Excellent Hemodynamic Results Research Articles

Single-center real-world data and technical considerations from 100 consecutive patients treated with the Perceval aortic bioprosthesis.

Although the Perceval sutureless aortic valve bioprosthesis presents a feasible alternative to conventional aortic valve prostheses, the extent of its applicability with respect to technical considerations for a real-world patient collective is still under debate. One hundred patients received the Perceval prosthesis [males: 59; age: 72.5 (7.3-79) years] between December 2015 and February 2023 [EuroSCORE II: 2.8 (1.7-5.4)] for an aortic valve replacement (AVR), with additional concomitant procedures, for underlying severe aortic valve stenosis [n = 93 (93)], endocarditis [n = 5 (5)], and redo AVR [n = 7 (7)] including a prior surgical AVR [n = 4 (4)] and a failed transcatheter aortic valve implantation [n = 3 (3)]. Surgery was conducted primarily by median sternotomy [n = 71 (71)] and, alternatively, by the upper hemisternotomy approach [n = 29 (29)]. Over a median follow-up time of 36.5 (16.5-53) months, eight patients (8%) underwent postoperative pacemaker implantation, with five (5%) due to high-grade atrioventricular block, while nine patients experienced a stroke (9%). The median values of maximum and mean gradients across all valve sizes were 22 (18-27.5) mmHg and 10 (13-18) mmHg, respectively. Two patients (2%) had moderate and one (1%) had severe paravalvular leakage, with the latter presenting the only case of underlying valve migration and induced redo AVR with valve explantation 2 days following initial surgery. Thirty-day mortality (and overall mortality) was 5% and 26%, respectively. The implantation of the Perceval bioprosthesis is feasible for a variety of indications, with excellent hemodynamic results and low complication rates in a real-world high-risk patient collective.

Midterm outcomes of the Ozaki procedure in patients with a bicuspid aortic valve: retrospective single-center, non-randomized, parallel-group study

BACKGROUND: An alternative to plastic surgery on the bicuspid aortic valve (BAV) can be replacement of the leaflets with autopericardium using the Ozaki technique. The procedure is characterized by excellent hemodynamic results in the short and long term in patients with tricuspid aortic valve (TAV). However, the question remains about the long-term results of the procedure and the frequency of reoperations in patients with BAV.
 OBJECTIVE: To analyze the midterm outcomes of the Ozaki procedure in patients with BAV.
 MATERIALS AND METHODS: Retrospective single-center, non-randomized, parallel-group study was conducted. Since January 2015 to October 1, 2023, the clinic performed 809 Ozaki procedures. The work included 540 patients with studied midterm and long-term outcomes for up to 5 years. Both isolated aortic valve replacement and combined operations with coronary artery bypass grafting and (or) correction of mitral and tricuspid valve defects were performed.
 RESULTS: Midterm mortality was 5.7% (n=3) in the group with BAV and 7.3% (n=36) in the group with TAV. Reoperation for aortic regurgitation was required in 16 patients (2.9%): 1 patient (1.9%) in BAV group and 15 (3.3%) in TAV group. Freedom from reoperations in patients with BAV after the Ozaki procedure for up to 5 years was 95.4%, in the group with TAV — 92.6%. The peak gradient on the aortic valve in the group with BAV was 16±7.3, in TAV group— 16.4±10.9. 5 years after surgery, the mean gradient on the aortic valve does not exceed 10 mm Hg.
 CONCLUSION: The Ozaki operation in patients with BAV is an effective and safe procedure in the midterm follow-up period.

Exvivo biomechanical analysis of the Ross procedure using the modified inclusion technique in a 3-dimensionally printed left heart simulator.

The inclusion technique was developed to reinforce the pulmonary autograft to prevent dilation after the Ross procedure. Anticommissural plication (ACP), a modification technique, can reduce graft size and create neosinuses. The objective was to evaluate pulmonary valve biomechanics using the inclusion technique in the Ross procedure with and without ACP. Seven porcine and 5 human pulmonary autografts were harvested from hearts obtained from a meat abattoir and from heart transplant recipients and donors, respectively. Five additional porcine autografts without reinforcement were used as controls. The Ross procedure was performed using the inclusion technique with a straight polyethylene terephthalate graft. The same specimens were tested both with and without ACP. Hemodynamic parameter data, echocardiography, and high-speed videography were collected via the exvivo heart simulator. Porcine autograft regurgitation was significantly lower after the use of inclusion technique compared with controls (P<.01). ACP compared with non-ACP in both porcine and human pulmonary autografts was associated with lower leaflet rapid opening velocity (3.9±2.4cm/sec vs 5.9±2.4cm/sec; P=.03; 3.5±0.9cm/sec vs 4.4±1.0cm/sec; P=.01), rapid closing velocity (1.9±1.6cm/sec vs 3.1±2.0cm/sec; P=.01; 1.8±0.7cm/sec vs 2.2±0.3cm/sec; P=.13), relative rapid opening force (4.6±3.0 vs 7.7±5.2; P=.03; 3.0±0.6 vs 4.0±2.1; P=.30), and relative rapid closing force (2.5±3.4 vs 5.9±2.3; P=.17; 1.4±1.3 vs 2.3±0.6; P=.25). The Ross procedure using the inclusion technique demonstrated excellent hemodynamic parameter results. The ACP technique was associated with more favorable leaflet biomechanics. Invivo validation should be performed to allow direct translation to clinical practice.

Obesity Does Not Significantly Impact Operative and Long-Term Outcomes After Pulmonary Thromboendarerectomy

<h3>Purpose</h3> Although obesity is a common comorbidity among patients undergoing Pulmonary Thromboendarterectomy (PTE) for Chronic Thromboembolic Pulmonary Hypertension (CTEPH), the exact impact of this risk factor on operative and hemodynamic outcomes remains poorly described. Objectives are to assess the effects of BMI on operative mortality and major morbidity, survival, and post-discharge hemodynamic parameters after PTE. <h3>Methods</h3> From 2013 to 2021, 223 patients underwent PTE at a single referral institution. Median age was 51±15 years and mean BMI was 33.6±8.8kg/m². Diagnosis of CTEPH was confirmed on pulmonary artery catheterization with mean PA pressure 45.4±12.2mmHg. The primary outcome was a composite of in-hospital mortality, stroke, respiratory failure requiring tracheostomy and renal failure requiring dialysis. Secondary outcomes included late changes to hemodynamic parameters and sternal wound infection. <h3>Results</h3> In-hospital mortality was 6.3% (N=14), while 1.3% of patients (N=3) suffered stroke, 5.4% (N=12) required dialysis and 9.0% (N=20) required tracheostomy. Post-operative mean PA pressure was 30.4±9.6 mmHg just prior to discontinuation of invasive monitoring. Of the 106 patients with post-discharge echocardiogram, 12% had moderate-severe RV dysfunction, decreased from 53% pre-operatively (p=0.0004). Eighteen (8.1%) patients required reintervention for post-operative sternal infection, with 7 deep and 11 superficial infections. Of these, 12 required debridement and 6 required tissue flap. In a univariate logistic regression, BMI was not a significant predictor of the composite outcome (OR 1.00, CI 0.96-1.04), but was correlated with increased risk of wound infection (OR 1.06, CI 1.01-1.11). Changes to in-hospital PA pressures and post-discharge RV function were not correlated with BMI (p=0.97, p=0.96, respectively). In a Cox proportional hazards model, BMI was not associated with impaired long-term survival after PTE (HR 1.01, CI 0.96-1.06). <h3>Conclusion</h3> This study shows that PTE can be a safe and effective treatment for CTEPH in the obese population, although it does carry increased risk of post-operative wound infection. PTE has the potential to yield excellent hemodynamic results in all patients, regardless of BMI; and therefore, it should continue to represent the standard of care for obese patients with CTEPH.

Novel self-expanding ALLEGRA transcatheter aortic valve for native aortic stenosis and degenerated bioprosthesis.

To investigate the safety and efficacy of the ALLEGRA valve in routine use. The ALLEGRA aortic valve is a self-expanding transcatheter heart valve (THV) with bovine pericardial tissue and was CE approved in March 2017. Its unique design was developed to provide low prosthesis gradients. We analyzed patients receiving an ALLEGRA THV between May 2017 and March 2021 at our center for treatment of aortic valve stenosis or degenerated valve prosthesis. Hemodynamic results and clinical outcome according to the Valve Academic Research Consortium-2 consensus criteria were evaluated at discharge and three months post transcatheter aortic valve replacement (TAVR) procedure. 93 patients with a mean age of 82.5 ± 4.8 years and a median EuroScore II of 4.7 ± 3.4 were treated, 15 of them were valve-in-valve procedures. Implantation was successful in 97.8% (91/93) and VARC-2 defined device success was achieved in 94.6% (88/93). In-hospital all-cause mortality was 2.2% (2/93). Life-threatening bleeding, major vascular complications and strokes were 3.2% (3/93), 2.2% (2/93) and 3.2% (3/93), respectively. Paravalvular leakage was none to trace in 60.4%, mild in 38.5% and moderate in 1.1%. Permanent pacemaker implantation in pacemaker naive patients was necessary in 9.5% (8/84). Mean gradient at discharge was 8.2 ± 4.3 mmHg for all patients; 7.1 ± 2.6 mmHg in patients treated for stenosis of the native aortic valve and 13.8 ± 6.3 mmHg in patients treated valve-in-valve. The ALLEGRA THV provides excellent hemodynamic results and a good safety profile with a low complication rate.

Perceval S valve empire: healing the Achilles' heel of sutureless aortic valves.

Aortic valve replacement is the treatment of choice concerning aortic valve disease. Excellent short- and long-term clinical results are reported. Patients referred for aortic valve replacement are getting older and older, so bioprosthetic valves play a more central role worldwide. However, patient comorbidities are also increased more often rendering patients unsuitable for open conventional aortic valve replacement. As a result, transcatheter aortic valve implantation has become the treatment of choice in patients at very high surgical risk. However, the percutaneous technique is related to major disadvantages provided that the diseased native valve is left in place. Its durability is also uncertain. More recently, sutureless Perceval S valve bioprosthesis has gained ground in the field of aortic stenosis therapy filling the gap between conventional aortic valve replacement and transcatheter approach. Excellent hemodynamic and clinical results are reported. Its deployment is performed under direct view and ischemic and overall operative times are significantly decreased. Five-year follow-up results are also optimal. However, the "Achilles' heel" of sutureless technology is increased rates of postoperative permanent pacemaker implantation requirement compared to conventional approach. The incidence of this complication varies in literature. Patient-related factors such as preoperative conduction disorders, older age and short membranous septum are predictors of postoperative pacemaker requirement. However, several technical modifications regarding manufacturer recommendations can be adopted to mitigate this complication. Appropriate annular decalcification, higher guiding sutures placement, reduced balloon pressure and duration and avoiding of oversizing can contribute to prevent from this complication.

Clinical and Hemodynamic Results of Rapid Deployment Aortic Prostheses in Patients With Small Aortic Ring

Objective: The Edwards Intuity valve is a rapid deployment biological aortic prosthesis. It is another option to treat aortic stenosis. It favors less aggressive approaches and shortens surgical times. Little is known about the hemodynamic and clinical behavior of their smaller sizes. We present our experience with Intuity prostheses Nos. 19 and 21. Methods: From September 2012 to May 2020, 122 Intuity prostheses were implanted, 54 (45%) were no. 19 or 21 (69% women, 76 (72-78) years). Results: One patient (1.8%) died in the hospital and six in the follow-up (3.4%). Mean pressure gradient at the discharge of 11.3 ± 4.3, at one year of 10.9 ± 3, and two years of 9.2 ± 3.5 mm Hg. Survival of 95% at 1 year and 83% at 5 years. Twenty-five patients (46%) had a prosthesis-patient mismatch, but with no impact on long-term survival (log-rank: 0.66). Three patients (6%) required a permanent pacemaker in the hospital. Patients with small Intuity prostheses did not present higher in-hospital mortality than patients with larger prostheses (1.8% vs 4.4%, p = 0.430) or higher mortality during follow-up (15% vs 10%; p = 0.430). Having a small prosthesis did not influence long-term survival (log-rank: 0.623). Conclusions: Edwards Intuity Aortic Prosthesis size 19-21 have shown excellent clinical and hemodynamic results with good medium-term survival. The patient prosthesis mismatch had no prognostic influence in this group. The Edwards Intuity aortic prosthesis is an option to consider in patients with a small aortic ring, especially if they are elderly.

Transcatheter Aortic Valve Replacement for a Degenerated Transcatheter Valve-A Single Center Experience.

The transcatheter valve-in-valve treatment (TAV-in-TAV) of degenerated transcatheter aortic valves is becoming more relevant, as the use of transcatheter aortic valve replacement (TAVR) increases. We report our experience with TAV-in-TAV in patients with a degenerated transcatheter heart valve (THV). We retrospectively analyzed prospectively collected data from our designated TAVR database. Intraprocedural and intrahospital outcomes were reported. Ten patients out of a total of 3,144 TAVR implantations since 2007 presented with a degenerated THV, among those six with an Edwards Sapien XT (Edwards Lifesciences, Irvine, California, United States) valve, treated with a Medtronic Evolut R (Medtronic, Dublin, Ireland) valve. Four patients had severe stenosis, one pure insufficiency, and five combined stenosis and insufficiency. Average time between initial implantation and re-intervention was 6.8 ± 1.3 years. The mean preoperative maximum and mean gradients were 54.2 ± 14.8 mm Hg and 31.6 ± 9.9 mm Hg, respectively. Nine patients underwent transfemoral and one patient underwent transaortic TAV-in-TAV. Mean procedural time was 86.2 ± 51.5 minutes. Post-implantation, the maximum and mean gradients decreased to 18 ± 6.9 mm Hg and 8.4 ± 3.2 mm Hg (16 ± 8 mm Hg and 6.4 ± 1.7 mm Hg in the Evolut-in-Sapien subgroup), respectively. The valve area increased from 0.98 ± 0.28 mm Hg to 1.72 ± 0.32 mm Hg (0.8 ± 0.07 mm Hg to 1.9 ± 0.16 mm Hg in the Evolut-in-Sapien subgroup). Two patients experienced a vascular complication. No further Valve Academic Research Consortium-2 criteria complications occurred during hospitalization. TAV-in-TAV resulted in low procedural and peri-procedural complication rates. In particular, the usage of a supra-annular valve resulted in excellent hemodynamic results. Larger studies are required to validate this observational data and to establish a protocol for this procedure.

Transcatheter Aortic Valve Dislocation in Left Ventricular Outflow Tract with Successful Repositioning Using “Double Snare” Technique

Background: Transcatheter aortic valve implantation (TAVI) is a widely used treatment of severe aortic stenosis. Implantation of a self-expanding valve into a dense calcified aortic annulus can be challenging and may result in device malposition and malfunction. Aim: The aim of our case report is to present a novel technique of transcatheter aortic valve dislocation treatment. Case presentation: An 86-year-old woman with severely calcified aortic valve underwent TAVI using a 27-mm self-expanding Portico valve (Abbott Vasc, USA). In the last phase of implantation, the valve dislocated deep into the left ventricular outflow tract resulting in significant paravalvular regurgitation and patient instability. Repositioning of the valve with a single snare was ineffective because of severe aortic ring calcifications. A novel “double snare” technique was applied and the valve was successfully repositioned upward with an excellent anatomic and haemodynamic result. Conclusion: “Double snare” technique can be an effective strategy for repositioning of deeply implanted self-expanding transcatheter aortic valves. It represents an efficient bailout strategy in case of single snare approach failure, especially in cases of severe aortic ring calcifications.

Valve-in-valve transcatheter aortic valve implantation with fracturing of a failed small surgical aortic bioprosthesis: a case report.

BackgroundFailure of a small surgical aortic bioprosthesis represents a challenging clinical scenario with valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) often resulting in patient-prosthesis mismatch. Bioprosthetic valve fracture (BVF) performed as a part of the ViV TAVI has recently emerged as an alternative approach with certain types of surgical bioprostheses.Case summaryAn 81-year-old woman with a history of three surgical aortic valve procedures presented with heart failure. Aortic bioprosthesis degeneration with severe stenosis and moderate regurgitation was found. The patient was deemed a high-risk surgical candidate and the heart team decided that ViV TAVI was the preferred treatment option. Due to the very small 19 mm stented surgical aortic bioprosthesis Mitroflow 19 mm (Sorin Group, Italy) we decided to perform BVF as a part of ViV TAVI to prevent patient-prosthesis mismatch. Since this was the first BVF procedure in our centre, an ex vivo BVF of the same kind of bioprosthetic valve was performed first. Subsequently, successful BVF with implantation of Evolut R 23 mm (Medtronic, USA) self-expandable transcatheter valve was performed. Excellent haemodynamic result was achieved and no periprocedural complications were present. The patient had an immediate major improvement in clinical status and remains asymptomatic after 6 months.DiscussionBioprosthetic valve fracture together with ViV TAVI is a safe and effective emerging technique for treatment of small surgical aortic bioprosthesis failure. Bioprosthetic valve fracture allows marked oversizing of implanted self-expandable transcatheter aortic valves, leading to excellent haemodynamic and clinical results. An ex vivo BVF can serve as an important preparatory step when introducing the new method.

Performance of the Corevalve Evolut R and PRO in severely calcified anatomies: a propensity-score matched analysis

Abstract Background The Corevalve Evolut R and PRO belong to the newer generation of self-expandable valves and are increasingly used to treat patients with severe aortic stenosis. Over the years, technical advancements and increasing experience with the procedure itself are responsible for excellent clinical and hemodynamic results. Patients with severely calcified native aortic valve anatomies still pose a special task to the implanting team since the risk for intraprocedural complications might be increased. Purpose To evaluate the hemodynamic and clinical performance of the CoreValve Evolut R and PRO in patients with severely calcified native aortic valve anatomies. Methods Baseline characteristics, imaging data and procedural outcome of patients undergoing transfemoral transcatheter aortic valve implantation with the CoreValve Evolut R and PRO from 09/2015 to 03/2018 were prospectively collected. Patients underwent high-resolution multisclice computed tomography (MSCT). A pre-specific threshold of 600 Hounsfield units was set to account for the hyperdensity of the applied contrast medium and to enable comparability with MSCT thresholds, derived by non-contrast enhanced MSCT scans. Patients were divided by the extent of calcification into a severely calcified anatomy group (men &amp;gt;2062AU, woman &amp;gt;1377AU) or a not severely calcified anatomy group (men &amp;lt;2062AU, woman &amp;lt;1377AU). Propensity score matching with the variables log EuroSCORE, LVOT calcium load and the cover index in a 1:2 fashion was performed and clinical and hemodynamic results in accordance with VARC II were collected. Results Ninety-eight patients with severely calcified anatomies (SC) could be identified and were matched with 196 patients with lower calcified (LC) anatomies. Patients with severely calcified anatomies were older (SC: 83.1 years vs. LC: 80.3 years, p&amp;lt;0.001) and had a smaller aortic valve area (SC: 0.63cm2 vs. LC: 0.70cm2, p=0.028). The mean implantation depth did not differ (SC 5.4mm±2.4 vs. LC: 5.1±2.2, p=0.554). Pre-dilatation was more often performed in the SC group (SC: 30.6% vs. LC: 15.8%, p=0.003) and the stroke/TIA rate did not differ (SC: 5.1% vs. LC: 3.5%, p=0.532). In SC patients, a permanent pacemaker implantation was significantly more often needed (SC: 28.5% vs. LC:7.6%, p&amp;lt;0.001). The mean pressure gradient after the procedure was effectively reduced (SC: 7.1mmHg±3.9 vs. LC: 7.8±3.7mmHg, p=0.477). No aortic regurgitation (AR) was more often present in patients with SC anatomies (SC: 72.5% vs. LC: 85.2%, p=0.011). The aortic regurgitation index numerically differed between groups without reaching statistical significance (SC: 24.1±7.1 vs. LC: 27.3±6.7, p=0.067). Conclusion The CoreValve Evolut R and PRO show a good clinical safety profile and excellent hemodynamic results even in patients with severely calcified anatomies. In those patients, a permanent pacemaker implantation was more often necessary. Funding Acknowledgement Type of funding source: None

Performance of the CoreValve Evolut R and PRO in Severely Calcified Anatomy: A Propensity Score Matched Analysis

The CoreValve Evolut R and PRO (Medtronic, Minneapolis, MN, USA) are among the newest-generation of self-expandable transcatheter aortic valve replacement (TAVR) devices and show excellent results. Treating patients with severely calcified (SC) native aortic valve anatomy may be challenging because of the increased risk of periprocedural complications. This study investigated the performance of Evolut R and PRO in this special patient subset. Patients who underwent TAVR with the CoreValve Evolut R or PRO (n=381) from September 2015 to March 2018 were divided by aortic valve calcification extent. Patients with SC aortic valve anatomy (n=98; men, >2,062 and women, >1,377 Agatston units) were compared with those with non-severely calcified (NCS) aortic valve anatomy after 1:2 propensity score matching. Outcomes were evaluated according to the updated valve academic research consortium criteria. Patients with SC anatomy were older (83 years vs 80 years, p<0.001) and had a smaller aortic valve area (0.63 cm2 vs 0.70 cm2, p=0.028). Pre-dilatation was more often performed (30.6% vs 15.8%, p=0.003) and a permanent pacemaker implantation was more often necessary (32.9% vs 8.8%, p<0.001) in the SC group. None/mild aortic regurgitation (AR) was evenly distributed (SC, 96.9% vs NCS, 99.5%, p=0.109); moderate AR was present in 3.1% of SC patients and in 0.5% of NSC patients. Severe AR was not observed. The CoreValve Evolut R and PRO showed good clinical safety profiles and excellent haemodynamic results in patients with SC anatomy and who more often required permanent pacemaker implantation.

The Da Silva cone operation after the Starnes procedure for Ebstein's anomaly: New surgical strategy and initial results.

The Da Silva cone operation after the Starnes procedure for Ebstein's anomaly: New surgical strategy and initial results.

Muscle-sparing aortic coarctation repair.

ObjectiveSurgery for aortic coarctation repair provides excellent hemodynamic results but may be complicated by musculoskeletal issues. The purpose of the study was to determine the midterm results of a muscle-sparing surgical approach to aortic coarctation repair, with special emphasis on the repair and on the musculoskeletal changes associated with a posterior thoracotomy.MethodsWe included all children with aortic coarctation operated on with our minimally invasive approach between June 2002 and October 2004, with a follow-up of ≥4.5 years. Patients were assessed clinically and echocardiographically. The spine, left chest, and shoulder were assessed clinically and radiographically.ResultsThirty-one children were included. The age at operation ranged from 1 day to 15 months and weight ranged from 980 g to 10 kg. All patients underwent an extended end-to-end anastomosis coarctation repair through a minimal (n = 19) or total-muscle sparing (n = 12) or extrapleural (n = 18) approach. Five patients had an additional enlargement procedure on the aortic arch. 27 patients had no residual or recurrent gradient. Four patients exhibited restenosis, for which 1 underwent a percutaneous angioplasty and 2 underwent surgical reintervention. All patients were free of hypertension. One patient had borderline values. The musculoskeletal assessment was normal in all but 3 patients. Two patients who underwent other subsequent thoracic surgeries developed thoracogenic scoliosis of moderate severity. A third patient had a left winged scapula. No rib fusion or intercostal space enlargement was found.ConclusionsCompared with a conventional approach, our minimally invasive surgical approach led to excellent musculoskeletal outcomes without compromising the hemodynamic results.

Mid-term outcomes after percutaneous pulmonary valve implantation in complex right ventricular outflow tracts using the “folded” Melody® valve technique

Percutaneous pulmonary valve implantation (PPVI) using Melody®valve has been validated as a valuable therapeutic option for the management of right ventricular outflow tract (RVOT) dysfunction but remains challenging. The “Folded” modification of the Melody®valve has been reported as a safe and feasible technique in complex RVOT . We sought to evaluate mid-term outcomes in a multicentre cohort who underwent PPVI using the “folded” Melody® valve technique. Patients who underwent PPVI using a Foled Melody®between April 2012 and November 2018 in 6 European tertiary Centerswere retrospectively included. “Folded” Melody® valve technique was successfully performed in 28 patients (mean age = 17.7 ± 10 years old). Indications were: short RVOT and early bifurcation of pulmonary arteries in 12 (42.8%) ( Fig. 1 ) , bioprosthetic valves in 10 (35.7%), coronary arteries proximity in 4 (14.3%) and prevention of retrosternal compression in 2 (7.2%). No complication occurred during procedures. All patients had excellent hemodynamic results. Mean transvalvular peak velocity decreased from 3.8 ± 0.86 m/s before PPVI to 2.4 ± 0.55 m/s in the immediate post-PPVI period. Only 5 patients had trivial pulmonary regurgitation (PR) at discharge. After a median follow up (FU) of 27 ± 17.9 months, all patients were alive, and all, but 3 patients, were free from reintervention: 1 patient (3.5%) developed Melody® valve infective endocarditis 3 months after PPVI and underwent RVOT surgical replacement; Two underwent pulmonary artery stenting 2 and 4 years after of PPVI, but the lesions were not related to the Folded valve. At last FU mean transvalvular peak velocity was 2.6 ± 0.66 m/s and only 5 (17.8%) patients had mild or less PR. No stent fractures were observed. The “folded valve technique” is a safe and feasible modification of the Melody® valve which provides favourable mid-term results without increased rate of valve related complications.

Early Experience With Transcatheter Mitral Valve Replacement: A Systematic Review

BackgroundTranscatheter mitral valve replacement (TMVR) has emerged as an alternative therapeutic option for the treatment of severe mitral regurgitation in patients with prohibitive or high surgical risk. The aim of this systematic review is to evaluate the clinical procedural characteristics and outcomes associated with the early TMVR experience.Methods and ResultsPublished studies and international conference presentations reporting data on TMVR systems were identified. Only records including clinical characteristics, procedural results, and 30‐day and midterm outcomes were analyzed. A total of 16 publications describing 308 patients were analyzed. Most patients (65.9%) were men, with a mean age of 75 years (range: 69–81 years) and Society for Thoracic Surgery Predicted Risk of Mortality score of 7.7% (range: 6.1–8.6%). The etiology of mitral regurgitation was predominantly secondary or mixed (87.1%), and 81.5% of the patients were in New York Heart Association class III or IV. A transapical approach was used in 81.5% of patients, and overall technical success was high (91.7%). Postprocedural mean transmitral gradient was 3.5 mm Hg (range: 3–5.5 mm Hg), and only 4 cases (1.5%) presented residual moderate to severe mitral regurgitation. Procedural and all‐cause 30‐day mortality were 4.6% and 13.6%, respectively. Left ventricular outflow obstruction and conversion to open heart surgery were reported in 0.3% and 4% of patients, respectively. All‐cause and cardiovascular‐related mortality rates were 27.6% and 23.3%, respectively, after a mean follow‐up of 10 (range: 3 to 24) months.Conclusions TMVR was a feasible, less invasive alternative for treating severe mitral regurgitation in patients with high or prohibitive surgical risk. TMVR was associated with a high rate of successful valve implantation and excellent hemodynamic results. However, periprocedural complications and all‐cause mortality were relatively high.

Mid-term outcomes after percutaneous pulmonary valve implantation in complex right ventricular outflow tracts using the “folded” Melody® valve technique

BackgroundPercutaneous pulmonary valve implantation (PPVI) using Melody® valve has been validated as a valuable therapeutic option for the management of right ventricular outflow tract (RVOT) dysfunction but remains challenging [1–3]. The “Folded” modification of the Melody® valve has been reported as a safe and feasible technique in complex RVOT [4]. We sought to evaluate mid-term outcomes in a multicentre cohort who underwent PPVI using the “folded” Melody® valve technique. MethodsPatients who underwent PPVI using a Foled Melody® between April 2012 and November 2018 in 6 European tertiary Centers were retrospectively included. Results“Folded” Melody® valve technique was successfully performed in 28 patients (mean age=17.7±10 years old). Indications were: short RVOT and early bifurcation of pulmonary arteries in 12 (42.8%) (Fig. 1), bioprosthetic valves in 10 (35.7%), coronary arteries proximity in 4 (14.3%) and prevention of retrosternal compression in 2 (7.2%). No complication occurred during procedures. All patients had excellent hemodynamic results. Mean transvalvular peak velocity decreased from 3.8±0.86m/s before PPVI to 2.4±0.55m/s in the immediate post-PPVI period. Only 5 patients had trivial pulmonary regurgitation (PR) at discharge. After a median follow-up (FU) of 27±17.9 months, all patients were alive, and all, but 3 patients, were free from reintervention: 1 patient (3.5%) developed Melody® valve infective endocarditis 3 months after PPVI and underwent RVOT surgical replacement; Two underwent pulmonary artery stenting 2 and 4 years after of PPVI, but the lesions were not related to the Folded valve. At last FU mean transvalvular peak velocity was 2.6±0.66m/s and only 5 (17.8%) patients had mild or less PR. No stent fractures were observed. ConclusionThe “folded valve technique” is a safe and feasible modification of the Melody® valve which provides favourable mid-term results without increased rate of valve related complications.

EP26 PRELIMINARY RESULTS OF LAST GENERATION SURGICAL BIOPROSTHESES IN SMALL AORTIC ANNULI: TRIFECTA VS INTUITY

Background and Aim: Aortic valve replacement (AVR) in patients with small aortic annulus is associated with increased risk of patient-prosthesis mismatch. Results of 19–21 Trifecta vs Intuity bioprostheses in patients with annular size &lt;21 mm are compared. Methods: Between 2013 and 2017,we retrospectively analyzed 25 (22 women,76.8 ±6.6 years) Trifecta AVR patients vs 26 (23 women, 78.6 ± 4.7 years) Intuity AVR patients.Combined procedures and reinterventions were excluded.Body surface area, left ventricular mass index and Euroscore-II were not different (p:0.68, 0.92 and 0.96 respectively). Results: Cardiopulmonary-bypass time was 108.6 ± 22.5 and 84.4 ± 20.5 minutes(p: 0.012);aortic cross-clamp time was 79.3 ± 14.6 and 60.73 ± 15.3 minutes in the Trifecta and in the Intuity group respectively(p:0.001). There wasn’t significant difference in postoperative transvalvular gradients.Lenght of hospital stay and major complications were not significantly different between the two groups.Follow-up is still ongoing. At 3.5 ± 1.2 years,41.1% of patients were followed-up. Until now, no significant difference neither in term of mortality nor in major complications have been observed.Peak pressure gradients were 29.2 ± 11.5 and 20.7 ± 5.9 mmHg (p:0.04);mean 16.2 ± 6.4 and 11 ± 3.03 mmHg (p: 0.02).Effective orifice area (EOA) was 1.43 ± 0.24 and 1.3 ± 0.2 cm2(p:0.5).There is no significant difference in reverse cardiac remodeling (left ventricular mass index 134.4 vs 124.4 g/m2.p:0.43). Conclusions: Trifecta and Intuity prostheses provide excellent hemodynamic results in small aortic annulus AVR. Operative times with Intuity were significantly lower. EOA was similar in both groups,however Trifecta presented significantly higher gradients at follow-up. Preliminary data need to be confirmed: completion of follow-up (July 2018) could provide stronger evidence to these first surveys.

Determination of risk factors for pacemaker requirement following rapid-deployment aortic valve replacement.

Rapid-deployment aortic valve replacement (RD-AVR) potentially reduces procedure times providing excellent haemodynamic results compared to standard tissue aortic valve replacement. However, concerns have been raised regarding higher rates of postoperative pacemaker (PPM) requirement compared to standard aortic valve replacement. In this study, we sought to determine the PPM rate and its potential risk factors in RD-AVR patients. Between 2011 and 2017, 193 patients underwent RD-AVR. The main outcome investigated was PPM. Other outcome parameters included hospital mortality, major morbidity, length of stay and discharge condition. Predictors of PPM were determined using multivariable regression models. Isolated RD-AVR was performed in 72 (37%) patients and 121 (63%) patients underwent combined RD-AVR [coronary artery bypass grafting (n = 110), mitral repair (n = 6) and others (n = 5)]. Aortic cross-clamp and cardiopulmonary bypass times were 57.1 ± 25.1 min and 90.0 ± 40.1 min in the overall RD-AVR population and 39.4 ± 13.5 min and 67.6 ± 24.5 min, respectively, in isolated RD-AVR procedures. PPM occurred in 20 (10.4%) patients. Multivariable analysis revealed bypass grafting of the circumflex artery [odds ratio = 2.8] and preoperative right branch bundle block (odds ratio = 11.7) as independent predictors for PPM. RD-AVR is a safe and simple procedure resulting in favourable short aortic cross-clamp and cardiopulmonary bypass times and considerable low gradients in postoperative echocardiography. PPM following isolated RD-AVR remains in the range of standard aortic valve replacement. However, patients undergoing concomitant coronary artery bypass grafting, particularly of the circumflex artery, face a 3-fold increased risk for PPM implantation enhanced if right branch bundle block is present. Follow-up examination is necessary to determine whether these patients remain pacer dependent during long-term follow-up.

A new one-step procedure for pulmonary valve implantation of the melody valve: Simultaneous prestenting and valve implantation.

To describe a new modification, the one-step procedure, that allows interventionists to pre-stent and implant a Melody valve simultaneously. Percutaneous pulmonary valve implantation (PPVI) is the standard of care for managing patients with dysfunctional right ventricular outflow tract, and the approach is standardized. Patients undergoing PPVI using the one-step procedure were identified in our database. Procedural data and radiation exposure were compared to those in a matched group of patients who underwent PPVI using the conventional two-step procedure. Between January 2016 and January 2017, PPVI was performed in 27 patients (median age/range, 19.1/10-55 years) using the one-step procedure involving manual crimping of one to three bare metal stents over the Melody valve. The stent and Melody valve were delivered successfully using the Ensemble delivery system. No complications occurred. All patients had excellent hemodynamic results (median/range post-PPVI right ventricular to pulmonary artery gradient, 9/0-20 mmHg). Valve function was excellent. Median procedural and fluoroscopic times were 56 and 10.2 min, respectively, which significantly differed from those of the two-step procedure group. Similarly, the dose area product (DAP), and radiation time were statistically lower in the one-step group than in the two-step group (P < 0.001 for all variables). After a median follow-up of 8 months (range, 3-14.7), no patient underwent reintervention, and no device dysfunction was observed. The one-step procedure is a safe modification that allows interventionists to prestent and implants the Melody valve simultaneously. It significantly reduces procedural and fluoroscopic times, and radiation exposure.