Sutureless Valves, a "Wireless" Option for Patients With Aortic Valve Disease: JACC State-of-the-Art Review.

Transcatheter technologies triggered the recent revision of the guidelines that progressively widened the indications for the treatment of aortic stenosis. On the surgical realm, a technology avoiding the need for sutures to anchor the prosthesis to the aortic annulus has been developed with the aim to reduce the duration of cardiopulmonary bypass and simplify the process of valve implantation. In addition to a transcatheter aortic valve replacement (TAVR)-like stent that exerts a radial force, these so-called "rapid deployment valves" or "sutureless valves" for aortic valve replacement also have cuffs to improve sealing and reduce the risk of paravalvular leak. Despite promising, the actual advantage of sutureless valves over traditional surgical procedures (surgical aortic valve replacement) or TAVR is still debated. This review summarizes the current comparative evidence reporting outcomes of "sutureless valves" for aortic valve replacement to TAVR and surgical aortic valve replacement in the treatment of aortic valve stenosis.

Should we operate on patients with acute type A aortic dissection who present with cardiopulmonary resuscitation?

OBJECTIVES: Acute aortic dissection type A (AADA) is a life-threatening medical emergency. Emergent surgical repair is the gold standard but mortality remains high. Mortality is even higher in patients who arrive at the hospital in poor condition, especially after cardiopulmonary resuscitation (CPR). This study was designed to analyse the outcome of patients who underwent surgery for AADA and who require preoperative CPR. METHODS: Between 2000 and 2023, 810 patients underwent emergent surgery for AADA at our centre. Of these, 63 had preoperative CPR. We performed a retrospective analysis with follow-up. RESULTS: Mean age was 64 ± 13 years and 37 (59%) patients were male. Further, 50 (79%) patients had preoperative intubation, and 54 (86%) had pericardial effusion. Twenty-four (38%) patients had out-of-hospital CPR, 19 (30%) required CPR in hospital and 20 (32%) needed CPR in the operating room. Successful CPR with return of spontaneous circulation was achieved in 41 (65%) patients, and 22 (35%) underwent emergent surgery under ongoing CPR. The median time of CPR was 10 (interquartile range 12) min, and the median time from onset of symptoms to start of the operation was 5.5 (interquartile range 4.8) h. The majority of patients underwent ascending aortic replacement with hemiarch repair (n = 37, 59%). Further, 26 (41%) patients underwent full root replacement. Another 15 (24%) patients underwent total arch repair with or without (frozen) elephant trunk repair. Postoperative stroke was present in 8 (13%) patients. The 30-day mortality was 29 (46%). The 30-day mortality of patients with preoperative intubation was not significantly higher (n = 15/28, 54%, P = 0.446). The 1-, 5- and 10-year survival rates of the entire group were 42, 39 and 36%. CONCLUSIONS: Early mortality for patients undergoing surgery for AADA with preoperative CPR is extremely high (almost 50%). However, this means that also ∼50% of patients benefit from surgery despite poor preoperative prognosis. Patients with preoperative intubation after CPR and unknown neurological condition should also undergo surgery. Patients who survive the initial operation for AADA have acceptable long-term survival. Emergent surgery should be offered for all patients with AADA regardless of the preoperative condition, even after CPR.

Post-mortem examination of fatal acute type A aortic dissection: what does it teach us?

OBJECTIVES: Acute type A aortic dissection (ATAAD) remains a highly life-threatening condition. This study investigates factors associated with fatal ATAAD prior to surgical treatment. METHODS: We reviewed autopsy reports of ATAAD decedents who died before surgical intervention and underwent postmortem examination at our clinic from 1994 to 2022. RESULTS: Among 94 eligible cases, 50 (53.2%) decedents had DeBakey type I dissection, and 44 (46.8%) had DeBakey type II dissection. Most were males, 63 (67%), and 72 (77%) had a history of hypertension. The median age was 70.5 years, and the type II group was a decade older than the type I group (P < 0.001). Decedents in the type II group predominantly died during the first hour after symptoms onset 16 (52%), while in the type I group, fatalities occurred between 1 h and 1 day, 27 (66%). The most common site of the intimal tear was the midportion of the ascending aorta, 45 (48%). The median ascending aorta size was 5 cm for the entire cohort, 5.2 cm for type I and 4.6 cm for type II (P < 0.045). CONCLUSIONS: In this autopsy study of fatal acute aortic dissection, the median aortic size was below the current guideline threshold for elective repair. Type II acute aortic dissections were found more frequently than expected and were characterized by older age, advanced aortic atherosclerosis, smaller aortic size, a shorter interval from symptom onset to death and a higher frequency of syncope compared to type I dissection.

Acute Aortic Dissection Type A in Younger Patients (< 60 Years Old) - Does Full Arch Replacement Provide Benefits Compared to Limited Approach?

ABSTRACT Introduction: Acute aortic dissection Stanford type A (AADA) is a surgical emergency associated with high morbidity and mortality. Although surgical management has improved, the optimal therapy is a matter of debate. Different surgical strategies have been proposed for patients under 60 years old. This paper evaluates the postoperative outcome and the need for secondary aortic operation after a limited surgical approach (proximal arch replacement) vs. extended arch repair. Methods: Between January 2000 and January 2018, 530 patients received surgical treatment for AADA at our hospital; 182 were under 60 years old and were enrolled in this study - Group A (n=68), limited arch repair (proximal arch replacement), and group B (n=114), extended arch repair (> proximal arch replacement). Results: More pericardial tamponade (P=0.005) and preoperative mechanical resuscitation (P=0.014) were seen in Group A. More need for renal replacement therapy (P=0.047) was seen in the full arch group. Mechanical ventilation time (P=0.022) and intensive care unit stay (P<0.001) were shorter in the limited repair group. Thirty-day mortality was comparable (P=0.117). New onset of postoperative stroke was comparable (Group A four patients [5.9%] vs. Group B 15 patients [13.2%]; P=0.120). Long-term follow-up did not differ significantly for secondary aortic surgery. Conclusion: Even though young patients received only limited arch repair, the outcome was comparable. Full-arch replacement was not beneficial in the long-time follow-up. A limited approach is justified in the cohort of young AADA patients. Exemptions, like known Marfan syndrome and the presence of an intimal tear in the arch, should be considered.

Acute Aortic Dissection Type A in Younger Patients (< 60 Years Old) - Does Full Arch Replacement Provide Benefits Compared to Limited Approach?

INTRODUCTION: Acute aortic dissection Stanford type A (AADA) is a surgical emergency associated with high morbidity and mortality. Although surgical management has improved, the optimal therapy is a matter of debate. Different surgical strategies have been proposed for patients under 60 years old. This paper evaluates the postoperative outcome and the need for secondary aortic operation after a limited surgical approach (proximal arch replacement) vs. extended arch repair. METHODS: Between January 2000 and January 2018, 530 patients received surgical treatment for AADA at our hospital; 182 were under 60 years old and were enrolled in this study - Group A (n=68), limited arch repair (proximal arch replacement), and group B (n=114), extended arch repair (> proximal arch replacement). RESULTS: More pericardial tamponade (P=0.005) and preoperative mechanical resuscitation (P=0.014) were seen in Group A. More need for renal replacement therapy (P=0.047) was seen in the full arch group. Mechanical ventilation time (P=0.022) and intensive care unit stay (P<0.001) were shorter in the limited repair group. Thirty-day mortality was comparable (P=0.117). New onset of postoperative stroke was comparable (Group A four patients [5.9%] vs. Group B 15 patients [13.2%]; P=0.120). Long-term follow-up did not differ significantly for secondary aortic surgery. CONCLUSION: Even though young patients received only limited arch repair, the outcome was comparable. Full-arch replacement was not beneficial in the long-time follow-up. A limited approach is justified in the cohort of young AADA patients. Exemptions, like known Marfan syndrome and the presence of an intimal tear in the arch, should be considered.

Onset of pain to surgery time in acute aortic dissections type A: a mandatory factor for evaluating surgical results?

Objective: An acute aortic dissection type A (AADA) is a rare but life-threatening event. The mortality rate ranges between 18% to 28% and mortality is often within the first 24 h and up to 1%-2% per hour. Although the onset of pain to surgery time has not been a relevant factor in terms of research in the field of AADA, we hypothesize that a patient's preoperative conditions depend on the length of this time. Methods: Between January 2000 and January 2018, 430 patients received surgical treatment for acute aortic dissection DeBakey type I at our tertiary referral hospital. In 11 patients, the exact time point of initial onset of pain was retrospectively not detectable. Accordingly, a total of 419 patients were included in the study. The cohort was categorized into two groups: Group A with an onset of pain to surgery time < 6 h (n = 211) and Group B > 6 h (n = 208), respectively. Results: Median age was 63.5 years (y) ((IQR: 53.3-71.4 y); (67.5% male)). Preoperative conditions differed significantly between the cohorts. Differences were detected in terms of malperfusion (A: 39.3%; B: 23.6%; P: 0.001), neurological symptoms (A: 24.2%; B: 15.4%; P: 0.024), and the dissection of supra-aortic arteries (A: 25.1%; B: 16.8%; P: 0.037). In particular, cerebral malperfusion (A 15.2%: B: 8.2%; P: 0.026) and limb malperfusion (A: 18%, B: 10.1%; P: 0.020) were significantly increased in Group A. Furthermore, Group A showed a decreased median survival time (A: 1,359.0 d; B: 2,247.5 d; P: 0.001), extended ventilation time (A: 53.0 h; B: 44.0 h; P: 0.249) and higher 30-day mortality rate (A: 25.1%; B: 17.3%; P: 0.051). Conclusions: Patients with a short onset of pain to surgery time in cases of AADA present themselves not only with more severe preoperative symptoms but are also the more compromised cohort. Despite early presentation and emergency aortic repair, these patients show increased chances of early mortality. The "onset of pain to surgery time" should become a mandatory factor when making comparable surgical evaluations in the field of AADA.

Perioperative care differences of surgical aortic valve replacement between North America and Europe.

OBJECTIVE: To describe differences between North America and Europe in the perioperative management of patients undergoing surgical aortic valve replacement (SAVR). METHODS: Patients with moderate or greater aortic stenosis or regurgitation requiring SAVR were enrolled in a prospective observational cohort evaluating the safety and efficacy of a new stented bioprosthesis at 25 centres in North America (Canada and the USA) and 13 centres in Europe (Germany, the Netherlands, France, the UK, Switzerland and Italy). While all patients underwent implantation with the same bioprosthetic model, perioperative management was left to the discretion of participating centres. Perioperative care was described in detail including outcomes up to 1-year follow-up. RESULTS: Among 1118 patients, 643 (58%) were implanted in North America, and 475 (42%) were implanted in Europe. Patients in Europe were older, had a lower body mass index, less bicuspid disease and worse degree of aortic stenosis at baseline. In Europe, anticoagulant therapy at discharge was more aggressive, whereas length of stay was longer, and discharges directly to home were less common. Rehospitalisation risk was lower in Europe at 30 days (8.5% vs 15.9%) but converged at 1-year follow-up (26.5% vs 28.1%). Within continents, there were major differences between individual countries concerning perioperative management. CONCLUSION: Contemporary perioperative management of SAVR patients varies between North America and Europe in patient selection, procedural techniques, antithrombotic regimen and discharge management. Furthermore, rehospitalisation differed largely between continents and countries. Hence, geographical setting must be considered during design and interpretation of trials on SAVR. TRIAL REGISTRATION NUMBER: NCT02088554.

Features and risk factors of early intraluminal thrombus formation within the frozen elephant trunk stent graft.

OBJECTIVE: The frozen elephant trunk is a standard treatment method for aortic arch pathologies extending into the descending aorta. We previously described the phenomenon of early postoperative intraluminal thrombosis within the frozen elephant trunk. We investigated the features and predictors of intraluminal thrombosis. METHODS: A total of 281 patients (66% male, mean age 60 ± 12 years) underwent frozen elephant trunk implantation between May 2010 and November 2019. In 268 patients (95%), early postoperative computed tomography angiography was available to assess intraluminal thrombosis. RESULTS: The incidence of intraluminal thrombosis after frozen elephant trunk implantation was 8.2%. Intraluminal thrombosis was diagnosed early after the procedure (4.6 ± 2.9 days) and could be successfully treated with anticoagulation in 55% of patients. A total of 27% developed embolic complications. Mortality (27% vs 11%, P = .044) and morbidity were significantly higher in patients with intraluminal thrombosis. Our data showed a significant association of intraluminal thrombosis with prothrombotic medical conditions and anatomic slow flow features. The incidence of heparin-induced thrombopenia was higher in patients with intraluminal thrombosis (18% vs 3.3%, P = .011). Stent-graft diameter index, anticipated endoleak Ib, and degenerative aneurysm were significant independent predictors of intraluminal thrombosis. Therapeutic anticoagulation was a protective factor. Glomerular filtration rate, extracorporeal circulation time, postoperative rethoracotomy, and intraluminal thrombosis (odds ratio, 3.19, P = .047) were independent predictors of perioperative mortality. CONCLUSIONS: Intraluminal thrombosis is an underrecognized complication after frozen elephant trunk implantation. In patients with risk factors of intraluminal thrombosis indication for frozen elephant trunk should be carefully evaluated and postoperative anticoagulation considered. Early thoracic endovascular aortic repair extension should be considered in patients with intraluminal thrombosis to prevent embolic complications. Stent-graft designs should be improved to prevent intraluminal thrombosis after frozen elephant trunk implantation.

Open surgical replacement of the descending aorta: single-center experience.

Background: This study presents a single center's experience and analyzes clinical outcomes following elective open surgical descending aortic replacement. Methods: Between January 2000 and August 2019, 96 patients with mean age 64 years (range, 49.5-71 years) (62.5% (n=60) male) underwent elective descending aortic replacement due to aneurysm (n=60) or chronic dissection (n=36). Marfan syndrome was present in 12 patients (12.5%). Results: In-hospital mortality rate was 3.1% (n= 3. 2 in the aneurysm group, 1 in the dissection group). New-onset renal insufficiency postoperatively with (creatinine ≥ 2.5 mg/dl) manifested in 10 patients (10.8%). One patient (1%) suffered from stroke, and paraplegia developed in 1 pts (1%). The median follow-up time was 7 years (IQR: 2.5-13 years). The 5- and 10-year survival rates were 70.8% and 50.7% respectively. We did not observe any early or late prosthetic graft infection. The Cox proportional hazards regression analysis identified age (HR: 1.044, 95% CI: 1.009-1.080, p-value: 0.014), diabetes (HR: 2.544, 95% CI: 1.009-6.413, p-value: 0.048), and chronic obstructive pulmonary disease (COPD) (HR: 2.259, 95% CI: 1.044-4.890, p-value: 0.039) as risk factors for late mortality. Conclusions: This study showed that the elective open surgical replacement of the descending aorta can be achieved with excellent outcomes in terms of perioperative mortality and morbidity. Prosthetic graft is not a problem with open surgical descending aortic replacement, even in the long term. Supplementary Information: The online version contains supplementary material available at 10.1007/s12055-022-01443-x.

Preoperative pericardial hematoma in patients with acute type A aortic dissection (AAAD): Do we need an adjusted treatment?

OBJECTIVE: An acute type A aortic dissection (AAAD) is a critical emergency and remains one of the most challenging diseases in cardiothoracic surgery. The existence of a pericardial hematoma caused by an aortic rupture can dramatically reduce the chances of survival (Jerzewski and Kulik in J Card Surg 29(4):529-530, 2014; Mehta et al. in Circulation 105(2):200-206, 2002; Gilon et al. in Am J Cardiol 103(7):1029-1031, 2009; Isselbacher et al. in Circulation 90(5):2375-2378, 1994). We assessed the surgical outcome of a high-risk group of patients with AAAD and a pericardial hematoma. METHODS: In this study we included 430 Patients (67% male; median age: 64 years) who received surgical treatment between January 2000 and January 2018 at our facility for acute aortic dissection DeBakey type I. We divided the cohort in two groups: Group A consisted of high-risk patients with a pericardial hematoma (n = 162) and Group B of patients without pericardial hematoma (n = 268). RESULTS: Patients with a preoperative pericardial hematoma had a significantly higher requirement for preoperative mechanical resuscitation (A: 21%; B: 1.5%; P: < 0.001) and were relevantly more frequently admitted to the operation theater with an intubated status (A: 19.8%; B: 8.6%; P: < 0.001). The incidence of visceral malperfusion differed significantly between both groups (A. 11.7%, B. 6:0%; P: 0.034). Limited aortic arch repair (proximal aortic arch replacement) was preferred in the high-risk group (A: 51.9%; B: 40.3%; P: 0.020). However, survival time was generally reduced in these patients (A: 7.5 y; B: 9.9 y). CONCLUSION: AAAD patients with preoperative pericardial hematoma present themselves in potentially lethal conditions, with a significantly higher rate of visceral malperfusion. Despite the existence of this risk factor, a limited arch repair was favored. We have proven that cardiac compression is associated with preoperative intubation and mechanical resuscitation. Patients with pericardial hematoma must be further evaluated for preoperative pericardial drainage. In the event of long transfer times to an aortic center a slow drainage should be discussed to prevent early mortality.

Impact of preoperative malperfusion on postoperative outcomes in type A aortic dissection - importance of serum lactate estimation in ongoing malperfusion.

INTRODUCTION: Acute type A aortic dissection (ATAAD) is one of the most critical emergencies in cardiovascular surgery. Additional complications such as organ malperfusion can significantly decrease the chances of survival. Despite promptly performed surgical treatment, impaired organ perfusion may persist, thus close postoperative monitoring is recommended. But, is there a surgical consequence due to the existence of a preoperatively known malperfusion and is there a correlation between pre-, peri- and postoperative levels of serum lactate and proven malperfusion? METHODS: Between 2011 and 2018, 200 patients (66% male; median age: 62.5 years; interquartile range: +/-12.4 years) that received surgical treatment at our institution for an acute dissection DeBakey type I were enrolled in this study. The cohort was divided into two groups according to the preoperative existence of malperfusion and non-malperfusion. At least one kind of malperfusion occurred in 74 patients (Group A: 37%), while 126 patients (Group B: 63%) showed no evidence of malperfusion. Furthermore, lactate levels of both cohorts were differentiated into four periods: preoperative, intraoperative, 24 hours after surgery, and 2-4 days after surgery. RESULTS: The patients' status differed significantly prior to surgery. Group A (malperfusion) showed an elevated requirement for mechanical resuscitation (A: 10.8%; B: 5.6%; p: 0.173), were significantly more often admitted in an intubated state (A: 14.9%; B: 2.4%; p: 0.001) and showed higher incidences of stroke (A: 18.9% (n = 149); B: 3.2% (n = 4); p: 0.001). Levels of serum lactate from the preoperative period until days 2-4 were significantly increased in the malperfusion cohort at all times. CONCLUSIONS: Preexisting malperfusion due to ATAAD may significantly increase the chance of early mortality in patients with ATAAD. Serum lactate levels were a reliable marker for inadequate perfusion from admission until day 4 after surgery. Despite this, early intervention survival in this cohort remains limited.

Valve-sparing aortic root replacement using a straight tube graft (David I procedure).

OBJECTIVES: We present our 25-year experience with valve-sparing aortic root replacement using a straight tube graft (David-I). METHODS: From 1993 to 2019, 677 patients (median age, 56.0 years; range, 42-65) underwent the David-I procedure with a straight tube graft. A total of 24 different surgeons performed these operations. Marfan syndrome was present in 111 patients (16.4%), and bicuspid aortic valve was present in 71 patients (10.5%). Aortic root aneurysm was present in 544 patients (80.4%), and acute dissection was present in 133 patients (19.6%). RESULTS: Ministernotomy was used in 57 patients (8.4%). Additional cusp plasty was performed in 84 patients (12.4%). Concomitant procedures were coronary artery bypass grafting (n = 122, 18.0%), mitral valve surgery (n = 34, 5%), proximal arch replacement (n = 125, 18.4%), subtotal arch replacement (n = 43, 6.4%), and total arch replacement (n = 102, 15.1%). Overall in-hospital mortality was 4.0% (n = 27), and perioperative stroke occurred in 26 patients (3.8%). Postoperative echocardiography showed aortic insufficiency less than I° in 600 of 623 (96.3%). The 1-, 5-, 10-, 15-, and 20-year survivals were 97%, 92%, 79%, 68%, and 50%, respectively. The rates for freedom from aortic valve-related reoperation at 1, 5, 10, 15, and 20 years were 97%, 92%, 87%, 84%, and 80%, respectively. Multivariate Cox regression analysis identified age (odds ratio, 0.974; 95% confidence interval, 0.957-0.992; P = .004), senior surgeon (odds ratio, 0.546; 95% confidence interval, 0.305-0.979; P = .042), and residual postoperative aortic insufficiency (odds ratio, 4.864; 95% confidence interval, 1.124-21.052; P = .034) as independent risk factors for aortic valve-related reoperation. CONCLUSIONS: The aortic valve-sparing David-I procedure can be performed with very low perioperative morbidity and mortality. The short- and long-term results are excellent. The straight tube graft does not lead to increased leaflet erosion. This procedure is reproducible by multiple surgeons.

Elucidation of the genetic causes of bicuspid aortic valve disease.

AIMS: The present study aims to characterize the genetic risk architecture of bicuspid aortic valve (BAV) disease, the most common congenital heart defect. METHODS AND RESULTS: We carried out a genome-wide association study (GWAS) including 2236 BAV patients and 11 604 controls. This led to the identification of a new risk locus for BAV on chromosome 3q29. The single nucleotide polymorphism rs2550262 was genome-wide significant BAV associated (P = 3.49 × 10-08) and was replicated in an independent case-control sample. The risk locus encodes a deleterious missense variant in MUC4 (p.Ala4821Ser), a gene that is involved in epithelial-to-mesenchymal transformation. Mechanistical studies in zebrafish revealed that loss of Muc4 led to a delay in cardiac valvular development suggesting that loss of MUC4 may also play a role in aortic valve malformation. The GWAS also confirmed previously reported BAV risk loci at PALMD (P = 3.97 × 10-16), GATA4 (P = 1.61 × 10-09), and TEX41 (P = 7.68 × 10-04). In addition, the genetic BAV architecture was examined beyond the single-marker level revealing that a substantial fraction of BAV heritability is polygenic and ∼20% of the observed heritability can be explained by our GWAS data. Furthermore, we used the largest human single-cell atlas for foetal gene expression and show that the transcriptome profile in endothelial cells is a major source contributing to BAV pathology. CONCLUSION: Our study provides a deeper understanding of the genetic risk architecture of BAV formation on the single marker and polygenic level.

Pacemaker after Sutureless and Rapid-Deployment Prostheses: A Progress Report from the SURD-IR.

OBJECTIVES: The aim of this study was to investigate the need for postoperative permanent pacemaker implantation (PPI) following sutureless and rapid-deployment aortic valve replacement (SuRD-AVR) in the context of a progress report from a large multicenter international registry (SURD-IR). METHODS: We retrospectively analyzed 4,166 patients who underwent SuRD-AVR between 2008 and 2019. The primary outcome was the need for PPI before discharge. The study population was analyzed separately according to the implanted prostheses (Su cohort and RD cohort). Each cohort was divided into two groups based on the operation date: an early group ("EG" = 2008-2016) and a late group ("LG" = 2017-2019). RESULTS: The rate of PPI decreased significantly in the Su cohort over time (EG = 10.8% vs LG = 6.3%, p < 0.001). In the Su cohort, a decrease in age, risk profile, and incidence of bicuspid aortic valve, increased use of anterior right thoracotomy, reduction of cardiopulmonary bypass time and of associated procedures, and more frequent use of smaller prostheses were observed over time. In the RD cohort, the rate of PPI was stable over time (EG = 8.8% vs LG = 9.3%, p = 0.8). In this cohort, a younger age, lower risk profile, and higher incidence of concomitant septal myectomy were observed over time. CONCLUSION: Our analysis showed a significant decrease in the PPI rate in patients who underwent Su-AVR over time. Patient selection as well as surgical improvements and a more accurate sizing could be correlated with this phenomenon. The RD cohort revealed no significant differences either in patient's characteristics or in PPI rate between the two time periods.

Valve-sparing David procedure via minimally invasive access does not compromise outcome.

Objectives: Aortic valve sparing-aortic root replacement (David procedure) has not been routinely performed via minimally invasive access due to its complexity. We compared our results of elective David procedure via minimally invasive access to those via a full sternotomy. Methods: Between 1993 and 2019, a total of 732 patients underwent a valve sparing root replacement (David) procedure. Out of these, 220 patients underwent elective David-I procedure (isolated) without any other concomitant procedures at our center. Patients were assigned to either group A (n = 42, mini-access) or group B (n = 178, full sternotomy). Results: Cardiopulmonary bypass time were 188.5 ± 35.4 min in group A and 149.0 (135.5-167.5) in group B (p < 0.001). Aortic cross-clamp time were 126.2 ± 27.2 min in group A and 110.0 (97.0-126.0) in group B (p < 0.001). Post-operative echocardiography showed aortic insufficiency ≤ I° in 41 (100%) patients of group A and 155 (95%) of group B. In-hospital mortality was 2.4% (n = 1) in group A and 0% (n = 0) in group B (p = 0.191). Perioperative stroke occurred in 1 (2.4%) patient of group A and 2 (1.1%) patients of group B (p = 0.483). Reexploration for bleeding was necessary in 4 (9.5%) patients of group A and 7 (3.9%) of group B (p = 0.232). Follow-up was complete for 98% of all patients. The 1-, 2-, 4-, and 6-year survival rates were: 97, 97, 97, and 97%, in group A (mini-access) and 99, 96, 95, and 92% in group B (full sternotomy), respectively. The rates for freedom from valve-related re-operation at 1, 2, 4, and 6 years after initial surgery were: 97, 95, 95, and 84% in group A and 97, 95, 91, and 90% in group B, respectively. Conclusion: Early post-operative results after David procedure via minimally invasive access are comparable to conventional full sternotomy. Meticulous attention to hemostasis is a critical factor during minimally access David procedures. Long-term outcome including the durability of the reimplanted aortic valve seems to be comparable, too.

Randomized controlled trial between conventional versus sutureless bioprostheses for aortic valve replacement: Impact of mini and full sternotomy access at 1-year follow-up.

BACKGROUND: The present study is a sub-analysis of the multicenter, randomized PERSIST-AVR trial (PERceval Sutureless Implant versus Standard Aortic Valve Replacement) comparing the in-hospital and 1-year results of sutureless versus conventional stented bioprostheses in isolated surgical aortic valve replacement (SAVR) within two different surgical approaches: mini-sternotomy (MS) and full-sternotomy (FS). METHODS: A total of 819 patients (per-protocol population) underwent preoperative randomization to sutureless or stented biological valve at 47 centers worldwide. Sub-analysis on isolated SAVR was performed. Results were compared between sutureless and stented within the two different surgical approaches. RESULTS: 285 patients were implanted with Perceval (67% in MS) and 293 with stented valves (65% in MS). Sutureless group showed significantly reduced surgical times both in FS and MS. In-hospital results show no differences between Perceval and stented valves in FS, while a lower incidence of new-onset of atrial fibrillation (3.7% vs 10.8%) with Perceval in MS. After 1-year, use of sutureless valve showed a significant reduction of MACCE (5.2% vs 10.8%), stroke rate (1.0% vs 5.4%), new-onset of atrial fibrillation (4.2% vs 11.4%) and re-hospitalizations (21.8 days vs 47.6 days), compared to stented valves but presented higher rate of pacemaker implantation (11% vs 1.6%). CONCLUSIONS: Sutureless bioprosthesis showed significantly reduced procedural times during isolated SAVR in both surgical approaches. Patients with sutureless valves and MS access showed also better 1-year outcome regarding MACCEs, stroke, re-hospitalization and new-onset atrial fibrillation, but presented a higher rate of permanent pacemaker implantation compared to patients with stented bioprosthesis.

Hemodynamic Performance of Sutureless vs. Conventional Bioprostheses for Aortic Valve Replacement: The 1-Year Core-Lab Results of the Randomized PERSIST-AVR Trial.

OBJECTIVE: Sutureless aortic valves are an effective option for aortic valve replacement (AVR) showing non-inferiority to standard stented aortic valves for major cardiovascular and cerebral events at 1-year. We report the 1-year hemodynamic performance of the sutureless prostheses compared with standard aortic valves, assessed by a dedicated echocardiographic core lab. METHODS: Perceval Sutureless Implant vs. Standard Aortic Valve Replacement (PERSIST-AVR) is a prospective, randomized, adaptive, open-label trial. Patients undergoing AVR, as an isolated or combined procedure, were randomized to receive a sutureless [sutureless aortic valve replacement (Su-AVR)] (n = 407) or a stented sutured [surgical AVR (SAVR)] (n = 412) bioprostheses. Site-reported echocardiographic examinations were collected at 1 year. In addition, a subgroup of the trial population (Su-AVR n = 71, SAVR = 82) had a complete echocardiographic examination independently assessed by a Core Lab (MedStar Health Research Institute, Washington D.C., USA) for the evaluation of the hemodynamic performance. RESULTS: The site-reported hemodynamic data of stented valves and sutureless valves are stable and comparable during follow-up, showing stable reduction of mean and peak pressure gradients through one-year follow-up (mean: 12.1 ± 6.2 vs. 11.5 ± 4.6 mmHg; peak: 21.3 ± 11.4 vs. 22.0 ± 8.9 mmHg). These results at 1-year are confirmed in the subgroup by the core-lab assessed echocardiogram with an average mean and peak gradient of 12.8 ± 5.7 and 21.5 ± 9.1 mmHg for Su-AVR, and 13.4 ± 7.7 and 23.0 ± 13.0 mmHg for SAVR. The valve effective orifice area was 1.3 ± 0.4 and 1.4 ± 0.4 cm2 at 1-year for Su-AVR and SAVR. These improvements are observed across all valve sizes. At 1-year evaluation, 91.3% (n = 42) of patients in Su-AVR and 82.3% in SAVR (n = 51) groups were free from paravalvular leak (PVL). The rate of mild PVL was 4.3% (n = 2) in Su-AVR and 12.9% (n = 8) in the SAVR group. A similar trend is observed for central leak occurrence in both core-lab assessed echo groups. CONCLUSION: At 1-year of follow-up of a PERSIST-AVR patient sub-group, the study showed comparable hemodynamic performance in the sutureless and the stented-valve groups, confirmed by independent echo core lab. Perceval sutureless prosthesis provides optimal sealing at the annulus with equivalent PVL and central regurgitation extent rates compared to sutured valves. Sutureless valves are therefore a reliable and essential technology within the modern therapeutic possibilities to treat aortic valve disease.