High-risk Surgical Patients Research Articles

Patient-reported questionnaires to preoperatively identify high-risk surgical patients

PurposeLow cardiorespiratory fitness (CRF) increases the risk of postoperative morbidity and mortality following major surgery. Assessing CRF preoperatively, by measuring peak oxygen uptake (VO2peak) during cardiopulmonary exercise testing (CPET), is valuable yet not widely available. This study aimed to assess whether questionnaires could be used preoperatively to identify high-risk surgical patients.MethodsHealthy participants and patients who underwent CPET completed the FitMáx, Duke Activity Status Index (DASI), the modified 4-questions DASI (M-DASI-4Q), Veterans-Specific Activity Questionnaire (VSAQ), and Metabolic Equivalents of Task (MET) questionnaire. Questionnaire-VO2peak was compared with CPET-VO2peak. Overall performance of the questionnaires was assessed by the area under the curve (AUC) of receiver operating characteristic (ROC) curves. Furthermore, corresponding to the Youden index or pre-specified levels, sensitivity, specificity, and predictive values were determined.ResultsIn total, 361 participants were included. All questionnaires showed high AUC values to identify high-risk patients, defined on the basis of CPET-VO2peak thresholds. FitMáx and VSAQ demonstrated superior results compared to the other questionnaires. Based on the Youden index, the optimal questionnaire-VO2peak cut-off values were 20.6, 21.3, and 26.1 ml·kg−1·min−1 for the FitMáx and 16.3, 18.2, and 20.4 ml·kg−1·min−1 for the VSAQ corresponding to the VO2peak thresholds 16.0, 18.2 and 24.5 ml·kg−1·min−1 respectively.ConclusionThe ability to identify high-risk surgical patients preoperatively (defined by the CPET-VO2peak thresholds) by the FitMáx and the VSAQ indicates that they could be used to identify high-risk surgical patients. Patients with a poor predicted VO2peak ≤ 21.3 and ≤ 18.2 ml·kg−1·min−1, respectively for FitMáx and VSAQ, should be referred to formal preoperative (cardiopulmonary) exercise testing.Trial registrationThe study was registered as NL-OMON23304 in the Overview of Medical Research in the Netherlands, retrospectively at 28–04-2020.

Endoscopic transpapillary gallbladder drainage is associated with favorable long-term outcomes in patients with advanced liver disease

Background: Endoscopic gallbladder therapy is increasingly used in high-risk surgical patients, but data in advanced liver disease are lacking. Methods: We performed a single center retrospective analysis of patients with cirrhosis undergoing endoscopic transpapillary gallbladder drainage (ET-GBD) with cystic duct stenting (n=55). Short term outcomes were assessed at day 30. Long term outcomes were assessed at 6 months, 1 year, and 3 years or last known follow up. Subgroup analyses were completed by location (inpatient vs. outpatient). Results: A total of 52 patients, mean MELD-Na 16, underwent successful ET-GBD (38 inpatient, 14 outpatient). Most patients (n=48) experienced immediate symptomatic relief. Short-term adverse event rate was 7.7% and 30-day mortality was 1.9%. At 6 months, 86.5% of patients had a favorable outcome; unfavorable outcomes included death (n=2), recurrent cholecystitis and/or need for urgent cholecystectomy (n=5). At the end of the study, 80% of patients experienced a favorable outcome including 5 patients bridged to liver transplant and 20 who had their stent in place with adequate symptom control. Of those with imaging, 65% of patients experienced resolution of cholelithiasis. Recurrent cholecystitis (p=1.00) and stone resolution (p=0.35) did not differ in patients with one or two cystic duct stents in place. Conclusions: Transpapillary gallbladder stenting is technically feasible and associated with high rates of clinical success in patients with decompensated liver disease. Stone resolution is common after transpapillary gallbladder stenting and may portend favorable patient outcomes.

RADT-08. THIRD RECURRENT WHO 1 SPINAL MENINGIOMAS. CASE SERIES AND CLINICAL OUTCOMES FOLLOWING SURGERY OR DEFINITIVE RADIOTHERAPY

Abstract INTRODUCTION Spinal meningiomas (SM) account for approximately 1.2–12.7% of all meningiomas and 25% of spinal cord tumors. Most are benign (WHO grade 1), but a small percentage are atypical (WHO grade 2) or anaplastic (WHO grade 3). These tumors are typically solitary and non-invasive with low recurrence rates post-surgery. This study aims to compare the efficacy of definitive radiotherapy (RT) versus third surgery for recurrent SM WHO grade 1, focusing on local control, progression-free survival (PFS), and toxicity. METHODS A retrospective review approved by the Institutional Review Board included patients diagnosed with recurrent SM WHO grade 1 who underwent second surgery between 2008-2020. Patients who received radiation after the first surgery or upgraded to WHO grade 2 or 3 were excluded. Data on demographics, tumor characteristics, surgical techniques, and radiation therapy details were analyzed using descriptive and inferential statistics. RESULTS The study included 48 cases of third progression SM WHO grade 1. The median age was 53 years, and 70.8% were female. Tumor locations were primarily thoracic (75%). There was no significant difference in PFS between the third surgery and RT groups, with 36-month PFS rates of 77.4% and 76.4%, respectively. RT-related toxicities were manageable, and neurological improvements were noted in both groups, with more pronounced improvements in the surgical group. RT showed better pain control outcomes. CONCLUSION Both definitive RT and third surgery are effective for managing recurrent SM WHO grade 1, with comparable PFS. RT is a viable alternative, especially for high-risk surgical patients, providing effective pain control and manageable toxicities. Further studies with larger cohorts and longer follow-ups are recommended to validate these findings and refine treatment protocols for recurrent SM, ultimately improving patient outcomes and quality of life.

Identifying the high-risk surgical patient.

Identifying the high-risk surgical patient.

Comparison of pulse pressure and stroke volume variations measured by three monitors in high-risk surgical patients

IntroductionDynamic indices of fluid responsiveness (FR) such as pulse pressure variation (PPV) and stroke volume variation (SVV) differ among hemodynamic monitors, which use proprietary algorithms, and vary even over a short period of time. We aimed to compare the baseline values, fluctuation and predictive value for FR of PPV and SVV measured by three minimally invasive monitors. Patients and methodsTwenty patients undergoing high-risk abdominal surgery were included and 45 fluid challenges were analysed. The patients were simultaneously monitored using Carescape B650, LiDCO Rapid and FloTrac/Vigileo system. Cardiac output (CO), PPV and SVV were recorded before and after the fluid challenge of 500ml of balanced crystalloid solution. An increase in CO ≥ 15 % defined fluid responders. Concurrently recorded arterial waveform was used for offline calculation of PPV. ResultsMean baseline values of the indices ranged between 8.6% and 13.4%. LiDCO showed higher fluctuation of indices compared to the other monitors. Area under the receiver operating characteristic curve (AUROC) ranged from 0.71 to 0.76 with optimal cut-off value between 7.5% and 13.9%. AUROC increased for all indices when FR was defined as an increase in stroke volume. Furthermore, a decrease in PPV or SVV after fluid challenge (ΔPPV, ΔSVV) proved a better marker of FR (AUROC 0.82 – 0.93) than baseline values with a uniform threshold of approximately -3%. ConclusionsAlthough a significant range of baselines variations and optimal cut-off values was observed, the predictive value of PPV and SVV from all the monitors was only moderate and comparable. Nevertheless, ΔPPV and ΔSVV appear to be a reliable and device-independent markers of FR.

An interrater reliability analysis of preoperative mortality risk calculators used for elective high-risk noncardiac surgical patients shows poor to moderate reliability

BackgroundMultiple preoperative calculators are available online to predict preoperative mortality risk for noncardiac surgical patients. However, it is currently unknown how these risk calculators perform across different raters. The current study investigated the interrater reliability of three preoperative mortality risk calculators in an elective high-risk noncardiac surgical patient population to evaluate if these calculators can be safely used for identification of high-risk noncardiac surgical patients for a preoperative multidisciplinary team discussion.MethodsFive anesthesiologists assessed the preoperative mortality risk of 34 high-risk patients using the preoperative score to calculate postoperative mortality risks (POSPOM), the American College of Surgeons surgical risk calculator (SRC), and the surgical outcome risk tool (SORT). In total, 170 calculations per calculator were gathered.ResultsInterrater reliability was poor for SORT (ICC (C.I. 95%) = 0.46 (0.30–0.63)) and moderate for SRC (ICC = 0.65 (0.51–0.78)) and POSPOM (ICC = 0.63 (0.49–0.77). The absolute range of calculated mortality risk was 0.2–72% for POSPOM, 0–36% for SRC, and 0.4–17% for SORT. The coefficient of variation increased in higher risk classes for POSPOM and SORT. The extended Bland–Altman limits of agreement suggested that all raters contributed to the variation in calculated risks.ConclusionThe current results indicate that the preoperative risk calculators POSPOM, SRC, and SORT exhibit poor to moderate interrater reliability. These calculators are not sufficiently accurate for clinical identification and preoperative counseling of high-risk surgical patients. Clinicians should be trained in using mortality risk calculators. Also, clinicians should be cautious when using predicted mortality estimates from these calculators to identify high-risk noncardiac surgical patients for elective surgery.

Meta-Analysis of Dedicated vs Off-Label Transcatheter Devices for Native Aortic Regurgitation.

Transcatheter aortic valve replacement (TAVR) for high surgical risk patients with severe native aortic regurgitation (AR) presents unique challenges. Dedicated devices such as the JenaValve (JenaValve Technology) and J-Valve (JC Medical Inc) show promising results in addressing these challenges. This study compares the safety and efficacy of dedicated vs off-label devices among high surgical risk patients with pure native AR. We systematically searched PubMed, EMBASE, and Cochrane Central Register of Controlled Trials through July 11, 2024, for studies on TAVR among patients with pure severe native AR. The primary endpoint was 30-day all-cause mortality. Secondary endpoints were device success, residual AR≥ moderate, valve embolization/migration, pacemaker implantation, reintervention, and all-cause mortality at 1 year. Summary estimates were constructed using a random effects model. A total of 34 studies encompassing 2,162 patients (mean age 75.4 ± 0.2, 42.8% women) were included in the meta-analysis. Patients undergoing TAVR with dedicated devices had a lower all-cause 30-day mortality rate (3% vs 9%; P< 0.01) and higher device success (93% vs 82%; P< 0.01) compared with off-label devices. The risk of AR≥ moderate (2% vs 5%; P=0.03), valve embolization/migration (2% vs 8%; P< 0.01), pacemaker implantation (11% vs 20%; P< 0.01), and reintervention (4% vs 10%; P< 0.01) at 30days and all-cause mortality at 1 year (6% vs 24%; P< 0.01) were lower in the dedicated device group. Dedicated TAVR devices for native AR show superior device success and reduced mortality, residual AR, and reintervention rates compared with off-label devices. These findings support the use of dedicated devices as a safer alternative for high-risk patients.

Stroke and Death Following Carotid Endarterectomy or Carotid Artery Stenting: A Ten Year Nationwide Study in France

This retrospective, nationwide cohort study aimed compare periprocedural stroke or death within 30 days of the procedure (PPSD30) in patients who underwent carotid endarterectomy (CEA) or carotid stenting (CAS). This retrospective cohort study used data from the French hospital database PMSI. All patients who underwent CEA or CAS between 2010 and 2019 in France were included. Information on individual patients and hospital characteristics was retrieved. A random effects logistic regression model compared the occurrence of PPSD30 after CEA or CAS. High surgical risk was accounted for by using propensity score matching and adjusted for patient and hospital characteristics. Analyses were also stratified to consider symptomatic and asymptomatic patients separately. Between 2010 and 2019, 164 248 patients underwent a carotid artery procedure in France: 156 561 CEA and 7 687 CAS (including about 25.0% asymptomatic women and 40.0% high risk patients). The PPSD30 rate was 1.5% overall (n = 2 514 patients) (1.5% after CEA vs. 2.4% after CAS), 1.3% in asymptomatic patients (1.2% after CEA vs. 1.8% after CAS), and 3.3% in symptomatic patients (3.1% after CEA vs. 6.5% after CAS). After matching and adjustment, the risk of PPSD30 was statistically significantly greater in patients who underwent CAS than in patients who underwent CEA (adjusted OR [aOR] 1.4, 95% CI 1.1 - 1.8 in overall patients; aOR 1.4, 95% CI 1.1 - 1.8 in asymptomatic patients; and aOR 2.7, 95% CI 1.8 - 4.0 in symptomatic patients). This nationwide real life study showed that CEA performed better than CAS, more markedly in symptomatic patients, but also in asymptomatic patients. Moreover, many patients received procedures that were more likely to be harmful than beneficial according to conclusions from past randomised trials (i.e., all asymptomatic women, all high surgical risk patients, and all who had undergone CAS).

Septal Myectomy for Isolated Midventricular Obstruction After Alcohol Septal Ablation for Obstructive Hypertrophic Cardiomyopathy

BackgroundAlcohol septal ablation is an alternative to surgical myectomy for septal reduction in obstructive hypertrophic cardiomyopathy, particularly in high-risk surgical patients. However, alcohol septal ablation can sometimes result in residual left ventricular obstruction, typically in the subaortic area and, much more rarely, in the midventricular region. MethodsThis report presents 3 unique cases of isolated midventricular obstruction without systolic anterior motion that required surgical myectomy after alcohol septal ablation. ResultsThree patients presented with persistent or recurrent symptoms of left ventricular outflow obstruction after alcohol septal ablation. Surgical myectomy, performed through a transapical approach alone or in combination with a transaortic approach, successfully reduced intracavitary gradients and septal thickness in all 3 patients. One patient underwent cardiac transplantation 2 years after septal myectomy due to diastolic heart failure without obstruction. ConclusionsThis case series highlights concerns about the use of alcohol septal ablation for patients with long-segment subaortic obstruction and midventricular involvement, suggesting that surgical myectomy may be a more suitable treatment option for this anatomic subtype.

Effectiveness and Safety of Cholecystectomy Versus Percutaneous Cholecystostomy for Acute Cholecystitis in Older and High-Risk Surgical Patients: A Systematic Review.

Acute cholecystitis (AC) is a prevalent surgical emergency, particularly among elderly individuals who present with high perioperative risks. While early cholecystectomy (CCY) is the standard treatment, percutaneous cholecystostomy (PC) isproposedas an alternative for high-risk patients. This systematic review aims to evaluate the comparative safety and efficacy of CCY versus PC in managing AC among elderly and high-risk surgical patients. This review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. A comprehensive search was conducted across multiple electronic databases, including PubMed/Medline, Cochrane Central Register of Controlled Trials (CENTRAL), ScienceDirect, Europe PMC, ClinicalTrials.gov, and EBSCO Open Dissertations, from July 1to 15, 2024. Studies published from January 2019 to July 15, 2024, were included if they focused on patients aged 65 and older or those classified as high-risk surgical candidates. The review encompassed 72,366 participants across 22 studies, predominantly observational. Key outcomes assessed included postoperative complications, readmission rates, recurrence of cholecystitis, and mortality rates. This study highlights the need for individualized treatment strategies for managing AC in elderly populations. While CCY remains the preferred approach when feasible, PC offers a critical alternative for high-risk patients. Future research is necessary to optimize outcomes for this vulnerable population.

Protective mechanical ventilation in critically ill patients after surgery.

This review aims to provide an updated overview of lung protective strategies in critically ill patients after surgery, focusing on the utility of postoperative open-lung ventilation during the transition from the operating room to the intensive care unit. Mechanically ventilated patients after surgery represent a challenge in the intensive care unit. Different protective strategies have been proposed to minimize the risk of ventilator-induced lung injury (VILI) and facilitate adequate weaning from mechanical ventilation. Fast-track extubation protocols, increasingly standard in the care of critically ill patients postsurgery, have demonstrated improvements in recovery and reductions in acute lung injury, primarily based on retrospective studies. Open-lung ventilation strategies, such as individualization of positive-end expiratory pressure based on driving pressure and postoperative noninvasive ventilation support with high-flow nasal cannula, are becoming standard of care in high-risk surgical patients after major abdominal or thoracic surgeries. Mechanical ventilation in surgical patients should adhere to lung protective strategies (i.e., individualizing positive end expiratory pressure and prioritize alveolar recruitment) during the transition from the operating room to the intensive care unit.

A Needle's Misdirection: Unravelling Vascular Injuries in Malpositioned Central Venous Catheters and Safe Removal Approaches

Central venous catheters (CVC) are commonly inserted to obtain vascular access. Complications such as vascular injuries arising from malpositioned CVC may occur, and safe surgical removal is required to prevent further complications. We retrospectively reviewed all patients treated in the cardiothoracic surgery department at our institution in the past 10 years for intrathoracic vascular injuries in malpositioned CVC without the need for concurrent cardiac or thoracic surgical procedures. Among the 21 patients in our series, 2 patients (10%) had a single arterial injury, 16 patients (76%) had venous injuries only, and 3 patients (14%) had both arterial and venous injuries. 16 patients (76%) underwent surgery to remove the malpositioned CVC; majority of them underwent sternotomy (n=12, 57%) and 7 of them had repair of blood vessels, and 4 patients (19%) underwent video assisted thoracoscopic surgery (VATS). 2 out of the 5 patients who had their CVC directly removed followed by external compression required emergency sternotomy due to pericardial effusion. In patients with artery or mediastinal vessel injuries, a sternotomy approach was preferred, whereas VATS was chosen when subclavian vessels or brachiocephalic vein injuries were noted. Endovascular procedures are alternatives for high surgical risk patients, but these advanced procedures are currency limited due to high expertise and facilities requirements.

Cerebral oximetry in high-risk surgical patients: where are we?

This review aims to summarize the latest evidence on the role of near-infrared spectroscopy (NIRS) in monitoring cerebral oxygenation in high-risk surgical patients, including both cardiac and noncardiac surgeries, and to present a new algorithm for its application. NIRS effectively measures brain oxygen saturation noninvasively, proving valuable in cardiac surgeries to reduce neurological complications, though its impact on nonneurological outcomes is less clear. In noncardiac surgeries, NIRS can help prevent complications like postoperative cognitive dysfunction, particularly in high-risk and major surgeries. Studies highlight the variability of cerebral oxygenation impacts based on surgical positions, with mixed results in positions like the beach chair and sitting positions. A structured algorithm for managing cerebral desaturation has been proposed to optimize outcomes by addressing multiple factors contributing to blood oxygen content and delivery. Despite its limitations, including spatial resolution and interindividual variability, NIRS is a useful tool for intraoperative cerebral monitoring. Further studies are needed to confirm its broader applicability in noncardiac surgeries, but current evidence supports its role in reducing postoperative complications especially in cardiac surgeries.

The use of perioperative Impella 5.5 support in high-risk cardiac surgery: a retrospective cohort study.

Although the Impella device has an established role in high-risk percutaneous intervention and cardiogenic shock, its role in open cardiac surgery remains unclear. We undertook this study to better understand the role of Impella support in cardiac surgical intervention. This is a retrospective cohort study of consecutive patients who underwent cardiac surgery with surgically placed Impella 5.5 device support from October 2020 through June 2023. Patient charts were identified and systematically reviewed for relevant information. The primary outcome for this study was patient survival to discharge. Secondary outcomes included intraoperative survival, 30-day survival and 1-year survival. From 2020-2023, ten patients underwent open cardiac surgery with Impella 5.5 support. Five patients were male and the median age was 56.5 years [interquartile range (IQR), 52-63.8 years]. Three patients (30%) presented for isolated revascularization, 3 patients (30%) presented for single valve surgical intervention, 3 patients (30%) presented for revascularization and valve intervention, and 1 patient (10%) presented for multivalve intervention. The median ejection fraction (EF) of patients was 25% (IQR, 21.25-32.5%), the median Society of Thoracic Surgeons risk score was 4.32% (IQR, 1.73-11.06%). Of the patients, 40% underwent axillary cannulation while 60% had central cannulation. Intraoperative survival was 100%, survival to discharge was 90% and 30-day survival was 80%. Our study suggests the use of surgical Impella in high-risk cardiac surgical patients is associated with acceptable survival regardless of site or timing of cannulation. However, Impella usage is associated with significant morbidity. Further investigation is warranted to better understand which patients benefit perioperative Impella support.

The Role of Structured Goals of Care Discussions in Critically Ill Thoracic Surgery Patients.

Objective: The American College of Surgeons recommends structured family meetings (FM) for high-risk surgical patients. We hypothesized that goals of care discussions (GOCD) in the form of an FM, multidisciplinary family meeting (MDFM), or palliative care consult (PCC) would be underutilized in imminently dying thoracic surgery patients. Methods: A retrospective chart review at a tertiary academic medical center was performed on all inpatient mortalities and discharges to hospice after any thoracic surgery operation. The utilization of GOCDs was compared between the 2 groups. Secondary outcomes were length-of-stay, comatose status and ventilator dependence during initial GOCD, and timing of code status change. Results: In total, 56 patients met inclusion criteria: 44 of 56 (78.6%) died and 12 of 56 (21.4%) were discharged to hospice. Most patients had a FM (79.5% mortality vs 100% hospice, P = .29) and few had an MDFM (25.0% mortality vs 25.0% hospice, P = 1.00). Patients discharged to hospice were more likely to have a PCC (66.7% vs 31.2%, P = .03) and less likely to be comatose (16.7% vs 59.1%, P = .009) or ventilator dependent during initial GOCD (16.7% vs 70.5%, P = .001). Among patients who died and were DNR-CC (do not resuscitate-comfort care; 37 of 44), 75.7% died the same day of code status change and 67.6% died within 48 h of initial GOCD. Discussion: Although FMs were common, MDFMs were infrequent. Patients discharged to hospice were more likely to have a PCC. Most deaths occurred shortly after initial GOCD and most code status changes occurred on day-of-death. This data suggest an opportunity to improve GOCDs in critically ill thoracic surgery patients.

High Flow Oxygen Therapy and Secondary Spontaneous Pneumothorax: A Case Report

Treatment of secondary spontaneous pneumothorax in high-risk surgical patients with chronic pulmonary disease is a challenge in standard and emergency care. The observation that supplementary oxygen may lead to better reabsorption of pneumothorax has been known for over 50 years. It can help to avoid potential high-risk interventions or surgery in multimorbid patients.

An extraperitoneal single-port robotic approach to low anterior resection-Cadaveric experience.

A minimally invasive surgery (MIS) extraperitoneal (XP) approach to left-sided colorectal resection utilizing the laparoscopic approach has recently been shown to be safe and feasible and to have potential advantages over the transperitoneal approach, especially in high-risk surgical patients. The aim of this article is to provide a first cadaveric demonstration of the use of a single-port robotic platform in performing XP low anterior resection by MIS. A single-port robotic platform (DaVinci®SP™) was used to perform XP single-port low anterior resection in two cadavers with body mass indexes (BMIs) of 19 and 40 kg/m2. The single-port robotic platform with versatile arms was successfully used to perform a complete low anterior resection with splenic flexure mobilization and total mesorectal excision through a single port. A single-port robotic platform enhances complete XP dissection in the supine patient in extreme BMI ranges. Clinical studies are necessary to confirm these findings.

Transitions from Aerobic to Anaerobic Metabolism and Oxygen Debt during Elective Major and Emergency Non-Cardiac Surgery.

Intraoperative hemodynamic and metabolic optimization of both the high-risk surgical patients and critically ill patients remains challenging. Reductions in oxygen delivery or increases in oxygen consumption can initiate complex cellular processes precipitating oxygen debt (OXD). This study tested the hypothesis that intraoperative changes in sublingual microcirculatory flow reflect clinically relevant transitions from aerobic to anaerobic metabolism (TRANAM). We included patients undergoing elective major and emergency non-cardiac surgery. Macro- and microcirculatory variables, oxygen extraction, and transitions of metabolism were assessed in both cohorts. In the elective group, OXD was progressively increased over time, with an estimated 2.24 unit increase every 30 min (adjusted p < 0.001). Also, OXD was negatively correlated with central venous pressure (ρ = -0.247, adjusted p = 0.006) and positively correlated with stroke volume variation (ρ = 0.185, adjusted p = 0.041). However, it was not significantly correlated with sublingual microcirculation variables. In the emergency surgery group, OXD increased during the first two intraoperative hours and then gradually decreased until the end of surgery. In that cohort, OXD was positively correlated with diastolic arterial pressure (ρ = 0.338, adjpatients and the critically ill patients remains challengingsted p = 0.015). Also, OXD was negatively correlated with cardiac index (ρ = -0.352, adjusted p = 0.003), Consensus Proportion of Perfused Vessels (PPV) (ρ = -0.438, adjusted p < 0.001), and Consensus PPV (small) (ρ = -0.434, adjusted p < 0.001). TRANAM were evident in both the elective major and emergency non-cardiac surgery cohorts independent of underlying alterations in the sublingual microcirculation.

Performance of balloon-expandable transcatheter bioprostheses in inoperable patients with pure aortic regurgitation of a native valve: The BE-PANTHEON international project

BackgroundThe off-label utilization of transcatheter heart valve (THV) devices for the treatment of inoperable or high-surgical risk patients with pure native aortic valve regurgitation (NAVR) has demonstrated suboptimal outcomes, both with self- and balloon-expandable (BE) devices. The aim of this study is to compare the use of different BE scaffolds in treating pure NAVR. MethodsConsecutive patients with pure severe NAVR who were deemed to be at high-risk and were treated with last-generation BE-THVs among seventeen Centers in Europe and US. Technical and device success rates were the primary objectives. ResultsBetween February 2018 and July 2023, among 144 patients, 41 (28 %) received a MyVal device and 103 (72 %) were treated with a Sapien THV. Patients treated with a MyVal THV had an extra-large annulus more frequently compared to the Sapien group (49%vs.20 %, p < 0.001).Technical and device success rates were 90 % and 81 %, respectively, p > 0.1. The rate of THV migration/embolization (MyVal 4.9%vs. Sapien 11 %, p = 0.4) and second valve needed (4.9%vs.7.8 %, p = 0.7) were numerically lower in the MyVal group, whereas the rate of at least moderate paravalvular leak (15%vs.7.8 %, p = 0.2) and permanent pacemaker implantation (25%vs.18 %, p = 0.16) were numerically higher in the Myval group. ConclusionsOff-label use of BE devices for pure NAVR represents a potential alternative in high-risk patients in the absence of dedicated devices. However, BE in NAVR is associated with suboptimal outcomes. The availability of larger THV sizes may introduce transcatheter aortic valve replacement as an effective treatment for patients traditionally deemed unsuitable. Non-standard abbreviations and acronymsAR = aortic regurgitation, BE = balloon-expandable, NAVR = native aortic valve regurgitation, PM = pacemaker, TAVR = transcatheter aortic valve replacement, THV = transcatheter heart valve, TVEM = transcatheter valve embolization and migration, VARC-3 = Valve Academic Research Consortium 3.

Chinese expert consensus on transfemoral transcatheter aortic valve replacement for pure aortic regurgitation (2023)

Transcatheter aortic valve replacement (TAVR) was initially used to treat aortic stenosis (AS), and gradually expanded into aortic regurgitation (AR) treatment. Scholars worldwide have explored the use of marketed transfemoral TAVR (TF-TAVR) valves for AR patients, offering another option for high-risk surgical patients. However, AR presents distinct challenges compared to AS, including anatomical differences, valve selection, procedural nuances, and complication profiles. Overall, TF-TAVR for AR is more complex with lower success rate than for AS. In order to promote the safe and standardized TF-TAVR for AR in China, the Structural Heart Disease Group of Chinese College of Cardiovascular Physician drafted this consensus. The writing expert team focused on key clinical challenges in TF-TAVR for AR patients, combining evidence from literature up to September 1, 2023, to formulate nine core viewpoints. These encompass indications, valve selection, preoperative evaluation, intraoperative techniques, complication prevention and management, postoperative care, and other aspects.