Selective placement of novel compression suture technique to reduce pacemaker implantation rate following surgical aortic valve replacement with rapid deployment INTUITY valve.

OBJECTIVE: The use of RDV in SAVR is associated with risk of conduction abnormality requiring PPM implantation, when compared to conventional bioprosthetic valves. We aimed to evaluate the outcome after selective placement of annular compression sutures during surgical aortic valve replacement (SAVR) using Intuity rapid deployment valve (RDV). METHODS: This is a retrospective study of prospectively enrolled patients receiving SAVR using Intuity RDV. Selective placement of commissural compression suture was assessed for all patients based on their annular morphology. Outcomes including operative mortality, rate of pacemaker rate, paravalvular leak and change in trans-valvular pressure gradient were analyzed. RESULTS: 56 consecutive patients underwent SAVR with the INTUITY RDV at our institution from January 2020 to November 2021. The Mean age of our cohort was 69.9 ± 10.6 years with a EuroSCORE II of 3.4 ± 2.4%. 28.6% (16/56) of patients had notable conduction abnormalities pre-operatively, which included atrial fibrillation and left/right bundle branch block. Compression sutures were selectively applied in 19/56 (33.9%) patients. Of which, 13 were bicuspid aortic valve. Post-operatively, we observed no conduction abnormality requiring PPM implantation. In addition, only 3 of the 56 (5.4%) had any degree of paravalvular leak on post-operative echocardiography (all ≤ mild). The mean reduction in trans-valvular gradient was 29.9 mmHg and the mean pressure gradient at 1 month and 1 year follow-up were 9.3 ± 3.6 mmHg and 10.2 ± 4.1 mmHg, respectively. CONCLUSIONS: Selective placement of compression suture helps to avoid unnecessary oversizing, which may reduce the risk of paravalvular leak and post-operative PPM implantation.

Early Outcomes of Intuity Rapid Deployment Aortic Valve Replacement Compared With Conventional Biological Valves in Japanese Patients.

BACKGROUND: This study aimed to elucidate the short-term surgical outcomes and hemodynamics of the Intuity valve compared to the standard bioprosthesis in Japanese patients.Methods and Results: Among the 307 consecutive patients who underwent aortic valve replacement (AVR) between February 2019 and March 2021, the Intuity valve was implanted in 95 patients (Intuity group) and a conventional stented bioprosthesis was implanted in 193 patients (conventional group). After propensity score matching, there was no significant difference in in-hospital mortality between the Intuity (n=2, 3%) and conventional groups (n=0, P=0.490). Operation, cardiopulmonary bypass, and aortic cross-clamping times were significantly shorter in the Intuity group. Although the effective orifice area index, trans-prosthetic mean pressure gradient, and peak velocity were similar between the 2 groups at 1 week postoperatively, the Intuity group showed a better mean pressure gradient and peak velocity at 1 year postoperatively. Complete atrioventricular block requiring permanent pacemaker implantation developed in 2 patients (3%) in the Intuity group and none in the conventional group (P=0.476). Mild or greater paravalvular leakage was present in 8 patients (13%) in the Intuity group and 2 patients (3%) in the conventional group (P=0.095). CONCLUSIONS: AVR using the Intuity valve in Japanese patients is satisfactory, with a better valve performance and a low incidence of complete atrioventricular block at 1 year postoperatively.

Evaluation of oversizing in association with conduction disorder after implantation of a rapid deployment valve.

Rapid deployment valve has expanded surgical indication for high-risk patients with aortic stenosis despite its accommodated risk for conduction disorder (CD). The purpose of this study was to evaluate the degree of oversizing in association with postoperative CD. During June 2019 to September 2021, 25 patients underwent aortic valve replacement with Edwards INTUITY. Device size selection was evaluated intraoperatively using provided sizers. Oversizing was evaluated retrospectively by measuring the difference of the dimension of the annulus and left ventricular outflow tract (LVOT) compared to the dimensions of the device used by preoperative-computed tomography. Although there was no incidence of pacemaker implantation, seven patients (28.0%) experienced CD after surgery. There was no difference in device area and annulus area (CD: - 37 ± 22.7 mm2 vs. no CD: - 56 ± 63.6 mm2, p = 0.47), and device circumference and annulus circumference (CD: - 4.4 ± 2.77 mm vs. no CD: - 6.9 ± 5.60 mm, p = 0.26) in patients with and without CD. However, there was a significant difference in area of the device skirt and sub-annular area at the LVOT (CD: 114 ± 28.4 mm2 vs. no CD: - 8 ± 80.0 mm2, p < 0.001), and circumference of device skirt and the LVOT (CD: 3.9 ± 2.08 mm vs. no CD: - 4.6 ± 5.24 mm, p < 0.001) between the two groups. Receiver operating characteristic curve analysis showed that an area difference of 77.7 mm2 and circumference difference of 0.91 mm at LVOT were associated with postoperative CD with specificities of 0.83, 0.78 and sensitivity of 1.0, 1.0, respectively. Preoperative measurement of the LVOT may be useful in evaluating the risk of postoperative CD in patients receiving rapid deployment valve.

Rapid deployment technology versus conventional sutured bioprostheses in aortic valve replacement.

OBJECTIVES: Despite the benefits of rapid deployment aortic valve prostheses (RDAVR), conventional sutured valves (cAVR) are more commonly used in the treatment for aortic stenosis. Given the paucity of randomized studies, this study aimed to synthesize available data to compare both treatment options. METHODS: A systematic search of Pubmed, OVID, and MEDLINE was conducted to retrieve comparative studies for RDAVR versus cAVR in the treatment of aortic stenosis. Out of 1773 returned titles, 35 papers were used in the final analysis, including 1 randomized study, 1 registry study, 6 propensity-matched studies, and 28 observational studies, incorporating a total of 10,381 participants (RDAVR n = 3686; cAVR n = 6310). RESULTS: Random-effects meta-analysis found no difference between the two treatment groups in terms of operative mortality, stroke, or bleeding (p > .05). The RDAVR group had reduced cardiopulmonary bypass (standardized mean difference [SMD]: -1.28, 95% confidence interval [CI]: [-1.35, -1.20], p < .001) and cross-clamp times (SMD: -1.05, 95% CI: [-1.12, -0.98], p < .001). Length of stay in the intensive care unit was also shorter in the RDAVR group (SMD: -0.385, 95% CI: [-0.679, -0.092], p = .010). The risk of pacemaker insertion was higher for RDAVR (odds ratio [OR]: 2.41, 95% CI: [1.92, 3.01], p < .001) as was the risk of paravalvular leak (PVL) at midterm follow-up (OR: 2.52, 95% CI: [1.32, 4.79], p = .005). Effective orifice area and transvalvular gradient were more favorable in RDAVR patients (p > .05). CONCLUSIONS: Despite the benefits of RDAVR in terms of reduced operative time and enhanced recovery, the risk of pacemaker insertion and midterm PVL remains a significant cause for concern.

Pearls, pitfalls, and surgical indications of the Intuity TM heart valve: A rapid deployment bioprosthesis. A systematic review of the literature.

OBJECTIVES: To highlight short- and long-term clinical outcomes of the Intuity TM rapid deployment prosthesis for surgical aortic valve replacement. METHODS: We reviewed on PubMed/MEDLINE, Embase, SciELO, LILACS, CCTR/CENTRAL, and Google Scholar for clinical trials, retrospective clinical studies, meta-analysis, and gray literature. RESULTS: Fourty-five clinical studies with 12.714 patients were included in the analysis. Thirty-day mortality ranged from 3.8% for Intuity and 3.9% for transcatheter aortic valve replacement (TAVR). The incidence of paravalvular leak (PVL) (Intuity 0% and TAVR 2.17%), permanent pacemaker implantation (Intuity 11.11% and TAVR 12.5%), stroke (Intuity 2.2% and TAVR 2.6%), myocardial infarction (MI) (Intuity 0% and TAVR 1%), were all higher in the TAVR group. Compared to other sutured bioprosthesis (SB), mortality ranged from 0% to 3.9% for Intuity and 0%-6.9% for SB. Long-term cardiac mortality ranged from 0.9% to 1.55% for Intuity and 1.4%-3.3% for the Perceval valve. The incidence of PVL (Intuity 0.24%-0.7% and Perceval 0%-1%), endocarditis (Intuity 0.2%-0.7% and Perceval 1.6%-6.6%), stroke (Intuity 0.36%-1.4% and Perceval 0%-0.8%), MI (Intuity 0.07%-0.26%), and SVD (Intuity 0.12%-0.7% and Perceval 0%) were comparable. Compared to standard full sternotomy (SFS), minimally invasive surgery (MINV) mortality ranged from 0% to 4.3% for MINV and 0%-2.1% for SFS. Hospital costs outcomes ranged from $37,187-$44,368 for the Intuity, $69,389 for TAVR, and $13,543 for SB. Intuity short-term mortality ranged between 0.9% and 12.4% while long-term mortality ranged between 2.6% and 20%. CONCLUSIONS: This manuscript provides a 360° overview of the current rapid deployments, sutureless, and TAVR prosthesis.

The use of sutureless and rapid-deployment aortic valve prosthesis in patients with bicuspid aortic valve: A focused review.

OBJECTIVE: The objective of this scoping review is to describe the postoperative outcomes and complications of patients with bicuspid aortic valve (BAV) treated with sutureless or rapid-deployment prosthesis. BACKGROUND: The use of sutureless and rapid-deployment prostheses is generally avoided in patients with BAV due to anatomical concerns and the elevated risk of para-prosthetic leaks. Multiple studies have reported the use of these prostheses into patients with BAV with varying degrees of success. The focus of this review is to consolidate the current available evidence on this topic. METHODS: A scoping review was conducted using a comprehensive search strategy in multiple databases (Medline, Embase, Cochrane Central Register of Controlled Clinical Trials) for relevant articles. All abstracts and full texts were screened by two independent reviewers according to predefined inclusion and exclusion criteria. Thirteen articles, including case reports and case series were ultimately included for analysis. RESULTS: Of 1052 total citations, 44 underwent full text review and 13 (4 case reports, 6 retrospective analyses, and 3 prospective analyses) were included in the scoping review. Across all 13 studies, a total of 314 patients with BAV were used for data analysis. In sutureless and rapid-deployment prostheses, the mean postoperative aortic valvular gradients were less than 15 mmHg in all studies with mean postoperative aortic valvular areas all greater than 1.3 cm.2 There were 186 total complications for an overall complication rate of 59%. Individual complications included new onset atrial fibrillation (n = 65), required pacemaker insertion (n = 24), intraprosthetic aortic regurgitation (n = 20), new onset atrioventricular block (n = 18), and new onset paravalvular leakage (n = 10). CONCLUSIONS: The use of sutureless and rapid deployment prostheses in patients with BAV showed comparable intraoperative and implantation success rates to patients without BAV. Postoperative complications from using these prostheses in patients with BAV included new onset atrial fibrillation, intraprosthetic aortic regurgitation, new onset atrioventricular block, and required pacemaker insertion. Various techniques have been described to minimize these complications in patients with BAV receiving sutureless or rapid deployment prostheses.

High Incidence of Transient Permanent Pacemaker Rate After Rapid Deployment Valve Replacement: Insights of a 9-Year Single-Centre Experience.

INTRODUCTION: The incidence of new permanent pacemaker implantation (PPI) after rapid deployment aortic valve replacement (RDAVR) remains debated. Expertise in this field has significantly increased over the last decade. This study aimed to investigate the need for PPI following implantation of a rapid deployment (RD) valve. METHODS: Analysis of n=372 patients who underwent Edwards INTUITY (Edwards Lifesciences, Irvine, CA, USA) (n=251) and Perceval (Sorin/LivaNova Group, Saluggia, Italy) (n=121) valve replacement at the current institution between May 2012 and August 2018 was performed. Coronary artery bypass graft procedures were additionally performed in patients with coronary artery disease. Baseline, preoperative and postoperative outcomes were examined regarding correctness and completeness of the procedure. Statistical analysis was performed using SPSS Version 23.0.0 (IBM Corp, Armonk, NY, USA). RESULTS: A total of 372 patients (aged 75±6.3 yrs) with a high grade of aortic valve stenosis underwent either Edwards INTUITY (67%) or Perceval (33%) valve replacement. Seventy-six (76) patients (20%) presented with preoperative conduction disorders. Sixty (60) patients (16%) underwent PPI, which in most cases was performed during the first month after the initial operation. Follow-up was performed up to 9 years, presenting a persistent pacemaker dependency rate of 50% among all patients who underwent PPI. Twenty (20) (40%) PPI recipients showed no dependency on pacemaker, while 10 (10%) required temporary pacemaker support. Mean length of ICU stay was 4±5.1 days and in-hospital stay was 8.2±7.6 days. CONCLUSIONS: The incidence of PPI after RD valve implantation still remains high compared with conventional aortic valve replacement. However, this study shows that this phenomenon appears to be transient in a significant proportion of the patients undergoing RD valve replacement. These findings might contribute to the scientific discussion and should be taken into consideration for the indication of RD valve replacement.

Rapid deployment versus trans-catheter aortic valve replacement in intermediate-risk patients: A propensity score analysis.

BACKGROUND: There are insufficient studies comparing rapid deployment aortic valve replacement (RDAVR) and trans-aortic valve replacement (TAVR) in intermediate-risk patients with severe aortic stenosis (AS). AIMS: We compared 2-year outcomes between RDAVR with INTUITY and TAVR with SAPIEN 3 in intermediate-risk patients with AS. METHODS: Inclusion criteria were patients with severe AS at a EuroSCORE II ≥ 4%, who received RDAVR or TAVR implantation and clinical evaluation by the Heart Team. Regression adjustment for the propensity score was used to compare RDAVR and TAVR. Primary outcome was the composite criterion of death, disabling stroke, or rehospitalization. SECONDARY OUTCOMES: major bleeding complications postoperation, paravalvular regurgitation ≥ 2, patient-prosthesis mismatch, and pacemaker implantation. RESULTS: A total of 152 patients were included from 2012 to 2018: 48 in the RDAVR group and 104 in the TAVR group. The mean age was 82.7 ± 6.0,51.3% patients were female, the mean EuroSCORE II was 6.03 ± 1.6%, mean baseline LVEF was 56 ± 13%, mean indexed effective orifice area was 0.41 ± 0.1 cm/m2 , and the mean gradient was 51.7 ± 14.7 mmHg. RDAVR patients were younger (79.5 ± 6 years vs. 82.6 ± 6 years; p = .01), and at higher risk (EuroSCORE II, 6.61 ± 1.8% vs. 5.63 ± 1.5%; p = .005), Twenty-two patients (45.99%) in the RDAVR group and 32 (66.67%) in the TAVR group met the composite criterion. Through the 1:1 propensity score matching analysis, there was a significant difference between the groups, favoring RDAVR (HR = 0.58 [95% CI: 0.34-1.00]; p = .04). No differences were observed in terms of patient-prosthesis mismatch (0.83 [0.35-1.94]; p = .67), major bleeding events (1.33 [0.47-3.93]; p = .59), paravalvular regurgitation ≥ 2 (0.33[0-6.28]; p = .46), or pacemaker implantation (0.84 [0.25-2.84]; p = .77) CONCLUSION: RDAVR was associated with better 2-year outcomes than TAVR in intermediate-risk patients with severe symptomatic AS.

Right anterior mini thoracotomy approach for isolated aortic valve replacement: Early outcomes at a Canadian center.

OBJECTIVE: The goal of this manuscript was to report the clinical outcomes of the initial series of 100 consecutive Right Anterior Mini Thoracotomy (RAMT) aortic valve replacement (AVR) implantations at a Canadian Center. METHODS: This retrospective study reported the clinical outcomes of the first 100 patients who underwent the RAMT approach for isolated surgical AVR in Calgary, Canada, between 2016 and 2020. Primary outcomes were death within 30 days of surgery and disabling stroke. Secondary outcomes included surgical times, the need for permanent pacemaker (PPM), incidence of postoperative blood transfusion in the intensive care unit (ICU), postsurgical atrial fibrillation (AF), length of ICU/hospital stay, postsurgical AF, residual paravalvular leak (PVL), postoperative transvalvular gradient, need for postsurgical intravenous opioids, duration of invasive ventilation in the ICU, and chest tube output in the first 12 h postsurgery. RESULTS: In this study, 54 patients were male, and the average age of the cohort was 72 years. Mortality within 30 days of surgery was 1% with no disabling postoperative strokes. Mean cardiopulmonary bypass and cross clamp was 84 and 55 min, respectively. PPM rate was 3%, incidence of blood transfusion in the ICU was 4%, and the rate of postoperative AF was 23%. Median length of ICU and hospital stay was 1 and 5 days, respectively. Rate of mild or greater residual PVL was 3%, while the average residual transvalvular mean gradient was 8.5 mmHg. CONCLUSION: The sternum-sparing RAMT approach can be safely integrated into surgical practice as a minimally invasive alternative for isolated AVR, and can reduce postoperative bleeding and narcotic requirements.

Minimally invasive aortic valve replacement with sutureless bioprosthesis through right minithoracotomy with completely central cannulation-Early results in 203 patients.

OBJECTIVES: Minimally invasive aortic valve replacement (mini-AVR) might improve clinical outcomes, particularly in high-risk and elderly patients. Sutureless/rapid deployment bioprosthesis can offer advantage of decreasing the cross-clamp time (XCT) and easing the procedure. Our aim was to evaluate the safety and perioperative outcomes of mini-AVR using sutureless bioprothesis via the right minithoracotomy approach with our modified technique of central cannulation. METHODS: We performed a single-center retrospective analysis of 203 patients consecutively undergoing isolated AVR between March 2016 and June 2018 with the right minithoracotomy approach and our modified technique of central cannulation. Aortic valve diseases were stenosis (89.9%), regurgitation (1.6%), and mixed valve disease (8.5%). Patients with concomitant procedures were excluded. Primary endpoints were 30-day and 4-month mortality. RESULTS: Mean age was 76 ± 6.2 years, 63 (31%) patients were 80 years or older. Cardiopulmonary bypass and XCT were 60.5 (39-153) and 35 (24-76) min, respectively. Thirty-day and 4-month mortality were 1% (two patients). We have observed minor paravalvular leak (PVL) which occurred in seven patients (3.4%), and no moderate/severe PVL was found perioperatively. One patient developed moderate/severe PVL during the 4-month follow-up. There was no structural valve degeneration. Two (1%) patients needed conversion to full sternotomy, and two (1%) patients to ministernotomy. CONCLUSIONS: Mini-AVR via the right minithoracotomy approach with central cannulation is an effective and safe procedure and demonstrates excellent early clinical outcomes. This approach can be particularly valuable in higher risk and elderly patients.

Use of rapid-deployment aortic valve prosthesis and patch reconstruction in complex endocarditis.

We describe the case of a 59-year-old female affected by aortic extensive endocarditis with communication between aortic annulus and right cavities, treated with double pericardial patch reconstruction and rapid-deployment aortic valve prosthesis implantation.

Rapid-deployment aortic valve replacement after aortic root replacement: A safe alternative to redo root replacement.

Reoperative aortic root replacement, following prior biologic or mechanical valved conduit aortic root prosthesis, presents a technical challenge. The rapid-deployment aortic valve prosthesis is an approved alternative to traditional bioprosthetic aortic valve replacement. We present three clinical cases in which rapid-deployment aortic valve prostheses were utilized in lieu of reoperative full aortic root replacement. All three patients recovered uneventfully. The rapid-deployment valve insertion in a prior surgical aortic root prosthesis is a safe option to avoid reoperative full aortic root replacement.

Rapid deployment aortic valve replacement through anterior right thoracotomy: Clinical outcomes and haemodynamic performance.

BACKGROUND: The ease of implantation of the rapid deployment (RD) and sutureless valves has contributed to the adoption of anterior right thoracotomy (ART) approach for aortic valve replacement (AVR). AIM OF THE STUDY: This study evaluates the safety and haemodynamic performance of minimally invasive AVR through ART using the RD valves. METHODS: This is a retrospective, single-center review of a total of 50 consecutive patients who received RD-AVR through ART. RESULTS: The median age of patients was 75 years (interquartile range [IQR]: 69-80), and median Euroscore II was 5.1 (IQR: 2.4-7.5). ART RD-AVR was successfully performed in all cases with no conversion to sternotomy, paravalvular leaks or need for valve explantation. The mean size of the implanted valve was 23.2 ± 2.3 mm. In-hospital mortality was 2%. The mean and maximum pressure gradients across the aortic prosthesis were 10 mm Hg (IQR: 9-12) and 19 mm Hg (IQR: 16-23). CONCLUSIONS: Rapid deployment aortic valve replacement can be safely performed through anterior right thoracotomy wit excellent haemodynamic performance and low postoperative complications rate.

Minimally invasive aortic valve replacement: extracorporeal circulation optimization and minimally invasive extracorporeal circulation system evolution.

Treatment of aortic valve disease has become less and less invasive during the last years, thanks to progress in anesthesiology, surgical techniques, and perfusion management. In fact, it has been demonstrated that shorter skin incision, combined with ultra-fast-track anesthesia and minimized extracorporeal circuit could improve clinical outcomes. Current evidence shows that minimally invasive extracorporeal circulation system is associated with reduced red blood cells' transfusion rate, improved end-organ perfusion, decreased incidence of postoperative atrial fibrillation, air embolism leakage, and so less cerebral accidents with better neurological outcomes. Moreover, the use of a closed circuit seems to be more physiologic for the patients, reducing systemic inflammatory response due to less air-blood contact and the use of biocompatible surfaces. In the literature, the benefits of minimally invasive extracorporeal circulation are described mostly for coronary surgery but few data are nowadays available for minimally invasive extracorporeal circulation during aortic valve replacement. In this article, we describe our perfusion protocol in minimally invasive aortic valve replacement.

Does Quicker Mean Better? Comparison of Rapid Deployment Versus Conventional Aortic Valve Replacement.

The aim of this meta-analysis was to compare the clinical outcomes in patients who underwent rapid deployment aortic valve replacement (RDAVR) and conventional bio prosthetic aortic valve replacement (CAVR).We performed a literature search by August 2018. The primary outcomes were hospital and 1-year mortality, and the secondary endpoints included the aortic cross-clamp (ACC), cardiopulmonary bypass (CPB) time, and postoperative and valve-related complications.Two randomized controlled trials and 13 propensity score-matched studies were included. There was no difference between RDAVR and CAVR in hospital mortality (2.5% versus 2.1%; risk ratio (RR) 1.16 [95% confidence interval (CI) 0.80-1.68]) or 1-year mortality (2.9% versus 4.1%; RR 0.69 [95% CI 0.34-1.34]). RDAVR significantly reduced the ACC time ( (mean difference (MD) -24.33 [95% CI -28.35 to -20.32]) and CPB time (MD -21.51 [95% CI -22.83 to -20.20]). The pooled analysis showed that RDAVR doubled the occurrence of permanent pacemaker implantation (8.6% versus 4.3%; RR 2.05 [95% CI 1.62-2.60]). Meanwhile, the blood transfusion amount (MD -1.54 [95% CI -2.22 to -0.86]) and postoperative atrial fibrillation (POAF) occurrence (RR 0.83 [95% CI 0.69-0.99]) was reduced. The difference of paravalvular leakage frequency between RDAVR and CAVR was marginal (RR 1.77 [95% CI 1.00-3.17]; P = 0.05). Furthermore, RDAVR was related to larger valves (MD 0.70 cm [95% CI 0.33-1.07]) and lower mean pressure gradients (MD -1.93 mmHg [95% CI -3.58 to -0.28]).The hospital and 1-year survival rates between RDAVR and CAVR are comparable. RDAVR reduces POAF occurrence and blood transfusion but is associated with a higher occurrence of pacemaker implantation.

Rapid Deployment Aortic Valve Replacement via Right Lateral Mini-Thoracotomy　- First Clinical Experience in Japan.

BACKGROUND: Rapid deployment aortic valve replacement has been developed to shorten procedural times and to facilitate minimally invasive cardiovascular surgery. Methods and Results: As a representative rapid-deployment valve, the balloon-expanding INTUITY Elite (the 2nd-generation Edwards INTUITY Valve System) was uneventfully implanted via a right lateral mini-thoracotomy in 2 patients with severe aortic valve stenosis. Both of them recovered quickly and were discharged from hospital without significant adverse events. CONCLUSIONS: Implantation of the INTUITY Elite valve via right mini-thoracotomy is feasible and safe.

Incidence and causes of pacemaker implantation during postoperative period of aortic valve replacement with rapid deployment prosthesis.

BACKGROUND: Aortic stenosis is currently the most frequently occurring valve pathology. Developments, such as transcatheter prostheses and rapid deployment prostheses, allow for the offer of a valve replacement to higher risk patients, but these techniques are linked with a higher need for a permanent pacemaker during the immediate postoperative period. METHODS: We studied the incidence and the factors associated with permanent pacemaker implantation after aortic valve replacement with Edwards Intuity rapid deployment prosthesis. RESULTS: Between October 2012 and December 2016, the Edwards Intuity prosthesis was implanted in 71 patients (68% male, 75.3 ± 5 years old). Six patients (8%) required a permanent pacemaker during immediate postoperative period. Univariate analysis showed that a history of acute myocardial infarction (AMI) (P = .046, B = 7.5, 95% CI [1.039-54.1]) and preoperative amiodarone (P = .009, B = 31.5; 95% CI [2.32-426]) were associated with a higher need for a pacemaker during the postoperative period. CONCLUSIONS: The incidence of permanent pacemaker implantation during the immediate postoperative period of aortic valve replacement with Edwards Intuity prosthesis was 8%, a value which is within the limits reported for conventional aortic prostheses. Preoperative amiodarone treatment and previous AMI may increase the need for a pacemaker during the postoperative period of these aortic prostheses.

Balloon aortic valvuloplasty: Treatment of rapid deployment aortic valve replacement complicated by a paravalvular leak.

The Edwards Intuity Elite valve system was designed to facilitate minimally invasive surgery and streamline complex aortic valve replacements and has since gained more popularity. Despite the superior results shown with rapid deployment aortic valve replacement (RDAVR) utilizing this valve system, paravalvular leaks (PVL), as a complication, remains a concern. Currently, there is no universally agreed single treatment option. A 53-year-old male with a history of well-controlled diabetes mellitus and hypertension presented to the emergency room with a 1-month history of angina, syncope on exertion and dyspnea. On further workup, he was found to have severe aortic stenosis in the setting of a bicuspid aortic valve, with non-obstructive coronary artery disease. He proceeded to urgent RDAVR with a 23 mm Edwards Intuity Valve. Six months post-RDAVR he re-presented with dyspnea on exertion and near syncopal episodes. Postoperative transthoracic and transesophageal echocardiography revealed moderate to severe PVL posterior to the prosthetic aortic valve. Balloon valvuloplasty with a 25 mm True Balloon was performed. Resolution of the PVL was confirmed postprocedure both by angiography and echocardiography. The patient was followed for 1 year and remained symptom-free with evidence of mild PVL on surveillance echocardiography. In conclusion, multiple treatment options for RDAVR complicated by PVL exist; however mid to long-term outcome data are lacking. We presented one such case successfully treated with balloon aortic valvuloplasty.

Permanent pacemaker implantation and paravalvular leak rates following sutureless aortic valve operations.

BACKGROUND: Permanent pacemaker (PPM) implantation and paravalvular leak (PVL) rates after sutureless aortic valve replacement (SuAVR) vary widely. The aim of this meta-analysis was to examine the incidence of new PPM implantation and PVL after SuAVR. METHODS: Studies evaluating PPM implantation and PVL rates after SuAVR were searched in Medline/PubMed, Ovid Journals, Clinicaltrials.gov, Cochrane central register of controlled trials and database. Studies with a sample size ≥10 were included in this analysis. Pooled proportions were calculated using both the fixed and random-effects models. The heterogeneity among studies was tested using I2 statistic. The study design was written in accordance with PRISMA guidelines. RESULTS: Thirty studies involving 3993 patients with a median follow-up of 12 months were included. The median age was 77 years and males constituted 50%. There was a history of stroke and coronary artery disease in 6% and 31% of the population. Pooled proportions demonstrate a cumulative postoperative PPM rate of 8.5% (95% confidence interval [CI] 7.6-9.5%, I2 = 68.8%) and the overall rate of any PVL was 4.2% (95%CI 3.4-5%, I2 = 76.1%) across all major SuAVR devices. The rate of severe PVL was only 0.4% (95%CI 0.2-0.7%, I2 = 0%) at discharge and 0.5% (95%CI 0.2-0.9%, I2 = 0%) at 12 months. CONCLUSIONS: In SuAVR prostheses implanted in this meta-analysis, the postoperative permanent pacemaker rate was higher (8.5%) than reported for non-SuAVR prosthesis. While the overall PVL rate was 4.2%, the incidence of severe PVL was only 0.4% at discharge and remained stable at 0.5% at 12 months.

Composite graft using an Edwards Intuity Elite rapid deployment bioprosthesis for aortic root replacement.

We describe a technique using an Edwards Intuity Elite rapid deployment bioprosthesis to construct a composite graft for an aortic root replacement.