Dataset Information

Interdisciplinary and cross-sectoral perioperative care model in cardiac surgery: implementation in the setting of minimally invasive heart valve surgery (INCREASE)-study protocol for a randomized controlled trial.

ABSTRACT:

Background

Valvular heart diseases are frequent and increasing in prevalence. Minimally invasive heart valve surgery embedded in an interdisciplinary enhanced recovery after surgery (ERAS) program may have potential benefits with regard to reduced length of stay and improved patient reported outcomes. However, no prospective randomized data exist regarding the superiority of ERAS program for the patients' outcome.

Methods

We aim to randomize (1:1) a total of 186 eligible patients with minimally invasive heart valve surgery to an ERAS program vs. standard treatment at two centers including the University Medical Center Hamburg-Eppendorf, Germany, and the University Hospital Augsburg, Germany. The intervention is composed out of pre-, peri-, and postoperative components. The preoperative protocol aims at better preparation for the operation with regard to physical activity, nutrition, and psychological preparedness. Intraoperative anesthesiologic and surgical management are trimmed to enable an early extubation. Patients will be transferred to a specialized postoperative anesthesia care unit, where first mobilization occurs 3 h after surgery. Transfer to low care ward will be at the next day and discharge at the fifth day. Participants in the control group will receive treatment as usual. Primary endpoints include functional discharge at discharge and duration of in-hospital care during the first 12 months after index surgery. Secondary outcomes include health-related quality of life, health literacy, and level of physical activity.

Discussion

This is the first randomized controlled trial evaluating the effectiveness of an ERAS process after minimally invasive heart valve surgery. Interprofessional approach is the key factor of the ERAS process and includes in particular surgical, anesthesiological, physiotherapeutic, advanced nursing, and psychosocial components. A clinical implication guideline will be developed facilitating the adoption of ERAS model in other heart teams.

Trial registration

The study has been registered in ClinicalTrials.gov ( NCT04977362 assigned July 27, 2021).

SUBMITTER: Klotz SGR

PROVIDER: S-EPMC9229105 | biostudies-literature | 2022 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Interdisciplinary and cross-sectoral perioperative care model in cardiac surgery: implementation in the setting of minimally invasive heart valve surgery (INCREASE)-study protocol for a randomized controlled trial.

Klotz Susanne G R SGR Ketels Gesche G Behrendt Christian A CA König Hans-Helmut HH Kohlmann Sebastian S Löwe Bernd B Petersen Johannes J Stock Sina S Vettorazzi Eik E Zapf Antonia A Zastrow Inke I Zöllner Christian C Reichenspurner Hermann H Girdauskas Evaldas E

Trials 20220623 1

<h4>Background</h4>Valvular heart diseases are frequent and increasing in prevalence. Minimally invasive heart valve surgery embedded in an interdisciplinary enhanced recovery after surgery (ERAS) program may have potential benefits with regard to reduced length of stay and improved patient reported outcomes. However, no prospective randomized data exist regarding the superiority of ERAS program for the patients' outcome.<h4>Methods</h4>We aim to randomize (1:1) a total of 186 eligible patients ...[more]

PMID: 35739541

Similar Datasets

Project description:ObjectivesMitral valve (MV) disease is often accompanied by tricuspid valve (TV) disease. The indication for concomitant TV surgery during primary MV surgery is expected to increase, especially through a minimally invasive surgical (MIS) approach. The aim of the current study is to investigate the safety of the addition of TV surgery to MV surgery in MIMVS in a nationwide registry.MethodsPatients undergoing atrioventricular valve surgery through sternotomy or MIS between 2013 and 2018 were included. Patients undergoing MV surgery only through sternotomy or MIS were used as comparison. Primary outcomes were short-term morbidity and mortality and long-term survival. Propensity score matching was used to correct for potential confounders.ResultsThe whole cohort consisted of 2698 patients. A total of 558 patients had atrioventricular double valve surgery through sternotomy and 86 through MIS. As a comparison, 1365 patients underwent MV surgery through sternotomy and 689 patients through MIS. No differences in 30- and 120-day mortality were observed between the groups, both unmatched and matched. 5-year survival did not differ for double atrioventricular valve surgery through either sternotomy or MIS in the matched population (90.1% vs. 95.3%, Log-Rank p = .12). A higher incidence of re-exploration for bleeding (n = 12 [15.2%] vs. n = 3 [3.8%], p = .02) and new onset arrhythmia (n = 35 [44.3%] vs. n = 13 [16.5%], p < .001) was observed in double valve surgery through MIS. Median length of hospital stay (LOHS) was longer in the minimally invasive double valve group (9 days [6-13]) compared with sternotomy (7 days [6-11]; p = .04).ConclusionNo differences in short-term mortality and 5-year survival were observed when tricuspid valve was added to MV surgery in MIS or sternotomy. The addition of tricuspid valve surgery is associated with higher incidence of re-exploration for bleeding, new onset arrhythmia. A longer LOHS was observed for MIS compared to sternotomy.

Dataset Information

Interdisciplinary and cross-sectoral perioperative care model in cardiac surgery: implementation in the setting of minimally invasive heart valve surgery (INCREASE)-study protocol for a randomized controlled trial.

Background

Methods

Discussion

Trial registration

Publications

Interdisciplinary and cross-sectoral perioperative care model in cardiac surgery: implementation in the setting of minimally invasive heart valve surgery (INCREASE)-study protocol for a randomized controlled trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets