Early mobilization after transcatheter aortic valve implantation: observational cohort study.

AIMS: Early mobilization is associated with improved outcomes in hospitalized older patients. We sought to determine the effect of a nurse-led protocol on mobilization 4 h after transfemoral transcatheter aortic valve implantation (TAVI) across different units of care. METHODS AND RESULTS: We conducted a prospective observational cohort single-centre study of consecutive patients. We implemented a standardized protocol for safe early recovery and progressive mobilization in the critical care and cardiac telemetry units. We measured the time to first mobilization and conducted descriptive statistics to identify patient and system barriers to timely ambulation. We recruited 139 patients (82.5 years, SD = 6.7; 46% women). At baseline, patients who were mobilized early (≤4 h) and late (>4 h) did not differ, except for higher rates of diabetes (25.5% vs. 43.9%, P = 0.032) and peripheral arterial disease (8.2% vs. 26.8%, P = 0.003) in the late mobilization group. The median time to mobilization was 4 h [inter-quartile range (IQR) 3.25, 4]; 98 patients (70.5%) were mobilized successfully after 4 h of bedrest; 118 (84.9%) were walking by the evening of the procedure (<8 h bedrest); and 21 (15.1%) were on bedrest overnight and mobilized the following day. Primary reasons for overnight bedrest were arrhythmia monitoring (n = 10, 7.2%) and haemodynamic and/or neurological instability (n = 6, 4.3%); six patients (4.3%) experienced delayed ambulation due to system issues. Procedure location in the hybrid operating room and transfer to critical care were associated with longer bedrest times. CONCLUSION: Standardized nurse-led mobilization 4 h after TF TAVI is feasible in the absence of clinical complications and system barriers.

New Practices in Transcatheter Aortic Valve Implantation: How I Do It in 2023.

Transcatheter aortic valve implantation (TAVI) went through a huge evolution in the last decades. Previously performed under general anesthesia, with transoperative transesophageal echocardiography guidance and using cutdown femoral artery access, the procedure has now evolved into a minimalist approach, with local anesthesia, conscious sedation, and the avoidance of invasive lines becoming the new standards. Here, we discuss the minimalist TAVI approach and how we incorporate it into our current clinical practice.

Setting a Benchmark for Quality of Care: Update on Best Practices in Transcatheter Aortic Valve Replacement Programs.

Transcatheter aortic valve replacement (TAVR) is an established therapy for the treatment of severe aortic stenosis. The evolution of technology and procedural approaches has facilitated the development of streamlined clinical pathways to optimize patient care and improve outcomes. The revision of historical practices and the adoption of contemporary best practices throughout patients' journey from referral to discharge create opportunities to drive quality improvement. Nursing expertise and leadership are essential to recalibrate preprocedure, periprocedure, and postprocedure practice to transform the way we care for TAVR, achieve excellent outcomes, and promote high-performing health services for the treatment of valvular heart disease.

Balloon aortic valvuloplasty: current status and future prospects.

INTRODUCTION: Balloon aortic valvuloplasty (BAV) improves hemodynamic and clinical status of patients with severe aortic stenosis (AS) for a limited period of 6-12 months. However, there is a high number of procedures performed worldwide and an upward trend over the last decades. AREAS COVERED: Epidemiology of AS and the advent of transcatheter aortic valve implantation (TAVI) contribute to the extensive referral of patients. The expansion of recommendations for TAVI has occasionally led to financial reimbursement-related problems that do not exist for BAV. BAV is indicated as a bridge to valve replacement, to decision in complex cases, and to extracardiac surgery. BAV may play a role in preparing for TAVI and optimizing procedural results. The minimalist approach and reduced complication rate make it applicable in fragile patients. EXPERT OPINION: In the near future, BAV will continue to be a useful asset in managing patients with AS given the multiple indications, broad applicability, safety profile, low cost, and repeatability. Specific studies are necessary to explore technical solutions, stronger indications, the finest technique, and to standardize the procedural result. Pending the development of potential competitive devices, the role that BAV plays will remain closely intertwined with the one played by TAVI.

'Minimalist approach' for transcatheter mitral valve replacement using intracardiac echocardiography and conscious sedation: a case series.

BACKGROUND: Transcatheter aortic valve implantation operators have adapted to a less invasive technique by foregoing the use of general anaesthesia and transoesophageal echocardiography. This is known as a 'minimalist approach'. This approach has yet to be explored in transcatheter mitral valve replacement (TMVR). Two patients with high perioperative risk underwent TMVR using only monitored conscious sedation (CS) and intracardiac echocardiography (ICE). CASE SUMMARY: The patients were symptomatic and required treatment of severe mitral regurgitation and severe mitral stenosis in a mitral valve ring and prosthetic mitral valve, respectively. With the use of an antegrade transseptal approach, the procedure was conducted under CS using ICE only. After placement of the prosthetic mitral valve, the valve was assessed by advancing the ICE catheter through the interatrial septal defect and no significant paravalvular leak occurred. In one case, ad hoc treatment of right to left shunting was successfully pursued. Valve function was excellent immediately and at 24 h after implantation and resulted in significant haemodynamic improvement. CONCLUSION: With more TMVR cases being conducted, the 'minimalist approach' with CS and ICE may be considered in selected cases.

An Optimized Approach for Transfemoral Transcatheter Aortic Valve Implantation: A Comprehensive Review and Current Evidence.

Device iterations and technical refinements have enabled transcatheter aortic valve implantation (TAVI) to be offered as a routine interventional procedure in many centers with high reproducibility and success. The concept of a streamlined procedure with appropriate procedural optimization, namely "optimized approach," has become increasingly relevant, aimed at minimizing perioperative burden and promoting early recovery. Relatively high device costs may be mitigated by reducing length of hospital stay and resource utilization. This review summarizes current evidence of components related to the optimization process during transfemoral TAVI. It is important to customize the procedure specific to each patient for its optimization.

Post-procedure protocol to facilitate next-day discharge: Results of the multidisciplinary, multimodality but minimalist TAVR study.

BACKGROUND: Evidence is lacking to standardize post-procedure care after transcatheter aortic valve replacement (TAVR). OBJECTIVE: We report on the findings of the post-procedure sub-study of the multimodality, multidisciplinary but minimalist TAVR (3M TAVR) study. METHODS: A standardized protocol to guide monitoring, early mobilization, reconditioning, communication, and criteria-driven discharge was implemented in a multicenter, prospective, sequential case series study in 13 North American low, medium, and high-volume centers in 2015-2017. Outcome measures pertaining to post-procedure care included avoidance of invasive lines and delirium, in-hospital bed utilization, patient disposition at the time of discharge, and 30-day use of nonelective medical services. RESULTS: Four hundred eleven participants were enrolled. In the post-procedure phase, 365 (88.8%) participants were admitted without a temporary pacemaker; urinary catheterization was avoided in 402 (97.8%) participants. Of note, 91.7% received care in a single unit (critical care: 72.5%; cardiac telemetry: 19.2%); 99.0% were discharged home. At the time of 30-day follow-up, 6 (1.6%) participants required admission to a rehabilitation or a skilled nursing facility; 30-day emergency department visits were 13.5%. CONCLUSIONS: The implementation of the 3M TAVR standardized accelerated reconditioning protocol is a safe and effective strategy to facilitate next-day discharge home after TAVR in centers of varying size.

Comparison of TransFemoral Transcatheter Aortic Valve Replacement Performed With a Minimally Invasive Simplified Technique: "FAST" Versus a Standard Approach.

OBJECTIVES: To assess the safety and efficacy of a new simplified procedure for transfemoral (TF) transcatheter aortic valve replacement (TAVR): the FAST protocol. BACKGROUND: A minimalist approach for TF-TAVR has been reported. The goal of this simplified strategy is to reduce the rate of specific complications associated with general anesthesia, second vascular access, and use of temporary pacemaker, and to reduce the length of stay. METHODS: We retrospectively reviewed all TF-TAVR cases performed at our center between January 2015 and December 2017. The FAST strategy consisted of local anesthesia with conscious sedation, echocardiographically guided TF puncture for main vascular access, radial approach for secondary arterial access, and left ventricular guidewire rapid pacing. Patients were sorted according to the initial strategy (FAST vs standard). The primary outcome was an early safety composite outcome including all-cause mortality, all stroke, life-threatening bleeding, acute kidney injury, coronary artery obstruction, major vascular complication, and valve-related dysfunction. RESULTS: A total of 285 consecutive patients were included in the present analysis (76 FAST patients and 209 standard patients). There were no baseline differences between groups. Complete FAST procedure was feasible in 83.0% of cases and all FAST procedures were successful. The primary outcome was significantly lower in the FAST group (1.3% vs 14.3%; P<.001). The use of FAST protocol resulted in a reduction of major bleeding (1.3% vs 10.1%; P=.01), blood transfusion (2.6% vs 14.3%; P<.01), and vascular complications related to the secondary access (0.0% vs 5.3%; P=.04). The length of stay was also significantly lower in the FAST group (4.9 days vs 6.4 days; P<.01). CONCLUSIONS: FAST can be safely performed and is associated with lower rates of iatrogenic complications and a shorter length of stay.

Minimalist approach meets green chemistry: Synthesis of 18 F- labeled (hetero)aromatics in pure ethanol.

The application of toxic solvents and additives is inevitable for most of the described protocols for 18 F-labeling. Herein, a novel "green" procedure for nucleophilic aromatic radiofluorination of highly activated (hetero)aromatic substrates in pure EtOH is described. Using this method a series of 18 F-labeled (hetero)arenes have been synthesized in radiochemical yields (RCYs) of up to 97%.

Feasibility and Safety of Adopting Next-Day Discharge as First-Line Option After Transfemoral Transcatheter Aortic Valve Replacement.

OBJECTIVES: Data on next-day discharge (NDD) after transcatheter aortic valve replacement (TAVR) are limited. This study investigated the feasibility and safety of NDD as a first-line option (the very-early discharge [VED] strategy) compared with the early-discharge (ED) strategy (2-3 days as a first-line option) after TAVR. METHODS: We reviewed 611 consecutive patients who had minimalist TAVR (transfemoral approach under conscious sedation) and no in-hospital mortality; a total of 418 patients underwent ED strategy (since December 2013) and 193 patients underwent VED strategy (as part of a hospital initiative to reduce length of stay, since August 2016). NDD in the VED strategy was performed with heart team consensus in patients without significant complications. The primary outcome was a composite of 30-day all-cause mortality/rehospitalization. RESULTS: Sixty-five patients (33.7%) in the VED strategy and 10 patients (2.4%) in the ED strategy were discharged the next day (P<.001). NDD patients had received balloon-expandable (n = 30) or self-expanding valves (n = 45) and showed a similar primary outcome rate compared with non-NDD patients. After adjustment using propensity score matching (172 pairs), post-TAVR length of stay was significantly shorter in the VED group (3.2 ± 3.1 days) than in the ED group (3.5 ± 2.7 days; P<.01). The primary outcome did not differ between the two groups (7.0% vs 11.6%; P=.14), with comparable 30-day mortality rate (1.2% vs 2.3%; P=.68) and rehospitalization rate (5.8% vs 11.1%; P=.08). CONCLUSIONS: Utilization of NDD as a first-line option after minimalist TAVR is feasible and safe, and leads to further reduction in length of stay compared with an ED strategy.

Short-Term and Long-Term Outcomes of Patients Undergoing Urgent Transcatheter Aortic Valve Replacement Under a Minimalist Strategy.

OBJECTIVES: Urgent transcatheter aortic valve replacement (TAVR) is associated with worse short-term outcomes compared with elective TAVR; however, little is known about long-term outcomes or the safety of the minimalist strategy in this setting. This study investigated the short-term and long-term outcomes of urgent TAVR compared with elective TAVR under a minimalist strategy (transfemoral [TF] approach with conscious sedation and no transesophageal echocardiography guidance). METHODS: After excluding 2 emergent patients requiring immediate procedures, a total of 474 consecutive patients underwent elective TF-TAVR (396 patients; 83.6%) or urgent TF-TAVR (78 patients; 16.4%). Urgent TAVR was defined as a procedure performed in the same hospitalization in patients emergently admitted due to cardiac arrest, severe acute decompensated heart failure, acute coronary syndrome, or repeated syncopal episodes. RESULTS: A minimalist approach was used in 77 patients (98.7%) undergoing urgent TAVR and in 392 patients (99.0%) undergoing elective TAVR (P=.59). Urgent TAVR had similar procedure-related complications, such as stroke, myocardial infarction, bleeding or vascular complications, and in-hospital mortality compared with elective TAVR (mortality, 1.3% vs 0.8%; P=.51) with no intraprocedural cross-over from conscious sedation to general anesthesia. However, 30-day and 1-year survival rates were reduced in patients undergoing urgent TAVR. After adjustment with baseline and procedural factors, urgent TAVR remained significantly predictive of 1-year mortality (adjusted hazard ratio, 2.26; 95% confidence interval, 1.16-4.23; P=.01). CONCLUSIONS: Urgent minimalist TAVR can be safely performed with favorable in-hospital outcomes, while increased 30-day and 1-year mortality rates suggest the importance of appropriate diagnosis and timely treatment of severe aortic stenosis.

Avoidance of urinary catheterization to minimize in-hospital complications after transcatheter aortic valve implantation: An observational study.

BACKGROUND: Contemporary transcatheter aortic valve implantation (TAVI) devices and approach present opportunities to review historical practices initially informed by early treatment development and cardiac surgery. The avoidance of urinary catheterization in the older TAVI population is a strategy to minimize in-hospital complications. The purpose of the study was to explore elimination-related complications following the phased implementation of a default strategy of avoiding urinary catheterization in patients undergoing transfemoral (TF) TAVI. METHODS: We conducted an observational study using a retrospective chart review of patients treated between 2011 and 2013 to identify patient characteristics, peri-procedure details, in-hospital outcomes and elimination-related complications in patients who did or did not receive a peri-procedure indwelling catheter. Descriptive analyses were used to report differences between the groups; we conducted a regression analysis to explore the relationship between the practice of urinary catheterization and total procedure time. RESULTS: Of the 408 patients who underwent TF TAVR, 188 (46.1%) received a peri-procedure indwelling urinary catheter and 220 (53.9%) did not. There was no difference in in-hospital mortality (2.2%), disabling stroke (0.5%), or other major cardiac adverse events. The avoidance of a urinary catheter resulted in significantly lower rates of urinary tract infection requiring a new antibiotic regimen (1.4% versus 6.1%, p = 0.014), haematuria documented by medicine or nursing (3.7% versus 17.6%, p = 0.001), and the need for continuous bladder irrigation (2.7% versus 0%, p = 0.027). CONCLUSION: The avoidance of a urinary catheter may contribute to improved outcomes in patients undergoing TAVI. The intervention should be further evaluated within the broader study of minimalist TAVI.

Anesthetic Techniques in Transcatheter Aortic Valve Replacement and the Evolving Role of the Anesthesiologist.

The development of transcatheter aortic valve replacement (TAVR) has transformed the treatment of patients with aortic valve disease. This procedure now is used widely for patients at high and intermediate risk for surgical aortic valve replacement. The rapid acceptance and popularity of TAVR most clearly was enabled by advancements in device technology and procedural experience. Such a dramatic change to the standard medical practice is not without consequence to fields of medicine beyond cardiology and cardiac surgery. Anesthesiologists have witnessed this movement first hand, and while improved anesthetic techniques have contributed to the success of the procedure, in return these improved outcomes likely will result in further changes to perioperative anesthetic management. In this review the authors sought to evaluate the role and responsibility of the cardiac anesthesiologist in the development of TAVR. Future advancements in device technology and considerations of how the anesthetic technique for TAVR may continue to evolve in future years are discussed.

Outcome After General Anesthesia Versus Monitored Anesthesia Care in Transfemoral Transcatheter Aortic Valve Replacement.

OBJECTIVE: To evaluate outcomes of monitored anesthesia care (MAC) compared with general anesthesia (GA) in patients undergoing transfemoral transcatheter aortic valve replacement (TAVR). DESIGN: Secondary analysis from the observational and prospective OBSERVANT (OBservational Study of Effectiveness of avR-taVi procedures for severe Aortic steNosis Treatment) study. SETTING: Multicenter study, including Italian hospitals performing TAVR interventions. PARTICIPANTS: One thousand four hundred ninety-four patients with severe and symptomatic aortic stenosis. INTERVENTIONS: Transfemoral TAVR under general or local anesthesia. MEASUREMENTS AND MAIN RESULTS: A propensity score procedure was applied, and 310 pairs were matched with similar baseline characteristics (EuroSCORE II: local anesthesia 6.6±5.9% v general anesthesia 7.0±7.7%, p = 0.430). MAC was associated with similar 30-day mortality compared with GA (3.9% v 4.8%, p = 0.564). TAVR was performed under MAC without any increased risk of other adverse events. The risk of paravalvular regurgitation≥mild was similar between the study groups (MAC 49.5% v general anesthesia 57.0%, p = 0.858). Two patients receiving on MAC had severe paravalvular regurgitation, whereas this complication was not observed after GA. Permanent pacemaker implantation was 19.1% in the MAC group v 14.8% in the GA group (p = 0.168). Mean intensive care unit stay was 3.5 days for the GA group v 2.9 days for the MAC group (p = 0.086). A similar 3-year survival rate was observed (MAC 69.4% v GA 69.9%, p = 0.966). CONCLUSIONS: Transfemoral TAVR can be performed under MAC with similar immediate and late outcomes as compared with GA. A possible risk of severe paravalvular regurgitation and pacemaker implantation with TAVR under MAC requires further investigation.

Automated synthesis of 4-[(18)F]fluoroanisole, [(18)F]DAA1106 and 4-[(18)F]FPhe using Cu-mediated radiofluorination under "minimalist" conditions.

The application of the "minimalist" approach to Cu-mediated radiofluorination allows the efficient preparation of (18)F-labeled arenes regardless of their electronic properties. The implementation of this methodology on a commercially available synthesis module (hotbox(three), Scintomics, Germany) enabled the automated production of 4-[(18)F]fluoroanisole as well as the clinically relevant PET-tracers, 4-[(18)F]FPhe and [(18)F]DAA1106, in radiochemical yields of 41-61% and radiochemical purities of >95% within 30-60min. These results demonstrated the high efficacy and versatility of the developed method that will open up opportunities for a broad application of Cu-mediated radiofluorination in PET-chemistry.

Outcomes of a novel minimalist approach for the treatment of cubital tunnel syndrome.

We describe a minimalist approach to perform in situ decompression of the ulnar nerve. Our technique employs a unique small skin incision strategically placed to minimize postoperative scarring over the ulnar nerve and potentially decrease the risk of iatrogenic injury to the medial antebrachial cutaneous nerve. We retrospectively report the outcome of patients who have undergone this procedure at our institution, the Michael E. DeBakey Veterans Affairs Medical Center, from January 1 2007 through November 29 2010. All individuals underwent in situ decompression via the previously described minimalist approach. Outcome variables were Louisiana State University Medical Center (LSU) ulnar neuropathy grade, patient satisfaction, subjective improvement, complications and re-operation rate. A total of 44 procedures were performed in this cohort of 41 patients. Overall, patients' postoperative LSU grades showed a statistically significant improvement (p=0.0019) compared to preoperative grades. Improvement of at least one grade in the LSU scale was observed in 50% of the procedures with a preoperative grade of four or less. Overall procedure satisfaction rate was 88% (39 of 44) with 70% (31 of 44) of the procedures resulting in improvement of symptoms. There were no intraoperative or postoperative complications. One patient required re-operation due to failure of neurological improvement. Our minimalistic approach to perform in situ decompression of the ulnar nerve at the cubital tunnel is both safe and effective. We observed a statistically significant improvement in LSU ulnar neuropathy grades and a success rate comparable to those reported for other more extensive surgical techniques while providing the benefit of a smaller incision, less scarring, decreased risk of iatrogenic nerve injury and minimal complications.

Transcatheter aortic-valve implantation with one single minimal contrast media injection.

OBJECTIVES: Performing transcatheter aortic valve implantation (TAVI) with the use of minimal contrast in patients at high-risk for acute kidney injury (AKI). BACKGROUND: Contrast-induced nephropathy (CIN) is a major cause of AKI following TAVI and is associated with increased morbidity and mortality. The amount of contrast media used increases the risk for CIN. METHODS: Computed tomography was omitted during the screening process. For the procedure transfemoral access was default. The self-expanding CoreValve prosthesis was chosen in all patients to minimize the risk of annular rupture in case of oversizing. Valve sizing was based on echocardiography, aortography, calcification on fluoroscopy, as well as weight and height of the patient. A single contrast injection was performed to confirm correct position of the pigtail catheter at the level of the annulus. The pigtail then served as the marker for the device landing zone. Intraprocedural assessment of the implantation result relied on echocardiography and hemodynamics. RESULTS: Five patients with severe aortic stenosis and at high risk for developing CIN were included. Device success was achieved in all patients and no major complications occurred. The median dose of injected contrast media was 8 ml (4-9). All but one patient had improved renal function after the intervention compared to baseline. CONCLUSIONS: Our study shows feasibility of performing TAVI with a single minimal contrast media injection, using a self-expandable valve. This technique has the potential to reduce the incidence of CIN.