The PIGTAIL paradigm for a fast and safe transfemoral transcatheter aortic valve replacement.

Transfemoral transcatheter aortic valve replacement is the preferred primary access route whenever possible. Despite advancements in expertise and delivery system profiles, complications associated with the primary femoral access still significantly affect procedural morbidity and outcomes. The current standard for accurate main access planning involves proper preprocedural evaluation guided by computed tomography. Several baseline clinical and anatomical features serve as predictors for the risk of vascular injury occurring during or after transcatheter aortic valve replacement. In this paper, we aimed at reviewing the most up-to-date knowledge of the topic for a safe transfemoral access approach according to a paradigm we have called "PIGTAIL."

See It Best: A Propensity-Matched Analysis of Ultrasound-Guided versus Blind Femoral Artery Puncture in Balloon-Expandable TAVI.

Background: Currently, transcatheter aortic valve implantation (TAVI) is the standard procedure recommended for patients over 75 years of age with symptomatic aortic valve stenosis. Percutaneous transfemoral (TF) access is the main route used to perform the procedure. Among periprocedural complications, access-related ones are the most frequent, potentially leading to prolonged in-hospital stays and transfusions. Methods: We performed a retrospective analysis of prospectively collected data on consecutive patients undergoing TF-TAVI with the latest generation balloon-expandable transcatheter valve between 2013 and 2022. Results: A total of 600 patients were analyzed, differentiating the population between ultrasound-guided and blind common femoral artery puncture. Valve Academic Research Consortium 3 (VARC-3)criteria were used to report at 30 days and follow-up. In our propensity-matched comparison of the two groups, we found a strong reduction in access-related complications in the echo-guided group, particularly in terms of reduction of major and minor bleedings. We also found a significant trend in reduction of local complications, such as pseudoaneurysms, hematomas, arterio-venous fistulas, dissection of the femoral or iliac arteries, and stenosis. Conclusions: Although there is a lack of consensus on the role of ultrasound-guided puncture, we found better outcomes for patients having an echo-guided puncture of the main access, particularly with regard to access-related complications, early mobilization, and early discharge home.

Pre-TAVI aortic annulus sizing: comparison between manual and semi-automated new generation software measurements in operators with different experience.

OBJECTIVES: Aim of the study is to compare manual and semi-automatic measurements for aortic annulus assessment among different operators. METHODS: Eighty patients who underwent TAVI were retrospectively enrolled. The measurements manually performed by an experienced reader for aortic annulus (minimum and maximum diameters, perimeter, area), annulus-to-coronary ostia distance and time needed for the whole evaluation, were collected. The same operator (observer 1) and two less experienced readers (observer 2 and 3, with >5 years and 1 year of experience, respectively) assessed the same measurements using a semi-automatic software. Differences between manual and semi-automatic measurements, reading time and suggested valves size derived by CT were compared. RESULTS: Very good correlations were found between manual and software-aided measurements for aortic annulus area and perimeter in comparison with standard measurements for the three readers (ICC range 0.81-0.98). Good correlations were found for the distance with coronary ostia(0.75-0.79). The same area-derived prosthesis size for manual and semi-automatic measurements was selected in 96% of cases for observer 1; very good correlations were also found for observer 2 and 3 (ICC = 0.89 and 0.88, respectively). Using semi-automatic measurements, the mean time needed for CT images was significantly lower for observers 1 and 2 (1.50 and 1.72versus 3.14 min), respectively. CONCLUSIONS: Pre-TAVI CT using semi-automatic software allows accurate and reproducible measurements, reducing reconstruction time up to 50% and is reliable even for operators with different experience. ADVANCES IN KNOWLEDGE: The use of semi-automatic dedicated software for CT in TAVI planning is reliable even for operators without long time experience and allows accurate and reproducible measurements improving pre-TAVI workflow.

Tips and Tricks in Transaortic TAVR

ABSTRACT Transfemoral transcatheter aortic valve replacement (TAVR) is currently the standard catheter-based treatment of severe aortic stenosis patients. Being the transfemoral route not feasible, other access sites could be chosen. Transaortic TAVR via either a J mini-sternotomy or a right anterolateral mini-thoracotomy is a good option for patients having tricky thoracoabdominal aorta. Some tips and tricks may help in getting a fast and safe transaortic procedure.

Management of Iatrogenic Aortic Dissections During Percutaneous Right Coronary Artery Interventions.

Iatrogenic acute aortic dissections during percutaneous coronary interventions are an extremely rare but potentially life-threatening complication, occurring in less than 0.02% of transcatheter procedures. We report three patients with different characteristics suffering from iatrogenic aortic dissection during percutaneous coronary intervention successfully treated with an emergency open-heart surgery. A conservative strategy should be pursuit only in small, localized lesions.

Management of Iatrogenic Aortic Dissections During Percutaneous Right Coronary Artery Interventions

ABSTRACT Iatrogenic acute aortic dissections during percutaneous coronary interventions are an extremely rare but potentially life-threatening complication, occurring in less than 0.02% of transcatheter procedures. We report three patients with different characteristics suffering from iatrogenic aortic dissection during percutaneous coronary intervention successfully treated with an emergency open-heart surgery. A conservative strategy should be pursuit only in small, localized lesions.

Tips and Tricks in Transaortic TAVR.

Transfemoral transcatheter aortic valve replacement (TAVR) is currently the standard catheter-based treatment of severe aortic stenosis patients. Being the transfemoral route not feasible, other access sites could be chosen. Transaortic TAVR via either a J mini-sternotomy or a right anterolateral mini-thoracotomy is a good option for patients having tricky thoracoabdominal aorta. Some tips and tricks may help in getting a fast and safe transaortic procedure.

The prognostic value of left ventricular dimensions at the time of transcatheter aortic valve replacement: A propensity-matched analysis.

AIMS: In the clinical practice a noteworthy proportion of severe symptomatic aortic stenosis patients presents with low-flow low-gradients features, these having reported a less favorable prognosis even when surgically or transcatheter treated. METHODS AND RESULTS: We retrospectively analyzed the prospectively collected data on 1051 consecutive patients undergone balloon-expandable transcatheter aortic valve replacement at our Institution from January 2008 to January 2020. We divided the population according with a mean aortic gradient (MAG) < or ≥40 mmHg and we performed a propensity-matched analysis based on the Society of Thoracic Surgery Score and age, obtaining two homogeneous groups of 314 patients each (Groups A and B, respectively). We then analyzed the outcomes of the two groups by implementing adjusted Cox models adjusted for significant clinical differences between the two groups, such as sex, ejection fraction, comorbidities and other variables not included in the propensity-matched analysis. The only variable associated with both cardiovascular and all-cause events was an ejection fraction ≤35%. Finally, a sensitivity analysis found that an ejection fraction ≤35% was associated with an increase cardiovascular and all-cause mortality only in patients with an indexed end-diastolic volume >97 ml/m2 (p = .0438 and .3363, respectively). CONCLUSIONS: In our series a MAG <40 mmHg was not found to be per se an independent risk factor for cardiac and all-cause mortality after transcatheter aortic valve replacement. The ejection fraction was found to be an independent risk factor only in the context of enlarged left ventricular dimensions.

Minimum requirements in emergency kits for bailout strategies in TAVR complications.

INTRODUCTION: The proportion of patients with symptomatic severe aortic stenosis treated by transcatheter aortic valve replacement (TAVR) is increasing, driven by favorable outcomes from randomized trials and current valve guidelines recommendations. Despite device and technique improvements having reduced procedural morbidities, complications during or immediately after TAVR still carries significant mortality risk. METHODS: We propose a check-list of essential items to anticipate potentially life-threatening complications in TAVR. RESULTS: Purpose of this review is to discuss the most common life-threatening complications during TAVR from a troubleshooting perspective, depicting the minimum required equipment needed in emergency situations. CONCLUSIONS: Prevention of complications remains the most important strategy to optimize outcomes in TAVR procedures. Each specialized Center should institute and make easily accessible standardized emergency kits for the most common life-threatening conditions during TAVR that should be readily available in the cath-lab or hybrid operating room.

Conservative, surgical, and percutaneous treatment for mitral regurgitation shortly after acute myocardial infarction.

AIMS: Severe mitral regurgitation (MR) following acute myocardial infarction (MI) is associated with high mortality rates and has inconclusive recommendations in clinical guidelines. We aimed to report the international experience of patients with secondary MR following acute MI and compare the outcomes of those treated conservatively, surgically, and percutaneously. METHODS AND RESULTS: Retrospective international registry of consecutive patients with at least moderate-to-severe MR following MI treated in 21 centres in North America, Europe, and the Middle East. The registry included patients treated conservatively and those having surgical mitral valve repair or replacement (SMVR) or percutaneous mitral valve repair (PMVR) using edge-to-edge repair. The primary endpoint was in-hospital mortality. A total of 471 patients were included (43% female, age 73 ± 11 years): 205 underwent interventions, of whom 106 were SMVR and 99 PMVR. Patients who underwent mitral valve intervention were in a worse clinical state (Killip class ≥3 in 60% vs. 43%, P < 0.01), but yet had lower in-hospital and 1-year mortality compared with those treated conservatively [11% vs. 27%, P < 0.01 and 16% vs. 35%, P < 0.01; adjusted hazard ratio (HR) 0.28, 95% confidence interval (CI) 0.18-0.46, P < 0.01]. Surgical mitral valve repair or replacement was performed earlier than PMVR [median of 12 days from MI date (interquartile range 5-19) vs. 19 days (10-40), P < 0.01]. The immediate procedural success did not differ between SMVR and PMVR (92% vs. 93%, P = 0.53). However, in-hospital and 1-year mortality rates were significantly higher in SMVR than in PMVR (16% vs. 6%, P = 0.03 and 31% vs. 17%, P = 0.04; adjusted HR 3.75, 95% CI 1.55-9.07, P < 0.01). CONCLUSIONS: Early intervention may mitigate the poor prognosis associated with conservative therapy in patients with post-MI MR. Percutaneous mitral valve repair can serve as an alternative for surgery in reducing MR for high-risk patients.

Challenges and future perspectives of transcatheter tricuspid valve interventions: adopt old strategies or adapt to new opportunities?

Tricuspid regurgitation (TR) is a highly prevalent valvular heart disease and is associated with an increased risk of cardiovascular events and death at long-term follow-up. Functional TR accounts for over 90% of TR and is mainly due to annular or right ventricular dilatation. Most often, TR is observed in patients with left-sided valvular heart disease (with or without previous surgical correction) and pulmonary hypertension. Isolated TR is less frequent, though burdened by high surgical mortality. This, together with an incomplete understanding of the disease, has brought to a significant undertreatment in spite of the growing evidence of the impact of severe TR on mortality. Moreover, uncertainties about the appropriate timing for intervention and the predictors of procedural success have contributed to limit TR treatment. Transcatheter tricuspid valve replacement or repair interventions represent novel and less invasive alternatives to surgery and have shown early promising results. The purpose of this review is to provide a complete and updated overview of TR pathology with a special focus on current percutaneous treatment options, future challenges and directions.

Cardiovascular tissue banking activity during SARS-CoV-2 pandemic: evolution of national protocols and Lombardy experience.

The worldwide pandemic outbreak due to severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) has created unprecedented challenges for public health services. Lombardy, region of the Northern Italy, has been the first area in the Western world whose organs and tissues procurement programs have had to face the virus pandemic emergency. We retrospectively collected and analyzed data about cardiovascular tissues (CT) in 2019 and in 2020. We aimed to describe the rapid evolution of SARS-CoV-2 regulation laws for tissue donor's selection and harvesting from February 2020 until January 2021. As expected the number of CT donors in 2020 was significantly lower than those of 2019 (66 vs. 99, p value 0.02). The total number of CT collected from donors have been 254 in 2019 and 206 in 2020 (p 0.28). Femoral arteries were the most required vascular tissues (55.5% in 2019 and 40% in 2020). Fifty-five and forty-eight pulmonary valves were implanted in 2019 and 2020, respectively. No differences were found for the types of CT requests between the 2 years. The median age of receivers of vascular tissues was 69.6 ± 14.6 years in the 2019 and 63.3 ± 14.9 years in 2020 (p < 0.01). The median age of receivers of pulmonary and aortic valves did not differ between the 2 years (9.32 ± 11.49 vs. 8.36 ± 10.66 and 48.67 ± 27.19 vs. 37.14 ± 31.97 respectively). Despite the dramatically reduction of donors, the number of CT collected has not decreased significantly and so far the CT distribution rate is comparable to those of 2019.

Mitral Valve Surgery After Transcatheter Edge-to-Edge Repair: Mid-Term Outcomes From the CUTTING-EDGE International Registry.

OBJECTIVES: The aim of this study was to determine clinical and echocardiographic characteristics, mechanisms of failure, and outcomes of mitral valve (MV) surgery after transcatheter edge-to-edge repair (TEER). BACKGROUND: Although >100,000 mitral TEER procedures have been performed worldwide, longitudinal data on MV surgery after TEER are lacking. METHODS: Data from the multicenter, international CUTTING-EDGE registry were retrospectively analyzed. Clinical and echocardiographic outcomes were evaluated. Median follow-up duration was 9.0 months (interquartile range [IQR]: 1.2-25.7 months) after MV surgery, and follow-up was 96.1% complete at 30 days and 81.1% complete at 1 year. RESULTS: From July 2009 to July 2020, 332 patients across 34 centers underwent MV surgery after TEER. The mean age was 73.8 ± 10.1 years, median Society of Thoracic Surgeons risk for MV repair at initial TEER was 4.0 (IQR: 2.3-7.3), and primary/mixed and secondary mitral regurgitation were present in 59.0% and 38.5%, respectively. The median interval from TEER to surgery was 3.5 months (IQR: 0.5-11.9 months), with overall median Society of Thoracic Surgeons risk of 4.8% for MV replacement (IQR: 2.8%-8.4%). The primary indication for surgery was recurrent mitral regurgitation (33.5%), and MV replacement and concomitant tricuspid surgery were performed in 92.5% and 42.2% of patients, respectively. The 30-day and 1-year mortality rates were 16.6% and 31.3%, respectively. On Kaplan-Meier analysis, the actuarial estimates of mortality were 24.1% at 1 year and 31.7% at 3 years after MV surgery. CONCLUSIONS: In this first report of the CUTTING-EDGE registry, the mortality and morbidity risks of MV surgery after TEER were not negligible, and only <10% of patients underwent MV repair. These registry data provide valuable insights for further research to improve these outcomes.

Transcatheter Mitral Valve Implantation: Current Status and Future Perspectives.

Mitral transcatheter therapies represent the treatment of choice for all patients deemed unsuitable for cardiac surgery. So far, the largest clinical experience has been limited to percutaneous repair techniques. However, given the complexity and heterogeneity of mitral valve anatomy and pathology, transcatheter mitral valve implantation will widen the mitral valve therapies horizon, toward a patient-tailored approach. Current data about transcatheter mitral valve implantation is still limited and, although some data are promising, there are still some issues to be addressed. This review provides a comprehensive insight into the available devices and describes potential advantages and limitations of transcatheter mitral valve implantation.

Safety and Feasibility of MitraClip Implantation in Patients with Acute Mitral Regurgitation after Recent Myocardial Infarction and Severe Left Ventricle Dysfunction.

Patients with severe mitral regurgitation (MR) after myocardial infarction (MI) have an increased risk of mortality. Transcatheter mitral valve repair may therefore be a suitable therapy. However, data on clinical outcomes of patients in an acute setting are scarce, especially those with reduced left ventricle (LV) dysfunction. We conducted a multinational, collaborative data analysis from 21 centers for patients who were, within 90 days of acute MI, treated with MitraClip due to severe MR. The cohort was divided according to median left ventricle ejection fraction (LVEF)-35%. Included in the study were 105 patients. The mean age was 71 ± 10 years. Patients in the LVEF < 35% group were younger but with comparable Euroscore II, multivessel coronary artery disease, prior MI and coronary artery bypass graft surgery. Procedure time was comparable and acute success rate was high in both groups (94% vs. 90%, p = 0.728). MR grade was significantly reduced in both groups along with an immediate reduction in left atrial V-wave, pulmonary artery pressure and improvement in New York Heart Association (NYHA) class. In-hospital and 1-year mortality rates were not significantly different between the two groups (11% vs. 7%, p = 0.51 and 19% vs. 12%, p = 0.49) and neither was the 3-month re-hospitalization rate. In conclusion, MitraClip intervention in patients with acute severe functional mitral regurgitation (FMR) due to a recent MI in an acute setting is safe and feasible. Even patients with severe LV dysfunction may benefit from transcatheter mitral valve intervention and should not be excluded.

Pre-Operative Continued Oral Anticoagulation Impact on Early Outcomes after Transcatheter Aortic Valve Implantation.

Considering that there is a lack of evidence and guideline-based recommendations on the best preoperative oral anticoagulation management (OAC) for transcatheter aortic valve implantation (TAVI), this cohort study aimed to evaluate bleeding, access site complications, and early safety in patients undergoing TAVI on continued OAC therapy vs no-OAC therapy. Three-hundred forty-four patients submitted to a TAVI procedure (66.3% no-OAC vs 33.7% OAC) were consecutively enrolled. Primary endpoint was defined as in-hospital VARC-2 life-threatening or disabling bleeding. Secondary endpoints were in-hospital VARC-2 major vascular complications and VARC-2 early safety at 30 days. Propensity score matching analysis was performed to reduce potential distribution bias, resulting in 2 well-balanced groups (92 patients in each arm). In the overall cohort, mean age, median EuroScore II, and STS-score were 78.7±7.6 years, 2.9% (1.7-5.9), and 2.3% (1.6-3.6), respectively. Despite being older (78 ± 8 vs 80 ± 6, p = 0.004) and having higher STS score (2.1 vs 2.6, p = 0.001), patients on OAC had similar incidence of in-hospital VARC-2 life-threatening or disabling bleeding (1.3% vs. 0.9%, p = 0.711), major vascular complications (4.8% vs 5.2%, p = 0.888), and VARC-2 early safety at 30 days (10.1% vs 12.1%, p = 0.575). No significant differences in the main outcomes were observed when propensity score matching was applied. In conclusion, the management of patients on OAC submitted to a TAVI procedure is challenging and requires balancing the risk of bleeding with the risk of thromboembolic events. The present study suggests that continued OAC was not associated with increased in-hospital VARC-2 life-threatening or disabling bleeding, major vascular complications, and VARC-2 early safety at 30 days.

Proper Selection Does Make the Difference: A Propensity-Matched Analysis of Percutaneous and Surgical Cut-Down Transfemoral TAVR.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is an established technique to treat severe symptomatic aortic stenosis patients with a wide range of surgical risk. Currently, the common femoral artery is the first choice as the main access route for the procedure. The objective of this observational study is to report our experience on percutaneous and surgical cut-down transfemoral TAVRs comparing the two approaches. METHODS: From January 2014 to January 2019, five hundred eleven consecutive patients underwent TAVR for severe symptomatic aortic stenosis. We analyzed only elective transfemoral procedures. After propensity score-matching based on age, sex, EuroSCORE II, mean aortic gradient, and left ventricular ejection fraction, we obtained two homogeneous populations: surgical cut-down (n = 119) and percutaneous (n = 225), which were labeled Group 1 and Group 2, respectively. RESULTS: The main findings were that there were no significant procedural outcome differences between the two groups, but Group 2 patients had a shorter length of hospital stay and were more frequently discharged home. At follow-up, Group 1 patients had lower survival rates. CONCLUSIONS: An accurate preoperative assessment of the femoral access is mandatory to achieve satisfactory outcomes with transfemoral TAVRs. Nevertheless, the percutaneous approach allows shorter in-hospital stay and the need for rehabilitation, thus potentially decreasing the costs of the procedure.

Percutaneous closure of femoral pseudaneurysm after TAVR.

Fully percutaneous transfemoral transcatheter aortic valve replacement (TF-TAVR) is currently the standard of the catheter-based treatment of severe aortic stenosis patients. Even though experience, lower delivery catheters profile and improved vascular closure devices performances have resulted in an overall reduction of both vascular and bleeding complications after TAVR, femoral pseudoaneurysm due to incomplete local hemostasis may occur, prolonging the in-hospital length of stay, causing discomfort to the patient and potentially evolving in serious consequences affecting the outcome. We report two successful percutaneous ultrasound-guided closure of both the main and secondary femoral access pseudoaneurysm.

Bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction technique in transcatheter aortic valve-in-valve procedures: a single-center initial experience.

AIM: To describe six cases using the bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction technique to prevent coronary artery obstruction during transcatheter aortic valve-in-valve procedures. METHODS: All patients presented degeneration of a bovine pericardium bioprosthesis [four Trifecta (19, 21, 23, and 25 mm); two Mitroflow (25 and 27 mm)] resulting in severe aortic stenosis (n = 5) or severe aortic regurgitation (n = 1). Procedures were performed under fluoroscopic and echocardiography guidance, and the transfemoral access was used to deliver a self-expanding valve. Data are expressed as frequency or median (Q1-Q3). RESULTS: Age, EuroScore II, and Society of Thoracic Surgeons score were 81 years (75-83.2), 2.9% (2.6-10.7), and 2.7% (2.3-3.2), respectively. Median left and right coronary heights were 9.1 mm (6.2-10.3) and 12.4 mm (10-13.5), respectively, with a median virtual transcatheter heart valve-to-coronary distance of 2.9 mm on the left and 4.6 mm on the right side. Isolated left leaflet laceration was planned in four patients, and bileaflet in two. One unsuccessful right leaflet laceration was reported, corresponding to the first patient (success rate 87.5%). All other seven leaflets lacerations were successfully performed, with no intraprocedure complications. No coronary obstruction, in-hospital death, valve complication, cardiovascular event, or pacemaker implantation were reported. All patients are being followed in routine outpatient visits, and no adverse events were registered. CONCLUSION: The high procedural success and low complication rate reported in this initial experience, demonstrates that the bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction technique can be a viable solution to prevent coronary obstruction in selected patients undergoing valve-in-valve procedures. Operator experience, periprocedural imaging and teamwork are essential to enable an accurate and successful procedure.

Veno-Arterial Extracorporeal Membrane Oxygenation in the Adult: A Bridge to the State of the Art.

Despite the technological advancements in the last 40 years, conditions such as refractory cardiogenic shock and cardiac arrest still present a very high mortality rate in real-world clinical practice. In this light, we have reviewed the techniques, indications, contraindications, and results of the socalled Veno-Arterial Extracorporeal Circulatory Membrane Oxygenation (VA-ECMO) in the adult population to evaluate the current results of this temporary cardio-pulmonary support as salvage and/or bridge therapy in the patient suffering from refractory cardiogenic shock or cardio-circulatory arrest. The results are encouraging, especially in the setting of refractory cardiogenic shock and in-hospital cardiac arrest. Among a selected population, the prompt institution of a VA-ECMO may radically change the prognosis by sustaining vital functions while looking for the leading cause or waiting for the reversal of the temporary cardio-respiratory negative condition. The future directions aim to standardized and shared protocols, miniaturization of the machines, and possibly the institution of specialized "ECMO teams" for in and the out-of-hospital institution of the tool.