Successful fast track protocol implementation for patients undergoing transapical transcatheter aortic valve implantation

TA-TAVI was introduced as a novel technique in our department in 2005 [8]. Fast-track protocol has been routinely applied for TA-TAVI patients since 2008. Between January 2008 and June 2013, 207 consecutive high-risk patients underwent TA-TAVI followed by the fast-track postoperative treatment approach. The choice of treatment was made at the discretion of the heart team, consisting of 2 cardiac surgeons, 2 interventional cardiologists and lately 2 anaesthesiologists. From 2007 on we assessed all TAVI candidates according to the established recommendations and guidelines in order to find the best possible TAVI approach for each individual patients. Patient data were collected prospectively during treatment using standardized forms to record demographic and clinical characteristics as well as procedural and follow-up data. The local Ethics Committee at the Hospital of the Johann Wolfgang Goethe University, Frankfurt/Main, Germany approved the study protocol and individual patient consent was waived.

After insertion of a radial artery catheter for invasive monitoring of arterial pressure, anesthesia was introduced using sufentatil (Janssen, Neuss, Germany), disoprivan (Fresenius Kabi, Bad Homburg, Germany) as well as rocuronium (Essex pharma, Munich, Germany), and was maintained with disoprivan (Fresenius Kabi, Bad Homburg, Germany) and remifentanil (Braun, Melsungen, Germany). Oropharyngeal intubation and insertion of a central venous catheter (in the internal jugular vein) was performed afterwards. Mechanical ventilation with biphasic positive airway pressure was established after the intubation adjusted to the gas exchange (Dräger Oxylog 3000, Dräger Medical Germany GmbH, Lübeck, Germany). Further anesthesiologic management included a peripheral venous and urinary catheter. Despite continuous peripheral oxygen saturation control, respiration was monitored at fixed time intervals by blood gas analysis measurements.

Our institutional protocol for TA-TAVI has been previously described in detail [9, 10]. Briefly, all operations were performed in a specially equipped angiography suite that fulfils the standards of a hybrid operating room. Besides standard hemodynamic monitoring, transesophageal echocardiography and CPB were routinely available. A limited left anterolateral incision (5–7 cm), in the fifth intercostal space, was used to access the apex of the heart. A bipolar epicardial pacing wire was placed and tested. Two U stitches with Teflon felt pledgets using 3–0 Prolene polypropylene (Ethicon, Inc., Somerville, NJ) were placed in the apex of the left ventricle. They served as purse string for linear closure of the left ventricle at the end of the procedure. Following balloon valvuloplasty, all valve deployments were performed with standard volumetric inflation of the balloon. Fluoroscopy and transesophageal echocardiography were used to guide the catheter across the native valve and direct deployment of the stent at the level of the annulus. During deployment, the heart was unloaded with rapid ventricular pacing. Valve function was immediately assessed by angiographic and echocardiographic visualization. Intercostal blockade was performed with ropivacaine (Ratiopharm GmbH, Ulm, Germany). The pericardium was partially closed over the apex and a left lateral chest tube inserted. The incision was closed in a standard fashion.

All patients were transferred postoperatively intubated to the intensive care unit (ICU) where ECG, chest radiography and clinical laboratory test as well as blood gas analysis were immediately performed. The ICU is a 36-bed unit run by full-time intensivists and cardiac surgeons with a 2:1 staff to patient ratio. Standard postoperative care consisted of mechanical ventilation, cardioacitve drugs if indicated, the use of warm air heaters to maintain noromothermia and analgesia with a combination of nonsteroidal anti-inflammatory drugs (paracetamol, Ratiopharm GmbH, Ulm, Germany) and intravenous morphine boluses (piritramid, Janssen-Cilag GmbH, Neuss, Germany) as required. Blood gas analyses were repeated half-hourly, the laboratory parameters 4 and 8 h after ICU admission. Hemodynamic monitoring was performed by continuous ECG recording, invasive blood pressure, central venous pressure measurement and monitoring of peripheral and central venous saturation. Mechanical ventilation with biphasic positive airway pressure was turned after the admission to the ICU as soon as possible to continuous positive airway ventilation with low positive end-expiratory pressure. Criteria for weaning from the ventilator included absence of bleeding signs (chest tube drainage <100 ml/h, stable haemoglobin values), stable cardiorespiratory conditions (mean arterial pressure >60 mmHg, central venous saturation >65 and Horowitz index >200), and absence of high inotropic support. If patients fulfilled these criteria, sedation agents were tapered and continuous positive airway ventilation gradually decreased to a minimum level (FiO2: 35 %, PEEP: 5–6 mbar and ASB: 6–7 mbar). Extubation was performed in the presence of appropriate level of consciousness, adequate airway protection reflexes (cough and swallow) and in the absence of respiratory or cardiac distress. Patients were discharged from the ICU to the cardiothoracic ward at least 4 h after extubation but no later than 09:00 p.m. on the day of surgery. During this period, any increasing requirements for cardioactive drugs, or significant decrease in oxygen saturation (<90 % despite oxygen mask), urine output, or level of consciousness, was considered a contraindication for discharge. In the cardiothoracic ward patients monitor surveillance has been performed for two days after the procedure via continuous ECG, peripheral oxygen saturation control and non-invasive blood pressure measurement in a room that fulfils the conditions of an intermediate care unit.

Reasons for readmission included (1) pulmonary (respiratory distress characterized by tachypnea, decrease in arterial saturation <90 %, Horowitz index <200, use of accessory muscles or abdominal paradox, inability to clear secretion); (2) bleeding or pericardial tamponade (new onset bleeding of more than 200 ml/h or more than 800 ml/6 h); (3) severe agitation requiring extended intravenous sedation; (4) upper or lower gastrointestinal bleeding requiring intervention or surgery; (5) any new permanent neurologic deficits (PNDs); (6) hemodynamic instability (any decrease in blood pressure requiring increasing use of cardioactive drugs).

Data are presented as frequency distributions and percentages. All continuous data are expressed as means ± standard deviation. Categorical data are expressed as counts and proportions. Comparisons were done with 2-tailed t test for means of normally distributed continuous variables and the Wilcoxon rank sum test for skewed data. Fisher exact or χ² test was used to analyse differences among categorical data. Univariate and stepwise multivariate logistic regression analysis of perioperative variables for adverse outcome was performed by calculating the odds ratio (OR) with 95 % confidence interval. Fourteen variables were analysed as follows: age older than 80, sex, chronic obstructive lung disease, chronic pulmonary hypertension, arterial hypertension, diabetes mellitus, cerebrovascular disease, peripheral vascular disease, chronic renal insufficiency, smoking history, ejection fraction <30 %, moderate to severe mitral valve regurgitation, previous cardiac surgery and prolonged fluoroscopy time. Statistical analysis of data was conducted with commercially available software (SPSS 20.0 for Windows, SPSS Inc.).

Data from all included patients were eligible for further analysis. Mean age was 79 ± 7 years, mean Log. EuroSCORE accounted for 24 ± 10, and 55 % (n = 113) of patients were men. Fast-track protocol could be successfully applied in 172 patients (83 %) (group S). In the remaining 17 % (n = 35) of TA-TAVI patients fast-track management failed (group F). Demographic data of both groups are summarized in Table 1.

Overall, 30-day mortality was 8 % (n = 17) and the incidence of early PND was 1 % (n = 3). Fast-track management failure was associated with a significant dramatic worsening of patient outcome compared to those with successful implementation of fast-track management, as reflected by an increased mortality (group S: 2 % vs. group F: 40 %, P = .001) and increased postoperative complication rate such as new renal failure requiring dialysis (group S: 7 % vs. group F: 26 %, P = .03). A detailed description of the postoperative course of both groups is presented in Table 2. Figure 1 illustrates the time to event curves for 30-day survival of both groups S and F. The in-hospital stay after failed fast-track protocol was significantly longer (group S: 10 ± 9 days vs. group F: 19 ± 12 days, P = .002).

Fast-track protocol failed in 35 patients (group F, 17 %). Twenty-one patients had prolonged ICU-stay and 14 patients required readmission to the ICU within 48 h after initial discharge. Four out of 14 patients, died after readmission to the ICU. The remaining 10 patients could be successfully discharged to the general yard and finally from hospital in the further postoperative course. Reasons for fast-track failure were as follows: respiratory failure (49 %, n = 17/35), major bleeding (29 %, n = 10/35), severe agitation (11 %, n = 4/35), gastrointestinal complications (9 %, n = 3/35) and PND (3 %, n = 1/35). Figure 2 illustrates the causes of fast-track failure.

Independent predictors of fast-track protocol failure were age ≥85 years (OR 3.1; CI 95 % 1.89–6.21, P = .004), ejection fraction (EF) ≤30 % (OR 2.6; CI 95 % 1.99–7.52, P = .03), moderate to severe preoperative mitral valve regurgitation (OR 2.7; CI 95 % 1.27–6.43, P = .008) and fluoroscopy time ≥12 min (OR 2.9; CI 95 % 1.28–7.46, P = .04).