim of this study was to report on the long-term efficacy and safety of sPVI in patients with paroxysmal AF. METHODS AND RESULTS: The study design was observational and retrospective. From July 2005 to January 2011, 42 patients with drug-refractory paroxysmal AF underwent video-assisted sPVI in two different centres. Patients were eligible for sPVI when suffering from symptomatic, drug-refractory paroxysmal AF and they agreed to the alternative of sPVI. The median preoperative AF duration was 24 months (range 3-200). Success was defined as the absence of AF on 24 h or 96 h Holter monitoring during follow-up, off antiarrhythmic drugs (AAD). Adverse events and follow-up monitoring were based on the Heart Rhythm Society Consensus Statement 2012 for the catheter and surgical ablation of AF. Mean age was 55 ± 10 years, and 76% were males. After a mean follow-up of 5 years (SD 1.7), 69% of all patients were free from atrial arrhythmias without the use of AAD, and 83% with the use of AAD. Major peri-procedural adverse events occurred in four (9.5%) patients, no strokes or mortalities were registered during long-term follow-up. CONCLUSION: This retrospective study shows that sPVI for the treatment of paroxysmal AF is effective and that the outcomes are maintained at long-term follow-up.

Surgical minimally invasive pulmonary vein isolation for lone atrial fibrillation: midterm results of a multicenter study.

OBJECTIVE: Minimally invasive surgical pulmonary vein isolation (SMI-PVI) is an emerging therapy for the treatment of symptomatic drug-refractory atrial fibrillation (AF). Nevertheless, the midterm and long-term results of SMI-PVI remain unknown. The aim of this retrospective multicenter study was to report on midterm efficacy and safety of SMI-PVI. METHODS: The study design was retrospective, multicentric, and observational. From July 2005 to November 2011, a total of 86 patients with drug-refractory paroxysmal or persistent AF underwent SMI-PVI in three centers. Patients were eligible for SMI-PVI if they had symptomatic, drug-refractory AF or after failed transcatheter pulmonary vein isolation. Success was defined as absence of AF on 24- or 96-hour Holter monitoring during follow-up, in the absence of antiarrhythmic drugs (AADs). RESULTS: The mean ± SD age was 54 ± 11 years, and 78% were men. The median AF duration was 30 months (range, 2-203); paroxysmal AF was present in 86% of the patients, persistent in 14%. Fifteen patients (17%) underwent previous transcatheter ablations. After a median follow-up of 24 months (range, 6-78), 72% of all patients were free from atrial arrhythmias without the use of AADs. With AADs, this was 83%. Major perioperative adverse events occurred in 7 patients (8%). CONCLUSIONS: This retrospective multicenter study shows that SMI-PVI is effective at a median follow-up of 24 months for the treatment of mostly paroxysmal drug-refractory AF. Perioperative adverse events do remain a point of caution.

Guideline for the surgical treatment of atrial fibrillation.

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia and its prevalence is ∼1-2% of the general population, but higher with increasing age and in patients with concomitant heart disease. The Cox-maze III procedure was a groundbreaking development and remains the surgical intervention with the highest cure rate, but due to its technical difficulty alternative techniques have been developed to create the lesions sets. The field is fast moving and there are now multiple energy sources, multiple potential lesion sets and even multiple guidelines addressing the issues surrounding the surgical treatment of AF both for patients undergoing this concomitantly with other cardiac surgical procedures and also as stand-alone procedures either via sternotomy or via videothoracoscopic techniques. The aim of this document is to bring together all major guidelines in this area into one resource for clinicians interested in surgery for AF. Where we felt that guidance was lacking, we also reviewed the evidence and provided summaries in those areas. We conclude that AF surgery is an effective intervention for patients with all types of AF undergoing concomitant cardiac surgery to reduce the incidence of AF, as demonstrated in multiple randomized studies. There is some evidence that this translates into reduced stroke risk, reduced heart failure risk and longer survival. In addition, symptomatic patients with AF may be considered for surgery after failed catheter intervention or even as an alternative to catheter intervention where either catheter ablation is contraindicated or by patient choice.

The impact of transcatheter aortic valve implantation on patients' profiles and outcomes of aortic valve surgery programmes: a multi-institutional appraisal.

OBJECTIVES: The aim of this retrospective multicenter study was to assess how the development of transcatheter aortic valve implantation (TAVI) influenced the characteristics and outcomes of patients undergoing aortic valve procedures. METHODS: We reviewed 1395 patients who underwent isolated surgical aortic valve replacement (SAVR) or TAVI in three centres with a high-volume TAVI programme. Patients were divided into two groups: 'Pre-TAVI' (395 patients, 28.3%) and 'Post-TAVI' (1000 patients, 71.7%) operated on before and after the introduction of TAVI into clinical practice. We evaluated age, logistic EuroSCORE I (LES) and hospital mortality according to time periods and the procedure performed, whether SAVR or TAVI. RESULTS: 'Post-TAVI' patients were older (78.2 ± 7.8 vs 76.8 ± 6.7 years; P = 0.002) and with a significantly higher LES (17.8 ± 14.7 vs 9.1 ± 9.2%; P < 0.001) than 'Pre-TAVI' patients. Hospital mortality was not significantly different between groups ('Pre-TAVI' vs 'Post-TAVI': 2 vs 3.4%; P = 0.17). Of the 1000 'Post-TAVI' patients, 605 (60.5%) underwent TAVI and 395 (39.5%), SAVR. Patients undergoing TAVI were older (79.9 ± 7.1 vs 75.5 ± 9.2 years; P < 0.001) and with a higher LES (22.9 ± 15.3 vs 9.7 ± 9.3%; P < 0.001) than 'Post-TAVI' SAVR patients, but their hospital mortality was similar (3.9 vs 2.5%; P = 0.22). LES was similar between 'Pre-TAVI' and 'Post-TAVI' SAVR patients (9.1 ± 9.2 vs 9.7 ± 9.3%; P = 0.26). Furthermore, we did not find significant differences in the overall hospital mortality between SAVR and TAVI patients: 2.3 vs 3.9%, P = 0.08. CONCLUSIONS: This analysis shows that the development of TAVI has caused an increase in the preoperative risk profile of patients scheduled for aortic valve procedures (SAVR or TAVI) without increasing hospital mortality.

Sutureless aortic valve replacement as an alternative treatment for patients belonging to the "gray zone" between transcatheter aortic valve implantation and conventional surgery: a propensity-matched, multicenter analysis.

OBJECTIVE: The aim of this propensity-matched, multicenter study was to compare early clinical and echocardiographic outcomes of patients undergoing transapical aortic valve implantation (TA-TAVI) versus patients undergoing sutureless aortic valve replacement (SU-AVR) for severe symptomatic aortic valve stenosis. METHODS: We reviewed 468 TA-TAVIs performed in 20 centers from April 2008 to May 2011, and 51 SU-AVRs performed in 3 centers from March to September 2011. Based on a propensity score analysis, 2 groups with 38 matched pairs were created. Variables used in the propensity analysis were age, sex, body surface area, New York Heart Association class, logistic EuroSCORE, peripheral vascular disease, chronic obstructive pulmonary disease, aortic valve area, mitral regurgitation, and left ventricular ejection fraction. RESULTS: Preoperative characteristics of the 2 groups were comparable. Hospital mortality was 5.3% and 0% in the TA-TAVI and SU-AVR groups, respectively (P = .49). We did not observe stroke or acute myocardial infarction in the 2 groups. Permanent pacemaker implantation was needed in 2 patients of each group (5.3%, P = 1.0). Dialysis was required in 2 patients (5.3%) in the SU-AVR group and in 1 patient (2.7%) in the TA-TAVI group (P = 1.0). Predischarge echocardiographic data showed that the incidence of paravalvular leak (at least mild) was greater in the TA-TAVI group (44.7% vs 15.8%, P = .001), but there were no differences in terms of mean transprosthetic gradient (10.3 ± 5 mm Hg vs 11 ± 3.7 mm Hg, P = .59). CONCLUSIONS: This preliminary experience showed that, in patients at high risk for conventional surgery, SU-AVR is as safe and effective as TA-TAVI and that it is associated with a lower rate of postprocedural paravalvular leak.

EACTS guidelines for the use of patient safety checklists.

The Safety Checklist concept has been an integral part of many industries that face high-complexity tasks for many decades and in industries such as aviation and engineering checklists have evolved from their very inception. Investigations of the causes of surgical deaths around the world have repeatedly pointed to medical errors that could be prevented as an important cause of death and disability. As a result, the World Health Organisation developed and evaluated a three-stage surgical checklist in 2007 demonstrating that complications were significantly reduced, including surgical infection rates and even mortality. Together with the results from other large cohort studies into the utility of the surgical checklist, many countries have fully implemented the use of surgical checklists into routine practice. A key factor in the successful implementation of a surgical checklist is engagement of the staff implementing the checklist. In surgical specialties such as our own it was quickly seen that there were many important omissions in the generic checklist that did not cover issues particular to our specialty, and thus the European Association for Cardio-Thoracic Surgery embarked on a process to create a version of the checklist that might be more appropriate and specific to cardiothoracic surgery, including checks on preparations for excessive bleeding, perfusion arrangements and ICU preparations, for example. The guideline presented here summarizes the evidence for the surgical checklist and also goes through in detail the changes recommended for our specialty.

Clinical and hemodynamic outcomes of "all-comers" undergoing transapical aortic valve implantation: results from the Italian Registry of Trans-Apical Aortic Valve Implantation (I-TA).

OBJECTIVE: The aim of this study was to assess clinical and hemodynamic outcomes of transapical aortic valve implantation (TA-TAVI) in patients enrolled in the Italian Registry of Trans-Apical Aortic Valve Implantation (I-TA). METHODS: From April 2008 until November 2010, 504 patients from 20 Italian centers were enrolled in the I-TA registry. Mean logistic EuroSCORE and Society of Thoracic Surgeons score were 24% ± 16% and 11% ± 4%, respectively. Mean follow-up was 9.2 ± 6.5 months (range, 1-26 months). Outcomes were analyzed according to intraoperative complications, procedural volume (high-volume centers, >20 cases; low-volume centers, < 20 cases) and learning curve (first 50% cases vs second 50% cases of each center). RESULTS: All-cause overall mortality was 8.3% (42 patients). Device success was 99% (500/504 patients). Intraoperative severe complications occurred in 24 (4.8%) patients. Overall 2-year survival was 71.5% ± 6.2%. At discharge, peak and mean gradients were 16.4 ± 11.2 and 8.7 ± 4.1 mm Hg, respectively, and effective orifice area was 1.67 cm(2). These values remained stable at 3, 6, and 12 months after surgery. Independent risk factors for mortality after TA-TAVI were as follows: New York Heart Association class III and IV (odds ratio [OR], 4.43; 95% confidence intervals [CI], 1.28-15.40; P = .02); logistic EuroSCORE greater than 20 (OR, 1.83; 95% CI, 1.02-3.29; P = .04); creatinine concentration greater than 200 µmol/L (OR, 2.56; 95% CI, 1.07-6.15; P = .03), and intraoperative complications (OR, 5.80; 95% CI, 2.68-12.55; P < .001). There were no significant differences in outcomes between high- and low-volume centers and between the first and the second 50% of cases. CONCLUSIONS: TA-TAVI represents a safe and effective alternative treatment for patients who are inoperable or at high risk for surgery. The occurrence of an intraoperative complication significantly affects survival. Procedural volume and learning curve have no impact on patient survival.

Neochordae implantation made easy with an adjustable device: early report of acute and chronic animal experiments.

OBJECTIVE: Neochordae implantation is a well-established surgical solution for the treatment of mitral valve prolapse. The main limitation to wide usage of the technique has been the difficulty associated with accurate determination of neochordal length. We describe a system specifically designed to facilitate rapid, uncomplicated implantation and off-pump, beating heart adjustment of neochordae. METHODS: Five swine underwent implantation of the adjustable neochordal system (V-Chordal; Valtech Cardio LTD, Israel) while on cardiopulmonary bypass after cutting native chordae to create a significant lesion. Neochordae length was adjusted with millimeter-level resolution, off-pump after discontinuation from bypass. RESULTS: In all animals, the implant was successful. Under echocardiographic monitoring, flail lesions were corrected in all cases, using the anatomic landmarks or the degree of mitral regurgitation for real-time guidance. At postmortem gross examination, the implant and the neochordae were completely healed with evidence of tissue ingrowth. CONCLUSIONS: Preliminary animal experience suggests that the V-Chordal-adjustable neochordae system can be safely and effectively implanted, with accurate and precise adjustment of chordal length. The design of the device is suitable for a minimally invasive environment because of the long, flexible shafted design of the delivery system.

Transcatheter valve implantation for patients with aortic stenosis: a position statement from the European Association of Cardio-Thoracic Surgery (EACTS) and the European Society of Cardiology (ESC), in collaboration with the European Association of Percutaneous Cardiovascular Interventions (EAPCI).

AIMS: To critically review the available transcatheter aortic valve implantation techniques and their results, as well as propose recommendations for their use and development. METHODS AND RESULTS: A committee of experts including European Association of Cardio-Thoracic Surgery and European Society of Cardiology representatives met to reach a consensus based on the analysis of the available data obtained with transcatheter aortic valve implantation and their own experience. The evidence suggests that this technique is feasible and provides haemodynamic and clinical improvement for up to 2 years in patients with severe symptomatic aortic stenosis at high risk or with contraindications for surgery. Questions remain mainly concerning safety and long-term durability, which have to be assessed. Surgeons and cardiologists working as a team should select candidates, perform the procedure, and assess the results. Today, the use of this technique should be restricted to high-risk patients or those with contraindications for surgery. However, this may be extended to lower risk patients if the initial promise holds to be true after careful evaluation. CONCLUSION: Transcatheter aortic valve implantation is a promising technique, which may offer an alternative to conventional surgery for high-risk patients with aortic stenosis. Today, careful evaluation is needed to avoid the risk of uncontrolled diffusion.