Abstract: Background. Hemopericardium is a major complication of balloon mitral valvotomy (BMV). Only a few studies are available to address this issue following transseptal access. In addition, the management strategy regarding completion of BMV is uncertain. Objective. We sought to determine the incidence of hemopericardium complicating transseptal puncture during BMV. In addition, the management strategy adopted and outcomes are highlighted. Methods. This prospective study included 29 consecutive patients who developed hemopericardium following transseptal access during BMV. Results. Out of 1424 patients who underwent BMV, hemopericardium developed in 29 patients following transseptal access (2.0%). The mean age of the study cohort was 36.9 ± 13.7 years and 82.8% were women. A second transseptal puncture was done and BMV was completed in 26 patients (89.6%). An acceptable hemodynamic result was obtained in 22 patients (84.6%). Six patients (20.7%) underwent emergency surgery for hemopericardium. The sites of perforation were inferior vena cava-right atrial junction in 4 cases, left atrial posterior wall in 1 case, and left atrial appendage in 1 case. In addition to repair of the perforation, a total of 2 patients underwent mitral valve replacement and 1 patient underwent open mitral commissurotomy. The in-hospital mortality rate was 6.9%. Conclusions. The incidence of hemopericardium complicating transseptal access during BMV was 2.0%, and was associated with a mortality rate of 6.9%. BMV can be safely performed in the same sitting with a second transseptal puncture, in patients with a favorable valve morphology. Surgical intervention can be reserved for a subset of patients with persistent pericardial collection.
J INVASIVE CARDIOL 2019 October 15 (Epub Ahead of Print).
Key words: balloon mitral valvotomy, hemopericardium, outcomes, transseptal access
Hemopericardium is a major complication of balloon mitral valvotomy (BMV).1 It is a result of chamber perforation either during transseptal puncture or manipulation of the balloon and wire while performing BMV. The incidence of hemopericardium during BMV varies from 0.6% to 4% and is one of the most common indications for emergency surgery.1,2
Obtaining transseptal access is a critical step in performing BMV. With the widespread application of newer transcatheter therapies for mitral regurgitation and left atrial appendage closure, transseptal access is gaining increasing importance. Studies addressing the issue of hemopericardium following transseptal puncture during BMV are sparse. We report our institutional experience with hemopericardium complicating BMV, with due attention to management strategy and outcome.
Study design and population. This is a prospective, single-center study from a tertiary cardiac-care teaching hospital. Consecutive patients who developed hemopericardium following transseptal puncture during BMV were enrolled in the study. From January 2010 to July 2011, a total of 1424 BMVs were done in symptomatic patients with moderate-to-severe mitral stenosis. Twenty-nine consecutive patients who developed hemopericardium following transseptal puncture formed our study group. The study was approved by the ethics committee and the hospital research board.
Procedure. Two-dimensional transthoracic echocardiography (2D-TTE) was performed before and during BMV in all patients. The mitral valve morphology was assessed according to the grading described by Wilkins et al.3 Transesophageal echocardiographic examination was performed prior to the procedure in the presence of one or more of the following: left atrial clot on 2D-TTE; suboptimal transthoracic imaging; age >40 years old; atrial fibrillation; and prior embolic episodes.
A right femoral arterial and venous access was obtained. Anticoagulation was achieved with unfractionated heparin and all patients received 2500 IU at the start of the procedure. A pigtail catheter was positioned in the non-coronary cusp of the aortic root. The transseptal access was performed with the assembly of Mullin’s sheath and Brockenbrough needle. The septum was punctured after confirmation of the position of the needle in at least two views.4 Subsequently, coiled left atrial guidewire was advanced and septal dilation was performed. A 2D-TTE was routinely performed immediately after septal dilation, to exclude pericardial effusion. In the absence of pericardial effusion, an additional 2500 IU of heparin was given. If there was mild pericardial effusion following transseptal access without evidence of tamponade, BMV was completed after repeat puncture of the interatrial septum in a different plane. Cardiac tamponade was suspected by a sudden drop in blood pressure, increase in size of the cardiac silhouette, and decrease in cardiac pulsations on fluoroscopy, and was confirmed by 2D-TTE. In the presence of tamponade, patients were first stabilized by performing emergency pericardiocentesis (subxiphoid approach) and simultaneous autohemoperfusion via a left femoral vein access. The septal dilator was reintroduced across the septum to prevent further pericardial collection. Further management plan was based on the valve morphology and the likelihood of acceptable result by BMV. Patients who subsequently underwent BMV had a second transseptal access; this second septal puncture was done by taking a right femoral vein access at a point 1 cm above the first femoral vein puncture site. All cases of BMV were completed by Inoue technique using the Accura balloon catheter (Sanare Medical Products).5,6 The details of performing BMV in patients with cardiac tamponade are illustrated in Figure 1. These patients were monitored in the cardiac catheterization laboratory, and when the activated clotting time was <150 seconds, an attempt was made to remove the septal dilator from the initial puncture site under 2D-TTE guidance. In the presence of rapid pericardial collection, the septal dilator was repositioned across the septum and the patients were referred for surgery. The operative findings with respect to the site of cardiac perforation were noted in patients referred for surgery. All patients who underwent BMV and did not require surgical intervention were monitored in the intensive cardiac care unit for 48 hours. An overview of management strategies adopted during BMV complicated by hemopericardium is highlighted in Figure 2.
Data collection and study outcomes. Baseline clinical characteristics, preprocedural echocardiographic data, and hemodynamic data were collected prospectively. The procedural data were recorded, and the outcomes of patients complicated by hemopericardium were analyzed. The study endpoints of interest were the incidence of hemopericardium following transseptal access during BMV, the subsequent management strategies adopted, and outcomes. The echocardiographic and hemodynamic data of patients who completed the BMV procedure were documented. An acceptable BMV result was defined as a mitral valve orifice area (MVOA) ≥1.5 cm2 and/or >50% increase in the MVOA, with a split of at least one of the commissures.
Statistical analysis. Continuous data are expressed as mean ± standard deviation; discrete variables are given as absolute values and percentages. Data were analyzed using the statistical software package SPSS, version 20.0 (IBM).
A total of 1424 patients underwent BMV at our institute from January 2010 to July 2011. Twenty-nine cases (2.0%) developed hemopericardium following transseptal puncture and formed our study group. The baseline clinical, 2D-TTE, and hemodynamic characteristics of the study population group are shown in Tables 1 and 2. The mean age was 36.9 ± 13.7 years and 82.8% of the patients were women. The majority of patients were in New York Heart Association class II and III at the time of admission. Atrial fibrillation/flutter was present in 34.5% of patients. The mean MVOA was 0.80 ± 0.13 cm2 and the Wilkin’s score was 8.03 ± 1.05. The mean preprocedure left atrial pressure was 28.55 ± 5.98 mm Hg and pulmonary artery systolic pressure was 61.72 ± 17.51 mm Hg.
The 2D-TTE and hemodynamic characteristics of patients who underwent BMV are highlighted in Table 3. A second transseptal puncture was done and BMV was completed in 89.6% of patients who developed hemopericardium. The mean MVOA following BMV was 1.65 ± 0.17 cm2. The mean postprocedure left atrial pressure was 15.80 ± 7.13 mm Hg and pulmonary artery systolic pressure was 40.76 ± 12.73 mm Hg.
Table 4 presents the key findings of the study. The incidence of hemopericardium following transseptal access during BMV was 2.0%. An acceptable hemodynamic result following a second transseptal puncture was obtained in 84.6% of patients. Six patients (20.7%) underwent emergency surgery for hemopericardium. Of these, four patients were referred for persistent collection after completion of BMV. The sites of perforation in patients undergoing surgery were the inferior vena cava-right atrial junction in 4 cases, left atrial posterior wall in 1 case, and left atrial appendage in 1 case. In addition to repair of the perforation, a total of 2 patients underwent mitral valve replacement and 1 patient underwent open mitral commissurotomy. Two patients (6.9%) died as a result of hemopericardium complicating transseptal puncture. The cause of mortality was multiorgan dysfunction syndrome in 1 patient following surgery, while the other patient succumbed to a massive pulmonary embolism before a second transseptal access could be obtained. The mean duration of hospital stay of the study cohort was 8.18 ± 4.11 days.
This is a single-center prospective study of patients developing hemopericardium following transseptal puncture during BMV. Hemopericardium developed in 2.0% of the patients during transseptal puncture. The majority of patients in this study who developed hemopericardium underwent BMV with a second transseptal puncture and had an acceptable outcome. The need for emergency surgery in this cohort of patients was relatively low.
BMV is a safe procedure with a high success rate. However, the occurrence of hemopericardium following transseptal access is one of the major complications. Our study is one of the largest series of patients reporting hemopericardium following transseptal access during BMV. In mitral stenosis, there is enlargement of the left atrium with or without right atrial enlargement. The enlargement of the free wall of the atria alters the interatrial septum profile to a relatively inferior position. A high septal puncture will probably result in tearing of the atrial roof, whereas a very low puncture may predispose to tear at the inferior vena cava-right atrial junction. Hence, it is important to realize the alteration of normal geometry of atrial chambers in patients with mitral stenosis.
The other important factor related to the development of hemopericardium during transseptal access is operator experience. Our center has performed more than 15,000 BMVs in the last 20 years. During our study, all BMVs were performed by either experienced operators (those who had done more than 100 BMVs/year for at least 5 years) or under the supervision of an experienced operator. The incidence of hemopericardium complicating transseptal access in our study is acceptable, and similar to those published in literature.7 The incidence for other transcatheter therapies (mitral valve repair, pulmonary vein isolation, and left atrial appendage closure) requiring transseptal access ranges from 1% to 3%.8,9 The use of transesophageal echocardiography and intracardiac echocardiography to guide transseptal access will significantly reduce the complication of hemopericardium.10,11 In a study of 2952 patients by Sorajja et al, the incidence of hemopericardium complicating transseptal puncture during transcatheter mitral valve repair was 0.9% with transesophageal echocardiographic guidance.12 Although this complication rate is reduced with imaging assistance, cardiac imaging may not be cost effective and feasible in all BMV cases.
A new pericardial effusion with or without tamponade following transseptal access is usually the result of perforation. The manifestation (effusion/tamponade) depends on the device responsible for the perforation (needle/sheath/dilator), the structure that is perforated, the hemodynamic status, and the coagulation status. If hemopericardium is the result of passage of only the needle into the pericardial space, withdrawing the needle and reversing anticoagulation with close monitoring is usually sufficient. In this scenario, rescheduling the procedure for an alternative day is reasonable. However, if a sheath or dilator has been advanced, the tear in the cardiac structure will be larger, with a higher likelihood of developing tamponade. In our study, all patients had new effusion after septal dilation, with more than three-fourths (23/29) manifesting tamponade. Prior studies have recommended emergency surgery for cardiac tamponade complicating BMV,2,7 as percutaneous pericardial drainage alone is unlikely to resolve the issue. One of the important factors contributing to hemopericardium is the hemodynamic status. Patients with mitral stenosis will invariably have high atrial pressures. Hence, even in the absence of hemodynamic compromise, it is important to prevent the transition from effusion to cardiac tamponade. This can be achieved by relieving mitral valve stenosis and reducing atrial pressures. The reduction of atrial pressures is likely to hasten the closure of atrial perforation and resolution of pericardial collection. Hence, this study was undertaken to evaluate the feasibility of a second transseptal puncture in the same sitting, and to assess outcomes.
In the present study, no procedures were abandoned following hemopericardium after transseptal access. Patients were treated with a second transseptal puncture and reassessed or referred immediately for emergency surgery. Persistent collection following an acceptable hemodynamic result warrants surgery to close the rent.13 Four patients required surgery for persistent hemopericardium after completion of BMV. Two patients were directly referred for emergency surgery following hemopericardium without reattempting a second septal puncture. These 2 patients had a Wilkin’s score >8 and were deemed to have low probability of an acceptable result prior to initiation of the procedure. However, it is reasonable to attempt BMV even in patients with a Wilkin’s score >8.14 Nonetheless, after a major complication (hemopericardium) following a transseptal access with unfavorable valve characteristics, the consensus was to consider an emergency surgery rather than a second transseptal puncture. Our study suggests that an emergency surgery – which carries higher morbidity and mortality – is not required for all patients developing hemopericardium following transseptal puncture during BMV. It is reasonable to attempt BMV with a second transseptal puncture and monitor the patient closely to avoid a major surgery. There were no cases of mortality directly attributable to a second transseptal puncture. In addition, there was no in-hospital mortality among the patients who underwent BMV and subsequently did not necessitate a surgical intervention. Hence, it would be reasonable to proceed with a second transseptal puncture in experienced centers with an active on-site surgical back-up.
Study limitations. This study enrolled a relatively small number of patients at a single center and is non-randomized. However, it highlights the outcomes of consecutive patients in a real-world setting. The study population consisted of only patients who were planned for BMV. We did not perform transesophageal echocardiography or intracardiac echocardiography to guide transseptal access. This may have influenced the incidence of hemopericardium during transseptal puncture.
The incidence of hemopericardium complicating transseptal access during BMV in our study was 2.0%. BMV can still be safely performed in the same sitting with a second transseptal puncture after hemodynamic stabilization. Emergency surgery for hemopericardium in patients with favorable valve morphology should be reserved for persistent collection following BMV. The inferior vena cava-right atrial junction is the most common site of perforation in patients undergoing emergency surgery for hemopericardium complicating transseptal access.
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From the Department of Cardiology, Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore, India.
Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. The authors report no conflicts of interest regarding the content herein.
Manuscript submitted April 1, 2019, provisional acceptance given May 14, 2019, final version accepted June 10, 2019.
Address for correspondence: Dr. Satvic C. Manjunath, Department of Cardiology, Sri Jayadeva Institute of Cardiovascular Sciences & Research, Jaya Nagar 9th Block, BG Road, Bangalore, India 560069. Email: firstname.lastname@example.org