DEVICES
Systematic Implantation of Pacemaker/ICDs under Active Oral Anticoagulation Irrespective of Patient’s Individual Preoperative Thromboembolic Risk ´ ´ M.D.,*,† REBECA JIMENEZ, ´ OSCAR CANO, M.D., PH.D.,*,† ANA ANDRES, M.D.,* ´ ´ JOAQUIN OSCA, M.D., PH.D.,* PAU ALONSO, M.D.,*,† YDELISE RODRIGUEZ, M.D.,* ¨ M.D.,* JOSE´ E. CASTRO, M.D.,* MAR´IA-JOSE´ SANCHO-TELLO, M.D.,* JOSE´ OLAGUE, ANTONIO SALVADOR, M.D., PH.D.,* and LUIS MART´INEZ-DOLZ, M.D., PH.D.* From the *Electrophysiology Section, Cardiology Department, Hospital Universitari i Polit`ecnic La Fe, Valencia, Spain; and †Instituto Investigacion ´ Sanitaria La Fe, Valencia, Spain
Background: A wide variability in the perioperative management of oral anticoagulation (OAC) has been documented in patients receiving cardiac rhythm management devices (CRMDs). We sought to evaluate the safety and feasibility of a new perioperative strategy consisting in systematically continuing OAC in all patients irrespective of their individual thromboembolic (TE) risk. Methods: A total of 278 consecutive patients on chronic OAC receiving CRMDs were prospectively included. Patients were classified in high and low TE risk according to current guidelines for the perioperative management of antithrombotic therapy, but underwent implantation under active OAC (international normalized ratio 2–4) irrespective of their preoperative TE risk. Bleeding and TE complications were evaluated as well as other procedure-related complications, hospital stays, and the feasibility of outpatient implantations. Results: A total of 117 patients were considered at high TE risk and 161 at low TE risk. Overall, the incidence of pocket hematoma was 2.9% with only three patients requiring pocket revision. Low TE risk patients had a very low incidence of pocket hematoma (1.9%) without needing pocket revision. The mean hospital stay was 1.17 ± 1.8 days and 169 patients (61%) received their CRMD in an outpatient basis, including 77 patients who were implanted with an implantable cardioverter defibrillator. No TE events were detected during the 30-day postimplant observation period in any patient. No other significant complications related with the implant (pneumothorax, hemothorax, cardiac tamponade) were registered. Conclusions: Systematic continuation of OAC in all patients undergoing implantation of CRMDs is safe and feasible, thus simplifying and standardizing the perioperative management in this setting. (PACE 2015; 38:723–730) anticoagulants, pacemakers, thromboembolic risk Introduction The optimal perioperative management of oral anticoagulation (OAC) in patients undergoing implantation of cardiac rhythm management devices (CRMDs) remains controversial. Traditionally, OAC is withheld in patients considered
Conflict of Interest: None declared. ´ Address for reprints: Oscar Cano, M.D., PH.D., Electrophysiology Section, Cardiology Department, Hospital Universitari ´ i Polit`ecnic La Fe, Area de Enfermedades Cardiovasculares, Planta 4-Torre F, Av. Fernando Abril Martorell, 106, 46026, Valencia, Spain., 46026, Valencia, Spain. Fax: 34 96 124 62 38; e-mail: [email protected] Received December 14, 2014; revised January 18, 2015; accepted February 9, 2015. doi: 10.1111/pace.12613
at high thromboembolic (TE) risk and bridging therapy with heparin is administered before and after the procedure,1–9 while OAC is usually stopped without administration of any perioperative heparin in patients considered at low TE risk. Recently, different studies have shown that implantation of CRMDs under active OAC in high TE risk patients is not only safe, but also associated with a lower incidence of pocket bleeding complications when compared with the classic heparin bridging strategy.10–23 In any case, both strategies rely on an adequate classification of patients according to their TE risk and this process may be time consuming and subjected to a great variability depending on the attending physician criteria.24–26 On the other hand, despite being not frequent, TE events associated with complete interruption of OAC in patients considered at low TE risk may
©2015 Wiley Periodicals, Inc. PACE, Vol. 38
June 2015
723
CANO, ET AL.
occur and can be associated with an unacceptable high rate of death or disability.27 Recent data have pointed out a nonnegligible TE risk during short interruptions of OAC in patients undergoing invasive procedures, even in the case of patients considered at low TE risk according to our current criteria.15,19,28,29 Considering the low rate of bleeding complications associated with continuing OAC during implantation of CRMDs and in order to simplify and standardize the perioperative management of OAC in this setting, we sought to evaluate the safety and feasibility of a new perioperative strategy consisting of systematically continuing OAC in all patients irrespective of their TE risk. Methods Consecutive patients under OAC who received a CRMD at our institution from February 2011 to October 2014 were prospectively included in the study. Patients were classified depending on their TE risk following current guidelines for the perioperative management of antithrombotic therapy30 but, finally, all patients underwent CRMD implantation under active OAC systematically irrespective of their preoperative TE risk. The targeted international normalized ratio (INR) at the time of the procedure was set between 2 and 4. Patients with preoperative INR < 2 were excluded. Evaluation of bleeding and TE complications were considered the principal objectives of the study. Other procedure-related complications as well as hospital stays and the feasibility of outpatient implantations were also evaluated. The study was carried out following the institutional guidelines of the Hospital Universitari i Polit`ecnic la Fe and all patients gave informed written consent. Surgical Technique Patients were brought to the operating room in the fasting state and received intravenous prophylactic antibiotics and conscious sedation. All procedures were performed under local anesthesia by the same three experienced implanting physicians (O.C, J.O., and J.E.C). INR was measured in all patients just before surgery. INR values above 4 were considered exclusion criteria for device implantation and the patient was rescheduled for surgery the next day. Venous access was gained by a direct subclavian puncture in all patients undergoing first implantation of a CRMD, and generators were placed in a subcutaneous prepectoral pocket. Bleeding was controlled with electro cautery ± ligatures at the discretion of the implanting physician in order to obtain complete hemostasis. A pressure dressing was applied to the pocket for at least 48 hours after surgery in all cases. All measures employed to obtain adequate hemostasis were consistent throughout the study.
724
Pocket hematoma was defined as a palpable mass protruding at least 2 cm anterior to the pulse generator. Pocket hematoma evacuation was considered in the presence of tense swelling, severe or uncontrollable pain, as well as in cases with progressive growing or not expected to resolve spontaneously. Severe pocket hematoma was defined if one of the following four conditions was present: required surgical evacuation or blood transfusion, prolonged hospital stay, or if a hospital re-admission due to pocket hematoma was necessary. Other implant and postimplant complications were evaluated including TE events, pericardial effusion, pneumothorax, hemothorax, and pocket or system infection. TE events were defined as pulmonary embolism, stroke, transient ischemic attack, and deep vein thrombosis, and were evaluated during the first 30 days after the implant. Inpatients were evaluated 24 hours after the implant and then after 7–10 days in the outpatient clinic. For outpatients, telephonic contact was established 24 hours after the implant and a visit to the outpatient clinic was scheduled if any changes in the pocket were reported. If no changes were noticed they were otherwise evaluated after 7– 10 days in the outpatient clinic. Patients who developed pocket hematoma were followed weekly until total recovery or until reintervention. Minor complains, including pocket pain or bruising, were not taken into consideration in terms of pocket-related complications. Candidates for an outpatient implantation included all patients requiring a generator exchange and asymptomatic or mildly symptomatic patients with a bradycardia indication for pacemaker implantation. Patients implanted with an implantable cardioverter defibrillator (ICD) for primary prevention of sudden cardiac death routinely expended an in-hospital observation period of 24 hours. If no additional stay was necessary beyond the standard 24-hour observation period, those patients were also considered as outpatients. The proportion of patients who were able to receive a pacemaker (PM)/ICD in an outpatient basis was also evaluated. Statistical Analysis Results are reported as mean ± standard deviation or using median as appropriate. Student’s t-test was used for comparison of continuous variables while categorical variables were compared using the χ 2 test or the exact method as appropriate. Independent predictors of pocket hematoma were evaluated by using binary logistic regression. A P value ࣘ0.05 was considered statistically significant. All data were analyzed using SPSS (IBM SPSS Statistics, Version 22.0, Armonk, NY, USA).
June 2015
PACE, Vol. 38
PACEMAKER/ICD IMPLANTATION UNDER ORAL ANTICOAGULATION
Table I. Baseline Characteristics of the Patients by Group Assignment
Age (mean ± SD) Male (n, %) Hypertension (n, %) Diabetes (n, %) Dyslipidemia (n, %) Obesity (n, %) Structural heart disease (n, %) Atrial fibrillation (n, %) Mechanical prostheses (n, %) Previous stroke (n, %) Renal insufficiency (n, %) CHADS2 score (mean ± SD) HAS-BLED score (mean ± SD) Antiplatelet treatment (n, %) Active aspirin Active clopidogrel Active dual antiplatelet treatment
Overall (n = 278)
High TE Risk (n = 117)
Low TE Risk (n = 161)
P Value
71 ± 12 166 (60) 174 (64) 74 (27) 118 (43) 108 (40) 196 (71) 230 (84) 61 (22) 28 (10) 43 (16) 1.89 ± 1.27 1.82 ± 1.05
74 ± 12 68 (58) 90 (77) 55 (47) 59 (50) 45 (39) 100 (86) 94 (80) 49 (42) 21 (18) 25 (21) 2.87 ± 1.20 2.15 ± 0.99
70 ± 12 98 (61) 84 (54) 19 (12) 59 (38) 63 (41) 96 (60) 137 (87) 12 (7.6) 7 (4.5) 18 (12) 1.18 ± 0.75 1.58 ± 1.02
0.004 0.71
Systematic Implantation of Pacemaker/ICDs under Active Oral Anticoagulation Irrespective of Patient’s Individual Preoperative Thromboembolic Risk ´ ´ M.D.,*,† REBECA JIMENEZ, ´ OSCAR CANO, M.D., PH.D.,*,† ANA ANDRES, M.D.,* ´ ´ JOAQUIN OSCA, M.D., PH.D.,* PAU ALONSO, M.D.,*,† YDELISE RODRIGUEZ, M.D.,* ¨ M.D.,* JOSE´ E. CASTRO, M.D.,* MAR´IA-JOSE´ SANCHO-TELLO, M.D.,* JOSE´ OLAGUE, ANTONIO SALVADOR, M.D., PH.D.,* and LUIS MART´INEZ-DOLZ, M.D., PH.D.* From the *Electrophysiology Section, Cardiology Department, Hospital Universitari i Polit`ecnic La Fe, Valencia, Spain; and †Instituto Investigacion ´ Sanitaria La Fe, Valencia, Spain
Background: A wide variability in the perioperative management of oral anticoagulation (OAC) has been documented in patients receiving cardiac rhythm management devices (CRMDs). We sought to evaluate the safety and feasibility of a new perioperative strategy consisting in systematically continuing OAC in all patients irrespective of their individual thromboembolic (TE) risk. Methods: A total of 278 consecutive patients on chronic OAC receiving CRMDs were prospectively included. Patients were classified in high and low TE risk according to current guidelines for the perioperative management of antithrombotic therapy, but underwent implantation under active OAC (international normalized ratio 2–4) irrespective of their preoperative TE risk. Bleeding and TE complications were evaluated as well as other procedure-related complications, hospital stays, and the feasibility of outpatient implantations. Results: A total of 117 patients were considered at high TE risk and 161 at low TE risk. Overall, the incidence of pocket hematoma was 2.9% with only three patients requiring pocket revision. Low TE risk patients had a very low incidence of pocket hematoma (1.9%) without needing pocket revision. The mean hospital stay was 1.17 ± 1.8 days and 169 patients (61%) received their CRMD in an outpatient basis, including 77 patients who were implanted with an implantable cardioverter defibrillator. No TE events were detected during the 30-day postimplant observation period in any patient. No other significant complications related with the implant (pneumothorax, hemothorax, cardiac tamponade) were registered. Conclusions: Systematic continuation of OAC in all patients undergoing implantation of CRMDs is safe and feasible, thus simplifying and standardizing the perioperative management in this setting. (PACE 2015; 38:723–730) anticoagulants, pacemakers, thromboembolic risk Introduction The optimal perioperative management of oral anticoagulation (OAC) in patients undergoing implantation of cardiac rhythm management devices (CRMDs) remains controversial. Traditionally, OAC is withheld in patients considered
Conflict of Interest: None declared. ´ Address for reprints: Oscar Cano, M.D., PH.D., Electrophysiology Section, Cardiology Department, Hospital Universitari ´ i Polit`ecnic La Fe, Area de Enfermedades Cardiovasculares, Planta 4-Torre F, Av. Fernando Abril Martorell, 106, 46026, Valencia, Spain., 46026, Valencia, Spain. Fax: 34 96 124 62 38; e-mail: [email protected] Received December 14, 2014; revised January 18, 2015; accepted February 9, 2015. doi: 10.1111/pace.12613
at high thromboembolic (TE) risk and bridging therapy with heparin is administered before and after the procedure,1–9 while OAC is usually stopped without administration of any perioperative heparin in patients considered at low TE risk. Recently, different studies have shown that implantation of CRMDs under active OAC in high TE risk patients is not only safe, but also associated with a lower incidence of pocket bleeding complications when compared with the classic heparin bridging strategy.10–23 In any case, both strategies rely on an adequate classification of patients according to their TE risk and this process may be time consuming and subjected to a great variability depending on the attending physician criteria.24–26 On the other hand, despite being not frequent, TE events associated with complete interruption of OAC in patients considered at low TE risk may
©2015 Wiley Periodicals, Inc. PACE, Vol. 38
June 2015
723
CANO, ET AL.
occur and can be associated with an unacceptable high rate of death or disability.27 Recent data have pointed out a nonnegligible TE risk during short interruptions of OAC in patients undergoing invasive procedures, even in the case of patients considered at low TE risk according to our current criteria.15,19,28,29 Considering the low rate of bleeding complications associated with continuing OAC during implantation of CRMDs and in order to simplify and standardize the perioperative management of OAC in this setting, we sought to evaluate the safety and feasibility of a new perioperative strategy consisting of systematically continuing OAC in all patients irrespective of their TE risk. Methods Consecutive patients under OAC who received a CRMD at our institution from February 2011 to October 2014 were prospectively included in the study. Patients were classified depending on their TE risk following current guidelines for the perioperative management of antithrombotic therapy30 but, finally, all patients underwent CRMD implantation under active OAC systematically irrespective of their preoperative TE risk. The targeted international normalized ratio (INR) at the time of the procedure was set between 2 and 4. Patients with preoperative INR < 2 were excluded. Evaluation of bleeding and TE complications were considered the principal objectives of the study. Other procedure-related complications as well as hospital stays and the feasibility of outpatient implantations were also evaluated. The study was carried out following the institutional guidelines of the Hospital Universitari i Polit`ecnic la Fe and all patients gave informed written consent. Surgical Technique Patients were brought to the operating room in the fasting state and received intravenous prophylactic antibiotics and conscious sedation. All procedures were performed under local anesthesia by the same three experienced implanting physicians (O.C, J.O., and J.E.C). INR was measured in all patients just before surgery. INR values above 4 were considered exclusion criteria for device implantation and the patient was rescheduled for surgery the next day. Venous access was gained by a direct subclavian puncture in all patients undergoing first implantation of a CRMD, and generators were placed in a subcutaneous prepectoral pocket. Bleeding was controlled with electro cautery ± ligatures at the discretion of the implanting physician in order to obtain complete hemostasis. A pressure dressing was applied to the pocket for at least 48 hours after surgery in all cases. All measures employed to obtain adequate hemostasis were consistent throughout the study.
724
Pocket hematoma was defined as a palpable mass protruding at least 2 cm anterior to the pulse generator. Pocket hematoma evacuation was considered in the presence of tense swelling, severe or uncontrollable pain, as well as in cases with progressive growing or not expected to resolve spontaneously. Severe pocket hematoma was defined if one of the following four conditions was present: required surgical evacuation or blood transfusion, prolonged hospital stay, or if a hospital re-admission due to pocket hematoma was necessary. Other implant and postimplant complications were evaluated including TE events, pericardial effusion, pneumothorax, hemothorax, and pocket or system infection. TE events were defined as pulmonary embolism, stroke, transient ischemic attack, and deep vein thrombosis, and were evaluated during the first 30 days after the implant. Inpatients were evaluated 24 hours after the implant and then after 7–10 days in the outpatient clinic. For outpatients, telephonic contact was established 24 hours after the implant and a visit to the outpatient clinic was scheduled if any changes in the pocket were reported. If no changes were noticed they were otherwise evaluated after 7– 10 days in the outpatient clinic. Patients who developed pocket hematoma were followed weekly until total recovery or until reintervention. Minor complains, including pocket pain or bruising, were not taken into consideration in terms of pocket-related complications. Candidates for an outpatient implantation included all patients requiring a generator exchange and asymptomatic or mildly symptomatic patients with a bradycardia indication for pacemaker implantation. Patients implanted with an implantable cardioverter defibrillator (ICD) for primary prevention of sudden cardiac death routinely expended an in-hospital observation period of 24 hours. If no additional stay was necessary beyond the standard 24-hour observation period, those patients were also considered as outpatients. The proportion of patients who were able to receive a pacemaker (PM)/ICD in an outpatient basis was also evaluated. Statistical Analysis Results are reported as mean ± standard deviation or using median as appropriate. Student’s t-test was used for comparison of continuous variables while categorical variables were compared using the χ 2 test or the exact method as appropriate. Independent predictors of pocket hematoma were evaluated by using binary logistic regression. A P value ࣘ0.05 was considered statistically significant. All data were analyzed using SPSS (IBM SPSS Statistics, Version 22.0, Armonk, NY, USA).
June 2015
PACE, Vol. 38
PACEMAKER/ICD IMPLANTATION UNDER ORAL ANTICOAGULATION
Table I. Baseline Characteristics of the Patients by Group Assignment
Age (mean ± SD) Male (n, %) Hypertension (n, %) Diabetes (n, %) Dyslipidemia (n, %) Obesity (n, %) Structural heart disease (n, %) Atrial fibrillation (n, %) Mechanical prostheses (n, %) Previous stroke (n, %) Renal insufficiency (n, %) CHADS2 score (mean ± SD) HAS-BLED score (mean ± SD) Antiplatelet treatment (n, %) Active aspirin Active clopidogrel Active dual antiplatelet treatment
Overall (n = 278)
High TE Risk (n = 117)
Low TE Risk (n = 161)
P Value
71 ± 12 166 (60) 174 (64) 74 (27) 118 (43) 108 (40) 196 (71) 230 (84) 61 (22) 28 (10) 43 (16) 1.89 ± 1.27 1.82 ± 1.05
74 ± 12 68 (58) 90 (77) 55 (47) 59 (50) 45 (39) 100 (86) 94 (80) 49 (42) 21 (18) 25 (21) 2.87 ± 1.20 2.15 ± 0.99
70 ± 12 98 (61) 84 (54) 19 (12) 59 (38) 63 (41) 96 (60) 137 (87) 12 (7.6) 7 (4.5) 18 (12) 1.18 ± 0.75 1.58 ± 1.02
0.004 0.71
![[Bleeding complications under oral anticoagulation].](/assets/img/hold.png)
