Patent foramen ovale closure versus drug therapy in patients over 60 years and a follow-up of 5 years.

BACKGROUND: The advantages of patent foramen ovale (PFO) closure as protection from a recurrence of stroke remains controversial compared to drug therapy, especially in patients over 60 years. HYPOTHESIS: The aim of the study is to compare recurrence of stroke in patients over 60 years old with PFO closure versus drug therapy alone. METHODS: We included 342 patients over 60 years who suffered a crytopgenic stroke, and were also accepted for a PFO closure. 199 patients refused a PFO closure and were treated with medical therapy alone, whereas 143 patients underwent a PFO closure procedure. RESULTS: The mean follow up time was 5.5 ± 1.5 years. All patients in Group B showed persistent shunt in the follow-up period (n = 199, 100%). In Group A, seven patients were diagnosed with residual shunt during echocardiography examination (5%). A new onset of atrial fibrillation occurred in seven patients in Group A (5%) and six patients in Group B (3%), p = .117. Recurrent stroke occurred in 3 patients in Group A (2%) and 11 patients in Group B (6%), p = .021. One patient died of unknown reason (1%) and two patients were lost due to neurological death (1%) in Group B, whereas no patients in Group A died during the follow-up period. CONCLUSION: Our results show that strict exclusion of patients over 60 years from PFO closure should be reconsidered. As life expectancies are increasing, patients should be considered for same treatment as younger patients, since the outcomes are improved compared to patients treated with medical therapy alone.

Conventional vs. Sutureless Aortic Valve Bioprosthesis: Is Faster Better?

Purpose: The benefits of sutureless compared to conventional aortic valve prosthesis replacement remain controversial. Supposed advantages of sutureless aortic valve replacement include shortened cross-clamp and implantation time, as well as improved overall safety and good post-operative performance. We aimed to compare the early outcomes and performance of sutureless aortic valve replacement (su-AVR) with the sutureless Perceval (Corcym, Milan, Italy) vs. the conventional AVR with a conventional counterpart, in this case, the Labcor Dokimos Plus (LDP) aortic bioprosthesis. Methods: We compared two types of aortic valve prostheses, the sutureless (Corcym, Milan, Italy) and the conventional valve Labcor Dokimos Plus (LDP), implanted between August 2014 and May 2019 in our Department of Cardiac Surgery at RWTH Aachen University Hospital. Data were collected from 141 patients who received the Perceval (Corcym, Milan, Italy) and 138 who received the Labcor Dokimos Plus (LDP) aortic bioprosthesis. After matching the two groups considering STS mortality risk and pre-operative LDH levels, 201 patients were included in our final study cohort. Seventy-one patients (17 from the Perceval group and 54 from the Dokimos group) were excluded due to the lack of complete data, particularly standardized echocardiographic data (n = 71). Primary endpoints were 30-day mortality, length of hospital stay, and pacemaker implantation. Secondary endpoints were echocardiographic parameters, major adverse cardiovascular events, and prosthesis failure (grade II aortic regurgitation, paravalvular leak with reintervention). Results: Bypass and cross-clamp time proved to be shorter in the Perceval group, while hospital stays were longer. The faster implantation had no effect on the 30-day mortality primary endpoint. Transvalvular gradients were significantly higher in the Perceval group, in addition to a smaller effective orifice area. The LDH values were remarkably higher post-operatively in the Perceval group. Conclusions: Regarding the clinical outcomes, Perceval was equivalent and not superior to the Dokimus bioprosthesis. The suitability of a Perceval prosthesis implantation must be determined on a case-by-case basis and reserved for elderly patients with increased comorbidity.

Conventional Prostheses versus Sutureless Perceval for Aortic Valve Replacement: A Meta-Analysis.

PURPOSE: Perceval sutureless valves have gained popularity. Whether this implant performs superior to the traditional sutured prosthesis remains unclear. This meta- analysis compared the Perceval implants versus the sutured conventional valves for aortic valve replacement (AVR). METHODS: This meta-analysis was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The following databases were accessed: PubMed, Google Scholar, Web of Science, Scopus, and EMBASE. All clinical investigations comparing Perceval versus the conventional prostheses for AVR were considered. RESULTS: The Perceval group demonstrated higher rate of pacemaker implantation (P <0.00001). Aortic cross-clamp (ACC) time (P <0.00001) and cardiopulmonary bypass (CPB) time (P <0.00001) were shorter in the Perceval group. Similarity was found in mean and peak pressure gradient (P = 0.8 and P = 0.2, respectively), mean aortic valve area (P = 0.3), length of intensive care unit (P = 0.4) and hospital stay (P = 0.2), rate of revision (P = 0.11), hemorrhages (P = 0.05), paravalvular leak (P = 0.3), cerebrovascular complication (P = 0.7), and early mortality (P = 0.06). CONCLUSION: Given the shorter ACC time and CPB time, Perceval AVR can be an alternative in high-risk patients. The higher rate of pacemaker implantation following Perceval may limit its routine implantation.

Pregabalin administration in patients with fibromyalgia: a Bayesian network meta-analysis.

Several studies investigated the effectiveness and the safety of different doses of pregabalin in fibromyalgia. However, the optimal protocol remains controversial. A Bayesian network meta-analysis comparing 300, 450, and 600 mg/daily of pregabalin for fibromyalgia was conducted. The literature search was conducted in January 2022. All the double-blind randomised clinical trials comparing two or more dose protocols of pregabalin for fibromyalgia were accessed. Studies enrolling less than 50 patients were not eligible, nor were those with a length of follow-up shorter than eight weeks. The outcomes of interests were: Fibromyalgia Impact Questionnaire (FIQ), sleep quality, and adverse events. The network meta-analyses were performed using the routine for Bayesian hierarchical random-effects model analysis, with log odd ratio (LOR) and standardized mean difference (SMD) effect measure. Data from 4693 patients (mean age 48.5 years) were retrieved. 93.1% (4370 of 4693 patients) were women. The median follow-up was 14.8 weeks. Pregabalin 450 mg/daily resulted in greater reduction in Fibromyalgia Impact Questionnaire (SMD - 1.83). Pregabalin 600 demonstrated the greatest sleep quality (SMD 0.15). Pregabalin 300 mg/daily evidenced the lowest rate of adverse events (LOR 0.12). The dose of pregabalin must be customised according to patients' characteristics and main symptoms.

Stent deformation in a sutureless aortic valve bioprosthesis: a pilot observational analysis using imaging and three-dimensional modelling.

OBJECTIVES: The goal of this analysis of the Perceval aortic bioprosthesis was to investigate the ovalization/deformation of the Perceval prosthesis stent after implantation and its propensity for cusp dysfunction, fluttering, fibrosis and blockage. METHODS: Between August 2014 and May 2019, a total of 134 patients (52% female) underwent aortic valve replacement with the Perceval bioprosthesis. We reconstructed three-dimensional models of the Perceval stent using thorax computed tomography scans for 16 patients employing the software Mimics (Materialise NV, Leuven, Belgium) and analysed the ovality of the stents. Radial force (RF) measurements were performed to compare the stiffness of the Perceval bioprosthesis to that of other valves. RESULTS: The three-dimensional reconstructions showed that all Perceval stents exhibited some degree of deformation and ovalization. Ovality in the annulus and commissure section of the Perceval stents ranged from 6.8% to 45% with mean values of 13.6% and 21.9%, respectively. The RF of the Perceval prosthesis was noticeably lower than that of the Edwards Intuity and several transcatheter aortic valve implantation devices. The stent adopted the preoperative shape of the aorta in the 2 patients for whom pre- and postoperative computed tomography data existed. CONCLUSIONS: The Perceval bioprostheses were deformed to different degrees in all analysed cases. The comparably low RFs might be an explanation for the propensity towards this deformation, which can lead to fluttering, a reduction of the cusps' mobility. This condition could potentially result in fibrosis as well as increased transvalvular pressure gradients and might be the cause for the increase in lactate dehydrogenase and the decrease in platelet count.

Dual-center experiences with interventional closure of patent foramen ovale: A medium-term follow-up study comparing two patient groups aged under and over 60 years.

BACKGROUND: Current guidelines recommend interventional closure of patent foramen ovale (PFO) in patients with cryptogenic ischemic stroke who are under 60 years of age. HYPOTHESIS: The hypothesis of this study was to compare follow-up results of PFO closure in patients over 60 years of age to those of patients under 60 years of age in order to determine whether the procedure is safe and effective for both age groups. METHODS: We included 293 patients who had a cryptogenic ischemic stroke and a PFO confirmed by transesophageal echocardiography (TEE) and who were scheduled for percutaneous closure of the PFO between 2014 and 2019. The device implantation was completed in all patients using an Amplatzer™, Occlutec™, or Cardia Ultrasept PFO occluder. RESULTS: Follow-up TEE examinations were performed at intervals of 1, 3, and 6 months after implantation. Patients were followed for a median of 3.6 ± 1.2 years. Recurrent ischemic stroke or transient ischemic attack, cardiac death, arrhythmias, and residual shunt were reported equally in both groups. CONCLUSIONS: Interventional closure of PFO can be as safe and effective in patients over 60 years of age as it is in patients under 60 years of age regardless of the device used. In this older patient group, rigorous discussion and a case-by-case decision-making process including cardiologists and neurologists is warranted to ensure optimal procedure selection.

Prevention of Sternal Wound Infections in Women Using an External Sternum Fixation Corset.

PURPOSE: Deep sternal wound infection (DSWI) and mediastinitis are devastating complications after median sternotomy. Previous studies demonstrated an effective prevention of sternal wound infection (SWI) using an external sternal corset in high-risk cardiac surgery patients. The aim of this study is to assess the preventive effect of the Stern-E-Fix corset in high-risk poststernotomy female patients. METHODS: A total of 145 high-risk female patients undergoing cardiac surgery through median sternotomy were retrospectively analyzed. Patients were divided into group A (n = 71), who received the Stern-E-Fix corset (Fendel & Keuchen GmbH, Aachen, Germany), and group B (n = 74), who received the elastic thorax bandage (SanThorax) postoperatively for 6 weeks. The mean follow-up period was 12 weeks. RESULTS: Incidence of SWI was 7% in group A vs. 17.6% in group B (p = 0.025). One patient presented with DSWI in group A vs. seven patients in group B (p = 0.063). No patient developed mediastinitis in group A vs. four patients in group B (p = 0.121). In all, 4.2% of group A patients required operative wound therapy vs. 16.2% of group B patients (p = 0.026). The length of hospital stay was significantly longer in group B (p = 0.006). CONCLUSION: Using an external supportive sternal corset (Stern-E-Fix) yields a significantly better and effective prevention against development of sternal dehiscence, DSWI, and mediastinitis in high-risk poststernotomy female patients.

Rescue operation retrieving an incorrectly implanted cardiac event recorder from the left main pulmonary artery.

Continuous heart rhythm monitoring with cardiac event recorders is increasing in clinical practice and may be helpful in diagnosing a wide range of disorders and pathologies. This case study describes the case of an 80-year-old female patient with a medical history of previous cardiac surgery in which a cardiac event recorder had to be retrieved from the left main pulmonary artery.

The flutter-by effect: a comprehensive study of the fluttering cusps of the Perceval heart valve prosthesis.

OBJECTIVES: Sutureless aortic valve prostheses are gaining popularity due to the substantial reduction in cross-clamp time. In this study, we report our observations on the cusp-fluttering phenomenon of the Perceval bioprosthesis (LivaNova, London, UK) using a combination of technical and medical perspectives. METHODS: Between August 2014 and December 2016, a total of 108 patients (69% women) with a mean age of 78 years had aortic valve replacement using the Perceval bioprosthesis (34 combined procedures). All patients underwent transoesophageal echocardiography (TOE) intraoperatively. TOE was performed postoperatively to detect paravalvular leakage and to measure gradients, acceleration time, Doppler velocity indices (Vmax and LVOT/Vmax AV) and effective orifice area indices. In addition, a TOE examination was performed in 21 patients postoperatively. Data were collected retrospectively from our hospital database. RESULTS: The retrospective evaluation of the intraoperative TOE examinations revealed consistent fluttering in all patients with the Perceval bioprosthesis. The echocardiographic postoperative measurements showed a mean effective orifice area index of 0.91 ± 0.12 cm2/m2. The overall mean pressure and peak pressure gradients were in a higher range (13.5 ± 5.1 mmHg and 25.5 ± 8.6 mmHg, respectively), whereas acceleration time (62.8 ± 16.4 ms) and Doppler velocity indices (0.43 ± 0.11) were within the normal range according to the American Society of Echocardiography or european association of echocardiography (EAE) guidelines. The 2-dimensional TOE in Motion Mode (M-Mode) that was performed in patients with elevated lactate dehydrogenase (LDH) levels revealed remarkable fluttering of the cusps of the Perceval bioprosthesis. CONCLUSIONS: In our study cohort, we observed the fluttering phenomenon in all patients who received the Perceval bioprosthesis, which was correlated with elevated LDH levels and higher pressure gradients.

Comparison between radial artery tonometry pulse analyzer and pulsed-Doppler echocardiography derived hemodynamic parameters in cardiac surgery patients: a pilot study.

BACKGROUND: Bedside non-invasive techniques, such as radial artery tonometry, to estimate hemodynamic parameters have gained increased relevance as an attractive alternative and efficient method to measure hemodynamics in outpatient departments. For our pilot study, we sought to compare cardiac output (CO), and stroke volume (SV) estimated from a radial artery tonometry blood pressure pulse analyzer (BPPA) (DMP-Life, DAEYOMEDI Co., Gyeonggi-do, South Korea) to pulsed-wave Doppler (PWD) echocardiography derived parameters. METHODS: From January 2015 to December 2016, all patients scheduled for coronary artery bypass (CABG) surgery at our department were screened. Exclusion criteria were, inter alia, moderate to severe aortic- or Mitral valve disease and peripheral arterial disease (PAD) > stage II. One hundred and seven patients were included (mean age 66.1 ± 9.9, 15 females, mean BMI 27.2 ± 4.1 kg/m2). All patients had pre-operative transthoracic echocardiography (TTE). We measured the hemodynamic parameters with the BPPA from the radial artery, randomly before or after TTE. For the comparison between the measurement methods we used the Bland-Altman test and Pearson correlation. RESULTS: Mean TTE-CO was 5.1 ± 0.96 L/min, and the mean BPPA-CO was 5.2 ± 0.85 L/min. The Bland-Altman analysis for CO revealed a bias of -0.13 L/min and SD of 0.90 L/min with upper and lower limits of agreement of -1.91 and +1.64 L/min. The correlation of CO measurements between DMP-life and TTE was poor (r = 0.501, p < 0.0001). The mean TTE-SV was 71.3 ± 16.2 mL and the mean BPPA-SV was 73.8 ± 19.2 mL. SV measurements correlated very well between the two methods (r = 0.900, p < 0.0001). The Bland-Altman analysis for SV revealed a bias of -2.54 mL and SD of ±8.42 mL and upper and lower limits of agreement of -19.05 and +13.96 mL, respectively. CONCLUSION: Our study shows for the first time that the DMP-life tonometry device measures SV and CO with reasonable accuracy and precision of agreement compared with TTE in preoperative cardiothoracic surgery patients. Tonometry BPPA are relatively quick and simple measuring devices, which facilitate the collection of cardiac and hemodynamic information. Further studies with a larger number of patients and with repeated measurements are in progress to test the reliability and repeatability of DMP-Life system.

Risk factors for the development of right ventricular failure after left ventricular assist device implantation-a single-centre retrospective with focus on deformation imaging.

OBJECTIVES: Right heart failure (RHF) after the implantation of a left ventricular assist device (LVAD) remains a dreaded postoperative complication. Using 2D speckle-tracking echocardiography, it is possible to acquire right ventricular global and regional function. The aim of our study was to assess whether speckle-tracking echocardiography values will better predict the RHF post-continuous-flow LVAD implantation. METHODS: From January 2014 to January 2016, 54 patients who underwent LVAD implantation were included and retrospectively analysed. Clinical, invasive haemodynamic (right and left heart catheterization), laboratory and transthoracic echocardiography data were reviewed. Multivariable logistic regression was performed using RHF as dependent variable. RESULTS: Thirteen patients (24%) developed RHF. These patients had significantly elevated procalcitonin (P = 0.011), elevated central venous pressure (CVP) pre- and post-LVAD implantation (P = 0.002 and 0.031, respectively), higher right ventricular (RV) and pulmonary systolic pressure (P = 0.016 and 0.013, respectively), higher Michigan Risk Score (P = 0.001) and a lower peak systolic longitudinal strain of the basal RV free wall (P = 0.032). Haemoglobin, procalcitonin, RV systolic pressure, basal right ventricular free wall and pre-CVP entered the final multivariable analysis, only basal right ventricular free wall (P < 0.001) and pre-CVP (P < 0.001) remained significant predictors of RHF. The sensitivity and specificity of the final model were 85.7% and 95.4%, respectively. The negative predictive value reached 94%. CONCLUSIONS: 2D strain parameters of the RV free wall seem to be auspicious for RV function and predicting RHF. Moreover, intraoperative CVP should not be neglected since elevated values proved to be highly associated with RHF. Our results represent a valuable supplement to other scores by considering both echocardiography and intraoperative data.

Perioperative onset of acquired von Willebrand syndrome: Comparison between HVAD, HeartMate II and on-pump coronary bypass surgery.

OBJECTIVES: Acquired von Willebrand syndrome (AvWS) is associated with postoperative bleeding complications in patients with continuous flow left ventricular assist devices (CF-LVADs). The aim of this study is to analyze the perioperative vWF profile comparing an axial pump (HMII) to a centrifugal pump (HVAD) regarding the correlation between perioperative occurrence of AvWS, early- and late-postoperative bleeding events. METHODS: From July 2013 until March 2015 blood samples of 33 patients (12 HMII/ 8 HVAD/ 13 controls) were prospectively collected at 12 different time points and analyzed for the vWF antigen (vWF:Ag), its activity (vWF:Ac) and the vWF:Ac/vWF:Ag-ratio (vWF:ratio). The follow up period for postoperative bleeding events was from July 2013 until July 2016. RESULTS: Postoperatively, there was no difference in the vWF-profile between HVAD and HMII groups. However, a subgroup of patients already had significantly lower vWF:ratios preoperatively. Postoperatively, both CF-LVAD groups presented significantly lower vWF:ratios compared to the control group. Bleeding events per patient-year did not differ between the two groups (HMII vs. HVAD: 0.67 vs. 0.85, p = 0.685). We detected a correlation between vWF:ratio <0.7at LVAD-start (r = -0.583, p = 0.006) or at the end of surgery (r = -0.461, p = 0.035) and the occurrence of pericardial tamponade. In the control group, the drop in both vWF:Ag and vWF:Ac recovered immediately postoperatively above preoperative values. CONCLUSION: A subgroup of patients with end-stage heart failure already suffers AvWS preoperatively. In both CF-LVAD groups, AvWS begins immediately after surgery. Intraoperative vWF:ratios <0.7 correlate with higher incidences of pericardial tamponade and re-operation. The presumably dilutive effect of the heart lung machine on vWF vanishes immediately at the end of surgery, possibly as part of an acute-phase response.

Performance of the Labcor Dokimos Plus pericardial aortic prosthesis: a single-centre experience.

Objectives: In patients with a small aortic annulus, aortic valve replacement (AVR) is frequently associated with high residual pressure gradients. Supra-annular pericardial aortic prostheses are gaining popularity due to the increased effective orifice areas (EOA) and resulting lower gradients. This study reports the clinical and echocardiographic results following implantation of the new supra-annular pericardial aortic prosthesis Dokimos Plus (Labcor, Belo Horizonte, Brazil). Methods: Between October 2013 and July 2015, 137 patients (41% women, mean age: 74 years) underwent supra-annular AVR with or without concomitant procedures using the Dokimos Plus prosthesis in our department. Transthoracic echocardiography was performed pre- and postoperatively on all patients to assess haemodynamic parameters (gradients, acceleration time [AT], Doppler velocity indices [DVIs] and indexed EOA [EOAI]) and to detect paravalvular leakage (PVL). Data were collected retrospectively from our hospital databases. Methods: Patients were grouped by prosthesis size: Most patients received 23-mm (57.6%), followed by 21-mm (19%), 25-mm (15.4%) and 27-mm (8%) prostheses. The mean EOAI in all groups was 1.1 ± 0.26 cm 2 /m 2 . Pressure gradients were low in all groups (mean: 8.9 ± 4.4 mmHg; peak: 18.8 ± 6.8 mmHg); AT and DVI were in the normal range according to American Society of Echocardiography/European Association of Cardiovascular Imaging recommendations (mean AT 73.3 ± 29 ms; mean DVI 0.5 ± 0.2). One patient had severe PVL and one presented with central regurgitation, both requiring re-intervention. The mortality rate was 5.1% ( n = 7); none of the cases was associated with valve insufficiency. Conclusions: The Dokimos prosthesis showed a satisfactory overall performance, presenting low gradients and DVIs as well as high EOAI. Further investigations are needed to analyse the cases of regurgitation and monitor long-term performance.

Interatrial conduction disturbance in postoperative atrial fibrillation: a comparative study of P-wave dispersion and Doppler myocardial imaging in cardiac surgery.

OBJECTIVE: Disturbances of interatrial conduction have been proposed as one of the contributing mechanisms of postoperative atrial fibrillation (AF). P-wave dispersion has been recognized as a sensitive tool for detecting interatrial conduction disturbances. Doppler myocardial imaging (DMI) has been validated as a non-invasive tool to indirectly reflect electrical atrial activation and therefore is used in this study to detect possible interatrial electromechanical disturbances after cardiac surgery. METHODS: 30 patients (23 men, age 62 ± 1 years) admitted for coronary bypass surgery with no prior history of AF were included in this investigation. Echocardiography and electrocardiograms (ECG) were obtained on the day before and after surgery. In addition to standard echocardiography, DMI-loops were acquired from the apical window. The following time intervals were derived off-line from the free right atrial (RA), left atrial (LA) lateral and LA posterior wall: onset P-wave to start (P to A'start), to peak (P to A'peak) and to end of atrial deformation (total electromechanical activity). These intervals were compared to each other and to P-wave dispersion derived from the recorded ECGs. RESULTS: All patients were in sinus rhythm during their postoperative assessment, but 11 patients presented episodes of AF within the first three postoperative days. Atrial electromechanical activation was earliest in the RA and latest in the lateral LA. In patients with AF, P-wave dispersion was significantly prolonged postoperatively (mean: +18.6 ms; 95% confidence interval (CI): 12.1-25.2 ms; p < 0.001) compared to non-AF patients (mean: -2.4 ms; CI: -6.6-1.9 ms). P dispersion was closely correlated to P to A'start intervals (from RA to LA lat.: preop.: rho = 0.74, postop.: rho = 0.87; p < 0.001). Prolonged right to left conduction interval was associated with an elevated risk for AF (from RA to LA lat.: odds ratio 1.13 (CI:1.03-1.24); p: 0.007. CONCLUSION: DMI enabled detection of interatrial conduction disturbances in concordance to findings of prolonged postoperative P-wave dispersion. Equally effective to P-wave dispersion, this simple and reproducible tool might help to early identify the risk for postoperative AF, thus extending the informative value of routine postoperative echocardiography.