Sex-related characteristics and short-term outcomes of patients undergoing transcatheter tricuspid valve intervention for tricuspid regurgitation.

AIMS: The impact of sexuality in patients with significant tricuspid regurgitation (TR) undergoing transcatheter tricuspid valve intervention (TTVI) is unknown. The aim of this study was to investigate sex-specific outcomes in patients with significant TR treated with TTVI vs. medical therapy alone. METHODS AND RESULTS: The Transcatheter Tricuspid Valve Therapies (TriValve) registry collected data on patients with significant TR from 24 centres who underwent TTVI from 2016 to 2021. A control cohort was formed by medically managed patients with ≥severe isolated TR diagnosed in 2015-18. The primary endpoint was freedom from all-cause mortality. Secondary endpoints were heart failure (HF) hospitalization, New York Heart Association (NYHA) functional status, and TR severity. One-year outcomes were assessed for the TriValve cohort and compared with the control cohort with the inverse probability of treatment weighting (IPTW). A total of 556 and 2072 patients were included from the TriValve and control groups, respectively. After TTVI, there was no difference between women and men in 1-year freedom from all-cause mortality 80.9% vs. 77.9%, P = 0.56, nor in HF hospitalization (P = 0.36), NYHA Functional Classes III and IV (P = 0.17), and TR severity >2+ at last follow-up (P = 0.42). Multivariable Cox-regression weighted by IPTW showed improved 1-year survival after TTVI compared with medical therapy alone in both women (adjusted hazard ratio 0.45, 95% confidence interval 0.23-0.83, P = 0.01) and men (adjusted hazard ratio 0.42, 95% confidence interval 0.18-0.89, P = 0.03). CONCLUSION: After TTVI in high-risk patients, there were no sex-related differences in terms of survival, HF hospitalization, functional status, and TR reduction up to 1 year. The IPTW analysis shows a survival benefit of TTVI over medical therapy alone in both women and men.

Management of left subclavian artery in type B aortic dissection treated with thoracic endovascular aorta repair.

OBJECTIVE: Thoracic endovascular aortic repair (TEVAR) has been the favored approach for the treatment of type B aortic dissection (TBAD). To obtain an adequate proximal landing zone, coverage of the left subclavian artery (LSA) will often be necessary. The occurrence of possible neurologic complications has continued to be debated. We investigated the management of the LSA in patients with TBAD undergoing endovascular repair. METHODS: We searched the PubMed and MEDLINE databases to October 2020 for studies of TEVAR for TBAD. Data on the study design, demographics, endograft details, LSA coverage and revascularization, mortality, complications, and follow-up were extracted and analyzed. The effects of LSA coverage and revascularization on neurologic complications and outcomes were investigated. RESULTS: A total of 26 reports (24 retrospective and 2 prospective) were deemed eligible for our study. A total of 1483 patients (mean age, 56.9 ± 6.2 years) had undergone TEVAR for acute (n = 932; 62.9%), subacute (n = 36; 2.4%), or chronic (n = 515; 34.7%) TBAD, with a success rate of 97.8% and hospital mortality of 4.9%. The LSA origin had been covered for 707 patients (47.7%), and 326 had undergone LSA revascularization (surgical, n = 96; endovascular, n = 170; unspecified or not reported, n = 60). LSA revascularization was concomitant for 68.1% of cases, after TEVAR for 1.8%, and not reported for 30.1%. Of 1146 patients, 10 (0.9%) had experienced left arm claudication, and the overall stroke rate was 3.3% (2.7% for the LSA group and 1% for the uncovered LSA group; P = .0815). Of the patients with stroke and a covered LSA, 1% (2 of 203) had undergone LSA revascularization and 4.8% (5 of 105) had not (P = .0478). Twenty-six patients (1.9%) had developed paraplegia: 0.7% (3 of 433) with a covered LSA, 1.4% (7 of 491) with an uncovered LSA (P = .3508), and not reported for 16 patients. Endoleak was present in 138 patients (13.4%) at a mean follow-up of 32.1 ± 25.6 months. CONCLUSIONS: Our review has shown that LSA coverage during endovascular repair for complicated TBAD will does not significantly increase the risk of neurologic complications; however, revascularization of the LSA should be always recommended.

Apical closure device for full-percutaneous transapical structural and valve procedures with large-sized introducer sheaths: The final preclinical study.

BACKGROUND: Closed-chest transapical valve implantations (aortic, mitral, and tricuspid) and cardiac structural procedures requiring large-sized introducer sheaths cannot be safely performed with the available technology. We tested a self-expanding apical closure device in a closed-chest animal model, using large-sized introducer sheaths and human-sized animals to establish the technique for future tests in humans. METHODS: Six human-sized pigs (mean weight: 89.7 ± 3.7 kg) received general anesthesia, intubation, and full heparinization (15,000 IU/animal; expected activated clotting time >200 s). Under fluoroscopy and multimodality imaging guidance with next-generation fusion imaging prototypes, a 15-cm long needle and a standard guidewire were percutaneously inserted under the xiphoidal aponeurosis and into the ventricular apex. After the exchange with a stiff guidewire, a 21-Fr introducer sheath for transapical procedures (outer diameter: 25-Fr) was placed in the left ventricle through the apex. The self-expanding closure device was inserted and deployed under fluoroscopic guidance while the 21-Fr sheath was gently removed. Hemodynamic conditions were monitored for 30 min and then the chest was opened to inspect the closure device and quantify the blood loss in the pericardium. Animals were killed and the hearts were removed and inspected. RESULTS: All six apical closure devices were successfully deployed without adverse events. No death, hemodynamic collapse, or cardiac tamponade occurred during the 30-min observational period (mean systolic and diastolic pressures: 88 ± 11 and 58 ± 13 mmHg, respectively; mean heart rate: 60 ± 11 beats per minutes). Pre- and postdeployment (after protamine administration) mean activated clotting time was 541 ± 263 and 217 ± 62 s, respectively. The plugs provided good sealing with a mean of 27.2 ± 13.86 ml of blood lost in the pericardium. Postmortem inspection showed good plug fixation without myocardial damage. CONCLUSION: This self-expanding apical closure device successfully sealed the percutaneous access sites made with large-sized introducer sheaths in human-sized animals. This preclinical study suggests that transapical valve and structural procedures requiring large-sized introducer sheaths can be performed percutaneously.

Twenty-year experience with skeletonized bilateral internal thoracic arteries for surgical myocardial revascularization. A single center experience.

BACKGROUND AND AIM OF THE STUDY: The mammary artery shows excellent long-term patency and encourages the use of skeletonized bilateral internal thoracic arteries (BITA) for coronary surgery. We analyzed the long-term outcome of patients operated for myocardial revascularization with BITA in a single center. MATERIALS AND METHODS: Clinical data and surgical details of patients undergoing coronary surgery with BITA were prospectively collected and retrospectively analyzed. Selected variables were studied as risk factors for sternal wound complication and a subanalysis of clinical outcome for patients aged 70 years or greater was performed. A long-term follow-up of the study group is provided. RESULTS: From January 2001 to November 2021, 750 patients underwent myocardial revascularization using BITA grafts (mean age: 61 ± 9.5 years; males: 91%) at our institute. Patients with triple-vessel disease were 81%, 15.3% of all procedures were performed off-pump and 3.6% were urgent cases. Hospital mortality was 0.5%. Sternal wound complication was observed in 67 patients (9.0%) with 7 deep sternal wound infections (0.9%). Female gender (odds ratios [OR]: 3.7, p < 0.01), BMI >30 (OR: 1.8, p = 0.04), smoking (OR: 1.8, p = 0.02), and chronic kidney failure (OR: 3.7, p = 0.05) were independent predictors for sternal complications. During a mean follow-up time of 8.7 ± 5.3 years, 34 patients (4.5%) underwent a repeated myocardial revascularization, and there were 89 all-cause deaths (11.9%) and the cumulative survival at 5, 10, 15, and 20 years was 97%, 89%, 76%, and 60% for the whole study group 92%, 74%, 47%, and 43% for the subgroup of elderly patients (mean age: 74 ± 3.5 years). CONCLUSIONS: Use of skeletonized bilateral thoracic arteries shows low-rate of wound infection and good long-term outcome with low risk of repeated revascularizations, regardless of patients' age.

Outcomes of patients operated for acute type A aortic dissection requiring preoperative cardiopulmonary resuscitation.

BACKGROUND AND AIM: Acute type A aortic dissection (AAAD) is a life-threatening condition. The emergency operation usually results in 20% perioperative mortality. If preoperative cardiopulmonary resuscitation (CPR) is necessary, there is an increase in the rate of mortality. The aim of the present study was to report the outcomes of AAAD surgery in patients requiring preoperative CPR in a high-volume center. METHODS: A retrospective analysis of preoperative, intraoperative, postoperative, and follow-up data in patients requiring preoperative CPR in the setting of AAAD surgery was performed. RESULTS: Between January 2006 and December 2018, 637 patients underwent emergency surgery for AAAD. In total, 26 (4%) patients received CPR; the mean age was 63 ± 13 years; and 18 were male (69%). The reason for CPR was acute tamponade (N = 14, 54%), pulseless electrical activity (N = 5, 19%), asystole or ventricular fibrillation (N = 7, 27%), and four (15%) patients were not operated due to prolonged CPR and severe initial neurological impairment. There was no intraoperative mortality. The in-hospital mortality rate was 50% (N = 11), due to severe cerebral damage confirmed by computed tomography, and six patients (55%) were older than 70 years. The median follow-up was 35 months (7-149), which was 100% complete; two patients had permanent hemiplegia, one had anterior spinal syndrome, and other two died during the follow-up. The overall survival rate was 41% (n = 9). CONCLUSION: Surgery outcomes were still reasonable in AAAD patients requiring preoperative CPR in a high-volume center.

Clinical Outcomes in Patients with Severe Aortic Valve Stenosis Treated with a Portico Transcatheter Aortic Valve System.

The Portico™ transcatheter aortic valve implantation (TAVI) system (Abbott Vascular, Santa Clara, CA, USA) was specifically designed to reduce some of the limitations associated with first-generation TAVI devices. Most of the currently available clinical evidence was obtained from randomized studies that compared TAVI to aortic valve replacement using first-generation transcatheter heart valve devices. The aim of this review is to describe the characteristics of the repositionable and retrievable Portico™ system and the technique of implantation, as well as to provide an overview of the most recent outcomes in the literature, along with our institutional experience.

Percutaneous tricuspid valve therapies: the new frontier.

Moderate-to-severe tricuspid regurgitation (TR) affects ∼1.6 million patients in the USA, of whom only 8000 undergo tricuspid surgery annually; this results in an extremely large number of untreated patients with significant TR. Therefore, there is a large unmet clinical need for patients with severe TR who are not referred for conventional surgery, mainly due to expected high surgical risk. Percutaneous procedures are an attractive alternative to surgery for patients deemed to be high-risk surgical candidates. Whereas over the past few years, the development and clinical use of percutaneous approaches to the aortic valve and mitral valve have been widespread, few data are available about the feasibility and the efficacy of the percutaneous tricuspid valve treatment. This review will explore the available technologies, which are today under evaluation and the preliminary clinical results.

Prognostic Impact and Late Evolution of Untreated Moderate (2/4+) Functional Tricuspid Regurgitation in Patients Undergoing Aortic Valve Replacement.

OBJECTIVES: The aim of the present study was to evaluate the prognostic impact and late evolution of associated tricuspid regurgitation (TR) 2/4+ after aortic valve replacement (AVR). METHODS: We evaluated 61 patients who underwent AVR between 2003 and 2012 (35 for aortic stenosis [AS], 26 for aortic regurgitation [AR]) with associated untreated TR 2/4+. Patients with concomitant mitral disease were excluded. Median follow-up was 3.2 years. Serial echocardiographic and clinical data were collected and analyzed. RESULTS: Mean age was 65 ± 13 years; 26% of the patients were in NYHA class III-IV. Left ventricular ejection fraction was 53 ± 11%. Comorbidity included: chronic obstructive pulmonary disease in 5%, chronic renal failure in 13%, coronary artery disease in 20%, history of stroke/TIA in 8%. Thirty-day mortality was 1.6%. Overall actuarial survival was 83 ± 6% at 6.5 years, with a freedom from cardiac death of 90 ± 5%. Freedom from TR ≥3+ was 86 ± 6% at 6.5 years. At last follow-up, 82% of the patients had TR 0-1/4+, 9% had TR 2/4+, 4.5% had TR 3/4+ and 4.5% had TR 4/4+. Occurrence of TR ≥ 3+ at follow-up was associated with increased cardiac mortality (HR 10.5; p = 0.009). CONCLUSIONS: preoperative untreated TR 2/4+ improves or remains stable in the majority of patients. The poor outcomes associated with TR > 2+ suggest the need for better methods to identify subjects at risk for TR progression.

Edge-to-edge surgical mitral valve repair in the era of MitraClip: what if the annuloplasty ring is missed?

PURPOSE OF REVIEW: The purpose of this review is to define the role of annuloplasty in the surgical edge-to-edge repair, an issue that seems particularly relevant in the current MitraClip era, when more than 15 000 patients have been submitted to a percutaneous transcatheter edge-to-edge repair without concomitant annuloplasty. RECENT FINDINGS: Only a few studies have reported the clinical and echocardiographic outcomes of the ringless edge-to-edge mitral repair. In all of them, however, only mid-term data were provided. Recently, the long-term results of the surgical edge-to-edge procedure performed without a concomitant annuloplasty in a selected group of patients with degenerative mitral regurgitation have been published. SUMMARY: The surgical edge-to-edge technique should always be combined with prosthetic ring annuloplasty in order to provide excellent long-term outcomes in patients with degenerative mitral regurgitation. The overall long-term results of the surgical edge-to-edge technique without annuloplasty are not satisfactory. The ringless edge-to-edge technique is not effective in the challenging setting of extensively calcified annulus. In patients without annular calcification, in whom annuloplasty was intentionally avoided, the ringless edge-to-edge repair provides acceptable results in the mid term but is associated with a high failure rate in the long term. In the MitraClip perspective, these findings emphasize the need for a reliable annuloplasty to improve the long-term outcomes of the currently available transcatheter edge-to-edge procedure.

Long-term results of surgical minimally invasive pulmonary vein isolation for paroxysmal lone atrial fibrillation.

AIMS: Transcatheter pulmonary vein ablation is the current treatment of choice for symptomatic drug-refractory atrial fibrillation (AF). Video-assisted surgical pulmonary vein isolation (sPVI) is an alternative therapy to percutaneous ablation for the treatment of AF. Long-term results of sPVI are currently unknown. The aim of this study was to report on the long-term efficacy and safety of sPVI in patients with paroxysmal AF. METHODS AND RESULTS: The study design was observational and retrospective. From July 2005 to January 2011, 42 patients with drug-refractory paroxysmal AF underwent video-assisted sPVI in two different centres. Patients were eligible for sPVI when suffering from symptomatic, drug-refractory paroxysmal AF and they agreed to the alternative of sPVI. The median preoperative AF duration was 24 months (range 3-200). Success was defined as the absence of AF on 24 h or 96 h Holter monitoring during follow-up, off antiarrhythmic drugs (AAD). Adverse events and follow-up monitoring were based on the Heart Rhythm Society Consensus Statement 2012 for the catheter and surgical ablation of AF. Mean age was 55 ± 10 years, and 76% were males. After a mean follow-up of 5 years (SD 1.7), 69% of all patients were free from atrial arrhythmias without the use of AAD, and 83% with the use of AAD. Major peri-procedural adverse events occurred in four (9.5%) patients, no strokes or mortalities were registered during long-term follow-up. CONCLUSION: This retrospective study shows that sPVI for the treatment of paroxysmal AF is effective and that the outcomes are maintained at long-term follow-up.

Surgical vs. transcatheter pulmonary vein isolation as first invasive treatment in patients with atrial fibrillation: a matched group comparison.

AIMS: Pulmonary vein isolation (PVI) can be considered for treatment of symptomatic atrial fibrillation (AF). Nowadays, in addition to transcatheter ablation, thoracoscopic surgical PVI is available. The aim of this study is to compare clinical outcome of surgical with transcatheter PVI as first invasive treatment strategy of AF. METHODS AND RESULTS: From June 2009 to November 2011, 33 patients underwent minimally invasive surgical PVI, and were matched (1:2 fashion) retrospectively according to age, sex, and AF type, with 66 patients who underwent transcatheter PVI. Success was defined as freedom from atrial arrhythmias on 24 h Holter monitoring without use of anti-arrhythmic drugs (AADs) at 1 year. Mean age was 52 ± 10 years, 82% were male. Paroxysmal AF was present in 76 patients (77%), persistent AF in 23 (23%) patients. None underwent prior ablations, and failed on 1.2 ± 0.6 AADs. At 12 months, complete freedom from atrial arrhythmias without AADs in the surgical PVI group was 88% compared with 41% in the transcatheter PVI group (P < 0.001). Freedom from atrial arrhythmias with AADs was 91 vs. 62%, in the surgical vs. transcatheter PVI group, respectively (P = 0.002). Complications occurred in seven (21%) surgical PVI patients, and three (5%) transcatheter PVI patients (P = 0.015). CONCLUSION: In present matched study comparing a surgical with transcatheter PVI treatment strategy in symptomatic AF patients failed on AADs, but without prior ablations, a surgical PVI strategy was more effective to prevent recurrence of atrial arrhythmias, than a transcatheter PVI treatment strategy. However, complications were more frequent with surgical PVI.

Extracorporeal venovenous membrane oxygenation in the treatment of respiratory insufficiency following cardiac surgery.

Following cardiac surgery, patients can develop acute respiratory failure. We present the case of a 66-year-old male successfully treated with extracorporeal venovenous membrane oxygenation (vvECMO) for acute respiratory failure postsurgery and review the literature on vvECMO in this specific setting.

Minimally Invasive Isolated and Hybrid Surgical Revascularization for Multivessel Coronary Disease: A Single-Center Long-Term Follow-Up.

INTRODUCTION: Some evidence suggests that surgical minimally invasive (MIDCAB) and hybrid coronary revascularization (HCR) are safe and potentially effective at short-term follow-up. Data on long-term outcomes are more limited and inconclusive. METHODS: Between February 2013 and December 2023, a total of 1997 patients underwent surgical coronary artery revascularization at our institution, of whom, 92 (4.7%) received left anterior mini-thoracotomy access (MIDCAB), either isolated (N = 78) or in combination with percutaneous coronary intervention (N = 14, HCR group). RESULTS: After a median follow-up of 75 months (range 3.1: 149 months), cardiac mortality was 0% while overall mortality was 3%, with one in-hospital mortality and two additional late deaths. Conversion to sternotomy happened in two patients (2.1%), and surgical re-explorations occurred in five patients (4.6%), of whom three for bleeding and two for graft failure. All patients received left internal mammary (LIMA) to left anterior descending artery (LAD) grafting (100%). In the HCR group, 10 patients (72%) showed percutaneous revascularization (PCI) after MIDCAB, showing PCI on a mean of 1.6 ± 0.6 vessels and implanting 2.1 ± 0.9 drug-eluting stents. CONCLUSIONS: MIDCAB, in isolation or in association with hybrid coronary revascularization, is associated with encouraging short- and long-term results in selected patients discussed within a dedicated heart-team.

Continuous Glucose Monitoring System After Coronary Artery Bypass Graft Surgery: A Feasibility Study.

BACKGROUND: Blood glucose level variability has been associated with increased risk of complication in the postoperative setting of cardiovascular surgery. Although interesting for optimization of blood glucose management in this context, continuous blood glucose (CBG) devices can have a limited reliability in this context, in particular because of the use of paracetamol. The aim of this study was to evaluate the reliability of Dexcom G6®, a recently developed continuous glucose monitoring device. METHODS: We performed a prospective, observational, non-randomized, single-centre study comparing Dexcom G6® CBG level monitoring with the standard methods routinely used in this context. The standard blood glucose values were paired to the time corresponding values measured with Dexcom G6®. Agreement between the two methods and potential correlation in case of paracetamol use were calculated. RESULTS: From May 2020 to August 2021, 36 out of 206 patients operated for isolated coronary artery bypass grafting were enrolled; 673 paired blood glucose level were analyzed. Global agreement (ρc) was 0.85 (95% C.I.: 0.84-0.86), intensive care unit agreement was 0.78 (95%C.I.: 0.74-0.82) and ward agreement was 0.91 (95%C.I.: 0.89-0.93). In the diabetic population, it was 0.87 (95%C.I.: 0.85-0.90). When paracetamol was used, the difference was 0.02 mmol/l (95%C.I.: 0.29-0.33). CONCLUSIONS: Dexcom G6® provides good blood glucose level accuracy in the postoperative context of cardiac surgery compared to the standard methods of measurements. The results are particularly reliable in the ward where the need for repeated capillary glucose measurements implies patient discomfort and time-consuming manipulations for the nursing staff.

Effects of tricuspid transcatheter edge-to-edge repair on tricuspid annulus diameter - Data from the TriValve registry.

AIMS: T-TEER is an effective therapy for the treatment of tricuspid regurgitation (TR). However, the effects of leaflets clipping on tricuspid valve annulus (TA) have not been investigated in detail. The aim of this study is to investigate the effects of tricuspid transcatheter edge-to-edge repair (T-TEER) on TA diameter. METHODS AND RESULTS: The TriValve registry (Transcatheter Tricuspid Valve Therapies, NCT03416166) collected 556 patients from 22 European and North American centres undergoing transcatheter tricuspid valve interventions from 2016 to 2022. Patients undergoing T-TEER with available pre- and post-procedural data on TA diameter measured in the apical 4-chamber view on transthoracic echocardiography were selected for this study. Primary end-point was the reduction of TA diameter after T-TEER. A total of 186 patients were included in the study. In 115 patients (62%) TA diameter was reduced by at least 1 mm as compared to baseline. A significant reduction of TA dimension was observed following T-TEER (mean 2.3 mm [from pre-procedural diameter 46.7 mm to post-procedural diameter 44.4 mm], p < 0.001). In particular, the greatest reduction was observed in those with T-TEER in antero-septal commissure (mean 2.7 mm [from 47.1 mm to 44.4 mm], p < 0.001) as compared to those combining both antero-septal and postero-septal commissures (mean 1.4, from 46.0 mm to 44.6 mm, P = 0.06). A significant reduction of TA dimension was recorded in patients with 1 or 2 clips implanted but not in those patients with ≥3 clips implanted. CONCLUSIONS: In almost two third of patients T-TEER reduces TA diameter in addition to leaflet approximation. CONDENSED ABSTRACT: The effects of tricuspid transcatheter edge-to-edge repair (T-TEER) on tricuspid valve annulus (TA) have not been studied in details. This study investigates TA diameter as measured in apical 4-chamber view on transthoracic echocardiography before and after T-TEER. A total of 186 patients from the TriValve registry were included in the study. The study results show that 62% of patients have a TA reduction after T-TEER, especially in those receiving 1 or 2 clips in the antero-septal commissure. These suggest that T-TEER reduces tricuspid regurgitation not only by approximation of leaflets, but also by TA diameter reduction.