Flurbiprofen in the subglottic space to prevent postoperative sore throat after cardiac surgery: A randomized double-blind study.

STUDY OBJECTIVE: Postoperative sore throat (POST) and hoarseness are common complications of tracheal intubation. This study aims to evaluate the efficacy of flurbiprofen administered through the subglottic port of tracheal tubes to prevent POST after cardiac surgery. DESIGN: Single-center, prospective, randomized, double-blind, placebo-controlled trial. SETTING: Tertiary Care Referral University Hospital (Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome). PATIENTS: Included 71 patients undergoing for elective cardiac surgery. Inclusion criteria were (a) age between 50 and 75 years, (b) NYHA class I or II, (c) surgery for myocardial revascularization or valve repair or replacement under cardiopulmonary bypass. INTERVENTION: Patients were double blind randomized to receive flurbiprofen or saline in the subglottic port of the endotracheal tube (groups F and P). The solution was injected ten minutes after tracheal tube placement, ten minutes after ICU admission and ten minutes before tracheal tube removal. MEASUREMENTS: The primary outcome was to assess the effect of topical flurbiprofen administered through the subglottic port of the tracheal tube to prevent post-operative sore throat (POST). The secondary outcomes were the presence of hoarseness safety and patient's subjective satisfaction with their recovery. We did not report any exploratory outcomes. MAIN RESULTS: We analyzed 68 patients, 34 patients in each group. In group F, two patients complained of POST and hoarseness (5.9%), while all controls did. The two groups significantly differed in the severity scores (VAS and TPS for sore throat and HOAR for hoarseness) at all time points. In group P, patients reported mild to moderate symptoms that significantly improved or disappeared 36 h after tracheal tube removal. According to the multivariable model, hoarseness affected women less than men, in the control group (p = 0.002). None of the patients in either group reported any adverse effects. CONCLUSIONS: Repeated administration of flurbiprofen through the subglottic port of tracheal tubes reduced the incidence of sore throat and hoarseness after cardiac surgery without evidence of complications.

Outcomes of Minimally Invasive Aortic Valve Replacement in Obese Patients: A Propensity-Matched Study.

INTRODUCTION: Obese patients are at risk of complications after cardiac surgery. The aim of this study is to investigate safety and efficacy of a minimally invasive approach via upper sternotomy in this setting. METHODS: We retrospectively reviewed 203 obese patients who underwent isolated, elective aortic valve replacement between January 2014 and January 2023 - 106 with minimally invasive aortic valve replacement (MIAVR) and 97 with conventional aortic valve replacement (CAVR). To account for baseline differences, a propensity-matching analysis was performed obtaining two balanced groups of 91 patients each. RESULTS: The 30-day mortality rate was comparable between groups (1.1% MIAVR vs. 0% CAVR, P=0.99). MIAVR patients had faster extubation than CAVR patients (6 ± 2 vs. 9 ± 2 hours, P<0.01). Continuous positive airway pressure therapy was less common in the MIAVR than in the CAVR group (3.3% vs. 13.2%, P=0.03). Other postoperative complications did not differ significantly. Intensive care unit stay (1.8 ± 1.2 vs. 3.2 ± 1.4 days, P<0.01), but not hospital stay (6.7 ± 2.1 vs. 7.2 ± 1.9 days, P=0.09), was shorter for MIAVR than for CAVR patients. Follow-up survival was comparable (logrank P-value = 0.58). CONCLUSION: MIAVR via upper sternotomy has been shown to be a safe and effective option for obese patients. Respiratory outcome was promising with shorter mechanical ventilation time and reduced need for post-extubation support. The length of stay in the intensive care unit was reduced. These advantages might be important for the obese patient to whom minimally invasive surgery should not be denied.

Outcomes of Minimally Invasive Aortic Valve Replacement in Obese Patients: A Propensity-Matched Study

ABSTRACT Introduction: Obese patients are at risk of complications after cardiac surgery. The aim of this study is to investigate safety and efficacy of a minimally invasive approach via upper sternotomy in this setting. Methods: We retrospectively reviewed 203 obese patients who underwent isolated, elective aortic valve replacement between January 2014 and January 2023 - 106 with minimally invasive aortic valve replacement (MIAVR) and 97 with conventional aortic valve replacement (CAVR). To account for baseline differences, a propensity-matching analysis was performed obtaining two balanced groups of 91 patients each. Results: The 30-day mortality rate was comparable between groups (1.1% MIAVR vs. 0% CAVR, P=0.99). MIAVR patients had faster extubation than CAVR patients (6 ± 2 vs. 9 ± 2 hours, P<0.01). Continuous positive airway pressure therapy was less common in the MIAVR than in the CAVR group (3.3% vs. 13.2%, P=0.03). Other postoperative complications did not differ significantly. Intensive care unit stay (1.8 ± 1.2 vs. 3.2 ± 1.4 days, P<0.01), but not hospital stay (6.7 ± 2.1 vs. 7.2 ± 1.9 days, P=0.09), was shorter for MIAVR than for CAVR patients. Follow-up survival was comparable (logrank P-value = 0.58). Conclusion: MIAVR via upper sternotomy has been shown to be a safe and effective option for obese patients. Respiratory outcome was promising with shorter mechanical ventilation time and reduced need for post-extubation support. The length of stay in the intensive care unit was reduced. These advantages might be important for the obese patient to whom minimally invasive surgery should not be denied.

Comparison of De-Kay repair versus De Vega suture for functional tricuspid regurgitation: a preliminary experience.

BACKGROUND: In patients undergoing mitral valve surgery, restrictive suture annuloplasty (De Vega) for less-than-severe functional tricuspid regurgitation has been proven to be safe and effective. The aim of this study is to determine whether the adjunct of the plication of the posterior tricuspid leaflet with the same running suture (bicuspidized De Vega or "De Kay") is equally safe and effective. METHODS: Single center, retrospective study on patients submitted to suture repair of the tricuspid valve during mitral valve surgery, with either conventional or De Kay, between January 2014 and December 2020. Comparison was based on degree of residual tricuspid valve regurgitation and right ventricular assessment at discharge. RESULTS: Over the course of the study period, 255 patients undergoing mitral valve surgery had a dilated (>40 mm or >20 mm/m2) tricuspid valve annulus, with less-than-severe tricuspid regurgitation. Conventional De Vega was employed in 166 patients (65.1%) and De Kay in the remaining 89 (34.9%). At discharge the adjunct of postero-septal commissure plication has similar outcomes to the classic De Vega repair. It seems to preserve right ventricular function. CONCLUSIONS: De Kay repair guarantees the same tricuspidal regurgitation reduction as compared with conventional De Vega early after surgery.

Performance, clinical outcomes and implementation of an original heart valve clinic model.

BACKGROUND: Valvular heart disease (VHD) requires optimized outpatient management that is generally considered to be best delivered by a dedicated, multidisciplinary team (Heart Valve Clinic [HVC]). Although HVC is promoted by clinical guidelines and organized in many centers, real world outcome assessments are limited. Thus, we evaluated the performance, clinical and management outcomes during a 6-year experience with an original HVC model. METHODS: By interrogating the local database, 1047 consecutive patients admitted to the HVC from January 2015 to October 2020 were found. Management and mortality were checked for all patients. After 3 years of HVC activity, in order to improve appropriateness and efficiency, access priority criteria were introduced. Thus, the study population was divided in two period subgroups (before and after access criteria introduction) that were compared. RESULTS: A total of 1047 consecutive patients admitted to the HVC constituted the study population; 346 patients (33%) were recommended for invasive treatment. After a mean follow-up of 25.7±3.1 months, 37 patients (3.5%) died. When comparing study periods, statistically significant increase inpatients' complexity and VHD severity was noticed in Period 2, also translating into higher rate of referral to intervention (39.0% vs. 29.4% in Period 1; P=0.001). Finally, despite higher rate of elderly and frail patients, operative mortality was not jeopardized. CONCLUSIONS: The present study reports a comprehensive assessment of the characteristics and outcomes achieved through an original HVC model. Standardization of access criteria supports the HVC improvement.

Clinical Impact of Heart Team Decisions for Patients With Complex Valvular Heart Disease: A Large, Single-Center Experience.

Background A multidisciplinary approach might be pivotal for the management of patients with valvular heart disease (VHD), but clinical outcome data are lacking. Methods and Results At our institution, since 2014, internal guidelines recommended heart team consultations for patients with VHD. The clinical/echocardiographic characteristics, treatment recommendations, performed treatment, and early clinical outcomes of consecutive, hospitalized patients with VHD undergoing heart team evaluation were collected. Surgical risk was prospectively assessed by the EuroSCORE II and STS-PROM. The primary end point of the study was early mortality. A total of 1004 patients with VHD with high clinical complexity (mean age, 75 years; mean EuroSCORE II, 9.4%; mean STS-PROM, 5.6%; 48% ischemic heart disease; 29% chronic kidney disease, 9% oncologic/hematologic diseases) were enrolled. The heart team recommended an interventional treatment for 807 (80%) patients and conservative management for 197 (20%) patients. Management crossovers occurred in only 5% of patients. The recommended intervention was cardiac surgery for 230 (23%) patients, percutaneous treatment in 516 (51%) patients, and hybrid treatment in 61 (6%) patients. Early mortality occurred in 24 patients (2.4%) and was independently predicted by aortic stenosis, left ventricular ejection fraction, pulmonary artery systolic pressure, and conservative management recommendation. In patients referred to treatment, observed early mortality (1.7%) was significantly lower (P<0.001) than expected on the bases of both the STS-PROM (5.2%) and EuroSCORE II (9.7%). Conclusions Within the limitations of its single-center and observational design, the present study suggests that heart team-based management of patients with complex VHD is feasible and allows referral to a wide spectrum of interventions with promising early clinical results.

Bicuspidized De Vega for Functional Tricuspid Valve Regurgitation: "De-Kay Repair".

Functional tricuspid valve regurgitation in the contest of mitral valve disease is a highly prevalent disease. We describe a ringless technique that combines restrictive annuloplasty (De Vega) with posterior tricuspid leaflet obliteration (Kay) used for patients with less-than-severe functional tricuspid valve regurgitation undergoing mitral valve surgery. The technique has been in use at our center since 2012, showing promising long-term echocardiographic results, with stable reduction of the annulus size and stable reduction of the degree of regurgitation.

Bleeding Complications in Patients With Perioperative COVID-19 Infection Undergoing Cardiac Surgery: A Single-Center Matched Case-Control Study.

OBJECTIVE: Previous studies reported a poor outcome in patients with coronavirus 2019 (COVID-19) undergoing cardiac surgery. Complications most frequently described were respiratory failure, renal failure, and thromboembolic events. In their recent experience, the authors observed a very high incidence of bleeding complications. The purpose of the study was to investigate a possible significant correlation between perioperative COVID-19 infection and hemorrhagic complications compared to non-COVID-19 patients. DESIGN: Single-center, observational, retrospective, matched case-control (1:2) study involving patients who underwent open-heart cardiac surgery from February 2020 and March 2021 with positive perioperative diagnosis of COVID-19 infection, matched with patients without COVID-19 infection. SETTING: Cardiac surgery unit and intensive care unit of a university tertiary center in a metropolitan area. PARTICIPANTS: In the study period, 773 patients underwent cardiac surgery on cardiopulmonary bypass (CPB). Among them, 23 consecutive patients had perioperative diagnosis of COVID-19 infection (study group). These patients were compared with 46 corresponding controls (control group) that matched for age, sex, body mass index, and Society of Thoracic Surgeons score. INTERVENTIONS: Open-heart cardiac surgery on CPB. MEASUREMENTS AND MAIN RESULTS: In the study group, 2 patients (9%) died in the intensive care unit from severe respiratory failure, shock, and multiple organ failure. In the study group, patients showed a significantly higher incidence of bleeding complications (48% v 2%, p = 0.0001) and cases of surgical reexploration for bleeding (35% v 2%, p = 0.0001), a higher incidence of severe postoperative thrombocytopenia (39% v 6%, p = 0.0007), and a higher need of blood components transfusions (74% v 30%, p = 0.0006). Chest tubes blood loss and surgical hemostasis time were markedly prolonged (p = 0.02 and p = 0.003, respectively). CONCLUSIONS: A worrisome increased risk of early and late bleeding complications in COVID-19 patients was observed, and it should be considered when assessing the operative risk. CPB-related inflammatory reaction could exacerbate the deleterious effect of COVID-19 on the coagulation system and likely deviate it toward a hemorrhagic pattern.

[Heart Team and heart valve diseases: the importance of a multidisciplinary approach]. / Heart Team e malattie valvolari: l'importanza di un approccio multidisciplinare.

Valvular heart diseases (VHD) are common in the elderly population and several therapeutic options are available to treat them. When selecting the management strategy for VHD patients, to evaluate the operatory risk, using special scores like STS score, EuroSCORE II and other more specific ones is pivotal. However, the risk scores do not consider some aspects, such as the clinical needs of the single patients, the management of local resources and the expertise of the center. The Heart Team, combining the experience of various specialists, can optimize the decision-making process through a better evaluation of the risk/benefit ratio of the therapeutic choices. The multidisciplinary discussion of the most complex cases is recommended by the international guidelines for the management of VHD and it is part of the clinical practice of many centers. So far, both trials and large clinical studies supporting such multidisciplinary management are lacking. Despite these important limitations, the Heart Team can be actually regarded as a promising tool to locally promote best practices for the treatment of VHD patients.

Influence of cardiopulmonary bypass set-up and management on clinical outcomes after minimally invasive aortic valve surgery.

INTRODUCTION: Minimally invasive aortic valve replacement (MIAVR) requires changes in cannulation strategy and cardiopulmonary bypass (CPB) management when compared to the conventional approach (CAVR). We aimed at evaluating if these differences could influence perfusion-related quality parameters and impair postoperative outcomes. METHODS: Overall, 339 consecutive patients underwent MIAVR or CAVR between 2014 and 2020 and were analyzed retrospectively. To account for baseline differences, a propensity-matching analysis was performed, obtaining two groups of 97 patients each. RESULTS: MIAVR group had longer CPB time [107 (95-120) vs 95 (86-105) min, p = .003] than CAVR group. Of note, average pump flow rate index [2.4 (2.2-2.5) vs 2.7 (2.4-2.8) l/min/m2, p = .004] was lower in the MIAVR group. Mean arterial pressure was 73 = 9 mmHg vs 62 = 11 mmHg for the MIAVR and CAVR group, respectively (p < .001). Cell-salvaged blood was most commonly used in the MIAVR group (25.8% vs 11.3%, p = .02). Finally, CPB temperature was 32.8°C (32.1-34.8) for MIAVR group vs 34.9°C (33.2-36.1) for the CAVR group (p = .02). Postoperative complications were similar between groups. CONCLUSIONS: In conclusion, despite differences in CPB parameters in patients undergoing CAVR and MIAVR, the incidences of adverse outcomes were similar. However, compared to CAVR, MIAVR was associated with shorter durations of mechanical ventilation and hospital stay as well as less transfusion of blood products.

Telemedicine for adult congenital heart disease patients during the first wave of COVID-19 era: a single center experience.

AIM: To summarize our experience on the implementation of a telemedicine service dedicated to adult congenital heart disease (ACHD) patients during the lockdown for the first wave of Coronavirus disease 2019 (COVID-19). METHODS: This is a prospective study enrolling all ACHD patients who answered a questionnaire dedicated telematic cardiovascular examination. RESULTS: A total of 289 patients were enrolled, 133 (47%) were male, 25 (9%) were affected by a genetic syndrome. The median age was 38 (29-51) years, whereas the median time interval between the last visit and the telematic follow-up was 9.5 (7.5-11.5) months. Overall, 35 patients (12%) reported a worsening of fatigue in daily life activity, 17 (6%) experienced chest pain, 42 (15%) had presyncope and 2 (1%) syncope; in addition, 28 patients (10%) presented peripheral edema and 14 (5%) were orthopneic. A total of 116 (40%) patients reported palpitations and 12 had at least one episode of atrial fibrillation and underwent successful electrical (8) or pharmacological (4) cardioversion. One patient was admitted to the emergency department for uncontrolled arterial hypertension, five for chest pain, and one for heart failure. Two patients presented fever but both had negative COVID-19 nasal swab. CONCLUSION: During the COVID-19 pandemic, the use of telemedicine dramatically increased and here we report a positive experience in ACHD patients. The postpandemic role of telemedicine will depend on permanent regulatory solutions and this early study might encourage a more systematic telematic approach for ACHD patients.

Heart Valve Critical Pathway and Heart Valve Clinic: Novel Benchmarks for Modern Management of Valvular Heart Disease.

The growing burden of valvular heart disease in Western countries represents a challenge for the daily clinical practice, especially in the light of the ever-increasing number of therapeutic options. The Euro Heart Survey showed that, among elderly subjects with severe, symptomatic valve dysfunction, surgery is denied for 33% of patients with aortic stenosis and for 50% of patients with mitral regurgitation. Current management (from diagnosis to follow-up) is often fragmented in multiple-sometimes unnecessary-steps. Such a "patchy" approach may translate into a suboptimal management, especially in the geriatric population. New healthcare models exist that can coordinate care, reduce fragmentation, limit costs and, ultimately, improve outcomes: the clinical pathways.

Minimally Invasive Aortic Valve Surgery in Octogenarians: Reliable Option or Fallback Solution?

OBJECTIVE: Aortic valve disease is more and more common in western countries. While percutaneous approaches should be preferred in older adults, previous reports have shown good outcomes after surgery. Moreover, advantages of minimally invasive approaches may be valuable for octogenarians. We sought to compare outcomes of conventional aortic valve replacement (CAVR) versus minimally invasive aortic valve replacement (MIAVR) in octogenarians. METHODS: We retrospectively collected data of 75 consecutive octogenarians who underwent primary, elective, isolated aortic valve surgery through conventional approach (41 patients, group CAVR) or partial upper sternotomy (34 patients, group MIAVR). RESULTS: Mean age was 81.9 ± 0.9 and 82.3 ± 1.1 years in CAVR and MIAVR patients, respectively (P = 0.09). MIAVR patients had lower 24-hour chest drain output (353.4 ± 207.1 vs 501.7 ± 229.9 mL, P < 0.01), shorter mechanical ventilation (9.6 ± 2.4 vs 11.3 ± 2.3 hours, P < 0.01), lower need for blood transfusions (35.3% vs 63.4%, P = 0.02), and shorter hospital stay (6.8 ± 1.6 vs 8.3 ± 4.3 days, P < 0.01). Thirty-day mortality was zero in both groups. Survival at 1, 3, and 5 years was 89.9%, 80%, and 47%, respectively, in the CAVR group, and 93.2%, 82.4%, and 61.8% in the MIAVR group, with no statistically significant differences (log-rank test, P = 0.35). CONCLUSIONS: Aortic valve surgery in older patients provided excellent results, as long as appropriate candidates were selected. MIAVR was associated with shorter mechanical ventilation, reduced blood transfusions, and reduced hospitalization length, without affecting perioperative complications or mid-term survival.

Unexpected diagnosis following screening breast ultrasound.

Any instrumental examination may lead to unexpected diagnosis that in turn can radically change the clinical pathway of a patient.

Psychological Effects of Skin Incision Size in Minimally Invasive Valve Surgery Patients.

OBJECTIVE: Clinical benefits of minimally invasive cardiac valve surgery (MIVS) have been reported. Improved postoperative mental status was never analyzed with dedicated psychological tests. In the present study we intend to investigate potential benefits of MIVS for patient psychological well-being, with special attention to the relevance of the patient perception of the chest surgical scar, of the self body image and cosmetic aspects. METHODS: Between 2016 and 2017, 87 eligible patients, age 66.5 ± 14.5 years, operated on for heart valve surgery, underwent either conventional full sternotomy (CS; n = 48) or MIVS by V-shape hemi-sternotomy approach (n = 39). Before selection of the surgical approach, patients had undergone preoperative evaluation of their psychological status using Beck Depression Inventory-II (BDI-II), State-Trait Anxiety Inventory Form Y (STAI-Y), and EuroQol-5D (EQ-5D) psychological tests. Six months postoperatively, patients filled in dedicated questionnaires to assess their psychological status, quality of life, and subjective perception, thus repeating the above-mentioned tests and adding the Body Image Questionnaire (BIQ) and Patient and Observer Scar Assessment Scale (POSAS) v2.0 tests for scar-healing process evaluation. RESULTS: No patient died during the study.The 4 post-test scales of psychological well-being (BDI-II P = 0.04, STAI-Y P = 0.04, 2 indices of EQ-5D P = 0.03, P = 0.01) showed significant differences between the MIVS group and CS group, with MIVS-small incision patients having lower level of depression and anxiety symptoms and better quality of life. Mean score differences of scar perception (BIQ and POSAS v2.0) were significant, with MIVS patients having evaluated the scar quality significantly better than CS patients. CONCLUSIONS: MIVS appears associated with significant esthetical and related psychological benefits, as documented by technical tests. These findings should be considered when selecting the most appropriate technique for heart valve surgery.

Improved Patient Recovery With Minimally Invasive Aortic Valve Surgery: A Propensity-Matched Study.

OBJECTIVE: Despite conflicting evidence available, minimally invasive aortic valve replacement (MIAVR) is increasingly used as an alternative to full sternotomy. We sought to compare early outcomes of aortic valve replacement through a full sternotomy (conventional aortic valve replacement [CAVR]) and upper ministernotomy (MIAVR). METHODS: We analyzed 297 patients having undergone primary, elective, isolated MIAVR or CAVR between January 2014 and June 2018. Following propensity score matching, 120 patients remained in each group. RESULTS: MIAVR required longer bypass (93 ± 26 vs 81 ± 24 minutes, P < 0.01) and operative times (214 ± 39 vs 182 ± 37 minutes, P < 0.01). However, aortic cross-clamp times were comparable (57 ± 17 vs 54 ± 14 minutes for MIAVR and CAVR, respectively, P = 0.14). MIAVR had less 24-hour blood loss (253 ± 204 vs 323 ± 296 mL, P = 0.03), less red blood cells transfusions [1.4 packs (1.1 o 1.9) vs 2.1 packs (1.8 to 2.7), P = 0.01], and shorter assisted ventilation time (7.1 ± 3.3 vs 9.7 ± 3.8 hours, P < 0.01) when compared to CAVR. These results led to significantly shorter intensive care unit and hospital stays for MIAVR patients (2.5 ± 1.3 vs 3.4 ± 1.1 days, P < 0.01 and 6.9 ± 4.1 vs 8.2 ± 4.8 days, P = 0.03, respectively). Thirty-day mortality and clinical outcomes did not differ significantly among groups. CONCLUSIONS: MIAVR through upper ministernotomy was shown to be as safe and reliable as CAVR. Patient recovery time was improved by shortening mechanical ventilation and reducing blood loss and transfusions. These results may be significant for high-risk patients undergoing aortic valve surgery.

The "Heart Valve Clinic" Pathway for the Management of Frail Patients With Valvular Heart Disease: From "One for All" to "All for One".

Valvular heart disease (VHD) is frequently diagnosed in old patients with clinical evidence of heart failure. This elderly population typically presents a high prevalence of frailty and comorbidities, which are associated with increased operative risk for surgical and percutaneous procedures. Recently, the Euro Heart Survey reported a clear gap between treatment guidelines and their application in the "real world". A more realistic approach to the treatment of older VHD patients treatment, mostly if associated with heart failure, is advocated. A multidisciplinary approach, as obtained with the Heart Valve Clinic methodology (intended to put the patient in the "center" of the scene and the specialists "around him"), has been applied in a group of 79 patients, aged >70 years, with symptomatic VHD, divided in 2 groups according to their frailty status (58 robust and 21 frail). No in-hospital mortality and no difference in late mortality and complications were observed. Infections were more frequent (14.3 vs. 1.7 %; P = 0.02) in frail patients. In patients with postoperative complications, serum levels of interleukin 6 (67.6 vs. 49.6; P = 0.01) and of CAF (C-terminal agrin fragment) as sarcopenia marker (67.9 vs. 62.0; P = 0.04) were higher than that in uncomplicated patients. This study was designed to determine the outcomes of the multidimensional geriatric assessment in the management of older patients with heart failure eligible for heart valve surgery. Geriatric assessment and measurement of inflammatory and sarcopenia markers may represent valid tools for a more realistic evaluation of elderly patients with VHD.