Efficacy of target controlled infusion of remifentanil with spontaneous ventilation for procedural sedation and analgesia (Remi TCI PSA): A double center prospective observational study.

OBJECTIVE: Remifentanil, a rapid onset rapid offset synthetic opioid and potent analgesic, is often used for procedural conscious sedation in spontaneous ventilation, especially when delivered in target controlled infusion (TCI), which allows precise titration. We assessed efficacy, tolerance, and adverse events related with the use of remifentanil TCI during various procedures. DESIGN: Prospective, observational. SETTING: Two teaching hospitals. PATIENTS: We enrolled 434 patients undergoing procedures suitable for conscious sedation. INTERVENTIONS: The following procedures considered suitable were included: interventional radiology, gastrointestinal (GI) endoscopy, interventional cardiology, and peripheral dermatology. Sedation options were determined during the preoperative anesthesia assessment. MAIN OUTCOME MEASURES: Demographics were recorded as well as success rate, remifentanil dosage, pain scores, respiratory or cardiovascular events, and patient and operator satisfaction. RESULTS: The procedure was successful in 429 patients (99 percent), canceled in four patients because of agitation, apnea, desaturation, and converted to general anesthesia in two for major pain. The maximal remifentanil target was around 2-3 ng/ml for most procedures, but it was 3-5 ng/ml for GI endoscopy and urology. A total of 172 patients (40 percent) had bradypnea < 8 min-1, but only 26 (6 percent) had hypoxemia < 90 percent. Eighteen patients (4 percent) required mandibular luxation, and twelve needed face mask ventilation. There were no major cardiovascular adverse events. CONCLUSIONS: Remifentanil TCI is a suitable protocol for procedural sedation, but respiratory depression is a permanent concern. This risk requires equipped environment and competent medical personnel on hand to adjust the target before hypoxemia occurs. Respiratory rate monitoring, based on capnography or thoracic impedance is of a great help in anticipating this threat.

Causes and temporal trends in procedural deaths after transcatheter aortic valve implantation.

BACKGROUND: The causes of procedural deaths after transcatheter aortic valve implantation (TAVI) have been scarcely detailed. AIMS: To assess these causes and their temporal trends since the beginning of the TAVI era. METHODS: From October 2006 to April 2014, 601 consecutive high-risk/inoperable patients with severe aortic stenosis underwent TAVI using the Edwards SAPIEN or SAPIEN XT or the Medtronic CoreValve. The transfemoral route was the default approach; the transapical or left subclavian approaches were alternative options. Patients were divided into three tertiles according to the date of the procedure. RESULTS: Procedural death occurred in 45 patients (7.5%), with a median±standard deviation age of 83±7 years; 23 were men (51%) and the mean logistic EuroSCORE was 26±16%. The main cause of death was heart failure (n=19, 42%), followed by cardiac rupture (n=12, 27%), intensive care complications (n=9, 20%) and vascular complications (n=5, 11%). The mortality rate was higher after transapical than transfemoral TAVI (17% vs. 5%; P<0.001). The mortality rate decreased over time (11.9% in the first tertile, 6.0% in the second and 4.5% in the third [P=0.007]), driven by a reduction in heart failure-related deaths (6.5% in the first tertile vs. 1.5% in the third; P=0.011). Vascular complication-related deaths disappeared in the third tertile. However, there was no decrease in deaths related to cardiac ruptures and intensive care complications. CONCLUSIONS: The procedural mortality rate of TAVI decreased over time, driven by the decrease in heart failure-related deaths. However, efforts should continue to prevent cardiac ruptures and improve the outcomes of patients requiring intensive care after TAVI.

Long-term outcome after transcatheter aortic valve implantation.

OBJECTIVE: To assess late outcome after transcatheter aortic valve implantation (TAVI) up to 6 years and to analyse its predictive factors with a particular emphasis on functional status. Very few data exist on the long-term results of TAVI, and these data are crucial for decision making. METHODS: Between October 2006 and December 2009, 123 consecutive patients were discharged alive after TAVI in our institution. Mean age was 82±8 years, and 88% of patients were highly symptomatic in New York Heart Association (NYHA) class III-IV. RESULTS: Follow-up was complete in 122 patients (99%). The overall 6-year survival rate was 31%±5%, the majority of deaths being non-cardiac. Predictive factors of late mortality were the presence of lower limb arteritis (p=0.009), a higher Charlson comorbidity index (p=0.03) and post-TAVI paraprosthetic aortic regurgitation ≥2/4 (p=0.01). Late outcomes according to Valve Academic Research Consortium-2 criteria were analysed, and the 5-year event-free survival rate was 28%±4%. Finally, the rate of good functional results, defined as survival in NYHA class I or II, was 32%±5% at 5-year follow-up. In the survivors, the EQ-5D questionnaire further confirmed the benefit in terms of quality of life. CONCLUSIONS: About one-third of patients discharged alive after TAVI were alive at 6-year follow-up, and the survivors exhibited good functional results assessed by NYHA class and quality-of-life standardised evaluation.

Transfemoral implantation of transcatheter heart valves after deterioration of mitral bioprosthesis or previous ring annuloplasty.

OBJECTIVES: This study sought to evaluate the feasibility of transfemoral transcatheter heart valve (THV) implantation in failed mitral bioprostheses and ring annuloplasties. BACKGROUND: Redo mitral surgery may be high risk or contraindicated due to comorbidity. THV implantation has been recently reported in this setting. METHODS: Transfemoral implantation of Edwards Sapien prosthesis was performed in 17 patients for degenerated mitral bioprosthesis or previous ring annuloplasty (6 bioprostheses, 11 ring annuloplasties). The procedure was elective for 14 patients and attempted as a rescue in 3 patients. Mean age was 61 ± 24 years. All patients were in New York Heart Association class ≥III, and the surgical risk was high (EuroSCORE [European System for Cardiac Operative Risk Evaluation]: 37 ± 29%, Society of Thoracic Surgeons score: 18 ± 22%). RESULTS: Procedure was successful in 14 patients (82%). Two complications occurred during rescue procedures: 1 procedural death and 1 THV migration. One patient had moderate paraprosthetic regurgitation following the procedure, whereas residual regurgitation was trace or less in 11 patients (69%) and mild in 4 patients (25%). Mean gradient decreased from 12 ± 6 mm Hg to 8 ± 3 mm Hg. During a mean follow-up of 22 months, 4 patients died, 3 from cardiac cause. The 18-month survival was 68 ± 14% in the overall population and 78 ± 14% for patients with elective procedure. One patient underwent mitral valve replacement due to periprosthetic mitral regurgitation. At last follow-up, 12 patients were in New York Heart Association class ≤II (75%) and 4 in class III (25%). CONCLUSIONS: This single-center series suggests that transfemoral THV implantation for deterioration of mitral bioprosthesis or surgical repair is feasible in selected patients and improves early hemodynamic and midterm functional status.

Agreement between the new EuroSCORE II, the Logistic EuroSCORE and the Society of Thoracic Surgeons score: implications for transcatheter aortic valve implantation.

BACKGROUND: The Logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) and the Society of Thoracic Surgeons (STS) score are routinely used to identify patients at high surgical risk as potential candidates for transcatheter aortic valve implantation (TAVI). AIMS: To compare the new EuroSCORE II with the Logistic EuroSCORE and the STS score. METHODS: From October 2006 to June 2011, patients with severe symptomatic aortic stenosis who underwent a TAVI were enrolled prospectively. RESULTS: Among 272 patients, the EuroSCORE II was significantly lower and moderately correlated with the Logistic EuroSCORE (9±8% vs. 23±14%, P<0.01; r=0.61, P<0.001), but similar to and poorly correlated with the STS (10±9%, P=0.10; r=0.25, P<0.001). Based on recommended high-risk thresholds (Logistic EuroSCORE≥20%; STS≥10%), a EuroSCORE II≥7% provided the best diagnostic value. However, using the EuroSCORE II, Logistic EuroSCORE or STS score, only 51%, 58% and 37% of patients, respectively, reached these thresholds. Contingency analyses showed that agreements between the EuroSCORE II and the Logistic EuroSCORE or the STS score were modest or poor, respectively, with a risk assessment different in 28% and 36% of patients, respectively. CONCLUSIONS: A EuroSCORE II≥7% corresponded to a Logistic EuroSCORE≥20% or STS score≥10%, but correlations and agreements were at best modest and only approximately half of the patients reached these thresholds. Our results highlight the limits of current scoring systems and reinforce the European guidelines stressing the importance of clinical judgment in addition to risk scores.

How should I treat prosthetic tricuspid stenosis in an extreme surgical risk patient?

BACKGROUND: A 64-year-old female with rheumatic heart disease and multiple prior valve replacements presented with progressive oedema, ascites and dyspnoea on exertion. INVESTIGATION: Physical examination, transthoracic echocardiography, intracardiac echocardiography, transoesophageal echocardiography, right heart cathetherisation, computed tomography. DIAGNOSIS: She had a mitral homograft and Physio ring in the tricuspid position, and presented with severe bioprosthetic tricuspid valve stenosis (mean gradient 16 mmHg) and right-sided heart failure. TREATMENT: A transcatheter 26 mm Edwards SAPIEN valve was placed in the tricuspid position, resulting in near normalisation of tricuspid valve gradient. This represents the first report of a combined valve-in-ring (VIR) and valve in a homograft valve (VIV) SAPIEN implantation.

Feasibility and outcomes of transcatheter aortic valve implantation in high-risk patients with stenotic bicuspid aortic valves.

Little is known about transcatheter aortic valve implantation (TAVI) in patients with bicuspid aortic valve stenosis, which usually represents a contraindication. The aim of this study was to assess the feasibility and the results of TAVI in this patient subset. Of 316 high-risk patients with severe aortic stenosis who underwent TAVI from January 2009 to January 2012, 15 (5%) had documented bicuspid aortic valves. They were treated using a transarterial approach, using the Medtronic CoreValve system. Patients were aged 80 ± 10 years, in New York Heart Association functional classes III and IV. The mean aortic valve area was 0.8 ± 0.3 cm(2), and the mean gradient was 60 ± 19 mm Hg. The mean calcium score, calculated using multislice computed tomography, was 4,553 ± 1,872 arbitrary units. The procedure was successful in all but 1 patient. Major adverse events, according to Valvular Academic Research Consortium definitions, were encountered in 1 patient (death). The mean postimplantation prosthetic gradient was 11 ± 4 mm Hg, and ≤1+ periprosthetic leaks were observed in all but 2 patients. The mean prosthetic ellipticity index was 0.7 ± 0.2 at the level of the native annulus and 0.8 ± 0.2 at the level of the prosthetic leaflets. After a mean follow-up period of 8 ± 7 months, 1 patient had died from aortic dissection; there were no additional adverse events. All but 2 hospital survivors were in New York Heart Association class I or II. In conclusion, the present series suggests that transarterial Medtronic CoreValve implantation is feasible in selected patients with bicuspid aortic valve and may lead to short-term hemodynamic and clinical improvement.

Transcatheter aortic valve implantation: our vision of the future.

Transcatheter aortic valve implantation (TAVI), introduced 10 years ago by Alain Cribier, has now been performed in more than 50,000 patients worldwide. Our vision of the main directions for the future are fourfold. Firstly, the 'Heart Team' is and will remain, essential for patient selection and the performance of the procedure. Careful training and controlled diffusion of the technique to medico-surgical centres are also keys to success. Secondly, patient selection must be refined, in order to predict the risk of surgery and that of TAVI. The technique is currently limited to very high-risk patients or those with contraindications to surgery. It will be extended to include lower risk patients once there are adequate trial data, the safety of the procedure has been improved and better knowledge of long-term outcomes from the procedure has been obtained. Thirdly, the procedure will be simplified, and should also be safer with an expected decrease in the occurrence of strokes, vascular complications and perivalvular regurgitation. Fourthly, the devices will also improve, with the addition of the potential for repositioning and improvement in durability. The role of imaging with the use of multimodality techniques will no doubt increase and ease the efficacy and safety of the procedure. Overall, the use of TAVI will undoubtedly increase over time, enabling a larger number of patients with severe aortic stenosis to be treated in an effective and safe way, in complement to surgical aortic valve replacement.

Transfemoral implantation of an Edwards SAPIEN valve in a tricuspid bioprosthesis without fluoroscopic landmarks.

AIMS: We describe the first report of an Edwards SAPIEN valve implanted in a tricuspid bioprosthesis from the femoral vein. We highlight the feasibility of this previously avoided approach and the techniques involved. METHODS AND RESULTS: A 61-year-old woman with multiple valve replacements for rheumatic heart disease presented with NHYA IV dyspnoea secondary to a severely stenosed tricuspid bioprosthesis. After failed aggressive medical therapy and surgical turn down, an Edwards SAPIEN XT valve was deployed in the tricuspid bioprosthesis via the right femoral vein. Adaptations to the standard transfemoral transcatheter aortic valve implantation (TAVI) technique included: (1) crossing the tricuspid bioprosthesis with a balloon floatation catheter; (2) temporary pacing wire in the coronary sinus rather than the right ventricle; (3) mounting of the SAPIEN XT valve in the reverse orientation to transfemoral TAVI; and (4) fine positioning of the final valve position pre-deployment by 3D transoesophageal echocardiography (3D TOE) alone due to complete radiolucency of the tricuspid bioprosthesis. The procedure was completed without complication and resulted in significant symptomatic improvement. CONCLUSIONS: Deployment of an Edwards SAPIEN valve in a tricuspid bioprosthesis via the femoral vein is feasible and, with careful adaptations to established TAVI techniques, can be performed without complications and with good clinical response.

Anesthesia and perioperative management of patients who undergo transfemoral transcatheter aortic valve implantation: an observational study of general versus local/regional anesthesia in 125 consecutive patients.

OBJECTIVE: To describe differences in intra- and postoperative care between general (GA) and local/regional anesthesia (LRA) in consecutive high-risk patients with aortic stenosis who underwent transfemoral transcatheter aortic valve implantation (TAVI). DESIGN: A retrospective review of data collected in an institutional registry. SETTING: An academic hospital. PARTICIPANTS: One hundred twenty-five consecutive patients with severe aortic stenosis who underwent transfemoral TAVI. INTERVENTIONS: GA versus LRA followed by postoperative care. Complications were defined by pre-established criteria. MATERIAL AND METHODS: Consecutive patients referred for transfemoral TAVI between October 2006 and October 2010 initially underwent GA (n = 91) followed by LRA after March 2010 (n= 34). Results are presented as mean ± standard deviation or median (25-75 percentiles) as appropriate. GA and LRA TAVI patients had similar preoperative characteristics. LRA was associated with a significantly shorter procedure duration (LRA: 80 [67-102]; GA: 120 [90-140 minutes]; p < 0.001), hospital stay (LRA: 8.5 [7-14.5]; GA: 15.5 [10-24] days; p < 0.001), intraoperative requirements of catecholamines (LRA 23%; GA: 90% of patients; p < 0.001), and volume expansion (LRA: 11 [8-16]; GA: 22 [15-36] mL/kg; p < 0.001). There were significant differences in delta creatinine (day 1, preoperative creatinine values; LRA: 0 [-12 to 9]; GA: -15 (-25 to 2.9) µmol, p < 0.004). The frequency of any postoperative complications was 38% (LRA) and 77% (GA) (p = 0.11). Thirty-day mortality was 7% (GA) and 9% (LRA) (p = 0.9). CONCLUSIONS: This observational study suggests that LRA was associated with less intraoperative hemodynamic instability and significant shortening of the procedure and hospital stay. Changes in the anesthetic technique adapted to changes in TAVI interventional techniques and did not increase the rate of postoperative complications.

Anesthesia and perioperative management of patients undergoing transcatheter aortic valve implantation: analysis of 90 consecutive patients with focus on perioperative complications.

OBJECTIVE: To describe, from the point of view of anesthesia and intensive care specialists, the perioperative management of high-risk patients with aortic stenosis who underwent transcatheter (transfemoral and transapical) aortic valve implantation (TAVI). The authors specifically focused on immediate postoperative complications. DESIGN: Retrospective review of collected data. SETTING: Academic hospital. PARTICIPANTS: Ninety consecutive patients with severe aortic stenosis who underwent TAVI. INTERVENTIONS: General anesthesia followed by postoperative care. Complications were defined by pre-established criteria. MEASUREMENTS AND MAIN RESULTS: Of 184 patients referred between October 2006 and February 2009, 90 were consecutively treated with TAVI because of a high surgical risk or contraindications to surgery. The transfemoral approach was used as the first option (n = 62), and the transapical approach when contraindications to the former were present (n = 28). Results are presented as mean ± standard deviation or median (25-75 percentiles) as appropriate. Patients were 81 ± 8 years old, in New York Heart Association classes II (9%), III (54 %), or IV (37%); left ventricular ejection fraction was below 0.5 in 38% of patients. The predicted surgical mortality was 24% (16-32) and 15% (11-23) with the logistic EuroSCORE and STS-Predicted Risk of Mortality, respectively. The valve was implanted in 92% of the cases. The duration of anesthesia and (intra- and postoperative) mechanical ventilation was 190 (160-230) minutes and 245 (180-420) minutes, respectively. Hospital mortality was 11%. The most frequent cardiac complications were heart failure (20%) and atrioventricular block (16%), with 6% requiring a pacemaker. Vascular complications (major and minor) occurred in 29% of the patients. CONCLUSIONS: Despite their severe comorbidities, the mortality of the patients in this cohort was below that predicted by cardiac surgery risk scores. Monitoring, hemodynamic instability, and the frequency of complications require management and follow-up of these patients in similar ways as for open cardiac surgery. The frequency of complications in this cohort was comparable to that published by other groups.

Understanding risk assessment in cardiac surgery patients.

Understanding the risk of surgery in valvular disease is of interest because aging of the population renders decision making more difficult and the magnitude of risk will influence not only the decision to intervene but also the choice of intervention and its timing. To assist clinicians in assessing the risk of cardiac surgery, multivariate risk scores are increasingly used to estimate operative mortality. Overall, the currently available scores, mostly U.S. Society of Thoracic Surgeons score and European System for Cardiac operative Risk Evaluation, achieve acceptable discrimination but suboptimal calibration in estimating the operative mortality of heart valve surgery. The intrinsic limitations of scoring systems highlight the fact that risk scores should be integrated into clinical judgment but should not be a substitute for it. A multidisciplinary approach involving cardiologists, cardiac surgeons, and anesthesiologists is required for this purpose, especially in high-risk patients.

Contemporary surgical or percutaneous management of severe aortic stenosis in the elderly.

AIMS: To assess patient characteristics, therapeutic options, and their results in patients referred to a tertiary centre with on-site capabilities for surgical and percutaneous valvular interventions for the management of severe symptomatic aortic stenosis (AS). METHODS AND RESULTS: Sixty-six consecutive patients >70 years (83 +/- 6 years) were referred for severe AS. Their mortality risk predicted by the logistic European System for Cardiac Operative Risk Evaluation and the Society of Thoracic Surgeons-Predicted Risk of Mortality scores were on average 20 +/- 14% and 17 +/- 7%, respectively. Thirty-nine patients (59%) were considered at high-risk for surgery or inoperable after multidisciplinary evaluation: 12 (31%) underwent a transfemoral aortic valve implantation and 27 were considered unsuitable and treated medically (n = 16) or with valvuloplasty (n = 7), or were re-directed towards surgery (n = 4). The 27 other patients underwent valve replacement. In-hospital mortality was 9% (6 of 66). There were three hospital deaths in patients treated percutaneously, two in those treated medically, and one after surgery. At 6 months, 10% (6 of 60) of the survivors died: two after valvuloplasty and four after medical treatment. CONCLUSION: A large proportion of elderly patients referred for management of severe AS have a high-risk profile. The availability of percutaneous valvular interventions increases the number of those who are offered interventions.