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1.
Article in English | MEDLINE | ID: mdl-38751044

ABSTRACT

OBJECTIVES: Surgical aortic valve replacement through conventional sternotomy yields excellent results. Minimally invasive techniques are deemed equally safe and serve as a viable and less traumatic alternative. However, it is unclear how both surgical techniques affect patient-reported outcomes. The objective of this trial is to compare postoperative cardiac-related quality of life and postoperative pain after upper hemisternotomy and conventional surgical aortic valve replacement. METHODS: In this single-centre, open-label, investigator-initiated randomized clinical trial, patients were randomized to upper hemisternotomy or conventional full median sternotomy. Patients unable to undergo randomization were monitored prospectively (registry group). Primary outcome was cardiac-specific quality of life, measured with the Kansas City Cardiomyopathy Questionnaire up to 1 year postoperatively. RESULTS: Patients undergoing upper hemisternotomy had a significantly higher physical limitation domain score across all postoperative time points than patients undergoing conventional surgical aortic valve replacement (estimated mean difference 2.12 points; P = 0.014). Patients undergoing upper hemisternotomy were more likely to have a pain score <30 the first 2 days postoperatively than patients undergoing conventional surgical aortic valve replacement (odds ratio 2.63; P = 0.007). This was associated with reduced opioid analgesic intake. Postoperative surgical outcome did not differ between both groups. CONCLUSIONS: Surgical aortic valve replacement through both conventional sternotomy and upper hemisternotomy resulted in clinically similar and important improvements in quality of life, with a small advantage for upper hemisternotomy, while there was no compromise in safety.

2.
Contemp Clin Trials Commun ; 21: 100700, 2021 Mar.
Article in English | MEDLINE | ID: mdl-33506139

ABSTRACT

BACKGROUND: Surgical aortic valve replacement (SAVR) via limited access approaches ('mini-AVR') have proven to be safe alternative for the surgical treatment of aortic valve disease. However, it remains unclear whether these less invasive approaches are associated with improved quality of life and/or reduced postoperative pain when compared to conventional SAVR via full median sternotomy (FMS). STUDY DESIGN: The LImited access Aortic valve Replacement (LIAR) trial is a single-center, single blind randomized controlled clinical trial comparing 2 arms of 80 patients undergoing limited access SAVR via J-shaped upper hemi-sternotomy (UHS) or conventional SAVR through FMS. In all randomized patients, the diseased native aortic valve is planned to be replaced with a rapid deployment stented bioprosthesis. Patients unwilling or unable to participate in the randomized trial will be treated conventionally via SAVR via FMS and with implantation of a sutured valve prosthesis. These patients will participate in a prospective registry. STUDY METHODS: Primary outcome is improvement in cardiac-specific quality of life, measured by two domains of the Kansas City Cardiomyopathy Questionnaire up to one year after surgery. Secondary outcomes include, but are not limited to: generic quality of life measured with the Short Form-36, postoperative pain, perioperative (technical success rate, operating time) and postoperative outcomes (30-day and one-year mortality), complication rate and hospital length of stay. CONCLUSION: The LIAR trial is designed to determine whether a limited access approach for SAVR ('mini-AVR') is associated with improved quality of life and/or reduced postoperative pain compared with conventional SAVR through FMS.The study is registered at ClinicalTrials.gov, number NCT04012060.

3.
Eur J Cardiothorac Surg ; 53(suppl_2): ii3-ii8, 2018 05 01.
Article in English | MEDLINE | ID: mdl-29718230

ABSTRACT

Minimally invasive aortic valve replacement (MIAVR) has proved to be a safe approach for the treatment of aortic valve stenosis and/or insufficiency and is associated with a number of additional benefits for patients. This includes reduced blood loss, reduced transfusion requirements, reduced length of hospital stay and improved aesthetic appearance. As all types of minimally invasive surgery rely on optimizing exposure within a more limited field of view, a thorough preoperative assessment of patients is important to identify and address potential exposure problems. MIAVR through an upper hemisternotomy is considered feasible in almost every patient, but various clinical conditions or anatomical variations can complicate the procedure and may impact on the postoperative outcome. MIAVR through an anterior right thoracotomy requires suitable anatomy, and this should be evaluated preoperatively through a computed tomography or magnetic resonance imaging scan. In this review, we aimed to present an overview of the current literature and to reflect on our personal experiences with MIAVR techniques. This should provide an aid-especially to surgeons wanting to start or have little experience with MIAVR-for a structured preoperative patient assessment and planning to increase the chance of a safe procedure with a good outcome.


Subject(s)
Aortic Valve/surgery , Minimally Invasive Surgical Procedures/methods , Aortic Valve Insufficiency/diagnostic imaging , Aortic Valve Insufficiency/surgery , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/surgery , Heart Valve Prosthesis Implantation , Humans , Patient Care Planning
4.
Europace ; 18(10): 1528-1537, 2016 Oct.
Article in English | MEDLINE | ID: mdl-26721977

ABSTRACT

AIMS: To assess the results and impact of lesion set and surgical technique on long-term success of surgical ablation during mitral surgery. METHODS AND RESULTS: The patient population consisted of 685 subjects with persistent and long-standing persistent atrial fibrillation (AF) undergoing cardiac surgery for mitral valve disease as the primary indication and concomitant ablation between January 2003 and January 2012 at three institutions. One hundred and sixty-six underwent unipolar (24.2%), 371 (54.2%) bipolar, and 148 (21.6%) had combined ablation. Median follow-up was 58.4 months (interquartile range 43.3-67.9). To appropriately account for death, a competing risk model was employed to identify predictors of cumulative incidence of recurrent AF among lesion set and surgical techniques. Eight-year freedom from recurrent arrhythmia without antiarrhythmic drugs was 0.60 ± 0.02. Success rate was higher using bipolar radiofrequency (RF) (P < 0.001), after performing mitral isthmus line (P = 0.003) and following the biatrial technique (P < 0.001). Competing risk regression revealed that use of unipolar RF [sub-hazard ratio (SHR) 2.41 (1.52-3.43), P < 0.001], combined unipolar/bipolar ablation [SHR 1.93 (0.89-2.57), P = 0.003] and the absence of right atrial ablation [SHR 2.79 (1.27-3.48), P < 0.001] were predictors of cumulative incidence of long-term recurrence. CONCLUSIONS: Our experience suggests that the use of bipolar clamp improves long-term results in surgical treatment of AF and that right-sided ablation should be routinely added. Randomized studies are necessary to confirm our findings.


Subject(s)
Atrial Fibrillation/surgery , Cardiac Surgical Procedures/methods , Catheter Ablation/methods , Heart Valve Diseases/complications , Heart Valve Diseases/surgery , Mitral Valve/surgery , Aged , Female , Follow-Up Studies , Humans , Italy , Male , Middle Aged , Netherlands , Postoperative Complications/mortality , Recurrence , Regression Analysis , Retrospective Studies , Treatment Outcome
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